louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03458065: T-ICD vs S-ICD Shocks: Myocardial Injuries
Official title: Myocardial Injuries and Hemodynamic Stress Biomarkers: a Comparison Between Transvenous and Subcutaneous ICD Shock
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ICD Shock Myocardial Injuries
Lead sponsor: Monaldi Hospital
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who met the criteria for ICD implantation according to the current guidelines

Brief summary: Implantable cardioverter defibrillator (ICD) shocks are associated with a subsequent increased risk of death, and an elevation of cardiac enzymes has been measured after defibrillation testing (DFT). The aim of our study was to investigate the association between S-ICD vs T-ICD shocks and acute cardiac damage in humans, as evaluated by means of sensitive and highly specific circulating biomarkers


Eligibility criteria: Inclusion Criteria:

patients who met the criteria for ICD implantation according to the current guidelines

Exclusion Criteria:

-

Primary outcomes:
measure: myocardial micro-damage
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Monaldi Hospital
Study officials:
References:
Clinical trial NCT06334926: BMI and Lymph Node Count in Colorectal Cancer
Official title: Prediction of Survival in Colorectal Cancer Patients on the Basis of Body Mass Index and Lymph Node Yield - a Retrospective Single Center Cohort Analysis Over a Quarter of a Century
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Aim of This Study is to Determine the Influence of BMI and Lymph Node Status on OS in CRC Patients in the Long Term
Keywords: colorectal cancer, survival, prognostic factors, body mass index, obesity paradox, lymph node count
Lead sponsor: Klinikum Floridsdorf
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
name: Klinik Favoriten
name: Salzkammergut Klinikum Vöcklabruck
First posted: 2024-03-28
Enrollment: 1192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had surgery at the department of surgery at the Klinik Favoriten between 1998 and 2011 were analyzed. 1192 patients met the inclusion criteria were therefore pseudonymized and recorded in a newly developed database.

Brief summary: Background and aim: Colorectal Cancer (CRC) is one of the most frequent cancer entities in the western world. It is known that obesity is one of the major risk factors for CRC. In contrast, mild obesity seems to have a positive effect on postoperative outcome, which is known as the "obesity paradox". Also, the number of resected lymph nodes (LN) during surgery is very important for correct staging. The aim of the present project is to evaluate the impact of BMI and LN-yield on long term overall survival (OS) of CRC patients treated with curative intent.

Methods: Patients treated for CRC between 1998 and 2011 at the Klinik Favoriten in Vienna, Austria were analyzed in this retrospective single-center cohort analysis concerning OS.


Eligibility criteria: Inclusion Criteria:

* colorectal carcinoma
* treated at the Klinik Favoriten between 1998 and 2011
* elective or acute surgical setting
* curative intent
* older than 18 years

Exclusion Criteria:

* other carcinoma (anal, metastases, ...)
* treated before 1998 or after 2011
* palliative intent
* younger than 18 years

Primary outcomes:
measure: overall survival
timeFrame: median follow up of 11.3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Klinik Floridsdorf
Study officials:
affiliation: Klinik Floridsdorf
name: Tamara Braunschmid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00455026: Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia
Official title: Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depth of Anaesthesia
Lead sponsor: Melbourne Health
Sponsor class: OTHER
Collaborators: name: Biopharmica Limited
First posted: 2007-04-03
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Current cortical EEG based depth of anaesthesia monitors do not accurately reflect the effect of opioid drugs. We have developed a new theoretically-based method of analysing the EEG. Our hypothesis is that this new method will more accurately predict depth of anaesthesia than the Bispectral Index (BIS) monitor in patients having elective surgery.

Detailed description: Patients aged 18-60 years presenting for elective surgery under general anaesthesia will be recruited. They will be randomised to receive remifentanil effect-site target 0, 2 or 4 ng/ml. Then anaesthesia will be induced with propofol. Loss of the eyelash reflex, response to command and response to electrical stimulation will be measured. The raw EEG will be recorded and analysed off-line using our new method and also for BIS values. Anaesthesia will then proceed according to the needs of the patient and the surgery.

Eligibility criteria: Inclusion Criteria:

* Male and female patients, aged 18-60 years, of ASA physical status 1-3, presenting for elective surgery under general anaesthesia

Exclusion Criteria:

* Inadequate English comprehension due to a language barrier, cognitive deficit or intellectual disability
* Epilepsy or other EEG abnormality
* Prescription or illicit drugs known to affect the EEG

Primary outcomes:
measure: Prediction probability for prediction of anaesthetic endpoints
timeFrame: During induction of anaesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Hawthorn
country: Australia
facility: Swinburne University
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: Melbourne Health
name: Kate Leslie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00728026: Autonomic Profiles in Pediatric Patients With Cyclic Vomiting Syndrome (CVS), Irritable Bowel Syndrome (IBS),Postural Orthostatic Tachycardia Syndrome (POTS), Functional Abdominal Pain (FAP) or Chronic Nausea
Official title: Autonomic Profiles in Pediatric Patients With Cyclic Vomiting Syndrome, Irritable Bowel Syndrome, Postural Orthostatic Tachycardia Syndrome, Functional Abdominal Pain or Chronic Nausea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vomiting Syndrome
Irritable Bowel Syndrome
Postural Orthostatic Tachycardia Syndrome
Abdominal Pain
Chronic Nausea
Keywords: Chart must reveal the following procedures:
Heart rate variability,
Deep Breathing Test,
Valsalva maneuver,
Table test,
Thermoregulatory Sweat Testing,
Quantitative Sudomotor Axon Reflex Test (QSART),
Vital signs,
postural changes in heart rate and blood pressure,
composite autonomic score
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Children's Hospital and Health System Foundation, Wisconsin
First posted: 2008-08-05
Enrollment: 19
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of either: Cyclic Vomiting Syndrome (CVS), Irritable Bowel Syndrome (IBS), Chronic nausea, Postural Orthostatic Tachycardia Syndrome (POTS), Functional Abdominal Pain (FAP)

Brief summary: Retrospectively review the charts of all children who had heart rate variability, deep breathing test, valsalva maneuver, tilt table test, thermoregulatory sweat testing, quantitative sudomotor axon reflex test (QSART) completed and were cared for at Children's Hospital of Wisconsin.


Eligibility criteria: Inclusion Criteria:

* Outpatient services

Exclusion Criteria:

* Inpatient services

Primary outcomes:
measure: To gather preliminary data to characterize autonomic function in children and adolescents with functional gastrointestinal disorders.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical College of Wiconsin
name: B UK Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02219126: Effect of Homogenization and Pasteurization of Milk on the Stomach Problems in Adults
Official title: Effect of Homogenization and Pasteurization of Milk on the Stomach Problems in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unidentified Stomach Discomfort Following Dairy Consumption
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to investigate differences in digestion rates and stomach problems caused by pasteurized and homogenized milk compared with raw milk in healthy adults by ingestible capsule that measures pH and pressure, diary of symptoms, blood glucose and triacylglycerol levels and plasma cytokine levels.


Eligibility criteria: Inclusion Criteria:

* Homogenized and pasteurized milk causes stomach problems (self-reported)
* unhomogenized and unpasteurized milk does not cause stomach problems (self-reported)
* age 18-65
* BMI 18,5 - 30
* hemoglobin under normal range
* fasting plasma alanine aminotransferase ALAT \< 60 U/l (normal liver function)
* fasting plasma thyroid-stimulating hormone (TSH) 0.4 - 4.5 mU/l (normal thyroid function)
* fasting plasma creatinine \< 118 umol/l (normal kidney function)

Exclusion Criteria:

* pace maker
* Crohn's disease or other disease of the intestinal tract
* intestinal operation within the last 3 months
* difficult dysphagia
* smoking
* constipation

Primary outcomes:
measure: Pressure in the intestinal tract
timeFrame: Day 0 - Day 5
measure: Gastrointestinal symptoms (self-reported)
timeFrame: Day 0 - Day 5
Secondary outcomes:
measure: Plasma triacylglycerols
timeFrame: 20min, 40min, 60min, 120min, 180min, 240min
measure: Plasma glucose
timeFrame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
measure: Plasma triacylglycerols
timeFrame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
measure: Plasma insulin
timeFrame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Department of Biochemistry University of Turku
Study officials:
affiliation: University of Turku
name: Kaisa M Linderborg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01563926: Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency
Official title: An Open, Multi-Centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin Simplexx™ in Children With GH Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Hormone Disorder
Growth Hormone Deficiency in Children
Genetic Disorder
Turner Syndrome
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-27
Enrollment: 168
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of this trial is to evaluate the new liquid somatropin formulation in children with growth hormone deficiency.


Eligibility criteria: Inclusion Criteria:

* Written Informed Consent by patient and/or guardian/parents
* Patients with one of the following diagnosis: Growth failure due to growth hormone deficiency (GHD), Turner syndrome, or growth retardation in children with chronic renal disorders
* Patients who are willing to inject themselves and answer questionnaires or young patients whose parents/guardian are willing to inject their child and answer questionnaires
* Patients on growth hormone therapy for at least 6 weeks before entering the trial

Exclusion Criteria:

* Pregnancy or breast feeding women
* Suspected or known allergy to trial product
* Other daily injection therapy (non-growth hormone, e.g insulin-therapy)
* Participating in any other trial involving other investigational products within the last 3 months

Primary outcomes:
measure: Patient acceptance of the new liquid growth hormone formulation
Secondary outcomes:
measure: Number of Adverse Events (AE)
measure: Number of Serious Adverse Events (SAE)
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Novo Nordisk Investigational Site
city: Beer Sheva
country: Israel
facility: Novo Nordisk Investigational Site
city: Jerusalem
country: Israel
facility: Novo Nordisk Investigational Site
city: Petah Tikva
country: Israel
facility: Novo Nordisk Investigational Site
city: Rehovot
country: Israel
facility: Novo Nordisk Investigational Site
city: Tel - Aviv
country: Israel
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02865226: Comparison of the Clinical Efficacy of 2 Paravertebral Block Strategies in Thoracic Surgery by Thoracotomy: by the Anesthetist (Paravertebral Block Guided by Ultrasound) and by the Thoracic Surgeon (Paravertebral Block Visual)
Official title: Comparison of the Clinical Efficacy of 2 Paravertebral Block Strategies in Thoracic Surgery by Thoracotomy: : by the Anesthetist (Paravertebral Block Guided by Ultrasound) and by the Thoracic Surgeon (Paravertebral Block Visual)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: thoracic surgery
thoracotomy
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Post-thoracotomy pain is one of the most severe. The local analgesia allows its effective control and a reduction of postoperative morbidity and mortality.

The gold standard for local analgesia is the thoracic epidural. However, this technique can be dangerous with severe complications.

The paravertebral block showed comparable efficacy to the thoracic epidural for local analgesia . In addition, it has a better safety profile. There are several installation techniques. The difference in efficiency of these laying techniques is unknown.

Detailed description: Compare the clinical effectiveness of two strategies of realization of paravertebral block: by the anesthetist before incision (paravertebral block guided by ultrasound) and by the thoracic surgeon at chest closure (paravertebral block visual).

Eligibility criteria: Inclusion Criteria:

* patient with thoracotomy indication for segmentectomy (s), lobectomy (s) lung or pulmonary wedge resection
* patient consenting to participate to the study
* patient enrolled in the national healthcare insurance program
* patient older than 18 years

Exclusion Criteria:

* patient with neuropathy
* patient with body mass index superior to 35 kg/m2
* patient with contraindication for paravertebral block or local analgesia

Primary outcomes:
measure: pain
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu de Reims
Study officials:
References:
Clinical trial NCT01753726: Diaphragm Stretching Increases Spine and Thoracic Mobility
Official title: Diaphragm Stretching Technique Increases Spine Mobility and Thoracic Movement: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: stretching, diaphragm, spinal movement, thoracic movement
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2012-12-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Physical therapists have traditionally included various forms of manual therapy among the therapeutic approaches to spinal pathologies. The aim of this study was to evaluate the effect of diaphragmatic stretching on spine and thoracic movement in healthy adults.

Detailed description: Spinal pain is a well recognized condition associated with significant personal and community burdens. Recent studies estimated the prevalence between 6 and 22% in neck pain, from 4-72% in thoracic pain and from 1.0% to 58.1% in low back pain, which increases with age. During the last decades numerous researches have been conducted on stretching effects, evidencing an increased muscle control, flexibility and range of motion. The main purpose of this investigation is to examine the effects of diaphragm stretching in spine and thoracic mobility in healthy subjects in order to apply the results in a specifics pathologies in future studies.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Age: between 18 and 65 years old.

Exclusion Criteria:

* Pathological subjects

Primary outcomes:
measure: Assessment of lumbar mobility
timeFrame: up to 2 months
Secondary outcomes:
measure: Assessment of trunk mobility
timeFrame: baseline, 2 months
measure: Cervical mobility
timeFrame: baseline, 2 months.
measure: Abdominal and Thoracic Dimensions and Kinematics
timeFrame: baseline, 2 months.
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Faculty of Health Sciences. University of Granada.
Study officials:
affiliation: Department of Physical Therapy. University of Granada.
name: M. Carmen Valenza, PH MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gonzalez-Alvarez FJ, Valenza MC, Torres-Sanchez I, Cabrera-Martos I, Rodriguez-Torres J, Castellote-Caballero Y. Effects of diaphragm stretching on posterior chain muscle kinematics and rib cage and abdominal excursion: a randomized controlled trial. Braz J Phys Ther. 2016 Jun 16;20(5):405-411. doi: 10.1590/bjpt-rbf.2014.0169.
Clinical trial NCT04699526: Evaluation of Universal Prevention Curriculum for Schools in Peru
Official title: Evaluation of Universal Prevention Curriculum for Schools in Peru
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Lead sponsor: HBSA
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 27012
Sex: ALL
Minimum age (years): 11
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized controlled trial was conducted to evaluate a universal prevention curriculum (UPC) training for Peruvian school administrators and teachers to reduce substance use among students. Twenty-eight schools were randomly assigned to intervention and control conditions (14 per condition). Substance use outcomes were assessed with repeated cross-sectional samples of students in 2018 and 2019. Multi-level analyses were conducted to assess intervention effects on students' substance use and related problems.

Detailed description: This randomized controlled trial was conducted to evaluate a universal prevention curriculum (UPC) training for Peruvian school administrators and teachers to reduce substance use among students. Twenty-eight schools were randomly assigned to intervention and control conditions (14 per condition). Prevention leadership action teams were formed at intervention schools to implement evidence-based school policies and positive school climate activities, and a classroom substance use prevention curriculum. Substance use outcomes were assessed with repeated cross-sectional samples of students in 2018 and 2019. Multi-level analyses were conducted to assess intervention effects on students' substance use and related problems.

Eligibility criteria: Inclusion Criteria:

* Students in participating schools aged 11 to 19

Exclusion Criteria:

* Not attending participating schools

Primary outcomes:
measure: Cigarette smoking
timeFrame: 1 year
measure: Alcohol use
timeFrame: 1 year
measure: Heavy drinking
timeFrame: 1 year
measure: Marijuana use
timeFrame: 1 year
measure: Other drug use
timeFrame: 1 year
measure: Problems
timeFrame: 1 year
measure: Friends' substance use
timeFrame: 1 year
measure: Awareness of school policies
timeFrame: 1 year
measure: School bonding
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Prevention Research Center
state: California
Study officials:
affiliation: HBSA
name: Mallie J Paschall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04782726: Radiation Therapy Plan Quality Improvement Using Ideal Theoretical Isodose Distribution
Official title: Radiation Therapy Plan Quality Improvement Using Ideal Theoretical Isodose Distribution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Neoplasms
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The researchers hope that based on the study findings future patients may benefit from a more precise radiation treatment plan that can be developed more quickly and thus decrease the time from Computerized Tomography Simulation to start of treatment.

Detailed description: As part of this study participants will receive the standard of care treatment for all head and neck cancer patients. The researchers plan to use a software program to see if it will assist in developing the best radiation treatment plan possible. The researchers will also measure the quality of each treatment plan so areas of improvement can be identified.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Ability to provide informed written consent in either English or Spanish.
* Patient planned to undergo radiation therapy for Head and Neck Cancer.

Exclusion Criteria:

* Current pregnancy, as this is a contraindication to receiving radiation therapy.
* History of prior radiotherapy to the head and neck.
* Any condition or history as evidenced by patient record and/or self-report that, in the opinion of the investigator, would interfere with adherence to daily radiation therapy.

Primary outcomes:
measure: Mean radiation dose to Organs at Risk (OAR)
timeFrame: Baseline to last treatment (up to 33 treatments or about 7 weeks)
measure: Maximum radiation dose to Organs at Risk (OAR)
timeFrame: Baseline to last treatment (up to 33 treatments or about 7 weeks)
Secondary outcomes:
measure: Time required to plan radiation therapy dose
timeFrame: CT Simulation to first treatment (about 1 week)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Mays Cancer Center
state: Texas
Study officials:
affiliation: UT Health San Antonio
name: Sotirios Stathakis, PhD
role: PRINCIPAL_INVESTIGATOR
References: