louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04097249: Infrared Thermography for the Diagnosis of Musculoskeletal Pain
Official title: The Contribution and Validity of Infrared Thermography in the Diagnosis of Musculoskeletal Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Pain
Temperature Change, Body
Keywords: Musculoskeletal pain
Delayed Onset Muscle Soreness
Pain sensitivity
Infrared thermography
Referred pain
Lead sponsor: Universidad San Jorge
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with no acute pain, chronic pain or other medical disorders relevant to this study.

Brief summary: This study sought to evaluate the vasomotor response in the pain referral area of healthy individuals, performing the same procedure with and without the experience of delayed onset muscle soreness.

Detailed description: Validity of infrared thermography for properly diagnosing musculoskeletal pain and their clinical applicability is lacking. This study investigates temperature changes on the upper extremity before and after a suprathreshold stimulation (painful stimulus) with a digital algometer over the infraspinatus muscle. The same procedure is performed in two consecutive days, 24 hours apart (Day-1 and Day-2). At the end of Day-1, an eccentric exercise is performed in order to to induce delayed onset muscle soreness on the external rotators of the shoulder.

Eligibility criteria: Inclusion Criteria:

* Being healthy and free from any pain specific to the upper limbs and/or in general.

Exclusion Criteria:

* Previous history of chronic pain.
* Any systemic diseases or regional pathology which can interfere with the outcome measures.

Primary outcomes:
measure: Changes in temperature of pixels on the upper extremity: infrared thermography
timeFrame: Day-1 (baseline assessment, pre exercise before painful stimulus), Day-1 (baseline assessment, pre exercise after painful stimulus), Day-2 (24 hours post-exercise before painful stimulus), Day-2 (24 hours post-exercise after painful stimulus)
Secondary outcomes:
measure: Changes in Pressure Pain Thresholds: pressure algometry
timeFrame: Day-1 (baseline assessment, pre exercise before painful stimulus), Day-2 (24 hours post-exercise before painful stimulus)
Other outcomes:
Locations:
Study officials:
affiliation: Universidad San Jorge
name: Pablo Herrero, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05256849: Treatment of Humeral Fractures With Long PHILOS Plates Using a Modified Technique and Approach Avoids Radial Nerve Palsy
Official title: Treatment of Humeral Fractures With Long PHILOS Plates Using a Modified Technique and Approach Avoids Radial Nerve Palsy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Humeral Fracture
Keywords: PHILOS plate
minimal invasive plate osteosynthesis (MIPO)
radial paralysis
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients aged 18 and over who underwent surgery at the University Hospital Basel between 06/2010 and 12/2020 for a proximal humeral shaft fracture

Brief summary: Radial paralysis is a well-known complication of plate osteosynthesis on the humeral shaft. At the University Hospital Basel, these fractures have been treated in an adapted procedure with long PHILOS plates using a modified technique and approach. This study is to retrospectively analyze the effectiveness of the surgical technique in relation to iatrogenic radial paralysis.

Detailed description: Radial paralysis is a well-known complication of plate osteosynthesis on the humeral shaft. With regard to surgical treatment, there are major differences in terms of surgical access and implant selection. At the University Hospital Basel, these fractures have been treated in an adapted procedure for about 10 years. A long Philosplatte (Synthes company) is inserted from the proximal end via a deltoido-pectoral approach. This is a minimally invasive procedure (MIPO = minimally invasive plate osteosynthesis). The standard implant is first twisted distally by approx. 45°-90° and then lies anterior to the humerus. The distal screws can then be filled via anterior stab incisions. This adapted surgical technique is adapted to the anatomical course of the radial nerve. This ensures a safe distance from the plate/access to the nerve. The nerve does not have to be explored openly and the distal row of screws can be used minimally invasively via stab incisions. This study is to retrospectively analyze the effectiveness of the surgical technique in relation to iatrogenic radial paralysis.

Eligibility criteria: Inclusion Criteria:

* surgery at the University Hospital Basel between 06/2010 and 12/2020 for a proximal humeral shaft fracture

Exclusion Criteria:

* Patients with a documented rejection

Primary outcomes:
measure: descriptive statistical analysis of datasets from patients treated with the adapted surgical technique
timeFrame: one time assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Orthopedics and Traumatology
Study officials:
affiliation: University Hospital Basel, Clinic for Orthopedics and Traumatology
name: Daniel Rikli, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06603649: Evaluation of Updated Procedure for Management of Refractory Out-of-hospital Cardiac Arrests
Official title: Evaluation of the Updated Procedure for the Management of Refractory Out-of-hospital Cardiac Arrests with SAMU 54 : the Revised ACEP Protocol in 02/2024
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Arrest, Out-Of-Hospital
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting with refractory out-of-hospital cardiac arrest and enrolled in the ECPR program in Nancy, France.

Inclusion criteria for the ECPR program are the following:

* Age: 18-65 years
* No major comorbidity
* Witnessed non traumatic cardiac arrest
* Low-flow to ECPR estimated of less than 60 minutes

Brief summary: ECPR is a technique that has been rapidly developed in many cardiac arrest specialized centers In 2013, a specific management protocol was developed for patients in refractory out-of-hospital cardiac arrest around Nancy, France. To select patients with the best prognosis, the inclusion criteria defined were strict. This led to an over-selection of patients and a significant reduction in the number of eligible patients. A balance needed to be struck between over-selecting patients and maintaining the expertise of medical and paramedical teams in the field. In addition, it has also been shown that ECPR also increases the number of organs and transplants.

In February 2024, the criteria for inclusion in the protocol were redefined to include any witnessed non-traumatic cardiac arrest, whatever the initial rhythm. This simplification should enable more patients to be included in the procedure.

The aim of the study is to assess the patient's outcome


Eligibility criteria: Inclusion Criteria:

* Out-of-hospital cardiac arrest
* enrolled in the ECPR program
* 18 years old or more
* Low-flow estimated \<60minutes

Exclusion Criteria:

* traumatic cardiac arrest
* major comorbidities

Primary outcomes:
measure: Survival
timeFrame: 90 days after cardiac arrest
Secondary outcomes:
measure: Delays
timeFrame: From event to implementation of ECMO, in minutes, Up to 180 minutes
measure: Neurological outcome
timeFrame: 30 days and 90 days after cardiac arrest
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU
Study officials:
References:
Clinical trial NCT06517849: Beliefs About Mental Health Treatment - Gambling Addiction Study in Colorado
Official title: The Stanford Gambling Addiction Therapy Study (SGATS) in Colorado
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gambling Disorder
Gambling Problem
Mental Health Issue
Keywords: Beliefs
Bias
Incentive
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Kindbridge Research Institute
First posted: 2024-07-24
Enrollment: 375
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants in the control group will take two (paid) surveys and have access to free cognitive behavioral therapy (CBT). Participants in the treatment group will be offered an additional payment (in the form of gift cards) to undergo a certain number of CBT sessions with Kindbridge Behavioral Health.
Primary purpose: OTHER

Brief summary: Many people with mental health conditions do not seek treatment, and it is unclear what exactly prevents people from taking up treatment. The goal of this interventional study is to learn about how people think about cognitive behavioral therapy (CBT) for gambling disorders. The main questions it aims to answer are:

* Do people have incorrect beliefs about the net benefits of CBT? If yes, which beliefs are those, and how much do people underestimate or overestimate the benefits?
* Is a small monetary incentive (that participants receive conditional on trying out CBT) helpful in increasing take-up of CBT?

Apart from these questions, the researchers will also study how well CBT works to treat gambling disorders.

Participants will be asked to complete two surveys over four months and might be offered a modest monetary incentive for doing (free) CBT if they are in the treatment group. Researchers will compare that treatment group to a control group. Participants in the control group will have access to free CBT and do the same two surveys as those in the treatment group, but will not receive the monetary incentive.


Eligibility criteria: Inclusion Criteria:

* must reside in Colorado
* must be English-speaking

Exclusion Criteria:

* does not reside in Colorado
* is not English-speaking

Primary outcomes:
measure: Change in Willingness to Pay for CBT
timeFrame: Baseline and 4 months
measure: Change in Beliefs about CBT
timeFrame: Baseline and 4 months
measure: Attendance of CBT sessions
timeFrame: 4 months
measure: Change in Gambling Consumption
timeFrame: Baseline and 4 months
measure: Change in Subjective Well-Being
timeFrame: Baseline and 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Sarah Bogl
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Matt Brown
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Mariana Guido
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Nick Grasley
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03475849: Effects of Gastric Bypass Surgery on Bile Acid Homeostasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Roux-en-Y Gastric Bypass Surgery
Bile Acid Circulation
Obesity
Bariatric Surgery
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2018-03-23
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are recruited from the population undergoing gastric bypass surgery at Hvidovre Hospital (Denmark) Controls are recruited from www.forsoegsperson.dk (Danish webpage for recruitment of trial persons). Controls are recruited by advertisement.

Brief summary: The purpose of this study is to determine whether the bile acid circulation is changed after gastric bypass surgery. Further, to account for how the changed anatomy of the gut influences how the bile acid and food is mixed in the gut and how this is associated with the changes in gut hormone release after the surgery.

Our hypothesis is that bile acid reabsorption from the gut is increased as animal models suggest so and bile acid blood concentration increases after surgery.


Eligibility criteria: Inclusion Criteria:

* Age between 25 and 65 years
* For patients: uncomplicated Roux-en-Y Gastric Bypass surgery more than 12 months before study initiation
* For controls: Age, BMI and gender matched with patient group

Exclusion Criteria:

* Previous removal of gall bladder or other abdominal surgeries except appendectomy (and gastric bypass surgery for patient group)
* Known liver disease or thyroid disease requiring antithyroid medication
* Chronic gastrointestinal symptoms
* Any chronic disease interfering with, or susceptive of interfering with appetite or gastrointestinal function
* Any medication interfering with, or susceptive of interfering with appetite or gastrointestinal function
* Smoking within the last month
* Alcohol consumption above 168 grams per week
* Currently pregnant or breast-feeding
* Anaemia with haemoglobin \<6,5 mmol/L (\<117 mg/dl)
* Loss or gain of more than 3 kg within the last 3 months

Primary outcomes:
measure: Differences in time from food intake to mix of food in the gut with bile acid between patients and controls
timeFrame: Patients: >12 months after Gastric Bypass Surgery
measure: Percentage of orally ingested exogenic bile acid that is retained in the body after 7 days
timeFrame: Patients: >12 months after Gastric Bypass Surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Department of Endocrinology at Hvidovre University Hospital
state: Copenhagen
Study officials:
References:
Clinical trial NCT01590849: Assessment of Autonomic Tone in Normotensive Women Using Combined Hormonal Oral Contraceptive Containing Drospirenone
Official title: Assessment of Autonomic Tone in Normotensive Women Using Combined Hormonal Oral Contraceptive Containing Drospirenone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Contraceptive Affecting the Autonomic Nervous System
Contraceptive Affecting Blood Pressure
Keywords: contraceptive agents
autonomic nervous system
blood pressure
risk
Lead sponsor: Instituto do Coracao
Sponsor class: OTHER_GOV
First posted: 2012-05-03
Enrollment: 69
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The use of combined oral contraceptives has been associated with increased risk of adverse cardiovascular events. The exact mechanism by which these drugs exert this influence is uncertain. It is possible that changes in autonomic nervous system are involved. The objective of these study was to evaluate the effect of the use of a contraceptive containing 20 mcg of ethinyl estradiol and 3mg of drospirenone in the autonomic nervous system in healthy women. Few studies have been conducted in the field of hormonal contraception and evaluation of the autonomic nervous system work and no prospective, controlled study was published so far. These study will be the first.


Eligibility criteria: Inclusion Criteria:

* 20 to 40 years old
* no use of hormonal contraceptives for at least 6 months before the study
* need for contraceptive method
* willingness to participate in the study

Exclusion Criteria:

* positive pregnancy test
* category 3 or 4 classification on WHO's Medical Eligibility Criteria for Contraceptive
* smoking
* obesity
* fasting glucose above 100 mg/dL
* abnormalities in lipid profile
* use of other medications

Primary outcomes:
measure: combined hormonal oral contraceptive with drospirenone and its influence on the autonomic nervous system
timeFrame: six months after the intervention
Secondary outcomes:
measure: combined hormonal oral contraceptive with drospirenone and its influence on blood pressure
timeFrame: six month after the intervention
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Marcelo Gil Nisenbaum
state: São Paulo
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Marcelo G Nisenbaum
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carter JR, Klein JC, Schwartz CE. Effects of oral contraceptives on sympathetic nerve activity during orthostatic stress in young, healthy women. Am J Physiol Regul Integr Comp Physiol. 2010 Jan;298(1):R9-R14. doi: 10.1152/ajpregu.00554.2009. Epub 2009 Oct 14.
citation: Minson CT, Halliwill JR, Young TM, Joyner MJ. Sympathetic activity and baroreflex sensitivity in young women taking oral contraceptives. Circulation. 2000 Sep 26;102(13):1473-6. doi: 10.1161/01.cir.102.13.1473.
Clinical trial NCT02863549: MitraClip for Severe TR
Official title: Transcatheter Treatment of Severe Tricuspid Regurgitation Using the MitraClip System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tricuspid Regurgitation
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the procedural feasibility and 30-day results of transcatheter tricuspid valve repair using the MitraClip® system (Abbott Vascular) in selected, highly symptomatic patients with severe tricuspid regurgitation (TR).

Detailed description: The primary objectives of this prospective analysis were to determine the feasibility in terms of success rate and short-term clinical follow-up at 30 days. In this context procedural success was defined as reduction of at least one TR grade. At 30-days after the procedure, a clinical follow up was performed in the heart failure outpatient clinic of our department including transthoracic echocardiography for the evaluation of TR grades. Furthermore, the investigators determined NYHA functional class and the incidence of major adverse cardiac and cerebrovascular events (MACCE).

Secondary objectives were the assessment of right ventricular function, the 6-minute walk distance, NT-proBNP as well as quality of life as assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) score at 30-days follow up.

Eligibility criteria: Inclusion Criteria:

* right-sided heart failure due to moderate-to-severe tricuspid regurgitation
* patients deemed inoperable by the heart Team

Exclusion Criteria:

* poor Echo-image quality

Primary outcomes:
measure: TR grade, Echo (grade 0-4)
timeFrame: 1-12 months
measure: MACCE
timeFrame: 1-12 months
Secondary outcomes:
measure: NYHA status
timeFrame: 1-12 months
measure: 6 Minute walk distance
timeFrame: 1-12 months
measure: NT-proBNP
timeFrame: 1-12 months
measure: MLHFQ
timeFrame: 1-12 months
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinikum Großhadern University Hospital
state: Bavaria
Study officials:
affiliation: Klinikum der Universität München
name: Daniel Braun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02166749: Clinical Follow up After Subtotal and Total Hysterectomy
Official title: Ultra Long-term Follow-up of the Outcome After Subtotal Versus Total Abdominal Hysterectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Hysterectomy (& Wertheim)
Keywords: Hysterectomy, long term follow up, subjective outcome
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2014-06-18
Enrollment: 212
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population included 212 patients operated on during February 1978 and May 1979 in Turku University Hospital. 107 women underwent subtotal and 105 women total abdominal hysterectomy.

Brief summary: The purpose of this study was to find out subjective and objective outcomes of patients undergoing subtotal or total abdominal hysterectomy during a follow up of a mean 33 years after the operation. The hypothesis is that there are similar outcomes after both types of operations.

Detailed description: Objective: To evaluate ultra long-term follow-up after subtotal and total hysterectomy in patients operated on during 1978-1979 in Turku University Hospital, Finland.

Methods: From the original cohort of 212 patients 193 were sent a postal questionnaire in 1997 to find out possible symptoms related to hysterectomy. Again in 2011 a questionnaire based evaluation with a possibility of a clinical visit to study hospital was done for 153 patients. In the first evaluation a self-made questionnaire and in the second evaluation validated questionnaires were used. During a follow-up visit a clinical examination using also POP-Q-system was done. Additionally, hospital records of the patients were reviewed to find out subsequent operations after hysterectomy.

Eligibility criteria: Inclusion Criteria:

* benign indication for hysterectomy

Exclusion Criteria:

* abnormal Pap smear

Primary outcomes:
measure: Number of participants having subjective symptoms after hysterectomy
timeFrame: 19 years and 33 years postoperatively
Secondary outcomes:
measure: Objective evaluation of pelvic organ prolapse after hysterectomy
timeFrame: 33 years postoperatively
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Department of Obstetrics and Gynecology, Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Juha Mäkinen, Professor
role: STUDY_DIRECTOR
References:
citation: Ala-Nissila S, Haarala M, Jarvenpaa T, Makinen J. Long-term follow-up of the outcome of supracervical versus total abdominal hysterectomy. Int Urogynecol J. 2017 Feb;28(2):299-306. doi: 10.1007/s00192-016-3143-0. Epub 2016 Sep 17.