louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00398242: Treatment of Stable Both-Bone Midshaft Forearm Fractures in Children
Official title: Treatment of Stable Both-Bone Midshaft Forearm Fractures in Children: A Randomized Trial Between Treatment With Above Elbow Cast and a Combination of Above- and Below Elbow Armcast.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture
Forearm
Midshaft
Child
Treatment
Keywords: fracture
forearm
midshaft
child
treatment
Lead sponsor: Colaris, Joost, M.D.
Sponsor class: INDIV
First posted: 2006-11-10
Enrollment: 60
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We create a randomized clinical trial between the treatment with above elbow armcast alone and the treatment of above elbow in combination with a short arm cast for stable midshaft both-bone forearm fractures.

Detailed description: children who arrive at the emergency unit with a stable both-bone midshaft forearm fracture will be asked to join the trial.

If the fracture will be stable during reposition in the operating room, a randomization between 2 kinds of plaster treatment will be done.

Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complains in daily living and complications.

Eligibility criteria: Inclusion Criteria:

* both-bone forearm fracture
* age \< 16 years
* dislocation
* stable

Exclusion Criteria:

* fracture older than 1 week
* no informed consent
* refracture
* open fracture (Gustillo 2 and 3)

Primary outcomes:
measure: pronation and supination
Secondary outcomes:
measure: complications, function, esthetics, complains in daily living, X-rays
Other outcomes:
Locations:
city: Den Haag
country: Netherlands
facility: HAGA, location Juliana Children's Hospital
state: Zuid Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre location Sophia Children's hospital
state: Zuid Holland
Study officials:
name: Joost W Colaris, Drs
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04768842: A Study of Two Different Formulations of LY3209590 in Healthy Participants
Official title: Comparative Pharmacokinetics of LY3209590 After Administration of a Lyophilized Formulation and a Solution Formulation in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-02-24
Enrollment: 50
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: The main purpose of this study is to look at the amount of the study drug, LY3209590, that gets into the blood stream and how long it takes the body to get rid of LY3209590 when given as different formulations. The tolerability of LY3209590 will also be evaluated and information about any side effects experienced will be collected. The study will last up to 142 days.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy males or non-pregnant females. Additionally, women of childbearing potential must test negative for pregnancy
* Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m²), inclusive at screening
* Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
* Have veins suitable for blood sampling
* Have given written informed consent approved by Lilly and the ethical review board governing the site

Exclusion Criteria:

* Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Are women who are pregnant or lactating
* Have a history of multiple and/or severe allergic reactions
* Show clinical evidence of HIV, hepatitis C, or hepatitis B, and/or test positive
* Regularly use known drugs of abuse or with positive drug results

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3209590
timeFrame: Predose on Day 1 through Day 65
measure: PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3209590
timeFrame: Predose on Day 1 through Day 65
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06664242: Effects of TENS in Patients Admitted to the ICU After Cardiac Surgery
Official title: Effects of TENS Application in Patients Admitted to the ICU After Cardiac Surgery: a Randomized Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Transcutaneous Electric Nerve Stimulation
Keywords: tens
transcutaneous electrical nerve stimulation
heart surgery
cardiac surgical procesures
thoracic surgery
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Cardiac Surgery (CH) aims to increase survival and improve quality of life in eligible cardiac patients. However, as with any invasive intervention, pain is one of the main complaints of patients in the post-surgical period. This research is justified by the evaluation of the potential impact of the use of TENS as an alternative for analgesia in reducing the length of hospital stay and directly in the effective cost of patients undergoing cardiac surgeries, in reducing morbidity and mortality, as well as in the quality of life and early return to their daily activities, in addition to reducing the use of drugs and potentially their side effects. The objective of this study is to evaluate the effect of TENS for analgesia in hospitalized patients undergoing cardiac surgery, investigating its efficacy, safety and impact on postoperative recovery.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes
* over 18 years of age,
* undergoing elective cardiac surgery,
* who have a sternotomy access route,
* with or without the use of pleural or mediastinal drains,
* after the first postoperative day will be selected.

Exclusion Criteria:

* with unstable angina,
* patients with arrhythmias,
* whether symptomatic or asymptomatic,
* with changes in the level of consciousness and cognition that may interfere with the assessment,
* use of metal implants,
* pacemakers and implantable cardioverter (ICD),
* those who presented postoperative complications such as infection in the sternotomy

Primary outcomes:
measure: respiratory muscle strength
timeFrame: through study completion, an average of 1 year
measure: cough peak flow
timeFrame: through study completion, an average of 1 year
measure: slow vital capacity
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: painful sensation
timeFrame: through study completion, an average of 1 year
measure: length of stay
timeFrame: through study completion, an average of 1 year
measure: cardiac variability
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: UFPE
state: Pernambuco
Study officials:
References:
Clinical trial NCT06483542: Bionenergetic Balance During CVVH
Official title: A Retrospective Analysis of the Impact of Non-nutritional Calories During Continuous Veno-Venous Hemofiltration
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Kidney Injury
Continuous Venovenous Hemofiltration
Energy Metabolism
Resting Energy Expenditure
Nutrition Therapy
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult critically ill patients with acute kidney injury who require CVVH

Brief summary: The bioenergetic balance is the sum of energy exchanged during CRRT and is mostly defined by citrate glucose and lactate. When CRRT was performed with the older dialysis fluids, glucose and lactate could be an important source of energy next to citrate when used as predilution (6, 7). During continuous venovenous hemofiltration (CVVH), a subgroup of CRRT which is performed with the newer dialysis fluids without lactate or glucose as advocated by the KDIGOguidelines, glucose and in a minor way lactate mostly induce a loss of energy. The first aim is to determine how this bioenergetic balance impacts energy need compared to the measured energy with indirect calorimetry and how nutrition therapy needs to be adapted.

Also, disease specific predicting equation have been created for patients suffering from acute kidney injury treated with renal replacement therapy. How this predicting equation and other existing predicting equations agree with the measured REE has not been validated yet. The second aim is to determine how predictive equations correlate with measured REE in patients treated with CVVH.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the adult ICU (01/01/2021-30/09/2022)
* At least one indirect calorimetry measurement (ventilator) or calculation based on harris benedict OR 25Kcal/kg/day
* Combined with bio energetic balance measurement
* Receiving CVVH during intensive care stay

Exclusion Criteria:

* Patients admitted outside of the inclusion period will be excluded
* The absence of an indirect calorimetry measurement (ventilator) or calculation - based on the Harris Benedict OR 25Kcal/kg/day formula OR The absence of a bio energetic balance measurement
* The absence of CVVH during intensive care stay
* Pediatric (intensive care unit) patients

Primary outcomes:
measure: Energy
timeFrame: during study completion, on average 4weeks
Secondary outcomes:
measure: resting energy expenditure
timeFrame: during study completion, on average 4weeks
measure: protein to energy ratio
timeFrame: during study completion, on average 4weeks
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair ziekenhuis Brussel
state: Vlaams Brabant
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Joop Jonckheer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04108442: Patient Satisfaction With Virtual Postoperative Visit
Official title: Patient Satisfaction With Virtual Postoperative Visit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Op Complication
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective, randomized study designed to evaluate the effects of different initial postoperative follow-up modalities. Given the nature of the study, it is not possible for either the surgeons or the subjects to be blinded. To reduce bias that may occur due to each surgeon's personal preference for postoperative follow-up modality, the surgeons (rather than individual subjects) will be randomized to one of two postoperative follow-up modality groups (traditional or virtual).


Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* \< 60 years old
* Undergoing knee arthroscopy procedure

Exclusion Criteria:

* \< 18 years old
* \> 60 years old

Primary outcomes:
measure: Patient Satisfaction with their surgeon
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Health
name: Kirk Campbell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05850442: The Relationship Between Fibromyalgia Syndrome Parameters With Disease-Pain Severity and the Quality Of Life
Official title: The Relationship Between Fibromyalgia Syndrome Parameters With Disease Severity, Pain and the Quality Of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia Syndrome
Anxiety Disorders
Depressive Disorder
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-05-09
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with FMS according to ACR 2016 criteria

Brief summary: In this study, the investigators aim to evaluate the relationship between disease severity, quality of life, anxiety and pain level in patients diagnosed with Fibromyalgia Syndrome (FMS) with the parameters according to the American College of Rheumatology (ACR) 2016 diagnostic criteria. According to the 2016 ACR diagnostic criteria, there are 2 separate scales: Widespread Pain Index (WPI) and Symptom Severity (SS) . The relationship between these 2 parameters and the Fibromyalgia Impact Questionnaire, the World Health Organization Short Quality of Life Questionnaire, and the McGill Melzack Pain Questionnaire and Beck Anxiety Questionnaire will be examined.

Detailed description: The aim of this study is to observe the relationship between the WPI and SS parameters in the ACR 2016 criteria for fibromyalgia, separately, with the severity of the disease, pain level, quality of life and anxiety level. Accordingly, the investigators aim to evaluate whether WPI or SS has priority in assessing the severity of the disease. There is no study in the literature comparing the importance of the 2016 ACR diagnostic parameters on the disease effect. In this context, this study will be the first study in the literature and will be very valuable. Patients visiting the outpatient clinic with FMS diagnosis will be evaluated. Patients will be asked to fill the World Health Organization Short Quality of Life Questionnaire, and the McGill Melzack Pain Questionnaire and Beck Anxiety Questionnaire . The patients will be assed by an experienced Physical Medicine and Rehabilitation specialist for SS and WPI scores.

Eligibility criteria: Inclusion Criteria:

* Diagnosed as FMS according to ACR 2016 criterias

Exclusion Criteria:

* History of Malignity
* History of Rheumatological Disease

Primary outcomes:
measure: Widespread Pain Index Score
timeFrame: at the start of the study
measure: Symptom Severity Score
timeFrame: at the start of the study
Secondary outcomes:
measure: Beck Anxiety Score
timeFrame: at the start of the study
measure: WHO Short Quality of Life Score
timeFrame: at the start of the study
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Özlem Kaleoğlu
state: Üsküdar
Study officials:
References:
Clinical trial NCT05585242: Acceptance and Commitment Therapy (ACT) Adapted for Women With Infertility-related Distress
Official title: Randomized Control Trial of Acceptance and Commitment Therapy Adapted for Women With Infertility-related Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Lead sponsor: University of Regina
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants will be randomized either to the ACT conditions or to the waitlist control condition. Randomization will occur using a 1:1 allocation ratio and random block sizes to ensure comparable condition sizes while minimizing the ability to predict condition assignment.
Primary purpose: TREATMENT

Brief summary: This RCT will test the effect of a 7-week self-help ACT-based program in improving fertility-related quality of life and psychological flexibility, in women with infertility.

Detailed description: Ninety women with infertility living in Canada and the United States will be recruited. They will be emailed seven weekly 15-minute videos, each providing instructions on a new Acceptance and Commitment Therapy-based technique that addresses the impact of infertility on psychological inflexibility and distress. Fertility-related quality of life and psychological flexibility will be measured before and after the program. Outcomes will also be measured at one-month follow-up. Feedback about how to improve the program will also be collected.

Eligibility criteria: Inclusion Criteria:

* Has been trying to get pregnant for 12+ months and has failed OR is currently undergoing fertility treatments
* Lives in Canada or the United States
* Reports a high level of distress related to infertility, as indicated by a FertiQoL score below 71

Exclusion Criteria:

* Is currently experiencing active suicidal ideation, as indicated by a score of 7 or above on the Suicide Behaviours Questionnaire - Revised (SBQ-R)

Primary outcomes:
measure: Fertility Quality of Life tool (Fertiqol)
timeFrame: Pre-to-post intervention change and in the month following the intervention (post measures assessed 4 weeks after receipt of last module)
measure: Psychological flexibility (MPFI)
timeFrame: Pre-to-post intervention change and in the month following the intervention (post measures assessed 4 weeks after receipt of last module)
Secondary outcomes:
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Pre-to-post intervention change and in the month following the intervention (post measures assessed 4 weeks after receipt of last module)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Pre-to-post intervention change and in the month following the intervention (post measures assessed 4 weeks after receipt of last module)
Other outcomes:
Locations:
city: Regina
country: Canada
facility: University of Regina
state: Saskatchewan
Study officials:
References:
Clinical trial NCT01074242: ROTATEQ Reexamination Study (V260-037)
Official title: Re-examination Study for General Vaccine Use to Assess the Safety Profile of ROTATEQ in Usual Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroenteritis Rotavirus
Keywords: Gastroenteritis rotavirus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-02-24
Enrollment: 3798
Sex: ALL
Minimum age (years): 6
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 6-32 week old Korean Infants who are vaccinated with Rotateq in usual practice

Brief summary: This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Rotateq through collecting the safety information according to the Re-examination Regulation for New Drugs.


Eligibility criteria: Inclusion Criteria:

* Infants Who Are Vaccinated With Rotateq For The Prevention Of Rotavirus Gastroenteritis Within Local Labeling Will Be Included

Exclusion Criteria:

* Participants who are vaccinated with Rotateq before study start
* Participant who has a contraindication to Rotateq according to the local label

Primary outcomes:
measure: Percentage of Participants With Any Adverse Experience
timeFrame: Up to 42 days after any Rotateq vaccination
measure: Percentage of Participants With Any Adverse Drug Reaction
timeFrame: Up to 42 days after any Rotateq vaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04153942: Earlier Mobilization Post Acute Thrombolysis
Official title: Earlier Mobilization Post Acute Thrombolysis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Stroke
Stroke, Acute
Stroke, Ischemic
Keywords: Mobilization
Thrombolysis
Ischemia
Cerebrovascular Disorders
Brain Diseases
Recovery
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 0
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: This is a phase III trial trying to determine whether 12-hour bed rest following IV thrombolysis therapy (i.e. tPA) for ischemic stroke is non-inferior to 24-hour bed rest by measure of outcomes on the modified Rankin Scale (mRS) at 90 days post bed rest.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Received intravenous tPA for a clinical diagnosis of acute ischemic stroke
* Patient and/or Legally Authorized Representative provide consent

Exclusion Criteria:

* Venous thromboembolism present at symptom onset
* Pneumonia present at symptom onset
* STEMI at symptom onset
* Positive troponins at symptom onset according to local values
* Bone fracture at symptom onset
* Treatment includes or anticipated to include thrombectomy
* Intubation anticipated or occurred
* Symptomatic intracranial hemorrhage (defined as increase in NIHSS by 4 points or more accompanied by PH2 hemorrhage on imaging) at the time of screening.
* Pre-screening systolic blood pressure \< 110 mmHg
* Resting pulse oximetry \< 92% (with or without supplemental oxygen)
* Neurological worsening (defined as NIHSS increase of 4 points compared to initial score) prior to screening.
* Baseline modified Rankin Scale score \> 2
* Known pregnancy
* Patient not anticipated to survive 3 months
* Patient not anticipated to follow-up at 3 months

Primary outcomes:
measure: 90 day mRS
timeFrame: 90 days post bed rest
Secondary outcomes:
measure: Pneumonia
timeFrame: Duration of hospitalization stay, average 5 days
measure: Venous Thromboembolism
timeFrame: Duration of hospitalization stay, average 5 days
measure: Neurological Worsening
timeFrame: Duration of hospitalization stay, average 5 days
measure: Readmission
timeFrame: 90 days post bed rest
measure: Length of Stay
timeFrame: Duration of hospitalization stay, average 5 days
Other outcomes:
Locations:
Study officials:
affiliation: UMass Medical School
name: Brian Silver, MD
role: PRINCIPAL_INVESTIGATOR
References: