louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02904668: Self-management Program in Chronic Neck Pain
Official title: Effects of a Self-management Program in Patients With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: chronic pain
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neck pain is a complex biopsychosocial disorder often precipitated or aggravated by neck movements or sustained neck postures. The onset and course of this pain is influenced by environmental and personal factors.Many studies report that participants preferred self-care measures for the management of neck pain and they sought professional help only when those measures fail.

Detailed description: Neck pain is the fourth leading cause of disability worldwide causing an enormous impact on individuals and their families, communities and healthcare systems.While neck pain can be severely disabling and costly, treatment options have shown moderate evidence of effectiveness. No previous study has used foam roller in patients with neck pain. In addition, it has been suggested that neurodynamic interventions provide a peripheral stimulus, reducing the pressure existing within the nerve, improving blood flow, axonal transport and nerve conduction. It was hypothesized that a self-administered intervention focused on myofascial release of main muscles related to neck pain and upper-limb active neurodynamics could reduce the presence of active trigger points and pain, improving functionality and active mobility.

Eligibility criteria: Inclusion Criteria:

* Chronic neck pain (at least 6 months' duration) not related to trauma .

Exclusion Criteria:

* Whiplash related neck pain
* Previous cervical surgical intervention
* Cognitive impairments which prevent them to follow instructions
* Visual or acoustic limitations
* Physical therapy in the previous six months

Primary outcomes:
measure: Disability
timeFrame: Change from baseline pain at 3 weeks
Secondary outcomes:
measure: Pain severity
timeFrame: Change from baseline pain at 3 weeks
measure: Health related quality of life
timeFrame: Change from baseline health related quality of life at 4 weeks
measure: Fear avoidance beliefs
timeFrame: Change from baseline fear avoidance beliefs at 4 weeks
measure: Anxiety and depression
timeFrame: Change from baseline anxiety and depression at 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06655168: Orotracheal Intubation in Newborns: Videolaryngoscopy Vs Direct Laryngoscopy
Official title: Orotracheal Intubation in Newborns: Videolaryngoscopy Vs Direct Laryngoscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: The Time Taken for Successful Tracheal Intubation in Each Technique
Keywords: endotracheal intubation, newborn, direct laryngoscopy,video laryngoscopy
Lead sponsor: Tunis University
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 115
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The children were randomized into two groups to receive orotracheal intubation after anesthetic induction with neuromuscular blockade, either by direct laryngoscopy (DL, DL group) or by C-MAC video laryngoscopy (VL group)

Detailed description: prospective randomized study including newborns , requiring orotracheal intubation for surgery or mechanical ventilation in the intensive care unit. The children were randomized into two groups to receive orotracheal intubation after anesthetic induction with neuromuscular blockade, either by direct laryngoscopy (DL, DL group) or by C-MAC video laryngoscopy (VL group).

Eligibility criteria: Inclusion Criteria:

* newborns requiring orotracheal intubation for surgery or mechanical ventilation in the intensive care unit

Exclusion Criteria:

* age\> 01 month

Primary outcomes:
measure: time taken for successful tracheal intubation
timeFrame: during intubation
Secondary outcomes:
measure: the need for additional device
timeFrame: during intubation
measure: the number of attempts
timeFrame: during intubation
measure: Complications during intubation
timeFrame: during intubation
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Bechir Hamza hospital
Study officials:
References:
Clinical trial NCT01873768: Clinical Efficacy of Tranexamic Acid and ε-Aminocaproic Acid in Reducing Blood Loss Following Total Knee Replacement
Official title: A Randomized Controlled Trial of Tranexamic Acid and ε-Aminocaproic Acid to Reduce Blood Loss Following Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: Tranexamic acid
6-Aminocaproic Acid
Arthroplasty
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Antifibrinolytic Agents
Fibrin Modulating Agents
Pharmacologic Actions
Coagulants
Therapeutic Uses
Lead sponsor: Miller Orthopedic Specialists
Sponsor class: OTHER
Collaborators: name: CHI Health Mercy Hospital
name: Creighton University Medical Center
First posted: 2013-06-10
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tranexamic acid (TXA) and ε-aminocaproic acid (EACA) are two drugs shown to limit blood loss following major surgery, from cardiac to orthopedic procedures. Yet compared to tranexamic acid (TXA), research on the clinical impact of ε-aminocaproic acid (EACA) in total knee arthroplasty (TKA) is limited. The primary aim of this study is to determine whether TXA and EACA provide similar blood decreasing effects following TKA or whether one drug provides a superior effect over the other in reducing patients' blood loss.


Eligibility criteria: Inclusion Criteria:

* Persons aged 18 - 90 years who are scheduled to undergo a unilateral total knee replacement surgery

Exclusion Criteria:

* Non-English speaking individuals
* Individuals with a history of deep vein thrombosis or pulmonary embolism within one year
* Individuals with a history of coagulopathy
* Heart stent within one year
* Pre-operative autologous blood donation
* Unwilling or unable to take Coumadin for deep vein thrombosis (DVT) prophylaxis
* Received nonsteroidal anti-inflammatory drug (NSAID) or platelet antiaggregant treatment within five days prior to surgery
* Pre-operative creatinine greater than 1.5mg/dL

Primary outcomes:
measure: Transfusion rate
timeFrame: 1.5 to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Council Bluffs
country: United States
facility: Miller Orthopedic Specialists
state: Iowa
Study officials:
affiliation: Miller Orthopedic Specialists
name: Clifford K Boese, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01940068: A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates
Official title: A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cow Milk Allergy
Keywords: Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Lead sponsor: United Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-09-11
Enrollment: 86
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the impact of a new Amino-acid based formula on allergic symptoms and growth of infants with cow's milk protein allergy and intolerant to extensively hydrolysed formulas;


Eligibility criteria: Inclusion Criteria:

* less than 18 months old
* with a proven cow's milk protein allergy by a double blind placebo controlled food challenge or a positive Skin prick test (\>=6mm) or specific immunoglobulin E \>= 5 kilo-unit/L or combination
* still symptomatic while fed an extensively hydrolysed formula

Exclusion Criteria:

* Exclusively breast fed infants
* non allergic digestive enteropathy

Primary outcomes:
measure: Number of withdrawal for intolerance
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker Children's Hospital
Study officials:
References:
citation: Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
citation: Dupont C, Kalach N, Soulaines P, Bradatan E, Lachaux A, Payot F, De Blay F, Guenard-Bilbault L, Hatahet R, Mulier S, Kapel N, Waligora-Dupriet AJ, Butel MJ. Safety of a New Amino Acid Formula in Infants Allergic to Cow's Milk and Intolerant to Hydrolysates. J Pediatr Gastroenterol Nutr. 2015 Oct;61(4):456-63. doi: 10.1097/MPG.0000000000000803.
citation: Dupont C, Kalach N, Soulaines P, Bradatan E, Lachaux A, Payot F, de Blay F, Guenard-Bilbault L, Hatahet R, Mulier S. A thickened amino-acid formula in infants with cow's milk allergy failing to respond to protein hydrolysate formulas: a randomized double-blind trial. Paediatr Drugs. 2014 Dec;16(6):513-22. doi: 10.1007/s40272-014-0097-x.
Clinical trial NCT01733368: QUARTO-II Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead
Official title: Observational Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: CRT
Optimization
Responders
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-11-27
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart failure patients

Brief summary: Optimization and evolution of the patient will be evaluated over 6 months after the implant.

Detailed description: Patient will be enrolled into the study after Informed Consent signature and CRT-D+quadripolar (QuartetTM) LV lead.

Eligibility criteria: Inclusion Criteria:

* Patient with implanted CRT-D device and a QuartetTM quadripolar lead by St. Jude Medical in the left ventricle.
* Patient with an echocardiographic study performed during 1 month prior to the implant and in whom End Systolic Volume of the Left Ventricle (LVESV) has been measured
* Patients who have granted their informed consent.
* Patients above 18 years.

Exclusion Criteria:

* Patients that have been previously resynchronized.
* Patients with aortic stenosis or aortic valve prosthesis
* Patients who are or may potentially be pregnant.
* Patients with a life expectancy \<12 months.
* Patients who cannot attend the monitoring visits established by the protocol.

Primary outcomes:
measure: Number of Responder Patients (Structural Remodelling)
timeFrame: 6 months after implant
measure: Safety Outcomes in CRT Responders and Non-Responders
timeFrame: 6 months after implant
Secondary outcomes:
measure: Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector
timeFrame: 6 months after implant
measure: Number of Responder Patients With Conventional Left Ventricular Pacing Vector
timeFrame: 6 months after implant
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
Study officials:
affiliation: Hospital Clínico Universitario Virgen de la Victoria
name: Javier Alzueta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01677468: Survival According to the Feeding Artery Obliteration by Chemoembolization for Unresectable Hepatocellular Carcinoma
Official title: Phase Study About Feeding Artery Obliteration by Chemoembolization on Survival of Patients With Unresectable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Transarterial Chemoembolization
Keywords: Hepatocellular carcinoma
Transarterial chemoembolization
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2012-09-03
Enrollment: 250
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.

Detailed description: Subjective angiographic chemoembolization endpoints (SACE) levels were developed to standardize the embolic endpoints of transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC). It determined the antegrade arterial flow and residual tumor blush as follows: I, normal-normal; II, reduced-reduced; III, reduced-none; IV, none-none. SACE level II and III indicates intermediate-levels of embolization, whereas IV indicates overembolization. The aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.

Eligibility criteria: Inclusion Criteria:

* age over 18
* ECOG performance status 0-2
* Hepatocellular carcinoma diagnosed histologically or clinically
* Tumor numbers of 5 or less
* No history of treatment for hepatocellular carcinoma
* Patients with informed consent

Exclusion Criteria:

* Extrahepatic metastasis
* Rupture of hepatocellular carcinoma
* Infiltrative hepatocellular carcinoma
* Malignancy other than hepatocellular carcinoma

Primary outcomes:
measure: Survival rate of the subjects
timeFrame: 6 months after TACE
measure: Survival rate of the subjects
timeFrame: 12 months after TACE
measure: Survival rate of the subjects
timeFrame: 18 months after TACE
measure: Survival rate of the subjects
timeFrame: 24 months after TACE
Secondary outcomes:
measure: Disease free survival of the subjects
timeFrame: 6, 12, 18, and 24 months after TACE
measure: Complication rate of TACE
timeFrame: 6, 12, 18, and 24 months after TACE
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym Sacred Heart Hospital
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Kangnam Sacred Heart Hostpita
Study officials:
affiliation: Hallym University Medical Center
name: Sang Hoon Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03810768: Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness
Official title: Metabolomics Pilot Study on Postoperative Intensive Care Acquired Muscle Weakness (MIRACLE-I Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metabolomics
Critical Care
Critical Illness
Critical Illness Myopathy
Critical Illness Polyneuropathy
Intensive Care (ICU) Myopathy
Muscle Weakness
Keywords: pilot trial
muscle biopsy
blood metabolome
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Helmholtz Zentrum München
name: Charite University, Berlin, Germany
First posted: 2019-01-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: mechanically ventilated postoperative high-risk patients who are admitted to intensive care

Brief summary: In this mono-center pilot trial, surgical patients who are at high risk to be admitted to intensive care will be screened and asked for participation. We are going to take blood and muscle samples at respecified time points to do metabolic, histological and molecular testing.

Aim of the study is to investigate (1) changes of the blood metabolome in patients with ICUAW (intensive care unit acquired weakness) and (2) identify metabolic components who are responsible for ICUAW or can be used as marker for ICUAW.


Eligibility criteria: Inclusion Criteria:

* invasive mechanically ventilated critically ill patient with expected intensive care unit stay \> 3 days
* postoperative patient
* ≥ 18 years old
* American Society of Anesthesiology (ASA) classification ≥ III

Exclusion Criteria:

* moribund patient
* non-curative care (comfort care)

Primary outcomes:
measure: Metabolomics
timeFrame: a median of 14 days
Secondary outcomes:
measure: Muscle histology
timeFrame: a median of 14 days
measure: Phosphoproteomics
timeFrame: a median of 14 days
Other outcomes:
measure: Identify possible predictors of muscle wasting in the blood metabolome preoperatively
timeFrame: a median of 14 days
measure: Identify possible predictors of muscle wasting in the blood metabolome at ICU admission
timeFrame: a median of 14 days
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Munich
country: Germany
facility: Klinikum rechts der Isar, School of Medicine, Technical University of Munich
state: Bavaria
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Technical University of Munich
name: Stefan J Schaller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Technical University of Munich
name: Hennig Wackerhage, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04573868: National Study "AEC COVID-19"
Official title: National Study "AEC COVID-19" on Patients Undergoing Surgical Intervention During the SARS-CoV-2 Pandemic.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mortality
Keywords: COVID
Surgery
Lead sponsor: Hospitales Universitarios Virgen del Rocío
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who undergo a surgical procedure during the pandemic

Brief summary: Currently there is an important need to know the evolution, results and associated mortality of patients undergoing surgical intervention in Spain during the SARS-CoV-2 pandemic. With a national data collection, information could be obtained to guide the management of this group of complex patients operated on during the COVID-19 pandemic, with the aim of improving their treatment in the event of a second wave. The great spread of the virus and the difficulty in controlling it over time makes it a high priority for the scientific community in order to face new outbreaks.

The national study "AEC COVID-19" is a collaborative study (in the style of those carried out at European level such as Eurosurg, Globalsurg, etc.) that aims to know the evolution, results and associated mortality of patients undergoing surgical intervention in Spain during the SARS-CoV-2 pandemic. It is an observational study, with anonymized and coded data, which aims to demonstrate the following hypotheses:

* Patients with COVID-19 have high mortality.
* Patients with both oncological and benign pathologies have high morbidity.

The situation / follow-up at 7 days and 30 days after the intervention will be included in each patient.


Eligibility criteria: Inclusion Criteria:

Adult patients who undergo a surgical procedure during the pandemic

Exclusion Criteria:

-

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Morbidity
timeFrame: 30 days
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Salvador Morales-Conde
Study officials:
affiliation: Asociacion Española de Cirujanos
name: Salvador Morales-Conde
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02387268: Evaluation of the Performance of the CleanC System-Israel
Official title: Evaluation of the Performance of the "CleanC" System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer (CRC) Screening
Lead sponsor: Motus GI Medical Technologies Ltd
Sponsor class: INDUSTRY
First posted: 2015-03-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.

Detailed description: The study aim to evaluate the post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS).

Each subject was required to follow a bowel preparation regimen including split dose of 2 tablets of 5mg Bysacodyle followed by a colonoscopy procedure with the tested device.

Eligibility criteria: Inclusion Criteria:

1. Subjects in the age range of 18-75 years
2. Subjects with BMI within the range of 18.5-35
3. Subject is willing to sign informed consent form

Exclusion Criteria:

1. Active or severe inflammatory bowel disease (IBD)
2. Subjects with severe diverticulitis \\ diverticular disease (known or detected)
3. Known or detected colonic stenosis
4. Known or detected bowel obstruction
5. History of prior colon surgery
6. ASA≥IV (sever systemic disease)
7. Sever Renal insufficiency (Creatinine≥1.5mg%)
8. Sever Liver insufficiency (ALT/AST≥2UNL)
9. Contraindication for "colonoscopy" anesthesia \\ sedation \\ prep agent
10. pregnancy
11. Subjects with altered mental status/inability to provide informed consent
12. Subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly

Primary outcomes:
measure: Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 )
timeFrame: During the colonoscopy procedure withdrawal phase (10 min in average)
measure: Safety as Measured by Number of Serious Adverse Events and Major Complications.
timeFrame: Max of 9 days
Secondary outcomes:
measure: Percentage of Participants in Whom the Cecum Was Reached
timeFrame: During the colonoscopy procedure
Other outcomes:
Locations:
Study officials:
References: