louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00284362: Prospective and Comparative Analysis of Arthroscopic and Open Surgery for Hallux Rigidus
Official title: Prospective and Comparative Analysis of Arthroscopic and Open Surgery for Hallux Rigidus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hallux Rigidus
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Comparison between arthroscopic and open surgery for hallux rigidus.


Eligibility criteria: Inclusion Criteria:

* Hallux rigidus

Exclusion Criteria:

-

Primary outcomes:
measure: Duration of hospitalisation
measure: Duration of rehabilitation and sick leave
measure: Wound healing
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Ghent
name: Rene Verdonk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06343662: Group Music Therapy for Acquired Brain Injury
Official title: Meraki: Music Therapy Protocol for People with Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acquired Brain Injury
Keywords: music therapy-based treatment
psychological intervention
discomfort
Acquired Brain Injury
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aims to analyse the impact of music therapy-based treatment on the comfort and well-being of patients with acquired brain injury (ABI). To achieve this objective, it is proposed to validate and implement a music therapy-based assessment and treatment protocol. The protocol will be tested in a pilot sample to improve adaptation to the disease and promote integration with the usual health measures of patients with ABI. Implementing a group treatment programme based on music therapy applied to patients with ABI.


Eligibility criteria: Inclusion Criteria:

* Patient with acquired brain damage who has been admitted to the hospital for at least one week. The patient has experienced a sudden brain injury resulting in physical, psychological, cognitive, behavioural or sensory deficits that have reduced their previous functional capacity and quality of life. The patient is clinically stable enough to undergo rehabilitation and had a good functional situation prior to the episode (Barthel Index \> 60).
* Be over 18 years of age.
* The participant or their relatives have signed the informed consent form.
* They have completed the group music therapy intervention session, as well as the pre-test and post-test evaluations.

Exclusion Criteria:

* Failure to obtain informed consent
* The Barthel Index score is below 60, indicating functional dependency.

Primary outcomes:
measure: Change in Discomfort ( Baseline (3 Assessments), Pre- Post)
timeFrame: Baseline up to 1 week
Secondary outcomes:
measure: Barthel Index
timeFrame: Baseline
measure: Pfeiffer Short Form Mental State Questionnaire, SPMSQ
timeFrame: Baseline
measure: Charlson Comorbidity Index (CCI),
timeFrame: Baseline
Other outcomes:
Locations:
city: Serra
country: Spain
facility: Hospital Dr. Moliner
state: Valencia
Study officials:
affiliation: University of Valencia
name: Marián Pérez-Marín, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01499862: Mobility Training Using a Bionic Knee Orthosis in Patients Chronic Post-Stroke: A Case Series
Official title: Discriminatory Neurosensory Stimulation Neurological H5394-11417-15
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke
Keywords: Stroke
Tibion
Bionics
Rehab
Therapy
Robotics
Intention
Lead sponsor: Tibion Bionics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2011-12-26
Enrollment: 3
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot study examined the effect of task-oriented mobility training in three persons chronic post-stroke using a novel, wearable, mobile intention-based robotic orthosis (Tibion Bionic Leg).


Eligibility criteria: Inclusion Criteria:

* Male or female
* Aged 40 to 60 years
* One year status post-stroke
* Able to walk at least 10 meters
* Independence in self-care

Exclusion Criteria:

* Medically unstable
* Major cardiopulmonary deficiency
* Major depression
* Significant cognitive deficit
* Currently receiving gait training
* Younger than 40 years of age
* Older than 60 years of age
* Unable to walk at least 10 meters

Primary outcomes:
measure: Ambulation Speed
timeFrame: Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.
Secondary outcomes:
measure: 6 Minute Walk Test (6 MWT)
timeFrame: Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.
measure: Timed Up and Go (TUG) Test
timeFrame: Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.
measure: Five Times Sit to Stand Test (5 x STS)
timeFrame: Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.
measure: Step Length
timeFrame: Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Bakar Community Center at the University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Nancy N Byl, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong CK, Bishop L, Stein J. A wearable robotic knee orthosis for gait training: a case-series of hemiparetic stroke survivors. Prosthet Orthot Int. 2012 Mar;36(1):113-20. doi: 10.1177/0309364611428235. Epub 2011 Nov 14.
Clinical trial NCT03195062: Fructose Extra-splanchnic Metabolism and Its Effects on Systemic Flux of Substrates (FruPP)
Official title: Fructose Extra-splanchnic Metabolism and Its Effects on Systemic Flux of Substrates (FruPP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Test Meal
Keywords: Fructose
Obesity
Metabolism
Post-prandial kinetics
Lead sponsor: University of Lausanne
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In parallel to the dramatic rise in metabolic diseases and diabetes observed over the past fifty years, the generalization of added sugar in processed food led to a marked increase in fructose consumption in almost all countries, and epidemiological studies demonstrated that the consumption of sugar-sweetened beverage (containing at least 50% of fructose) is associated with the development of diabetes, hepatic steatosis, dyslipidemia and obesity.

The objective of the study is to measure the amount of fructose that escape first-pass hepatic extraction after oral ingestion (fructose+glucose), and gain insights into its metabolic fates with the use of tracers.


Eligibility criteria: Inclusion Criteria:

* Aged from 18 to 40 years
* Body Mass Index of 18.5 to 25 kg/m²
* Sex male of female

Exclusion Criteria:

* Fructose intolerance
* Antidiabetic and hypolipemic drugs
* Alcohol consumption \>10g/day
* Severe eating disorders
* Severe psychological problems
* Vegetarian diet or other specific diet
* Consumption of illicit substances
* Pregnancy
* Weight gain or weight loss \> 3 kg in the last 3 months

Primary outcomes:
measure: Measurement of the amount of fructose that escape first-pass hepatic extraction after oral ingestion.
timeFrame: The quantity of 13C fructose will be calculated, during the post prandial period, until 240 min.
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University of Lausanne
Study officials:
References:
Clinical trial NCT00597662: Safety Study of Polylactide-Caprolactone-Trimethylenecarbonate Copolymer for Post-Operative Adhesion Prophylaxis
Official title: Safety Study of Polylactide-Caprolactone-Trimethylenecarbonate Copolymer for Post-Operative Adhesion Prophylaxis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adhesions
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2008-01-18
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare adhesion prophylaxis with polylactide-caprolactone-trimethylenecarbonate copolymer to icodextrin 4% in terms of safety, side effects and usability in addition to gaining early evidence of the effectiveness of polylactide-caprolactone-trimethylenecarbonate copolymer.


Eligibility criteria: Inclusion Criteria:

* age 18-60 years
* sex female
* laparoscopic myomectomy indicated
* ability and intention to conform to the study protocol
* written informed consent

Exclusion Criteria:

* pregnancy
* indication for laparotomy
* inflammatory bowel disease
* additional surgical interventions
* known or suspected intollerance or hypersensibility to the interventions
* chronic pain
* systemic corticoids or irradiation
* alcohol abuse or other substance abuse
* clinical signs of malignancy
* psychiatric or neurological disease
* participation in another clinical trial within 30 days
* inability to understand the purpose of the trial or to conform to the study protocol
* absence of written informed consent
* inflammation of pelvic organs
* presence of adhesions which lead to a conversion from laparoscopy to laparotomy
* concurrent therapy with corticoids, anti-neoplastic agents or irradiation
* maintenance therapy with non-steroidal anti-inflammatory drugs or analgesics

Primary outcomes:
measure: Difference in visual analogue pain score on visit 8 after discharge minus visit 1 on admission
timeFrame: 3 months
Secondary outcomes:
measure: Use of analgesia
timeFrame: 1, 2 and 3 days
measure: Post-operative pyrexia
timeFrame: 3 months
measure: Post-operative infection
timeFrame: 3 months
measure: Requirement for re-operation
timeFrame: 3 months
measure: Dysmenorrhoea
timeFrame: 3 months
measure: Dyspareunia
timeFrame: 3 months
measure: Constipation
timeFrame: 3 months
measure: Diarrhoea
timeFrame: 3 months
measure: Nausea
timeFrame: 3 months
measure: Duration of adhesion prophylaxis
timeFrame: Day 1
measure: Usability as assessed by surgeon
timeFrame: Day 1
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Universitäts-Frauenklinik Tübingen
state: Baden-Wuerttemberg
Study officials:
affiliation: Universitäts-Frauenklinik Tübingen
name: Diethelm Wallwiener, Prof. Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT04522362: Modeling Stress-precipitated Vaping Behavior
Official title: Modeling Stress-precipitated Vaping Behavior Among E-Cigarette Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaping
Lead sponsor: Clemson University
Sponsor class: OTHER
Collaborators: name: University of Vermont
First posted: 2020-08-21
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The primary aims of this pilot study were to (1) initially validate the applicability of a human laboratory model of relapse initially developed for smokers to e-cigarette users; (2) to use this human laboratory model of lapse behavior to examine the effects of acute psychological stress on vaping-lapse behavior among adults who are experienced, e-cigarette users.


Eligibility criteria: Inclusion Criteria:

* at least 18 years old
* e-cigarette users
* using ≥1 mL of e-cigarette liquid per day with a nicotine concentration of ≥3mg/ml
* had used an e-cigarette for at least three months

Exclusion Criteria:

* Current smokers
* Psychiatric or medical condition based
* Using a prescription medication other than birth control

Primary outcomes:
measure: latency to initiate ad-lib vaping session (in minutes)
timeFrame: During the two laboratory sessions which occur within 1 week after screening/baseline.
measure: number of puffs purchased and consumed during the self-administration period
timeFrame: During the two laboratory sessions which occur within 1 week after screening/baseline
Secondary outcomes:
measure: Craving
timeFrame: The VAS will be collected at each laboratory session (within 1 week after screening/baseline) 5 times: baseline (pre task), post task (+15 minutes), decision to smoke (+20 minutes), +30 minutes smoking ab-lib, and +60 minutes during smoking ab-lib
measure: Stress
timeFrame: The VAS will be collected at each laboratory session (within 1 week after screening/baseline) 5 times: baseline (pre task), post task (+15 minutes), decision to smoke (+20 minutes), +30 minutes smoking ab-lib, and +60 minutes during smoking ab-lib
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
References:
citation: Pericot-Valverde I, Yoon JH, Byrne KA, Heo M, Niu J, Litwin AH, Gaalema DE. Effects of short-term nicotine deprivation on delay discounting among young, experienced, exclusive ENDS users: An initial study. Exp Clin Psychopharmacol. 2023 Jun;31(3):724-732. doi: 10.1037/pha0000612. Epub 2022 Nov 10.
citation: Pericot-Valverde I, Heo M, Litwin AH, Niu J, Gaalema DE. Modeling the effect of stress on vaping behavior among young adults: A randomized cross-over pilot study. Drug Alcohol Depend. 2021 Aug 1;225:108798. doi: 10.1016/j.drugalcdep.2021.108798. Epub 2021 May 30.
Clinical trial NCT06844162: Comparison of Postoperative Analgesic Efficacy of Suprainguinal Fascia Iliaca Block and Pericapsular Nerve Group Block With Lateral Femoral Cutaneous Nerve Block in Patients Undergoing Total Hip Arthroplasty
Official title: Comparison of Postoperative Analgesic Efficacy of Suprainguinal Fascia Iliaca Block (SFIB) and Pericapsular Nerve Group (PENG) Block With Lateral Femoral Cutaneous Nerve (LFCN) Block in Patients Undergoing Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coxarthrosis; Primary
Keywords: Suprainguinal fascia iliaca block
PENG block
Lateral femoral cutaneous nerve block
Postoperative analgesia
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 48 patients of American Society of Anesthesiologists physical status I-II between the age of 18 to 90 years who were scheduled to undergo primary Total hip arthroplasty with a diagnosis of coxarthrosis

Brief summary: The goal of this observational study is to compare the analgesic efficacy of SFIB and PENG with LFCN block, and study their effects on opioid consumption, motor strength and ability to perform physiotherapy in the postoperative period in patients who underwent primary total hip arthroplasty under general anesthesia.

Detailed description: 48 patients undergoing THA under general anesthesia who received either SFIB or PENG block with LFCN block using will be included in the study. Postoperative static and dynamic VAS scores, opioid consumption, quadriceps motor strength, ability to perform physiotherapy and presence of opioid or nerve block related complications will be recorded.

Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled to undergo primary total hip arthroplasty with a diagnosis of coxarthosis

Exclusion Criteria:

* Patients who have a history of neuropathy, patients with renal and hepatic insufficiency, patients with known coagulopathy, patients with a history of allergy to local anesthetics, patients with a history of inguinal surgery on the same side and patients with impaired mental status

Primary outcomes:
measure: Visual Analogue Scale scores
timeFrame: In the 48 hours following surgery
Secondary outcomes:
measure: Opioid consumption
timeFrame: In the 48 hours following surgery
measure: Quadriceps weakness
timeFrame: In the 48 hours following surgery
measure: Ability to perform physiotherapy
timeFrame: In the 48 hours following surgery
Other outcomes:
measure: Adverse effects
timeFrame: In the 48 hours following surgery
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Hospitals
Study officials:
References:
Clinical trial NCT04674462: Understanding Poor Vaccine Responses to Hepatitis B Vaccination
Official title: Understanding Poor Vaccine Responses to Hepatitis B Vaccination
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Vaccine Reaction
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2020-12-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Vaccines have prevented countless infections but poor vaccine responses remain a major challenge in many scenarios. Hepatitis B vaccine nonresponses are common but immunologically not well-understood.

This study aims to study the immunology of hepatitis B vaccine responses by comparing traditional HBV vaccine, which is associated with nonresponses in some patients, to CpG-adjuvanted HBV vaccine, which is associated with far fewer rates of nonresponses. This research will build upon prior studies of the human immune response to infection to gain a deeper understanding of the complexity of these responses. This information will be broadly useful as many vaccine candidates fail due to lack of immunogenicity, potentially enabling improved vaccine design and better protection.


Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age
2. Must be able to understand and sign the Informed Consent Form (ICF)

Exclusion Criteria:

1. Known chronic HBV infection
2. Pregnancy
3. Known clinically significant anemia or contraindication to phlebotomy; i.e., anti-coagulation therapy or clinically significant thrombocytopenia
4. Any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study
5. Use of immune-suppressing medications in the 30 days prior to enrollment HIV/AIDS patients will be included in the study as these patients often have poor responses to HBV vaccine.

Primary outcomes:
measure: Proportion of Participants with Weak Vaccine Response
timeFrame: Month 1 Post-Final Dose
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Ramin Herati, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00636662: FLU A+B Nasal Swab Clinical Study
Official title: Evaluation of the RAMP FLU A+B Test Versus Viral Culture Using Clinical Nasal Swab Samples From Patients With Suspected Influenza Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Lead sponsor: Response Biomedical Corp.
Sponsor class: INDUSTRY
First posted: 2008-03-14
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nasal swab samples will be collected from subjects suspected of having influenza infections and onset has occurred within 3 days of examination. Across the sites these samples will be drawn from an approximately 60% pediatric patients (\<21 years), and 40% adult patients (\>21 years) and it is expected that the population will be divided approximately equally between males and females.

Brief summary: The purpose of this clinical study is to obtain clearance for the nasal swab sample type by demonstrating the performance characteristics of the FLU A+B Test versus standard laboratory culture for Influenza A and B viruses using nasal swab samples.

Detailed description: Patients exhibiting symptoms of influenza enrolled in a fashion that confidentiality of all personal health information is maintained.

No patient treatment is affected by enrollment in this trial.

Eligibility criteria: Inclusion Criteria:

* Male and Female of all age groups
* Patients exhibiting influenza symptoms (i.e., fever, body aches, headaches, cough, sore throat, and other respiratory symptoms) at the time of examination
* Patients must either present with a fever (\>100ºF; \>37.8ºC) at time of examination or have had a fever (\>100ºF; \>37.8ºC) or declare at time of the examination that they had a fever within the previous 3 days prior to the examination
* Must be able to collect sample using the nasal swab sample type

Exclusion Criteria:

* Patients with no fever at time of examination or within the 3 days prior to examination and/or are currently undergoing treatment (including anti-virals) will be excluded from the study.

Primary outcomes:
measure: Support the addition of nasal swab sample type to labeling for the FLU A+B Test. The nasal swab sample data will be analyzed for the FLU A+B Test versus standard laboratory culture identification to determine the sensitivity and specificity.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Saint Louis
country: United States
facility: Washington University / St. Louis Children's Hospital
state: Missouri
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Austin
country: United States
facility: Dell Children's Hospital
state: Texas
city: Toronto
country: Canada
facility: Mt. Sinai Hospital
state: Ontario
Study officials:
References: