louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06685692: A Clinical Trial Investigating the Safety and Efficacy of Subjects With Alcohol Associated Hepatitis (Part 1)
Official title: A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects With Moderate Alcohol Associated Hepatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Alcohol Hepatitis
Keywords: ADX-629
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-12
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Moderate Alcohol Associated Hepatitis (Part 1)


Eligibility criteria: Inclusion Criteria:

* Adult ≥ 21 years old on the day of signing the informed consent form;
* Clinical diagnosis of alcoholic hepatitis, based on clinical features and laboratory testing, confirmed by the Investigator at screening
* Agreement to abstain from alcohol and utilize resources to cease at-risk behaviors during the trial, including addiction/alcohol abuse treatment
* Ability and willingness to swallow tablets
* Willingness to provide signed informed consent, prior to any trial-related procedures and willingness to comply with the trial procedures and requirements

Exclusion Criteria:

* Pregnant, intending to become pregnant (or father a child), or breastfeeding
* Current or recent enrollment in another interventional trial in the 30 days prior to screening

Primary outcomes:
measure: Treatment-Emergent Adverse Event Query
timeFrame: Day 1 to Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Synergry Healthcare
state: Florida
city: Tampa
country: United States
facility: Florida Health Sciences Center/Tampa General Hospital/USF
state: Florida
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas Medical Center
state: Texas
city: Houston
country: United States
facility: UDL Clinical Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Methodist Specialty and Transplant Hospital
state: Texas
city: Richmond
country: United States
facility: Bon Secours Liver Institute of Newport News
state: Virginia
Study officials:
References:
Clinical trial NCT02450292: Retrospective CT Imaging of BioComposite Interference Screw With BTB
Official title: Retrospective CT Imaging of BioComposite Interference Screw in Patients Undergoing Anterior Cruciate Ligament Reconstruction With Bone-Patellar Tendon-Bone Graft
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ACL Tear
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 18+ who had an anterior cruciate ligament (ACL) reconstruction about 5 years ago performed by one of the study investigators.

Brief summary: The purpose of this study is to examine the long-term appearance and resorption rate of biocomposite screws used during ACL reconstruction on X-ray and computed tomography (CT).


Eligibility criteria: Inclusion Criteria:

* Ages 18-50
* Patients who underwent primary ACL reconstruction performed by one of the study investigators at least 5 years ago
* Isolated ACL tear
* Type of graft used was bone-patellar tendon-bone autograft
* Type of screw used to attach graft to the tibia and/or femur was a BioComposite interference screws (Arthrex, Inc.)
* No degenerative joint disease on preoperative X-rays (\> 50% joint space loss, presence of osteophytes)

Exclusion Criteria:

* Revision ACL reconstructions
* Types of grafts other than bone-patellar tendon-bone autograft were used
* ACL tear with concomitant pathology
* Degenerative joint disease on preoperative X-ray (\> 50% joint space loss, presence of osteophytes)
* Metal or other types of bioabsorbable screws other than BioComposite interference screws (Arthrex, Inc.) were used
* ACL reconstruction performed less than 5 years ago
* Pregnancy
* Greater than Grade 2 laxity of other ligaments
* No additional fixation

Primary outcomes:
measure: Screw resorption
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University at Buffalo
name: Marc Fineberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00911092: Predictive Proteomic Factors of the Response to Concomitant Radiochemotherapy in Esophageal Cancer
Official title: Study of Predictive Proteomic Factors of the Response to Exclusive Concomitant Radiochemotherapy in Oesophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Esophageal Cancer
Keywords: Oesophageal cancer
exclusive concomitant radiochemotherapy
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2009-06-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The scope of the trial is to predict the early complete clinical response to exclusive concomitant radiochemotherapy in esophageal cancer by the study of the pre- and per- therapeutic proteomic profile.

Detailed description: Further informations will be provided by Centre Oscar Lambret.

Eligibility criteria: Inclusion Criteria:

* Invasive esophageal carcinoma at any stage (all T, N0 or N1, M0 or M1a), histologically proven
* Treated by exclusive concomitant radiochemotherapy
* Written informed consent

Exclusion Criteria:

* Presence of a second uncontrolled cancer
* Metastatic carcinoma
* Metastatic disease, except cervical lymphnodes... (M1a)
* In situ carcinoma
* Eso-gastric junction cancer (Siewert II ou III)
* Inclusion in a clinical trial with an experimental drug during the study and until 15 weeks after the end of radiotherapy)

Primary outcomes:
measure: Proteomic analysis by Protein-Chip Technology of Ciphergen and mass spectrometry
timeFrame: 15 weeks after the end of irradiation
measure: Initial complete clinical response
timeFrame: 15 weeks after the end of irradiation
Secondary outcomes:
measure: Prolonged clinical response at one year
timeFrame: One year after the end of irradiation
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Paul Papin
city: Brest
country: France
facility: Centre Hospitalier Universitaire
city: Caen
country: France
facility: Centre François BACLESSE
city: Lille
country: France
facility: Centre Oscar Lambret
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Rouen
country: France
facility: CHU - Hopital Charles Nicolle
Study officials:
affiliation: Centre Oscar Lambret
name: ADENIS Antoine, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04515992: High Intensity Body-weight Circuit Training in Type 2 Diabetics
Official title: Feasibility of Minimal Dose High Intensity Body-weight Circuit Training in Type 2 Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: Kennesaw State University
Sponsor class: OTHER
First posted: 2020-08-17
Enrollment: 6
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Exercise has been shown to be effective at improving fitness, as well as markers of glucose tolerance and control, in persons with type 2 diabetes. Recently, several investigations have demonstrated that improvements are realized by patients with high intensity interval exercise which is characterized by periods of vigorous exercise alternated by periods of moderate exercise. Typical interval training sessions require significantly less time to complete than traditional modes of exercise wherein moderate intensity activity is sustained for some time. This may be especially beneficial to those with type 2 diabetes, as lack of time is a frequently cited reason for not engaging in regular exercise. Bodyweight circuit training carries the potential to similarly improve health and metabolic function in persons with type 2 diabetes, and may do so with even a smaller accumulation of exercise because this type of exercise involves a greater percentage of the trainee's muscle mass compared with common forms of interval training (e.g., treadmill or cycle exercise). The purpose of this study is to quantify the effects of 3-4 sessions per week of bodyweight circuit training sustained for 5-10 minutes per session on health-related physical fitness and glucose tolerance/control in people with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Type 2 Diabetes of at least 1 year
* hemoglobin A1c level between 6.0% and 10%

Exclusion Criteria:

* Currently engaging in a physical activity
* Currently taking exogenous insulin
* Undertaking a regiment or lifestyle modification intervention.
* Cardiovascular or Pulmonary diseases.

Primary outcomes:
measure: Change from baseline of HbA1c
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kennesaw
country: United States
facility: Kennesaw State University
state: Georgia
Study officials:
affiliation: Kennesaw State University
name: Brian Kliszczewicz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01670344: Evaluation of an Innovative Medical Device Supporting Orthopedic Surgical Interventions
Official title: Virtual Implant Planning System - A Method to Support Image-guided Surgical Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fracture of Distal End of Radius
Lead sponsor: Siemens Healthcare QT
Sponsor class: INDUSTRY
First posted: 2012-08-22
Enrollment: 80
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 study is a randomized, controlled, 2-arm, open trial to evaluate an innovative positioning system in the clinical setting of orthopedic surgery.

Aim of the study is the validation and comparison of the innovative medical device with the current standard method.


Eligibility criteria: Inclusion Criteria:

* Patients with diastal fracture of the radius
* Patients with the mentioned fracture and indication for surgical treatment according to national guidelines
* Age \>/= 18 years of age
* Patients willing to participate and after having given their informed consent in written form

Exclusion Criteria:

* Participation in other interventional clinical trials
* Pregnant or lactating women

Primary outcomes:
measure: Number of screw replacements in both treatments arms
timeFrame: Participants will be followed for the duration of the hospital stay, an expected average of 3 days
Secondary outcomes:
measure: Comparison of the investigational method to the standard of care regarding radiation time.
timeFrame: Participants will be followed for the duration of the hospital stay, an expected average of 3 days
measure: Number of adverse events and serious adverse events during the clinical investigarion.
timeFrame: Participants will be followed for the duration of the hospital stay, an expected average of 3 days
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Siemens AG Healthcare Sector
Study officials:
affiliation: Sponsor GmbH
name: Kleinszig Gerhard, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT02516644: Feasibility and Effectiveness of Virtual Reality & Use of Body Weight Support Treadmill Training in Parkinson's Disease
Official title: Feasibility and Effectiveness of Virtual Reality and the Use of Body Weight Support Treadmill Training in Parkinson's Disease: an Explorative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Mobility
Balance
Virtual Reality
treadmill training
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 20
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary hypothesis of the investigators is that a virtual reality system combined with physical activity provided on a body weight support treadmill training would change clinical parameters of balance and mobility in people with Parkinson's Disease


Eligibility criteria: Inclusion Criteria:

* idiopathic Parkinson Disease diagnosis
* age under 80 years
* severity of disease rated 2 or 3 at Hoehn \& Yahr scale

Exclusion Criteria:

* impaired cognitive functioning: score less than 24 on the Mini Mental State Examination
* neurologic conditions in addition to Parkinson Disease that may affect motor function and other medical conditions likely to interfere with the ability to safely complete the study protocol
* severe Levodopa dyskinesia
* pregnancy

Primary outcomes:
measure: Six-Minute Walking Test
timeFrame: up to weeks 16
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: weeks: 0,4, 16
measure: Time Up and Go Test
timeFrame: weeks: 0,4, 16
measure: 10 meter walk test
timeFrame: weeks: 0,4, 16
measure: Unified Parkinson's Disease Rating Scale
timeFrame: weeks: 0,4, 16
measure: Postural sway (Center of pressure (COP) trajectories)
timeFrame: weeks: 0,4, 16
measure: Metabolic measurements by Near infrared spectroscopy
timeFrame: weeks: 0,4, 16
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Ferrara University Hospital
Study officials:
affiliation: Ferrara Rehabilitation Hospital
name: Sofia Straudi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00921544: Sucrose Analgesia for the Reduction of Pain During Retinopathy of Prematurity Screening
Official title: Sucrose and Non Nutritive Suck as Analgesia for Babies Undergoing Retinopathy of Prematurity Screening; a Randomised Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Retinopathy of Prematurity
Keywords: ROP
sucrose
pain
Lead sponsor: Coombe Women and Infants University Hospital
Sponsor class: OTHER
First posted: 2009-06-16
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Retinopathy of Prematurity (ROP) screening is one of many potentially painful diagnostic and therapeutic procedures performed routinely on preterm infants in the Neonatal Intensive Care Unit. Therefore strategies for stress reduction and pain management are essential to promote growth and development and minimize long-term sequelae. Procedural analgesia should include concepts of developmental care, non nutritive suck (NNS), pharmacological and non-pharmacological agents. Sucrose is thought to stimulate the body's activation of lingual sweet taste receptors and release of endogenous opioids, when combined with NNS, non-opioid mechanisms are also activated. The administration of sucrose or the combination of sucrose and non-nutritive sucking is one of the most frequently studied non-pharmacological interventions for relief of pain in neonates and oral sucrose has been shown to be an effective and safe therapy for common neonatal procedures such as heal lance, blood-letting and venepuncture. There is conflicting evidence on the benefit of sucrose in ROP screening. Therefore the purpose of this study is to determine the efficacy of sucrose combined with NNS as a potential regime for reduction of pain associated with retinopathy of prematurity screening.


Eligibility criteria: Inclusion Criteria:

* \< 1500 grams
* \< 32 weeks

Exclusion Criteria:

* Requiring mechanical ventilation excluding Continuous Positive Pressure Ventilation (CPAP), sedation
* Infants where consent to participate was not obtained

Primary outcomes:
measure: Pain profile score as assessed by NPASS
timeFrame: Scores assessed 3 months following completion of study
Secondary outcomes:
measure: Number of adverse events
timeFrame: Assessed 3 months following completion
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Coombe Women and Infants University Maternity Hospital
Study officials:
affiliation: Coombe Women and Infants University Hospital
name: Eugene Dempsey, MD, FRCPI
role: STUDY_DIRECTOR
References:
Clinical trial NCT03258944: Ventilatory Muscle Training by Breath-Stacking in Healthy Youngsters
Official title: Breath-Stacking and Ventilatory Muscle Strength
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In several diseases in which muscle weakness is a determining factor for morbidity and mortality, inspiratory muscle training has been shown to be useful in improving the function of ventilatory muscles, delaying or minimizing the development of complications due to the reduction of inspiratory muscle strength.

The breath-stacking technique emerges as an easily applicable alternative, and it can be used in poorly collaborative patients. The technique described in the literature aims to increase pulmonary volumes.

This gain occurs with the coupling of a silicone mask on the patient's face, a unidirectional valve and with the expiratory branch occluded. Thus, inspirations occur sequentially in this medium, generating pulmonary hyperinflation and increasing the contractility power of the expiratory muscles, which are fundamental for coughing. This hyperinflation also improves the peripheral air distribution in the lungs by increasing intrathoracic pressure.

The objective of this study is to evaluate the effect of the breath-stacking (BS) technique on the ventilatory muscle strength of young and healthy individuals.

Detailed description: Initially, participants will be submitted to a learning session on the evaluation of ventilatory muscle strength and the breath-stacking technique. Between 24-72 hours after the learning, the evaluation of the muscular muscular strength will be performed through the maximal inspiratory pressure (MIP) and the maximum expiratory pressure (MEP). PI max will be measured from a maximum expiration; While PE max will be measured from a maximum inspiration, using a digital manovacuometer (MVD 300®)

Eligibility criteria: Inclusion Criteria:

* No signs and symptoms of pulmonary diseases, normal ventilatory muscle strength and agreement to participate and sign the informed consent form.

Exclusion Criteria:

* Presenting neuromuscular diseases, claustrophobia, ruptured eardrum, history of spontaneous pneumothorax and playing wind instruments or being a singer. Sample loss will be considered as non-attendance at all training sessions.

Primary outcomes:
measure: Ventilatory Muscle Strength
timeFrame: four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Universidade Federal de Ciências da Saúde de Porto Alegre
state: RS
Study officials:
References:
Clinical trial NCT05114044: The Effects of Core Stability Training in Chronic Stroke Patients
Official title: The Effects of Core Stability Training on Functional Ability and Muscle Thickness in Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess effects of core stability training on functional ability, balance, gait, motor functions, quality of lite and core muscle thickness of chronic stroke patients.

Detailed description: After being informed about the study all the patients giving written informed consent were assessed. At the beginning the eligible patients were randomized into two groups: core stability and conventional therapy group. The therapy programs were performed 5 times a week for 45 min over a period of 3 weeks. Patients were assessed twice: before and after treatment.

Eligibility criteria: Inclusion Criteria:

* First onset
* Stroke duration from 6 months to 2 years
* With ability to cooperate
* Independent ambulation or ambulation with assistive device

Exclusion Criteria:

* Uncooperative
* Neglect syndrome
* Surgical history of abdominal and hip region
* Drugs that affect neuromuscular control
* Other neurological disorders
* Serious diseases, unstable medical condition
* BMI ≥ 35

Primary outcomes:
measure: Change from baseline score of Berg Balance Scale at week 3
timeFrame: Baseline and week 3 (after treatment)
measure: Change from baseline score of Motricity Index Scale for lower extremity at week 3
timeFrame: Baseline and week 3 (after treatment)
measure: Change from baseline score of Trunk Control Test at week 3
timeFrame: Baseline and week 3 (after treatment)
measure: Change from baseline score of 6 Minute Walk Test (6MWT) at week 3
timeFrame: Baseline and week 3 (after treatment)
measure: Change from baseline score of Functional Independence Measure (FIM) at week 3
timeFrame: Baseline and week 3 (after treatment)
measure: Change from baseline score of Trunk Impairment Scale (TIS) at week 3
timeFrame: Baseline and week 3 (after treatment)
measure: Change from baseline score of Timed Up and Go Test (TUG) at week 3
timeFrame: Baseline and week 3 (after treatment)
measure: Change from baseline score of Stroke Specific Quality of Life Scale (SS-QOL) at week 3
timeFrame: Baseline and week 3 (after treatment)
measure: Change from baseline measurements Core muscle thickness at week 3
timeFrame: Baseline and week 3 (after treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study officials:
References: