louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03840551: Definition of Biomechanical Indices Measurable During Sport Movements for the Prevention of Primary and Secondary ACL Injury
Official title: Definition of a Set of Biomechanical Indices Non-invasively Measurable During Basic Sport Movements Test Analysis Aimed to the Prevention of Primary and Secondary Anterior Cruciate Ligament Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sport Injury
Anterior Cruciate Ligament Injury
Biomechanical; Lesion
Keywords: injury prevention
biomechanical indices
inertial sensors
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
Collaborators: name: Isokinetic
First posted: 2019-02-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of the study is to define a set of quantitative parameters related to articular biomechanics, which will be evaluated during some specific motor tasks. The goal is the prevention of primary and secondary anterior cruciate ligament injury in athletes.

Specifically, the validation of a new comparative methodology of biomechanics analysis will be performed, based on inertial sensors and musculoskeletal models. This way, brief but exhaustive description of functional characteristics of athletes could be created and easily used in ambulatory environment.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects, men of women, 18 years old minimum and 50 maximum, which read and signed the informed consent

Exclusion Criteria:

* evidence of any kind of musculoskeletal disease or impairment
* evidence of past surgical intervention to either lower or upper limbs
* age out of the inclusion range
* cardiac or pulmonary diseases
* inability to read and sign the informed consent
* inability to perform the motor tasks required

Primary outcomes:
measure: Lower limbs angles (extracted by inertial sensors/motion capture marker-based analysis): Hip, Knee, Ankle joint angles (all in degrees °)
timeFrame: 10 months
measure: Upper limbs angles (extracted by inertial sensors/motion capture marker-based analysis): Elbow, Wrist and Shoulder joint angles (all in degrees °)
timeFrame: 10 months
measure: Trunk angles (extracted by inertial sensors/motion capture marker-based analysis): Trunk sway and Trunk tilt (all in degrees °)
timeFrame: 10 months
measure: Trunk velocity (in m/s) extracted by inertial sensors/motion capture marker-based analysis
timeFrame: 10 months
measure: Trunk acceleration (in m/s^2) extracted by inertial sensors/motion capture marker-based analysis
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: BO
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Stefano Mr Zaffagnini, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03661151: Comparison of Treatment Outcome and Cost-effectiveness for GERD
Official title: Comparison of Treatment Effectiveness and Evaluation of Cost Between Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroesophageal Reflux
Keywords: Gastroesophageal reflux disease
Antireflux surgery
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
Collaborators: name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Kosin University Gospel Hospital
First posted: 2018-09-07
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: GERD patients who have history of PPI therapy and scheduled to undergo antireflux surgery

Brief summary: This study was designed to evaluate the effectiveness of laparoscopic antireflux surgery for treatment of gastroesophageal reflux disease (GERD) comparing with that of non-surgical treatment.

Detailed description: To treat GERD, the most patients with GERD are managed with acid suppressive medication first, and followed by antireflux surgery when the medical therapy is not effective or when the patient prefer surgery to quit the medicine.

This study has a single cohort in which the patient has the past history of GERD and medical treatment with proton pump inhibitors, and has scheduled to have laparoscopic antireflux surgery for treatment of GERD.

Treatment outcome of surgery will be evaluated comparing with the outcome of medical treatment before registration.

Eligibility criteria: Inclusion Criteria:

* Objectively diagnosed GERD
* Past history of medical treatment with PPI more than 8 weeks at any time before antireflux surgery
* Patients scheduled to undergo antireflux surgery to treat GERD

Exclusion Criteria:

* Other pathologic condition in upper gastrointestinal tract which needs surgical treatment
* No (or less than 8 weeks) past history of acid suppressive medical therapy with PPI
* Patients who underwent endoscopic antireflux procedure

Primary outcomes:
measure: Symptom Control Rate of Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)
timeFrame: Change from baseline GERD symptom at 3 months after antireflux surgery
Secondary outcomes:
measure: Medical Cost of Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)
timeFrame: Change from baseline medical cost (non-surgical) at 3 months after antireflux surgery
measure: Complication rate and adverse symptom rate related with antireflux surgery
timeFrame: Change from baseline GERD symptom at 3 months after antireflux surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Sungsoo Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03216954: Influence of n-Acetylcysteine Maintenance on Alcohol Effects
Official title: A Human Laboratory Study of n-Acetylcysteine for Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alcohol Use Disorder
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2017-07-13
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate the behavioral effects of alcohol during placebo and n-acetylcysteine maintenance using sophisticated human laboratory methods.


Eligibility criteria: Inclusion Criteria:

* able to speak/read English
* not seeking treatment at the time of the study
* one binge drinking episode (5+/4+ standard alcoholic drinks per drinking session for men and women, respectively) in the past 30 days
* recent alcohol use verified by ethyl glucuronide positive urine, as well as fulfillment of DSM-5 diagnostic criteria for alcohol use disorder
* ECG within normal limits
* otherwise healthy
* body mass index of 19-35
* females using an effective form of birth control and not pregnant or breast feeding
* judged by the medical staff to be psychiatrically and physically healthy
* able to abstain from alcohol for 12 hours prior to session
* no contraindications/allergies to n-acetylcysteine

Primary outcomes:
measure: Number of Alcohol Drinks Chosen
timeFrame: After at least four days of placebo or n-acetylcysteine maintenance
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: William W Stoops, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06357754: Transgene Assay Testing Service of Tumor Samples From Patients Who Received a Bristol-Myers Squibb Manufactured Gene Modified Cell Therapy and Have a Qualifying Second Primary Malignancy
Official title: Protocol for Transgene Assay Service
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukaemia
Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-04-10
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who receive a Bristol-Myers Squibb (BMS) manufactured Gene Modified Cell Therapy (GMCT) that have been diagnosed with a qualifying secondary malignancy

Brief summary: The purpose of this transgene assay testing service is to evaluate tumor samples for transgene levels in patients who received a commercially available Bristol-Myers Squibb manufactured gene modified cellular therapy and have reported a qualifying second malignancy.


Eligibility criteria: Inclusion Criteria:

* Participant has received a commercially available Bristol-Myers Squibb (BMS) manufactured Gene Modified Cell Therapy (GMCT) and has been diagnosed with a qualifying second primary malignancy or a second primary malignancy which BMS has qualified for testing.
* Participant has received a commercially available BMS manufactured GMCT in a clinical trial or other investigational setting (including non-conforming product) for which there is no testing protocol in place for that trial or investigational setting and has been diagnosed with a qualifying second primary malignancy or a second primary malignancy which BMS has qualified for testing.

Exclusion Criteria:

* Participant is actively participating in a clinical trial where information and sample collection is being conducted under that clinical trial.
* Participant has not received a BMS manufactured GMCT or has not been diagnosed with a qualifying second primary malignancy.

Primary outcomes:
measure: Participant in situ hybridization (ISH) or droplet-based digital Polymerase chain reaction (ddPCR) transgene testing results
timeFrame: Baseline
measure: Participant insertion site analysis (ISA) testing results
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Local Institution - 0008
state: Texas
city: Salt Lake City
country: United States
facility: Local Institution - 0010
state: Utah
city: Madison
country: United States
facility: Local Institution - 0004
state: Wisconsin
city: Essen
country: Germany
facility: Universitaetsklinikum Essen (AoR)
city: Toyokawa
country: Japan
facility: Local Institution - 0012
state: Aichi
city: Kumamoto-city
country: Japan
facility: Local Institution - 0003
state: Kumamoto
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06596954: Lymphocyte-sparing Thoracic Radiotherapy for Esophageal Squamous Cell Carcinoma
Official title: Lymphocyte-sparing Thoracic Radiotherapy Vs Conventional Radiotherapy for Esophageal Squamous Cell Carcinoma Treated with Neoadjuvant Therapy: an Open Label, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Squamous Cell Cancer
Keywords: esophageal cancer
neoadjuvant treatment
lymphocyte-sparing radiotherapy
prognosis
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Esophageal squamous cell carcinoma (ESCC) is one of the most aggressive malignant tumors. Although neoadjuvant chemoradiotherapy combined with surgery has significantly improved the survival rate of patients with locally advanced esophageal cancer, approximately half of the patients will experience local regional recurrence or distant metastasis. Lymphocytes are crucial immune cells in the human body, playing a key role in combating infections and tumor development. In recent years, an increasing body of research has indicated that lymphocyte depletion is a significant factor associated with poor prognosis in various solid tumors, including esophageal cancer. The lymphocyte depletion caused by radiotherapy has garnered considerable attention from oncologists. However, there is still a lack of prospective clinical research data on lymphocyte protection in thoracic tumors. Therefore, this study aims to provide high-level evidence from evidence-based medicine regarding the correlation between lymphocyte depletion and prognosis in esophageal cancer patients, offering more effective strategies and methods to improve the outcomes of neoadjuvant chemoradiotherapy for esophageal cancer.


Eligibility criteria: Inclusion Criteria:

1. patients approve and sign written informed consent;
2. Pathologically confirmed esophageal squamous cell carcinoma;
3. the age of patients should be more than 18 years, and less than 80 years;
4. KPS score of patients should be more than 80

Exclusion Criteria:

1. diagnosis of metastatic esophageal cancer;
2. Patient refuses to receive systemic drug treatment;
3. clinical diagnosis of pleural metastasis or malignant pleural effusion;
4. Pregnant or breastfeeding women;
5. Severe non-cancerous medical comorbidities that affect the implementation of radiotherapy.

Primary outcomes:
measure: acute grade 3/4 lymphopenia
timeFrame: 1 months after surgery
measure: Overall survival
timeFrame: 3 years
Secondary outcomes:
measure: recurrence-free survival
timeFrame: 2 year
measure: rate of pathological complete response
timeFrame: 1 months after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin hospital, Shanghai jiaotong university school of medicine
Study officials:
References:
Clinical trial NCT03253354: Neurostimulation for Dysphagia in Parkinson's Disease
Official title: Exploring Novel Neurostimulation Based Therapies for Swallowing Impairments in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Parkinson Disease
Swallowing Disorder.Other Specified
Brain Diseases
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Northern Care Alliance NHS Foundation Trust
First posted: 2017-08-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 arm randomised single dose study
Primary purpose: TREATMENT

Brief summary: This study will explore the effects of 3 different neurostimulation methods on swallowing function in patients with dysphagia secondary to Parkinson's Disease

Detailed description: The aim of this study is to assess 3 novel neuromodulation approaches - namely, pharyngeal stimulation, high frequency (5Hz) repetitive transcranial magnetic stimulation and low frequency (1Hz) repetitive transcranial magnetic stimulation on swallowing function in patients with dysphagia after Parkinson's Disease. A total of 66 patients are planned to be recruited, randomised to one of the 3 technologies or a sham treatment. A single treatment will be given and the effects will be assessed with a barium exam called videofluoroscopy within the 1st hour after the treatment. In addition, some measures of brain function will be recorded, before and after the treatments using single pulse transcranial magnetic stimulation.

Eligibility criteria: Inclusion Criteria:

Confirmed Parkinson's Disease with dysphagia

Exclusion Criteria:

Contraindications to magnetic stimulation, such as pacemakers, significant neuroleptic medications, pregnancy Other causes for dysphagia Unable to give informed written consent

Primary outcomes:
measure: Videofluoroscopy
timeFrame: 1 hour
Secondary outcomes:
measure: Brain excitability
timeFrame: Immediately after, 30 and 60 minutes
Other outcomes:
Locations:
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
state: Manchester
Study officials:
affiliation: University of Manchester
name: Shaheen Hamdy, PhD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06707454: Postoperative Clinical and Neurophysiological Assessment of Patients After Open Heart Surgery
Official title: Postoperative Clinical and Neurophysiological Assessment of Patients After Open Heart Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative
Clinical
Neurophysiological Assessment
Open Heart Surgery
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This prospective observational study will be conducted on 80 patients undergoing pump open heart surgery, either isolated coronary artery bypass grafting (CABG) or combined CABG and valve surgery, at the Cardiothorathic Academy of Ain Shams University hospitals.

Brief summary: This study aims to investigate postoperative clinical, cognitive and neurophysiological assessment of patients after open heart surgery among sample of Egyptian patients.

Detailed description: Coronary artery bypass grafting (CABAG) is one of the most common major surgical procedures, as more than 800,000 patients worldwide undergo myocardial revascularization procedures every year. Cardiopulmonary bypass (CPB) is an extracorporeal circulation procedure that assists the operation of cardiac and great vessels and is associated with perioperative morbidity and mortality.

Preoperative neurophysiological status as measured by electroencephalogram (EEG) had a specificity of 94.7% and a sensitivity of 76.9% for predicting 1-week postoperative cognitive status and with specificity of 78.3% and a sensitivity of 77.8% for predicting 3-months postoperative cognitive status.

Eligibility criteria: Inclusion Criteria:

* Patient ≥ 60 years.
* Both sexes.
* Patients who are scheduled for on-pump open heart surgery either isolated coronary artery bypass grafting (CABG) or combined CABG and valve surgery.

Exclusion Criteria:

* Patients with a past history of CNS disease (e.g. Epilepsy, brain tumors, or Dementia).
* Patients with metabolic disturbance.
* Illiterate patient.
* Patient with sever cognitive impairment on Mini-mental state Examination (MMSE) and/or Montreal Cognitive Assessment (MoCA)
* Patients who cannot undergo DEEG recordings (eg, uncooperative).
* Patients with abnormal brain images except for small vessel disease.

Primary outcomes:
measure: Neurological complications
timeFrame: 4 months postoperatively
Secondary outcomes:
measure: Electroencephalography (DEEG) monitoring
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT05920954: Urgent (<24 Hours) Versus Early (24 to 48 Hours) ERCP for Patients With Mild and Moderate Acute Cholangitis
Official title: Urgent (<24 Hours) Versus Early (24 to 48 Hours) ERCP for Patients With Mild and Moderate Acute Cholangitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Cholangitis
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 296
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: Acute Cholangitis is an emergency associated with significant morbidity and mortality which require prompt recognition and treatment. The decompression of biliary tree along with antibiotics are mainstay of therapy. Randomized comparative studies showed that ERCP achieves biliary decompression with markedly less morbidity and mortality compared with surgery, regardless of clinical drainage. Percutaneous trans hepatic drainage (PTBD) can be alternative to endoscopic drainage in selected group especially advanced hilar strictures and patients who are unfit for endoscopic procedure.

Recent ASGE guidelines suggested the performance of ERCP within 48 hours for patients with acute cholangitis; however it is conditional recommendation with very low quality of evidence. Till date, no randomized trial has compared urgent ERCP versus early ERCP for acute cholangitis.


Eligibility criteria: Inclusion Criteria:

* Patients who met criteria for a definite diagnosis acute cholangitis.

Exclusion Criteria:

* Patients with severe acute cholangitis at admission.
* Age \< 18 years.
* Pregnancy.
* Associated Acute Severe Pancreatitis.
* Patients with suspected high grade (Bismuth III/IV) biliary stricture in whom PTBD is considered as primary method of biliary drainage.
* Not giving consent.

Primary outcomes:
measure: ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization
timeFrame: Two Years
measure: ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization
timeFrame: Two Years
Secondary outcomes:
measure: ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization
timeFrame: Two Years
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: AIG Hospitals
state: Telangana
Study officials:
References:
Clinical trial NCT02267954: Fast Food Photo Study
Official title: What's Wrong With This Photo? Fast Food Literacy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Calories
Fast Food Literacy
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 309
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators aim to discover if people of different demographic levels are more or less attentive to changes in calorie information vs. changes in price information on a restaurant menu. The investigators will record whether the calorie/price change was noticed or not, as well as how quickly the calorie/price change was noticed, depending on condition and individual differences.

Detailed description: Participants complete a short study regarding their ability to detect "mistakes" in a printed version of a fast food restaurant menu. We ask participants to identify the differences between the menu board and a typical menu board at that location. Individuals list the differences that they find and have a chance to win a prize if they identify the most mistakes among participants recruited that day. The differences created will remain constant (e.g., featuring Pepsi products instead of the typical Coca-Cola offerings, including items from other restaurants on the menu), including changes to calorie labels and price labels. Additionally, we recruit participants in a variety of locations to test for differences between demographics (e.g., income groups, education levels, and BMI levels).

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Speaks English
* Willing to complete both task and follow-up survey

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Calorie and Price Mistakes Noticed
timeFrame: 10 minutes
Secondary outcomes:
measure: Time until Calorie and Price Mistakes Noticed
timeFrame: 10 minutes
measure: Mistake Number for Calorie and Price Mistakes Noticed
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Community College of Allegheny County
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
Study officials:
affiliation: Carnegie Mellon University
name: Eric M VanEpps, MS
role: PRINCIPAL_INVESTIGATOR
References: