louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04596605: Gastrointestinal Tolerance Assessment of T2309
Official title: Gastrointestinal Tolerance Assessment of T2309
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adult Subjects
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2020-10-22
Enrollment: 55
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gastrointestinal Tolerance assessment of T2309 compared to a food supplement in 50 subjects.


Eligibility criteria: Inclusion Criteria:

* Informed consent signed and dated
* Volunteer with no history of gastrointestinal disorders
* Volunteer agreeing not to consume a food supplement other than IP during the study period
* Registered, or agreeing to be registered, in the National Registry of Healthy Volunteers

Exclusion Criteria:

* Any known or suspected hypersensitivity or allergy
* History of or active severe chronic disease or relevant systemic condition incompatible with the study
* Pregnancy or breast-feeding or have planned pregnancy in the next 4 months
* Childbearing potential woman neither surgically sterilized nor using an adequate contraception
* Inability of the subject to understand the study procedures or to give informed consent
* Non-compliant subject
* Participation in this study at the same time as another clinical investigation/study
* Subject having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros
* Subject being institutionalized because of legal or regulatory order, inmate of psychiatric wards, prison or state institutions, or employee of the study site or of the Sponsor's company
* Subject not covered by the government health care scheme of the country in which he/she is living
* Subject with previous, current or anticipated prohibited treatment

Primary outcomes:
measure: Gastrointestinal Tolerance assessment
timeFrame: 12-week
Secondary outcomes:
measure: Composite score of gastrointestinal tolerance
timeFrame: 6 weeks
measure: Each component of the composite score of gastrointestinal tolerance
timeFrame: 6 weeks and 12 weeks
measure: Acceptability
timeFrame: 6 weeks and 12 weeks
Other outcomes:
Locations:
city: Nantes
country: France
facility: Centre Investigation Clinique
Study officials:
References:
Clinical trial NCT05698797: Proprioceptive Training vs. Hip Abductor With External Rotator Strengthening in Patients With Patellofemoral Pain
Official title: Effects of Proprioceptive Training vs. Hip Abductor With External Rotator Strengthening on Pain and Functions in Patients With Patellofemoral Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Keywords: Hip muscles strengthening
Rehabilitation
Proprioceptive training
Exercises
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patellofemoral pain syndrome (PFPS) is a common musculoskeletal disorder characterized by an insidious onset of pain in the knee's anterior /retro-patellar / peripatellar region. Even though various rehabilitation approaches, including hip strengthening and proprioceptive training, are being considered for managing PFPS, the most appropriate treatment from these two is still unclear. Therefore, this study aimed to compare the program consisting of hip abductors and external rotators strengthening exercises vs. the program consisting of proprioceptive training of the knee to identify the most effective rehabilitation approach for patients suffering from PFPS.


Eligibility criteria: Inclusion Criteria:

* Age 18-35 years
* Patients diagnosed recently by an orthopedic surgeon for Patello-femoral pain syndrome
* experiencing anterior/retro patellar knee pain during activities,
* insidious onset of symptoms not linked to trauma,
* pain persisting for no less than four weeks,
* pain on palpation of the patellar facets,
* pain when stepping down from a 25-cm step or during a double-legged squat.

Exclusion Criteria:

* Patients with recent lower limb fractures or dislocations,
* knee/hip joint surgery,
* signs, symptoms, or radiological findings of intra-articular pathology such as effusion, ligamentous or meniscal involvement,
* those with indications of patellar apprehension,
* referred pain from the hip, back, or sacroiliac joint,
* acute knee strain or sprain,
* on medication such as NSAIDs or corticosteroids,
* degenerative and infectious arthritis

Primary outcomes:
measure: Kujala Anterior Knee Pain Scale (AKPS)
timeFrame: 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: King Saud University
name: Masood Khan, M.P.Th
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06405997: The Genotype and Phenotype of Lymphangioleiomyomatosis
Official title: The Genotype and Phenotype of Lymphangioleiomyomatosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sporadic Lymphangioleiomyomatosis
TSC-associated Lymphangioleiomyomatosis
Keywords: Lymphangioleiomyomatosis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with Chest CT showed cystic lung disease, suspected Lymphangioleiomyomatosis in National Taiwan University Hospital

Brief summary: This study aims to differentiate between sporadic Lymphangioleiomyomatosis and Tuberous Sclerosis Complex-associated Lymphangioleiomyomatosis.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 y/o
* Patient with Chest CT showed cystic lung disease, suspected Lymphangioleiomyomatosis

Exclusion Criteria:

* age \< 18 y/o

Primary outcomes:
measure: The genotype and phenotype of lymphangioleiomyomatosis
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yao-Wen Kuo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06792305: The Sequence of Fixation in Tile C1.2 and C1.3 Vertical Shear Pelvic Ring Injuries.
Official title: SEQUENCE OF FIXATION IN VERTICALLY UNSTABLE TILE C1.2 AND C1.3 PELVIC RING INJURIES: A PROSPECTIVE COMPARATIVE STUDY
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Ring Fractures
Pelvic Ring Injury
Keywords: pelvic ring injuries
vertical shear pelvic fracture
tile classification
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this study is to compare the sequence of fixation in Vertically Unstable Tile C1.2 and C1.3 pelvic ring injuries, as regards clinical, radiological outcomes and implant failure rates. Our hypothesis is that starting with anterior ring fixation will achieve superior results as regards easier reduction, less operation time, and finally better radiological and functional outcomes when compared with starting with posterior ring fixation.


Eligibility criteria: Inclusion Criteria:

1. Age: 18 years - 60 years.
2. Tile C1.2 and C1.3 pelvic ring injuries.
3. Pure anterior ring ligamentous injuries.

Exclusion Criteria:

1. Bony fracture of the pubic rami.
2. Tile C2 and C3 pelvic ring injuries.
3. Associated acetabular fracture that requires intervention.

Primary outcomes:
measure: Radiological outcome scores
timeFrame: 12 months
measure: Clinical outcome score
timeFrame: 12 months
Secondary outcomes:
measure: Operative time in minutes.
timeFrame: 3 hours
measure: Implant failure rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams University Hospitals
Study officials:
References:
Clinical trial NCT03552705: The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients
Official title: Novel Strategies to Combat Post-Traumatic Osteoarthritis (PTOA):The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Anterior Cruciate Ligament Reconstruction
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2018-06-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients who tear their ACL are at high risk for developing arthritis (post-traumatic osteoarthritis-PTOA) just 10 years later. Joint bleeding and inflammation contribute to deterioration of joint health. This study will determine whether treatment with Tranexamic Acid (TXA), an FDA approved medication that reduces bleeding right after ACL injury and reconstructive surgery reduces inflammation and improves joint health as a new strategy to prevent or delay the onset of PTOA.


Eligibility criteria: Inclusion Criteria:

* age 18-30 years
* within 4 days of unilateral ACL injury
* presence of effusion/hemarthrosis.

Exclusion Criteria:

* inflammatory arthritis, radiographic osteoarthritis (K-L Grade 2 or higher), gout/ pseudogout
* systemic or acute illness requiring medications
* concomitant knee injury aside from meniscus tear and MCL tear not requiring surgery
* prior surgery to either knee
* prior injury to either knee requiring crutches
* history of thromboembolic disease
* current use of combination hormonal contraception
* chronic NSAID use
* cortisone injection to either knee within the prior 3 months
* not indicated for or unable to undergo ACLR within 3 months of injury

Primary outcomes:
measure: Synovial fluid IL-1
timeFrame: Day 5
measure: Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 6 months post-ACLR
Secondary outcomes:
measure: Quantitative MRI (qMRI)
timeFrame: 6 months post-ACLR
measure: Quantitative MRI
timeFrame: 2 years post-ACLR
measure: Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 2 years post-ACLR
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Constance Chu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03193905: Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery
Official title: Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia Following Anesthesia
Neurosurgery
Scoliosis
Kyphosis
Forced Air Warming
Major Spinal Fusion
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background

Major spinal surgery tend to be lengthy with an increased risk of hypothermia. A quality improvement project of patients undergoing major spinal surgery showed that 67 % were hypothermic at the beginning of surgery. Several patients expressed a feeling of coldness at the arrival of the operating theatre.

Aim

To evaluate if Bairhuggers Full Access Underbody blanket can prevent hypothermia at initiation if used as prewarming and intraoperative warming compared to the results from the local quality improvement project. In addition we aim to explore patients´ experiences of comfort in relation to their temperature.

Method

Temperature of patients undergoing major spinal surgery (n=30) will be assessed at arrival to the theatre, after insertion of bladder catheter, at the start and end of surgery using a bladder temperature. The patients´ experiences of comfort will be evaluated with a 5 point Likert at the arrival to the operating theatre and after ten minutes of active prewarming with Bairhuggers Full Access Underbody blanket. Preoperatively ten randomly chosen patients will be observed and later interviewed in order to obtain further information regarding their experiences of comfort in relation to their temperature.

Conclusion and perspectives

By increasing the investigators knowledge on Bairhuggers Full Access Underbody blanket and its effects in preventing hypothermia as well as gaining insight to patients´ experiences of comfort in relation to temperature, the investigators anticipate to improve pre-anesthetic care and minimize risk factors associated with hypothermia for patients undergoing major spinal surgery.


Eligibility criteria: Inclusion Criteria:

* Patients for elective major spinal surgery
* Patients ≥ 14 years
* Danish language

Exclusion Criteria:

* Patients\> 110 kg
* Patients with a temperature \> 37.5 ° C
* Patients with a temperature ≤ 35 ° C
* Cognitive impairment to such an extent that the patient does not understand the purpose of, nor is able to cooperate, with the project

Primary outcomes:
measure: Core temperature > 36 degrees Celsius
timeFrame: Althrough completion of the study 5 months from now
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Aalborg University Hospital
name: Mia Nørgaard Granum
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00764205: Randomized Trial of Prehospital Tropin Levels in Acute Coronary Syndrome (ACS)
Official title: Randomized Trial of Prehospital Troponin Assessment Using the i-STAT Blood Analyzer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Keywords: ACS
non STEMI
ECG troponin
iSTAT
Acute coronary syndrome without ST-segment elevation
Lead sponsor: Redmond Fire Department Medic One
Sponsor class: OTHER_GOV
Collaborators: name: Medic One Foundation
First posted: 2008-10-01
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen and treated by Redmond Fire Department Medic One.

Brief summary: This study randomizes patients seen by Redmond Medic One into a control arm and a study arm when they present with acute coronary syndrome and have non-contributory ECG's (i.e.non-STEMI). The control group is treated normally and delivered to the receiving hospital. The study group is treated normally as well, however troponin measurements are made using an i-STAT blood analyzer prior to hospital arrival. The results are presented to the receiving physician. Door-to-reperfusion time is monitored for both groups.


Eligibility criteria: Inclusion Criteria:

* Over years of age
* ACS without ST-segment elevation
* Patient being transported to one of two participating hospitals

Exclusion Criteria:

* Less then 18 years of age.
* Post cardiac arrest.
* ACS with ST-segment elevation.

Primary outcomes:
measure: Decrease door-to-reperfusion time for patients with non-STEMI's by measuring troponin levels prior to hospital arrival
timeFrame: 3-4 years
Secondary outcomes:
Other outcomes:
Locations:
city: -Mobile Units in King County-
country: United States
facility: Redmond Fire Department Medic One Units
state: Washington
Study officials:
affiliation: Redmond Fire Department Medic One
name: James P Jordan, BS, MS, MICP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02277405: Pediatric Intubation During Resuscitation
Official title: A Comparison of Endotracheal Intubation Using the Shikani Optical Stylet or the Endoeye Flexible Intubation During Pediatric Resuscitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation
Resuscitation
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-10-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study was to compare time and success rates of four intubation devices in a cardiopulmonary scenario with and without chest compressions with a standardized pediatric manikin model.

Detailed description: Emergency airway management during resuscitation is a critical skill in emergency medicine. According to the European Resuscitation Council (ERC) guidelines for resuscitation 2010 , endotracheal intubation (ETI) is considered the gold standard during resuscitation.

Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medical personnel (paramedics, nurses, physicians)

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases

Primary outcomes:
measure: Time to intubation
timeFrame: 1 month
Secondary outcomes:
measure: Success of intubation
timeFrame: 1 month
measure: VAS score
timeFrame: 1 month
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01905605: Phosphatidylcholine Supplementation in Infants
Official title: Phosphatidylcholine Supplementation in Infants With Diminished Sensory Gating
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Schizophrenia
Diminished P50 Sensory Gating
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Sensory gating is defined as the automatic process of inhibiting brain response to repeated auditory sounds. Infants who brains respond similarly to two identical sounds presented about 1/2 second apart are more likely to have later problems with attention than infants who suppress response to the second sound. This study will examine whether providing a nutritional supplement, phosphatidylcholine, for two months in infancy will result in an increased likelihood of developing more robust sensory gating.


Eligibility criteria: Inclusion Criteria:

* Healthy infant has an age (adjusted for gestational age at birth) of 1-7 weeks
* Diminished P50 sensory gating (ratio greater than or equal to 0.50)

Exclusion Criteria:

* No maternal reported tobacco use for greater than 1 year and no current tobacco use (as measured by urine cotinine levels)
* Trimethylaminuria, renal disease, liver disease, known chromosomal abnormality, chronic neurological disorder, premature birth, prenatal exposure to exogenous steroid use

Primary outcomes:
measure: Ratio of P50 auditory sensory gating
timeFrame: 8 weeks post initiation of treatment
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 4 weeks and 8 weeks after initiation of intervention
Other outcomes:
measure: Percentage of planned dietary supplement
timeFrame: 8 weeks
measure: Change in serum choline, betaine, and dimethylglycine levels
timeFrame: Randomization and 8 weeks
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Robert Freedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01510405: Phosphoproteomic Patterns as a Novel Biomarker for Aurora and Polo-like Kinase Inhibitors in Non-Small Cell Lung Cancer
Official title: Phosphoproteomic Patterns as a Novel Biomarker for Aurora and Polo-like Kinase Inhibitors in Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Keywords: Subjects undergoing or who have undergone thoracic surgery for presumed lung cancer.
The following procedures are allowed: Wedge resection, lobectomy, bilobectomy, segmentectomy and pneumonectomy thoracic surgical operations are permitted.
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2012-01-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have presumed lung cancer

Brief summary: The investigators have characterized in preclinical Non-Small Cell Lung Cancer (NSCLC) models the proteomic expression profile associated with exposure to Aurora and Polo-like kinase inhibitors. The identification of proteomic expression patterns in patients with NSCLC would be an important step in defining the possible role of these agents as potential targeted therapies for this clinically important disease. This study proposes to evaluate resected non-small cell lung cancer specimens for these proteomic expression profiles.


Eligibility criteria: Inclusion Criteria:

* Subjects undergoing or who have undergone thoracic surgery for presumed lung cancer
* Wedge resection, lobectomy, bilobectomy, segmentectomy and pneumonectomy thoracic surgical operations are permitted.
* Age ≥ 18 years.
* Subject meets criteria for thoracic surgery as determined by the thoracic surgeon.
* Able to provide written informed consent.

Exclusion Criteria:

* Subjects undergoing or who have undergone thoracic surgery for metastatic disease from other primary sources such as colorectal cancer, sarcoma, melanoma, breast cancer, bladder cancer, prostate cancer, esophageal cancer, pancreatic cancer, or gastric cancer will be excluded.
* Subjects who have received prior preoperative lung cancer anticancer therapy will be excluded.

Primary outcomes:
measure: Correlation between the Phosphoproteomic expression pattern of specific substrates of Aurora Kinase A and/or Polo-like kinase 1 (PLK1)
timeFrame: 2 years
Secondary outcomes:
measure: Phosphoproteomic Expression Profiles and Correlated Global Phosphoproteomics Expression patterns
timeFrame: 2 years
measure: Time to Disease Recurrence
timeFrame: 2 years
measure: Lung Cancer Specific Survival
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 Years
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: James R Rigas, MD
role: PRINCIPAL_INVESTIGATOR
References: