louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02988557: Walking Inclined Plane
Official title: Evaluation of the Effect of an Inclined Plane on the Walking of Children With Cerebral Palsy: What Are the Paths for Rehabilitation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Spastic Diplegia
Keywords: cerebral palsy
gait
slope
electromyography
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 29
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The adaptations in kinematics and muscle activity, investigated by 3D gait analysis and dynamic electromyography recordings, will be studied in children with bilateral spastic cerebral palsy during level walking, and before and after a training on a treadmill with a sloped surface (7°). Data will be compared with those obtained in a sample of typically developing (TD) children (controls)

Detailed description: 15 CP children and 15 TD children aged 6 to 14 years will take part in this study. Dynamic EMG recordings will be performed as well as kinematic data assessments through a gait analysis system. Three different slopes will be assessed, using a treadmill. The primary outcome measure will be the minimal knee extension value in the stance phase. The changes in kinematics will be overall assessed through the Gait Profile Score (Baker et al.). The details in changes will be assessed through statistical parametric mapping (SPM). The changes in muscle activity induced by the slope will be investigated by statistical parametric mapping of the EMG or kinematic data.

Eligibility criteria: Inclusion Criteria for children with CP:

* age = 6-14 years old
* children with cerebral palsy: spastic type, bilateral involvement, forefoot initial contact and/or excessive knee flexion at mid-stance and/or decreased hip extension in late stance.
* GMFCS I or II,
* Score on Gillette scale between 8 and 10
* able to walk at least 10 min without help

Inclusion Criteria for TD children:

* age = 6-14 years old

Exclusion Criteria:

* botulinum toxin injection or lower limb surgery within the last year.
* Uncontrolled seizures

Primary outcomes:
measure: minimal knee extension in stance (kinematics)
timeFrame: 1 day (single evaluation)
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
References:
Clinical trial NCT00976157: Serial Changes in sTREM-1 During Ventilator-associated Pneumonia (VAP)
Official title: Serial Changes of Soluble TREM-1 Level in Bronchoalveolar Lavage Fluid During Ventilator-associated Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Keywords: STREM-1
BAL
VAP
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2009-09-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were clinically suspected to have VAP were enrolled in the study. VAP was clinically diagnosed with a new infiltrate on a chest radiograph in a patient receiving mechanical ventilation for more than 48 hr with at least one of the following: purulent tracheal secretions, a body temperature \>38°C or \<36°C, and leukocytosis (WBC \> 10,000/mm³) or leukopenia (WBC \< 4000/mm³)

Brief summary: Triggering receptor expressed on myeloid cells (TREM)-1 is a recently described molecule that plays an important role in myeloid cell-activated inflammatory responses. The aim of this study was to investigate the evolutional change of soluble TREM-1 (sTREM-1) in bronchoalveolar lavage (BAL) fluid of clinically diagnosed ventilator-associated pneumonia (VAP) and its correlation with response to treatment and outcome.

Detailed description: A prospective, interventional study conducted between August 2006 and August 2007 in MICU in Mackay Memorial Hospital, 35 patients with clinically diagnosed VAP were investigated. sTREM-1 was measured in BAL samples using ELISA at the onset, 4th - 5th and 7th - 9th day of clinical diagnosis of VAP.Of these 35 patients, 27 had positive BAL culture. The sTREM-1 levels in BAL fluid were measured and compared between patients with positive BAL culture and negative BAL culture. Serial changes in sTREM-1 levels were evaluated in relation to patient outcome.

Eligibility criteria: Inclusion Criteria:

* adult patients (older than 18 years)with clinically suspected VAP

Exclusion Criteria:

* mechanically ventilated patients post cardiopulmonary resuscitation
* patients with end stage diseases with life expectancy less than 3 months
* patients with solid or hematology transplantation
* patients on immunosuppressive agents

Primary outcomes:
measure: mortality
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
affiliation: Mackay Memorial Hospital, Taipei, Taiwan
name: Chien Liang Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01094457: Effects of Intensive Antiplatelet Therapy for Patients With Clopidogrel Resistance After Coronary Stent Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndromes
Percutaneous Coronary Intervention
Clopidogrel Low Responsiveness
Keywords: antiplatelet therapy
clopidogrel low responsiveness
acute coronary syndromes
percutaneous coronary intervention
cilostazol
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2010-03-29
Enrollment: 840
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clopidogrel resistance (CR) or low-responsiveness is associated with increased risk of ischemic events and can be detected by laboratory tests. This multicenter, randomized study is aimed to explore the efficacy and safety of intensive antiplatelet therapy (i.e. double clopidogrel maintenance dose and/or additional cilostazol)for patients with CR after coronary stenting.


Eligibility criteria: Inclusion Criterial:

* aged 35 to 75 years
* acute coronary syndromes
* underwent successful coronary stent implantation
* informed consent

Exclusion Criteria:

* contraindications to antiplatelet therapy
* history of intracranial bleeding
* known bleeding disorders
* severe liver or kidney disease
* pregnancy
* left main coronary artery disease
* planned non cardiac surgery within 1 year
* end stage of other serious disease with life expectancy less than 1 year
* heart failure with NYHA grade 3 to 4

Primary outcomes:
measure: Major ischemic cardiovascular events
timeFrame: 1 year
Secondary outcomes:
measure: Stent thrombosis
timeFrame: 1 year
measure: major adverse cardiac and cerebral events(MACCE)
timeFrame: 1 year
measure: Hemorrhagic events
timeFrame: within 1 year
measure: reduction in ADP induced platelet aggregation
timeFrame: 30 days
Other outcomes:
Locations:
city: Shenyang
country: China
facility: 463 Hospital of PLA
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shenyang Northern Hospital
state: Liaoning
Study officials:
affiliation: Shenyang Northern Hospital
name: Yaling Han, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01744457: Reproducibility of Tearfilm Osmolarity Measurements Using TearLab® in Patients With Dry Eye Syndrome and Healthy Subjects
Official title: Reproducibility of Tearfilm Osmolarity Measurements Using TearLab® in Patients With Dry Eye Syndrome and Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Keywords: tear film osmolarity
objective scattering index
tear break up time
Schirmer I test
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Dry Eye Syndrome (DES) is a common condition that affects approximately 20% of adults aged 45 and older. Although several clinical tests for the diagnosis and monitoring of DES are available, currently no gold standard for the assessment of DES exists. It has, however, been hypothesized that the assessment of tear film osmolarity may be a new and promising approach of an objective and non-invasive method for diagnosis and monitoring of treatment success.

Recently, a new commercially available instrument (TearLab®, OcuSens Inc, San Diego, USA) for the assessment of tear film osmolarity has been introduced. This instrument allows for the easy and non-invasive determination of tear film osmolarity. Unfortunately, no data about reproducibility are yet available. Consequently, the current study sets out to investigate the short time reproducibility of tear film osmolarity measurements using the TearLab® instrument.


Eligibility criteria: Inclusion Criteria:

Patients with dry eye syndrome (DES):

* Men and Women aged between 45 and 80 years, with DES defined as a pathological Schirmer I test and / or a pathological break-up time test. Schirmer I test and break up time will be tested and analyzed according to the guidelines published in the Report of the International Dry EyeWorkShop (DEWS) 2007
* normal findings in the ophthalmic examination other than DES

Healthy control group:

* Men and Women aged between 45 and 80 years,
* normal findings in the medical history and ophthalmic examination

Exclusion Criteria:

* Abuse of drugs or alcoholic beverages
* Participation in a clinical trial
* Symptoms of a clinically relevant illness

Primary outcomes:
measure: Coefficient of variation of tear film osmolarity after repeated measurements
timeFrame: Measurement of tear film osmolarity 3 times daily within 30 minutes for 3 consecutive days
Secondary outcomes:
measure: Subjective symptoms assessed using the OSDI test
timeFrame: on the screening day
measure: Tear break up time
timeFrame: on 3 consecutive study days once a day
measure: Schirmer I test
timeFrame: on 3 consecutive study days once a day
measure: OSI (Objective Scattering Index)
timeFrame: on 3 consecutive study days once a day
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
References:
Clinical trial NCT01068457: Chronic Pain After Thoracotomy (Video Assisted Thoracic Surgery - VATS)
Official title: Chronic Pain After Thoracotomy (VATS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropathic Pain
Thoracic Surgery, Video Assisted
Chronic Pain
Keywords: persistent pain
neuropathic pain
Thoracic Surgery, Video Assisted
Chronic Pain
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2010-02-15
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung cancer patients

Brief summary: This is an explorative study investigating potential nerve injury after VATS.


Eligibility criteria: Inclusion Criteria:

* Able to understand and give consent
* Can read
* Residing in Denmark

Exclusion Criteria:

* Unable to understand the written information in Danish
* Abuse (Medicine, Drugs, Alcohol)
* Severe psychiatric Illness
* Conflicting neurological disease

Primary outcomes:
measure: Thresholds via QST
timeFrame: Late postoperatively (3months)
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Section for Surgical Pathophysiology 4074 andSection of Acute Pain management and Palliative Medicine.
Study officials:
References:
citation: Wildgaard K, Ravn J, Kehlet H. Chronic post-thoracotomy pain: a critical review of pathogenic mechanisms and strategies for prevention. Eur J Cardiothorac Surg. 2009 Jul;36(1):170-80. doi: 10.1016/j.ejcts.2009.02.005.
Clinical trial NCT05942248: The Use of Image-Based Computer Gradings in the Analysis of Acne, Rosacea, Melasma, and Seborrheic Dermatitis
Official title: The Use of Image-Based Computer Gradings in the Analysis of Acne, Rosacea, Melasma, and Seborrheic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acne
Melasma
Rosacea
Seborrheic Dermatitis
Keywords: Artificial Intelligent
Skin
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: Codex Labs
First posted: 2023-07-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study is conducted to determine if image-based computer grading can of acne, melasma, rosacea and seborrheic dermatitis correlate well to expert based clinical severity grading.

Detailed description: The study is conducted to determine if image-based computer grading can of acne, melasma, rosacea and seborrheic dermatitis correlate well to dermatologist based clinical severity grading.

Eligibility criteria: Inclusion Criteria:

* Adults with acne, rosacea, melasma or seborrheic dermatitis

Exclusion Criteria:

* Prisoners
* Adults unable to consent
* Artificial facial markings on day of facial photography (such as piercings and tattoos) that may interfere with imaging in the opinion of the investigator

Primary outcomes:
measure: Correlation of image-based grading to clinical gradings for acne
timeFrame: Baseline
measure: Correlation of image-based grading to clinical gradings for rosacea
timeFrame: Baseline
measure: Correlation of image-based grading to clinical gradings for melasma
timeFrame: Baseline
measure: Correlation of image-based grading to clinical gradings for seborrheic dermatitis
timeFrame: Baseline
Secondary outcomes:
measure: Sebum excretion rate
timeFrame: Baseline
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin and Research
state: California
Study officials:
affiliation: Integrative Skin and Research
name: Raja Sivamani, MD, MS, AP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05730348: Mealtime Anxiety in Eating Disorders
Official title: Mealtime Anxiety in Eating Disorders: An Ecological Momentary Assessment (EMA) Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eating Disorders
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Dam Foundation
First posted: 2023-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be patients suffering from eating disorders, treated at a specialized eating disorder unit, at tertiary level of health care. The population is expected to primarily consist of individuals suffering from anorexia nervosa, but all patients admitted to the ward will be invited to participate, independent of eating disorder diagnosis.

Brief summary: The goal of this observational study is to assess mealtime anxiety in patients with eating disorders receiving treatment at an in-patient unit. Anxiety wil be assessed using ecological momentary assessment (EMA). The main research question is:

• Does post meal activity reduce anxiety in patients with eating disorders?

Study participation will last for two weeks. Participants will be reporting current levels of anxiety/distress on an EMA mobile app during treatment as usual. During one of the two study participation weeks, the participants will perform post mealtime activity.


Eligibility criteria: Inclusion Criteria:

* All patients admitted to the Regional Department for Eating Disorders adult in-patient unit (\>16 years old) will be invited to participate.

Exclusion Criteria:

* Patients who receive tube feeding for all meals during the study period will be excluded.

Primary outcomes:
measure: Change in Self Reported Anxiety During Treatment as Usual vs Treatment as Usual plus Post-Mealtime Activity
timeFrame: Two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Regional Department for Eating Disorders
Study officials:
affiliation: Oslo University Hospital
name: Kristin Stedal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06171048: Study Evaluating the Pharmacokinetics of CM310 in Healthy Subjects
Official title: A Pharmacokinetics Study of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2023-12-14
Enrollment: 236
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-center, randomized, open-label study to evaluate the pharmacokinetics of CM310 in healthy subjects.

Detailed description: This study includes screening and treatment and follow-up periods.

Eligibility criteria: Inclusion Criteria:

* 20 years ≤ age ≤ 45 years.
* Voluntarily participate in the study and sign the ICF.
* Have the ability to understand the study.

Exclusion Criteria:

* With history of chronic or serious illness.
* With any medication within 28 days prior to administration;
* Plan to undergo surgery during the research period;
* With any situations unsuitable to participate in this study.

Primary outcomes:
measure: Pharmacokinetic: the maximum concentration (Cmax)
timeFrame: up to week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
Study officials:
affiliation: The Second Hospital of Anhui Medical University
name: Wei Hu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03183648: A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-BI-201 Clinical Trial
Official title: A Follow-up Study to Evaluate the Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 2 Clinical Trial of ALLO-ASC-BI-201
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burn
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-12
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subject is enrolled who are treated with ALLO-ASC-DFU sheet in phase 2 clinical trial of ALLO-ASC-BI-201

Brief summary: This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-BI-201) for 23 months.

Detailed description: This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-BI-201) for 23 months.

ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor(VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a burn.

Eligibility criteria: Inclusion Criteria:

1. Subjects who are treated with ALLO-ASC-DFU sheet in phase 2 clinical trial of ALLO-ASC-BI-201.
2. A subject who is willing to follow the protocol and provide informed consent on screening, given that the information with respect to the clinical trial is provided.

Exclusion Criteria:

1. Subjects who are considered not suitable for the study by the principal investigator.

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: up to 24 months
Secondary outcomes:
measure: Vancouver Burn Scar Scale
timeFrame: Every time of visit for follow up to 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hallym university Medical Center
Study officials:
affiliation: Hallym University Medical Center
name: Wook Chun, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06232148: Cost Evaluation of Robotic Ventral Hernia Repair
Official title: Procedural Cost Analyses of Robotic Ventral Hernia Repair Compared With Laparoscopic or Open Repair: A Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventral Hernia
Keywords: cost
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing ventral hernia repair in the inclusion period

Brief summary: To evaluate the procedural cost of robotic ventral hernia repair compared with open ventral hernia repair.

Detailed description: Ventral hernia repair is one of the most frequently performed elective surgeries worldwide. The surgical approaches vary depending on the patient characteristics, type, and location the of ventral hernia, as well as the surgeons' preferences and equipment availability.

The choice between an open or minimally invasive approach has been debated for years, and it seems clear that the risk of wound infection is significantly decreased when choosing a minimally invasive approach, whereas there are no significant difference in recurrence rates. In the past decades, the use of a robotic system for ventral hernia repair has gained increasing popularity due to an easy access to the preperitoneal or retromuscular plane with a minimally invasive technique.

Two nationwide cohort studies concluded that length of stay and postoperative morbidity was decreased for robot-assisted repairs compared to open or laparoscopic ventral hernia repairs. Critics of robot-assisted surgery argue that it is time-consuming, too expensive, and that further cost-effectiveness analyses are needed to weigh the clinical benefits.

The aim of these studies was to compare the procedure-specific cost of robot-assisted with open primary ventral and incisional hernia repair and thereafter with laparoscopic repairs.

Eligibility criteria: Inclusion Criteria: patients undergoing elective primary ventral and incisional hernia repair -

Exclusion Criteria: none

-

Primary outcomes:
measure: Mean procedural cost
timeFrame: at the procedure
Secondary outcomes:
measure: Cost incisional
timeFrame: at the procedure
measure: Cost primary ventral
timeFrame: at the procedure
Other outcomes:
Locations:
Study officials:
References:
citation: Henriksen NA, Helgstrand F, Jensen KK. Short-term outcomes after open versus robot-assisted repair of ventral hernias: a nationwide database study. Hernia. 2024 Feb;28(1):233-240. doi: 10.1007/s10029-023-02923-8. Epub 2023 Nov 30.
citation: Jensen KK, Helgstrand F, Henriksen NA. Short-term Outcomes After Laparoscopic IPOM Versus Robot-assisted Retromuscular Repair of Small to Medium Ventral Hernias: A Nationwide Database Study. Ann Surg. 2024 Jan 1;279(1):154-159. doi: 10.1097/SLA.0000000000005915. Epub 2023 May 22.