louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02055027: Adherence to Continuous Positive Airway Pressure Among Obstructive Sleep Apnoea Patients.
Official title: Adherence to Continuous Positive Airway Pressure Among Obstructive Sleep Apnoea Patients. An Anaesthetic Algorithmic Approach to Prevent Postoperative Complications.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea, Obstructive
Keywords: Sleep Apnea, Obstructive
Continuous Positive Airway Pressure
Perioperative Period
Lead sponsor: Astes
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 90
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: Sleep Study Center

Brief summary: Prospective study designed to identify factors that would predict patient adherence to CPAP (Continuous Positive Airway Pressure) therapy.

Detailed description: Prospective study designed to identify factors that would predict patient adherence to CPAP therapy.

Comparison between data recorded among patients and the data of the CPAP microchip.

Eligibility criteria: Inclusion Criteria:

* Adults (\> 18 patients)
* All patients under CPAP (Continuous Positive Airway Pressure) therapy coming for annual visit in the Sart-Tilman Sleep Study Center

Exclusion Criteria:

* Patient refusal

Primary outcomes:
measure: Number of hours of CPAP use by night
timeFrame: Baseline
Secondary outcomes:
measure: Lickert's scale to assess criteria of non-adherence
timeFrame: Baseline
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire (CHU) Sart-Tilman
Study officials:
affiliation: Astes
name: Eric Deflandre, MD, FCCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01745627: 755nm Alex Laser for Treatment of Pigmented and Vascular Lesions and Scars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Pigmented and Vascular Lesions and Scars
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-10
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of the safety and efficacy of the 755nm Alex laser for the treatment of benign pigmented and vascular lesions and scars


Eligibility criteria: Inclusion Criteria:

1. Healthy male or female subjects between 18 and 85 years of age.
2. Subjects with Fitzpatrick skin types I to VI.
3. Subjects who have unwanted pigmented lesions, vascular lesions, striae and/or hypertrophic or atrophic scars
4. Subject who are willing to consent to participate in the study.

4.2 Exclusion Criteria

1. Subject who will not be photographed or who will not cooperate with the post treatment care and follow up schedule
2. Hypersensitive to light exposure.
3. Active localized or systemic infections.
4. Taking medication for which sunlight is a contraindication.
5. History of squamous cell carcinoma or melanoma.
6. History of keloid scarring.
7. Use of oral isotretinoin (Accutane®) within 12 months of initial treatment or during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
8. Prior treatment with laser or other devices in treatment area within 3 months
9. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
10. Subjects who are pregnant, have been pregnant within the last 3 months, are currently breast feeding or are planning a pregnancy within the study period.
11. Subjects that the physician determines ineligible based on standard of care treatment.

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Primary outcomes:
measure: Clearance Based on Photographic Scale
timeFrame: 1 months post last treatment
measure: Clearance Based on Photographic Scale
timeFrame: 3 months post last treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Laser & Skin Surgery Center of New York
state: New York
Study officials:
affiliation: Cynosure, Inc.
name: Patricia Krantz
role: STUDY_DIRECTOR
References:
Clinical trial NCT04838327: Rare Subtypes of Gastrointestinal Cancers
Official title: Rare Subtypes of Gastrointestinal Cancers - Real-world Data and Liquid Biopsies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer of Gastrointestinal Tract
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 130
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: The study population consists of patients with rare subtypes of cancer of the gastrointestinal tract, who by standard of care are candidates for targeted treatment

Brief summary: A single-arm prospective observational translational study of biomarkers in patients receiving targeted treatment for rare subtypes of cancer of the Gastrointestinal Tract.

Detailed description: In this study, the investigators seek to investigate biological aspects in patients receiving targeted treatment for rare subtypes of cancer of the Gastrointestinal.

The targeted treatment will be given as per standard of care. Translational blood samples will be drawn pre-treatment, before the third cycle of chemotherapy, and hereafter corresponding to the planned imaging during treatment and follow up.

The total cell free DNA will be quantified in all samples. The samples will be analyzed for tumor specific mutations such as the KRAS, BRAF, and NRAS oncogenes, by ddPCR. Circulating tumor DNA will also be identified by hypermethylation markers, and a focused panel of next generation sequencing can be applied. The samples will also be analyzed for immune-related biomarkers.

The investigators expect to include up to 130 patients.

This is a purely observational translational study. Results will be analysed in relation to outcome data.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of a rare subtype of GI cancer including BRAF V600E mutation, MSI-H, HER2 and others
* Diagnosis of cancer of the gastrointestinal tract may be made by histo- or cyto-pathology, or by clinical and imaging criteria
* Planned for targeted treatment
* Age 18 years or older
* Able to understand written information
* Consent to samples for translational research

Exclusion Criteria:

* Conditions precluding translational blood sampling
* Another concomitant cancer

Primary outcomes:
measure: Feasibility and translational analysis
timeFrame: 2 years last patient
Secondary outcomes:
measure: Response rate
timeFrame: 6 months post-treatment
measure: Progression Free Survival
timeFrame: 2 years last patient
measure: Overall Survival
timeFrame: 2 years last patient
measure: Quality of Life by EORTC QLQ-C30
timeFrame: 2 years last patient
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Oncology, Aarhus University Hospital
Study officials:
affiliation: Experimental Clinical Oncology
name: Louise B Callesen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05340127: Summative Usability Study of CEREBO® - a Non Invasive Intracranial Hemorrhage Detector
Official title: Summative Usability Study of a Novel Device - CEREBO® for Non Invasive Detection of Intracranial Haemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Usability
Keywords: Ease of Use
Ease of learning
Satisfaction
Lead sponsor: Bioscan Research Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Traumatic brain injury is one of the most common reasons for visits to the Emergency Department. More than 90% of patients who have suffered from head trauma present with a mild traumatic brain injury. Most of these patients do not present any symptom at the time of diagnosis thus delaying the detection. CEREBO®, a non-invasive, portable, rapid, point-of-care intracranial haemorrhage detector can avoid delayed detection by decreasing the time from injury to the initial CT scan. The study aims at assessing the summative usability of the device by determining its ease of use, ease of learning and satisfaction among the medical health professionals. The participants will be trained before the study and will be assessed periodically. Each participant will use the device on at least 10 subjects.

Detailed description: A prospective interventional study designed to assess the summative usability and rapidity of CEREBO® - a portable device to detect intracranial haemorrhage. 10 participants from a Primary Health Centre will be enrolled in this study. The participants will be trained by the study staff before the study. The participant will fill in a questionnaire periodically. At the end of the study, the statistical analysis will be performed on the recorded data to establish the ease of use, ease of learning and satisfaction.

Eligibility criteria: Inclusion Criteria:

Operators

* Medical health professionals \>18 years of age with a valid medical license to practice medicine belonging to one of the following categories and have given a written consent to participate in the study.
* MBBS
* Ayush
* Nurse
* Others

Subjects

* Of all ages and gender, have understood the study and gave a written informed consent.

Exclusion Criteria:

Subjects

* Cognitively impaired subjects unable to understand the study procedure

Primary outcomes:
measure: To assess the usability of CEREBO® to detect intracranial haemorrhage
timeFrame: 2 week
Secondary outcomes:
measure: To assess the rapidity of CEREBO® to detect intracranial haemorrhage
timeFrame: 2 week
Other outcomes:
Locations:
Study officials:
affiliation: PHC, India
name: Dr.Kaushik Vitthlapara
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06911827: A Study of QLP2117 in Combination With QL2107 in Advanced Solid Tumor Patients
Official title: A Phase Ib/II Open-Label, Dose-Escalation and Dose-expansion Clinical Study to Evaluate the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in Combination With QL2107 in Advanced Solid Tumor Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumor
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the safety and efficacy of QLP2117 in combination with QL2107 in Advanced Solid Tumor Patients.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
* At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(phase Iba dose escalation only requires at least one assessable lesion)
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Agree to provide archived tumor tissue samples of primary or metastatic lesions.
* Have adequate organ function as described in the protocol.

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* HBsAg/HBcAb positive and HBV-DNA\>1000 copy/mL;HCV-Ab positive and detection of HCV-RNA suggested viral replication
* Is currently participating and receiving study medication in another study within 4 week prior to the first dose of study treatment
* Has an active autoimmune disease that has required systemic treatment in past 2 years.
* Has an active infection requiring systemic therapy
* Has received a live vaccine wihtin 30 days of planned start of study treatment
* Known history of, or any evidence of interstitial lung disease

Primary outcomes:
measure: Dose-limiting toxicity(DLT)
timeFrame: 21days
measure: Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
timeFrame: up to 96 weeks
measure: Objective Response Rate for phase II
timeFrame: up to 96 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00444327: Use Cord Blood Single Nucleotide Polymorphism to Predict the Later Development of Atopy and Allergy
Official title: Observational Study of Cord Blood Single Nucleotide Polymorphisms of Genes Related to Atopy and Allergic Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atopy
Allergic Disease
Keywords: single nucleotide polymorphism
Lead sponsor: Min-Sheng General Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
First posted: 2007-03-07
Enrollment: 900
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital and primary care clinic based study

Brief summary: The aim of our study was firstly to detect in cord bloods the polymorphism of genes related to atopy and allergic diseases and to examine their mutual interaction and their associations with cord blood IgE and cytokines. After that, in the prospective follow-up visits, we liked to investigate if the measurement of cord blood SNPs of genes related to atopy and allergic diseases was helpful in predicting the development of atopy and allergic diseases later in life.


Eligibility criteria: Inclusion Criteria:

* Apgar score of 5 minutes not less than 7 gestational age not less than 36 weeks

Exclusion Criteria:

* Apgar score of 5 minutes \< 7 gestational age \< 36 weeks

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Min-Sheng General Hospital
city: Taoyuan
country: Taiwan
facility: Min-Sheng General Hospital
Study officials:
affiliation: Min-Sheng General Hospital
name: Chien-Han Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00121927: Use of the Atkins Diet for Adults With Intractable Epilepsy
Official title: Use of the Atkins Diet for Adults With Intractable Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: intractable
ketogenic
ketosis
Atkins
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2005-07-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective study to determine whether the Atkins diet reduces seizures, creates ketosis, and is well tolerated in adults with epilepsy. Approximately 30 patients will be enrolled, expecting 20 to complete the 6-month study. The investigators plan to establish the seizure baseline and type, initiate the Atkins diet, then monitor its administration in terms of seizure reduction, ketosis, and side effects for a 6-month period.

Detailed description: Patients are seen in the Johns Hopkins General Clinical Research Center (GCRC) and started on a modified Atkins diet (15g/day of carbohydrates). Medications remain unchanged and labs are drawn. Followup is at 1 month, 3 months, and 6 months into the study. After 1 month, carbohydrates and medications can be altered. Ketosis (urine) is measured by patients semiweekly, weight weekly, and seizures daily and recorded on a calendar.

This study is ongoing with approximately 20 patients of 30 enrolled as of February 2006.

Eligibility criteria: Inclusion Criteria:

* Ages 18 and over
* Weekly seizures or 4 times per month
* Use of at least 2 anticonvulsant drugs

Exclusion Criteria:

* Prior use of the Atkins diet for \> 1 week
* Prior use of the ketogenic diet within the past year
* Kidney, heart disease, renal disease
* Hypercholesterolemia
* Pseudoseizures
* Pregnancy
* Body mass index (BMI) below 18.5
* Status epilepticus within the past 6 months
* 2 week seizure-free period within the past 6 months

Primary outcomes:
measure: Seizure reduction
Secondary outcomes:
measure: Ketosis
measure: tolerability
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital GCRC
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Eric H Kossoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kossoff EH, Krauss GL, McGrogan JR, Freeman JM. Efficacy of the Atkins diet as therapy for intractable epilepsy. Neurology. 2003 Dec 23;61(12):1789-91. doi: 10.1212/01.wnl.0000098889.35155.72.
Clinical trial NCT03608527: Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
Official title: The Impact of Motor Rehabilitation on the Dynamic Properties of the Brain: Towards the Individual Tailoring of Therapeutic Interventions in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Upper limb motor rehabilitation
Voluntary movements
functional magnetic resonance imaging
Lead sponsor: Fondazione Italiana Sclerosi Multipla
Sponsor class: OTHER
Collaborators: name: Universita degli Studi di Genova
First posted: 2018-08-01
Enrollment: 30
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: Motor learning can induce significant changes in the human brain through neural plasticity processes, which play a crucial role in the brain functional reorganization in response to external stimuli and/or to pathological conditions. For example, people with multiple sclerosis present motor deficits often associated with cerebral activity alteration. However, whether these brain activation changes contribute to or protect against motor performance deficits still needs to be determined.

Moreover, rehabilitation protocols could be designed to obtain efficient brain adaptation to preserve patients' outcome, but consistent data on the real efficacy of rehabilitative procedures are lacking, in particular concerning the rehabilitation effect on brain networks.

Therefore, this project focuses on the degree to which imaging measures of functional brain activity can give new hints on the effects of motor rehabilitative protocols in multiple sclerosis patients' performance. Particularly, the investigator's aim is to investigate the effects of upper limb rehabilitation, focused on hand motor function, and the correlation between motor performance and functional magnetic resonance data.


Eligibility criteria: Inclusion Criteria:

* Multiple sclerosis diagnosis according to McDonald criteria
* right handedness as assessed by the Edinburgh Handedness Inventory
* absence of relapses in the last three months
* mild or moderate sensorimotor impairment in one or both upper limbs as evaluated by means of the Medical Research Council scale (grade 3-4)

Exclusion Criteria:

* steroid-use or a worsening of the Expanded Disability Status Scale (EDSS) score in the last three months
* psychiatric disorders
* severe cognitive impairment
* magnetic resonance imaging contraindications

Primary outcomes:
measure: Change in the time to perform the Nine Hole Peg Test (NHPT)
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Score obtained at the Action Research Arm Test (ARAT)
timeFrame: Baseline and 8 weeks
measure: Grip and pinch strength
timeFrame: Baseline and 8 weeks
measure: Brain activity (blood-oxygenation-level dependent signal)
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Universita degli Studi di Genova
name: Marco Bove, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05637827: The Initiating Factors of Myopia Among Primary and Secondary School Students in Tianjin
Official title: The Initiating Factors of Myopia Among Primary and Secondary School Students in Tianjin
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myopia; Refractive Error
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 200
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy children with hyperopia, emmetropia and myopia

Brief summary: There was a prospective cohort observational study. Forty hyperopic children, 40 myopic children and 120 emmetropia children were randomly selected from grade 1 to grade 3, and were followed up every six months for 3 years. All patients received cycloplegic refraction examination, ocular biological test, binocular visual function test and a questionnaire related to daily eye habits. A multi-level and multi-dimensional data analysis model was constructed to explore the possible factors affecting the occurrence and development of myopia in children.


Eligibility criteria: Inclusion Criteria:

* students in grades 1-3
* Can cooperate with the examination of students

Exclusion Criteria:

* Obvious strabismus and amblyopia
* Eye diseases that affect vision, such as congenital cataracts, glaucoma, and retinal diseases
* History of ocular surgery

Primary outcomes:
measure: The changes of refractive error
timeFrame: Every 6 months for a period 3 years
measure: The changes of axial length
timeFrame: Every 6 months for a period 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
state: Tianjin
Study officials:
References:
citation: Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.
citation: Rose KA, French AN, Morgan IG. Environmental Factors and Myopia: Paradoxes and Prospects for Prevention. Asia Pac J Ophthalmol (Phila). 2016 Nov/Dec;5(6):403-410. doi: 10.1097/APO.0000000000000233.
citation: Seidemann A, Schaeffel F. An evaluation of the lag of accommodation using photorefraction. Vision Res. 2003 Feb;43(4):419-30. doi: 10.1016/s0042-6989(02)00571-0.