louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05851469: Study of a Non-invasive Glucose Measuring Device
Official title: An Explorative, Non-randomized, Open-label, In-clinic Study, Investigating the Performance of a Novel Non-invasive Glucose Monitoring Device Using a New Guided Calibration Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Non-invasive
Blood sugar
Raman spectroscopy
Lead sponsor: RSP Systems A/S
Sponsor class: INDUSTRY
First posted: 2023-05-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This explorative clinical investigation has been launched to collect spectral Raman data paired with validated glucose reference values in persons with diabetes.


Eligibility criteria: Inclusion Criteria:

1. Male or female subject ≥18 years.
2. Subject with type 2 diabetes.
3. Signed informed consent form (ICF).

Exclusion Criteria:

1. Individual treated with intensified insulin treatment.
2. Sodium, Potassium. Creatinine, eGFR, and ALAT (more than three times the upper limit of normal range).
3. Clinically relevant anaemia or thrombocytopenia.
4. Infection with hepatitis B, C or HIV (if subject participates in subprotocol 1).
5. Intake of anticoagulant medication (with the exception of acetylsalicylic acid, ASS 100).
6. For female subjects: Pregnancy or breastfeeding or lack of a negative pregnancy test (except in case of menopause, sterilization, or hysterectomy).
7. Subjects not able to understand and read local language.
8. Cognitive impairment, or in investigator's opinion, subject is not able to follow instructions provided and as specified in the clinical investigation plan (CIP).
9. Subject not able to hold hand/arm steady (including tremors and Parkinson's Disease).
10. Skin changes, tattoos, or diseases on right thenar (measurement site).
11. Reduced circulation in right hand evaluated by Allen's test.
12. Known allergy to medical grade alcohol.
13. Haemodialysis.
14. Topical administration of glucocorticoids at the right hand for the past 7 days or during the study period.
15. Any disorder, which in the investigator's opinion, might jeopardise subject's safety or compliance with the CIP.
16. Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g., mental, or visual incapacity, language barriers, alcohol or drug abuse.
17. Dependency from the sponsor or the clinical investigator (e.g., co-workers of the sponsor, the study site, and/ or their families).
18. Subjects currently participating in another study.

Primary outcomes:
measure: Clinical performance
timeFrame: 2 days
Secondary outcomes:
measure: Adverse events
timeFrame: 4 days
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Study officials:
References:
Clinical trial NCT01033669: Assessment Of The Inhalation Profiles Of Four Dry Powder Inhalers In Patients With Variable Degrees Of Lung Obstruction
Official title: A Randomized Cross-Over Study Investigating The Inhalation Profiles Of Four Dry Powder Inhalation Devices In Subjects With Asthma And Chronic Obstructive Pulmonary Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Pulmonary Disease, Chronic Obstructive
Keywords: Inhalation profiles
asthma
COPD
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-12-16
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Asthma and COPD patients

Brief summary: Assessment of the inhalation profiles of four dry powder inhalers in patients with variable degrees of lung obstruction

Detailed description: Randomized to device sequence

Eligibility criteria: Inclusion Criteria:

* Subjects with a physician documented history or diagnosis of asthma for at least 6 months
* Reversibility, defined as an increase in FEV1 at the Screening visit of greater than or equal to 12% and 200 mL
* Subjects with a physician documented history or diagnosis of mild or severe Chronic Obstructive Pulmonary Disease

Exclusion Criteria:

* Female subjects who are pregnant
* Subjects who have a history of life-threatening asthma/COPD or who have experienced two or more exacerbations requiring hospitalization in the 12 months prior to screening
* Evidence of lower respiratory tract infection
* Subjects diagnosed with pulmonary fibrosis, bronchiectasis, pneumoconiosis, sarcoidosis or tuberculosis

Primary outcomes:
measure: Peak Inspiratory Flow Rate
timeFrame: Day 3-10
Secondary outcomes:
measure: Pressure Slope
timeFrame: Day 3-10
measure: Peak Pressure Drop
timeFrame: Day 3-10
measure: Time to Peak Pressure Drop
timeFrame: Day 3-10
measure: Inhaled Volume
timeFrame: Day 3-10
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06533969: Assessment of Neural Signals for the Control of Assistive Devices
Official title: Assessment of Neural Signals for the Control of Assistive Devices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injury (SCI), Initial Encounter
Keywords: Brain Computer Interface
Epidural Spinal Cord Stimulation
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study will investigate the use of motor intention-based cortical signals to trigger epidural spinal cord stimulation (ESCS) with individuals with SCI. Motor intention of UL tasks will be decoded using brain-computer interface (BCI) system based on cortical signals recorded using an Electroencephalographic (EEG) system or using their intracranially implanted devices Electrocorticographic (ECoG).


Eligibility criteria: Inclusion Criteria:

* Patients age 18 and older
* Able to sign informed consent
* Not participating in other studies that limit participation
* Chronic (\>6 month) traumatic Spinal Cord Injury (SCI) (C4-T1 neurological injury with American Spinal Injury Association Impairment Scale (AIS A-D) with some residual function.

Exclusion Criteria:

* Patients that are pregnant
* Patients under the age of 18
* Patients unable to provide informed consent

Primary outcomes:
measure: Change in Hand Motor Function
timeFrame: Baseline, up to 2 months post-implant
measure: Change in Hand Motor Evoked Potential (MEP)
timeFrame: Baseline, up to 2 months post-implant
Secondary outcomes:
measure: Change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP)
timeFrame: Baseline, up to 2 months post-implant
measure: Change in Muscle Coordination Measured by Electromyography (EMG)
timeFrame: Baseline, up to 2 months post-implant
measure: Change in Movement Kinematics
timeFrame: Baseline, up to 2 months post-implant
measure: Change in Muscle Strength
timeFrame: Baseline, up to 2 months post-implant
measure: Change in Quality of Life
timeFrame: Baseline, up to 2 months post-implant
measure: Change in Independence Measured by Spinal Cord Independence Measure (SCIM III)
timeFrame: Baseline, up to 2 months post-implant
measure: Change in Satisfaction of Life
timeFrame: Baseline, up to 2 months post-implant
measure: Change in Pain Levels
timeFrame: Baseline, up to 2 months post-implant
Other outcomes:
Locations:
city: Miami
country: United States
facility: Lynn Rehabilitation Center
state: Florida
city: Miami
country: United States
facility: The Miami Project to Cure Paralysis
state: Florida
Study officials:
affiliation: University of Miami
name: Jonathan R Jagid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06073769: A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia
Official title: Onureg® (Oral Azacitidine) Post-Marketing Surveillance in Korean Patients With Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myeloid Leukemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-10-10
Enrollment: 154
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults in Korea with acute myeloid leukemia receiving maintenance therapy with oral azacitidine who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction chemotherapy with or without consolidation therapy, and who are not eligible for hematopoietic stem cell transplantation (HSCT).

Brief summary: The purpose of this observational study is to assess the real-world safety of maintenance therapy with oral azacitidine in Korean participants with acute myeloid leukemia (AML) who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction chemotherapy with or without consolidation therapy, and who are not eligible for hematopoietic stem cell transplantation (HSCT).


Eligibility criteria: Inclusion Criteria:

* Adult participants 19 years of age or older
* Participants who receive oral azacitidine according to the approved label
* For the first 2 years after marketing authorization, all participants who have received or are receiving oral azacitidine will also be registered
* Participants who sign the informed consent form

Exclusion Criteria:

* Participants who are prescribed oral azacitidine for therapeutic indications not approved in Korea
* Participants for whom oral azacitidine is contraindicated per the Korean prescribing information approved by ministry of food and drug safety

Primary outcomes:
measure: Number of participants with adverse events (AES)
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0001
city: Seoul
country: Korea, Republic of
facility: Novotech Laboratory Korea Co., Ltd.
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04947969: Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue
Official title: Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer-related Fatigue
Keywords: Laser acupuncture
Lead sponsor: Taichung Tzu Chi Hospital
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized controlled, double blind, cross-over study.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the clinical effect of laser acupuncture on improving cancer-related fatigue

Detailed description: This study adopted a randomized controlled design, 2-arm trial cross-over study. All eligible patients included in the study agreed to participated and signed the informed consent from and the study procedures were approved by the ethical committee of Taichung Tzu Chi general hospital (REC110-09). Patients were recruited from the hematology oncology department of Taichung Tzu Chi general hospital. After random assignment to 2 groups, patients in the RS and SR groups will receive real and shame laser acupuncture. Before laser acupuncture, one week later, we will evaluate the patient-reported cancer-related fatigue index and other co-morbid symptoms.

Eligibility criteria: Inclusion Criteria:

* Adults between 18 to 85 years old
* Patients who signed the informed consent form
* Patients who have been given a diagnosis of cancer
* Able to communicate verbally and completely fill the questionnaires

Exclusion Criteria:

* Patients who have given a diagnosis of cognitive impairment are unable to completely the questionnaires

Primary outcomes:
measure: Cancer-related fatigue evaluation
timeFrame: 30 minutes
measure: Cancer-related fatigue Assessment
timeFrame: 15 minutes
Secondary outcomes:
measure: Quality of Life Assessments
timeFrame: 15 minutes
measure: Symptoms distress Assessments
timeFrame: 20 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06644469: Whole Body Vibration in Middle Aged Men
Official title: Effects of Whole-Body Vibration on Bone Mineral Density, Hand Grip Strength, and Vitamin D Levels in Middle-Aged Men: a Preliminary Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bone Density
Muscle Weakness
Keywords: Pilot Study
Bone Density
Vibration Therapy
Vitamin D
Muscle Strength
Lead sponsor: Jouf University
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 34
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims of this clinical trial is to evaluate the effect of an 8-week Whole Body Vibration (WBV) intervention on Bone Mineral Density (BMD), hand grip strength, and vitamin D levels in middle-aged men. Findings from this study will contribute to understanding whether WBV is a viable alternative to conventional exercise, especially for those with limitations in physical activity.

Study Objectives:

• Primary Objective: To assess the effectiveness of an 8-week WBV intervention in improving BMD, hand grip strength, and vitamin D levels compared to a placebo intervention.


Eligibility criteria: Inclusion Criteria:

* Male participants aged 50 years or older
* Participants with physical activity or exercise program involvement
* Participants with no history of serious medical conditions such as tumors, fractures, epilepsy, cardiac disease, or stroke within the past year.
* Participants must be non-smokers and not receiving hormone or calcium supplement therapy

Exclusion Criteria:

* Participants unable to stand on the WBV platform
* Participants with conditions contraindicating vibration therapy
* Participants participating in other clinical trials

Primary outcomes:
measure: Bone Density
timeFrame: 8 weeks
measure: Grip Strength
timeFrame: 8 weeks
measure: Vitamin D
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sakaka
country: Saudi Arabia
facility: prince Mutaib bin Abdulaziz hospital
state: Aljouf
Study officials:
affiliation: Jouf University
name: Fahad Alanazi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03228069: Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in HIV-infected Adults
Official title: Humoral and Cell-mediated Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rabies
Keywords: rabies vaccination
Lead sponsor: Queen Saovabha Memorial Institute
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The volunteers who participated in the previous clinical trials were invited to join this study. Of which, there were 2 groups, one received a single visit 4-site intradermal rabies booster vaccination. The another received a conventional intramuscular rabies booster vaccination on day 0 and 3.
Primary purpose: TREATMENT

Brief summary: To study the humoral and cell-mediated immune responses in HIV-infected adults who had previously received rabies booster vaccination more than a year before

Detailed description: Previous study has shown the higher immunogenicity response among HIV-infected adults who received a single visit 4-site intradermal rabies booster vaccination than those who received the conventional intramuscular regimen. The investigators follow the persistence of these effects. Also, the regulatory T cell levels were examined after the rabies booster vaccination .

Eligibility criteria: Inclusion Criteria:

* Healthy HIV-infected adults
* Previously received rabies booster vaccination by participation in the previous clinical trials of the investigators.

Exclusion Criteria:

* Have any active opportunistic infections
* Received blood or blood product within 3 months
* Received anti-malarial drugs
* Received rabies vaccination in a previous year.

Primary outcomes:
measure: Rabies Neutralizing Antibody Titers (RNab)
timeFrame: GMTs of RNab and proportion of volunteers who have had RNab above protective antibody levels (0.5 IU/ml) after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.
Secondary outcomes:
measure: Rabies specific T cell response
timeFrame: Numbers of spots, of which represent the rabies specific T cell response after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.
Other outcomes:
measure: Rabies specific regulatory T cells
timeFrame: Numbers of Rabies specific regulatory T cells after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.
Locations:
city: Bangkok
country: Thailand
facility: Queen Saovabha Memorial Institute
Study officials:
affiliation: Queen Saovabha Memorial Institute
name: Suda Sibunruang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01297569: Ranibizumab "Treat and Extend" in Diabetic Macular Edma
Official title: An Open-label, Prospective, Multicentre, Uncontrolled, Proof of Concept Study Assessing the Efficacy of Lucentis (Ranibizumab) Administered by an Individualized "Treat and Extend" Dosing Regimen in Patients With Visual Impairment Due to Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Macular Edema
Keywords: Diabetic macular edema
Macular edema
DME
Diabetic retinopathy
Diabetic eye disease
anti-VEGF
ranibizumab
Lucentis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-02-16
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to explore a more individualized treatment regime based on achievement of disease stability to define a personal optimal treatment interval with ranibizumab in patients with visual impairment due to diabetic macular edema.


Eligibility criteria: Inclusion Criteria:

* Visual impairment due to focal or diffuse macular edema with center involvement
* Diabetes type 1 or 2, HbA1c \< 12.0%
* CRT = or \> 250 μm

Exclusion Criteria:

* Active inflammation or infection
* Uncontrolled glaucoma
* Iris neovascularization, active proliferative retinopathy or vitreomacular traction
* Prior laser photocoagulation according to defined timelines
* History of stroke, uncontrolled hypertension

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change in Best Corrected Visual Acuity(BCVA)
timeFrame: from month 0 (baseline) to month 12
Secondary outcomes:
measure: change in central retinal thickness (CRT)
timeFrame: from month 0 to month 12
measure: the number of injections needed
timeFrame: 12 months
measure: the number of patients with improvement in BCVA from baseline
timeFrame: 12 months
measure: the number of patients with > 5, 10 and 15 letters improvement from baseline, the latter including patients reaching BCVA >84
timeFrame: 12 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02653469: Augmented Pulse Pressure Variation to Predict Fluid Responsiveness in Open Laparotomy
Official title: Pulse Pressure Variation With Augmented Ventilation to Predict Fluid Responsiveness in the Patients Undergoing Open Laparotomy Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecologic Neoplasms
Abdominal Neoplasms
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-01-12
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing elective open laparotomy surgery.

Brief summary: Pulse pressure variation (PPV) is a well-known and widely used dynamic preload indicator based on heart-lung interaction to predict fluid responsiveness. Generally, patients are considered to be fluid-responsive when the PPV value larger than 11-13%. However, several previous researches demonstrated that there is a zone of uncertainty (grey zone) in PPV. To predict fluid-responsiveness accurately in the patients with PPV within grey zone (9-13%), the investigators would evaluate the augmented PPV using augmented ventilation.


Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing elective open laparotomy surgery.

Exclusion Criteria:

* Irregular heart beats,
* cardiac arrhythmia,
* moderate or severe valvular heart disease,
* preoperative left ventriular ejection fraction less than 40%,
* moderate t severe obstructive pulmonary disease,
* preoperative need of inotropics infusion,
* preoperative serum Cr \> 1.3ml/dl,
* moderate to severe renal or liver disease,
* acute lung injury or acute lung problem,
* coexisting open chest condition,
* severe bradycardia,
* patients with spontaneous breathing

Primary outcomes:
measure: Augmented PPV (Pulse Pressure Variation) to predict fluid responsiveness
timeFrame: within 2 min from augmented ventilation
Secondary outcomes:
measure: Conventional baseline PPV to predict fluid responsiveness
timeFrame: when patients PPV in grey zone, before augmented ventilation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: Min JJ, Gil NS, Lee JH, Ryu DK, Kim CS, Lee SM. Predictor of fluid responsiveness in the 'grey zone': augmented pulse pressure variation through a temporary increase in tidal volume. Br J Anaesth. 2017 Jul 1;119(1):50-56. doi: 10.1093/bja/aex074.