louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06076798: Clinical Performance of AFGen1
Official title: Clinical Performance of the AFGen1 Device Over a 7-day Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Afib
ECG
Keywords: ECG signal quality
Lead sponsor: TriVirum, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study shall involve 15 participants (approximately equal number of males and females, meeting inclusion and exclusion criteria.

Brief summary: AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib. The purpose of this study is to establish the clinical performance of AFGen1 on human participants.

Detailed description: The primary purpose of this study is to demonstrate the ECG signal acquired by the AFGen1 device is of adequate quality and is suitable to support its intended use for the detection of Afib. This will be evaluated by comparing the ECG data acquired by AFGen1 to that acquired by an FDA cleared 12-lead ECG device. The study will also seek to demonstrate that there is no degradation in the quality of the ECG signal it acquires over the maximum 7-day wear period that it can be prescribed for use.

The secondary purpose of this study is to confirm the adhesive performance of the device is appropriate to support its intended use per the requirements of sections 4.4 and 5.4 of ANSI AAMI EC12-1 .

Eligibility criteria: Inclusion Criteria:

1. 18+ willing to sign the consent form

Exclusion Criteria:

1. Implanted pacemakers
2. Implanted cardioverter defibrillators
3. Implanted cardiac resynchronization devices
4. Potential life-threatening arrythmias
5. Physical or mental health conditions that would prevent the person from being able to follow instructions regarding participation in the study
6. Open wounds, abraded or irritated skin at the application site
7. Planned to undergo a MRI during the course of the study duration
8. Known or suspected to be pregnant
9. Student or employee of TriVirum

Primary outcomes:
measure: Quantitative Evaluation
timeFrame: 7 days
measure: Adhesive performance
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: 4927 Lillian Street
state: California
Study officials:
References:
Clinical trial NCT06963398: A Study of HS-10529 in KRAS G12D Patients With Advanced Solid Tumors
Official title: A Phase 1 Study, Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10529 Monotherapy in KRAS G12D Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Advanced Solid Tumors
KRAS G12D
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-09
Enrollment: 520
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: HS-10529 is an oral, highly selective, small molecular inhibitor of KRAS G12D. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10529 in KRAS G12D patients with advanced solid tumors.

Detailed description: This is a phase 1, first-in-human, study of HS-10529, consisting of dose escalation and dose expansion, which is aimed to assess the safety and tolerability of HS-10529 in KRAS G12D patients with advanced solid tumors and evaluate the preliminary efficacy of HS-10529.

Eligibility criteria: Inclusion Criteria:

* At least age of 18 years at screening.
* Patients of advanced solid tumor，who have progressed on or intolerant to standard therapy.
* With measurable lesion according to RECIST 1.1.
* Agree to provide fresh or archival tumor tissue.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1.

Exclusion Criteria:

* Previous or current treatment with KRAS G12D inhibitors.
* Uncontrolled pleural, ascites or pericardial effusion.
* Known and untreated, or active central nervous system metastases.
* History of other primary malignant tumors.
* Serious, uncontrolled, or active comorbidities.
* Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications.

Primary outcomes:
measure: The maximum tolerated dose (MTD) or maximum applicable dose (MAD)
timeFrame: up to 24 months
Secondary outcomes:
measure: Incidence and severity of treatment-emergent adverse events
timeFrame: up to 24 months
measure: Plasma concentration of HS-10529
timeFrame: up to 36 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06618898: Orofacial Pain in Woodwind and Cello Musicians in German Orchestras
Official title: Orofacial Pain and Oral Health-related Quality of Life in Woodwind and Cello Musicians in German Orchestras
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orofacial Pain
Sleep Problems
Keywords: Musicals
orchestra
orofacial pain
quality of life
stress
sleep disorders
Lead sponsor: University Medical Center Goettingen
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Professional musicians whose primary instruments are oboe, flute, clarinet, bassoon, or cello in German professional orchestras.

Brief summary: Professional musicians in German professional orchestras represent a population group that has received little attention so far, despite being exposed to a variety of work-related factors that may pose potential health risks to the orofacial system. These factors include environmental noise, irregular working hours, tight schedules, and high demands for quality and discipline, all of which can lead to stress, sleep disturbances, and physical impairments. This prospective, non-interventional survey study aims to assess the health challenges faced by woodwind players (oboe, flute, clarinet, bassoon). It will explore the relationship between the type of instrument played, orofacial pain, sleep problems, and oral health-related quality of life (OHRQoL). Woodwind players, due to their playing techniques, may be more susceptible to orofacial complaints, which could negatively impact their quality of life. A control group of cellists, whose playing techniques put less strain on the orofacial system, will be used for comparison. Participation will be via an online questionnaire targeting musicians who have been employed in a German professional orchestra for at least 12 months.


Eligibility criteria: Inclusion Criteria:

* musicians whose primary instruments are oboe, flute, clarinet, bassoon, or cello
* at least 12 months of employment or freelance work in the past 5 years with a German professional orchestra

Exclusion Criteria:

* consent not given

Primary outcomes:
measure: Online-Questionnaire
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Medical Center Göttingen
Study officials:
References:
Clinical trial NCT00776698: A Study of Avastin (Bevacizumab) in Combination With Thoracic Radiation and Chemotherapy in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer.
Official title: An Open Label Study to Establish the Preferred Dose and to Assess Safety and Overall Response Rate of Avastin in Combination With Concomitant Thoracic Radiation and Chemotherapy (Cisplatin and Etoposide) in Locally Advanced Unresectable Non-squamous Non-small Cell Lung Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-10-21
Enrollment: 1
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 single arm study will evaluate the feasibility of treatment with 2 dose levels of Avastin in combination with concurrent thoracic radiation and chemotherapy in patients with locally advanced unresectable non-squamous non-small cell lung cancer. Two cohorts of patients will receive 3 cycles of Avastin treatment (7.5mg/kg and 15mg/kg iv every 3 weeks, respectively), concurrently with thoracic radiation and chemotherapy (cisplatin and etoposide). Once a preferred dose has been established, this dose will be applied to a 3rd cohort, who will then receive maintenance treatment with Avastin as a single agent for 6 additional cycles. The anticipated time on study treatment is \<3 months for cohorts 1 and 2, and 3-12 months for cohort 3, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>= 18 years of age;
* non-squamous non-small cell lung cancer, locally advanced and unresectable;
* ECOG performance status 0 or 1;
* no prior thoracic or head and neck radiation;
* no prior surgical resection for current lung cancer.

Exclusion Criteria:

* malignancies other than non-small cell lung cancer within 2 years prior to inclusion, except for basal cell cancer of the skin, squamous cancer of the skin, or cancer in situ of the cervix;
* prior systemic therapy for non-small cell lung cancer;
* clinically significant cardiovascular disease;
* history of \>= grade 2 hemoptysis;
* current or recent use of aspirin (\>325mg/day) or full dose anticoagulants or thrombolytic agents for therapeutic purposes.

Primary outcomes:
measure: Dose limiting toxicity
timeFrame: Throughout Study
Secondary outcomes:
measure: AEs, laboratory parameters
timeFrame: Throughout Study
measure: Tumor response
timeFrame: Throughout Study
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
city: Groningen
country: Netherlands
city: Maastricht
country: Netherlands
city: Aberdeen
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01288898: Multiple Dose Escalating Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1941
Official title: A Double-blind, Placebo-controlled, Dose Escalating Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of ASP1941 and to Explore the Effect of ASP1941 on Urine and Blood Glucose Levels in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ASP1941
Diabetes Mellitus
Multiple ascending doses
Healthy subjects
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-02-03
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study determined the safety of ASP1941 after a single and multiple once-daily doses for 10 days in healthy subjects. In addition, the Pharmacokinetics (PK) and Pharmacodynamics (PD) of ASP1941 were assessed.


Eligibility criteria: Inclusion Criteria:

* Body weight between 60-100kg, body mass index (BMI) between 20-30 kg/m2, inclusive

Exclusion Criteria:

* Fasting Plasma Glucose (FPG) \> 6.4 mmol/l
* HbA1c \> 6.2%
* Abnormal pulse of blood pressure at screening, as judged by the investigator

Primary outcomes:
measure: Safety and Tolerability assessed by the incidence of adverse events, vital signs, physical examinations, 12-lead ECG and lab-tests
timeFrame: 31 days
Secondary outcomes:
measure: Pharmacokinetics assessed by the ASP1941 plasma concentration change
timeFrame: up to 96 hours after last dose
measure: Pharmacodynamics assessed by the ASP1941 glucose concentration changes in blood and urine
timeFrame: up to 96 hours after last dose
Other outcomes:
Locations:
city: Groningen
country: Netherlands
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: Veltkamp SA, Kadokura T, Krauwinkel WJ, Smulders RA. Effect of Ipragliflozin (ASP1941), a novel selective sodium-dependent glucose co-transporter 2 inhibitor, on urinary glucose excretion in healthy subjects. Clin Drug Investig. 2011 Dec 1;31(12):839-51. doi: 10.1007/BF03256922.
Clinical trial NCT04653298: Health-related Quality of Life in Adults After Veno-arterial Extra-Corporeal Membrane Oxygenation Which is a Salvage Therapy Used in Patients With Severe Respiratory or Cardiac Failure Who Have Not Responded to Maximal Conventional Medical Therapy
Official title: Health-related Quality of Life in Adults After Veno-arterial Extra-Corporeal Membrane Oxygenation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Veno-arterial Extra-Corporeal Membrane Oxygenation
Health Related Quality of Life
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with veno-arterial ECMO between April 2008 and December 2019 in NHC surgical intensive care of Strasbourg are included in this study. Those patients are retrieved thanks to the Software ICCA.

Brief summary: Extracorporeal Membrane Oxygenation (ECMO) is a salvage therapy used in patients with refractory cardiogenic shock. This rescue technique is associated to a high mortality rate and to many complications that can impact the quality of life of the survivors. The aim of this study is to evaluate the Health-related quality of life in adults after veino-arterial Extra-Corporeal Membrane Oxygenation. The quality of life will be evaluated thanks to several methods : the Short Form 36, the EQ 5D 5L and the return to work status.

Then, the investigators will analyze by subgroup the quality of life according to the cardiogenic shock etiology and try to determine the risk factors of an altered quality of life. The investigators will also evaluate current comorbidities of the patient thanks to the Groll Index.


Eligibility criteria: Inclusion Criteria:

* Adults \>18 years
* Veno-arterial ECMO between April 2008 and December 2019 in NHC surgical intensive care of Strasbourg
* Affiliated to the French social security system

Exclusion Criteria:

- Patients under guardianship or with legal protection

Primary outcomes:
measure: Evaluation of health-related quality of life after veino-arterial ECMO
timeFrame: The quality of life will be evaluated from 1 to 12 years after the ECMO
measure: Evaluation of health-related quality of life after veino-arterial ECMO
timeFrame: The quality of life will be evaluated from 1 to 12 years after the ECMO
Secondary outcomes:
measure: Analysis by subgroup according to the cardiogenic shock etiology
timeFrame: The quality of life will be evaluated from 1 to 12 years after the ECMO
measure: Research of risk factors of an altered quality of life
timeFrame: The quality of life will be evaluated from 1 to 12 years after the ECMO
measure: Evaluation of the current comorbidities thanks to Groll index
timeFrame: The quality of life will be evaluated from 1 to 12 years after the ECMO
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT02794298: tDCS Effects on GABA Concentration and Brain Functional Connectivity in Young Adults
Official title: Effects of Transcranial Direct Current Stimulation (tDCS) on GABA Concentration and Brain Functional Connectivity in Young Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Young Adults
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Physikalisch-Technische Bundesanstalt Institut Berlin (PTB)
First posted: 2016-06-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether anodal tDCS over the left M1 leads to a decrease of GABA concentration and alterations of functional brain connectivity in younger people, compared to sham tDCS.


Eligibility criteria: Inclusion Criteria:

* unobtrusive neuropsychological screening
* age: young adults: 18-30 years

Exclusion Criteria:

* Mild cognitive impairment (MCI) or other neurological diseases
* History of severe alcoholism or use of drugs
* Severe psychiatric disorders such as depression, psychosis (if not in remission) and severe untreated medical problems
* Contraindication for MRI (claustrophobia, metallic implants, ferromagnetic metals in the body, disorders of thermoregulation, pregnant women)

Primary outcomes:
measure: Measurement of GABA concentration by magnetic resonance spectroscopy (MRS) after anodal tDCS adjusted for baseline levels.
timeFrame: assessed immediately before and after a 15-min stimulation time
Secondary outcomes:
measure: GABA concentration assessed by MRS after cathodal tDCS adjusted for baseline levels
timeFrame: assessed immediately before and after a 15-min stimulation time
measure: Resting-state functional connectivity changes
timeFrame: assessed during a 15-min stimulation time
measure: Genotyping of learning related polymorphisms.
timeFrame: assessed during baseline screening
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Agnes Flöel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bachtiar V, Near J, Johansen-Berg H, Stagg CJ. Modulation of GABA and resting state functional connectivity by transcranial direct current stimulation. Elife. 2015 Sep 18;4:e08789. doi: 10.7554/eLife.08789.
citation: Amadi U, Allman C, Johansen-Berg H, Stagg CJ. The Homeostatic Interaction Between Anodal Transcranial Direct Current Stimulation and Motor Learning in Humans is Related to GABAA Activity. Brain Stimul. 2015 Sep-Oct;8(5):898-905. doi: 10.1016/j.brs.2015.04.010. Epub 2015 May 1.
citation: Stagg CJ, Bachtiar V, Amadi U, Gudberg CA, Ilie AS, Sampaio-Baptista C, O'Shea J, Woolrich M, Smith SM, Filippini N, Near J, Johansen-Berg H. Local GABA concentration is related to network-level resting functional connectivity. Elife. 2014 Mar 25;3:e01465. doi: 10.7554/eLife.01465.
Clinical trial NCT03007498: Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation
Official title: Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Skin Irritability
Lead sponsor: Kley Hertz S/A
Sponsor class: INDUSTRY
First posted: 2017-01-02
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with age from 18 to 70 years old, with skin color varying between clear caucasian to dark.

Brief summary: Check the safety under normal conditions of use through the verification of emergence signs of irritability and sensitisation of the genital mucosa.


Eligibility criteria: Inclusion Criteria:

* Age between 18 to 70 years old;
* Skin types: I (light caucasian), II (caucasian), III (light dark) and IV (dark)
* intact skin where the product will be applied
* Agreement to comply with the test procedures and attend the clinic in the days and ixed times for medical assessments and application and reading of dressings
* Signature of informed consent form

Exclusion Criteria:

* Pregnancy and lactation
* Use of anti-inflammatory and immunosuppressive drugs from 30 days up to three months prior to selection;
* Diseases that cause immune suppression;
* Personal history of atopy;
* History of sensitisation and irritability to topical products;
* Active cutaneous pathologies (local and / or scattered) that may interfere in the study results;
* Use of new drugs and/or cosmetics during the experiment;
* Skin reactivity;
* Previous participation in a study with the same product under test;
* Volunteers who have congenital or acquired known immunodeficiency;
* Relevant medical history or current evidence of alcohol or other drugs abuse;
* Known historical or suspected intolerance to any ingredient of the product under study (product under test or comparator);
* Sponsor's employees involved in the study, or close family member of an employee involved in the study;

Primary outcomes:
measure: Evaluation of adverse effects in maximized conditions
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: