louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05550636: A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Midazolam in the Blood
Official title: The Effect of Multiple Oral Doses of BI 1015550 on Metabolism of Midazolam Administered Orally in Healthy Male Subjects (Open-label, Two-period Fixed Sequence Design Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2022-09-22
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The main objective of this trial is to investigate the induction effect of multiple doses of BI 1015550 on the pharmacokinetics of the sensitive CYP3A4 substrate midazolam.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Further exclusion criteria apply

Primary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
timeFrame: Up to Day 6
measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: Up to Day 6
Secondary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: Up to Day 6
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: CRS Clinical Research Services Mannheim GmbH
Study officials:
References:
Clinical trial NCT06053736: 1-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact Lenses
Official title: 1-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Ametropia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2023-09-26
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Experienced soft contact lens wearing subjects will be enrolled in this 1-week, post-market, bilateral, repeated measures, dispensing study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria and none of the exclusion criteria, subjects will be fit and dispensed study lenses. If unsuccessful in the dispensed lenses, additional lenses may be trialed. Once vision and lens fit are determined to be acceptable, eligible subjects will wear study lenses in both eyes for at least 8 hours per day (with the exception of the follow-up visits where the lenses should be worn for a minimum of 2 hours), for approximately 1 week (7 days +/-3 days). Measurements will be taken at the insertion visit and at the 7-day follow-up visit.


Eligibility criteria: Inclusion Criteria:

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis.
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent

Exclusion Criteria:

1. Participating in a conflicting study in the opinion of the Investigator.
2. Considered by the Investigator to not be a suitable candidate for participation.

Primary outcomes:
measure: Mean logMAR Visual Acuity at 6m
timeFrame: At one week follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb, Incorporated
state: New York
Study officials:
References:
Clinical trial NCT01212536: Airtraq Versus Conventional Laryngoscopy in Children
Official title: Randomised Controlled Trial of the Airtraq Optical Laryngoscope and Conventional Laryngoscopy in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
General Anesthesia
Intubation
Keywords: children
intubation
laryngoscope
Lead sponsor: University Hospitals Bristol and Weston NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Oxford University Hospitals NHS Trust
First posted: 2010-09-30
Enrollment: 60
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators aim to compare the new paediatric Airtraq indirect optical laryngoscope with conventional direct laryngoscopy for tracheal intubation in a randomised crossover study during routine anaesthesia. The investigators hypothesise that the Airtraq is as good as conventional laryngoscopy for tracheal intubation of infants and children. This will be an equivalence rather than a non-inferiority study.


Eligibility criteria: Inclusion Criteria:

* All children less than 6 years of age, in whom a size 2.5 - 5.5 tracheal tube would be considered suitable.
* Classified by the American Society of Anesthesiology (ASA) as grade 1-3.
* Scheduled for surgery under general anaesthesia, and in whom tracheal intubation and neuromuscular blocking drugs are planned to be used.

Exclusion Criteria:

* inability of patient or parents to understand the study or consent process
* known or suspected difficult airway
* ASA 4 and above

Primary outcomes:
measure: time taken to successful intubation
timeFrame: 30 mins
Secondary outcomes:
measure: Grade of laryngoscopy
timeFrame: 30 mins
measure: POGO score
timeFrame: 30 mins
measure: VAS ease of intubation
timeFrame: 30 mins
measure: evidence of traumatic intubation
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Bristol Childrens hospital
Study officials:
References:
Clinical trial NCT06334536: Multi-country Survey on Violence Against Women Among Medical Staff
Official title: Multi-country Survey on Violence Against Women Among Medical Staff.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Violence Against Women
Keywords: medical staff
violence against women
gender-based violence
knowledge
attitude
practice
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Asia and Oceania Federation of Obstetrics and Gynaecology
First posted: 2024-03-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any medical staff in the Department of Obstetrics and Gynecology or Women Health Units, who are aged 18 and over, and agree to fill the questionnaire will be eligible to participate in this study. Medical staff are licensed healthcare providers (medical doctors, nursing staff, and others).

Brief summary: The goal of this observational study is to investigate the knowledge, attitude, and practice (KAP) towards violence against women (VAW) among medical staff in the Department of Obstetrics and Gynecology in Asia and Oceania countries

The main question it aims to answer is:

* the KAP towards VAW among medical staff in the Department of Obstetrics and Gynecology in Asia and Oceania countries
* the KAP towards support service of VAW among medical staff in the Department of Obstetrics and Gynecology in Asia and Oceania countries

Participants will be asked to complete the online self-administrated questionnaire.

Detailed description: The medical staff in the Department of Obstetrics and Gynecology or Women Health Units are in an optimal position to address VAW.

This survey aimed to investigate 1) the KAP towards VAW among medical staff in the Department of Obstetrics and Gynecology in Asia and Oceania countries, and 2) KAP towards the support service of VAW among medical staff in the Department of Obstetrics and Gynecology in Asia and Oceania countries.

This multinational, cross-sectional study will be carried out using an online self-administrated questionnaire.

Eligibility criteria: Inclusion Criteria:

* Any medical staff in Department of Obstetrics and Gynecology or Women Health Units, who are aged 18 and over and agree to fill out the questionnaire will be eligible to participate in this study.

Exclusion Criteria:

* There is no demographic restriction on participation.

Primary outcomes:
measure: KAP towards VAW
timeFrame: through study completion, an average of 1 year
measure: KAP towards support service of VAW
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chulalongkorn University
name: Unnop Jaisamrarn, MD,MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01107236: Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction
Official title: A Phase 2, Single-center, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group Study of a Single Dose of IW-6118, in Patients Undergoing Third Molar Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: Healthy subjects
Lead sponsor: Ironwood Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety of IW-6118 when administered as a single oral dose to patients undergoing third molar extraction. Efficacy will be assessed in an exploratory manner.


Eligibility criteria: Inclusion Criteria:

* Between 18 and 30 years old at time of screening;
* BMI \> 18.5 and \< 30.0;
* In overall good health with no clinically-significant laboratory, ECG, or physical exam findings;
* Patient requires two ipsilateral third molar extractions of which one must be a full or partial bony mandibular impaction;
* Women of childbearing potential must have a negative pregnancy test and must agree to use double-barrier contraception;
* Other inclusion criteria per protocol.

Exclusion Criteria:

* History of any clinically-significant medical condition;
* Previous usage of prescription, OTC, or investigational drugs as per protocol requirements;
* Inadequate levels of pain to be included in the study;
* Other exclusion criteria per protocol.

Primary outcomes:
measure: Safety Assessments
timeFrame: Duration of the Study
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Ironwood Investigational Site
state: Utah
Study officials:
References:
Clinical trial NCT01571336: Photodynamic Therapy of Actinic Keratoses With Alacare®
Official title: Non-interventional Observational Study on Photodynamic Therapy of Actinic Keratoses With Alacare®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Actinic Keratosis
Lead sponsor: photonamic GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2012-04-05
Enrollment: 388
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: Community sample

Brief summary: This study aims to collect data on the frequency of SCCs in the Alacare®-treated area during an interval of two years after Alacare®-PDT.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Patients with 3 to 6 mild AK lesions on the hairless areas of the head and face which were treated with Alacare®-PDT according to the SPC

Primary outcomes:
measure: Number of SCCs in areas treated with Alacare®-PDT
timeFrame: Two years after Alacare®-PDT
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Medizinisches Zentrum Bonn Friedensplatz
city: Freising
country: Germany
facility: Hautarztpraxis Prof. Kurzen
city: Friedrichshafen
country: Germany
facility: Hautärztliche Gemeinschaftspraxis Dr. med. Peter Dworzak Dr. med. Peter Radny
city: Hildesheim
country: Germany
facility: Gemeinschaftspraxis Dres.Ina Röhrig-Petering und Holger Petering
city: Königstein im Taunus
country: Germany
facility: Dermatologische Gemeinschaftspraxis Prof. Dr. J. Gille & Dr. K. Spieth-Gille
city: Mönchengladbach
country: Germany
facility: ZENTderma
city: Radolfzell
country: Germany
facility: Facharzt für Haut- und Geschlechtskrankheiten
city: Wuppertal
country: Germany
facility: Praxis Prof. Dr. Thomas Dirschka
Study officials:
affiliation: Dermatological group practice, Charlottenstraße 12, D-88045 Friedrichshafen, Germany
name: Peter Radny, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01644136: Microspheres in Preventing Lymphatic Fluid Collection After Surgery in Patients With Prostate Cancer
Official title: A Pilot Clinical Trial for the Prevention of Postoperative Lymphoceles Using Absorbable Micorporous Polysaccharide Hemosphere Particles During Robotic Assisted Prostatectomy With Lymph Node Dissection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lymphocele
Prostate Cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 99
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is being performed to investigate if the application of Arista absorbable hemostat (AH)®, a product approved to stop surgical bleeding, can prevent lymphoceles. Lymphoceles are collections of lymphatic fluid which can occur after a lymph node dissection for cancer. These fluid collections can become symptomatic in some patients. Arista would be applied to one side of the pelvis after a pelvic lymph node dissection, to see if this decreases the number of postoperative lymph fluid collections seen on a computed tomography (CT) scan after surgery

Detailed description: PRIMARY OBJECTIVES:

I. To determine whether, if applied to the lymph node basins after pelvic lymph node dissection, Arista could potentially reduce the formation of lymphoceles and consequently the need for secondary interventions.

OUTLINE:

Patients undergo standard robotic assisted laparoscopic prostatectomy with pelvic lymph node dissection. After lymph node dissection, patients undergo microsphere-mediated lymphocele prevention to the lymph node basin on one side of the pelvis.

After completion of study treatment, patients are followed up at 3 months.

Eligibility criteria: Inclusion Criteria:

* Male patients
* Patients with prostate cancer who are electing to undergo robotic radical prostatectomy with pelvic lymph node dissection at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center by Dr. Ronney Abaza

Primary outcomes:
measure: Incidence of postoperative lymphocele formation
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Ronney Abaza, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04127318: Low-moderate Intensity Pedaling During Immunotherapy Administration
Official title: Evaluating the Effects of Low-moderate Intensity Pedaling During Immunotherapy Administration on Immune Biomarkers and Quality of Life
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cancer of Skin
Cancer of Kidney
Cancer of Bladder
Exercise, Aerobic
Immunotherapy
Keywords: Sarcopenia
Quality of Life
Immunologic Markers
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the feasibility pedaling using an under-the desk bike during immunotherapy infusions. Also, the study hopes to evaluate how pedaling impacts quality of life and treatment response biomarkers. Lastly, the study will evaluate the relationships between treatment response and muscle mass which is evaluated with computerized tomography (CT) scans.


Eligibility criteria: Inclusion Criteria:

* Minimum age of 18
* Renal Cell Carcinoma, cutaneous malignancies (Melanoma, Merkel Cell Carcinoma or Squamous Cell CA) or bladder cancer.
* Planned intravenous immunotherapy treatment (Pembrolizumab, Nivolumab, or combinations as clinically indicated by standards of care).
* ECOG Performance Status of Grade 0-2
* No uncontrolled cardiac disease

Exclusion Criteria:

* ECOG Performance Status of Grade 3-5
* Severe cardiac history or comorbidities (i.e. heart failure, clinically significant aortic stenosis, history of cardiac arrest, have a cardiac defibrillator, uncontrolled angina, uncontrolled arrhythmias, major heart surgery, stroke, or pulmonary embolus).
* Chest pain or severe shortness of breath at rest or with physical activity.
* Orthopedic impediments to exercise (i.e. joint immobility or lower extremity lymphedema).
* Limitations to sustained exercise (i.e. bone metastases in the femur neck).
* Severe arthritis (i.e. osteoarthritis or rheumatoid arthritis).
* Patients will be excluded from study if their immunotherapy treatment requires the use of sedating antihistamines prior to treatment.

Primary outcomes:
measure: Feasibility of Pedaling Concurrent to Immunotherapy Infusions
timeFrame: 12 weeks
Secondary outcomes:
measure: Quality of life scores
timeFrame: 12 weeks
measure: Treatment response biomarkers
timeFrame: 12 weeks
measure: CT-derived sarcopenia rates
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Timothy M Kuzel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04304118: Rajaie Cardiomyopathy and Myocarditis Registry
Official title: Rajaie Cardiomyopathy and Myocarditis Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clinical Characteristics
Natural History
Long-term Outcomes
Current Therapeutic Approaches
Lead sponsor: Rajaie Cardiovascular Medical and Research Center
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 6000
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with documented cardiomyopathy/ myocarditis fulfilling standard diagnostic criteria based on the ESC guideline for cardiomyopathy/ myocarditis

Brief summary: The prevalence of patients with cardiomyopathies who referred to Rajaei Cardiovascular medical and research center is remarkable, and also the mission of this center is to achieve center of excellence in the field of cardiomyopathy. Rajaie Cardiomyopathy and myocarditis Registry study is an observational registry of consecutive patients with four cardiomyopathy subtypes: hypertrophic cardiomyopathy (HCM), dilated cardiomyopathy (DCM), arrhythmogenic right ventricular cardiomyopathy (ARVC), and restrictive cardiomyopathy (RCM) as well as myocarditis designed to determine clinical characteristics, natural history, current therapeutic approaches, response to treatment and long-term outcomes of patients with cardiomyopathy and myocarditis and to address limitations in extant evidence to improve prognostication in cardiomyopathies and myocarditis. Prediction of mortality and response to different treatments in these patients using artificial intelligence is another aim of this registry


Eligibility criteria: Inclusion Criteria:

1. age greater than one year
2. documented cardiomyopathy/ myocarditis fulfilling standard diagnostic criteria
3. able to give informed consent or in the case of child consent from a parent

Exclusion Criteria:

Patients who have not consent to participate in the study.

Primary outcomes:
measure: Admissions to hospital
timeFrame: 1 year
measure: Development of chronic heart failure
timeFrame: 1 year
measure: Prevalence of Stroke/Transient ischemic attack
timeFrame: 1 year
measure: Incidence of sudden death
timeFrame: 1 year
measure: Incidence of heart trasplantation
timeFrame: 1 year
Secondary outcomes:
measure: response to current therapeutic approaches
timeFrame: 1 year
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Behshid Ghadrdoost
Study officials:
References: