louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00169546: Study In Airway Physiology In Children SERETIDE DISKUS ® Inhlaer and FLIXOTIDE® Inhaler Are Trademarks of GSK Group of Companies.
Official title: Randomised, Double-blind Parallel Group Study to Assess the Bronchodilative and Bronchoprotective Properties of SERETIDE DISKUS ® Inhlaer 50/100mcg Twice Daily vs. FLIXOTIDE® Inhaler 200mcg Twice Daily.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
inhaled corticosteroids
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 64
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of two asthma treatments by lung function measures.


Eligibility criteria: Inclusion criteria:

* Currently receiving 200-800mcg/day beclomethasone dipropionate.
* sRAW value of 1.3 kPa's.

Exclusion Criteria:

* 3 or more courses of oral steroids in last 12 months.

Primary outcomes:
measure: sRAW (k.Pa.s) measured before the study medication dose at the end of treatment (week 6)
Secondary outcomes:
measure: sRAW measured pre-dose at Week 3. sRAW measured 48 hours after last study medication dose. % symptom-free days over Weeks 1-6. % symptom-free nights over Weeks 1-6. Type and frequency of adverse events.
Other outcomes:
Locations:
city: Wellington
country: New Zealand
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: This study has not been published in the scientific literature.
Clinical trial NCT06568146: A Single Group Study to Evaluate the Effects of a Multivitamin on a Range of Health and Wellbeing Outcomes.
Official title: A Single Group Study to Evaluate the Effects of a Multivitamin on a Range of Health and Wellbeing Outcomes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health and Wellbeing
Keywords: Multivitamin
Cognitive Function
Iron
Vitamin D
Vitamin B12
Insulin
Lead sponsor: Love Wellness
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2024-08-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a hybrid single-group clinical trial designed to evaluate the effects of a multivitamin on a range of health and wellbeing outcomes over a 12-week period.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a hybrid single-group clinical trial that will last 12 weeks. Participants will take 2 capsules daily with the first meal of the day in the morning. Participants will undertake blood tests at Baseline and Week 12. Study-specific questionnaires will be completed at Baseline, Week 4, Week 8, and Week 12. Cognitive Battery Testing will take place at Baseline, Week 4, Week 8, and Week 12.


Eligibility criteria: Inclusion Criteria:

* Female at birth.
* Aged 18+.
* Interested in supporting their health and wellbeing.
* Not planning to introduce or change prescription medications, vitamins, minerals, or supplements one month prior to and during the study.
* Generally healthy with no uncontrolled chronic conditions.

Exclusion Criteria:

* Recent surgeries or invasive treatments.
* Introduction of new health-related products in the last 12 weeks.
* Allergies to product ingredients or use of Epi-Pen.
* Chronic health conditions affecting participation.
* Endocrine or glucose-related disorders, including diabetes.
* Hematological disorders, including anemia.
* Pregnant, breastfeeding, or planning to conceive.
* History of substance abuse or recent smoking.
* Unwillingness to follow the study protocol.
* Participation in other clinical trials.

Primary outcomes:
measure: Changes in Blood Levels of Vitamin B12
timeFrame: Baseline and Week 12
measure: Changes in Blood Levels of Insulin
timeFrame: Baseline and Week 12
measure: Changes in Blood Levels of Vitamin D
timeFrame: Baseline and Week 12
measure: Changes in Blood Levels of Iron
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Participants' Perceptions of Health and Wellbeing
timeFrame: Baseline, Week 4, Week 8, and Week 12
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT00933946: Dermacyd Silver Frutal (Lactic Acid) - Compatibility.
Official title: Study for Dermatological Evaluation of Topic Compatibility Primary and Accumulated Dermical Irritability and Dermical Sensitivity for the Product Dermacyd Silver Frutal (Lactic Acid).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-07-07
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Silver Frutal.


Eligibility criteria: Inclusion criteria:

* Phototype Skin I,II, III e IV
* Integral skin test in the region
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion

Exclusion criteria:

* Lactation or pregnancy
* Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection
* Diseases which can cause immunosuppresion, such as diabetes, HIV
* Personal history of atopy
* History of sensitivity or irritation for topic products
* Cutaneous active disease (local and/or general) which can modify the study results
* Use of new drugs and/or cosmetics during the study
* Cutaneous reaction
* Previous participation in studies using the same product in test
* Volunteer which has immunodeficiency congenital or acquired
* Relevant history or confirmation of alcohol or other drugs abuse
* Intolerance detected or suspected for some component of the sample tested
* Medecin or sponsor employees or their close family.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Evaluation of the absence of primary and accumulated dermical irritability and dermical sensitivity by using International Contact Dermatitis Research Group (ICDRG) scale.
timeFrame: from the treatment start to the end of the study (treatment period 6 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT01522846: Heparin Solution and INTEM/HEPTEM Analysis
Official title: Influence by Heparinized Flush Solution of the Radial Artery Catheter: INTEM and HEPTEM Analysis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Tumor
Spinal Stenosis
Cerebral Artery Anuerysm
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring continuous invasive arterial pressure monitoring during operation for anesthetic management.

Brief summary: Heparinized solution has been used for maintenance of arterial catheter during perioperative period. Although the infused dose of heparin is very low, the investigators examine whether the heparin effect is remained or not in blood using rotational thromboelastometry (ROTEM) analysis.


Eligibility criteria: Inclusion Criteria:

* Patients requiring continuous invasive arterial pressure monitoring during operation for anesthetic management.

Exclusion Criteria:

* heparin hypersensitivity
* hematologic disease
* anticoagulant medication

Primary outcomes:
measure: INTEM test
timeFrame: at 30 min before operation and 30 min after operation
measure: HEPTEM test
timeFrame: at 30 min before operation and 30 min after operation
Secondary outcomes:
measure: Total infused units of heparin
timeFrame: periond from starting operation to finishing operation (espected average of 5 hours).
Other outcomes:
Locations:
city: Seonnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyounggi
Study officials:
References:
Clinical trial NCT03403946: Macintosh and D-Blade® in Simulated Difficult Airway
Official title: Comparison of Direct and Indirect Laryngoscopy Using C-MAC PM® With Macintosh Blade and D-Blade® in Simulated Difficult Airway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult Intubation
Cervical Injury Spine
Keywords: difficult airway
carvical collar
endotracheal intubation
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In the presented study, our aim was to compare intubation conditions regarding the modified Cormack \& Lehane score (CL) between the D-Blade® in indirect laryngoscopy or Macintosh blade in direct and indirect laryngoscopy with C-MAC PM® in a simulated setting of a difficult airway in human subjects.

Detailed description: Patients with unexpected difficult airway requiring endotracheal intubation (ETI) remain extremely challenging for emergency physicians and intubation failure with subsequent hypoxic complications still represents the majority of cases in a recent closed claims analysis.

An incidence of major complications in airway management of 1 in 5,500 was estimated in the Fourth National Audit Project in the UK.

Therefore, our aim was to compare intubation conditions regarding the modified Cormack \& Lehane score (CL) between the D-Blade® in indirect laryngoscopy or Macintosh blade in direct and indirect laryngoscopy with C-MAC PM® in a simulated setting of a difficult airway in human subjects.

Eligibility criteria: Inclusion Criteria:

* Patients requiring general anesthesia for orthopedic surgery

Exclusion Criteria:

* known or expected difficult airway
* undergoing urgent or emergent surgery
* non-fasted
* American Society of Anesthesiology Class (ASA) IV-VI
* no consent for participation

Primary outcomes:
measure: Best view of the glottic structures
timeFrame: 120 seconds after induction of narcosis
Secondary outcomes:
measure: Evaluate the process of Intubation using a questionnaire
timeFrame: Directly after successful tracheal intubation
measure: Subjective assessment of satisfaction using numeric rating scale
timeFrame: Directly after successful tracheal intubation
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: University Hospital Frankfurt
state: Hessen
Study officials:
affiliation: Department of Anesthesia, Intensive Care Medicine and Pain Therapy
name: Haitham Mutlak, Dr. med.
role: STUDY_DIRECTOR
References:
citation: Raimann FJ, Dietze PE, Cuca CE, Meininger D, Kessler P, Byhahn C, Gill-Schuster D, Zacharowski K, Mutlak H. Prospective Trial to Compare Direct and Indirect Laryngoscopy Using C-MAC PM(R) with Macintosh Blade and D-Blade(R) in a Simulated Difficult Airway. Emerg Med Int. 2019 Apr 1;2019:1067473. doi: 10.1155/2019/1067473. eCollection 2019.
Clinical trial NCT02231346: Postmarketing Surveillance Study to Assess Handling and Patient Satisfaction on Berodual® Respimat® Solution for Inhalation in Comparison to a Powder Inhaler in Patients With Chronic Obstructive Pulmonary Disease
Official title: Berodual® Respimat® 20/50 Microgram/Dose Solution for Inhalation: Assessment of Handling and Patient Satisfaction in Comparison to a Powder Inhaler
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-04
Enrollment: 150
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: Patients with diagnosis of chronic obstructive pulmonary disease recruited at pneumologists in practice

Brief summary: New perceptions about handling and patient satisfaction of the everyday use of Berodual® Respimat® compared to a powder inhaler in patients with chronic obstructive lung disease (COLD). Moreover, further knowledge should be attained about the tolerability of Berodual® Respimat®


Eligibility criteria: Inclusion Criteria:

* Male and female patients aged at least 18 years
* Patients who are suffering from symptoms of a chronic obstructive lung disease (COLD) can be included in the PMS. To reduce influences caused by the use of a variety of different powder inhaler, only patients who are already regularly using Diskus® powder inhaler should be included, as the Diskus® as well as the Berodual® Respimat® are multiple dose devices
* During the PMS the Diskus® therapy is to be continued

Exclusion Criteria:

* Patients who meet one or more of the general or specific contraindications mentioned in the Summary of Product Characteristics (SmPC) are excluded from the Postmarketing Surveillance (PMS)

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: up to 4 weeks
measure: Number of patients who prematurely discontinued therapy with Berodual® Respimat®
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Assessment of patient satisfaction with regard to handling of Berodual® Respimat® inhaler
timeFrame: up to 4 weeks
measure: Assessment of patient satisfaction with regard to handling of Diskus® inhaler
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06716346: Investigation of Posture, Postural Stability and Core Endurance in Adults with Forward Head Posture: a Controlled Study
Official title: Investigation of Posture, Postural Stability and Core Endurance in Adults with Forward Head Posture: a Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Forward Head Posture
Keywords: forward head posture
postural stability
balance
core
endurans
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a CVA of 50 degrees and less than 50 degrees will be included in the head forward posture group, and participants with a CVA above 50 degrees will be included in the control group.

Brief summary: Forward head posture (FHP) is defined as the position in which the head is in front of the shoulder and is one of the most common musculoskeletal problems caused by increasing computer and smartphone use. The aim of this study is to compare the posture, postural stability and core endurance of participants with normal posture and participants with FHP.

Detailed description: Forward head posture (FHP) is defined as the position in which the head is in front of the shoulder and is one of the most common musculoskeletal problems caused by increasing computer and smartphone use. FHP affects the muscle functions in the neck and thoracic region, reduces the expansion of the rib cage, diaphragm activation and strength with the kyphotic posture it causes, and causes a restrictive pulmonary disorder. In addition, FHP causes various postural alignment disorders in the body, leading to weakening of the core region and affecting postural stability. Posture analysis, postural stability and core endurance tests will be applied to the participants. The aim of this study is to compare the posture, postural stability and core endurance of participants with normal posture and participants with FHP.

Eligibility criteria: Inclusion Criteria:

-18-35 years

Exclusion Criteria:

* Diagnosed respiratory, neurological, orthopaedic, psychiatric or cardiac problems
* Pregnancy or breastfeeding
* Having a history of neck trauma
* Having undergone spinal surgery

Primary outcomes:
measure: postur
timeFrame: Baseline
measure: Postural stability
timeFrame: Baseline
Secondary outcomes:
measure: Core endurance
timeFrame: Baseline
Other outcomes:
Locations:
city: Niğde
country: Turkey
facility: Nigde Omer Halisdemir University
Study officials:
affiliation: Niğde Ömer Halisdemir Üniversitesi
name: Gürkan Demirtaş, Msc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06465446: A Study of IMM01 Plus Tiselizumab Versus Physician's Choice Chemotherapy in PD(L)1-refractory Classical Hodgkin Lymphoma
Official title: A Phase III Randomized, Open-label, Multicenter Clinical Study of IMM01 (Timdarpacept) in Combiniation With Tiselizumab Versus Physician's Choice Chemotherapy in PD-(L)1-refractory Classical Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Classic Hodgkin Lymphoma
Lead sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 202
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: The purpose of this study is to compare efficacy of IMM01 plus Tiselizumab with physician's choice chemotherapy of bendamustine or gemcitabine in participants with PD-(L)1-refractory classical Hodgkin Lymphoma. The study will also assess the safety and tolerability of IMM01 plus Tiselizumab. The primary study hypotheses are that IMM01 plus Tiselizuma is superior to physician's choice chemotherapy with respect to progression-free survival (PFS) and overall survival (OS).


Eligibility criteria: Inclusion Criteria:

* Has histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL).
* PD (L)-1 refractory cHL and exhausted all available treatment options with known clinical benefit.
* Has adequate bone marrow reserves and organ functions.

Exclusion Criteria:

* History of central nervous system (CNS) metastases or active CNS involvement.
* Received prior systemic anticancer therapy within 4 weeks before randomization.
* Received prior ani-CD47 or SIRPa treatment.
* History of human immunodeficiency virus (HIV).
* Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
* History of severve allergic reactions to any components of trail durg, humanized antibodies or fusion proteins.

Primary outcomes:
measure: Progression Free Survival (PFS) per Lugano 2014 as Assessed by Independent Review Committee (IRC)
timeFrame: approximately 24 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: approximately 36 months
measure: Duration of Response (DOR)
timeFrame: approximately 24 months
measure: Number of Participants Who Experienced At Least One Adverse Event (AE)
timeFrame: approximately 18 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02555046: Muscle and Cerebral Oxygenation Under EVAR of AAA: GA vs LA
Official title: Muscle and Cerebral Oxygenation Under Endovascular Aortic Repair (EVAR) of Abdominal Aortic Aneurysm: General Versus Local Anesthesia - an Randomised Controlled Trial Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Keywords: Spectroscopy, Near-Infrared
Endovascular Procedures
Local Anesthesia
General Anesthesia
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-09-21
Enrollment: 26
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: The purpose of this study is to determine the effect of General versus Local Anaesthesia on muscle and cerebral oxygenation under EVAR-treatment in a prospective unblinded randomised controlled trail.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Scheduled procedure

Exclusion Criteria:

* allergies for used local anaesthesia
* have had vascular surgery before in the femoral area
* the need for thromboendarterectomy in common femoral artery
* the need for aortouniiliac stent-graft with cross-over bypass
* severe back pain
* expected time of surgery more than 1.5 hour
* cognitive dysfunction making cooperation during procedure impossible
* Femoral amputee

Primary outcomes:
measure: Near-Infrared Spectroscopy-determined Cerebral Oxygenation
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: Near-Infrared Spectroscopy-determined Muscle oxygenation
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: