louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02595788: Haemodynamic Changes During Anaesthesia in the Prone Position, Evaluated Using Transoesophageal Ultrasound
Official title: Haemodynamic Changes During Anaesthesia in the Prone Position, Evaluated Using Transoesophageal Ultrasound
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Spinal Surgery
Anaesthesia
Changes in Left and Right Ventricle Dimension
Changes in Bloodflow Across Cardiac Valves
Changes in Dimensions of Inferior Caval Dimension and Hepatic Venous Bloodflow
Changes i Myocardial Velocities
Changes in Diastolic Function
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 20
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 scheduled for spinal surgery in the prone position. Body mass index above 30.

Brief summary: Transoesophageal ultrasound examination before and after prone position.

Detailed description: Patients undergoing spinal surgery in the prone position are anaesthetized and then an ultrasound probe is placed in the oesophagus and the heart physiology is examined. Following prone position the examination is repeated.

Eligibility criteria: Inclusion Criteria:

* adult patients scheduled for spinal surgery in the prone position. Body mass index above 30.

Exclusion Criteria:

* significant cardiomyopathy or valvular disease
* heart rhythm other than normal sinus rhythm
* coagulopathy
* increased risk of oesophageal injury during probe insertion

Primary outcomes:
measure: End systolic and diastolic dimension of the left and right ventricle.
timeFrame: The day of surgery
Secondary outcomes:
measure: Left and rigth ventricle eccentricity index.
timeFrame: The day of surgery
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Specialist Registrar
name: Joachim Hoffmann-Petersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01450488: Masitinib in Primary Progressive Multiple Sclerosis or Relapse-free Secondary Progressive Multiple Sclerosis
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Activity of Oral AB1010 Administered at 2 Dose Levels to Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: primary progressive multiple sclerosis
relapse-free secondary progressive multiple sclerosis
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2011-10-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the activity of oral AB1010, administered at two dose levels during 3 years to patients with primary or secondary progressive multiple sclerosis.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 to 60 years, from both sex, and suffering from multiple sclerosis either primary progressive or secondary progressive without relapse within 2 years before inclusion.
2. Patients with EDSS score in the range of 2 to 6.5, inclusive
3. EDSS progression ≥ 1 point within 2 years before inclusion

Exclusion Criteria:

1. Disease other than MS responsible for clinical signs and/or MRI lesions
2. Secondary progressive MS with relapse in the 2 years before inclusion
3. Treatment with interferon or glatiramer acetate within four weeks prior to treatment allocation
4. Treatment with oral or systemic corticosteroids or ACTH within four weeks prior to treatment allocation.
5. Active current bacterial, viral (including hepatitis B and C, HIV, EBV, CMV, herpes zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection

Primary outcomes:
measure: change in MSFC
timeFrame: 12 months
Secondary outcomes:
measure: MSFC subcategories
timeFrame: 12 months
measure: Expanded Disability Status Scale (EDSS)
timeFrame: 12 months
measure: MFSC subcategories
timeFrame: 12 months
measure: MFSC subcategories
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Vermersch P, Benrabah R, Schmidt N, Zephir H, Clavelou P, Vongsouthi C, Dubreuil P, Moussy A, Hermine O. Masitinib treatment in patients with progressive multiple sclerosis: a randomized pilot study. BMC Neurol. 2012 Jun 12;12:36. doi: 10.1186/1471-2377-12-36.
Clinical trial NCT05553288: Effectiveness of a Real Time Data Safety Study Tool
Official title: Determining the Effectiveness of a Real Time Data Safety Study Tool for Clinical Research Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Study Subjects Currently Enrolled in a Clinical Research Trial
Keywords: text messaging, safety, real time data
Lead sponsor: Perseverance Research Center, LLC
Sponsor class: OTHER
Collaborators: name: HDC
First posted: 2022-09-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -Men and women from 18-85 years of age inclusive, who are currently enrolled in a clinical trial at Perseverance Research Center. All subjects must meet all inclusion and no exclusion criteria to be eligible for enrollment.

Brief summary: Study RTD-01 is a non-interventional, pilot study designed to determine if a specific coded SMS text message study tool is effective in collecting daily real time safety data in subjects participating in clinical trials.

Detailed description: This study is to determine if a daily SMS text message study tool will improve adverse event and concomitant medication reporting. Patient reported adverse events and changes in concomitant medications are essential in clinical trials to determine drug-related symptoms and side effects. This study will help identify the benefits and challenges of real time daily reported outcome measures that can later be implemented in future clinical trials to enhance trial outcomes. In addition, data collected from this study will support a more sophisticated safety study tool for future study participants.

Eligibility criteria: Inclusion Criteria:

* 18-85 age inclusive
* Male or Female
* Currently enrolled in an ongoing clinical trial
* Capable of providing informed consent and complying with daily study procedures
* Must be able to receive and respond to text messages through phone provider

Exclusion Criteria:

* Subjects not currently involved in a clinical trial
* Subjects who cannot receive text messages
* Unable to comply to the study protocol and study visits

Primary outcomes:
measure: To improve AE and concomitant medication reporting
timeFrame: 6 weeks
Secondary outcomes:
measure: Decrease recall bias
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Perseverance Research Center, LLC
state: Arizona
Study officials:
References:
Clinical trial NCT05872178: Omegia Softgel Clinical Research Program
Official title: Chia Nan University of Pharmacy & Science
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Manifestations
Antioxidative Stress
Eye Strain
Vaginal Disease
Lead sponsor: Chia Nan University of Pharmacy ＆ Science
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluate the improvement of regulation of skin and blood index composition after consumption of Omegia® Softgel

Detailed description: The blood biochemical analysis at Weeks 0 and 12, including Catalase, Tumor necrosis factor-α, Cholesterol, Triglyceride, High-density lipoprotein-Cholesterol and Low-density lipoprotein- Cholesterol.

The Skin assessment at Weeks 0, 4 and 12, including Skin brightness, Skin redness sensitivity index, Skin moisture, Skin elasticity, Facial skin pores, Facial skin texture and Skin collagen content.

Eligibility criteria: Inclusion Criteria:

● Female subjects older than 45 years

Exclusion Criteria:

* Involuntary subjects
* Skin disease, liver cirrhosis or chronic renal failure
* Those with known cosmetic, drug or food allergies
* Pregnant women and nursing mothers.
* Those taking chronic disease medication
* The subject has received laser facial treatment, fruit acid facial peeling, long-term sunlight, etc. within four weeks of the test

Primary outcomes:
measure: Skin brightness
timeFrame: Subjects will be tested in the 4th week
measure: Skin redness
timeFrame: Subjects will be tested in the 4th week
measure: Skin moisture
timeFrame: Subjects will be tested in the 4th week
measure: Skin elasticity
timeFrame: Subjects will be tested in the 4th week
measure: Facial skin pores
timeFrame: Subjects will be tested in the 4th week
measure: Facial skin texture
timeFrame: Subjects will be tested in the 4th week
measure: Skin collagen content
timeFrame: Subjects will be tested in the 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Chia Nan University of Pharmacy ＆ Science
Study officials:
References:
citation: Gold MH, Goldman MP, Biron J. Efficacy of novel skin cream containing mixture of human growth factors and cytokines for skin rejuvenation. J Drugs Dermatol. 2007 Feb;6(2):197-201.
citation: Rodrigues F, Sarmento B, Amaral MH, Oliveira MB. Exploring the antioxidant potentiality of two food by-products into a topical cream: stability, in vitro and in vivo evaluation. Drug Dev Ind Pharm. 2016;42(6):880-9. doi: 10.3109/03639045.2015.1088865. Epub 2015 Sep 22.
Clinical trial NCT05158478: Hematocrit Effect on a Blood Glucose Monitor
Official title: Evaluation of the Hematocrit Effect on the Blood Glucose Monitor for Personal Use JT100
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Institut fur Diabetes Karlsburg GmbH
Sponsor class: OTHER
Collaborators: name: Tyson Bioresearch Inc., Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan
First posted: 2021-12-15
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study assesses the repeatability precision of a blood glucose monitoring system pursuant to ISO 15197

Detailed description: This study assesses the repeatability precision the blood glucose monitoring systems for personal use TJ100 pursuant to ISO 15197:2015 guidelines

Eligibility criteria: Inclusion Criteria:

* Male or female patients with clinical indication for blood glucose testing
* Signed form of consent
* Minimum age of 18 years
* Subjects are legally competent and capable to understand character, meaning and consequences of the study

Exclusion Criteria:

* Pregnancy or lactation
* Severe acute disease (at study physician's discretion)
* Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion)
* Current constitution that does not allow participating in the study (e.g. hematocrit out of
* the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197)
* Being unable to give informed consent
* Age younger than 18 years
* Legally incompetent

Primary outcomes:
measure: repeatability precision
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Karlsburg
country: Germany
facility: Institut für Diabetes Karlsburg GmbH
state: Mecklenburg Vorpommern
Study officials:
affiliation: Institut fur Diabetes Karlsburg GmbH
name: Eckhard Salzsieder, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02857478: Supervised Outdoor-Use Test to Assess the Safety of a Sunscreen C-Spray on Sport Users
Official title: To Assess the Safety of a Sunscreen Product,BAY 987519, Bayer Sponsored, CC Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreen Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-08-05
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective of this study was to assess the safety and appropriateness of a sunscreen product for use on sport users, under supervised outdoor-use conditions. The study was conducted under the supervision of a Board-Certified Dermatologist at an outdoor, chlorinated swimming pool facility.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects, aged 18 to 65 years
* No actinic keratosis, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions
* Must not have visible erythema, blistering or peeling that would indicate recent sunburn
* Must not have asthma. Must not be undergoing therapy with system or topical corticosteroids, anti-inflammatories or antihistamine agents
* Must not be taking any medication in which exposure to the sun is contraindicated
* Must be willing to obey all rules of the test facility

Primary outcomes:
measure: Evaluation of Erythema as graded on a 5 point scale.
timeFrame: approximately 24 hours
measure: Evaluation of AEs, including eye stinging
timeFrame: approximately 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
state: Florida
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04481178: A Retrospective Study on Laser Treatment of Nevus of Ota in Thai Patients
Official title: A Retrospective Study on Laser Treatment of Nevus of Ota in Thai Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Focus on Laser Treatment of Nevus of Ota in Thai Patients
Keywords: Nevus of Ota, laser treatment, Thai
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 79
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with Nevus of Ota

Brief summary: A retrospective study on efficacy and complication of laser treatment (Q-switched Nd:YAG and picosecond laser) of nevus of Ota in Thai patients

Detailed description: Nevus of Ota is a benign dermal melanocytic nevus found most commonly in Asians. About 50-60% of all cases have the age of onset at birth or within the first year of life, others appear before puberty. It typically presents as a unilateral mottled blue-gray macules and patches distributed along the first and second branches of trigeminal nerve. Due to its marked hyperpigmentation on the face which does not resolved spontaneously, patients may experience psychosocial disturbances and often seek for treatments. Based on selective photothermolysis theory, Q-switched lasers (ruby 694nm, alexandrite 755nm, Nd:YAG 1064nm) have been used for the treatment of nevus of Ota with a success rate of 95% after 6-8 sessions. Reported complications from the lasers are hypopigmentation(15.3%), hyperpigmentation(2.9%), texture changes (2.9%), and scarring (1.9%). Siriraj Skin Laser Center provides laser treatment for nevus of Ota using mainly Q-switched Nd:YAG laser and Picosecond laser. The study of efficacy and complications of Q-switched Nd:YAG and Picosecond laser in the treatment of Nevus of Ota in Thai patients has never been reported. Therefore, we conduct a retrospective study on efficacy and complication of laser treatment (Q-switched Nd:YAG and picosecond laser) of nevus of Ota in Thai patients.

Eligibility criteria: Inclusion Criteria:

* Patient with Nevus of Ota
* Complete data between January 2008 - December 2018

Exclusion Criteria:

* Incomplete data

Primary outcomes:
measure: Efficacy of laser treatment in paitients with Nevus of Ota
timeFrame: 2008-2018
Secondary outcomes:
measure: Complication of laser such as hyperpigmentation, hypopigmentation, and scars
timeFrame: 2008-2018
measure: Relapse rate after laser treatment
timeFrame: 2008-2018
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
state: Bangkok
Study officials:
References:
citation: Achavanuntakul P, Manuskiatti W, Wanitphakdeedecha R, Jantarakolica T. Early Treatment Initiation Improves Outcomes in Nevus of Ota: A 10-Year Retrospective Study. Am J Clin Dermatol. 2022 Jan;23(1):105-114. doi: 10.1007/s40257-021-00637-0. Epub 2021 Oct 24.
Clinical trial NCT03958578: The Effect of Preoperative Anxiety on Duration and Efficacy of Motor and Sensory Block in Spinal Anesthesia
Official title: The Effect of Preoperative Anxiety on Duration and Efficacy of Motor and Sensory Block in Spinal Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: It is planned to enroll healthy individuals undergoing elective surgery under spinal anaesthesia.

Brief summary: Spinal anaesthesia results in blockade of sympathetic efferent neurones. Patients with higher baseline sympathetic activation have been shown to have more marked hypotension after spinal anaesthesia. Anxiety causes generalized sympathetic activation. It was aimed to find the effect of preoperative anxiety on the duration and efficacy of neuraxial anaesthesia.


Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 55 years.
* ASA I-II
* BMI 18-25

Exclusion Criteria:

* Major surgery

Primary outcomes:
measure: State-Trait Anxiety Inventory questionnaire
timeFrame: 20-30 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yadigar Yılmaz
Study officials:
References:
Clinical trial NCT06219278: A Retrospective Review Evaluating the Matrix Pro Applicator for Treatment of Wrinkles
Official title: A Retrospective Review Evaluating the Matrix Pro Applicator for Treatment of Wrinkles
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wrinkle
Lead sponsor: Candela Corporation
Sponsor class: INDUSTRY
First posted: 2024-01-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data was extracted from the records of 32 subjects previously enrolled in the source study who satisfied current study eligibility criteria, were aged 25-70 years, with Fitzpatrick Skin Types II-IV and had received full face treatments with the 27W Matrix Pro Applicator

Brief summary: This is a retrospective chart review of data from the multi-site prospective clinical trial, "Functional Usability and Feasibility Testing of the Profound Matrix™ System (FUFT2002)" to evaluate the safety and efficacy of the Profound Matrix System Matrix Pro applicator for the treatment of wrinkles.

Detailed description: This was a retrospective medical record review of subject data from the source study FUFT2002 to evaluate the safety, efficacy, tolerability, and usability of the Profound MatrixTM System with the Matrix Pro Applicator for the treatment of wrinkles.

Eligibility criteria: Inclusion Criteria:

1. Met eligibility criteria under source study FUFT2002 and enrolled into FUFT2002 study (NCT # pending).
2. Received full face treatment with 27W Matrix Pro applicator only.
3. Have baseline and follow-up assessments obtained.
4. Have photography obtained with the VISIA standardized camera system (Appendix III).

Exclusion Criteria:

1. Sun exposure during the course of the study.
2. Aesthetic procedures and/or treatments during the course of the study.
3. Any violation of study treatment instructions.
4. Upon inspection, any differences in baseline and follow up photos that would not make evaluation of photos viable (e.g. chin placement, facial expression).
5. Any protocol deviation or change in study visit activities that would jeopardize reliability or validity of the retrospective review

Primary outcomes:
measure: Improvement in Facial Wrinkles
timeFrame: Approximately 6 months following baseline assessment
Secondary outcomes:
measure: Subject Global Aesthetic Improvement Scale (GAIS)
timeFrame: Approximately 6 months following baseline assessment
measure: Subject Global Aesthetic Improvement Scale (SGAIS)
timeFrame: Approximately 4 months following baseline assessment
Other outcomes:
Locations:
city: Marlborough
country: United States
facility: Candela Institue for Excellence
state: Massachusetts
city: Yoqne'am 'Illit
country: Israel
facility: Syneron Medical
Study officials:
affiliation: Candela Medical
name: Konika Patel Schallen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01939678: Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease
Official title: Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Aortic Valve Stenosis
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 3
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with aortic valve calcification that will be treated with an aortic valve replacement

Brief summary: The purpose of this study is to investigate whether mutations in genes coding for Na/Pi-cotransporters are associated with aortic valve calcification. A patient population with premature aortic valve calcification treated with aortic valve replacement will be screened for mutations in these specific genes. Furthermore, aortic valve tissue received from the operations, will be examined for the presence of Na/Pi-cotransporters, and for molecular characterization of the transporters.


Eligibility criteria: Inclusion Criteria:

* Patients with aortic valve calcification that will be treated with an aortic valve replacement.
* Age ≤ 65 years.
* Signed and dated informed consent.

Exclusion Criteria:

* Inability to provide informed consent
* Earlier radiation therapy of the thorax
* Severe renal disease (patients in treatment with dialysis)

Primary outcomes:
measure: Mutations in sodium-phosphate cotransporters in patients with calcific aortic valve disease
timeFrame: At the time of aortic valve replacement
Secondary outcomes:
Other outcomes:
Locations:
city: Orebro
country: Sweden
facility: Department of Cardiology, Orebro University Hospital
Study officials:
References: