louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06178406: Brain Structural and Functional Connectivity Changes in the Period of Dysmenorrhea: a Prospective fMRI Study
Official title: Brain Structural and Functional Connectivity Changes in the Period of Dysmenorrhea: a Prospective Functional Magnetic Resonance Imaging Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dysmenorrhea
Keywords: dysmenorrhea, magnetic resonance imaging
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients with dysmenorrhea underwent pelvic ultrasonography to identify the cause of dysmenorrhea. The study will be conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Women's Hospital School of Medicine Zhejiang University. All participants will give their written informed consent.

Brief summary: Observational prospective study with an analysis of the changes in brain structure and related functional connectivity in women with dysmenorrhea.

Detailed description: Dysmenorrhea is a common gynecological disease and chronic pain disorder.Understanding the neural mechanisms of dysmenorrhea and the brain changes affecting pain factors is important for finding dysmenorrhea treatment methods. The emergence and progress of non-invasive neuroimaging technology can help us better understand pain at the neural level. Recent developments in identifying brain-based biomarkers of pain through advances in advanced imaging can provide some foundations for predicting and detecting pain. Twenty patients with dysmenorrhea and twenty matched female healthy controls were recruited from our hospital. All participants underwent the head magnetic resonance imaging scans to calculate grey matter volume and Diffusion Tensor Imaging parameters. Questionnaire assessment was also conducted.

Eligibility criteria: Inclusion Criteria:

* Right-handedness, as confirmed by the Edinburgh Handedness Inventory
* A regular menstrual cycle of approximately 21 to 35 days
* A history of menstrual pain longer than 6 months
* Not taking any medication or using other methods to treat dysmenorrhea in the past month
* Score of \>= 40mm on the VAS (visual analogue scale) in recent three menstrual cycles

Exclusion Criteria:

* Any psychiatric or neurological disorders, particularly premenstrual dysphoric disorder
* Using oral contraceptives, hormonal supplements, or any central-acting medication (eg, opioid, antiepileptics) within 6 months before the study
* Having a metal or pacemaker implant, claustrophobia, or any contraindications to MR
* Head injury with loss of consciousness

Primary outcomes:
measure: The functional connectivity of functional magnetic resonance imaging
timeFrame: 1 month
Secondary outcomes:
measure: Grey Matter volume
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01553006: Study of Cefditoren Pivoxil in Treatment of Childhood With Acute Rhinosinusitis
Official title: A Comparison of Cefditoren Pivoxil 10 mg/kg/Day and Cefditoren Pivoxil 20 mg/kg/Day in Treatment of Childhood With Acute Rhinosinusitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rhinosinusitis
Keywords: rhinosinusitis
cefditoren pivoxil
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cefditoren pivoxil has been used in rhinosinusitis treatment. However, little is known about the efficacy of this drug at low and high doses.

Detailed description: The investigation was a randomized, investigator-blinded, and parallel study, conducted in patients (age 1-15 years) with acute rhinosinusitis. Two groups of patients were randomized received low (10 MKD) or high (20 MKD) of drug for 14 days. Changes in sinus symptoms scores, response rate and adverse effect were evaluated at days 7 and 14. Relapse rate was recorded at days 21 and 28. Recurrence of sinus symptoms at day 60 were assessed.

Eligibility criteria: Inclusion Criteria:

* children age 1-15 years old diagnosed acute rhinosinusitis

Exclusion Criteria:

* poor compliance
* other infections

Primary outcomes:
measure: sinus symptoms scores
timeFrame: 14 days
Secondary outcomes:
measure: relapse rate
timeFrame: at day 28
Other outcomes:
Locations:
city: Prathumthani
country: Thailand
facility: Thammasat University
Study officials:
affiliation: Thammasat University
name: Orapan Poachanukoon, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02626806: Exercise-induced High-sensitivity Troponin Levels as a Predictor for Obstructive Coronary Artery Disease
Official title: Exercise-induced High-sensitivity Troponin Levels as a Predictor for Obstructive Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: exercise test
HS -troponin
Coronary artery disease
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To compare hs-TnT levels after a cardiac stress test in patients with vs. patients without CAD

Brief summary: 1. To compare hs-TnT levels after a cardiac stress test in patients with vs. patients without CAD
2. To assess the level of post-exercise hs-TnT predicting CAD (using ROC-analysis)
3. To determine the sensitivity, specificity and accuracy of this exercise-induced hsTopT level in predicting CAD, either alone or in relation to traditional patient-related and exercise test-related metrics


Eligibility criteria: Inclusion Criteria:

1. Patients with suspected CAD, planned for diagnostic coronary angiogram
2. Patients with previous revascularization, suspected of recurrent ischemia

Exclusion Criteria:

1. Congestive cardiomyopathy with LV EF \< 35%
2. Renal failure with eGFR \< 30 ml/min
3. Known structural or severe valvular heart disease
4. Prior CABG
5. Previous ACS \< 6 weeks
6. Known incomplete revascularization after previous PCI
7. Unstable angina or ACS (defined as unstable anginal symptoms + ECG changes or hs-TnT \> 0.053 ng/L)

Primary outcomes:
measure: Presence of coronary artery stenosis more than 50%
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
References:
Clinical trial NCT01126606: Comparative Safety and Efficacy Evaluation Between Dermacyd Silver and Glycerine Vegetal Soap Granado Traditional
Official title: Single Center, Open, Cross-over, Phase III Study for Safety and Efficacy (Subjective and Instrumental) Comparative Evaluation Between Dermacyd Silver and Glycerine Vegetal Soap Granado Traditional for Intimate Use in Menopauses Woman.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-05-19
Enrollment: 70
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To evaluate the potential of hydratation and renewal of the mucosa, through corneometry measurement and individual questionnaire perception.

Secondary Objective:

To evaluate the safety in normal condition of use.


Eligibility criteria: Inclusion criteria:

* Active sex life
* Menopause for at least 6 months
* Perfect mucosa in the evaluated area
* Use the same cosmetics category

Exclusion criteria:

* Use of antiinflammatory / immunosuppression / antihistaminic drugs
* Personal history of atopy to cosmetic products
* Cutaneous active disease (local and/or general) in the evaluated area
* Disease which can cause immunosuppression, such as diabetes, HIV
* Endocrine pathology such as thyroid disease, ovarian disorder or adrenal gland
* Intense solar exposure (to get a tan) during the 15 days before the evaluation
* Gynaecologic treatment until four weeks before the evaluation
* Whatever vaginal infection detected at time of inclusion
* Other conditions considered by the investigator as reasonable to exclude the patient from the study

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

Primary outcomes:
measure: Transepidermal water loss measurement (TEWL) and corneometry
timeFrame: Up to Week 9
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT04563806: Safety of MRI Compatible Hardware for MRI-based Image Guidance During Spine Surgery
Official title: A Pilot Study to Evaluate the Safety of MRI Compatible Hardware for Intraoperative MRI-Based Image Guidance for Spinal Procedures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Thoracic Spine Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-09-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This trial investigates the safety and accuracy of using 2 pieces of hardware (a clamp and a needle) that are able to be used with magnetic resonance imaging (MRI) during spinal surgery. During a standard spinal surgery, a computed tomography (CT) scan is used to help plan the placement of surgical instruments used during the procedure or for needle biopsies. Then, the patient is moved to the MRI. For this study, the patient is able to stay in place as the hardware used in this study is able to work with the MRI. Using MRI compatible hardware may allow for an extra degree of safety and facilitate better surgical workflow.

Detailed description: PRIMARY OBJECTIVE:

I. To document the safety of utilizing MRI compatible hardware for intraoperative MRI-based image guidance to perform percutaneous spinal procedures.

SECONDARY OBJECTIVE:

I. To determine the accuracy of the MRI-based image guidance.

OUTLINE:

Patients undergo standard of care spine surgery with MRI-based image guidance.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing percutaneous spinal procedures requiring image guidance at MD Anderson
* Age \> 18 years old. (The indication for this technique is controversial in skeletally immature patients.)
* All diagnoses are eligible
* Vertebral body site to be treated located from T2 to T12
* Signed informed consent

Exclusion Criteria:

* Requires open spinal procedure or a percutaneous procedure without the use of image guidance
* Unable to tolerate general anesthesia and prone position
* Unable to undergo MRI scan of the spine

Primary outcomes:
measure: Incidence of intraoperative adverse events
timeFrame: During surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Claudio E Tatsui
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01571206: An Extension Study to Demonstrate the Equivalence of Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1
Official title: An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ankylosing Spondylitis
Keywords: AS
Biosimilar
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2012-04-05
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label, single-arm, multicenter, multiple single-dose intravenous (IV) infusion, efficacy, and safety extension study of the Phase 1 Study CT-P13 1.1 is designed to assess the long-term efficacy and safety of multiple doses of CT-P13.


Eligibility criteria: Inclusion Criteria:

* Patient who has completed the scheduled visits, including the End-of-Study Visit, in Study CT-P13 1.1
* Patient who has not had any major protocol violation in Study CT-P13 1.1

Exclusion Criteria:

* Patient who has been withdrawn from Study CT-P13 1.1 for any reason
* Patient who, at the time of providing informed consent, has any ongoing medical issues such as serious adverse events(SAEs) or intolerance issues that mean continuation in this extension study could be detrimental to their health, in the option of the investigator
* Patient who plans to participate in a study with an investigational drug during the period of this extension study

Primary outcomes:
measure: Long term efficacy evaluated by Assessment of Spondylo Arthritis International Society(ASAS) criteria and Long term safety evaluated by immunogenicity and clinical laboratory test
timeFrame: Up to Week 40
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
affiliation: Inha University Hospital
name: Won Park, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
citation: Park W, Yoo DH, Miranda P, Brzosko M, Wiland P, Gutierrez-Urena S, Mikazane H, Lee YA, Smiyan S, Lim MJ, Kadinov V, Abud-Mendoza C, Kim H, Lee SJ, Bae Y, Kim S, Braun J. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis. 2017 Feb;76(2):346-354. doi: 10.1136/annrheumdis-2015-208783. Epub 2016 Apr 26.
Clinical trial NCT00285506: The Effect of Contrast Media on Erythrocytes in Healthy Volunteers
Official title: The Effect of Low-Osmolar and Iso-Osmolar Contrast Media on Erythrocytes in Healthy Volunteers.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2006-02-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: The purpose of the study is to test the effect that contrast media (dye) has on cellular integrity (structure)

Detailed description: The influence of several radiological contrast media on erythrocyte morphology and function has been investigated in the past (1). However, published data is sparse and does not include the assessment of iso-osmolar agents as compared to low-osmolar agents.

In addition, the effect of the injection of contrast media at higher temperatures (i.e. \> room or body temperature), which may be beneficial for the rapid injection of more viscous contrast media at multi detector-row CT angiography, has never been evaluated.

We intend to assess the hypothesis, that iso-osmolar contrast media (i.e. Visipaque) exerts less effect on erythrocyte morphology and function as compared to low-osmolar agents.

In addition, we intend to identify the upper temperature limit, at which contrast media can be injected, without affecting erythrocyte integrity.

Subjects will have up tp 400 mLs (approximately 26 tablespoons) of blood drawn. The blood will be kept at body temperature in a petri dish or similar container and exposed to contrast media (dye).

Eligibility criteria: Inclusion Criteria:

* Subjects must be at least 18 years old
* Subjects must be at least 110lbs and

Exclusion Criteria:

* Subjects may not be pregnant
* Subjects must not possess any medical conditions that would preclude them from participating

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: U. Joseph Schoepf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01814306: Supreme LMA and Proseal LMA in Prone Anesthetized Patient
Official title: Comparison of the Effectiveness Between the LMA SupremeTM and the LMA ProsealTM for Airway Management in Patient Undergoing Elective Orthopaedic Surgery in Prone Position
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inadequate or Impaired Breathing Pattern or Ventilation
Keywords: LMA Supreme,LMA Proseal,airway management,prone position
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2013-03-19
Enrollment: 100
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: There is no significant difference about success rate of two devices.

Detailed description: There is no significant difference about success rate of two device: efficacy and safety

Eligibility criteria: Inclusion Criteria:

* American Society Anesthesiologists physical status I-III
* Patient undergo elective orthopedics surgery in prone position under general anaesthesia

Exclusion Criteria:

* Age \<15year
* Non-fast
* Morbid obesity (BMI \> 35kg/m2)
* Pregnancy
* Known or predicted difficult airway
* GERD
* History of laryngeal problem (injury,subglottic stenosis)
* Local pharyngeal problem (abscess,tumor)
* Poor dentation
* Pulmonary disease

Primary outcomes:
measure: Success rate of insertion (quality of ventilation)
timeFrame: 1 year
Secondary outcomes:
measure: Ease of insertion, Complication and Glottic seal pressure
timeFrame: 1 year
Other outcomes:
Locations:
city: Had yai
country: Thailand
facility: Faculty of Medicine, Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Prince of Songkla University
name: Chatchai Prechawai
role: STUDY_CHAIR
References:
Clinical trial NCT05606406: Hypoxia and Heart Rate Variability
Official title: Hypoxia and Heart Rate Variability
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Hypoxia
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate how variations in oxygen demands may change heart electrical activity in individuals with and without oxygen dependence.


Eligibility criteria: Healthy Participants

Inclusion Criteria:

• Ability to provide consent

Exclusion Criteria:

* BMI \> 40 kg/m2
* Prevalent myocardial infarction, coronary revascularization, heart failure, and stroke
* Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, cancer, and active psychiatric disease (e.g., major depression)

Nocturnal Hypoxemia

Inclusion Criteria:

* Ability to provide consent
* Chronic respiratory condition resting Sat \< 95% off oxygen

Exclusion Criteria:

* BMI \> 40 kg/m2
* Prevalent myocardial infarction, coronary revascularization, heart failure, and stroke
* Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression)

Primary outcomes:
measure: QT Variability Index
timeFrame: Up to 10 hours
Secondary outcomes:
measure: Normalized variance of the heart rate (HRVN)
timeFrame: Up to 10 hours
measure: QT-RR interval
timeFrame: Up to 10 hours
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Trishul Siddharthan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06175806: Granisetron Versus Ondansetron for Nausea and Vomiting in Pediatric Age Group
Official title: Oral Granisetron Versus Oral Ondansetron for Treatment of Gastroenteritis: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nausea and Vomiting in Pediatric Age Group
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 160
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current clinical trial will include 160 children who will be presented with vomiting to the Outpatient Department of the Children's Hospital, Faculty of Medicine, Ain Shams University. Participants will be assigned randomly to receive either a dispersible film Ondansetron or oral Granisetron. After initial assessment, both groups will be followed up after 6 and 48 hours to check the frequency of vomiting, diarrhea, fever, headache as well as the return of appetite and the need for further treatment. The impact of nausea and vomiting on patients' daily lives will be assessed using a modified version of the Functional Living Index-Emesis (FLIE).


Eligibility criteria: Inclusion Criteria:

• Patients presenting with vomiting within the past 24 hours, including patients without dehydration and those who have mild to moderate dehydration.

Exclusion Criteria:

* Patients who are severely dehydrated.
* Patients who have bloody vomiting.
* Children with chronic diseases like type 1 diabetes mellitus, end stage renal disease and who are receiving chemotherapy.
* Patients who have vomiting due to surgical causes like intestinal obstruction.

Primary outcomes:
measure: To compare the effectiveness of Granisetron oral solution and Ondansetron oral dispersible film for treatment of vomiting in pediatric patients.
timeFrame: at 6 hours and at 48 hours of adminsteration
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine-Ain Shams University
state: Abbasia
Study officials:
affiliation: Professor of Family Medicine, Faculty of Medicine, Ain shams University
name: Mohamed F Allam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of pediatrics, Faculty of Medicine, Ain shams University
name: May F Nassar, MD
role: STUDY_DIRECTOR
affiliation: Professor of pediatrics, Faculty of Medicine, Ain shams University
name: Ehab K Emam, MD
role: STUDY_CHAIR
affiliation: lecturer of pediatrics,Faculty of Medicine, Ain shams University
name: Haya E Ibrahim, MD
role: PRINCIPAL_INVESTIGATOR
References: