louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00359489: Methods Study to Evaluate Use of Cardiac Ultrasound to Assess Heart Valve Abnormality in People.
Official title: A Randomized, Open-Label, Methodology Trial To Investigate The Utility Of Echocardiography In Assessment Of Cardiac Valvular Regurgitation In Adult Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Valve Diseases
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Methods study to evaluate use of cardiac ultrasound to assess heart valve abnormality in people.


Eligibility criteria: Inclusion Criteria:

* \>=18 years of age subjects with stable concomitant diseases with BMI \>=30 kg/m2

Exclusion Criteria:

* Pregnant females
* Those with unstable/new onset diseases
* Those who are on agents known to be associated with cardiac valvular heart disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03606889: Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-prostatectomy Analgesia
Official title: Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-prostatectomy Analgesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostatic Cancer
Pain, Postoperative
Pain
Anesthetics, Local
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recently, the uses of peripheral axial blocks that deliver local anesthetic into the transversus abdominis fascial plane have become popular for operations that involve incision(s) of the abdominal wall. Thus, the Transversus Abdominis plane (TAP) block has been shown to reduce perioperative opioid use in elective abdominal surgery, including open appendicectomy, laparotomy, and laparoscopic cholecystectomy.

Currently, the Quadratus Lumborum block (QL block) is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery. The local anesthetic injected via the approach of the posterior QL block ( QL 2 block ) can more easily extend beyond the TAP to the thoracic paravertebral space or the thoracolumbar plane, the posterior QL block entails a broader sensory-level analgesic and may generate analgesia from T7 to L1. Use of posterior QL block in laparoscopic prostatectomy has not been investigated before and it is the variant that will be discussed in our study.

Detailed description: In laparoscopic prostatectomy, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain), visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with carbon dioxide insufflation. Moreover, it has been hypothesized that intense acute pain after laparoscopic prostatectomy may predict development of chronic pain. Without effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and thereby increase the cost of such care.

Eligibility criteria: Inclusion Criteria:

* Pateints who will have prostatectomy ASA II or III

Exclusion Criteria: Patient refusal Local infection at the site of injection Allergy to study medications Sepsis Anatomic abnormalities Systemic anticoagulation or coagulopathy Inability to comprehend or participate in pain scoring system Inability to use intravenous patient controlled analgesia

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Primary outcomes:
measure: Total oxycodone used in the first 24 hours after surgery
timeFrame: 24 hours
Secondary outcomes:
measure: Severity of postoperative pain via visual analogue pain scale (VAS)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: University Hospital in Cracow
Study officials:
affiliation: Jagiellonian University
name: Tomasz Skladzien, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01958489: A Study of Evacetrapib in Japanese and Non-Japanese Participants
Official title: Effect of Evacetrapib on the Pharmacokinetics of Pravastatin in Healthy Japanese and Non-Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-10-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to look at the effect of evacetrapib on pravastatin levels in the blood when both drugs are taken at the same time. The study will also assess how well the body handles evacetrapib and pravastatin when given at the same time.

This study has two periods in fixed order. Each participant will enroll in both periods. This study will last approximately 25 days, not including screening.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy participants, as determined by medical history and physical examination
* Have a body mass index of 18 to 32 kilograms per square meter (kg/m²)
* Japanese participants must be first generation Japanese

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Pravastatin
timeFrame: Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose
measure: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pravastatin
timeFrame: Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose
measure: PK: Time of Maximum Observed Concentration (Tmax) of Pravastatin
timeFrame: Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: West Yorkshire
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05890989: Relationship of Epicardial Adiposity With Sedentary Time, Physical Activity and Performance in Hypertensives
Official title: Relationship Between Epicardial Adipose Tissue Thickness and Sedentary Time, Physical Activity Level, and Physical Performance in Patients With Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Epicardial adipose tissue
Hypertension
Physical activity
Sedentary time
Physical performance
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
Collaborators: name: Karaman Training and Research Hospital
First posted: 2023-06-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Volunteers who had been diagnosed with hypertension for at least 6 months

Brief summary: Epicardial adipose tissue is associated with the development of cardiovascular disease and its increase is positively correlated with blood pressure elevation in hypertensive individuals. In the literature, being physically active has been shown to be effective in the treatment of hypertension and reduction of epicardial adipose tissue thickness. The aim of this study was to evaluate the relationship between epicardial adipose tissue thickness and sedentary time, physical activity level and physical performance in patients with hypertension. The study included 40 patients with hypertension. The physical and demographic characteristics of the participants were collected using a sociodemographic form. Waist/hip circumference was measured with tape measure and epicardial adipose tissue thickness with echocardiography device. Physical activity levels and sedentary time were recorded via IPAQ-7. Physical performance was determined using the 30-s sit-and-stand test. There is no previous study in the literature evaluating the relationship between epicardial adipose tissue thickness and sedentary time and physical activity levels in hypertensive patients. With this study, we aim to contribute to the literature by filling this deficiency.


Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study
* Being diagnosed with hypertension for at least 6 months
* Speaking Turkish
* to be able to read and write,
* To be between 18-65 years old

Exclusion Criteria:

* Severe valvular disease
* be heart failure
* being cardiomyopathy
* having chronic kidney disease
* being thyroid diseases
* active infectious or inflammatory diseases
* serious psychiatric illnesses such as panic disorder or major depression

Primary outcomes:
measure: EPICARDIAL ADIPOSIS TISSUE MEASUREMENT
timeFrame: measured at admission
Secondary outcomes:
measure: PHYSICAL PERFORMANCE
timeFrame: measured at admission
Other outcomes:
measure: PHYSICAL ACTIVITY
timeFrame: measured at admission
measure: SEDENTARY TIME
timeFrame: measured at admission
Locations:
city: Karaman
country: Turkey
facility: Karamanoğlu Mehmetbey University
Study officials:
References:
Clinical trial NCT00668889: Dermacyd Tina Gel Tangerina Mix - Photo Evaluation
Official title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Tina Gel Tangerina Mix.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-04-29
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Tina Gel Tangerina Mix.


Eligibility criteria: Inclusion Criteria:

* Phototype Skin II and III
* Integral skin test in the region

Exclusion Criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection
* Diseases which can cause immunity decrease, such as HIV, diabetes
* Use of drug photosensitizer
* History of sensitivity or irritation for topic products
* Active cutaneous disease which can change the study results
* History or photodermatosis active
* Family or personal antecedent of cutaneous photoinduced neoplasias
* Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium
* Intense solar exposure in the study area
* Use of new drugs or cosmetics during 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: The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. The sensibility will be evaluated according to the skin type.
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-aventis administrative office
Study officials:
affiliation: Sanofi-aventis administrative office Brazil
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT02559089: Multicenter and Prospective Clinical Registry Study of Anti-N-methyl-D-aspartate Receptor Encephalitis in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anti-NMDA Receptor Enphalitis
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: Xuanwu Hospital, Beijing
name: Peking Union Medical College Hospital
name: Beijing Children's Hospital
First posted: 2015-09-24
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the unidentified encephalitis patients who meeting the inclusion criteria and exclusion criteria and signing the written informed consent form。

Brief summary: Anti-NMDA receptor encephalitis is the most common curable non-infectious autoimmune encephalitis，but because of the lack of recognition in the clinic, usually been misdiagnosed as other causes of encephalitis. Therefore, it is urgent to establish a database of anti-NMDA receptor encephalitis in Chinese population. The multi-center, prospective clinical trial of anti-NMDA receptor encephalitis in China's , combined with Beijing Xuanwu hospital, Beijing Tiantan Hospital, Beijing Children's Hospital and other hospitals around the country, by screening the NMDA receptor antibody and summarizing the cases analysis, in order to provide evidence for clinical diagnosis and treatment of anti-NMDA receptor encephalitis.


Eligibility criteria: Inclusion Criteria:

1. Older than 6 months.
2. Encephalopathy symptoms (change of mental state and consciousness level) persist for more than 24 hours;
3. At least one or more clinical features of the followings: fever, epilepsy, focal neurological deficiency symptoms, changes in CSF(cerebrospinal fluid inflammatory), changes in EEG (electroencephalogram), radiographic abnormalities;
4. Clinical suspected encephalitis, but conventional detected methods cannot make etiology clear.
5. Signed informed consent

Exclusion Criteria:

1. Infants less than 6 months;
2. The metabolic encephalopathy;
3. Infectious encephalitis with clear pathogen clinically, referring the specific pathogenic microorganisms, including: bacteria, virus, fungus, parasite, spirochete and so on;
4. Non-infectious encephalitis with clear diagnosis clinically, including: multiple sclerosis, neuromyelitis optic, acute disseminated encephalomyelitis and so on.

Primary outcomes:
measure: death
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT07019389: SOFAA Turkish Version Study
Official title: Assessment of the Validity and Reliability of the Turkish Adaptation of the Child- and Parent-Rated Scales of Food Allergy Anxiety (SOFAA)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Food Hypersensitivity
Allergy
Phobic Disorders
Caregiver Burden
Validation Study
Cross-Cultural Comparison
Parents
Anxiety
Pediatrics
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 105
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 8-18 with food allergy and their parents, recruited from pediatric allergy outpatient clinics in Turkey.

Brief summary: This study aims to assess the psychometric properties of the Turkish translation of the Scale of Food Allergy Anxiety (SOFAA), including both child- and parent-report versions. The goal is to validate its reliability and construct validity among children with IgE-mediated food allergies and their caregivers in Turkey.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with IgE-mediated food allergy
* At least one parent/caregiver willing to participate
* Fluent in Turkish

Exclusion Criteria:

* Major neurodevelopmental or psychiatric disorders that impair ability to complete scales

Primary outcomes:
measure: Internal Consistency of the Turkish Version of the SOFAA-C and SOFAA-P
timeFrame: Within 1 week of initial administration
measure: Construct Validity of the Turkish Version of SOFAA
timeFrame: Within 1 week of initial administration
measure: Test-Retest Reliability of the Turkish Version of SOFAA
timeFrame: Approximately 10-14 days after baseline assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Study officials:
References:
citation: Protudjer JLP. Scales of Food Allergy Anxiety (SOFAA): A Novel Tool to Assess Anxiety Among Children with Food Allergy and Their Caregivers. J Allergy Clin Immunol Pract. 2022 Jan;10(1):170-171. doi: 10.1016/j.jaip.2021.10.036. No abstract available.
citation: Dahlsgaard KK, Wilkey LK, Stites SD, Lewis MO, Spergel JM. Development of the Child- and Parent-Rated Scales of Food Allergy Anxiety (SOFAA). J Allergy Clin Immunol Pract. 2022 Jan;10(1):161-169.e6. doi: 10.1016/j.jaip.2021.06.039. Epub 2021 Jul 12.
Clinical trial NCT03504189: Evaluating the Safety of PregSense™ and Compare Its Performance to CTG in Prenatal Monitoring of Pregnant Subjects
Official title: Clinical Study Evaluating the Safety of PregSense and Comparative Performance of PregSense Versus CTG in Prenatal Monitoring of Pregnant Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Fetal monitoring, Prenatal monitoring
Lead sponsor: Nuvo-Group, Ltd.
Sponsor class: INDUSTRY
First posted: 2018-04-20
Enrollment: 151
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Label
Primary purpose: OTHER

Brief summary: This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.

Detailed description: PregSense™ is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate, maternal hear rate and uterine contractions. This study will be performed to collect and digitally record data from PregSense™ and the standard of care (CTG) in order to provide evidence of safety and agreement between PregSense™ and the gold standard NST device.

Eligibility criteria: Inclusion Criteria:

* Female age between 18-50
* Gestational age \> 32 + 0 weeks
* Singleton gestation
* Ability to understand and sign informed consent

Exclusion Criteria:

* BMI (Body Mass Index) ≥ 45 and ≤15 prior pregnancy
* Multiple gestation
* Uncontrolled Hypertension
* Fetal Anomaly
* Subjects with skin problems in the abdominal area (such as flesh wounds, cuts in the skin, skin rashes, etc.)
* Subjects with implanted electronic devices (pacemaker, defibrillator, etc.)
* Subjects who, in the judgement of the investigator, are likely to be non-compliant or uncooperative during the study

Primary outcomes:
measure: Fetal Heart Rate
timeFrame: 30 Minutes
measure: Maternal Heart Rate
timeFrame: 30 MInutes
Secondary outcomes:
measure: Uterine Contractions
timeFrame: 30 Minutes
Other outcomes:
measure: Safety Measures
timeFrame: Through study completion, an average of 1 hour
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Heidelberg
country: Germany
facility: Heidelberg University Womens Hospital
city: Jerusalem
country: Israel
facility: Hadassah-Hebrew University Medical Center
Study officials:
References:
citation: Mhajna M, Schwartz N, Levit-Rosen L, Warsof S, Lipschuetz M, Jakobs M, Rychik J, Sohn C, Yagel S. Wireless, remote solution for home fetal and maternal heart rate monitoring. Am J Obstet Gynecol MFM. 2020 May;2(2):100101. doi: 10.1016/j.ajogmf.2020.100101. Epub 2020 Mar 17.
Clinical trial NCT04886089: Pleth Variability Index as a Predictor for Post-induction Hypotension in Elderly Patients
Official title: Pre-anesthesia Pleth Variability Index as a Predictor for Post-induction Hypotension in Elderly Patients Undergoing General Anesthesia: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-induction Hypotension
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 85
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients. Patients ≥ 65 years, ASA physical status I or II, and scheduled for elective surgery under general anesthesia will be enrolled in the study.

Brief summary: Hypotension after induction of general anesthesia and before surgical stimulation is a prevalent anesthesia-related side effect. The post-induction hypotension disrupts organ perfusion and may cause organ damage particularly acute kidney injury, cerebrovascular stroke, and myocardial ischemia. Post-induction hypotension occurs with greater frequency and severity in the elderly. This is because of aged-related diminished cardiac reserve and impaired autonomic homeostasis. Pleth variability index (PVI) is a software program that measures the dynamic changes of the PI that occurs during a complete respiratory cycle. Our primary outcome is to determine the predictive ability and the optimal cut-off value of pre-anesthesia PVI for predicting elderly patients who are at risk of developing post-induction hypotension


Eligibility criteria: Inclusion Criteria:

* patients with ASA physical status I or II
* patients will receive general anesthesia

Exclusion Criteria:

* Patients with a history of cardiorespiratory disorders
* patients with uncontrolled hypertension or cardiac dysrhythmias
* Patients with renal or hepatic diseases.
* Patients with long-standing diabetes and peripheral vascular diseases.

Primary outcomes:
measure: The accuracy (Area under receiver operating characteristic curves) of pre-induction PVI for prediction of post-induction hypotension
timeFrame: before induction of general anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Maadi
country: Egypt
facility: Abeer Ahmed Mohamed
state: Cairo
Study officials:
References: