louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00654355: Measuring Adherence to Topical Therapy in Children With Atopic Dermatitis and the Impact of a Return Visit
Official title: Measuring Adherence to Topical Therapy in Children With Atopic Dermatitis and the Impact of a Return Visit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
eczema
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2008-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to better understand how the study drug works when people use it to treat atopic dermatitis.

Detailed description: To evaluate adherence to topical therapy using adherence data collected by the MEMS cap (Medication Electronic Monitoring System) in pediatric patients with atopic dermatitis (AD) and the impact of a return visit.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects age 2-15.
2. Stable or worsening atopic dermatitis affecting 5% or greater body surface area. Face and genital areas can be included in the body surface area determination and treatment area.
3. The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
4. The ability to understand and sign a written informed consent/assent form, which must be obtained prior to treatment.

Exclusion Criteria:

1. Known allergy to tacrolimus or to any component of the formulations.
2. The use of systemic therapy for atopic dermatitis within the past 4 weeks.
3. Use of prescription topical therapy for atopic dermatitis (e.g., corticosteroids or retinoids) within the past 2 weeks.
4. Use of any investigational therapy within the past 4 weeks.
5. Pregnant females, females who are breast feeding, or females of childbearing potential who are not practicing an acceptable method of birth control (abstinence, birth control pill/patch, barrier with spermicidal jelly, IUD, etc.), as determined by the investigator. Acceptable contraception must be used during the entire study. A pregnancy test will be performed on females of childbearing potential at baseline and at week 4.
6. Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.

Primary outcomes:
measure: Adherence
timeFrame: Week 4
Secondary outcomes:
measure: The % Change From Baseline to Week 4 (or End of Treatment) in the IGA.
timeFrame: Week 4
measure: EASI
timeFrame: Week 4
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Dept of Dermatology, WFUHS
state: North Carolina
Study officials:
affiliation: WFUHS
name: Steve Feldman, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06986655: The Effect of an Augmented Reality Game on Pain, Fear, and Care Satisfaction Levels During Allergy Testing in Children Aged 4-12 Years
Official title: The Effect of an Augmented Reality Game on Pain, Fear, and Care Satisfaction Levels During Allergy Testing in Children Aged 4-12 Years: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Augmented Reality
Keywords: allergy
pediatric
augmented reality
pain
anxiety
care satisfaction
Lead sponsor: Koç University
Sponsor class: OTHER
Collaborators: name: Koç University Hospital
First posted: 2025-05-23
Enrollment: 66
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to examine the effects of augmented reality (AR) games on pain, fear, and care satisfaction, and to contribute to the literature on innovative interventions that enhance the healthcare experiences of children undergoing allergy testing.

H1: The pain level of children undergoing allergy testing in the AR group is lower than that of children in the control group.

H2: The fear level of children undergoing allergy testing in the AR group is lower than that of children in the control group.

H3: The care satisfaction level of children undergoing allergy testing in the AR group is higher than that of children in the control group.


Eligibility criteria: Inclusion Criteria:

* Aged between 4 and 12 years.
* Scheduled to undergo an allergy test.
* No visual impairments that would interfere with the use of augmented reality -applications.
* No use of anxiolytic or analgesic medications within the last six hours.
* Willing to participate in the study, with parental/legal guardian consent as applicable.

Exclusion Criteria:

* Younger than 4 years or older than 12 years.
* Not scheduled for an allergy test.
* Presence of visual impairments.
* Use of anxiolytic or analgesic medications within the last six hours.
* Unwilling to participate in the study or lacking informed consent.

Primary outcomes:
measure: Pain Level
timeFrame: Immediately after the allergy testing procedure.
measure: Fear level
timeFrame: Immediately before and after the allergy testing procedure.
measure: Care Satisfaction
timeFrame: Immediately after the allergy testing procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koç University Hospital
state: Zeytinburnu
Study officials:
affiliation: Koç University
name: Remziye Semerci Şahin, Assistant professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00585455: Vascular Effects of Sertraline in Heart Failure
Official title: Effects of Chronic Sertraline Hydrochloride Administration on Vascular Endothelial and Autonomic Function in Patients With Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure
Depression
Keywords: vascular endothelium
nitric oxide
depression
heart failure
vascular biology
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-01-03
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic heart failure patients with concomitant depression

Brief summary: To determine the effects of chronic sertraline treatment on brachial artery flow-mediated dilation in patients with chronic heart failure and depression


Eligibility criteria: Inclusion Criteria:

* Chronic heart failure with LVEF\<40%, age \>21 years
* Depression requiring medical treatment with sertraline

Exclusion Criteria:

* Known intolerance of sertraline

Primary outcomes:
measure: Brachial artery flow-mediated dilation
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Stuart Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04502355: Voriconazole-Induced QT Interval Prolongation: A Prospective Study
Official title: Voriconazole-Induced QT Interval Prolongation: A Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Voriconazole Induced QT Interval Prolongation
Keywords: voriconazole, ECG, arrhythmia
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 60
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 0-20 years treated with oral or IV voriconazole at the Schneider Children's Medical Center from Oct 31st 2016.

Brief summary: The antifungal voriconazole is effective for the treatment of invasive fungal infections in immunocompromised patients. A serious adverse reaction is QT interval prolongation, which may precede life-threatening arrhythmias, such as torsades de pointes. Although ventricular arrhythmias are mentioned as a possible adverse effect of voriconazole, thus far, the incidence and clear recommendations for QT follow-up have not been published. This prospective observational study aimed at describing the incidence of voriconazole induced- QT interval prolongation in the pediatric population and determine the risk factors for this phenomenon.


Eligibility criteria: Inclusion Criteria:

* oral or IV treatment with voriconazole

Exclusion Criteria:

* No data prior to initiation of voriconazole treatment on QT interval (baseline ECG)
* Renal insufficiency or dialysis treatment

Primary outcomes:
measure: QT interval prolongation
timeFrame: up to three months of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Schneider childrens medical center of Isreal
Study officials:
References:
Clinical trial NCT02426255: Post Traumatic Critical Complications: a Prospective Cohort Study (ATLANREA)
Official title: Prospective Cohort of Severe Trauma Patients Hospitalized in West French Intensive Care Units
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Trauma (With or Without Traumatic Brain Injury)
Keywords: Severe trauma
traumatic Brain injury
Hemorrhage
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2015-04-24
Enrollment: 5000
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in ICU for severe trauma

Brief summary: The purpose of this observational epidemiological study is to investigate the management and the complications associated with severe trauma. Data will be analysed to answer pre-defined scientific projects and to improve management of these conditions.

Detailed description: Pseudonymized data will be collected by study coordinators in a secured e-database.

Cross audit will be performed to check data.

Eligibility criteria: Inclusion Criteria:

* severe trauma
* and/or traumatic brain injury
* and/or hemorrhage

Exclusion Criteria:

* Consent withdrawal

Primary outcomes:
measure: in ICU stay complications
timeFrame: Within the 28 first days after ICU admission date
Secondary outcomes:
measure: Duration of mechanical ventilation
timeFrame: in ICU (up to 90 days)
measure: ICU length of stay
timeFrame: in ICU (up to 90 days)
Other outcomes:
measure: Death
timeFrame: in ICU (up to 90 days)
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Tours
country: France
facility: Tours University Hospital
Study officials:
name: Karim ASEHNOUNE, PhD, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04285255: Quality of Recovery Following Opioids Free Anaesthesia in Laparoscopic Sleeve Gastrectomy
Official title: Quality of Recovery of Opioid Free Anaesthesia Versus Opioids Anaesthesia Within Enhanced Recovery Protocol Following Laparoscopic Sleeve Gastrectomy in Saudi Arabia, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Narcotics
Recovery Quality
Analgesia
Bariatric Surgery
Lead sponsor: Al Mashfa Medical Center
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Laparoscopic sleeve gastrectomy is widely employed nowadays. Multimodal analgesia approach is implemented within the enhanced recovery protocol in our facility to improve participants' recovery. Due to side effects of narcotics, the may adversely affect the quality of recovery, the investigators intended to test the efficacy of opioids free anaesthesia on the quality of recovery and postoperative narcotic use.


Eligibility criteria: Inclusion Criteria:

* 70 ASA II - III adult patients (18-60 years old)
* Elective laparoscopic bariatric surgery.
* Body mass index (BMI) is from 40 to 60
* Trocar sites at or above the umbilicus (T 10 dermatome).

Exclusion Criteria:

* Allergy to amino-amide local anaesthetics,
* presence of coagulopathy
* local skin infection at injection sites,
* preoperative chronic dependence upon opioid and NSAID medications,
* liver or renal insufficiency,
* history of psychiatric or neurological disease, deafness,
* previous open surgery,
* patients who need to be converted to open surgery with more tissue trauma,
* ASA (American society of anesthesiologists) class above III were excluded.

Primary outcomes:
measure: Quality of recovery 40 questionnaire (QoR-40)
timeFrame: At 6 hours
measure: Quality of recovery 40 questionnaire (QoR-40)
timeFrame: At 24th h (period of time between 6 and 24 hours) as repeated measurement
Secondary outcomes:
measure: Pethidine consumption
timeFrame: 24 hours
measure: Numerical rating scale (NRS)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Khobar
country: Saudi Arabia
facility: Al Mashfa medical center
state: Eastern Provence
Study officials:
References:
citation: Ibrahim M, Elnabtity AM, Hegab A, Alnujaidi OA, El Sanea O. Combined opioid free and loco-regional anaesthesia enhances the quality of recovery in sleeve gastrectomy done under ERAS protocol: a randomized controlled trial. BMC Anesthesiol. 2022 Jan 21;22(1):29. doi: 10.1186/s12871-021-01561-w.
Clinical trial NCT05632055: miRNA (microRNA) and FGF21 (Fibroblast Growth Factor-21) Profile in First Trimester and Gestational Diabetes Prediction
Official title: miRNA and FGF21 Profile in First Trimester and Efficacy of Gestational Diabetes Prediction and Pregnancy Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gestational Diabetes
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 160
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy pregnant women with single alive fetus Participants will be subgroup based on the result of 100gm OGTT

Brief summary: The goal of this observational study is to compare miRNA and FGF21 in pregnancy with and without GDM (Gestational Diabetes) The main question it aims to answer that miRNA and FGF21 are different between two groups.

Participants will be retrieved blood sample during first trimester and undergone 100 gm OGTT (oral glucose challenge test) during 24-28 weeks of gestation.

Detailed description: Pregnant women who attended antenatal care at Maharaj Nakorn Chiang Mai hospital during first trimester were recruited.

Participants received routine standard prenatal care except,

1. additional blood test during 11-13 week 6 days (Blood was collected for further analysis)
2. performed 75gm OGTT during 24-28 week

Baseline data and pregnancy outcome were reviewed.

Eligibility criteria: Inclusion Criteria:

* singleton pregnant women who attend at our clinic in first trimester

Exclusion Criteria:

* known underlying disease such as chronic hypertension, pregestational diabetes, SLE
* normal structural fetal anatomical screening
* incomplete obstetric data

Primary outcomes:
measure: miRNA profile
timeFrame: within 1 month after blood drawn
Secondary outcomes:
measure: FGF21 profile
timeFrame: 6 months after blood drawn
Other outcomes:
Locations:
city: ChiangMai
country: Thailand
facility: Maharaj Nakorn ChiangMai Hospital
Study officials:
References:
Clinical trial NCT02249455: Effectiveness of Acapella and ELTGOL Technique to Promote Airway Clearance in COPD:a Comparative Study
Official title: Effectiveness of Acapella and ELTGOL (Expiration in Lateral Position With Open Glottis)Technique to Promote Airway Clearance in COPD Patients:a Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: PSG College of Physiotherapy
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of acapella and expiration against open glottis (ELTGOL) technique in promoting airway clearance of chronic obstructive pulmonary disease (COPD) patients

Detailed description: This study is carried out to determine the effectiveness of acapella and expiration in lateral position with open glottis to clear the secretion in COPD patients. The sessions will be carried twice daily for twenty minutes. The outcome measures are values of pre and post intervention fev1/fvc and breathlessness cough sputum scale. Duration of the study will be for five days.

Eligibility criteria: Inclusion Criteria:

* Mild copd
* Moderate copd
* Patient able to sustain expiratory flow greater than 15l/min
* Patient expectorate more than 25.-30ml

Exclusion Criteria:

* Severe copd
* Peripheral oxygen saturation lower than 85%
* Rr\>35breaths/min
* Current acute chest pain
* Recent history of haemoptysis

Primary outcomes:
measure: Change in Force expiratory volume in one second
timeFrame: change from baseline at 30 minutes
Secondary outcomes:
measure: Change in breathlessness cough sputum score
timeFrame: change from baseline at 5 days
Other outcomes:
Locations:
city: Coimbatore
country: India
facility: Steffi Varghese
state: Tamilnadu
Study officials:
affiliation: psg ims&r
name: steffi varghese, mpt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06623955: Maternal Serum Stathmin-1 Levels in Preeclampsia
Official title: A Comparative Study of Maternal Serum Stathmin-1 Levels in Pregnancies With Preeclampsia, Severe Preeclampsia, and Healthy Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-Eclampsia
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-02
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The groups in this study will be selected consists of pregnant women receiving care at a referral center for maternal care.

Brief summary: This study investigates maternal serum Stathmin-1 (STMN-1) levels in pregnancies complicated by preeclampsia and severe preeclampsia, compared to healthy pregnancies. The aim is to explore potential differences in STMN-1 levels among these groups to better understand its role in preeclampsia pathophysiology. Maternal serum STMN-1 levels will be measured between 32-34 weeks of gestation, and patients will be monitored until delivery to assess whether they develop preeclampsia or severe preeclampsia.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Preeclampsia: Defined by New-onset hypertension (Systolic Blood Pressure ≥140 mmHg and/or Diastolic Blood Pressure ≥90 mmHg) after 20 weeks of gestation, with or without proteinuria.
* Clinical diagnosis of Severe Preeclampsia: Defined by criteria such as severe hypertension (systolic BP ≥160 mmHg or diastolic BP ≥110 mmHg), organ dysfunction (renal insufficiency, liver involvement, neurological complications), thrombocytopenia, pulmonary edema, or fetal growth restriction.
* Control Group: Healthy pregnancies without preeclampsia

Exclusion Criteria:

* Multiple Pregnancies
* Pregestational Diabetes
* Chronic Hypertension
* Systemic Diseases (Chronic kidney disease, autoimmune diseases)
* Fetal Anomalies
* Premature Rupture of Membranes

Primary outcomes:
measure: Maternal Serum Stathmin-1
timeFrame: Up to 8 weeks (Patients will be followed from inclusion in the study until the end of their pregnancy.)
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cam and Sakura City Hospital
Study officials:
References:
Clinical trial NCT00546455: A Randomized, Double-blind Study of the Effects of Fenretinide Administered in Subjects With Obesity
Official title: Phase 2 Study of the Assessment of the Insulin Sensitizing Activity of Fenretinide in Subjects With Insulin Resistance With BMI >30Kg/m2, and Liver Inflammation Related to Non-alcoholic Fatty Liver
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Obesity
Insulin Resistance
Keywords: Obesity
insulin resistance
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2007-10-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many metabolic complications of obesity are a consequence of abnormal responses of the liver, muscle, and fat to insulin actions. Fenretinide may improve the effects of insulin, preventing metabolic complications.


Eligibility criteria: Inclusion Criteria:

* BMI \>30

Exclusion Criteria:

* Diabetes Requiring Medication
* Poorly Controlled Co-Morbidities

Primary outcomes:
measure: Assessment of the Effect on Insulin Resistance
timeFrame: 30 days
Secondary outcomes:
measure: Assessment of the Biochemical Response in Cholesterol, Glucose and Related Blood Tests.
timeFrame: 30 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California at San Diego Hospitals
state: California
Study officials:
affiliation: University of California, San Diego and San Diego VA Healthcare Medical Center
name: Mario Chojkier, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02590055: Phase 2 Study of Gemcitabine and Docetaxel Combination Chemotherapy in Patients With Carcinoma of Unknown Primary
Official title: Phase 2 Study of Gemcitabine and Docetaxel Combination Chemotherapy in Patients With Carcinoma of Unknown Primary
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma of Unknown Primary
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 29
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It's a phase 2, single arm study of gemcitabine an docetaxel combination in patients with carcinoma of unknown primary.


Eligibility criteria: Inclusion Criteria:

* 1. age\>=20 2. pathologically confirmed patients with carcinoma of unknown primary 3. unfavorable type of CUP 4. ECOG PS 0-2 5. more than 1 evaluable lesion 6. life expectancy \> 12 weeks 7. no prior history of chemotherapy 8. more than 2 weeks after surgery or radiotherapy 9. proper organ function 10. written informed consent

Exclusion Criteria:

* 1. favorable group CUP

  * squamous cell carcinoma in the cervical or inguinal LN only women with axillary LN metastasis only women with peritoneal carcinomatosis only well-differentiated neuroendocrine tumors poorly-differentiated tumors with midline tumor or elevated human HCG/AFP men with adenocarcinoma and elevated PSA 2. severe, unstable heart disease 3. uncontrolled systemic disease (DM, HTN, hypothyroidism, infection...) 4. pregnant or feeding women 5. current CNS tumor (except total removal or WBRT/GKS done)

Primary outcomes:
measure: Overall survival
timeFrame: one year after later patients enrolled
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: department of medicine, Samsung Medical Center
name: Su Jin Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: