louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05747612: Mental Coaching and Counseling for Bipolar Patients: Dealing With Moments of Crisis in Times of COVID-19.
Official title: Mental Coaching and Counseling for Bipolar Patients: Dealing With Moments of Crisis in
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: To Determine the Incidence of Depression in Subjects Affected by Bipolar Disorder
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The goal of this interventional study is to evaluate some outcome parameters at the time of enrollment (T0), during the treatment (T1 and T2) and at the end (T3) of the subjects who will have carried out an individual counseling intervention or mental coaching. The aim is to determine the incidence of depression, trait anxiety, state anxiety, sleep disorders, resilience, defense mechanisms, distress caused by stressful events in a sample of subjects affected by Bipolar Disorder.


Eligibility criteria: Inclusion Criteria:

* Recruited subjects have a diagnosis of Bipolar Disorder and are 18 years of age or older.

Exclusion Criteria:

* Previous or current intellectual disability in accordance with the Diagnostic and Statistical Manual of Mental Disorders, DSM-5.
* Patients who are unable to express consent and who do not have a caregiver who can give it for them.

Primary outcomes:
measure: To determine the incidence of depression, trait anxiety, state anxiety, sleep disorders, resilience, defense mechanisms, distress caused by stressful events in a sample of subjects affected by Bipolar Disorder.
timeFrame: 12 months
Secondary outcomes:
measure: To ascertain the presence of evolutionary and maturational trends in the defensive structure especially in the face of a totally unpredictable and unexpected situation such as the COVID-19 pandemic.
timeFrame: 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Gemelli IRCCS
state: Roma
Study officials:
References:
Clinical trial NCT04398212: Computer Vision Syndrome Visual Sequelae
Official title: Visual and Ocular Sequelae of Computer Vision Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Computer Vision Syndrome
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 733
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: the university students will respond to CVS-F3 survey form and then they will be subjected to complete ophthalmic examination and investigations

Detailed description: CVS-F3 is a survey form consisted of up to 30 questions regarding Computer Vision Syndrome (CVS) complains, thereafter a randomized sample of students will be subjected to complete ophthalmic examination including visual acuity and refractive measurements, intraocular pressure measurements, Slitlamp and fungus examinations, mfERG examinations. the sudents will be requested to decrease their screen time and the examinations will be repeated one month later.

Eligibility criteria: Inclusion Criteria:

- University students

Exclusion Criteria:

* Amblyopia
* Anisometropia
* strabismus
* Previous eye surgery

Primary outcomes:
measure: visual acuity
timeFrame: 1 month
measure: near vision
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of medicine
Study officials:
affiliation: Sohag University
name: Mohammed Iqbal, MD. PhP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04402112: Efficacy and Safety of Pitavastatin in a Real-world Setting
Official title: Efficacy and Safety of Pitavastatin in a Real-wOrld Setting: Observational Study Evaluating saFety in Patient With Pitavastatin for Lipid Lowering Therapy in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Keywords: Pitavastatin
LIVALO
Safety data
South Korea
Large-scale prospective trial
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-05-26
Enrollment: 28343
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving Livalo tablets in clinical practice in South Korea

Brief summary: The prospective, observational, non-comparative trial in South Korea was designed to evaluate the efficacy and safety of pitavastatin (Livalo) in clinical practice in 28,343 patients.

Detailed description: This study was conducted in 893 facilities in Korea from 2 Apr 2012 to 1 Apr 2017. This study was designed to administer 1mg, 2mg, or 4mg pitavastatin to patients with hyperlipidemia at the age of 20 or older for at least 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients in need of statin treatment who are taking or are planning to take Livalo tablets, or who are taking other statins or are planning to change to Livalo tablets.

Exclusion Criteria:

* Patients with hypersensitivity to pitavastatin
* Patients with active liver disease or untranslated transaminase levels Patients with a constant rise in
* Patients with severe liver failure or biliary obstruction and patients with cholestasis
* Patients who are receiving cyclosporine
* Myopathy patients
* Pregnant women or women of childbearing age and lactating women
* Children
* Patients with genetic problems, such as galactose intolerance, Lapp lactose deficiency or glucose-galactose
* Patients deemed inappropriate by the investigator

Primary outcomes:
measure: Number of participants with adverse events as assessed by CTCAE v4.0
timeFrame: At 8 weeks after administration of pitavastatin
Secondary outcomes:
measure: Overall symptom satisfaction evaluation
timeFrame: At 8 weeks after administration of pitavastatin
measure: Change in serum lipid profile before and after administration of pitavastatin
timeFrame: At screening and after 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: The Catholic University of Korea
name: Sung-Rae Kim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeong IK, Kim SR. Efficacy and Safety of Pitavastatin in a Real-World Setting: Observational Study Evaluating SaFety in Patient Treated with Pitavastatin in Korea (PROOF Study). Endocrinol Metab (Seoul). 2020 Dec;35(4):882-891. doi: 10.3803/EnM.2020.723. Epub 2020 Dec 2.
Clinical trial NCT01685112: Comparison of ECMO Use and Conventional Treatment in Adults With Septic Shock
Official title: Comparison of ECMO Use and Conventional Treatment in Adults With Septic Shock
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Shock
Keywords: adults
ECMO
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-09-13
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patient who admitted to ICU and had severe sepsis and progressed to septic shock

Brief summary: Although few cases reported successful treatment of septic shock using extracorporeal membrane oxygenation (ECMO) in adults, no studies compared ECMO to conventional treatment (without ECMO) as treatment for adults with septic shock. Since it is difficult to conduct a randomized study to allocate patients in such critical condition, we aimed to conduct a retrospective observational study using propensity score matched analysis to compare the survival of adults with septic shock treated by ECMO or conventional treatment.


Eligibility criteria: Inclusion Criteria:

* age \>20
* admitted at ICU
* septic shock

Exclusion Criteria:

* nil

Primary outcomes:
measure: In hospital mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: YuChung Chuang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06934746: Evaluation of Screen Time and Digital Media on ADHD
Official title: Evaluation of Screen Time and Digital Media on ADHD
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Monitor Adverse Events
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 130
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neuro-psychiatric Outpatient clinic in Assiut University Children Hospita

Brief summary: 1. Assess how different types of digital media influence inattention, impulsivity, and hyperactivity in children with ADHD.
2. Analyze the role of screen time duration, content type, parental supervision, and socioeconomic status in ADHD symptom severity.

Detailed description: Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most prevalent neurodevelopmental disorders in children, characterized by persistent patterns of inattention, hyperactivity, and impulsivity. Studies suggest that its prevalence has risen due to improved recognition and changing diagnostic criteria. Children with ADHD experience significant challenges in school performance, including difficulty sustaining attention, frequent careless mistakes, and trouble following instructions, all of which contribute to lower academic achievement and increased need for special education support. ADHD is linked to problematic eating behaviors, as irregular meal patterns, increased consumption of unhealthy foods, and a higher risk of obesity due to impulsivity and poor self-regulation. Beyond academics and nutrition, ADHD also affects sleep quality, emotional regulation, and social interactions, leading to increased behavioral issues and conflicts with peers and family members. The widespread use of digital media further complicates these challenges, as excessive screen time has been associated with exacerbating ADHD symptoms and negatively impacting cognitive and emotional development. These findings highlight the urgent need for targeted interventions to support children with ADHD across multiple aspects of their daily lives

Eligibility criteria: Inclusion Criteria:

* Diagnosed children with ADHD, confirmed by DSM-5 and Gilliam ADHD rating scale. • Parental consent for participation.

Exclusion Criteria:

* Comorbid neurodevelopmental disorders (e.g., autism, intellectual disability). • Chronic medical conditions affecting cognitive or behavioral function.

Primary outcomes:
measure: Change in Inattention Symptoms Measured by the ADHD Rating Scale-IV
timeFrame: Baseline (Day 1) and after 6 months of follow-up
measure: Change in Hyperactivity/Impulsivity Symptoms Measured by the ADHD Rating Scale-IV
timeFrame: Baseline (Day 1) and after 6 months of follow-up
Secondary outcomes:
measure: Correlation between Socioeconomic Status and ADHD Symptom Severity
timeFrame: After 6 months of follow-up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00764946: A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055)
Official title: A Phase III Open-Label Single Arm Study to Evaluate the Safety, Tolerability, and Efficacy of MK0518/Raltegravir in a Diverse Cohort of HIV-Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Human Immunodeficiency Virus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 209
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study to test the safety and effect of twice daily raltegravir in a diverse cohort of patients currently infected with human immunodeficiency virus (HIV), where at least 50% are African American and at least 25% are female, either having received antiretroviral drugs before or not.


Eligibility criteria: Inclusion Criteria:

* Patient is HIV positive
* Patient agrees to use (or have their partner use) birth control as defined by the study doctor

Exclusion Criteria:

* If female, pregnant or breastfeeding
* Patient has used an investigational agent in the last 30 days
* Patient has acute hepatitis
* Patient has received MK0518 (raltegravir) before
* Patient has used another experimental HIV-integrase inhibitor

Primary outcomes:
measure: Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
timeFrame: Week 48
measure: Number of Participants With One or More Adverse Events
timeFrame: Week 48
measure: Number of Participants Who Discontinued Due to an Adverse Event
timeFrame: Week 48
Secondary outcomes:
measure: Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48
timeFrame: Week 48
measure: Mean Change From Baseline to Week 48 in HIV RNA
timeFrame: Baseline and Week 48
measure: Mean Change From Baseline to Week 48 in CD4 Cell Count
timeFrame: Baseline and Week 48
measure: Number of Participants Without Loss of Virologic Response
timeFrame: Week 48
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Squires KE, Bekker LG, Eron JJ, Cheng B, Rockstroh JK, Marquez F, Kumar P, Thompson M, Campo RE, Mounzer K, Strohmaier KM, Lu C, Rodgers A, Jackson BE, Wenning LA, Robertson M, Nguyen BY, Sklar P; REALMRK Investigators. Safety, tolerability, and efficacy of raltegravir in a diverse cohort of HIV-infected patients: 48-week results from the REALMRK Study. AIDS Res Hum Retroviruses. 2013 Jun;29(6):859-70. doi: 10.1089/AID.2012.0292. Epub 2013 Feb 26.
Clinical trial NCT03656146: Food for Thought: Food Insecurity Screening in the Emergency Department
Official title: Food for Thought: A Randomized Trial of Food Insecurity Screening in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hunger
Child Nutrition Disorders
Keywords: social determinants of health
food insecurity
screening
pediatrics
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2018-09-04
Enrollment: 1818
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study compares food insecurity disclosure rates in face-to-face interviews versus electronic formats, and explores caregiver preferences regarding screening modality and location, in a large, urban pediatric emergency department. Half of the participants were screened for food insecurity verbally, face-to-face by a research assistant, and half of the participants were screened electronically by a tablet.

Detailed description: Children are disproportionately affected by the rise in poverty rates in the United States, and economic hardships can compromise their development, negatively affect their overall health, and adversely affect their abilities to succeed in school and in life. Food insecurity (FI)-the limited or uncertain availability of nutritionally adequate or safe foods- while strongly associated with poverty, is an independent predictor of poor health outcomes for children.

The Emergency Department (ED) of academic medical centers often serves as a point of care entry for impoverished and high-risk families. Although there is a growing interest in the healthcare system's ability to address Social Determinants of Health (SDH), little is known about food insecurity in the pediatric ED. Additionally, there are limited data on how to implement FI screening into practice in a way that maximizes elicitation of social need, while assuring patient and family comfort.

Eligibility criteria: Inclusion Criteria:

* English speaking
* Adult caregiver accompanying pediatric patient in the Children's Hospital of Philadelphia (CHOP) emergency department

Exclusion Criteria:

* Patient (child) in critical condition
* Patient (child) \>18 years of age
* Previously enrolled in study

Primary outcomes:
measure: Presence of Food Insecurity
timeFrame: 12 months
Secondary outcomes:
measure: Preferred Screening Modality
timeFrame: 4 weeks
measure: Comfort level with screening location
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03675646: Spinal Morphine for Postoperative Analgesia in Urology
Official title: Comparison of Spinal Morphine With Systemic Analgesia After Urologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: morphine spinal
prostatectomy
nephrectomy
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patient elicited for open prostatectomy or open nephrectomy were given intrathecal morphine in normal saline before induction to general anaesthesia (GA) or GA only. After surgery, time to the first opioid request, total opioid consumption during first 24 hours and 48 hours after surgery and opioid side effects were noticed.
Primary purpose: TREATMENT

Brief summary: The study was performed in urology patients elicited for open prostatectomy or open nephrectomy. Comparison of analgesic effect between group (M) with spinal morphine before general anaesthesia and group without this intervention was measured.

Detailed description: Patients elicited for open prostatectomy or open nephrectomy were randomly divided in 2 groups. Group M were administered preservative-free morphine 250 mcg in 2.5 ml NS intrathecal using 25 G needle in L1/2 - L5/S1 interspaces. Control group (C) were given no intervention. Placebo intrathecal injection in C was not used because of ethical reason. Standard general anaesthesia was used in both groups. After surgery all patients were transferred to urology ICU and were given standard analgesic regimen according to level of pain measured by numeric rating scale (NRS) 0 - 10: NRS \> 3 metamizol 1 g IV every 6 h., max. 4 g/24 h., NRS \> 3 paracetamol 1g IV every 6 h., max. 4 g/24 h., NRS \> 3 lasting 30 min. after administration of previous ones diclofenac 75 mg IM á 12 h., max. 150 mg/24 h., NRS \> 4 morphine 10 mg SC á 6 h. Personnel of ICU was blinded to the analgesic method used.

Noticed parameters: pain intensity (NRS), time to NRS ≥ 4, time to the first morphine request, side effects (respiratory rate \<8, SpO2\<90 %, nausea, vomiting, naloxone administration for SpO2\<88 %, itching).

Standard statistical analysis was used, p value \< 0.05 was considered significant.

Eligibility criteria: Inclusion Criteria

* elicited open prostatectomy or open nephrectomy

Exclusion Criteria

* drug or alcohol dependence
* psychiatric drug use
* ASA classification IV or V
* general contraindication to neuroaxial injection

Primary outcomes:
measure: Duration of analgesia
timeFrame: 48 hours
Secondary outcomes:
measure: Morphine side effects
timeFrame: 48 hours
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: University Hospital Kralovske Vinohrady
Study officials:
affiliation: 3rd Medical Faculty, Charles University
name: Jiri Malek, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02883946: Rituximab in Hairy Cell Leukemia: a Multicenter Retrospective Study
Official title: Rituximab in Hairy Cell Leukemia: a Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hairy-cell Leukemia
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hairy-cell leukemia.

Brief summary: Hairy-cell leukemia is a rare and indolent lymphoid disorder, representing 2% of all cases of lymphoid leukemias. Treatment of hairy-cell leukemia relies mainly on the purine analogs, cladribine and pentostatin, which have shown similar efficacy and constitute the gold standard of care either as front-line therapy or for relapsed patients.

However, despite the remarkable response rates obtained with purine analogs therapy, some patients will eventually relapse and the efficacy of these agents seems to decrease at each line of treatment. The addition of new molecules to purine analogs may improve the response rates and prevent relapse.

Rituximab is a chimeric IgG1 kappa-type monoclonal antibody directed against the CD20 molecule. It was first used in relapsed patients with hairy-cell leukemia more than 10 years ago and several series of patients treated with rituximab as monotherapy were published in the following decade, reporting response rates ranging from 25% to 80%.

Detailed description: Aims of the study were :

* to assess the overall efficacy of rituximab in a cohort of unselected patients with hairy-cell leukemia
* to identify factors associated to treatment response, to duration of treatment response and to patient survival in a cohort of unselected patients with hairy-cell leukemia

Eligibility criteria: Inclusion Criteria:

* patients with hairy-cell leukemia diagnosed between July 2002 and September 2012
* patients had received at least 3 subsequent injections of rituximab
* aged \> 18 years

Primary outcomes:
measure: Complete hematologic response to rituximab therapy
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu de Reims
Study officials:
References:
citation: Leclerc M, Suarez F, Noel MP, Vekhoff A, Troussard X, Claisse JF, Thieblemont C, Maloisel F, Beguin Y, Tamburini J, Barbe C, Delmer A. Rituximab therapy for hairy cell leukemia: a retrospective study of 41 cases. Ann Hematol. 2015 Jan;94(1):89-95. doi: 10.1007/s00277-014-2175-0. Epub 2014 Sep 7.