louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04960254: Prevalence of Internet Gaming Addiction in Adolescent
Official title: Prevalence of Internet Gaming Addiction in Adolescent
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Addictive Behavior
Adolescent Behavior
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 140
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Egyptian adolescent will be the target population. Target students will be selected randomly by using a multistage stratified cluster sampling technique.

Brief summary: Excessive problematic use of the internet has been a topic of discussion in the academic literature for many years and has gained more attention recently. The majority of those at risk are in early adulthood. Pathological internet use (PIU) is also termed internet addiction disorder (IAD), with both terms used to link internet use with addiction terminology.

Consistent with other psychiatric conditions such as depression symptoms, PIU prevalence rates among adolescents vary widely from as low as 0.3% to 38%. Likewise, PIU prevalence among college students (young adults) showed a wide variation ranging from 3% to 34%, worldwide. Nowadays, internet gaming addiction became a problematic issue in adolescent.

This is a case -control study, aimed to evaluate the prevalence and risk factors of internet gaming addiction among adolescents and its relationship with emotion regulation and comorbid psychiatric disorders.


Eligibility criteria: Inclusion criteria:

1. Both males and females were included.
2. Age ranges from 10- 18 years.
3. Willing of the parents or the caregivers to participate in the study.

Exclusion criteria:

* Children with intelligence quotient below 70.
* Children with history of substance use or psychiatric disorders.
* Children with medical or other neurological conditions.

Primary outcomes:
measure: measure prevalence of internet gaming addiction in adolescent
timeFrame: through study completion, an average of 1 year
measure: measure possible risk factor of internet gaming addiction in adolescent
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
References:
citation: Abdel-Salam DM, Alrowaili HI, Albedaiwi HK, Alessa AI, Alfayyadh HA. Prevalence of Internet addiction and its associated factors among female students at Jouf University, Saudi Arabia. J Egypt Public Health Assoc. 2019 Feb 26;94(1):12. doi: 10.1186/s42506-019-0009-6.
citation: Ahmer Z, Tanzil S. Internet addiction among social networking sites users: Emerging mental health concern among medical undergraduates of Karachi. Pak J Med Sci. 2018 Nov-Dec;34(6):1473-1477. doi: 10.12669/pjms.346.15809.
Clinical trial NCT00252954: Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury
Official title: Effects of Levetiracetam on Chronic Neuropathic Pain Following Spinal Cord Injury: a Randomized, Double-blind, Placebo-controlled, Cross-over, Multi-center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Injuries, Spinal Cord
Pain
Keywords: Spinal cord injury
Neuropathic pain
Spasms
Lead sponsor: Danish Pain Research Center
Sponsor class: OTHER
Collaborators: name: UCB Nordic A/S
First posted: 2005-11-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Purpose: To evaluate the efficacy and safety of levetiracetam on chronic neuropathic pain after spinal cord injury, and to examine its effect on spasms and evoked pain.

Detailed description: Study design: Randomized double-blind cross-over study of levetiracetam (Keppra) against corresponding placebo with a 1 week baseline period followed by 2 x 5 weeks treatment periods separated by a 1 week wash-out period.

Methodology: Levetiracetam and corresponding placebo is gradually increased during two weeks from 500 mg x 2 daily to 1500 mg x 2 daily (1000 mg x 2 daily is allowed if 1500 mg x 2 is not tolerated), and kept on that dose for three weeks.

The study will be monitored by the GCP units of Aarhus and Copenhagen University.

Eligibility criteria: Inclusion Criteria:

* 1. age 18 or more
* 2. neuropathic pain (that have lasted at least 3 month) after a spinal cord injury with a pain intensity of at least 4 on a 0-10 point numeric rating scale

Exclusion Criteria:

* 1. pregnancy or lactation
* 2. allergy to levetiracetam
* 3. alcohol or substance abuse, mental disease, epilepsy, depression and psychiatric disorders, severe liver disease, decreased kidney function, and known concomitant cerebral damage

Primary outcomes:
measure: Change in median pain intensity (measured daily on a 10 point NRS) of spontaneous pain from baseline week to last week of treatment.
timeFrame: Last week of each 5-week treatment period
Secondary outcomes:
measure: Spasms and spasticity; pain relief for total, at- and below-level pain; evoked pain; escape medication; NPSI; predictive value of the presence of evoked pain; Global impression of change; sleep disturbance.
timeFrame: Last day of each 5-week treatment period
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Danish Pain Research Center, Aarhus University Hospital
city: Hornbaek
country: Denmark
facility: Clinic for Spinal Cord Injuries, Rigshospitalet
city: Viborg
country: Denmark
facility: The Spinal Cord Unit, Dept of Rheumatology
Study officials:
affiliation: Aarhus University Hospital
name: Nanna B Finnerup, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Finnerup NB, Grydehoj J, Bing J, Johannesen IL, Biering-Sorensen F, Sindrup SH, Jensen TS. Levetiracetam in spinal cord injury pain: a randomized controlled trial. Spinal Cord. 2009 Dec;47(12):861-7. doi: 10.1038/sc.2009.55. Epub 2009 Jun 9.
Clinical trial NCT00696254: Impact of General Anaesthetics on Excitability of the Peripheral Sensory Nerve
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scheduled for Surgery
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2008-06-12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion criteria: German speaking patients scheduled for surgery under general anaesthesia

Brief summary: The aim of this study is to investigate the effect of general anaesthetics on nerve excitability. We use the method of threshold tracking to measure selected parameters of nerve excitability.


Eligibility criteria: Inclusion criteria: German speaking patients scheduled for surgery under general anaesthesia.

Weight 50 - 100 kg signed informed consent

Exclusion criteria: 1. known peripheral neuropathy 2. Diabetes mellitus 3. Neuro-psychiatric Diagnosis 4. pregnant/ breast-feeding women 5. congestive heart disease 6. more than 2 risk factors (out of 4) for PONV (female, non-smoker, known PONV, opioids postoperatively) 7. participants of other studies 8. inability of verbal expression

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT01448954: A Study to Evaluate Safety, Tolerability and Pharmacokinetics of ADC3680B in Subjects With Partly Controlled Atopic Asthma
Official title: A Randomised, Placebo-Controlled, Double-Blind, Parallel Group Phase II Study to Assess the Safety, Tolerability and Pharmacokinetics of ADC3680B in Subjects With Partly Controlled Atopic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Asthma
Lead sponsor: Pulmagen Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-10-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to examine the safety, tolerability, pharmacokinetics and functional activity of ADC3680B administered once daily for 28 days in subjects with partly controlled atopic asthma.


Eligibility criteria: Inclusion Criteria:

* Partially controlled mild-moderate atopic asthma
* Receiving inhaled corticosteroids
* Non-smoker or former smoker
* Males and females aged 18 to 55 years inclusive
* If female, must be of non-childbearing potential

Exclusion Criteria:

* History of acute severe asthma attacks
* History of COPD
* Other serious respiratory or other medical condition which may interfere with the outcome of the study

Primary outcomes:
measure: Evaluation of the change in frequency and severity of adverse events as a measure of safety and tolerability
timeFrame: Baseline to Day 35
measure: Evaluation of the change in incidence of routine haematology and biochemistry abnormalities as a measure of safety
timeFrame: Baseline to Day 35
measure: Evaluation of the change in vital signs as a measure of safety
timeFrame: Baseline to Day 35
measure: Evaluation of the change in Pulmonary function as a measure of safety and tolerability
timeFrame: Baseline to Day 35
measure: Assessment of the change in asthma symptoms using the Asthma Control Questionnaire as a measure of safety and tolerability
timeFrame: Baseline to Day 28
Secondary outcomes:
measure: Determination of concentrations of ADC3680B in plasma
timeFrame: Days 1-2 and Days 28-30
measure: Exploratory assessment of exhaled nitric oxide and selected markers of inflammation in blood
timeFrame: Day 1 and Day 28
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
References:
Clinical trial NCT02748954: Mood Management Effects of Brief Unsupported Internet Interventions
Official title: Mood Management Effects of Brief Unsupported Internet Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood
Lead sponsor: i4Health
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 765
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main goal of this study was to compare the effect of a one-session unsupported Internet intervention on participants' clinical symptoms (depressive and anxiety symptoms) and related variables (mood, confidence and motivation).

Detailed description: The main goal of this study was to compare the effect of a one-session unsupported Internet intervention on participants' clinical symptoms (depressive and anxiety symptoms) and related variables (mood, confidence and motivation).

Method: A total of 765 adults residing in the United States took part in a randomized controlled trial. Participants were randomly assigned to one of five brief plain text interventions lasting five to ten minutes. The interventions designed to address depressive symptoms were: Thoughts (increasing helpful thoughts), Activities (increasing activity level), Sleep Hygiene, Assertiveness (increasing assertiveness awareness), Own Methods (utilizing methods that were previously successful). They were followed-up one week after consenting.

Eligibility criteria: Inclusion Criteria:

- most be U.S. citizens

Exclusion Criteria:

- non-U.S. residents

Primary outcomes:
measure: Change in Patient Health Questionnaire (PHQ-9; Kroenke & Spitzer, 2002) scores
timeFrame: Baseline - 1 week follow-up
Secondary outcomes:
measure: mood- Likert-type question
timeFrame: Baseline - 10 minutes after the intervention - 1 week follow-up
measure: Motivation - Likert-type question
timeFrame: Baseline - 10 minutes after the intervention - 1 week follow-up
measure: Confidence - Likert-type question
timeFrame: Baseline - 10 minutes after the intervention - 1 week follow-up
measure: usefulness - Likert-type question
timeFrame: Baseline - 10 minutes after the intervention
measure: 7-item Generalized Anxiety Disorder questionnaire
timeFrame: Baseline - 1 week follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Palo Alto University
name: Ricardo F Muñoz, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02049554: Preconception Women's Health in Pediatric Practice Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preconception Care
Women's Health
Keywords: preconception care
women's health
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Zanvyl and Isabelle Krieger Fund
name: Abell Foundation
First posted: 2014-01-30
Enrollment: 415
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aims of the intervention are:

1. Assess the feasibility and effectiveness of preconception health care initiated by pediatric clinicians on outcomes including women's access to primary care and contraceptive services; contraception and rapid repeat pregnancy rate and interpregnancy interval; and women's immunization rate, control of chronic illnesses, nutritional status, smoking and substance use, mental health and violence exposure; child and family health.
2. Assess the cost-effectiveness of preconception health care initiated in pediatric practices.

The investigators will evaluate these outcomes with a clinic based trial comparing usual care to preconception care intervention.


Eligibility criteria: Inclusion Criteria:

Mothers with children ages 0 to 12 months presenting with their child for care at a participating pediatric office.

Exclusion Criteria:

-

Primary outcomes:
measure: Receipt of preconception care
timeFrame: 6 months
measure: Receipt of Preconception Care
timeFrame: 12 months
Secondary outcomes:
measure: Use of Highly Effective Contraception
timeFrame: 6 months
measure: Use of Highly Effective Contraception
timeFrame: 12 months
measure: Attendance at Preventive Health Care Visit
timeFrame: 6 months
measure: Attendance at Preventive Health Care Visit
timeFrame: 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Harriet Lane Clinic
state: Maryland
Study officials:
References:
citation: Chilukuri N, Cheng TL, Psoter KJ, Mistry KB, Connor KA, Levy DJ, Upadhya KK. Effectiveness of a Pediatric Primary Care Intervention to Increase Maternal Folate Use: Results from a Cluster Randomized Controlled Trial. J Pediatr. 2018 Jan;192:247-252.e1. doi: 10.1016/j.jpeds.2017.09.020.
Clinical trial NCT02543554: ED Lung Protective Ventilation to Reduce Complications
Official title: The Effect of Lung Protective Ventilation Initiated in the Emergency Department on the Incidence of Pulmonary Complications and Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation
Ventilator-associated Conditions
ARDS
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 1705
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: mechanically ventilated patients in the emergency department

Brief summary: Early mechanical ventilation, if delivered with injurious settings, can lead to pulmonary complications, such as acute respiratory distress syndrome (ARDS). Mechanical ventilation in the emergency department (ED) has been studied infrequently when compared to the intensive care unit; however, data suggests that ED-based mechanical ventilation has significant room for improvement and may also be a causative factor in ARDS incidence.

Detailed description: This is a before-after study examining the impact of implementing lung protective ventilation in the emergency department.

Eligibility criteria: Inclusion Criteria:

* mechanically ventilated via an endotracheal tube in the ED

Exclusion Criteria:

* death in the ED,
* death or discontinuation of ventilation within 24 hours,
* chronic mechanical ventilation,
* ARDS while in the ED
* transfer to another hospital.

Primary outcomes:
measure: Number of Patients That Experience Pulmonary Complications After Admission From the Emergency Department
timeFrame: 7 days
Secondary outcomes:
measure: Number of Patients That Die During the Hospitalization
timeFrame: Patients will be followed for the duration of hospital stay
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washinton University School of Medicine in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Brian M Fuller, MD, MSCI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roberts BW, Mohr NM, Ablordeppey E, Drewry AM, Ferguson IT, Trzeciak S, Kollef MH, Fuller BM. Association Between Partial Pressure of Arterial Carbon Dioxide and Survival to Hospital Discharge Among Patients Diagnosed With Sepsis in the Emergency Department. Crit Care Med. 2018 Mar;46(3):e213-e220. doi: 10.1097/CCM.0000000000002918.
citation: Fuller BM, Ferguson I, Mohr NM, Stephens RJ, Briscoe CC, Kolomiets AA, Hotchkiss RS, Kollef MH. Lung-protective ventilation initiated in the emergency department (LOV-ED): a study protocol for a quasi-experimental, before-after trial aimed at reducing pulmonary complications. BMJ Open. 2016 Apr 11;6(4):e010991. doi: 10.1136/bmjopen-2015-010991.
Clinical trial NCT00628654: Glycan Analysis in Diagnosing Cancer in Women With Ovarian Epithelial Cancer and in Healthy Female Participants
Official title: Clinical Protocol to Evaluate Glycans Analysis As a Diagnostic Test for Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: ovarian germ cell tumor
ovarian epithelial cancer
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-03-05
Enrollment: 581
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: volunteers and patients with ovarian, peritoneal, and fallopian tube cancers

Brief summary: RATIONALE: New diagnostic procedures, such as glycan analysis, may be effective in finding ovarian epithelial cancer.

PURPOSE: This clinical trial is studying how well glycan analysis works in diagnosing cancer in women with ovarian epithelial cancer and in healthy female participants.

Detailed description: OBJECTIVES:

Primary

* Evaluate the accuracy of glycan analysis to distinguish between normal healthy control female subjects and those with ovarian epithelial cancer.

Secondary

* Compare the new assay to the standard CA 125 for diagnostic accuracy.

OUTLINE:

* Ovarian cancer patients: Blood samples are obtained periodically for up to 2 years. Patients undergoing surgery have blood samples drawn before and after surgery. Medical charts are reviewed periodically for up to 3 years.
* Healthy volunteers: One blood sample is obtained. Volunteers also complete a 1-page questionnaire.

PROJECTED ACCRUAL: A total of 300 healthy female participants and 400 patients will be accrued for this study.

Eligibility criteria: Inclusion Criteria:

* Able to understand consent document for participation in the study
* Not pregnant
* Negative pregnancy test

Participants must meet 1 of the following criteria:

* Patients scheduled for ovarian surgery for an ovarian mass
* Healthy female volunteers with no active cancer or history of cancer

Primary outcomes:
measure: Accuracy of glycan analysis
timeFrame: one time for healthy volunteers; up to 2 years for patients with cancer
Secondary outcomes:
measure: Comparison of the new assay to the standard CA 125 assay
timeFrame: one time for healthy volunteers; up to 2 years for patients with cancer
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Cancer Center
state: California
Study officials:
affiliation: University of California, Davis
name: Gary Leiserowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01809054: Pilot Study Evaluating Alterations in Thrombogenicity and Platelet Reactivity Following Lower Extremity Arthroplasty
Official title: Pilot Study Evaluating Alterations in Thrombogenicity and Platelet Reactivity Following Lower Extremity Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Total Hip and Knee Arthroplasty
Keywords: Hip, Knee, Arthroplasty, venous thromboembolic events, blood loss
Lead sponsor: LifeBridge Health
Sponsor class: OTHER
Collaborators: name: Haemonetics Corporation
First posted: 2013-03-12
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized study from pre-surgery to 6 weeks post-surgery designed to detect changes in coagulability following elective total knee and hip arthroplasty. Patients will be randomized to one of the two standard prophylaxis treatments used at Sinai Hospital:

1. Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks, or
2. Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.


Eligibility criteria: Inclusion Criteria:

1. Men or women age ≥ 18 years old
2. Total knee or total hip arthroplasty planned in the 60 days following study enrollment

Exclusion Criteria:

1. Pre-existing anti-coagulant therapy (Heparin, Lovenox, Arixtra, Warfarin, Xarelto, and all other non-mentioned anticoagulants) on admission
2. History of bleeding diathesis
3. Known active malignancy
4. Prothrombin time \>1.5 x control
5. Platelet count \< 100,000/mm3, hematocrit \< 30%, creatinine clearance \<30 mL/min
6. Immunosuppression, e.g., human immunodeficiency virus (HIV) infection, Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, Bacterial endocarditis
7. Major surgery within past 3 months of enrollment
8. Patients requiring bilateral arthroplasty
9. Body weight \<50 kg (venous thromboembolism prophylaxis only)
10. Unable to return to site for follow-up visit

Primary outcomes:
measure: Blood Loss
timeFrame: 6 weeks
Secondary outcomes:
measure: Deep Vein Thrombosis
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Sinai Center for Thrombosis Research
state: Maryland
Study officials:
References: