louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04348604: Improving Adherence in Adolescents and Young Adults With Bipolar Disorder
Official title: Improving Adherence in Adolescents and Young Adults With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 36
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although poor medication adherence occurs in more than 65% of adolescent and young adults (AYA) with bipolar disorder (BD) and is associated with poor recovery, high rates of relapse, and a 5.2 fold increased suicide risk, there have been no interventions that specifically target adherence in AYA with BD. This proposal will modify and test a customized adherence enhancement (CAE) intervention developed by the investigative team and found to be effective in BD adults in a high-risk, high-need group: AYAs with BD who are poorly adherent with prescribed BD medications. The project addresses the critical need for evidence-based interventions to improve adherence in AYAs with BD and has the potential to change outcome trajectories in high-risk young people with BD as they transition to adulthood.


Eligibility criteria: Inclusion Criteria:

* DSM-5 diagnosis of bipolar disorder (BD), type I or II as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-5)
* Poor adherence defined as missing ≥ 20% of prescribed evidence-based BD medications, i.e., mood stabilizer (e.g., lithium, valproic acid, or carbamazepine) or second generation antipsychotics, on the TRQ for the past week or past month
* If \< 18 years, able and willing to give written informed assent and have a legal guardian provide written informed consent; if \> 18 years, able and willing to provide written informed consent
* Fluent in English

Exclusion Criteria:

* Unable to receive care in the outpatient setting due to illness severity
* A DSM-5 diagnosis of an autism spectrum disorder or primary psychotic disorder
* Documented or suspected IQ \< 70
* Prior enrollment in CAE or Phase 2
* Have recently (in the past month) started a new psychotherapy/behavioral intervention

Primary outcomes:
measure: Change From Baseline in the Tablet Routine Questionaire (TRQ) "Past Month" Item at 24 Weeks
timeFrame: Baseline and 24 weeks
measure: Change From Baseline in the Tablet Routine Questionaire (TRQ) "Past Week" Item at 24 Weeks
timeFrame: Baseline and 24 weeks
measure: Change From Baseline in Treatment Adherence as Measured by Special Pill Counter at 24 Weeks
timeFrame: Baseline and 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve Universty
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Martha Sajatovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05617404: Blunt Thoracic Trauma: Definition of a Standard Operating Procedure
Official title: Blunt Thoracic Trauma: Definition of a Standard Operating Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rib Fractures
Polytrauma
Thoracic Injury
Respiratory Failure
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 553
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We included all patients older than 18 years old admitted to our hospital due to a polytrauma that were admitted to the ICU and had a CT scan in the first 24 hours.

Brief summary: Rib fractures are the most frequent injury after blunt thoracic trauma. It is very important to choose the most appropriate interventions to prevent complications. But who will benefit most of those interventions remains a challenge.

This study analyses the correlation between chest X-Ray and CT scan. We also analyse different scores to predict respiratory failure.


Eligibility criteria: Inclusion Criteria:

* Polytrauma patients admitted to de ICU with a thoracic CT scan in the first 24h of arrival

Exclusion Criteria:

* Penetrating trauma
* Patients referred from other hospitals

Primary outcomes:
measure: Best predictor of respiratory complications
timeFrame: 01/02/2021 - 18/08/2022
Secondary outcomes:
measure: Compare XRay and CT
timeFrame: 01/02/2021 - 18/08/2022
measure: Number of fractures to predict complications
timeFrame: 01/02/2021 - 18/08/2022
measure: Compare scores
timeFrame: 01/02/2021 - 18/08/2022
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Tauli
Study officials:
References:
Clinical trial NCT03629704: Relationship Between Blood Glucose Variability and Prognosis in Critically Ill Patients
Official title: Relationship Between Blood Glucose Variability and Prognosis in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 200
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 admitted into care unit of Nanjing First Hospital.

Brief summary: This study is to evaluate the glycemic variation using Continuous Glucose Monitoring System in patients in the intensive care unit, find out the occult hypoglycemia, and investigate the relationship between glycemic variation, especially the incidence of hypoglycemia and prognosis of patients. Meanwhile, the inflammatory factors were measured and the relationship between inflammatory factors and glycemic variation.


Eligibility criteria: Inclusion Criteria:

1. Patients with history of diabetes;
2. Patients without history of diabetes, but their random blood glucose≧7.8mmol/L or fast blood glucose≧5 mmol/L;
3. The patients hospitalized in care unit (ICU or CCU) for more than 48 hours.

Exclusion Criteria:

1. Patient had history of mental illness;
2. Patient was not suitable for using the CGMS;
3. blood glucose \> 22.2 mmol/L at admission.

Primary outcomes:
measure: 28 day prognosis
timeFrame: 0-28 days
Secondary outcomes:
measure: Acute Physiology and Chronic Health Evaluation II score
timeFrame: 0-28 days
measure: Global registry of acute coronary events risk score
timeFrame: 0-28 days
measure: Twenty-four-hour mean blood glucose
timeFrame: 1-4 days
measure: Mean amplitude of glycemic excursion every 24 h
timeFrame: 1-4 days
measure: Incidence of hypoglycemia
timeFrame: 1-4 days
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Jianhua Ma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03988504: Impact of Predictive Genetic Testing
Official title: Impact of Predictive Genetic Testing on Quality of Life and Health-related Behaviour
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genetic Testing
Quality of Life
Physical Activity
Lead sponsor: Robert Bosch Medical Center
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subjects with request for health check up at Robert-Bosch-Hospital

Brief summary: Analysing Impact of preemptive genetic testing on quality of life, physical activity and eating behavior at baseline and 3 months after testing.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* informed consent for genetic testing
* informed consent for study participation

Exclusion Criteria:

* Age \<18 years
* renal replacement dependency
* pregnancy
* active cancer disease
* no informed consent for genetic testing or study participation

Primary outcomes:
measure: Quality of Life assessed by the SF-36 questionnaire [followed by its scale information in the Description]
timeFrame: 3 months
measure: Physical activity assessed by the IPAQ questionnaire [followed by its scale information in the Description]
timeFrame: 3 months
measure: Eating behavior assessed by the modified LEI questionnaire [followed by its scale information in the Description]
timeFrame: 3 months
Secondary outcomes:
measure: Satisfaction with check up and genetic testing: Likert scale (1-10)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03840304: Effect of Yoga@Work Program
Official title: Effectiveness of Yoga@Work Program on Neck and Shoulder Pain in Information Technology (IT) Employees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Neck Pain
Shoulder Pain
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Warwick Research Services
name: Yog-Kulam
First posted: 2019-02-15
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Employees working in IT industry are prone to develop musculoskeletal pain,specifically back, neck and shoulder pain. This study evaluates the effectiveness of work-site yoga intervention, Yoga@work on neck and shoulder pain in IT employees.


Eligibility criteria: Inclusion Criteria:

* IT companies employee
* Full time employment
* Neck and Shoulder Pain
* pain of at least 3 months duration
* able to comply with intervention schedule

Exclusion Criteria:

* Pregnancy
* Refuse to give informed consent
* spinal fracture
* recent cervical spine or shoulder surgery
* recent (3 months) chemotherapy/radiotherapy/ intervention

Primary outcomes:
measure: Visual analogue scale for pain
timeFrame: change from baseline to 8 weeks
Secondary outcomes:
measure: Neck disability index (NDI)
timeFrame: Change from baseline to 8-weeks
measure: Shoulder pain disability index
timeFrame: Change from baseline to 8-weeks
Other outcomes:
Locations:
city: Jaipur
country: India
facility: NMP Medical Reserach Institute
state: Rajasthan
Study officials:
affiliation: Yog-Kulam
name: Neha Sharma
role: STUDY_DIRECTOR
affiliation: International Labour Organization, UN
name: Durga Prasad Sharma
role: STUDY_CHAIR
affiliation: NMP Medical Research Institute, India
name: Divya Gaur
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00461604: High Dosage Esomeprazole and Baclofen for Therapy of Gastroesophageal Reflux Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With Persistent Objectified Gastroesophageal Reflux and Reflux-Associated Symptoms Despite PPI-Therapy With 40mg Esomeprazole
Keywords: gastroesophageal reflux disease
baclofen
impedance
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2007-04-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: It has been reported that Baclofen is an appropriate tool in the therapeutic management of Gastroesophageal Reflux Disease. To objectify gastroesophageal reflux combined pH-metry/impedance monitoring was applied to patients with persistent reflux-associated symptoms despite PPI-therapy (40mg esomeprazole for 2 weeks). After provement of pathological findings in the test PPI-dosage was escalated to double standard-dosage for another for weeks. In case of persistent symptoms another ph-metry/impedance monitoring was performed. In case of pathological findings additional baclofen was administered to the therapeutic regime. After 3 months another ph-metry/impedance monitoring was performed. At the time point of the tests a questionnaire was completed.

Aim of the study was to evaluate the influence of high dosage PPI-therapy and additional baclofen in patients with persistent symptoms and objectified gastroesophageal reflux.


Eligibility criteria: Inclusion Criteria:

* age between 18-70 years
* informed consent
* patients with persistent reflux-associated symptoms despite PPI-therapy

Exclusion Criteria:

* epilepsy
* synthetic liver diseases
* renal failure
* disability to understand informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Technical University of Munich
state: Bavaria
Study officials:
affiliation: Technische University Munich
name: Alexander Meining, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002404: The Effect of Valacyclovir on the Detection of HIV From Genital Herpes Lesions in HIV-Infected Patients
Official title: The Effect of Treatment With Valacyclovir 500 mg BID on the Detection of HIV From Genital HSV Lesions in HIV-Infected Patients: A Double-Blind Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Herpes Simplex
HIV Infections
Keywords: HIV-1
Antiviral Agents
Herpes Genitalis
Recurrence
DNA, Viral
RNA, Viral
valacyclovir
Herpesvirus 2, Human
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if valacyclovir affects the detection of HIV in genital herpes lesions in HIV-infected patients. Valacyclovir is used to treat recurrent genital herpes.

Detailed description: Following evaluation for 2 consecutive episodes of genital herpes in this double-blind, crossover study, 30 HIV-1 positive patients are randomized to receive either valacyclovir or placebo.

All patients are treated for 10 days.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Serologically documented HSV-2 and HIV-1 infection.
* History of recurrent genital herpes that presents at least 3 recurrences within the 12 months prior to the start of study.
* No contraindications to valacyclovir.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

1. Hepatic impairment.
2. Impaired renal function (creatinine above 2 mg/dl).
3. Malabsorption syndrome or other gastrointestinal dysfunction.
4. Any other condition that in the investigator's opinion would interfere with study procedures or successful completion of protocol.

Patients with the following prior conditions are excluded:

History of hypersensitivity to acyclovir or valacyclovir.

Prior Medication:

Excluded:

* Participation in any investigational drug trial within 1 month prior to entry on study.
* Systemic anti-HSV therapy within 7 days prior to start of study drug.

  1. Probenecid.
* Suppressive treatment with medication that has anti-HSV activity.

Required:

- Stable antiretroviral therapy or no therapy for at least 1 month.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04239404: Prognostic Impact of PMI in Stable CAD Undergoing PCI
Official title: The Prognostic Impact of Periprocedural Myocardial Injury in Stable Coronary Artery Disease Patients Undergoing Elective Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periprocedural Myocardial Injury
Coronary Artery Disease
Percutaneous Coronary Intervention
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In-patients with stable coronary artery disease undergoing elective percutaneous coronary intervention in Zhongshan Hospital will be enrolled.

Brief summary: This is a single-center, observational, prospective study. This study aims to observe the effect of periprocedural myocardial injury on cardiovascular events in patients undergoing elective percutaneous coronary intervention, and to detect the levels of serum inflammatory factors before and after intervention to predict the occurrence of periprocedural myocardial injury and its association with cardiovascular events.


Eligibility criteria: Inclusion Criteria:

* underwent elective coronary stenting
* patients permit informed consents

Exclusion Criteria:

* acute STEMI
* NYHA class III-IV heart failure
* moderate-to-severe valvular disease
* missing post-PCI troponin results
* active infection, respiratory failure
* liver dysfunction (liver enzyme \>3xURL or bilirubin \>2xURL),
* malignancy and systemic connective tissue disease
* unable to get a informed consents

Primary outcomes:
measure: Major cardiac events
timeFrame: 12 months after PCI
Secondary outcomes:
measure: Serum level of inflammatory factors
timeFrame: 1 day after PCI
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
state: Shanghai
Study officials:
References:
Clinical trial NCT04190004: Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia
Official title: Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: National Institute of Mental Health and Neuro Sciences, India
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: After completion of clinical assessments all subjects will receive either 40 IU of vasopressin or saline in counterbalanced order on two separate days and perform the behavioral tasks
Primary purpose: OTHER

Brief summary: The study investigates the effect of 40IU of intranasal vasopressin on cooperative behavior in patients with schizophrenia


Eligibility criteria: Inclusion Criteria:

* Age 18-45 years
* Diagnosed as Schizophrenia or Schizophreniform disorder as per DSM IV TR
* At least 7 years of formal education
* MOCA score \>24

Exclusion Criteria:

* Diagnoses of SIADH, Diabetes Insipidus
* Substance dependence in the past 12 months, excluding nicotine dependence
* Current comorbid axis 1 psychiatric disorder
* Hypersensitivity or previous allergy to Vasopressin
* Serious medical or neurological illness which may interfere with assessment and administration of vasopressin
* Hypertension
* Impaired renal functions based on serum creatinine above 1.5
* Electrolyte imbalance
* Receiving ECT or has received ECT in the past 8 weeks
* Clinical history of mental retardation
* Pregnancy • Lactation
* Risk of harm to self or others
* Any significant nasal pathology which may hinder the intranasal absorption of the drug
* Hearing or visual impairment that significantly affects the comprehension and execution of the study

Primary outcomes:
measure: Performance in Dictator game
timeFrame: 60 minutes
measure: Performance in stag hunt game
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: National Institute of Mental Health and Neurosciecnes
state: Karnataka
Study officials:
References:
Clinical trial NCT01612104: Psychological First Aid With Children in a High Risk Group - a Repeated Single Case Design
Official title: Psychological First Aid With Children in a High Risk Group - a Repeated Single Case Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Post Traumatic Stress Disorder
Adjustment Disorder
Keywords: Post Traumatic Stress Disorder
Anxiety symptoms
Depressive symptoms
Externalizing behavior
Reduced quality of life
Lead sponsor: NORCE Norwegian Research Centre AS
Sponsor class: OTHER
First posted: 2012-06-05
Enrollment: 11
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot-study is to evaluate a cognitive behavioral method "Psychological First Aid" used with a group of children (11-16 years) in high risk of developing psychological problems. Participants are recruited from a low-threshold program ("The Children's House in Oslo") where counseling is given to children suspected of being physically or sexually abused, or having witnessed domestic violence. The study includes twelve children and teenagers that receive 2 to 6 sessions of counseling. Psychological problems (e.g. anxiety, depression, reactions to trauma) and quality of life will be assessed at pre- post and follow-up (after 3, 6 and 12 months). In addition, some symptoms of will be assessed daily.


Eligibility criteria: Inclusion Criteria:

* Children/adolescents that:

  * contact "The Children's House in Oslo" after having experienced potential traumatic event(s).
  * are assessed as having psychological symptoms related to potential trauma
  * are between 11 and 16 years old
  * agree to participate in the study (both the youth and his/her parents(s)
* understand and speak Norwegian

Exclusion Criteria:

- Children/adolescents with:

* mental retardation
* reading skills below 8 year
* psychosis
* high risk of suicidal behavior is assumed

Primary outcomes:
measure: Children's Revised Impact of Event Scale (CRIES)
timeFrame: One year
Secondary outcomes:
measure: Child Post-Traumatic Cognition Inventory (CPTCI)
timeFrame: One year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: The Children's House in Oslo
Study officials:
affiliation: Centre for Child and Adolescent Mental Health, Western Norway
name: Bente SM Haugland, PhD
role: PRINCIPAL_INVESTIGATOR
References: