louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05211713: Opp - a Universal Mental Health Promoting Mobile Application for Adolescents
Official title: Opp: The Development and Evaluation of a Mental Health App for Adolescents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Health Wellness 1
Keywords: Mental health promotion
Coping
Adolescents
Mobile application
Lead sponsor: University of Tromso
Sponsor class: OTHER
Collaborators: name: The Dam Foundation
name: Norwegian Council for Mental Health
name: Norwegian Directorate of Health
First posted: 2022-01-27
Enrollment: 700
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention and control group
Primary purpose: PREVENTION

Brief summary: The aim of the project is firstly, to develop an app-based mental health intervention for adolescents. Secondly, to evaluate the effect of this app. The overarching goal is to offer a low-threshold intervention, called Opp, that is easily accessible and free to use for all adolescents in Norway.

Detailed description: The intervention "Opp" will be delivered through a mobile application. The overall goals of Opp are to 1) increase well-being and mental well-being, 2) increase knowledge about mental health, 3) increase coping skills to deal with stress, 4) increase help-seeking behavior, 5) increase self-esteem, 6) increase sleep quality and 7) reduce mental health problems.

To evaluate the mobile application two studies will be conducted: A user survey and an effectiveness study with a follow-up examination after about six weeks. The effectiveness study will be conducted as a randomized controlled trial with an intervention group and a waiting-list control group.

Eligibility criteria: Inclusion Criteria:

* Adolescents under 16 years whose guardians have given consent

Exclusion Criteria:

* severe developmental or cognitive challenges

Primary outcomes:
measure: Change in WHO-5 (WHO-Five Well-being Index)
timeFrame: Change from baseline to six weeks after intervention.
measure: Change in SDQ (Strengths and Difficulties Questionnaire)
timeFrame: Change from baseline to six weeks after intervention.
Secondary outcomes:
measure: General Self-efficacy scale (GSE)
timeFrame: Change from baseline to six weeks after intervention.
measure: Help-seeking behavior
timeFrame: Change from baseline to six weeks after intervention.
measure: Self-liking and Competence Scale
timeFrame: Change from baseline to six weeks after intervention.
measure: Sleeping quality
timeFrame: Change from baseline to six weeks after intervention.
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: UiT The Arctic University of Norway
Study officials:
affiliation: UiT The Arctic University of Norway
name: Henriette Kyrrestad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04160013: Mitigating ACEs in Pediatric Primary Care: Cohort #2 With 6-24 Month Old Children
Official title: Mitigating ACEs in Pediatric Primary Care: Cohort #2 With 6-24 Month Old Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Violence
Child Abuse
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 533
Sex: ALL
Minimum age (years): 6
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

Brief summary: The aim is to determine if a brief intervention can affect parents' attitudes about physical punishment and other parenting behaviors.

Detailed description: A public health problem that needs to be solved is how to educate more parents about healthy discipline options. The investigators aim to mitigate adverse childhood experiences (ACEs) by integrating evidence-based parent training into pediatric primary care. Some of the most modifiable ACEs are associated with parenting behaviors that can lead to child abuse. The investigators define unhealthy parenting behaviors such as spanking, threatening, yelling, and humiliation. For adults in the original ACEs study, it was exposure to these behaviors that led to the categorization of child abuse/neglect and that were associated with heart disease, obesity, depression, smoking, drug use, violence, and many other problems. This study may help change policy and practice related to mitigating ACEs in primary care. To accomplish this goal, randomized controlled trials are needed to test brief screening tools and evidence-based resources. A population-based approach is needed to reach all parents (i.e. primary prevention). In the study, parents in the intervention group will receive 3 minutes of education about healthy discipline strategies.

Eligibility criteria: Inclusion Criteria:

* Parents of 6 month to 2 year old children presenting to the Vanderbilt Pediatric Primary Care Clinic for a well visit or an acute care visit.

Exclusion Criteria:

* Parents who do not speak and read English, Spanish, or Arabic. The interventions are only available in English, Spanish, and Arabic.

Primary outcomes:
measure: Attitudes toward spanking
timeFrame: 3-6 months post-enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
Clinical trial NCT01813513: Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004)
Official title: A Phase I, Randomized, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C Infection
Keywords: HCV
Hepatitis C Virus
Hepatitis C
antiviral drugs
liver
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2013-03-19
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this 3-part study is to evaluate the potential impact of simeprevir and food on pharmacokinetics (PK) of IDX719 in healthy participants. Part 1 will evaluate potential PK interactions between IDX719 and simeprevir. Part 2 will evaluate the effect of food on the PK of IDX719 in combination with simeprevir. Part 3 will evaluate the impact of high- versus low-fat meals on the PK of IDX719.


Eligibility criteria: Inclusion Criteria:

* Has no clinically significant abnormalities on medical history, physical examination, or 12-lead electrocardiogram (ECG)
* Agrees to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of study drug
* Agrees to avoid nicotine-containing products from 3 months prior to Screening and for the duration of the study

Exclusion Criteria:

* Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) antibodies
* Is pregnant or breastfeeding
* Has previously received either IDX719 or simeprevir
* Has participated in another clinical drug study within 30 days of Screening

Primary outcomes:
measure: Area under the plasma concentration-time curve (AUC) at steady-state over dosing interval (AUCss)
timeFrame: Up to 30 days
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 30 days
measure: AUC from time zero to infinity
timeFrame: Up to 30 days
measure: Trough plasma concentration (Ctrough)
timeFrame: Up to 30 days
Secondary outcomes:
measure: Percentage of participants experiencing serious adverse events (SAEs)
timeFrame: Up to 30 days
measure: Percentage of participants experiencing adverse events (AEs)
timeFrame: Up to 30 days
measure: Percentage of participants experiencing Grade 1-4 laboratory abnormalities
timeFrame: Up to 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04972513: Impact of E-cigarette Use on the Body
Official title: The Emerging Adulthood Health Project
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cigarette Smoking-Related Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 182
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: E-cig (cigarette) users and non-users in Ohio

Brief summary: This study examines how electronic (e)-cigarette use impacts the body, by studying both users and non-users of e-cigarettes. Early evidence indicates that e-cig users experience adverse health effects. Results of this study may help policy-makers develop standards for different types of tobacco.

Detailed description: PRIMARY OBJECTIVE:

Examine the short-term impacts of vaping on pulmonary and respiratory outcomes.

OUTLINE:

Current e-cigarette users will vape their own e-cigarette device ad libitum for 30 minutes; non-users will watch a neutral video for 30 minutes. Before and after the 30 minute vaping \[video\] session, participants will undergo the following assessments: computer-based spirometry testing, nitric oxide breath testing, airwave oscillometry, and an assessment of endothelial function. Participants will also undergo collection of blood.

Eligibility criteria: Inclusion Criteria:

* 75 e-cig users and 75 never-users
* No self-reported diagnosis of lung disease (e.g., coronavirus disease-2019 \[COVID-19\], pneumonia, cystic fibrosis)
* No history of cardiac event or distress
* Not currently breastfeeding, pregnant, or planning to become pregnant (e-cig users only; will be confirmed via pregnancy test)

Primary outcomes:
measure: Airway inflammation as assessed by exhaled nitric oxide
timeFrame: Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
measure: Airway reactivity as assessed by airwave oscillometry
timeFrame: Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
measure: Respiratory functioning as assessed by a mobile Spirometry device
timeFrame: Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
measure: Endothelial function
timeFrame: Procedure will last approximately 20 minutes; the procedure will occur twice during the laboratory session (separated by approximately 90 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Megan E Roberts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06906913: Oral and Anal Swab Sampling in Patients With HPV Positivity
Official title: Evaluation of Oropharyngeal and Anal Swab Samples in Patients With HPV Positivity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HPV
Keywords: Anal
cervical
human papillomavirus
oropharyngeal
screening
Lead sponsor: Medipol University
Sponsor class: OTHER
Collaborators: name: gaziantep university medicine faculty
First posted: 2025-04-02
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 30 women of reproductive age, who consented to participate, will be included in the study.

Brief summary: Patients whose pathology results are reported as cervical intraepithelial neoplasia (CIN) 1, CIN 2, and CIN 3, are recruited. We aimed to evaluate HPV-positive women presenting to the Obstetrics and Gynecology clinic, whose cervical pathology results were reported as CIN 1, CIN 2, and CIN 3, by collecting oropharyngeal and anal swab samples. A total of 30 women of reproductive age, who consented to participate, were included in the study.

Detailed description: Human papillomavirus (HPV) positivity is associated with cervical, oropharyngeal, and anal cancers. There is insufficient data in the current literature regarding the effectiveness of obtaining oropharyngeal and anal swabs from patients with HPV positivity is an effective method for detecting potential pathologies. HPV-positive women presenting to the Obstetrics and Gynecology clinic, whose cervical pathology results were reported as CIN 1, CIN 2, and CIN 3, will be evaluated by collecting oropharyngeal and anal swab samples.

Eligibility criteria: Inclusion Criteria:

* HPV-positive women presenting to the Obstetrics and Gynecology clinic, whose cervical pathology results were reported as CIN 1, CIN 2, and CIN 3

Exclusion Criteria:

* HPV-negative women

Primary outcomes:
measure: Oropharyngeal Swab Sample - HPV Testing
timeFrame: 1 month
measure: Anal Swab Sample - HPV Testing
timeFrame: 1 month
Secondary outcomes:
measure: Oropharyngeal Swab Sample - HPV Testing (if positive)
timeFrame: 1 month
measure: Anal Swab Sample - HPV Testing (if positive)
timeFrame: 1 month
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep Cengiz Gokcek Women's, Obstetrics and Pediatrics Hospital
Study officials:
affiliation: University of Gaziantep
name: Neslihan Bayramoglu Tepe, Doctor of Medicine
role: STUDY_DIRECTOR
affiliation: Istanbul Nisantasi University
name: Ozan Dogan, Prof. Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT03477513: Personalized Radiation Therapy for GBM
Official title: Personalized Treatment of Glioblastoma Via Image-Guided Predictive Modeling of Recurrence: A Single-Arm, Single Institutional Pilot Prospective Study of Dose-Escalated Radiation Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Glioblastoma
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is a pilot study to estimate the efficacy of personalized dose-escalation radiation therapy in patients with glioblastoma, as measured by estimating the median of progression-free survival. Toxicity, patterns of recurrence, and overall median survival will be measured as secondary endpoints. Adverse events will be monitored.


Eligibility criteria: Inclusion Criteria:

* Patients with biopsy-proven WHO Grade IV glioblastoma, after gross-total or near-total resection, who are undergoing definitive chemoradiation as part of their treatment regimen
* Age 18 or older
* Ability to give signed informed consent
* Karnofsky Performance Status (KPS) at least 70

Exclusion Criteria:

* Placement of Gliadel wafers
* Participation in another investigational trial
* Active treatment of another malignancy

Primary outcomes:
measure: Adverse Events
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Michelle Alonso-Basanta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01640613: Anterior Ultrasound-guided Cervical Plexus Block for Carotid Endarterectomy
Official title: Anterior Approach Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Endarterectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Atherosclerosis
Regional Anesthesia Morbidity
Keywords: carotid endarterectomy
regional anaesthesia
ultrasound guided block
Lead sponsor: Hôpital Edouard Herriot
Sponsor class: OTHER
First posted: 2012-07-16
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing carotid endarterectomy under regional anaesthesia

Brief summary: The aim of this study is to describe technique, efficiency, safety and satisfaction of ultrasound guided intermediate cervical plexus block for carotid endarterectomy.

The investigators present a simple approach for carotid regional anaesthesia by an anterior way that has not been published yet.

Detailed description: * description of the anaesthetic procedure (duration, volume of anaesthetic local, efficiency)
* realization of the surgery (pain, injection of anaesthetic local...)
* post operative evaluation (pain, satisfaction...)

Eligibility criteria: Inclusion Criteria:

* adult
* carotid endarterectomy performed under regional anaesthesia

Exclusion Criteria:

* age \< 18 years
* contralateral phrenic palsy

Primary outcomes:
measure: conversion to general anaesthesia
timeFrame: surgery time
Secondary outcomes:
measure: amount of additional local anaesthetic
timeFrame: surgery time
measure: additional injection of remifentanil
timeFrame: surgery time
measure: complications
timeFrame: anaesthesia time
measure: patient and surgeon satisfactions
timeFrame: after surgery
measure: additional injection of remifentanil
timeFrame: surgery time
Other outcomes:
Locations:
city: Lyon
country: France
facility: Departement of Anaesthesiology and Intensive Care, Edouard Heriot Hospital, HCL
Study officials:
affiliation: Edouard Heriot Hospital, HCL
name: Bernard Allaouchiche, MD PhD
role: STUDY_CHAIR
affiliation: Edouard Heriot Hospital, HCL
name: Emmanuel Boselli, MD PhD
role: STUDY_DIRECTOR
affiliation: Edouard Heriot Hospital, HCL
name: Anne-Laure Calderon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Edouard Heriot Hospital, HCL
name: Cyrille Truc, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Edouard Heriot Hospital, HCL
name: Julien Davidson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Edouard Heriot Hospital, HCL
name: Najia Rahali, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Edouard Heriot Hospital, HCL
name: Farida Benatir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06409013: Evaluation of Tumor Resection Guided by Intraoperative Indocyanine Green Dye Fluorescence Angiography in Patients With Sarcoma
Official title: Sarcoma Resection Guided by Intraoperative Indocyanine Green Dye Fluorescence Angiography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Sarcoma
Soft Tissue Sarcoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with biopsy-proven bone or soft tissue sarcoma undergoing resection recruited through Mayo Clinic

Brief summary: This study evaluates the effectiveness of intraoperative indocyanine green dye and fluoroscopic technology in confirming negative margins after tumor removal.

Detailed description: PRIMARY OBJECTIVE:

I. To evaluate the use of indocyanine green (ICG) as an intraoperative guide during bone and soft tissue sarcoma resection.

OUTLINE: This is an observational study.

Patients receive ICG infusion prior to undergoing scheduled resection and have medical records reviewed on study.

Eligibility criteria: Inclusion Criteria:

* Patients with biopsy-proven bone or soft tissue sarcoma undergoing resection

Exclusion Criteria:

* \* Age less than 18

  * Chronic kidney disease
  * Anaphylaxis to dyes

Primary outcomes:
measure: Accuracy of intraoperative ICG fluorescence compared to final pathology results
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Matthew T. Houdek, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00715013: Patupilone (EPO 906) in Patients With Recurrent or Progressive Glioblastoma
Official title: Patupilone (EPO 906) in Patients With Recurrent or Progressive Glioblastoma Multiforme Prior to and After Secondary Resection: an Open-label Phase I/II Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Recurrent Glioblastoma Planned for Reoperation
Keywords: recurrent Glioblastoma
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patupilone trial for patients with recurrent glioblastoma, which are planned for re-operation. Objectives: prolongation of PFS compared to patients with re-operation only, Patupilone tumor concentrations, pharmacokinetic, Perfusion in MRI pre - and post Patupilone. Translational research of tumor tissue exposed to patupilone.

* Trial with medicinal product

Detailed description: Prior to and after re-operation patients with recurrent glioblastoma receive the investigational drug Patupilone, a tubulin-inhibitor.

The purpose of the trial is to prolong PFS in this patient population. Patupilone is already used in clinical trials of other tumor entities such as ovarian cancer, breast and lung cancer. Side effects are expected to be manageable.

Eligibility criteria: Inclusion criteria:

* Recurrent glioblastoma at least 2 cm in diameter after standard treatment (Surgery, Radiotherapy and Chemotherapy), which has to be completed at least three weeks earlier.
* \> 18 years of age, KPS 70-100%
* No liver disease, no malignancies (except curative treated skin tumors, DCIS of the breast and curative treated cervix carcinoma)
* Lc \> 3000 und Tc \> 100 000, Hb\> 9, Bilirubin \</= 1.5mg/dl, AST/ALT less than 2.5 x upper limit, creatinine \</= 132umol/l
* No pregnancy or breast feeding
* Written Informed Consent prior to study entry
* No reasons for incompliance
* Reoperation planned

Exclusion criteria:

* KPS \< 70%
* Radiotherapy- or Chemotherapy within 6 weeks
* Enzyme inducing medication or St John's wort
* Other study medication within 28 days
* Other malignancies
* Intolerance of Patupilone
* Prior Patupilone
* Neuropathy \> Grad 1
* Other life threatening illnesses
* Acute or chronic liver diseases
* HIV Infection
* Known non-compliance in medication intake,inability to give informed consent
* Cardiac problems (NYHA III oder IV) with uncontrolled insufficiency or angina pectoris
* Active or uncontrolled infection
* Pregnancy or breast feeding
* Hematologic Growth Factors (without Erythropoetin) colostomy
* Patients with uncontrolled diarrhea in the last 7 days prior to study entry.

Primary outcomes:
measure: Progression free survival
timeFrame: 3 years
measure: PFS, OS translational research
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: Silvia Hofer, MD
role: PRINCIPAL_INVESTIGATOR
References: