linjc16/ctgov huggingface dataset:
Validating Interventions for Diverse Adolescents

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare a culturally adapted and a non-culturally adapted group-based substance abuse treatment with Latino adolescents.

Official Title
-----------------
Efficacy of Group Treatment for Hispanic Adolescents - RCT

Conditions
-----------------
Substance-Related Disorders

Intervention / Treatment
-----------------
* Behavioral: Standard Cognitive Behavioral Treatment
* Behavioral: Culturally Adapted Cognitive-Behavioral Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescent between 13-18 years of age Parental consent Adolescent speaks English and Spanish Adolescent assent to participate in treatment and assessments Adolescent meets either DSM-IV diagnostic criteria for substance abuse or dependence Adolescent identifies as Hispanic Exclusion Criteria: Adolescent younger than 13 or older than 18 years of age Adolescent requires higher level of care than what is provided in study Adolescent speaks only English or Spanish Parental consent not obtainable Adolescent does not assent to study Adolescent is overtly psychotic, severely depressed/suicidal, and/or presents with other mental disorder that will limit participation in group treatment Adolescent has completed substance abuse treatment elsewhere in the past 90 days Adolescent does not identify as Hispanic

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Culturally Adapted Cognitive-Behavioral Treatment<br>Culturally Adapted CBT for Substance Abuse | Behavioral: Culturally Adapted Cognitive-Behavioral Treatment<br>* Culturally Adapted CBT for Substance Abuse<br>|
| Active Comparator: Standard Cognitive-Behavioral Treatment<br>Standard Cognitive-Behavioral Treatment for Substance Abuse | Behavioral: Standard Cognitive Behavioral Treatment<br>* Standard CBT for Substance Abuse<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance Use Levels |  | Posttreatment, 3, 6, 12-month follow-ups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with Treatment |  | Posttreatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Substance Abuse, Substance Addiction
Periimplant Bone Changes in Different Abutment Heights and Insertion Timing in Posterior Mandibular Areas

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to compare the influence of the abutment height and insertion timing on early marginal bone loss (MBL) in posterior mandibular partial implant-supported restorations. Material and methods: The study was planned as a prospective, randomized, controlled parallel group including subjects in need of two implants for the restoration of an edentulous posterior mandibular area. Data were gathered on age, gender, attached gingiva height, bleeding on probing (BoP), smoking habits and previous periodontitis. The patients were allocated into three groups: Group A implants were immediately connected to 2 mm height abutments; Group B implants were immediately connected to 1 mm height abutments; Group C implants were left to heal in a sub-mucosal position and 2 mm abutments were inserted in a second stage surgery. Peri-apical radiographs were taken at the implant surgery (baseline), 4 weeks after surgery (T1), 16 weeks after implant placement at the final restoration delivery (T2) and 1-year after implant placement (T3).

Official Title
-----------------
Periimplant Bone Changes in Different Abutment Heights and Insertion Timing in Posterior Mandibular Areas: Results From a Randomized Prospective Clinical Trial

Conditions
-----------------
Dental Implant Failed

Intervention / Treatment
-----------------
* Procedure: One time abutment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients age > 18 years; American Society of Anaesthesiologists (ASA) status I; no systemic medication or condition known to potentially alter bone metabolism; - absense of acute periodontal condition. Exclusion Criteria: lack of primary stability at implant surgery; need for bone regeneration procedures during surgery; inability to correct place the implant in accordance with the prosthetic requirements.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: One time abutment|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal bone changes | Crestal bone changes that occur around the dental implant | 60 months |
Clinical Study of Curcumin in Preventing Postoperative Adhesion of Bilateral Vocal Cords

Study Overview
=================
Brief Summary
-----------------
To provide a novel therapy idea and method to solve the clinical problem of postoperative adhesion of bilateral vocal cords, patients enrolled in this study will be applied with curcumin on both wound sites of bilateral vocal cords after the surgery on the bilateral vocal cord endoscopically.

Official Title
-----------------
Clinical Study of Curcumin in Preventing Postoperative Adhesion of Bilateral Vocal Cords

Conditions
-----------------
Glottic Web of Larynx, Laryngeal Stenosis, Glottic Carcinoma, Laryngeal Leucoplakia, Laryngeal Polyp, Laryngeal Papilloma

Intervention / Treatment
-----------------
* Drug: Curcumin
* Drug: Mitomycin-C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with bilateral vocal cord diseases who are going to undergo resection of bilateral vocal cord lesions endoscopically. Patients with bilateral vocal cord adhesion who are going to undergo incision of bilateral vocal cord adhesion endoscopically. Exclusion Criteria: Patients with other laryngeal diseases. Patients with cardiac and pulmonary insufficiency. Patients unable to cooperate with the follow-up on time after surgery. Patients who refuse to sign the informed consent after notification. Patients who have a severe allergic disease or allergic history to a variety of drugs. Other circumstances that are not appropriate to be included in the clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curcumin<br> | Drug: Curcumin<br>* Curcumin was applied to both wound sites of bilateral vocal cords. After evenly applied, gently massage the applied site for 3-5 minutes until the drug was fully absorbed.<br>|
| Active Comparator: Mitomycin<br> | Drug: Mitomycin-C<br>* Mitomycin-C was applied to both wound sites of bilateral vocal cords. After evenly applied, gently massage the applied site for 3-5 minutes until the drug was fully absorbed.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with laryngeal web formation as assessed by videolaryngoscope | All participants received the videolaryngoscope every month post-surgery, and a laryngeal web is defined as a visible adhesion whose length reached 1 mm or greater. | 1 year postsurgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Curcumin
Amotosalen and Platelet Transfusion in Adult Heart Surgery

Study Overview
=================
Brief Summary
-----------------
Blood safety is ensured by the rigorous selection of donors and biological tests. However, infectious agents can escape this detection and be transmitted to recipients during transfusion. Amotosalen is a derivative of psoralens that intercalates with nucleic acids and inactivates them after UV exposure; it therefore makes it possible to inhibit any replication of an infectious agent present. Preliminary studies have shown its safety and efficacy in preventing the transmission of infectious agents during the administration of labile blood products (fresh frozen plasma and platelet concentrates) as well as the absence of loss of efficacy (absence of loss of pro-aggregating and procoagulant properties) of the transfused products. In addition, there is a significant reduction in side effects for platelet concentrates, especially compared to irradiated concentrates. Treatment of platelet concentrates with Amotosalen may be responsible for a reduction in the platelet concentration in each concentrate with an overall decrease in efficiency and transfusion yield compared to untreated concentrates.

Official Title
-----------------
Impact of Treatment With Amotosalen on the Practice of Platelet Transfusion in Adult Heart Surgery

Conditions
-----------------
Heart Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subjects ≥18 years old Cardiac surgery or ascending aorta Platelet transfusion for any reason Subject not having expressed their opposition, after information, to the reuse of their data for the purposes of this research Exclusion criteria Subject having expressed opposition to participating in the study Presence or - installation of transient circulatory assistance (outside of the CEC) or definitive Heart or cardiopulmonary transplantation Subject under guardianship or guardianship Subject under safeguard of justice

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective study of the impact of the treatment with Amotosalen on the platelet transfusion practice in adult cardiac surgery unit |  | Files analysed retrospectively from January 01, 2016 to June 30, 2019 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amotosalen, Platelet transfusion, Bleeding, heart surgery
Managed Access Program for Momelotinib in Myelofibrosis

Study Overview
=================
Brief Summary
-----------------
Compassionate use access to Momelotinib/GSK3070785 for eligible participant with diagnosis of intermediate or high-risk myelofibrosis (MF), including primary myelofibrosis (PMF) or secondary myelofibrosis (post- polycythemia vera/ essential thrombocytopenia (PV/ET)), with anemia.

Official Title
-----------------
Managed Access Program for Momelotinib in Patients With a Diagnosis of Intermediate or High-risk Myelofibrosis (MF), Including Primary Myelofibrosis (PMF) or Secondary Myelofibrosis (Post- Polycythemia Vera/ Essential Thrombocytopenia (PV/ET)), With Anaemia

Conditions
-----------------
Myelofibrosis, Primary Myelofibrosis

Intervention / Treatment
-----------------
* Drug: Momelotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent can be obtained from the patient or legally authorised representative as per local regulations Diagnosis of intermediate or high-risk myelofibrosis (MF), including primary myelofibrosis (PMF) or secondary myelofibrosis (post- polycythemia vera/ essential thrombocytopenia (PV/ET)), with anemia 18 years or older (at the time consent is obtained) The patient is willing to abide by the contraception requirements. No known hypersensitivity to momelotinib, its metabolites, or any of the formulation excipients Exclusion Criteria: Pregnant or breastfeeding female

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Momelotinib|Momelitinib available as tablets.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Momelotinib, GSK3070785
Body-Oriented Therapy for Sexual Abuse Recovery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine and compare the effects of two body therapy approaches in women who have experienced child sexual abuse.

Detailed Description
-----------------
Women who have experienced child sexual abuse often display symptoms of dissociation and lack of bodily self-awareness which hinder the recovery process. Mind-body researchers have examined alternative therapeutic approaches to eliminating these factors. This study will compare a standardized therapeutic message to body-oriented therapy which involves a combination of hands-on bodywork and verbal therapy focused on somatic and emotional awareness.

Official Title
-----------------
Delving Intervention and Mindbody Integration

Conditions
-----------------
Child Abuse, Sexual, Post-Traumatic Stress Disorder, Dissociation

Intervention / Treatment
-----------------
* Behavioral: Body-Oriented Therapy
* Behavioral: Standardized Massage Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self-reported child sexual abuse In current psychotherapy for child sexual abuse recovery Exclusion Criteria: Over 6 months of past experience with body-oriented therapy Diagnosis or medications for psychosis Drug or alcohol addiction Current abusive relationship Dissociative disorder In transition on psychotropic medication

Ages Eligible for Study
-----------------
Minimum Age: 25 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Body-Oriented Therapy|nan|
|Behavioral: Standardized Massage Therapy|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mental Health, Psychotherapy
Dormia Basket Versus Extraction Ballon in Proximally Migrated Biliary Stents

Study Overview
=================
Brief Summary
-----------------
Dormia basket versus extraction ballon in proximally migrated biliary stents:A randomized controlled clinical trial

Detailed Description
-----------------
Dormia basket versus extraction ballon in proximally migrated biliary stents:A randomized controlled clinical trial The study aims to evaluate the efficacy of dormia basket versus extraction biliary balloon in management of proximal stent migration

Official Title
-----------------
Dormia Basket Versus Extraction Ballon in Proximally Migrated Biliary Stents:A Randomized Controlled Clinical Trial

Conditions
-----------------
Biliary Obstruction

Intervention / Treatment
-----------------
* Device: dormia basket
* Device: Extraction biliary ballon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults both gender Patients with biliary stenting following ERCP and who had signs of biliary obstruction. Exclusion Criteria: ERCP without stent insertion.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: the efficacy of dormia basket in management of proximal stent migration<br> | Device: dormia basket<br>* Use of dormia basket in management of proximal stent migration<br>|
| Active Comparator: the efficacy of extraction biliary balloon in management of proximal stent migration<br> | Device: Extraction biliary ballon<br>* Use of extraction biliary balloon in management of proximal stent migration<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare between dormia basket and extraction ballon in management of proximally migrated biliary stents regarding operative time (min) | Operative time was measured by minutes | 4 weeks |
A Comparison of McGrath MAC Videolaryngoscopy and Macintosh Laryngoscopy for Orotracheal Intubation in Children

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on the intubation time for orotracheal intubation in children. The secondary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on Cormack and Lehane Grade for orotracheal intubation in children.

Conditions
-----------------
Anesthesia, Endotracheal

Intervention / Treatment
-----------------
* Device: McGrath MAC videolaryngoscopy
* Drug: Macintosh Laryngoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: orotracheal intubation under general anesthesia Exclusion Criteria: oral lesions, congenital anomaly, cervical spine instability, rapid sequence intubation

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mcgrath group<br>Orotracheal intubation with McGrath MAC videolaryngoscopy | Device: McGrath MAC videolaryngoscopy<br>* Orotracheal intubation with McGrath MAC videolaryngoscopy after anesthetic induction<br>|
| Placebo Comparator: Macintosh group<br>Orotracheal intubation with Macintosh laryngoscopy | Drug: Macintosh Laryngoscopy<br>* Orotracheal intubation with Macintosh Laryngoscopy after anesthetic induction<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation time | Time interval between laryngoscopy passing the teeth to the confirming of end tidal CO2 | through intubation completion, an average of 30 second | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of glottic exposure as assessed by Cormack and Lehane Grade | Grade 1: full view of glottis, grade 2: Partial view of glottis, grade 3:only epiglottis seen, grade 4:neither glottis nor epiglottis seen | Up to 5 second after laryngoscopy passing the teeth |
Study of Pediatric Migraine: The Pediatric Migraine Registry

Study Overview
=================
Brief Summary
-----------------
This is a multi-center registry that will prospectively collect regulatory compliant data from children and adolescents with migraine. This study will enroll approximately 200 participants from approximately 20 sites and will examine migraine symptoms, therapeutics used, and biomarkers associated with migraine.

Official Title
-----------------
Observational Study of Pediatric Migraine: The Pediatric Migraine Registry

Conditions
-----------------
Migraine

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 4 to 17 years of age inclusive at the time of enrollment visit Meets International Classification of Headache Disorders, 3rd edition criteria for migraine with or without aura Guardian provides informed consent/HIPAA Participant provides assent if developmentally appropriate and required by the institutional review board Exclusion Criteria: Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children and adolescents<br>Children and adolescents between the ages of 4 and 17 years old (inclusive) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine frequency | Number of days per month participant experiences migraine | Approximately 12 months |