louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01825694: An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents
Official title: An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Traumatic Stress
Keywords: Substance Abuse
Traumatic Stress
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 117
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study plans to develop an integrated treatment for comorbid post-traumatic stress disorder (PTSD) and substance abuse (SA) in adolescents. The investigators aim to develop a treatment approach that is community-friendly, well-tolerated, and deliverable by substance abuse counselors (SAC) in outpatient settings. The proposed Trauma-Focused Substance Abuse Treatment (TFSAT) aims to reduce PTSD symptoms and substance use and build coping skills. The investigators propose to adapt an evidence-based trauma program, Cognitive-Behavioral Intervention for Trauma in Schools (CBITS), for adolescent substance abusers (ASAbusers); to assess the acceptability and feasibility of the integrated approach; and to pilot test the new program against standard care.

The investigators hypothesize that the intervention group, compared to the control group, will reduce substance use and symptoms for traumatic stress.


Eligibility criteria: Inclusion Criteria: Youth

* Between ages of 13 \& 19;
* meeting DSM IV criteria for substance abuse/dependence and PTSD;
* previously enrolled at recruitment site for at least 2 weeks;
* parent/guardian provides permission for minors to participate.

Exclusion Criteria: Youth

* Not within the specified age range;
* presence of organic brain damage;
* inability to understand enrollment forms (e.g. Informed Assent/Consent Form)

Inclusion Criteria: Parents/Guardians

* Age 18 or above;
* parents/guardians of youth who meets inclusion criteria.

Exclusion Criteria: Parents/Guardians

* presence of organic brain damage.

Primary outcomes:
measure: Timeline Follow-back (TFLB) Assessment of Substance Use
timeFrame: Participants will be followed for an expected average of 12 weeks.
measure: Urine Toxicology Screen (UTS)
timeFrame: Participants will be followed for an expected average of 12 weeks.
measure: Child PTSD Symptom Scale (CPSS)
timeFrame: Change from Baseline in Child PTSD Symptom Scale at 8 weeks and change from Baseline in Child PTSD Symptom Scale at 12 weeks.
Secondary outcomes:
measure: Child Post-Trauma Attitudes Scale (C-PTAS)
timeFrame: Baseline & 8 weeks & 3 months
measure: Strengths & Difficulties Questionnaire (SDQ)
timeFrame: Baseline & 8 weeks & 3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Behavioral Health Services
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Nancy S Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00581594: Traditional vs. Graft-augmented Posterior Colporrhaphy
Official title: Traditional vs. Graft-augmented Posterior Colporrhaphy: A Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pelvic Organ Prolapse
Posterior Vaginal Wall Defects
Keywords: Pelvic organ prolapse
Posterior wall defects
Graft-augmented repair
Posterior colporrhaphy
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2007-12-27
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Women who undergo posterior colporrhaphy with graft augmentation will have a lower recurrence of their posterior wall defect than women who undergo a traditional posterior colporrhaphy.

Detailed description: The traditional approach to surgical repair of posterior wall defect is the posterior colporrhaphy. Although this technique has been successful in the anatomic correction of the defect, the functional outcomes have been disappointing. This fact suggests improvement in the functional and anatomic outcomes following a traditional posterior colporrhaphy. Consequently, the idea of incorporating graft material into the repair to augment the patient's own tissue has been examined. Placing a piece of graft material in between the vagina and rectum adds an extra layer of support and thus augments the strength of the repair. The purpose of this study is to evaluate the anatomic and functional outcomes of posterior compartment, graft-augmented traditional posterior colporrhaphy vs. traditional posterior colporrhaphy alone.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Posterior wall defect with point Ap or Bp at 0 or greater
* Desires surgical correction
* Willing to accept randomization to graft vs. no graft
* Competent to sign an informed consent
* Completed childbearing
* Non-pregnant

Exclusion Criteria:

* Current anal sphincter disruption with planned incontinent surgical repairs
* Poor surgical candidate
* History of rectal cancer or inflammatory bowel disease
* Current rectovaginal
* History of vaginal cancer
* History of vaginal/pelvic radiation
* Foreshortened vagina
* Previous adverse reaction to Xenform matrix graft material

Primary outcomes:
measure: The primary outcome of recurrence of stage II posterior wall defects will be measured using the pelvic organ prolapse quantification exam (POPQ).
timeFrame: 5 Years
Secondary outcomes:
measure: The secondary outcomes will be measuring the effects of the surgical repair on various aspects of life using a series of questionnaires: SF-36 as a measure of quality of life, PISQ to measure sexual function, and FISI to measure rectal function.
timeFrame: 5 Years
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Karen L Noblett, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00889694: Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis
Official title: Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis: a 12-Week, Multiple Centers, Randomized Double-Blind, Positive Drug and Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Early Ankylosing Spondylitis
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2009-04-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a 12-week, randomized, placebo and positive drug controlled clinical trial to investigate whether tripterygium capsule is effective and safe in treating patients with ankylosing spondylitis. The investigators expect that the tripterygium capsule is more effective than placebo and has few adverse effects.


Eligibility criteria: Inclusion Criteria:

1. Fulfill the ESSG criteria for SpA and not fulfill any criteria for the subtype including ankylosing spondylitis, psoriatic arthritis, reactive arthritis and inflammatory bowel disease associated arthritis.
2. Disease is in active status defined by BASDAI\>=40mm.
3. DMARDs administration must be suspended for at least 4 weeks before screening. NSAIDs dose must be stable for at least 4 weeks before screening.

Exclusion Criteria:

1. Intra-articular injection of glucocorticoid within 3 months.
2. Previous history of heart failure, multiple sclerosis, chronic obstructive pulmonary disease, recurrent infection, lymphoma or other tumors.
3. Accompanied by fibromyalgia syndrome or other rheumatic diseases.
4. Female of pregnancy or breast-feeding.
5. Poor compliance or with mental diseases.

Primary outcomes:
measure: ASAS20
timeFrame: 12th week
Secondary outcomes:
measure: BASDAI20/50/70
timeFrame: 12th week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00794794: Taste Test Between Desloratadine and Cetirizine Syrup in Children (Study P03826)
Official title: A Single-Center, Pediatric, Comparative Taste Test of Desloratadine and Cetirizine Antihistamine Syrup Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-11-20
Enrollment: 204
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study was conducted to compare the taste acceptability of Zyrtec syrup with desloratadine syrup in children. Children between 6 and 11 years of age received 5 mL of each syrup, separated by 15 to 20 minutes on a single day.

Detailed description: This study is a cross-over study design.

Eligibility criteria: Inclusion Criteria:

Subjects must be:

* Between 6 and 11 years of age in good general health
* Premenarcheal if female

Exclusion Criteria:

Subjects who:

* Have known allergies or sensitivities to either of the drug formulations
* Have a medical condition that may interfere with the subject's ability to discriminate between tastes
* Have used any antihistamines within 24 hours prior to dosing
* Were taking sedatives, tranquilizers, or monoamine oxidase inhibitor drugs
* Were involved in another clinical or market research study within the past 30 days

Primary outcomes:
measure: Taste acceptability as determined from smiley-face scale of 1 (frowning child) to 5 (happy child face).
timeFrame: During the only study visit
Secondary outcomes:
measure: Taste flavor preference between bubble-gum, banana-grape, or grape flavors
timeFrame: During the only study visit
measure: Adverse Events
timeFrame: During the only study visit
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05728294: Femoral or Sciatic Nerve Block to Provide Analgesia After Proximal Tibial Osteotomy
Official title: Femoral or Sciatic Nerve Block to Provide Analgesia After Proximal Tibial Osteotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: femoral nerve block or sciatic nerve block with ropivacaine
Primary purpose: TREATMENT

Brief summary: Proximal tibial osteotomy is associated with moderate to severe postoperative pain. The proximal part of the tibia is innervated by branches from the femoral nerve anteriorly and the sciatic nerve posteriorly. Little is known on the type of peripheral nerve block to perform so that optimal postoperative analgesia is provided with minimum impact on the motor function. This randomised controlled double-blinded trial tested the hypothesis that a femoral nerve block provides superior analgesia than a sciatic nerve block after proximal tibial osteotomy.


Eligibility criteria: Inclusion Criteria:

* proximal tibial osteotomy

Exclusion Criteria:

* femoral or sciatic nerve deficit,
* pre-existing peripheral neuropathy,
* chronic pain diagnosis,
* pregnancy,
* identified contraindications to peripheral nerve block (e.g., local anesthetic allergy, coagulopathy, or infection at the block site).

Primary outcomes:
measure: Intravenous morphine consumption
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Intravenous morphine consumption
timeFrame: 2 hours after surgery
measure: Intravenous morphine consumption
timeFrame: 48 hours after surgery
measure: rest pain score
timeFrame: 2 hours after surgery
measure: rest pain score
timeFrame: 24 hours after surgery
measure: rest pain score
timeFrame: 48 hours after surgery
measure: dynamic pain score
timeFrame: 2 hours after surgery
measure: dynamic pain score
timeFrame: 24 hours after surgery
measure: dynamic pain score
timeFrame: 48 hours after surgery
measure: Rate of postoperative nausea and vomiting
timeFrame: 2 hours after surgery
measure: Rate of postoperative nausea and vomiting
timeFrame: 24 hours after surgery
measure: Rate of postoperative nausea and vomiting
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University Hospital of Lausanne
state: Vaud
Study officials:
References:
Clinical trial NCT00705094: Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients
Official title: Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Testicular Cancer
Seminoma
Non-seminomatous
Keywords: cardiovascular risk factors
cardiac function
VO2peak
Chemotherapy
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2008-06-25
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: testicular cancer patients who have recieved surgery and are scheduled for either chemotherapy or surveillance

Brief summary: For many years, researchers and doctors have studied different kinds of treatments to improve the survival of men with testicular cancer. However, recent research has shown that many years later, men who had testicular cancer appear to be at higher risk for developing heart disease (heart attack or heart failure), especially if they received chemotherapy. Since these studies were done many years after men received treatment, there was no way to know if other factors contributed to the health problems they experienced. This study is being done because it would be helpful to study heart function and cardiovascular disease risk factors of men who have been diagnosed with testicular cancer, before and after they receive chemotherapy treatment compared to men who receive treatment with surgery alone.

Detailed description: The aim of this pilot study is to examine global and regional LV systolic and diastolic function, cardiac output, cardiac reserve, VO2peak and CVD risk profile in males recently diagnosed with testicular cancer treated with surgery alone or surgery and chemotherapy.

Eligibility criteria: Inclusion Criteria:

* surgery and surveillance
* surgery and multi-cycle chemotherapy
* both good and intermediate prognosis seminoma and non-seminomatous germ cell testicular tumors
* Karnofsky performance index \> 70%
* no contraindications to cardiopulmonary testing

Exclusion Criteria:

* documented cardiovascular disease or evidence of myocardial ischemia on the incremental exercise (VO2peak) test.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: University of Alberta
name: Mark Haykowsky, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00569894: A Post Marking Study to Evaluate the Safety of FluMist in Children
Official title: A Post Marketing Evaluation of the Safety of FluMist in Children 24-59 Months of Age in a Managed Care Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2007-12-10
Enrollment: 29296
Sex: ALL
Minimum age (years): 24
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The populations to be assessed are FluMist recipients, TIV recipient controls, and unvaccinated controls.

Members of the Kaiser Permanente Health Care Plan may be included in this study as part of routine care at their participating health centers within the Kaiser Permanente health maintenance organization (HMO) of Northern California.

Brief summary: To assess the safety of FluMist vaccination

Detailed description: * To assess the safety of FluMist vaccination Rates of medically attended events in FluMist recipients, including serious adverse events (SAEs), anaphylaxis , urticaria, asthma, wheezing, pre-specified grouped diagnoses, and rare events potentially related to wild-type influenza, will be compared to rates in multiple non-randomized control groups.
* To assess the safety of annual FluMist re-vaccination \[Rates of MAEs in the subset of children who receive FluMist in ≥2 consecutive years will be compared to rates in first-time vaccinees during the same season.\]
* To assess the safety of FluMist vaccination in children previously vaccinated with trivalent inactivated influenza vaccine (TIV) \[Rates of MAEs in the subset of children who received one or more prior TIV vaccinations will be compared to rates in children who did not receive prior TIV.\]

Eligibility criteria: Inclusion Criteria:

* Healthy
* Age: born within the same calendar quarter as the reference FluMist vaccinee.

Exclusion Criteria:

* Children who have evidence of medical conditions that put them at high risk for complications of influenza (e.g., chronic cardiovascular and pulmonary disease) will be excluded from this control group.

Primary outcomes:
measure: Assess Medically Attended Events(MAEs)of anaphylaxis,urticaria, asthma,wheezing,pre-specified grouped diagnoses,and rare events related to wild-type influenza,MAEs-qualify as SAEs,in:emergency department,clinic,and hospital setting.
timeFrame: 1, 3, 21, or 42 days post dose; 6 months post dose; entire study period)
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Research Site
state: California
Study officials:
affiliation: MedImmune LLC
name: Seth Toback, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00304694: Whole-Body 18F-FDG PET in Induction Chemotherapeutic Response for Advanced NPC Patients
Official title: Whole-Body 18F-FDG PET in Evaluating Induction Chemotherapeutic Response for Locally Advanced Nasopharyngeal Cancer Patients and Correlating With Histopathology: a Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Cancer
Keywords: NPC
Induction chemotherapy
Therapeutic response
18F-FDG PET
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2006-03-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: 18F-FDG PET, a whole-body imaging technology based on glucose metabolism, can effectively detect subclinical and clinical therapeutic responses at stages that are earlier than those detected by conventional approaches.

We propose to conduct a prospective study to evaluate therapeutic response using 18F-FDG PET before and after induction chemotherapy for locally advanced NPC patients.

Detailed description: In order to improve locoregional control and to eradicate micrometastases for patients with locally advanced nasopharyngeal carcinoma (NPC), induction chemotherapy followed by concurrent chemoradiotherapy has been the preferred therapeutic approach.Although it would be of great advantage to identify non-responder during or immediately after therapy to formulate an alternative treatment strategy, non-invasive methods for early evaluation of therapeutic response for advanced NPC patients have not been fully evaluated. Decrease of tumor volume in anatomical images and relief of symptoms in clinical follow-up have been used in many conventional approaches to evaluate the effectiveness of therapy. However, an effective therapy could very well have resulted in early subclinical alterations in tumor physiology and biochemistry. These alterations may have occurred long before changes in the tumor mass become apparent. Thus therapeutic effect may not be assessed accurately using the conventional anatomical imaging studies, such as CT and MRI.Recent studies have shown that 18F-FDG PET, a whole-body imaging technology based on glucose metabolism, can effectively detect subclinical and clinical therapeutic responses at stages that are earlier than those detected by conventional approaches.We therefore propose to conduct a prospective study to evaluate therapeutic response using 18F-FDG PET before and after induction chemotherapy for locally advanced NPC patients.

Eligibility criteria: Inclusion Criteria:

* newly diagnosed locally advanced NPC patients who are receiving induction chemotherapy for treatment

Exclusion Criteria:

* age below 18 year old
* pregnancy women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ruoh-Fang Yen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04727294: MGUS, SMM, and MM Patient Experience With Coronavirus 19 (COVID-19) Survey
Official title: Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Myeloma (SMM), and Multiple Myeloma Patient Experience With COVID-19 Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma
Smoldering Multiple Myeloma
Monoclonal Gammopathy of Undetermined Significance
Coronavirus
Keywords: Questionnaire
Lead sponsor: HealthTree Foundation
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2021-01-27
Enrollment: 1500
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 diagnosed with MGUS, smoldering myeloma, or multiple myeloma.

Brief summary: The purpose of this study is to examine how patients with multiple myeloma (MM) have been impacted by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic.

The study will use a questionnaire to further understand how patients are being affected and gather information in order to track the long-term effects of the coronavirus.

The scope of the questionnaire will include, COVID-19 diagnosis and treatment, changes in myeloma treatment and care, clinical trial familiarity, health and fitness, and quality of life.

This questionnaire is a follow-on to the "MM and COVID-19" questionnaire.


Eligibility criteria: Inclusion Criteria:

* Adult patients (greater than 18 years) diagnosed with MGUS, smoldering myeloma, and multiple myeloma.
* Access to a computer or electronic device with internet access, or phone
* Willing to create a patient profile on the HealthTree Cure Hub For Multiple Myeloma
* Willing to give electronically-signed consent
* Ability to read questions in English

Primary outcomes:
measure: COVID-19 Diagnosis and Treatment
timeFrame: Up to one year
measure: Changes to Myeloma Treatment and Care
timeFrame: Up to one year
measure: Health and Fitness
timeFrame: Up to one year
measure: Quality of Life (QOL) Distress Screening tool
timeFrame: Up to one year
Secondary outcomes:
measure: Clinical Trial Familiarity
timeFrame: Upon enrollment
Other outcomes:
Locations:
city: Lehi
country: United States
facility: HealthTree.org (Online)
state: Utah
Study officials:
affiliation: HealthTree Foundation
name: Nathan Sweeney, PhD
role: STUDY_CHAIR
References: