louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01560728: Bringing What Works to Youth in Corrections: A Trauma Intervention
Official title: Bringing What Works to Youth in Prison: An Evidence-Based Trauma Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Post-Traumatic Stress Disorder
Keywords: Post Traumatic Stress Disorder
Major Depressive Disorder
Dysthymia
Generalized Anxiety Disorder
Social Phobia
Panic Disorder
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-03-22
Enrollment: 57
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Youth with mental illnesses are disproportionately represented in juvenile correctional facilities and limited evidence exists about effective treatments in this setting. This study will adapt Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), a treatment found to be efficacious in community settings, to the correctional setting and study the feasibility of its implementation. Conducted within Texas youth correctional facilities, the findings will be rapidly disseminated in the state. The goal is to enhance the TF-CBT approach to meet the unique needs of incarcerated youth and the correctional system, one of the priorities outlined in the National Institute of Mental Health Strategic Plan.


Eligibility criteria: Inclusion Criteria:

* Evidence of one or more significant traumatic life events
* Current diagnosis of one of the following:

  * Post Traumatic Stress Disorder
  * Major Depressive Disorder
  * Dysthymia
  * Generalized Anxiety Disorder
  * Social Phobia
  * Panic Disorder
* Trauma symptom severity scores of 25 or greater.

Exclusion Criteria:

* Expected release date or transfer date within 5 months from study enrollment date
* Current inclusion in the Sex Offender Treatment Program
* Intellectual Quotient (IQ) less than 70
* Current high risk of suicidality
* Current symptoms of active psychosis

Primary outcomes:
measure: Rate of change in UCLA PTSD Reaction Index (UCLA PTSD RI) Trauma Symptom Severity
timeFrame: Participants will be assessed at baseline and every 2 weeks for an average of 6 months
Secondary outcomes:
measure: Rate of change in Child Behavioral Checklist Youth Self-Report Total Score
timeFrame: Participants will be assessed at baseline and every 2 weeks for an average of 6 months
Other outcomes:
Locations:
city: Brownwood
country: United States
facility: Ron Jackson State Juvenile Correctional Facility
state: Texas
city: Giddings
country: United States
facility: Giddings State School
state: Texas
city: Mart
country: United States
facility: McClennan County State Juvenile Correctional Facility
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Molly M Lopez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00567528: Comparison of the Efficacy of Topical Ibuprofen to Oral Ibuprofen in Adolescent Athletes
Official title: Comparison of the Efficacy of Topical Ibuprofen to Oral Ibuprofen in Adolescent Athletes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Soft Tissue Injury
Keywords: Soft tissue injuries
Topical ibuprofen
Adolescent athletes
Lead sponsor: Akron Children's Hospital
Sponsor class: OTHER
First posted: 2007-12-05
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was made to compare the efficacy of topical ibuprofen in gel form with oral ibuprofen in the treatment of sub-acute soft tissue injuries while comparing the tolerability of the delivery methods


Eligibility criteria: Inclusion Criteria:

* Age 12-19yo
* soft tissue injury or flare up of soft tissue injury within 10 days to 8 weeks

Exclusion Criteria:

* Known hypersensitivity to aspirin or any NSAID,
* allergy to eggs or egg products
* history of asthma, renal disease, GI disease, active or suspected bleeding peptic ulcer (past or present), anemia, hypertension, other systemic disease significantly affecting liver or renal function
* serious injury within six months
* currently on anticoagulants
* pregnant or lactating females
* active arthritis in affected limb
* open wounds, infected skin or fractures
* opioid use within 7 days
* severe psychological disorder
* prior topical medication applied to the painful region/area of study

Primary outcomes:
measure: Efficacy of Topical Ibuprofen to Oral Ibuprofen measured by numeric pain rating, swelling at injury site, and change in sports activity.
timeFrame: 10 days to 8 weeks after initial injury or flare up
Secondary outcomes:
measure: Compare the tolerability of the two delivery methods measured by side effects.
timeFrame: 2 weeks after starting topical and oral ibuprofen
Other outcomes:
Locations:
city: Akron
country: United States
facility: Sports Medicine Department at Akron Children's Hospital
state: Ohio
Study officials:
affiliation: Akron Children's Hospital
name: Emmanuel O Adekunle, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Akron Children's Hospital
name: Joseph Congeni, M.D.
role: STUDY_DIRECTOR
affiliation: Akron Children's Hospital
name: Cynthia Bennett, MSN, CNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Whitefield M, O'Kane CJ, Anderson S. Comparative efficacy of a proprietary topical ibuprofen gel and oral ibuprofen in acute soft tissue injuries: a randomized, double-blind study. J Clin Pharm Ther. 2002 Dec;27(6):409-17. doi: 10.1046/j.1365-2710.2002.00439.x.
Clinical trial NCT00587028: Cathartic-Free DECT Colonography for Detection of Colonic Polyps
Official title: Cathartic-Free Dual Energy Computerized Tomography (DECT) Colonography.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colonic Polyps
Keywords: Colonography
Colonoscopy
Virtual
Computed Tomographic Colonography
Large intestine
colon
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-01-07
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mayo Clinic, Rochester, Minnesota and Mayo Clinic, Scottsdale, Arizona Colonoscopy schedules.

Brief summary: Asses the clinical performance of dual-energy CTC for the detection of larger polyps 1 cm or larger without cathartic preparation.

Detailed description: Determine the feasibility to differentiate polyps from stool with or without the use of contrast agents and to assess the feasibility and accuracy of dual energy techniques in a pilot patient study.

1.1 Formulate algorithms that use dual-energy information to quantitatively measure specific material density of colon polyps in physics based simulation.

1.2 Determine optimal scanning parameters on prototype CT equipment.

2.1 Measure the material composition density and Hounsfield number of polyps with and without simulated contrast enhancement.

2.2 Measure the accuracy of dual-energy techniques to differentiate between polyps and stool and if needed using a combination of simulated intravenous enhanced polyps and contrast material tagged stool.

3.0 Asses the clinical performance of dual-energy CTC for the detection of larger polyps 1 cm or larger without cathartic preparation.

Eligibility criteria: Inclusion Criteria:

* Participants with a known colorectal polyp or colon carcinoma with pathology, at or greater than 1 cm in size on a colonoscopy that is completed either eight weeks before or after CT Colonography study visit.
* If receiving iodine oral or IV contrast, must have a creatinine less than 1.4 on record within last 30 days of study visit date. If no creatinine is available, one will be drawn for enrollment criteria purposes.

Exclusion Criteria:

* Pregnant females.
* Presence of colostomy or right hemicolectomy.
* Inflammatory bowel disease (Crohn's, chronic ulcerative colitis).
* Familial polyposis syndrome.
* Pregnant female.
* Creatinine at or greater than 1.4
* Severe or uncontrolled chronic obstructive pulmonary disease (COPD) or chronic obstructive lung disease (COLD).
* Iodine contrast allergy.

Primary outcomes:
measure: Clinical performance of dual-energy CT colonography (CTC).
timeFrame: Three Months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jeff L. Fidler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01802528: Clinical Effectiveness of Obturator Externus Muscle Injection in Chronic Pelvic Pain Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pelvic Pain
Keywords: obturator externus
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population was defined as chronic pelvic pain patients with a localized tenderness on inferolateral side of the pubic tubercle corresponding to obturator foramen who received OE muscle injection with local anesthetic for their pain treatment.

Brief summary: Obturator externus (OE) muscle has the possibility as a pain generator, considering its anatomical and functional aspects, but this muscle as a possible target for therapeutic intervention is currently understudied in pain practice.


Eligibility criteria: Inclusion Criteria:

* 1. 20-75 adults/ 2. Chronic pelvic pain patients who required the interventional procedures/ 3. patients with a localized tenderness on inferolateral side of the pubic tubercle

Exclusion Criteria:

* 1. Severe cardiovascular disease /2. Coagulation abnormality /3. Patient denial

Primary outcomes:
measure: Post-injection pain score
timeFrame: at 2 weeks after injection
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute,
Study officials:
References:
Clinical trial NCT02158728: Supraventricular Tachycardia Collection Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Supraventricular Arrhythmias
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2014-06-09
Enrollment: 80
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: Implantable cardioverter defibrillator (ICD) indicated

Brief summary: To collect supraventricular tachycardia (SVT) data for developing and testing sensing and detection algorithms for a subcutaneous implantable cardioverter defibrillator (ICD).

Detailed description: The purpose of the SVT Collect study is to collect supraventricular tachycardia episode data for developing and testing new sensing and detection algorithms for a future subcutaneous ICD.

Eligibility criteria: Inclusion Criteria:

* Subjects aged 18 or above, or of legal age to give consent specific to the national law of the countries in which the trial is being conducted
* Subjects indicated for implantable cardioverter defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) implant or ICD/CRT-D change-out, OR subjects indicated for an ICD/CRT-D that are undergoing ablation or electrophysiology (EP) study (including Non-invasive EP Study \[NIPS\])
* Subjects are willing to provide Informed Consent

Exclusion Criteria:

* Subjects who are ventricular pacing dependent
* Subjects with a preexisting dual/triple chamber pacemaker or ICD who have a history of atrioventricular (AV) block with atrial pacing \< 120 beats per minute (BPM) while awake.
* Subjects who are unable to tolerate elevated ventricular rates (≥170BPM)
* Any condition which precludes the subject's ability to comply with the study requirements
* Enrollment in a concurrent study (without prior study management approval) that may confound the results of this study
* Subjects who are legally incompetent
* Subjects meet exclusion criteria required by local laws and regulations (e.g. age, breast feeding, etc).

Primary outcomes:
measure: Number of Electrocardiograms (ECGs) Collected
timeFrame: After recorded ECGs had been received, which were collected until the end of the indicated procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University
Study officials:
References:
Clinical trial NCT01942928: Cranial Osteopathy in Infantile Colic
Official title: Cranial Osteopathic Manipulative Therapy in Addition to Usual Care in Excessively Crying Infants, Sometimes Called Colic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infantile Colic
Lead sponsor: European School of Osteopathy
Sponsor class: OTHER
Collaborators: name: Sutherland Cranial College of Osteopathy
name: Sutherland Society
First posted: 2013-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background Excessive Crying (Infantile Colic) is one of the most common complaints for which parents seek treatment. These otherwise healthy and well fed infants show no signs of failure to thrive, cry without identifiable cause, fuss a lot and are hard-to-soothe.

Objective To explore the feasibility of running a Randomised Controlled Trial (RCT) that investigates the effectiveness of cranial osteopathy in addition to usual National Health Service (NHS) care in infants with colic.

Methods Pragmatic randomised controlled trial, involving United Kingdom (UK) osteopaths in private practice and NHS health visitors. Parents of 60 excessively crying infants/infants with colic will be recruited by NHS health visitors. Infants will be included into the study if they are healthy (full-term) and aged 1-7 weeks, diagnosed with excessive crying/infantile colic, and have no co-morbidities. Participants will be randomised into the usual NHS care group or the usual NHS care plus cranial osteopathic intervention group.

Usual NHS care will be provided by health visitors and osteopathic treatment will be carried out by experienced osteopaths in private practice.

Primary outcome measures are acceptability and feasibility of intervention procedures. Furthermore, changes in the frequency and duration of crying will be documented in a daily crying diary. Parental quality of life will also be assessed.

This pilot investigation will provide useful information in order to further develop and adapt the current interventions and trial procedures with a view to a full-scale randomised controlled trial.


Eligibility criteria: Inclusion Criteria:

* healthy, diagnosed with excessive crying by NHS Health Visitors No comorbidities Parents are able to adequately communicate in English

Exclusion Criteria:

* Currently participating in other therapeutic clinical trials Currently receive manual therapy treatment

Primary outcomes:
measure: Change in daily hours crying time
timeFrame: 4 weeks
Secondary outcomes:
measure: Parental Quality of life
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Maidstone
country: United Kingdom
facility: European School of Osteopathy
state: Kent
Study officials:
References:
Clinical trial NCT03964428: Serum Ferritin and Hepicidin Concentration in Chronic Periodontitis Patients With T2DM
Official title: Decreased Ferritin And Increased Hepcidin Serum Levels In Periodontitis Patients With Diabetes Mellitus Type 2. Controlled Before-And-After Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Type2 Diabetes
Keywords: periodontitis
ferritin
hepicidin
type 2 diabetes mellitus
non surgical perioontal therapy
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: participants were collected from the Outpatient Clinic, Department of Oral Medicine, Periodontology and Diagnosis, and the restorative clinic for the control subjects, Faculty of Oral and Dental Medicine, fayoum University

Brief summary: serum level of ferritin and hepicidin were evaluated in periodontitis patient with and without type 2 diabetes before and after non surgical periodontal treatment to clarify their in periodontal disease


Eligibility criteria: Inclusion Criteria:

* patients with more than 30% of the sites had clinical attachment level (CAL) 3-4mm with T2DM
* systemically healthy patients with more than 30% of the sites had clinical attachment level (CAL) 3-4mm
* healthy subjects had clinically healthy gingiva with ≤ 3mm pocket probing depth (PPD), nearly zero plaque index (PI), gingival index (GI), zero CAL.

Exclusion Criteria:

* (I) Pregnancy or lactation, (II) History of receiving professional periodontal treatment during the past 6 months; (III) Treatment with any type of medications and/ or antibiotics during the past 3 months and (IV) Current or former smokers.

Primary outcomes:
measure: ferritin concentration
timeFrame: 0-3 months
measure: hepicidin concentration
timeFrame: 0-3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Nayroz Abelfattah Tarrad
Study officials:
References:
Clinical trial NCT02478528: Study of Effects of Light on the Vigilance and Cognitive Performance Following a Night Without Sleep
Official title: Study of Effects of Light on the Vigilance and Cognitive Performance Following a Night Without Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-06-23
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Sleep disorders are a major public health issue, affecting 1 in 6 French. The medical impact at the individual level but also social and economic level (loss of productivity, morbidity, mortality) emphasize the need for one hand, to improve the investigators' understanding of these disorders in order to develop appropriate therapeutic tools and on the other hand, to increase the investigators' support abilities of patients with these disorders.

The investigators' team of unity sleep from Strasbourg University Hospitals, in collaboration with the UPR 3212 CNRS team, is working on the development and adjustment of new concepts and tools to compensate the investigators' sleep debt in order to apply them to patients with sleep disorders and persons who face with sleep restriction.


Eligibility criteria: Inclusion Criteria:

* Man or woman
* Age from 18 to 40 years
* With a Body Mass Index (BMI) between 17 and 30 kg m-2
* Healthy volunteer determined by clinical examination and psychological interview
* Agreeing to abstain from caffeine, nicotine, alcohol, psychotropic drugs, cannabis or other drugs, the week before the start of Stage 2 of the study until the end of the study
* Dated and signed informed consent
* Subjet affiliated to a social security scheme
* Subject has been informed about the results of the medical examination

Exclusion Criteria:

* Participation in other clinical trials in the month preceding the inclusion
* Shift work in the year before inclusion
* Cons-indications to the use of the medical device
* Ocular disease
* Unable to give informations to the subject (subject in an emergency situation, difficulties in understanding, ...)
* Subjet under judicial protection
* Subject under guardianship or curatorship
* pregnancy
* breastfeeding

Primary outcomes:
measure: Analysis of the perception of fatigue
timeFrame: Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition
measure: Analysis of the circadian variation of melatonin and cortisol secretion
timeFrame: Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition
Secondary outcomes:
measure: Cognitive performance
timeFrame: Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Unité du Sommeil - Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT04312828: Assessment of Orthopedic Care of the Z-shaped Foot in Infant
Official title: Assessment of Orthopedic Care of the Z-shaped Foot in Children From 6 Months to 2 Years Old
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Foot Deformities
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 76
Sex: ALL
Minimum age (years): 6
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who suffered from a congenital idiopathic Z-foot deformation, aged 6 months to 2 years at the time of orthopedic treatment.

Brief summary: Real-life, observational, monocentric, ambispective study, carried out in France. The aim of the study is to evaluate the success rate of orthopedic management of the Z-foot after at least 9 months of follow-up.

Detailed description: The study will include a single prospective data collection, which will make it possible to obtain prospective clinical data at the longest follow-up after treatment, with a minimum follow-up of 9 months. This collection will be done during a visit to the office or a phone call, depending on the preference of patients and their parents.

Early data (before the intervention, immediately after, and at 3 months of follow-up) will be collected retrospectively in medical records.

Eligibility criteria: Inclusion Criteria:

* Child having presented a congenital idiopathic malformation uni- or bilateral of foot in Z, defined by the presence of an angular adduction of the mid-forefoot and a dorsolateral hump;
* Orthopedic treatment with femoropedic plasters and slotted splints in 1st intention, having started at least 9 months before inclusion;
* Child aged 6 months to 2 years at the start of care;
* Authorization of the parents or the legal representative of the child to collect personal information about their child.

Exclusion Criteria:

* Child having presented a secondary Z foot;
* History of foot surgery;
* Lack of retrospective data to assess the convexity of the external edge of the foot before orthopedic care;
* Inability of the parents or the child's legal representative to understand the study protocol.

Primary outcomes:
measure: The main criterion of the study is the success rate of orthopedic management of the Z-foot.
timeFrame: 9 months
Secondary outcomes:
measure: Moderate success rate of the procedure
timeFrame: 9 months
measure: Partial and total success rate (relative to the number of patients treated)
timeFrame: 9 months
measure: Convex angle of the outer edge of the foot during follow-up
timeFrame: 9 months
Other outcomes:
Locations:
city: Boulogne-billancourt
country: France
facility: Clinique Marcel SEMBAT
Study officials:
affiliation: Clinique Marcel SEMBAT
name: Mira MD RAMANOUDJAME
role: PRINCIPAL_INVESTIGATOR
References: