louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03258463: Travelling for Rights
Official title: Travelling for Rights
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Termination
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 650
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Charts of women obtaining an induced abortion.

Brief summary: This will be a retrospective cohort study comparing women obtaining an abortion in New Mexico and living in Texas and women obtaining an abortion in New Mexico and living in New Mexico .

Detailed description: This will be a retrospective cohort study comparing women obtaining an abortion in New Mexico and living in Texas and women obtaining an abortion in New Mexico and living in New Mexico in two different time periods (time period #1 is from January 1 2012-December 31 2012 and time period #2 is from May 1 2014-April 30 2015. Our exposure is a state in which a woman lives in (New Mexico or Texas). Our intervention is the change in Texan laws occurring from July 2013-January 2014.

Eligibility criteria: Inclusion Criteria:

* Women obtaining an induced abortion at one of the following clinics:

University of New Mexico's Center for Reproductive Health (UNM CRH), Planned Parenthood - Albuquerque Surgical Center or Southwestern Women's Options.

* Women residing in Texas or New Mexico. -Women obtaining an induced abortion between January 1 2012-

Exclusion Criteria:

* No chart available for data extraction
* Gestational age at time of abortion initiation ≥ 24 weeks gestation as determined by ultrasound imaging.

Primary outcomes:
measure: Proportion of women from Texas travelling to NM, to obtain an abortion.
timeFrame: 2012-2015
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Eve Epsey, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02087163: The Use of Clear Aligners With Movement Enhancement Techniques
Official title: The Use of Clear Aligners With Movement Enhancement Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Lead sponsor: Align Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-14
Enrollment: 90
Sex: ALL
Minimum age (years): 16
Maximum age (years): 46
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to use clear aligners to measure tooth movement and length of treatment.

Detailed description: Orthodontic tooth movement is the result of a force applied to the crown of a tooth and the biological remodeling of the gum and bony tissues.

Eligibility criteria: Inclusion Criteria:

* Require Orthodontic Treatment
* Have a permanent dentition
* No craniofacial anomaly present
* No past and present signs and symptoms of periodontal disease
* No significant medical history or medication that would adversely affect the development or structure of the teeth and jaws and any subsequent tooth movement
* No previous orthodontic or orthopaedic relapse
* No history of trauma, bruxism or parafunction
* 16- 46 years old, inclusive
* No skeletal jaw discrepancy
* Angle Class I or Class II molar and canine relationship
* Crowding of at least 4mm per arch
* No osteoporosis drugs

Exclusion Criteria:

* Subjects who do not fulfill all inclusion criteria requirements

Primary outcomes:
measure: Tooth Movement Change
timeFrame: Baseline and end of treatment, an average of 78 weeks
Secondary outcomes:
measure: Length of Treatment Change
timeFrame: Baseline and end of treatment, an average of 78 weeks
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Align Technology, Inc.
state: California
Study officials:
name: Chenin
role: PRINCIPAL_INVESTIGATOR
name: Kottemann
role: PRINCIPAL_INVESTIGATOR
name: Mariani
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05563363: Home Treatment for Individuals Suffering From Severe Addictive Disorders
Official title: A Pilot Study on Home Treatment for Individuals Suffering From Severe Addictive Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use Disorders
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot study, randomized, open, non-blinded
Primary purpose: TREATMENT

Brief summary: Home Treatment (HT) has been successfully implemented in adult psychiatry in several countries including Switzerland. Patients with addiction problems were generally excluded even if the latter was not the main diagnosis. On the other hand, community treatments have successfully been established for these individuals. The investigators have recently offered HT to persons with severe addictive disorders which was well accepted.

The investigators intend to conduct a pilot study to prepare a large-scale study if successful. The investigators intend to compare HT to treatment as usual (regular inpatient treatment) on a specialized ward with respect to readmission rates during 6 months after discharge. The data show that 70.8% of all readmissions occur during the first 6 months. Therefore, a period of 6 months is considered an adequate time interval to sufficiently answer this pilot study's question.


Eligibility criteria: Inclusion Criteria:

* Substance use disorder
* age 18 or above
* sufficient french language skills
* competent subjects
* consent to randomization progress

Exclusion Criteria:

* organic brain disease or developmental disorder
* non voluntary admission
* severe somatic comorbidity
* History of complicated substance withdrawal
* acute suicidal ideation
* aggressive behavior
* acute psychiatric disease such as mania or psychosis
* distance to center (must be reachable within 60 minutes)

Primary outcomes:
measure: readmission rates
timeFrame: 6 month post-discharge
Secondary outcomes:
measure: time to readmission
timeFrame: 6 months
measure: length of hospitalization
timeFrame: 6 months
measure: number of emergency room visits
timeFrame: 6 months
measure: clinical outcome
timeFrame: 6 months
measure: patient satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospital
Study officials:
References:
Clinical trial NCT00622063: An Extension Study for Patients Previously Treated With ARQ 501
Official title: An Extension Study for Patients Previously Treated With ARQ 501
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cancer
Keywords: cancer, solid tumor
Lead sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 1
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: To provide ongoing treatment with ARQ 501 for patients who have benefited from prior treatment with ARQ 501


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Has previous participated in a clinical trial with ARQ 501 and is eligible for continued treatment

Exclusion Criteria:

* Have not received previous treatment with ARQ 501 under a treatment protocol
* Uncontrolled intercurrent illness, uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements

Primary outcomes:
measure: To provide ongoing treatment with ARQ 501 for patients who have benefited from prior treatment with ARQ 501
timeFrame: No time frame
Secondary outcomes:
measure: To collect additional safety and tolerability information for ARQ 501 treatment
timeFrame: No time frame
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
Study officials:
affiliation: Mary Crowley Medical Research Center
name: Neil Nathan Senzer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01586663: Serial Night Time Position Splint on Systemic Sclerosis
Official title: Evaluation of Serial Night Time Position Splint on Range of Motion for Patients With Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diffuse Systemic Sclerosis
Keywords: Diffuse Systemic Sclerosis
Hand
Range of motion
Splint
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-04-27
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial with blinded evaluator and follow-up of one year. Seventy six patients with diffuse systemic sclerosis, will be randomized into two groups.The patients can not change their medication during the study. Patients will be evaluated at baseline and at 3, 6, 9 and 12 months. The experimental group will use a serial night time position splint who will be adjusted monthly, while the control group will remain the drug treatment. The outcomes assessed will be: pain, hand range of motion, quality of life, functional capacity, upper limb function and dexterity. Our hypothesis is that the serial night time position splint will improve the hand range of motion in diffuse systemic sclerosis patients.


Eligibility criteria: Inclusion Criteria:

* Diffuse Systemic scleroses diagnosed following the ACR criteria
* Older than 18 years old
* Sclerodactyly

Exclusion Criteria:

* Neurological, psychiatric diseases and other rheumatic disease (including overlapping)
* Previous use of splints or allergy to splint material
* Surgery schedule to the next 12 months

Primary outcomes:
measure: Change in hand range of motion
timeFrame: Baseline and after 3, 6, 9 and 12 months
Secondary outcomes:
measure: Change in pain
timeFrame: Baseline, after 10, 20 and 40 weeks
measure: Change in functional capacity
timeFrame: Baseline, after 10, 20 and 40 weeks
measure: Change in quality of life
timeFrame: Basline, after 10, 20 and 40 weeks
measure: Change in upper limb function
timeFrame: Baseline, after 10, 20 and 40 weeks
measure: Change in dexterity
timeFrame: Baseline, after 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Jamil Natour, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02145663: Helsinki Ultra-acute Stroke Biomarker Study
Official title: Helsinki Ultra-acute Stroke Biomarker Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Stroke
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: HUS area Prehospital Emergency Service
First posted: 2014-05-23
Enrollment: 1046
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with suspected acute stroke, being transported by emergency medical services (EMS) to a tertiary hospital stroke center, as candidates for thrombolytic treatment of acute ischemic stroke.

Brief summary: The aim of this study is to establish diagnostic and predictive biomarkers for patients with suspected acute stroke, that are transported by EMS as candidates for thrombolytic treatment. The study focuses on the ultra acute phase, \<4.5 hours from symptom onset, including the prehospital setting. Analyses will include known biomarkers (e.g. GFAP, NR2 peptide) and a discovery phase for novel markers. Patient outcome will be evaluated at 3 month using the modified Rankin Scale (mRS).


Eligibility criteria: Inclusion Criteria:

* Acute stroke suspected by EMS personnel
* Transport to tertiary hospital as possible candidate for thrombolytic treatment of ischemic stroke
* Age ≥18
* Successful prehospital blood sampling by EMS personnel

Exclusion Criteria:

* Unsuccessful prehospital blood sampling by EMS personnel

Primary outcomes:
measure: Diagnostic accuracy of biomarkers for identifying ischemic stroke, transient ischemic attack, intracerebral hemorrhage and stroke mimics.
timeFrame: 90 days +/- 5 days
measure: Predictive accuracy of biomarkers for identifying patients not responding to thrombolytic treatment.
timeFrame: 90 days +/- 5 days
measure: Predictive accuracy of biomarkers for identifying patients facing hemorrhagic complications of thrombolytic treatment
timeFrame: 90 days +/- 5 days
measure: Predictive accuracy of biomarkers for predicting outcome
timeFrame: 90 days +/- 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
state: Uusimaa
Study officials:
affiliation: Helsinki University Central Hospital
name: Perttu Lindsberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mattila OS, Puolakka T, Ritvonen J, Pihlasviita S, Harve H, Alanen A, Sibolt G, Curtze S, Strbian D, Pystynen M, Tatlisumak T, Kuisma M, Lindsberg PJ. Targets for improving dispatcher identification of acute stroke. Int J Stroke. 2019 Jun;14(4):409-416. doi: 10.1177/1747493019830315. Epub 2019 Feb 13.
Clinical trial NCT00891163: Evaluate the Depth and Duration of Anesthesia
Official title: A Randomized, Double-Blind, Two-Period, Crossover Study to Evaluate the Depth and Duration of Anesthesia of Synera™ Patches Compared to Placebo Patches Applied to Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Topical anesthesia
Analgesia
Lead sponsor: ZARS Pharma Inc.
Sponsor class: INDUSTRY
Collaborators: name: Endo Pharmaceuticals
First posted: 2009-05-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the depth (mm) of anesthesia provided by the Synera topical patch (using sensory depth and pain depth evaluations), and to determine the duration (minutes) of anesthesia provided by the Synera topical patch (using dermal sensory testing and thermal sensory testing evaluations), compared with a matching heated placebo patch.


Eligibility criteria: Inclusion Criteria:

* Had no known significant diseases
* Normal 12-lead electrocardiogram
* Willing to refrain from using any local topical preparations

Exclusion Criteria:

* Taken over-the-counter (OTC) or prescription analgesics in any form within 24 hours
* Known allergy or sensitivity to any component of the Synera patch, including lidocaine, sympathomimetic amines, other local anesthetics of the amide type, epinephrine, or other patch components
* Had an active dermatological disease of any origin that may have interfered with their ability to participate

Primary outcomes:
measure: Sensory and pain depth measurements
timeFrame: 0, 30, 60, 90, 120 and 150 minutes
measure: Dermal and thermal sensory testing evaluations
timeFrame: 0, 30, 60, 90, 120 and 150 minutes
Secondary outcomes:
measure: Assess the safety and tolerability of the Synera topical patch compared with a matching heated placebo patch
timeFrame: Throughout the study
measure: Evaluate local effects on the skin at the site of patch application for dermal adverse events (AEs)
timeFrame: Throughout the study
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Medical Center, Thornton Hospital
state: California
Study officials:
References:
Clinical trial NCT00969163: A Study to Investigate Biomarkers of Skin Androgenization Following Testosterone Administration (0000-015)(COMPLETED).
Official title: A Pilot Study to Investigate Biomarkers of Skin Androgenization Following Short-Term Testosterone Administration in Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Skin Androgenization
Keywords: Biomarkers of Skin Androgenization
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-09-01
Enrollment: 30
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Postmenopausal women will receive testosterone gel or matching placebo gel daily. Sebum excretion rates will be measured before and after 6 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Subject is at least 3 years postmenopausal
* Subject is in good general health
* Subject is willing to avoid excess alcohol or strenuous physical activity during the study

Exclusion Criteria:

* Subject has donated a unit of blood or has taken an investigational drug in another clinical trial in the last 4 weeks
* Subject is a regular user of any illicit drugs
* Subject drinks excessive amounts of coffee, tea or cola
* Subject has used an estrogen or progestogens hormone replacement therapy in the past 6 months
* Subject has a history of cancer
* Subject has acne

Primary outcomes:
measure: serum free testosterone concentrations following multiple doses of AndroGel
timeFrame: 6 weeks
Secondary outcomes:
measure: mean percent change from baseline in sebum excretion
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00043563: Cognitive Behavioral Treatment of Pediatric Trichotillomania
Official title: Cognitive Behavioral Treatment of Pediatric Trichotillomania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trichotillomania
Keywords: Cognitive-behavior Therapy
Minimal Attention Control
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2002-08-12
Enrollment: 24
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will compare the effectiveness of cognitive-behavior therapy (CBT) to a minimal attention control (AC) condition for treatment of pediatric trichotillomania (TTM).

Detailed description: TTM is a persistent impulse control disorder in which the individual acts on urges to pull out his or her own hair. Onset typically occurs by adolescence, and TTM is often associated with significant functional impairment and distress. CBT is a type of psychotherapy designed to change problematic behaviors and thinking. It includes self-monitoring of hair-pulling urges and homework assignments to practice the use of cognitive and behavioral strategies.

Participants are assigned randomly to receive either CBT or AC for 8 weeks. Participants assigned to CBT receive weekly 1-hour sessions of CBT for 8 weeks; participants assigned to AC receive 6 telephone contacts and 2 in-person sessions for 8 weeks. After 8 weeks, CBT participants who respond to treatment enter Phase II, which lasts an additional 8 weeks and includes 4 in-person maintenance sessions. AC participants who are still symptomatic after 8 weeks are offered CBT.

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of Trichotillomania
* Minimum symptom duration of 6 months
* Presence of a stable parent or guardian

Exclusion Criteria:

* Other primary psychiatric diagnosis
* Bipolar illness, pervasive developmental disorder, thought disorder, current major depression, ADD/ADHD
* Concurrent psychotherapy
* Currently receiving psychotropic medications

Primary outcomes:
measure: National Institute of Mental Health (NIMH) Trichotillomania Severity Scale
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for the Treatment and Study of Anxiety
state: Pennsylvania
Study officials:
References:
citation: Franklin ME, Edson AL, Ledley DA, Cahill SP. Behavior therapy for pediatric trichotillomania: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2011 Aug;50(8):763-71. doi: 10.1016/j.jaac.2011.05.009. Epub 2011 Jul 1.
citation: Franklin ME, Edson AL, Freeman JB. Behavior therapy for pediatric trichotillomania: Exploring the effects of age on treatment outcome. Child Adolesc Psychiatry Ment Health. 2010 Jun 28;4:18. doi: 10.1186/1753-2000-4-18.
Clinical trial NCT02903563: Knowledge Attitudes Beliefs and Practices Relative to HIV Among Sex Workers in French Guiana
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 256
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: sex workers

Brief summary: The aim was to determine the knowledge attitudes, beliefs, and practices regarding HIV in a population of sex workers in French Guiana and in the Brazilian border town of Oiapoque. A standardized questionnaire was administered face to face to sex workers. Analysis of the questionnaires led to descriptive statistics. Multiple logistic regression models were computed to determine the predictors of condom use.


Eligibility criteria: Inclusion Criteria:

* sex worker

Exclusion Criteria:

* not wishing to participate

Primary outcomes:
measure: knowledge attitudes practices regarding HIV and sexually transmitted diseases
timeFrame: when the interview was conducted
Secondary outcomes:
Other outcomes:
Locations:
city: Cayenne
country: France
facility: Centre Hospitalier de Cayenne
state: French Guiana
Study officials:
References: