louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00463164: Functional MRI of Cognitive Control in Autism
Official title: Functional MRI of Cognitive Control in Autism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism
Keywords: functional MRI
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2007-04-20
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: This study aims to investigate the role of fronto-striatal circuits and cognitive control in the perseverative and inflexible behavior that is a defining feature of autism. We hypothesize that deficits in the development of fronto-striatal circuitry may underlie cognitive inflexibility in autism. Specifically, we hypothesize that repetitive, inflexible behavior arises as (1) fronto-striatal systems are capable of learning patterns present in the environment (as in implicit learning paradigms), but are unable to adapt behavior to changing circumstances, related to either (2) decreased ability of basal ganglia to detect violations of expectancy, (3) decreased ability of prefrontal cortex to respond to detected violations, or (4) decreased connectivity of the circuits. We are conducting three functional Magnetic Resonance Imaging (fMRI) studies to address these hypotheses.


Eligibility criteria: Inclusion Criteria:

* Aged 6 - 12 years at inclusion

Inclusion criteria for subjects with autism

* DSM-IV (APA, 1994) diagnosis of autism, according to ADI-R interview

Inclusion criteria for controls

* No DSM-IV (APA, 1994) diagnosis, according to DISC interview
* No scores in the clinical range on the Child Behavior Checklist (CBCL) and Teacher Rating Form (TRF)
* IQ \> 70

Exclusion Criteria:

* Major illness of the cardiovascular, the endocrine, the pulmonal or the gastrointestinal system
* Presence of metal objects in or around the body (pacemaker, dental braces)
* History of or present neurological disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Dept. of Child and Adolescent Psychiatry, UMC Utrecht
Study officials:
affiliation: Rudolf Magnus Institute of Neuroscience, University Medical Center Utrecht
name: Sarah Durston, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rudolf Magnust Institute of Neuroscience, UMC Utrecht
name: Herman van Engeland, M.D. Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03666364: Magnetic Nanoparticle Sperm Separation for Teratozoospermia Male and Women Older Than 35 Years
Official title: Magnetic Nanoparticle Sperm Separation for ICSI Cycles With Teratozoospermia and Over 35 Years Old Women Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Banon IVF Center Assiut, Egypt
First posted: 2018-09-11
Enrollment: 1400
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Women over 35 years old are likely to suffer from impaired oocyte repair capacity. Teratozoospermia is a condition reflects morphological affection of sperm. These spermatozoa would add an extra burden on the oocyte after ICSI. Whether selecting mature sperm by magnetic nanoparticle protocol would provide a more competent sperm to a likely affected oocyte would improve ICSI outcomes is the question of this research.


Eligibility criteria: Inclusion Criteria:

* women indicated for ICSI but with teratozoospermia

Exclusion Criteria:

* Women not failing in this group

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: Twelve weeks of gestation
Secondary outcomes:
measure: Embryo development after ICSI
timeFrame: Six days of culture
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Banon Assiut
city: Qena
country: Egypt
facility: Qena Fertility Center
city: Sohag
country: Egypt
facility: IbnSina IVF Center
Study officials:
References:
Clinical trial NCT02267564: MPFL Reconstruction With or Without Tibial Tubercle Transfer
Official title: Medial Patellofemoral Ligament (MPFL) Reconstruction With or Without Tibial Tubercle Transfer for Recurrent Patellar Instability
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patellar Dislocation
Keywords: patellar dislocation
medial patellofemoral ligament
tibial tubercle transfer
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 70
Sex: ALL
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the clinical outcome of Medial PatelloFemoral Ligament (MPFL) reconstruction with and without tibial tubercle transfer for recurrent patellar dislocation.

Detailed description: 70 patients with recurrent patellar instability were randomly assigned to undergo MPFL reconstruction with or without tibial tubercle transfer. Follow-ups were performed at 12 and 24 months postoperatively, and computed tomography (CT) was performed immediately after the operation and at follow-up. The knee function was evaluated preoperatively and at 2 years postoperatively using Lysholm,Tegner and Kujala scales. Redislocation or multiple episodes of patellar instability were considered failures.

Eligibility criteria: Inclusion Criteria:

* recurrent patellar dislocation or instability,patients with TT-TG value equal to or greater than 20 mm,patients with closed epiphyseal plate

TT-TG：Two lines drawn perpendicular to posterior bicondylar line, one line through middle of the trochlear groove(TG) and the second through tibial tuberosity (TT). Distance between the lines is measured.

Exclusion Criteria:

* bilateral patellar dislocation, a previous surgery in the involved leg,patients with open epiphyseal plate,patients with severe trochlear dysplasia

Primary outcomes:
measure: Lysholm score of the knee
timeFrame: two years
measure: Tegner score of the knee
timeFrame: two years
measure: Kujala score of the knee
timeFrame: two years
Secondary outcomes:
measure: CT images of the knee
timeFrame: two years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Jia-Kuo Yu, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT01184664: Combination of Nicotine Replacement Therapy (NRT) and Varenicline to Increase Cessation of Tobacco (CONVICT Study)
Official title: Effects of a Combination of Varenicline and Transdermal Nicotine Patch on Post-quitting Urges to Smoke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tobacco Dependence
Smoking Cessation
Keywords: Smoking cessation
Tobacco dependence
Varenicline
Nicotine Replacement Therapy
Combination therapy
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2010-08-19
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Varenicline and nicotine replacement therapy (NRT) are both effective smoking cessation treatments. Anecdotally smokers who are finding their quit attempt difficult have reported benefiting from adding NRT to varenicline. This proof-of-principle placebo-controlled double-blind study will examine whether combining NRT and varenicline provides better withdrawal and craving relief than varenicline alone. A total of 120 smokers would be randomised to receive varenicline +15mg/16hr patch or varenicline + placebo patch. All participants will receive standard NHS Stop Smoking Service support. The primary outcome would be ratings of craving and withdrawal discomfort 24 hours and one week after the target quit date.


Eligibility criteria: Inclusion Criteria:

* Smokers seeking treatment
* Aged 18 and over
* Consenting to take part in the trial

Exclusion Criteria:

* Pregnant or breastfeeding
* End-stage renal disease
* Unable to fill in questionnaires in English
* Previous allergy to Varenicline
* Previous allergy to Nicotine Patches Previous allergy to varenicline

Primary outcomes:
measure: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale
timeFrame: 1 week
Secondary outcomes:
measure: Validated abstinence rates over weeks 1-12 post target quit date
timeFrame: 12 weeks post target quit date
measure: Rating of withdrawal symptoms up to 4-weeks post quitting assessed by Mood and Physical Symptoms Scale
timeFrame: 4-weeks post quitting
measure: Profile of all adverse effects reported up to 12-weeks post quitting
timeFrame: Up to 12-weeks post quitting
measure: Ratings of urges to smoke 24 hours after the target quit date
timeFrame: 24 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Tobacco Dependence Research and Treatment Unit
city: London
country: United Kingdom
facility: Tobacco Dependence Research Unit
Study officials:
affiliation: Queen Mary University of London
name: Al-Rehan A A Dhanji, MB BS BSc MRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hajek P, Smith KM, Dhanji AR, McRobbie H. Is a combination of varenicline and nicotine patch more effective in helping smokers quit than varenicline alone? A randomised controlled trial. BMC Med. 2013 May 29;11:140. doi: 10.1186/1741-7015-11-140.
Clinical trial NCT06099964: Brief Mindfulness Intervention for Orthopedic Patients
Official title: Brief Mindfulness Intervention for a Heterogenous Mix of Orthopedic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded mindfulness intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.


Eligibility criteria: Inclusion Criteria:

* Age ≥18
* Seeking foot or ankle treatment at the Tallahassee Orthopedic Center

Exclusion Criteria:

* • Cognitive impairment preventing completion of study procedures.

  * Current cancer diagnosis,
  * Other unstable illness judged by medical staff to interfere with study involvement.

Primary outcomes:
measure: Change in Pain Unpleasantness Numeric Rating Scale
timeFrame: Immediately before to after 4-minute audio recording
Secondary outcomes:
measure: Change in Pain Intensity Numeric Rating Scale
timeFrame: Immediately before to after 4-minute audio recording
measure: Change in Anxiety Numeric Rating Scale
timeFrame: Immediately before to after 4-minute audio recording
measure: Change in Depression Numeric Rating Scale
timeFrame: Immediately before to after 4-minute audio recording]
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Tallahassee Orthopedic Clinic (TOC)
state: Florida
Study officials:
References:
Clinical trial NCT00298064: Assessment of EGFR Genomic Alterations as Prognostic Markers in Cervical Cancer
Official title: Assessment of EGFR Genomic Alterations as Prognostic Markers in Cervical Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cervical Cancer
Cervix
Keywords: Cervical cancer
EGFR
cervical
genomic
DNA
markers
prognostic
gene
epidermal growth factor
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2006-03-01
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The Tissue Repository will search for cases, pull slides, Paraffin-embedded tissue (PET) blocks.

Detailed description: This study is done to gather preliminary data for determining the best way to test EGFR expression in patients with cervical cancer who will receive treatment with EGFR inhibitors in the future.

This study is designed to obtain preliminary data of genomic and phenotypic alterations of the EGFR pathway in high grade cervical intraepithelial lesions (HG-SIL) and invasive cervical cancers (CC) to be used later for therapeutic guidance and to evaluate genomic (over-expression, amplification, point mutations, etc.) and phenotypic alterations of other transduction pathways interacting with the EGFR pathway.

Eligibility criteria: Inclusion Criteria:

* Samples from patients diagnosed with HG-SIL (n=300) and CC (n=300) with a follow-up of at least 24 months, existing at the Department of Pathology will be retrieved by the Tissue Repository, de-identified them and provided with code numbers that will not be linked to patient's data.

Exclusion Criteria:

* None Specified.

Primary outcomes:
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: Claire Verschraegen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02272764: A Drug-Drug Interaction Study of ALKS 5461 in Healthy Volunteers
Official title: A Phase 1 Study of the Effects of Itraconazole on the Pharmacokinetics of ALKS 5461 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the impact of Itraconazole on the pharmacokinetics of ALKS 5461.


Eligibility criteria: Inclusion Criteria:

* Has a body mass index (BMI) of 18.0 - 30.0 kg/m2
* Is in good physical health
* Agrees to use an approved method of contraception for the duration of the study
* Additional criteria may apply

Exclusion Criteria:

* Has current evidence, or history of any clinically significant medical or psychiatric condition or observed abnormality
* Is currently pregnant or breastfeeding
* Has a history of or current infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV)
* Has a lifetime history of opioid abuse or dependence
* Has current abuse or dependence on alcohol or any drugs
* Has used nicotine within 90 days prior to randomization
* Additional criteria may apply

Primary outcomes:
measure: Drug-Drug Interaction - AUC0-t
timeFrame: Up to 48 hours
measure: Drug-Drug Interaction - AUC0-inf
timeFrame: Up to 48 hours
measure: Drug-Drug Interaction - Cmax
timeFrame: Up to 48 hours
Secondary outcomes:
measure: Safety and tolerability will be measured by incidence of adverse events
timeFrame: Up to 32 Days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Alkermes Investigational Site
state: Kansas
Study officials:
affiliation: Alkermes, Inc.
name: Sanjeev Pathak, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06215664: Game-Based Intervention to Reduce Alcohol-Related Harms Among Sexual and Gender Minority Youth
Official title: A Randomized Controlled Trial of a Game-Based Intervention to Reduce Alcohol-Related Harms Among Sexual and Gender Minority Youth
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alcohol Problem
Harm Reduction
Alcohol-Related Harm
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-01-22
Enrollment: 1992
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-armed parallel randomized controlled trial
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled trial to examine the efficacy of a game-based intervention to reduce alcohol-related harms among sexual and gender minority youth.


Eligibility criteria: Inclusion Criteria:

* Able to participate in English
* Live in the U.S.,
* 14-18 years old
* Have a sexual minority identity (i.e., gay, lesbian, bisexual, or queer) or a gender minority identity (i.e., consider themselves to be transgender or nonbinary),
* Have an internet-accessible computer, smart phone, or tablet,
* Provide an email address.
* Have drank alcohol in their lifetime or intend to in the next year.

Exclusion Criteria:

* Cisgender heterosexuals.

Primary outcomes:
measure: Alcohol-related harms
timeFrame: 3 months
Secondary outcomes:
measure: Drinking Quantity
timeFrame: 3 months
measure: Drinking Frequency
timeFrame: 3 months
measure: Binge Drinking
timeFrame: 3 months
measure: Alcohol Use Initiation
timeFrame: 3 months
measure: Alcohol Harm Reduction Skills
timeFrame: 3 months
measure: Bystander Alcohol Harm Reduction Skills
timeFrame: 3 months
measure: Emotional distress tolerance skills
timeFrame: 3 months
measure: Emotion regulation and decentering practices
timeFrame: 3 months
measure: Healthy social media use
timeFrame: 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Robert WS Coulter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05654064: Comparing Fetoscopic Surgery Protocols
Official title: Comparison of Remifentanil-dexmedetomidine and Dexmedetomidine-fentanyl Sedation Protocols for Pregnant Patients Undergoing Minimally Invasive Fetoscopic Procedures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Minimally Invasive Fetoscopic Procedures
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Determine surgeon and patient satisfaction with remifentanil-dexmedetomidine (REMI) and dexmedetomidine-fentanyl (DEX) sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures


Eligibility criteria: Inclusion Criteria:

Pregnant patients undergoing one of the following procedures

* Laser photocoagulation of abnormal anastomotic vessels in patients with a twin-twin transfusion syndrome
* Selective radiofrequency ablation or fetoscopic cord coagulation in patients with TRAP sequence or in the presence of intrauterine death of one twin
* Vesicoamniotic shunts or placement of amnioports in patients with LUTO
* Placement of amnioports in patients with oligohydramnios or anhydramnios
* Fetal thoracentesis or placement of thoracoamniotic shunts in patients with congenital pulmonary airway malformation or fetal hydrothorax
* FETO (fetoscopic endotracheal occlusion) as well as balloon removal in patients with congenital diaphragmatic hernia and laser release of amniotic bands

Exclusion Criteria:

Pregnant patients undergoing fetoscopic procedures requiring the following

* Additional procedures (e.g. cerclage)
* Laparotomy with uterine exteriorization to access the uterine cavity
* General anesthesia
* Mid-gestation neural tube defect repair
* EXIT procedures
* Preoperative opioid use
* Diagnosed substance abuse
* Moderate to severe obstructive sleep apnea
* History of allergic reactions to medications to be administered during the study

Primary outcomes:
measure: Determine surgeon satisfaction with remifentanil-dexmedetomidine sedation
timeFrame: Immediately after procedure completion
measure: Determine surgeon satisfaction with dexmedetomidine-fentanyl sedation
timeFrame: Immediately after procedure completion
measure: Determine patient satisfaction with remifentanil-dexmedetomidine sedation
timeFrame: 6 hours after procedure completion
measure: Determine patient satisfaction with dexmedetomidine-fentanyl sedation
timeFrame: 6 hours after procedure completion
Secondary outcomes:
measure: Sedation scores
timeFrame: Every 15 minutes from start of procedure to one hour post-operative
measure: Side-effect measures
timeFrame: Up 24 hours after procedure
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Mario Patino, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01083264: Relative Bioavailability, Transdermally Administered EE and GSD, 3 Applications Sites
Official title: Open-label, Randomized, Crossover Study to Investigate the Relative Bioavailability of Transdermally Administered Ethinylestradiol (EE) and Gestodene (GSD) After Repeated Applications of a Fertility Control Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene to 3 Different Application Sites (Buttocks, Arm Versus Abdomen) in Healthy Young Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Contraception
Keywords: Pharmacokinetics
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-03-09
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Influence of different application sites on the blood levels after administration of a fertility control patch


Eligibility criteria: Inclusion Criteria:

* Healthy female subjects
* Age 18-45 years
* Body mass index (BMI) 18-30kg/m²
* At least 3 months since delivery, abortion, or lactation before the first screening examination
* Ability to understand and follow study-related instructions
* Willingness to accept the synchronizing cycle and to use non-hormonal methods of contraception after starting the synchronizing cycle and during the treatment periods

Exclusion Criteria:

* Contra-indications for use of combined (estrogen/progestin) contraceptives (e.g. history of venous/arterial disease, liver disorders, migraine)
* Skin diseases with suspected alteration of dermal resorption and /or increased risk for dermal intolerance
* Regular use of medicines other than contraceptives
* Smokers (at the age of 31 to 45 years)
* Clinically relevant findings (e.g. blood pressure, physical and gynecological examination, laboratory examination)

Primary outcomes:
measure: AUC(0-168) for EE and Gestodene during week 4 of each treatment period
timeFrame: Week 4 of each treatment period ( 3 periods)
Secondary outcomes:
measure: Pharmacokinetic parameters of EE and GSD: Cmax, Cmin, Cav, tmax, t1/2 obtained during week 4, Ctrough obtained at the end of each week
timeFrame: Week 1-5 of each treatment period
measure: Adverse Events
timeFrame: Week 1-5 of each treatment period
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: