louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02295345: Open Pilot of Cognitive Behavioural Therapy for Insomnia in Pregnancy
Official title: Open Pilot of Cognitive Behavioural Therapy for Insomnia in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: University of Alberta
First posted: 2014-11-20
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Despite the literature showing cognitive behavioural therapy for insomnia (CBT-I) to be effective in a variety of populations including postpartum women, as well as the demonstrated harmful consequences of sleep disturbances in late pregnancy, no trials have investigated its efficacy during pregnancy. This project will investigate the efficacy and acceptability of cognitive behavioral therapy for insomnia (CBT-I) in pregnancy.

Detailed description: Study details are included in the publication listed here: https://www.ncbi.nlm.nih.gov/pubmed/27124405

Eligibility criteria: Inclusion Criteria:

* English speaking women
* Over the age of 18
* Between twelve and twenty-eight weeks of gestation
* Identify as experiencing sleep disturbances will be recruited.

Exclusion Criteria:

* Women who identify as experiencing symptoms of sleep disorders other than insomnia (i.e. restless legs syndrome, obstructive sleep apnea)
* Women who are experiencing a current major depressive episode, or have been diagnosed with bipolar disorder or other disorders that have a psychotic, dissociative, hallucinatory, or delusional component
* Currently taking prescribed medications for sleep problems
* Inability to attend at least 4 out of the 5 weekly therapy sessions, participate in the assessments
* Smoking, drinking alcohol or drug use during pregnancy.

Primary outcomes:
measure: Change in Actigraphy indices from baseline to post-treatment
timeFrame: Baseline (Week 1), Post-treatment (Week 7)
measure: Change in Sleep Diary variables from baseline to post-treatment
timeFrame: Baseline (Week 1), Treatment (Weeks 2-6), Post-treatment (Week 7)
measure: Change in Insomnia Severity Index (ISI) scores from baseline to post-treatment
timeFrame: Baseline (Week 1), Post-treatment (Week 7)
measure: Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to post-treatment
timeFrame: Baseline (Week 1), Post-treatment (Week 7)
Secondary outcomes:
measure: Change in Edinburgh Postpartum Depression Scale (EPDS) scores from baseline to post-treatment
timeFrame: Baseline (Week 1), Post-treatment (Week 7)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University Of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Lianne Tomfohr-Madsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00440245: Bronchoprotection of Salbutamol in Asthma and Chronic Obstructive Pulmonary Disease
Official title: Bronchoprotection of Salbutamol in Asthma and COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
COPD
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2007-02-26
Enrollment: 28
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: This study will investigate potential differences in how two puffs of salbutamol protects airway smooth muscle from contracting in people with asthma and chronic obstructive pulmonary disease (COPD).

Detailed description: In asthma, the administration (inhalation) of a selective β2 receptor agonist (e.g. salbutamol), prior to methacholine challenge has been shown to shift the dose response curve to the right and "bronchoprotect" the airway against airway smooth muscle contraction. The extent of β2 receptor agonist bronchoprotection in COPD is unknown.

Airway hyperresponsiveness (AHR) to direct acting agents such as histamine and methacholine is a feature of both asthma and COPD. In asthma, the abnormality leading to AHR is believed to be due to changes in airway smooth muscle (e.g. hypertrophy, hyperplasia, contractile apparatus) whereas in COPD the AHR is likely due to structural or geometric changes.

The investigators hypothesize that the bronchoprotection afforded by salbutamol against methacholine challenge will be greater in asthma than in COPD due to differences in underlying airway abnormalities.

Eligibility criteria: Inclusion Criteria:

* asthma or COPD

Exclusion Criteria:

* asthma and COPD

Primary outcomes:
measure: methacholine PC20 dose shift
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Donald Cockcroft, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02960945: Open-Label Crossover Study Comparing CTP-543 to Jakafi®
Official title: An Open-Label Single-Dose Crossover Pharmacokinetic Study to Compare CTP-543 to Jakafi® in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-11-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess the metabolite and pharmacokinetic (PK) profile of a single dose of CTP-543 compared to a single dose of Jakafi® in healthy volunteers.

Detailed description: The crossover design will assess the safety, tolerability, PK and metabolite profiles of a single dose of CTP-543 compared to a single dose of Jakafi. Approximately 12 healthy volunteers will be enrolled in this open label study.

Eligibility criteria: Inclusion Criteria:

* Healthy adult males and females between 18 and 50 years of age, inclusive
* Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive

Exclusion Criteria:

* History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions
* PR interval \> 220 msec or QRS duration \> 120 msec or QTcF interval \> 450 msec obtained at screening visit or prior to the first dose of study drug
* History of herpes zoster
* Hemoglobin, white blood cell, or platelet levels below the lower reference limit at screening or prior to the first dose of study drug
* Liver function tests greater than the upper limit of normal
* Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody
* Urinalysis positive for protein or glucose
* A positive screen for alcohol, drugs of abuse, or tobacco use
* Donation of blood, plasma or other blood products prior to screening
* A positive tuberculosis test

Primary outcomes:
measure: Measurement of CTP-543 metabolites and exposure in plasma under fasted conditions
timeFrame: 24 hours
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 24 hours
measure: Measurement of CTP-543 metabolites and exposure in urine under fasted conditions
timeFrame: 24 hours
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
Study officials:
References:
Clinical trial NCT02416505: The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
First posted: 2015-04-15
Enrollment: 67
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 study is a Non-funded, Single Center, Multi-Arm, Parallel Group Randomize Control Trial.

In this study, the investigators aim to evaluate the impact of a visual aid on patient comprehension an orthopedic informed consent discussion in low socioeconomic populations.

The primary outcome is patient comprehension measured by a Validated Knowledge-Based Multiple Choice Questionnaire.

The secondary outcomes include: Patient satisfaction and Time efficiency.

The investigators hypothesize that using an Anatomic Model Visual Aid during an orthopedic informed consent discussion will improve patient comprehension, satisfaction and time-efficiency of orthopedic care.


Eligibility criteria: Inclusion Criteria:

* Patients newly diagnosed with Knee Osteoarthritis managed with steroid injections
* Patients who express lack of knowledge regarding knee osteoarthritis (causes, diagnosis, treatment, anatomy)
* English speaking
* Patients that meet the Federal Poverty Guideline for Healthcare (i.e. Medicaid)

Exclusion Criteria:

* Patients under the age of 18
* College graduates
* Non-English speaking
* Patient without the capacity to give consent
* Patients with a tactile, mental, visual or auditory disability

Primary outcomes:
measure: The Nkem Test
timeFrame: 20 minutes
Secondary outcomes:
measure: Patient Satisfaction Survey
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
affiliation: UMKC Department of Orthopaedic Surgery
name: Mark Bernhardt, MD
role: STUDY_CHAIR
affiliation: UMKC Department of Orthopaedic Surgery
name: Johnathan Dubin, MD
role: STUDY_DIRECTOR
affiliation: UMKC Dept of Bioinformatics
name: Karen Williams, PhD
role: STUDY_DIRECTOR
affiliation: UMKC Dept of Orthopaedic Surgery
name: Nkem Egekeze, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00774605: A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Solution And A Varenicline Patch Applied To The Skin
Official title: A Phase 1, Open-Label, Nonrandomized, Single Dose Study To Characterize The Pharmacokinetics Of A Varenicline (CP-526,555) Transdermal Solution And A Varenicline Transdermal Delivery System Applied To The Skin Of Adult Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking Cessation
Keywords: percutaneous, transcutaneous, topical, varenicline, transdermal, transdermal delivery system, patch
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-10-17
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: To evaluate the absorption, safety, and tolerability of a varenicline solution and a varenicline patch applied to the skin.

Detailed description: Additional Study Purpose Details: Evaluation of the pharmacokinetic profile of a varenicline solution and a varenicline patch applied to the skin

Eligibility criteria: Inclusion Criteria:

* healthy, adult, male smokers

Exclusion Criteria:

* significant medical illness

Primary outcomes:
measure: Varenicline area under the curve from 0 to the last quantifiable concentration (AUClast) and varenicline area under the curve from 0 to infinity (AUCinf)
timeFrame: 8 days
Secondary outcomes:
measure: Evaluation of adverse events (including skin irritation)
timeFrame: 8 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04856605: Umblical Pilonidal Sinus Evaluation
Official title: The Factors Associated With Occurrence and Healing Of Umbilical Pilonidal Sinus Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pilonidal Sinus
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 82
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who have umblical pilonidal disease

Brief summary: Purpose: Pilonidal sinus disease (PSD) is a chronic inflammatory condition of skin due to implanted loose hair. PSD is commonly seen in sacrococcygeal region, but can also be seen in axilla, perineum, suprapubic regions, on hands and umbilicus. The aim of this project was to find factors influencing the development and treatment of umbilical pilonidal sinus.

Material and methods: In this cross-sectional prospective study, the investigators evaulated 82 (19 female, 63 male) patients with a history of umbilical pilonidal disease (e.g. predisposing factors, treatment modalities) between 2012 and 2020.

Detailed description: In this study, participants were volunteer patients admitted to Erzincan University Medical Faculty to the General Surgery Outpatient Clinic between March of 2012 and December of 2020 with umbilical symptoms such as umbilical discharge and umbilical pain. All patients were diagnosed by physical examination confirmed with ultrasonography . Patients with diseases other than umbilical sinus were excluded from the study. Examined patients' characteristics include age, gender, intergluteal sinus disease history, family history, belly shaving histoy, daily shower, treatment modality and healing status. There were 3 treatment modalities: conservative approach (daily shower, shaving, antibitics if infected); topical silver nitrate treatment; surgical operation for umbilical sinus as excracting the hairs from the sinus ± excising the sinus. To determine if "healed" the investigators followed up our patients ensuring no symptoms for a minimum 2 years.

Chi-square tests were conducted to compare the distribution of categorical variables. Age was analyzed as a continuous variable with a t-test. Univariable and multivariable logistic regression models were used to calculate odds ratios and 95% confidence intervals. P-values of less than 0.05 were considered statistically significant. Statistical analyses were conducted with R version of 3.6.1 (R Foundation for Statistical Computing, Vienna, Austria, https://www.r-project.org) software packages.

Eligibility criteria: Inclusion Criteria:

* all patients with umblical pilonidal sinus

Exclusion Criteria:

* no disease

Primary outcomes:
measure: healing status
timeFrame: 2 year
Secondary outcomes:
measure: recurrence status
timeFrame: 2 year
Other outcomes:
measure: duration of wound healing
timeFrame: 2 year
Locations:
Study officials:
affiliation: MEDENIYET UNIVERSITY
name: ARDA ISIK
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06793605: Community Burden of MG Infection
Official title: Community Burden of Mycoplasma Genitalium Infection and Its Implications for Test-and-treat Strategies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sexually Transmitted Infection (STI)
Mycoplasma Genitalium Infection
Keywords: Mycoplasma genitalium
Chlamydia trachomatis
Neisseria gonorrhoeae
men who have sex with men
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 920
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: men who have sex with men in Hong Kong

Brief summary: Objective: To assess the burden and the transmission dynamics of Mycoplasma genitalium (MG) infection in men who have sex with men in Hong Kong.

Design and setting: involving a) a cross-sectional study (completion of an online self-administered survey, followed by self-sampling for testing in the laboratory, and performance of HIV self-test); b) a mathematical modelling study to simulate the transmission dynamics of MG infection and resistant MG infection and compare the impacts of test-and-treat strategies.

Participants: Around 920 men who have sex with men would be recruited

Detailed description: Cross-sectional study: A total of 920 men who have sex with men aged 18 or above and normally living in Hong Kong would be recruited. Eligible participants would be asked to complete a self-administered online survey, submit self-collected urine specimen and rectal swabs for Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium testing in the laboratory, and submit HIV self-test results.

Mathematical modelling study: A compartmental model would be constructed to simulate the transmission dynamics of MG infection and resistant MG infection, and analyse the impact of different test-and-treat strategies.

Eligibility criteria: Inclusion Criteria:

* men who have sex with men aged 18 or above, normally living in Hong Kong, and could communicate in written and spoken English or Chinese

Exclusion Criteria:

* cannot provide consent

Primary outcomes:
measure: prevalence of MG infection
timeFrame: 1 year
measure: prevalence of MG resistance mutations
timeFrame: 1 year
Secondary outcomes:
measure: prevalence of CT infection
timeFrame: 1 year
measure: prevalence of NG infection
timeFrame: 1 year
measure: co-infection of STIs
timeFrame: 1 year
measure: history of STI and HIV testing
timeFrame: ever
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References:
Clinical trial NCT02551705: Functional Imaging of Social Cognition in Premanifest Huntington's Disease
Official title: Functional Imaging of Social Cognition in Premanifest Huntington's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Huntington's Disease
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Huntington's disease (HD) is a genetic progressive fatal neurodegenerative disorder. In the western world it affects 5-10 persons per 100000. The main brain changes include the loss of brain cells in subcortical structures. The symptoms of HD include involuntary movements, cognitive deterioration and behavioural disturbances. It has been shown that changes in emotion comprehension occur before the onset of the motor symptoms (preHD). This deficit in perception of emotions has been primarily investigated by means of facial expressions. However, emotions can also be expressed through body language. Here, the investigators propose to investigate whether the emotion comprehension deficit in preHD also includes body language comprehension.

Detailed description: The investigators will perform a detailed evaluation of body language comprehension abilities in persons that carry the genetic mutation causing HD, but who do not show any movement symptoms yet. In addition, the associated changes in brain structure and function will be studied. The aim is to perform the study with the same group of participants who participated in a recent study carried on by this research group, in which the functional brain changes associated with increased irritability were investigated. This will allow to relate emotion experience with emotion perception. The results of the study may provide a target to further develop therapeutic interventions and aid caregivers of preHD subjects.

Eligibility criteria: Inclusion Criteria:

* Huntington's disease positive genotype and non-carrier siblings

Exclusion Criteria:

* visible chorea
* MRI contra-indications
* major neurological/psychiatric comorbidity

Primary outcomes:
measure: Significant group differences in brain activation for perceiving emotional vs neutral faces by following random effects analyses
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05803005: Evaluation of Some Inflammatory Markers in Autism Spectrum Disorders
Official title: Evaluation of Some Inflammatory Markers in Autism Spectrum Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism Spectrum Disorder
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: : 50 patients aged 3_18 years, equally sex distributed, who visit pediatric neurology outpatients clinic with autistic disorder at assiut university hospital will enrolled in this study and 50 controls . (According to DSM IV and ADT-R)

Brief summary: Evaluate some Inflammatory markers \[IL-6, IL-8, TNF_alpha\] in children with autism spectrum disorder

Detailed description: several studies have suggested a correlation between ASD and abnormal immune activation (9) For instance, there is a high incidence of autistic subjects in families with other autoimmune disorders such as celiac disease and rheumatoid arthritis, suggesting a potential role for immune dysfunction in the pathophysiology of ASD High levels of IL-6 in the brain could determine alterations of synapse formation, dendritic spine development, and neuronal circuit balance \[13\], while in plasma they have been associated with increased stereotypical behaviors and with regressive forms of ASD

Eligibility criteria: Inclusion Criteria:

* 50 patients aged 3_18 years, equally sex distributed, who visit pediatric neurology outpatients clinic with autistic disorder at assiut university hospital will enrolled in this study and 50 controls . (According to DSM IV and ADT-R)

Exclusion Criteria:

* : Asperger syndrome, pervasive developmental disorder not otherwise specified (PDD-NOS), chronic seizures and recent infection and patients with congenital anomalies

Primary outcomes:
measure: inflammatory marker in autism
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: assiut universtiy
name: gehan kamal, prof.
role: STUDY_DIRECTOR
References: