louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06337383: Study of the Prevalence of Autistic Traits in Angelman Syndrome
Official title: Study of the Prevalence of Autistic Traits in Angelman Syndrome, the Correlation With Cognitive Level, Epilepsy, With Socio-communication Skills and Parenting Styles
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Angelman Syndrome
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 46
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are recruited at I.R.C.C.S. "E. Medea", in Conegliano (Italian referral centre for Anelman Syndrome) in collaboration with Or.S.A (the Italian organisation for the syndrome).

Brief summary: The goal of this observational cross-sectional study is to establish the prevalence of autism spectrum disorder in children and adolescents with Angelman syndrome. The main questions it aims to answer are:

* which clinical variables differentiate AS patients with and without Autism Spectrum Disorder between genetics, epilepsy, pharmacotherapy, behavioural problems, parenting style and parents' perceived stress.
* which clinical variables differentiate parenting styles and levels of perceived stress.

Data from neuropsychological, speech therapy and physiotherapeutic assessments are collected during regular clinical follow-ups, regarding: cognitive development ("Bayely Scales of Infant Development-III", Cognitive Scale) and adaptive behaviour; Autism and Autism Spectrum Disorder ("Autism Diagnostic Observational Schedule-2"); parental stress and parenting styles; social-communicative skills; motor development.


Eligibility criteria: Inclusion Criteria:

* genetically confirmed diagnosis of Angelman Syndrome
* chronological age between 4-15 years

Exclusion Criteria:

* genetic examination pending report
* mental age lower than 12 months
* brain injury acquired in the peri- or postnatal period

Primary outcomes:
measure: Total score of the Autism Diagnostic Observation Schedule -2 (ADOS-2), Module 1,
timeFrame: Once at recruitment
Secondary outcomes:
measure: Age-equivalent score at the Cognitive Scale of the Bayley Scales of Infant Development - 3rd version (Bayley-III)
timeFrame: Once at recruitment
measure: Total Stress score at the Parent Stress Index - 4th edition (PSI-4) questionnaire
timeFrame: Once at recruitment
measure: Global score at the Aberrant Behaviour Checklist (ABC)
timeFrame: Once at recruitment
measure: Total Raw score at the Social Communication Questionnaire - Current version(SCQ)
timeFrame: Once at recruitment
Other outcomes:
Locations:
city: Conegliano
country: Italy
facility: I.R.C.C.S. "E.Medea"
state: Treviso
Study officials:
affiliation: Scientific Institute IRCCS E. Medea, Epilepsy Unit, Conegliano 31015, Italy
name: Martina Baggio
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03486483: Spastic Cerebral Palsy and Slackline
Official title: The Slackline as a Rehabilitation Tool for Children and Teenagers With Spastic Cerebral Palsy: a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Cerebral Palsy
Lead sponsor: University of Oviedo
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 27
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to assess whether supervised slackline training improves postural control in children and teenagers with spastic cerebral palsy (grade I and II of the Gross Motor Function Classification System).


Eligibility criteria: Inclusion Criteria:

* Diagnosis with any expression of spastic cerebral palsy and rated I-II on the Gross Motor Functional classification.
* Between 9 and 16 years of age.
* Ability to cooperate with simple instructions.
* Able to stand for at least 2 min without assistance.
* Able to walk at least 10 m without assistance.

Exclusion Criteria:

* Individuals were excluded if they underwent neuro or orto surgery during or up to one year prior to the study, botulinum toxin injection or intrathecal pump during or up to six months prior to the study and/or rotational osteotomies, if they expressed gait deviations limited by musculoskeletal contracture, presented specific medical or orthopedic conditions that precluded exercising
* or if they did not meet the eligibility criteria.

Primary outcomes:
measure: Static posturography (a composite measure).
timeFrame: 6 weeks.
Secondary outcomes:
measure: Myoelectrical activity.
timeFrame: 6 weeks.
measure: Jump Performance
timeFrame: 6 weeks.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00990483: A Comparison of the 15 and 30 Acquisition Angle Breast Tomosynthesis Mammography for Breast Abnormalities
Official title: A Comparison of 15 and 30 Acquisition Angle Breast Tomosynthesis Mammography in the Visualization and Characterization of Breast Abnormalities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Tomosynthesis
3D Mammogram
Diagnostic mammogram
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-06
Enrollment: 110
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to conduct an initial investigation into whether an alternative method of using 3D imaging might offer accurate diagnostic performance at a reduced patient radiation exposure in comparison to conventional 2D screening and diagnostic mammography and conventional 2D + 3D imaging methods.


Eligibility criteria: Inclusion Criteria:

* Subject is female of any race and ethnicity
* Subject is at least 40 years old
* The screening and diagnostic mammograms were performed at the recruiting institution on a Hologic Selenia System
* Subject is categorized as BI-RADS 0 because if mass, density, or calcifications detected on the basis of screening or diagnostic mammography
* Subject will undergo study imaging within 30 days of standard of care imaging

Exclusion Criteria:

* Patients who are pregnant or think they may be pregnant
* Patients who are breast feeding
* Subjects unable or unwilling to undergo informed consent
* Subjects with breast implants

Primary outcomes:
measure: If the new imaging modes are successful, they will represent a method of reducing patient exposure for future imaging because they are designed to be used in 3D imaging only.
timeFrame: Fall 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Laurie Farjardo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03457883: Risk Factors for Recurrence After Pelvic Reconstruction
Official title: Risk Factors for Recurrence After Pelvic Reconstruction of Pelvic Organ Prolapse：1 Year Follow-up in Patients Implanted Hernia Mesh and Biological Graft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Pelvic organ prolapse
Vaginal mesh
biological graft
Recurrence
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 232
Sex: FEMALE
Minimum age (years): 52
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 232 women underwent transvaginal mesh repair (TVM)with /without transvaginal hysterectomy for symptomatic POP, including group A（accepted herniamesh polypropylene mesh， 117 patients)；group B （underwent biological graft of cook，115 patients)；follow-ups for six months and one year after the surgery and a questionnaire about the life habits associated with relapse.

Detailed description: We prospectively study a total of 232 women who underwent transvaginal mesh repair (TVM)with /without transvaginal hysterectomy for symptomatic POP, the patients into two groups :group A was accepted herniamesh polypropylene mesh(117)；group B underwent biological graft of cook(115)；Each patient underwent an interview that included a POP-Q which was quantified according to the Pelvic Organ Prolapse Quantitation (POPQ) system;follow-ups for six months and one year after the surgery and a questionnaire about the life habits associated with relapse.

Eligibility criteria: Inclusion Criteria:

242 postmenopausal patients with primary prolapse of the anterior vaginal wall or concomitant uterine prolapse,that was stage Ⅲ or higher (according to the Pelvic Organ Prolapse Quantification \[POP-Q\] system).

Exclusion Criteria:

pelvic floor repair surgery history and recurrent patients ; pelvic cancer and radiation to the pelvic area in the previous 6 months; simple uterine prolapse; combined with severe stress urinary incontinence or overactive bladder (OAB); local or systemic conditions that would preclude surgery or affect healing such as restricted leg motion (inability to conform to the lithotomy position) ; vaginal bleeding; infection; coagulation disorders; uncontrolled hypertension and diabetes mellitus;

Primary outcomes:
measure: recurrence
timeFrame: at 12 months after surgery
Secondary outcomes:
measure: perioperative complications
timeFrame: 12 months after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01640483: Differential Efficacy of Supportive and Interpretative Psychodynamic Techniques for Dependent and Self-critical Depressive Patients
Official title: Differential Efficacy of Supportive and Interpretative Psychodynamic Techniques for Dependent and Self-critical Depressive Patients: an Experimental Single Case Design.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Funding by BOF (Bijzonder Onderzoeksfonds)
First posted: 2012-07-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Post-hoc analysis of psychotherapy outcome data suggest that psychodynamic techniques for Major Depressive Disorder are differentially efficacious dependent on personality traits of the patient. More specifically, supportive techniques are hypothesized to be more efficacious for dependent patients, interpretative techniques to be more efficacious for self-critical patients, and mixed supportive/interpretative techniques to be more efficacious for mixed dependent/self-critical patients. Moreover, supportive techniques are hypothesized to impact on depressive symptoms through increased relational capacities while interpretative techniques impact through increased self-understanding.

These hypotheses are tested in an experimental single case design with three dependent, three self-critical and three mixed dependent/self-critical depressive patients. These patients go through a time-limited (50 sessions) experimental treatment which exists of a sequence of four A phases (control conditions), one B phase (supportive techniques only), one C phase (interpretative techniques only), and one BC phase (mixed supportive/interpretative techniques).


Eligibility criteria: Inclusion Criteria:

* Patient meets criteria for Major Depressive Disorder (as assessed by SCID-I and DSM-IV-TR)
* Patient is prepared to give informed consent

Exclusion Criteria:

* Patient uses antidepressant medication during the treatment
* Patient scores 3 on the suicide item of the BDI-II
* Patient meets criteria for psychotic or personality disorder (as assessed by SCID-II)

Primary outcomes:
measure: Reduction in depressive symptoms at 25 weeks (50 sessions, 2 sessions/week).
timeFrame: 25 weeks
Secondary outcomes:
measure: improvement in relational capacities
timeFrame: 25 weeks
measure: improvement in insight
timeFrame: 25 weeks
measure: improvement in quality of life, a broad range of physical and psychological symptoms.
timeFrame: 25 weeks
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
affiliation: University Ghent
name: Stijn Vanheule, Prof Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Ghent
name: Gilbert Lemmens, Phd MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03732183: A Podcast Mind-Body Program for Military Caregiver
Official title: A Brief Mind-Body Program to Support Military and Veteran Caregiver Wellness: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Keywords: Stress
Military Caregiver
Caregiver
Online
Podcast
Mind-Body
Wellness
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Elizabeth Dole Foundation
First posted: 2018-11-06
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this pilot study is to test the efficacy, feasibility, and acceptability of a brief, online, mind-body wellness program to reduce stress and promote resilience in military caregivers.

Detailed description: The investigators are piloting a brief, online, mind-body program to reduce stress in military caregivers. Eligible participants are, 1) At least 18 years old 2) Serving as military caregivers and 3) have regular access to a smartphone or computer. The investigators have adapted the SMART-3RP into a brief podcast, which we plan to administer daily. Participants will be administered questionnaires at baseline, mid-program, and post-program to assess for symptoms of stress, anxiety, and depression. Participants will be compensated for completing all measures.

Eligibility criteria: Inclusion Criteria:

* Military Caregivers
* 18 years of age
* Regular Access to smartphone or computer

Exclusion Criteria:

* Non-Military Caregivers
* Under 18 years of age
* No regular access to smartphone or computer

Primary outcomes:
measure: Perceived Stress Scale (PSS-10)
timeFrame: 1 month
Secondary outcomes:
measure: Patient Health Questionnaire-8 (PHQ-8)
timeFrame: 1 month
measure: Generalized Anxeity Disorder-7 (GAD-7)
timeFrame: 1 month
measure: Medical Symptom Checklist (MSCL)
timeFrame: 1 month
measure: PROMIS - Satisfaction with Participation in Social Roles - Short Form (SPSR):
timeFrame: 1 month
measure: PROMIS - Ability to Participate in Social Roles and Activities - Short Form 4A (ASPRA):
timeFrame: 1 month
Other outcomes:
Locations:
city: Boston
country: United States
facility: MassGH
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Eric Bui, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04033783: Impact of Walking Behind the COPD Patient on 6MWD
Official title: The Impact of Walking Behind the Patient on Six-Minute Walk Test Distance in Chronic Obstructive Pulmonary Disease: a Randomized Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Six minute walk test
Field test
Exercise capacity
Functional capacity
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The six-minute walk test (6MWT) is a well established field exercise test to assess the functional exercise capacity in chronic obstructive pulmonary disease (COPD). The objective of this study is to assess the impact of walking behind the patient on 6MWT distance in patients with COPD.

Detailed description: In a single-center, randomized crossover study, the investigators aim to elucidate whether there is a difference in the 6MWT distance when the assessor walks behind the patient compared to the patient walking alone.

Patients with COPD referred for pulmonary rehabilitation will be invited to perform an accompanied 6MWT (assessor walks behind the patient) and unaccompanied 6MWT (assessor does not walk behind the patient) in random order.

The tests will be performed at the end of a pulmonary rehabilitation program, after patients are familiarised with the 6MWT testing procedure and learning effects can be excluded.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of COPD according to GOLD II-IV (FEV1/FVC \< 0.7, FEV1%Norm \< 80%)

Exclusion Criteria:

* Inability to perform a 6MWT when arriving at the clinic (e.g., lower limb joint surgery within preceding 3 months, unstable cardiac disease, predominant neurological limitations)
* Inability to understand the instructions of the 6MWT, either of language or cognitive reasons

Primary outcomes:
measure: Exercise capacity
timeFrame: During pulmonary rehabilitation, approximately 14 days
Secondary outcomes:
measure: Six minute walk test
timeFrame: During pulmonary rehabilitation, approximately 14 days
Other outcomes:
measure: Oxygen saturation
timeFrame: During pulmonary rehabilitation, approximately 14 days
Locations:
city: Heiligenschwendi
country: Switzerland
facility: Berner Rehazentrum AG
state: Bern
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
affiliation: University of Zurich, EBPI, Switzerland
name: Anja Frei, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05873283: Papillary Thyroid Cancer and Central Lymp Node Dissection
Official title: Is Central Lymph Node Dissection Necessary in Suspected Papillary Thyroid Cancer and Papillary Thyroid Cancer?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Papillary Thyroid Cancer
Keywords: papillary thyroid cancer
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-05-24
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with B5 and B6 biopsy results who underwent bilateral total thyroidectomy and central lymph node dissection

Brief summary: Papillary cancer is a disease that spreads through lymphatic ways and its treatment is surgery. We performed prophylactic central dissection in addition to bilateral total thyroidectomy in patients with bethesda 5 and bethesda 6 biopsy results. We evaluated the pathology results retrospectively.


Eligibility criteria: Inclusion Criteria:

- B5 and B6 biopsy results

Exclusion Criteria:

- lobectomy

Primary outcomes:
measure: Reaching 100 patients was the first target
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: BasaksehirCamSakuraSehirH
Study officials:
References:
Clinical trial NCT03321383: Health Related Quality of Life in Functional Dyspepsia
Official title: Factors Associated With Health Related Quality of Life in Patients With Functional Dyspepsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyspepsia
Keywords: dyspepsia
health related quality of life
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Functional dyspepsia patients at Gastroenterology Clinic in Cipto Mangunkusumo Hospital Jakarta

Brief summary: Previous studies reported health related quality of life impairment in functional dyspepsia patients. Anxiety, depression, disease severity, age, and employment status associated with HRQOL in functional dyspepsia patients. However, data about HRQOL in Asian population was limited.This study aimed to evaluate factors associated with health related quality of life in patients with functional dyspepsia.

Detailed description: 126 functional dyspepsia patients will answer SF-36 HRQOL questionnaire, Hospital Anxiety, and Depression Scale, and Short Form Nepean Dyspepsia Index. Functional dyspepsia and Irritable Bowel Syndrome Rome III diagnostic questionnaire and GERD-Q questionnaire will be used to determine FD type and IBS or GERD overlap.

Eligibility criteria: Inclusion Criteria:

* Dyspepsia patients
* Normal or non ulcer esophagogastroduodenescopy finding

Exclusion Criteria:

* History of GI bleeding
* History of GI malignancies
* Hepatobiliary tract disease
* Diabetes mellitus
* Chronic kidney disease

Primary outcomes:
measure: Health related quality of life
timeFrame: 1 month
Secondary outcomes:
measure: Anxiety
timeFrame: 2 weeks
measure: Depression
timeFrame: 2 weeks
measure: Dyspepsia symptoms severity
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Ari F Syam, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hantoro IF, Syam AF, Mudjaddid E, Setiati S, Abdullah M. Factors associated with health-related quality of life in patients with functional dyspepsia. Health Qual Life Outcomes. 2018 May 2;16(1):83. doi: 10.1186/s12955-018-0913-z.
Clinical trial NCT05606783: Using Bluetooth Home Blood Pressure Monitors With Pharmacist Interventions
Official title: Using Bluetooth Home Blood Pressure Monitors With Pharmacist Interventions to Manage Uncontrolled Hypertension in the Community Setting - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: National Association of Chain Drug Stores
First posted: 2022-11-07
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Family Medicine patients with uncontrolled hypertension will be given a Bluetooth enabled home blood pressure machine to monitor their blood pressure every day for 6 weeks. The blood pressure results will be sent automatically to the patient's electronic medical record via applications on their iPhone. Study pharmacists will follow-up with the patients once per week via a telehealth appointment using the app VSee, where the blood pressure results will be reviewed. The pharmacists will also counsel the patients on lifestyle modifications in order to improve blood pressure.


Eligibility criteria: Inclusion Criteria:

* must be at least 18 years old
* have a smartphone compatible with the mobile intervention (iPhone)
* have been previously diagnosed with hypertension
* have uncontrolled hypertension (SBP \> 130 mmHg and/or DBP \> 80 mmHg)
* be under the care of a primary care physician in the Family Medicine Department of the USF Morsani Center for Advanced Care
* have had at least one prescription filled at Pharmacy Plus within the last six months
* speaks English fluently

Exclusion Criteria:

* already under the care of a clinical pharmacist in the Family Medicine department
* pregnant
* have a serious existing medical condition(s) that may affect their ability to self-monitor their blood pressure (for example, stroke, dementia)

Primary outcomes:
measure: Comfort
timeFrame: 8 weeks
Secondary outcomes:
measure: Determine if pharmacists' interventions improved BP
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: USF Pharmacy Plus
state: Florida
Study officials:
affiliation: University of South Florida College of Pharmacy
name: Wendy H Updike, PharmD
role: PRINCIPAL_INVESTIGATOR
References: