louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06213220: Wearable Devices System Diagnoses Mood Disorder in Children and Adolescents
Official title: A Diagnostic Test of Mood Disorder Recognition in Children and Adolescents Based on Wearable Devices
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mood Disorders
Diagnosis, Psychiatric
Lead sponsor: Institute of Psychology, Chinese Academy of Sciences
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children and adolescents mood disorders patients and healthy controls age between 6 - 16 boys and girls

Brief summary: As a diagnostic test, this study aims to explore the effectiveness of systems based on wearable devices in identifying mood disorders in children and adolescents.


Eligibility criteria: Inclusion Criteria:

* Subjects in the MDD group met the DSM-5 diagnostic criteria for MDD and those in the BD group met the DSM-5 criteria for BD
* able to cooperate to complete the study
* had signed the informed consent prior to the study

Exclusion Criteria:

* with severe physical illness
* demonstrated symptoms comorbid with other psychiatric disorders (e.g., schizophrenia, conduct disorder, personality disorder) and developmental disorders (e.g., autism spectrum disorder, intellectual impairment)
* other conditions deemed inappropriate for inclusion in the group

Primary outcomes:
measure: R-R interval
timeFrame: In the experiment conducted over a period of four weeks, the sampling frequency was 25Hz (based on seconds).The report will be available approximately one year after the end of the experiment.
measure: Hamilton Depression Rating Scale (HAM-D)
timeFrame: In the experiment conducted over a period of four weeks, data collection was performed once per week. The report will be available approximately one year after the end of the experiment.
measure: Young Mania Rating Scale (YMRS)
timeFrame: In the experiment conducted over a period of four weeks, data collection was performed once per week. The report will be available approximately one year after the end of the experiment.
Secondary outcomes:
Other outcomes:
measure: sensitivity
timeFrame: The model fitting will be completed approximately 6 months after the end of the experiment. The report will be available approximately one year after the end of the experiment.
measure: specificity
timeFrame: The model fitting will be completed approximately 6 months after the end of the experiment. The report will be available approximately one year after the end of the experiment.
measure: accuracy
timeFrame: The model fitting will be completed approximately 6 months after the end of the experiment. The report will be available approximately one year after the end of the experiment.
Locations:
city: Beijing
country: China
facility: Institute of Psychology, Chinese Academy of Sciences
Study officials:
References:
Clinical trial NCT05532020: An Open-Label Study of Diazoxide Choline in Patients With Genetic Obesities
Official title: An Open-Label Study to Assess the Preliminary Efficacy and Safety of DCCR (Diazoxide Choline) Extended-Release Tablets in Patients With Genetic Obesities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: SH2B1 Deficiency Obesity
Obesity Associated With PCSK1 Mutation (rs6232 Variant)
SIM1 Deficiency Obesity
Keywords: SH2B1 deficiency obesity
Obesity associated with PCSK1 mutation
(rs6232 variant)
SIM1 deficiency obesity
Genetic obesity
Lead sponsor: Soleno Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-08
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase 2 open-label, one-arm, clinical study to evaluate the efficacy and safety of DCCR (diazoxide choline) extended-release tablets over 1 year of treatment, in patients with genetic obesities.

Detailed description: Patients aged 5 years and older with obesity due to SH2B1 deficiency obesity, obesity associated with PCSK1 mutation (rs6232 variant), or SIM1 deficiency obesity will be enrolled into this phase 2 open-label clinical trial at a single clinical center in North America. All eligible participants will receive DCCR (diazoxide choline) extended-release tablets for 1 year.

Eligibility criteria: Key Inclusion Criteria:

* Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (patients, as appropriate)
* Genetically-confirmed diagnosis of SH2B1 deficiency obesity, obesity associated with PCSK1 mutation (rs6232 variant), or SIM1 deficiency obesity

Key Exclusion Criteria:

* Have participated in an interventional clinical study (i.e., investigational drug or device, approved drugs or device evaluated for unapproved use) within 60 days prior to Screening
* Any known disease and/or condition, which would prevent, in the opinion of the Investigator, the patient from completing all study visits and assessments required by the protocol
* Positive urine pregnancy test (in females of child-bearing potential) or females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation

Primary outcomes:
measure: Proportion of participants who achieve at least 5% body weight reduction
timeFrame: Baseline to Week 26
Secondary outcomes:
measure: Leptin
timeFrame: Baseline to Week 26
measure: Fasting serum insulin
timeFrame: Baseline to Week 26
measure: Body fat mass
timeFrame: Baseline to Week 26
measure: Feelings of hunger
timeFrame: Baseline to Week 26
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02139020: Collection of Plasma Samples for Squamous Cell Carcinoma of the Head and Neck Patients
Official title: Prospective Collection of Plasma Samples From Patients Treated With Molecular Targeted Therapies for Squamous Cell Carcinoma of the Head and Neck
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: Targeted therapies
Plasma samples
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2014-05-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: PATIENTS TREATED WITH MOLECULAR TARGETED THERAPIES FOR SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK

Brief summary: The investigators will collect plasma samples at baseline, during treatment, and at progression.

Detailed description: In this study, the investigators will collect plasma samples at baseline, during treatment, and at progression. This plasma bank will be used to study the potential value of some biomarkers to predict treatment activity or resistance to cetuximab or other targeted agents

Eligibility criteria: Inclusion Criteria:

* patients treated with radiation therapy and cetuximab according to Bonner et al
* patients treated with cetuximab in combination with chemotherapy according to Vermorken et al.
* patients treated with a molecular targeted agent as a part of a clinical study

Exclusion Criteria:

* patients with another type of head and neck cancer
* patients non treated with targeted therapies

Primary outcomes:
measure: Prospective storage of plasma samples of patients treated with cetuximab or other targeted agents
timeFrame: one year after the collection
Secondary outcomes:
Other outcomes:
Locations:
city: Ottignies
country: Belgium
facility: Clinique Saint-Pierre
state: Brabant Wallon
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi
state: Hainaut
city: Haine-Saint-Paul
country: Belgium
facility: Centre Hospitalier Jolimont-Lobbes-Nivelles-Tubize
city: Liège
country: Belgium
facility: CHU Liège
city: Namur
country: Belgium
facility: Clinique et Maternité Sainte-Elisabeth
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Jean-Pascal Machiels, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00408720: Comparison of a Spectral OCT/SLO With the Stratus OCT for Imaging Various Retinal Pathologies
Official title: Comparison of a Spectral OCT/SLO With the Stratus OCT for Imaging Various Retinal Pathologies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Hole
RPE Detachment
Epiretinal Membrane
Posterior Vitreous Detachment
Keywords: Spectral OCT
SLO
Retinal Imagining
Lead sponsor: The New York Eye & Ear Infirmary
Sponsor class: OTHER
First posted: 2006-12-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: The purpose of this study is to compare the newly released Spectral OCT/SLO (OTI, Toronto, Canada) with the Zeiss Stratus OCT (Carl-Zeiss Meditec, Dublin, CA) with regards to the quality of the images obtained as well as the ease of use.


Eligibility criteria: Inclusion Criteria:

* N/A

Exclusion Criteria:

* N/A

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
Study officials:
affiliation: New York Eye and Ear Infirmary
name: Richard B Rosen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05491720: Electrical Brain Stimulation and Pharmacological Treatments in Autism Spectrum Disorder
Official title: Comparable Efficacy of Transcranial Direct Current Stimulation and Pharmacological Treatments in Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Autism Spectrum Disorder
Lead sponsor: The National Brain Mapping Laboratory (NBML)
Sponsor class: OTHER
Collaborators: name: Ardabil University of Medical Sciences
name: Leibniz Research Centre for Working Environment and Human Factors
name: University of Tehran
First posted: 2022-08-08
Enrollment: 45
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project aims to comparing the effectiveness of transcranial direct current stimulation with common pharmacological treatments on behavioral problems and cognitive deficits of children with autism spectrum disorder

Detailed description: 45 children with autism spectrum disorder are recruited in Fatemi Hospital at Ardabil University of Medical Sciences. The patients will be randomized into 3 Intervention groups of 15 with tDCS stimulation, risperidone, and placebo medication as the interventions. The study will be a randomized double-blind controlled design. The experimenter and the patient are blinded and are not aware of the study. Intervention group 1: TDCS intervention protocol consists of 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days. Anodal electrode will be placed over the F3 and cathodal electrode will be placed over the Fp2. They will also receive a placebo tablet (Galenus pharmaceutical company) in each stimulation session. Intervention group 2: Participants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days. Intervention group 3: Participants in this group undergo 10 daily sessions of sham tDCS concurrent with a placebo tablet (Galenus pharmaceutical company) for 10 consecutive days.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of autism spectrum disorder by a psychiatrist and behavioral checklist
* being 6-16 years old
* providing written informed consent signed by parents

Exclusion Criteria:

* comorbidity with other neurodevelopmental disorders
* comorbidity with other neurological disorders
* previous history of neurosurgery
* presence of any ferromagnetic metal in the head
* implanted medical devices in the head or neck region
* history of noncontrolled epilepsy with seizures in the last year

Primary outcomes:
measure: Gilliam Autism Rating Scale (GADS)
timeFrame: up to 3 months after the intervention
measure: verbal fluency task
timeFrame: up to 3 months after the intervention
measure: Theory of mind
timeFrame: up to 3 months after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: The National Brain Mapping Laboratory (NBML)
Study officials:
References:
Clinical trial NCT03115320: Frozen-thawed Embryo Transfer in a Natural Cycle: hCG Triggering Versus LH Home Test
Official title: A Protocol for a Randomized, Two-Parallel-group Study to Compare the Efficacy of Testing LH Surge at Home Versus Medically Triggered Ovulation With hCG (Pregnyl®) in the Naturally Stimulated Cycle in the Frozen-thawed Embryo Transfer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Infertility
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to find out if ovulation triggered with hCG provides any additional benefit in comparison to spontaneous LH surge measured with the LH surge home test when transferring frozen-thawed embryo in a natural cycle.

Detailed description: The aim of this study is to find out the best method for the ovulation triggering. We study the live birth rates in the both groups.

Eligibility criteria: Inclusion Criteria:

* - Patient with IVF or ICSI cycle and therefore having frozen-thawed embryos
* Regular menstruation cycle
* Patient's willingness to participate in the study

Exclusion Criteria:

* - Irregular menstrual cycle demanding preparing endometrium with hormones for frozen-thawed embryo
* No frozen embryos after IVF cycle
* Allergy to Pregnyl® or some of its ingredients in the medication or other contraindications due to Pregnyl®

Primary outcomes:
measure: Live birth rate
timeFrame: At possible delivery (about 40 weeks)
Secondary outcomes:
measure: Ongoing pregnancy rate
timeFrame: After two weeks
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Helena Tinkanen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06509620: Physical and Cognitive Performance in Older Adults With Fatigue
Official title: Physical and Cognitive Performance in Older Adults With Fatigue
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Fatigue
Keywords: fatigue
older adult
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Community dwelling elderly participants (caregivers of inpatients, attendants of primary care , elderly clubs and other community gatherings).

Brief summary: Fatigue is a common symptom in older adults, often linked to various medical conditions, medications, and psychosocial factors, and it can adversely affect both physical and cognitive performance in the aging population, contributing to functional decline and reduced quality of life.

Assessment of the physical impact of fatigue on physical and cognitive performance in older adults can offer valuable insights for clinical practice and holistic geriatric care. Therefore, this study will validate subjective tools used for measuring the impact of fatigue against objective measures.


Eligibility criteria: Inclusion Criteria:

* Participants aged 60 years old and above both males and females

Exclusion Criteria:

* o Patients with acute medical illness.

  * Patients with life threatening illnesses.
  * Bedridden patients.
  * Patients with diagnosed malignancy.
  * Patients with debilitating chronic disease (end organ failure) (e.g. heart failure , renal failure, and liver cell failure).
  * Patients with neurological diseases (e.g. moderate to severe dementia, stroke, parkinsonism) that interfere with the assessment process.
  * Patients with musculoskeletal conditions that interfere with the assessment process (fracture, disabling osteoarthritis, painful arthritis).
  * Patients with severe uncorrected hearing loss, vision impairment, or aphasia that may impede effective communication during the assessment.

Primary outcomes:
measure: The primary outcome measure the difference in cognitive performance between older adults with and without fatigue, assessed using the Montreal Cognitive Assessment (MoCA)
timeFrame: 6 months
measure: The primary outcome measure the difference in physical performance between older individuals with and without fatigue, assessed using 6 minutes walk test
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT01009320: The Potential Interference of Magnets From a Surgical Magnetic Drape With Cardiac Pacemakers
Official title: The Potential Interference of Magnets From a Surgical Magnetic Drape With Cardiac Pacemakers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Pacemaker, Artificial
Keywords: Pacemaker
Magnets
Drape
Ferrite
Magnetic field
Pacemaker interference
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2009-11-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Out-patient clinic

Brief summary: Magnetic fields may interfere with the function of cardiac pacemakers. A magnetic drape to hold surgical instruments is widely used in surgery. The use of this drape on pacemaker patients has not yet been tested. Our objective is to conduct a clinical study to evaluate the potential interference of the surgical magnetic drape on patients with cardiac pacemakers. We are testing the magnetic drape on forty patients in the pacemaker clinic. The totality of the drape is applied over the pacemaker and depending on the result, the drape is either folded in two over the pacemaker or the magnets are applied individually up to the totality of the drape, 70 magnets. Thereafter, the drape is pulled in increments of 3 cm caudally until the interference is ceased. Results are in process as we are presently actively recruiting.


Eligibility criteria: Inclusion Criteria:

* Cardiac pacemaker

Exclusion Criteria:

* Unstable angina
* Hemodynamic instability
* Subjects whom the cardiologist believes are unsuitable for asynchronous pacing

Primary outcomes:
measure: Asynchronous pacing
timeFrame: Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Maisonneuve-Rosemont hospital
state: Quebec
Study officials:
affiliation: Maisonneuve-Rosemont hospital, University of Montreal
name: Louis-Philippe Fortier, MD, FRCPC
role: STUDY_DIRECTOR
affiliation: Maisonneuve-Rosemont hospital, University of Montreal
name: Valerie Zaphiratos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03974620: Individual Placement and Support and/or Cognitive Remediation Therapy Added to TAU in Patients With Early Schizophrenia
Official title: Individual Placement and Support (IPS) and Cognitive Remediation Therapy (CRT) as an Adjunct to Treatment as Usual (TAU) in Patients With Early Schizophrenia Spectrum Disorder: Study Protocol for a Randomized Controlled Feasibility Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Schizophrenia
Schizophreniform Disorders
Schizoaffective Disorder
Psychosis
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study aims to test the hypothesis that addition of Individual Placement and Support (IPS) and/or Cognitive Remediation Therapy (CRT) in addition to treatment as usual in patients with early psychosis will be feasible and acceptable in patients with early schizophrenia.

Detailed description: This is an assessor blind, randomised controlled trial, employing a factorial design. This trial aims to assess the feasibility of IPS, CRT or their combination as an add on to treatment as usual. Patients with early schizophrenia spectrum disorder will be recruited from major psychiatric units in Pakistan. Treatment as usual (TAU) will comprise of patient's current antipsychotic medication as prescribed by their responsible clinician. Patients will be randomised into IPS, CRT, their combination or TAU, according to the 2x2 factorial schedule in the table. A total of 30 participants will be recruited in each cell, giving a total of 120 participants.

Eligibility criteria: Inclusion Criteria:

1. Male/Female patients aged between 18-35 years.
2. Diagnosis of schizophrenia confirmed by SCID meeting DSM-V criteria for schizophrenia, schizophreniform or schizoaffective psychosis.
3. Stable on medication for the past four weeks.
4. In contact with mental health services
5. Within 5 years of diagnosis.
6. Able to demonstrate the capacity to provide informed consent to take part in this feasibility trial, as assessed by their own clinician.

Exclusion Criteria:

1. Active DSM-V substance abuse (except nicotine or caffeine) or dependence within the last three months
2. Relevant CNS or other medical disorders
3. Diagnosis of Learning Disability.

Primary outcomes:
measure: Feasibility of undertaking a trial of the intervention, as determined by: Recruitment and attrition rates
timeFrame: 6 month post intervention
measure: Acceptability of the intervention, as determined by: number of sessions attended
timeFrame: 6 months post intervention
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 6 month post intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: