louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04005378: Disengagement in CSC: Identifying Those at Risk and Addressing Their Needs
Official title: Disengagement in CSC: Identifying Those at Risk and Addressing Their Needs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: First Episode Psychosis
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-07-02
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assigned to either treatment as usual or to the disengagement treatment
Primary purpose: OTHER

Brief summary: Maintaining treatment engagement is critical for first episode psychosis patients to experience gains possible with coordinated specialty care (CSC). This study is designed to identify CSC participants still receiving care but at high risk for disengagement and to intervene to prevent/delay disengagement.

Detailed description: In Phase 1 of the project, we will confirm a model predicting factors associated with later disengagement from CSC treatment. In Phase 2, we will compare disengagement among high-risk individuals with a CSC Step-down intervention to that with standard CSC care. The Step-down intervention will use web-based telemedicine and a smartphone app, to decrease disengagement likelihood. High-risk participants identified by predictors found in Phase 1 will be offered the intervention.

Eligibility criteria: Inclusion Criteria:

* Enrolled into a CSC program

Exclusion Criteria:

* None

Primary outcomes:
measure: Disengagement rate
timeFrame: Minimum of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lauderdale Lakes
country: United States
facility: Henderson Behavioral Health
state: Florida
city: Grand Rapids
country: United States
facility: InterAct of Michigan
state: Michigan
city: Kalamazoo
country: United States
facility: InterAct of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT02506478: Juice Preference in the Emergency Department
Official title: Journey to Understand and Interpret Juice Preference in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: All Eligible ED Patients (Not Limited to a Particular Condition)
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 385
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Emergency Department patients, of any age, who are cleared by their treating physician to drink juice, and are able to communicate a juice preference.

Brief summary: ED patients who are able to drink juice will be approached and asked their beverage preference.

Detailed description: Once per week for 26 weeks, patients will be enrolled during a randomly selected 1-hour block. The random blocks will be assigned using STATA. During these enrollment periods, all current ED patients will be screened by the treating physicians and research associates, excluding patients in the "Special Care" unit, where most patients are intoxicated with alcohol.

Eligibility for oral consumption of water and juice will be determined by treating physicians. Patients who are deemed eligible to drink water or juice will be approached and asked their beverage preferences. Their response will be recorded, and the beverage will be procured for them.

Eligibility criteria: Inclusion Criteria:

* All Emergency Department patients, of any age, who are cleared by their treating physician to drink juice, and are able to communicate a juice preference. Patients are only enrolled during randomly selected 1-hour blocks once per week for 26 weeks.

Exclusion Criteria:

* Previously enrolled in the study
* Patients who are placed in the "special care" unit of the Emergency Department, which generally cares for intoxicated patients.

Primary outcomes:
measure: Juice preference
timeFrame: 1 hour
Secondary outcomes:
measure: Beverage preference
timeFrame: 1 hour
measure: Ice preference
timeFrame: 1 hour
measure: Alternate juice preference
timeFrame: 1 hour
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin Healthcare Research Institute
name: Brian E Driver, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02269878: Effect of FAS and FAS Ligand Polymorphisms on Patients With Platinum-Based -Treated Malignant Pleural Mesothelioma
Official title: The Effect of FAS and FAS Ligand Genetic Polymorphisms on the Clinical Outcome of Patients With Malignant Pleural Mesothelioma Treated With Platinum-Based Regimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Pleural Mesothelioma
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with malignant pleural mesothelioma (MPM)

Brief summary: To Study the Effect of Polymorphisms in Fas Ligand Gene Promoter Region (rs 763110) and Fas gene (rs1800682) on Platinum-Based regimens used in treatment of malignant pleural mesothelioma (MPM)

Detailed description: This study tries to find a correlation between single nucleotide polymorphisms (SNP) found in promoter region of Fas Ligand gene (rs 763110) and Fas (rs1800682) and clinical outcome on patients with MPM treated with platinum-Based agents as first line. the patients will have one of three following genotypes : Thymine/Thymine, Thymine/Cytosine or Cytosine/Cytosine (for Fas ligand polymorphism) and Adenine/Adenine, Adenine/Guanine or Guanine/Guanine ( for Fas polymorphism).

Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed Malignant Pleural Mesothelioma
* Age of 18 years or more.
* first-line chemotherapy with platinum-Based agents

Exclusion Criteria:

* history of prior malignancy.
* pregnancy or lactation or any other reason preventing him from taking platinum-Based chemotherapy (AST more than 2.5\* Upper Limit of Normal or Serum bilirubin more than 1.5\* Upper Limit of Normal)

Primary outcomes:
measure: response rate
timeFrame: After 6 cycles of chemotherapy (each cycle is 21 days )
Secondary outcomes:
measure: progression free survival (PFS)
timeFrame: one year
measure: overall survival (OS)
timeFrame: one year
measure: estimation of treatment related toxicity
timeFrame: during the chemotherapy period, average duration 4 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
state: Abbasia
Study officials:
References:
Clinical trial NCT04683978: Effect of Neck Extension on Intraocular Pressure in Patients Undergoing Palatoplasty
Official title: Effect of Neck Extension on Intraocular Pressure in Patients Undergoing Palatoplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cleft Palate
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 37
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone a palatoplasty with cleft palate and who are 6 months or older and under 24 months

Brief summary: The purpose of this study is to investigate the change in intraocular pressure according to the neck extension during palatoplasty in pediatric patients.


Eligibility criteria: Inclusion Criteria:

* Patients who have undergone a palatoplasty with cleft palate and who are 6 months or older and under 24 months
* Patients with ASA class 1-2
* Patients who agree to voluntarily participate in this study

Exclusion Criteria:

* Patients who refused to participate in clinical studies
* History of diagnosis of neurologic or ophthalmic disease
* History of neurosurgery or ophthalmic surgery

Primary outcomes:
measure: Intraocular pressure after neck extension
timeFrame: at 5 minutes after the position change (neck extension)
Secondary outcomes:
measure: Intraocular pressure 10 minutes after anesthetic induction
timeFrame: at 10 minutes after anesthetic induction (supine position)
measure: Intraocular pressure at end of surgery
timeFrame: immmediately after skin closure (neck extension)
measure: Intraocular pressure 5 minutes after supine position
timeFrame: at 5 minutes after the position change to the supine position (after the end of the surgery)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical Center
Study officials:
References:
Clinical trial NCT03363178: Study to Investigate the Safety and Efficacy of GC3107 (BCG Vaccine) in Healthy Adults
Official title: A Single-arm, Open-label, Single-center, Phase 1 Study to Investigate the Safety and Efficacy of GC3107 (BCG Vaccine) After Intradermal Administration in Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Tuberculosis
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2017-12-06
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Healthy adults will be once administered GC3107(BCG Vaccine) Intradermally.

Detailed description: Healthy adults will be once administered GC3107(BCG Vaccine) Intradermally. Tuberculin Skin Test(TST) will be conducted after 84+7 days after IP injection and TST result will be read in 48\~72 hours.

Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 19-64 years old
* Informed consent form has been signed and dated
* Able to comply with the requirements of the study
* Female subjects who have negative results in Urine hCG test at screening, or menopausal women.

Exclusion Criteria:

* Subjects who have positive results(;induration diameter over 5mm) in Tuberculin Skin Test(TST) at screening
* Subjects who shown abnormal results(including inactive tuberculosis) on Chest X-ray at screening
* Subjects who received a vaccination(including live vaccine) within 28 days before enrollment
* Subjects who are on antituberculosis drugs
* Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy
* Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
* Pregant or lactating women

Primary outcomes:
measure: Adverse Event
timeFrame: for 7 days from Day0/during study period
Secondary outcomes:
measure: Whether the maximum Induration diameter greater than 5mm after TST.
timeFrame: Day0+84days
measure: Whether the maximum Erythema/Redness diameter greater than 5mm after TST.
timeFrame: Day0+84days
measure: Maximum diameter of Induration after TST.
timeFrame: Day0+84days
measure: Maximum diameter of Erythema/Redness after TST.
timeFrame: Day0+84days
measure: Maximum diameter variation of Induration after TST.
timeFrame: Day0+84days
measure: Maximum diameter variation of Erythema/Redness after TST.
timeFrame: Day0+84days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Woo Joo Kim, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05551078: Thrombophilia Screening After Severe IUGR
Official title: Thrombophilia Screening in Women After Severe IUGR
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: IUGR
Thrombophilia
Pregnancy Complications
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Women over 18 years old
* Pregnant women
* IUGR defined by an EFW \<3rd centile
* IUGR before 25 GW

Brief summary: This retrospective study aims to assess the input of thrombophilia screening in pregnant women with severe intra-uterine growth restricted babies.


Eligibility criteria: Inclusion Criteria:

* Women over 18 years old
* Pregnant women
* IUGR defined by an EFW \<3rd centile
* IUGR before 25 GW

Exclusion Criteria:

* none

Primary outcomes:
measure: Rate of positive's thrombophilia screening
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Matthieu Dap
Study officials:
References:
Clinical trial NCT03497078: Comparison of Image Quality Between New Collimator LEHRS vs Siemens LEHR on Bone Scintigraphy
Official title: Comparison of Image Quality Between New Collimator LEHRS (General Electric - GE Healthcare) vs Siemens LEHR on Bone Scintigraphy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Comparison of Two Collimators During Bone Scintigraphy
Keywords: collimator
bone scintigraphy
image quality
scintigraphy
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Comparison of quality image with a new LEHRS GE collimator vs standard LEHR Siemens collimator on bone scintigraphy.


Eligibility criteria: Inclusion Criteria:

* Refered patients for scintigraphy

Exclusion Criteria:

* Under 18 y. old patients
* Pregnancy or supposed to be pregnant patients
* Kidney failure
* Painful patients
* Patients under guardianship
* Patients in whom a standard exam is not feasible

Primary outcomes:
measure: visual quality of bone exams
timeFrame: Day 0
Secondary outcomes:
measure: Quantitative signal-noise-ratios
timeFrame: Day 0
measure: quantitative datas on phantom
timeFrame: Day 0
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHR d'Orléans
Study officials:
affiliation: CHR d'Orléans
name: Gilles METRARD, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gilland DR, Welch BL, Lee S, Kross B, Weisenberger AG. Evaluation of a novel collimator for molecular breast tomosynthesis. Med Phys. 2017 Nov;44(11):5740-5748. doi: 10.1002/mp.12564. Epub 2017 Oct 13.
citation: Songy B, Lussato D, Guernou M, Queneau M, Geronazzo R. Comparison of myocardial perfusion imaging using thallium-201 between a new cadmium-zinc-telluride cardiac camera and a conventional SPECT camera. Clin Nucl Med. 2011 Sep;36(9):776-80. doi: 10.1097/RLU.0b013e31821a294e.
Clinical trial NCT02470078: Pharyngeal Electrical Stimulation for the Treatment of Post-extubation Dysphagia in Acute Stroke
Official title: Randomised Controlled Trial of Pharyngeal Electrical Stimulation for the Treatment of Post-extubation Dysphagia in Acute Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Dysphagia
Keywords: extubation
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2015-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether pharyngeal electrical stimulation in addition to standard care can enhance swallowing recovery in severely dysphagic stroke patients post extubation compared to sham treatment plus standard care.


Eligibility criteria: Inclusion Criteria:

- severe dysphagia post extubation due to acute stroke

Exclusion Criteria:

* preexisting dysphagia
* comorbidities that can possibly cause dysphagia
* psychiatric comorbidities
* pacemaker or other implanted electronic devices

Primary outcomes:
measure: Reintubation rate
timeFrame: 120 hours
measure: Pneumonia rate
timeFrame: 120 hours
Secondary outcomes:
measure: Length of stay
timeFrame: Participants will be followed for the duration of stay on the intensive care unit, an expected average of 3 weeks
measure: Time until oral nutrition
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: PEG tube placement
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks.
measure: Swallowing function
timeFrame: after 3 days of treatment
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Department of Neurology, University of Muenster
Study officials:
affiliation: University Hospital Münster
name: Rainer Dziewas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06996171: Comparative Efficacy of Magnesium Supplement and Melatonin Congener in Young Adults With Primary Insomnia
Official title: Comparative Efficacy of Magnesium Supplement and Melatonin Congener in Young Adults With Primary Insomnia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Insomnia
Keywords: Primary Insomnia
Magnesium supplement
Melatonin congener
Lead sponsor: CMH Kharian Medical College
Sponsor class: OTHER_GOV
First posted: 2025-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sleep is essential for our overall health and well-being, much like food and water. It plays a vital role in numerous bodily functions. Many studies have been conducted to determine the efficacy of melatonin congeners and Mg supplements in patients with insomnia separately. This study aims to compare the efficacy of melatonin and magnesium supplements in young adults with primary insomnia. Most insomnia studies focus on older adults or individuals with comorbidities. Targeting otherwise healthy young adults brings age-specific relevance and novel insight.


Eligibility criteria: Inclusion Criteria:

* Age 18-40 years
* Gender: Male and Females (Non-pregnant \& Non lactating)
* Diagnosed cases of primary insomnia according to following criteria:

  * Difficulty falling asleep, staying asleep or nonrestorative sleep
  * This difficulty is present despite adequate opportunity \& circumstance to sleep
  * This impairment in sleep is associated with daytime impairment or distress
  * This sleep difficulty occurs at least 3 times per week and has been a problem for at least 1 month

Exclusion Criteria:

* Insomnia due to a known underlying cause
* Any psychiatric illness
* Active use of sedative hypnotics

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kharan
country: Pakistan
facility: CMH Kharian Medical College
state: Punjab
Study officials:
References:
Clinical trial NCT02160171: ANSeR- The Algorithm for Neonatal Seizure Recognition Study
Official title: A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure Detection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Seizures
Keywords: Decision Support Algorithm
Neonatal Seizures
EEG
Lead sponsor: University College Cork
Sponsor class: OTHER
Collaborators: name: University College, London
name: Wellcome Trust
First posted: 2014-06-10
Enrollment: 240
Sex: ALL
Minimum age (years): 36
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Term neonates who are undergoing continuous video aEEG/EEG monitoring for clinical purposes (e.g. because seizures were suspected, or the neonate is being treated with therapeutic hypothermia)

Brief summary: A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure Detection: ANSeR

Detailed description: This is a multi-centre study. It will be based on routine clinical practice but will also allow for the off-line retrospective application of ANSeR to a well-defined clinical population in order to establish the potential diagnostic utility of the algorithm.

Eligibility criteria: Inclusion Criteria:

All term neonates at risk of seizures are eligible for the ANSeR study.

Neonates ≥ 36 weeks gestation will be recruited if:

They have a need for EEG monitoring.

Exclusion Criteria:

Consent of parents not obtained.

Primary outcomes:
measure: To quantify the overall diagnostic accuracy of the Algorithm.
timeFrame: up to 72 hours
Secondary outcomes:
measure: Inappropriate use/non-use of Anti Epileptic Drugs (AEDs)
timeFrame: up to 72 hours
measure: To examine factors that influence diagnostic accuracy in clinical practice.
timeFrame: up to 72 hours
Other outcomes:
Locations:
city: Wilton
country: Ireland
facility: Cork University Maternity Hospital
state: Cork
city: Dublin
country: Ireland
facility: Rotunda Maternity Hospital
city: Utrecht
country: Netherlands
facility: University Medical Centre Utrecht, Wilhelmina Children's Hospital
city: Huddinge
country: Sweden
facility: Karolinska Institutet and University Hospital
state: Stockholm
city: London
country: United Kingdom
facility: The London and Homerton Hospital
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
Study officials:
affiliation: University College Cork
name: Geraldine Boylan, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University College, London
name: Janet Rennie, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rennie JM, de Vries LS, Blennow M, Foran A, Shah DK, Livingstone V, van Huffelen AC, Mathieson SR, Pavlidis E, Weeke LC, Toet MC, Finder M, Pinnamaneni RM, Murray DM, Ryan AC, Marnane WP, Boylan GB. Characterisation of neonatal seizures and their treatment using continuous EEG monitoring: a multicentre experience. Arch Dis Child Fetal Neonatal Ed. 2019 Sep;104(5):F493-F501. doi: 10.1136/archdischild-2018-315624. Epub 2018 Nov 24.