louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05511142: Intubation and Ventilation Skill Training Using Modified Peyton's Four-Step Approach
Official title: Effectiveness of Endotracheal Intubation and Mask Ventilation Procedural Skills Training on Preclinical Student Using Modified Peyton's Four-Step Approach During COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Problems
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 229
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Endotracheal intubation and mask ventilation procedural skills are basic skills which have to be learnt by medical student and have to be practiced directly. However, during COVID-19 pandemic, offline training was difficult to be conducted and new specific learning method has not established yet. The study aims to assess the effectiveness of modified Peyton's four-step approach, which can be implemented through online training, compared to the classic Peyton's four-step approach in learning endotracheal intubation and mask ventilation procedural skills.


Eligibility criteria: Inclusion Criteria:

* Preclinical students of Faculty of Medicine Universitas Indonesia agreed to participate and signed the consent
* Preclinical students of Faculty of Medicine Universitas Indonesia registered to attend every training session of endotracheal intubation and mask ventilation under Basic Clinical Skills module
* 100% attendance in every session

Exclusion Criteria:

* Students who have attended endotracheal intubation and mask ventilation training beforehand
* Students who have learnt endotracheal intubation and mask ventilation under Basic Clinical Skills module beforehand

Drop out Criteria:

* Preclinical students of Faculty of Medicine Universitas Indonesia who quit from Basic Clinical Skills module during research
* Students who have never attended the training session

Primary outcomes:
measure: Global rating
timeFrame: by the end of Basic Clinical Skill module, approximately 1-3 months after training
measure: Actual mark
timeFrame: by the end of Basic Clinical Skill module, approximately 1-3 months after training
Secondary outcomes:
measure: Satisfaction score
timeFrame: by the end of Basic Clinical Skill module, approximately 1-3 months after training
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Central National Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Aldy Heriwardito, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02686242: Spinal Aesthesia in Women With Placenta Previa Percreta
Official title: Influence of Spinal Anaesthesia on Hemodynamic Stability in Women With Placenta Previa Percreta Undergoing Caesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complications; Cesarean Section
Keywords: cesarean section
spinal anesthesia
general anesthesia
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2016-02-19
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: parturients with placenta praevia/accreta scheduled for cesarean section

Brief summary: Placenta previa percreta is a dangerous complication during surgery. Due to the high risk of hemorrhage, most parturients with placenta previa have to accept cesarean section. In this study investigators compare the effect of different anesthetic techniques on these patients.


Eligibility criteria: Inclusion Criteria:

* women with placenta previa and increta-percreta (diagnosed by ultrasound and/or magnetic resonance imaging and confirmed during cesarean section)
* women accepted cesarean section

Exclusion Criteria:

* women with baseline systemic blood pressure higher than 180 mmHg
* women with coagulation disorder

Primary outcomes:
measure: incidence of hypotension
timeFrame: from beginning of the surgery to the end of the surgery,approximately 1 hour
Secondary outcomes:
measure: usage of norepinephrine
timeFrame: from beginning of the surgery to the end of the surgery,approximately 1 hour
measure: dose of norepinephrine
timeFrame: from beginning of the surgery to the end of the surgery,approximately 1 hour
measure: lowest systemic blood pressure
timeFrame: from beginning of the surgery to the end of the surgery,approximately 1 hour
measure: maximal decrease of systemic blood pressure
timeFrame: from beginning of the surgery to the end of the surgery,approximately 1 hour
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Xijing hosptial
name: Hailong Dong
role: STUDY_CHAIR
References:
citation: Kocaoglu N, Gunusen I, Karaman S, Ergenoglu AM, Firat V. Management of anesthesia for cesarean section in parturients with placenta previa with/without placenta accreta: a retrospective study. Ginekol Pol. 2012 Feb;83(2):99-103.
citation: Ioscovich A, Mirochnitchenko E, Halpern S, Samueloff A, Grisaru-Granovsky S, Gozal Y, Einav S. Perioperative anaesthetic management of high-order repeat caesarean section: audit of practice in a university-affiliated medical centre. Int J Obstet Anesth. 2009 Oct;18(4):314-9. doi: 10.1016/j.ijoa.2009.01.014. Epub 2009 Aug 7.
citation: Mok M, Heidemann B, Dundas K, Gillespie I, Clark V. Interventional radiology in women with suspected placenta accreta undergoing caesarean section. Int J Obstet Anesth. 2008 Jul;17(3):255-61. doi: 10.1016/j.ijoa.2007.11.010. Epub 2008 Jun 2.
Clinical trial NCT01175642: Cognitive Remediation and Functional Skills Training in Schizophrenia
Official title: Specificity and Generalizability of Cognitive Remediation and Functional Skills Training in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Psychosis
Schizoaffective Disorder
Lead sponsor: National Alliance for Research on Schizophrenia and Depression
Sponsor class: OTHER
First posted: 2010-08-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized trial is examining whether a treatment called cognitive remediation is more effective when it is paired with a social and functional skills training component.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* Enrolled in outpatient mental health care
* Reading level of 6th grade or higher
* English speaking

Exclusion Criteria:

* Medical conditions known to affect cognition

Primary outcomes:
measure: neurocognition
timeFrame: 12 weeks
Secondary outcomes:
measure: functional competence
timeFrame: 12 weeks
measure: neurocognition
timeFrame: 24 weeks
measure: neurocognition
timeFrame: 36 weeks
measure: functional competence
timeFrame: 24 weeks
measure: functional competence
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Christopher R Bowie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bowie CR, McGurk SR, Mausbach B, Patterson TL, Harvey PD. Combined cognitive remediation and functional skills training for schizophrenia: effects on cognition, functional competence, and real-world behavior. Am J Psychiatry. 2012 Jul;169(7):710-8. doi: 10.1176/appi.ajp.2012.11091337.
Clinical trial NCT04029142: Screening for Hemoglobinopathies in Pregnant Women
Official title: Screening for Hemoglobinopathies in Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemoglobinopathies
Keywords: thalassemia
sickle cell anaemia
molecular genetic analysis
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 1785
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women seen at the Frauenklinik at University Hospital Basel

Brief summary: This prospective monocentric study project is to identify hemoglobinopathies in pregnant women in order to optimize antenatal care and to investigate the prevalence of hemoglobinopathies in pregnant women in Switzerland.


Eligibility criteria: Inclusion Criteria:

* pregnant women seen at the Frauenklinik at University Hospital Basel

Exclusion Criteria:

* pregnant women with already known hemoglobinopathy
* refusal of participation

Primary outcomes:
measure: identification of hemoglobinopathies
timeFrame: single time point assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Frauenklinik University Hospital Basel
Study officials:
affiliation: Frauenklinik Universitätsspital Basel
name: Irene Hoesli, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amstad Bencaiova G, Geissler F, Hoesli I. Cohort profile: targeted antenatal screening for haemoglobinopathies in Basel. BMJ Open. 2020 Jul 22;10(7):e035735. doi: 10.1136/bmjopen-2019-035735.
Clinical trial NCT01750242: Retrospective, Non-significant Risk, Deep Brain Stimulation (DBS) Care Management Software Feasibility Study
Official title: OPTIVISE Map Concordance Study in DBS for Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2012-12-17
Enrollment: 20
Sex: ALL
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: Parkinson's disease patients who have been implanted with the DBS system

Brief summary: To evaluate DBS device settings and match with the features of the DBS care management software.

Detailed description: This is a study done on Parkinson disease subjects who have received the DBS system implanted in their subthalamic nucleus.

Eligibility criteria: Inclusion Criteria:

* Patient with Medtronic Deep Brain Stimulation therapy for idiopathic levodopa responsive Parkinson's Disease
* Patient who has had lead placement in the Subthalamic nucleus
* Patient with pre-op MRI available
* Patient with post-op CT scan available showing placement of the lead
* Patient who has documented improvement of at least 35% on UPDRS III scores from baseline preoperative off medication state compared to post DBS implant stimulation on/medications off

Exclusion Criteria:

* Patient who has had clinically significant persistent stimulation related adverse effects
* Patient who has evidence of lead migration without lead revision
* Patient with other brain malformations that would make it difficult to process images (ablative surgery in the basal ganglia, resective surgery, brain tumor)

Primary outcomes:
measure: To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap
timeFrame: 18 months
Secondary outcomes:
measure: Additional Study Measure on Unified Parkinson's Disease Rating Scale (UPDRS) III Scores
timeFrame: Change from baseline to 18 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic, Division of Neurology
state: California
city: Kansas City
country: United States
facility: Parkinson's Disease and Movement Disorder Center, University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: Parkinson's Disease and Movement Disorder Center, University of Kansas Medical Center
name: Rajesh Pahwa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scripps Clinic Division of Neurology
name: Melissa Houser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03624842: Expanded Access With Trappsol(R) Cyclo (TM) for an Individual Patient With Late Onset Alzheimer's Disease
Official title: Expanded Access With Trappsol(R) Cyclo(TM) for an Individual Patient With Late Onset Alzheimer's Disease
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Late Onset Alzheimer Disease
Lead sponsor: Cyclo Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Kerwin Research Center, LLC
First posted: 2018-08-10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: To afford urgent access to a potential-disease modifying treatment, Dr. Diana Kerwin, in partnership with CTD Holdings, the manufacturer of Trappsol (R) Cyclo(TM), will administer the product to a patient with Alzheimer's Disease who has no other disease-modifying treatment options.

Detailed description: Trappsol(R) Cyclo(TM) will be administered via intravenous (IV) infusion. The initial dose will be 500 mg/kg (T=Day 0). Subsequent dosing is anticipated to increase over 9 months, with all subsequent doses given monthly at the maximum dose determined by tolerability, lack of toxicity or adverse event, pharmacokinetic analysis and patient preference. So long as the overall risk/benefit profile favors continued dosing, the patient will continue to receive Trappsol (R) Cyclo (TM) for a minimum of 12 months, if not perpetually.

Risk/benefit assessments will include:

* Vital signs, ECG and laboratory parameters (CBC, chemistry panel, hematology, urinalysis, lipids, coagulation)
* Brain MRI without gadolinium for safety monitoring
* Amyloid and Tau PET (positron emission tomorgraphy) imaging
* Adverse Events
* Mini-mental status score
* Digital Cognition Technologies (DCT) Clock
* Changes in blood biomarkers
* Pharmacokinetic data

Eligibility criteria: Inclusion Criteria: Patient with Alzheimer's Disease who continued to decline neurologically and had no other treatment options with intent to halt progression available. All other medical conditions stable \& well-managed.

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kerwin Research Center
name: Diana R Kerwin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05478642: Influence of Psychological Status on the Results of Pain Treatment in Patients With Gunshot and Mine-explosive Wounds
Official title: Influence of Psychological Status on the Results of Pain Treatment in Patients With Gunshot and Mine-explosive Wounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Psychological Disorders
Keywords: Chronic pain, gunshot wounds, mine-explosive wounds, psychological disorders
Lead sponsor: Bogomolets National Medical University
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 2215
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study was carried out on the basis of the National Military Medical Clinical Center "Main Military Clinical Hospital". All patients participated in Operation Joint Forces and received gunshot wounds during combat operations.

A retrospective analysis of disease histories for the period from 2014 to 2021 was carried out. Data collection was carried out at all stages of treatment: medical and nursing brigade, military mobile hospital, military medical clinical center, during rehabilitation, within 12 months of the injury.

Recruitment of patients for the prospective study was carried out in the period from 02.24.2022 to 05.24.2022. Data collection was carried out during the Russian invasion of Ukraine and the offensive on Kyiv.

Brief summary: 82.1% of patients with gunshot and mine-explosive wounds and wounds during hostilities in Ukraine have negative results of pain treatment, which leads to its chronicity. Examining the effect of psychological status on pain management outcomes in these patients may improve their treatment outcomes.

Detailed description: The influence of the amount of damage and operative interventions on the results of pain treatment in patients with gunshot and mine-explosive wounds at the stages of treatment needs to be studied, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions through the prism of psychological disorders have its features. Since in 82.1% of cases it is not possible to achieve a positive result of treatment, the data of our study will play an important role in their treatment.

Eligibility criteria: Inclusion Criteria:

* availability gunshot and mine-explosive wounds

Exclusion Criteria:

* absence gunshot and mine-explosive wounds

Primary outcomes:
measure: visual analog scale
timeFrame: 12 months
measure: Didier Bouhassiraa DN4
timeFrame: 12 months
measure: The Hospital Anxiety and Depression Scale
timeFrame: 12 months
measure: Chaban Quality of Life Scale
timeFrame: 12 months
measure: Mississippi PTSD scale (military version)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Bogomolets National Medical University, Ministry of Health of Ukraine
Study officials:
References:
Clinical trial NCT05494242: Single Superior ILM/ERM Flap for the FTMH.
Official title: Single Superior Internal Limiting Membrane/Epiretinal Membrane Flap for the Full Thickness Macular Hole
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ophthalmopathy
Keywords: Full thickness macular hole
Epiretinal membrane
Internal limiting membrane
Flap
Lead sponsor: Ibinsina Modern Eye and Retina Center
Sponsor class: OTHER
Collaborators: name: Ibinsina Modern Eye and Retina Center
First posted: 2022-08-09
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this study, the investigators will make the only upper flap either from the internal limiting membrane or from the epiretinal membrane to cover the full thickness macular hole.

Detailed description: After the investigators completed the clinical trial NCT05269563, which was a double flap technique; that consists of two flaps from the internal limiting membrane and the epiretinal membrane. The inferior flap was implanted inside the hole, but the upper flap was utilized to cover the hole. The results were encouraging. Therefore, in this study, the investigators will make the only upper flap to cover the full thickness macular hole, to compare both visual and anatomical outcomes with the double flapped technique (NCT05269563) results. Therefore the double flap will be our control.

Eligibility criteria: Inclusion Criteria:

* Full thickness macular hole

Exclusion Criteria:

* Lamellar and pseudo holes

Primary outcomes:
measure: Anatomical outcome
timeFrame: The fourth weeks post-operatively
Secondary outcomes:
measure: Functional outcome
timeFrame: The fourth week post-operatively.
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Omer Othman Abdullah
Study officials:
References:
Clinical trial NCT03890042: Dienogest for Treatment of Adenomyotic Uteri
Official title: Dienogest Versus a Low-dose Combined Oral Contraceptive for Treatment of Adenomyotic Uteri
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenomyosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adenomyosis is a common disease in women aged 40-50 years. It associates with dysmenorrhea and menorrhagia. Hysterectomy was considered the main treatment that could definitively cure this disease. Other treatment options are increasingly offered, including hormonal suppression with gonadotropin-releasing hormone agonists or danazol and endometrial ablation. However, deep adenomyosis responds weakly to the above treatment options, which are commonly not considered for long-term management because of the associated side effects.

Dienogest is a progestin medication which is used in birth control pills and in the treatment of endometriosis and adenomyosis. Low-dose combined oral contraceptive (COC) pills have been widely used as the primary treatment for menorrhagia. COCs can also be used to induce endometrial atrophy and to decrease endometrial prostaglandin production, which can consequently improve menorrhagia and dysmenorrhea that are associated with adenomyosis


Eligibility criteria: Inclusion Criteria:

* Women aged 20-40 years
* Women with ultrasonographic evidence of adenomyosis
* Woman complains of vaginal bleeding or pelvic pain related to adenomyosis

Exclusion Criteria:

* Women with a history of malignancy or histological evidence of endometrial hyperplasia
* any adnexal abnormality on ultrasound
* undiagnosed vaginal
* contraindication to receive Vissane or gynera .

Primary outcomes:
measure: Number of women who will improved from the pelvic pain measured by visual analogue scale
timeFrame: 6 months
Secondary outcomes:
measure: Uterine volume (cm 3 ) measure by ultrasound
timeFrame: 6 month
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References:
citation: Hassanin AI, Youssef AA, Yousef AM, Ali MK. Comparison of dienogest versus combined oral contraceptive pills in the treatment of women with adenomyosis: A randomized clinical trial. Int J Gynaecol Obstet. 2021 Aug;154(2):263-269. doi: 10.1002/ijgo.13600. Epub 2021 Feb 11.