louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06543472: Dural Arteriovenous Fistulas Research at China INI
Official title: Dural Arteriovenous Fistulas Research at China INI
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fistula
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 1180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All are from Chinese individuals.

Brief summary: Dural arteriovenous fistula (DAVF) refers to abnormal connections between meningeal arteries and dural venous sinuses and/or subarachnoid veins. DAVF accounts for approximately 10% to 15% of intracranial vascular malformations. With advancements in imaging technology, increased awareness among physicians, and an aging population, the incidence of DAVF appears to be on the rise. Some literature even suggests it may surpass the occurrence of arteriovenous malformations. Several large-scale retrospective studies have been conducted internationally, involving over 1,000 cases, but some of their findings differ from what is commonly understood. Currently, there is a lack of large-sample single-center studies on DAVF, highlighting the urgent need for such research.

Detailed description: Title：Dural Arteriovenous Fistulas Research at China INI.

Purpose：The incidence of DAVF is low. By collecting clinical data, we aim to establish a comprehensive database and biobank. This will help us elucidate the potential pathogenesis, vascular architecture, biological markers, and treatment outcomes of DAVFs. Furthermore, this study aims to address current controversies (such as treatment strategies for DAVF with pial arterial supply), unresolved issues (such as the optimal treatment and prognosis of infantile type DAVF), and further explore possible mechanisms of DAVF development.

Eligibility criteria: Inclusion Criteria:

* Adult patients with DAVFs who were admitted to Xuanwu Hospital.

Exclusion Criteria:

* Non-DAVF lesions confirmed by DSA.

Primary outcomes:
measure: Long term prognosis
timeFrame: assessed at 3, 6, 12 and 24 months after procedure
Secondary outcomes:
measure: Long-term cure rate
timeFrame: assessed at 3, 6, 12 and 24 months after procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
affiliation: Xuanwu Hospital Department of Neurosurgery
name: Hongqi Zhang, MD
role: STUDY_CHAIR
affiliation: Xuanwu Hospital Department of Neurosurgery
name: Xin Su, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xuanwu Hospital Department of Neurosurgery
name: Zihao Song, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xuanwu Hospital Department of Neurosurgery
name: Huiwei Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xuanwu Hospital Department of Neurosurgery
name: Peng Zhang, MD
role: STUDY_DIRECTOR
affiliation: Xuanwu Hospital Department of Neurosurgery
name: Yongjie Ma, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04824872: Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults
Official title: A Double-Blind, Placebo-Controlled, Cross-over Trial, Evaluating Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hypoglycemia
Glucose Metabolism Disorders
Lead sponsor: Zealand Pharma
Sponsor class: INDUSTRY
First posted: 2021-04-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the trial is to assess the effect of single subcutaneous doses of dasiglucagon versus placebo on post-prandial plasma glucose nadir following a Mixed Meal Test in Roux-en-Y Gastric Bypass (RYGB) subjects


Eligibility criteria: Inclusion Criteria:

* Previously undergone Roux-en-Y gastric bypass (RYGB) surgery at least 6 months prior to screening
* Previous diagnosis of post-bariatric hypoglycemia (PBH), requiring intake of oral carbohydrates.
* Body mass index (BMI) ≤ 40 kg/m2
* Fasting plasma glucose between 72-106 mg/dL (4.0-6.0 mmol/l)

Exclusion Criteria:

* History of hypersensitivity reactions to glucagon or dasiglucagon or any of the excipients
* History of insulinoma, pheochromocytoma, MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease.
* Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m2 or end-stage renal disease at screening
* Hepatic disease, including serum alanine aminotransferase or aspartate aminotransferase ≥ 2.5 times the upper limit of normal (ULN)
* Active malignancy, except for basal or squamous cell skin cancers
* History of a cerebrovascular accident within 6 months prior to screening
* History of myocardial infarction, unstable angina, or revascularization within 6 months prior to screening.
* Congestive heart failure, New York Heart Association Class III or IV
* Concurrent administration of β-blocker therapy
* Clinically significant ECG abnormalities at screening

Primary outcomes:
measure: Nadir plasma glucose concentration
timeFrame: From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Secondary outcomes:
measure: Percent time spent in hypoglycemia
timeFrame: From trial drug administration to 240 minutes after initiation of Mixed Meal Test
measure: Percent time spent in clinical significant hypoglycemia
timeFrame: From trial drug administration to 240 minutes after initiation of Mixed Meal Test
measure: Percent time spent in target range
timeFrame: From trial drug administration to 240 minutes after initiation of Mixed Meal Test
measure: Percent time spent in hyperglycemia
timeFrame: From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04372472: SQuISH-COVID: A Pilot Study
Official title: SQuISH-COVID: A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
COVID-19
Keywords: Sepsis
COVID
Lead sponsor: Cytovale, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
First posted: 2020-05-04
Enrollment: 300
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: The study will enroll up to 300 participants from the emergency department at one clinical research site. Subjects who are suspected of having COVID-19 or other infectious respiratory diseases may be eligible for the study.

Brief summary: This is a single-site prospective study to evaluate the diagnostic performance of the investigational SeptiScan System for patients presenting to the Emergency Department with signs or suspicion of COVID-19 or other infectious respiratory diseases.


Eligibility criteria: Inclusion Criteria:

Subjects meeting the following criteria may be eligible for participation in the study:

1. ≥ 18 years old or older
2. The first vital sign (any one of: blood pressure, temperature, pulse or respiratory rate) has been recorded in the medical record
3. A complete blood count has been ordered for which a blood sample has been collected within 4.5 hours since the first vital sign was recorded
4. Signs or suspicion of a respiratory infection, defined as:

   1. Subject designated for evaluation in the ED respiratory or pulmonary pod or similar location. OR
   2. An order placed for a respiratory viral panel. OR
   3. An order placed for a SARS-CoV-2 test. OR
   4. A subject self-reported as having tested positive for the SARS-CoV-2 test within the previous 7 days and returning with a related complaint.

Exclusion Criteria:

Subjects are excluded from study participation if they meet any of the following criteria:

a. Blood sample volume is \< 300 ul; insufficient quantity for SeptiScan testing.

Primary outcomes:
measure: To demonstrate the performance of the SeptiScan System as a diagnostic marker of life-threatening organ dysfunction caused by a dysregulated host immune response to infection.
timeFrame: Day of enrollment through Day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Regional Medical Center
state: Louisiana
Study officials:
affiliation: Pulmonary & Critical Care LSUHSC, Baton Rouge
name: Hollis R O'Neal, Jr., MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04914572: Therapeutic Rainforest Study in Generating Positive Energy Among Undergraduate Students
Official title: Using Therapeutic Rainforest Mindful Walking in Generating Positive Mental Well-being Among Undergraduate Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Anxiety
Keywords: Mental health; well-being; stress;
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: * The first arm of the study includes the use of mindful walking through the therapeutic rainforest trail from Kent Ridge Park to Hort Park and Hort Park back to Kent Ridge Park.
* The second arm of the study includes a walk through the therapeutic rainforest trail from Kent Ridge Park to Hort Park and Hort Park back to Kent Ridge Park.
* The third arm of the study includes a walk through the Kent Ridge Road Trail curated by the Office of Facility Management.
Primary purpose: OTHER

Brief summary: This study looked into how therapeutic forest walking will impact the well-being of undergraduate students at the National University of Singapore. A three-arm randomized control trial on 108 participants is being planned for this study. The primary aim of this study is to assess the feasibility and primary effect of the Therapeutic Rainforest Walking in generating positive energy among undergraduate students project in enhancing the quality of life, physical, mental, and psycho-social well-being among University students.


Eligibility criteria: Inclusion Criteria:

* Current NUS undergraduate students
* No self-reported physical mobility issue
* No self-reported existing mental health conditions
* Enjoys nature

Exclusion Criteria:

-

Primary outcomes:
measure: Perceived Stress Scale 4 (PSS-4)
timeFrame: 8 weeks
measure: Generalised Anxiety Disorder Scale (GAD-7)
timeFrame: 8 weeks
measure: English Brief Resilience Scale (BRS)
timeFrame: 8 weeks
measure: Saliva Cortisol
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Alice Lee Centre for Nursing Studies
Study officials:
affiliation: National University of Singapore
name: Yong Shian Goh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06067672: The Patient's First Point of Contact
Official title: The Patient's First Point of Contact (PINPOINT) - Protocol of a Prospective Multicentre Study of Communication and Decision-making During Patient Assessments by Primary Care Practice Nurses
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nurse-Patient Relations
Keywords: Communication
Decision-making
Nurse
Primary care
Lead sponsor: University of Boras
Sponsor class: OTHER
Collaborators: name: Mälardalen University
name: Netherlands Instititute for Health Services Research
name: Vastra Gotaland Region
First posted: 2023-10-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Audio-recorded observations from a purposive sample of 150 patient-nurse consultations, including 30 nurses and 150 patients will be recruited at primary care centres in three different geographic areas of the southwest of Sweden.

Brief summary: The overall objective of this observational study is to investigate practices of communication and decision-making during nurses' initial assessment of patients' health problems in primary care, examine working mechanisms in good practices and develop feasible solutions.

The specific aims are:

1. To investigate patients' expectations and experiences with the communication and decision-making during their first contact with a registered nurse (RN) in primary care.
2. To investigate patient-RN communication on the level of patient involvement.
3. To investigate RNs' actual communication, assessments and decision-making, value conflicts and the challenges and strategies they use in prioritizing.
4. To analyse the underlying working mechanisms of good communication practices.
5. To develop methodologies for facilitating efficient processes in assessing, managing, and prioritizing patients in primary care for RNs.

Project PINPOINT aims for a prospective multicenter study, using various methods for data collection and analysis.


Eligibility criteria: Inclusion Criteria:

* Registered Nurses at primary care centres and patients seeking primary care for a new health concern or a new episode of a problem

Exclusion Criteria:

* Patients visiting the primary care nurse with a chronic or continuous health problem

Primary outcomes:
measure: Patient-reported expectations and experiences of the communication during consultations
timeFrame: At baseline (day 1), after visit (day 1) and at 2-4 weeks
measure: Communication processes and patient involvement as observed during consultations
timeFrame: Day 1.
Secondary outcomes:
measure: Assessment and decision-making processes, and related priorities and value conflicts - from observations and RN experiences
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Borås
country: Sweden
facility: University of Borås
Study officials:
affiliation: University of Borås
name: Annelie Sundler, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06426472: An Intervention on Psychosocial Health in Women With Unsuccessful IVF Experience
Official title: The Effect of Web-Based Support Program on Psychosocial Health Status in Women With Unsuccessful IVF Experience
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infertility
Failed in Vitro Fertilisation
Keywords: infertility
web-based
support
psychosocial health
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 120
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this interventional study is to learn if web-based support program can improve the psychosocial health status in women with unsuccessful IVF experience. The main questions it aims to answer are:

Does web-based support decrease the depressive symptoms, anxiety and infertility-related stress? Does web-based support decrease the hopelessness? Does web-based support increase the coping skills with infertility-related stress?

Researchers will compare this intervention to a control group to see if web-based support program improves psychosocial health.

Participants will:

Use the web-based support intervention for 5 weeks or have no intervention. Complete the surveys on the website before and after the intervention.


Eligibility criteria: Inclusion Criteria:

1. Having at least three repeated unsuccessful IVF experiences,
2. Maximum one month has passed since the negative IVF experience,
3. Participating in the study voluntarily,
4. Being able to read, understand and communicate in Turkish.

Exclusion criteria

1. Not having access to the internet/not knowing how to use it,
2. Having any psychiatric disease/being in the 'severe depression' grade as a result of the Beck Depression Inventory,
3. Having at least one living child.

Exclusion criteria from the study in the stages after including the study:

1. Spontaneous pregnancy occurring,
2. Starting a new treatment cycle,
3. Not continuing to monitor the modules on the website.

Primary outcomes:
measure: Depression (Beck Depression Inventory)
timeFrame: 24 months
measure: Infertility-related stress (The Infertility Stress Scale)
timeFrame: 24 months
measure: Coping Skills with Infertility Stress (Coping with Infertility Stress Scale)
timeFrame: 24 months
Secondary outcomes:
measure: Hopelessness
timeFrame: 24 months
measure: Effect of the Web-based study program
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00720772: Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis
Official title: The Treatment Effect of Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Calcification
Vascular Calcification
Keywords: coronary calcification
vascular calcification
sodium thiosulfate
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2008-07-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study will examine the treatment effect of sodium thiosulfate on coronary calcification in patients on hemodialysis.

Detailed description: Coronary calcification (CAC) is prevalent among patients with end-stage renal disease (ESRD). High serum phosphate, the intake of calcium containing phosphate binder as well as dialysis vintage have been shown to be associated with the increasing prevalence of CAC. High CAC score examined by electron-beam CT scan or multi-slice CT scan associates with an increased cardiovascular mortality in ESRD. In series of case reports, intravenous sodium thiosulfate (STS) reduced the calcium burden in calcific uremic arteriopathy and soft tissue calcification. This was believed to be due to the calcium chelation effect of STS.

Eligibility criteria: Inclusion Criteria:

* CAC score \> 300
* Life expectancy \> 6 months
* Dialysis vintage \> 6 months

Exclusion Criteria:

* Non-compliance to hemodialysis

Primary outcomes:
measure: CAC score
timeFrame: 6 months
Secondary outcomes:
measure: Bone mineral density, calcium removal
timeFrame: 6 months, 1 and 2 months
Other outcomes:
Locations:
city: Phayathai
country: Thailand
facility: Ramathibodi Hospital
state: Bangkok
Study officials:
affiliation: Ramathibodi Hospital, Mahidol University
name: Sinee Disthabanchong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goodman WG, Goldin J, Kuizon BD, Yoon C, Gales B, Sider D, Wang Y, Chung J, Emerick A, Greaser L, Elashoff RM, Salusky IB. Coronary-artery calcification in young adults with end-stage renal disease who are undergoing dialysis. N Engl J Med. 2000 May 18;342(20):1478-83. doi: 10.1056/NEJM200005183422003.
citation: London GM, Guerin AP, Marchais SJ, Metivier F, Pannier B, Adda H. Arterial media calcification in end-stage renal disease: impact on all-cause and cardiovascular mortality. Nephrol Dial Transplant. 2003 Sep;18(9):1731-40. doi: 10.1093/ndt/gfg414.
citation: Matsuoka M, Iseki K, Tamashiro M, Fujimoto N, Higa N, Touma T, Takishita S. Impact of high coronary artery calcification score (CACS) on survival in patients on chronic hemodialysis. Clin Exp Nephrol. 2004 Mar;8(1):54-8. doi: 10.1007/s10157-003-0260-0.
citation: Cicone JS, Petronis JB, Embert CD, Spector DA. Successful treatment of calciphylaxis with intravenous sodium thiosulfate. Am J Kidney Dis. 2004 Jun;43(6):1104-8. doi: 10.1053/j.ajkd.2004.03.018.
Clinical trial NCT04642872: Upper Limb Intensive Therapies in Babies With Unilateral Cerebral Palsy.
Official title: Effects of Infant Constraint Induced Movement Therapy and Infant Bimanual Intensive Therapy in Unilateral Cerebral Palsy. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infantile Hemiplegia
Upper Extremity Paresis
Family
Constraint Induced Movement Therapy
Bimanual Intensive Therapy
Lead sponsor: CEU San Pablo University
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 40
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: mCIMT and BIT are therapies applied in children with hemiplegia which have a great evidence, but not in a early age. This research has the objective to know the effects of this therapies in infants diagnosed of infantile hemiplegia from 9 to 18 months applying 50 hours of dose for both interventions during 10 weeks, executing them at home by familes.


Eligibility criteria: Inclusion Criteria:

* Infantile hemiplegia
* Age from 9 months to 18 months.
* No use of the affected upper limb

Exclusion Criteria:

* Associated pathologies
* Epilepsy no controlled with medicins
* No collaborated families

Primary outcomes:
measure: mini Assisting Hand Assesment
timeFrame: 10 weeks
Secondary outcomes:
measure: Satisfaction questionnaire for familes
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hemiweb
Study officials:
References:
Clinical trial NCT05624372: Speech Perception in Noise in Children With ADHD
Official title: Speech Perception in Noise in Children With ADHD
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: no Conditions
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel Aviv University
First posted: 2022-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kids aged 4-18, diagnosed with ADHD, who get treatment and follow-ups in the ADHD outpatient clinic in the Sheba Medical Center

Brief summary: We are going to assess an ability of speech perception in voice in children diagnosed with ADHD (Attention Deficit Hyperactivity Disorder), comparing to normal control group. This is an attempt to understand the factors influencing on this ability.

Detailed description: Participants will undergo a battery of hearing tests -Standard Hearing Test; Speech Perception in Noise - Hebrew Matrix; Transient Evoked Otoacoustic Emission (TEOAE) and cognitive tests - Working Memory Test (from (Wechsler Intelligence Scale for Children, WISC); Visual Attention Test (TMT (Trail Making Test)); Non-Verbal Intelligence Test (RAVEN)

Eligibility criteria: Inclusion Criteria:

* Research group: Kids diagnosed with ADHD, without previous hearing problems.
* Control group: Kids with regular development without previous hearing problems.

Exclusion Criteria:

For both groups:

* Having previous hearing problems or disorders
* Other psychiatric disorders
* Treatment with psychiatric medications other than stimulants
* Having autism
* Having severe learning disabilities.

Primary outcomes:
measure: Speech perception in noise
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: ADHD Medical Clinic, Child and Adolescent Psychiatry Unit, Sheba Medical Center
Study officials:
References: