louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01838018: Brain Perfusion in Pantothenate Kinase-associated Neurodegeneration (PKAN)
Official title: Brain Perfusion in Pantothenate Kinase-Associated Neurodegeneration (PKAN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pantothenate Kinase-associated Neurodegeneration (PKAN)
Keywords: PKAN
brain iron
NBIA
neurodegeneration with brain iron accumulation
Hallervorden Spatz Syndrome
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: Oregon Clinical and Translational Research Institute
First posted: 2013-04-23
Enrollment: 10
Sex: ALL
Minimum age (years): 7
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The PKAN group consists of individuals in the United States diagnosed with PKAN.

Brief summary: The purpose of this study is to learn whether blood flow in the brain is normal in people with pantothenate kinase-associated neurodegeneration (PKAN). Specifically, preliminary data suggest a region of the brain called the globus pallidus (GP), a key region affected by PKAN, may have reduced blood flow. Standard MRI and perfusion scanning techniques will be used to learn about cerebral blood flow in the globus pallidus and compare it to blood flow in other brain regions as well as to healthy controls.


Eligibility criteria: Inclusion Criteria:

* diagnosis of PKAN confirmed by MRI and gene testing
* able to undergo MRI for approximately 1 hour without sedation

Exclusion Criteria:

* deep brain stimulators or other conditions that warrant avoidance of a strong magnetic field
* previous reaction to gadolinium (Gd) contrast agent
* acute or chronic kidney dysfunction
* pregnant and/or nursing at time of study

Primary outcomes:
measure: ASL-derived cerebral blood flow(CBF)
timeFrame: Single MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Susan J Hayflick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06548113: Sensory Synchronized Imaging and Neuromodulation
Official title: Investigation of Sensory Synchronized Human Brain Imaging and Neuromodulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: National Institute of Mental Health (NIMH)
name: Stanford University
First posted: 2024-08-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research study is to better understand the relationship between the type of brain stimulation used and how it changes brain activity in adult military Veterans. The goal is to use this understanding to develop new, personalized brain stimulation. The investigators evaluate brain changes from different types of transcranial magnetic brain stimulation (TMS).


Eligibility criteria: Inclusion Criteria:

* Men and women, ages 18 years and up
* English speaking
* Military Veterans

Exclusion Criteria:

* Those with a contraindication for MRIs (e.g. implanted metal)
* History of head trauma with loss of consciousness
* History of seizures or on medications that substantially reduce seizure threshold
* Neurological or uncontrolled medical disease
* Active substance abuse
* Currently pregnant or breastfeeding

Primary outcomes:
measure: Transcranial Magnetic Stimulation (TMS) / Electroencephalography (EEG) change
timeFrame: 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Jessica M Ross, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05222113: OBSERVATIONAL STUDY OF COMPARISON EFFECTIVITY BETWEEN REMDESIVIR AND FAVIPIRAVIR IN SURABAYA, INDONESIA
Official title: OBSERVATIONAL STUDY OF COMPARISON EFFECTIVITY BETWEEN REMDESIVIR AND FAVIPIRAVIR IN SURABAYA, INDONESIA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duration of Hospitalization
Clinical Manifestation of COVID-19
Lead sponsor: Universitas Katolik Widya Mandala Surabaya
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 97
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients' medical records from Gotong Royong Surabaya Hospital were obtained from January 2021 to March 2021 and June 2021 to August 2021, since remdesivir was rarely used from April 2021 to May 2021.

Brief summary: In order to compare the effectiveness between Remdesivir and Favipiravir, an observational analytic study using a retrospective cohort design. Eighty-eight medical records of COVID-19 patients from January to August 2021

Detailed description: Coronavirus Disease 2019 (COVID-19) is an infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2). Antiviral therapies are considered to be one of the COVID-19 treatments. Remdesivir and favipiravir are the antivirals recommended by Indonesia's 3rd COVID-19 Management Guidelines. They have a similar mechanism to inhibit virus replication, specifically by inhibiting RNA-dependent RNA polymerase (RdRp) of the virus. Several studies reported that patients who received these antivirals had a lower duration of hospitalization. However, the effectiveness comparison of remdesivir and favipiravir remains unknown.

An observational analytic study using a retrospective cohort design. Eighty-eight medical records of COVID-19 patients from January to August 2021 are collected by consecutive sampling technique, and this research was carried out at Gotong Royong Hospital Surabaya.

Eligibility criteria: Inclusion Criteria:

* Adult patients (eighteen years old or above) with moderate to severe COVID-19 (categorized based on KEPUTUSAN MENTERI KESEHATAN REPUBLIK INDONESIA NOMOR HK. 01. 07/MENKES/413/2020);
* Admitted to Gotong Royong Hospital Surabaya from January 2021 to August 2021;
* Received remdesivir OR favipiravir with minimal five days of treatment
* Not in pregnancy and lactating condition

Exclusion Criteria:

* female patient with pregnancy and lactation
* patient whom was passed away or forced home during two-weeks observation period

Primary outcomes:
measure: Clinical manifestation
timeFrame: 2 weeks since drug (remdesivir OR favipiravir) administration
Secondary outcomes:
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Gotong Royong Surabaya Hospital
state: East Java
Study officials:
References:
Clinical trial NCT04217213: Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery
Official title: Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery -- a Single-center Randomized, Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Xuzhou Medical University
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project intends to investigate the effects of intercostal nerve block with ropivacaine combined with mecobalamin on chronic post-surgical pain (CPSP) in thoracic postoperative patients. Related clinical characteristics of postoperative chronic pain. The results of the study provide clinicians with a simple and inexpensive new method of preventing CPSP, in order to prevent the occurrence of CPSP and reduce the incidence of CPSP, thereby reducing CPSP to patients and their families, hospitals. And public resources.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old, conscious;
2. ASA class Ⅰ \~ Ⅲ;
3. Thoracoscopic lobectomy was proposed;
4. The han nationality;
5. Native speaker of Chinese;
6. Agree to participate in this study and sign the informed consent.

Exclusion Criteria:

1. Patients allergic to meccobalamin or ropivacaine;
2. Patients with previous history of chest surgery;
3. Patients with tumor invasion of chest wall, abscess, tumor intercostal neuropathy or pathological rib fracture;
4. Patients with a history of analgesic addiction or abuse, epilepsy, one or other neurological disease;
5. Diabetic patients;
6. Patients who need other drugs for pain relief but have not completed treatment or have completed treatment.

Primary outcomes:
measure: Incidence of chronic pain after chest surgery
timeFrame: At the 3rd month after surgery
Secondary outcomes:
measure: The incidence of acute pain after chest surgery
timeFrame: 24 to 72 hours after surgery
measure: Incidence of postoperative neuropathic pain
timeFrame: At the 3rd month after surgery
measure: Incidence of other postoperative complications
timeFrame: At the 3rd month after surgery
measure: Incidence of readmission within 30 days after surgery
timeFrame: At the 30 days after surgery
measure: Incidence of death within 30 days after surgery
timeFrame: At the 30 days after surgery
measure: Length of stay
timeFrame: At the 3rd month after surgery
measure: Cost of stay
timeFrame: At the 3rd month after surgery
measure: icu length of stay
timeFrame: At the 3rd month after surgery
measure: Incidence of secondary operation
timeFrame: At the 3rd month after surgery
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
Study officials:
References:
Clinical trial NCT06138613: Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness
Official title: Motion Delos: An Open Label Study to Investigate the Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness During Travel
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Motion Sickness
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An open label study to investigate the safety and efficacy of tradipitant in participants affected by motion sickness during travel

Detailed description: This is an open label study to investigate the efficacy and safety of tradipitant in motion sickness affected male and female participants during events historically known to cause motion sickness.

Eligibility criteria: Inclusion Criteria:

* History of Motion Sickness
* Age 18-75

Exclusion Criteria:

* Nausea-inducing disorder other than motion sickness
* BMI \> 40
* History of intolerance and/or hypersensitivity to Neurokinin-1 Receptor antagonists

Primary outcomes:
measure: Safety and tolerability of tradipitant as measured by reporting of adverse events (AEs).
timeFrame: through study completion, approximately 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Santa Monica Clinical Trials
state: California
Study officials:
References:
Clinical trial NCT00955513: Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain
Official title: A Randomized, Double-blind, Multi-center, Placebo-controlled, 3-treatment Arm, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Grade I/II Ankle Sprain
Keywords: Ankle sprain
soft tissue injury
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-08-10
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this trial is to compare the efficacy and safety of diclofenac diethylamine 2.32% gel applied twice (b.i.d) or three times a day (t.i.d.) with placebo in the treatment of acute ankle sprains (distortions).


Eligibility criteria: Inclusion Criteria:

1. Acute sprain of the lateral ankle, Grade I-II .

Exclusion Criteria:

1. Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient.
2. Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated.

Primary outcomes:
measure: Measure: Pain on Movement on Day 5 (Change From Baseline).
timeFrame: baseline and day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Gilching
country: Germany
facility: Novartis Investigative Site
city: Grunwald
country: Germany
facility: Novartis Investigative Site
city: Munchen
country: Germany
facility: Novartis Investigative Site
Study officials:
References:
Clinical trial NCT02358213: Evaluation of the Reproducibility Inter-observer of the Ultrasound Anomalies of the Salivary Glands in Sjogren's Disease
Official title: Evaluation of the Reproducibility Inter-observer of the Ultrasound Anomalies of the Salivary Glands in Sjogren's Disease : Etude ETREINTE.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sjogren's Disease
Keywords: reproductibility
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This aim of this study is to compare the reproducibility of reading of five international experts concerning the anomalies of the salivary glands.

The reproducibility is measure on patients and not on recorded data.


Eligibility criteria: Inclusion Criteria:

* Men and women from 18 to 80 years old
* Patients recruited during the multidisciplinary consultation of Sjogren's Disease, filling the criteria of Sjogren's Disease or patients having a salivary recidivate pathology and selected players on the basis of their voluntary service to benefit from an ultrasound of the main salivary glands
* The patients will have to be capable of adhering to the protocol of study and of having understood it.
* The patients will have to be capable of giving a signed informed consent, the latter being obtained before the inclusion

Exclusion Criteria:

* Not cooperative patient and having refused to sign the informed consent.
* Patient incapable to understand the protocol, under guardianship or under guardianship.
* Unaffiliated patients to the Social Security.

Primary outcomes:
measure: Reproducibility between experts
timeFrame: 1 day
Secondary outcomes:
measure: Reproducibility by the sonographer
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Brest
name: Valérie DEVAUCHELLE, PUPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02618213: Comparison of High Flow Oxygenation Therapy and CPAP in Children With Bronchiolitis.
Official title: Comparison of High Flow Oxygenation Therapy and CPAP in Children With Bronchiolitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Syncytial Virus Bronchiolitis
Keywords: Continuous Positive Airway Pressure
High Flow Oxygenation therapy
Bronchiolitis
Children
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bronchiolitis in infants and young children often requires respiraty support. In Denmark Continous Positive Airway Pressure ( CPAP) are routinely used in children with moderate-severe bronchiolitis. The aim of the study is to compare CPAP and High Flow Oxygenation Therapy (HFOT) as tools of respiratory support in infants and young children with bronchiolitis.

Infants and young children with moderate-severe bronchiolitis and are randomized to either CPAP or HFOT.


Eligibility criteria: Inclusion Criteria:

* infants and children with moderate respiratoric syncytial virus bronchiolitis or other viral bronchiolitis and need of respiratory support. ( clinical decision)

Exclusion Criteria:

* severe bronchiolitis with P C02 \> 9, decreased consciusness and risk for early progression to intensive therapy.

Primary outcomes:
measure: respiration rate
timeFrame: after 6 12 18 24 and 48 hour of intervention
measure: PCo2
timeFrame: after 6 12 24 and 48 hours of intervention
measure: Modified asthma score (MWAS)
timeFrame: Once daily as long as intervention precedes ( 1-14 days)
Secondary outcomes:
measure: treatment length
timeFrame: from beginning of intervention to discontinuation (1-14 days)
measure: Hspitalization
timeFrame: from hospitalization to release (1-21 days)
measure: Intervention failure.
timeFrame: from beginning of intervention to discontinuation.(1-14 days)
measure: patient acceptance of intervention
timeFrame: daily VAS score (0-5) from beginning of intervention to discontinuation (1-14 days)
Other outcomes:
Locations:
city: Kolding
country: Denmark
facility: Hospital Lillebaelt
city: Kolding
country: Denmark
facility: Signe Vahlkvist
Study officials:
affiliation: Pediatric Award, Hospital of South West Denmark
name: Signe VAhlkvist, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01498913: Observational Study of NovoNorm® in Subjects With Diabetes
Official title: NovoNorm Post Marketing Surveillance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-26
Enrollment: 5841
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Korean people with diabetes mellitus

Brief summary: This study is conducted in Asia. The aim of this study is to review the safety and efficacy of Novonorm® (repaglinide) in post-marketing use.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes

Primary outcomes:
measure: HbA1c (glycosylated haemoglobin)
measure: 2 hours postprandial blood glucose (2-hr PPBG)
measure: Fasting blood glucose (FBG)
measure: Body weight
Secondary outcomes:
measure: Adverse events
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01154413: Implementation of a Diabetes Management Protocol as Compared to Conventional Management in a Heart Hospital's Non-Intensive Care Unit: Randomized Clinical
Official title: Implementation of a Diabetes Management Protocol as Compared to Conventional Management in a Heart Hospital's Non-Intensive Care Unit: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2010-06-30
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To asses the effectiveness of implementing a diabetes management protocol (early insulinization, avoiding use of SSI) in a hearth hospital's non-intensive care unit.

Detailed description: Management of diabetes in patients admitted to non-intensive unit of a cardiology hospital in order to reduce the number of episodes of hypo-and hyperglycemia, improve glucose control and reducing the number of hospital days.

Eligibility criteria:

Patients with previous history of diabetes mellitus type 2, or are in use of oral antidiabetics or insulin or having fasting glucose or less 126 mg / dL or random blood glucose greater 200 mg / dL in both sexes, aged greater 18 years.

Eligibility criteria: Inclusion Criteria:

* Previous history of diabetes mellitus type 2, or they were using oral anti-diabetic or insulin had a fasting glucose greater than or equal to 126 mg / dL or random blood glucose greater 200 mg / dL in both sexes, age greater than or equal 18 years

Exclusion Criteria:

* Patients with known presence of cancer, while using corticosteroids, immunosuppressants on hemodialysis, with cognitive and neurological sequelae, patients whose admission had shorter duration than 72 hours, when they came transferred from intensive care units in other protocols using insulin when no doctor would agree to join the protocol and those who do not agree to participate in the study

Primary outcomes:
measure: Reduction in hypo/hyperglycemia episodes
Secondary outcomes:
measure: Lower mean glycemia, reduced time of stay in hospital
Other outcomes:
Locations:
Study officials:
References:
citation: Moraes MA, Rodrigues J, Cremonesi M, Polanczyk C, Schaan BD. Management of diabetes by a healthcare team in a cardiology unit: a randomized controlled trial. Clinics (Sao Paulo). 2013 Nov;68(11):1400-7. doi: 10.6061/clinics/2013(11)03.