louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01184768: HBA1c and Diagnosis of Type 2 Diabetes
Official title: HBA1c and Diagnosis of Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
HbA1c
vitamin D
diagnosis
Lead sponsor: University of Tromso
Sponsor class: OTHER
First posted: 2010-08-19
Enrollment: 3509
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: random sample of subjects living in Tromso and who participated in the 6 th Tromsø study

Brief summary: Following the 6th Tromso study subjects with HbA1c \> 5.7 plus a subsample of subjects with lower hba1c values will be invited to an oral glucose tolerance test to see the predictive value of HBA1c in the diagnosis of type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* participated in the 6 Tromso study

Exclusion Criteria:

* type 2 diabetes

Primary outcomes:
measure: Number of subjects with new diagnosis of type 2 diabetes
timeFrame: Up to 2 years after participation in the 6th Tromso study
Secondary outcomes:
measure: Number of subjects with new diagnosis of impaired glucose tolerance
timeFrame: Up to 2 years after participation in the 6th Tromso study
measure: Number of subjects with new diagnosis of impaired fasting glucose
timeFrame: Up to 2 years after participation in the 6th Tromso study
measure: Effect of vitamin D status on glucose tolerance
timeFrame: Up to 2 years after participation in the 6th Tromso study
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: University of Tromso
name: rolf jorde, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04096768: The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation
Official title: Combining Dexmedetomidine and Ketamine in Intensive Care Sedation: Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: ICU Patients
Sedation
Lead sponsor: Lebanese American University Medical Center
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to compare the use of dexmedetomidine + ketamine with dexmedetomidine + placebo for sedation in ICU patients in terms of safety and efficacy


Eligibility criteria: Inclusion Criteria:

* Age between 18-80 years old
* Admitted to Intensive care unit at LAUMCRH
* Need for sedation for at least 24 hours
* Informed Consent Form signed by patient or surrogate

Exclusion Criteria:

* Pregnant patients
* At risk of increased intracranial pressure
* Aortic dissection
* Acute coronary syndrome
* Hypertension (SBP \> 180 mmHg)
* Chronic alcoholism
* Acute alcohol intoxication
* Alcohol withdrawal
* Refractory status epilepticus
* History of psychiatric disorder
* Known allergy or contraindication to use of dexmedetomidine or ketamine
* Baseline hypotension (MAP\<65 mmHg)
* Baseline bradycardia (HR\<48 bpm)
* Patients receiving neuromuscular blocking agents
* Patients requiring deep sedation as determined by the ICU attending

Primary outcomes:
measure: Measuring blood pressure to assess hypotension when using a combination of the two drugs for sedation versus Dexmedetomidine and placebo only
timeFrame: Within 24 hours of drugs administration
Secondary outcomes:
measure: Measuring the doses of dexmedetomidine and ketamine when combined and the doses of dexmedetomidine when used alone to achieve desired level of sedation
timeFrame: Within 24 hours of drugs administration
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Lebanese American University Medical Center- Rizk Hospital
Study officials:
References:
Clinical trial NCT06141668: Optimal Stimulation Parameters to Disrupt Epileptiform Activity
Official title: Optimal Stimulation Parameters for Spike-ripple Disruption in Patients Undergoing Invasive Monitoring
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Refractory Epilepsy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Boston University
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2023-11-21
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Open-loop electrical stimulation has been found to reduce spike activity and seizures, but determining the optimal parameters to achieve these effects requires a brute force trial-and-error approach that relies on subjective physician discretion. We will compare the performance of stimulation parameters identified in rodent models to the recommended parameters for neuromodulation used in clinical practice.


Eligibility criteria: Inclusion Criteria:

- Undergoing intracranial EEG investigation at Massachusetts General Hospital during presurgical epilepsy evaluation

Exclusion Criteria:

- Baseline spike ripple rate \< 0.5/min.

Primary outcomes:
measure: Spike ripple rate
timeFrame: 1-3 hours
Secondary outcomes:
measure: Spike rate
timeFrame: 1-3 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Catherine Chu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04189068: Fatal Cerebral Infarction After Nasal Augmentation With Hyaluronic Acid
Official title: Fatal Cerebral Infarction and Ophthalmic Artery Occlusion After Nasal Augmentation With Hyaluronic Acid - A Case Report and Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Magnetic Resonance Angiography
Keywords: Cerebral Infarction Hyaluronic Acid Embolism
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2019-12-06
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with severe cerebral infarction and ophthalmic artery occlusion after nasal augmentation by HA.

Brief summary: this study discussed the pathogenesis, treatment, and prognosis of severe cerebral infarction and ophthalmic artery occlusion for Aisan induced by hyalruonic acid filler injection.

Detailed description: Intra-arterial thrombolysis and retrobulbar injection of hyaluronidase have been used for HA-induced ophthalmic artery obstruction.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of cerebral infarction

Exclusion Criteria:

* fat embolism

Primary outcomes:
measure: pulse
timeFrame: 0-6 day
measure: blood pressure
timeFrame: 0-6 day
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Qing
state: Shaan XI Province
Study officials:
affiliation: Xijing Hospital
name: Ma
role: STUDY_DIRECTOR
References:
citation: Li KT, Huang YH, Chen CH, Chou LW. Delayed-onset cerebral infarction after cosmetic facial injection using hyaluronic acid. J Formos Med Assoc. 2016 Jul;115(7):587-8. doi: 10.1016/j.jfma.2015.11.012. Epub 2016 Jan 4. No abstract available.
Clinical trial NCT01264068: The Influence of Chinese Medicine on Metabolomics in Menopausal or Postpartum Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Menopausal Women
Keywords: Suan-Tsao-Jen-Tang ,Jia-Wey-Shiau-Yau-San,metabolomics,menopause
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: National Taiwan University Hospital
First posted: 2010-12-21
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Traditional Chinese herbal medicine, no matter mono-therapy or poly-pharmacy, is composed of complicated chemical constituents. Many confounding factors influence activity of Chinese herbs, including the origin of the herbs, safety of the products and consistency between batches. Study of the effectiveness and mechanism of Chinese herbs in vivo is much more challengeable due to unresolved problems of product quality control, screen of effective principles, monitor of the marker constituents and the targets for site of action. In this project, we will introduce the concept of metabolomics to detect total metabolites spectra as the biomarkers of Chinese herbs intervention. Correlation will be analyzed between changes in total metabolites and clinical improvements when menopausal women receive Suan Tsao Jen Tang or Jia Wey Shiau Yau San, and postpartum women receive生化湯.


Eligibility criteria: Inclusion Criteria:

* Insomnia according to PSQI\>6
* Informed consent
* Female
* Age 40-65 years

Exclusion Criteria:

* In 3 months before participating in and studying, happen great accident or heavy night shift or have time difference problems (such as the long-range flight) .
* Spiritual disease (melancholia,etc.) ,obstructive sleep apnea, heart disease history (the acute heart attack, cardiac arrhythmia) , hypertension , diabetes mellitus, cancer.
* Take melatonin or melatonin agonist, such medicines as acetylcholine, glutamate, serotonin, norepinephrine, GABA, histamine, adenosine, prostaglandins,etc..

Primary outcomes:
measure: Total metabolites detection using LC/MS/MS
timeFrame: one month
Secondary outcomes:
measure: 1.Menopause rating scale (MRS) 2.Pittsburgh sleep quality index (PSQI)
timeFrame: one month
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei City Hospital
Study officials:
affiliation: Associate Professor, School of Pharmacy,National Taiwan University
name: Yen-Hui Chen, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT02008968: Effect of Allopurinol Treatment on Insulin Resistance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperuricemia
Prediabetes
Insulin Resistance
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 130
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Several studies showed that hyperuricemia is an independent risk factor for development of diabetes mellitus. However none of the previous studies have investigated the effect of lowering serum uric acid levels on insulin resistance of which is also named as prediabetes. With this background in mind, we aimed to test the effect of lowering serum uric acid level with allopurinol on insulin resistance.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 30
* Serum uric acid level ≥7mg/dL
* Glomerular filtration rate ≥60 ml/min

Exclusion Criteria:

* presence of Diabetes Mellitus
* history of gout
* history of allopurinol use
* body mass index ≥35 kg/m2
* proteinuria ≥ 1gr/ day
* presence of autoimmune disease
* rheumatology associated disease
* presence of hypothyroidism or hyperthyroidism
* presence of diseases which may cause chronic inflammation or microalbuminuria (e.g. malignancy, chronic liver disease, hypertension, chronic lung disease)

Primary outcomes:
measure: Change in insulin resistance (HOMA-IR)
timeFrame: baseline and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University Goztepe Training and Research Hospital
state: Marmara
Study officials:
affiliation: Istanbul Medeniyet University
name: Ali Bakan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03441568: In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control
Official title: In-home Use Test of the New Modified Diprobase® Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-02-22
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the safety and tolerability of the modified Diprobase formulation over 14 days in infants and children with a history of Atopic Dermatitis (AD).


Eligibility criteria: * Children with normal or dry skin and a history of mild to moderate AD, but without any signs or symptoms within the last month prior to enrollment
* Skin type I - VI according to Fitzpatrick skin classification
* Aged 6 months to 48 months

Primary outcomes:
measure: Number of participants with adverse event (AE)
timeFrame: Up to 14 days
measure: Severity of adverse event
timeFrame: Up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Altrincham
country: United Kingdom
facility: West Timperley Medical Centre
Study officials:
References:
Clinical trial NCT04168268: Patient-reported Outcome Measures After Post-anesthesia Care Unit Delirium
Official title: Influence of Post-anesthesia Care Unit Delirium After Radical Prostatectomy on Self-reported Cognitive Function and Health-related Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Neurocognitive Disorders
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 222
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective radical prostatectomy for prostate cancer at a high-volume prostate cancer center were screened on the day before surgery.

Brief summary: To assess self-reported cognitive function and health-related quality of life in patients with and without early postoperative delirium

Detailed description: Neurocognitive disorders including postoperative delirium are a serious complication after surgery and anesthesia in the elderly. Postoperative delirium is an acute-onset diffuse brain dysfunction that is characterized by a fluctuating course of confusion, disorganized thinking, inattention, irritability, disturbances of the circadian rhythm, and disorders of consciousness. Post-anesthesia care unit (PACU) delirium occurs immediately after emergence from anesthesia and affects up to 45% of patients after elective surgery.

It is unclear, whether PACU delirium is associated with intermediated or long-term adverse outcomes including neurocognitive disorders or mortality. The aim of this prospective observational was to assess self-reported cognitive function and health-related quality of life in patients with and without PACU delirium three months after radical prostatectomy.

Eligibility criteria: Inclusion Criteria:

* elective radical prostatectomy
* \>60 years
* fluent in German

Exclusion Criteria:

* preexisting cognitive impairment
* cerebrovascular disease

Primary outcomes:
measure: Self-reported cognitive failures
timeFrame: three months
Secondary outcomes:
measure: Health-related quality of life
timeFrame: three months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
Study officials:
References:
citation: Kainz E, Stuff K, Kahl U, Wiessner C, Yu Y, von Breunig F, Nitzschke R, Haese A, Graefen M, Fischer M. Impact of postanesthesia care unit delirium on self-reported cognitive function and perceived health status: a prospective observational cohort study. Qual Life Res. 2022 Aug;31(8):2397-2410. doi: 10.1007/s11136-022-03087-1. Epub 2022 Jan 27.
Clinical trial NCT05914168: Clinical Data Collection in Breast Tomosynthesis (COBRIS)
Official title: Clinical Data Collection in Breast Tomosynthesis: COBRIS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 150
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the study is to assess an image acquisition application for breast tomosynthesis in a clinical environment

Detailed description: After being informed about the study and potential risks, all patients giving written informed consent will undergo their routine mammography examination. One additional mammography view will be obtained with the investigational application and analyzed. Subject participation is expected to last no more than 30 minutes. After the mammography examination, subjects will be followed according to the hospital standard of care.

Eligibility criteria: Inclusion Criteria:

* Women aged 35 years or older;
* Women referred for unilateral or bilateral 2D and 3D mammography;
* Women able and willing to comply with study procedures;
* Women able and willing to participate in this study who have signed and dated the informed consent form; and
* Women surgically sterile or postmenopausal or, the possibility of pregnancy is ruled out based on a negative urine pregnancy test

Exclusion Criteria:

* Women who have been previously included in this study; or
* Be a minor, protected adult, adult deprived of liberty by judicial or administrative decision, pregnant, parturient or a breastfeeding mother; or
* Women with BRCA 1 or BRCA 2 gene mutation

Primary outcomes:
measure: Data Collection
timeFrame: 1 year
Secondary outcomes:
measure: Assessment of Image Quality
timeFrame: 1 year
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Balleyguier
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05152368: Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells Exosomes for Trigeminal Neuralgia
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells Exosomes for the Treatment of Trigeminal Neuralgia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Peripheral Neuropathy
Trigeminal Neuralgia
Keywords: Peripheral Neuropathy
Trigeminal Neuralgia
stem cell treatment
Lead sponsor: The Foundation for Orthopaedics and Regenerative Medicine
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will study the safety and efficacy of instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes for the treatment of Trigeminal Neuralgia.

Detailed description: This patient funded trial aims to study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cell (UC-MSCs) exosomes for the treatment of Trigeminal Neuralgia. Patients will receive an intranasal instillation of UC-MSCs exosomes. The total dose will be approximately 800 billion exosomes split evenly between both nasal cavities via Tian Syringe through 4 CCs of AlloEx. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Trigeminal Neuralgia or Peripheral Neuropathy
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur

Primary outcomes:
measure: Safety (adverse events)
timeFrame: Four year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: St. John's
country: Antigua and Barbuda
facility: Medical Surgical Associates Center
Study officials:
affiliation: The Foundation for Orthopaedics and Regenerative Medicine
name: Chadwick Prodromos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02411604: Expanded Access Study for Renal Transplant Patients With Envarsus XR ™
Official title: Expanded Access Study for Renal Transplant Patients With Envarsus XR™: Envarsus 3007
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Renal Failure
Lead sponsor: Veloxis Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-04-08
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Open label, multi-center, expanded access study for renal transplant patients with once daily Envarsus XR (Tacrolimus).

Detailed description: The study is designed to facilitate expanded access of Envarsus XR treatment to renal transplant patients. Patients are identified by the site investigator as a patient who has experienced favorable outcomes while in an Envarsus XR (LCP-Tacro) clinical study and/or the site investigator has identified a renal transplant patient with a medical need for an alternative tacrolimus treatment versus the patient's current tacrolimus treatment.

Eligibility criteria: Inclusion Criteria:

* Eligible patients will fulfill all of the following criteria:

  1. Patient age ≥18years old
  2. Willing to give written informed consent and is able to speak, write and understand English
  3. Patient understands potential risks or benefits with treatment of Envarsus XR
  4. Patients who have received a primary or secondary kidney transplant
  5. Patient who have received prior treatment with Envarsus XR (LCP-Tacro) and who are not currently participating in an Envarsus/LCP-Tacro study OR
  6. The treating Investigator has identified the patient as having a medical necessity for switching from their current tacrolimus treatment to Envarsus XR: Investigator is aware the medical necessity for switching is not related to the inability to purchase available tacrolimus.

Exclusion Criteria:

* Patients fulfilling any of the following criteria are NOT eligible for study inclusion:

  1. Recipients of organ transplants other than kidney
  2. Pregnant or nursing (lactating) women, or planning to become pregnant, where pregnancy is defined as a state of female after conception and until the termination of gestation, confirmed by a positive hCG serum or urine laboratory test.
  3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant who are unwilling to use a defined SOC method of contraception, UNLESS they are
* Women whose career, lifestyle, or sexual orientation preclude intercourse with a male partner
* Women whose partners have been sterilized by vasectomy or other medically approved means

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: