louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01725607: Postoperative Sleep Quality in Patients Undergoing Thoracic Surgery With Different Types of Anesthesia Management
Official title: Postoperative Sleep Quality in Patients Undergoing Thoracic Surgery With Different Types of Anesthesia Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: General Anesthesia, Thoracic Epidural Anesthesia
Keywords: dexmedetomidine, thoracic epidural anesthesia
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2012-11-14
Enrollment: 219
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: We designed a study to determine whether a single dose of dexmedetomidine or thoracic epidural anesthesia combined with general anesthesia would provide hemodynamic stability, reduce stress hormone responses, inhibit inflammatory cytokine secretion, and improve sleep quality in patients after thoracic surgery.

Detailed description: We designed a prospective, single-blinded, randomized, and controlled study to determine whether a single dose of dexmedetomidine or thoracic epidural anesthesia combined with general anesthesia would provide hemodynamic stability, reduce stress hormone responses, inhibit inflammatory cytokine secretion, and improve sleep quality in patients after thoracic surgery.

Eligibility criteria: Inclusion Criteria:

* lung surgery
* one-lung ventilation.

Exclusion Criteria:

* body mass index exceeding 30 kg/m2,
* autonomic dysfunction,
* cardiovascular disease,
* neurological or psychiatric diseases

Primary outcomes:
measure: inflammatory cytokine secretion and postoperative sleep quality
timeFrame: immediately before anesthesia (T1), 5 min after endotracheal intubation (T2), immediately after incision (T3), 5 min after OLV initiation (T4), 5 min after double-lung ventilation initiation (T5), and immediately after extubation (T6)
Secondary outcomes:
measure: amine secretion during the surgical period and hemodynamic stability
timeFrame: immediately before anesthesia (T1), 5 min after endotracheal intubation (T2), immediately after incision (T3), 5 min after OLV initiation (T4), 5 min after double-lung ventilation initiation (T5), and immediately after extubation (T6)
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Department of Anesthesiology, the First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: Dept. of Anesthesiology, the First Hospital of CMU
name: Hong Ma, M.D.,PhD.
role: STUDY_CHAIR
References:
Clinical trial NCT02525107: Prevention of Vaso-occlusive Painful Crisis by Using Omega-3 Fatty Acid Supplements
Official title: Omega 3 Fatty Acid Therapy for Prevention of Vaso-occlusive Crisis and Manifestations in Omani Patients With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Sickle Cell Disease
Keywords: Prevention of Vaso Occlusive Painful Crisis
Lead sponsor: Sultan Qaboos University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Sultanate of Oman
name: London Metropolitian University
First posted: 2015-08-17
Enrollment: 280
Sex: ALL
Minimum age (years): 13
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 140 SCD patients \[70 on Hydroxyurea\] will receive Omega-3 capsules whereas another 140 SCD patients \[70 on Hydroxyurea\] will receive placebo and will be recruited from the Sultan Qaboos University Hospital \[SQUH\] haematology specialty clinics. Patients will be randomized in a 1:1 ratio to receive placebo or Omega-3 for 52 weeks. The aim is to investigate the therapeutic potential of omega-3 fatty acids in the prevention of vaso-occlusive crisis in Omani patients with sickle cell disease\[SCD\].


Eligibility criteria: Inclusion Criteria:

* Moderate to severe Sickle cell disease patients.
* Patients already receiving Hydroxyurea\[HU\] are eligible for the study.
* Patients able and willing to comply with the procedures in the study protocol.

Exclusion Criteria:

* Acute episodes (infection, vaso-occlusive crises (VOC), acute chest syndrome (ACS), stroke, priapism, splenic sequestration) in the past one month before enrolment.
* Previous stroke, and other co-morbid diseases like Essential Hypertension, Cardiomyopathy and Heart failure, Diabetes, Chronic Renal Failure.
* Patients with a history of adverse reaction to omega-3 fatty acid supplementation.
* Blood transfusion in the previous 3 months.

Primary outcomes:
measure: Frequency of VOC
timeFrame: 52 weeks
measure: Severity of VOC
timeFrame: 52 weeks
measure: Duration of Hospitalization
timeFrame: 52 weeks
Secondary outcomes:
measure: Red blood cells membrane fatty acids profile
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Muscat
country: Oman
facility: Department of Haematology, Sultan Qaboos University
Study officials:
References:
Clinical trial NCT01613807: Humalog® Mix50/50(tm) as a Treatment for Gestational Diabetes
Official title: Phase 4 Humalog® Mix50/50(tm) for the Treatment of Insulin Requiring Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gestational Diabetes Mellitus
Keywords: gestational diabetes mellitus
insulin analogues in pregnancy
Lead sponsor: Sansum Diabetes Research Institute
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2012-06-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the Safety and Efficacy of Humalog® Mix50/50TM administered as 3 injections daily to Humalog® plus Humulin N® insulin administered as 6 separate injections daily in terms of glucose control for women with Gestational Diabetes.

Detailed description: Controlling hyperglycemia during pregnancy decreases the risk of adverse neonatal and maternal outcomes. Not only must fasting glucose be normalized, but clinical evidence also indicates that controlling postprandial hyperglycemia will significantly reduce the risk of adverse neonatal and maternal outcomes.

Standard therapy to achieve near-normal glycemia in gestational diabetes involves combining intermediate-acting basal (NPH) insulin with rapid-acting insulin (insulin lispro), thereby requiring 6 daily injections. Premixed Humalog® Mix50/50TM has the potential advantage over combination rapid-acting plus NPH insulin because it involves fewer injections, and those injections are associated with mealtime. The potential downside to the premixed formulation is nocturnal hypoglycemia associated with the time lag between the dinner and breakfast dose. This study will evaluate the efficacy and safety of Humalog® Mix50/50TM compared to that of Humalog® plus Humulin N® insulin for the treatment of insulin-requiring patients with gestational diabetes mellitus, while monitoring glucose control, intrauterine growth and assessing pregnancy outcomes.

Eligibility criteria: Inclusion Criteria:

* Pregnant and at least 13 weeks gestation
* Diagnosed with gestational diabetes mellitus
* Failed diet therapy

Exclusion Criteria:

* \<18 years old or over 45 years old
* urine dipstick \>2+ protein
* blood pressure \>140/80 mmHg
* hematocrit \<30%
* refusal to take insulin
* inability to understand instructions or to consent to participate.

Primary outcomes:
measure: Hemoglobin A1C
timeFrame: During Pregnancy (at approximately 28 weeks gestation)
Secondary outcomes:
measure: Birthweight of Infant
timeFrame: End of pregnancy
Other outcomes:
Locations:
Study officials:
affiliation: Sansum Diabetes Research Institute
name: Kristin Castorino, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05699707: Metabolomic Signature of Exogenous Ketosis
Official title: The Effect of Acute Exogenous Oral Ketone Supplementation on the Plasma Metabolomic Signature in Healthy Individuals: An Exploration of Novel Ketone-derived Metabolites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ketosis
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2023-01-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm pilot study
Primary purpose: BASIC_SCIENCE

Brief summary: Ketone bodies are a fuel source and signaling molecule that are produced by your body during prolonged fasting or if you consistently eat at low-carbohydrate diet. Blood ketones can be used as a source of energy during fasting and are used by your brain as an alternative source of fuel to glucose. Previous studies have found that ketones, when consumed in form of a supplement drink, can increase blood ketone levels and lower blood glucose, the amount of sugar in your blood. This is of potential interest for individuals with high blood sugar, such as people living with type 2 diabetes. However, how ketone supplements impact metabolism is not fully understood but using high throughput analysis techniques that can characterize hundreds to thousands of metabolites in the blood (known as "metabolomics") may allow researchers to discover novel compounds within the body that are altered by ketone supplements. This will improve our understanding of how ketones impact metabolism and guide future research.


Eligibility criteria: Inclusion Criteria:

* over the age of 18 years
* able to fast overnight

Exclusion Criteria:

* being a competitive endurance athlete
* following a ketogenic diet, low-calorie diet, periodic fasting regimen, or regular consuming ketone supplements
* being unable to travel to and from the university
* being pregnant or planning to become pregnant during the study
* having been diagnosed with a chronic disorder of glucose or fat metabolism, including type 2 diabetes, chronic pancreatitis, or gallbladder disease
* being unable to read or communicate in English

Primary outcomes:
measure: Beta-hydroxybutyrate-derived metabolites
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia
Study officials:
References:
Clinical trial NCT04197388: Inspiratory Muscle Training in Pulmonary Arterial Hypertension
Official title: Inspiratory Muscle Training in Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Hypertension
Lead sponsor: Golden Jubilee National Hospital
Sponsor class: OTHER_GOV
First posted: 2019-12-13
Enrollment: 20
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
Primary purpose: TREATMENT

Brief summary: Pulmonary arterial hypertension is a rare condition characterised by high blood pressure in the lungs and results in breathlessness and reduced exercise capacity for patients. Previous research has shown weakness in respiratory muscles in these patients that may contribute towards their symptoms. Despite advances in medical therapy, the condition still results in a significant symptom burden.

Inspiratory muscle training is a non-invasive intervention involving a device that provides resistance to the muscles of inspiration and increases their strength.

This study will investigate the benefit of inspiratory muscle training in patients with pulmonary arterial hypertension who are stable on medical therapy for three months. This will be performed as an outpatient and they will then be reviewed following this with assessment of exercise capacity, breathing capacity (spirometry), quality of life, and assessment of neural respiratory drive (the signals from the brain to the muscles controlling breathing).

The study will be based at the Golden Jubilee National Hospital and patients will be recruited from outpatients who are already under the care of the Scottish Pulmonary Vascular Unit.


Eligibility criteria: Inclusion Criteria:

* diagnosed by pulmonary hypertension specialist with precapillary pulmonary hypertension
* able to give consent
* stable on medical therapy for at least 3 months

Exclusion Criteria:

* significant contribution to pulmonary hypertension from lung disease
* pregnant

Primary outcomes:
measure: Six minute walking distance
timeFrame: 3 months
Secondary outcomes:
measure: Quality of life: emPHasis 10 score
timeFrame: 3 months
measure: Peak VO2
timeFrame: 3 months
measure: VE/VCO2 slope
timeFrame: 3 months
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
Study officials:
References:
Clinical trial NCT00795288: Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)
Official title: Effect of Statins on Cerebral Blood Flow After Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Subarachnoid Hemorrhage
Keywords: subarachnoid hemorrhage
vasospasm
cerebral blood flow
cerebral metabolism
autoregulation
statin
Vasospasm associated with Subarachnoid hemorrhage
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2008-11-21
Enrollment: 42
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 primary objective of this project is to investigate the effect of statin therapy on cerebral blood flow in patients with aneurysmal SAH who are randomized to receive or not receive statins in a blinded design.

Detailed description: We will determine if statin therapy improves CBF in patients with aneurysmal subarachnoid hemorrhage. This improvement, if present, may be due to improved basal CBF, improved autoregulatory function, or a mitigation of large arterial narrowing. The information gain from this study will help us to better understand the mechanism of action of statins. This knowledge may be useful in the design of future studies with statins and in the development of other therapies aimed at similar mechanisms.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* SAH from ruptured cerebral aneurysm within 48 hours of admission.
* Modified Fisher grade 2,3,or 4
* Planned surgical or endovascular aneurysm repair

Exclusion Criteria:

* Pregnancy
* SAH secondary to traumatic or mycotic aneurysms
* Pre-ictal statin therapy
* Contraindication to stain therapy
* WFNS grade 5
* Contraindications to MAP elevation on day 7-10

Primary outcomes:
measure: Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk
timeFrame: 7-10 days after hemorrhage
measure: Cerebral Autoregulation During Peak Period of Vasospasm Risk
timeFrame: 7-10 days after hemorrhage
Secondary outcomes:
measure: Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk
timeFrame: 7-10 days after hemorrhage
Other outcomes:
Locations:
city: ST Louis
country: United States
facility: Washington Univeristy
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Michael Diringer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diringer MN, Dhar R, Scalfani M, Zazulia AR, Chicoine M, Powers WJ, Derdeyn CP. Effect of High-Dose Simvastatin on Cerebral Blood Flow and Static Autoregulation in Subarachnoid Hemorrhage. Neurocrit Care. 2016 Aug;25(1):56-63. doi: 10.1007/s12028-015-0233-7.
Clinical trial NCT02386488: Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and Women
Official title: A Randomised, Open-label, Single-centre, Single- and Multiple-dose Interventional Study Investigating the Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2015-03-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the pharmacokinetic (PK) parameters of vortioxetine after single and multiple oral dosing to healthy Chinese men and women.


Eligibility criteria: Inclusion Criteria:

* Healthy young Chinese men or women
* Between 18 and 45 years of age (extremes included)
* BMI between 18.5 and 24 kg/m2 (extremes included)
* Body weight ≥45 kg.

Exclusion Criteria:

* Pregnant or lactating.
* Previously been dosed with vortioxetine
* The subject has taken any investigational medicinal products within 3 months prior to the first dose of IMP (investigational medicinal product)

Other protocol defined inclusion and exclusion criteria may apply

Primary outcomes:
measure: Pharmacokinetics (PK) of vortioxetine and its metabolites: Cmax, AUC, t1/2, oral clearance, apparent volume of distribution, accumulation index, metabolic ratio
timeFrame: Day 1 to 312 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: CB801
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT02838888: Computer-assisted Detection of Colonic Polyps
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Adenoma
Keywords: Adenoma
computer
automatic
polyp
detection
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Fraunhofer Institut Erlangen
First posted: 2016-07-20
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving colonoscopy at the study site are eligible for participation.

Brief summary: Screening colonoscopy is considered the gold standard for adenoma detection in the colon. However, it has been shown that a considerable number of polyps can be missed during screening colonoscopy. Until now the endoscopist himself is responsible for the detection of adenomatous polyps. No automatic tools are available supporting the colonoscopist to detect lesions. Recently, a computer program was developed that can be used to recognize and extract suspicious structure from colonoscopy video sequences. The program was built to automatically detected colonic polyps and to highlight the polyps by colour marking. The program was now refined so that the respective structures can be highlighted during real time colonoscopy. The aim of this feasibility study is to test whether the software is applicable during real time colonoscopy.


Eligibility criteria: Inclusion Criteria:

* Indication for colonoscopy
* age ≥ 40 years

Exclusion Criteria:

* American Society of Anesthesiologists class IV or higher
* pregnant women
* indication for colonoscopy: inflammatory bowel disease
* indication for colonoscopy: polyposis syndrome
* indication for colonoscopy: emergency colonoscopy e.g. acute bleeding

Primary outcomes:
measure: Polyp detection
timeFrame: up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
state: Bayern
Study officials:
References:
citation: Klare P, Sander C, Prinzen M, Haller B, Nowack S, Abdelhafez M, Poszler A, Brown H, Wilhelm D, Schmid RM, von Delius S, Wittenberg T. Automated polyp detection in the colorectum: a prospective study (with videos). Gastrointest Endosc. 2019 Mar;89(3):576-582.e1. doi: 10.1016/j.gie.2018.09.042. Epub 2018 Oct 17.
Clinical trial NCT06965088: Comparison of Recurrence Rate of Keloid After Excision Between Intra-operative Steroid Injection and Steroid With Platelet-rich Plasma Injection Combination Therapy
Official title: Comparison of Recurrence Rate of Keloid After Excision Between Intra-operative Steroid Injection and Steroid With Platelet-rich Plasma Injection Combination Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Patients With Keloid Scar
Keywords: Keloid
Steroid
Triamcinolone
Platelet rich plasma
PRP
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 212
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: Keloid scars are benign skin lesions characterized by excessive collagen deposition, and their treatment remains challenging due to a high recurrence rate even after surgical excision. Combination therapies have been shown to be more effective than monotherapy. A common approach for treating recurrent keloids is surgical excision followed by intralesional corticosteroid injection; however, recurrence rates remain substantial. This study was conducted to evaluate the recurrence rate of keloid scars following surgical excision combined with intralesional corticosteroid and platelet-rich plasma (PRP) injection, compared to corticosteroid injection alone administered intraoperatively.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Having keloid scars less than 10 centimeters in length
* Undergoing complete keloid excision (extralesional excision)
* Undergoing surgery under local anesthesia

Exclusion Criteria:

* Patients currently receiving immunosuppressive drugs or systemic steroids
* Patients with chronic diseases under active treatment, such as tuberculosis
* Pregnant or breastfeeding women
* Patients likely to have poor treatment adherence, such as those with cancer, epilepsy, or psychiatric disorders
* Patients with vascular diseases or hematologic/coagulation abnormalities

Primary outcomes:
measure: Recurrence rate of keloid
timeFrame: Within 12 months after end of the intervention
Secondary outcomes:
measure: Itching at scar
timeFrame: Within 12 months after end of the intervention
measure: Pain at scar
timeFrame: Within 12 months after end of the intervention
measure: Skin atrophy
timeFrame: Within 12 months after end of the intervention
measure: Skin telangiectasia
timeFrame: Within 12 months after end of the intervention
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Study officials:
References: