louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02650726: Purified Anthocyanins Supplementation and High-Density Lipoprotein (HDL) Function
Official title: Effect of Purification Anthocyanins on HDL and Endothelial Function in Subjects With Type 2 Diabetes Mellitus: A Randomized, Double-Blinded, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Diabetes Mellitus，Type 2
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: HDL function is impaired in patients with type 2 diabetes mellitus. Anthocyanin, a water-soluble compounds,is beneficial for vascular function by increasing nitric oxide (NO) bioavailability and decreasing oxidative stress. This study was designed to evaluate whether anthocyanin supplementation might improve cardiovascular function in diabetic patients.

Detailed description: The study is designed as a randomized, double-blind label, interventional study on patients with T2DM. The eligible participants are randomly assigned to control and anthocyanins group. During the 24 weeks trial period, the participants are instructed to consume two anthocyanin capsules or placebo capsules twice daily (30 minutes after breakfast and supper).

Eligibility criteria: Inclusion Criteria:

* Subject is diagnosed with type 2 diabetes mellitus according to the Chinese type 2 diabetes prevention guide 2010, diagnostic criteria are as follows: (1) Diabetes symptoms（polydipsia、polyphagia, polyuria, weight loss、skin itching、blurred vision and other acute metabolic network disorder that caused by high blood sugar）combined with random blood sugar ≥11.1 OR, (2) fasting plasma glucose (FPG) ≥7.0 OR, (3) 2 h blood sugar after oral glucose tolerance test (OGTT) ≥11.1
* Subject is between 40 and 60 years of age, inclusive
* Subject's BMI is \>18.5 kg/m2 and \<35 kg/m2.

Exclusion Criteria:

* Subject that is diagnosed as type 1 diabetes, gestational diabetes and other kinds of diabetes expect type 2
* Subject that is pregnant
* Subject that has coronary artery disease, mental disorder, cancer, cirrhosis, renal disease and hepatic disease
* Subject that has had operation less than six months prior to screening visit
* Subject that uses multivitamin supplement or other polyphenol supplement

Primary outcomes:
measure: HDL-associated PON1 activity
timeFrame: 24 weeks
measure: The anti-oxidative ability of HDL
timeFrame: 24 weeks
measure: anti-inflammatory ability of HDL
timeFrame: 24 weeks
Secondary outcomes:
measure: endothelium-dependent flow-mediated dilatation (FMD)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus)
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Di Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03859726: Predictive Value of Sublingual Microcirculation and Peripheral Tissue Oxygen Monitoring
Official title: Predictive Value of Sublingual Microcirculation and Peripheral Tissue Oxygen Monitoring in Sepsis Patients With Successful Fluid Resuscitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: Sepsis, NIRS, sublingual microcirculation
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 72
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: Results for continuous variables with normal distributions were presented as mean±standard deviations (SD)．Results for continuous variables that were not normally distributed were presented as median(Ql，Q1)．

Brief summary: Change and predictive Value of Sublingual Microcirculation and Peripheral Tissue Oxygen Monitoring in Sepsis Patients With Successful Fluid Resuscitation

Detailed description: Fluid therapy for sepsis patients has always been a research hotspot. Early studies suggest that early goal-directed therapy (EGDT) can reduce mortality in patients with sepsis and septic shock, which is included in the guidelines. However, recent studies suggest that EGDT does not reduce mortality. This may be related to the fact that EGDT only pays attention to systemic circulation and neglects microcirculation.

In the past few decades, arterial blood pressure, blood lactic acid and other circulatory indicators have been the target of septic shock treatment, but normal systemic circulation does not mean normal tissue perfusion. Obstacles to tissue perfusion, oxygenation and microcirculation may still exist. At the same time, compared with systemic hemodynamic parameters, microcirculation parameters may play a stronger role in predicting the prognosis of sepsis patients. It is believed that the ideal goal of resuscitation therapy for sepsis should be based on whether microcirculation function has been restored or not.

Objective:to observe the success rate of microcirculation imaging and oxygen saturation of peripheral tissues in sepsis patients under the guidance of current guidelines and procedures. At the same time, we compared the predictive value of microcirculation indicators to the prognosis of septic shock patients.

Eligibility criteria: Inclusion Criteria:

* patients fullfilled the diagnostic criteria of Sepsis 3.0

Exclusion Criteria:

* Patients who were younger than 18 years old，
* pregnant women
* patients who had been admitted to the Intensive Care Unit(ICU for\<24 h)

Primary outcomes:
measure: Sepsis Related Organ Failure Assessment
timeFrame: 72 hours
Secondary outcomes:
measure: 28-day mortality
timeFrame: 28-day
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT05371626: Cicatricial Upper Eyelid Entropion Management
Official title: Suture-less Procedure for Management of Cicatricial Upper Eyelid Entropion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Entropion
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Suture-less technique will be used in treatment for cicatricial upper eyelid entropion to detect its long-term efficacy


Eligibility criteria: Inclusion Criteria:

* Upper eyelid cicatricial entropion with no history of previous surgery.
* Cooperative patients older then 16 years old.

Exclusion Criteria:

* Previous lid surgery.
* Senile and mechanical entropion.

Primary outcomes:
measure: Eyelid margin reposition to the normal position
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Medicine
state: Minia
Study officials:
References:
Clinical trial NCT02031926: Evaluation of Correct PEP Use With the Time
Official title: Evaluation of the Reproductibility of the Pressure Generated by a Positive Expiratory Pressure Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Healthy subjects will be trained to used correctly a positive expiratory pressure device. The aim of the study is to evaluate te reproductibility of the correct used of the device after training


Eligibility criteria: Inclusion Criteria:

* No lung disease
* Older than 18 years

Exclusion Criteria:

* Psychological disorder

Primary outcomes:
measure: Expiratory pressure
timeFrame: within the 7 first days
Secondary outcomes:
measure: Succes rate
timeFrame: Every day
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT01550926: A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms
Official title: A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Keywords: orlistat
overweight
bioequivalence
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-03-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to determine whether a new dosage form and dose of orlistat is equivalent to the currently marketed form.


Eligibility criteria: Inclusion Criteria:

* age: 18-60 years
* Body Mass Index: 25-33

Exclusion Criteria:

* gastrointestinal disease
* organ transplant
* HIV, hepatitis B or C
* food allergies
* alcohol or other substance abuse
* smoking

Primary outcomes:
measure: Fecal fat excretion
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: MDS Pharma Services
state: N. Ireland
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00581126: Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B
Official title: Evaluation of Efficacy and Safety of Benefix®- Coagulation Factor ix, Recombinant, in Previously Treated Patients With Hemophilia b.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemophilia B
Keywords: BENEFIX
Hemophilia B
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-27
Enrollment: 14
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess efficacy and safety of BeneFix® for prophylaxis in "Short-term" therapy and on demand therapy for all bleeding episodes of subjects with hemophilia B.

Detailed description: Phase IV, open-label, non comparative, multicenter, previously treated patients (PTP) clinical trial. Patients with severe or moderate hemophilia B with baseline levels of plasma factor IX \< 5% activity will participate in this study for both treatment regimens: "on demand" therapy for acute bleeding episodes and therapy for prophylaxis of bleeding episodes ( "Short-term therapy")\*.

\* Short-Term Therapy: Prophylactic therapy given before surgery, including dental procedures, prior to a event that would likely result in bleeding ( sports, exercise, or heavy work), as well as to prevent further bleeds into a target joint). This short-term therapy for intermittent secondary therapy.

Eligibility criteria: Inclusion Criteria:

1. Patients with moderate to severe hemophilia B ( \< 5% circulating factor IX activity) having acute hemorrhage or requiring "short-term therapy" for intermittent secondary prophylaxis regimens.
2. HIV seropositive ( asymptomatic) or seronegative subjects.
3. No history or detectable inhibitors.

Primary outcomes:
measure: The primary variable will be the clinical response of BeneFix* in avoiding stopping or avoiding bleeding.
timeFrame: 9 months
Secondary outcomes:
measure: The secondary variables will be hemostasis and blood loss during and after surgery.
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04730726: In Vivo Multispectral Optoacoustic Imaging of Thyroid Nodules
Official title: In Vivo Multispectral Optoacoustic Imaging of Thyroid Nodules
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Nodule
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Thyroid nodules are common in clinical practice. Head and neck ultrasound is recommended as a routine examination for all patients with thyroid lesions. The Thyroid Imaging Reporting And Documentation System (TIRADS) criteria helps to estimate the risk of malignancy based on ultrasound patterns and nodule sizes guiding the performance of fine-needle-aspiration (FNA). Approximately 20% of FNA results cannot be specified whether being benign or malig-nant tissue. A definitive diagnosis can only be made from histopathology after diagnostic (hemi)thyroidectomy. However, (hemi)thyroidectomy has disadvantages as it leads to over-treatment and has a risk of postoperative morbidity (e.g. hypothyroidism and laryngeal nerve injury). Furthermore, (hemi)thyroidectomy is known to be associated with poor quality of life. Clearly, there is an unmet need for additional diagnostic tools in order to identify malignant thyroid nodules and thereby support the decision making for treatment of the thyroid.

Multispectral optoacoustic tomography (MSOT) is an innovative, non-invasive imaging method currently available in the UMCG that enables visualization of endogenous chromophores and exogenous contrast agents using the generation of ultrasound waves due to light absorption by using high frequency pulsed laser light. Recently, this system has been used by other groups for non-invasive determination of thyroid nodules. Results show that multispectral optoacoustic imaging of thyroid nodules may distinguish benign from malignant nodules. However, most certainly, a larger cohort is necessary to confirm this finding.


Eligibility criteria: Inclusion Criteria:

1. Patients with thyroid nodules who underwent or will undergo an ultrasonography (with TIRADS score) with FNA if indicated and will be scheduled for a (hemi)thyroidectomy if indicated;
2. Age ≥ 18 years;
3. Written informed consent.

Exclusion Criteria:

1. Medical or psychiatric conditions that compromise the patients' ability to give informed consent;
2. Previous surgery in head and neck area
3. Previous radiotherapy in head and neck area
4. Pregnancy

Primary outcomes:
measure: MSOT signals of endogenous biomarkers
timeFrame: 2 years
Secondary outcomes:
measure: Potential correlation FNA
timeFrame: 2 years
measure: Potential correlation ultrasound
timeFrame: 2 years
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
Clinical trial NCT04089826: Long Term Oxygen Therapy in Patients With Interstitial Lung Disease
Official title: Role of LTOT in Pateints With ILD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Long Term Oxygen Therapy
Interstitial Lung Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with ILDs who are prescribed for LTOT between eighteen and seventy years old

Brief summary: Study the effect of using long term oxygen therapy in patients with interstitial lung disease and chronic hypoxia

Detailed description: long term oxygen can be used in patients with interstitial lung disease with hypoxia and the aim of this study is to k ow whether this will improve life style , exercise tolerance in those patients

Eligibility criteria: Inclusion Criteria :

* patients with ILD and hypoxia with SO2\<88 at room air and PO2 \< or equal 7.3k.pa or \< or equal 8 k.pa in presence of lower limb edema , pulmonary hypertension or polycythemia
* age group 18 : 70

Exclusion Criteria :

* Causes of chronic respiratory failure other than ILD.

Primary outcomes:
measure: Dyspnea score improvement
timeFrame: Baseline
measure: Quality of life improvement
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Cobo-Ibanez T, Lopez-Longo FJ, Joven B, Carreira PE, Munoz-Fernandez S, Maldonado-Romero V, Larena-Grijalba C, Cubas IL, Muriel ET, Mateos CB, de la Pena Lefebvre PG, Gomez-Gomez A, Nogal LB, Perez A, Almodovar R, Lojo L, Ruiz-Gutierrez L, Lopez-Robledillo JC, Garcia de Yebenes MJ, Nuno-Nuno L. Long-term pulmonary outcomes and mortality in idiopathic inflammatory myopathies associated with interstitial lung disease. Clin Rheumatol. 2019 Mar;38(3):803-815. doi: 10.1007/s10067-018-4353-2. Epub 2018 Nov 3.
Clinical trial NCT01758926: Association Between Inflammatory Activities and Gap Density
Official title: Association Between Inflammatory Activities and Epithelial Gap Density in Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Disease
Keywords: Inflammatory Bowel Disease
Confocal Laser Endomicroscopy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2013-01-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with indications for colonoscopy in Qilu Hospital outpatient and inpatient department.

Brief summary: The study aims to:

1. To determine the relationship between inflammatory activities and epithelial gaps in IBD by CLE and evaluate epithelial gaps healing via dexamethasone treatment.
2. To demonstrated the alteration of local barrier function in IBD using CLE.

Detailed description: The primary end-point of this study was the cohort comparison of epithelial gap density and local barrier function as determined by CLE of subjects with IBD versus controls. Despite discontinuities in the cellular layer, the intestinal barrier function is maintained during this high cell turnover rate at the apical pole of the epithelial layer. Gaps first identified in vivo through acriflavine have pivotal definitions (lacked nuclei or cytosol, appeared to be filled with an impermeable substance). However, Current endoscopic technology does not identify whether there is material present in human gaps, so investigators could not formally resolve whether human epithelial gaps compromise or defend the epithelial barrier.

Eligibility criteria: Inclusion Criteria:

* Male or Female aged 18-80
* IBD： Patients previously diagnosed as having IBD
* Health control: Asymptomatic individuals admitted for health surveillance or patients for follow up after polypectomy.
* Subjects who experienced successful intubation of the terminal ileum.

Exclusion Criteria:

* Subjects age \< 18 or \>80 years
* Subjects under conditions unsuitable for performing CLE including coagulopathy (prothrombin time \<50% of control, partial thromboplastin time \>50 s), cirrhosis, renal dysfunction (creatinine level \>1.2 mg/dL), pregnancy or breastfeeding, acute gastrointestinal bleeding, jaundice and known allergy to fluorescein sodium.

Primary outcomes:
measure: gap density
timeFrame: 6 months
Secondary outcomes:
measure: local barrier function
timeFrame: 6 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Department of Gastroenterology, Qilu Hospital
name: Yanqing Li, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04066426: Efficacy of Naproxen-codeine, Naproxen+Dexamethasone, and Naproxen on Myofascial Pain
Official title: Analgesic Efficacy of Naproxen-codeine, Naproxen+Dexamethasone, and Naproxen on Myofascial Pain: A Randomized Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Temporomandibular Disorder
Keywords: naproxen sodium
codeine phosphate
dexamethasone
pain
temporomandibular joint
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Temporomandibular disorders (TMDs) are one of the most common muco-skeletal disorders, seen in the dental clinics. Many factors work together to initiate or aggravate the condition, so it is a multifactorial disorder. The etiology of TMDs may be a result of parafunctional habits such as clenching and bruxism, acute trauma to the jaw, trauma from hyperextension e.g. after a long dental treatment, joint laxity, psychological distress, occlusal disharmony like presence of high crown or free-end saddle leading to joint instability or systemic diseases such as Rheumatoid arthritis or Osteoarthritis. The aim of this study was to evaluate the effects of naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, and naproxen sodium on pain in patients complaining from temporomandibular pain.


Eligibility criteria: Inclusion Criteria:

* Without a systemic disease,
* Not used any medication in the last week
* Have a habit of clenching and / or grinding teeth, individuals with normal preoperative results, suffering with pain and / or limitation of the mouth opening in the temporomandibular region

Exclusion Criteria:

Individuals who smoke

* Have a parafunctional habits (except for squeezing and grinding teeth)
* Pregnant and breastfeeding individuals
* Allergies to study medicines
* Do not use their medications / use different drugs and non-follow-up

Primary outcomes:
measure: Pain Evaluation
timeFrame: Pre-treatment (baseline)
measure: Pain Evaluation
timeFrame: At the first week
measure: Pain Evaluation
timeFrame: At the second week
measure: Pain Evaluation
timeFrame: At the first month
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Yuzuncu Yil University, Faculty of Dentistry
state: Tuşba
Study officials:
affiliation: Cairo University
name: Volkan KAPLAN, PhD
role: STUDY_CHAIR
References: