louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02300181: Effect of the Extract of the Flour Fermented With Bacillus Subtilis Var Natto DC-15 on Postprandial Glucose
Official title: A Randomized, Double-blind, Placebo Controlled, Crossover Study to Determine the Effect of the Flour Fermentation Products by Bacillus Subtilis Var Natto DC-15 on Postprandial Glucose Profile in Prediabetic Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Lead sponsor: Hiroshima University
Sponsor class: OTHER
Collaborators: name: NewBio Enterprise Co., ltd.
First posted: 2014-11-24
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of the present study is to evaluate the effect of the extract of the flour fermented with Bacillus subtilis var natto DC-15 on postprandial glucose level in subjects with prediabetes.


Eligibility criteria: Inclusion Criteria:

* Fasting plasma glucose 110-125 mg/dL

Exclusion Criteria:

* Taking anti-diabetic drugs
* Taking drugs or functional food that may affect blood glucose level
* Pregnant or nursing a child
* Participation in any clinical trial within 90 days of the commencement of the trial
* Renal or hepatic dysfunction
* Heart disease
* History of severe disease and/or major surgery

Primary outcomes:
measure: Difference in plasma glucose profile including AUC and Cmax after taking 50 g carbohidrate.
timeFrame: Overall 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: Hiroshima University
Study officials:
affiliation: Hiroshima University
name: Fumiko Higashikawa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06018181: Outcomes After Intravenous Alteplase / Tenecteplase With or Without Shuxuetong Injection in Routine Clinical Practice
Official title: Outcomes After Intravenous Alteplase / Tenecteplase With or Without Shuxuetong Injection in Routine Clinical Practice: A Patient Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ischemic Stroke, Acute
Keywords: Shuxuetong Injection
Intravenous Thrombolysis
Patient Registry
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 2008
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute ischemic stroke who received alteplase or tenecteplase within 4.5 hours of onset

Brief summary: Acute ischemic stroke is one of the main diseases leading to high risk of disability and morbidity worldwide. Since intravenous thrombolysis(IVT) can effectively improve the long-term functional prognosis of acute ischemic stroke(AIS), IVT within 4.5 hours of onset has been widely recommended by international guidelines.

Although 35-53% of AIS patients achieve functional independence after receiving IVT, there are still a large number of patients who are disabled or even dead, and nearly 70% of patients have ineffective recanalization. Therefore, there is an urgent need for therapeutic drugs after IVT to further improve the prognosis and reduce the burden of AIS.

Shuxuetong injection is widely used in China in patients with AIS after IVT, but the situation in real clinical practice is unclear. Therefore, the study aims to evaluate the effectiveness and safety of Shuxuetong Injection in patients with AIS treated with intravenous alteplase and tenecteplase, and obtain high-quality clinical evidence.


Eligibility criteria: Inclusion Criteria:

* Hospitalized patients aged ≥18 years
* Diagnosis of acute ischemic stroke
* Receiving alteplase or tenecteplase treatment ≤ 4.5 hours of onset
* Signed informed consent by patient or legally authorized representatives

Exclusion Criteria:

* Having received or planing to undergo endovascular therapy (including mechanical thrombectomy, arterial thrombolysis, angioplasty, etc.)
* Life expectancy is less than 90 days
* Other factors that the researchers think are not suitable for participating in the research
* Currently receiving any experimental treatment

Primary outcomes:
measure: Proportion of mRS (0-1)
timeFrame: 90±7 days
Secondary outcomes:
measure: Proportion of mRS (0-2)
timeFrame: 90±7 days
measure: Proportion of mRS (0-1) or returning to baseline
timeFrame: 90±7 days
measure: Distribution of mRS
timeFrame: 90±7 days
measure: Change of NIHSS
timeFrame: baseline, 14 days or the day of discharge
measure: BI
timeFrame: 90±7 days
measure: Total mortality
timeFrame: Within 90 days
measure: Serious Adverse Events
timeFrame: Within 90 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03532581: Indocyanine Green Lymphangiography in Identifying Thoracic Duct During Neck Surgery
Official title: A Novel Surgical Technique: Indocyanine Green Lymphangiography for Identification of the Thoracic Duct During Neck Dissection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Dissection
Radical Lymph Node Dissection
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 48
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: This phase I trial studies how well indocyanine green lymphangiography works in identifying thoracic duct during neck surgery. Diagnostic procedures, such as near infrared fluorescence imaging with indocyanine green may help recognize and prevent injury to thoracic duct during neck surgery.

Detailed description: PRIMARY OBJECTIVES:

I. Feasibility and optimization of thoracic duct identification using indocyanine green (ICG) lymphangiography.

II. To explore specifically how identifying the thoracic duct (TD) will prevent injury intra-operatively.

III. To understand if a TD injury can be recognized by leakage of fluorescent chyle into the operating field.

OUTLINE:

Participants receive indocyanine green solution subcutaneously (SC) and undergo near-infrared imaging over 1-2 minutes during their standard of care neck surgery.

After completion of study treatment, participants are followed up for up to 1 year.

Eligibility criteria: Inclusion Criteria:

* Healthy adult patients who are undergoing LEFT modified radical or selective (including zone IV) lymph node dissection for any indication; this includes patients who have had prior neck surgery

Exclusion Criteria:

* Children, minors, pregnant women, women who are breast feeding, institutionalized patients
* Known prior allergic reaction to ICG or allergy to iodine
* Patients with excessively high anesthesia risks who cannot tolerate the extra time under general anesthesia needed to perform this study; the surgeon and anesthesiologist will determine this pre-operatively

Primary outcomes:
measure: Identify thoracic duct (TD) using indocyanine green (ICG)
timeFrame: Up to 1 year
measure: Prevent injury to the TD
timeFrame: Up to 1 year
measure: Recognize injury intra-operatively
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: John Phay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01209481: Impact of Educational Group Intervention on the Consumption of Fruit and Vegetables
Official title: Impact of Educational Group Intervention on the Consumption of Fruit and Vegetables by Adult People Attended to Primary Health Care.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inclusion Criteria:
Adult
No Pregnancy
No Lactation
No Morbidity
Keywords: fruits
vegetables
primary health care
nutritional education
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
First posted: 2010-09-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The right to food and nutrition is established in the Universal Declaration of Human Rights as they are basic requirements for promoting and protecting good health. They can also be instruments to evaluate the quality of life of human beings and communities. Awareness of a healthy diet is the first step in behavioral change, and nutritional education can be an instrument for avoiding diseases resulting from both intake deficit and excess. Educational group actions can change food intake. This study will aim at evaluating, planning and implementing the impact of a nutritional education group action concerning the consumption of fruit and vegetables in adult and elderly individuals attended to by a Primary Health Care (PHCU) Unit. It will be a randomized assay involving two groups comprising male and females individuals distributed in the following fashion: Intervention Group, in which the educational group action (EGA) will be performed in addition to routine activities; and Control Group, the individuals from which will only participate in the routine activities in the PHCA (Teaching Health Care Unit). The total sample will comprise 80 individuals with 40 in each group. In order to determine the consumption of fruit and vegetables, a weekday and a Sunday 24-hour recalls will be performed 2 (short-term effects) and 6 (medium-term effects) months after completing the intervention. The educational group activities will consist of two-hour group dynamics and cooking workshops once a week and for five weeks. Serum carotenoid dosages will also be performed in the two groups by sub-sampling (n=40) with the purpose to validate the estimated intake of fruit and vegetables obtained from the recalls.


Eligibility criteria: Inclusion Criteria:

* adult healthy

Exclusion Criteria:

* pregnancy, lactation, morbidity

Primary outcomes:
measure: consumption of fruit and vegetables
timeFrame: Jan 2011
Secondary outcomes:
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Sao Paulo State University, Faculty of Medicine
state: São Paulo
Study officials:
affiliation: Sao Paulo State University, Faculty of Medicine
name: Maria Antonieta BL Carvalhaes, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02454881: Dose Response Study of Dexmedetomidine in Orthopaedic Spine Surgery Patients
Official title: Dose Response Study of Patient Controlled Analgesia (PCA) of Dexmedetomidine in Orthopaedic Spine Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Helsinki
First posted: 2015-05-27
Enrollment: 107
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the multimodal protocol combining adjunct dexmedetomidine with oxycodone in intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation.


Eligibility criteria: Inclusion Criteria:

* Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia.
* Written informed consent from the participating subject

Exclusion Criteria:

* A previous history of intolerance to the study drug or related compounds and additives
* Concomitant drug therapy with oxycodone or buprenorphine.
* History of ischemic heart disease or conduction disturbance
* BMI \> 35
* Existing significant haematological, endocrine, metabolic or gastrointestinal disease
* History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent
* Allergy to dexmedetomidine or oxycodone
* Blood loss exceeding 1500 ml during operation

Primary outcomes:
measure: Change in opioid consumption (mg) postoperatively
timeFrame: 24 hours
Secondary outcomes:
measure: Change in numerical rating scale (NRS 0-10)
timeFrame: 72 hours
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 72 hours
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital
Study officials:
affiliation: Dept. Anaesthesiology and Intensive Care, University Of Turku
name: Teijo I Saari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00962481: Study to Evaluate the Effect of Bimosiamose on Ozone Induced Sputum Neutrophilia
Official title: A Double-blind, Placebo Controlled, Randomized, Cross-over, Phase IIa Study to Evaluate the Effect of Bimosiamose on Ozone Induced Sputum Neutrophilia in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Revotar Biopharmaceuticals AG
Sponsor class: INDUSTRY
First posted: 2009-08-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability and efficacy of repeated inhalative doses of Bimosiamose on ozone induced sputum neutrophilia in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Able to produce sputum with normal sputum neutrophil levels at screening (\< 65% of non-epithelial cells).
* Ozone responsive, defined as ≥ 20% relative increase in sputum neutrophils cell count after 3 h ozone challenge.
* At screening FEV1 at least 80% of predicted.

Exclusion Criteria:

* Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening for all subjects. Smokers will be defined as any subject who reports of a recent tobacco use and/or who has a urine cotinine ≥ 500 ng/mL.
* Significant illness within two weeks prior to dosing (e.g., infection).
* Recent (within the last three years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Großhansdorf
country: Germany
facility: Pneumologisches Forschungsinstitut GmbH am Krankenhaus Großhansdorf
Study officials:
References:
Clinical trial NCT05093010: The Relationship Between Body Surface Gastric Mapping and Gastric Emptying Rate
Official title: The Relationship Between Body Surface Gastric Mapping (BSGM) and Gastric Emptying Rate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Motility Disorder
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who will receive gastric emptying breath test

Brief summary: Currently, a new generation of high-resolution electrogastrograms recording technology with 64-channel electrode array is being developed by Alimetry Limited. This BSGM provide a more complete understanding of the origin and propagation of human gastric slow-wave activity non-invasively, such as frequency, amplitude, velocity, and pattern, in high spatiotemporal detail. The system is also capable of providing a novel meal response metric, which might correlate with the gastric emptying time. The system includes an App for tracking patient-reported symptoms throughout the test.The aim of the present study is to assess and compare BSGM and breath-based gastric emptying parameters and to study the relation between BSGM and presence or severity of individual symptoms and clinical features.The investigators will perform a study in 100 subjects to record gastric bioelectrical activity by non-invasive multi-channel body-surface electrode arrays during gastric emptying breathing test.


Eligibility criteria: Inclusion Criteria:

* Aged \>18 years old;
* Male or female patients;
* Patients planned GEBT;
* Negative PCR on nasopharyngeal swab 24 or 48 hours prior to the test;
* Signed informed consent.

Exclusion Criteria:

* Females who are pregnant or lactating.
* History of skin allergies or a history of extreme sensitivity to cosmetics or lotions
* Fragile skin vulnerable to skin tears.
* Damaged epigastric skin (open wounds, rash, inflammation)
* Patients unable to remain in a relaxed reclined position for the test duration

Primary outcomes:
measure: Validation of body surface gastric mapping for delayed gastric emptying
timeFrame: 30 minutes before the meal and 4 hours after having meal.
Secondary outcomes:
measure: To assess correlation between electrogastrography abnormality and upper gastrointestinal symptoms.
timeFrame: 30 minutes before the meal and 4 hours after having meal.
Other outcomes:
Locations:
Study officials:
References:
citation: Carson DA, O'Grady G, Du P, Gharibans AA, Andrews CN. Body surface mapping of the stomach: New directions for clinically evaluating gastric electrical activity. Neurogastroenterol Motil. 2021 Mar;33(3):e14048. doi: 10.1111/nmo.14048. Epub 2020 Dec 4.
Clinical trial NCT01612481: Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma
Official title: Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma: Chest Radiograph Versus Chest CT
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Soft Tissue Sarcoma
Lung Metastasis
Keywords: soft tissue sarcoma
lung metastasis
surveillance
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2012-06-05
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cancer surveillance has a significant cost and generate anxiety for the patient.

It is important to avoid exams that will not modify health support or whose results wont allow to decide.

Detailed description: Cancer surveillance has a significant cost and generate anxiety for the patient.

It is important to avoid exams that will not modify health support or whose results wont allow to decide.

Our study will help rationalise surveillance of soft tissue sarcoma and standardize medical practices.

Eligibility criteria: Inclusion Criteria:

* soft tissue sarcoma, histologically proven
* tumor size \> 5 cm (SBR grade 2) or whatever size (SBR grade 3)
* complete excision (R0 or R1)
* no metastasis (checked by spiral chest CT)
* social security covered
* informed signed consent

Exclusion Criteria:

* bone, visceral, uterine, retroperitoneal sarcoma
* GIST
* other malignant tumor
* patients over 70, or for whom thoracic surgery is excluded
* pneumoconiosis or known system disease
* breast feeding or pregnant woman
* patient unable to undergo trail medical follow up for geographic, social or psychological reasons

Primary outcomes:
measure: proportion of patients having an isolated and operable pulmonary relapse
timeFrame: 2 years
Secondary outcomes:
measure: evaluate quality of life
timeFrame: every 3 months for 2 years then every 6 months for the 3rd year
measure: evaluate free disease survival
timeFrame: 5 years
measure: evaluate overall survival
timeFrame: 5 years
measure: evaluate irradiation received
timeFrame: 2 years
measure: estimate false positive rate
timeFrame: 2 years
measure: evaluate global health
timeFrame: every 3 months for 2 years then every 6 months for the 3rd year
measure: medico economic evaluation
timeFrame: 5 years
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Lille
country: France
facility: Oscar Lambret Center
city: Lyon
country: France
facility: Léon BERARD Center
Study officials:
affiliation: Oscar Lambret Center
name: Nicolas PENEL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01097681: A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment
Official title: An Open-Label Study to Assess the Effect of Different Grades of Renal Impairment in Japanese Patients With Type 2 Diabetes Mellitus on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP1941 Relative to Type 2 Diabetes Mellitus Patients With Normal Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Urinary glucose excretion
Diabetes mellitus
ASP1941
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-04-02
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary objective of this study is to compare the pharmacokinetics of ASP1941 in type 2 diabetes mellitus patients with normal renal function and those with mild or moderate renal impairment.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients for at least 12 weeks
* Fasting plasma glucose level of \< 240 mg/dL
* Body Mass Index ( BMI )20.0 - 35.0kg/m2
* GFR value based on the Japanese GFR estimation equation at screening, of ≥ 30 ml/min/1.73m2

Exclusion Criteria:

* Type 1 diabetes mellitus patients
* Receiving insulin within 12 weeks before screening
* Diabetic ketoacidosis
* Dysuria and/or urinary tract infection, genital infection
* Significant renal, hepatic or cardiovascular diseases
* Severe gastrointestinal diseases

Primary outcomes:
measure: Plasma concentration of ASP1941
timeFrame: For 72 hours after dosing
Secondary outcomes:
measure: Urinary levels of ASP1941
timeFrame: For 72 hours after dosing
measure: Urinary glucose excretion
timeFrame: For 72 hours after dosing
measure: Safety assessed by adverse events, vital signs, laboratory tests and 12-lead ECGs
timeFrame: For 72 hours after dosing
Other outcomes:
Locations:
city: Kansai
country: Japan
city: Kantou
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References: