louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01492166: Observational Study on Efficacy, Safety and Convenience of Using Mixtard® 30 NovoLet® Alone or Combined With OHA in Treatment of Type 2 Diabetes in Routine Clinical Practice
Official title: A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Mixtard® 30 NovoLet® as Monotherapy, or in Combination With Oral Hypoglycaemic Agent ( OHA ), in Treatment of Subjects With Type 2 Diabetes in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-14
Enrollment: 1935
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with type 2 diabetes not achieving adequate control and being prescribed Mixtard® 30 Novolet® either as a single treatment or in combination with oral hypoglycaemic agents (OHAs).

Brief summary: This study is conducted in Asia. The aim of this study is to assess the efficacy, safety and convenience of the use of Mixtard® 30 NovoLet® used alone or combined with oral hypoglycaemic agent (OHA) in the management of type 2 diabetes mellitus in an out-patient setting.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Not adequately controlled on their current therapy

Primary outcomes:
measure: Change in fasting blood glucose (FBG)
measure: Change in 2-hour post prandial blood glucose
measure: Change in HbA1c (glycosylated haemoglobin)
measure: Change in prandial glucose increment (PGI)
Secondary outcomes:
measure: Frequency of minor and major hypoglycaemia
measure: Occurrence of Adverse Drug Reactions (ADR)
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00683566: State Dependent Resonance in the BG-cortical Loops
Official title: State Dependent Resonance in the BG-cortical Loops
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: parkinson
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2008-05-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Neuronal activity in circuits between the basal ganglia (BG) and motor cortical areas is abnormally synchronized and rhythmic. The oscillatory activity prevails at 8-30 Hz in untreated Parkinson's Disease (PD) and its amplitude at both subthalamic and cortical levels inversely correlates with motor impairment. Moreover, these different levels in BG-cortical loops are coherent in this frequency band. The 8-30 Hz activity is suppressed by treatment following treatment with dopaminergic drugs and is partially suppressed prior to and during voluntary movements. An unanswered question is how do BG-cortical loops become so prominently engaged in this oscillatory activity? One possible explanation is that the resonance frequencies of the loops fall in the 8-30 Hz band in the untreated state, so that oscillations in this band are transmitted particularly well. So we hypothesize loop resonances in the 8-30 Hz frequency band at rest, which should be suppressed during movement and following dopaminergic therapy.

Detailed description: Stimulate STN (at 0, 5, 10, 15, 20, 25, 30, 40, 70 and 130 Hz) in chronically implanted patients at rest and during simple and complex motor tasks while recording the steady state evoked potential over the cortex using EEG over the 19 sites of the classical 10/20 system and a channel to record artifact over the stimulator. Experiments will be carried out both in the OFF medication and ON medication condition.

Eligibility criteria: Inclusion Criteria:

* Parkinson's disease idiopathic evolving for more than 5 years
* Electrodes of stimulation implanted in 2 nuclei under - thalamic in the service of functional and stereotaxic neurosurgery of the CHU La timone for at least 6 months
* Doped sensibility superior to 50 % (estimated by the section III of the score UPDRS)
* Efficiency of the stimulation superior to 30 % (estimated by the section III of the score UPDRS)

Exclusion Criteria:

* Patients not verifying the criteria of inclusion
* Absence of data concerning the location of electrodes

Primary outcomes:
measure: The results are expected to bring further light into the understanding of the mechanisms underlying the propagation of pathological oscillatory activities in PD and may provide a basis for different therapeutic strategies.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: AP-HM Timone
state: Bouches Du Rhone
Study officials:
affiliation: AP-HM
name: jean philippe AZULAY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01702766: Bifidobacterium Animalis Subsp. Lactis for Lowering the Risk of Common Infections in Hospitalized Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Tract Infections
Respiratory Tract Infections
Lead sponsor: Children's Hospital Zagreb
Sponsor class: OTHER
First posted: 2012-10-08
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common nosocomial (gastrointestinal and respiratory) infections. Nosocomial infection will be defined as infections which develop more than 48 hours after admission and they are not present or incubating on admission

This study is a prospective, randomized, double blind, placebo- controlled parallel study in children hospitalized at Children's hospital Zagreb.

The study will investigate the effect of supplementation with the probiotic strain Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and respiratory infections.

The test product is a sachet containing 1 gram of powder. The test product will contain minimum 1 billion CFU (colony forming units) probiotic per serving.

The placebo product is an identical product except for the absence of probiotics.

The study includes an intervention period lasting the length of the hospital stay.

The study product will be consumed daily in the morning together with breakfast.

The consumption of the study products will be taken under the surveillance of the physician.

Data on infections will be diagnosed by a physician and recorded in a CRF. The incidence of infections will be analyzed based on the information recorded in the CRF.


Eligibility criteria: Inclusion Criteria:

* Children hospitalized at the Department of Paediatrics, Children's Hospital Zagreb
* Age from 1 year to 18 years
* Signed informed consent by the parents

Exclusion Criteria:

* Immunodeficiency
* Infants from neonatal period until 1 year of age
* Re-hospitalisation (readmission in a hospital within one month)
* Receiving probiotic and /or prebiotic products prior to enrolment (2 weeks prior to hospitalization)
* Neoplasms
* Severe chronic diseases
* Hospitalization shorter than 3 days

Primary outcomes:
measure: Common infections in children
Secondary outcomes:
measure: Duration of symptoms
Other outcomes:
measure: Severity of infection
Locations:
city: Zagreb
country: Croatia
facility: Children's Hospital Zagreb
Study officials:
References:
citation: Hojsak I, Tokic Pivac V, Mocic Pavic A, Pasini AM, Kolacek S. Bifidobacterium animalis subsp. lactis fails to prevent common infections in hospitalized children: a randomized, double-blind, placebo-controlled study. Am J Clin Nutr. 2015 Mar;101(3):680-4. doi: 10.3945/ajcn.114.102004. Epub 2015 Jan 7.
Clinical trial NCT01870466: Pharmacodynamic Drug Interaction Between Cilostazol and Statins
Official title: A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacodynamic Drug Interaction Between Cilostazol and Statins in Healthy Male Volunteer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 63
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate pharmacodynamic drug interaction between cilostazol and statins (simvastatin as a CYP3A substrate and rosuvastatin as a non-CYP3A substrate) in healthy male subjects.

Detailed description: Subjects suitable for this study will visit to the Clinical Trial Center, Samsung Medical Center for 7 days and pharmacodynamic samplings will be performed following the administration of study drugs.

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects aged 20 - 55 years
* A body mass index in the range 18.5 - 27 kg/m2
* Willingness to participate during the entire study period
* Written informed consent after being fully informed about the study procedures

Exclusion Criteria:

* Any past medical history of hepatic, renal, neurologic, cardiovascular, respiratory, endocrine, hemato-oncologic or psychiatric disease
* Active bleeding or bleeding tendency
* History of gastrointestinal disease or surgery possibly affecting drug absorption
* History of clinically significant drug hypersensitivity
* Use of medication within 7 days before the first dose
* Heavy drinker (\>140 g/week)
* Whole blood donation during 60 days before the study
* Judged not eligible for study participation by investigator

Primary outcomes:
measure: lipid lowering effect
timeFrame: 7 days
Secondary outcomes:
measure: anti-platelet effect
timeFrame: 7 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jae-Wook Ko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00151866: Efficacy of Transfusions With Platelets Stored in Platelet Additive Solution II Versus Plasma
Official title: A Multicentre Randomised Study of the Efficacy of Transfusions With Platelets Stored in Platelet Additive Solution II Versus Plasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemato-Oncologic Patients
Myelosuppression
Thrombocytopenia
Keywords: Thrombopenia
Platelet transfusion
Increment
Transfusion reactions
Bleeding complication
Lead sponsor: Sanquin Research & Blood Bank Divisions
Sponsor class: OTHER
First posted: 2005-09-09
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical efficacy of transfusions with platelets stored in platelet additive solution II compared to plasma storage.

Detailed description: Introduction: Utilization of platelet additive solutions (PASs) for storage of platelets has several advantages, however randomised studies testing the clinical efficacy are scarce. A prospective, randomised study comparing the efficacy of transfusions with platelets stored in Platelet Additive Solution II (PAS II) versus plasma showed that CCIs after transfusion with platelets stored in PAS II were significantly lower (1). Major drawbacks of this study were the exclusion of patients with clinical factors known to increase platelet consumption and a limited number of patients. A multicenter, randomised study to investigate clinical efficacy of platelets stored in PAS II versus plasma, also including patients with factors of increased platelet consumption, was performed. Methods: After consent patients \> 18 years, without HLA- and/or HPA-alloantibodies, were randomised to receive pooled platelet concentrates (PC) suspended in either plasma or PAS II, leucoreduced, and stored up to 5 days. 1- and 24-hour CCI were the primary endpoints. Secondary endpoints were transfusion interval, adverse reactions and bleeding complications. An inclusion-period was defined as a maximum of 8 transfusions or 30 days after the first transfusion.

Eligibility criteria: Inclusion Criteria:patients \> 18 years expected to receive platelet transfusions and informed consent -

Exclusion Criteria:HLA- and/or HPA- alloimmunization

-

Primary outcomes:
measure: Corrected count increment
Secondary outcomes:
measure: Bleeding complications
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical centre
Study officials:
affiliation: Sanquin rbbd
name: J.L.H. Kerkhoffs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03266666: Welcome to WellnessRX: Steps Toward a Healthier Life!
Official title: An Evaluation of Lifestyle Change Classes and Grocery Credits to Promote Healthy Behavior Change
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Life Style
Behavior
Food Habits
Stress
Physical Activity
Keywords: grocery
lifestyle
lifestyle change
behavior
nutrition
Lead sponsor: ProofPilot
Sponsor class: INDUSTRY
Collaborators: name: North Coast Opportunities, Inc.
name: Thrive Market
name: Adventist Health Clear Lake
First posted: 2017-08-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Wellness Rx is a 6 class prescription for a healthier lifestyle developed for people in Lake County at all levels of health including those struggling with chronic disease. The classes are running across the community at all times. It is designed for patients that could benefit from healthy diet, exercise, and other healthy lifestyle modifications.

For those participants attending the classes, they have the option of engaging in this evaluation. For those that do, participants will answer questions about their current lifestyle, their and their previous history. They will register attendance at each class and answer questions about their perception of the class. Then at 45 days and 90 days the participants will revisit the same baseline lifestyle questionnaires.

As participants attend classes, and complete questionnaires, they'll unlock grocery credits from online food store ThriveMarket, a basket of fresh produce from the local farmers market and local fitness classes to help you towards your goals. The use of these credits will be tracked through the 90-day point.


Eligibility criteria: Inclusion Criteria:

* Lake County, California Resident
* able to attend 6 lifestyle change classes held around the community

Primary outcomes:
measure: Activity Questionnaire with Eating Behaviors
timeFrame: 45 day
measure: Activity Questionnaire with Eating Behaviors
timeFrame: 90 day
measure: Thrive Market Purchase Decisions
timeFrame: through 90 days
Secondary outcomes:
measure: Customer Satisfaction
timeFrame: within 45 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06720766: Assessment of FibbroScan in Diagnosing MASLD Among the Chinese Population With Obesity
Official title: Assessment of FibbroScan in Diagnosing MASLD Among the Chinese Population With Obesity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fatty Liver Disease
Lead sponsor: The Third People's Hospital of Chengdu
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of patients aged 18 years or older who provided written informed consent and were scheduled to undergo bariatric surgery.

Brief summary: The non-invasive evaluation of liver steatosis and fibrosis with FibroScan is a routinely procedure in clinical practice for people with obesity. However, there are still considerable uncertainties regarding the potential influence of confounding factors and the optimal application of cut-off values for obesity.

The goal of this observational study is to learn about the optimal application of cut-off values of for Chinese people with obesity.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 years or older who provided written informed consent
2. Patients who schedule to undergo bariatric surgery and a liver biopsy (LB) for the investigation of suspected MASLD
3. Patients who schedule to undergo FibroScan examination

Exclusion Criteria:

1. Patients with ascites or pregnant women
2. Patients with any active implantable medical device (such as a pacemaker or defibrillator)
3. Patients who have undergone liver transplantation
4. Patients with cardiac failure and/or significant valvular disease
5. Patients with haemochromatosis
6. Patients who have refused to undergo LB or blood tests
7. Patients with a confirmed diagnosis of active malignancy, or other terminal disease
8. Patients participating in another clinical trial within the preceding 30 days

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: Through study completion, an average of 1 year
measure: Cut-off values
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: The Third People's Hospital of Chengdu
state: Sichuan
Study officials:
References:
Clinical trial NCT03767166: The Archimedes Biodegradable Biliary and Pancreatic Stents
Official title: A Prospective, Single Arm Study to Evaluate the Feasibility of the Archimedes Biodegradable Biliary and Pancreatic Stents Placement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Diseases
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with benign and malignant bilio-pancreatic diseases with an indication to biliary or pancreatic plastic stent positioning during ERCP.

Brief summary: This is a prospective, phase II, single-centre, non-randomised, single-arm study, enrolling patients with benign and malignant bilio-pancreatic diseases with an indication to biliary or pancreatic plastic stent positioning during ERCP.

On procedure day, the study team will confirm that the patient meets all the inclusion criteria and none of the exclusion criteria.

The patient will undergo the ABS insertion and monitored and follow-up accordingly to biodegration variant.


Eligibility criteria: Inclusion Criteria:

* Patients with an indication to position one ore more biliary plastic stents during ERCP
* Patients with an indication to position a pancreatic plastic stent during ERCP

Exclusion Criteria:

* Age \< 18 y
* Life expectancy \< 1 m,
* Inability to pass a guidewire through stricture
* Contra-indication for endoscopy or interventional radiology
* Presence of partial gastric resection
* Unsigned informing consent form, ICF
* Pregnancy
* Pseudo Klatskin tumors (metastases in the liver hilum) and gallbladder carcinoma

Primary outcomes:
measure: Biodegradation time
timeFrame: 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Endoscopy Unit, Humanitas Research Hospital
state: Milano
Study officials:
References:
citation: Anderloni A, Fugazza A, Maroni L, Ormando V, Maselli R, Carrara S, Cappello A, Mangiavillano B, Omodei P, Preatoni P, Galtieri PA, Pellegatta G, Repici A. New biliary and pancreatic biodegradable stent placement: a single-center, prospective, pilot study (with video). Gastrointest Endosc. 2020 Aug;92(2):405-411. doi: 10.1016/j.gie.2020.02.049. Epub 2020 Mar 5.
Clinical trial NCT00966966: Study Evaluating Potential Interaction Between SAM-531 And Gemfibrozil When Co-Administered
Official title: An Open-Label, Nonrandomized Study To Evaluate The Potential Pharmacokinetic Interaction Between SAM-531 and Gemfibrozil, A Cytochrome P-450 2C8 Inhibitor, When Coadministered Orally To Healthy Young Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Alzheimer Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2009-08-27
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of multiple doses of Gemfibrozil on the plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to assess the safety and tolerability of co-administration of SAM-531 and Gemfibrozil.


Eligibility criteria: Inclusion Criteria:

* Body mass index in the range of 18 to 30 kg/m2 and body weight greater than 50 kg.
* Healthy as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG readings.

Exclusion Criteria:

* Presence or history of any disorder that may prevent the successful completion of the study.
* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

Primary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: 24 days
measure: Time to maximum plasma concentration (tmax)
timeFrame: 24 days
measure: Area under the concentration-time curve (AUC)
timeFrame: 24 days
Secondary outcomes:
measure: Safety as measured by adverse event monitoring, ECG, vital signs, and laboratory tests
timeFrame: 24 days
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: