louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00103857: MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)
Official title: A Multicenter, Randomized, Double-Blind Factorial Study of the Co-Administration of MK0431 and Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-02-16
Enrollment: 1208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus (T2DM) (a specific type of diabetes).


Eligibility criteria: Inclusion Criteria:

54-Week Base Study:

* Patients between the ages of 18 and 78 with Type 2 Diabetes Mellitus (a specific type of diabetes)

  50-Week Extension Study:
* Patients who complete the 54-week base study are eligible to enter the 50-week extension study

Exclusion Criteria:

* Patients who do not have Type 2 Diabetes Mellitus (a specific type of diabetes)

Primary outcomes:
measure: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24
timeFrame: Week 24
measure: Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24
timeFrame: Week 24
measure: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54
timeFrame: Week 54
measure: Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54
timeFrame: Week 54
measure: Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54
timeFrame: Week 54
measure: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104
timeFrame: Week 104
measure: Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104
timeFrame: Week 104
measure: Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104
timeFrame: Week 104
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Goldstein BJ, Feinglos MN, Lunceford JK, Johnson J, Williams-Herman DE; Sitagliptin 036 Study Group. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care. 2007 Aug;30(8):1979-87. doi: 10.2337/dc07-0627. Epub 2007 May 7.
citation: Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
Clinical trial NCT04016857: Remote Ischemic Preconditioning During Lower Limb Revascularization
Official title: Effects of Remote Ischemic Preconditioning on Renal Outcomes Following Lower Limb Revascularization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Preconditioning
Acute Kidney Injury
Limb Ischemia
Keywords: remote ischemic preconditioning
lower limb revascularization
TIMP-2
IGFBP-7
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients were randomly assigned in 1:1 ratio to either control group or RIPC using computerized randomization table
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the role of remote ischemic preconditioning (RIPC) in preventing acute kidney injury after lower limb revascularization.

Remote ischemic preconditioning(RIPC) is a simple, cost-free and non invasive procedure (transient upper limb ischemia/reperfusion) that could provide organ protection (Heart, Brain and Kidney) following ischemia injuries.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for open limb revascularization

Exclusion Criteria:

* Peripheral vascular disease affecting upper limbs
* Chronic kidney disease in stage 4 or 5 (eGFR\<30 ml/min/1,73m2)
* Patients underwent contrast-enhanced radiological exams in the previous 7 days
* Treatment with glibencamide or prostaglandins

Primary outcomes:
measure: AKI
timeFrame: 72 Hours
measure: AKI
timeFrame: 72 Hours
Secondary outcomes:
measure: AKI Risk Score
timeFrame: 24 Hours
Other outcomes:
Locations:
city: Messina
country: Italy
facility: A.O.U. G.Martino - University of Messina
Study officials:
affiliation: University of Messina
name: Alberto Noto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00094757: An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)
Official title: A Multicenter, Randomized, Double-Blind Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-10-25
Enrollment: 521
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus.


Eligibility criteria: Inclusion Criteria:

* Patients at least 18 years of age and not older than 75 who have a specific type of diabetes called Type 2 Diabetes Mellitus

Exclusion Criteria:

* Younger than 18 years of age or older than 75
* Any condition, which in the opinion of the investigator, may not be in the patient's best interest to participate

Primary outcomes:
measure: Change From Baseline in A1C at Week 18
timeFrame: Weeks 0-18
Secondary outcomes:
measure: Change From Baseline in FPG at Week 18
timeFrame: Weeks 0-18
measure: Change From Baseline in A1C at Week 54
timeFrame: Weeks 0-54
measure: Change From Baseline in FPG at Week 54
timeFrame: Weeks 0-54
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Raz I, Hanefeld M, Xu L, Caria C, Williams-Herman D, Khatami H; Sitagliptin Study 023 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus. Diabetologia. 2006 Nov;49(11):2564-71. doi: 10.1007/s00125-006-0416-z. Epub 2006 Sep 26.
Clinical trial NCT00985257: Performance of a New Glucose Meter System in Children and Young Adults
Official title: Performance of the DIDGET Blood Glucose Monitoring System in Children and Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2009-09-28
Enrollment: 123
Sex: ALL
Minimum age (years): 4
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the performance of a new blood glucose meter in the hands of children, teens, young adults.


Eligibility criteria: Inclusion Criteria:

* Type 1 or Type 2 diabetes
* Age 4 to 24 years
* Routinely performs blood glucose testing at home
* If age 18 or older at time informed consent is signed, subject must be able to speak, read, and understand English.
* If younger than age 18, subject's parent/guardian must be able to speak, read, and understand English, and is able to provide appropriate supervision.
* Is willing to complete all study procedures, with or without parent / guardian supervision, if appropriate

Exclusion Criteria:

* Currently pregnant
* Hemophilia or any other bleeding disorder
* Taking prescription anticoagulants (such as Warfarin or heparin) or has clotting problems that may prolong bleeding. Taking Plavix or aspirin daily is not excluded
* Infection with a blood borne pathogen (e.g., HIV, hepatitis)
* Subject or parent/guardian is employee of competitive medical device company
* Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study

Primary outcomes:
measure: Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method
timeFrame: 1-2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Tallahassee
country: United States
facility: Larry C. Deeb, MD PA
state: Florida
Study officials:
affiliation: AMCR Institute
name: Timothy Bailey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Larry C. Deeb, MD PA
name: Larry C Deeb, MD PA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00592657: Incidence of Rhabdomyolysis Among Patients Admitted With Jimsonweed Ingestions
Official title: Incidence of Rhabdomyolysis Among Pediatric and Adolescent Patients Admitted for Jimsonweed (Datura Stramonium) Ingestions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhabdomyolysis
Myoglobinuria
Hemoglobinuria
Keywords: retrospective chart review
Jimsonweed ingestion
Lead sponsor: Akron Children's Hospital
Sponsor class: OTHER
First posted: 2008-01-14
Enrollment: 46
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with rhabdomyolysis/ myoglobinuria/ hemoglobinuria (in-patient, out-patient, ER visit) at a CHMCA facility

Brief summary: Retrospective chart review to determine the presence of rhabdomyolysis among patients admitted to CHMCA from 1997-2007 with Jimsonweed ingestions and to define possible risk factors predisposing patients to the developement of Jimsonweed-associated rhabdomyolysis.


Eligibility criteria: Inclusion Criteria:

* admitted to CHMCA between 1/1/1997 to 12/31/2007 with a qualifying ICD-9 diagnosis code for rhabdomyolysis, myoglobinuria, and hemoglobinuria (728.88, 791.2, 791.3)or other ICD-9 codes identified during the study
* between the ages of 0-21 years at diagnosis

Exclusion Criteria:

* rhabdomyolysis or serum CK concentrations not actually documented
* patient admitted to the burn center
* patient \> 21 years of age

Primary outcomes:
measure: The presence of rhabdomyolysis based on serum CK concentrations in patients admitted with history of Jimsonweed ingestion.
timeFrame: From admission until discharge
Secondary outcomes:
measure: Renal function, liver function, vital signs, physical exam
timeFrame: From admission until discharge
Other outcomes:
Locations:
city: Akron
country: United States
facility: Children's Hospital Medical Center of Akron
state: Ohio
Study officials:
affiliation: CHMCA
name: Martha Blackford
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forrester MB. Jimsonweed (Datura stramonium) exposures in Texas, 1998-2004. J Toxicol Environ Health A. 2006 Oct;69(19):1757-62. doi: 10.1080/15287390600631284.
citation: Ertekin V, Selimoglu MA, Altinkaynak S. A combination of unusual presentations of Datura stramonium intoxication in a child: rhabdomyolysis and fulminant hepatitius. J Emerg Med. 2005 Feb;28(2):227-8. doi: 10.1016/j.jemermed.2004.11.006. No abstract available.
citation: Giannoglou GD, Chatzizisis YS, Misirli G. The syndrome of rhabdomyolysis: Pathophysiology and diagnosis. Eur J Intern Med. 2007 Mar;18(2):90-100. doi: 10.1016/j.ejim.2006.09.020.
Clinical trial NCT02166957: Evaluation of the Effectiveness of Endoscopic "Rendez-vous" Technique Foresophageal Reconstructions for the Treatment of a Total and Extensive Disruption of the Esophagus
Official title: Evaluation of the Effectiveness of Endoscopic "Rendez-vous" Technique for Esophageal Reconstructions for the Treatment of a Total and Extensive Disruption of the Esophagus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Disruption
Esophageal Obstruction
Keywords: Esophageal disruption
anterograde-retrograde endoscopy
rendez-vous technique
NOTES
recanalization
dilatations
Stenting
radiation therapy
head and neck carcinoma
Lead sponsor: Société Française d'Endoscopie Digestive
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a retrospective report about six patients referred for complete esophageal disruption

Brief summary: Complete esophageal obstructions leads to definitive fasting. The rendez-vous endoscopic approach had already been described for complex stenoses but never for disruption with loss of tissue and SES. Patients and methods: This is a retrospective observationnal study about patients referred for complete esophageal disruption and classified in two groups: 1/ Long disruption (\> 5cm), after caustic ingestion or due to an esophageal stripping during SEMS removal; 2/ Short disruption (\< 5cm), consecutive to radiation therapy. All the procedures are performed according the anterograde retrograde approach, using CO2 and under X-rays guidance. We report the characteristeristics of the procedures, the efficacy, the time before discharge and refeeding, the complications, and the follow-up, especially the number of dilatation sessions for each group. The hypothesis is that anterograde retrograde endoscopic technique is safe and effective for the management of esophageal disruptions in patients for which the surgical treatment confers a high risk of morbidity and mortality.


Eligibility criteria: Inclusion Criteria:

* Esophageal disruption with or without loss of SES

Exclusion Criteria:

* Esophageal Complex stenosis
* Mediastinitis
* Severe sepsis
* Coagulation abnormalities
* Contra-indications to general anesthesia

Primary outcomes:
measure: Effectiveness of the rendez vous approach for treating esophageal disruption
timeFrame: 2 days
Secondary outcomes:
measure: Number of endoscopic sessions
timeFrame: Up to 2 years
measure: Time before refeeding
timeFrame: 15 days
measure: Complications
timeFrame: 7 days
measure: Number of endoscopic dilation sessions after recanalization
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: APHM, North Hospital, Department of gastroenterology
Study officials:
References:
Clinical trial NCT03105557: Rickets Device - Feasibility Study
Official title: Rachitis Device Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rickets
Keywords: Prematurely born newborns
Urine
Collecting device
Lead sponsor: Capturin Distribution B.V.
Sponsor class: INDUSTRY
Collaborators: name: Fonds NutsOhra
name: FrieslandCampina
name: Rijnstate Hospital
name: Scint B.V.
name: Hertog Hendrik BV
name: University of Twente
name: Radboud University Medical Center
First posted: 2017-04-10
Enrollment: 10
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will consist of prematurely born neonates who are admitted to the neonatology unit. And for which the attending physician has an indication to screen for rickets using calcium,phosphate and creatinine level measurement in urine.

Brief summary: On a daily basis many (prematurely born) newborn are subjected to different urine collecting techniques to study biochemical abnormalities. Neonatology nurses and pediatricians are looking for a better and less invasive manner to collect urine in these vulnerable patients. We hypothesise that the urine collecting device as presented in this protocol is less invasive and has good functional abilities to collect urine in these newborns

Objective of the study:

Clinical feasibility of the urine collection device, indicated by staff and parents.

Study design:

The study will be an open label, clinical feasibility study, of the urine collection device. During a period of 6 months, 30 feasibility tests will be performed.

Study population:

Prematurely born newborns, admitted to the neonatology unit of the department of pediatrics at Rijnstate Hospital Arnhem.


Eligibility criteria: Inclusion Criteria:

* Neonates admitted to the neonatology unit of the paediatrics department of Rijnstate Hospital Medical indication for urine testing for Calcium, Phosphate and Creatinine levels Informed consent from parents

Exclusion Criteria:

* No informed consent
* Defective skin in genital region
* Three previous tests in the same subject

Primary outcomes:
measure: Questionnaire based clinical feasibility of the urine collection device, indicated by staff and parents
timeFrame: 1 day
Secondary outcomes:
measure: Skin reactions
timeFrame: 1 week
measure: Skin irritability
timeFrame: 1 week
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Petra Van Setten
state: Gelderland
Study officials:
References:
Clinical trial NCT02781857: Mass Spectral Fingerprinting in Lung Cancer
Official title: Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS) in Patients With Lung Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Cancer
Keywords: Exhaled Breath
Mass Spectrometry
Fingerprinting
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology
First posted: 2016-05-25
Enrollment: 393
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with lung cancer will be included according to the predefined inclusion and exclusion criteria.

Matched controls will be recruited from the general population by printed flyers, newspaper advertisements and personal communication.

Brief summary: To answer the question whether a disease specific profile of breath in patients with lung cancer can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.


Eligibility criteria: Inclusion Criteria:

* Confirmed lung cancer based on cytological or histological analysis.
* Group A: any type of lung cancer eligible for surgical resection (up to TNM stage IIIa).
* Group B: any type of lung cancer (small-cell carcinoma, non-small-cell carcinoma) not amenable for surgical resection.
* Group C: matched controls.
* Age between 18 and 85 years at study entry

Exclusion Criteria:

* Another 'active' secondary malignant disease (e.g. breast cancer, colon carcinoma) in group A and B, presence of any active malignant disease in group C (based on personal information).
* Acute inflammatory disease (e.g. common cold) within the last 4 weeks.
* Any other acute lung disease which affects breath measurements
* Acute or chronic hepatic disease.
* Renal failure or renal replacement therapy.

Primary outcomes:
measure: Concentration of volatile organic compounds (VOCs) in the exhaled breath will be analysed using mass spectrometry
timeFrame: 1 day, single measurement
Secondary outcomes:
measure: Group A: Concentration of volatile organic compounds (VOCs) in the exhaled breath will be analysed using mass spectrometry before and after lung cancer surgery
timeFrame: Group A: 2 measurements on 2 different days; Day 1: 1. measurement (before surgery), Day 2: (6-12 weeks after surgery): 2. measurement
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Pneumology
state: ZH
Study officials:
affiliation: University of Zurich
name: Malcolm Kohler, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04246957: Quality of Life Comparison in Patients With Different Types of Alopecia
Official title: Quality of Life Comparison in Patients With Different Types of Alopecia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alopecia
Quality of Life
Keywords: alopecia
quality of life
partner
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every patient consulting in the dermatology department of Amiens' University Hospital for a primary alopecia will have to fill out 2 questionnaires of quality of life: one general (DLQI : Dermatology Life Quality Index) and one specific (Hair Specific Skindex 29). Every patient partner will have to complete one questionnaire of quality of life: FDLQI (Family DLQI).

Brief summary: Hair loss is a frequent cause of patient consultation in dermatology. It is known to have a strong impact on patients' quality of life for many reasons; such as esthetic aspect, financial implications, social consequences. Numerous studies have assessed the impact of some types of alopecia on patients' quality of life. One study compared the quality of life in patients with scarring alopecia with patients of non-scarring alopecia. No studies have compared quality of life between the different types of scarring alopecia nor different types of non-scarring alopecia. However, none have assessed the impact on the patient partner quality of life. In addition, few treatments for alopecia are covered by national health insurance in France. The main objective is to compare the impact on the quality of life in different types of alopecia. By using the average scores of the questionnaire Dermatology Life Quality Index (DLQI) for each type of alopecia.


Eligibility criteria: Inclusion Criteria:

* patients affiliated to social security
* patients able to understand and fill out a questionnaire
* patients over 18 years old
* patient consulting in the dermatology department of Amiens University Hospital for a primary alopecia

Exclusion Criteria:

* minors
* patients under guardianship, deprived of liberty
* scalp affections other than alopecia
* secondary alopecia

Primary outcomes:
measure: Variation of score of questionnaire Dermatology Life Quality Index (DLQI) according alopecia type in patient life
timeFrame: at day 0
Secondary outcomes:
measure: Variation of score of questionnaire Dermatology Life Quality Index (DLQI) according alopecia type in spouse life
timeFrame: at day 0
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Catherine LOK, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Thomas Baltazard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Nesrine Zitouni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Fanny Dessirier, MD
role: PRINCIPAL_INVESTIGATOR
References: