louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00260156: A Clinical Study to Assess the Effect of Vildagliptin on Beta Cell Function in Drug Naive Patients With Type 2 Diabetes
Official title: A Clinical Study to Assess the Effect of Vildagliptin on Beta Cell Function in Drug Naive Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-12-01
Enrollment: 59
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is not being conducted in the United States. The purpose of this study is to assess the effect of vildagliptin, an unapproved drug, on various measures of pancreatic islet function in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.


Eligibility criteria: Inclusion Criteria:

* Not currently on drug therapy for type 2 diabetes
* Blood glucose criteria must be met

Exclusion Criteria:

* History of type 1 diabetes
* Evidence of significant diabetic complications
* Serious cardiovascular events within the past 6 months
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in hyperglycemia and arginine-stimulated first phase insulin secretion at 52 weeks
timeFrame: 52 weeks
Secondary outcomes:
measure: Change from baseline in disposition index at 52 weeks
timeFrame: 52 weeks
measure: Change from baseline in hyperglycemia and arginine stimulated second phase insulin secretion at 52 weeks
timeFrame: 52 weeks
measure: Change in hyperglycemia-stimulated first phase insulin secretion at 52 weeks
timeFrame: 52 weeks
measure: Change in hyperglycemia-stimulated second phase insulin secretion at 52 weeks
timeFrame: 52 weeks
measure: Beta-cell function parameter derived from standard meal challenge
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Foley JE, Bunck MC, Moller-Goede DL, Poelma M, Nijpels G, Eekhoff EM, Schweizer A, Heine RJ, Diamant M. Beta cell function following 1 year vildagliptin or placebo treatment and after 12 week washout in drug-naive patients with type 2 diabetes and mild hyperglycaemia: a randomised controlled trial. Diabetologia. 2011 Aug;54(8):1985-91. doi: 10.1007/s00125-011-2167-8. Epub 2011 May 6.
Clinical trial NCT01673256: DEtermining Accuracy and TrEnding CharacTerization of AF
Official title: DEtermining Accuracy and TrEnding CharacTerization of AF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-08-27
Enrollment: 90
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: Primary Care Clinic

Brief summary: The objective of this study is to assess the atrial fibrillation (AF) episode detection when using the SJM(St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor).


Eligibility criteria: Inclusion Criteria:

* The subject has been implanted with a SJM Confirm ICM, DM2102.
* The subject has or is suspected to have paroxysmal AF.
* The subject is ≥ 18 years of age.
* The subject is willing and able to provide written Informed Consent (prior to any investigational related procedure).

Exclusion Criteria:

* The subject has persistent (\>7 days and ≤1 year or requiring cardioversion), longstanding persistent (continuous AF \>1 year) or permanent AF (not attempting to restore sinus rhythm).
* The subject has AF of reversible etiology (e.g. electrolyte imbalance, thyroid disease).
* The subject has a contraindication to Holter recording.
* The subject has already received an active implantable medical device other than the SJM Confirm ICM, DM2102.
* The subject is unable to comply with the follow up schedule.
* The subject is participating in another investigational device or drug investigation.
* The subject is pregnant or is planning to become pregnant during the duration of the investigation.

Primary outcomes:
measure: Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording.
timeFrame: 4 days after Holter starts
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Neustadt
country: Germany
facility: Rhön-Klinikum, Herz- und Gefäß-Klinik
city: Bad Oeynhausen
country: Germany
facility: Herz -und Diabeteszentrum
city: Berlin
country: Germany
facility: Charite, Campus Virchow-Klinikum
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Dresden
country: Germany
facility: University of Dresden - Heart Center
city: Frankfurt
country: Germany
facility: Klinikum Frankfurt Höchst GmbH
city: Ingolstadt
country: Germany
facility: Klinikum Ingolstadt GmbH
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Munich
country: Germany
facility: Isar Heart Center
city: Singen
country: Germany
facility: Hegau-Bodensee-Kliniken
city: Villingen Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum GmbH
city: Den Haag
country: Netherlands
facility: Hagahospital
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital
Study officials:
affiliation: Isar Heart Center Munich
name: Thorsten Lewalter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05773456: Iodine Status After Intake of Sushi and Seaweed Salad
Official title: Iodine Status at Several Time Points During 48 Hours After Intake of Sushi and Seaweed Salad- a Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iodine Deficiency
Keywords: seaweed
bioavailability
iodine
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Institute of Marine Research
First posted: 2023-03-17
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Seaweed is becoming increasingly popular in the Western part of the world, especially sushi wrapped in nori and seaweed salad, also called wakame. There are limited data on the iodine content of different seaweed products in the Norwegian Food composition table. Furthermore, there is limited available research regarding in vivo bioavailability of iodine from seaweeds. The objective of this study is to assess whether iodine from a sushi meal (with nori, Porphyra spp), and a wakame salad (Undaria pinnatifida) has similar bioavailability as a potassium iodide reference supplement of similar iodine content.


Eligibility criteria: Inclusion Criteria:

* healthy women aged 18 to 40 years

Exclusion Criteria:

* pregnant or lactating
* known thyroid disease or thyroid autoimmunity,
* planning to conceive,
* known kidney problems or kidney disease.
* women with coeliac disease could not participate due to possible gluten exposure from the wakame salad

Primary outcomes:
measure: Urinary iodine concentration during 48 hours
timeFrame: 48 hours
measure: Bio-availability of iodine in the intervention/supplement
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University of Bergen
Study officials:
affiliation: Institute of Marine Research
name: Inger Aakre, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06064656: A Non-Interventional Study of Clinical Characteristics and Mortality of US Patients With Fibrodysplasia Ossificans Progressiva (FOP)
Official title: Clinical Characteristics and Mortality in Patients With Fibrodysplasia Ossificans Progressiva (FOP): A Non-Interventional US National Retrospective Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibrodysplasia Ossificans Progressiva (FOP)
Keywords: Genetic disease
Heterotopic ossification (HO)
Skeletal dysplasia
Activin A receptor, type I (ACVR1)
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-10-03
Enrollment: 131
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a confirmed diagnosis of FOP in the United States

Brief summary: Primary Objective(s):

* To describe the demographic characteristics of people living with FOP
* To describe the prevalence of clinical characteristics of interest in people living with FOP
* To describe the use of key medications in people living with FOP
* To estimate the crude mortality rate among people with FOP


Eligibility criteria: Inclusion Criteria:

1. Confirmed FOP diagnosis
2. Members from the International Fibrodysplasia Ossificans Progressiva Association (iFOPA) cohort who have opted-in to be tokenized by Health Verity Marketplace
3. Must be enrolled in the closed medical claims data source for any duration of time between January 1, 2018 and December 31, 2022

Exclusion Criteria:

1. Failure to meet inclusion criteria

Primary outcomes:
measure: Demographic characteristics
timeFrame: Up to 5 years
measure: Prevalence of cardiovascular disease
timeFrame: Up to 5 years
measure: Prevalence of metabolic disease
timeFrame: Up to 5 years
measure: Prevalence of hematology disease
timeFrame: Up to 5 years
measure: Prevalence of infection
timeFrame: Up to 5 years
measure: Prevalence of respiratory disease
timeFrame: Up to 5 years
measure: Prevalence of reproductive disease
timeFrame: Up to 5 years
measure: Prevalence of neurologic disorders
timeFrame: Up to 5 years
measure: Prevalence of skeletal disorders
timeFrame: Up to 5 years
measure: Prevalence of gastrointestinal disease
timeFrame: Up to 5 years
measure: Prevalence of deafness
timeFrame: Up to 5 years
measure: Prevalence of dermatologic disorders
timeFrame: Up to 5 years
measure: Prevalence of neoplasms
timeFrame: Up to 5 years
measure: Average number of prescriptions per FOP patient per year
timeFrame: Up to 5 years
measure: Cumulative number of prescriptions per FOP patient
timeFrame: Up to 5 years
measure: Incidence of all-cause death
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Regeneron
state: New York
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
Clinical trial NCT01903356: A Regulatory Requirement Non Interventional Study to Monitor Safety and Effectiveness of Trajenta Duo in Type 2 Diabetes Patients in Korea
Official title: A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta Duo® (Linagliptin/Metformin HCl, 2.5 mg/500 mg, 2.5 mg/850 mg and 2.5 mg/1000 mg, b.i.d) in Korean Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2013-07-19
Enrollment: 724
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Korean patients with T2DM

Brief summary: The primary objective of this study is to monitor the safety profile of Trajenta Duo in Korean patients with type 2 diabetes mellitus (T2DM) in a routine clinical setting.

Detailed description: Study Design:

Post Marketed Study- Observational study

Eligibility criteria: Inclusion criteria:

Potential subjets must meet all of the following inclusion criteria to enter this trial:

1. No previous exposure to Trajenta, Trajenta Duo
2. Should have been started on Trajenta Duo in accordance with the approved label in Korea
3. No current participation in clinical trials
4. No metformin is inappropriate due to contraindications
5. Must sign on the data release consent form

Exclusion criteria:

Individuals with any of the following characteristics will not be able to enter this study:

1. Previous exposure to Trajenta, Trajenta Duo
2. Current participation in clinical trials
3. Patients for whom metformin is inappropriate due to contraindications

Primary outcomes:
measure: Incidence Rate of Adverse Events (AE)
timeFrame: Up to 26 weeks
Secondary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.
timeFrame: Baseline and Week 24
measure: Target Effectiveness Response Rate
timeFrame: 24 Weeks
measure: Relative Effectiveness Response Rate
timeFrame: 24 Weeks
measure: Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment.
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Korea, Republic of
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT02652156: TAP Block for Postoperative Pain Control
Official title: Transversus Abdominis Plane (TAP) Block Study for Postoperative Pain Control
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: transversus abdominis plane
postoperative
pain
Lead sponsor: Midwestern Regional Medical Center
Sponsor class: OTHER
First posted: 2016-01-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial will examine differences in the effectiveness between three (3) commonly used methods and/or medications used to perform a transversus abdominis plane (TAP) block for post-operative pain control. The transversus abdominis muscle is either side between the lowest rib and the hip bone. Group A subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine injected into the TAP. Group B subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine into the TAP. Group C subjects will be treated with a continuous infusion of the local anesthetic ropivacaine with the ON-Q® pump. There will be no placebo group in this study.


Eligibility criteria: Inclusion Criteria:

* Ability to give written informed consent
* Scheduled for open abdominal surgery
* American Society of Anesthesiologists physical status 1 to 3

Exclusion Criteria:

* Inability to understand the study or provide written informed consent
* Inability to follow protocol instructions
* Complicated history of chronic opioid use including daily use of opioids for a period greater than 2 weeks prior to surgery
* Allergy to local anesthetic agents
* Contraindication to regional nerve block such as:
* Bleeding disorder
* Sepsis
* Infection at site of block
* Body Mass Index (BMI) \>40
* Pregnancy

Primary outcomes:
measure: Total Dosage of Narcotic
timeFrame: 3 postoperative days
Secondary outcomes:
measure: Postoperative Vomiting (Events)
timeFrame: 3 postoperative days
measure: Patient Reported Pain by VAS Scale
timeFrame: Postoperative Day 1
measure: Patient Reported Pain by VAS Scale
timeFrame: Postoperative Day 2
measure: Patient Reported Pain by VAS Scale
timeFrame: Postoperative Day 3
measure: Number of Days Required for a Patient to Get Out of Bed
timeFrame: Assessed daily for up to 3 days post-surgery
measure: Number of Days Required for a Patient to Walk Unassisted
timeFrame: Assessed daily for up to 3 days post-surgery
Other outcomes:
Locations:
Study officials:
affiliation: Midwestern Regional Medical Center
name: Joshua Herskovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05725356: Effectiveness of Physical Exercise on Chronic Non-Specific Neck Pain
Official title: Effectiveness of Physical Exercise on Job Stress and Quality of Life in Office Workers With Chronic Non-Specific Neck Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neck Pain
Lead sponsor: Qassim University
Sponsor class: OTHER
Collaborators: name: University of Tabuk
First posted: 2023-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neck pain is a common medical condition among office workers all over the world. The purpose of this study was to see if physical exercise, such as basic body awareness, neck-specific training exercises, and ergonomic modifications, could help reduce pain, disability, and job stress while also improving quality of life among office workers. Participants will be assigned at random to either an experimental (exercise therapy and ergonomic modification) or a control group (ergonomic modification).


Eligibility criteria: Inclusion Criteria:

* Age 25-60 years
* Greater than 3 months of chronic NSNP.
* Office workers and computer users
* The ability to continue working

Exclusion Criteria:

* A history of severe injury
* Previous physical therapy treatments
* Joint instability
* Frequent migraines
* Spasmodic torticollis
* Inflammatory rheumatic diseases
* Peripheral nerve entrapment
* Severe psychiatric illness
* Pregnancy
* Other conditions that prevent physical loading.

Primary outcomes:
measure: Numerical Pain Rating Scale
timeFrame: Change from baseline pain at 8 weeks
measure: Neck Disability Index
timeFrame: Change from baseline pain at 8 weeks
Secondary outcomes:
measure: Health and Safety Executive Management Standards Indicator Tool
timeFrame: Change from baseline pain at 8 weeks
measure: The Short Form Health Survey
timeFrame: Change from baseline pain at 8 weeks
Other outcomes:
Locations:
city: Buraidah
country: Saudi Arabia
facility: King Fahad Specialist Hospital
Study officials:
affiliation: Physical Therapy Department, College of Medical Rehabilitation Sciences, Qassim University
name: Sattam M Almutairi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04807556: The Alusti Test:Functional Evaluation Scale of Physical Performance in the Geriatric Population
Official title: The Alusti Test: Turkish Validity and Reliability Study of the "Functional Evaluation Scale of Physical Performance in the Geriatric Population".
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Assessment Scale of Physical Performance (Alusti Test) for the Geriatric Population
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 75
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Over the age of 65 geriatrics

Brief summary: With the Alusti Test, which is created by Josu Alustiza Navarro considering the existing tests, the physical performances of geriatricians with different levels and cognitive capacity are evaluated in a very short time and without tiring the patient. There are 2 versions, short and full. The short version is applicable to 100% of the large population, including "and cases of cognitive impairment. With the full version, it has nearly 85-90% applicability."

However, there is no study regarding the English version and validity reliability of the 'Alusti Test.

For this purpose, it is to investigate the English validity and reliability of the functional assessment scale of physical performance (Alusti Test) for the geriatric population and to provide a measurement tool to be used in the English literature to the sciences who want to work in this field.


Eligibility criteria: Inclusion Criteria:

* Being over the age of 65,
* volunteering
* to be able to read and write
* To be able to read and write in Turkish

Exclusion Criteria:

* None

Primary outcomes:
measure: Alusti test
timeFrame: 5 minute
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB).
timeFrame: 5 minute
measure: TimedUp and Go (TUG).
timeFrame: 3 minutes
measure: Mini-Mental State Examination (MMSE)
timeFrame: 3 minutes
measure: Tinetti Test
timeFrame: 5 minutes
measure: Rivermead Mobility Index
timeFrame: 10 minute
measure: Barthel Index
timeFrame: 5 minute
Other outcomes:
Locations:
city: Tuzla
country: Turkey
facility: Emine Atıcı
state: İstanbul
Study officials:
References:
Clinical trial NCT01782456: Tolerance of an Oral Nutritional Supplement(ONS)
Official title: Tolerance of an Oral Nutritional Supplement(ONS)With a New Protein Blend in Healthy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro-Intestinal Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2013-02-04
Enrollment: 25
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The objective of this study is to capture information on gastrointestinal tolerance (GI) of an oral nutritional supplement containing a new protein blend in healthy children aged ≥ 3 to ≤ 10 years.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 3 and ≤ 10 years of age
* Healthy and not suffering from any physical disability.
* Height-for-age and BMI-for-age between the 5th and the 95th percentile as well as a weight-for-age between the 5th and the 85th percentile
* Consumption of 2 servings/day of the investigational product for 7 consecutive days
* Willingness to follow the study procedures and record the data in the diary and complete any forms or assessment as needed throughout the study
* Agreement to not consume a nutritional product that is not study product during the study period

Exclusion Criteria:

* History of an acute or chronic condition that may affect feeding habits or nutritional status
* Medications or nutritional supplements, taken on a daily basis for more than 2 weeks during the past month prior to screening visit that may profoundly affect feeding habits or nutritional status
* Clinically significant nutritional deficiency requiring specific treatment
* Acute/chronic condition requiring medical treatment which may include hospitalization such as diabetes or stress induced hyperglycemia, dialysis treatment, inflammatory bowel disease, pancreatitis, autoimmune disease or immunodeficiency, celiac disease, cystic fibrosis, active tuberculosis, malformation of the gastrointestinal tract or gastroesophageal reflux disease
* History of constipation
* Allergy or intolerance to any ingredient in the study product
* Gastrointestinal infection or acute diarrhea at the time of study start
* Hepatitis B or C, or HIV, or malignancy
* Congenital cardiac defects
* Antibiotic therapy within last 2 weeks of start of study
* Dysphagia, aspiration risk, difficulty in swallowing due to acquired/congenital abnormalities

Primary outcomes:
measure: Gastro-Intestinal Tolerance
timeFrame: Study Day 1-7
Secondary outcomes:
measure: Study Supplement Compliance
timeFrame: Study Day 1-7
measure: Weight
timeFrame: Study Day 1 and 8
measure: Height
timeFrame: Study Day 1 and 8
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Radiant Research, Inc.
state: Ohio
Study officials:
affiliation: Abbott Nutrition
name: Jennifer Williams, MPH
role: STUDY_CHAIR
References: