louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00396357: Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone
Official title: A Multicenter, Double-blind, Randomized Parallel-group, Study to Demonstrate the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd as add-on to Metformin 500 mg Bid Compared to Metformin 1000 mg Bid in Patients With Type 2 Diabetes Inadequately Controlled on Metformin 500 mg Bid Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
vildagliptin
hemoglobin A1c
metformin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-11-06
Enrollment: 914
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* 18-78 years inclusive
* Type 2 diabetes diagnosis at least 2 months prior to study entry
* Body mass index in the range of 22-45 kg/m2
* HbA1c in the range of 6.5 to 9% inclusive
* Fasting plasma glucose \<270 mg/dL (15 mmol/L)

Exclusion Criteria:

* A history of type 1 diabetes
* Evidence of significant diabetic complications
* Treatment with insulin or any other oral antidiabetic agents
* Congestive heart failure requiring pharmacologic treatment
* Clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels \>/= 1.5 mg/dl (males) and \>/= 1.4 mg/dl (females)

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in hemoglobin A 1 c (HbA1c) after 24 weeks of treatment
timeFrame: 24 weeks
Secondary outcomes:
measure: Adverse event profile after 24 weeks of treatment
timeFrame: 24 weeks
measure: Gastrointestinal tolerability after 24 weeks of treatment
timeFrame: 24 weeks
measure: Patients with endpoint HbA1c <7% and <6.5% after 24 weeks
timeFrame: 24 weeks
measure: Patients with reduction in HbA1c >0.7% after 24 weeks
timeFrame: 24 weeks
measure: Change from baseline in fasting plasma glucose after 24 weeks
timeFrame: 24 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
city: Multiple Locations
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06659757: A Study to Investigate the Safety and Tolerability of Single and Multiple Ascending Doses of KIT2014 in Healthy Subjects
Official title: A Single-Centre, Double-Blinded, Randomised, Placebo-Controlled Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of KIT2014 in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cystic Fibrosis
Lead sponsor: Kither Biotech Srl
Sponsor class: INDUSTRY
Collaborators: name: Avance Clinical Pty Ltd.
First posted: 2024-10-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is the first-in-human study with KIT2014 designed to provide safety, tolerability and pharmacokinetic data in healthy volunteers.

Detailed description: This is a double-blind, randomised, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of ascending doses of inhaled KIT2014 administered via nebulizer to healthy adult participants. The study will be conducted in 2 parts, Part A (single ascending dose, SAD) and Part B (multiple ascending doses, MAD).

Eligibility criteria: Major Inclusion Criteria:

1. Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
2. Adult males and females, 18 to 55 years of age (inclusive) at screening.
3. BMI ≥ 18.0 and ≤ 32.0 kg/m2, with a body weight of at least 60 kg for males and 50 kg for females.
4. Medically healthy, as determined by pre-study medical history, and without clinically significant abnormalities.
5. Normal spirometry results at Screening based on FEV1 ≥ 80% of predicted, FVC ≥ 80% of predicted and FEV1/FVC ratio ≥0.70.

Major Exclusion Criteria:

1. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, determined by the PI to be clinically relevant.
2. Any respiratory infection or relevant respiratory problem within 14 days of Day 1.

Other inclusion/exclusion eligibility criteria apply.

Primary outcomes:
measure: Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs)
timeFrame: Up to 10 days post-dose in SAD and up to 14 days after the last dose in MAD
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX Clinical Research Pty Ltd
state: South Australia
Study officials:
References:
Clinical trial NCT00708357: Does eNOS Gene Polymorphism Play a Role in the Maintenance of Basal Vascular Tone in the Choroid or Optic Nerve Head?
Official title: Does eNOS Gene Polymorphism Play a Role in the Maintenance of Basal Vascular Tone in the Choroid or Optic Nerve Head?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Ocular Physiology
Regional Blood Flow
Keywords: eNOS Gene Polymorphism
ocular blood flow
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-07-02
Enrollment: 12
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Nitric oxide (NO) is a potent endothelium-derived vasodilatator that plays a major role in the control of ocular blood flow. Endothelial NO synthase (eNOS) is one of three isoforms of NOS producing NO through hydroxylation of L-arginine. The eNOS gene is located on the long arm of chromosome 7, and different polymorphic variations have been identified. These single nucleotide polymorphisms (sNP´s) have the ability to change transcription activity and therefore enzyme levels. Recent data indicate that the T -786C polymorphism (especially the homozygous variant) is associated with reduced eNOS activity and consequently impaired NO production.

In the present study the investigators want to investigate if the T -786C eNOS gene polymorphism determines choroidal and optic nerve head blood flow.


Eligibility criteria: Inclusion Criteria:

* Men aged between 19 and 35 years, nonsmokers
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Homozygous variants of the T -786C genotyping (CC or TT)
* Normal ophthalmic findings, ametropia less than 3 diopters

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks

Primary outcomes:
measure: Genotyping
timeFrame: performed during the first year before measurements
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology
Study officials:
affiliation: Department of CLinical Pharmacology
name: Michael Wolzt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01815957: Impact of Ranolazine on Coronary Microcirculatory Resistance
Official title: Impact of Ranalozine on Coronary Microcirculatory Resistance- A Prospective Single Center Study to Evaluate the Effect of Ranalozine in Microcirculatory Resistance (MICRO Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Microcirculation
Coronary Artery Disease
Myocardial Disease
Ischemia
Keywords: coronary microcirculation
coronary artery disease
myocardial disease
ischemia
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2013-03-21
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being done to determine if Ranolazine treatment improves coronary microcirculation function among patients with coronary microcirculation dysfunction. We are also looking to learn if symptomatic improvement of chest pain during treatment with Ranalozine is related to improved coronary microcirculation function.


Eligibility criteria: Inclusion Criteria:

* - Patients with subjective symptoms of ischemia without flow limiting angiographic CAD (\<50% epicardial coronary stenosis) and abnormal IMR (\>20 U).
* Definition of ischemia (any one):

  * chest pain with dynamic ischemic ECG changes (t wave inversions or \> 1 mm ST depressions
  * Exercise treadmill testing induced chest pain with ≥1 mm of downsloping or flat ST segment depression during exercise or recovery; ≥2 mm of ischemic ST depression at a low workload (stage 2 or less or ≤130 beats/min); early onset (stage 1) or prolonged duration (\>5 min) of ST depression; multiple leads (\>5) with ST depression
  * Nuclear stress perfusion defect \> 10%
  * Stress echocardiogram with stress induced wall motion abnormality

Exclusion Criteria:

* - Age \< 18 yrs
* Flow Limiting epicardial CAD \>50%
* Life expectancy \< 6 months
* Recent (\<1 week) myocardial infarction or positive biomarkers
* Severe aortic stenosis
* Contraindications to IMR testing including inability to utilize antithrombotic therapy and/or intravenous adenosine
* Contraindications to Ranolazine therapy:
* Patients with known hepatic insufficiency, prolonged QT or renal failure (GFR \< 60)
* use of drugs that inhibit CYP3A such as diltiazem, verapamil, ketoconazole, macrolides and HIV protease inhibitors
* Pregnancy, breastfeeding
* Patients taking drugs which prolong QT interval

Primary outcomes:
measure: Number of Participants Assessed for Relative Change in the Index of Microcirculatory Resistance Before and After Ranolazine Therapy
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Health Science Center
state: New Mexico
Study officials:
affiliation: Assistant Professor, IM Div Cardiology
name: Bina Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06298357: Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation
Official title: Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation Patients: Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pediatric Cancer
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 16
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: There will be 2 parallel groups, immediate start group and waitlist control group. Once control participants finish the wait period (8 weeks), they will start the intervention (8 weeks). Participants in the immediate start group will start exercise and mindfulness in the hospital and continue the program for 8 weeks outside of the hospital.
Primary purpose: TREATMENT

Brief summary: This study will explore the potential benefits of a virtual reality gaming program that focuses on mindfulness and exercise among pediatric cancer rehabilitation patients. The program will last 8 weeks outside of the hospital. Participants will start immediately in the hospital (immediate start group) or wait 8 weeks after hospital discharge to start the program (waitlist control group).


Eligibility criteria: Inclusion Criteria:

* \>7 years of age
* medical diagnosis of malignancy or non-malignant condition requiring hematopoietic stem cell transplant or a hospital stay that is anticipated to last for at least 2 weeks
* a caregiver who can assist the child with the study procedures

Exclusion Criteria:

* complete blindness or deafness
* inability to operate the hand-held controllers
* susceptible to motion sickness in virtual reality
* inability to communicate in English

Primary outcomes:
measure: Physical activity
timeFrame: Daily, starting after consent in the hospital (week 0) and ending after the intervention (intervention week 9)
Secondary outcomes:
measure: Minutes of gameplay
timeFrame: Hospital discharge (approximately week 4), Intervention week 4, and Intervention Week 8.
measure: Global Health
timeFrame: Week 0, ~Week 2 (Post-Transplant), ~Week 4 (hospital discharge), Intervention or Wait Period Week 4, Intervention or Wait Period Week 8.
measure: Forced Expiratory Volume in the first second (FEV1)
timeFrame: Week 0, ~Week 2 (Post-Transplant), ~Week 4 (hospital discharge), Intervention or Wait Period Week 4, Intervention or Wait Period Week 8.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama
state: Alabama
Study officials:
References:
Clinical trial NCT04980157: CARES-HCV: Promoting Screening Uptake Among Diverse Baby Boomers
Official title: CARES-HCV: Promoting Concurrent Hepatitis C Virus Screening and Colorectal Cancer Screening Uptake Among Diverse Baby Boomers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Virus Infection
Colorectal Cancer
Keywords: HCV Screening
CRC Screening
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 39
Sex: ALL
Minimum age (years): 56
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients born between 1945-1965 up to age 75 who have clinic visits at a partnering federally qualified health center.

Brief summary: The purpose of the study is to examine the efficacy of educational materials to promote hepatitis C virus (HCV) screening and colorectal cancer (CRC) screening uptake among adults born between 1945-1965.


Eligibility criteria: Inclusion Criteria:

* Born between 1945 and 1965 and up to age 75
* No personal history of colorectal cancer (CRC) or current presumptive colorectal cancer symptoms (e.g., unresolved rectal bleeding or abdominal pain/bloating)
* No personal history of hepatitis C virus (HCV) or liver cancer
* Able to read, write, speak, and understand English or Spanish
* Not currently enrolled in another CRC screening or a HCV screening study
* At average risk for CRC (that is, no hereditary CRC syndromes such as lower gastrointestinal (GI) bleeding, persistent diarrhea, bloating, or lower GI pain, no strong family history of CRC)
* Not currently up-to date with CRC screenings
* Not having previously completed HCV screening
* Able and willing to complete a phone interview
* Able to provide informed consent

Primary outcomes:
measure: Change in Hepatitis C Virus (HCV) knowledge
timeFrame: Day 1 & Day 7
measure: Change in Colorectal Cancer (CRC) knowledge
timeFrame: Day 1 & Day 7
measure: Hepatitis C Virus Screening Status
timeFrame: at 6 months
measure: Colorectal Cancer Screening Status
timeFrame: at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Shannon M Christy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Clement K Gwede, PhD, MPH, RN, FAAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00704457: Impact Of Sacral Neuromodulation On Urine Markers For Interstitial Cystitis (IC)
Official title: Impact Of Sacral Neuromodulation On Urine Markers For IC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Cystitis
Keywords: Interstitial Cystitis
IC
Sacral Nerve Stimulation
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: William Beaumont Hospitals
First posted: 2008-06-25
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone sacral nerve stimulation.

Brief summary: Urine will be collected and sent to the University of Maryland. Urines will be analyzed for urine markers.

Detailed description: Urine will be collected and flash frozen in liquid nitrogen then placed in a -70 C freezer. All urine will be collected and stored until the final follow-up is complete. The urine samples will then be sent as a single batch to the Department of Infectious Disease, University of Maryland. Urines will be assayed in a blinded fashion and a written report of the levels of each of the 3 urine markers will be sent to Beaumont Hospital. Change in urine marker levels will be analyzed and correlated with change in symptom scores.

Eligibility criteria: Inclusion Criteria:

* Patients will be drawn from Dr. Peters patient base that covers Southeast Michigan.

Exclusion Criteria:

* Male

Primary outcomes:
measure: The purpose of this study is measure urine biomarkers levels in patients with interstitial cystitis who have elected to undergo sacral nerve stimulation as a treatment modality for their disease.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Hospital - Royal Oak
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Kenneth Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06785857: An Intervention Effect Study of a Mobile Medical Supportive Care Program for Family Caregivers with Dementia Combined with Diabetes: a Randomized Controlled Trial
Official title: An Intervention Effect Study of a Mobile Medical Supportive Care Program for Family Caregivers with Dementia Combined with Diabetes: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Senile Dementia, Alzheimer Type
Keywords: Dementia
Diabetes
Family caregivers
Mobile healthcare
Supportive care programs
A randomized controlled trial
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this project is to evaluate the effectiveness of the clinical application of a mHealth supportive care program for family caregivers with dementia combined with diabetes based on the supportive care framework. The results of the study will provide family caregivers with more economical and efficient care guidance, thereby improving the quality of care and quality of life for people with dementia and diabetes in general.


Eligibility criteria: Inclusion Criteria:

Caregivers: ① caregivers and patients have legal kinship (such as spouses, children or siblings) and other non-costly caregivers such as babysitters, bellhops, etc.; ② caregiving work ≥ 8 hours / day, care for the patient ≥ 5 days a week, the care time ≥ 1 month; ③ conscious adults with a certain degree of reading and comprehension; ④ at least have a smart phone (with Internet access) and will be able to use it proficiently; ⑤ informed consent and voluntary participation in the study. Informed consent and voluntary participation in the study.

Targets: ① meet the diagnostic criteria of Alzheimer's disease; ② meet the diagnostic criteria of type 2 diabetes mellitus; ③ age ≥ 60 years old, permanent residents of the district.

Exclusion Criteria:

Caregivers: ① severe physical or mental illness; ② people with drug or alcohol dependence; ③ caregivers who are participating in a similar intervention study.

Caregivers: ① patients with severe physical illnesses, major illnesses, or terminal illnesses; ② patients with drug or alcohol dependence.

Primary outcomes:
measure: Caregiver Burden Inventory
timeFrame: First and third months
Secondary outcomes:
measure: Social Support Rating Scale
timeFrame: First and third months
measure: Dementia Caring Knowledge Scale
timeFrame: First and third months
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Community Health Center
state: Fujian
Study officials:
References:
Clinical trial NCT02038257: Comparative Study Using Dermabrasion vs CO2 Laser & Collagen Dressing vs Vaseline Gauze in MKTP
Official title: Prospective Open Label Parallel Study Comparing Use of Carbon Dioxide Laser Versus Dermabrasion for Denuding Epithelium and Collagen Dressing Versus Vaseline Impregnated Gauze for the Melanocyte Keratinocyte Transplant Procedure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitiligo
Depigmented Scars
Depigmentation
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to:

1. Compare two different techniques in the melanocyte keratinocyte transplant procedure: Use of carbon dioxide laser versus use of dermabrasion
2. Compare two different dressings in the melanocyte keratinocyte transplant procedure: vaseline impregnated gauze versus collagen dressing

Detailed description: The melanocyte keratinocyte transplant procedure (MKTP) has been shown to be effective in treating vitiligo and other conditions with depigmented skin. MKTP involves the transplantation of melanocytes and keratinocytes from normal skin onto the depigmented skin in order to repigment the skin.

Both dermabrasion and carbon dioxide lasers have been used effectively in MKTP to denude the epithelium. This study will compare the efficacy of these two techniques.

The study will also compare the efficacy of two different dressings used in MKTP, vaseline impregnated gauze and collagen dressings.

Eligibility criteria: Inclusion Criteria:

* Depigmented patches of skin

Exclusion Criteria:

* History of Acral Vitiligo
* Unstable Vitiligo, defined as new areas of depigmentation or enlarging areas of depigmentation within the last 6 months
* History of hypertrophic scarring or keloids
* History of koebnerization (new patches of vitiligo at sites of injury or trauma)

Primary outcomes:
measure: Vitiligo Assessment Scoring Index (VASI)
timeFrame: 6 months
Secondary outcomes:
measure: Time to De-Epithelialization
timeFrame: Assessed at Visit 1 (Day of Procedure)
measure: Pain Severity Scale
timeFrame: Assessed on Visit 1 (Day of Procedure)
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Dermatology
state: Michigan
Study officials:
affiliation: Henry Ford Dermatology
name: Iltefat H Hamzavi, MD
role: PRINCIPAL_INVESTIGATOR
References: