louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01166893: Ability of Modulated Imaging and Laser Speckle Imaging to Determine Burn Wound Severity and Healing Potential
Official title: Ability of Modulated Imaging and Laser Speckle Imaging to Determine Burn Wound Severity and Healing Potential
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Skin Burn Multiple
Keywords: burn wound
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2010-07-21
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be selected from University of California Irvine Medical Center Burn Unit.

Brief summary: According to the National Burn Repository 2007, the most common type of burn injury is a partial thickness burns. The current standard of care for partial thickness burns is two weeks of topical therapy and wound care. Burns that do not heal within two weeks undergo surgical excision and skin grafting.

Detailed description: Researcher can use the combination of Modulated Imaging and Laser Speckle Imaging can be used as an adjuvant to standard clinical evaluation to gauge burn wound and severity of infection. Researcher can image the burn wounds of and compare with current standard of care, clinical exam, and can use the outcomes information in terms of time to healing and treatment

Modulating Imaging is a noninvasive optical modality measure the metabolic functions of the burn wound.

Laser Speckle Imaging is a noninvasive optical modality can measure blood flow of burn wound.

Eligibility criteria: Inclusion Criteria:

1. Male / female all age
2. Subjects is an inpatient or out patient with burn wound

Exclusion Criteria:

1. Subjects cannot lied flat and still for the duration of the imaging
2. Subjects pregnant.

Primary outcomes:
measure: Noninvasive burn wound severity assessment
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: UCIMC
state: California
Study officials:
affiliation: University of California, Irvine
name: Anthony Durkin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00239993: A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®
Official title: An Open-Label, Randomized, Single Cross-over Study of Warm Compress Versus Usual Injection Site Preparation on Local Injection Site Reactions Among Persons With MS Who Perform Daily Injections of Copaxone®.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study is designed to compare skin reactions with or without the use of warm compress prior to performing a Copaxone® injection.


Eligibility criteria: Inclusion Criteria:

1. Male or Female, 18 years or older, with a diagnosis of RRMS
2. Willing and able to complete all procedures and evaluations related to the study.
3. Willing to provide Informed Consent

Exclusion Criteria:

1. Taking any other immunomodulatory therapy in conjunction with Copaxone®.
2. Has a significant medical illness other than MS which may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study.
3. Any situation which the investigator or nurse feels may interfere with participation in the study.
4. Pregnant, or trying to become pregnant, or breast feeding during the study.
5. Previously participated in this study.

Primary outcomes:
measure: The number of local injection site reactions (LISRs) noted at 5-minutes post-injection
timeFrame: 2-week diaries kept by the patients for Period 1 and for Period 2
Secondary outcomes:
measure: The total and partial number of LISRs noted at 2-minutes post-injection The total and partial number of LISRs noted immediately after injection
timeFrame: 2-week diaries kept by the patients for Period 1 and for Period 2
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Fullerton Neurology & Headache Center
state: California
city: Miami
country: United States
facility: Neurological Center of South Florida
state: Florida
city: Springfield
country: United States
facility: Springfield Neurology Associates
state: Massachusetts
city: Brooklyn
country: United States
facility: Multiple Sclerosis Care Center
state: New York
city: Nashville
country: United States
facility: Advanced Neurosciences Institute
state: Tennessee
city: Virginia Beach
country: United States
facility: Virginia Beach Neurology
state: Virginia
Study officials:
affiliation: Teva Neuroscience, Inc.
name: MerriKay Oleen-Burkey, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT02318693: Efficacy of Sitagliptin and Glibenclamide on the Glucose Variability in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431-355)
Official title: A Randomized, Open-label, Comparative Clinical Trial to Study the Efficacy of Sitagliptin and Glibenclamide in a Short Term Treatment on the Daily Glucose Variability Using Continuous Glucose Monitoring (CGM) in Japanese Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2014-12-17
Enrollment: 53
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study of the efficacy of sitagliptin and glibenclamide in a short-term treatment on the glucose variability using continuous glucose monitoring (CGM) in Japanese participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is that treatment with sitagliptin will be superior to treatment with glibenclamide in the change from baseline in mean amplitude of glycemic excursions (MAGE) through continuous glucose monitoring (CGM) after 13 days of treatment.


Eligibility criteria: Inclusion Criteria:

* Japanese participants with a diagnosis of Type 2 diabetes mellitus

Exclusion Criteria:

* History of Type 1 diabetes mellitus or ketoacidosis
* History of insulin or thiazolidinedione (including fixed-dose drug combinations containing one of these drugs) in the 12 weeks before study participation

Primary outcomes:
measure: Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) at Day 13
timeFrame: Baseline (Day -2) and Day 13
Secondary outcomes:
measure: Change From Baseline in the Standard Deviation of Blood Glucose Levels
timeFrame: Baseline (Day -2) and Day 13
measure: Change From Baseline in Maximum Incremental Postprandial Glucose Levels in Each Meal
timeFrame: Baseline (Day -2) and Day 13
measure: Change From Baseline in 24-hour Mean Glucose Level
timeFrame: Baseline (Day -2) and Day 13
measure: Change From Baseline in Percentage of Hypoglycemic Values (Glucose Sensor Readings: < 70, <60, <50 mg/dL)
timeFrame: Baseline (Day -2) and Day 13
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Suzuki R, Eiki JI, Moritoyo T, Furihata K, Wakana A, Ohta Y, Tokita S, Kadowaki T. Effect of short-term treatment with sitagliptin or glibenclamide on daily glucose fluctuation in drug-naive Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2018 Sep;20(9):2274-2281. doi: 10.1111/dom.13364. Epub 2018 Jun 11.
Clinical trial NCT00384293: Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED)
Official title: A Worldwide, Double-Blind, Randomized, Placebo-Controlled Study of MK0524A 2g Coadministered With Intensive LDL-C Lowering Therapy Compared to Intensive LDL-C Lowering Therapy Alone on Carotid Artery Intima Media Thickening (cIMT) in Patients With Heterozygous Familial Hypercholesterolemia (heFH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hypercholesterolemia, Familial
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-10-06
Enrollment: 937
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 105-week clinical study in patients with heterozygous familial hypercholesterolemia on intensive Low Density Lipoprotein-cholesterol (LDL-C) lowering therapy intended to assess the affects of MK0524A on carotid intima media thickening using ultrasound compared to patients taking placebo. There will be 12 scheduled clinic visits involving review of medical history, physical exam, vital signs, laboratory testing, ultrasound imaging, and electrocardiograms.


Eligibility criteria: Inclusion Criteria:

* Patients who are 18 to 70 years of age with Heterozygous Familial Hypercholesterolemia and a LDL-C greater than or equal to 100mg/dL and triglycerides less than or equal to 400mg/dL at Visit 1 while on a stable dose of intensive LDL-C lowering therapy

Exclusion Criteria:

* A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study
* Patients with less than 80% drug study compliance
* Patients with chronic medical conditions known to influence serum lipids or lipoproteins or significantly affect the ultrasound acoustic window
* Patients with unstable dose of medications
* Pregnant or lactating women, or women intending to become pregnant are excluded
* Patient with diabetes mellitus that is poorly controlled, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)
* Patients with the following conditions: high grade stenosis (greater than 75%) of the carotid artery, chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary or hepatic disease, HIV positive, episode of gout (within 1 year)

Primary outcomes:
measure: Change in Mean Carotid Intima Media Thickness
timeFrame: after 96 weeks of postrandomization treatment
Secondary outcomes:
measure: Change in Lipid Profile
timeFrame: after 96 weeks of postrandomization treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03701893: Evaluate the Use of a New Probiotic Strain in Couples With Fertility Problems and Dysbiosis.
Official title: Evaluate the Effect of the Strain Lactobacillus PS11610 on the Microbiota of the Female and Male Genital Tract in Couples With Fertility Problems and Dysbiosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Vaginal Flora Imbalance
Genital Disorder
Lead sponsor: ProbiSearch SL
Sponsor class: INDUSTRY
First posted: 2018-10-10
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label intervention study.
Primary purpose: SCREENING

Brief summary: Pilot study to evaluate the effect of the strain Lactobacillus PS11610 on the microbiota of the female and male genital tract in couples with fertility problems. Couples who have started treatment for artificial insemination or who are on the waiting list for an invitro fertilization treatment will be invited to participate. The estimated duration of the study will be 7 and a half months.

Detailed description: Pilot study to evaluate the effect of the strain Lactobacillus PS11610 on the microbiota of the female and male genital tract in couples with fertility problems. Couples who have started treatment for artificial insemination or who are on the waiting list for an invitro fertilization treatment will be invited to participate. The estimated duration of the study will be 7 and a half months.

Four visits are included in the study period.

Eligibility criteria: Inclusion Criteria:

* Couples with ages between 20 and 40
* Couples under an assisted reproduction treatment: Artificial Insemination or In vitro Fertilization.
* Signature of informed consent

Exclusion Criteria:

* Anovulation
* Hyperprolactinemia
* Hypogonadotropic hypergonadism
* Hypergonadotropic Hypergonadism
* Hyperandrogenisms
* Polycystic ovary syndrome
* Endometriosis
* Pelvic adhesions
* Myomas, polyps and / or uterine synechia
* Diagnosis of tubal factor (hydrosalpinx, tubal obstructions)
* Low ovarian reserve
* Azoospermia
* Sperm motility (A + B) \<25%
* Sperm morphology ≤2%
* With chronic diseases that cause intestinal malabsorption
* With known congenital or acquired immunodeficiency.
* Obesity (IMC ≥ 30)
* Current history or diagnosis of alcohol, tobacco and drug abuse
* Uncertainty about the willingness or ability of the participants to comply with the requirements of the protocol.

Primary outcomes:
measure: Counts of microorganisms presents in cultured samples of genital tracts obtained from infertility couples.
timeFrame: 7 months and a half
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: ProbiSearch SL
name: Susana Manzano, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04353193: Hemodynamic Profile of Terlipressin and Octreotide in Patients With Cirrhosis and Portal Hypertension. A Randomised, Single Blinded Clinical Trial.
Official title: Hemodynamic Profile of Terlipressin and Octreotide in Patients With Cirrhosis and Portal Hypertension. A Randomised, Single Blinded Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Liver Cirrhosis Portal
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 36
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: Clinical trial to compare the effects of terlipressin and octreotide in the reduction of portal hypertension measured as hepatic venous pressure gradient (HVPG) in patients with liver cirrhosis


Eligibility criteria: Inclusion Criteria:

1. Age: 18-75 years old.
2. Liver Cirrhosis
3. Portal hypertension
4. Stable disease in the absence of vasoactive agents
5. Signed informed consent form

Exclusion Criteria:

* 1. Patients on medications that can prolong QT interval 2. Patients with HCC not fulfilling Milan criteria for transplant 3. Grade II-IV hepatic encephalopathy 4. GI bleeding in the last 10 days 5. Child-Pugh C above 12 points 6. Bacterial infection in the last 10 days 7. HVPG \<12mmHg 8. Plasma sodium \<130mmol/l 9. Serum creatinine \>2mg/dl 10. Serum bilirubin \>5mg/dl 11. INR\>2.5 12. Uncontrolled cardiovascular disease 13. HIV infection 14. Extra hepatic malignancies 15. Heart failure NYHA Grade III/IV, COPD GOLD\>2 16. Morbid obesity 17. Coronary heart disease or intestinal ischemia 18. Pregnancy or breastfeeding

Primary outcomes:
measure: Change in HVPG
timeFrame: 30 minutes, 1 hour and 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
References:
Clinical trial NCT00470093: Interferon Alfa and Interleukin-6 in Treating Patients With Recurrent Multiple Myeloma
Official title: A Pilot Study of Differentiation Therapy in Multiple Myeloma Using Interleukin-6 and Interferon-a
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Keywords: refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-05-07
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-6 may stimulate the white blood cells to kill cancer cells. Giving interferon alfa together with interleukin-6 may kill more cancer cells.

PURPOSE: This clinical trial is studying the side effects and how well giving interferon alfa together with interleukin-6 works in treating patients with recurrent multiple myeloma.

Detailed description: OBJECTIVES:

* Determine the response rate in patients with recurrent multiple myeloma treated with recombinant interferon alfa and recombinant interleukin-6.
* Determine the safety and optimal dose of this regimen in these patients.
* Determine the toxicity of this regimen in these patients.
* Determine the impact of this regimen on clonogenic growth of myeloma cells in serial in vitro assays.

OUTLINE: This is a pilot study.

Patients receive recombinant interferon alfa subcutaneously (SC) once daily. Beginning 1 month later, patients also receive recombinant interleukin-6 SC once daily. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of recurrent multiple myeloma
* Must have received ≥ 2 prior therapies

PATIENT CHARACTERISTICS:

* Performance status 0-3

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria.
timeFrame: Up to 5 months
measure: Toxicity as Measured by Number of Participants Who Discontinued Treatment Due to Adverse Events
timeFrame: Up to 5 months
measure: Optimal Dose of Interleukin-6
timeFrame: Up to 5 months
measure: Impact of Treatment on Growth of Myeloma Cells
timeFrame: Day 0, Day 14, Months 1, 2, 4, and 6 of combined therapy, and end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Carol A Huff, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05174793: Using Urine Color as a Marker of Hydration Status
Official title: Urine Color Expressed in CIE L*a*b* Colorspace During Rapid Changes in Hydration Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dehydration
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2022-01-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: urine color was measured during dehydration and rehydration
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study was to determine if rapid changes in hydration status could be determined by urine color expressed in CIE color space

Detailed description: The study will examine if urine color expressed in CIE color space can reflect hydration status. Hydration staus will be rapidly altered via exercise in the heat.

Eligibility criteria: Inclusion Criteria:

* 18-35 years of age,
* no previous heat intolerance

Exclusion Criteria:

- Pregnant women,

Primary outcomes:
measure: can urine color expressed in CIE color space reflect hydration status
timeFrame: one hour dehydration and rehydration
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
affiliation: San Diego State University
name: Michael Buono
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00905593: Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Official title: An Open-label, Multicenter Study Providing Continuation of Nilotinib in Adult Patients With Imatinib-(Glivec®/Gleevec®) - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Chronic Myeloid Leukemia
Keywords: chronic myeloid leukemia,
blast crisis,
accelerated phase,
nilotinib,
imatinib,
resistant,
intolerant,
chronic phase
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-05-20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: Multi-center, open-label, non-randomized trial to evaluate long-term safety and efficacy of nilotinib. Approximately 20 patients will be enrolled in this trial at 3 centers in Mexico, which means all ongoing patients participating on \[CAMN107A2109\] excluding discontinued patients. During this study, patients will receive nilotinib orally, at a dose of 400 mg b.i.d. Patients will normally receive nilotinib on an outpatient basis. This trial will have a maximum of 24 months of follow-up time.


Eligibility criteria: Inclusion Criteria:

* Having participated in Novartis study CAMN107A2109, and
* Written signed and dated informed consent prior to any study procedures being performed.

Exclusion Criteria:

* Impaired cardiac function,
* Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon) up to the day before study drug administration; Other concurrent severe and/or uncontrolled medical conditions,
* Patients who are currently receiving treatment with any of the medications that have the potential to prolong the QT interval,
* patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days,
* Patients who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control, OR
* Patients unwilling or unable to comply with the protocol.

Other protocol -defined inclusion/exclusion criteria may apply

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara, Jalisco
country: Mexico
facility: Novartis Investigative Site
city: Mexico City
country: Mexico
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: