louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01464099: Bioequivalence of Two NovoLog® Formulations in Subjects With Type 1 Diabetes
Official title: A Single Center, Randomized, Double-blind, Balanced Two-period Cross-over Trial to Test for Bioequivalence Between a Marketed NovoLog® Formulation Containing 100 U/mL Versus a New NovoLog® Formulation Containing 200 U/mL in a Combined Regimen of a Continuous Subcutaneous Infusion and a Meal-time Bolus in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-11-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the clinical performance of two formulations of insulin aspart (NovoLog®) in subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Subjects with type 1 diabetes treated with insulin for at least 12 months
* BMI (Body Mass Index) between 18.0-29.0 kg/m\^2
* Negative fasting C-peptide (below or equal to 0.6 ng/mL)
* HbA1c (glycosylated haemoglobin A1c) below or equal to 10.0%
* Current treatment with insulin below or equal to 1.2 U/kg/day
* Subject should be in good health based on medical history, physical examination and routine laboratory data

Exclusion Criteria:

* Any known/suspected allergies to trial medication or similar products/devices
* A subject who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
* Clinically significant active disease of any kind
* Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator
* Blood donation (more than 500 mL) within the previous 9 weeks

Primary outcomes:
measure: Area under the insulin aspart bolus concentration-time curve
timeFrame: From 0 and up to 12 hours post bolus dose administration
measure: Maximum plasma concentration (Cmax) of insulin aspart
timeFrame: From 0 and up to 12 hours post bolus dose administration
Secondary outcomes:
measure: Time to maximum concentration (Tmax) of insulin aspart
timeFrame: From 0-12 hours post bolus dose administration
measure: AUC (area under the curve) of insulin aspart
timeFrame: From -4 to 0 hours after dose administration
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Novo Nordisk Investigational Site
state: California
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05209399: Comparison of Ultrasound-guided Intraarticular Hip Injections With and Without Prior Local Anesthesia
Official title: Comparison of Ultrasound-guided Intraarticular Hip Injections With and Without Prior Local Anesthesia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Pain
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: American Medical Society for Sports Medicine
First posted: 2022-01-26
Enrollment: 42
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: In this single-center randomized controlled trial, subjects undergoing a first-time ultrasound-guided unilateral intraarticular hip injection will be randomized into one of two groups: hip injection with prior local anesthesia (With LA) or hip injection without prior local anesthesia (Without LA). Visual analog scale (VAS) pain scores (0-100) will be collected after the local anesthesia injection (With LA group) and intraarticular hip injection (both groups). The primary outcome measure for comparison between the two groups will be VAS score for the intraarticular hip injection.


Eligibility criteria: Inclusion Criteria:

* patients undergoing a first-time ultrasound-guided unilateral intraarticular hip injection
* Subjects must be fluent in English
* Subject must be able to consent for themselves and mark pain levels on a visual analog scale.

Exclusion Criteria:

* previous intraarticular hip injection (to remove bias from prior injection experiences)
* prior surgery on the hip to be injected
* use of opioid medication on the day of or day before the procedure
* diabetes mellitus
* body mass index (BMI) greater than 40

Primary outcomes:
measure: mean pain score
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center Physical Medicine and Rehabilitation
state: New York
Study officials:
References:
Clinical trial NCT02843399: Economic Outcomes of EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine) in T2D Patients Who Are New to Injectable Therapy
Official title: Clinical and Economic Outcomes of Patients With Type 2 Diabetes Mellitus Initiating Bydureon and Glargine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus Type 2
Keywords: Diabetes Mellitus Type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Truven health
First posted: 2016-07-25
Enrollment: 15498
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Commercial Insurance

Brief summary: Primary objective of this study is to compare diabetes-related healthcare utilization and costs in patients initiating exenatide once weekly vs insulin glargine.

Detailed description: This retrospective, observational cohort analysis will assess medical and pharmacy claims for adult patients with type 2 diabetes from the Truven Health MarketScan® Commercial and Medicare Supplemental claims databases between 2011 and 2015. Diabetes-related healthcare utilization and costs will be measured as a primary outcome. Secondary outcomes include all-cause healthcare utilization and costs, major adverse cardiovascular event (MACE)-related utilization and costs, and medically attended hypoglycemia events.

Eligibility criteria: Inclusion Criteria:

1. One or more outpatient prescription claim for EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine) between February 1, 2012, and June 30, 2014 (date of first claim = index date; medication to which first claim corresponds = index therapy).
2. Aged 18 or older as of the index date.
3. Continuous enrollment in medical and pharmacy benefits for 12 months before (baseline period) and 12 months after (follow-up period) the index date. (6 months follow-up will be provided to determine the effect on sample size.)
4. One or more medical claims with a diagnosis code for T2DM (ICD-9-CM 250.x0 or 250.x2) in the baseline period or on the index date.

Exclusion Criteria:

1. No outpatient prescription claims for any injectable glucose-lowering medication during the baseline period (GLP-1RA or insulins).
2. No medical claims with a diagnosis (or procedure, where appropriate) code indicative for type 1 diabetes mellitus (ICD-9-CM 250.x1 or 250.x3), gestational diabetes (ICD-9-CM 648.8x), or pregnancy or childbirth in the baseline or follow-up periods.

Primary outcomes:
measure: Diabetes-related HCRU/costs
timeFrame: Up to 12 months
Secondary outcomes:
measure: Overall HCRU/Costs
timeFrame: Up to 12 Months
measure: MACE-related HCRU/Costs
timeFrame: Up to 12 Months
measure: Medical Hypoglycemic events
timeFrame: Up to 12 Months
Other outcomes:
measure: Composite of A1C <7%/no weight gain/no hypoglycemia
timeFrame: Up to 12 Months
Locations:
city: Wilmington
country: United States
facility: Research site
state: Delaware
Study officials:
affiliation: AstraZeneca
name: Eric T. Wittbrodt, PharmD, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT01536899: Medical Marijuana Use in HIV+ Patients Prospective Cohort Study
Official title: Behavioral Economic Analysis of Medical Marijuana Use in HIV+ Patients Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Positive
Marijuana Smoking
Keywords: HIV positive
Medical Marijuana
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-02-22
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV positive and marijuana using volunteers

Brief summary: The investigators are interested in understanding personal factors such as medical conditions and mental health, as well as social and economic factors, that influence marijuana (and other substance) use in HIV-positive patients.

Several alternative hypotheses will be evaluated in the proposed project:

1. healthier patients may self-select marijuana use;
2. marijuana use may be associated with consequences that create barriers to seeking healthcare;
3. marijuana use may have medicinal value that reduces the need for such care.

Detailed description: The study will involve a total of 5 interviews with clinical research staff members, the total involvement will be for about 1 year.

The first interview will establish a baseline of current behaviors and health status; this will take about 3-4 hours. This interview will take place at the Tolan Park Medical Building, located at 3901 Chrysler Service Dr. The remaining 4 interviews - which will be shorter in length - will be conducted about 3, 6, 9, and 12 months after the baseline interview; each follow-up interview will take about 2 hours.The purpose of the 4 remaining interviews is to assess changes in behaviors and health status over time.

We will collect urine samples at each of the 5 interview sessions to assess health and illicit drug use.

Eligibility criteria: Inclusion Criteria:

* Participants will be patients in the HIV clinic.
* Participants will have HIV.
* Participants will sign a single consent form.
* Participants will be marijuana users.

Exclusion Criteria:

* Participants who test negative for marijuana will be excluded.
* Volunteers who exhibit signs of drug intoxication or cognitive/mental impairment during the consent process will be excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University (HIV clinic, Tolan Park Medical Buiding)
state: Michigan
Study officials:
affiliation: Wayne State University
name: Mark Greenwald, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03198299: Therapeutic Effects of Arch Support Insoles on Children
Official title: Therapeutic Effects of Physical Function and Balance of Arch Support Insoles on Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal Development
Keywords: therapeutic effects
insoles
children
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2017-06-26
Enrollment: 45
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Using double blind, randomized controlled design to study the short-term therapeutic effects of customized arch support insoles on children

Detailed description: A total of 45 children were enrolled. The children were randomized into two groups, including the study group (insoles group) and the control group (without insoles group).

All participants in the insoles group were evaluated at baseline, that was before the customized arch-support insoles were prescribed. All the evaluations, including functional performance, physical function, and quality of life, were re-evaluated up to 12 weeks after the insoles wearing in the study group (insoles group).

The control group were evaluated at baseline and up to 12 weeks.

Eligibility criteria: Inclusion Criteria:

* children with age 3 to 10 can walk independently for 15 meters can follow up for 12 weeks

Exclusion Criteria:

* age less than 3 years or older than 10 years children with developmental delays children with pathological flat feet

Primary outcomes:
measure: change of baseline of level walking time to 12 weeks
timeFrame: baseline and up to 12 weeks
measure: change of baseline of stairs climbing time to 12 weeks
timeFrame: baseline and up to 12 weeks
measure: change of baseline of up and go time to 12 weeks
timeFrame: baseline and up to 12 weeks
measure: change of baseline of chair raising time to 12 weeks
timeFrame: baseline and up to 12 week
Secondary outcomes:
measure: change of baseline balance (scores) to 12 weeks
timeFrame: baseline and up to 12 weeks
measure: change of baseline functional performance(scores) to 12 weeks
timeFrame: baseline and up to 12 weeks
measure: change of baseline quality of life (scores) to 12 weeks
timeFrame: baseline and up to 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Ru-Lan Hsieh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00032799: Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease
Official title: A Phase 3 International, Multicenter, Double-blind, Placebo-controlled Study of the Safety, Efficacy, and Tolerability of Intravenous Antegren (Natalizumab) in Subjects With Moderate to Severely Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Elan Pharmaceuticals
First posted: 2002-04-04
Enrollment: 905
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: The purpose of this study is to determine the safety and efficacy of natalizumab in individuals diagnosed with moderately to severely active Crohn's disease. It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease.


Eligibility criteria: Male and female patients at least 18 years of age who have at least a six-month history of Crohn's disease and who are currently experiencing moderately to severely active Crohn's disease. Women must not be breastfeeding or pregnant, and must not become pregnant during the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Elan Pharmaceuticals
state: California
Study officials:
References:
citation: Sandborn WJ, Colombel JF, Enns R, Feagan BG, Hanauer SB, Lawrance IC, Panaccione R, Sanders M, Schreiber S, Targan S, van Deventer S, Goldblum R, Despain D, Hogge GS, Rutgeerts P; International Efficacy of Natalizumab as Active Crohn's Therapy (ENACT-1) Trial Group; Evaluation of Natalizumab as Continuous Therapy (ENACT-2) Trial Group. Natalizumab induction and maintenance therapy for Crohn's disease. N Engl J Med. 2005 Nov 3;353(18):1912-25. doi: 10.1056/NEJMoa043335.
Clinical trial NCT05231499: Immunity and Nasal Fungal Colonization
Official title: Host Immunity and Nasal Fungal Colonization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonization, Asymptomatic
Keywords: colonization
microbiota
fungi
immunocompromised
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Immunocompromised subjects have rhinosinusitis or not using nasal irrigation or not using nasal irrigation

Brief summary: Fungal colonization causes opportunistic infection that may manifest when the host's immune status deteriorates. The purpose of this study was to determine the prevalence of fungal colonization in immunocompromised subjects compared to healthy controls.


Eligibility criteria: Inclusion Criteria:

* Immunocompromised subjects included those who had known risk factors for fungal infection, including malignant diseases, diabetes, autoimmune disorders, renal or hepatic insufficiency, organ transplantation, or use of immunosuppressants
* Healthy volunteers had neither sinonasal symptoms nor nasal endoscopic inflammation.

Exclusion Criteria:

* Patients were excluded if they were under 20 years old, were receiving antifungal medication, or were pregnant.

Primary outcomes:
measure: nasal lavage pooled fungal microbiota
timeFrame: 1 month
Secondary outcomes:
measure: nasal lavage aspergillus qPCR
timeFrame: 1 month
Other outcomes:
Locations:
city: Taichang
country: Taiwan
facility: Department of Otolaryngology, Taichung Veterans General Hospital
Study officials:
References:
Clinical trial NCT00746499: Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.
Official title: A Phase 1, Open-Label Study, Investigating First-Dose and Steady-State Pharmacokinetics of Raltegravir in the Genital Tract of HIV Uninfected Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2008-09-04
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Healthy subjects will take study drug by mouth twice a day for 7 consecutive days, blood and cervicovaginal samples will be taken most mornings around the AM dose. Two visits, \~14 hrs in length will be required on Day 1 and 7. The purpose of this study is to measure how much raltegravir is found in the genital tract after taking it orally.

Detailed description: This study is looking at blood and cervicovaginal fluid (CVF) samples of healthy volunteers taking raltegravir. The purpose of this study is to measure the extent that raltegravir penetrates into other body compartments, such as the genital tract. Subjects will take the study drug for 7 days, a total of 10 visits to the research center will be required. A screening visit will occur on no more than 28 days On Days 1 and 7 the subject will stay in the research center for approximately 12 hours for scheduled blood and CVF sampling. Days 3-6 and 8-9 will involve a short visit to the research center for one pre-dose blood and CVF sample before the morning dose. A follow up visit will occur about 7-10 days after last dose.

Eligibility criteria: Inclusion Criteria:

* Healthy pre-menopausal female subjects
* Between the ages of 18 and 49 years
* With an intact uterus and cervix

(Healthy is defined as no irregular menstrual cycles or clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

Exclusion Criteria:

* Negative serum pregnancy test at screening and should be using at least one method of contraception
* Body Mass Index (BMI) of approximately 18 to 30 kg/m\^2
* And a total body weight \> 50 kg (110 lbs)

Primary outcomes:
measure: Drug levels in CVF and blood plasma
timeFrame: Day 1-9
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Angela DM Kashuba, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02260999: Experimental Study of Detection an Intentional Performance Degradation in Grip Strength
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2014-10-09
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: chronic pain patients patients with injury at the upper extremity healthy subjects

Brief summary: In this study, the detection of the feigning weakness in grip strength is measured using different grip strength testing instruments. Patients with injury of the upper limb are compared to patients with injury of the lower limb as well as healthy controls.


Eligibility criteria: Inclusion Criteria:

- \>18 years, signed consent form, stable pain mediaction for 48 hours

Exclusion Criteria:

- \<18, unsigned consent form, dose change of the pain medication during the last 48 hours...

Primary outcomes:
measure: grip strength
timeFrame: 1 hour
measure: range of motion
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: