louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00004939: Phase III Randomized, Double-Blind, Placebo-Controlled Study of 3,4-Diaminopyridine for Demyelinating Polyneuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Keywords: demyelinating neuropathy
neurologic and psychiatric disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Mayo Clinic
First posted: 2000-02-25
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Assess the efficacy of 3,4-diaminopyridine in patients with stable chronic demyelinating polyneuropathy.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are randomly assigned to oral 3,4-diaminopyridine (3,4-DAP) or placebo administered for 4 days. After a washout of at least 5 days, patients cross to the alternate therapy for 4 days.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Clinical diagnosis of demyelinating neuropathy, i.e.: Hereditary motor and sensory neuropathy type I Chronic inflammatory demyelinating polyneuropathy meeting American Academy of Neurology AIDS Task Force criteria Multifocal motor neuropathy and conduction block Clinically stable for at least 6 months prior to entry --Prior/Concurrent Therapy-- At least 6 months since change in immunosuppressive dose --Patient Characteristics-- Age: 20 to 80 Hepatic: No predisposition to hepatic disease Renal: No predisposition to renal disease Cardiovascular: No predisposition to cardiac disease Other: No other medical condition affecting neuropathy or study evaluation No predisposition to seizures

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Anthony J. Windebank
role: STUDY_CHAIR
References:
citation: Russell JW, Windebank AJ, Harper CM Jr. Treatment of stable chronic demyelinating polyneuropathy with 3,4-diaminopyridine. Mayo Clin Proc. 1995 Jun;70(6):532-9. doi: 10.4065/70.6.532.
Clinical trial NCT01374139: Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects
Official title: A Phase 1, Open-Label, Randomized, Single-Dose, 2-Cohort, 2-Way Crossover Bioequivalence Study To Compare The Bosutinib Clinical Tablet And Clinical Capsule And To Investigate Food Effect On Bosutinib Commercial Formulation in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)
Keywords: Bosutinib
Bioequivalence and Food Effect Studies
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-06-15
Enrollment: 88
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the bioequivalence of the clinical tablet formulation (100 mg x 5) to the clinical capsule formulation (100 mg x 5) in healthy subjects under fed condition (Cohort 1) and to investigate the effect of a high-fat meal on the pharmacokinetics of bosutinib after administration of the proposed commercial tablet formulation (100 mg x 4) in healthy subjects (Cohort 2).


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female of non childbearing potential subjects between the ages of 21 and 55 years, inclusive.
* Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 Lead ECG or clinical laboratory tests.

Exclusion Criteria:

* Pregnant or nursing women or women of childbearing potential.

Primary outcomes:
measure: Plasma Cmax for bosutinib.
timeFrame: 96 hr post dose in each period
measure: AUCt for bosutinib.
timeFrame: 96 hr post dose in each period
measure: Plasma AUCinf for bosutinib.
timeFrame: 96 hr post dose in each period
measure: AUClast for bosutinib.
timeFrame: 96 hr post dose in each period
measure: Tmax for bosutinib.
timeFrame: 96 hr post dose in each period
measure: t½ for bosutinib.
timeFrame: 96 hr post dose in each period
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02710539: Once-daily Fixed Combination of Three Antihypertensive Drugs
Official title: Randomized Comparison of Once-daily Fixed combiNation vErsus freE-drug cOmbination of Three aNtihypertensive Agents in arteriaL hYpertension (the ONE&ONLY Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Arterial Hypertension
Keywords: arterial hypertension
antihypertensive drugs
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Randomized comparison of once-daily fixed combiNation versus free-drug combination of three antihypertensive agents in arterial hypertension

Detailed description: The aim of this randomized study is to compare a once-daily fixed combination pill with a free-drug combination of three antihypertensive agents in arterial hypertension

Eligibility criteria: Inclusion Criteria:

Patients with arterial hypertension resistant to monotherapy

Exclusion Criteria:

None

Primary outcomes:
measure: Number of patients who reach target blood pressure
timeFrame: From baseline to the end of the 3-month study period
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University La Sapienza
Study officials:
affiliation: Sapienza University
name: Carlo Gaudio, MD
role: STUDY_CHAIR
References:
citation: Marazzi G, Pelliccia F, Campolongo G, Cacciotti L, Massaro R, Poggi S, Tanzilli A, Di Iorio M, Volterrani M, Lainscak M, Rosano GM. Greater cardiovascular risk reduction with once-daily fixed combination of three antihypertensive agents and statin versus free-drug combination: The ALL-IN-ONE trial. Int J Cardiol. 2016 Nov 1;222:885-887. doi: 10.1016/j.ijcard.2016.07.163. Epub 2016 Jul 29.
Clinical trial NCT03192839: Early DHA Supplementation in Very Low Birth Weight Infants
Official title: Early DHA Supplementation in Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
Collaborators: name: North Shore Research Institue
First posted: 2017-06-20
Enrollment: 30
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This clinical trial will evaluate the effects of giving supplements of PUFA to premature infants.


Eligibility criteria: Inclusion Criteria:

* Very low birth weight infants weighing less than 1500 grams
* Consent signed within 72 hours of life

Exclusion Criteria:

* Infants with know metabolic disorder
* Infants with known congenital GI anomaly
* Infants who are deemed to be inappropriate for enrollment per attending neonatologist

Primary outcomes:
measure: Red Blood Cell polyunsaturated fatty acids (PUFA) levels
timeFrame: 2 weeks of age
Secondary outcomes:
measure: Red Blood Cell PUFA levels
timeFrame: 8 weeks of age
measure: Feeding tolerance
timeFrame: 8 weeks
measure: Incidence of necrotizing enterocolitis
timeFrame: 8 weeks
measure: Incidence of bronchopulmonary dysplasia
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Evanston
country: United States
facility: North Shore University Health System
state: Illinois
Study officials:
affiliation: Mead Johnson Nutrition
name: Timothy Cooper, M.D
role: STUDY_DIRECTOR
References:
citation: Frost BL, Patel AL, Robinson DT, Berseth CL, Cooper T, Caplan M. Randomized Controlled Trial of Early Docosahexaenoic Acid and Arachidonic Acid Enteral Supplementation in Very Low Birth Weight Infants. J Pediatr. 2021 May;232:23-30.e1. doi: 10.1016/j.jpeds.2020.12.037. Epub 2021 Feb 20.
Clinical trial NCT05059639: Exploring the Role of Almonds in Enhancing Immune Strength
Official title: Exploring the Role of Almonds in Enhancing Immune Strength
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune Health
Keywords: Almonds
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: forty-eight overweight/non-obese (BMI=24-30) adult (ages 40-65 years) men (n=24) and women (n=24) will be recruited to participate. A randomized, parallel-arm design will be utilized.
Primary purpose: OTHER

Brief summary: The COVID-19 pandemic highlights the importance of good nutritional status for immune strength and for reducing comorbidities that increase morbidity and mortality of infections. The major aim of this study is test if almond consumption can improve immune function.

Detailed description: Investigators will conduct an 8-week parallel-arm trial of 48 overweight/non-obese (BMI=24-30) adult (aged 40-65 years) men (n=24) and women (n=24) who will be randomly assigned to consume daily isoenergetic portions of almonds or a common snack (pretzels).

Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects aged 40-65 y
* Body mass index (BMI) 24-30 kg/m.2

Exclusion Criteria:

* Not willing to stop taking multivitamins, and supplements (with the exception of vitamin D and calcium), for 30 days prior to or during study participation, if currently taking these.
* Almond allergies
* Alcohol consumption \>2 drinks per day.
* Smoking or using nicotine containing products in the last 6 months.

Primary outcomes:
measure: change in Natural Killer Function
timeFrame: Baseline, after 8 weeks
Secondary outcomes:
measure: change in Cytokines
timeFrame: Baseline, after 8 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Mark Kern, PhD, RD
state: California
Study officials:
affiliation: San Diego State University
name: Shirin Hooshmand, PhD, RD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03329339: The Effect of 1L Polyethylene Glycol Plus Ascorbic Acid With Prepackaged Low-Residue Diet for Bowel Preparation
Official title: 1L Morning-only Polyethylene Glycol Plus Ascorbic Acid With Prepackaged Low-residue Diet Versus 2L Polyethylene Glycol Plus Ascorbic Acid for Bowel Preparation: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Colon Polyp
Bowel Preparation Solutions
Keywords: diet
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background 2L polyethylene glycol plus ascorbic acid (PEGA) is known to be as effective as standard 4L polyethylene glycol for bowel preparation. However, the volume of this regimen is still large. Therefore, the present investigators evaluated the potential of 1L PEGA with prepackaged low-residue diet (PLD) for an alternative to 2L PEGA.

Aim: To evaluate efficacy of 1L PEG with ascorbic acid combined with prepackaged low-residue diet as bowel preparation for colonoscopy.

Methods: The subjects were randomly assigned to either groups. PEGA group received 2L PEGA split regimen. PLD group received PLD on the day preceding colonoscopy and 1L PEGA on the morning of colonoscopy. One blinded physician performed colonoscopy and evaluated the degree of bowel preparation using Boston bowel preparation score (BBPS). A questionnaire regarding tolerability and safety were also gathered.


Eligibility criteria: Inclusion Criteria:

* anyone who were scheduled for an outpatient colonoscopy below indication

  1. patient who need colonic polyp screening
  2. patient who have hematochezia
  3. patient who have fecal occult blood test positive result

Exclusion Criteria:

* ileus
* inflammatory bowel disease-
* gastrointestinal malignancy
* severe cardiac disease (heart failure beyond NYHA Class III)
* chronic obstructive pulmonary disease,
* decompensated liver cirrhosis; coagulopathy
* Female patients with pregnant or breastfeeding.
* who use long-term use of sedative, anti-spasmodic, prokinetic, laxative or anti-diarrheal medications

Primary outcomes:
measure: Achievement of preparation adequacy
timeFrame: assessed at the colonoscopy day
Secondary outcomes:
measure: Tolerability and adverse events
timeFrame: assessed at the colonoscopy day
Other outcomes:
Locations:
Study officials:
References:
citation: Lee JW, Choi JY, Yoon H, Shin CM, Park YS, Kim N, Lee DH. Favorable outcomes of prepackaged low-residue diet on bowel preparation for colonoscopy: Endoscopist-blinded randomized controlled trial. J Gastroenterol Hepatol. 2019 May;34(5):864-869. doi: 10.1111/jgh.14499. Epub 2018 Oct 24.
Clinical trial NCT05872139: Role of Mitochondrial-derived Oxidative Stress to Promote Vascular Endothelial Dysfunction in Non-exercisers With Aging
Official title: Influence of Exercise/Cardiorespiratory Fitness on Enhanced Endothelial Function With Aging: Role of Mitochondrial-derived Oxidative Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Endothelial Dysfunction
Cardiovascular Function
Arterial Stiffness
Lead sponsor: Ball State University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The primary goal of this intervention is to determine the efficacy of acute mitochondrial-specific antioxidants to improve vascular endothelial function in middle-aged and older (≥45 y) adults who do no perform regular aerobic exercise. In a double-blind, randomized, placebo-controlled crossover design participants with receive both MitoQ and placebo arm of the study. Primary endpoints will include vascular endothelial function assessed by brachial artery flow-mediated dilation and cardiac function assessed via pulse wave analysis. Secondary endpoints will include measures of aortic stiffness assessed by carotid-femoral pulse wave velocity and carotid artery stiffness (e.g. β-stiffness) and elasticity (carotid compliance, distensibility, and Youngs elastic modulus) from ultrasonography.


Eligibility criteria: Inclusion Criteria:

* Resting brachial blood pressure \<160 mmHg (systolic)/\<100 mmHg (diastolic)
* Body mass index ≤ 35 kg/m2
* Nonsmoker
* Women must be postmenopausal defined as cessation of menses ≥ 1 year.

Exclusion Criteria:

* cardiovascular/metabolic medications
* known clinical disease
* absolute contraindications to exercise testing

Primary outcomes:
measure: Change in vascular endothelial function
timeFrame: Baseline and Post 1 hour
Secondary outcomes:
measure: Change in cardiovascular function
timeFrame: Baseline and Post 1 hour
measure: Change in Aortic Stiffness
timeFrame: Baseline and Post 1 hour
measure: Change in carotid artery stiffness - beta-stiffness index
timeFrame: Baseline and Post 1 hour
measure: Change in carotid artery compliance
timeFrame: Baseline and Post 1 hour
measure: Change in carotid artery distensibility
timeFrame: Baseline and Post 1 hour
measure: Change in carotid artery Young's elastic modulus
timeFrame: Baseline and Post 1 hour
Other outcomes:
Locations:
city: Muncie
country: United States
facility: Ball State University
state: Indiana
Study officials:
affiliation: Associate Professor
name: Brad Fleenor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00894439: Study Evaluating BLI-489 and Piperacillin in Healthy Subjects
Official title: A Randomized, Open-label, Single-dose, 3-period Crossover Study to Describe the Pharmacokinetic Parameters of BLI-489 and Piperacillin When Administered Simultaneously Compared to When Each is Administered Alone.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-05-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate how BLI-489 and piperacillin interact when given together to healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Men or women of non-childbearing potential, aged 18 to 50 years of age inclusive at screening.
2. Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to 50 kg.
3. Healthy as determined by the investigator on the basis of the screening evaluations.
4. Nonsmoker of smoker of fewer than 10 cigarettes per day as determined by history.

Exclusion Criteria:

1. Presence of history of any disorder that may prevent the successful completion of the study.
2. History of drug abuse within 1 year.

Primary outcomes:
measure: Pharmacokinetics as evaluated by drug concentrations in the blood and urine.
timeFrame: 10 days
Secondary outcomes:
measure: Safety as measured by the number of adverse events and serious adverse events.
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04410939: COVID-19 PCR Test Results in Asymptomatic Pregnants
Official title: COVID-19 PCR Test Results in Asymptomatic Pregnants Admitted for Birth and Other Interventions in Our Clinic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Asymptomatic Pregnant
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 179
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant patients who apply to Istanbul Medipol University Hospital

Brief summary: In order to prevent contamination from the pregnant women hospitalized in this clinic, the RT-PCR test is performed from the oropharyngeal and nasal swab sample taken before hospitalization. In addition, the same test is done before each operation and before the operation. The aim of the study is to scan these tests retrospectively and to determine the rate of positive COVID-19 cases in asymptomatic pregnant women. The results will determine the importance of the measures to be taken in the pregnant women who undergo intervention.


Eligibility criteria: Inclusion Criteria:

* Asymptomatic pregnant women who will give birth in this clinic, dilatation and curettage due to missed abortion, cerclage due to cervical insufficiency, medical evacuation due to fetal anomaly, and routine PCR test taken for service for some treatments.

Exclusion Criteria:

* Having any COVID-19 infection symptoms (fever, cough, weakness, shortness of breath, sore throat, etc.)

Primary outcomes:
measure: Rate of positive COVID-19 cases in asymptomatic pregnant women
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
References:
citation: Sutton D, Fuchs K, D'Alton M, Goffman D. Universal Screening for SARS-CoV-2 in Women Admitted for Delivery. N Engl J Med. 2020 May 28;382(22):2163-2164. doi: 10.1056/NEJMc2009316. Epub 2020 Apr 13. No abstract available.
Clinical trial NCT06464939: Phase 2 Study of KH001 in Long-term Relief from Dentin Hypersensitivity
Official title: A Randomized, Double-blinded, Placebo-controlled, Phase 2 Study to Assess the Efficacy and Safety of Three Topical Applications of KH001 in Providing Long-term Relief from Dentin Hypersensitivity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Dentin Hypersensitivity
Keywords: Dentin Sensitivity
Denin Hypersensitivity
Lead sponsor: HysensBio Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: The Forsyth Institute
First posted: 2024-06-18
Enrollment: 120
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 evaluate the efficacy and safety of KH001 in subjects with dentin hypersensitivity.

Detailed description: The study will consist of a screening period, a treatment period, and a follow-up period. The total duration of the study for each subject will be approximately 8 to 12 weeks. All subjects will be randomly assigned in a 1:1:1 ratio, with Group A, Group B and Group C.

Eligibility criteria: Inclusion Criteria:

* Is at least 18 years old by the time of the screening visit
* Is in good general health as determined by the investigator
* Has at least 2 non-adjacent teeth and is diagnosed with hypersensitive

Exclusion Criteria:

* Is allergic to the active drug substance or other excipients used in the investigational product
* Has any history of alcohol or drug abuse
* Has received any treatment related to dentin hypersensitivity within 8 weeks prior to the screening visit
* Is jedged by the investigator as ineligible for participation for other reasons

Primary outcomes:
measure: Change from baseline in Schiff sensitivity score
timeFrame: Baseline and Week 5
Secondary outcomes:
measure: Change from baseline in a Schiff sensitivity score
timeFrame: Baseline, Up to 8 Weeks
measure: Change from baseline in a Tactile threshold
timeFrame: Baseline, Up to 8 Weeks
measure: Change from baseline in Visual Analogue Scale
timeFrame: Baseline, Up to 8 Weeks
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: ADA Forsyth
state: Massachusetts
city: Cambridge
country: United States
facility: Forsyth Institute
state: Massachusetts
Study officials:
affiliation: ADA Forsyth
name: Hatice Hasturk
role: PRINCIPAL_INVESTIGATOR
References: