louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00306163: Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101)
Official title: Nebulizer Trial: Evaluation of the Influence of Particle Size of Aerosolized AMP on Bronchial Responsiveness in Patients With Asthma and the Effects of Treatment With Ciclesonide Versus Fluticasone.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
AMP
Ciclesonide
Fluticasone propionate
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-03-23
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the responsiveness of lower airways in adult patients with stable asthma after treatment with ciclesonide and fluticasone propionate. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily at one dose level, fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (5 weeks) and a treatment period (5 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Eligibility criteria: Main Inclusion Criteria:

* History of bronchial asthma
* FEV1 \> 1.20 L
* Positive Skin Prick Test
* Not more than 500 mcg/day fluticasone propionate or equivalent for at least 28 days prior to baseline visit

Main Exclusion Criteria:

* Clinically relevant abnormal laboratory values
* Concomitant severe diseases, diseases expected to interfere with the outcome of the study and diseases which are contra-indications for the use of inhaled steroids
* Chronic obstructive pulmonary disease (COPD) and /or other relevant lung diseases
* One asthma exacerbation within 2 months or more than 3 exacerbations within the last year prior to baseline visit
* Current smokers or ex-smokers with more than 10 pack years, or having smoked within 1 year prior to baseline visit
* Positive response to saline challenge at baseline visits
* Positive bronchial hyperresponsiveness

Primary outcomes:
measure: PC20 AMP (Post-treatment Compared to Baseline)
timeFrame: Baseline and 5 weeks
Secondary outcomes:
measure: Δ (FVC/SVC) at PC20 (AMP)
timeFrame: Baseline and 5 weeks
measure: Safety and Tolerability
timeFrame: 5 weeks
Other outcomes:
Locations:
city: RB Groningen
country: Netherlands
facility: Altana Pharma/Nycomed
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
citation: Cohen J, Postma DS, Douma WR, Vonk JM, De Boer AH, ten Hacken NH. Particle size matters: diagnostics and treatment of small airways involvement in asthma. Eur Respir J. 2011 Mar;37(3):532-40. doi: 10.1183/09031936.00204109. Epub 2010 Jul 1.
Clinical trial NCT02175563: Tilt Cardiopulmonary Resuscitation With a Feedback Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary Resuscitation
Basic Cardiac Life Support
Keywords: Chest
Compression
Lead sponsor: Hanyang University
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: According to the European Resuscitation Council (ERC) Guidelines for patient to a depth of approximately 5-6 cm on a firm and flat surface when possible. However, Cardiopulmonary resuscitation (CPR) performers may need to continue the chest Resuscitation 2010, CPR performers should compress the sternum of a compression in an oblique direction, such as in elevators. For a pregnant patient in cardiac arrest, the 2010 ERC Guidelines recommend that the performer place the patient in a left-lateral tilt of 15 - 30° using a firm wedge to support the pelvis and thorax because the pregnant uterus can compress the inferior vena cava. We hypothesized Smartphone based chest compression feedback app would improves quality of CPR in an angulated surface.


Eligibility criteria: Inclusion Criteria:

* Healthy person
* \> 18 years old
* Basic life support educated person

Exclusion Criteria:

* Cardiovascular disease
* Musculoskeletal disease
* Psychiatric disease
* Pregnant
* \> 65 years old

Primary outcomes:
measure: Chest compression depth
timeFrame: within the first 30 days after the end of recording
measure: Chest compression rate
timeFrame: within the first 30 days after the end of recording
Secondary outcomes:
measure: Accurate chest compression
timeFrame: within the first 30 days after the end of recording
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University, College of medicine
Study officials:
References:
Clinical trial NCT01712763: Degarelix in the Treatment of Endometriosis Recurrence
Official title: Treatment With Long Acting GnRH Antagonist Degarelix in Women With Endometriosis Recurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometriosis
Keywords: Endometriosis
long acting GnRH antagonist
Degarelix
Recurrence
Pelvic Pain
Lead sponsor: Centre for Endocrinology and Reproductive Medicine, Italy
Sponsor class: NETWORK
First posted: 2012-10-24
Enrollment: 360
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The long acting GnRH antagonist degarelix will be tested for the treatment of women with endometriosis recurrence compared with classical GnRH analog treatment. Pain symptom disappearance and disease free time during follow-up will be the outcomes for establishing which medical treatment is the best in endometriosis recurrence treatment.

Detailed description: Endometriosis is a chronic disease affecting 5-10% of women in reproductive age, showing recurrence after surgery at least in 20-50% after 5 years of follow-up. The long acting GnRH antagonist degarelix, which do not have the flare-up effect at the opposite of GnRH agonist and strongly suppress LH secretion and thecal cell activity may show a better effects on endometrial implants than GnRH agonist.

Eligibility criteria: Inclusion Criteria:

* women affected by endometriosis showing recurrence of pain symptoms
* previous surgery for endometriosis

Exclusion Criteria:

* presence of other systemic diseases

Primary outcomes:
measure: disease free time
timeFrame: 24 months
Secondary outcomes:
measure: time of disappearance pain
timeFrame: 24 months
Other outcomes:
measure: reduction of endometriosis lesions
timeFrame: 24 months
Locations:
city: Tirana
country: Albania
facility: Albania Spitali Amerikan
city: Sofia
country: Bulgaria
facility: Nadezda Women's Health Hospital
city: Rome
country: Italy
facility: Cerm-Hungaria
Study officials:
affiliation: Centre for Endocrinology and Reproductive Medicine, Italy
name: MARCO SBRACIA, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04255563: Drug-coating Balloon Treatment in Coronary Artery Disease
Official title: Drug-coating Balloon Treatment in Coronary Artery Disease: a Prospective, Multicenter, Registry Study (ULTIMATE-DCB)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects with coronary artery disease undergoing DCB treatment will be enrolled in this study.

Brief summary: Drug-coated balloon (DCB) is an alternative choice for patients with coronary artery disease (CAD). This study is to investigate the efficacy and safety of DCB treatment in patients with CAD.

Detailed description: This is a prospective, multi-center, registry to enroll patients undergoing DCB treatment.

All subjects undergoing DCB treatment will be enrolled in this study without strict inclusion and exclusion criteria. Data and images will be collected during the index procedure, and at the clinical and angiographic follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients suitable for DCB treatment

Exclusion Criteria:

* Pregnancy
* Contraindications to contrast media, antiplatelet therapy, or paclitaxel
* Expected life less than 12 months
* Cardiac shock

Primary outcomes:
measure: target vessel failure (TVF) at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Parameter by quantitative coronary angiography at 7 months
timeFrame: 7 months
measure: Bleeding at 12 months
timeFrame: 12 months
measure: Bailout drug-eluting stents (DES) implantation rate
timeFrame: During procedure
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Shao-Liang Chen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01017263: Vyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD) and Obesity
Official title: Vyvanse and Glucose Intolerance in Children With ADHD and Obesity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Glucose Intolerance
Obesity
Keywords: ADHD
Glucose Intolerance
Obesity
Vyvanse
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Shire
First posted: 2009-11-20
Enrollment: 14
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study to assess the effects of chronic administration of Vyvanse (lis-dexamphetamine) on glucose metabolism in a sample of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who also have glucose intolerance and are obese.


Eligibility criteria: Inclusion Criteria:

* male or female, ages between 8 and 17
* Body Mass Index \> 30
* fasting blood sugar between 90-100 mg/dl
* 2 hour post prandial \>140 \<180 mg/dl
* meets criteria for a diagnosis of ADHD, any subtype

Exclusion Criteria:

* known cardiovascular disease or diabetes
* structural cardiac abnormalities, abnormal ECGs, family history of sudden death
* positive urine drug screen
* fasting blood sugar level \> 126 mg/dl
* HbA1c \> 6.5 %
* Weight \> 300 lbs

Primary outcomes:
measure: Pre and Post Study Fasting Blood Sugar and Two Hour Post Prandial.
timeFrame: Baseline to end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Child and Family Study Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Scott H Kollins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00607763: Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
Official title: A Phase 1, Open-Label Study Of The Safety And Pharmacokinetics Of Repeated-Dose Micafungin (FK463) In Infants And Toddlers (≥4 Months TO < 24 Months Of Age) With Esophageal Candidiasis Or Other Invasive Candidiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Invasive Candidiasis
Esophageal Candidiasis
Oropharyngeal Candidiasis
Candidemia
Keywords: Antifungal
Echinocandin
Candidiasis
Micafungin
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-02-06
Enrollment: 9
Sex: ALL
Minimum age (years): 4
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Infants and toddlers with fungal infections will receive 10 to 14 days of treatment with an antifungal drug. Safety and drug blood levels will be assessed

Detailed description: This is a prospective, multicenter, open-label, repeat-dose study. Subjects will receive treatment with intravenous micafungin for 10 to 14 days (per investigator clinical judgment) at a daily dose of 4.5 mg/kg (determined by the subject's weight at baseline). Serial blood samples for assessment of pharmacokinetics will be collected.

Eligibility criteria: Inclusion Criteria:

1. Subject is ≥4 months to \< 24 months
2. Subject has suspected, proven or probable candidiasis, candidemia or other invasive candidiasis
3. Subject has sufficient venous access to permit administration of study medication, collection of pharmacokinetic samples, and monitoring of laboratory safety variables

Exclusion Criteria:

1. Subject has evidence of significant liver disease, as defined by aspartate transaminase (AST), alanine transaminase (ALT), bilirubin or alkaline phosphatase \> 5 times the upper limit of normal (ULN)
2. Subject has a concomitant medical condition that in the opinion of the investigator and/or medical monitor precludes enrollment into the study
3. Subject has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
4. Subject has received treatment with an echinocandin within one week prior to first dosing
5. Subject status is unstable and subject is unlikely to complete all study required procedures

Primary outcomes:
measure: Evaluation of Micafungin pharmacokinetics
timeFrame: 10 - 14 Days
Secondary outcomes:
measure: Assess safety and tolerability of micafungin by adverse events, vital signs, hematology and chemistry laboratory tests, ECGs and physical evaluation
timeFrame: Day 1 to End of Study
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: Louisville
country: United States
state: Kentucky
city: Kansas City
country: United States
state: Missouri
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Astellas Pharma Global Development
name: Central Contact
role: STUDY_DIRECTOR
References:
Clinical trial NCT01425463: A Double-blind, Double-dummy, Parallel, Active-controlled, Randomized Trial to Evaluate Efficacy & Safety in Anemia Subjects
Official title: A Double-blind, Double-dummy, Parallel, Active-controlled, Randomized and Multi-center Trial to Investigate Efficacy and Safety in Subjects With Iron Deficiency Anemia for Ferrous (II) Glycine Sulphate Complex Versus Polyferose Capsules Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Iron Deficiency Anemia
Keywords: Ferrous (II) Glycine Sulphate Complex
Polyferose
Ferro Sanol duodenal
Niferex
Iron Deficiency Anemia
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2011-08-30
Enrollment: 256
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of 12 weeks treatment with Ferrous (II) Glycine Sulphate Complex in comparison to Polyferose capsules in Chinese subjects with manifest Iron Deficiency Anemia.


Eligibility criteria: Inclusion Criteria:

* An iron deficiency anemia patient with Serum Ferritin \< 12 ng/mL, serum Hb-values \>60 and \< 120 g/L in males, \< 110 g/L in females

Exclusion Criteria:

* With any Mal-absorption Syndrome
* With a history of Thalassemia or Sickle Cell Anemia
* With untreated concurrent Vitamin B12 or Folate deficiency at Baseline

Primary outcomes:
measure: Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12
timeFrame: From Baseline to Week 12
Secondary outcomes:
measure: Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2
timeFrame: From Baseline to Week 2
measure: Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4
timeFrame: From Baseline to Week 4
measure: Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8
timeFrame: From Baseline to Week 8
measure: Percentage of Responders at Week 12
timeFrame: End of Treatment Period (Week 12)
Other outcomes:
Locations:
city: Changsha
country: China
facility: 15
city: Changsha
country: China
facility: 16
city: Fuzhou
country: China
facility: 1
city: Guangzhou
country: China
facility: 10
city: Hangzhou
country: China
facility: 5
city: Hangzhou
country: China
facility: 6
city: Jinan
country: China
facility: 7
city: Jinan
country: China
facility: 8
city: Shanxi
country: China
facility: 13
city: Shanxi
country: China
facility: 14
city: Shenyang
country: China
facility: 12
city: Tianjin
country: China
facility: 2
city: Wenzhou
country: China
facility: 17
city: Wuxi
country: China
facility: 4
city: Xi'an
country: China
facility: 9
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03192163: Cultural Differences in Treatment Preferences and Perceptions of Acne
Official title: Cultural, Racial, and Ethnic Differences in Treatment Preferences and Perceptions of Acne Vulgaris
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acne Vulgaris
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with Acne vulgaris in the US

Brief summary: This study will use a survey to examine relationships between culture, race, and ethnicity with treatment preferences and perceptions for acne vulgaris.

Detailed description: The purpose of this study is to determine how explanatory models, perceptions, and treatment preferences of acne vulgaris vary across different cultures and racial and ethnic backgrounds. This study will also use Willingness to Pay to investigate differences in treatment valuation. Clarifying these differences will better inform patient counseling and treatment adherence by improving the quality of shared decision making.

Eligibility criteria: Inclusion Criteria:

* Subjects must have acne vulgaris, be at least 18 years of age, and must be able to complete a survey published in English.

Exclusion Criteria:

-

Primary outcomes:
measure: Willingness to Pay
timeFrame: 15 minutes
measure: Preferred and Least Preferred Treatments
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine Department of Dermatology
state: Illinois
Study officials:
References:
Clinical trial NCT00528463: Pre-emptive Sciatic Bloc to Prevent Lower Limb Phantom Pain
Official title: a Prospective Case Series of Pre-emptive Pre-amputation Sciatic Nerve Block to Prevent Lower Limb Phantom Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Phantom Limb Pain
Keywords: Pre-emptive analgesia
Peripheral nerve block (sciatic)
phantom lomb pain
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2007-09-12
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Phantom limb pain is a complication of amputation. Although pre-empitve epidural analgesia was once thought to prevent such a com plication, recent studies did not demonstrate this. Peripheral blocks are more powerful then epidurals, and can even influence somatotropic representation in the brain. This a prospective case series in which the investigators hope to show a decrease, against historical control, of the incidence of post-operative amputation lower limb phantom pain. The investigators established the block at least 24 hours pre-operative and continue it for at least 2 days. Patient are followed daily for the 1st 3 days and then up to 3 month for the incidence of phantom limb pain. The investigators hope to recruit 30 patients.


Eligibility criteria: Inclusion Criteria:

* Patient scheduled for lower limb amputation

Exclusion Criteria:

* Inability to consent
* Contraindication to peripheral nerve block
* Inability to perform the block
* Inadequate time frame (less than 24 hours prior to surgery)

Primary outcomes:
measure: incidence of lower limb phantom pain
timeFrame: 3 month post amputation
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: CHU
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: ETIENNE DE MEDICIS, MD, MSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01142063: A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects
Official title: A Single Dose Bioequivalence Study Comparing The Commercial Tablet Formulation To The Clinical Tablet Of Neratinib In Healthy Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Neratinib
Lead sponsor: Puma Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cohorts will be selected from healthy volunteers.

Brief summary: The purpose of the study is to demonstrate the bioequivalence of the proposed commercial neratinib tablet formulation (240 mg strength x 1) to the reference Phase 3 tablet formulation (40 mg tablet strength x 6) under fed and fasted conditions in healthy subjects.

Detailed description: The study will be an open label, randomized, 4 period, 4 treatment, 4 sequence (Williams design), cross over.

Eligibility criteria: Inclusion Criteria:

* An informed consent document signed and dated by the subject or a legally acceptable representative.
* Healthy male and/or female of non-childbearing potential subjects between the ages of 18 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, and clinical laboratory tests).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).

Primary outcomes:
measure: Maximum plasma concentration (Cmax) and Area under the plasma concentration-time profile from time zero extrapolated to infinite time for neratinib (AUCinf)
timeFrame: 0 to 48 hour post-dose
Secondary outcomes:
measure: Plasma Time for Cmax (Tmax), Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast) (AUClast) and Terminal elimination half-life (t1/2) for neratinib
timeFrame: 0 to 48 hour post-dose
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Investigational Site
state: Connecticut
Study officials:
affiliation: Biotechnology
name: Puma
role: STUDY_DIRECTOR
References: