louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01676987: Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma
Official title: Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma:a Randomized, Double-blind, Multicenter, Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Budesonide
Adrenergic beta-2 receptor agonists.
Lead sponsor: Ache Laboratorios Farmaceuticos S.A.
Sponsor class: INDUSTRY
First posted: 2012-08-31
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of a fixed-dose, single-capsule budesonide(400µg)-formoterol(12µg) combination, in comparison with budesonide alone, both delivered via a dry powder inhaler, in 181 patients with uncontrolled asthma.This was Randomized, double-blind, multicenter, phase III, parallel clinical trial.

Detailed description: the age of the patients ranged from 18 to 77 years. After a run-in period of 4 weeks, during which all of the patients received budesonide twice a day, they were randomized into one of the treatment groups for 12 weeks, twice a day.

The primary outcome measures were FEV1, FVC and morning PEF. We performed an intention-to-treat analysis of the data.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of uncontrolled asthma
* Age ranged from 18 to 77 years
* Nonsmokers

Exclusion Criteria:

* Use of oral corticosteroids, anti-leukotrienes, immunoglobulins, beta blockers, digitalis, amiodarone, antifungals, antidepressants, monoamine oxidase inhibitors and tricyclics during the standardization
* Atrial fibrillation, Flutter, severe and complex tachyarrhythmias atrioventricular block 1,2 and 3
* Diabetes mellitus
* Pregnancy
* Neuropsychiatric diseases
* Pulmonary malformations, tuberculosis, Cystic fibrosis
* Immunosuppressive treatment
* Hospitalization for asthma or respiratory infection in last 30 days
* Severe systemic disease

Primary outcomes:
measure: Evaluation of the efficacy and safety of a fixed-dose, single capsule budesonide-formoterol combination in comparison with budesonide alone in patients with uncontrolled asthma
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NUPAIVA Asthma Research Center, UFSC- Brazil
name: Emílio Pizzichini
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stirbulov R, Fritscher CC, Pizzichini E, Pizzichini MM. Evaluation of the efficacy and safety of a fixed-dose, single-capsule budesonide-formoterol combination in uncontrolled asthma: a randomized, double-blind, multicenter, controlled clinical trial. J Bras Pneumol. 2012 Jul-Aug;38(4):431-7. doi: 10.1590/s1806-37132012000400004. English, Portuguese.
Clinical trial NCT03313687: SafeTy and Outcome of contemPorary Treatment Strategies for Cardiogenic SHOCK
Official title: SafeTy and Outcome of contemPorary Treatment Strategies for Cardiogenic SHOCK - an International, Observational Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiogenic Shock
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to a tertiary care hospital.

Brief summary: International, observational registry to investigate the outcome in patients with cardiogenic shock. The primary aim of this study is to investigate the clinical outcome of patients in cardiogenic shock.

Detailed description: There is a focus on interventional therapies, mechanical circulatory support and new cardiovascular therapeutics in patients with cardiogenic shock (CS). The investigators will describe current practice in study sites including concomitant patients with CS. Therefore, the investigators will monitor drug therapies initiated, devices being utilized as well as outcome and side effect of possible interventions

Eligibility criteria: Inclusion Criteria:

* Patients with cardiogenic shock treated at a tertiary care hospital.

Exclusion Criteria:

* Age ≤17 years.

Primary outcomes:
measure: All-cause mortality
timeFrame: Within 30 days after admission.
Secondary outcomes:
measure: Ischemic events, bleeding events, heart failure, sepsis, dialysis.
timeFrame: Within 30 days after admission.
measure: All-cause mortality
timeFrame: Within 12 months after admission.
measure: Ischemic events, bleeding events, heart failure, sepsis, dialysis.
timeFrame: Within 12 months after admission.
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Heart Center
Study officials:
affiliation: UHZ
name: Dirk Westermann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schrage B, Ibrahim K, Loehn T, Werner N, Sinning JM, Pappalardo F, Pieri M, Skurk C, Lauten A, Landmesser U, Westenfeld R, Horn P, Pauschinger M, Eckner D, Twerenbold R, Nordbeck P, Salinger T, Abel P, Empen K, Busch MC, Felix SB, Sieweke JT, Moller JE, Pareek N, Hill J, MacCarthy P, Bergmann MW, Henriques JPS, Mobius-Winkler S, Schulze PC, Ouarrak T, Zeymer U, Schneider S, Blankenberg S, Thiele H, Schafer A, Westermann D. Impella Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock. Circulation. 2019 Mar 5;139(10):1249-1258. doi: 10.1161/CIRCULATIONAHA.118.036614.
Clinical trial NCT01091987: Non-pharmacological Treatment of Insomnia in Nursing Homes.
Official title: Pilot Study on the Feasibility of Non-pharmacological Treatment of Insomnia in Nursing Homes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Flemish Minister for Welfare, Public Health and Family, Belgium
name: Farmaka vzw, Belgium
name: Domus Medica vzw, Belgium
First posted: 2010-03-24
Enrollment: 45
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study wants to examine the feasibility of a non-pharmacological approach for insomnia in nursing homes provided by trained nurses/paramedics and physicians.


Eligibility criteria: Inclusion Criteria:

* Male and female nursing home residents of age 55+ with insomnia, defined as difficulty in getting to sleep, difficulty in staying asleep, early wakening, or non-restorative sleep

Exclusion Criteria:

* insufficient cognitive ability for self-reflection
* dementia
* insomnia caused by a medical disorder (hyperthyroidism, congestive heart failure, peripheral arterial disease, GORD, COPD/asthma, angina pectoris, benign prostatic hyperplasia, arthritis, other
* insomnia caused by medication
* substance misuse
* other sleep disorder: restless legs syndrome, periodic limb movement disorder, sleep apnoea, narcolepsy
* psychiatric disorder: psychotic or bipolar disorder in anamnesis, major depression present or more than 2 episodes in anamnesis
* short stay

Primary outcomes:
measure: The proportion of eligible residents who accepted to participate in the non-pharmacological program and the proportion of eligible residents who completed the non-pharmacological program.
timeFrame: after 3 months
Secondary outcomes:
measure: Insomnia, as measured by the Groningen Sleep Quality Questionnaire
timeFrame: at baseline and after 3 months
measure: quality of life
timeFrame: at baseline and after 3 months
measure: Use of sleep medication
timeFrame: at baseline and after 3 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Ghent
Study officials:
affiliation: University Ghent
name: Thierry Christiaens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00811187: Paracervical Block During Office Hysteroscopy
Official title: Paracervical Block During Office Hysteroscopy: A Randomized Double Blind Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Paracervical Block
Keywords: Hysteroscopy
Pain medication
Lidocaine
Office Procedures
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2008-12-18
Enrollment: 80
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of paracervical block for pain relief in office hysteroscopy - particularly with the placement of the Essure device. Subjects will be randomized to receive either paracervical block or saline, and will have pain assessments performed throughout the procedure. Subjects and physicians will be blinded to group assignments.


Eligibility criteria: Inclusion Criteria:

* Women eligible and scheduled for office hysteroscopic placement of essure devices

Exclusion Criteria:

* Planned secondary procedures
* Lidocaine allergy
* Repeat procedures

Primary outcomes:
measure: Assessment of Pain on a 10-point Visual Analog Pain Scale During the Procedure.
timeFrame: During Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Centennial Women's Center / Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center/Albert Einstein College of Medicine
name: Scott Chudnoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chudnoff S, Einstein M, Levie M. Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):26-34. doi: 10.1097/AOG.0b013e3181c51ace.
Clinical trial NCT05687487: Residual or Recurrent Obstruction After Septal Myectomy
Official title: Residual or Recurrent Obstruction After Septal Myectomy in Young Children and Infants With Hypertrophic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertrophic Obstructive Cardiomyopathy
Keywords: Septal myectomy
Residual or recurrent obstruction
children and infants
hypertrophic obstructive cardiomyopathy
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 56
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with HOCM who remain severely symptomatic despite medical therapy or have a particularly high resting LVOT gradients (\>100mmHg) underwent septal myectomy by the same surgeon Y from January 2013 to December 2020. A total of 56 consecutive children younger than 14 were included. All patients were on Beta blockers therapy and symptomatic.

Brief summary: The goal of this observational study is to report the outcomes after septal myectomy in young children and infants and identify the mechanisms of residual or recurrent obstruction after surgery. in The main question\[s\] it aims to answer are:

* What is the early and mid-term results of septal myectomy in young children and infants with severe and extensive obstructive hypertrophic cardiomyopathy (HCM)?
* What are the mechanisms of residual or recurrent obstruction?

Echocardiography and clinical course of children and infants under the age of 14 who underwent septal myectomy for hypertrophic obstructive cardiomyopathy from January 2013 to December 2020 will be followed up.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hypertrophic obstructive cardiomyopathy (HOCM)
* Age young than 14 years
* Patients who have undergone septal myectomy

Exclusion Criteria:

* older than 14 years old;
* secondary left ventricular hypertrophy (LVH) related to subaortic stenosis or aortic stenosis.

Primary outcomes:
measure: death
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: recurrent obstruction
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06518187: Investigating the Influence of Catheter Advancement Techniques on Needle Tip Movement During Intravenous Insertion
Official title: Investigating the Influence of Catheter Advancement Techniques on Needle Tip Movement During Intravenous Insertion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Health Care Utilization
Keywords: IV Technique
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants for this study are Anesthesiology healthcare professionals/providers who perform IV catheter placement

Brief summary: This proposed study aims to fill this gap by investigating whether needle tip movement during catheter advancement is affected by whether the individual performing the insertion pushes the catheter off the needle themselves or if it is done by another person.

Detailed description: Participant arrives at the simulation setting. Participant undergoes orientation and consent. This includes orientation to study procedure and equipment, explanation of catheter advancement techniques, and informed consent process. Following consent, participant fills out Participant Questionnaire. Total time required: Approximately 10 minutes.

Participant performs IV catheter insertion using 3 techniques: 1 (Self-advancement single hand), technique 2 (Self-advancement both hands), and technique 3 (second person assisted) in randomized order. Total time required: Approximately 5 minutes. Participant completes Participant Questionnaire. Participant's participation is concluded.

In this study, the observation to be carried out is the total distance of needle tip movement while performing the initial intravenous catheter advancement off of the needle using three different catheter advancement techniques including: Self-advancement with one hand; Self-advancement with two hands; Catheter advancement by another individual.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Willing to consent to the study
3. has some experience placing IV catheters

Exclusion Criteria:

1. Subject refuses to consent
2. Younger than 18 years of age
3. No experience inserting IV catheters

Primary outcomes:
measure: Needle tip movement (displacement) in mm during initial advancement of a 16ga IV catheter off of its needle during simulated intravenous catheter insertion with three different catheter advancement techniques..
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Shands
state: Florida
Study officials:
affiliation: University of Florida Department of Aneshtesiology
name: Nikolaus Gravenstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01497587: Pharmacokinetics of Insulin Detemir in Healthy Volunteers From Taiwan
Official title: A Single Centre, Open-labelled Trial to Investigate the Pharmacokinetics of Insulin Detemir in Healthy Taiwanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-22
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of this trial is to investigate pharmacokinetics of insulin detemir in healthy Taiwanese subjects.


Eligibility criteria: Inclusion Criteria:

* Considered generally healthy upon completion of medical history and physical examination as judged by the investigator
* Body mass index (BMI) between 18 and 27 kg/m\^2, inclusive
* Fasting plasma glucose maximum 6.1 mmol/l
* Non-smoker or smoking maximum 5 cigarettes per day or the equivalent

Exclusion Criteria:

* Participation in any other clinical trial involving other investigational products within the last 3 months
* Subject with a history of alcohol or drug dependence
* Subject with a first-degree relative with diabetes mellitus

Primary outcomes:
measure: Area under the insulin detemir concentration curve
Secondary outcomes:
measure: Maximum insulin detemir concentration
measure: Time to maximum insulin detemir concentration
measure: The mean residence time of insulin detemir
measure: Insulin detemir half-life
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Kwok C-F, Tsai T-H, Lim S-H, Vaz J, Ho L-T. The Pharmacokinetic Profile of Insulin Detemir in Healthy Male Taiwanese and Caucasian Subjects. ASEAN Federation of Endocrine Societies (AFES); Country: Malaysia City: Kuala Lumpur
Clinical trial NCT03052387: Vertical Augmentation Using Onlay Versus Inlay Autogenous Graft With Simultaneous Implant Placement.
Official title: Assessment of Vertical Bone Augmentation Using Autogenous Onlay Versus Inlay Grafting Techniques With Simultaneous Implant Placement in the Anterior Maxillary Area on Patient's Esthetic Satisfaction : A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Resorption
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using autogenous Chin block for vertical augmentation with simultaneous implant placement at anterior maxilla region comparing between the Onlay and Inlay grafting techniques.

Detailed description: to study the vertical augmentation with simultaneous implant placement at anterior maxillary region.

* P: Patient requires implant at anterior maxillary ridge with vertical deficiency.
* I:Inlay Sandwich Technique with immediate implant placement.
* C:Onlay autogenous graft immediate implant placement.
* O:Outcome name Measuring device Measuring unit

Primary outcome: Vertical bone gain CBCT Millimeter

-Secondary outcome(a): Crestal bone loss CBCT Millimeter

Eligibility criteria: Inclusion Criteria:

* \* Patients with partially edentulous anterior maxillary ridges.

  * Patients were free from any systemic disease that interferes with bone healing.
  * Absence of local pathosis at anterior maxillary area.
  * No history of any grafting procedure at the designated edentulous ridge.

The edentulous ridge vertical dimension was less than 10 mm measured from the alveolar crest to the nasal floor (i.e.ridge had vertical inadequacy) with normal horizontal alveolar dimension or patient with Increased Inter-Arch Space.

Exclusion Criteria:

* \* Patient with fully dentulous maxilla.

  * Pregnant females.
  * Presence of bad habits (severe bruxism, clenching).
  * Systemic diseases that may interfere with bone healing.e.g. uncontrolled Diabetes.

Primary outcomes:
measure: vertical Bone gain
timeFrame: 6 months
Secondary outcomes:
measure: crestal bone loss
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06913387: Comparative Efficacy of Lipid Based Artificial Tears vs Aqueous Based Artificial Tears in Managing EDE
Official title: Comparative Efficacy of Lipid Based Artificial Tears vs Aqueous Based Artificial Tears in Managing EDE: A 6 Week RCT
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Evaporative Dry Eye
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This randomized clinical trial aims to compare the efficacy of lipid-based (Recuro) versus aqueous-based (Softeal) artificial tears in managing Evaporative Dry Eye (EDE) over six weeks. Conducted in a hospital or ophthalmology clinic, the study includes 60 participants (aged 18-55, both genders) diagnosed with EDE.

Detailed description: Participants are randomly assigned to receive either lipid-based or aqueous-based artificial tears, following a block randomization method (block size of 4) generated using Research Randomizer. The primary objectives are to assess symptom reduction and improvement in quality of life, measured by the Ocular Surface Disease Index (OSDI) and the SANDE questionnaire. Objective assessments include tear film stability, Meibomian gland function, tear volume, and ocular surface health.

Eligibility criteria: Inclusion Criteria:

* Adults (both genders) aged 18-55 years diagnosed with evaporative dry eye (EDE).
* Willingness to adhere to the prescribed treatment regimen (lipid-based or aqueous-based artificial tears).
* Include patients with a history of dry eye symptoms for at least 1-3 months.
* Ocular Surface Disease Index (OSDI) score ≥13, indicating the presence of mild to severe dry eye symptoms.
* Patients with tear break-up time (TBUT) \<10 seconds, indicating tear film instability.(16)

Exclusion Criteria:

* Use of any topical ophthalmic medications (e.g., lubricants, anti-inflammatory drugs, or cyclosporine) for dry eye within the last 1 month.
* Active ocular infection or inflammation (e.g., conjunctivitis, uveitis).
* History of ocular surgery or trauma within the past 6 months.
* Participants currently wearing contact lenses or those who have worn contact lenses in the past three months.
* Systemic conditions known to impact ocular surface health, such as uncontrolled diabetes, autoimmune disorders, or Sjögren's syndrome.

Primary outcomes:
measure: Ocular Surface Disease Index (OSDI)
timeFrame: 12 Months
measure: SANDE Questionnaire (Symptom Assessment in Dry Eye)
timeFrame: 12 Months
measure: Tear Break-Up Time (TBUT) Test
timeFrame: 12 Months
measure: Meibomian Gland Function Score
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Mughal eye Hospital Johar town
state: Punjab
Study officials:
References: