louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01452581: Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty
Official title: Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthroplasty, Hip
Keywords: Transfusion
Red blood cells
Postoperative
Dizziness
Hip Arthroplasty
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2011-10-17
Enrollment: 5
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 effects of transfusion of red blood cells in treating postoperative dizziness in patients with moderate postoperative anemia after total hip arthroplasty.

Detailed description: Hip arthroplasty is associated with bleeding and postoperative anemia. However, the optimal strategy for transfusing red blood cells (RBC) remains to be elucidated. Postoperative anemia may cause dizziness and fatigue which delays early mobilization after surgery and may trigger the transfusion of one or more RBC units. However, it is not known whether the administration of 1-2 units of RBC to patients suffering from moderate postoperative anemia (HB 7.5 - 10 g/dl) will improve postoperative dizziness.

Thus, this randomized controlled study aims to evaluate whether the administration of 1-2 RBC units on the first postoperative day improves postoperative dizziness in patients undergoing total hip arthroplasty.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 and able to give consent
* Hip arthroplasty or hip revision arthroplasty
* Haemoglobin \> 4.8 mmol/L and \< 6.0 mmol/L on the first postoperative day
* Dizziness score ≥ 2.

Exclusion Criteria:

* Large ongoing bleeding
* Has already received RBC during the current admission
* New onset of cardiac arrhythmia suspected to be related to anemia
* Severe ischemic heart disease
* Renal failure with dialyses or oligouria / anuria.

Primary outcomes:
measure: Postoperative Dizziness scale
timeFrame: Day 1 after surgery
Secondary outcomes:
measure: Timed up and go test (TUG)
timeFrame: Day 1 after surgery and on the day of discharge (expected mean 4 days after surgery)
measure: Fatigue score
timeFrame: Day 1 after surgery and on the day of discharge (expected mean 4 days after surgery)
measure: FACT-Anemia scale
timeFrame: 7 and 14 days
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Gentofte Hospital, Department of orthopedic surgery
city: Vejle
country: Denmark
facility: Vejle Sygehus, Department of orthopedic surgery
Study officials:
affiliation: Rigshospitalet, Denmark
name: Oeivind Jans, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04598581: Low Dose Radiation Therapy for Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2), COVID-19
Official title: Low Dose Radiation Therapy for Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2)
Keywords: Low dose radiation therapy (LD-RT)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to analyse the efficacy of LD-RT for treatment of Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2).

Detailed description: Management of patients with SARS-CoV-2 presents a great challenge in the ongoing pandemic. The inflammatory reaction, evident in the later stages of the disease, is linked with high mortality rates. Pharmaceutical interventions at this stage often do not achieve the desired effects. Low Dose Radiation Therapy (LD-RT) has been utilized for treatment of inflammatory conditions because of its immunomodulatory effects. Thus, LD-RT may be an option in SARS-CoV-2 based on pre-clinical models and early clinical data. This study is to analyse the efficacy of LD-RT for treatment of Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2).

Eligibility criteria: Inclusion Criteria:

* Age of male patients \>40 years
* Age of female patients \>50 years
* Patients with SARS-CoV-2 requiring mechanical ventilation
* Informed consent obtained by the legal representative of the patient

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Ventilator free days (VFD)
timeFrame: at day 15 after LD-RT
Secondary outcomes:
measure: Change in pulmonary function, measured as relative change (%) from baseline in oxygenation index (PaO2 / FiO2)
timeFrame: at day 5, 10, 15, 28 after LD-RT
measure: Overall mortality
timeFrame: at day 15 and 28 after LD-RT
measure: Change in levels of ferritin (ng/ml)
timeFrame: up to day 15 after LD-RT
measure: Change in levels of c-reactive protein (mg/l)
timeFrame: up to day 15 after LD-RT
measure: Change in levels of white blood cell counts (number of white blood cells per volume of blood)
timeFrame: up to day 15 after LD-RT
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Radiooncology, University Hospital Basel
Study officials:
affiliation: Department of Radiooncology, University Hospital Basel
name: Alexandros Papachristofilou, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Papachristofilou A, Finazzi T, Blum A, Zehnder T, Zellweger N, Lustenberger J, Bauer T, Dott C, Avcu Y, Kohler G, Zimmermann F, Pargger H, Siegemund M. Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia: A Randomized Double-Blind Study. Int J Radiat Oncol Biol Phys. 2021 Aug 1;110(5):1274-1282. doi: 10.1016/j.ijrobp.2021.02.054. Epub 2021 Mar 5.
Clinical trial NCT01318681: Rhinitis, Cognition and Driving Performance
Official title: Effects of Treated and Untreated Allergic Rhinitis on Mood, Cognitive Functions and Actual Driving Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seasonal Allergic Rhinitis
Driving Ability
Cognition
Keywords: driving, memory, cognition
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2011-03-18
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study investigates the effects of Allergic Rhinitis (AR) on driving ability and memory functions. Our group has previously shown that patients suffering from AR symptoms perform less well on tasks requiring sustained attention compared to non symptomatic controls. Car driving is a typical behavior that is susceptible for changes in sustained attention and might therefore become worse under conditions when patients suffer from AR symptoms. We will compare the driving performance of untreated, symptomatic AR patients with the performance of symptomatic patients that have been treated with either a systemic AR medication (a pill) or a topical medication (nasal spray)


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers known with Seasonal Allergic Rhinitis
* Experienced drivers holding a license
* 21- 45 years of age

Exclusion Criteria:

* Asthma or other chronic illness
* current psychoactive medication
* History of drug abuse

Primary outcomes:
measure: Standard Deviation of Lateral Position (SDLP) in highway driving
timeFrame: 2:00 - 3:00 hrs post dosing
Secondary outcomes:
measure: Word Learning Test (WLT-15) verbal memory score
timeFrame: 2:30 hrs post dosing
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
References:
Clinical trial NCT00724581: Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer
Official title: Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer: A Controlled, Randomized, Double Blinded Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation, amiodarone
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2008-07-29
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients undergoing lung resection due to pulmonary cancer can be compromised in their postoperative period due to atrial fibrillation.

A retrospective analysis performed at our institution indicates that 30 % of the population develope atrial fibrillation in the postoperative period.

Amiodarone is known to diminish the occurence of postoperative atrial fibrillation after heart surgery, why this drug is chosen as a prophylactic agent for the mentioned population.

Amiodarone is administrated twice a day for 5 days at a dose of 600 mg oral treatment after an initial loading bolus og 300 mg intravenously.


Eligibility criteria: Inclusion Criteria:

* Resection of the lung due to confirmed diagnosis of cancer pulmones.
* Elective operation (scheduled operation for at least one day)
* Ready to be randomized
* Patient must be at least 18 at time of operation

Exclusion Criteria:

* Former operation of the lung
* Former heart surgery
* Bradycardia below 40 beats/ min
* Hypotension with systolic blood pressure below 80 mmHg
* AV-blockage of any degree or sick sinus node
* QTc interval above 440 ms for men or above 460 ms for women
* Paroxysmal, persistent or permanent atrial fibrillation or flutter
* Former atrial fibrillation or flutter for more than a month.
* Pregnant or positive pregnancy test
* Breastfeeding
* ALAT of more than twice the normal over limit
* Treatment with monoamineoxidase inhibitors (MAOI)
* Allergy to one or more components in amiodarone

Primary outcomes:
measure: Free of atrial fibrillation
timeFrame: 31082009
Secondary outcomes:
measure: Cost-benefit analysis of amiodarone prophylactic
timeFrame: 31082009
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Skejby
Study officials:
affiliation: Aarhus University Hospital Skejby
name: Lars R Zebis, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01984281: Effects of a Pedometer-based Unsupervised Exercise Program Upon Lifestyle Physical Activity of Asthmatic Adults
Official title: Effects of a Pedometer-based Unsupervised Exercise Program Upon Lifestyle Physical Activity of Asthmatic Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Physical Activity
Pedometers
Quality of Life
Lead sponsor: Federal University of Juiz de Fora
Sponsor class: OTHER
First posted: 2013-11-14
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine whether a pedometer-based unsupervised exercise program is more effective than a general exercise recommendation to increase lifestyle physical activity in adult patients with asthma.

Detailed description: The patients will be randomized in two groups: the intervention group will receive a standardized advice to physical activity practice plus pedometers and step goals to achieve over the next twelve weeks and the control group will receive the same standardized advice to physical activity practice and usual care.

Eligibility criteria: Inclusion Criteria:

* Asthma diagnosis for at least 6 months (according to Global Initiative for Asthma criteria)
* Regular drug therapy (inhaled corticosteroids or inhaled corticosteroids plus long-acting beta-agonists)
* Clinical stability during the run-in period (3 weeks)

Exclusion Criteria:

* Physical activity practice over once a week
* Disabling musculoskeletal disease
* Cardiopathy
* Other lung disease
* More than 10 pack-years of smoking
* Pregnancy
* Refusal to participate

Primary outcomes:
measure: Lifestyle physical activity
timeFrame: 12 weeks
Secondary outcomes:
measure: Exercise capacity
timeFrame: 12 weeks
measure: Asthma Health related quality of life
timeFrame: 12 weeks
measure: Asthma Control
timeFrame: 12 weeks
measure: Depression and anxiety
timeFrame: 12 weeks
measure: Asthma exacerbations
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Juiz de Fora
country: Brazil
facility: University Hospital of the Federal University of Juiz de Fora
state: Minas Gerais
Study officials:
affiliation: Federal University of Juiz de Fora
name: Bruno V Pinheiro, DSc
role: STUDY_DIRECTOR
affiliation: Federal University of Juiz de Fora
name: Cristina M Coelho, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01491581: Efficacy of a Milk-based Nutrient-rich Bar on Nutritional Status and Cognitive Performance of School Children in Vietnam
Official title: Efficacy of a Milk-based Nutrient-rich Bar on Nutritional Status and Cognitive Performance of School Children in Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Performance
Keywords: anthropometry
zinc
iodine
vitamin D
calcium
school children
food supplement
Lead sponsor: Institut de Recherche pour le Developpement
Sponsor class: OTHER_GOV
Collaborators: name: Can Tho University
name: National Institute of Nutrition, Vietnam
name: Global Alliance for Improved Nutrition
name: ILSI, Japan
First posted: 2011-12-14
Enrollment: 415
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of the study is to evaluate the impact of the milk-based nutrient-rich bar, specifically the effect of its fortification with zinc, iodine, vitamins A and D and calcium on nutritional status of school children, focusing on vitamin A and, zinc, iodine, calcium and iron status, and on their cognitive performances.

Detailed description: Design: double-masked randomized control trial Place: three schools in South Vietnam, Can Tho district, South Vietnam Subjects: School children aged 6 to 10 years old, from first grade to third grade of 3 primary schools.

Duration of intervention: 6 months (consumption of Goody or "control bar")

Study groups: 2 groups:

Group 1: children will receive micronutrient enriched milk bar. Group 2: children will receive the same milk-based food except for the micronutrient fortification.

Eligibility criteria: Inclusion Criteria:

* pupil in one of the 2 selected schools, in grade 1 - 3
* weight for height \> -3 z-scores
* hemoglobin concentration \> 70 g/L

Exclusion Criteria:

* weight for height \< -3 z-scores
* hemoglobin concentration \<= 70 g/L

Primary outcomes:
measure: micronutrient status
timeFrame: 6 months intervention study with baseline and endpoint data collection
Secondary outcomes:
measure: cognitive function
timeFrame: 6 months intervention study with baseline and endpoint data collection
Other outcomes:
Locations:
city: Can Do
country: Vietnam
facility: Can Do primary school
state: Can Tho
Study officials:
References:
Clinical trial NCT01057381: Dexmedetomidine in Pediatric Tonsillectomy
Official title: Dose Response Relationship of Dexmedetomidine in Decreasing Post Operative Analgesic Requirements in the Pediatric Tonsillectomy Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pediatric Adenotonsillectomy
Post Operative Analgesia
Keywords: Adenotonsillectomy
Postoperative analgesia
Pediatrics
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2010-01-27
Enrollment: 109
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis of this study is that the administration of an intra-operative dose of dexmedetomidine will result in adequate analgesia without respiratory depression thereby resulting in an early discharge from the post anesthetic care unit following adenotonsillectomy.

Detailed description: Dexmedetomidine, an alpha 2 agonist provides some analgesia without respiratory depression. Children undergoing tonsillectomy and adenoidectomy occasionally have episodes of respiratory obstruction in the recovery room following administration of opioids.

As dexmedetomidine provides some analgesia without respiratory depression,an intra-operative dose of dexmedetomidine may provide adequate analgesia without significant side effects thereby allowing for quick post operative recovery.

Eligibility criteria: Inclusion Criteria:

* Children between ages 3 and 17 years with American Society of Anesthesiology classification 1 or 2.

Exclusion Criteria:

* Children less than 3 years
* Children with uncorrected cardiac lesions
* Children with heart block or liver impairment
* Children with American Society of Anesthesiology Class 3 or 4.

Primary outcomes:
measure: Amount of Post-Operative Rescue Morphine Required for Analgesia
timeFrame: From admission to discharge from PACU, up to 1 hour
Secondary outcomes:
measure: Morphine Rescue Doses Needed by Participants
timeFrame: From admission to discharge from PACU, up to 1 hour
measure: Duration of Oxygen Supplementation
timeFrame: From admission to PACU until room air saturations greater than or equal to 95% for 5 minutes
measure: Time to PACU Discharge Readiness
timeFrame: From admission to discharge from PACU, no time limit
measure: Number of Participants With Emergence Agitation
timeFrame: From admission to discharge from PACU, no time limit
measure: Number of Participants With Postoperative Complications
timeFrame: From admission to discharge from PACU, up to 1 hour
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital, Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Olutoyin A Olutoye, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02423681: A Comparison of CPAP With and Without Humidification: A Pilot Study
Official title: Evaluation of Overall Therapy Cost Comparing First Intention and Second Intention Heated Humidification for CPAP: A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2015-04-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To compare a group of patients with our standard treatment of continuous positive airway pressure (CPAP) and another group of patients with CPAP and a humidifier attached. The therapy cost and the successfulness of the treatment will be measured. A humidifier is a water chamber that is currently added to CPAP only if the patients needs it.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years of age
* Diagnosed with OSA (obstructive sleep apnea) and eligible for CPAP treatment under local requirements (NICE guidelines: AHI (apnea hypopnea index) ≥ 15, or AHI \> 5 with significant daytime sleepiness)
* Naïve to CPAP therapy, i.e. have not been prescribed, or used CPAP in the last 5 years.
* Fluent in spoken and written English

Exclusion Criteria:

* Significant uncontrolled cardiac disease, as per the principal investigator's discretion
* Co-existing lung disease, as per the principal investigator's discretion
* Co-existing sleep disorder, such a predominant central sleep apnoea
* Pregnancy
* Participants that are unable or unwilling to give informed consent.

Primary outcomes:
measure: Overall cost of equipment
timeFrame: 6 months
measure: Number and type of additional interventions
timeFrame: 6 months
measure: Duration of appointments
timeFrame: 6 months
measure: Number of unplanned follow-ups
timeFrame: 6 months
Secondary outcomes:
measure: Adherence to therapy
timeFrame: 6 months
measure: Therapy Acceptance
timeFrame: 6 months
measure: Apnea Hypopnea Index (AHI)
timeFrame: 6 months
measure: Leak
timeFrame: 6 months
measure: Side effects and symptoms reported
timeFrame: 6 months
measure: Self-reported satisfaction
timeFrame: 6 months
measure: Patient sleeping environment temperature and humidity
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Lung Function and Sleep Unit, St George's Hospital
Study officials:
affiliation: Lung Function and Sleep Unit, St George's Hospital
name: Sara Parsons, Chief Clinical Physiologist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03804281: Clinical Evaluation of Conventional Versus Microsurgical Techniques of Esthetic Crown Lengthening
Official title: Clinical Evaluation of Gingival Margin Stability Following Conventional Versus Microsurgical Techniques of Esthetic Crown Lengthening
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gummy Smile
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the study compare gingival margin stability following conventional approach versus microsurgical approach of esthetic crown lengthening in management of patients with short clinical crowns in the upper anterior region.In management of patients with short clinical crowns in the upper anterior region, there is no difference in gingival margin stability between conventional and microsurgical approaches of esthetic crown lengthening.


Eligibility criteria: Inclusion Criteria:

* Patients with healthy systemic condition.
* Adult patients ˃ 18 years old.
* The presence of the six upper anterior teeth.
* Absence of sites with attachment loss and probing depth (PD) \>3 mm
* Keratinized gingiva of at least 2mm width.
* Compliance with good oral hygiene.
* Patients accepts 6-months follow-up period (cooperative patients).
* Patients provides an informed consent

Exclusion Criteria:

* Gummy smile with normal tooth proportions
* Presence of prosthetic crowns
* Extensive restorations
* Extensive incisal edge attrition.
* Misalignment on maxillary anterior teeth.
* Smokers ˃ 10 cigarettes / day.

Primary outcomes:
measure: Mid-buccal gingival margin level
timeFrame: 6 months
Secondary outcomes:
measure: Pink Esthetic Score (PES)
timeFrame: 6 months
measure: Post-Surgical swelling
timeFrame: 7days
measure: Post-Surgical Patient Satisfaction: 3-item questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: