louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02035722: Intravitreal Injections-related Anxiety
Official title: A Visual Approach to Reducing Anxiety and Improving Knowledge Transfer for Patients Receiving Intravitreal Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Age-related Macular Degeneration
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 73
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: Intravitreal injection of Ranibizumab (Lucentis, Genentech) is clinically indicated for patients with wet age-related macular degeneration (AMD) An disadvantage of this technique is the anxiety and discomfort which patients often experience due to the idea of "getting a needle in the eye". In addition, a recent case study indicated the importance of patient education in achieving positive outcomes from intravitreal injections of anti-vascular endothelial growth factor (VEGF) agents. The purpose of our study is to determine whether visual education on AMD and intravitreal injection can reduce patients' anxiety prior to the treatment, and lessen the impact of socioeconomical status on their understanding of the treatment and prognosis.

Detailed description: The use of intravitreal injections of Ranibizumab (Lucentis, Genentech) is becoming increasing common for the management of age-related macular degeneration (AMD). It is therefore important to acknowledge and address patients' anxiety due to anticipated discomfort from the idea of "getting a needle in the eye". In addition, visual provision of information at diagnosis concerning long-term treatment expectation may enhance the informed consent process. The use of visual aids may also accommodate patients of different educational background when presented with new and complex treatment information. The purpose of our study is to determine whether visual education on AMD and intravitreal injection can reduce patients' anxiety prior to the treatment, and lessen the impact of socioeconomical status on their understanding of the treatment and prognosis. Although this tool will be developed in the context of injection-requiring retinal diseases, it has applications in the care of disease requiring long-term treatments.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* AMD patients requiring intravitreal injections

Exclusion Criteria:

* Unable to read or comprehend English
* Any contraindications to intravitreal injections, such as IOP elevations

Primary outcomes:
measure: Anxiety
timeFrame: Cross-sectional study, where questionnaires will be completed on the same day of clinic visit.
Secondary outcomes:
measure: Knowledge of AMD
timeFrame: Cross-sectional study, where questionnaires will be completed on the same day of clinic visit.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Wai-Ching Lam
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03749122: Time to Hip Fracture Surgery
Official title: Preoperative Waiting Time to Surgery Related to Mortality in Hip Fracture Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Mortality
Surgery
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 10000
Sex: ALL
Minimum age (years): 60
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute hip fracture

Brief summary: The purpose of the study is to evaluate how time from hospital admission to start of surgery influence mortality in patients with acute hip fracture. Data on patients with hip fracture surgery will be collected from the hospital's registration system and will be analyzed regarding age, gender, American Society of Anesthesiologists (ASA) Physical Status Classification, type of surgery and time from admission to surgery along with data on mortality.


Eligibility criteria: Inclusion Criteria: undergoing

* hip fracture surgery between 2007-2016.
* Over 60 years of age.

Exclusion Criteria:

* Pathological fracture.
* In-hospital falls.
* Diagnostic delay.

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mölndal
country: Sweden
facility: Bengt
state: V. Götaland
Study officials:
References:
Clinical trial NCT01545622: Surgeon Compared to Nuclear Radiology Readers for Tc-99m Sestamibi Scans for Parathyroid Disease
Official title: Surgeon Compared to Nuclear Radiology Readers for Tc-99m Sestamibi Scans for Parathyroid Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parathyroid Disease
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of 30 surgeons and 30 nuclear radiologists.

Brief summary: The purpose of this study is to analyze the findings of 30 surgeons and 30 nuclear radiologists of 61 individual thyroid scans. The goal is to determine if surgeons are more prone to making a definitive diagnosis based on a given scan than a nuclear radiologist. Accuracy of localization of the two groups will be analyzed. A secure website has been designed to which the physician will be able to login and view and rate the quality of each image and make a localizing diagnosis. Once they are finished, they will not be able to make any more changes, and their responses will be compared to the responses of their colleagues. The results will be analyzed to find if there is a significant variation in the ratings between the surgeons and the nuclear radiologists as to the quality, location, and number of parathyroid glands, if any, on the scans.


Eligibility criteria: Inclusion Criteria:

* Must be a surgeon or nuclear radiologist to be eligible read scans for this study.

Exclusion Criteria:

* None

Primary outcomes:
measure: Analyze the findings of individual thyroid scans
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Brendan Stack, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02081222: The Predictability of Intraoperative Rotational Thromboelastometry on Postoperative Bleeding and Transfusion Requirements
Official title: The Predictability of Intraoperative Rotational Thromboelastometry on Postoperative Bleeding and Transfusion Requirements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery for Congenital Heart Disease
Pediatric Patients
Keywords: congenital heart disease
rotational thromboelastometry
blood loss
transfusion requirements
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 119
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients who underwent surgery for congential heart disease with cardiopulmonary bypass

Brief summary: Viscoelastic hemostatic assay has been reported to be superior to predict perioperative bleeding in cardiac surgical patients compared with conventional blood coagulation test. However, the role of rotational thromboelastometry (ROTEM) in predicting perioperative bleeding and transfusion requirements in pediatric patients who undergoing surgery for congenital heart disease. Therefore, the investigators attempt to evaluate the predictability of intraoperative rotational thromboelastometry for perioperative bleeding and transfusion requirements in pediatric cardiac surgical patients by comparing with conventional coagulation test. The investigators also attempt to evaluate the correlation between ROTEM parameters, platelet count, and results of conventional coagulation test results.

Detailed description: Viscoelastic hemostatic assay has been reported to be superior to predict perioperative bleeding in cardiac surgical patients compared with conventional blood coagulation test. However, the role of rotational thromboelastometry (ROTEM) in predicting perioperative bleeding and transfusion requirements in pediatric patients who undergoing surgery for congenital heart disease. Therefore, the investigators attempt to evaluate the predictability of intraoperative rotational thromboelastometry for perioperative bleeding and transfusion requirements in pediatric cardiac surgical patients by comparing with conventional coagulation test. The investigators also attempt to evaluate the correlation between ROTEM parameters, platelet count, and results of conventional coagulation test results.

Eligibility criteria: Inclusion Criteria:

* pediatric patients (\< 10 years) who underwent surgery for congenital heart disease with cardiopulmonary bypass in 2013 at Samsung Medical Center

Exclusion Criteria:

* incomplete data about blood loss count or transfusion requirements during seven days after surgery

Primary outcomes:
measure: postoperative blood loss
timeFrame: during seven days after surgery
Secondary outcomes:
measure: postoperative transfusion requirements
timeFrame: during seven days after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT00180622: Markers for Chronic Obstructive Pulmonary Disease (COPD)
Official title: Non-Invasive Markers for Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Healthy Non-smokers
Current Smokers
COPD Patients
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2005-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE

Brief summary: The primary aim of this study is to exploit a difference between COPD patients, chronic smokers without COPD and healthy non-smoking subjects. This will help to assess the utility of inflammatory and oxidative markers in exhaled air and sputum and to compare them with the lung function, clinical parameters and computerised tomography (CT).


Eligibility criteria: Inclusion Criteria:

Healthy non-smokers

* FEV1 \>80% predicted
* FEV1 reversibility of \<10% after inhaled (beta2-agonists

Current smokers

* FEV1 no less than 80% predicted
* FEV1 reversibility of \<10% after inhaled (beta2-agonists
* Smoking history of \> 10 pack-years

Moderate COPD

* FEV1 40-59% predicted
* FEV1 reversibility of \<10% after inhaled (beta2-agonists
* Smoking history of \> 10 pack-years\*\*

Severe COPD

* FEV1 \<40% predicted
* FEV1 reversibility of \<10% after inhaled (beta2-agonists
* Smoking history of \> 10 pack-years

Exclusion Criteria:

* FEV1 increases by 200 ml and 15% of the baseline value after inhaled (beta2-agonists
* Asthma
* unstable disease (FEV1 \<35% predicted) and/or current, or within the last 4 weeks, respiratory tract infection.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
Study officials:
affiliation: Imperial College London
name: Sergei A Kharitonov, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Peter J Barnes, MA DM DSc FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01231022: Study the Role of Stem Cell in Curing Drug Induced Liver Injury in Metastatic Breast Cancer (MBC)
Official title: Study the Role of Stem Cell in Curing Drug Induced Liver Injury in Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Neoplasm Metastasis
Keywords: breast neoplasm
Neoplasm Metastasis
Stem Cells
Drug-Induced Liver Injury
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2010-11-01
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: female patients with metastatic breast cancer

Brief summary: The investigators want to know the role of Peripheral hematopoietic stem cell infusion in avoiding Drug Induced Liver Injury,and also try to research SNPs genotyping associated with Drug Induced Liver Injury.

Detailed description: 1. The researcher investigate the incidence and the cause of Drug Induced Liver Injury in MBC.
2. Patients having a complete clinical history and physical examination, receive routine chemotherapy.
3. Venous blood Sample(4 ml)is collected before and after each cycle according to the planning time.
4. Genomic DNA,RNA and upper serum is isolated. ELISA、rt-PCR or PCR-direct sequencing is used to detect the protein or gene expression associated with liver function.

Eligibility criteria: Inclusion Criteria:

* Patients should be histologically confirmed with metastatic breast cancer;
* an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
* Normal cardiac, hepatic, renal and bone marrow functions;
* Life expectancy ≥3 months;

Exclusion Criteria:

* previous history of other malignancies;
* Central nervous system metastases;
* Serious or uncontrolled concurrent medical illness.

Primary outcomes:
measure: Protective effection of peripheral hematopoietic stem cell infusion for DILI
timeFrame: 3 months
Secondary outcomes:
measure: SNPs genotyping associated with Drug Induced Liver Injury
timeFrame: 3 months
measure: Change of cytokines
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: XU LIANG, MD and PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Cancer Hospital & Institute
name: JUN REN, MD and PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03061422: Effect of Xylitol-Containing Chewing Gum With/Without Bicarbonate Versus Paraffin Pellet on Salivary pH
Official title: Effect of Xylitol-Containing Chewing Gum With/Without Bicarbonate Versus Paraffin Pellet on Salivary pH in High Caries Risk Patients (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 36 eligible participants will be randomly divided into three groups (n=12) according to the tested chewing gum (A), where (A1) represents participants exposed to xylitol chewing gum, (A2) represents participants exposed to bicarbonate and xylitol chewing gum and (A3) represents control group where participants are exposed to paraffin pellet chewing. The pH of saliva will be evaluated according to time in relation to the gum chewing (T) where (T0) represent the pH before chewing, (T1) represent 5 minutes after gum chewing at fixed time of the day (in the morning from 10 to 11 am).

Direct benefit of the research to the human volunteer:

It is important for high caries risk patients to decrease caries susceptibility as this will eventually decrease their dental treatments and subsequently the treatment cost.

Scientific value and social benefits:

This study will benefit the dentist as the main goal of a dentist is to prevent rather than cure. Also, it will decrease the restorative work carried out by dentist and save this time for educating more patients about caries prevention methods.

Expected risk to the human subjects:

Allergic reactions due to any of the components of the materials used which is rare to occur.


Eligibility criteria: Inclusion Criteria:

* Patients eligible for the trial must comply with all of the following at randomization.

  1. Age range from 20-50 years
  2. High caries risk patients defined according to American Dental Association (ADA)
  3. Acidic baseline saliva pH
  4. Systematically healthy
  5. Not taking any medication interfering with saliva secretion
  6. Subjects who signed informed consent

Exclusion Criteria:

* (1) Subjects who wore orthodontic appliances or removable prosthesis (2) Subjects suffering from any medical or systematic disease (3) Smokers (4) Pregnant females (5) Allergy to any of chewing gum ingredients

Primary outcomes:
measure: Salivary pH change
timeFrame: an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Howaida Fakhry Fouad
Study officials:
References:
citation: Ballal RK, Bhat SS, Ramdas SS, Ballal S. Effect of Chewing Bicarbonate-containing Sugar-free Gum on the Salivary pH: An in vivo Study. Int J Clin Pediatr Dent. 2016 Jan-Mar;9(1):35-8. doi: 10.5005/jp-journals-10005-1330. Epub 2016 Apr 22.
Clinical trial NCT02362022: The Effects of Morphine on Desflurane Consumption and Recovery Time
Official title: Comparison of Two Different Doses of Intravenous Morphine on Desflurane Consumption and Recovery Time in Patients Undergoing Total Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abdominal Hysterectomy (& Wertheim)
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 90
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Combination of volatile and opioid agents are used to achieve unconsciousness, haemodynamic stability and analgesia for surgical prosedures. This prospective, randomized, double-blind, controlled study evaluates the effects of two different doses of morphine sulphate (0.1 mg/kg and 0.2 mg/kg), on desflurane consumption, recovery characteristics, postoperative analgesic requirements and side effects during total abdominal hysterectomy.


Eligibility criteria: Inclusion Criteria:

* undergoing total abdominal hysterectomy with general anaesthesia

Exclusion Criteria:

* renal dysfunction (cre\>1.2), liver failure, cardiovascular, psychiatric, allergic and metabolic disorders

Primary outcomes:
measure: postoperative desflurane consumption
timeFrame: postoperative first hour
measure: sedation scores for OASS scale
timeFrame: postoperative first hour
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Baskent University School of Medicine Adana Teaching and Research Hospital
Study officials:
affiliation: Baskent University
name: cagla bali
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05809622: Upper Extremity-based Exercises and Elbow-focused Exercises in LET
Official title: Comparison of the Effectiveness of Upper Extremity-based Exercises and Elbow-focused Exercises in Lateral Elbow TendiNopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lateral Epicondylitis
Elbow Tendinopathy
Keywords: tendinopathy
elbow
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 46
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: TREATMENT

Brief summary: The aim of the study is to investigate the effects of rotator cuff and scapular muscle strengthening exercises applied in addition to the 8-week elbow focused rehabilitation program in lateral elbow tendinopathy, by comparing it with the elbow focused rehabilitation program.


Eligibility criteria: Inclusion Criteria:

* Cases are between the ages of 18-65
* Getting a diagnosis of unilateral lateral elbow tendinopathy
* At least two positive Thomsen, Maudsley's Mill's and Cozen tests on clinical examination
* Continuing symptoms for at least 3 months
* The absence of any chronic disease that would prevent participation in the treatment program

Exclusion Criteria:

* History of trauma or surgery in the involved elbow joint
* Having orthopedic problems in the cervical spine, shoulder joint or wrist
* To have participated in the rehabilitation program in the last 3 months
* Corticosteroid injection application in the last 3 months
* Systemic arthritis

Primary outcomes:
measure: Patient-Rated Tennis Elbow Evaluation (PRTEE)
timeFrame: Baseline
measure: Patient-Rated Tennis Elbow Evaluation (PRTEE)
timeFrame: 8th week
measure: Patient-Rated Tennis Elbow Evaluation (PRTEE)
timeFrame: 16th week
measure: Patient-Rated Tennis Elbow Evaluation (PRTEE)
timeFrame: 6th month
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 8th week
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 16th week
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 6th month
Secondary outcomes:
measure: Pain Pressure Threshold (PPT)
timeFrame: Baseline
measure: Pain Pressure Threshold (PPT)
timeFrame: 8th week
measure: Pain Pressure Threshold (PPT)
timeFrame: 16th week
measure: Pain Pressure Threshold (PPT)
timeFrame: 6th month
measure: Hand Grip Strength
timeFrame: Baseline
measure: Hand Grip Strength
timeFrame: 8th week
measure: Hand Grip Strength
timeFrame: 16th week
measure: Hand Grip Strength
timeFrame: 6th month
measure: Pain-free Hand Grip Strength
timeFrame: Baseline
measure: Pain-free Hand Grip Strength
timeFrame: 8th week
measure: Pain-free Hand Grip Strength
timeFrame: 16th week
measure: Pain-free Hand Grip Strength
timeFrame: 6th month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpaşa
Study officials:
References:
Clinical trial NCT00760422: Clinical Evaluation of NIR (Non-Invasive Infrared) Thermometer Performance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elevated Temperature
Lead sponsor: Medisim Ltd
Sponsor class: INDUSTRY
First posted: 2008-09-26
Enrollment: 500
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 500 patients from both genders, 0-18 years old

Brief summary: The study is conducted in order to evaluate the performance of the NIT thrmometer by comparing the predictive measurement to equilibrium measurement and to make a final tuning to the thermometer algorithm.


Eligibility criteria: Inclusion Criteria:

* Children 0-18 years old, with or without fever that arrive at the unit of emergency medicine in Schneider medical center.
* An informed Consent was signed by the patient or his guardian.

Exclusion Criteria:

* The medical stuff decides that the patient can't participate.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
References: