louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06369987: Visual Performance of Dailies Total1 Multifocal and Acuvue Oasys Max 1-Day Multifocal in Presbyopic Lens Wearers
Official title: Visual Performance of Dailies Total1 Multifocal and Acuvue Oasys Max 1-Day Multifocal in Presbyopic Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2024-04-17
Enrollment: 28
Sex: ALL
Minimum age (years): 42
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to measure the logMAR visual acuity when presbyopic soft lens wearers are fit with Dailies Total1 Multifocal and ACUVUE OASYS MAX 1-DAY Multifocal.


Eligibility criteria: Inclusion Criteria:

1. Are at least 42 years of age and has full legal capacity to volunteer;
2. Have signed an information consent letter;
3. Are willing and able to follow instructions and maintain the appointment schedule;
4. Habitually wears soft contact lenses for the past 3 months (minimum);
5. Are presbyopic and require a reading addition of at least +0.75D and no more than +1.75D;
6. Can be refracted and achieve monocular spectacle distance vision of at least 20/25 Snellen (or +0.10logMAR) visual acuity;
7. Have contact lens power requirements that fall within the available study lens parameters (distance sphere: +6D to -9D; near addition as per each lens design);
8. Can be fit with the initial fitting guidelines provided by the lens manufacturer and use either Low or Medium Add (same add in both eyes).

Exclusion Criteria:

1. Are a current habitual wearer of Dailies Total1 Multifocal or ACUVUE OASYS MAX 1-DAY Multifocal;
2. Has refractive astigmatism higher than -0.75DC in either eye;
3. Are participating in any concurrent clinical or research study involving intervention or invasive ocular tests;
4. Have any known active ocular disease and/or infection;
5. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
6. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
7. Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;
8. Have undergone refractive error surgery;
9. Are a member of the Centre for Ocular Research \& Education (CORE) directly involved in the study.

Primary outcomes:
measure: High contrast visual acuity (logMAR) at 6m
timeFrame: Day 1
measure: High contrast visual acuity (logMAR) at 40cm
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Ocular Research & Education (CORE)
state: Ontario
Study officials:
affiliation: Centre for Ocular Research & Education (CORE)
name: Lyndon Jones, PhD, FCOptom
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000587: Erythropoietin for Anemia Due to Zidovudine in Human Immunodeficiency Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acquired Immunodeficiency Syndrome
Anemia
Hematologic Diseases
HIV Infections
Blood Disease
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 1999-10-28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: To determine whether administration of human recombinant erythropoietin (REPO) improved or eliminated the anemia seen in human immunodeficiency virus (HIV) infected patients after therapy with zidovudine (ZDV).

Detailed description: BACKGROUND:

Reports had shown that between 24 and 78 percent of patients with Acquired Immune Deficiency Syndrome treated with zidovudine for four to six months developed significant bone marrow toxicity, requiring zidovudine dosage alterations, blood transfusions, or cessation of therapy. While zidovudine efficacy had been demonstrated in patients with AIDS or ARC, it was also evaluated in patients with AIDS-related illness, as well as in asymptomatic HIV-infected individuals. The clinically significant zidovudine-induced anemia developing in a substantial number of these patient groups and requiring blood transfusions could cause a significant drain on the blood supply in the United States.

The project was part of an Institute-initiated study on the Pathobiology of Bone Marrow Suppression in AIDS or AIDS-Related Complex. The concept was approved at the May 1987 National Heart, Lung, and Blood Advisory Council. The Request for Applications was released in December 1987.

DESIGN NARRATIVE:

Double-blind, placebo-controlled. Patients received intravenous REPO (1000 IU/kg) or placebo twice per week. The five patients in Group A had no transfusion history. The five patients in Group B had a history of transfusions. Prior to the study, the authors determined that treatment would continue for twelve weeks or until the hemoglobin reached 12.5 g/dl. After the twelve week study period, patients were eligible to receive open label erythropoietin (500 IU/kg, twice a week). For numerous reasons, recruitment of patients was a major problem in this trial. The study originally estimated a total of 64 patients.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Jefferson Medical College of Thomas Jefferson University
name: Stephen Hauptman
References:
Clinical trial NCT06424587: The Effect of Music Intervention on Anxiety, Fear, and Pain in Pediatric Patients Receiving Intrathecal Chemotherapy
Official title: The Effect of Music Intervention on Anxiety, Fear, and Pain in Pediatric Patients Receiving Intrathecal Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse's Role
Keywords: anxiety
hematology-oncology nursing
pain intervention
randomized controlled trial
fear
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a parallel group, randomized, controlled experimental study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Intrathecal chemotherapy is often used to prevent the spread of cancer to the central nervous system in pediatric patients and is one of the most invasive procedures. It is believed that the way it is administered and the complications experienced after treatment negatively affect the comfort of the pediatric patient, leading them to refuse the treatment.

Detailed description: Receiving sedation is one of the pharmacological procedures for intrathecal chemotherapy which creates a particularly difficult situation for the child. However, since pharmacological methods increase the cost and cause toxicity in children, in recent years, the symptoms that occur in cancer treatment have been tried to be controlled with non-pharmacological methods. Music intervention facilitates a sense of control in patients and provides mental distraction, emotional smoothness, and relaxation, which have been found to have pain relief effects.

Eligibility criteria: Inclusion Criteria:

* To be between 6-12 years old,
* Being treated in the Hematology and Oncology Clinic,
* About to receive intrathecal chemotherapy treatment,
* The child not having pain before intrathecal chemotherapy treatment

Exclusion criteria were,

* Refusing to participate in the study,
* Being under 6 years of age and over 10 years of age,
* The child having pain prior to intrathecal chemotherapy treatment,
* Having any physical or mental disability,
* Not being able to speak Turkish.

Primary outcomes:
measure: anxiety
timeFrame: 30 minutes before intrathecal chemotherapy treatment and just after music intervention
measure: fear
timeFrame: 30 minutes before intrathecal chemotherapy treatment and just after music intervention
measure: pain scale
timeFrame: 60 minutes after intrathecal chemotherapy treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
state: Black Sea
Study officials:
affiliation: ondokuz mayıs üniversity
name: Hatice Uzsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02792387: The Role of CVP and EF in Patients With Cardio-renal Syndromes
Official title: Some Characteristics of Interaction Between Heart and Kidneys in Cardio-Renal Syndrome Type 1 and Type 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: cardio-renal syndrome
right heart dysfunction
central venous pressure
eGFR
low-flow theory
Lead sponsor: Tbilisi State University
Sponsor class: OTHER
First posted: 2016-06-07
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent in-patient treatment at medical centers

Brief summary: The aim of the study is to explore association between increased central venous pressure, Ejection Fraction and renal dysfunction (eGFR) in patients with Cardio-Renal Syndromes type 1 and 2. The pilot study was set to provide the expected correlation coefficient for a sample size determination of the subsequent study.

Detailed description: OBJECTIVES

The aim of the study is to explore association between increased central venous pressure (CVP), Ejection Fraction (EF) and renal dysfunction (eGFR) in patients with Cardio-Renal Syndromes type 1 and 2.

BACKGROUND

The pathophysiology of impaired renal function in cardiovascular disease is multifactorial. Recent investigations suggest that management of patients based on low-flow theory does not lead to improved outcomes. Relative importance of right heart dysfunction (manifested as increased CVP) has not been evaluated . Precise understanding of bidirectional pathways by which the heart and kidneys influence each other is necessary to define optimal treatment strategies specific to the subtypes, as therapies directed towards one organ system may have beneficial or unfavorable effects on the other.

METHODS

The study is of non-experimental (observational) type, based on retrospective chart review. The patients' personal identifiers are concealed and an anonymized datasets used (unique code given to each patient, which is kept secure under the control of hospital staff).

Eligibility criteria: Inclusion Criteria:

* HF (NYHA class I - IV, with preserved and reduced EF) and reduced GFR (Cardio-Renal Syndromes 1 and 2)

Exclusion Criteria:

* Independent risk factors for renal impairment (e.g. diabetes, sepsis)
* Primary nephropathy or secondary nephropathy due to diseases other than HF

Primary outcomes:
measure: renal impairment (defined as a Glomerular Filtration Rate less than 60 mL/min per 1.73 m2)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tbilisi State University
name: George Lobzhanidze, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01826253: Observational Study of Oxygen Delivery During a Fractional Fluid Expansion
Official title: Observational Study of Oxygen Delivery During a Fractional Fluid Expansion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypovolemia
Impaired Oxygen Delivery
Cardiac Output, Low
Keywords: Hypovolemia
Fluid challenge
Fluid expansion
Oxygene delivery
Cardiac output
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 20
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: Mechanically ventilated patients after elective cardiac surgery with oesophageal Doppler for cardiac output monitoring and arterial and venous central line

Brief summary: Fluid expansion during cardiocirculatory insufficiency was helped by cardiac output monitoring. However, the goal of fluid expansion was to increase the oxygen delivery, which consider cardiac output, but also Haemoglobin which decrease during a fluid challenge. The maximalization of cardiac output could decrease the oxygen delivery if the haemodilution was too wide. The aim of this study was to describe the oxygen delivery during a fluid expansion conducted for cardiac output maximalization, following actual guidelines.

Detailed description: One group of 20 anticipated patients

Eligibility criteria: Inclusion Criteria:

* Adults over 18 years
* Patients in intensive care after cardiac surgery under mechanically ventilation and with oesophageal Doppler

Exclusion Criteria:

* Arrythmia
* Pregnancy or childrens
* Patients without cardiac output monitoring with oesophageal Doppler
* Patients without medical indication for fluid expansion
* Urgency surgery

Primary outcomes:
measure: Measurement of oxygen delivery
timeFrame: only during the fluid challenge
Secondary outcomes:
measure: Study of central venous saturation
timeFrame: only during the fluid challenge
Other outcomes:
measure: study of cerebral and muscular oxygenation measured with near-infrared spectroscopy
timeFrame: only during the fluid challenge
Locations:
city: Caen
country: France
facility: University Hospital of Caen
Study officials:
References:
Clinical trial NCT05804253: Maxillary Sinus Grafting With Deproteinized Porcine or Bovine Bone Mineral.
Official title: Clinical, Radiographic and Histological/Histomorphometric Analysis of Maxillary Sinus Grafting With Deproteinized Porcine or Bovine Bone Mineral: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Histomorphometry
Lead sponsor: Camlog Oral Reconstruction Foundation
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial.
Primary purpose: TREATMENT

Brief summary: The present study aimed to compare the histomorphometrically evaluated new bone formation, the radiographically measured graft stability and the clinical implant outcome between maxillary sinuses grafted either with deproteinized porcine bone mineral (DPBM) or deproteinized bovine bone mineral (DBBM). Conclusions: From a clinical point of view, the present results demonstrate that DPBM provides for comparable bone formation and stable graft dimension and high implant success rates combined with healthy peri-implant condition:

Detailed description: Materials and Methods: Thirty maxillary sinuses in 28 participants were initially included and randomly assigned to the test group (TG;DPBM: n=15) or the control group (CG,DBBM: n=15). After a healing period (6 months) bone core biopsies were axially retrieved in the molar site for histological/ histomorphometrical analysis of new bone formations. In addition, radiographically measured graft stability as well as the clinical implant outcome (implant survival/success/peri-implant health) were assessed at the 1-year and 3-year follow-up evaluations.

Eligibility criteria: Inclusion Criteria:

* maxillary sinus atrophy in the need of sinus augmentation, 2 stage augmentation procedure

Exclusion Criteria:

* drug abuse, additional augmentation procedure, heavy smokers, bisphosphonate abuse

Primary outcomes:
measure: New bone formation
timeFrame: 3 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06490653: Tranexamic Acid Versus Blood Stopper Treatments in Epistaxis Management
Official title: Comparison of the Efficacy of Tranexamic Acid and Blood Stopper Treatments in Bleeding Control in Patients With Epistaxis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Epistaxis Nosebleed
Keywords: Epistaxis
Nosebleed
Ankaferd
Tranexamic acid
Lead sponsor: Ankara Ataturk Sanatorium Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-07-08
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, there are two parallel treatment arms (tranexamic acid and blood stopper (Ankaferd®) determined by randomization
Primary purpose: TREATMENT

Brief summary: In this randonmized controlled trial, aim to compare the effectiveness of local administration of tranexamic acid and blood stopper (Ankaferd®) on cessation of bleeding in epistaxis patients.

Detailed description: Anterior tamponade is frequently used in the management of anterior epistaxis. However, this procedure is often uncomfortable for patients. Therefore, instead of this physical tampon, various pharmacologic agents such as tranexamic acid, blood stoppers (ankaferd®), and adrenaline can be used in epistaxis management. Although the superiority of various agents used in the management of anterior epistaxis has been evaluated in published network meta-analyses, these meta-analyses do not compare ankaferd and Tranexamic acid since there are no studies with each other. In order to close the gap in the existing literature, this study aims to evaluate the superiority of local administration of tranexamic acid and ankaferd® in terms of cessation of bleeding in patients with anterior epistaxis.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age with epistaxis will present to the emergency department with non-traumatic epistaxis and whose bleeding do not stop with simple external compression for 10 minutes.

Exclusion Criteria:

* Patients demonstrating hemodynamic instability
* Patients with documented allergy to tranexamic acid or Ankaferd
* patients with known bleeding disorders,
* patients using anticoagulants,
* pregnant patients

Primary outcomes:
measure: Cessation of bleeding
timeFrame: 10-minutes after performing local drug interventions.
Secondary outcomes:
measure: Re-bleeding
timeFrame: From cessation of bleeding to re-bleeding within 24-hours.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01403753: Children's Familiarity With Snack Foods Changes Expectations About Fullness
Official title: Children's Familiarity With Snack Foods Changes Expectations About Fullness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children
Keywords: Obesity
Child
Dietary Habits
Lead sponsor: University of Bristol
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 70
Sex: ALL
Minimum age (years): 11
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: The purpose of this study was to measure and quantify children's beliefs about the satiating properties (i.e. expected satiation)of snack foods. The investigators predicted that children who were especially familiar with snack foods would expect them to deliver greater satiation.

Detailed description: Palatability is regarded as a major determinant of children's energy intake. However, few studies have considered other "non-hedonic" beliefs about foods. In adults there is emerging evidence that expectations about the satiating properties of foods are an important determinant of meal size, and that these beliefs are learned over time.

In the current study, we measured and quantified children's 'expected satiation' across energy-dense snack foods using a psychophysical technique known as method of adjustment. Participants changed a comparison-food portion (pasta and tomato sauce) to match the satiation that they expected from a snack food. We predicted that children who were especially familiar with snack foods would expect them to generate greater satiation, and that children who were unfamiliar would match expected satiation based on the physical characteristics (perceived volume) of the foods.

In our study, seventy 11- to 12-year-old children completed computerised measures of expected satiation, perceived volume, familiarity, and liking across six snack foods. Our analyses focused on the associations between these measures. This approach enabled us to establish differences in healthy behaviours that are evident across individuals.

Eligibility criteria: Inclusion Criteria:

* aged 11 to 12 years
* English speaking
* normal or corrected-to-normal vision

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: University of Bristol
Study officials:
affiliation: University of Bristol
name: Jeffrey M Brunstrom, PhD
role: STUDY_DIRECTOR
References:
citation: Brunstrom JM, Shakeshaft NG, Scott-Samuel NE. Measuring 'expected satiety' in a range of common foods using a method of constant stimuli. Appetite. 2008 Nov;51(3):604-14. doi: 10.1016/j.appet.2008.04.017. Epub 2008 May 1.
citation: Hardman CA, McCrickerd K, Brunstrom JM. Children's familiarity with snack foods changes expectations about fullness. Am J Clin Nutr. 2011 Nov;94(5):1196-201. doi: 10.3945/ajcn.111.016873. Epub 2011 Sep 14.
Clinical trial NCT03279653: Pancreatic Exocrine Insufficiency After Bariatric Surgery
Official title: Effect of Sleeve Gastrectomy on Pancreatic Exocrine Insufficiency.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity, Morbid
Pancreatic Insufficiency
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2017-09-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are eligible for bariatric surgery with NIH criteria and American Society of Anesthesiologists (ASA)-Physical Status Classification System.

Brief summary: Main proposed benefit of sleeve gastrectomy is loss of ghrelin secreting tissue. Some studies express that ghrelin augment pancreatic regeneration. Therefore we hypothesized that with sleeve gastrectomy it may result with pancreatic insufficiency.

Detailed description: Mechanism of weight loss differs in bariatric surgery according to type of surgery.

With sleeve gastrectomy which has restrictive mechanism, ghrelin excretion decreases, and this condition is attributed as an additional mechanism in weight loss.

Ghrelin effects pancreatic regeneration, and loss of ghrelin may result with pancreatic insufficiency. Therefore we aimed to deteremine this association.

Eligibility criteria: Inclusion Criteria:

Patients underwent bariatric surgery (Sleeve gastrectomy) after concordonce with NIH criteria

Exclusion Criteria:

Additional operations to sleeve gastrectomy like duodenal switch. Other bariatric operations.

Primary outcomes:
measure: Pancreatic excorine enzyme difference
timeFrame: post operative 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Umraniye Education and Research Hospital
state: Ümraniye
Study officials:
affiliation: University of Health Science, Umraniye Education and Research Hospital
name: Fatih Basak, MD
role: PRINCIPAL_INVESTIGATOR
References: