louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01328262: A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching
Official title: A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anemia
Keywords: Hemoglobins
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2011-04-04
Enrollment: 12
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate whether the targeted hemoglobin increment (2 grams per decilitre) in the patient can be predicted from the hemoglobin dose/weight of the blood bag transfused. In the test group, the hemoglobin dose needed will be calculated, whereas in the control group, the prescribed number of red cell units will be transfused.

Hypothesis: By matching the hemoglobin dose to the individual needs of the patient the investigators will reduce the total usage of red cell concentrates.

Detailed description: This is a randomized clinical study on hemoglobin dose and patient matching. The aim of the study is to evaluate whether the targeted hemoglobin increment (2 grams per decilitre) in the patient can be predicted from the hemoglobin dose/weight of the blood bag transfused. In the test group, the hemoglobin dose needed will be calculated, whereas in the control group, the prescribed number of red cell units will be transfused.

Eligibility criteria: Inclusion Criteria:

* Patients receiving red cell transfusions or expected to receive one or more red cell transfusions
* Patients over 16 years of age
* Patients for whom height and weight information is available
* Patients who have consented to participate

Exclusion Criteria:

* Patients who are hemodynamically unstable (ongoing bleeding or hemolysis)
* Patients with a known hemolytic anemia (congenital or acquired)
* Patients with a positive Direct Antiglobulin Test (DAT)
* Patients for whom informed consent has not been obtained
* Patients where the hemoglobin concentration increment target is above 2g/dl.
* Patients with auto- or alloantibodies against RBCs (red blood cells)..

Primary outcomes:
measure: Hemoglobin Concentration Change
timeFrame: Measurements of hemoglobin concentration taken from 30 min to 24hours after transfusion (earliest observation recorded)
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
name: Tor A Hervig, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05230862: Does a Multi-ingredient Pre-workout Supplement Enhance Cycling Time Trial Performance?
Official title: Does a Multi-ingredient Pre-workout Supplement Enhance Cycling Time Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: OpenFit LLC
First posted: 2022-02-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to test the effect of ingesting a multi-ingredient pre- exercise supplement containing caffeine, creatine, beta-alanine and L-Citrulline compared to a placebo, on endurance exercise performance.


Eligibility criteria: Exclusion criteria:

* Any diagnosed metabolic health condition
* Pregnant
* Non-habitual caffeine intake
* Smoker
* No endurance training
* Diagnosed Cardiovascular disease
* Recent history of musculoskeletal injury
* Anti-depressant and anti-anxiety medication

Inclusion criteria

* Age 18-40
* Healthy
* Highly trained endurance athletes (V̇O2max: males \>55 and females \>50 mL⋅kg bm-1⋅min-1)
* Both males and females are allowed to participate. If females are on the oral contraceptive pill they are to be tested on consecutive weeks. If they are not on the oral contraceptive pill, then female subjects are to be tested every 4 weeks, at the same point of their menstrual cycle.

Primary outcomes:
measure: Exercise Performance
timeFrame: 15 Minitues
Secondary outcomes:
measure: Alertness
timeFrame: 1 Hour
measure: Motivation
timeFrame: 1 Hour
measure: Rate of perceived exertion
timeFrame: 1 Hour
measure: Gas analysis
timeFrame: 1 Hour
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: School of Sport and Health Sciences
Study officials:
References:
Clinical trial NCT05808062: The Effect of Canal Dryness on the Quality of Obturation
Official title: The Effect of Different Canal Dryness Protocols on the Quality of Matched Single Cone Obturation: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obturation
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 24
Sex: ALL
Minimum age (years): 23
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate root canal obturation quality. The questions to answer are

* what is the best protocol for canal dryness before obturation ?
* Is compaction necessary ? Volunteer participants will perform root canal treatment in teeth planned for extraction due to orthodontic reasons


Eligibility criteria: Inclusion Criteria:

* healthy males and females (Category: American Society of Anesthesiologists class 1)
* aged 23-25 years
* presenting with sound maxillary premolars (non-carious and not previously restored)
* a radiographically visible root canal outline

Exclusion Criteria:

* dental students of any level were not eligible to avoid including vulnerability factors.
* pregnant volunteers
* volunteers with complicating systemic disease (ASA 3-6)
* poor oral hygiene
* periodontal disease (probing depth \>3 mm) related to the tooth

Primary outcomes:
measure: obturation quality
timeFrame: after 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, The British University in Egypt
state: El-Sherouk
Study officials:
affiliation: Faculty of Dentistry, The British University in Egypt
name: Shehabeldin Saber, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zavattini A, Knight A, Foschi F, Mannocci F. Outcome of Root Canal Treatments Using a New Calcium Silicate Root Canal Sealer: A Non-Randomized Clinical Trial. J Clin Med. 2020 Mar 13;9(3):782. doi: 10.3390/jcm9030782.
Clinical trial NCT03774862: Clinicopathological Importance of Colorectal Medullary Carcinoma: Retrospective Cohort Study
Official title: Clinicopathological Importance of Colorectal Medullary Carcinoma: Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Medullary Carcinoma
Keywords: Medullary carcinoma
Colorectal cancer
Microsatellite instability
Lead sponsor: V.K.V. American Hospital, Istanbul
Sponsor class: OTHER
First posted: 2018-12-13
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 427 patients with colorectal cancer who were underwent surgery between January 2011 and December 2017, were evaluated retrospectively into 2 groups as MC (n:13) and non-MC (n:414) in terms of demographic characteristics, pathological data and oncological outcomes.

Brief summary: Medullary carcinoma (MC) is a rare tumor with solid growth pattern without glandular differentiation and constitute less than 1% of colorectal cancer. Lymph node positivity and distant organ metastasis were reported to be lower than other poorly differentiated adenocarcinomas. Therefore, the diagnosis of MC is pathologically important in terms of follow-up and treatment. MC is commonly localized in the right colon, has a large tumor size, and is mostly diagnosed in the T4 stage. As MC most likely have defects in DNA MMR, the correct pathological diagnosis is important for the postoperative treatment and the prognosis of the patients.

Detailed description: 427 patients with colorectal cancer who were underwent surgery between January 2011 and December 2017, were evaluated retrospectively into 2 groups as MC (n:13) and non-MC (n:414) in terms of demographic characteristics, pathological data and oncological outcomes.

Eligibility criteria: Inclusion Criteria:

* colorectal cancer diagnosis, medullary carcinoma

Exclusion Criteria:

* none

Primary outcomes:
measure: Overall survival of medullar colorectal carcinomas
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02082262: AGN-229666 Ophthalmic Solution for the Treatment of Seasonal or Perennial Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Conjunctivitis, Allergic
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-03-10
Enrollment: 140
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of AGN-229666 for the treatment of seasonal or perennial allergic conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* Japanese patients living in Japan with allergic conjunctivitis with itching and redness
* Able and willing to discontinue wearing any contact lenses during the study period.

Exclusion Criteria:

* Eye surgical intervention and/or a history of refractive surgery within 6 months
* History of retinal detachment, diabetic retinopathy, or progressive retinal disease
* Presence of active eye infection (bacterial, viral, or fungal)
* History of an eye herpetic infection
* Use of corticosteroids within 6 months or anticipated use during the study.

Primary outcomes:
measure: Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale
timeFrame: Baseline, Day 70
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04251962: Role of Opioids in Epidural Solutions
Official title: The Role of Epidural Opioids in Pain Management After Abdominal Surgery in Adult Patients - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Israel Society of Anesthesiologists
First posted: 2020-02-05
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is unclear whether addition of opioids to epidural solutions for postoperative analgesia is beneficial. In this multicenter randomized double-blinded trial, we aim to test the primary hypothesis that epidural solutions containing only bupivacaine are as effective as solutions containing both bupivacaine and fentanyl in promoting analgesia in patients recovering from open abdominal surgery. We also aim to assess the incidence of epidural-induced hypotension, the difference in patient-reported opioid side-effects between the two groups. If we demonstrate no clinically important difference between the two interventions, clinicians will be able to substantially reduce the amount of opioids patients receive during their postoperative recovery, and potentially decrease the associated high incidence of opioid adverse effects in post-surgical patients.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent
2. 18-85 years old
3. Undergoing open abdominal surgery (including colorectal, intestinal, gastric, pancreatic, hepatobiliary, urological, or gynecological surgery)
4. For which a clinical decision has been made to provide epidural analgesia preoperatively and extending to the post-operative period
5. Anticipated hospitalization of at least 2 nights

Exclusion Criteria:

1. Known allergy to bupivacaine or fentanyl
2. Chronic liver disease, defined as cirrhosis, portal hypertension, or variceal bleeding
3. Patients under chronic alpha-blocking agents for hypertension
4. Clinical contraindications to epidural introduction, as judged by the anesthesia provider (thrombocytopenia, un-interrupted anticoagulation, clinically-significant atrio-ventricular conduction block, etc.)
5. Pregnant women

Primary outcomes:
measure: Postoperative analgesia
timeFrame: 48 postoperative hours
Secondary outcomes:
measure: Clinically significant postoperative hypotension
timeFrame: 48 postoperative hours
Other outcomes:
measure: Recovery of gastrointestinal function
timeFrame: Throughout the postoperative hospital stay, up to 30 days
measure: Opioid-related side effects
timeFrame: 48 postoperative hours
Locations:
city: Tel-Aviv
country: Israel
facility: Division of Anesthesia, Pain and Critical Care, Tel-Aviv Sourasky Medical Center
Study officials:
References:
Clinical trial NCT00281762: Urinary Aquaporin 2 Excretion After NSAID in Fasting Healthy Human
Official title: Urinary Aquaporin 2 Excretion After NSAID in Fasting Healthy Human
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: AQP-2
NSAID
Urinary concentrating ability
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2006-01-25
Enrollment: 20
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: We wanted to test the hypothesis that prostaglandin inhibition reduces the down regulation of u-AQP-2 induced by fasting


Eligibility criteria: Inclusion Criteria:

* (1) Genders; both mal and female
* (2) Age; 18- 65 years old
* (3) BMI; below 30
* (4) Females had to bee in oral contraceptive treatment

Exclusion Criteria:

* (1) Clinical signs or history of disease in the heart, lungs, kidneys or endocrine organs
* (2) Abnormal laboratory test (blood haemoglobin, white cell count, platelets, plasma sodium, plasma potassium, plasma creatinine, plasma albumin, plasma bilirubin, plasma alanine aminotransferase, plasma cholesterol and blood glucose)
* (3) Albuminuria or glucosuria
* (4) Cancer
* (5) Arterial hypertension
* (6) Alcohol abuse
* (7) Use of tobacco
* (8) Medical treatment, except oral contraceptives
* (9) Pregnancy or breast feeding
* (10) Medicine abuse
* (11) Donation of blood less than 1 month before the study.

Primary outcomes:
measure: FeNa
measure: U-AQP-2
Secondary outcomes:
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Medicine, Holstebro Hospital
Study officials:
affiliation: Regional Hospital Holstebro
name: Erling B Pedersen, Professor
role: STUDY_CHAIR
affiliation: Regional Hospital Holstebro
name: Thomas G Knudsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lauridsen TG, Vase H, Starklint J, Graffe CC, Bech JN, Nielsen S, Pedersen EB. Increased renal sodium absorption by inhibition of prostaglandin synthesis during fasting in healthy man. A possible role of the epithelial sodium channels. BMC Nephrol. 2010 Oct 28;11:28. doi: 10.1186/1471-2369-11-28.
Clinical trial NCT06892262: Relationship Between FMS and Trunk Muscle Strength, Balance, Body Composition.
Official title: Relationship Between FMS and Trunk Muscle Strength, Balance, Body Composition.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Athletes
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to investigate relatationship between FMS and trunk muscle stregth, balance and body compostition


Eligibility criteria: Inclusion Criteria:

For Athletes

* He or she has been professionally doing sports for 5 years
* At least three training per week For Sedentary
* Sedentary people who have not regular exercises in daily life

Exclusion Criteria:

* Ankle instability
* Neurological diseases
* Surgical history (last one year)

Primary outcomes:
measure: FMS total score of athletes and sedentary
timeFrame: For athletes whenever they have complete 3 years in their professionel carrier
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of health science
state: Yenimahalle
Study officials:
affiliation: specify Unaffiliated
name: Nevin Atalay Güzel, Ass.Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02659462: Cardio Pulmonary Exercise Testing in Patients Post the Fontan Palliation in Comparison With Patients With Repaired Congenital Heart Disease and Healthy Volunteers.
Official title: Cardio Pulmonary Exercise Testing in Patients Post the Fontan Palliation in Comparison With Patients With Repaired Congenital Heart Disease and Healthy Volunteers.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fontan Palliation
Congenital Heart Disease
Keywords: Repaired Congenital Heart Disease
Cardio Pulmonary Exercise Testing
Fontan
Fontan Palliation
functional capacity
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 45
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. 15 patients post the Fontal palliation for single ventricular heart
2. 15 subjects post surgical correction of congenital heart disease.
3. 15 healthy subjects.

Brief summary: prospective cardio respiratory evaluation for patients post the Fontan palliation for single ventricle, compared to subjects post successful cardiac repaired surgery compared to healthy volunteers in order to evaluate the functional capacity and the primary etiology for reduction in functional capacity.


Eligibility criteria: Inclusion Criteria:

* Children at age of 8-25 post fontan palliation
* Patients With Repaired Congenital Heart Disease without chronic lung disease
* Healthy patients ate age of 8-25

Exclusion Criteria:

* Patients with chronic lung disease
* Pregnant women
* Patients with acute active disease or chronic disease that may affect the exercise function

Primary outcomes:
measure: Comparing Cardio Pulmonary Exercise function between the three groups in the study
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: RAMBAM health care center
Study officials:
References:
citation: Rhodes J, Ubeda Tikkanen A, Jenkins KJ. Exercise testing and training in children with congenital heart disease. Circulation. 2010 Nov 9;122(19):1957-67. doi: 10.1161/CIRCULATIONAHA.110.958025. No abstract available.
citation: American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available.
Clinical trial NCT03097562: Wound Architecture and Functional Outcome After Cataract Surgery With Manual vs.Femtosecond Laser Assisted Procedures
Official title: Wound Architecture and Functional Outcome After Cataract Surgery With Manual vs. Femtosecond Laser Assisted Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Cataract
Femtosecond laser
Cornea
Anatomy
FSL
surgery
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 1123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Post market study (Phase IV)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is the long term analysis of two types of FSL 3-plane corneal wound profiles, namely CT1 and CT2 obtained after a FSL cataract surgery.

Detailed description: Femtosecond laser cataract surgery offers several major advantages for wound construction, including high precision, repeatability and a large variety of corneal wound profiles. The aim of this study is the long term analysis of two types of FSL 3-plane corneal wound profiles, namely CT1 and CT2, CT2 being constructed with a reversed front corneal incision segment to ensure tigher wound closure and better corneal wound reapposition. The traditional manual wound performed with a standard keratome will be used as a reference. As FSL cataract surgery may be associated with a greater incidence of wound leaks at the end of surgery as compared to manual wound construction with keratomes, this study will also aim at determining wich clinical and OCT wound parameters are associated with a higher likelihood of wound leaks.

Eligibility criteria: Inclusion Criteria:

* Consecutive cases of cataract surgery performed between January 2015 and june 2015 by a single surgeon (PH) at the clinique d'ophtalmologie Bellevue, using either the Catalys or a manual technique.
* One eye per patient, the first eye
* Uneventful cataract only

Exclusion Criteria:

* Combined glaucoma filtering surgery
* Any previous corneal surgery in this eye
* Any pathology of the interior segment
* Inflammatory eye disease of the interior segment

Primary outcomes:
measure: Preservation of a physiological postoperative anatomy will be considered as a criterion of success
timeFrame: 2 Months
Secondary outcomes:
measure: The absence or a lower incidence of wound leak will also be considered as a criterion of success
timeFrame: 2 Months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Glaucoma Institut
state: Quebec
Study officials:
affiliation: Ciusss de L'Est de l'Île de Montréal
name: Paul Harasymowycz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00995462: Prevention of Weight Gain in University Students
Official title: Prevention of Weight Gain in University Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention
Weight Gain
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Canadian Diabetes Association
name: Danone Institute
First posted: 2009-10-15
Enrollment: 319
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study assess whether a small-group seminar intervention to prevent weight gain is effective in a general university student population, and to address the relative role of biological vs. lifestyle factors in predicting weight gain in humans.


Eligibility criteria: Inclusion Criteria:

* First year students at the Université de Sherbrooke.

Exclusion Criteria:

* Presence of diseases or medications that would be expected to affect weight (cystic fibrosis, diabetes, inflammatory bowel diseases, anorexia nervosa, bulimia, etc.).
* Pregnancy or planning a pregnancy in the next two years.
* Unable to give an informed consent.

Primary outcomes:
measure: Weight change
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Université de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Marie-France Langlois, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langlois F, Langlois MF, Carpentier AC, Brown C, Lemieux S, Hivert MF. Ghrelin levels are associated with hunger as measured by the Three-Factor Eating Questionnaire in healthy young adults. Physiol Behav. 2011 Sep 1;104(3):373-7. doi: 10.1016/j.physbeh.2011.04.013. Epub 2011 Apr 22.