louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02898038: Acceptability and Tolerance Study of a New Oral Nutritional Supplement (ONS)
Official title: Tolerance and Acceptability of AYMES PARIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Lead sponsor: Aymes International Limited
Sponsor class: INDUSTRY
Collaborators: name: Alison Clark Health and Nutrition
First posted: 2016-09-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Tolerance and Acceptability of new oral nutritional supplement - AYMES PARIS

Detailed description: To evaluate tolerance and acceptability of AYMES PARIS in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference,convenience etc.

To obtain data to support an ACBS submissions for AYMES PARIS (to allow for prescription in the community at NHS expense).

Eligibility criteria: Inclusion Criteria:

* Adult patients (≥18 years) who are able to communicate their views regarding acceptability.
* Patients established on an oral nutritional supplement, being prescribed 1-2 ONS providing approximately 300kcal/day
* Patients expected to require oral nutritional supplementation for at least 2 further weeks.
* Informed consent obtained.

Exclusion Criteria:

* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
* Patients requiring a milk-free diet
* Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 of protocol for full list)
* Patients with significant renal or hepatic impairment
* Patients with swallowing impairment requiring thickened fluids
* Patients with inflammatory bowel disease or previous bowel resection.

Primary outcomes:
measure: GI side effects when using AYMES PARIS
timeFrame: 9 DAYS
Secondary outcomes:
measure: Change to bodyweight of subjects when using AYMES PARIS
timeFrame: 9 DAYS
measure: Compliance with prescription of AYMES PARIS
timeFrame: 9 DAYS
measure: Bowel habits of subjects when using AYMES PARIS - frequency
timeFrame: 9 days
measure: Bowel habits of subjects when using AYMES PARIS - stool consistency
timeFrame: 9 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02060838: The Impact of Storage Techniques on Platelets Number and Function After Acute Normovolemic Hemodilution (ANH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgical Procedures
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing open-heart surgery who will be having acute normovolemic hemodilution (ANH) as part of their surgery.

Brief summary: Acute normovolemic hemodilution (ANH) is part of our current protocol to decrease post-operative bleeding and homologous blood transfusions post cardiopulmonary bypass. Blood is drawn from our patients pre-bypass after obtaining the arterial line and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine. In our practice we noticed some variability in the impact of ANH on postoperative bleeding; with some patients appearing to show more hemostasis after separation from CPB than others. This is a prospective study to find out if there is an optimal time period that guarantees the largest amount of functioning platelets and what is the best practice for drawing and storing of ANH to guarantee the largest amount of functioning platelets.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing cardiac surgery on CPB and are determined to be suitable for ANH by the cardiac team during the huddle process per our standard protocol.

Exclusion Criteria:

* Patients who are undergoing cardiac surgery on CPB who are determined not to be suitable candidates for ANH by the cardiac team during the huddle process per our standard protocol.

Primary outcomes:
measure: Time to Platelet Aggregation as Measured Using Collagen-epinephrine (EPI)
timeFrame: Just prior to re-transfusion, assessed up to 5 minutes
measure: Time to Platelet Aggregation as Measured Using Collagen-Adenosine (ADP)
timeFrame: Just prior to re-transfusion, assessed up to 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
citation: Sebastian R, Ratliff T, Winch PD, Tumin D, Gomez D, Tobias J, Galantowicz M, Naguib AN. Revisiting acute normovolemic hemodilution and blood transfusion during pediatric cardiac surgery: a prospective observational study. Paediatr Anaesth. 2017 Jan;27(1):85-90. doi: 10.1111/pan.13014. Epub 2016 Oct 13.
Clinical trial NCT06047938: FMF and Atheroscelerosis
Official title: Familial Mediteranean Fever in Upper Egypt, and Its Relation to Atherosclerosis in Children
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: FMF
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that present with FMF in Assiut University Pediatric Hospital (allergy , immunology and rheumatology department)in one year.

Brief summary: The aim of this study is to search for subclinical atherosclerosis in children diagnosed as FMF in Assiut University children's Hospital, and to correlate the risk to develop atherosclerosis to the different characters and genetic variants of FMF.

Detailed description: * To describe the clinical characteristics of patients diagnosed as FMF in Upper Egypt, and to find the most common presenting symptoms.
* To mention the most common genetic variants reported in FMF patients in Upper Egypt, and to correlate the genetic variant with the risk to develop atherosclerosis.
* To assess the growth parameters in patients with FMF and compare it with the control group.
* To estimate the differences in Complete blood count (CBC) parameters, lipid profile, CIT in patients with FMF and control group.
* To search for subclinical atherosclerosis in patients with FMF based on their lipid profile and CIT.

Eligibility criteria: Inclusion Criteria:

1. Age at enrollment less than18 years.
2. Both sexes.
3. Diagnosed as familial Mediterranean fever according to Tel Hashomer criteria. \[10\]

Exclusion Criteria:

1. Patients with acute or chronic active infections.
2. Patients with pre-existing illness as chronic lung, liver or renal diseases.
3. Patients with diabetes mellitus, atherosclerotic vascular disease.
4. Patients with malignancy

Primary outcomes:
measure: detecting subclinical atheroscelerosis
timeFrame: It will be measured in one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00153738: Phytosterol Supplementation and Cardiovascular Risk
Official title: Effectiveness of Phytosterol Supplementation on Select Indices of Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesteremia
Keywords: LDL-C, phytosterol
Lead sponsor: The Cooper Institute
Sponsor class: OTHER
Collaborators: name: Cargill
First posted: 2005-09-12
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study examined the effects of 2.6 g/d of phytosterol ingestion on LDL cholesterol metabolism. It is expected that this dose will significantly reduce LDL cholesterol after 12 weeks of supplementation.

Detailed description: This study examined the effects of 2.6 g/d of phytosterol ingestion on LDL cholesterol metabolism. It is expected that this dose will significantly reduce LDL cholesterol after 12 weeks of supplementation.

The study recruited 72 men and women 20-70 years of age with mild hypercholesteremia (\>130 mg/dl LDL-C). They were assigned to 1 of 2 groups. Participants ingested the supplement or a placebo for 12 weeks, with an interim assessment at 6 weeks. Participants agreed to maintain current diet, medication, and exercise habits and to not donate blood during the trial.

Eligibility criteria: Inclusion Criteria:

* mild hypercholesteremia, sign informed consent, not donate blood, maintain diet and exercise habits

Exclusion Criteria:

* BMI \<18.5 or \>34.9, recent blood donation, serious or life-threatening disease

Primary outcomes:
measure: Ingestion of the supplement will result in reduced LDL cholesterol.
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The Cooper Institute
state: Texas
Study officials:
affiliation: The Cooper Institute
name: Conrad Earnest, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03889938: Serum Level of Bioactive Mediators and Urinary Biopyrins in Psoriasis
Official title: Serum Level of Bioactive Mediators and Urinary Biopyrins in Psoriasis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psoriasis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with psoriasis

Brief summary: 1. Assess the level of lipid mediators in patients with psoriasis
2. Assess the urinary level of biopyrins as New marker of oxidative stress in patients with psoriasis
3. Correlate the serum level of bioactive lipid mediators and urinary level of biopyrins with Psoriasis Area and Severity Index

Detailed description: Psoriasis is acommon immune mediated inflammatory skin disorder of complex pathomechanisms which is generically conditioned and influenced by environmental factors

Eligibility criteria: Inclusion Criteria:

* age from12 to 80 and both sex

Exclusion Criteria:

* patients with other dermatological disorders

Primary outcomes:
measure: the serum level of bioactive lipid mediators in patients with psoriasis
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sorokin AV, Domenichiello AF, Dey AK, Yuan ZX, Goyal A, Rose SM, Playford MP, Ramsden CE, Mehta NN. Bioactive Lipid Mediator Profiles in Human Psoriasis Skin and Blood. J Invest Dermatol. 2018 Jul;138(7):1518-1528. doi: 10.1016/j.jid.2018.02.003. Epub 2018 Feb 15.
citation: Bakry OA, El Hefnawy S, Mariee AH, El Gendy Y. Urinary Biopyrrins: A New Marker of Oxidative Stress in Psoriasis. Indian J Dermatol. 2016 Mar-Apr;61(2):169-73. doi: 10.4103/0019-5154.177756.
Clinical trial NCT06857838: Myocardialbridge Bypass Graft Surgery Efficacy Verification
Official title: Myocardialbridge Bypass Graft Surgery Efficacy Verification
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Bridge of Coronary Artery
Myocardial Bridge
Myocardial Bridging
Myocardial Infarction
Myocardial Ischemia
Pectoris, Stable Angina
Sudden Cardiac Death
Bypass Graft Stenosis
Bypass Graft Occlusion
Bypass Graft Thrombosis
Lead sponsor: Xi'an International Medical Center Hospital
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Myocardial Bridge Bypass Graft surgery is introduced to relieve the unmedical symptoms of patients with long-segment or deep myocardial bridge, clinical outcomes will be collected to verify the effectiveness of the surgery.


Eligibility criteria: Inclusion Criteria:

* Patients with myocardialbridge requiring drug therapy or surgical intervention.

Exclusion Criteria:

* patients with myocardialbridge not requiring drug therapy or surgical intervention, or unwilling to be enrolled for any reason

Primary outcomes:
measure: All-Cause Mortality
timeFrame: Up to 240 months
measure: Rate of counduit patency
timeFrame: Up to 180 months
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xi'an International Medical Center Hospital Affiliated TO Northwest University
state: Shaanxi
Study officials:
affiliation: Xi'an International Medical Center Hospital Affiliated To Northwest University
name: Zhen Wang, Doctorate
role: PRINCIPAL_INVESTIGATOR
affiliation: Xi'an International Medical Center Hospital Affiliated To Northwest University
name: Jinzhou Zhang, Doctorate
role: STUDY_DIRECTOR
affiliation: Xi'an International Medical Center Hospital Affiliated To Northwest University
name: Jinzhou Zhang, Doctorate
role: STUDY_CHAIR
References:
citation: Zhang JZ, Zhu GY, Zhang Y, Bai LJ, Wang Z. Myocardial Bridge Bypass Graft: A Novel Surgical Procedure for Extensive Myocardial Bridges. Ann Thorac Surg. 2021 Aug;112(2):e115-e117. doi: 10.1016/j.athoracsur.2020.11.055. Epub 2021 Jan 20.
Clinical trial NCT01422538: Ultherapy™ Treatment Following Sculptra® Treatment
Official title: Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck Following Sculptra® Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Keywords: Ulthera® System
Ultherapy™ treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening
Skin laxity on the face and neck.
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-24
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial will evaluate clinical outcomes associated with the non-invasive Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.

Detailed description: This study is a prospective,single-center, randomized clinical trial. Up to thirty (30) subjects will be treated. Enrolled subjects will be assigned to one of three (3) groups. Up to 10 subjects per group.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged 35 to 60 years.
* Subject in good health.
* Skin laxity in the lower face and neck.
* Grade 1 and 2 on the Knize Scale

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat in the face and neck.
* Excessive skin laxity on the face and neck.
* No scarring in areas to be treated.
* Any open facial wounds or lesions.
* Acne on the face.
* Patients who have a history with keloid formation or hypertropic scarring
* Patients who have a hypersensitivity to injectable poly-L-lactic acid
* Presence of a metal stent or implant in the facial area to be treated.

Primary outcomes:
measure: Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs.
timeFrame: 90 days post-treatment
Secondary outcomes:
measure: Overall Aesthetic Improvement at 90 Days Post-treatment
timeFrame: 90 days post-treatment.
measure: Overall Aesthetic Improvement at 180 Days Post-treatment
timeFrame: 180 days post-treatment
measure: Subject Satisfaction at 90 Days Post-treatment
timeFrame: 90 days post-treatment.
measure: Subject Satisfaction at 180 Days Post-treatment
timeFrame: 180 days post-treatment
Other outcomes:
measure: Subject's Assessment of Pain
timeFrame: During Ulthera study treatment
Locations:
city: Dallas
country: United States
facility: EpiCentre Park Lane
state: Texas
Study officials:
affiliation: EpiCentre Park Lane
name: Jay Burns, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04720638: Clinical Performance of Short Fiber Reinforced Flowable Resin Composite Restorations 2y RCT
Official title: Clinical Performance of Short Fiber Reinforced Flowable Resin Composite Restorations Versus Conventional Resin Composite Restorations in Posterior Teeth (2y Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Decay, Dental
Caries Class II
Keywords: short fiber reinforced flowable resin composite
Clinical performance
Ever X flow
Randomized clinical study
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 70
Sex: ALL
Minimum age (years): 17
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical performance of short fiber reinforced flowable resin composite restorations versus conventional resin composite restorations will be tested in posterior teeth (2y randomized clinical trial).


Eligibility criteria: Inclusion Criteria:

* Patients with large proximal carious cavities in molars.
* Pulp asymptomatic vital carious upper or lower molars.
* Good oral hygiene.

Exclusion Criteria:

* Presence of signs and symptoms of irreversible pulpitis or pulp necrosis
* Severe medical complications.
* Allergic history concerning methacrylates
* Evidence of parafunctional habits.

Primary outcomes:
measure: Clinical performance (Alpha is the best score, bravo, charlie the worst score)
timeFrame: Change from baseline at 6, 12 ,18, 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Lecturer at faculty of Dentistry- Cairo University
name: Rawda Hesham
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04978038: Fourth Dose of mRNA COVID-19 Vaccine in Residents of LTCFs
Official title: Fourth Dose of Pfizer mRNA COVID-19 Vaccine in Residents of Long-Term Care Facilities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: SARS-CoV2 Infection
Coronavirus Infection
Keywords: COVID-19
Immunization
Long-term care
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 414
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: PREVENTION

Brief summary: This study is a multi-centre, blinded, randomized controlled trial. LTCF residents ≥ 65 years who have received three doses of mRNA vaccine will be randomized to vaccination with a fourth dose of Pfizer-BioNtech mRNA- COVID-19 vaccine or to vaccination with a control (Prevnar-13 vaccine).

Detailed description: The primary objective of this study is to test whether vaccinating LTCF residents ≥65 years with a fourth dose of Pfizer-BioNtech mRNA- COVID-19 vaccine as compared to control (PCV13) leads to an increase in detectable neutralizing antibodies. Participants will be randomized to receive either the Pfizer COVID-19 vaccine or the Pnemoccocal Prevnar-13 vaccine at baseline after bloodwork is drawn. Another blood sample will be taken 28 days later. After completion of the study, participants in the control group (pneumococcal Prevnar-13 vaccine) will be given a fourth dose of mRNA COVID-19 vaccine and will have their blood drawn 28 days post-vaccination.

Eligibility criteria: Inclusion Criteria:

* LTCF residents ≥ 65 years who have received three doses of mRNA vaccine.

Exclusion Criteria:

* Immunocompromised individuals due to known or suspected immunodeficiency or due to receipt of immunosuppressive medication (e.g., steroids, biologics).
* Having had a severe adverse reaction (e.g., anaphylactic allergy) to mRNA or pneumococcal vaccine.
* Having received pneumococcal polysaccharide vaccine within 12 months.
* LTCF residents who have an interval less than 3 months from their third mRNA COVID vaccine dose.

Primary outcomes:
measure: Detection of neutralizing antibodies
timeFrame: 28 days
Secondary outcomes:
measure: Total IgG spike response
timeFrame: 28 Days
measure: Total IgM spike response
timeFrame: 28 Days
measure: IgA spike antibodies titre
timeFrame: 28 Days
measure: Anti-RBD antibody titre
timeFrame: 28 Days
measure: ADCC Response
timeFrame: 28 Days
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Mark Loeb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00708838: Levels of Circulating T Cells Expressing VLA-1 Collagen Receptors
Official title: VLA-1 Receptors on Peripheral T Cells in Ischemic Heart Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-07-02
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE

Brief summary: The examination of the percentage of peripheral T cells carrying VLA-1 in ischemic heart disease patients. The hypothesis is that the percentage levels of cells carrying this integrin rise according to the severity of the ischemic heart disease.

Detailed description: Atherosclerosis is considered an inflammatory disease in which lymphocytes have an important role. The study was disigned to find out the changes in T cell levels carrying VLA-1 involvement in this process.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of acute MI for group 1
* clinical diagnosis of ACSl for group 2
* clinical diagnosis of Chronic Heart Disease for groups 3 and 4
* Chest pain but normal heart scan for group 5

Exclusion Criteria:

* none

Primary outcomes:
measure: The differance in percentage of T cells in the 5 different groups involved.
timeFrame: 2002-2006
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: