louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02800239: Protein Requirements for Active Adolescent Females
Official title: Evaluation of Protein Requirements in Active Adolescent Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Increased Metabolic Requirement
Healthy
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Ajinomoto Co., Inc.
First posted: 2016-06-15
Enrollment: 7
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Protein requirements in active individuals have been suggested to be greater than the current recommended dietary allowance (RDA).

Nutritional requirements for dietary amino acids in adolescents have traditionally been determined utilizing the nitrogen balance technique, which is prone to underestimating protein requirements. As a result, there is a need to re-evaluate recommendations in order to characterize how dietary amino acid needs may be modulated by physical activity.

Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 50% higher than the RDA based on nitrogen balance data.

The purpose of this study is to measure the protein requirement in adolescent, females using the IAAO technique in the presence of a variable intensity exercise stimulus.


Eligibility criteria: Inclusion Criteria (Adolescents):

* Healthy, active adolescent who regularly participates in moderate to vigorous physical activity 5 times a week for a minimum of 1 hour.
* Being -0.5 to +1.0 years from peak height velocity, determined by the ratio of standing to sitting height, with the maximal age for adolescents being 16 years.

Obtaining a minimum level of 5.8 on the Beep Test

Exclusion Criteria (All Subjects):

* Inability to meet health and physical activity guidelines according to the Physical Activity Readiness Questionnaire (PAR-Q+) and Physical Activity Questionnaire,
* An inability to adhere to any of the protocol guidelines (i.e. caffeine consumption)
* A biological age falling outside of the aforementioned ranges

Primary outcomes:
measure: 13CO2 ([13]Carbon Dioxide) Excretion (µmol/kg/h)
timeFrame: 4 hours/ study day
Secondary outcomes:
measure: [13C]Phenylalanine Oxidation (µmol/kg/h)
timeFrame: 4 hours/ study day
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Goldring Centre for High Performance Sport
state: Ontario
Study officials:
affiliation: University of Toronto
name: Daniel Moore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00508339: Functional Outcomes Following Limb Sparing Surgery for Sarcoma Patients
Official title: Functional Outcomes Following Limb Sparing Surgery for Soft Tissue Sarcoma and Pre-Operative Radiotherapy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sarcoma
Keywords: Soft Tissue Sarcoma
Limb Sparing Surgery
Toronto Extremity Salvage Score
Radiotherapy
Quality of Life
Questionnaire
Survey
TESS
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-07-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of soft tissue sarcoma.

Brief summary: Primary Objectives:

1. To classify the types of wound healing complications that occur after pre-operative radiation therapy and limb sparing resection for the treatment of soft tissue sarcomas of the extremity.
2. To evaluate the impact of each complication type on patient function and quality of life using the Toronto Extremity Salvage Score (TESS).


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of soft tissue sarcoma with histopathologic confirmation.
2. Treatment protocol that includes pre-operative radiation therapy.
3. Treatment protocol that includes limb-sparing surgical resection.
4. Patient has received MD Anderson Cancer Center multidisciplinary care.
5. Patient must be at least three years post-operative.

Exclusion Criteria:

1. Previous radiotherapy to the local site.
2. Presence of regional or distant metastases.
3. Major medical co-morbidities (eg. cerebrovascular accident, congestive heart failure, concurrent malignancy) or disabilities unrelated to treatment for soft tissue sarcoma.

Primary outcomes:
measure: Endpoints for this study will be anatomic site, histological subtype, primary wound closure, wound complication type, need for secondary operation and type of secondary operation.
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: U.T.M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Charles E. Butler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05122039: ProspectIve Cohort psoriASiS fOllow-up (PICASSO)
Official title: ProspectIve Cohort psoriASiS fOllow-up (PICASSO)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriasis
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Psoriasis patients with disease duration less than three years, aged 12-70 years old at time of inclusion

Brief summary: The main purpose of the PICASSO-project is to facilitate future psoriasis-research in dermatology. This register biobank will enable us to perform research in the field of metabolomics, mRNA-expression, cardiovascular impact and the microbiome. The final aims are patient stratification, better insight in disease-evolution and improved understanding of markers that predispose to severe disease.

Detailed description: The PICASSO-project is a prospective register with extensive biobanking in which patients with a recent onset of psoriasis (\<3 years) can be enrolled. Participants are followed for a period of 10 years, with scheduled visits every 2.5 years. The same protocol is followed for every visit. The registry captures patient demographics, medical history (personal and family), details of psoriasis treatment (previous and current), physical examination, disease activity scores and PROMs. Some patients (substudy) will undergo ultra-sound to determine carotid intima media thickness. Biobanking in this project encompasses extensive biosampling of multiple tissues. It is not within the scope of this project to administer study medication: patients receive standard of care treatment as prescribed by their physician.

Eligibility criteria: Inclusion Criteria:

* Clinical signs of Psoriasis since \>3 years
* adults (70 years old or less) and children (\>12 years old)
* willing and able to understand and sign the informed consent (plus legal representative in case of a minor)

Exclusion Criteria:

* unwilling or unable to understand and sign the informed consent
* disease duration longer than 3 years

Primary outcomes:
measure: We hypothesize that metabolic state in early disease (<3 years of disease onset) is linked to and predictive of more severe course of psoriasis after five years.
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Department of Dermatology, University Hospitals Leuven
name: Tom Hillary, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02412839: Sublingual Microcirculation of Healthy Volunteers by Using the Third Generation Microcirculation Video Microscope
Official title: Population Research of Sublingual Microcirculation Data of Healthy Volunteers by Using the Third Generation Microcirculation Video Microscope
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy Volunteers

Brief summary: This study will enroll 150 healthy volunteers, and the grouping is as follows: group 20-39 (30 males and 30 females); group 40-59 (30 males and 30 females); and group 60-79 (15 males and 15 females). The sublingual microcirculation will be examined with the incident dark field video microscope (Cytocam，Braedius Battery Powered Transilluminator). The study aims to compare the differences of microcirculation among the three groups and between genders.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers aged from 20 to 79 years old
* BMI ranged from 18.5 to 27 kg/m2

Exclusion Criteria:

* Systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 95 mm Hg, or systolic blood pressure \< 90 mm Hg at enrollment
* Body temperature \> 37.5 ℃ or \< 35.5 ℃ at enrollment
* had been diagnose with any one of the following diseases

  * hypertension
  * diabetes mellitus
  * peripheral arterial occlusive disease
  * coronary arterial disease
  * liver cirrhosis
  * chronic kidney disease
  * stroke
  * anemia
  * asthma
  * chronic bronchitis
  * any metabolic diseases
  * any hematologic disease
  * uncured cancer
  * chronic uncontrolled infection
  * other disease may limit daily activities
  * non-native speakers

Primary outcomes:
measure: Total small vessel density of sublingual small vessels measured by Cytocam
timeFrame: Once at enrollment
Secondary outcomes:
measure: Perfused small vessel density of sublingual small vessels measured by Cytocam
timeFrame: Once at enrollment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yu-Chang Yeh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01376739: Magnevist Post-marketing Surveillance in Japan
Official title: Drug Use Investigation of Magnevist
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnostic Imaging
Keywords: Magnevist
MR angiography
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 2051
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: The target population of this study is patients who received Magnevist for MR angiography. The study is expected to collect data of 2,000 patients in approximately 150 hospitals in Japan.

Brief summary: This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Magnevist at a dose of more than 0.2 ml/kg for MR angiography of peripheral vasculature with continuous imaging from the abdomen to the lower extremities. The objective of this study is to assess safety, especially in relation to renal dysfunction, and efficacy of using Magnevist in clinical practice. A total 2,000 patients will be recruited.


Eligibility criteria: Inclusion Criteria:

* Patients who received a dose of more than 0.2 mg/kg of Magnevist for MR angiography of peripheral vasculature with continuous imaging from the abdomen to the lower extremities

Exclusion Criteria:

* Patients who are contraindicated based on the product label

Primary outcomes:
measure: Incidence of adverse drug reactions and serious adverse events in subjects who received Magnevist
timeFrame: After Magnevist administration, up to 3 years
measure: Incidence of adverse drug reactions, especially Nephrogenic Systemic Fibrosis and Nephrogenic Fibrosing Dermopathy (NSF/NFD) in patients with reduced renal functions
timeFrame: After Magnevist administration, up to 3 years
Secondary outcomes:
measure: MRI image evaluation assessment by the four rank scales of 1 to 4: 1) sufficient extraction; 2) almost sufficient extraction; 3) not sufficient extraction; and 4) insufficient extraction
timeFrame: After Magnevist injection, up to 3 years
measure: Incidence of adverse drug reactions in subpopulation with baseline data
timeFrame: At baseline and after Magnevist administration, up to 3 years
Other outcomes:
Locations:
city: Many Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04170439: Added Value of N Acetyle Cysteine to Clomiphene Citrate in PCO
Official title: The Added Value of n Acetyle Cysteine and Chromium to Clomiphene Citrate in PCO
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PCO
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2019-11-20
Enrollment: 108
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Women who will receive clomiphe citrate plus N acetyle cysteine rally in arm number 1 And women who will receive clomiphene citrate and chromoum in arm number 22
Primary purpose: TREATMENT

Brief summary: PCO is one of the factors associated with delayed conception

Detailed description: In an attempt to induce ovulation Clomiphene citrate can be given in conjunction with N acetyle cysteine

Eligibility criteria: Inclusion Criteria:

* women with PCO

Exclusion Criteria:

* women who donot have PCO

Primary outcomes:
measure: The number of women who will have mature follicles wih their size and number of mqture follicles The number of women who will have mature follicles
timeFrame: within 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah and Kasralainy hospital
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algezeera
name: Mahmoud Alalfy, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05625139: Implementation of an Enhanced Rehabilitation Protocol After Liver Transplantation: Feasibility and Analysis of Results
Official title: Implementation of an Enhanced Rehabilitation Protocol After Liver Transplantation: Feasibility and Analysis of Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant Disorder
Keywords: Liver Transplant Disorder
Liver transplantation
ERAS
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject operated at HUS for a liver transplant whose management was scheduled in the Surgical Intensive Care Unit fbetween December 01, 2018 and August 31, 2020

Brief summary: Currently, there are no expert recommendations regarding enhanced rehabilitation after liver transplantation. The development of Enhanced Rehabilitation After Surgery (ERAS) protocols in major surgery, particularly cardiothoracic surgery, has motivated some anesthesia teams to extubate liver transplant patients earlier who meet predefined criteria (young patient, absence of comorbidities, absence of intraoperative transfusion) in order to limit the occurrence of complications of mechanical ventilation (pneumopathies, tracheal wound, muscle loss, etc.) On the other hand, improved rehabilitation in this case was often synonymous with early extubation in the operating room. Few studies, on the other hand, relate the implementation of a complete rehabilitation protocol including pre-, intra- and postoperative guidelines.


Eligibility criteria: Inclusion criteria:

* Major subject operated at HUS for a liver transplant whose management was scheduled in the Surgical Intensive Care Unit fbetween December 01, 2018 and August 31, 2020
* Subject who does not question, after information, the reuse of his data for the purpose of this research

Exclusion criteria:

* Subject having expressed his opposition to participate in the study
* Liver transplant patient hospitalized in the Medical Intensive Care Unit before or after the surgery

Primary outcomes:
measure: Retrospective description of the protocol of improved rehabilitation after liver transplantation, to study the possibility of its implementation in the anesthesia-intensive care department and to analyze the first results
timeFrame: Files analysed retrospectively from December 01, 2018 to August 31, 2020 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Anesthésie, Réanimation et Médecine péri-Opératoire - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT06178939: Effects of Cognitive Intervention Therapy on Postoperative Delirium
Official title: Effects of Cognitive Intervention Therapy on Postoperative Delirium in Elderly Non-cardiac Surgical Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Stenosis
Disc Herniation
Lung Neoplasms
Carcinoma, Hepatocellular
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is a prospective, single-center, randomized controlled trial to compare whether applying cognitive intervention therapy before and after surgery in elderly patients aged 65 years or older undergoing non-cardiac surgery can reduce the incidence of postoperative delirium compared to conservative treatment.


Eligibility criteria: Inclusion Criteria:

* Elderly patients aged 65 and above.
* Patients undergoing orthopedic, thoracic, or hepatopancreatobiliary surgery under general anesthesia with an expected surgery duration of 2 hours or more.
* Patients scheduled for arterial catheterization.

Exclusion Criteria:

* Patients with uncontrolled systemic conditions such as diabetes and hypertension.
* Those with visual impairment.
* Patients with cognitive impairment based on the MMSE-DS criteria.
* Individuals experiencing difficulty in communication.
* Those diagnosed with neurological disorders (such as brain hemorrhage, stroke, brain tumor, dementia, Parkinson's disease, cognitive impairment, depression, etc.).
* Patients diagnosed with alcohol or substance addiction.

Primary outcomes:
measure: incidence of postoperative delirium
timeFrame: from postoperative day 0 to postoperative day 7
Secondary outcomes:
measure: comprehensive geriatric assessment(CGA),
timeFrame: from postoperative day 0 to postoperative day 7
measure: duration of delirium
timeFrame: from postoperative day 0 to postoperative day 7
measure: type of delirium
timeFrame: from postoperative day 0 to postoperative day 7
measure: total score of QOR-40
timeFrame: from postoperative day 0 to postoperative day 7
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine
name: Bon-Nyeo Koo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03960086: Effectiveness of Custom-made Foot Orthoses vs Heel Lifts in Children With Calcaneal Apophysitis
Official title: Effectiveness of Custom-made Foot Orthoses vs Heel Lifts in Children With Calcaneal Apophysitis (Sever Disease): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Calcaneal Apophysitis
Sever's Disease
Lead sponsor: Fundacion Podoactiva
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 234
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was a parallel-group, randomized controlled trial with concealed allocation, blinding of investigators and assessors and intention-to-treat analysis.
Primary purpose: TREATMENT

Brief summary: The study was a parallel-group, randomized controlled trial with concealed allocation, blinding of investigators and assessors and intention-to-treat analysis. It examined the effect of custom-made foot orthoses and heel lifts in children with calcaneal apophysitis.

It was hypothesized that the primary outcome, pain relief, would be significantly improved with the custom-made orthosis compared to the heel lift.


Eligibility criteria: Inclusion Criteria:

* diagnosed radiologically with calcaneal osteochondritis
* diagnosed radiologically with calcaneal osteochondritis
* have signed informed consent

Exclusion Criteria:

* had suffered some trauma on the heel in the past 2 months
* had received anti-inflammatory drugs and/or physical treatment for pain in the past 3 months
* had presented physical or neurological impairment
* were not interested

Primary outcomes:
measure: Visual analogical scale (VAS)
timeFrame: At baseine and after the intervention period
measure: Algometry
timeFrame: At baseine and after the intervention period
measure: Sport activity pain perception
timeFrame: At baseine and after the intervention period
Secondary outcomes:
measure: Foot Posture Index (FPI)
timeFrame: At baseline
measure: lunge test values
timeFrame: At baseline
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Alejandro Jesús Almenar Arasanz
Study officials:
References: