louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04064528: Effects of Age on Amino Acid Delivery to Tendon
Official title: Effects of Age on Amino Acid Delivery to Tendon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: amino acid
tendon
aging
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Young (21-30 years old) and older (60-75 years) adults will each receive an oral bolus of 10 g of essential amino acids.
Primary purpose: BASIC_SCIENCE

Brief summary: Dietary amino acid supplementation may provide an effective means to promote tendon injury recovery and enhance collagen synthesis. While most published research has been completed in animal models, research with young adults has shown that a leucine-rich whey isolate consumed during a chronic resistance training (RT) intervention resulted in greater gains (\~60%) in tendon CSA when compared to placebo. Leucine-rich diets have also improved tendon collagen content in rodents. Further, in our preliminary work utilizing microdialysis, we demonstrate that oral consumption of a leucine-rich amino acid beverage increased delivery of amino acids to tendons in young adults (21-30 years). However, whether aging alters the delivery of amino acids to tendons after oral consumption has not be investigated. In order to optimize amino acid dosing for chronic interventional studies, we wish to determine if aging influences amino acid concentration in the peritendinous (space around the tendon) space after oral consumption.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* body mass index \>35 kg•m-2, those on medications known to affect protein or collagen metabolism, e.g. acetaminophen, ibuprofen, or prescription cyclooxygenase inhibitors, previous history of tendinopathy, or diabetes.

Primary outcomes:
measure: Achilles Peritendinous Amino Acid Levels in young and older adults
timeFrame: 0-6 hours post consumption
Secondary outcomes:
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Chad C Carroll, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02496728: NUYou:mHealth Intervention to Preserve and Promote Ideal Cardiovascular Health
Official title: American Heart Association Strategically Focused Research Network: mHealth Intervention to Preserve and Promote Ideal Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Mobile Health
Smartphone
Cardiovascular health
College students
Smoking
Physical activity
Diet
BMI
Blood pressure
Cholesterol
Glucose
Text
Facebook
Instagram
Push Notifications
Ecological Momentary Assessment
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2015-07-14
Enrollment: 302
Sex: ALL
Minimum age (years): 17
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to investigate the preservation or promotion of health in students during the college years.

Detailed description: Freshman college students at Northwestern University will be cluster randomized to two groups based on their dorm. The intervention for one group will target smoking, physical activity, BMI and consumption of fruits and vegetables. The intervention in the second group will target traveling behavior, sexual risk behaviors, sunscreen use and hydration. Baseline health and lifestyle measures will be assessed for each participant prior to intervention. Health assessments will measure height, weight, fasting glucose, total cholesterol and carbon monoxide. The lifestyle measure will ask questions about physical activity, diet, alcohol and tobacco use, safe sex practices, driving habits, and sunscreen use. These same measures will be repeated during the fall of the students' sophomore and junior years.

Participants will be given a mobile application and encouraged to track some behaviors. In addition, participants will be asked to answer weekly questions regarding health behaviors.

Eligibility criteria: Inclusion Criteria:

* Freshman at Northwestern University in the fall of 2015
* Live on campus
* Read, write and speak English
* Own an Iphone or Android smart phone

Exclusion Criteria:

* Pregnant or trying to become pregnant
* Established cardiovascular disease
* Unstable psychiatric or medical condition

Primary outcomes:
measure: American Heart Association MyLifeCheck (Simple 7) score as a measure of cardiovascular health
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Bonnie Spring, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pfammatter AF, Champion KE, Finch LE, Siddique J, Hedeker D, Spring B. A mHealth intervention to preserve and promote ideal cardiovascular health in college students: Design and protocol of a cluster randomized controlled trial. Contemp Clin Trials. 2020 Nov;98:106162. doi: 10.1016/j.cct.2020.106162. Epub 2020 Oct 8.
Clinical trial NCT06429228: Comparison of 1 Versus 2 Days Post-Operative Catheterization After Anterior Colporrhaphy
Official title: Comparison of 1 Versus 2 Days Post-Operative Catheterization After Anterior Colporrhaphy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Related Complication
Anterior Vaginal Wall Prolapse
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Patients who undergo anterior vaginal wall plastic surgery and place the bladder catheter during surgery are selected. The purpose of the study is to evaluate the presence of statistically significant differences in bladder catheter repositioning within 12 hours after bladder catheter removal in the group of patients in whom the bladder catheter is removed on postoperative day I or II.

Secondary outcomes include evaluation of the incidence of urinary tract infections, number of hospitalization days and total hospitalization costs for patients undergoing anterior vaginal wall surgery in patients in whom the bladder catheter is removed on postoperative day I or II.


Eligibility criteria: Inclusion Criteria:

* Women 18 years of age or older
* Patients who are candidates for cystopexy surgery
* Patients who have consented to the signing of the Informed Consent

Exclusion Criteria:

* Micturition dysfunction with preoperative bladder stagnation \> 200 cc at pessary evaluation
* History of recurrent cystitis
* Positive preoperative urine culture
* Azotemia \> 40 mg/dL or creatininemia \> 1 mg/dL
* Not collected signed consent endorsed
* Diabetes mellitus
* Contraindications to transurethral bladder catheterization
* Major protocol violations due to unforeseen intraoperative complications (bladder and/or rectal damage, severe bleeding with need for urinary monitoring)

Primary outcomes:
measure: differences in bladder catheter repositioning within 12 hours after bladder catheter removal
timeFrame: 12 hours
Secondary outcomes:
measure: incidence of urinary tract infections for patients undergoing cystopexy surgery in patients in whom the bladder catheter is removed on postoperative day I or II.
timeFrame: During hospital stay
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Hospital
Study officials:
References:
Clinical trial NCT01992328: IVIG Treatment for Asthmatic Patients With IgG Subclass Deficiency
Official title: IVIG Treatment for Asthmatic Patients With IgG Subclass Deficiency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Asthma
Keywords: Immunoglobulin G Deficiency
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Immunoglobulin G deficiency subtypes in patients with asthma six months once a month intravenous immunoglobulin (400mg/kg/4weeks) infection in treatment-related effect on reducing the frequency of asthma exacerbations appreciate.

Detailed description: Patients Registration

•It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms.

Procedure

•six months once a month intravenous immunoglobulin (400mg/kg/4weeks)

Eligibility criteria: Inclusion Criteria:

* The patient from over 16 years to under 75 years
* Patients diagnosed with asthma over six months ago
* immunoglobulin G subtypes who were diagnosed with immune deficiency
* more than 2 years Upper and lower respiratory tract infections

  , and asthma exacerbations in this regard.
* ① calculated creatinine clearance ≧ 50ml/min

  * ALT and AST \<x 3 times the upper limit of normal

    * ALP \<x 3 times the upper limit of normal

      * total bilirubin \<x 1.5 times the upper limit of normal

Exclusion Criteria:

* within six months of the onset of the experiment who received immunoglobulin therapy
* immune globulin for those with a history of hypersensitivity reactions
* six months ago, another clinical trial participants.
* Systemic steroids and immunomodulators, such as asthma control that may affect the resources required drug administration.
* pregnant or lactating women.

Primary outcomes:
measure: Infection rate
timeFrame: 6months
Secondary outcomes:
measure: lung funtion
timeFrame: 6 months
measure: steroid
timeFrame: 6 months af
measure: antibiotic
timeFrame: 6months
measure: asthma syptoms
timeFrame: 6months
measure: Questionnaire
timeFrame: 6months
measure: Questionnair
timeFrame: 6months
measure: IgG subclass
timeFrame: 6months
measure: Cytokines
timeFrame: 6months
measure: adverse events
timeFrame: 6months
Other outcomes:
Locations:
Study officials:
affiliation: Department of medicine, Ajou University School of Medicine
name: hae-sim park
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04832828: Sensitivity and Specificity of the Roth Test in Patients With COVID-19 Positive
Official title: Sensitivity and Specificity of the Roth Test in Patients With COVID-19 Positive
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 114
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects aged 18 to 90 years were recruited by non-probabilistic convenience sampling in Primary Health Care Centres of the Primary Health Care Management of SERMAS and the Intensive Care Unit of the University Hospital of Gran Canaria Doctor Negrín of the Canary Health Service

Brief summary: The presence of the described silent hypoxia in subjects diagnosed with COVID19 highlights the need for valid tools to assess respiratory capacity. The Roth test has been associated with acceptable sensitivity and specificity criteria in patients with previous respiratory pathology; however, its validity in this type of patient has not been proven.


Eligibility criteria: Inclusion Criteria:

1. having been diagnosed as COVID-19 positive and with symptoms compatible with Sars-Cov-2 infection in the last 7 days prior to assessment,
2. having an understanding of Spanish,
3. and having no history of respiratory pathology prior to the current infection.

Primary outcomes:
measure: Oxygen Saturation
timeFrame: 12 weeks
Secondary outcomes:
measure: Roth´s test
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CS Entrevías
Study officials:
References:
Clinical trial NCT05272228: Comparative Single-dose Bioavailability Clinical Study of Different Coenzyme Q10 Products
Official title: The Single-centre, Randomized, Comparative Single-dose Bioavailability Clinical Study of Different Coenzyme Q10 Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coenzyme Q Deficiency
Keywords: coenzyme Q10
single dose bioavailability
Lead sponsor: University of Primorska
Sponsor class: OTHER
Collaborators: name: Biovis d.o.o.
First posted: 2022-03-09
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The randomized, open-label, three period crossover single-dose bioavailability study with three coenzyme Q10 products

Detailed description: The randomized, open-label, three period crossover single-dose bioavailability study with three coenzyme Q10 products will include 25 subjects who will test three different coenzyme Q10 products. Serum concentration of coenzyme Q10 will be measured.

Eligibility criteria: Inclusion Criteria:

* subject informed consent form
* aged between 40 and 55 years old
* body mass for women 65± 5 kg and for men 85± 5 kg
* non-smoking
* healthy, without cardio-vascular diseases, diabetes, neurodegenerative diseases
* absence of any prescribed medication during the study
* willing to avoid a consumption of any food supplements at least 2 weeks before and during the study
* willing to study all study procedures

Exclusion Criteria:

* cardio-vascular diseases,
* diabetes,
* neurodegenerative diseases,
* gastrointestinal disorders
* hypotension
* pregnancy
* breast-feeding
* intake of any prescribed medication within two week of the beginning of the study
* intake of any food supplements within two week of the beginning of the study
* drug or alcohol abuse

Primary outcomes:
measure: Serum coenzyme Q10 concentrations
timeFrame: 0,2,4,6,8,12 and 24 hours after ingestion
Secondary outcomes:
Other outcomes:
Locations:
city: Izola
country: Slovenia
facility: University of Primorska
Study officials:
affiliation: University of Primorska, Faculty of Health Sciences
name: Zala Jenko-Pražnikar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01707628: Response to Influenza Vaccination in Lymphoma Patients Treated With Rituximab
Official title: Response to Influenza Vaccination in Lymphoma Patients Treated With CHOP and Rituximab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Hodgkin Lymphoma (NHL)
Keywords: NHL
influenza vaccination
rituximab
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the number of responders to vaccination with the influenza virus vaccine at different time points after last dose of rituximab in patients with lymphoma. Secondly to study the immune-response to vaccination with influenza virus vaccine, after treatment with rituximab in relation to the reconstitution of immune-function.


Eligibility criteria: Inclusion Criteria:

1. Patients with non-Hodgkin's lymphoma, treated with rituximab (with a range of 6-12 cycles) and who are in remission.
2. Completion of rituximab therapy in the last twelve months before start of the study.
3. Age ≥ 18 years.
4. Signing of informed consent.

Exclusion Criteria:

1. Completion of rituximab therapy 7-8 months before start of the study.
2. Fever at time of vaccination.
3. Previous/known allergic reaction to any of the components of the vaccines given.

Primary outcomes:
measure: Influenza antibody titre
timeFrame: 3 weeks after vaccination
Secondary outcomes:
measure: number of memory B cells
timeFrame: 6 months
measure: lymphocyte subsets
timeFrame: 6 months
measure: immunoglobulin levels
timeFrame: 6 months
measure: IgG subclasses
timeFrame: 6 months
measure: production of IFN-γ by CD4+ cells
timeFrame: 6 months
measure: Cytokines
timeFrame: 6 months
measure: genetic factors
timeFrame: 6 months
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
state: Friesland
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Hospital
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwen Gasthuis
state: Noord-Holland
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: Overrijssel
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
state: Utrecht
city: Delft
country: Netherlands
facility: Reinier de Graaf Groep
state: Zuid-Holland
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital
state: Zuid-Holland
Study officials:
affiliation: St. Antonius Hospital
name: Minke AE Rab, Drs.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04364828: NGS Diagnostic in COVID-19 Hosts - Genetic Cause Relating to the Course of Disease Progression
Official title: NGS Diagnostic in COVID-19 Hosts - Genetic Cause Relating to the Course of Disease Progression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
SARS-CoV-2
Next-Generation-Sequencing
Whole Genome Analysis
MultiOmics
Extreme phenotypes
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: In this study (i) the host genome to identify susceptibility regions of infection, inflammation, and host defense, (ii) host response to Severe Acute Respiratory Syndrome-Corona-Virus-2 (SARS-CoV-2) infection, and (iii) viral sequence composition to define viral sequences which may be correlated with disease severity in addition to the metagenome of the throat swab will be analysed .

Detailed description: This study aims to recruit adult persons with diagnostically confirmed Corona-Virus- Disease-19 (COVID-19) infection and with different disease manifestation who are included into diagnostic or therapeutic care at the University Hospital Tübingen (UKT).

The COVID-19 Next-Generation-Sequencing (NGS) study aims to cover as many patients in Germany as possible. It is expected to include in Phase 1 (pilot study): 250 patients with different disease manifestation (extreme phenotypes) and individual risk factors by whole genome analysis Phase 2 (verification study): 1.000 clinically well-defined patients to ensure a broader range of overlapping phenotypes, to verify data from the pilot study.

Phase 3 (confirmation study): \> 10.000 patients to increase the power (anticipated).

Eligibility criteria: Inclusion Criteria:

* COVID-19 infection confirmed
* COVID-19 disease manifestation
* Age \> 18 years

Exclusion Criteria:

* Missing informed consent of the patient/ legal guardian/ relatives

Primary outcomes:
measure: Viral evolution
timeFrame: Day 1, Day 3-5, Day 7-9, 48 hours after recovery
Secondary outcomes:
measure: Immune response
timeFrame: Day 1, Day 3-5, Day 7-9, 48 hours after recovery
measure: Disease severity
timeFrame: Day 1, Day 3-5, Day 7-9, 48 hours after recovery
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen
Study officials:
affiliation: University Hospital Tübingen
name: Olaf Rieß, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02091128: Pregnancy Chances in Classic Galactosemia
Official title: Pregnancy Chances in Classic Galactosemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Galactosemias
Primary Ovarian Insufficiency
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Academic hospital

Brief summary: With this study, in which the incidence of pregnancy in classic galactosemia patients is studied, we aim to provide new insights to improve counselling. Our hypothesis is that the chance that a galactosemic woman with POI becomes pregnant is higher than the 5-10% that has been reported for women with POI due to other causes. Chance of spontaneous pregnancy will be evaluated through semi standardized interview in women with classic galactosemia aged 18 years or older. During the interview, questions will be asked regarding fertility and pregnancy.


Eligibility criteria: Inclusion Criteria:

* Classic galactosemia diagnosed by GALT enzyme activity assay or GALT-gene mutation analysis
* Eighteen years of age or older
* Diagnosed with POI defined as symptoms of hypergonadotrophic hypogonadism measured by serum concentrations of FSH and estradiol
* Capable of giving informed consent

Exclusion Criteria:

* Any known congenital or acquired disease or disorder negatively affecting pubertal development and/or fertility.

Primary outcomes:
measure: Pregnancy incidence despite POI diagnosis
timeFrame: day 1
Secondary outcomes:
measure: Whether women have tried to conceive
timeFrame: day 1
measure: Time to pregnancy (in case a participant has been pregnant)
timeFrame: day 1
measure: Menstrual history
timeFrame: day 1
measure: Hormonal replacement therapy usage
timeFrame: day 1
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Maastricht University Medical Center
name: M. Estela Rubio-Gozalbo, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gubbels CS, Land JA, Rubio-Gozalbo ME. Fertility and impact of pregnancies on the mother and child in classic galactosemia. Obstet Gynecol Surv. 2008 May;63(5):334-43. doi: 10.1097/OGX.0b013e31816ff6c5.