louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04054505: Effectiveness of a Nutraceutical in Raising Circulating Serum Vitamin, Mineral and Amino Acid Levels in Patients.
Official title: Quantitative Analysis of Clinical Data for the Effectiveness of a Nutraceutical in Raising Circulating Serum Vitamin, Mineral and Amino Acid Levels in Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin Deficiency
Lead sponsor: Optimal Health Research
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 275
Sex: ALL
Minimum age (years): 26
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Triple blind
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to correlate the findings of an early study with current data.


Eligibility criteria: Inclusion Criteria: Healthy volunteers whose circulating serum vitamin A1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF-1 and FT-3 are within normal limits.

A1; 48-85 ug/dl, E; 5.3-17.5 mg/L, B1; 66.5-200 nmo/L, B2; 137-370 ug/L, B6; 2-32.8 ug/L, B12; 211-946 pg/mL, C; 0.2-2.0 mg/dL, D; 30-100 ng/mL, Calcium; 8.7-10.2 mg/dL, Iron; 27-159 ug/dL, IGF-1; 67-205 ng/mL, FT-3; 2-4.4 pg/mL

Exclusion Criteria: Volunteers whose circulating serum vitamin A1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3 are outside normal limits.

A1; 48-85 ug/dl, E; 5.3-17.5 mg/L, B1; 66.5-200 nmo/L, B2; 137-370 ug/L, B6; 2-32.8 ug/L, B12; 211-946 pg/mL, C; 0.2-2.0 mg/dL, D; 30-100 ng/mL, Calcium; 8.7-10.2 mg/dL, Iron; 27-159 ug/dL, IGF-1; 67-205 ng/mL, FT-3; 2-4.4 pg/mL -

Primary outcomes:
measure: Raise in Circulating Serum Vitamin A1, E, B1,B2,B6,B12,C,D, Calcium, Iron, IGF and FT-3.
timeFrame: Three months
Secondary outcomes:
measure: Control group
timeFrame: Three months
measure: Placebo group
timeFrame: Three months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Optimal Health Research
state: Utah
Study officials:
affiliation: Optimal Health Research
name: Steven Osguthorpe, ND
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nenseth HZ, Sahu A, Saatcioglu F, Osguthorpe S. A Nutraceutical Formula Is Effective in Raising the Circulating Vitamin and Mineral Levels in Healthy Subjects: A Randomized Trial. Front Nutr. 2021 Sep 1;8:703394. doi: 10.3389/fnut.2021.703394. eCollection 2021.
Clinical trial NCT04391205: A Study to Investigate the Possible Causes of Secondary Effects During Use of Peripheral Midline Type Catheter in Patients Hospitalized in Different Care Settings
Official title: Safety and Efficiency oh the Use of Midline Peripheral Venous Catheter (MIDES)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Extremity Deep Vein Thrombosis, Secondary
Keywords: Midline
peripheral venous catheter
vascular access device
deep venous thrombosis
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 211
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were recruited in 3 different settings in the Molinette Hospital (Turin) - Home Health Hospitalization service, Geriatric Department and Intermediate Care service.

Brief summary: Although the use of peripheral venous catheters (CVP) with brachial insertion with echo-guide (Midline) has increased significantly over the last 5-10 years, there are no sensitive data concerning complications in the literature during their use, particularly as regards incidence of thrombotic complication.The prospective observational study will enroll all the patients admitted to Home Health Hospitalization service, Geriatric Department and Intermediate Care service, to whom a Midline-type CVP will be placed for infusional therapy and who will give their consent to participate.


Eligibility criteria: Inclusion Criteria:

* Subjects admitted to wards adhering to the study (Home Health Hospitalization service, Geriatric Department and Intermediate Care service)
* Subjects submitted to Midline type venous catheter insertion

Exclusion Criteria:

* History of deep venous thrombosis or pulmonary embolism
* Be hospitalized for less than a week

Primary outcomes:
measure: Number of participants with Peripheral deep venous thrombosis (DVP) suspected with Compression ultrasound (CUS) and confirmed by echodoppler
timeFrame: Once a week from the implant day until CVP removal or patient discharge, whichever came first, assessed up to 40 days
Secondary outcomes:
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Marinello Renata
Study officials:
affiliation: OAU Città della Salute e della Scienza di Torino, Turin, Italy
name: Renata Marinello, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05715905: Analyzing Clinical Trial Experiences of Colon Cancer Patients
Official title: An In Depth Study Evaluating Patterns in the Colon Cancer Patients Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colon Cancer
Colon Disease
Keywords: Colon Cancer
Colon Disease
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Colon cancer patients who are actively considering participating in a clinical trial, but have not yet completed enrollment and randomization.

Brief summary: Participation in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This trial will admit a wide range of data on the clinical trial experience of Colon Cancer patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future Colon Cancer patients.


Eligibility criteria: Inclusion Criteria:

* Patient has been diagnosed with colon cancer
* Patient has self-identified as planning to enroll in an observational clinical trial
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Pregnant or nursing patients
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form

Primary outcomes:
measure: Number of colon cancer patients who decide to enroll in a clinical trial
timeFrame: 3 months
measure: Rate of patients who remain in a colon cancer clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Labianca R, Beretta GD, Kildani B, Milesi L, Merlin F, Mosconi S, Pessi MA, Prochilo T, Quadri A, Gatta G, de Braud F, Wils J. Colon cancer. Crit Rev Oncol Hematol. 2010 May;74(2):106-33. doi: 10.1016/j.critrevonc.2010.01.010.
citation: Mody K, Bekaii-Saab T. Clinical Trials and Progress in Metastatic Colon Cancer. Surg Oncol Clin N Am. 2018 Apr;27(2):349-365. doi: 10.1016/j.soc.2017.11.008.
citation: Iqbal A, George TJ. Randomized Clinical Trials in Colon and Rectal Cancer. Surg Oncol Clin N Am. 2017 Oct;26(4):689-704. doi: 10.1016/j.soc.2017.05.008. Epub 2017 Aug 18.
Clinical trial NCT00741897: Fexofenadine Study On Filipino Children for The Relief of Perennial And Intermittent Allergic Rhinitis
Official title: A Monitored Release Study On The Efficacy And Safety of Fexofenadine (Telfast®) 30mg Pediatric Tablets On Filipino Children Aged 6 To 11 for The Relief of Perennial And Intermittent Allergic Rhinitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rhinitis, Allergic, Perennial
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-08-26
Enrollment: 264
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the safety and efficacy of Fexofenadine (Telfast®) 30mg pediatric tablets on Filipino children aged 6 to 11 for the relief of symptoms associated with perennial and intermittent allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Children who manifest allergic rhinitis symptoms such as sneezing, rhinorrhea, itchy nose/palate/throat and/or itchy/watery/red eyes.

Primary outcomes:
measure: Patient's assessment of symptoms and drug activity (Total symptom scores)
timeFrame: At baseline, D 7 and D 14
measure: Physician's assessment of symptoms and drug activity (Total symptom scores)
timeFrame: At D 14
Secondary outcomes:
measure: AE and SAE collection
timeFrame: From the signature of the informed consent up to the end of the study
Other outcomes:
Locations:
city: Makati City
country: Philippines
facility: Sanofi-aventis administrative office
Study officials:
affiliation: Sanofi
name: Carmela Pagunsan
role: STUDY_DIRECTOR
References:
Clinical trial NCT00165997: Quality of Life in Patients Post Radiofrequency Ablation
Official title: The Effects of Radiofrequency Ablation Procedures on Quality of Life in the Pediatric Cohort
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Radiofrequency Catheter Ablation
Quality of Life
Arrhythmia
Keywords: pediatrics
cardiology
Radiofrequency ablation
structurally normal heart
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Radiofrequency ablation is a procedure done in the Catheterization Laboratory to help correct specific problems that cause the heart to beat faster than it should. Quality of life includes the physical as well as the emotional aspects of a patient. Doctors have always tried to take care of a medical problem with minimal physical and emotional risk. It is assumed that once the medical problem is fixed, the patient will have an improved quality of life. To know if this assumption is true, the investigators are asking children scheduled for this procedure, along with their family, to answer questions before the ablation, then answer the same questions 5-6 months after the ablation.

Detailed description: When a patient (age 5-18 years) is scheduled for an ablation at Children's Healthcare of Atlanta, the research coordinator contacts the family prior to the procedure and describes the study to them, details the goals, benefits versus risks, and answers any questions they may have. Written consent is obtained from the parents. Assent is obtained from the child. Both the parent and child are given the age appropriate Peds QL (tm) Pediatric Quality of Life Inventory, version 4.0. The forms are returned to the research coordinator. If the child is ablated, then 5-6 months after the ablation, the same questionnaire is sent to the child and parent. Data are entered into a database.

Eligibility criteria: Inclusion Criteria:

* 5-18 years of age
* English is the primary language
* Scheduled for an ablation at Children's Healthcare of Atlanta
* Normally structured heart

Exclusion Criteria:

* Congenital heart defect
* English is not the primary language
* Children with significant neurocognitive deficits as determined by the investigator

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University and Children's Healthcare of Atlanta
name: Margaret J Strieper, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06430697: Hemodynamic Impact of the Administration of PAracetamol in Patients Hospitalized in the Intensive Resuscitation Medicine Department [PAREA]
Official title: Prospective Study Evaluating the Hemodynamic Impact of PAracetamol Administration in Patients Hospitalized in the REAnimation Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intensive Care Unit Syndrome
Keywords: Intensive Care Unit
PARACETAMOL
blood pressure
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Paracetamol is commonly used in case of pain or fever. Few previously clinical studies has highlighted an arterial hypotension linked to intravenous administration of paracetamol. Currently, fewer data are available on the link of intravenous administration of paracetamol and effects on arterial tension. The aim of this study is to describe the frequency of occurrence of significative arterial hypotension within one hour following intravenous or per os administration of paracetamol . Other factors who can be associated to occurence of significative arterial hypotension will be also observe (for example age, weight, pain, vasopressor dosage or sedative...)


Eligibility criteria: Inclusion Criteria:

Inclusion:

* 18 years of age or older
* Patient with arterial catheter
* Indication of paracetamol's administration by the patient's attending practitioner.
* No opposition to patient or support person participation in the study if the patient is unable to participate

ExclusionCriteria:

* No Social Security Patient
* Pregnant or nursing patient.
* Patient with a legal protection measure
* Hypersensitivity and/or allergy to paracetamol.
* Contraindication to the use of paracetamol.
* Patient opposition to health data collection.

Primary outcomes:
measure: Measure frequency of low blood pressure following paracetamol administration
timeFrame: One hour after administration of paracetamol
Secondary outcomes:
measure: Measure of blood pressure following paracetamol administration according to IGS II score
timeFrame: One hour after administration of paracetamol
measure: identify predictors linked to paracetamol administration route
timeFrame: One hour after administration of paracetamol
measure: identify predictors linked to paracetamol dosage
timeFrame: One hour after administration of paracetamol
measure: Measure of blood pressure following paracetamol administration according to SOFA score
timeFrame: One hour after administration of paracetamol
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de NICE ARCHET
Study officials:
References:
Clinical trial NCT03575897: Serial Assessment of Body Fat Accrual in Very Preterm Infants
Official title: Serial Assessment of Body Fat Accrual in Very Preterm Infants: A Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infant,Premature
Body Weight
Adiposity
Keywords: Premature Infants
Body composition
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-07-03
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Despite evidence that both rapid weight gain and excessive body fat accrual are associated with overweight and obesity, usual neonatal care of preterm infants does not include assessment of body fat accrual. The study hypothesis is that identification of early changes in infant body composition (i.e. amount of fat mass and fat-free mass) reduces % body fat at 3 months of age.

Detailed description: Infants in the intervention group will have the information about infant body composition known to the clinicians caring for them (including reference data). Infants in the control group will also undergo serial measurements of infant body composition, but this information will not be available to the clinicians.

If parent agrees, stool "dirty" diapers will be collected 2 times (at the time of hospital discharge and at 3 months of corrected age).

Eligibility criteria: Inclusion Criteria:

* Gestational age between 28 and 32 weeks of gestation

Exclusion Criteria:

* Gastrointestinal or neurologic malformations
* Terminal illness requiring limited or withheld support

Primary outcomes:
measure: Infant Body Composition
timeFrame: Assessed at 3 months of corrected age
Secondary outcomes:
measure: Growth
timeFrame: Birth to 3 months of corrected age
measure: Length
timeFrame: 3 months of corrected age
measure: Head Circumference
timeFrame: 3 months of corrected age
measure: Body Mass Index
timeFrame: 3 months of corrected age
measure: Infant Body Composition
timeFrame: Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first)
Other outcomes:
measure: Changes in Intestinal Microbiome
timeFrame: Birth to 3 months of corrected age
measure: Changes in Metabolic Pathways
timeFrame: Birth to 3 months of corrected age
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Ariel A. Salas, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salas AA, Jerome ML, Chandler-Laney P, Ambalavanan N, Carlo WA. Serial assessment of fat and fat-free mass accretion in very preterm infants: a randomized trial. Pediatr Res. 2020 Nov;88(5):733-738. doi: 10.1038/s41390-020-1052-x. Epub 2020 Jul 7.
Clinical trial NCT04218097: Food Addiction and Follow-up in Subjects With Obesity
Official title: Impact of Follow-up in Subjects With Obesity and Food Addiction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Eating Disorders
Food Addiction
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese patients grade 2 and 3, Hospitalized in Endocrinology A from January 1, 2017 to January 1, 2018

Brief summary: Obesity is a chronic disease. Its prevalence, which is constantly increasing, as well as the morbidity and mortality caused, require the development of new treatments, particularly for associated eating disorders. Indeed, it has been shown that a participation of abnormalities of food addiction type behaviour was frequently found in patients hospitalized for obesity (25% of patients). These disorders require specific management if you want to achieve a good weight result. The aim of the study is to compare the weight evolution of patients with addiction-type disorder (addict) versus those without addiction (non-addict) as well as the management modalities.


Eligibility criteria: Inclusion Criteria:

* Obese patients grade 2 and 3
* Hospitalized in Endocrinology A from January 1, 2017 to January 1, 2018
* Over 18 years of age
* Not objecting to its participation

Exclusion Criteria:

* No understanding of French

Primary outcomes:
measure: Weight change: difference between the current weight reported in a questionnaire and the weight measured at the end of hospitalization
timeFrame: month 36
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service Endocrinologie, Hôpital Lyon Sud,
Study officials:
affiliation: Hospices Civils de Lyon
name: Martine LAVILLE, PR
role: STUDY_DIRECTOR
References:
Clinical trial NCT00661297: Study Evaluating the Efficacy, Safety, and Reliability of Vardenafil
Official title: A Randomised, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy, Safety, and Reliability of 10mg Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Vardenafil
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-04-18
Enrollment: 523
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to investigate the efficacy and safety of Vardenafil


Eligibility criteria: Inclusion Criteria:

* Heterosexual males
* \>/= 18 years old with ED for more than six months
* Subjects also needed a positive first-time response to a single dose of 10mg vardenafil to be eligible for randomisation

Exclusion Criteria:

* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy
* Other exclusion criteria apply according to the Summary of Product Characteristics

Primary outcomes:
measure: Sexual Encounter Profile question 2 (SEP 2)
timeFrame: 12 weeks
Secondary outcomes:
measure: Sexual Encounter Profile question 3 (SEP 3)
timeFrame: 12 weeks
measure: International Index of Erectile Function (IIEF) - EF (Erectile Function) domain
timeFrame: 12 weeks
measure: Safety and Tolerability
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05170997: Strategies to Improve Iodine Status in Early Pregnancy
Official title: Strategies to Improve Iodine Status in Early Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iodine Deficiency
Pregnancy Related
Keywords: Iodine
Pregnancy
Diet
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: Belfast Health and Social Care Trust
name: Public Health Agency (Northern Ireland)
name: Dairy Council for Northern Ireland
First posted: 2021-12-28
Enrollment: 119
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be four parallel groups in this study, stratified by iodine supplementation and then randomised to milk or control group.
Primary purpose: PREVENTION

Brief summary: This study aims to investigate the benefit of increased intake of cows' milk during pregnancy on iodine status.

Detailed description: Women of child bearing age, and those who are currently pregnant, have been found to be iodine deficient in the United Kingdom (UK). Dairy products are an essential source of iodine in the UK as iodised salt is not widely available. This study will ask women in the intervention group to drink approximately one pint of milk a day for 12 weeks during pregnancy.

Eligibility criteria: Inclusion Criteria:

* women at 6-16 weeks pregnant
* women receiving antenatal care within Belfast Health and Social Care Trust

Exclusion Criteria:

* women with known thyroid disease currently taking thyroid medication
* women with type one diabetes
* women under 18 years of age
* those unable to provide informed consent
* women with abnormal thyroid function tests at booking appointment.

Primary outcomes:
measure: Urinary iodine concentration
timeFrame: 18 months
Secondary outcomes:
measure: Iodine knowledge
timeFrame: 24 months
measure: Iodine intake
timeFrame: 24 months
measure: Offspring
timeFrame: 24 months.
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Royal Jubilee Maternity Hospital
Study officials:
affiliation: Belfast Health and Social Care Trust
name: Karen Mullan, MD
role: PRINCIPAL_INVESTIGATOR
References: