louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00932945: Dermacyd PH_DESILSTY_FR (Lactic Acid) - Acceptability - Stay on Frutal
Official title: Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up - Dermacyd PH_DESILSTY_FR (Lactic Acid).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-07-07
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Primary Objective:

To prove the safety of the gynecological formulation in normal conditions of use.


Eligibility criteria: Exclusion criteria:

* Integral vaginal mucosa in the product analysis region
* Use the same category of cosmetics products
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time

Exclusion criteria:

* Use of Anti-inflammatory, immunossupression or antihistaminics drugs
* Allergic or atopic history to cosmetics products
* Cutaneous active disease (local and/or general) in the evaluated area
* Disease which can cause immunosuppresion, such as diabetes, HIV
* Endocrinology pathology such as thyroid gland, ovary and adrenal gland
* Intensive solar exposure until 15 days before evaluation
* Gynecological treatment until four weeks before the study
* Other reason considered by the investigator as a reason for not being included.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Evaluation of the absence of irritation and the good acceptability by using one specific scale which describes the intensity of the reaction.
timeFrame: From the treatment start up to the end of the study (treatment period 21 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT05437445: Utilizing Augmented Artificial Intelligence for Aminoacidopathies
Official title: Utilizing Augmented Artificial Intelligence for Aminoacidopathies: Experience of Collaborative Laboratory Integrated Reporting From Pakistan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inborn Errors of Metabolism
Keywords: Clinical Laboratory Integrated Reports (CLIR)
Inherited metabolic disorders (IMDs)
Lead sponsor: Aga Khan University Hospital, Pakistan
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 2081
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data of all those who had Plasma amino acid analyzed at the Biogenetic laboratory of Aga Khan University, symptomatic as well as asymptomatic children with suspicion of Inherited Metabolic Disorders (IMDs), from August 2019-August 2020 were included. Plasma amino acids analysis was performed using cation-exchange high-performance liquid chromatography (HPLC) on Biochrom 30+ model using lithium column diameter 4.6 mm and detected at 440/570 nm.

Brief summary: The objective of the study was to interpret metabolic profiles of plasma amino acid (PAA) and compare reference intervals (RI) of PAA data from Pakistan with data from other countries using Clinical Laboratory Integrated Reports (CLIR). One-year data (reference and cases data) of twenty-two PAA, analyzed by ion exchange high performance chromatography at Biochemical Genetics Laboratory (BGL) of Aga Khan University Pakistan, was compiled in a comma-separated values (.csv) file and uploaded on CLIR Software using AAQP (Amino Acid in Plasma) application for statistical analysis. Among total of 2081 PAA profiles, 92% (n=1913) were completely normal with all PAA values falling within the age-specific reference range. A concordance of 98.8% was noted between the reporting done by the BGL at AKU and then after applying CLIR tools.


Eligibility criteria: Inclusion Criteria:

All plasma samples during 1 year received at Biogenetic Lab

Exclusion Criteria:

Subjects with age greater than 16 years

Primary outcomes:
measure: postanalytical interpretation of concentration of plasma leucin, isoleucine and valine in nmol/L using Clinical Laboratory Integrated Reports (CLIR)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
Study officials:
affiliation: Aga khan hospital karachi, Pakistan
name: Dr lena Jafri
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00354445: A Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD
Official title: A Phase IV, Open Label, Multi-Center, Study of Maintenance Intravitreous Injections of Macugen (Pegaptanib Sodium) Given Every 6 Weeks for 48 Weeks in Subjects With Subfoveal Neovascular Age-Related Macular Degeneration (AMD) Initially Treated With a Modality Resulting in Maculopathy Improvement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Age-Related Macular Degeneration (AMD)
Keywords: Age-Related Macular Degeneration (AMD)
pegaptanib sodium
subfoveal CNV
macugen
Lead sponsor: Eyetech Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2006-07-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the safety and efficacy of Macugen given as maintenance therapy in patients who have had initial success with another AMD treatment. Patients must have 1, but not more than 3 prior treatments for Neovascular AMD.


Eligibility criteria: Inclusion Criteria:

* Subfoveal CNV secondary to AMD
* At least 1 but not more than 3 prior treatments for AMD

Exclusion Criteria:

* Subfoveal scar or subfoveal atrophy
* Significant media opacities, including cataract, which might interfere with visual acuity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Abilene
country: United States
facility: Retina Research Institute of Texas, LLC
state: Texas
Study officials:
References:
citation: Friberg TR, Tolentino M; LEVEL Study Group; Weber P, Patel S, Campbell S, Goldbaum M. Pegaptanib sodium as maintenance therapy in neovascular age-related macular degeneration: the LEVEL study. Br J Ophthalmol. 2010 Dec;94(12):1611-7. doi: 10.1136/bjo.2009.174946. Epub 2010 May 14.
Clinical trial NCT02119845: A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001
Official title: A Prospective Clinical Evaluation of the TVA FLEX-1 Device Protocol FLEX-1-001
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease (CKD)
Keywords: Chronic kidney disease
Arteriovenous fistula (AVF)
Hemodialysis
Vascular access
Endovascular AVF (EndoAVF)
Lead sponsor: TVA Medical Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) in patients requiring chronic hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Eligible for a native surgical arteriovenous fistula, as determined by the treating physician.
* Adult (age \>18 years old).
* Advanced chronic kidney disease (CKD), stage 4 or 5 electing for hemodialysis.
* Written informed consent obtained

Primary outcomes:
measure: Adverse Events
timeFrame: 6 months
Secondary outcomes:
measure: Access Functionality
timeFrame: 6 Months
Other outcomes:
Locations:
city: Asuncion
country: Paraguay
facility: Italian Hospital
Study officials:
affiliation: Italian Hospital
name: Adrian Ebner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01985945: Yoga for Breast Cancer
Official title: A Randomized Study of the Effect of Yoga in Patients With Breast Cancer Receiving Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women With Stage I or II Breast Cancer Undergoing Active Radiation Therapy
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2013-11-18
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine the use of Eischens yoga for 8 weeks in one cohort of 20 women with stage I and II breast cancer receiving radiation therapy treatment, while a second cohort of the same type of and number of patients who, instead of yoga will receive standard supportive therapy, Questionnaire measuring cancer-related quality of life (FACT-G instrument) and fatigue (Brief Fatique Inventory) will be given to patients at several points.


Eligibility criteria: Inclusion Criteria:

* Stage I and II breast cancer patients undergoing active radiation therapy
* Above the age of 18
* Must sign informed consent form
* Must speak English
* Only women are eligible

Exclusion Criteria:

* Patients with medical restrictions that may interfere with yoga participation per their physicians' decision
* Those who have smoked in the last 6 months because smoking can interfere with the breathing and relaxation techniques of yoga.
* Those who have regularly taken yoga in the last 6 months, because they would not come to the intervention with the same baseline as other participants.

Primary outcomes:
measure: Number of Adverse Events
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Gary Freedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03908905: Sleep Disturbances and Chronic Widespread Pain
Official title: Prevalence of Sleep Disturbances in Individuals With Chronic Widespread Pain
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Chronic Widespread Pain
Sleep Disturbance
Keywords: Pain
Sleep
Neuropsychology
Fatigue
Activity level
Attention
Executive function
Memory
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects that are referred for an inpatient multidisciplinary analysis of complex chronic pain conditions at a regional pain center at Uppsala University Hospital.

Brief summary: Chronic widespread pain (CWP), defined as long-lasting pain in multiple body regions, has a prevalence of 10-14% in Europe and is associated with other physical symptoms such as fatigue and cognitive problems. Individuals with longstanding pain also have a high prevalence of sleep disturbances, and sleep problems can in itself lead to tiredness, lower neurocognitive function and higher pain ratings. However, studies of comorbid sleep problems for individuals with CWP are a lacking, and the primary aim for the present study is to assess the prevalence of sleep disturbances in individuals with CWP, and to see how this covariates with pain, fatigue, activity level, neurocognitive functioning, and biomarkers. As a secondary aim the study will assess a subgroup of the individuals, that has received multimodal pain management treatment, a second time after 6 months to analyze how the prevalence of sleep disturbances and other associated problems covaries over time.


Eligibility criteria: Inclusion Criteria:

* Chronic Widespread Pain

Exclusion Criteria:

* Other untreated and or serious psychiatric or somatic conditions

Primary outcomes:
measure: Polysomnography
timeFrame: 6 months
Secondary outcomes:
measure: CANTAB
timeFrame: 6 months
measure: Actigraph
timeFrame: 6 months
measure: Biomarkers
timeFrame: 6 months
measure: Pain level
timeFrame: 6 months
measure: Fatigue
timeFrame: 6 months
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala university hospital
state: Uppsala Län
Study officials:
References:
Clinical trial NCT02366598: A FINEH Protein Trial - Part 1
Official title: Acute Food INtake Effect of Hemp Protein (A FINEH Protein) Trial - Part 1 - Acute Effects of Hemp Protein on Blood Glucose, Appetite, Blood Pressure and Food Intake.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Prevention
Obesity Prevention
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Manitoba Harvest
First posted: 2015-02-19
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objectives of this trial are to assess the health benefits of acute hemp protein consumption compared to soybean protein and a non-protein control on: 1) blood glucose, appetite and blood pressure for one hour following consumption, 2) food intake at an ad libitum meal one hour following consumption and 3) blood glucose, appetite and blood pressure following the ad libitum meal to determine the "second meal effect" of hemp protein.


Eligibility criteria: Inclusion Criteria:

* Normoglycemic (\<5.6 mmol/L)
* Body mass index (BMI) of 18.5-29.9 kg/m2 Participants will be excluded if they regularly skip breakfast, smoke, or consuming medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year.

Exclusion Criteria:

* Restrained eaters
* Regularly skip breakfast
* Smokers
* Those who are active (organized activities or athletic training at a high intensity; ≥ 150 min per week of moderate to vigorous physical activity)
* Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year.

Primary outcomes:
measure: Blood glucose concentration
timeFrame: 0-200 min
measure: Appetite
timeFrame: 0-200 min
measure: Food intake
timeFrame: 0-200 min
measure: Blood pressure
timeFrame: 0-200 min
Secondary outcomes:
measure: Palatability of treatments and meal
timeFrame: 5 -80 minutes
measure: Physical comfort
timeFrame: 0 - 200 min
measure: Energy/fatigue
timeFrame: 0 - 200 min
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods
state: Manitoba
Study officials:
affiliation: University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals
name: Peter JH Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01091298: A Study to Evaluate the Safety of Tetravalent Rotavirus Vaccine in Healthy Indian Adult Male Volunteers
Official title: Phase I Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Tolerability of a Single Administration (10e6.25 FFU of Each Constituent Serotype Per 0.5 ml) of Live Attenuated Tetravalent (G1-G4) Bovine-human Reassortant Rotavirus Vaccine [BRV-TV] Administered to Healthy Indian Adult Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rotavirus Gastroenteritis
Keywords: Safety of vaccine
Lead sponsor: Shantha Biotechnics Limited
Sponsor class: INDUSTRY
First posted: 2010-03-24
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a Phase I study to evaluate the safety and tolerability of the tetravalent rota virus vaccine in healthy Indian adult male volunteers administered a single dose of the vaccine at the highest possible viral concentration in 0.5 mL of vaccine.


Eligibility criteria: Inclusion Criteria:

* Healthy Indian adult male volunteers.
* No apparent signs or symptoms of ill health.
* Properly informed about the study and having signed the informed consent form (ICF). In case of the volunteer being unable to read or write, having had the ICF explained to them in the presence of a study independent witness and the witness having signed the ICF;
* Subject available for the entire period of the study and reachable by study staff for post-vaccination follow-up.

Exclusion Criteria:

* Known or suspected impairment of immunological function;
* Known hypersensitivity to any component of the rotavirus vaccine;
* Fever, with axillary temperature ≥38.1oC (≥100.5oF); measured by study staff.
* History of chronic diarrhea;
* Clinical evidence of active gastrointestinal illness;
* Receipt of any intramuscular (IM), oral, or intravenous (IV) corticosteroid treatment in the past 30 days
* Subjects suspected to be HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) positive from the available clinical history
* Prior receipt of a blood transfusion or blood products, including immunoglobulins;
* Any subject who cannot be adequately followed for safety;
* Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
* Subject unable to maintain diary card

Primary outcomes:
measure: Severity and causality of all Adverse Events following the dose of vaccine/placebo
timeFrame: upto 10 days following administration of vaccine/placebo
Secondary outcomes:
measure: The frequency and the percentage change, as compared to baseline, in the protocol defined laboratory parameters following the single dose of Vaccine/placebo
timeFrame: Upto 10 days following administration of vaccine/placebo
Other outcomes:
Locations:
city: Vellore
country: India
facility: Christian Medical College
state: TamilNadu
Study officials:
affiliation: Shantha Biotechnics Limited
name: Raman Rao, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05543798: VT Ablation in the iCMR
Official title: Vision-MR Ablation Catheter 2.0 for the Treatment of Ventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventricular Tachycardia
Lead sponsor: Imricor Medical Systems
Sponsor class: INDUSTRY
First posted: 2022-09-16
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The VISABL-VT is a prospective, single-arm, multi-center, interventional investigation of the safety and efficacy of radiofrequency (RF) ablation of ventricular tachycardia associated with ischemic cardiomyopathy performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.


Eligibility criteria: Inclusion Criteria:

* Roll-in subjects only: Documentation of premature ventricular contractions indicated for ablation therapy (subjects may or may not be diagnosed with Ischemic Cardiomyopathy)
* Documented (ECG/EGM) spontaneous episode of sustained ventricular tachycardia within 6 months of the procedure
* Diagnosis of Ischemic Cardiomyopathy
* AAD therapy refractory, contraindicated, not tolerated, or not desired
* 18 years or older

Exclusion Criteria:

* Implanted with non-MR compatible medical devices or contraindicated for an MRI
* Presence of intracardiac thrombus (verified via CT/MRI/TEE/TTE within 48 hours of procedure - or at start of procedure)
* Thrombocytopenia or coagulopathy
* Mechanical mitral and/or aortic valve precluding access to the left ventricle
* Severe aortic stenosis
* Myocardial infarction requiring stent implantation within 90 days of procedure
* Previous cardiac surgery within 60 days of procedures
* Known/uncontrolled stroke risks
* Class IV Heart Failure
* Ejection Fraction (EF) \< 25%
* Patients with a glomerular filtration rate (GFR) \< 30
* Women who are pregnant
* Allergy to contrast agents (e.g., Gadolinium)
* Active infection
* Known or suspected myxoma
* Unstable angina
* Patients who do not tolerate anticoagulation therapy
* Previous intertribal septal patch or prosthetic atrial septal defect closure device
* Life expectancy \< 12 months
* Enrollment in another study without sponsor approval

Primary outcomes:
measure: Primary Efficacy Endpoint
timeFrame: Perioperative/Periprocedural
measure: Primary Safety Endpoint
timeFrame: 7 days
Secondary outcomes:
measure: Secondary Efficacy Endpoint
timeFrame: 6 months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
state: Saxony
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis
Study officials:
References:
Clinical trial NCT05876598: BACTERIUM: Study for a Machine-learning-based Model to Predict Bloodstream Infections
Official title: BACTERIUM: Study for a Machine-learning-based Model to Predict Bloodstream Infections
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infection, Bloodstream
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients hospitalized at the Gemelli Polyclinic Foundation

Brief summary: An increase of healthcare-associated infections caused by multidrug- resistant organisms (MRDO) is currently observed. One of the main causes of the emergence of a MDRO infection is an overuse of antibiotics. Therefore, saving useless antibiotic treatment is currently a priority from a public health point of view. The evaluation of the risk of having a bloodstream infection will allow both activating faster treatment decisions (when the risk is significantly high) or to save useless resources in terms of diagnostic tests and treatments, also limiting the potential for side effects (when the risk is significantly low).


Eligibility criteria: Inclusion Criteria:

1. adult patients hospitalized at the Gemelli Polyclinic Foundation
2. having at least one performed blood culture
3. starting an antibiotic therapy

Exclusion Criteria:

1. blood cultures with contaminants
2. \<18 years old
3. died after less than 48 hours from blood cultures positivity

Primary outcomes:
measure: Rate of appropriate antibiotic therapy in patients with bloodstream infections
timeFrame: 24 months
measure: Blood cultures
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Agostino Gemelli Irccs
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Rita Murri
role: PRINCIPAL_INVESTIGATOR
References: