louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01734889: Taste and Palatability of Orfadin Suspension
Official title: Taste and Palatability of Orfadin Suspension. An Open, Non-controlled 3 Day Study in Pediatric Patients With Hereditary Tyrosinemia Type 1 Treated With Orfadin.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hereditary Tyrosinemia, Type I
Keywords: nitisinone
Orfadin
suspension
taste
acceptability
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
First posted: 2012-11-28
Enrollment: 18
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to verify that pediatric patients, especially those who are not old enough to swallow capsules, accept the taste and palatability of a new suspension.

Detailed description: This is an open, non-randomized, non-controlled, multiple-dose study in 18 pediatric patients. The treatment period is three days, and during the study the subjects will rate the taste and palatability of the suspension or (for younger children) their parents will rate the child´s acceptance of the suspension.

The study consists of a screening period, a 3 day treatment period and a 1 week follow-up period.

Eligibility criteria: Inclusion Criteria:

* Patients with HT-1 currently managed on Orfadin (nitisinone) capsules.
* Age from 1 month to less than 18 years.
* Signed informed consent.

Exclusion Criteria:

* Any medical condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
* Enrollment in another concurrent clinical study, or intake of an investigational medicinal product (IMP), within one month prior to inclusion in this study.
* Foreseeable inability to cooperate with given instructions or study procedures.

Primary outcomes:
measure: The Taste Score for the Last Dose of the Suspension on Day 3 for Subjects 5 - <18 Years
timeFrame: Day 3
measure: The Acceptability Score for the Last Dose of the Suspension on Day 3 for Subjects < 5 Years
timeFrame: Day 3
Secondary outcomes:
measure: The Palatability Scores on Day 1 (Subjects 5 - < 18 Years)
timeFrame: Day 1
measure: The Palatability Scores on Day 2 (Subjects 5 - < 18 Years)
timeFrame: Day 2
measure: The Palatability Scores on Day 3 (Subjects 5 - < 18 Years)
timeFrame: Day 3
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Necker
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: München
country: Germany
facility: Klinikum der Universität München
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
city: London
country: United Kingdom
facility: Evelina Children's Hospital, St Thomas' Hospital
city: Manchester
country: United Kingdom
facility: St Mary's Hospital
Study officials:
affiliation: Swedish Orphan Biovitrum
name: Erik Brouwer, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02917889: Acute Caffeine Effects on Cardiac Autonomic and Cardiorespiratory Parameters Responses After Aerobic Exercise
Official title: Acute Caffeine Effects on Cardiac Autonomic and Cardiorespiratory Parameters Responses After Aerobic Exercise
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autonomic Nervous System
Cardiorespiratory Parameters
Keywords: Caffeine
Autonomic Nervous System
Recovery
Aerobic exercise
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Check the acute influence of caffeine on the autonomic modulation and cardiorespiratory parameters after aerobic exercise. Hypothesized that caffeine can promote a slower recovery of the cardiorespiratory parameters and the SNA recovery after aerobic exercise.

Detailed description: The experimental procedure is divided into three phases, all performed on a treadmill, with a minimum interval of 48 hours between them, in order to allow adequate recovery of the participants. Before the start of the first stage of the experimental protocol or control anthropometric measurements will be carried out, body weight by a digital scale (Plenna, TIN 00139 MAXIMA, Brazil)) and then, using a stadiometer (Plenna, TIN 00139 MAXIMA, Brazil)). The protocols are:

I) Maximum stress test protocol: assessment of the maximum oxygen consumption (VO2max) on a treadmill (Inbrasport / Millennium), using the Bruce protocol.

II) Control Protocol (PC): at this stage the volunteer will ingest compressed form of placebo similar to Protocol III and remained at rest after 15 minutes in the supine position, followed by 30 minutes of aerobic exercise on a treadmill, 5 minutes with speed 6.0 km / h followed by 25 minutes with 60% of VO2max and the final 60 minutes lying recovery.

III) Experimental protocol (PE): In this stage, the volunteer had performed activities similar to the PC, but will make the tablet intake consists of 300mg of caffeine, a value that is within the maximum daily amount allowed under the FDA.

Eligibility criteria: Inclusion Criteria:

* healthy men.

Exclusion Criteria:

* cardiovascular, orthopedic, respiratory and neurological disorders reported or other pathological conditions that prevent the subject to perform the protocols;
* smokers, alcoholics, or who use drugs that influence the activity of the heart.

Primary outcomes:
measure: Caffeine effects on heart rate variability (based on frequency, time domain and Chaos)
timeFrame: up to 1 year
measure: Blood pressure (mmHg)
timeFrame: up to 1 year
measure: Heart rate (beats per minute)
timeFrame: up to 1 year
measure: Respiratory rate (per minute)
timeFrame: up to 1 year
measure: Oxygen saturation pulse (oximeter-SpO2)
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Presidente Prudente
country: Brazil
facility: Universidade Estadual Paulista
state: São Paulo
Study officials:
References:
Clinical trial NCT02087189: TD01 Master Study (Safety and Efficacy Study)
Official title: TD01 Master Study (Safety and Efficacy Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ICD/CRT-D Indication
Keywords: ICD, CRT-D, lead
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2014-03-14
Enrollment: 30
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: The patients selected for the investigation should be from the investigator's general patient population according to the inclusion and exclusion criteria.

Brief summary: This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD lead.


Eligibility criteria: Inclusion Criteria:

* Meet standard indication for ICD/CRT-D therapy
* First ICD/CRT-D implantation or upgrade from pacemaker
* Duly signed informed consent form
* Willing to participate for the whole study duration
* Patient accepts Home Monitoring concept and is able to activate and use the CardioMessenger
* Patient has a legal capacity and ability to consent

Exclusion Criteria:

* Meet a standard contraindication for an ICD/CRT-D therapy
* Age \< 18 years
* Pregnant or breast-feeding
* Cardiac surgery planned within the next six months
* Enrollment in another cardiac clinical investigation with active treatment arm
* Mechanical tricuspid valve prosthesis or severe tricuspid valve disease
* Known dexamethasone acetate intolerance

Primary outcomes:
measure: TD01 Pacing Threshold
timeFrame: 3 month follow-up
measure: TD01 Sensing Amplitude
timeFrame: 3 month follow-up
Secondary outcomes:
measure: SADE-free Rate Related to TD01
timeFrame: 3 month follow-up
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler Universitätsklinikum
city: Frankfurt (Oder)
country: Germany
facility: Klinikum Frankfurt (Oder) GmbH
state: Brandenburg
city: Berlin
country: Germany
facility: Vivantes-Krankenhaus Neukölln
city: Chemnitz
country: Germany
facility: DRK Krankenhaus Chemnitz-Rabenstein
city: Kösching
country: Germany
facility: Kliniken im Naturpark Altmühltal
Study officials:
affiliation: Coordinating Investigator, former PI at the Klinikum Frankfurt (Oder)
name: Oliver Gunkel, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06425289: Macrohemodynamic Impact of Fluid Removal With Net Ultrafiltration in Patients With Continuous Renal Replacement Therapy
Official title: Macrohemodynamic Impact of Fluid Removal With Net Ultrafiltration in Patients With Continuous Renal Replacement Therapy: A Monocentric Ancillary Study of the EarlyDry Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Fluid Removal
Critically Ill
Continuous Renal Replacement Therapy
Fluid Overload
Keywords: Fluid removal
Hemodynamic
Net ultrafiltration
Continuous renal replacement therapy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients with fluid overload and renal replacement therapy for fluid overload, included in EarlyDry trial (NCT05817539) and monitored with transpulmonary thermodilution.

Brief summary: Macrohemodynamic impact of fluid removal with net ultrafiltration in patients with continuous renal replacement therapy. A monocentric ancillary study of the EarlyDry randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* Acute kidney injury treated by continuous renal replacement therapy in ICU less than 7 days,
* At least 1 organ failure during ICU in addition to AKI (mechanical ventilation or vasopressors administration\>12 hours),
* Cumulative UF net less than 1000ml before inclusion,
* Norepinephrine \< 0,5 µg/kg/min,
* Absence of hypoperfusion signs,
* Fluid overload defined as follows: fluid overload \> 5% of base weight (based on cumulative fluid balance or a weight gain) and/or peripheral edema (AKIKI edema scale \> 2).

Exclusion Criteria:

* Chronic renal failure hemodialyzed before admission to the ICU,
* Mechanical circulatory support (ECMO, LVAD),
* Pregnant, child -bearing age or lactating women,
* Stroke less than 30 days,
* Intestinal ischemia less than 7 days documented non-operated,
* Interventional study participation or exclusion period on going,
* Guardianship, curatorship or safeguard of justice,
* Absence of signature of free and informed consent by the patient and/or relative,
* Patients not affiliated to a social security scheme or beneficiaries of a similar scheme
* Absence of transpulmonary thermodilution monitoring

Primary outcomes:
measure: Area under the curve of a low cardiac index
timeFrame: Every 6 hours between day 0 to day 5 (intervention period)
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service d'anesthésie-réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT02861989: Qualitative Study on Osteoporosis Representation and Management in the General Population and in General Practitioners.
Official title: Qualitative Study on Representations of Osteoporosis in the General and At-risk Population and in General Practitioners.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Keywords: osteoporosis
prevention
care management
focus groups
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 114
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: women aged 50 to 85 years and men aged 60 to 85 years, and general practitioners.

Brief summary: Osteoporosis (OP) and subsequent fractures (OP fractures) are a source of morbidity and high mortality in the elderly. Despite numerous programs aiming at improving OP care, the prevention, diagnostic and treatment remain suboptimal. Barriers to a better care are multiple, both in the general and at-risk population, and in medical practitioners. Since they do not perceive their susceptibility to OP, people do not see the benefit of prevention. In addition, physicians do not give sufficient importance to OP prevention and care, despite the existence of guidelines.

The investigators implemented a qualitative study to explore the knowledge and representations regarding osteoporosis in the general and at-risk population and in doctors in Rhône-Alpes Region, France, using focus groups with women and men and semi-structured face-to-face interviews with general practitioners. Understanding barriers to osteoporosis care in patients and general practitioners will help to set up effective strategies to improve prevention and treatment.


Eligibility criteria: Inclusion Criteria:

* group 1: women aged 50 to 85 years with a history of fragility fracture or an osteoporosis diagnostic
* group 2: women aged 50 to 85 years without a history of fragility fracture or an osteoporosis diagnostic
* group 3: men aged 60 to 85 years with a history of fragility fracture or an osteoporosis diagnostic
* group 4: men aged 60 to 85 years without a history of fragility fracture or an osteoporosis diagnostic
* group 5: general practitioners in Region Rhône-Alpes, France
* who signed the consent form

Exclusion Criteria:

* no signed consent
* legal disability
* difficulty in understanding French
* psychiatric disorder

Primary outcomes:
measure: Focus Group Interview
timeFrame: 24 hours
Secondary outcomes:
measure: Factors favoring and barriers to a better management of OP in each group
timeFrame: At the day of inclusion
measure: Specific communication needs for the different groups: men/women, fractured/non-fractured.
timeFrame: At the day of inclusion
Other outcomes:
Locations:
city: Lyon
country: France
facility: Pôle IMER, Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Anne-Marie Schott, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05734989: Improving Screening and Therapy for Hispanic/Latinx at Risk for CKD
Official title: Improving Screening and Therapy Provision Among Hispanics/Latinx at Risk for Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Chronic Kidney Diseases
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-02-21
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Aim 1:

Adults in the Durham, NC Hispanic/Latinx community at risk for hypertension and/or CKD

Brief summary: In this study, the investigators will utilize community organizations to screen Hispanics/Latino(a)s for kidney disease, diabetes, and other risk factors, and refer them for care with a PCP. Additionally, the investigators will implement an intervention in local health clinics to assist PCPs with screening and treating patients with diabetes.

Completion of the project will hopefully slow progression of kidney disease among Hispanic/Latino(a) patients in Durham, and the information gained will allow the investigators to eventually perform the intervention on a larger scale.

Detailed description: The goals of this study are to (1) Increase rates of screening and monitoring of CKD and CKD risk factors for Hispanic/Latinx community members in Durham by utilizing existing community resources and screening events and (2) Pilot test a PCP-facing intervention to promote guideline concordant testing and evidence-based therapy provision for Hispanics/Latinx with T2D at community health centers, utilizing clinical champions and pharmacists. The investigators anticipate the study will identify patients with CKD or CKD risk factors and establish feasibility of the pilot intervention, which the investigators plan to ultimately apply on a large scale to reduce inequities and improve clinical outcomes among Hispanics/Latinx.

Eligibility criteria: Aim 1:

Inclusion Criteria:

* Age 18 or older at time of screening
* Self-identifying as Hispanic/Latinx ethnicity.

Exclusion Criteria:

* Unable to be reached by telephone

Primary outcomes:
measure: Number of patients referred to PCPs (Primary Care Providers) for CKD screening
timeFrame: 3 months from referral
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Matthew Sinclair, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06137989: Clinical Performance of Dual- and Light-cure Bulk-fill Resin Composites
Official title: Two-year Clinical Performance of Dual- and Light-cure Bulk-fill Resin Composites in Class ӀӀ Restorations: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries Class II
Keywords: Bulk-fill resin composite
Dual-cure
Light-cure
Class ӀӀ restorations
Clinical performance
Randomized clinical trial
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each patient received three Class ӀӀ restorations with the three tested bulk-fill resin composites.
Primary purpose: TREATMENT

Brief summary: This study (a double-blinded, prospective, randomized clinical trial) aimed to evaluate 2-year clinical performance of dual- and light-cure bulk-fill resin composites in Class ӀӀ restorations.

The null hypothesis tested in this study was that, there would be no difference in the 2-year clinical performance of all tested bulk-fill resin composites in Class II restorations.

Forty patients were enrolled in the study. Each patient received three bulk-fill resin composites Class ӀӀ restorations. One dual-cure and two light-cure bulk-fill resin composites were used for Class ӀӀ restorations following manufacturer's instructions. A universal adhesive was used with all restorations. All restorations were clinically evaluated after 1 week (baseline), 6 months, 12 months, 18 months and finally after 24 months using the FDI World Dental Federation criteria.


Eligibility criteria: Inclusion Criteria:

* each participant should have at least three permanent molars and premolars that need to be treated with Class II restorations due to primary carious lesions.
* all participants required to have a full and normal occlusion and to maintain adequate oral hygiene.

Exclusion Criteria:

General exclusion criteria:

* heavy bruxism.
* poor oral hygiene.
* chronic or severe periodontitis.
* a history of allergies to any of the materials utilized in this study.
* pregnant or nursing females.

Specific exclusion criteria:

* fractured or visibly cracked teeth.
* rampant caries.
* faulty restoration opposite or adjacent to the tooth to be restored.
* atypical extrinsic staining.

Primary outcomes:
measure: Esthetic properties (FDI criteria)
timeFrame: From baseline to 2-year follow-up
measure: Functional properties (FDI criteria)
timeFrame: From baseline to 2-year follow-up
measure: Biological properties (FDI criteria)
timeFrame: From baseline to 2-year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
state: Aldakhlia
Study officials:
References:
Clinical trial NCT00646789: A Study to Evaluate the Safety, Tolerability and Plasma Concentration Profiles of MK0633 in Asthmatic Children Aged 12 to Less Than 16 Years (0633-019)
Official title: A Multicenter, Open-Label, Single Dose Study to Evaluate the Safety, Tolerability and Plasma Concentration Profiles of MK0633 in Asthmatic Children Aged 12 to Less Than 16 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-03-31
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety, tolerability and pharmacokinetics (PK) of MK0633 in adolescent mild-to-moderate asthma patients to permit further clinical investigation.


Eligibility criteria: Inclusion Criteria:

* Patient is judged to be in good health, other than having mild to moderate asthma, based on medical history, physical examination, vital signs, and laboratory safety tests
* Patient has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
* Patient has at least 1 year of mild-to-moderate asthma
* Patient has been a nonsmoker for at least 6 months
* Patients of childbearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug
* Patients must be able to swallow tablets

Exclusion Criteria:

* Patient has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, other than asthma, or genitourinary abnormalities or diseases
* Patient has required a visit to a hospital or emergency room due to an asthma exacerbation within 3 months of the prestudy visit
* Patient has unresolved signs and symptoms of an upper respiratory tract infection (URI) or has had had an upper respiratory tract infection within 3 weeks prior to the prestudy visit
* Patient has a history of stroke, chronic seizures, or major neurological disorder
* Patient has a history of neoplastic disease
* Use of theophylline, Singulair (montelukast), Xolair (omalizumab), Zyflo amd Zyflo CR (zileuton), oral corticosteroids and oral beta agonists are excluded approximately 2 weeks prior to administration of study drug and throughout the study
* Patient consumes alcoholic beverages

Primary outcomes:
measure: To evaluate the safety and tolerability of MK0633 in adolescent asthma patients.
timeFrame: Blood and urine samples will be collected at specified intervals for 72 hours after study drug administration.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: