louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04903223: Liver Adiposity Effects on Pediatric Statin
Official title: Effects of Pediatric Liver Adiposity on Statin Disposition and Response
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cholesterol; Lipidosis
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single center, open-label, prospective, investigation to quantify the effects hepatocellular fat has on hepatic statin transport (SA1) and response (SA2) in children and adolescents.
Primary purpose: TREATMENT

Brief summary: Single center, open-label, prospective investigation to quantify the effects hepatocellular fat has on hepatic statin transport and response in children and adolescents in obese and non-obese children and adolescents 8-21 years of age with normal, wild-type SLCO1B1 c.521TT genotype that are dosed rosuvastatin


Eligibility criteria: Inclusion Criteria:

* 8-21 years
* LDL cholesterol \>130mg/dl (\>95% percentile)
* SLCO1B1 c.521TT genotype
* Provide informed permission-assent(\<18 yrs.) or consent (≥18 yrs.)
* Fasting overnight (\~8 hrs.)
* Enrolled in Cardiology Pharmacogenomic Repository

Exclusion Criteria:

* Pregnancy
* Non-fasting
* Non-removable metal in body or MRI unsafe
* Currently on statin therapy and unwilling to wash out of statin therapy for at least 4 weeks prior to Visit 1 and throughout the duration of the study.
* Underlying unrepaired congenital or acquired cardiovascular defects or repaired congenital or acquired cardiovascular defects with hemodynamically significant residual disease.
* History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter rosuvastatin disposition\* (absorption, metabolism, distribution, or clearance)
* Pharmacotherapy that interacts with statins (OATP1B1 inducers/inhibitors) \*
* Inability to swallow a tablet
* \>5x the age-specific upper limit of normal for AST, ALT, total and conjugated bilirubin
* Diarrhea in the last 24 hours
* Anything that would exclude a participant from completing an MRI, such as pacemakers, claustrophobia, or body habitus (e.g., weight greater than 350 lbs.)

Primary outcomes:
measure: Evaluate effect of Liver Fat Percentage (on MRI) on AUC
timeFrame: 2 years
measure: Evaluate effect of Liver Fat Percentage (on MRI) on change on plasma mevalonate level
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
References:
Clinical trial NCT00769223: Predicting the Risk of Failure in Patients Undergoing Radiation Therapy for Localized Prostate Cancer
Official title: Pre-Operative Gleason Score and PSA and Clinical Stage in Predicting the Risk of Failure in Patients Undergoing Radiation Therapy for Localized Prostate Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Radiation Toxicity
Keywords: radiation toxicity
recurrent prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage I prostate cancer
stage IV prostate cancer
adenocarcinoma of the prostate
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-10-09
Enrollment: 3561
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Prostate Cancer patients

Brief summary: RATIONALE: Gathering information about the Gleason score, prostate-specific antigen (PSA) level, and cancer stage from patients who have undergone radiation therapy for prostate cancer may help doctors predict how patients respond to treatment and help plan the best treatment.

PURPOSE: This clinical trial is studying the Gleason score, PSA level, and cancer stage in predicting outcome in patients who have undergone radiation therapy for localized prostate cancer.

Detailed description: OBJECTIVES:

* Evaluate the value of the pre-operative Gleason score, prostate-specific antigen level, and clinical stage in predicting the risk of failure and death in patients who have undergone radiotherapy for localized prostate cancer.

OUTLINE: This is a multicenter study.

Patient medical records are reviewed to collect data about pre-treatment prostate biopsy, assigned Gleason score, prostate-specific antigen level, and radionucleotide bone scan.

Patients complete a Bowel Toxicity questionnaire to assess quality of life related to acute and long-term bowel toxicity after radiotherapy.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of localized adenocarcinoma of the prostate
* Has undergone radiotherapy (external beam radiotherapy and/or brachytherapy) with or without hormonal therapy for adenocarcinoma of the prostate in the University of California, San Francisco (UCSF) Radiation Oncology Department at San Francisco General Hospital or Veterans Administration Medical Center of San Francisco between 1987 and 2006

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Value of the pre-operative Gleason score, prostate-specific antigen level, and clinical stage in predicting the risk of failure and death
timeFrame: Up to 30 years or until death
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Mack Roach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05817123: Validation of the Mutuality Scale in Patients With OSA and Their Partners
Official title: Psychometric Validation of the Mutuality Scale in Patients With Obstructive Sleep Apnea and Their Partners
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Obstructive Sleep Apnea Syndrome (OSAS) and their partners

Brief summary: Main objective of this study is to assess the psychometric characteristics of the Mutuality Scale both in patients with Obstructive Sleep Apnea Syndrome (OSAS) and in their partners-The association between the mutuality score in OSAS patients and their adherence to the use of Continuous Positive Airway Pressure (CPAP) therapy will also be investigated.

The results of the study may allow a validation of the Mutuality Score as an instrument for measuring mutuality between OSAS patients and their partners.


Eligibility criteria: OSA patients:

Inclusion Criteria:

* Age 18 years and older

Exclusion Criteria:

-

Primary outcomes:
measure: Score on Mutuality Scale in OSAS patients
timeFrame: At baseline
measure: Score on Mutuality Scale in partners
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano
Study officials:
References:
Clinical trial NCT02899923: Register of Autoimmune Bullous Dermatoses
Official title: Register of Autoimmune Bullous Dermatoses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmune Bullous Dermatoses
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with autoimmune bullous dermatosis

Brief summary: Autoimmune bullous dermatoses are a group of diseases with chronic course. They are provoked by the production of autoantibodies against the dermal-epidermal junction or against the inter-keratinocyte junctions, resulting in the formation of intra-epidermal or sub-epidermal blisters.

The diagnosis of autoimmune bullous dermatoses is based on clinical and immunopathological findings, including skin direct immunofluorescence.

Systemic corticosteroid therapy is generally considered as the mainstay of treatment for many years both for bullous pemphigoid and pemphigus which are the most frequent diseases.

Detailed description: The aim of the study is the creation of a register of patients suffering from autoimmune bullous dermatoses to quickly identify patients who can be included in clinical trials or retrospective epidemiological studies

Eligibility criteria: Inclusion Criteria:

* patients with autoimmune bullous dermatosis
* patients cared for in dermatology referral center of Reims, Rouen or Limoges
* patient consenting to participate to the study

Exclusion Criteria:

- patient \<18 years

Primary outcomes:
measure: autoimmune bullous dermatosis according to physical examination, skin biopsy and autoantibodies detection in blood sample
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
Clinical trial NCT04933123: Clinical Evaluation of a Dental Glass Ceramic
Official title: Clinical Evaluation of a New Dental Glass Ceramic in the Indirect Restorative Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Caries
Dental Trauma
Lead sponsor: Ivoclar Vivadent AG
Sponsor class: INDUSTRY
First posted: 2021-06-21
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A clinical trial with an experimental glass ceramic (shades A1, A2 and A3) to ensure the safety and efficacy of the product. It is a study with single-arm in which inlays and onlays for molars and premolars are adhesively luted.


Eligibility criteria: Inclusion Criteria:

* Age: 18-65 years
* Indication for indirect restorations (inlay, onlay) in molar or premolar - replacement of insufficient fillings (e.g. due to caries at margins, filling fracture, fracture of the tooth, poor quality of the surface, leaking margin, etc.) or extensive primary caries
* The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth.
* Participant wishes a restoration within the scope of the study (signed informed consent after detailed explanation and study of the patient information)
* Pre-operative discomfort of the tooth to be restored should not exceed 3 on the visual analogue scale (VAS) (0=no pain, 10=maximum conceivable pain) due to temperature stimulus or bite sensitivity
* Max. 2 restorations per participant in different quadrants.
* Healthy periodontium, no active periodontitis
* Contact with adjacent teeth (at least at one side) and opposing teeth present with at least one contact point.
* Sufficient language skills

Exclusion Criteria:

* Sufficient isolation not possible, dry working field cannot be guaranteed
* Participants with a proven allergy to one of the ingredients of the materials used
* Participants with proven allergy to local anaesthetics
* High caries activity/ poor oral hygiene
* Participants with severe systemic diseases
* Pregnancy
* Symptoms of SARS (severe acute respiratory syndrome)-CoV2 (Corona Virus 2) infection

Primary outcomes:
measure: Survival Rate of Inlays and Onlays
timeFrame: Baseline (7-10 days after insertion of restoration)
Secondary outcomes:
measure: Quality Criteria (Modified FDI Criteria)
timeFrame: Baseline (7-10 days after insertion of restoration)
Other outcomes:
Locations:
city: Schaan
country: Liechtenstein
facility: Ivoclar Vivadent
Study officials:
References:
Clinical trial NCT00890123: Preoperative Intravenous Omega 3 Fatty Acids Administration in Elderly Patients Undergoing Hip Surgery
Official title: Preoperative Intravenous Omega 3 Fatty Acids Administration in Elderly Patients Undergoing Hip Surgery: A Prospective, Randomized, Open-label, Comparative Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Surgery
Keywords: Omega 3 Fatty Acids
Inflammation
Hip Surgery
Inflammatory status
Infectious complications
Lead sponsor: Nizam's Institute of Medical Sciences University, India
Sponsor class: OTHER
First posted: 2009-04-29
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The perioperative administration of n-3 fatty acids has been shown to lead to favorable effects on outcome in patients with severe surgical interventions by lowering the magnitude of inflammatory response and by modulating the immune response. No study with preoperative administration of IV omega 3 fatty acids as a part of total parenteral nutrition (TPN) or monotherapy with it to demonstrate its effects on inflammatory and immune response has been conducted. So, this study has been planned to judge the inflammatory response of preoperative monotherapy with IV omega 3 fatty acids in elderly patients undergoing hip surgery considering the hyper-inflammation associated with this type of surgery in elderly patients.


Eligibility criteria: Inclusion Criteria:

1. Elderly male or female patients undergoing hip surgeries
2. Age \> 60 years
3. The patients who give written informed consent

Exclusion Criteria:

1. Refusal to participate in the study
2. Allergy to any of the constituents of nutritional products
3. HIV positive patients, patients with primary diagnosis of hypertriglyceridemia, patients on long term steroid therapy and cyclooxygenase inhibitors (more than 3 months)
4. Severe cardiac disease, hepatic disorders (total bilirubin \> 1.5 times the upper limit of normal), psychiatric disorders likely to affect compliance, severe hemorrhagic disorders, stroke, embolism
5. Uncontrolled severe renal failure (Serum creatinine \> 2 mg/dL) without dialysis/hemofiltration
6. Participation in any other clinical trial within the last 2 months

Primary outcomes:
measure: IL-6, 8, 10, HS-CRP levels
timeFrame: 5 days
Secondary outcomes:
measure: Infectious complications
timeFrame: 5 days
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Nizam's Institute of Medical Sciences
state: AP
Study officials:
affiliation: Professor and Head, Department of Anesthesia and critical care
name: Dr R Gopinath
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03292523: Work Productivity in Hyperventilation Syndrome
Official title: Work Productivity in Hyperventilation Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperventilation Syndrome
Keywords: Hyperventilation syndrome
Work productivity
Absenteeism
Presenteeism
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 50
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: patients with confirmed hyperventilation syndrome, virgin of any treatment.

Brief summary: Hyperventilation syndrome is associated with impaired quality of life. The aim of the study is to assess the relationship between work productivity, including absenteeism and presenteeism, and the severity of hyperventilation syndrome


Eligibility criteria: Inclusion Criteria:

* Holders of employment contracts for at least 8 days
* Diagnosis of hyperventilation syndrome confirmed by:

Compatible symptoms and at least two symptoms reproduced by the hyperventilation challenge test: Nijmegen's score\> 23 ; Demonstration of alveolar hyperventilation ( Either on rest blood and / or at rest (PaCO2 at rest \<36 mmHg and D (A-a) O2 normal; Either during the HV test (increased recovery time of the basic PETCO2 after voluntary hyperventilation (greater than 5 minutes)

Exclusion Criteria:

* Existence of another chronic pulmonary disease (asthma, bronchial dilation, COPD, diffuse interstitial pneumonia, neuromuscular pathology ...) or cardiac (rhythm disorder, ischemic heart disease ...) which can participate in dyspnea
* Psychiatric illness / psychotropic treatment
* Pregnancy
* Patient already included in a clinical research protocol involving new therapeutics may not be included in this protocol
* Specific physiotherapy or previous training

Primary outcomes:
measure: Association between the WPAI score and the Nijmegen score
timeFrame: At the time of diagnosis (Baseline)
Secondary outcomes:
measure: Association between the WPAI score and dyspnea scales
timeFrame: At the time of diagnosis (Baseline)
measure: Association between the WPAI score and quality of life scores
timeFrame: At the time of diagnosis (Baseline)
measure: Association between the WPAI score and PaCO2
timeFrame: At the time of diagnosis (Baseline)
measure: Association between the WPAI score and the Cognitive Failure Questionnaire score
timeFrame: At the time of diagnosis (Baseline)
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Calmette,CHU
Study officials:
affiliation: University Hospital, Lille
name: Cécile Chenivesse, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00764023: A Multi-Center Protocol for Obtaining and Storing Human Samples for Immediate or Future Microbial, Immune, or Host-Microbe Scientific Study
Official title: A Multi-Center Protocol for Obtaining and Storing Human Samples for Immediate or Future Microbial, Immune,or Host-Microbe Scientific Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections
Keywords: wound debridement
removed orthopedic implants
removed catheters or shunts
excised tonsils, amputated tissue
sputum
stool
other excretions.
Lead sponsor: Southwest Regional Wound Care Center
Sponsor class: OTHER
First posted: 2008-10-01
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The samples can include material such as wound debridement, removed orthopedic implants, removed catheters or shunts, excised tonsils, amputated tissue, sputum, stool, or other excretions.

Brief summary: The intent of this protocol is to salvage human-related material that is normally destined for destruction, so it can be used in infection-related scientific studies. This clinical material can be studied in order to better understand the molecular, cellular, or ecological components of the infected or potentially infected tissue or device.

Detailed description: The samples can include material such as wound debridement, removed orthopedic implants, removed catheters or shunts, excised tonsils, amputated tissue, sputum, stool, or other excretions. The samples can be cultured for microbes, examined using microscopy, or analyzed using molecular techniques. The studies can examine microbes or the host's response to microbes by examining the nucleic acids (e.g. 16S DNA, mRNA), proteins, or other metabolites.

Eligibility criteria: Inclusion Criteria:

1. The Subject must be 18 years of age or older
2. The Subject must be mentally competent as determined by the Investigator, or have a Legally Authorized Representative.

Exclusion Criteria:

1. The Subject may not be currently incarcerated.
2. The Subject may not be knowingly pregnant.
3. The Subject may not be institutionalized.
4. The Subject may not be an employee or student of the investigator or sponsor.

Primary outcomes:
measure: The samples can be cultured for microbes, examined using microscopy, or analyzed using molecular techniques.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Southwest Regional Wound Care Center
state: Texas
Study officials:
affiliation: Southwest Regional Wound Care Center
name: Randall Wolcott, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: A Possible Role of Bacterial Biofilm in the Pathogenesis of Atherosclerosis Bacteriol Parasitol Volume 3 • Issue 1 • 1000127 ISSN:2155-9597 JBP an open access journal
Clinical trial NCT02836223: Evaluation of the Addition of an Interdental Cleaning Device to Manual Brushing on Gingival Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Lead sponsor: Water Pik, Inc.
Sponsor class: INDUSTRY
Collaborators: name: All Sum Research Center Ltd.
First posted: 2016-07-18
Enrollment: 72
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the addition of an interdental cleaning device paired with a manual toothbrush compared to using a manual toothbrush only. Plaque removal, reduction of gingival bleeding and reduction of gingival inflammation.


Eligibility criteria: Inclusion Criteria:

* Between 25 and 70 years of age
* Able to provide written informed consent prior to participation
* Agree to not participate in any other oral/dental products clinical study for the study duration
* Good general health and be a non-smoker
* A minimum of 50% bleeding on probing sites
* A minimum pre-brushing plaque score of 0.6
* A minimum of 1.75 gingivitis score Have no probing depths greater than 5 mm
* A minimum of 20 teeth (not including 3rd molars)
* No partial dentures, orthodontic brackets, wires or other appliances
* Agree to refrain from the use of any non-study dental device or oral care product for the study duration
* Agree to return for the scheduled visits and follow study procedures
* Agree to delay dental prophylaxis until study completion
* Have a minimum pre-brushing plaque score of 0.6
* Have a minimum of 1.75 gingivitis score

Exclusion Criteria:

* Probing depth greater than 5 mm
* Systemic disease (ex. Diabetes, autoimmune disease)
* Advanced periodontitis
* Taking medication that can influence gingival health such as seizure meds, calcium channel blockers, Cyclosporine, anticoagulants
* Orthodontic appliances or removable partial dentures
* Pregnant at time of study
* Use of antibiotics within 6 months of study

Primary outcomes:
measure: Reduction of gingival bleeding
timeFrame: 4 weeks
Secondary outcomes:
measure: Reduction of gingival inflammation
timeFrame: 4 weeks
measure: Reduction in dental plaque
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: All Sum Research Center Ltd.
state: Ontario
Study officials:
References: