louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02803320: To Assess the Safety of a Sunscreen Product
Official title: Supervised Outdoor -Use Test to Assess the Safety of a Sunscreen Lotion on Sports Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Keywords: Sunscreen active
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-06-16
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this study was to assess the safety and appropriateness of a sunscreen product for use on sport users, under supervised outdoor use conditions.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females, 18 to 65 years of age with no medical conditions of the skin as determined by the subjects' dermatological medical history.
* The subject must have Fitzpatrick skin types I to VI.
* During the selection process, potential subjects must agree to restrict their sun exposure activities for at least 5 days immediately preceding participation in the study. Subjects must be willing and physically able to spend approximately 3 continuous hours in the sun, must agree to immerse their entire body under water (including face and hair) at least 2 times during the water activity phase, and must agree to refrain from taking any medications during the study that might alter their response to sun exposure
* Subjects must agree to refrain from alcohol and tobacco use during the course of the study
* Subjects must obey all rules of the test facility
* Subjects must agree to refrain from tanning bed usage and significant non study related sun exposure during the study

Primary outcomes:
measure: Dermatologist´s subjective and objective assessments of potential Adverse events
timeFrame: 2 days
measure: Final Skin Evaluation
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
state: Florida
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02517320: Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Nephropathy
Keywords: Diabetic Nephropathy
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2015-08-07
Enrollment: 293
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of MT-3995 in subjects with diabetic nephropathy, compared with placebo, using urine albumin- to-creatinine ratio (UACR) in the first morning void urine sample as an indicator.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Glycated hemoglobin(HbA1c) values (National Glycohemoglobin Standardization Program : NGSP) ≤10.5%
* estimated glomerular filtration rate(eGFR) of ≥30 mL/min/1.73 m2
* The median UACR of the first morning void urine samples is ≥50 mg/g Cr and \<300 mg/g Cr
* Stable blood pressure(diastolic blood pressure (DBP) \<100 mmHg and stable systolic blood pressure (SBP) \<160 mmHg)

Exclusion Criteria:

* Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.
* A diagnosis of non-diabetic renal disease.
* A following serum potassium level.

  * eGFR of 30-59mL/min/1.73m2; serum potassium level of \<3.5 or \>4.7 mmol/L,
  * eGFR of ≥60mL/min/1.73m2: serum potassium level of \<3.5 or \>5.0 mmol/L
* symptomatic and clinically significant hypotension(diastolic blood pressure(DBP)\<50mmHg and systolic blood pressure(SBP)\<110mmHg)
* QT prolongation or torsades de pointes, or, a history or family history of QT prolongation or torsades de pointes
* New York Heart Association (NYHA) Class III or IV heart failure

Primary outcomes:
measure: Change form baseline in UACR
timeFrame: Week 24
Secondary outcomes:
measure: Change in UACR classification
timeFrame: From baseline to 24 weeks
measure: Change in renal function
timeFrame: From baseline to 24 weeks
measure: Change in serum potassium
timeFrame: From baseline to 24 weeks
measure: Adverse events
timeFrame: From baseline to 24 weeks
Other outcomes:
Locations:
city: Hokkaido
country: Japan
facility: Investigational site
Study officials:
References:
citation: Wada T, Inagaki M, Yoshinari T, Terata R, Totsuka N, Gotou M, Hashimoto G. Apararenone in patients with diabetic nephropathy: results of a randomized, double-blind, placebo-controlled phase 2 dose-response study and open-label extension study. Clin Exp Nephrol. 2021 Feb;25(2):120-130. doi: 10.1007/s10157-020-01963-z. Epub 2020 Sep 24.
Clinical trial NCT05793320: Carpal Tunnel Release With Risk Factors for Amyloidosis
Official title: Prospective Histopathologic and Clinical Evaluation of Patients Undergoing Carpal Tunnel Release With Risk Markers for Amyloidosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amyloidosis
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 250
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Bilateral carpal tunnel syndrome has been demonstrated in previous literature to be a warning sign for potential amyloidosis. One study has been performed in which patients with bilateral carpal tunnel syndrome underwent tissue biopsy (either tendon sheath or transverse carpal ligament) at the time of carpal tunnel release to determine the strength of association as well as most common subtypes. However, no study has been done demonstrating whether or not patients with amyloid-positive carpal tunnel biopsy would benefit from an early referral to cardiology for a work-up of potential cardiac amyloidosis. In our study, patients with bilateral carpal tunnel symptoms who are indicated for carpal tunnel release would be identified in clinic and undergo biopsy for congo red staining at the time of surgery. All patients with positive biopsy results would be referred to cardiology. Outcomes would include the rate of amyloid positivity, common subtypes, and echocardiographic findings after cardiac referral.


Eligibility criteria: Inclusion Criteria:

Positive screening is defined as two characteristics from Tier 1 or one characteristic from Tier 1 and one from Tier 2 Tier 1

* Male \> 50 years old
* Female \> 60 years old
* Bilateral carpal tunnel symptoms or prior release surgery Tier 2
* Spinal stenosis
* History of biceps tendon rupture
* Atrial fibrillation or flutter (active or previous history)
* Pacemaker
* Congestive heart failure
* Family history of transthyretin amyloidosis (ATTR)

Exclusion Criteria:

* Unable or unwilling to follow up with cardiology.
* Previous diagnosis of cardiac amyloidosis.

Primary outcomes:
measure: Rate of amyloid positivity
timeFrame: Biopsy sent for testing immediately after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Main Campus
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Charles Day, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01811420: Chemomechanical Caries Removal Using Papain Gel
Official title: Chemomechanical Caries Removal Using a Papain-Based Gel: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: dental caries
caries removal
chemomechanical caries removal
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2013-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of a papain-based gel in caries removal.

Detailed description: Twenty children with at least two carious molar teeth without pulpal involvement participated in this randomized clinical trial. A total of 40 teeth were randomly divided into two treatment groups: group A, papain-based gel; and group B, conventional technique. Data collection included the time required for caries removal, need for local anesthesia, degree of discomfort, changes in the number of viable bacteria, and clinical evaluation of glass ionomer-cement restorations 6-month post-treatment.

Eligibility criteria: Inclusion Criteria:

* Children with active caries without pulpal involvement in two deciduous molar teeth participated in the trial.
* The caries were located on the occlusal surface.

Exclusion Criteria:

* Children with pathological process of the dental tissue, with pulpal involvement

Primary outcomes:
measure: restauration evaluation
timeFrame: 18 months
Secondary outcomes:
measure: discomfort or pain
timeFrame: 6 months
Other outcomes:
measure: radiographic status
timeFrame: 18 months
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Nove de Julho
state: Sao Apaulo
Study officials:
affiliation: University of Nove de Julho
name: Lara J Motta, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Motta LJ, Bussadori SK, Campanelli AP, Silva AL, Alfaya TA, Godoy CH, Navarro MF. Efficacy of Papacarie((R)) in reduction of residual bacteria in deciduous teeth: a randomized, controlled clinical trial. Clinics (Sao Paulo). 2014;69(5):319-22. doi: 10.6061/clinics/2014(05)04.
citation: Motta LJ, Bussadori SK, Campanelli AP, da Silva AL, Alfaya TA, de Godoy CH, Navarro MF. Pain during Removal of Carious Lesions in Children: A Randomized Controlled Clinical Trial. Int J Dent. 2013;2013:896381. doi: 10.1155/2013/896381. Epub 2013 Dec 4.
Clinical trial NCT05517720: An Exploratory Investigation of a Novel Skincare Regimen
Official title: An Exploratory Investigation of a Novel Skincare Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle
Photoaging
Acne
Skin Inflammation
Keywords: wrinkles
fine lines
photoaging
sun spots
acne
enlarged pores
skin health
Lead sponsor: Trophy Skin
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2022-08-26
Enrollment: 38
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This trial will assess the effectiveness of the Aria Trio Complete Facial system in being able to reduce blemishes, lines, and wrinkles. This skincare system that has three different functions in association with three unique serums. It is hypothesized that this customized skincare system will improve skin quality, reduce wrinkles, and reduce other skin related issues.


Eligibility criteria: Inclusion Criteria:

* Must experience early-stage wrinkles that are not treated by topical or oral prescription drugs/medication
* Must experience early-stage wrinkles that are not treated by over the counter products (e.g. Adapalene/Differin)
* May experience hyperpigmentation and/or dark spots
* In good general health
* Willing to follow the study protocol skincare routine
* Willing and able to share feedback and take skin pictures via the technology portal
* Discontinue use of any alpha-hydroxy acids (AHAs) or over the counter exfoliating, polishing, or peeling topical skincare treatments 1 week before and for the duration of the study.

Exclusion Criteria:

* Anyone with a diagnosed skin condition on their face
* Use of prescription medication relevant to the skin
* Undergoing any cosmetic procedures during the study including Botox, laser, or chemical peel treatments
* Use of oral acne treatment (e.g., Accutane)
* Severe chronic conditions, including oncological conditions or psychiatric disorders.
* Is pregnant, attempting pregnancy, or breastfeeding

Primary outcomes:
measure: To assess the effectiveness of the Aria Trio Complete Facial System in being able to reduce blemishes, lines, and wrinkles.
timeFrame: 4 weeks
Secondary outcomes:
measure: To determine the effectiveness of the Aria Trio Complete Facial System being able to improve perceptions of wrinkles, pore size, sun spots, and overall skin quality
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
affiliation: Citruslabs
name: Christopher Hill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01359020: Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children
Official title: Randomized, Open Label, Comparative, Parallel, Multicenter Trial to Determinate the Efficacy Anf Tolerability of Ibuprofen, Acetaminophen and Dipyrone Drops to Fever Control in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fever
Keywords: Fever
Ibuprofen
Acetaminophen
Dipyrone
Lead sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd.
Sponsor class: INDUSTRY
First posted: 2011-05-24
Enrollment: 396
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the efficacy and tolerability of acetaminophen, dipyrone and ibuprofen to fever control in children.

For the efficacy asses were compared:

* the time to start the action;
* the action duration;
* the difference between the basal temperature and the lower temperature in the study period.

For the tolerability asses all adverse events were recorded, as well as your intensity and the relation to the treatment.


Eligibility criteria: Inclusion Criteria:

* male and female children aged 06 months to 06 years old, weight above 5 kilo and axillary temperature above 37,5 celsius degree.

Exclusion Criteria:

* patients with a bad general heath state
* patients with neoplasia, pepic ulcer, gastrointestinal bleeding,history of fever convulsion;
* intolerant to dypirone, ibuprofen, acetaminophen or any other nonsteroidal antiinflammatory drug;
* moderated or severe dehydration;
* conscience state alteration;
* not capable of ingest oral drugs;
* patients being treated with steroids;
* patients treated with antiinflammatory, analgesic and antipyretic drugs in the last 06 hours before the study.

Primary outcomes:
measure: Antipyretic efficacy
timeFrame: Temperature was verified 15, 30, 45 and 60 minutes, 2, 3, 4, 5, 6, 7 and 8 hours after the administration of the drug.
Secondary outcomes:
measure: Adverse Events
timeFrame: Adverse Events were verified at 15, 30, 45 and 60 minutes, 2, 3, 4, 5, 6, 7 and 8 hours after the administration of the drug.
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Instituto de Medicina Integral Professor Fernando Figueira
state: Pernambuco
Study officials:
affiliation: Mantecorp Indústria Química e Farmacêutica Ltda.
name: Claudia Patrícia DN Moura
role: STUDY_DIRECTOR
References:
Clinical trial NCT03600220: Exploring the Effect of Combined Chinese and Western Treatment on Home Medical Care
Official title: Effectiveness of Combining Antihypertensive Drugs and Acupuncture on Isolated Systolic Hypertension of Elderly Patients at Home
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: acupuncture, hypertension, elderly, home health care
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
First posted: 2018-07-26
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: combine antihypertensive drugs and acupuncture to isolated systolic hypertension elderly patients at home

Detailed description: The investigators would like to compare the effectiveness of acupuncture and drug therapy on blood pressure.

The investigators chose acupuncture point according the Traditional Chinese Medicine theory, besides, each patient was using 1-3 antihypertensive drug of a heterogeneous pharmacological group ranging from angiotensin-converting enzyme inhibitor (ACE inhibitor), diuretics, and beta blockers.

Eligibility criteria: Inclusion Criteria:

1. patient with isolated blood pressure diagnosis by physicians and BP \>140/\<90 mmHg
2. patient took the drug to control blood pressure for more than one year
3. age\>65 years old
4. Willing to participate in this study

Exclusion Criteria:

1. Suspected acute stroke
2. chest pain or dyspnea
3. ingestion of short-acting antihypertensive medication within 2 h prior to the beginning of the study
4. body temperature \>37.5∘C(99.5∘F)

Primary outcomes:
measure: blood pressure
timeFrame: change from Baseline Systolic Blood Pressure at 3 months
Secondary outcomes:
measure: Traditional Chinese Medicine constitution
timeFrame: use the questionnaire at Baseline, 1.5 month, and three month later
measure: heart rate variability
timeFrame: use ANS watch to monitor patient's condition at Baseline, 1.5 month, and three month later
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei City Hospital
Study officials:
affiliation: Taipei City Hospital
name: Kuei-Yu Huang
role: STUDY_DIRECTOR
References:
Clinical trial NCT06092320: Does Teaching Before or After Simulation Improve Learning?
Official title: Outcome of a Lecture Before vs After Simulation-based Education on Pediatric Status Epileptics: A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Medical Education
Simulation
Keywords: Medical Education
Simulation
Pediatrics
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of the randomized educational intervention study is to test whether simulation preceding didactic teaching leads to improved knowledge and performance retention compared to a didactic lecture proceeding simulation for medical students

Participants will be randomized to one of two different groups with reverse orders for simulation and lectures.

Researchers will compare each group to see which way is better for learning.


Eligibility criteria: Inclusion Criteria:

- Second year medical student at the University of British Columbia

Exclusion Criteria:

- None

Primary outcomes:
measure: Change from baseline in resuscitation performance retention score 2 months post-initial training assessed using global simulation performance score
timeFrame: From initial simulation until repeat simulation 2 months later
Secondary outcomes:
measure: Change in knowledge assessment score at 2 months post-initial training assessed using an MCQ
timeFrame: From initial knowledge test until repeat testing 2 months later
measure: Learner satisfaction measured by Likert scale items after each simulation debrief
timeFrame: Single time metric completed five minutes after initial simulation session
measure: Time to resuscitation metrics
timeFrame: The time for each metric will be measured once during the second evaluatory simulation 2 months after the initial simulation and participant enrolment.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
affiliation: Provincial Health Services Authority
name: Melissa Chan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00142974: Assessment of the Effect of Tegaserod (2 mg Tid and 6 mg Tid) on Dyspeptic Symptoms in Diabetic Patients With Symptoms of Diabetic Gastropathy
Official title: Assessment of the Effect of Tegaserod (2 mg Tid and 6 mg Tid) on Dyspeptic Symptoms in Diabetic Patients With Symptoms of Diabetic Gastropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetic Gastropathy
Keywords: Diabetes, tegaserod, gastropathy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is being done to evaluate the safety, tolerability and satisfactory relief of tegaserod against dyspeptic symptoms in diabetic patients with symptoms of diabetic gastropathy.


Eligibility criteria: Inclusion Criteria:

* History of Type 1 or insulin-requiring Type 2 diabetes for at least 3 years
* GI symptoms for at least 2 months before entering study

Exclusion Criteria:

* Very high body weight
* Significant diarrhea
* Ulcers

Symptom severity score collected via diary Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Reduction in weekly mean of a daily composite diabetic gastropathy dyspeptic symptom severity score throughout 6 weeks of treatment.
Secondary outcomes:
measure: Weekly global measure of dyspeptic symptom relief.
measure: Weekly mean severity of individual dyspeptic symptoms (nausea, vomiting, retching, epigastric/stomach, discomfort/pain, postprandial fullness, bloating, early satiety).
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Basel
name: Novartis
role: STUDY_CHAIR
References: