louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00705744: Dermacyd Femina (Lactic Acid) - Photo Dermatological Evaluation of the Irritation and Sensitivity Potential.
Official title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Femina.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-06-26
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina.


Eligibility criteria: Inclusion Criteria:

* Phototype Skin II and III;
* Integral skin test in the region;

Exclusion Criteria:

* Lactation or gestation;
* Use of Anti-inflammatory and/or immuno-suppression drugs 15 days before the selection;
* Diseases which can cause immunity decrease, such as HIV, diabetes;
* Use of drug photosensitizer;
* History of sensitivity or irritation for topic products;
* Active cutaneous disease which can change the study results;
* History or photodermatosis active;
* Family or personal antecedent of cutaneous photoinduced neoplasias;
* Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium;
* Intense solar exposure in the study area;
* Use of new drugs or cosmetics during the study;

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

Primary outcomes:
measure: The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale
timeFrame: 5 weeks
measure: The sensibility will be evaluated according to the skin type.
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-aventis
Study officials:
affiliation: Sanofi
name: Jaderson Lima, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02384044: A Pilot Clinical Study to Evaluate the Safety and Efficacy of Marketed Oxalate Strips Compared to a Marketed Safety Pen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Keywords: Sensitivity
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2015-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot study will evaluate the safety and effectiveness of a marketed sensitivity strip on existing dentinal hypersensitivity compared to a marketed sensitivity pen.


Eligibility criteria: Inclusion Criteria:

* be at least 18 years of age
* sign an informed consent form and be given a copy
* be in good general health as determined by the Investigator/designee
* agree to delay any elective dentistry, including dental prophylaxis, and to report any dentistry received during the course of the study
* agree to not participate in any other oral care study for the duration of this study
* agree to return for scheduled visits and follow all study procedures
* have dentinal hypersensitivity with at least one tooth with a Schiff sensitivity score of at least 1 in response to the cold water challenge

Exclusion Criteria:

* severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
* active treatment for periodontitis
* any diseases or conditions that might interfere with the subject safely completing the study
* inability to undergo study procedures
* fixed facial orthodontic appliances
* a history of kidney stones
* self-reported pregnancy or nursing
* known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate

Primary outcomes:
measure: Change From Baseline Visual Analog Scale
timeFrame: 1 Day
Secondary outcomes:
measure: Change From Baseline for Air Challenge
timeFrame: 1 Day
Other outcomes:
Locations:
city: Mason
country: United States
facility: Oral Health Science Center
state: Ohio
Study officials:
affiliation: Procter and Gamble
name: Robert W Gerlach, DDS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04401644: COVID-19: Laser Interferometry for Rapid Single Coronavirus Detection
Official title: Laser Interferometry of Single Virus Particles Flowing Through Glass Microcapillaries to Detect Novel Coronavirus COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diagnoses Disease
Coronavirus
Lead sponsor: Somerset NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Exeter
name: University of Plymouth
First posted: 2020-05-26
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: within group comparison of methods of detection of virus by two test methodologies. Post hoc validation of test performance against reference set.
Primary purpose: DIAGNOSTIC

Brief summary: Using Laser light to detect COVID 19 virus particles in deep throat swab / nasal swab samples.

Detailed description: The investigators will develop novel primers to detect single virus particles in patient samples. The method involves the absorption of light by single virus particles giving a specific pattern. The investigators will develop the device to create a microdroplet of carrier fluid that is run through the trial device. The investigators will develop novel binding receptors for preferential capture of Coronavirus.

The investigators will review the results of the novel test against the standard diagnostic test and identify virus particles in test negative subjects.

The investigators will isolate the viral rna in test negative subjects and perform sequencing to find novel mutations that are not detected by the current test.

Eligibility criteria: Inclusion Criteria:

* clinical suspicion of coronavirus or staff member having a coronavirus test

Exclusion Criteria:

* unable to give written informed consent

Primary outcomes:
measure: kappa value
timeFrame: 6 months
Secondary outcomes:
measure: sensitivity and specificity
timeFrame: unknown this will require a centrally validated test set for known positives and negatives to be available estimated 1 year
Other outcomes:
measure: clinical utility of test
timeFrame: 3 months
Locations:
city: Taunton
country: United Kingdom
facility: Somerset NHS Foundation Trust
state: Somerset
Study officials:
References:
Clinical trial NCT04770844: Development of a Developmental Prognostic Tool for the Premature Child Based on Automated Spontaneous Motor Analysis
Official title: Development of a Developmental Prognostic Tool for the Premature Child Based on Automated Spontaneous Motor Analysis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Premature Birth
Keywords: premature children
motor skill
developmental prognostic
prognostic tool
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Jean Monnet University
name: Laboratoire EA SNA=EPIS 4607.
First posted: 2021-02-25
Enrollment: 129
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children borned before 33 week of amenorrhea

Brief summary: Prematurity is a major risk factor for poor neurodevelopmental outcomes. The clinical and neuroradiological evaluations proposed during the neonatal period to assess the developmental prognosis of children born prematurely are not sensitive and nor specific. The analysis of spontaneous motor activity by Prechtl's method has a better predictive value but is currently unfeasible in clinical routine. The study's principal objective is to describe the standardized values of complexity, variability, and fluidity of general movements.


Eligibility criteria: Inclusion Criteria:

* Birth before 33 week of amenorrhea;
* Hospitalization in the Neonatal Department of the Saint-Étienne University Hospital
* Patient affiliated or entitled to a social security scheme;
* Authorization to shoot the holders of parental authority;
* Consent to participate in the study by the holders of parental authority

Exclusion Criteria:

* Need for ventilatory support;
* Difficulty of thermal regulation contraindicating the use of a heating cradle;
* Refusal of authorization to shoot by holders of parental authority;
* Refusal of participation in the study of holders of parental authority.

Primary outcomes:
measure: Automatized quantification of complexity of general movements (spatial variation).
timeFrame: Year: 3
measure: Automatized quantification of variability of general movements (temporal variations)
timeFrame: Year: 3
measure: Automatized quantification of fluidity of general movements (uniform distribution)
timeFrame: Year: 3
Secondary outcomes:
measure: Comparison between our quantitative analysis and qualitative analysis according to the reference method of Pretchl
timeFrame: Year: 3
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu de St Etienne
Study officials:
affiliation: CHU ST ETIENNE FRANCE
name: ANTOINE GIRAUD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01063244: Comparison of Foley Balloon With or Without Traction for the Cervical Ripening
Official title: Comparison of Foley Balloon With or Without Traction for the Cervical Ripening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pregnancy
Keywords: pregnancy
induction of Labor
Cervical ripening
Foley balloon
Lead sponsor: St. Luke's Hospital, Pennsylvania
Sponsor class: OTHER
First posted: 2010-02-05
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We will compare the use of foley bulb catheters placed in the cervix for ripening of the cervix for labor induction,.

Detailed description: One arm will have the foley balloon placed alone in the cervix. And one arm will have the foley balloon placed in the cervix and then attached to a weight (1000 cc Iv Bag of fluid). Our hypothesis is that the weighted balloon will be more effective than the non-weighted balloon in the ripening of the cervix for induction of labor

Eligibility criteria: Inclusion Criteria:

* Term pregnancy scheduled for induction of labor

Exclusion Criteria:

* Preterm pregnancy that require induction for fetal indications

Primary outcomes:
measure: Time to effectively ripen cervix
timeFrame: to effective cervical ripening
Secondary outcomes:
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: St Luke's Hosptial & Health Network
state: Pennsylvania
Study officials:
affiliation: St. Luke's Hospital
name: James N Aansti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02443792: Unicirc vs Open Surgical Circumcision
Official title: Adult Male Circumcision With Unicirc Under Topical Anesthetic vs Open Surgical Circumcision: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Circumcision, Male
Lead sponsor: Simunye Primary Health Care
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 75
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical circumcision under local anesthetic with suturing.


Eligibility criteria: Inclusion Criteria:

* Healthy male
* Uncircumcised
* With normal penile anatomy

Exclusion Criteria:

* Concurrent illness
* History of bleeding disorder
* Past reaction to local anesthetic
* Infection
* Penile abnormality which could complicate circumcision

Primary outcomes:
measure: Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing
timeFrame: Up to 30 minutes
Secondary outcomes:
measure: Surgical Pain 0=no Pain; 10=Worst Pain Ever
timeFrame: Up to 30 minutes
measure: Completely Healed at 4 Weeks
timeFrame: At the 4-week followup visit
measure: Wound Dehiscence
timeFrame: Up to 4 weeks
measure: Infection
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Marikana
country: South Africa
facility: Lonmin Hospital
state: Northwest
Study officials:
References:
citation: Millard PS, Goldstuck ND. No-needle, single-visit adult male circumcision with Unicirc: a multi-centre field trial. PLoS One. 2015 Mar 30;10(3):e0121686. doi: 10.1371/journal.pone.0121686. eCollection 2015.
citation: Shenje J, Millard PS. Sutureless Adult Voluntary Male Circumcision with Topical Anesthetic: A Randomized Field Trial of Unicirc, a Single-Use Surgical Instrument. PLoS One. 2016 Jun 14;11(6):e0157065. doi: 10.1371/journal.pone.0157065. eCollection 2016.
Clinical trial NCT05747092: Pain Killer, Anxiety and Mucogingival Therapy
Official title: Is Pain Killer Cunsumption Dependent to Anxiety or Mucogingival Therapy?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety and Depression
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: group test free gingival graft group control connective tissue graft
Primary purpose: DIAGNOSTIC

Brief summary: Is the pain killer consumption after gingival treatment related to the level of patient anxiety or to the type of therapy?

Detailed description: Anxiety and depression (HAD) scale used could be reveal the level of the patient anxiety and/or depression before intervention.

Additionnaly the use of these specific questionnaires (7 items for anxiety, 7 items for depression) could reveal if the pain killer consumption after gingical treatment is dependant to the level of HAD or to the therapy .

This tool (HAD) could allows to recognize, before any (oral)surgery, profil with high risk and propose solution to decrease anxiety and/or depression before treatment.

Eligibility criteria: Inclusion Criteria:

* ASA type I and II subjects
* Localized Gingival Recessions
* Recessions Cairo RT I-II
* FMPS \< 10%
* FMBS\< 10%
* \<10 cigs/ day
* No contra-indication against oral surgical interventions
* Patient is able to give inform consent

Exclusion Criteria:

* Infection (local or systemic). Each infection will be evaluated prior to study procedure for suitability. Patients with gingivitis or local infection (fracture, apical reaction) will undergo a dental treatment prior to his entrance to the study. In case of systemic infection, the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
* ASA type \> II
* Current pregnancy or breastfeeding women
* Alcoholism or chronically drug abuse
* Smokers, ≳ 10 cigarettes per day
* Immunocompromised patients
* Uncontrolled diabetes
* Untreated periodontitis
* History of previous periodontal surgery (mucogingival or other) on the teeth to be included
* Presence of severe tooth malposition, rotation or significant version of the tooth to be treated

Primary outcomes:
measure: pin killer consumption
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: leila Salhi
state: Liege
Study officials:
References:
Clinical trial NCT01473992: Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis
Official title: Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other and Unspecified Complications of Amputation Stump
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Otto Bock Healthcare
name: Florida High Tech Corridor Council
First posted: 2011-11-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if transfemoral amputees of varied etiology will demonstrate increased function, safety and quality of life following accommodation with a new knee prosthesis as compared to their former C-Leg knee prosthesis.


Eligibility criteria: Inclusion criteria:

* Unilateral transfemoral or knee-disarticulation amputee
* 18 to 85 years of age
* K3 (variable cadence and community) ambulators;
* Current use of and experience with the C-Leg for at least 1 year
* Ability to descend stairs and hills without caregiver and assistive devices
* Be able to independently provide informed consent
* Be willing to comply with study procedures.

Exclusion criteria:

* History of chronic skin breakdown on the residual limb
* Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking)
* Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate
* Unwillingness/inability to follow instructions

Primary outcomes:
measure: 75 Meter Self Selected Walking Test
timeFrame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
measure: Physical Functional Performance (Continuous Scale; 10-items)
timeFrame: Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete.
Secondary outcomes:
measure: Balance and Stability
timeFrame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
measure: Prosthesis Evaluation Questionnaire: Utility Score.
timeFrame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: M. Jason Highsmith, PT,DPT,CP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03209492: Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"
Official title: Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-07-06
Enrollment: 333
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of participants with a diagnosis of prostate cancer and received dose of Leuplin PRO for Injection Kit 22.5 mg/Leuprorelin acetate in the routine medical care.

Brief summary: The purpose of this study is to evaluate the safety in patients with prostate cancer receiving the drug in the routine clinical setting.

Detailed description: The drug being tested in this study is called Leuprorelin acetate (Leuplin PRO for Injection Kit 22.5 mg). Leuprorelin acetate is being tested to treat people who have prostate cancer.

This study will look at the safety in patients with prostate cancer receiving the drug in the routine clinical setting.

The study will enroll approximately 300 patients.

• Leuprorelin acetate

This multi-center trial will be conducted in Japan.

Eligibility criteria: Inclusion Criteria:

* Participants with prostate cancer will be included.

Exclusion Criteria:

* Participants with previous history of hypersensitivity to any of the ingredients of the drug or synthetic LH-RH or LH-RH derivatives

Primary outcomes:
measure: Percentage of Participants Who Had One or More Adverse Events
timeFrame: Up to Week 24
Secondary outcomes:
measure: Percentage of Participants Who Had One or More Adverse Reactions
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00860392: A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation (0000-110)
Official title: A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-03-12
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will compare two approaches to the measurement of fatty acid oxidation (ketone body flux and ketone body concentration) and determine which method demonstrates superior sensitivity and variability in the detection of moderate increases in ketogenesis rates.


Eligibility criteria: Inclusion Criteria:

* Subject has a Body Mass Index of 18-25 kg/m2 OR 29-40 kg/m2
* Subject has been a nonsmoker or has not used nicotine for the past 6 months

Exclusion Criteria:

* Subject has a history of diabetes mellitus
* Subject has a history of stroke, chronic seizures, or other neurological disorder
* Subject has a history of cancer, except certain skin cancers
* Subject consumes more than 3 alcoholic beverages per day
* Subject consumes more than 6 servings of caffeinated beverages per day
* Subject has multiple and/or severe allergies to food or drugs
* Subject has allergy or sensitivity to eggs or soy
* Subject regularly uses illicit drugs or has a history of drug or alcohol abuse

Primary outcomes:
measure: Effects of increase in serum free fatty acid levels on ketogenesis as measured using a isotopic tracer and serum ketone body concentration in healthy lean subjects
timeFrame: 5 hours
Secondary outcomes:
measure: Effects of increase in serum free fatty acid levels on ketogenesis as measured using a isotopic tracer and serum ketone body concentration in obese subjects
timeFrame: 5 hours
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: