louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00729599: Safety Dermatological Evaluation: Acceptability With Odontological Follow up - Cepacol Teen.
Official title: Single Site Study, Phase III, for Safety Dermatological Evaluation: Basic Acceptability With Odontological Follow up - Cepacol Teen.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-08-07
Enrollment: 31
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To prove the safety, in normal conditions, of the Cepacol Teen, a formulation to odontological usage.


Eligibility criteria: Inclusion Criteria:

* Integral buccal mucous (without oral pathologies);
* Normal odontological exams;

Exclusion Criteria:

* Lactation or gestational risk or gestation;
* Use of Antiinflammatory or immunosuppression drugs 15 days before the study;
* Being in odontological treatment;
* Pathological or mucous disease which can interfere or active gynaecological disease which may interfere wtih study results;
* Personal history of allergic disease in the area to be treated;
* Allergic or atopic history;

Primary outcomes:
measure: Patients will be evaluated according to the adverse reactions and the intensity of them.
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-aventis
Study officials:
affiliation: Sanofi-aventis administrative office Brazil
name: Jaderson Lima, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02128399: Antimicrobial Stewardship Reduces MDRO Isolates in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: antimicrobial stewardship
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2014-05-01
Enrollment: 978
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who admitted into intensive care unit

Brief summary: Antimicrobial exposure is known to reduce the selection for various drug-resistant organisms. Numerous studies have demonstrated the association between antimicrobial use and MDR bacteria detection. However, to the investigators knowledge, there is few data to support the concept that reducing antibiotic use actually leads to improvements in antibiotic susceptibilities. Moreover, antimicrobial stewardship was demonstrated to reduce MDRO and was strongly recommended in clinics. As the investigators know, antimicrobial overuse, which occurs commonly in China, induces a severe antibacterial resistance. China's Ministry of Health (MOH) has established a policy about the antimicrobial stewardship. To date, the investigators do not have published documentation the effects of this policy on multidrug-resistant organism (MDRO) in critically ill patients.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized in the ICU

Exclusion Criteria:

* Patients who were readmitted to the ICU during a single hospital stay

Primary outcomes:
measure: The number of participates infection or colonization with MDRO in critically ill patients at ICU admission and discharge as a measure of effect of antimicrobial stewardship
timeFrame: up to 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ma X, Xie J, Yang Y, Guo F, Gao Z, Shao H, Huang Y, Yang C, Qiu H. Antimicrobial stewardship of Chinese ministry of health reduces multidrug-resistant organism isolates in critically ill patients: a pre-post study from a single center. BMC Infect Dis. 2016 Nov 25;16(1):704. doi: 10.1186/s12879-016-2051-8.
Clinical trial NCT05653999: Assessing Speech Perception and Amplification Benefit During Infancy
Official title: Assessing Speech Perception and Amplification Benefit During Infancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Children With Hearing Differences
Amplification
Speech Perception
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Sonova AG
First posted: 2022-12-16
Enrollment: 36
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants between 6 and 36 months of age (inclusively) will be be enrolled in either the normal hearing or hearing loss cohort based on hearing status. Infants will be recruited from the community as well as through established clinical relationships with the principal investigator at Children's Hospital Colorado Audiology Centers.

Brief summary: The goal of this project is to compare aided and unaided speech discrimination among infants with hearing loss and a cohort of infants with typical hearing.

Working Hypothesis: Among this group of infants with hearing loss, performance will be significantly better when infants are tested while using amplification (i.e., aided condition) compared to when tested without amplification (i.e., unaided condition). Infants fit with optimally programmed amplification will perform similarly to the infants with typical hearing on speech discrimination tasks.


Eligibility criteria: Inclusion Criteria:

* Children between the ages of 6 months and 36 months (inclusive) at the time of enrollment.
* English is the primary spoken language in the home
* Demonstrated ability to complete a conditioned head turn via visual reinforcement audiometry (VRA)
* If normal hearing

  -Normal hearing sensitivity bilaterally
* If Hearing Loss

  * Children with diagnosis of bilateral sensorineural hearing ranging from mild to severe
  * Children currently using hearing aids
  * Children currently enrolled in intervention

Exclusion Criteria:

* Children born earlier than 35 weeks gestation
* Children with abnormal tympanometry on the day of testing
* Children with concerns of secondary disabilities
* Children with Auditory Neuropathy
* Concerns of hearing loss in normal hearing children

Primary outcomes:
measure: Behavioral Speech Perception
timeFrame: Through study completion, up to 6 weeks pending subject factors (e.g., fatigue, otitis media)
Secondary outcomes:
measure: Aided Behavioral Speech Perception Improvement
timeFrame: Through study completion, up to 6 weeks pending subject factors (e.g., fatigue, otitis media)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado School of Medicine - Speech Perception Over Time Lab
state: Colorado
Study officials:
affiliation: University of Colorado School of Medicine
name: Kristin M Uhler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01037699: Luteinizing Hormone (LH) Supplementation in Gonadotropin-releasing Hormone (GnRH) Antagonist Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Stimulation
Keywords: Ovarian stimulation
In Vitro Fertilization
Luteinizing Hormone
GnRH antagonist
Implantation rate in infertile patients undergoing In vitro fertilization and embryo transfer.
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2009-12-23
Enrollment: 720
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To analyse the impact on cycle outcome of LH supplementation in ovarian stimulation controlled with a GnRH antagonist in two ages groups: patients upto 35 years old, and patients aged between 36 and 39 years old.

Detailed description: All patients received an oral contraceptive pill with 0.030 mg of ethinyl-estradiol and 3.0 mg of drospirenone the cycle prior to ovarian stimulation. On the second day of menstruation, patients started ovarian stimulation as follows:

Patients \< 36: 225 IU/day of recombinant FSH (FSH alone group) or 150 IU of rFSH and 75 IU of rLH/day (FSH+LH group) for 5 days. On day 6, a 0.25 mg/day dose of the GnRH antagonist Cetrorelix is added until the day of rCG administration.

Patients 36-39: Initial dose of 300 IU of rFSH /day (FSH alone group)) or 225 IU of rFSH and 75 IU of rLH/day (FSH + LH group) for 5 days. On day 6, a 0.25 mg/day dose of the GnRH antagonist Cetrorelix is added until the day of rCG administration.

A maximum of 3 embryos were transferred on day 3 of embryo development.

Eligibility criteria: Inclusion Criteria:

* 1st-2nd IVF cycle.
* Age until 39 years old
* BMI: 18-29.9.
* Basal FSH \< 12 IU/L

Exclusion Criteria:

* LH:FSH \> 2 (PCO)
* Low response background (\< 5 oocytes)
* Endometrioma
* Recurrent pregnancy loss
* Any preimplantational genetic diagnosis indication
* Any systemic, metabolic or endocrinological disorder.

Primary outcomes:
measure: Implantation rate
timeFrame: 4 weeks after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
affiliation: IVI Valencia
name: Ernesto Bosch, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01326299: Post Prandial Glucose Control Proof-of-Principle
Official title: Post Prandial Glucose Control Proof-of-Principle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2011-03-30
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the postprandial glycemic response of subjects with type 2 diabetes when consuming a meal along with beverages containing various combinations of nutritional ingredients and fibers versus control beverage.


Eligibility criteria: Inclusion Criteria:

1. type 2 diabetes
2. between 21 and 75 years of age
3. male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile
4. BMI is \> 18.5 kg/m2 and \<35 kg/m2
5. HbA1c \< 9.0%

Exclusion Criteria:

1. Subject uses exogenous insulin, exenatide, or sitagliptin phosphate
2. type 1 diabetes.
3. history of diabetic ketoacidosis.
4. current infection
5. active malignancy
6. has had a significant cardiovascular event or history of congestive heart failure.
7. end-stage organ failure or post organ transplant.
8. history of renal disease.
9. hepatic disease.
10. history of gastrointestinal disorders
11. chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
12. taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications
13. clotting or bleeding disorders.
14. allergic or intolerant to any ingredient found in the study products.

Primary outcomes:
measure: Positive AUC from 0 to 240 minutes for plasma glucose.
timeFrame: 0 to 240 minutes
Secondary outcomes:
measure: Plasma glucose concentrations
timeFrame: 0 to 240 minutes
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
Study officials:
affiliation: Abbott Nutrition
name: Amy Devitt-Maicher, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02383199: Polypropylene Mesh in Prolapse Surgery
Official title: Polypropylene Mesh in Prolapse Surgery; Long-term Outcome and Complications.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2015-03-09
Enrollment: 161
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 195 first patients with pelvic organ prolapse operated on a in Turku University Hospital using polypropylene mesh

Brief summary: The purpose of this study was to report the long-term objective and subjective outcome after prolapse surgery with polypropylene mesh. The complications and the effect of the learning curve of the surgeons to the outcome is also reported.


Eligibility criteria: 195 first patients with pelvic organ prolapse operated on using polypropylene mesh

Primary outcomes:
measure: Subjective outcome with validated questionnaires
timeFrame: 7 years
Secondary outcomes:
measure: Objective outcome: anatomic outcome with Pelvic Organ Prolapse Quantification (POP-Q) system
timeFrame: 7 years
measure: Number of patients with adverse events and reoperations.
timeFrame: 7 years
Other outcomes:
Locations:
Study officials:
affiliation: Turku university hospital, Department of gynecology and obsteterics, Turku, Finland':'
name: Pia Heinonen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04006899: Development of a Segmental Bioelectrical Impedance Spectroscopy Device for Body Composition Measurement
Official title: Development of a Segmental Bioelectrical Impedance Spectroscopy Device for Body Composition Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Device
Keywords: Bioelectrical Impedance spectroscopy
Body compositions
Segmental Bioelectrical impedance spectroscopy
Lead sponsor: Georgia Southern University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Students from Georgia Southern University

Brief summary: A device for measuring body composition with a small electric current, at 200 μA, (bioelectrical impedance analysis, or BIA) was designed. The goal of this study is to validate the device against several existing devices using the same method of measuring body composition with a small electric current.

Detailed description: The measurement of individual segments, instead of the body as a whole, with BIA has not been fully explored. The prototype device is capable of directly measuring multiple body segments (arm, trunk, and leg) simultaneously, and the final version will be able to provide composition about each segment and the body as a whole. Current devices on the market are not capable of this.

The reference devices will be used to measure segments as well, and the raw measurements will be compared. The Multiscan 5000 provides segmental body composition for the arm or leg, but requires measuring it separately. The SFB7 is designed only for measuring the whole body, but the raw impedance measurement data from the SFB7 can be used for comparison, as the impedance magnitudes of individual segments will be within its measurement range. The Seca 514 doesn't directly measure segments, but it can provide segmental data by measuring from hand to foot, then from hand to hand, and finally from foot to foot. It then uses these measurements, and assumptions about the subject to provide segmental composition data.

Eligibility criteria: Inclusion Criteria:

* Students from Georgia Southern University

Exclusion Criteria:

Primary outcomes:
measure: Impedance values from each devices
timeFrame: One year IRB period
Secondary outcomes:
Other outcomes:
Locations:
city: Statesboro
country: United States
facility: Georgia Southern University
state: Georgia
Study officials:
affiliation: Georgia Southern University
name: junghun choi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01673399: Oxytocin Antagonist in Patients With Repeated Failure of Implantation
Official title: Oxytocin Antagonist in Patients With Repeated Failure of Implantation. A Prospective Randomized Placebo-controlled Double-blind Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Implantation Failure
Keywords: repeated implantation failure (RIF)
atosiban
pregnancy
Lead sponsor: AZ Jan Palfijn Gent
Sponsor class: OTHER
Collaborators: name: Onze Lieve Vrouw Hospital
First posted: 2012-08-28
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study the investigators compare the usual way of embryo transfer (without medication) with an embryo transfer while administering oxytocine antagonist. This to improve implantation and increase the pregnancy rate.


Eligibility criteria: Inclusion Criteria:

* IVF/ ICSI patients below 38 years
* 2e to 6e IVF-cycle

Exclusion Criteria:

* patients with endocrinological diseases or problems

Primary outcomes:
measure: implantation rate
timeFrame: 16 days from eggretrieval
Secondary outcomes:
measure: pregnancy rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: AZ Jan Palfijn
state: Oost-vlaanderen
Study officials:
References:
citation: Craciunas L, Tsampras N, Kollmann M, Raine-Fenning N, Choudhary M. Oxytocin antagonists for assisted reproduction. Cochrane Database Syst Rev. 2021 Sep 1;9(9):CD012375. doi: 10.1002/14651858.CD012375.pub2.
Clinical trial NCT01815099: Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder
Official title: Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder: Substudy #2
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Generalized Anxiety Disorder
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
Collaborators: name: Neuronetics
First posted: 2013-03-20
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We are investigating the feasibility and efficacy of transcranial magnetic stimulation (TMS) for patients with GAD who were placebo nonresponders in DIEF003523.1.

Detailed description: We expected to enroll five patients with GAD who failed to respond to a sham (placebo) TMS intervention. In this pilot study we enrolled three participants into a protocol including 10 rTMS sessions (twice a week for five weeks) and one into a protocol including 15 rTMS sessions (three times a week for five weeks). Assessments occurred at pretreatment and at posttreatment.

Eligibility criteria: Inclusion Criteria:

* Participated in the study DIEF003523.1, received sham "placebo" TMS and achieved \< 50% improvement in HARS at 3 month follow-up.
* Fluency in English
* Capacity to understand the nature of the study and willingness to sign informed consent form

Exclusion Criteria:

* History of epilepsy or head trauma (LOC \> 5 minutes) within the past 6 months
* Lifetime history of increased intracranial pressure, seizure disorder, stroke, brain tumor, multiple sclerosis, or brain surgery
* A review of patient medications by the study physician indicates an increased risk of seizure
* An active autoimmune, endocrine, viral, or vascular disorder affecting the brain; any unstable cardiac disease; hypertension; or severe renal or liver insufficiency
* Substance use disorder or PTSD within the past 6 months
* Lifetime bipolar disorder, obsessive-compulsive disorder (OCD), psychotic disorder, mental retardation, or pervasive developmental disorder
* Any psychotic features, including dementia or delirium
* Concurrent psychotherapy and unwillingness to discontinue
* Medication change within the past 4 weeks
* Current serious suicidal or homicidal ideation, and/or serious suicidal attempt within the past 6 months
* Serious, unstable, or terminal medical condition or clinically judged too psychiatrically unstable to participate in the study
* Any contraindication for participation in MRI scan

Primary outcomes:
measure: Change in The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Before and After TMS Treatment.
timeFrame: Approximately 1 week prior to initial TMS treatment session, 1 week after final TMS treatment session
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: Gretchen J Diefenbach, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01097499: Low Level Laser (LED) Use to Increase Dental Implant Stability and Post Operative Analgesia
Official title: Role of Light Emitting Diode on Implant Stability, Bone Resorption and Analgesia Post Dental Implant Placement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Implant
Analgesia
Keywords: Dental implant initial stability
Initial bone resorption post implant placement
Analgesia effect of LED intervention
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2010-04-01
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study hypothesis: Low level laser (LED) will reduce initial bone resorption and improve primary stability of dental implant. It will also reduces post operative pain compared to patient without treatment

Implant osseointegration depends on many factors including biocompatibility of implant materials, design, surface, surgical access, patient conditions, biomechanical status, and lack of primary stability.

Several in vivo and in vitro studies showed the healing effect of low level laser therapy (LLLT) on bone by decreasing the initial bone resorption postoperatively and increasing the primary stability of the implant. It has also shown to have an analgesic effect intraorally when used post intraoral surgical procedures. The exact mechanism is unclear despite the fact that many hypothesis has been proposed.

In our study, our goal is to present, in a randomized standardized clinical trial, the effect of LLLT on post operative implant stability assessed by resonance frequency analysis (RFA). We will assess the subjective measures of postoperative pain using visual analog scale (VAS).


Eligibility criteria: Inclusion Criteria:

* 1) English speaking

Exclusion Criteria:

* 1) Systemic factors: Diabetes, systemic immune disease, smoking (non-smoking is not absolute, but preferable.)
* 2) Local factors: No immediate implants, No grafting to the site, No other implants at separate location in the mouth around the same treatment period.

Primary outcomes:
measure: Implant stability
timeFrame: Immediately post-op, 1, 2, 4, and 8 weeks
Secondary outcomes:
measure: Post-op analgesics
timeFrame: Every 3 hours the day of the surgery post-op, then every morning, and at bed time for the following 7 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: University of Toronto/Mount Sinai Hospital
name: Cameron Clokie, DDS, FRCS
role: STUDY_DIRECTOR
References: