louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03578965: Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions
Official title: Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions: A Double-Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Premalignant Vulvar Lesion
Benign Vulvar Lesion
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized control trial will provide the most reliable data to determine the role of prophylactic antibiotics to decrease the wound complication rate. The investigators plan to perform a pilot study to evaluate actual rates of wound complications and how long it takes to recruit 50 patients.


Eligibility criteria: Inclusion Criteria:

* All women, \>=18 undergoing vulvar surgery
* Biopsy proven benign or premalignant lesion requiring surgical management.
* Women of childbearing age will be required to have a negative human chorionic gonadotropin (HCG) test within seven days of surgery.
* Scheduled to undergo surgical management for their vulvar disease supervised by a faculty member within the Division of OBGYN at Washington University School of Medicine
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

* Women who are pregnant
* Women scheduled to undergo a radical vulvectomy
* Women scheduled to undergo a concomitant graft, flap or plastic surgery
* Women \<18 years of age
* History of prior vulvar radiation
* Inability to sign an informed consent form prior to registration on study
* Inability to understand spoken or written English
* Prisoner

Primary outcomes:
measure: Vulvar Wound Complications Compared Between the Two Arms
timeFrame: Within 30 days of surgery (estimated to be 30 days)
Secondary outcomes:
measure: Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection
timeFrame: Within 30 days of surgery (estimated to be 30 days)
measure: Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications
timeFrame: Within 30 days of surgery (estimated to be 30 days)
measure: Incidence of Adverse Events to Antibiotic Use
timeFrame: Within 30 days of surgery (estimated to be 30 days)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Mary M Mullen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05928065: Ultrasound Analysis of Suspected Long Bone Fractures in the Emergency Department - Diagnostic Performance Compared to Radiography.
Official title: Ultrasound Analysis of Suspected Long Bone Fractures in the Emergency Department - Diagnostic Performance Compared to Radiography.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Fracture
Keywords: bone trauma
bone
Ultrasound
fracture
radiography
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 186
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged between 0 to 18 with low kinetic, non-deforming, non-open long bone trauma will be included.

Brief summary: Ultrasound tool in bones trauma is underused in the emergency department of the University Hospital of Saint-Etienne. This prospective non randomized monocentric study will measure how much this non irradiant method of diagnostic is sensible and specific in long bones fractures, and will evaluate it advantages versus conventional X ray examination.

Detailed description: This study is based on physical examination (swelling, hematoma, edema) and concerns all long bones, including benign trauma (non deforming and closed fractures). The necessary time to make an ultrasound conclusion and the operator certitude degree will be measured.

Eligibility criteria: Inclusion Criteria:

* Children with low kinetic, non-deforming, non-open long bone trauma

Exclusion Criteria:

* Opened fracture, deforming trauma

Primary outcomes:
measure: Analysis concordance between the ultrasound and radiographic method for the diagnosis of long bone fractures.
timeFrame: Year: 1
Secondary outcomes:
measure: Analysis diagnostic performance between the ultrasound and radiographic method
timeFrame: Year: 1
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Aymeric CANTAIS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00315965: Development of a New Method for Steady-State Measurement of NO Lung Diffusing Capacity in Healthy Subjects
Official title: Development of a New Method for Steady-State Measurement of NO Lung Diffusing Capacity in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pulmonary Diffusing Capacity
Keywords: Diffusion
Membrane diffusing capacity
Alveolar capillary gas diffusion
Transfer factor
Nitric oxide diffusion
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2006-04-19
Enrollment: 107
Sex: ALL
Minimum age (years): 6
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Using a rapidly responding nitric oxide analyzer in a new developed modular lung-function-setup we are going to measure steady-state NO diffusing capacity in 107 healthy subjects (age 6-45 years). The results will be compared to those measured by using carbon monoxide single-breath estimates. We like to show that the new method is sufficient to measure exactly lung diffusion capacity in this collective.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Lung function testing possible
* Written consent

Exclusion Criteria:

* Pulmonary, neuromuscular, cardiovascular, endocrinological illness
* Pregnancy
* Abuse of nicotine, alcohol, drugs during the last two years

Primary outcomes:
measure: TLNOss
measure: TLCOsb
Secondary outcomes:
measure: Breathing frequency
measure: tidal volume
measure: functional residual capacity
measure: airway resistance
measure: lung clearance index
measure: forced expiratory volume in one second
measure: vital capacity
measure: total lung capacity
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University children´s hospital
Study officials:
affiliation: University Hospital Tuebingen, Germany
name: Tobias Pantalitschka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02767466: Affective Responses in Neurological Rehabilitation
Official title: A Preliminary Study on Acute Affective Responses Focussing on Differences Between Physical Therapy and Robotic Assisted Gait Training
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurological Incidents
Stroke
Traumatic Brain Injury
Lead sponsor: Universitaet Innsbruck
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with neurological disorders

Brief summary: Using a single blind within-subject design, 16 patients with neurological disorders were randomly exposed to two different treatments: physical therapy and robotic assisted gait training. Both before and after the treatments, a self-report Mood Survey Scale (MSS) was used to assess the effects on the treatment on distinct affective states. The subscales of the MSS were tested for pre-post changes and different effects between treatments with non-parametric tests.


Eligibility criteria: Inclusion Criteria:

* voluntary participation
* neurological incident

Exclusion Criteria:

* lack of communication ability
* interference of consciousness
* inability to speak German language

Primary outcomes:
measure: Change of subscales of mood survey scale from pre to post treatment
timeFrame: 30-60 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Univeryity of Innsbruck
name: Martin Kopp, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT02025166: Comparison Between Two Analgesic Methods for Pain Relief Following Surgical Abortion
Official title: Comparison Between Two Analgesic Methods for Pain Relief Following Surgical Abortion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Pain
abortion
paracetamol
lornoxicam
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare between the efficacy of Paracetamol IV vs. Lornoxicam IV in pain relief following surgical abortion.

The medication will be given at the time of the procedure. Following the abortion, pain level will be evaluated.

Detailed description: Patients with medical indication for surgical abortion during first trimester will be divided to two groups. The study groups, the surgeons and the nurses will be blinded to one of the treatment arms.

Pain will be evaluated at fixed intervals following the abortion. Comparison in pain levels between the study groups will be analysed.

Eligibility criteria: Inclusion Criteria:

* Elective surgical abortion for first trimester pregnancy

Exclusion Criteria:

* Chronic pelvic pain
* Fibromyalgia
* Pelvic inflammatory disease
* Chronic renal failure, liver disease, peptic ulcer
* cervical stenosis

Primary outcomes:
measure: Pain
timeFrame: Two hours
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Susana Mustafa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus
name: Nibal Awad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02840266: The Accuracy of Automated Audiometry Application on Smart Phone to Screen Hearing Loss
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hearing Loss
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 555
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who underwent hearing test in our otologic clinic

Brief summary: The purpose of study is to determine the diagnostic value of Hearing test program on smart phone for detected patients who has hearing loss.


Eligibility criteria: Inclusion Criteria:

* Patient who underwent hearing test in our otologic clinic

Exclusion Criteria:

* Age below 15 year
* Patients who cannot following command

Primary outcomes:
measure: The accuracy of automated audiometry application on smart phone to screen hearing loss
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
Study officials:
affiliation: Khon Kaen University
name: Pornthep Kasemsiri, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03300466: A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds
Official title: A Randomized, Controlled, Evaluator-blinded, Split Face Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasolabial Fold
Safety
Keywords: Hyaluronic Acid, Lidocaine
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2017-10-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to assess the performance and safety of GP0045 when injected in the nasolabial folds.

There is an 18 months follow up period.


Eligibility criteria: Inclusion Criteria:

* Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability to give consent to participate in the study
* Signed and dated informed consent to participate in the study, including photo consent
* Subjects with intent to undergo correction of both nasolabial folds

Exclusion Criteria:

* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel
* Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics
* Any condition (medical or other) that, in the opinion of the Investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study)
* Participation in any other clinical study with an investigational product within 30 days before treatment

Primary outcomes:
measure: Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale
timeFrame: 6 months
Secondary outcomes:
measure: Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale
timeFrame: 2 weeks, 3, 9, 12, 15 and 18 months
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Q-Med
Study officials:
affiliation: Galderma R&D
name: Q-Med AB
role: STUDY_DIRECTOR
References:
Clinical trial NCT03377166: Measuring Subjective Visual Vertical (SVV) Using a Smartphone Application
Official title: Measuring Subjective Visual Vertical (SVV) Using a Smartphone Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjective Visual Vertical
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-12-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A comparison between two methods evaluating SVV: Bucket Test and A smartphone-based test.


Eligibility criteria: Inclusion Criteria:

* Vestibular Disorder

Exclusion Criteria:

* Chronic ear disease, Neurological disorder, s/p Ear surgery

Primary outcomes:
measure: Results of Bucket test Smartphone-based evaluation of SVV
timeFrame: 5 minutes
measure: Results of Smartphone-based evaluation of SVV
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: The Tel Aviv Sourasky Medical Center
Study officials:
References:
Clinical trial NCT02009566: Healthy Volunteer Visibility Study of Micromachined Tags for the Detection of Surgical Sponges
Official title: Healthy Volunteer Visibility Study of Micromachined Tags for the Detection of Surgical Sponges
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Injury Due to Foreign Object Accidentally Left in Body During Surgical Operation
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-12-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Surgical sponges can be accidentally left inside patient's bodies. We are working on special tags (called microfabricated tags) that surgeons can put on their sponges. Then, if the surgeons forget to remove a sponge from a patient, they'll be able to detect these special tags in an x-ray.

Detailed description: Surgical sponges can be accidentally left inside patient's bodies. We are working on special tags (called microfabricated tags) that surgeons can put on their sponges. Then, if the surgeons forget to remove a sponge from a patient, they'll be able to detect these special tags in an x-ray. We wish to take x-rays of healthy people's abdomens with microfabricated tags lying on them. The x-rays will help us improve our system for detecting sponges left inside people's bodies.

Eligibility criteria: Inclusion Criteria:

1. Healthy men and women
2. Ages 18 or older -

Exclusion Criteria:

1. Under 18 years of age
2. Pregnant female or if female has not had a negative pregnancy test prior to the research scans.

   -

Primary outcomes:
measure: Validate the CAD (computer aided detection) system
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan Hospital
name: Aine Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01060566: Study of VX-770 on Midazolam and Rosiglitazone and the Effect of Fluconazole on VX-770
Official title: An Open-Label Phase 1 Study to Examine the Effect of VX-770 on Midazolam and Rosiglitazone and the Effect of Fluconazole on VX-770 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2010-02-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to evaluate the effects of VX-770 on Midazolam and Rosiglitazone, and the effect of Fluconazole on VX-770.


Eligibility criteria: Inclusion Criteria:

* Subjects must be male or female and between 18 and 55 years of age.
* Subjects must be judged to be in good health.
* Subjects must have a body mass index (BMI) from 18 to 30 kg/m2.

Exclusion Criteria:

* History of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject.
* Subjects who have human immunodeficiency virus (HIV), hepatitis C, or active hepatitis B.
* Female subjects and female partner(s) of male subjects who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug.
* History of cardiovascular disease, hypoglycemia, or edema.

Primary outcomes:
measure: Midazolam, Rosiglitazone and VX 770 pharmacokinetic (PK) parameter
timeFrame: 11 days
measure: Fluconazole and VX 770 PK parameters
timeFrame: 10 days
Secondary outcomes:
measure: 1´ hydroxy midazolam PK parameters in plasma
timeFrame: 11 days
measure: Safety as measured by adverse events, physical examinations, vital signs, ECGs, and clinically significant laboratory assessments
timeFrame: 21 days
measure: Metabolites PK parameters in plasma
timeFrame: 21 days
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covan CRU, Inc.
state: Florida
Study officials:
affiliation: Covance CRU, Inc.
name: H. Frank Farmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04465266: A Phase 1 PK Study of Tolperisone in Healthy Subjects
Official title: A Phase 1 Crossover Study of Single and Multiple Dose Pharmacokinetics, and Dose Linearity, of Tolperisone in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Neurana Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-10
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: sequence randomized
Primary purpose: OTHER

Brief summary: This is a randomized, single-blind, single and multiple dose crossover subjects in healthy adult subjects

Detailed description: This is a single-center, in-patient, treatment sequence-randomized, single-blind SD and MD crossover study in 27 healthy adult male and female subjects. Subjects will be admitted to the clinic on Day-1 and discharged the morning of Day 5 of each treatment period. Subjects will be on a standard diet during each inpatient treatment period; study drug will be administered in the fasted state for PK assessments on Days 1 and 4 of each treatment period. Subjects will have a follow-up phone call 7 to 10 days after the last dose in Period 3. There will be a 6 to 8 day washout between the last dose in Period 1 and the first dose in Period 2, and between the last dose in Period 2 and the first dose in Period 3.

Eligibility criteria: Inclusion Criteria:

* Generally Healthy Subjects
* BMI between 18.5 and 32.5 kg/m2

Exclusion Criteria:

- pregnant or breastfeeding

Primary outcomes:
measure: Cmax
timeFrame: taken over 4 days per dose
measure: Tmax
timeFrame: taken over 4 days per dose
measure: AUC
timeFrame: taken over 4 days per dose
measure: T1/2
timeFrame: taken over 4 days per dose
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Worldwide Clinical Trials Early Phase Services, LLC
state: Texas
Study officials:
References: