louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00877279: Multicenter Study of the Safety and Efficacy of Dermal Filler, Belotero® Soft
Official title: A Randomized,Blinded,Controlled,Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero® Soft, After Superficial to Mid Dermal Implantation for Correction of Mild Facial Wrinkles Over 4 Weeks.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Facial Wrinkles
Keywords: Facial wrinkles
Nasolabial folds
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to determine the safety and effectiveness of Belotero® Soft compared to active comparator in the correction of mild facial wrinkles, such as nasolabial folds.

Detailed description: The purpose of the study is to see if Belotero® Soft is safe and effective for correction of mild facial wrinkles, such as nasolabial folds. The second objective of the study is to see if Belotero® Soft works better than the active comparator. Subjects will receive Belotero® Soft injection to one side of the face and the active comparator to the other side of the face.

Eligibility criteria: Inclusion Criteria:

* Subjects must have bilateral facial wrinkles, such as nasolabial folds

Exclusion Criteria:

* Other nasolabial fold correction within 6 months prior to study entry.

Primary outcomes:
measure: The severity of the facial wrinkle
timeFrame: 2 weeks and 4 weeks
Secondary outcomes:
measure: Investigator and subject assessments
timeFrame: 2 weeks and 4 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Skin Care & Laser Physicians of Beverly Hills
state: California
city: San Francisco
country: United States
facility: Maas Clinic
state: California
city: New Haven
country: United States
facility: Savin Dermatology Center
state: Connecticut
city: Metairie
country: United States
facility: William Coleman, III, MD
state: Louisiana
city: White Plains
country: United States
facility: Dermatology Surgery and Laser Center
state: New York
Study officials:
affiliation: Dermatology Surgery and Laser Center
name: Rhoda Narins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01910779: Optimization of Initial Energy for Cardioversion of Atrial Fibrillation With Biphasic Shocks
Official title: Optimization of Initial Energy for Cardioversion of Atrial Fibrillation With Biphasic Shocks (OPTIMA Trial).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Cardioversion
Keywords: Atrial Fibrillation
Cardioversion
Biphasic Shock
Lead sponsor: Maria Vittoria Hospital
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Use of higher energy doses (120-150 J) may not offer additional benefits and higher success rate compared with low to moderate initial energy (100-120 J) of biphasic shock for atrial fibrillation cardioversion. In this prospective open-label randomized trial consecutive patients with AF and candidate to AF electrical cardioversion will be randomized to receive 100J or 120 J as initial dose of biphasic shock. Patients will be also randomized in each group to anterolateral or postero-anteriore placement of defibrillator electrodes.

Detailed description: Open-label randomized trial to assess the efficacy of alternative initial biphasic shocks (100 versus 120 J) for cardioversion of atrial fibrillation including alternative option for electrode placement (anterolateral or postero-anterior in each group).

Eligibility criteria: Inclusion Criteria:

* Adult (Age\>18 years)
* Candidate to Cardioversion for recent onset, persistent atrial fibrillation (\>48 hours but \< 12 months)
* Informed Consent

Exclusion Criteria:

* Atrial Flutter or other arrythmias

Primary outcomes:
measure: Electrical cardioversion success
timeFrame: Day 1
Secondary outcomes:
measure: Electrical cardioversion success
timeFrame: 3 months
measure: Complications rate
timeFrame: Day 1
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Cardiology Dpt. Maria Vittoria Hospital
Study officials:
affiliation: Cardiology Dpt. Maria Vittoria Hospital, Torino, Italy
name: Massimo Imazio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04877379: VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers
Official title: VNRX-7145-102: A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics (PK) of VNRX-7145 and VNRX-5024 (Ceftibuten) in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Venatorx Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2021-05-07
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Part 1: Crossover Parts 2\&3: Parallel
Primary purpose: BASIC_SCIENCE

Brief summary: This study will provide an initial assessment of the safety and PK of VNRX-7145 and VNRX-5024 (ceftibuten) when administered as single agents and with co-administration in a single dose cross-over design in Part 1. In Part 2, subjects will receive 500 mg of VNRX-7145 or matching placebo q8h for 10 days. VNRX-7145 and VNRX-5024 (ceftibuten) will be administered every 8 hours (q8h) for 10 days at 2 dose levels of VNRX-7145 in Part 3.


Eligibility criteria: Inclusion Criteria:

1. Healthy adults 18-55 years
2. Males or non-pregnant, non-lactating females
3. Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
4. Normal blood pressure
5. Normal lab tests

Exclusion Criteria:

1. History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders
2. History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
3. Use of antacid medications
4. Abnormal ECG or history of clinically significant abnormal rhythm disorder
5. Positive alcohol, drug, or tobacco use/test

Primary outcomes:
measure: Part 1: Cmax
timeFrame: 0-48 hours
measure: Part 1: AUC0-inf
timeFrame: 0-48 hours
measure: Parts 2&3: Number of subjects with adverse events
timeFrame: Day 15 (+2)
Secondary outcomes:
measure: Part 1: Number of subjects with adverse events
timeFrame: Day 14 (+2)
measure: Parts 2&3: AUC0-tau
timeFrame: Day 1
measure: Parts 2&3: AUC0-tau
timeFrame: Day 10
measure: Parts 2&3: Cmax
timeFrame: Day 1
measure: Parts 2&3: Cmax
timeFrame: Day 10
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences - Early Development Services
Study officials:
References:
Clinical trial NCT04605679: Hepatitis C Virus (HCV) Positive Kidney Grafts in HCV Negative Recipients
Official title: Transplantation of HCV Donor Kidneys in HCV Negative or Previously Successfully Treated Recipients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kidney Failure
Keywords: HCV
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the efficacy and safety of transplanting HCV positive kidney allografts to HCV sero-negative patients who are on the waiting list.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age 18 and older
* English and Spanish speaking patients
* Active on the waiting list for kidney transplantation
* Donor organ with Antibody and NAT (nucleic acid test) positive for HCV
* HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy.
* Willing and able to provide written informed consent

Exclusion Criteria:

* Participants co-infected with HIV
* Donor previously treated with an NS5a containing regimen (if treatment history of donor known)
* Known allergies or hypersensitivity to DAA or RBV
* Pregnancy and/or actively breastfeeding

Primary outcomes:
measure: 1-year graft and patient survival
timeFrame: From the date of transplant through the last day of 12 month post transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health-Transplant Institute
state: California
Study officials:
affiliation: Loma Linda University Health
name: Michael E de Vera, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reese PP, Abt PL, Blumberg EA, Van Deerlin VM, Bloom RD, Potluri VS, Levine M, Porrett P, Sawinski D, Nazarian SM, Naji A, Hasz R, Suplee L, Trofe-Clark J, Sicilia A, McCauley M, Gentile C, Smith J, Niknam BA, Bleicher M, Reddy KR, Goldberg DS. Twelve-Month Outcomes After Transplant of Hepatitis C-Infected Kidneys Into Uninfected Recipients: A Single-Group Trial. Ann Intern Med. 2018 Sep 4;169(5):273-281. doi: 10.7326/M18-0749. Epub 2018 Aug 7.
citation: Durand CM, Bowring MG, Brown DM, Chattergoon MA, Massaccesi G, Bair N, Wesson R, Reyad A, Naqvi FF, Ostrander D, Sugarman J, Segev DL, Sulkowski M, Desai NM. Direct-Acting Antiviral Prophylaxis in Kidney Transplantation From Hepatitis C Virus-Infected Donors to Noninfected Recipients: An Open-Label Nonrandomized Trial. Ann Intern Med. 2018 Apr 17;168(8):533-540. doi: 10.7326/M17-2871. Epub 2018 Mar 6.
Clinical trial NCT04003779: Reconfiguring the Patient Room to Increase Patient Stability
Official title: Reconfiguring the Patient Room for a Fall Protection Strategy to Increase Patient Stability During Ambulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly, Frail
Accidental Falls
Hospitals
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: The Center for Health Design
First posted: 2019-07-01
Enrollment: 18
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Using virtual reality and ergonomic measures, we will sequentially adjust features of the hospital room to determine the most stable gate in frail elderly patients.
Primary purpose: OTHER

Brief summary: Despite decades of research into patient falls, falls and the injuries incurred continue to be a serious threat to patient safety. Fall rates continue to be unacceptably high. The purpose of this project is to increase the safety of a hospital room for patient mobility, using innovative simulation strategies and patient-centric design.

Detailed description: Despite decades of research into patient falls, falls and the injuries incurred continue to be a serious threat to patient safety. Fall rates continue to be unacceptably high. The purpose of this project is to increase the safety of a hospital room for patient mobility, using innovative simulation strategies and patient-centric design.

An innovative simulation environment will be built to enable rapid assessment of room layout and fixture positioning and patient stability. The results from multiple simulations will be used to fabricate a prototype room layout that will be tested by patients with Parkinson disease and reviewed and updated with input from other relevant stakeholders. A final room prototype will be built and tested. Results will be translated and shared with all stakeholders and disseminated for implementation.

Eligibility criteria: Inclusion Criteria:

* Frail elderly, impaired gait

Exclusion Criteria:

* Use of walking aid

Primary outcomes:
measure: Gait: increased stability
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Dumke Health Professions Building
state: Utah
Study officials:
affiliation: University of Utah
name: Bob G Wong, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Andrew Merryweather, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02450279: Scintigraphic Comparison of Lung Deposition With Two Nebulizers During Invasive Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post-operative Neurosurgery
Keywords: Aerosol delivery
Invasive mechanical ventilation
Jet Nebulizer
Vibrating-Mesh nebulizer
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many devices are available for nebulising drug solution during invasive mechanical ventilation. Vibrating-mesh nebulizers ensure the highest lung deposition output. A recent international survey on aerosol therapy during mechanical ventilation (Ehrmann et al. 2013) reported that jet nebulizers remained the mostly used.

The aim of this study is to compare lung deposition of a radiolabeled administered with both nebulizers during invasive mechanical ventilation by planar scintigraphy.


Eligibility criteria: Inclusion Criteria:

* Invasive mechanical ventilation
* Healthy lungs

Exclusion Criteria:

* Discontinued procedure due to adverse events.

Primary outcomes:
measure: Pulmonary deposition
timeFrame: Immediately after nebulization by imaging assessment, an expected average of 30 minutes
Secondary outcomes:
measure: Penetration index
timeFrame: Immediately after nebulization by imaging assessment, an expected average of 30 minutes
measure: Mechanical ventilation settings
timeFrame: During nebulisation time, an expected average of 15 minutes
measure: Lung function
timeFrame: Preoperative assessment, the day before inclusion
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
affiliation: Head of Intensive Care Unit, Cliniques Universitaires Saint-Luc
name: Pierre-François Laterre
role: STUDY_CHAIR
References:
Clinical trial NCT01564979: Effect on Tear Functions of Pretarsal and Preseptal Techniques of Botulinum Toxin Type A Injection in Hemifacial Spasm
Official title: Effect on Tear Functions of Pretarsal and Preseptal Techniques of Botulinum Toxin Type A Injection in Hemifacial Spasm
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hemifacial Spasm
Keywords: botulinum toxin
facial nerve
hemifacial spasm
tears
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2012-03-28
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
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 determine whether pretarsal and preseptal techniques of Botulinum toxin type A injection have any effect on tear functions.

Detailed description: Botulinum toxin type A has been used for hemifacial spasm since 1986. of Botulinum toxin type A can be subcutaneously injected at pretarsal or preseptal portion of orbicularis muscle. Blepharoptosis has been reported less frequently with pretarsal technique, however dry eye was noticed in one patient treated with pretarsal botulinum toxin type A for cosmetic purpose.

Eligibility criteria: Inclusion Criteria:

* patient diagnosed with hemifacial spasm

Exclusion Criteria:

* previous history of botulinum toxin treatment for hemifacial spasm
* ocular surface disorders
* tear disorders
* evidence of infection at or around eyelids
* pregnant woman
* other neurologic disease, i.e. OMG
* coagulopathy or treatment with thrombolytic agent
* treatment with aminoglycosides, chloroquine, hydroxychloroquine

Primary outcomes:
measure: tear break up time
timeFrame: change from baseline in tear break up time at 12 weeks
Secondary outcomes:
measure: schirmer's test
timeFrame: change from baseline of schirmer's test at 12 weeks
Other outcomes:
Locations:
city: Muang
country: Thailand
facility: Khon Kaen University
state: Khon Kaen
Study officials:
affiliation: Khon Kaen University
name: kitthisak kithaweesin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Price J, O'Day J. A comparative study of tear secretion in blepharospasm and hemifacial spasm patients treated with botulinum toxin. J Clin Neuroophthalmol. 1993 Mar;13(1):67-71.
Clinical trial NCT05470179: Changes in Arch Parameters After Molar Distalization; Hybrid Hyrax Distalizer Versus Pendulum
Official title: Changes in Arch Parameters After Molar Distalization; Hybrid Hyrax Distalizer Versus Pendulum in Adolescent Class II Patients Prospective Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Angle Class 2 Malocclusion
Keywords: hybrid hyrax distalizer
Pendulum distalizer
class II division 1 and 2
molar distalization
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study was to compare the changes in arch parameters after molar distalization; hybrid hyrax distalizer versus Pendulum distalizer using CBCT.

Detailed description: Evaluation of maxillary molar amount of distal movement and the amount of anchorage loss Arch length, arch width, arch depth

Eligibility criteria: Inclusion Criteria:

* For group 1(Hybrid hyrax distalizer) Patients suffering maxillary collapse with a skeletal background with unilateral or bilateral posterior crossbite.
* For group 2 (Pendulum distalizer) Patients with skeletal class I or class II malocclusion who needed upper first and second molar distalization for incisor retraction or relieving of the upper arch crowding and minimum or no crowding in lower jaw were selected.
* All Patients had no systemic diseases that may affect bone quality or interfere with orthodontic treatment, periodontal disease and no previous orthodontic treatment.
* Age range was 13 to 17 years.

Exclusion Criteria:

* Missed upper first molar.
* un-cooperative patient

Primary outcomes:
measure: Angles in degree SNA,SNB,ANB, Molar Rotation
timeFrame: 6 months
measure: Arch parameters in millimeter Arch length, width,depth and circumference
timeFrame: 6 Months
Secondary outcomes:
measure: Nasopharyngeal airway dimensions in Cubic centimeters
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mohamed Shendy
state: Nasr City
city: Cairo
country: Egypt
facility: Cairo
Study officials:
affiliation: Lecturer - Orthodontic department -faculty of dental medicine -Al-Azhar university
name: Mohamed AE Shendy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bishara SE, Staley RN. Maxillary expansion: clinical implications. Am J Orthod Dentofacial Orthop. 1987 Jan;91(1):3-14. doi: 10.1016/0889-5406(87)90202-2.
citation: Haas AJ. Palatal expansion: just the beginning of dentofacial orthopedics. Am J Orthod. 1970 Mar;57(3):219-55. doi: 10.1016/0002-9416(70)90241-1. No abstract available.
Clinical trial NCT02685579: The Effect of Obstructive Sleep Apnea Treatment on Dizziness, Vertigo
Official title: The Effect of Obstructive Sleep Apnea Treatment on Dizziness, Vertigo
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sleep Apnea
Dizziness
Vertigo
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-02-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People coming to the Sleep Study Laboratory at the E. Wolfson Medical Center

Brief summary: Obstructive Sleep Apnea may cause dizziness or vertigo through hypoxia of the vestibular nuclei in the brain. Treating sleep apnea may improve dizziness or vertigo.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Diagnosed with Sleep Apnea
* DHI score equals or over 16 points

Exclusion Criteria:

* Pregnant women
* Patients diagnosed with mental diseases
* Patients taking anti-vertigo medications
* Patients after CVA or with peripheral neuropathy
* Patients who suffered severe head trauma
* Patients with chronic renal failure
* Patients with malignancy at the time of the study

Primary outcomes:
measure: Dizziness Handicap Inventory Score
timeFrame: 3 months
Secondary outcomes:
measure: Romberg on foam test
timeFrame: 3 months
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson Medical Centre
Study officials:
References:
Clinical trial NCT01623479: An Observational Study of Patients Treated With Bimatoprost 0.03% (Latisse®) for Hypotrichosis of the Eyelashes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eyelash Hypotrichosis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-06-20
Enrollment: 585
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: Subjects with hypotrichosis of the eyelashes

Brief summary: This is an observational study of patients treated with bimatoprost 0.03% (Latisse®) for at least 12 months for hypotrichosis of the eyelashes.


Eligibility criteria: Inclusion Criteria:

* Hypotrichosis of the eyelashes
* Using bimatoprost ophthalmic solution 0.03% (Latisse®) for at least 12 months

Exclusion Criteria:

* Use of any over-the-counter medication(s) for eyelash growth

Primary outcomes:
measure: Percentage of Subjects Satisfied With Latisse®
timeFrame: Day 1
Secondary outcomes:
measure: Number of Applications of Latisse® Per Week
timeFrame: Day 1
measure: Percentage of Subjects Satisfied Wtih Their Eyelashes
timeFrame: Day 1
Other outcomes:
Locations:
city: Santa Ana
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Yoelin SG, Fagien S, Cox SE, Davis PG, Campo A, Caulkins CA, Gallagher CJ. A retrospective review and observational study of outcomes and safety of bimatoprost ophthalmic solution 0.03% for treating eyelash hypotrichosis. Dermatol Surg. 2014 Oct;40(10):1118-24. doi: 10.1097/01.DSS.0000452658.83001.d9.