louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00495313: Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens
Official title: Determine the Effects of COL-101 Administered Once Daily With Metronidazole Topical Gel, 1% Versus Doxycycline Hyclate 100 mg Administered Once Daily With Metronidazole Topical Gel, 1% in Patients With Moderate to Severe Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rosacea
Keywords: Rosacea
Lead sponsor: CollaGenex Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-07-03
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1%

Detailed description: Compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1%

Eligibility criteria: Inclusion Criteria:

* 8-40 total lesions
* erythema
* telangiectasia

Exclusion Criteria:

* non-pregnant, non-lactating
* achlorhydric
* gastric by-pass surgery
* allergy to study medications
* drug/alcohol abuse
* use of proton pump inhibitors

Primary outcomes:
measure: Change in total lesion count from Baseline at the study endpoint
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in Investigator's Global Assessment from Baseline at the study endpoint
timeFrame: 16 weeks
measure: Change in Clinician's Erythema Assessment score from Baseline at the study endpoint
timeFrame: 16 weeks
measure: Change in total lesion count (papules + pustules + nodules) from Baseline at each visit
timeFrame: 4 weeks, 8 weeks, 12 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Joel Schlessinger
state: Nebraska
city: Las Vegas
country: United States
facility: James Del Rosso
state: Nevada
city: Arlington
country: United States
facility: Angela Moore
state: Texas
city: Dallas
country: United States
facility: William Abramovits
state: Texas
city: West Jordan
country: United States
facility: Douglas Forsha
state: Utah
city: Seattle
country: United States
facility: Bernard Goffe
state: Washington
city: Spokane
country: United States
facility: William Werschler
state: Washington
Study officials:
affiliation: CollaGenex Pharmaceuticals
name: Christopher V Powala, JD
role: STUDY_CHAIR
References:
Clinical trial NCT04134013: Nutrient Nutritional Advise for Low Back Pain Patients Seeking Chiropractic Care
Official title: Nutrition Plus Chiropractic Care for Low Back Pain: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Nutrition Poor
Keywords: Chiropractic manipulation
spinal manipulation therapy
osteopathic manipulation
Lead sponsor: Parker University
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into one of two arms: 1) nutrition+chiropractic or 2) chiropractic only
Primary purpose: TREATMENT

Brief summary: The nutritional intervention will reduce LBP and cause 10% weight loss.

Detailed description: This feasibility study will assess a two-armed low-back pain (LBP) randomized, prospective clinical trial with nutritional offerings provided for one-arm.

Eligibility criteria: Inclusion Criteria:

BMI 25-40, Experiencing LBP (VAS\>4, mechanical, chronic), not pregnant

Exclusion Criteria:

Primary outcomes:
measure: Low back pain evaluation using NPRS
timeFrame: Maximum six weeks of care
measure: Weight loss being measured using scale in pounds
timeFrame: Beginning of study and re-evaluation at the end of six weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Plano
country: United States
facility: Katie Pohlman
state: Texas
Study officials:
References:
Clinical trial NCT04572113: Comparison of Cervical Motion Restriction and Interface Pressure Between Two Cervical Collars
Official title: Comparison of Cervical Motion Restriction and Interface Pressure Between Two Cervical Collars
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Pain
Keywords: Neck pain
Cervical collar
Lead sponsor: More Foundation
Sponsor class: OTHER
Collaborators: name: DJO LLC
First posted: 2020-10-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited by word of mouth from the surrounding general population and may include staff of MORE Foundation and The CORE Institute.

Brief summary: Cervical orthoses are used to restrict motion for the purpose of preventing spinal instability following trauma or pre- and post-surgery or to protect from pain. Modern cervical orthoses are able to effectively restrict motion of the head however load is concentrated on areas of occipital tissue and may, with long term wear, lead to tissue breakdown in the form of pressure ulcers. Previous research has shown that the Miami J collar (Össur Americas Foothill Ranch, CA) effectively reduced cervical movement while providing superior pressure relief. As new cervical orthoses are developed and become commercially available it is useful to examine their performance in comparison to existing well-tested devices. DJO Global (Vista, CA) have recently developed a cervical collar. The purpose of this study is to compare the ability of this newly developed collar to restrict cervical range of motion while at the same time limit the tissue interface pressure exerted by the collar on patients when they are in an upright seated or supine position Data will be collected in a fully equipped 3D motion analysis laboratory. Cervical range of motion will be tracked and analyzed. Interface pressures between the head and collar will be measured using custom pressure mats.


Eligibility criteria: Inclusion Criteria:

* English speaking.
* Subjects who have read and signed IRB approved informed consent for this study.

Exclusion Criteria:

* History of neck pain or neck injury requiring medical care within the previous 12 months.
* History of spinal surgery, physical or chiropractic therapy of the neck.
* History of cervical spondylosis or osteoporosis.
* Pregnant.
* Currently Incarcerated

Primary outcomes:
measure: Cervical range of motion
timeFrame: At enrollment
measure: Tissue interface pressure
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: MORE Foundation
state: Arizona
Study officials:
affiliation: More Foundation
name: Marc Jacofsky, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01558713: Epidural Volume Extension and Intrathecal Use of Local Anesthetics in Cesarean Sections
Official title: Assessment of Sensory and Motor Block After Intrathecal Administration of Bupivacaine, Ropivacaine and Levo-bupivacaine Combined With Small Doses of Fentanyl, Followed by Administration of Normal Saline Epidurally:a Clinical Trial in Parturients Scheduled for C-section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Stillborn Caesarean Section
Keywords: parturient
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2012-03-20
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Intrathecal (i.t.) administration of isobaric bupivacaine, ropivacaine and levobupivacaine with addition of fentanyl for c-section either combined or not with administration of 10 ml of N/S 0,9% epidurally, in order to extent epidural space.Sensory and motor block profile, haemodynamics and side effects were assessed.

Detailed description: Parturients scheduled for elective caesarean section are randomly allocated to 6 groups: they receive double-blindly intrathecal isobaric bupivacaine 10 mg ( Group B), ropivacaine 15mg (Group R) , levobupivacaine 10mg (Group L) combined with 10 μg fentanyl and followed by epidural administration of 10 ml of N/S 0,9% respectively, and isobaric bupivacaine 10 mg ( Group BupivacaineF), ropivacaine 15mg (Group RopivacaineF) , and levobupivacaine 10mg (Group LevobupivacaineF) combined with 10 μg fentanyl without epidural administration of 10 ml of N/S 0,9%. Clinical endpoints are the sensory and motor block profile, haemodynamics (arterial pressure, heart rate) and side effects.

Eligibility criteria: Inclusion Criteria:

* Elective cesarean section
* ASA I-II

Exclusion Criteria:

* complicated pregnancy (i.e preeclampsia, eclampsia,arterial hypertension, diabetes mellitus)
* abnormal fetal heart rate at the time of admission
* body mass index \> 35 kg/m2
* height \<150cm and \>185 cm
* age \<18 yrs and \>40 yrs
* patients with contraindication to spinal anaesthesia( i.e anticoagulants)
* ASA \>III
* intraoperative excessive bleeding
* patients with previous psychiatric diseases

Primary outcomes:
measure: Dermatomes of Sensory block
timeFrame: up to 120 minutes average
measure: Motor block
timeFrame: up to 120 minutes average
Secondary outcomes:
measure: Arterial Blood Pressure
timeFrame: up to 120 minutes average
Other outcomes:
Locations:
city: Patras
country: Greece
facility: Department of Anesthesiology and Intensive Care Medicine, University Hospital of Patras
state: Achaia
Study officials:
affiliation: Department of Anesthesiology and Intensive Care Medicine, University Hospital of Patras
name: KRITON S FILOS, PROFESSOR
role: STUDY_CHAIR
affiliation: Department of Anesthesia and Intensive Care Medicine, University Hospital of Patras
name: Christina G Sklavou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02876913: Evaluation on the Proper Size of the Nasotracheal Tube and Depth in Nasotracheal Intubation: a Preliminary Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasotracheal Intubation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are scheduled for nasotracheal intubation for general anesthesia

Brief summary: The nasotracheal intubation is preferred for oral surgery; it provides an easier view of the surgical field. However, nasotracheal tubes are produced by foreign countries. Tubes are often not fitted in anatomy of Korean people because of small nostril. When the size of the tube is chosen by nostril size, the length of nasotracheal tube is not appropriate to the glottis. The aim of this study is to evaluate on the proper size of the nasotracheal tube and depth in nasotracheal intubation in Korean. Forty patients (20 males and 20 females) who are scheduled for nasal intubation for general anesthesia will be enrolled. The primary outcome is the proportion of patients who are in inappropriate insertion of nasotracheal tube; the proximal end of tube's cuff is less than 2 cm below vocal cord. The size of nostril, length from the nare to the carina and vocal cord are measured.


Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled for nasotracheal intubation for general anesthesia

Exclusion Criteria:

* age \< 20 years and age \> 70 years
* ASA(American Society of Anesthesiologist) class III or more
* pregnancy
* emergency surgery
* nasal airway disease
* expected difficult intubation (difficult intubation history, Modified Mallampati score 4, mouth opening \<2cm, facial anomaly)
* unstable teeth

Primary outcomes:
measure: Proportion of the inappropriate insertion of nasotracheal tube
timeFrame: 5 minutes after induction of general anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
citation: Lee B, Park WK, Yun SY, Kang S, Kim HJ. Insertion depth of nasotracheal tubes sized to fit the nostril: an observational study. J Int Med Res. 2019 Jan;47(1):235-243. doi: 10.1177/0300060518800105. Epub 2018 Dec 16.
Clinical trial NCT00739336: Diabetes Prevention and Control in the Workplace: A Pilot Study
Official title: Diabetes Prevention and Control in the Workplace: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes mellitus
obesity
prevention
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
Collaborators: name: County of Onondaga, NYS
name: NYS Department of Health
First posted: 2008-08-21
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This worksite program for Onondaga County employees is a pilot research study aimed at decreasing the risk of developing diabetes (or improving metabolic control for adults with diabetes). The main goal is to improve the nutrition and physical habits of the participants, and promote weight loss in those who are overweight. The investigators will also examine factors that predict participation in the program and influence a participant's outcome/success in the program.


Eligibility criteria: Inclusion Criteria:

* Adult employees of Onondaga County

Exclusion Criteria:

* Not an employee of Onondaga County
* Less than age 18

Primary outcomes:
measure: Body Weight
timeFrame: 3 months
Secondary outcomes:
measure: Fasting Glucose Level
timeFrame: Baseline
measure: Fasting Lipid Profile
timeFrame: Baseline
measure: Hemoglobin A1c
timeFrame: baseline
measure: Waist Circumference
timeFrame: baseline, 3, 6, 12 months
measure: Questionnaires
timeFrame: baseline, 3, 6, 12 months
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Ruth S Weinstock, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barham K, West S, Trief P, Morrow C, Wade M, Weinstock RS. Diabetes prevention and control in the workplace: a pilot project for county employees. J Public Health Manag Pract. 2011 May-Jun;17(3):233-41. doi: 10.1097/PHH.0b013e3181fd4cf6.
Clinical trial NCT04875936: Neurofeedback Intervention for Reading Deficits in Subacute Stroke
Official title: Rehabilitation of Reading Deficits in Subacute Stroke Using Functional Magnetic Resonance Imaging (fMRI) Neurofeedback and Motor Imagery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Dyslexia, Acquired
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of 2 groups
Primary purpose: TREATMENT

Brief summary: The overall goal of this project is to advance a biologically-based approach to treatment of reading disorders after stroke, which will expand the limits of cognitive rehabilitation. Using a novel brain imaging technique, called real-time functional magnetic resonance imaging (fMRI) neurofeedback combined with right hand motor imagery, this project will re-instate brain activity in the left language-dominant hemisphere. Stroke patients will practice modulating their own brain activity using fMRI neurofeedback signal and will select the most effective mental strategies that help them maintain brain activation patterns associated with better reading recovery.


Eligibility criteria: Inclusion Criteria:

* First-ever left-hemisphere stroke \< 3 months prior to study recruitment or healthy volunteer
* Age: 18 - 80 years old
* Fluent and literate in English prior to stroke
* Reading deficits, defined as \>3 errors on the Paragraphs test (subtests VIII, IX) of the Reading Comprehension Battery for Aphasia-2nd ed. (RCBA-2) in keeping with the healthy control accuracy criterion of 86-100% correct.

Exclusion Criteria:

* Inability to consent or complete study tasks
* Inability to undergo MRI (e.g., pregnancy, non-MRI compatible implants, claustrophobia)
* A history of prior neurological disease (e.g., brain tumor, Alzheimer's disease)

Primary outcomes:
measure: Reading Aloud Accuracy
timeFrame: change from baseline at intervention week 1, 2, and 3
measure: fMRI Brain Activity
timeFrame: change from baseline at intervention week 1, 2, and 3
Secondary outcomes:
measure: Reading Comprehension Battery for Aphasia (RCBA-2)
timeFrame: change from baseline at 1 week follow up
measure: Western Aphasia Battery-Revised (WAB-R) Bedside
timeFrame: change from baseline at 1 week follow up
measure: Boston Naming Test (BNT-short)
timeFrame: change from baseline at 1 week follow up
measure: Palm Trees and Pyramids test
timeFrame: change from baseline at 1 week follow up
measure: Geriatric Depression Scale (GDS)
timeFrame: change from baseline at 1 week follow up
measure: Neuro evaluation
timeFrame: baseline and 1 week follow up
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References:
Clinical trial NCT02097836: Targeted Training for Trunk Control_case Series Cerebral Palsy
Official title: Segmental Training for Trunk Control a Pilot Study for Children With Moderate to Severe Motor Impairment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Traumatic Brain Injury
Keywords: postural control
Targeted Training
cerebral palsy
trunk segments
Lead sponsor: University of Oregon
Sponsor class: OTHER
First posted: 2014-03-27
Enrollment: 11
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: If a child with cerebral palsy does not develop independent sitting balance by 4 years of age, their prognosis for walking is very poor. Surprisingly little is known about how to facilitate head control or upright sitting balance and functional mobility in the child who is not developing these skills. This is one of the first studies that will examine intermediate stages in the development of the postural control system in children with neurologic deficits. Clinical researchers at The Movement Centre in Oswestry, England have developed a method called Targeted Training in which trunk control is trained in children segment by segment using a specific training device. This study aims to examine kinematic and electromyographic changes in a case series of children who undergo a 6-month Targeted Training intervention.


Eligibility criteria: Inclusion Criteria:

* neurologic diagnosis that results in a deficit in trunk control (i.e. cerebral palsy, traumatic brain injury)
* age 4-17 years
* Gross Motor Function Classification System (GMFCS) level III, IV or V for children with cerebral palsy

Exclusion Criteria:

* spinal fixation
* fixed scoliosis
* uncontrolled seizures

Primary outcomes:
measure: Change in Gross Motor Function Measure
timeFrame: 6 months and followup post training 12 months
measure: Probe data, balance
timeFrame: baseline, intervention, 2 months post intervention
Secondary outcomes:
measure: Change in head stability
timeFrame: 6 months, 1,3, and 12 months post intervention
measure: Change in muscle activation strategy during quiet sitting with different levels of external support.
timeFrame: 6 months, 1 and 3 months post intervention
measure: Change in Pediatric Evaluation of Disability Inventory (PEDI)
timeFrame: 6 months and 1,3, 12 months post intervention
measure: Qualitative Parent, Teacher report
timeFrame: during intervention and post intervention
Other outcomes:
Locations:
Study officials:
affiliation: University of Oregon
name: Sandra L Saavedra, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05373836: Relationship of PNI and Clinical Outcome in Patients Undergoing Brain Tumor Surgery
Official title: Relationship of PNI and Clinical Outcome in Patients Undergoing Brain Tumor Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Clinical Outcome
Keywords: nutritional index
brain tumor surgery
mortality
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-05-13
Enrollment: 5000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing brain tumor surgery at Seoul National University Hospital, South Korea

Brief summary: There are several predictors of clinical outcome in patients undergoing brain tumor surgery. Among those, nutritional parameters and calculated nutritional index are known to have ability to predict mortality and clinical outcomes in some patients with brain tumor. However, there are lack of consistent results on predictability of nutritional index and clinical outcome in patients undergoing brain tumor surgery.

Detailed description: In this retrospective study, we evaluated the relationship between prognostic nutritional index, which was calculated from laboratory parameters, and clinical outcome including mortality in patients undergoing brain tumor surgery.

Eligibility criteria: Inclusion Criteria:

* adult patients undergoing brain tumor surgery at Seoul National University Hospital, South Korea

Exclusion Criteria:

* Lack of results of laboratory parameters, such as serum albumin, lymphocyte count, cholesterol
* Lack of data on clinical outcome, including mortality, acute kidney injury, renal replacement therapy, length of hospital stay, and other major adverse outcome

Primary outcomes:
measure: predictability of prognostic nutritional index for mortality after brain tumor surgery
timeFrame: From date of surgery until the date of death from any cause, whichever came first, assessed up to 50 years
Secondary outcomes:
measure: predictability of prognostic nutritional index for acute kidney injury after brain tumor surgery
timeFrame: From date of surgery until the date of acute kidney injury from any cause, whichever came first, assessed up to 50 years
measure: predictability of prognostic nutritional index for renal replacement therapy after brain tumor surgery
timeFrame: From date of surgery until the date of renal replacement therapy from any cause, whichever came first, assessed up to 50 years
measure: relationship of prognostic nutritional index for length of hospital stay after brain tumor surgery
timeFrame: From date of surgery until the date of hospital discharge
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Youn Joung Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: