louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00989729: Preoperative Methylprednisolone in Endovascular Aortic Repair
Official title: Preoperative Methylprednisolone in Endovascular Aortic Repair - a Randomized Double Blind Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysms
Keywords: Endovascular Aortic Repair
Methylprednisolone
Systemic inflammatory response syndrome
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2009-10-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
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 attenuate the systemic inflammatory response after Endovascular repair of abdominal aortic aneurysms, by administration of a single preoperative dosage of Methylprednisolone.


Eligibility criteria: Inclusion Criteria:

* Elective endovascular repair of an asymptomatic abdominal aortic aneurysm.
* Informed signed consent

Exclusion Criteria:

* Positive HIV status, positive hepatitis B or C status
* Immunoinflammatory disease - except topically treated skin disease and respiratory disease.
* Glaucoma
* Gastric or duodenal ulcer
* Systemic fungal infection
* Immunosuppressive treatment
* Current treatment for cancer
* Allergy towards contents of Solu-Medrol
* Alcohol consumption: Men \> 21 drinks and women \> 14 drinks weekly
* Pregnancy
* Lack of informed signed consent
* Patients where follow up is planned at other location than Rigshospitalet.

Primary outcomes:
measure: Systemic inflammatory response syndrome - SIRS
timeFrame: Within 5 postoperative days
Secondary outcomes:
measure: Length of postoperative hospital stay
timeFrame: Until discharge
measure: Interleukin 6 plasma level
timeFrame: Within 5 postoperative days
measure: Adverse events related to Methylprednisolone
timeFrame: Within 5 postoperative days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Vascular Surgery, Rigshospitalet 3111
Study officials:
affiliation: Rigshospitalet, Denmark
name: Louise de la Motte, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de la Motte L, Kehlet H, Vogt K, Nielsen CH, Groenvall JB, Nielsen HB, Andersen A, Schroeder TV, Lonn L. Preoperative methylprednisolone enhances recovery after endovascular aortic repair: a randomized, double-blind, placebo-controlled clinical trial. Ann Surg. 2014 Sep;260(3):540-8; discussion 548-9. doi: 10.1097/SLA.0000000000000895.
Clinical trial NCT05799729: Effect of Ketamine Infusion on BIS Values
Official title: Correlation Between Concentration at the Effector Site of Continuous Infusion of Ketamine (Calculated With DOMINO Pump) and Bispectral Index Values During General Anaesthesia for Breast Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia Brain Monitoring
Ketamine
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Authors will recruit patients who will undergo breast oncologic surgery and anesthetized with TIVA-TCI propofol,remifentanil and ketamine anesthesia.

Brief summary: Aim of this trial is to define if Concentration at the effector site (Ce) of Ketamine, during a continuous infusion and calculated with DOMINO model infusion pump are correlated with Bispectral Index BIS values during general anaesthesia for breast surgery.

Detailed description: Correlation between Concentration at the effector site (Ce) of Ketamine and Bispectral Index (BIS) values during general anaesthesia for breast surgery has not been defined yet during a continuous infusion.

Authors want to analyze this correlation during general anaesthesia conducted using Propofol, ketamine and remifentanil. All of these drugs will be delivered with Target-Controlled Infusion pumps (in particular Eleveld for Propofol, Minto for Remifentanil and Domino for Ketamine).

Ketamine will be observationally set at anaesthesiologist's discretion, but only CeK 0.1, 0.2, 0.4 and 0.6 for at least 30 minutes will be considered for analysis.

Eligibility criteria: Inclusion Criteria:

* Undergo general anaesthesia with Targeted Controlled Infusion of Ketamine (Domino model), Propofol (Schnider model) and Remifentanil (Minto model)

Exclusion Criteria:

* Neurological disease
* Psychiatric disease
* Benzodiazepines intake
* Obesity

Primary outcomes:
measure: Correlation between Concentration at the effector site of Ketamine and BIS values
timeFrame: Data about Drugs concentration and BIS during general anaesthesia will be collected, in particular BIS and TCI Ketamine values during all the duration of anesthesia, from the start of ketamine infusion until the stop of ketamine infusion(30minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Treviso
country: Italy
facility: Treviso Regional Hospital
state: TV
Study officials:
References:
Clinical trial NCT02692729: Transverse Supraumbilical Versus Pfannenstiel Incision for Cesarean Section in Morbidly Obese Women
Official title: Transverse Supraumbilical Versus Pfannenstiel Incision For Cesarean Section in Morbid Obese Patients" A Single Blinded Randomized Controlled Trial"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy and safety of transverse supraumbilical incision over Pfannenstiel incision in performing cesarean section for morbid obese pregnant women.

Detailed description: Research Question In Morbidly obese women undergoing cesarean section, is transverse supraumbilical incision superior to Pfannenstiel incision? Research Hypothesis Transverse supraumbilical incision is superior to Pfannenstiel incision in morbidly obese women undergoing cesarean section.

Eligibility criteria: Inclusion Criteria:

* BMI more than 40 kg/m2
* women scheduled for CS

Exclusion Criteria:

* patients receiving steroids or anticoagulation

Primary outcomes:
measure: occurence of surgical site infection
timeFrame: one week
Secondary outcomes:
measure: operative time in minutes
timeFrame: 2 hours
measure: blood loss in milliliter
timeFrame: 2 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Ain Shams University
state: Al Qahirah
Study officials:
affiliation: Ain Shams University
name: Ahmed M kotb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00624429: A Pilot Study Involving an Asthma Management Program for Inner-city Early Head Start Children
Official title: A Pilot Study Involving an Asthma Management Program for Inner-city Early Head Start Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Children
Lead sponsor: Phoenix Children's Hospital
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2008-02-27
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Early Head Start program serves lower socioeconomic inner-city children from birth to 3 years. This population has a higher incidence of asthma due to increased exposures. The primary objective of this study is:

To evaluate the effect of early identification of these high risk, inner-city asthmatic infants, age 1-3 years, and early treatment with pulmicort respules on asthma morbidity (asthma symptoms and use of rescue medications), infant pulmonary functions, and use of health care resources (unscheduled clinic visits, emergency room visits and hospitalizations).

To obtain pilot behavior information using Carey Temperament Scale, Bitsea and expand to Itsea if indicated.


Eligibility criteria: Inclusion Criteria:

* Children 12-36 months of age with a history of wheezing or airway reactivity responding to bronchodilators, or diagnosed with asthma by a physician.

Exclusion Criteria:

* Children less than 12 months or greater than 36 months of age.
* Children diagnosed with attention deficit disorder by a physician or psychologist.

Primary outcomes:
measure: FEV0.5
timeFrame: 2 months and 6 months into study
Secondary outcomes:
measure: emergency room visits
timeFrame: number of visits from baseline to 2 months and 2 months to 6months of study
measure: behavior scores
timeFrame: measured at baseline, 2 months and 6 months
measure: number of asthma exacerbations from baseline to 2 months and 2 months to 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
Study officials:
affiliation: Phoenix Children's Hospital
name: Peggy Radford, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00198029: An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study
Official title: An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpometacarpal Osteoarthritis
Keywords: Osteoarthritis
Hyaluronan
Carpometacarpal
Outcomes
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
name: National Institutes of Health (NIH)
First posted: 2005-09-20
Enrollment: 32
Sex: ALL
Minimum age (years): 45
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to find out if hyaluronan, an injectable medication for knee arthritis, also works for arthritis at the base of the thumb. This study will also evaluate how good ultrasound is at visualizing medication in the thumb joint. We are no longer recruiting for this part of the open label trial.


Eligibility criteria: Inclusion Criteria:

* Radiographic evidence of at least moderate narrowing (joint space \< 1mm) or the presence of osteophytes or sclerosis at the Carpometacarpal joint
* Patient complaint of unacceptable pain despite modification of activity, a trial of splinting and a therapeutic dose of NSAIDS
* If bilateral disease, only the most severely involved hand, (as defined by VAS for pain), will be entered in the study.
* Proficiency in English.

Exclusion Criteria:

* Previous bad injury to the thumb
* Previous hand surgery on the study thumb
* Known hand comorbidities (i.e. carpal tunnel syndrome, de Quervains Tenosynovitis etc)
* Rheumatoid arthritis or lupus
* Bleeding problems
* Being on blood thinners (except aspirin)
* Known allergies to any of the medications being used
* Allergies to chicken products
* Current use of oral steroids
* Cancer that is not cured or in remission
* Severe diabetes
* A serious infection somewhere else in the subject's body

Primary outcomes:
measure: The Disabilities of the Arm, Shoulder and Hand Outcome Measure
timeFrame: 26 weeks (6 months)
Secondary outcomes:
measure: Visual Analog Scale for Pain
timeFrame: 26 weeks (6 months)
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Lisa Mandl, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mandl LA, Hotchkiss RN, Adler RS, Lyman S, Daluiski A, Wolfe SW, Katz JN. Injectable hyaluronan for the treatment of carpometacarpal osteoarthritis: open label pilot trial. Curr Med Res Opin. 2009 Sep;25(9):2103-8. doi: 10.1185/03007990903084016.
Clinical trial NCT03162029: Assessment of Mandibular Osseous Changes in Patients With End Stage Renal Failure
Official title: Assessment of Mandibular Osseous Changes Using Radiomorphometric Indices By Cone Beam Computed Tomography in Patients With End Stage Renal Failure Versus Normal Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diagnosis
Keywords: CBCT
Bone quality
Renal failure
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Egyptian participants with End stage renal disease

Brief summary: This study will be observational study. The goal of this study is to evaluate the quality of mandible and to assess the correlation between the jaw bone quality in a sample of Egyptian patients with chronic renal failure and duration of dialysis using CBCT.

Detailed description: This study will be observational study. The goal of this study is to evaluate the quality of mandible and to assess the correlation between the jaw bone quality in a sample of Egyptian patients with chronic renal failure and duration of dialysis using CBCT. Twenty-six subjects will be included in this study. These will comprise (13) CKD patients "the study group" and (13) healthy patients "the control group" recommended for CBCT imaging for implant placement. The control group will be selected from the Prosthodontic department and Oral Medicine department of Faculty of Oral and Dental Medicine, Cairo University, the study group will be selected from Nephrology and the artificial kidney unit El Kasr -Al Ain Hospital, Cairo University.

Eligibility criteria: Inclusion Criteria:

* End stage renal failure (in study group)
* Undergone hemo-dialysis, three times/week (in study group)
* Duration of dialysis (≥1 year) (in study group)
* PTH (140-630)
* Age group (18-40 years)
* Mandible
* Free from any other systemic disease affecting the bone quality
* Egyptian population

Exclusion Criteria:

* Early stage of renal disease
* Patients with diabetes, hyperthyroidism, postmenopausal osteoporosis
* Maxilla
* Other language
* Completely Edentulous patients.

Primary outcomes:
measure: Mandibular cortical index(MCI)
timeFrame: Five months
Secondary outcomes:
measure: Mental index(MI)
timeFrame: Five months
measure: Panoramic mandibular index(PMI)
timeFrame: Fivemonths
measure: Anti-gonial index(AI)
timeFrame: Five months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Eman M Mohamed, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06224829: Response to Massage in Neck Pain
Official title: Characterizing Responses to Massage in Individuals With Neck Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is interested in whether baseline measures of pain sensitivity i.e. the amount of pressure required to feel pain predicts pain relief following a pain inducing massage AND whether pain relief following a pain inducing massage is different than a pain free massage or placing your hand in a cold water bath. Participants with neck pain will be randomly assigned to receive a pain inducing massage, pain free massage, or to place their hand in a cold water bath.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 60 years old
* Currently experiencing neck pain with or without arm pain
* Neck pain symptom intensity rated as 4/10 or higher during the last 24 hours
* Neck pain for greater than or equal to 3 months

Exclusion Criteria:

* Non- English speaking
* Systemic medical conditions known to affect sensation (e.g. diabetes)
* History of neck surgery or fracture within the past 6 months
* Current history of chronic pain condition other than neck pain
* Diagnosis of cervical radiculopathy or cervical myelopathy
* History of whiplash
* Currently using blood thinning medication
* Any blood clotting disorder such as hemophilia
* Any contraindication to application of ice, such as: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, and circulatory compromise
* Pregnancy

Primary outcomes:
measure: Pressure Pain Threshold
timeFrame: Baseline and immediately following the intervention
Secondary outcomes:
measure: Numeric Pain Rating Scale Resting Pain
timeFrame: Baseline, immediately following intervention
measure: Numeric Pain Rating Scale Movement Evoked Pain
timeFrame: Baseline, immediately following intervention
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
References:
Clinical trial NCT06525129: Multi-session Anodal Cerebellar Transcranial Direct Current Stimulation (tDCS) vs Anodal Cerebral tDCS
Official title: Comparison of Multi-session Anodal Cerebellar Transcranial Direct Current Stimulation vs Anodal Cerebral Transcranial Direct Current Stimulation on Balance, Its Components and Postural Stability in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To investigate which one of the two cerebellar and cerebral stimulation in comparison to sham stimulation is more effective in enhancing balance and postural stability in stroke patients


Eligibility criteria: Inclusion Criteria:

* The study focused on individuals who had their first stroke,
* Additionally, participants needed to have a score of 6 or higher on the Johns Hopkins Fall Risk Assessment Tool (JHFRAT).
* The inclusion criteria mandated that participants must have the ability to give written consent, walk without any help, and
* have a functional condition that allows them to actively participate in the Biodex balancing training program.

Exclusion Criteria:

* Individuals with concurrent neurological problems such as Alzheimer's, Parkinson's, or cerebellar abnormalities,
* as well as those with psychological ailments, were excluded during the initial assessment phase.
* In addition, individuals who scored below 20 on the Mini Mental Status Examination Test (MMSE),
* displayed motor disorders that affected their ability to walk or use their lower limbs,
* were currently taking sedative medications, had amnesia, depression, radiculopathy, lumbar spinal cord root involvement, auditory or visual impairments, vertigo, recent fractures, severe cardiac problems,
* or had undergone electrotherapy that affected their nervous system within the past two weeks were also not included in the study.

Primary outcomes:
measure: Biodex balance system
timeFrame: 2 weeks
measure: Berg balance scale
timeFrame: 2 weeks
measure: Timed up and go test
timeFrame: 2 weeks
measure: Bestest balance evaluation system
timeFrame: 2 weeks
measure: TDCSs adverse effects questionnaire
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gujrāt
country: Pakistan
facility: Akbar Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Iqbal Tariq, PhD*
role: STUDY_CHAIR
affiliation: Xi'an Jiaotong University
name: Qurat Ul Ain, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03708029: Efficacy of Human Placental Graft in Diabetic Foot Ulcers
Official title: A Clinical Investigation Into the Efficacy of Full-thickness Human Placental Graft (Revita) in Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Foot
Lead sponsor: StimLabs
Sponsor class: INDUSTRY
First posted: 2018-10-16
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the efficacy of full-thickness placental allograft in chronic wound healing

Detailed description: To evaluate the efficacy of Revita full thickness placental allograft in improving wound closure rates and mean closure time in diabetic foot ulcers (DFUs) as compared to the current standards of wound care treatment

Eligibility criteria: Inclusion Criteria:

* Male and female patients
* 18-80 years old
* Diagnosis of Type 1 or 2 Diabetes Mellitus
* Foot ulcers \>1cm2 and \<25cm2 for 4 weeks or more prior to enrollment
* Able to give consent to participate
* Compliance with all aspects of protocol and follow-up

Exclusion Criteria:

* Male and female patients younger than 18 years old
* Male or female patients older than 80 years old
* Smoking, and any additional health risk factors contraindicated with Revita use
* Involvement in any other ongoing studies

Primary outcomes:
measure: Complete Wound Closure
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent(%) Healed
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Pensacola
country: United States
facility: Gulf Coast Podiatry
state: Florida
city: Lake Charles
country: United States
facility: Louisiana Foot and Ankle Specialists
state: Louisiana
city: Springfield
country: United States
facility: Crozer/Keystone Health System, Center for Wound Healing
state: Pennsylvania
Study officials:
affiliation: StimLabs
name: Clinical Research Manager
role: STUDY_DIRECTOR
References: