louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01382446: Chlorhexidine Gluconate Oral Care for Adults Experiencing Trauma
Official title: Evaluating Effectiveness of Chlorhexidine Gluconate Oral Care for Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Associated Pneumonia
Keywords: Trauma
Mechanical Ventilation
Ventilator Associated Pneumonia
Oral Care
Lead sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Sponsor class: OTHER
Collaborators: name: 3M
First posted: 2011-06-27
Enrollment: 66
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: Examine the use of 0.12% Chlorhexidine Gluconate as an adjunct to current oral care protocol for trauma patients on ventilator support to decrease the incidence of Ventilator Associated Pneumonia and oral bacterial load.

Detailed description: To see a significant decrease in the bacterial load in the oral mucosa and subsequently, a decrease in the pathogenesis of Ventilator Associated Pneumonia through the use of an oral rinse containing 0.12% Chlorhexidine Gluconate as part of an oral care protocol. Current oral care protocol includes the use of 1.5% H2O2-coated swabs every four hours, toothbrushing with toothpaste every 12 hours, and use of continuous subglottic suction apparatus.

Eligibility criteria: Inclusion Criteria:

* Adults admitted to ICUs located in Tower Two Critical Care Units: Medical, Surgical, Medical #2, and Trauma Intensive Care Units.
* Patients will be randomized to either treatment or standard group based on day of admission to Intensive Care Units. No limitation regarding gender, race, and ethnicity so that the sample will reflect "typical" Trauma population.

Exclusion Criteria:

* All patients admitted under "Doe" Status
* All patients with acute cervical spine injuries or facial fractures that oral care will create further harm to the patient (physician order stating "no oral care to be given" will be in chart)
* All patients with Oral Trauma or Oral Surgery
* All minors (Study will be completed in Adult Critical Care Units)
* Patients with allergy to chlorhexidine
* Patients without Teeth, or with fewer than 6 teeth

Primary outcomes:
measure: Effectiveness of Chlorhexidine Gluconate Oral Care for Trauma Patients
timeFrame: 18 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
Study officials:
affiliation: St. Joseph's Hospital and Medical Center, Phoenix
name: Tracy Thomas, MSN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00586846: Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
Official title: Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteosarcoma
Keywords: Cisplatin
Doxorubicin
Methotrexate
Osteosarcoma
03-074
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-01-07
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to test the safety and feasibility of the simultaneous administration of a biphosphonate with chemotherapy for the treatment of osteosarcoma in newly diagnosed patients.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed, previously untreated biopsy proven high-grade osteosarcoma. Patient who have undergone a definitive surgical resection as their primary surgery are still eligible for participation in this study.
* No prior chemotherapy or radiation therapy
* Adequate renal function: creatinine \< or = to 1.5 upper limit of normal
* Adequate liver function as defined by bilirubin \< or = to 1.5 X upper limit of normal and AST \< or = to 3 X upper limit of normal institutional range Adequate hematopoietic function as defined by platelet count \> or = to 100,000/ram3 an absolute neutrophil count \> or = to 1,000/mm3.
* Adequate cardiac function as defined by shortening fraction \> or = to 28% by echocardiogram OR ejection fraction \> or = to 50% by radionuclide angiogram
* Performance status \< or = to 2

Exclusion Criteria:

* Prior history of cancer
* Prior treatment for cancer
* Prior history of Paget's disease
* Prior history of pericarditis, myocarditis, symptomatic arrhythmia or symptomatic cardiac conduction abnormalities
* Pregnancy or breast feeding

Primary outcomes:
measure: Radiographic Response
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Meyers Paul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03575338: Minimally Invasive Versus Open Scarf Osteotomy for Hallux Valgus Correction: a Randomized Controlled Trial
Official title: Minimally Invasive Versus Open Scarf Osteotomy for Hallux Valgus Correction: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hallux Valgus and Bunion (Disorder)
Keywords: scarf
minimally invasive surgery
hallux valgus
Lead sponsor: Hospital Mutua de Terrassa
Sponsor class: OTHER
First posted: 2018-07-02
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare a minimally invasive scarf technique and the well-established open scarf technique for correction of hallux valgus deformity.

Detailed description: Hallux valgus surgery is a common procedure being the open scarf osteotomy, one of the most studied techniques for correction of the hallux valgus. It is widely reported its capacity to reduce the angle of the first metatarso-phalangeal joint.

Minimally invasive scarf (MIS) technique has been designed to decrease the soft tissue damage and postoperative pain. This procedure does not require ischemia, being able to do under local anesthesia and sedation. This technique is more suitable for outpatient surgery.

There is a lack of studies comparing both techniques, and our purpose is to do a prospective comparative study among the two approaches of the scarf osteotomy: open vs MIS.

Eligibility criteria: Inclusion Criteria:

- Patients undergo hallux valgus surgery

Exclusion Criteria:

* Intermetatarsal angle \>20º
* Previous hallux valgus surgery
* Metatarsalgia of the lesser rays that requires an osteotomy during the surgical procedure
* 1st cuneometatarsal instability
* Infection
* Vascular ischemia
* Neuropathy

Primary outcomes:
measure: Hallux valgus angle postoperative
timeFrame: 1 year - 2 years
Secondary outcomes:
measure: Intermetatarsal 1-2 angle
timeFrame: 1 year - 2 years
measure: First metatarso-phalangeal range of movement
timeFrame: 1 year - 2 years
measure: Surgery duration
timeFrame: Measurement during the surgery
measure: Irradiation
timeFrame: Measurement during the surgery
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Josep Torrent
state: Barcelona
Study officials:
References:
Clinical trial NCT04281238: The Effects of Yoga Training in Ankylosing Spondylitis Patients
Official title: The Effects of Yoga Training in Ankylosing Spondylitis Patients
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Ankylosing Spondylitis
Yoga
Keywords: ankylosing spondylitis
yoga
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the effect of yoga training on functional level, disease activity, spinal mobility, balance, sleep quality, depression and quality of life in AS patients.

Detailed description: Yoga is an ancient Indian practice, dating back several thousand years, with objective of uniting mind, body, and spirit. In Western cultures, Hatha yoga is most commonly practiced, and generally includes a set of physical poses(asanas), breathing techniques(pranayama) and deep relaxation(savasana).Yoga has been shown to increase mobility, reduce pain, and improve quality of life in many diseases. However, there is no study examining the effects of yoga training in AS patients.Therefore, the aim of this study is to investigate the effects of yoga training in AS patients.

60 AS patients aged 20-60 years will be randomly assigned to yoga or control group. Home exercises will be taught to both groups, and a brochure with home exercises will be given. The yoga group will participate in a yoga class 3 days a week, during 8 weeks. The control group will not participate in a yoga class, only will do home exercises. Assessments will be done at baseline and after 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Ankylosing spondylitis(AS) patients diagnosed according to modified New York criteria
* To be volunteer

Exclusion Criteria:

* the presence of peripheral enthesitis, orthopedic disorders, cardiovascular disorders, neurological disorders, visual and auditory deficits,
* history of surgery for spine or lower limb,
* failure to complete the test

Primary outcomes:
measure: Bath Ankylosing Spondylitis Spinal Metrology Index (BASMI)
timeFrame: 5 minutes
Secondary outcomes:
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: 2 minutes
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: 3 minutes
measure: Short Form-36 (SF-36)
timeFrame: 6 minutes
measure: Beck Depression Inventory
timeFrame: 5 minutes
measure: Beck Anxiety Inventory
timeFrame: 4 minutes
measure: Pittsburgh Sleep Quality Index
timeFrame: 4 minutes
measure: Balance Master system
timeFrame: 10 minutes
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylül University
state: Eyalet/Yerleşke
Study officials:
References:
Clinical trial NCT00734838: Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy
Official title: Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Breast Biopsy
Reduction mammoplasty
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: William Marsh Rice University
First posted: 2008-08-14
Enrollment: 213
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The objective of the proposed research is to develop new diagnostic modalities based on optical spectroscopy (auto fluorescence, absorption, and scattering) for the diagnosis of breast cancer and test its performance as an adjunct to core needle biopsy. For the surgery part of the study, all patients scheduled to have a mastectomy or lumpectomy for the treatment of breast cancer will be asked if they would be willing to participate in this study. For the core needle biopsy part of the study, patients with a higher pre-probability of cancer (based on mammography) will be recruited to increase the number of patients with malignant lesions and enrolled in this investigation.


Eligibility criteria: Inclusion Criteria:

* Patients having a needle biopsy of a breast mass

Exclusion Criteria:

* none

Primary outcomes:
measure: Optical signatures
timeFrame: Day of procedure (less than 10 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Nimmi Ramanujam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04434443: Effects of Trunk Exercise on Trunk Control and Balance in Persons With Stroke
Official title: Effects of Trunk Exercise on Unstable Surface on Trunk Control and Balance in Persons With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cerebrovascular Accident
Balance Impairment
Keywords: stroke
balance
Trunk exercise
Trunk control
standing
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
Collaborators: name: Tainan Hospital, Ministry of Health and Welfare
First posted: 2020-06-16
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examined the effects of trunk exercise on unstable surfaces on trunk control and balance for persons in the sub-acute stage of stroke. The hypothesis was that, compared to upper limb exercises in well supported sitting position, this exercise would lead to better trunk control and sitting and standing balance. The results supported the hypothesis.

Detailed description: Inpatients in the sub-acute stage of stroke were randomly assigned to receive upper limb range of motion exercises in well supported sitting position or trunk exercises on unstable surfaces in supine and sitting, 30 min per session, 2 sessions per week for 6 weeks, in addition to their daily conventional stroke rehabilitation. Sensorimotor functions, including hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and Fugl-Meyer lower extremity motor scale, and clinical outcome assessments, including Trunk Impairment Scale and 6-meter walk test, were conducted by a blinded assessor. Biomechanical outcome measures included center of pressure area while maintaining static posture and peak displacement while leaning forward, and the average speed of the unaffected arm raising (to represent the ability to provide a stable foundation for focal movement). These measures were taken in sitting without foot support, sitting with foot support and standing to reflect trunk control, sitting balance and standing balance, respectively.

Eligibility criteria: Inclusion Criteria:

* age: between 20-80 years old
* first time stroke
* could sit without back support at least 20 seconds
* could understand and follow experimental instructions

Exclusion Criteria:

* medically unstable
* other neuromuscular/musculoskeletal problems that would affect balance

Primary outcomes:
measure: Center of pressure
timeFrame: 6 weeks
measure: Angular velocity of the non-affected arm raising
timeFrame: 6 weeks
Secondary outcomes:
measure: Trunk Impairment Scale
timeFrame: 6 weeks
measure: 6-meter walking tests
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
References:
Clinical trial NCT03671343: Physical Rehabilitation and Chronic Kidney Disease
Official title: Impact of Physical Rehabilitation on Sarcopenia Inolder and Chronic Kidney Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Chronic Kidney Disease
Older
Keywords: sarcopenia
chronic kidney disease
older
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 90
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Older patients with chronic renal failure suffer from sarcopenia. Loss of muscle function is associated with increased morbidity and mortality. Currently few treatment are available. The aim of this study is to evaluate the impact of physical rehabilitation in this population on muscle performance and quality of life.


Eligibility criteria: Inclusion Criteria:

* man or woman
* age over 70 years
* CKD stage 3B, 4 or 5 or a DFG \<45ml / min according to CKD-EPI formula
* an SPPB (Short Physical Performance Battery test )\<10
* having received a complete and loyal information and having given his written and informed consent.
* ability to rehabilitate

Exclusion Criteria:

* Subject not presenting previous inclusion criteria
* General condition not compatible for the realization of physical rehabilitation
* Patient protected under the terms of the law.
* Inability to respect the follow-up of the study for geographical, social or psychological reasons.
* depression or other psychiatric disorder
* Refusal to participate in the study
* Absence of affiliation to the social security system
* Subject in a exclusion period of an other study

Primary outcomes:
measure: Change from Baseline distance travelled (in meters) during the 6-minute walking distance (6MWD) test (muscular performance), at 3 months
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Nutritional parameter: Albuminemia
timeFrame: Baseline,3 and 6 months
measure: Nutritional parameter: Prealbuminemia
timeFrame: Baseline,3 and 6 months
measure: Nutritional parameter: Body mass index
timeFrame: Baseline,3 and 6 months
measure: Nutritional parameter: bioimpedancemetry
timeFrame: Baseline,3 and 6 months
measure: Muscle strength evaluated by Hand Grip strength test
timeFrame: Baseline,3 and 6 months
measure: Quality of life evaluated by the questionnaire SF-36 (36-item medical outcomes study Short-Form health survey)
timeFrame: Baseline,3 and 6 months
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service de Médecine du vieillissement, soins de suite et de rééducation, Centre Hospitalier Lyon SUd
city: Pierre-Bénite
country: France
facility: Service de Néphrologie, Centre Hospitalier Lyon Sud
Study officials:
References:
Clinical trial NCT03602950: PRP Use in Diabetic Patients Undergoing Cesarean Section
Official title: Role of Autologous Platelet-Rich Plasma Solution in Wound Healing in Diabetic Patients Undergoing Elective Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Diabetes, Gestational
Wound Complication
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group will receive PRP at surgery, whereas the control group will receive the usual care. All patients will be evaluated at baseline, one week, four weeks and eight week after the cesarean section.
Primary purpose: PREVENTION

Brief summary: this study will investigate the effectiveness of PRP in wound healing among diabetic patients undergoing elective cesarean sections

Detailed description: In this balanced, randomized, and controlled prospective study, 100 pregnant ladies at full term diabetic patients will be admitted to Minia University hospital. The patients will be randomly assigned into two groups. The intervention group will receive PRP at surgery, whereas the control group will receive the usual care. All patients will be evaluated at baseline, one week, two weeks, four weeks and eight week after the cesarean section.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria will be a fixed factor along with age(18 y:45 y),diabetic patients(any type of diabetes),elective delivery,average body mass index(BMI) (17 : 24.9),Non previously scared uterus ,single pregnancy

Exclusion Criteria:

* The exclusion criteria will be younger ages below 18 years ,older ages above 45 years, emergency caesarean delivery, previous scared uterus, underweight BMI below 17, overweight BMI above 24.9, no other medical problems, associated other diseases, and multiple pregnancy

Primary outcomes:
measure: changes in wound healing
timeFrame: one week post-operatively
Secondary outcomes:
measure: morbidly wound healing
timeFrame: 4-8weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06028646: Dynamic Airway CT is Diagnostic for Tracheomalacia in Children
Official title: Dynamic Airway CT is Diagnostic for Tracheomalacia in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tracheomalacia
Keywords: Tracheomalacia in Children
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 25
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this pilot interventional study is to evaluate the use of Dynamic Airway Computed Tomography (DA-CT) for diagnosis of tracheomalacia in children 0-18 years for whom flexible bronchoscopy has been performed. The primary aims are to evaluate the diagnostic accuracy, image quality, and radiation exposure of DA-CT as a potential noninvasive alternative to the gold standard of flexible bronchoscopy in the diagnosis of tracheomalacia. The results from this pilot study will help to estimate sample size for a larger-scale study with more precise estimates of DA-CT diagnostic potential.


Eligibility criteria: Inclusion Criteria:

* Participants 0-18 years old, with
* Clinically indicated flexible bronchoscopy has been performed

Exclusion Criteria:

* Pregnancy or breastfeeding
* Unable to undergo CT scanning without sedation
* Patients with tracheostomy

Primary outcomes:
measure: Severity of dynamic narrowing on Flexible Bronchoscopy
timeFrame: Through study completion, an average of 1 year
measure: Severity of Maximal Airway Change (MAC) on DA-CT
timeFrame: Through study completion, an average of 1 year
measure: Severity of Excessive dynamic airway collapse (EDAC) on DA-CT
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Contrast-to-noise-ratio (CNR) of DA-CT scanners
timeFrame: Through study completion, an average of 1 year
measure: Qualitative Analysis of DA-CT Image Quality based on 5-point Likert scale
timeFrame: Through study completion, an average of 1 year
measure: Qualitative Analysis of DA-CT image noise based on 5-point Likert scale
timeFrame: Through study completion, an average of 1 year
measure: Qualitative Analysis of DA-CT delineation of large airways based on 5-point Likert scale
timeFrame: Through study completion, an average of 1 year
measure: Qualitative Analysis of DA-CT delineation of small airways based on 5-point Likert scale
timeFrame: Through study completion, an average of 1 year
measure: Qualitative Analysis of DA-CT noise texture based on 5-point Likert scale
timeFrame: Through study completion, an average of 1 year
measure: Radiation exposure of DA-CT scanners
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Fink Children's Ambulatory Center/Hassenfeld Children's Center
state: New York
city: New York
country: United States
facility: Tisch Hospital
state: New York
Study officials:
affiliation: NYU Langone Health
name: Eleanor Muise, MD
role: PRINCIPAL_INVESTIGATOR
References: