louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00412347: Insulin Infusion in the Hospital Wards
Official title: Insulin Infusion and Outcomes for Non-Critical Wards
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperglycemia
Keywords: hyperglycemia
diabetes
insulin drip
hypoglycemia
general wards
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2006-12-18
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of hospitalized adult subjects in a teaching institution.

Brief summary: Increasing evidence from clinical studies in Intensive Care Unit (ICU) settings indicates that insulin infusion can improve outcome measures for patients with hyperglycemia (high blood sugar) independent of a previous diagnosis of diabetes mellitus. This improvement in health could also apply to patients that have high blood sugars in various other non-critical care areas of the hospital as well. However, the data that shows improvement in health outcomes has been collected from wards that have a lower patient to provider and patient to nurse ratio, resulting in the ability for a much tighter control of the insulin infusion. We hypothesize that tight blood glucose control will provide the same benefits for patients in non-intensive care units settings but that these protocols may lead to a higher incidence of hypoglycemia (low blood sugar) and potentially to adverse outcomes in patients.

This study aims to determine the clinical outcome of patients treated with insulin infusion as well as the rate of hypoglycemic episodes in non-intensive areas. We will conduct a chart review of patients treated with insulin infusions in non-critical wards at Emory University Hospital during the period of 7/1/04 to 6/30/05. Medical records of all patients treated with intravenous insulin infusion protocols will be analyzed. Data on demographics, laboratory values, mortality rate, rate of hypoglycemic events, length of stay, as well as disposition at discharge will be analyzed.


Eligibility criteria: Inclusion Criteria:

* All subjects over 18 years of age that received intravenous insulin treatment on general medical and surgical wards at Emory University Hospital during the period of 7/1/2004 to 6/30/2005

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Guillermo Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smiley D, Rhee M, Peng L, Roediger L, Mulligan P, Satterwhite L, Bowen P, Umpierrez GE. Safety and efficacy of continuous insulin infusion in noncritical care settings. J Hosp Med. 2010 Apr;5(4):212-7. doi: 10.1002/jhm.646.
Clinical trial NCT05458947: Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)
Official title: A Prospective Analysis of Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Pressure Injuries
Keywords: Wound Care
Physical Therapy
Pulsed wound irrigation
Electrical stimulation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To examine the effects of PT wound care modalities (PWI + ES, PWI only, and ES only) on wound healing in patients with SCI
Primary purpose: TREATMENT

Brief summary: To examine the effects of Physical Therapist (PT) wound care modalities (pulsed wound irrigation (PWI) + electrical stimulation (ES), PWI only, and ES only) on wound healing in patients with spinal cord injuries (SCI).

Detailed description: It is hypothesized that PWI + ES will demonstrate the greatest rate of wound healing due to the combined effect of these treatments, which positively impact several aspects of the wound healing cascade. It is hypothesized that all patients will demonstrate improved quality of life from receiving wound care treatments by Physical Therapists due to individualized education and treatments which engage patients in their wound healing process and promote self-efficacy.

Eligibility criteria: Inclusion Criteria:

* Currently enrolled at inpatient rehabilitation at Carolinas Rehabilitation Charlotte
* Diagnosis of spinal cord injury and concomitant pressure injury to sacrum or ischium
* Agreeable to wound care treatment by Physical Therapist (PT)
* Able to perform informed consent
* Over 18 years of age
* Physician order for PT wound care evaluation and treatment
* Bates-Jensen Wound Assessment Tool (BWAT) \>31 on initial evaluation

Exclusion Criteria:

* Pain which limits ability to tolerate wound care treatments
* Unable to perform informed consent
* Pregnancy
* Bates-Jensen Wound Assessment Tool (BWAT) \<30 on initial evaluation

Primary outcomes:
measure: Bates-Jensen Wound Assessment Tool (BWAT) score
timeFrame: Baseline
measure: Bates-Jensen Wound Assessment Tool (BWAT) score
timeFrame: Week 1
measure: Bates-Jensen Wound Assessment Tool (BWAT) score
timeFrame: Year 1
Secondary outcomes:
measure: Change in The Spinal Cord Injury Quality of Life measurement system (SCI-QOL) Short Form Score
timeFrame: Baseline and Year 1
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Rehabilitation
state: North Carolina
Study officials:
affiliation: Carolinas Rehabilitation
name: Erin Weeks, PT,DPT, CWS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04261647: Kinesio-taping Versus Pelvic Floor Exercise for Post Colonoscopy Coccydynia
Official title: The Effect of Adding Kinesio-taping Versus Pelvic Floor Exercise to Conventional Therapy in the Management of Post-colonoscopy Coccydynia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Keywords: pelvic floor exercise
coccydynia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 42
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Forty-two patients, with coccydynia following colonoscopy were selected from Kasr El-Aini teaching Hospital, with age ranged from 25-45 years. Patients were randomly assigned to the control or experimental groups. The patients in the three groups completed 3-weeks 3 sessions per week for traditional physical therapy treatment consisting of stretching exercise for the piriformis and iliopsoas muscles, clamshell exercise, seat cushioning and seat kitz. Experimental group I received kinsiotaping techniques in addition to the traditional physical therapy. While experimental group II received pelvic floor exercise in the form of reverse kegel exercise or pelvic pulges, in addition to conventional therapies. pain intensity were evaluated by numerical rating scale as a primary out come measure, and Oswestry disability index was used as a secondary out come measure.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from pain in or around the coccyx, following colonoscopy procedures.
* Age group ranging from 38-58 years old.

Exclusion Criteria:

* Cancer.

  , - Cysts in pelvic area.
* Pelvic fracture or recent trauma.
* Patient with pain in coccyx region referred from lumbar spine, pelvic floor muscles, degenerative disc, neoplasms, bony spurs, or infections.

Primary outcomes:
measure: pain intensity measured by numerical rating scale.
timeFrame: after 3 weeks of intervention.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04477447: PMCF Study on the Safety and Performance of CESPACE 3D
Official title: Multicenter PMCF Study on the Safety and Performance of CESPACE 3D - A Prospective Study on Total Indications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Instability
Spondylolisthesis
Post-discectomy Syndrome
Post-traumatic Instabilities
Keywords: Cervical Vertebrae;
Spondylolisthesis;
Treatment Outcome;
Interbody Fusion
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2020-07-20
Enrollment: 101
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: adult patients

Brief summary: Prospective, pure data collection of all CeSPACE 3D patients in selected centers (not interventional, multicenter)


Eligibility criteria: Inclusion Criteria:

* Patient is minimum 18 years old
* Written informed consent for the documentation of clinical and radiological results
* Patient's indication according to IFU
* Patient is not pregnant

Exclusion Criteria:

• Patient is not willing or able to participate at the follow-up examination

Primary outcomes:
measure: Change of Neck Specific Disability measured by Neck Disability Index (NDI)
timeFrame: preoperative, 12 months postoperative
Secondary outcomes:
measure: JOA score
timeFrame: preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
measure: Pain (VAS)
timeFrame: preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
measure: development of EQ-5D-5L
timeFrame: preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
measure: development of radiological outcome
timeFrame: preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
measure: Rate of AE/SAEs
timeFrame: preoperatively, intraoperatively and at one follow-up- assessment after a minimum of one year postoperatively
measure: Patient Satisfaction with Treatment Outcome
timeFrame: at one follow-up- assessment after a minimum of one year postoperatively
Other outcomes:
Locations:
city: Koblenz
country: Germany
facility: Katholisches Klinikum Koblenz
city: Kremmen
country: Germany
facility: Sana Kliniken Sommerfeld
Study officials:
affiliation: Abteilung für Wirbelsäulenchirurgie Sana Kliniken Sommerfeld
name: Stefan Nikolaus Kroppenstedt, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Katholisches Klinikum Koblenz
name: Francis Kilian, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03502447: Randomized Study of the Safety and Effectiveness of the TearCare System for the Signs and Symptoms of Dry Eye Disease
Official title: Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the TearCare® System in the Treatment of the Signs and Symptoms of Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dry Eye Syndromes
Lead sponsor: Sight Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-18
Enrollment: 17
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this study, the TearCare System will be compared with standard-of-care warm compress treatment and lid massage in patients with dry eye disease. The objective is to demonstrate that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye disease and that it is superior to a commonly prescribed, standard treatment of warm compress and lid massage.

NOTE: All sites have been selected for this study.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with dry eye disease
* Signs and symptoms of dry eye disease
* Best corrected visual acuity 20/100 or better
* Willing and able to comply with study procedures
* Willing and able to provide consent

Exclusion Criteria:

* Active ocular infection or inflammation
* History of eyelid, conjunctiva or corneal surgery within the past year.
* Recent office-based dry eye treatment, punctal occlusion or punctal plug placement
* Contact lens wearer
* Significant ocular surface or eyelid abnormalities, recent ocular trauma
* Certain corneal surface abnormalities
* Use of medications for treatment of dry eye or medications that cause dry eye
* Systemic disease that results in dry eye

Primary outcomes:
measure: Tear Break-Up Time
timeFrame: 1 month
Secondary outcomes:
measure: Ocular Surface Disease Index (OSDI)
timeFrame: 1 month
measure: Meibomian Gland Score
timeFrame: 1 month
measure: Corneal and conjunctival staining graded using the NEI/Industry Grading System.
timeFrame: 1 month
measure: Symptom Assessment in Dry Eye (SANDE) and Eye Dryness Visual Analog Scale (VAS)
timeFrame: 1 month
measure: Adverse Events
timeFrame: 1 month
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Miami
country: United States
facility: Center for Excellence in Eye Care
state: Florida
city: Edgewood
country: United States
facility: Cincinnati Eye Institute
state: Kentucky
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
Study officials:
References:
Clinical trial NCT00002147: Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.
Official title: Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sarcoma, Kaposi
HIV Infections
Keywords: Sarcoma, Kaposi
Liposomes
Doxorubicin
Acquired Immunodeficiency Syndrome
Drug Carriers
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To provide Stealth liposomal doxorubicin hydrochloride ( DOX-SL ) as a therapy for Kaposi's sarcoma patients who have no remaining treatment options other than DOX-SL or patients who have been participating in another DOX-SL protocol and for whom continuation in DOX-SL is medically indicated. Also, to evaluate the safety and efficacy of DOX-SL in patients with Kaposi's sarcoma who have previously received systemic chemotherapy with or without an anthracycline.

Detailed description: Patients receive DOX-SL every 3 weeks for up to 20 cycles.

Eligibility criteria: Inclusion Criteria

Patients must have:

* AIDS-related Kaposi's sarcoma that requires systemic chemotherapy.
* EITHER a medical indication for continuation of DOX-SL following treatment on another DOX-SL protocol, OR no remaining treatment options other than DOX-SL.

Prior Medication:

Allowed:

* Prior anthracyclines.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Cardiac ejection fraction \< 50 percent or clinically significant cardiac disease.
* Eligibility for a Liposomal Technology comparative protocol.

Concurrent Medication:

Excluded:

* Other cytotoxic chemotherapy.

Patients with the following prior condition are excluded:

History of idiosyncratic or allergic reaction to anthracyclines.

Prior Medication:

Excluded:

* Chemotherapy within the past 3 weeks.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Menlo Park
country: United States
facility: Sequus Pharmaceutical Inc
state: California
Study officials:
References:
citation: Jablonowski H, Szelenyi H, Armbrecht C, Mauss S, Niederau C, Strohmeyer G. Liposomal doxorubicin--a new formulation for the treatment of Kaposi's sarcoma: a study on safety and efficacy in AIDS patients. Int Conf AIDS. 1993 Jun 6-11;9(1):397 (abstract no PO-B12-1573)
Clinical trial NCT01505647: Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1)
Official title: A Phase III Double-Blinded, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ Made With an Alternative Manufacturing Process (AMP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Shingles
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-01-06
Enrollment: 498
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will determine whether ZOSTAVAX™ made with an alternative manufacturing process \[ZOSTAVAX™ (AMP)\] is well tolerated and immunogenic, and has a comparable immune response to ZOSTAVAX™.


Eligibility criteria: Inclusion Criteria:

* No fever on day of vaccination
* History of varicella or residence in a VZV-endemic area for ≥30 years
* Females of reproductive potential must have a negative pregnancy test and must agree to use acceptable methods of birth control

Exclusion Criteria:

* History of hypersensitivity reaction to any vaccine component
* Prior receipt of any varicella or zoster vaccine
* Prior history of herpes zoster
* Have recently had another vaccination
* Pregnant or breastfeeding
* Use of immunosuppressive therapy
* Known or suspected immune dysfunction
* Concomitant antiviral therapy

Primary outcomes:
measure: Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody
timeFrame: Day 1 and Week 6 postvaccination
measure: Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers
timeFrame: Day 1 (Baseline) to Week 6 postvaccination
Secondary outcomes:
measure: Number of Participants With One or More Adverse Experiences (AEs)
timeFrame: Day 1 to Day 42 postvaccination
measure: Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination
timeFrame: Day 1 to Day 42 postvaccination
measure: Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination
timeFrame: Day 1 to Day 182 postvaccination
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00768547: Risk Stratification in Acutely Admitted Medical Patients
Official title: Risk Stratification in Acutely Admitted Medical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Tests
Lead sponsor: Ribe County Hospital
Sponsor class: OTHER
First posted: 2008-10-08
Enrollment: 5900
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient acutely admitted to the medical department of Ribe County Hospital

Brief summary: The study has three main parts.

1. To see if we can develop a riskstratification tool that can be used to asses the risk for acutely admitted medical patients for inhospital death, admission to the ICU and death within 30 days of release.
2. To test existing tool as in 1.
3. To clarify if it is most reasonable to let the admitting doctor order blood test by clinical judgment or be using a predefined list of tests.


Eligibility criteria: Inclusion Criteria:

* Any patient acutely admitted to the medical department of Ribe County Hospital

Exclusion Criteria:

* Age below 15 years
* Unwilling to participate

Primary outcomes:
measure: Number of test taken in each group
timeFrame: Five months
Secondary outcomes:
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Ribe County Hospital
Study officials:
References:
Clinical trial NCT00455247: Efficacy of an Oral Formula in Prevention of Anti-cancer Therapy Side Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Digestive Cancers
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2007-04-03
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Anti-cancer treatment is often inducing side-effects that can affect the compliance to the treatment protocol and quality of life of the patients. The researchers will study if the nutritional intervention with the product could abrogate the undesired effects in a preventive manner.


Eligibility criteria: Inclusion Criteria:

* Patient with GI neoplasm
* Patient that must start a (new) line of chemotherapy with at least 2 cycles
* Age \> 18 ans
* Exclusively orally fed
* Life expectancy more than 3 months
* Intravenous 5FU-based chemotherapy with 2 or 3-week cycles
* Hematological toxicities from previous chemotherapies terminated or \<= 2

Exclusion Criteria:

* Positive HIV status
* Pregnant or lactating woman
* Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study
* Patient having diarrhoea of grade \> 1 for more than 2 weeks before the inclusion
* State of sub occlusion, chronic inflammatory diseases of the digestive tract, radiation enteropathy
* Sepsis
* Concomitant radiotherapy, except analgesic radiotherapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Avignon
country: France
facility: Institut Sainte-Catherine
city: Béziers
country: France
facility: CH Béziers
city: Lyon
country: France
facility: CRLCC Léon Bérard
city: Montpellier
country: France
facility: CRLC Val d'Aurelle
city: Montpellier
country: France
facility: CHU Montpellier
city: Perpignan
country: France
facility: CH Perpignan
city: Rouen
country: France
facility: CHU Charles Nicolle
Study officials:
affiliation: CRLC Val d'Aurelle
name: Pierre SENESSE, MD
role: PRINCIPAL_INVESTIGATOR
References: