louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00463021: A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection
Official title: A Phase 4, Multi Center, Open-Label, Randomized Study to Determine Clinically Appropriate Doses of Hectorol® (Doxercalciferol Capsules) When Converting From Zemplar® (Paricalcitol Injection) for the Treatment of Secondary Hyperparathyroidism in Stage 5 Chronic Kidney Disease (CKD) Subjects on Hemodialysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Secondary Hyperparathyroidism
Keywords: Hectorol (doxercalciferol capsules)
Zemplar (paricalcitol injection)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-04-19
Enrollment: 36
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: Protocol HECT00306 aims to determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting from Zemplar (paricalcitol injection) for the treatment of secondary hyperparathyroidism in Stage 5 chronic kidney disease on hemodialysis.


Eligibility criteria: Inclusion Criteria:

* The subject must be receiving hemodialysis three times per week for a minimum of six months.
* The subject must have been receiving Zemplar Injection for a minimum of 3 months. The subject must have been on a stable dose regimen, three times per week administration for a minimum of four weeks.
* The central laboratory assessment must be within the following ranges: serum iPTH between 150-600 pg/mL, inclusive; corrected calcium \< 10.0 mg/dL; phosphorus \< 7.0 mg/dL.

Exclusion Criteria:

* In the opinion of the Investigator, the subject currently has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any other clinically significant, unstable medical condition.
* Abnormal liver function as measured by ALT/AST greater than two times the upper limit of normal (ULN).
* The subject currently has malabsorption, severe chronic diarrhea, or ileostomy.
* Any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion.

Primary outcomes:
measure: Dose Conversion
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Downey
country: United States
state: California
city: Paramount
country: United States
state: California
city: Hudson
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Pittsburgh
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01179321: Malnutrition Screening in Acute Aged Care
Official title: Malnutrition Screening and Intervention in Hospitalised Older Patients: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Lead sponsor: Prince of Wales Hospital, Sydney
Sponsor class: OTHER_GOV
First posted: 2010-08-11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to determine the impact of malnutrition screening and nutrition intervention on acute aged care patient outcomes.


Eligibility criteria: Inclusion Criteria:

* admitted under a geriatrician into one of 2 acute geriatric medicine wards of the hospital

Exclusion Criteria:

* expected length of stay less than 72 hours
* palliative (not for active treatment)
* unable to be nutritionally assessed (non english speaking, severe dementia/confusion and non cooperative/refused)
* already seen by dietitian during current admission
* enrolled in the study during previous admission

Primary outcomes:
measure: Length of stay
Secondary outcomes:
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
Study officials:
affiliation: Prince of Wales Hospital
name: Margaret M Holyday, B.Sc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05937464: Effects of Robotic-Assisted Gait Training in Patients With Stroke (EoRAGTiPwS)
Official title: Effects of Robotic-Assisted Gait Training on Functional Independence, Functional Capacity, and Quality of Life in Patients With Stroke: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Robotic Rehabilitation
Keywords: Stroke
Robotic Rehabilitation
Functional Independence
Functional Capacity
Quality of Life
Lead sponsor: Antalya Bilim University
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to examine effects of gait training with exoskeleton ExoAthlet and Lokomat Free-D on functional independence, functional capacity and quality of life in stroke patients.

Detailed description: The study included 32 patients who had stroke. Participants were randomized into two groups. Functional independence of patients was evaluated with Functional Independence Measure (FIM), physical function with 30-second chair stand test (30-CST), functional capacity with 6-Minute Walk Test (6MWT), and their quality of life with Short Form 36 (SF36). Conventional physiotherapy program was applied to groups for eight weeks, three days a week, each session 60 minutes. Then, one group received walking exercise training with exoskeleton ExoAthlet (ExoAtlet 1 model/2019, Russia), other group with Lokomat Free-D (Hocoma, Lokomat Pro Free-D model/2015, Switzerland). Participants were assessed at baseline and post-intervention.

Eligibility criteria: Inclusion Criteria:

* Age between18-65 years old
* Patients who had a stroke at least three months ago
* Can independently ambulated

Exclusion Criteria:

* Heart failure and rhythm disorder,
* Visual and cognitive problems,
* Neglect phenomenon (Neglect Syndrome),
* Cerebellar pathology,
* Any lower extremity surgery
* An additional neurological pathology that could prevent receiving a training program

Primary outcomes:
measure: Functional Independence Measure
timeFrame: At baseline
measure: 30-Second chair stand test
timeFrame: At baseline
measure: 6- Minute walk test
timeFrame: At baseline
measure: 36-Item Short Form Health Survey
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Private rehabilitation center in Istanbul
state: Antalya
Study officials:
References:
Clinical trial NCT00279864: The Utility of Levofloxacin-Rifampin in the Therapy of Prosthetic Joint Infection
Official title: Prolonged Oral Levofloxacin-Rifampin for Staphylococcus Aureus Prosthetic Joint Infection (PJI) Treated With Debridement And Retention Of Components: A Prospective Observational Cohort Study. Mayo PJI Study Group (MPSG)*
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Staphylococcal Infection
Staphylococcus Aureus Prosthetic Joint Infection
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Ortho-McNeil, Inc.
First posted: 2006-01-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A maximum of 15 adult participants with total hip or total knee arthroplasty are approved for enrollment in this protocol at Mayo Clinic Rochester.

Brief summary: Prosthetic joint infection is a devastating complication of total joint arthroplasty ultimately leading to the failure of the total joint arthroplasty function and possibly death. Optimal treatment requires the resection of the infected total joint arthroplasty followed by prolonged parenteral antimicrobial therapy. This procedure is followed by reimplantation of a new total joint arthroplasty at a later date. Surgical debridement and retention of the infected total joint arthroplasty offers a more conservative surgical approach and has been proven to be cost-effective in selected groups of patients. Traditional medical therapy for staphylococcal infection would require an initial parenteral antimicrobial followed by chronic oral non-rifampin containing antimicrobial suppression regimen for the life of the total joint arthroplasty. With this strategy the success rate is close to 30%. Recently, several prospective studies of patients with THA, TKA and fracture fixation device infections conducted in Europe showed that the success rate with a 3-6 month course of a quinolone-rifampin combination is effective in 70% to 100% of cases. The proposed study will be a prospective open label observational cohort that will evaluate the outcome of Patients with S. aureus PJI treated with a medical regimen that includes oral levofloxacin- rifampin and debridement and retention of components. This medical regimen was approved for use by the Orthopedic Infectious Diseases focus group, Mayo Clinic, Rochester. 15 patients will be enrolled over a one-year period and followed up to minimum of 1 additional year. The outcome of this group will be compared to a historical group that is treated with traditional therapy.


Eligibility criteria: A maximum of 15 adult participants with total hip or total knee arthroplasty are approved for enrollment in this protocol at Mayo Clinic Rochester.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Elie F. Berbari, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03427164: Ultrasound Elastography Assessment of Spleen and Liver Stiffness Before and After Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure
Official title: Ultrasound Elastography Assessment of Spleen and Liver Stiffness Before and After Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Portal Hypertension
Keywords: Transjugular Intrahepatic Portosystemic Shunt
TIPS
cirrhosis
hepatitis
portal vein thrombosis
Budd-Chiari Disease
Elastography
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The primary purpose of this project is to determine if acute monitoring of shunt patency via ultrasound elastography measurements of splenic stiffness before and after TIPS placement results in reduced morbidity and mortality from shunt failure.

Detailed description: Portal hypertension is a condition that is caused by various disorders of the liver, including cirrhosis, hepatitis, portal vein thrombosis, or Budd-Chiari Disease. Portal hypertension can lead to the accumulation of fluid in the abdomen, called ascites, or put patients at risk for bleeding of the esophagus, stomach, and bowel. In certain patients, portal hypertension is treated by placement of a Transjugular Intrahepatic Portosystemic Shunt (TIPS).

Elastography is a newer exam which measures the consistency, or softness/stiffness, of various organs in the body. It is performed with ultrasound by sliding a transducer across the abdomen. Elastography is most commonly used to evaluate the liver, as disorders that cause damage to the liver result in stiffer liver tissue. The spleen has also been shown to get stiffer in the setting of portal hypertension.

Eligibility criteria: Inclusion Criteria:

* All patients who undergo TIPS placement at the University of Kansas Medical Center (KUMC) are eligible for participation in this study

Exclusion Criteria:

* Patients under 18 years of age
* Patients with prior splenectomy

Primary outcomes:
measure: Spleen stiffness
timeFrame: Change from Baseline to 2 weeks post-procedure
Secondary outcomes:
measure: Change in spleen stiffness
timeFrame: Change from Baseline to Month 12
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jill Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02456064: Impact of a Program of Non-pharmacological Intervention in Patients With Type 2 Diabetes Mellitus
Official title: Impact of a Program of Non-pharmacological Intervention in Patients With Type 2 Diabetes Mellitus With Poor Control of Their Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Equipo Multidisciplinar Sanitario CS Foietes
Sponsor class: OTHER
First posted: 2015-05-28
Enrollment: 25
Sex: ALL
Minimum age (years): 25
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 a non-drug intensive program can help improve control of type 2 diabetes mellitus.

Detailed description: This study is based on the creation of two groups of patients with type 2 diabetes mellitus over a period of six months .

In one of the groups an intensive program be developed through : group medical consultations , workshops , informative talks, " expert patient " telephone inquiries .. etc. Meanwhile , the control group that will be followed in the consultations as usual.

We will make a determination of HbA1c at 3 months and 6 months later to assess whether there are significant differences between the two groups .

Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes mellitus with poor control of their disease.
* No changes have been made in pharmacological previous 3 months.

Exclusion Criteria:

* Changes in their drug treatment in the past 3 months.

Primary outcomes:
measure: HbA1c
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
name: Ivan S Silvera
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01945164: XL999 Administered Intravenously to a Subject With Advanced Malignancies
Official title: Single Patient Treatment Study for the Use of XL999 Administered Intravenously to a Subject With Advanced Malignancies Previously Enrolled in Study XL999-900
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Advanced Malignancy
Keywords: XL999
Advanced Malignancy
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2013-09-18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Cancer is a worldwide clinical and economic problem. Conventional approaches to treating cancer include surgery, radiotherapy, and cytotoxic chemotherapy as single modalities or as combined therapies. Recently, targeted therapies including antibodies and small molecule inhibitors have also demonstrated clinical benefit. It is now possible to study different genetic lesions involved in cancer types due to advances in genomic methodologies. The investigational drug in this study, XL999 inhibits multiple receptor tyrosine kinases, including VEGF receptor (VEGFR2/KDR), platelet derived growth factor receptors (PDGFRβ), fms-like tyrosine kinase receptor 3 (FLT3), fibroblast growth factor receptors (FGFR1, FGFR3), RET, and KIT, and thus, interferes with multiple cellular processes simultaneously and will likely have effects on the integrity of tumor neovasculature and angiogenesis. Together with the ability to induce a novel cell cycle arrest, the spectrum of activities that XL999 exhibits may reduce both tumor cell proliferation and angiogenesis in the clinic.

The rationale and purpose of this maintenance study is to allow a subject receiving clinical benefit from XL999 to continue treatment.


Eligibility criteria: Inclusion Criteria:

* The subject is eligible to continue to receive XL999 in the absence of progressive disease and unacceptable XL999-related toxicity.

Exclusion Criteria:

* Progressive disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Cancer Therapy and Research Center at UTHSCSA
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: John Sarantopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02678364: Effect of Vitamin D-biofortified Eggs on Wintertime Serum 25-hydroxyvitamin D in Adults: Randomized Controlled Trial
Official title: A Dietary Intervention Study Examining the Effect of Consumption of Vitamin D-enhanced Eggs on Winter-time Vitamin D Status in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: Vitamin D-biofortified eggs
Vitamin D status
RCT
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 55
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: While there have been a considerable number of studies on the impact of additional vitamin D in the diets of hens on the resulting egg vitamin D content, the effect of consumption of such vitamin D-enhanced eggs on vitamin D status of healthy human subjects has not been tested in a RCT.

Detailed description: The aim of this study was to investigate the effect of consumption of vitamin D3 versus 25-hydroxyvitamin D3 biofortified eggs on winter serum 25(OH)D in adults using a 8-wk randomized controlled trial. This research will provide new data on the potential of vitamin D enriched eggs as a food-based strategy for prevention of vitamin D deficiency.

Eligibility criteria: Inclusion Criteria:

- consenting white men and women aged 45-70 years

Exclusion Criteria:

* consumption of vitamin D-containing supplements throughout the study. planning to take a winter vacation (during the course of the 8-wk intervention) - to a location at which either the altitude or the latitude would be predicted to result in significant cutaneous vitamin D synthesis from solar radiation
* planning to use tanning facilities of any type.
* a severe medical illness,
* allergy to egg products,
* medically advised to limit egg intake in relation to managing hypercholesterolemia,
* hypercalcaemia,
* known intestinal malabsorption syndrome,
* excessive alcohol use,
* the use of medications known to interfere with vitamin D metabolism

Primary outcomes:
measure: Response of serum total 25-hydroxyvitamin D concentration over 8 weeks of winter
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Serum parathyroid hormone
timeFrame: 0 weeks and 8 weeks
Other outcomes:
measure: Serum total calcium
timeFrame: 0 weeks and 8 weeks
measure: Serum total cholesterol
timeFrame: 0 weeks and 8 weeks
Locations:
city: Cork
country: Ireland
facility: Human Dietary Studies Facility, School of Food and Nutritional Sciences, University College Cork
Study officials:
affiliation: University College Cork
name: Kevin D Cashman, BSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hayes A, Duffy S, O'Grady M, Jakobsen J, Galvin K, Teahan-Dillon J, Kerry J, Kelly A, O'Doherty J, Higgins S, Seamans KM, Cashman KD. Vitamin D-enhanced eggs are protective of wintertime serum 25-hydroxyvitamin D in a randomized controlled trial of adults. Am J Clin Nutr. 2016 Sep;104(3):629-37. doi: 10.3945/ajcn.116.132530. Epub 2016 Aug 3.
Clinical trial NCT04313764: Ultrasound-Guided Erector Spinae Plan Block for Colorectal Surgery
Official title: The Comparison of the Erector Spinae Plane Block and Wound Infiltration on Postoperative Opioid Consumption in Patients Undergoing Laparoscopic Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Postoperative Pain
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Colorectal cancer is a common and lethal disease. It still remains the third most common cause of cancer death in women and the second leading cause of death in men. Pain control is an important direction of postoperative management in malignancy surgery. Inadequate pain control increases cardiac and respiratory complications in these critical patients. Erector spinae plane (ESP) block is a recently described regional anesthesia technique that blocks the dorsal and ventral rami of the spinal nerves and the sympathetic nerve fibers. While the ESP block has been shown to provide effective postoperative analgesia after thoracic, and abdominal surgeries.

Our aim in this study was to investigate bilateral thoracic ESP block for providing successful postoperative pain management following colorectal surgery.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-II-III patients undergoing Colorectal surgery

Exclusion Criteria:

* renal or hepatic insufficiency, chronic pain, patients with an allergic reaction to anesthesia and analgesia drugs to be used

Primary outcomes:
measure: Opioid Consumption
timeFrame: Postoperative first 24 hours
Secondary outcomes:
measure: Visual Analog Pain Score
timeFrame: Postoperative first 24 hours
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
citation: Hain E, Maggiori L, Prost A la Denise J, Panis Y. Transversus abdominis plane (TAP) block in laparoscopic colorectal surgery improves postoperative pain management: a meta-analysis. Colorectal Dis. 2018 Apr;20(4):279-287. doi: 10.1111/codi.14037.
citation: Tulgar S, Ahiskalioglu A, De Cassai A, Gurkan Y. Efficacy of bilateral erector spinae plane block in the management of pain: current insights. J Pain Res. 2019 Aug 27;12:2597-2613. doi: 10.2147/JPR.S182128. eCollection 2019.