louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01211184: Fluid and Nutrition in Elective Hip Surgery
Official title: Fluid and Nutrition in Elective Hip Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Surgery Corrective
Keywords: Hip surgery
Metabolism
Glucose
Body fluids
Complications
Lead sponsor: Sodertalje Hospital
Sponsor class: OTHER
First posted: 2010-09-29
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether fluid or glucose administration before hip replacement surgery minimizes postoperative muscle breakdown (catabolism), fatigue and disturbances in carbohydrate metabolism.

Detailed description: 1. How can a simple and safe way to measure the body's tendency to transient diabetes associated with surgery?
2. Can fluid or glucose administration before elective hip surgery, minimizing post-operative muscle breakdown (catabolism), fatigue and disturbances in carbohydrate metabolism?

Eligibility criteria: Inclusion Criteria: Patient scheduled for hip surgery. Exclusion Criteria: Endocrinological disorders.

Primary outcomes:
measure: Change in Insulin Sensitivity (Percent)
timeFrame: Day before surgery (approximately 3 PM) and in the morning after surgery (approx. 7.30 AM).
Secondary outcomes:
measure: Muscle Catabolism
timeFrame: From the morning after surgery (07.30) up to the morning two days after sthe surgery (07.30)
Other outcomes:
Locations:
city: Södertälje
country: Sweden
facility: Södertälje Hospital
Study officials:
affiliation: Linkoeping University
name: Robert G Hahn, Prof
role: STUDY_CHAIR
References:
citation: Ljunggren S, Hahn RG. Oral nutrition or water loading before hip replacement surgery; a randomized clinical trial. Trials. 2012 Jul 2;13:97. doi: 10.1186/1745-6215-13-97.
Clinical trial NCT04003584: Postop Pain in the MICS Patients Versus Sternotomy Patients
Official title: Is Postoperative Pain Different in the MICS CABG Cohort V. the Traditional Sternotomy Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Surgery
Keywords: Minimally invasive
Cardiac Surgery
Postoperative Pain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-07-01
Enrollment: 179
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The retrospective review was conducted over a six-month time frame, consisting of June 2017 through November 2017, at two hospitals within the same organization. One of the hospitals was a level one trauma center in the center of a major southeastern metropolitan area, and the second was a community hospital within the suburbs of the same city's geographic limits. All included patients fit the above inclusion and exclusion criteria per the aforementioned time frame and involved healthcare centers.

Brief summary: To adequately assess postoperative pain in the coronary artery bypass surgical population a multicentered retrospective chart review was carried out; the study utilized a nonexperimental comparative descriptive study design. The retrospective review was conducted over a six-month time frame, consisting of June 2017 through November 2017, at two hospitals within the same organization. The data collection process began in late December of 2017 and January of 2018. The assessment of postop pain was performed by using a standard 11-point numeric pain rating scale on post extubation day one and the day of discharge.


Eligibility criteria: Inclusion Criteria:

* Patients who had an isolated coronary artery bypass surgery at Charlotte Medical Center (CMC) and CMC-Pineville
* Minimally invasive cardiac surgery
* Traditional sternotomy cardiac surgery

Exclusion Criteria:

* Documented history of any chronic pain syndromes requiring active treatment
* The "relative" recent requirement of narcotic analgesic use for pain relief prior to operation
* Any CABG operation that inadvertently resulted in an operative surgical complication
* Patient cases that resulted in a readmission within 30 days from surgery.

Primary outcomes:
measure: Highest reported pain level, on the standard 0-10 pain scale, post extubation day one
timeFrame: The first 24 hours post extubation
measure: Highest reported pain level, on the standard 0-10 pain scale, on the day of discharge.
timeFrame: Within 24 hours from discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Jeko Madjarov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06158984: Managing Dry Eye in Patients Using Glaucoma Drops
Official title: Managing Dry Eye in Patients Using Glaucoma Drops
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Glaucoma
IPL
Diquafosol
Drug-induced Dry Eye
Lead sponsor: He Eye Hospital
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, comparative pilot study
Primary purpose: TREATMENT

Brief summary: A single center randomized controlled trial on managing dry eye signs and symptoms in patients using anti-glaucoma eye drops.

Detailed description: To compare the safety and efficacy of IPL therapy on drug-induced dry eye caused by long-term use of anti glaucoma drugs;

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Able and willing to comply with the treatment/follow-up schedule
* Bilateral signs and symptoms of dry eye disease

Exclusion Criteria:

* Participants with systemic immune-mediated illnesses, such as secondary Sjögren's syndrome or graft-versus-host disease
* Patients using topical medication(s) for the treatment of ocular disorders such as allergic conjunctivitis were excluded from the study.
* Previous ocular surgery or trauma
* 1-month history of blepharal and periorbital skin disease or allergies
* Severe dry eyes with corneal epithelial defect
* Limbic keratitis
* Pterygium
* Corneal neovascularization
* Breastfeeding
* Rheumatic immune systemic diseases
* Herpes zoster infection
* Pregnant women
* Allergic to fluorescein
* Contact lens wearers

Primary outcomes:
measure: Non-invasive tear break-up time
timeFrame: Day-0 (baseline), 2-week, 4-weeks
Secondary outcomes:
measure: Conjunctival hyperemia (RS score)
timeFrame: Day-0 (baseline), 2-week, 4-weeks
measure: Quality of meibum grade
timeFrame: Day-0 (baseline), 2-week, 4-weeks
measure: Expressibility of meibum grade
timeFrame: Day-0 (baseline), 2-week, 4-weeks
measure: Conjunctivocorneal epithelial staining grade
timeFrame: Day-0 (baseline), 1-week, 2-weeks
measure: Tear Film Lipid Layer
timeFrame: Day-0 (baseline), 2-week, 4-weeks
measure: OSDI Score
timeFrame: Day-0 (baseline), 2-week, 4-weeks
Other outcomes:
Locations:
city: Shenyang
country: China
facility: He Eye Hospital
state: Liaoning
Study officials:
affiliation: He Eye Hospital, Shenyang, China
name: Emmanuel Eric Pazo
role: STUDY_CHAIR
References:
Clinical trial NCT00156884: A Trial of Strontium +/- Cisplatin for the Palliation of Bone Pain Secondary to Hormone Refractory Prostate Cancer
Official title: A Randomized Phase II Trial of Strontium-89 With or Without Cisplatin for the Palliation of Bone Pain Secondary to Hormone Refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hormone Refractory Prostate Cancer
Bone Metastases
Keywords: prostate cancer
cisplatin
strontium-89
phase II
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: The Prostate Cancer Research Foundation of Canada
name: Amersham Health
First posted: 2005-09-12
Enrollment: 58
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to determine whether the combination of low dose cisplatin and strontium-89 shows clinical promise for the symptomatic treatment of bone metastases in hormone refractory prostate cancer.

Detailed description: This study is designed to determine whether the combination of low dose cisplatin and strontium-89 shows clinical promise for the symptomatic treatment of bone metastases in hormone refractory prostate cancer.

Eligibility criteria: Inclusion Criteria:

* adenocarcinoma of the prostate
* life expectancy \> 3 months,
* symptomatic from bone metastases
* radiologic evidence of metastatic bone disease
* stable level of pain control
* \>18 years
* ability to complete assessments
* prior treatment (chemo) \> 4 weeks previous
* discontinued anti-androgens for \> 4 weeks

Exclusion Criteria:

* prior strontium therapy
* previous hemibody RT within 6 weeks
* previous cytotoxic chemotherapy within 4 weeks
* use of bisphosphonate medications within 4 weeks
* change in steroid dose within 4 weeks
* active uncontrolled infection
* impending or present spinal cord compression
* significant neurological disorder
* impending pathological fracture
* severe urinary incontinence

Primary outcomes:
measure: Palliative pain response
measure: analgesic response
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Vancouver
country: Canada
facility: BC Cancer Agency
state: British Columbia
Study officials:
affiliation: Alberta Cancerboard
name: Bernie Eigl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alberta Cancerboard
name: Jackson Wu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02923284: NANOTECH RCC Biomarkers
Official title: Nanotech Biomarkers For Renal Cancer Intervention: Clinical Validation & Utility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Renal Cell Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-10-04
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that are 18 years of age and older and undergoing planned surgical procedure for removal of an imaged renal mass will be consented in the Center for Preoperative Assessment and Planning (CPAP), the holding area on the day of surgery, and the holding area of radiology. A urine sample will be collected from subject following informed consent. Additionally, discarded urine samples will be collected from the BJH Chemistry Labs from patients admitted for surgery for non-kidney cancer as a comparator group.

Brief summary: The incidence of renal cell carcinoma (RCC or kidney cancer) in men exceeds that of pancreatic cancer or leukemia. In women, the incidence of RCC is similar to that of leukemia, ovarian, or pancreatic cancer; thus, RCC is significant health issue. This study focuses on identifying specific molecules \[biomarkers\] of RCC that can be used to develop a reliable low-cost screening method at the point of service. If successful, our method would provide a diagnostic test to distinguish benign kidney masses from malignant ones, eliminating the need to surgically remove a kidney with a benign tumor.


Eligibility criteria: Inclusion Criteria:

Patients 18 years of age and older undergoing surgery. Patient samples are divided into 2 groups based on their surgery: Patients with an imaged renal mass, encompassing about 300 patients/year (about 1200 total) of both malignant (about 80-85% of time) and benign (about 15-20% of time), and patients with non-kidney cancers, encompassing about 6,000 patients/year (about 24,000 total),

Exclusion Criteria:

Age \<18 years and prisoners.

Primary outcomes:
measure: Urine AQP1
timeFrame: 28 days
measure: PLIN2 concentration
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University St Louis School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jeremiah Morrissey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00259584: Superior Vena Caval Obstruction (SVCO) - Management and Outcome
Official title: A Prospective Longitudinal Study of the Management and Outcome of Superior Vena Caval Obstruction (SVCO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Superior Vena Cava Syndrome
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2005-11-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: All patients with symptomatic malignant SVCO deemed suitable for treatment either with radiation therapy or by stenting will be eligible. They will receive whichever treatment is deemed most clinically appropriate. Symptomatic response, time to onset of palliation, duration of symptom control and survival will be assessed.


Eligibility criteria: Inclusion Criteria:

* Symptomatic clinical and radiological diagnosis of superior vena caval obstruction.
* Underlying histological diagnosis deemed appropriate for palliative radiotherapy as treatment by investigator. Patients with chemosensitive tumours such as small cell lung cancer (both untreated and recurrent), lymphoma and testicular tumours, will be eligible if radiation is deemed to be appropriate treatment.

Primary outcomes:
measure: Improvement in an index symptom at 4 weeks as recorded by a daily symptom diary
Secondary outcomes:
measure: Time to onset of palliation
measure: Duration of symptom control
measure: Survival
measure: Number of days spent in hospital
measure: Requirement for further treatment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Andrea Bezjak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03399084: A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia
Official title: An Open-label, Randomized, Parallel, Bioequivalence Study of 750 mg Intravenous Single Dose Ferric Carboxymaltose Versus Injectafer® (750 mg Iron/15 mL Colloidal Solution) in Adult Patients With Iron Deficiency Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Iron Deficiency Anemia
Keywords: Ferric carboxymaltose
Anemia
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2018-01-16
Enrollment: 71
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: OTHER

Brief summary: This study will evaluate bioequivalence of two formulations of Ferric Carboxymaltose as measured by serum total iron, in adult patients with iron deficiency anemia.


Eligibility criteria: Inclusion Criteria:

* Male and female patients at least 18 - 65 years of age;
* Patients with a body mass index (BMI) between 18.5 - 35 and with a body weight of ≥50 kg - ≤130 kg;

Exclusion Criteria:

* Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product
* Patients with chronic kidney disease who are on dialysis of any kind.
* If female, is pregnant or nursing.
* Patients with blood loss leading to hemodynamic instability
* Patients with recent parenteral iron within 3 months prior to screening.

Other inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Bioequivalence assessed by maximum serum concentration (Cmax)of serum total iron.
timeFrame: Up to 7 days
measure: Bioequivalence assessed by area under the serum concentration-time curve (AUC) of serum total iron.
timeFrame: Up to 7 Days
Secondary outcomes:
measure: Maximum serum concentration (Cmax) of serum transferrin-bound iron.
timeFrame: Up to 7 days
measure: Time of Cmax (Tmax) of serum total iron and transferrin-bound iron
timeFrame: Up to 7 Days
measure: Area under the serum concentration-time curve (AUC) of serum transferrin-bound iron
timeFrame: Up to 7 Days
measure: Apparent terminal rate constant of serum total iron and transferrin-bound iron
timeFrame: Up to 7 Days
measure: Apparent terminal half-life of serum total iron and transferrin-bound iron
timeFrame: Up to 7 Days
measure: Systemic clearance (CL) of serum total iron and transferrin-bound iron after intravenous dosing
timeFrame: Up to 7 Days
measure: Volume of distribution at steady state of serum total iron and transferrin-bound iron following intravenous dosing
timeFrame: Up to 7 Days
measure: Number of patients with adverse events as a measure of safety and tolerability
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Sandoz Investigative Site
state: Florida
Study officials:
affiliation: Novartis Pharmaceuticals
name: Sandoz Sandoz
role: STUDY_DIRECTOR
References:
Clinical trial NCT06423079: Scleral Fixation for Intraocular Lens-Bag Dislocation
Official title: Complex Intaocular Lens-Bag Fixation With Siepser's Scleral Sliding Knots
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pseudoexfoliation Syndrome
Lead sponsor: University of Naples
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex after cataract surgery.

Brief summary: Novel introflective sutures offer a minimally invasive approach for stable fixation of dislocated bag-IOL complexes, preserving visual acuity and reducing corneal complications in patients with pseudoexfoliation syndrome.

Detailed description: To assess the one-month outcomes of visual performance and positional stability of capsule-fixated intraocular lenses (IOLs) in patients with IOL-Bag complex dislocation. Patients with intraoperative complications or prior posterior capsule Nd-YAG laser were excluded. Surgical intervention involved creating a superior service keratotomy and using introflective sutures for IOL fixation. Best Corrected Visual acuity (BCVA), endothelial cell counts, and tonometry were assessed at multiple postoperative time points. We also evaluated the mean spherical equivalent (SE), and the residual cylinder and sphere at each follow-up.

Eligibility criteria: Inclusion Criteria:

* patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex

Exclusion Criteria:

* patients who underwent intraoperative complications,
* dislocation in the vitreous chamber of the bag-IOL complex,
* patients who had already undergone posterior capsule Nd-YAG laser

Primary outcomes:
measure: Best corrected visual acuity
timeFrame: 1 year
Secondary outcomes:
measure: Endothelial cells count
timeFrame: 1 year
Other outcomes:
Locations:
city: NAples
country: Italy
facility: University of Naples Federico II
Study officials:
References:
Clinical trial NCT00432679: A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study
Official title: Clinical Evaluation of Rosiglitazone Maleate (BRL49653C) in Patients With Type 2 Diabetes Mellitus (Combination Therapy With Sulfonyl Urea) - A Placebo-Controlled Double-Blind Study -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: rosiglitazone
Avandia
type 2 diabetes mellitus
diabetes
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-02-08
Enrollment: 149
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU).


Eligibility criteria: Inclusion criteria:

* Patients with type 2 diabetes mellitus managed by SU will be candidate for this study. These candidates will be checked up on their clinical laboratory data, and must have adequate blood, liver and kidney function.

Exclusion criteria:

* Patient with serious cardiovascular disease or serious hepatic disease will not be eligible.

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo Group
timeFrame: Baseline (Day 0) and Week 16
Secondary outcomes:
measure: Change From Baseline After 16 Weeks of Treatment in Fasting Plasma Glucose (FPG)
timeFrame: Baseline (Day 0) and Week 16
measure: Change From Baseline After 16 Weeks of Treatment in Fasting Insulin
timeFrame: Baseline (Day 0) and Week 16
measure: Change From Baseline After 16 Weeks of Treatment in Fasting Proinsulin
timeFrame: Baseline (Day 0) and Week 16
measure: Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: Baseline (Day 0) and Week 16
measure: Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Beta-cell Function (HOMA-beta)
timeFrame: Baseline (Day 0) and Week 16
measure: Change From Baseline After 16 Weeks of Treatment in Adiponectin
timeFrame: Baseline (Day 0) and Week 16
measure: Change From Baseline After 16 Weeks of Treatment in Leptin and High Sensitivity C-reactive Protein (Hs-CRP)
timeFrame: Baseline (Day 0) and Week 16
measure: Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment
timeFrame: Up to Week 16
Other outcomes:
Locations:
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kumamoto
country: Japan
facility: GSK Investigational Site
city: Oita
country: Japan
facility: GSK Investigational Site
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: This study has not been published in the scientific literature.