louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01575600: Effect of Intravenous Fluid Therapy on Postoperative Vomiting in Children Undergoing Otorhinolaryngological Surgery
Official title: Effect of Intravenous Fluid Therapy on Postoperative Vomiting in Children Undergoing Otorhinolaryngological Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Vomiting
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2012-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this randomized clinical trial is to evaluate the interaction of intravenous fluid therapy during otorhinolaryngological surgery, on postoperative vomiting. The hypothesis is that perioperative supplemental intravenous fluid administration reduces the incidence of postoperative vomiting.

Detailed description: Postoperative vomiting is a common complication on pediatric surgery, especially otorhinolaryngological surgery. Is one of the main reasons of prolonged hospital stay, and also a cause of patient´s discomfort and an increase on hospitalization cost.

There are studies in adults with inconclusive results related to supplemental fluid therapy and decrease of postoperative nausea and vomiting. But, in recent years a study in children showed favorable results in strabismus surgery. The foundation of this study consist in that hypovolemia may possibly cause a decrease in perfusion causing intestinal hypoxia, which in turn increase the incidence of nausea and vomiting. The objective of this study is to observe the effect of supplemental fluid therapy on postoperative vomiting on otorhinolaryngological surgery.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I or II
* Age 1-12 yr
* Scheduled for elective tonsillectomy or adenotonsillectomy

Exclusion Criteria:

* History of diabetes
* History of mental retardation
* Obesity (BMI ≥95th percentile for age and sex)
* Intake of antiemetic or psychoactive medication within 24 hours before surgery
* Known gastroesophageal reflux

Primary outcomes:
measure: Vomiting at 24 hours postoperative
timeFrame: First 24 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clinico Universidad Catolica
state: Region Metropolitana
Study officials:
References:
Clinical trial NCT00006200: Thalidomide and Dacarbazine for Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Melanoma
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-09-11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to assess the activity of thalidomide in combination with dacarbazine (DTIC) in patients with metastatic melanoma. Safety and toxicity of the two drugs will also be assessed. Dacarbazine is the standard medical treatment for metastatic melanoma. It has been shown to produce tumor shrinkage in approximately 20% of patients with advanced melanoma. This shrinkage is usually incomplete and lasts a short time. Thalidomide is a drug that inhibits tumor blood vessel growth. It can be given orally. It is hoped that this combination can be given to patients with metastatic melanoma without causing too much toxicity while increasing the response rate.


Eligibility criteria: Inclusion Criteria:

* Patients with metastatic melanoma.
* Lesions must be measurable.
* Patient must have the following minimum labs: ANC\> 1500/mm3, Hemoglobin \> 8 mg/dl; platelets \> 100,000 mm3; and liver function tests \< 5x normal; and creatinine \< 1.5 mg/dl.
* ECOG performance status \> 2.
* No prior therapy with DTIC or thalidomide
* No other history of malignancy other than curatively resected basal cell carcinoma of the skin or carcinoma in situ of the cervix.
* Patients must not be pregnant or lactating.
* Sexually active men and women of childbearing age must use adequate contraception. All patients must understand the potential for severe birth defects with thalidomide and must be able to follow instructions to avoid conception while taking thalidomide

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Kaplan Comprehensive Cancer Center
state: New York
Study officials:
References:
Clinical trial NCT01570452: Matrilysin Expression in Different Stages of Colorectal Tumors
Official title: Matrilysin Expression in Different Stages of Colorectal Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer Stage 0
Colorectal Cancer Stage I
Colorectal Cancer Stage II
Colorectal Cancer Stage III
Colorectal Cancer Stage IV
Keywords: matrilysin
MMP-7
colorectal cancer
adenoma
lymph nodes
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2012-04-04
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients affected by colorectal neoplasm admitted to our department of surgery

Brief summary: Matrix metalloproteinases (MMPs) have been shown to be involved in cancer biology. Significant expression of MMP-7 (matrilysin) in colorectal cancer is mainly associated with metastatic disease even though it is expressed in most tumor states. Our purpose is to analyse MMP-7 in bowel and lymph nodes of different tumor stages and to evaluate its expression as a potential biomarker of cancer disease in patients surgically treated for benign and malignant colorectal tumors. Tumoral tissue, lymph nodes and serum samples from recruited Patients plus serum samples from healthy volunteers are analysed for matrilysin expression by histology, immunohistochemistry, ELISA and Western blotting.

If Matrilysin increases with increasing dysplasia and cancer disease stage in tumor tissue as well as in the regional lymph nodes it might be used as a complement in investigating suspected locally advanced cancer.


Eligibility criteria: Inclusion Criteria:

* benign colonic neoplasm not suitable for endoscopic treatment,
* malignant colonic neoplasm with indication to primary surgical treatment

Exclusion Criteria:

* neo-adjuvant radiotherapy,
* chemo-radiotherapy,
* language problems and withdrawal of consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Departement of Surgery Pietro Valdoni
Study officials:
affiliation: Department of Surgery Pietro Valdoni, University La Sapienza Rome
name: Andrea Polistena, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mori M, Barnard GF, Mimori K, Ueo H, Akiyoshi T, Sugimachi K. Overexpression of matrix metalloproteinase-7 mRNA in human colon carcinomas. Cancer. 1995 Mar 15;75(6 Suppl):1516-9. doi: 10.1002/1097-0142(19950315)75:6+3.0.co;2-7.
Clinical trial NCT04301752: Cognitive Impairment and Neuropsychiatric Manifestations of Neurobrucellosis
Official title: Cognitive Impairment and Neuropsychiatric Manifestations of Neurobrucellosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brucellosis
Keywords: Brucellosis, neuropsychiatric manifestations, cognition
Lead sponsor: Mansoura University Hospital
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 82 consecutive patients with brucellosis (18 patients with neuropsychiatric manifestations and 64 patients without neuropsychiatric manifestations) were recruited.

Brief summary: Brucellosis is a common zoonotic infection in many parts of the world including the Mediterranean and Middle Eastern countries.

Neurobrucellosis may develop at any stage of disease and may have widely variable manifestations, including encephalitis, meningoencephalitis, radiculitis, myelitis, peripheral and cranial neuropathies, subarachnoid hemorrhage, and psychiatric manifestations.

Detailed description: Brucellosis is a common zoonotic infection in many parts of the world including the Mediterranean and Middle Eastern countries.

Neurobrucellosis may develop at any stage of disease and may have widely variable manifestations, including encephalitis, meningoencephalitis, radiculitis, myelitis, peripheral and cranial neuropathies, subarachnoid hemorrhage, and psychiatric manifestations.

The aimed is to shed light to the obscure areas of diagnosis in neurobrucellosis and have detailed general and neurologic features

Eligibility criteria: Inclusion Criteria:

* Patients \>18 years of age with laboratory-confirmed brucellosis

Exclusion Criteria:

* Previous neuropsychiatric disease

Primary outcomes:
measure: MoCA s
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
Study officials:
affiliation: Assistant Prof of Neurology
name: Esmael M Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Young EJ. Brucella species. In: Mandell GL, Bennett JE, Dolin R, eds. Principles and practice of infectious diseases. 7th ed. Philadelphia: Churchill Livingstone, 2010:2921-5.
citation: Pappas G, Akritidis N, Bosilkovski M, Tsianos E. Brucellosis. N Engl J Med. 2005 Jun 2;352(22):2325-36. doi: 10.1056/NEJMra050570. No abstract available.
citation: Finn TB. Brucellosis. In: Cohen J, Powderly WG, eds. Infectious diseases. 2nd ed. New York: Elsevier, 2004:1665-9.
citation: Eren S, Bayam G, Ergonul O, Celikbas A, Pazvantoglu O, Baykam N, Dokuzoguz B, Dilbaz N. Cognitive and emotional changes in neurobrucellosis. J Infect. 2006 Sep;53(3):184-9. doi: 10.1016/j.jinf.2005.10.029. Epub 2006 May 2.
Clinical trial NCT05177952: Low-Load Blood Flow Restriction on Patients With Multiple Sclerosis
Official title: The Chronic Effects of Low-Load Blood Flow Restriction or Standard of Care Resistance Exercise on Muscle and Neuromuscular Function in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Training Study
Multiple Sclerosis
Blood Flow Restriction
Keywords: Blood Flow Restriction
Multiple Sclerosis
Exercise
Lead sponsor: University of Central Florida
Sponsor class: OTHER
Collaborators: name: AdventHealth
First posted: 2022-01-05
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized between group parallel
Primary purpose: TREATMENT

Brief summary: This research is being done to compare the current standard of care for strength training for patients with Multiple Sclerosis to lightweight resistance training with blood flow restriction.

Detailed description: The purpose of this study is to compare the effectiveness of the current Multiple Sclerosis standard of care exercise recommendations to low-load resistance training with blood flow restriction on functional outcomes, strength, muscle size, and neuromuscular control in Multiple Sclerosis patients. This study involves completing 2 training sessions per week for 12 weeks as well as pre- and post-training assessment visits for a total of 29 visits over 14 weeks. All visits will be on UCF's campus with a member of the research team.

Eligibility criteria: Inclusion Criteria:

* Females between the ages of 18 to 55
* Diagnosed with Multiple Sclerosis
* Expanded Disability Status Score of 0 to 6.5
* Able to walk 10 meters without assistance
* Are willing to come in for all 29 testing visits over 14 weeks

Exclusion Criteria:

* No other known cardiovascular, pulmonary, metabolic, muscular, and/or coronary heart disease
* Multiple Sclerosis relapse in the past 30 days
* Are not currently undergoing a rehabilitation protocol
* Are not currently seeking medical care for a chronic condition that could limit exercise capacity other than multiple sclerosis
* Are not currently pregnant

Primary outcomes:
measure: Change in Functional Outcomes- 10meter
timeFrame: Day 2, Week 4 and 8, Day 28
measure: Change in Functional Outcomes- 6min walk
timeFrame: Day 2, Week 4 and 8, Day 28
measure: Change in Functional Outcomes- CST
timeFrame: Day 2, Week 4 and 8, Day 28
measure: Change in Functional Outcomes- 30CST
timeFrame: Day 2, Week 4 and 8, Day 28
measure: Change in Functional Outcomes- MFIS
timeFrame: Day 2, Week 4 and 8, Day 28
Secondary outcomes:
measure: Changes in Strength
timeFrame: Day 3, Week 4 and 8, Day 29
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Ethan Hill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06069752: Positional Stability and Refractive Behaviour After Implantation of an IOL After Cataract Surgery
Official title: Positional Stability and Refractive Behaviour After In-the-bag Implantation of an Aspheric Hydrophobic IOL After Conventional Phacoemulsification and Femtosecond Laser-Assisted Cataract Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ophthalmological Disorder
Lead sponsor: Johannes Kepler University of Linz
Sponsor class: OTHER
Collaborators: name: Carl Zeiss
First posted: 2023-10-06
Enrollment: 50
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 50 subjects requiring IOL implantation to treat aphakia after extracapsular cataract extraction or phacoemulsification.

Brief summary: The newest generation Lucia 621 has a step vault design that is claimed to provide excellent positional and refractive predictability.

In order to explore the positional stability, anterior chamber depth stability is examined as marker for haptic buckling comparing positional behaviour after conventional and femtosecond-laser assisted cataract surgery.

Detailed description: In order to explore the positional stability, anterior chamber depth stability is examined as marker for haptic buckling comparing positional behaviour after conventional and femtosecond-laser assisted cataract surgery.

Furthermore, the refractive outcome of CT Lucia 621P/PY is examined, providing optimized (en bloc optimization) formula constants for both, conventional and femtosecond-laser assisted cataract surgery for Haigis, Hoffer Q, Holladay I, SRK/T and Castrop formulae.

Besides ACD, further parameters for IOL stability are examined (IOL tilt/decentration) and consequences for the aberration profile are described.

Eligibility criteria: Inclusion Criteria:

* Adult subject with a minimum age of 22 years
* Planned natural lens replacement with posterior chamber IOL implantation
* Clear intraocular media other than cataract
* Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit
* Ability to consent to the participation in study
* Signed informed consent

Exclusion Criteria:

* Corneal pathology/ectasia
* Prior ophthalmic surgery
* Zonular-defects, unstable bag
* Macular pathologies
* Expected Visual acuity of less than 0.63 (decimal)
* Glaucoma
* Use of systemic or ocular medication that might affect vision
* Patient is pregnant, plans to become pregnant, is lactating
* Concurrent participation in any other clinical trial with an investigation product

Primary outcomes:
measure: Tilt and decentration of intraocular lens measured in degrees
timeFrame: 1 month post surgery compared with 12 months post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler University Hospital
state: Upper Austria
Study officials:
affiliation: JKU Linz
name: Matthias Bolz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03312452: The Incidence of IV Fluid Over-administration in Pediatric Dental Surgeries When Infusion Pumps Are Employed
Official title: The Role of Infusion Pumps in Preventing the Over-Administration of Intravenous Fluid in Pediatric Dental Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Pediatric
Perioperative
Intravenous fluid
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 103
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A prospective, analyst-blinded, randomized control trial to assess the incidence of intravenous (IV) fluid over-administration in the setting of pediatric dental surgeries. Anesthetists will be randomized to either administer their IV fluid through an infusion pump or a gravity drip device.

Detailed description: In the perioperative setting, IV fluids are administered to mitigate the effects of preoperative fasting and sources of fluid loss that are unique to surgical intervention. Significant harms have been associated with the over-administration of IV fluid in pediatric patients. Infusion pumps have been shown to reduce medication administration errors in inpatients receiving continuous IV infusions. In contrast, laboratory experiments have demonstrated that gravity driven fluid delivery systems are influenced by numerous extrinsic factors. To date, no work has investigated the perioperative incidence of IV fluid over-administration in pediatric patients randomized either to infusion pumps (intervention) or gravity-fed IV systems (control).

Eligibility criteria: Inclusion Criteria:

* ASA 1 and 2 children presenting for dental surgery

Exclusion Criteria:

* Children with pre-existing cardiac, renal, pulmonary or endocrine disease. In addition any child with an ASA score of 3 or greater.

Primary outcomes:
measure: Average absolute difference between volume prescribed and infused
timeFrame: From initiation of intravenous until arrival in the recovery room, up to three hours
Secondary outcomes:
measure: Volume of intravenous fluid administered
timeFrame: From initiation of intravenous until arrival in the recovery room, up to three hours
measure: Average percent difference between volume prescribed and infused
timeFrame: From initiation of intravenous until arrival in the recovery room, up to three hours
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: Resident principal investigator
name: Duncan EJ Bowes, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bowes DE, Gamble JJ, Bajwa JS. Using automated pump-delivery devices to reduce the incidence of excessive fluid administration during pediatric dental surgery: a randomized-controlled trial. Can J Anaesth. 2020 Nov;67(11):1535-1540. doi: 10.1007/s12630-020-01776-4. Epub 2020 Aug 5.
Clinical trial NCT01690052: Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva
Official title: Efficacy of Cevimeline vs. Pilocarpine in the Secretion of Saliva
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Mouth
Keywords: dry mouth
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main objectives were: 1) To determine the efficacy of both cevimeline and pilocarpine in the secretion of saliva in patients with xerostomia, and 2) To compare the side-effects between the treatment for xerostomia with cevimeline and with pilocarpine.

Detailed description: Pilocarpine is a cholinergic agonist with predominant muscarinic action.As such, it acts at muscarinic-cholinergic receptors found throughout the body and promotes fluid secretion. Due to this, one of the main side-effects of pilocarpine is an increased amount of sweating. Thus, not only are the salivary glands stimulated, but all of the body's exocrine glands' production is heightened. On the other hand, cevimeline is a drug with a high affinity for specific muscarinic receptors (M3) located on lachrymal and salivary gland epithelium. At least in theory, cevimeline will produce less side effects compared with pilocarpine because of the higher affinity for the muscarinic receptors located in the salivary glands. A limited number of human clinical trials in the efficacy of cevimeline and pilocarpine to increase the production of saliva and the side effects have been performed with no conclusive results.

The main purposes of this study were to determine the efficacy of cevimeline and pilocarpine in the secretion of saliva in patients with xerostomia, and to compare the side-effects between these two medications.

Eligibility criteria: Potential candidates with the diagnosis of moderate-severe xerostomia were identified from the Oral Medicine Clinic at the University Of Kentucky College Of Dentistry, or self referrals in response to IRB approved study announcements. Enrollment required no clinical evidence of oral lesions, subjective perception of dry mouth and less than 2 mL of saliva collected in 5 minutes without stimulation. Exclusion criteria included patients with non controlled chronic obstructive pulmonary disease (COPD), depression, asthma, cardiac arrhythmias, glaucoma, and the current use of any medication with interactions with cevimeline and pilocarpine.

Primary outcomes:
measure: Change From Baseline in Saliva Production in ml.
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
measure: Adverse Events
timeFrame: four weeks
Locations:
city: Lexington
country: United States
facility: University of Kentucky Orofacial Pain Center College of Dentistry
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Joel Thompson, PhD
role: PRINCIPAL_INVESTIGATOR
References: