louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03445897: Miltefosine Plus IL Pentamidine for Bolivian CL
Official title: Miltefosine Combined With Intralesional Pentamidine for Leishmania Braziliensis Cutaneous Leishmaniasis in Bolivia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leishmaniasis, Cutaneous
Lead sponsor: AB Foundation
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).
Primary purpose: TREATMENT

Brief summary: Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).

Detailed description: Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5). Efficacy and tolerance parameters were assessed. Efficacy was assessed at 1, 3, and 6 months post therapy. Tolerance was assessed on each day therapy was administered.

Eligibility criteria: Inclusion Criteria:

* one ulcerative lesion ≤ 900 mm2 in total area,
* ≥ 12 years,
* parasitologically diagnosed by visualization of amastigotes or culture of promastigotes from lesion material,
* no antileishmanial therapy in the last 3 months,
* no mucosal lesions,
* no history of significant concomitant diseases including immunosuppression.

Exclusion Criteria:

Primary outcomes:
measure: Lesion size
timeFrame: 6 months post therapy
Secondary outcomes:
measure: adverse effects at site
timeFrame: days 1, 3, 5 of therapy
measure: systemic adverse effects
timeFrame: days 1 to 28 of therapy
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00575497: More Frequent Dialysis (>3 Treatments Per Week)
Official title: Study of Clinical Outcomes of More Frequent Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Chronic Kidney Disease
Keywords: Hemodialysis
Adequacy
Frequency
Lead sponsor: Satellite Healthcare
Sponsor class: OTHER
First posted: 2007-12-18
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study compares the benefits of short daily hemodialysis six days a week, nocturnal (night time) hemodialysis six days a week, every other day and every other night hemodialysis to traditional three days a week hemodialysis.The hypothesis is that increasing hemodialysis treatment time and/or frequency will improve outcomes.


Eligibility criteria: Inclusion Criteria:

* Stable vascular access, i.e., lack of needling difficulties and stable flow rates. Accesses will include fistulae, grafts, catheters and ports.
* 18 years of age.
* History of compliance with a dialysis treatment schedule, or if a new patient, express a willingness to be compliant with a treatment schedule.
* Plan to continue care and follow-up at the investigational site.
* Able to sign the informed consent and other relevant documents.

Exclusion Criteria:

* History of poor compliance with thrice (or twice) weekly dialysis schedules as manifested by more than three unexplained missed treatments in the past six (6) months.
* Pregnancy.
* Intravenous drug abuser.
* Expects to receive a transplant or transfer to another facility within six months of entering the study.

Primary outcomes:
measure: Hospitalization days per year
timeFrame: Ongoing
Secondary outcomes:
measure: Nutritional Status measured by Subjective Global Assessment
timeFrame: Ongoing
measure: Anemia, measured by erythropoetin dose
timeFrame: Ongoing
measure: Control of hypertension, as measured by number of antihypertensive tablets taken per day
timeFrame: Ongoing
measure: Control of hyperphosphatemia, as measured by number of phosphate binder tablets taken per day
timeFrame: Ongoing
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Satellite Healthcare, Inc.
state: California
city: Mountain View
country: United States
facility: WellBound, Inc.
state: California
Study officials:
affiliation: Satellite Healthcare, Inc.
name: John Moran, MD
role: STUDY_DIRECTOR
affiliation: Satellite Healthcare, Inc.
name: Brigittte Schiller-Moran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01789697: Text Message Study
Official title: Using Mobile Phone Text Messaging and E-mailing to Decrease Anxiety, Pain, Follow-up Visits and Improve Reporting of Surgical Site Infection After Spine Surgery: A Double-Blind Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anxiety
Pain
Surgical Site Infection
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-02-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objectives of this double-blind, randomized, controlled study are to evaluate the efficacy of maintaining contact with low-back pain patients through text messaging and emailing, to decrease anxiety levels, pain, number of follow-up visits through text messaging and emailing, and to improve reporting of surgical site infection after spine surgery through text messaging and emailing. The outcomes that will be measured are anxiety, pain, follow-up visits and received phone calls, and reporting signs of surgical site infection. Participants will include Dr. Oren Gottfried's patients who underwent spine surgery at Duke Hospital or at Duke Raleigh Hospital. Patients will be approached after determination that the patient is going to undergo spinal surgery. All patients meeting inclusion criteria will be approached to participate irrespective of race or ethnicity. A total of 194 subjects will be recruited.


Eligibility criteria: Inclusion Criteria:

* Patients age greater than 18 years
* Patients who confirm they have an unlimited text message data plan and email capabilities on their mobile device
* Patients of Dr. Gottfried's underwent lumbar decompression or fusion surgery
* Patients with text message capabilities
* Patients who have an active email account

Exclusion Criteria:

* Patients who demonstrate an inability to fill out the pre-visit questionnaires
* Patients with a diagnosis of metastatic disease
* Patients with workers compensation or liability pending
* Patients who will require transfer to an acute rehabilitation facility following surgery

Primary outcomes:
measure: Change in Anxiety
timeFrame: Day 1-21, Month 3, Month 12
measure: Change in Pain
timeFrame: Day 1-21, Month 3, Month 12
measure: Change in Surgical Site
timeFrame: Day 1-21
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
Clinical trial NCT02041897: Clinical Evaluation of EUS-FNA on Diagnosis of Pancreatic Cystic Lesions
Official title: Clinical Evaluation of EUS-FNA on Diagnosis of Pancreatic Cystic Lesions----A Multiple Center,Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cyst
Keywords: EUS-FNA
Pancreatic cystic lesion
Diagnosis
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
Collaborators: name: Second Military Medical University
First posted: 2014-01-22
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: It is still controversial about the necessity of endoscopy ultrasound guide fine needle aspiration (EUS-FNA) on diagnosis of pancreatic cystic lesions(PCL).The aim of this study is to find the influence of EUS-FNA on diagnosis and suggestions of EUS specialists.

Detailed description: First, the investigators will send only EUS images of patients with PCL to diagnosis committee that is consisted with 8 EUS specialists from different countries.The diagnosis will be collected. Then the investigators send the results of EUS-FNA. The diagnosis and suggestions will be collected again. The investigators will calculate how much diagnosis has been changed because of results of EUS-FNA. The investigators will also follow up these patients for 5 years at least to find if these patients benefit from EUS-FNA and complications such as needle tract seeding metastases.

Eligibility criteria: Inclusion Criteria:

1. Adults with ages from 18-80 years old.
2. The patients with pancreatic cystic lesions, which diameter of cystic lesion more than 2cm.
3. Sign the informed consent voluntarily. -

Exclusion Criteria:

1. The patient can't accept the endoscopic procedure.
2. The patient has blood coagulation dysfunction.
3. The patient has mental disorders.
4. The patient has mild or severe cardiorespiratory insufficiency.
5. The patient has hypertension and can't be controlled to safe level.
6. Patients with alcohol dependence.
7. Pregnant and lactating women.
8. The patients the investigators don't think suitable for this study.

   -

Primary outcomes:
measure: Rate of change of diagnosis
timeFrame: During 2 weeks
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 5 years
Other outcomes:
Locations:
city: Xian
country: China
facility: Department of Gastroenterology,Xijing Hospital
state: Shanxi
Study officials:
affiliation: Xijing hospital,The Fourth Military Medical University
name: Kaichun Wu, MD,Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT02799797: Ultrasound-guided Continuous Adductor Canal Block for Analgesia After Total Knee Replacement: Comparison of Short-axis and Long-axis Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Analgesia
Nerve Block
Keywords: adductor canal block
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Medical Consulting Center
First posted: 2016-06-15
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study compares the long-axis and short-axis technique of continues adductor canal block for total knee replacement surgery. Half participants will receive long-axis catheterization, while the other half will receive short-axis catheterization.


Eligibility criteria: Inclusion Criteria:

* 18-80 years
* Knee-arthroscopy
* Written consent
* ASA I-III
* BMI 19-35

Exclusion Criteria:

* Unable to communicate with the investigators (e.g., a language barrier or a neuropsychiatric disorder).
* coagulopathy or on anticoagulant medication
* Allergic reactions toward drugs used in the trial
* History of substance abuse
* Infection at injection site
* Can not be mobilised to 5 meters of walk pre-surgery

Primary outcomes:
measure: the strength of quadriceps femoris
timeFrame: within 48hours after surgery
Secondary outcomes:
measure: postoperative nausea and vomiting score
timeFrame: 0-2, 2-4, 4-8, 8-24, 24-48 hours postoperative
measure: ambulation time
timeFrame: within the 7 days after surgery
measure: quality of recovery
timeFrame: 3days and 7days after surgery
measure: complications
timeFrame: within the 7 days after surgery
measure: the strength of quadriceps femoris
timeFrame: 0,2,4,8,24,48 hours postoperative
measure: Pain-score (VAS), patient at rest
timeFrame: 0,2,4,8,24,48 hours postoperative
measure: Pain-score (VAS), motion pain
timeFrame: 0,2,4,8,24,48 hours postoperative
measure: sulfentanil consumption
timeFrame: 0,2,4,8,24,48 hours postoperative
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xulei CUI
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yuguang Huang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02805283: Dapagliflozin Patient Satisfaction Survey
Official title: Direct to Patient Survey to Examine Treatment Satisfaction and Experience With Dapagliflozin Compared to Sulfonylureas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Optum, Inc.
First posted: 2016-06-20
Enrollment: 653
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 Diabetes patients with administrative claims data from Optum Research Database (US Commercial Claims Data)

Brief summary: The purpose of this study is to evaluate the diabetes related treatment satisfaction for patients with type 2 diabetes mellitus

Detailed description: This is a cross-sectional, observational patient survey study. Study subjects will be adult commercial members of the large US health plan affiliated with Optum with evidence of T2D initiating dapagliflozin or a sulfonylurea medication within the 3 months prior to survey mailing.

Eligibility criteria: Inclusion Criteria:

* At least one pharmacy claim for dapagliflozin or dapagliflozin/metformin ER in the most recent month of pharmacy data and no pharmacy claims for an SGLT2 medication during the 6 months prior to sample identification.
* Evidence of T2D diagnosis.
* Age ≥18 as of the drug index date.
* 6 months of continuous enrollment in a commercial health plan with both pharmacy and medical benefits during the identification period through the patient interview sample identification date.
* Self-reported T2D diagnosis during the patient interview.

Exclusion Criteria:

* Patients with evidence of type 1 diabetes mellitus and unknown type
* Patients who are pregnant

Primary outcomes:
measure: Condition-specific treatment satisfaction
timeFrame: 2 weeks
Secondary outcomes:
measure: Medical Outcomes Study (MOS) Short Form Health Survey SF-12 or SF-36
timeFrame: 4 weeks
measure: Morisky Medication Adherence Scale
timeFrame: 1 month
measure: Hypoglycemia Fear Survey
timeFrame: 4 weeks
measure: Self-reported body weight
timeFrame: 1 month
Other outcomes:
Locations:
city: Eden Prairie
country: United States
facility: Reasearch Site
state: Minnesota
Study officials:
affiliation: AstraZeneca
name: Kelly Bell, PharmD, MSPhr
role: STUDY_CHAIR
References:
Clinical trial NCT04301583: Procyanidin B2 Enriched Cocoa Effects on Mitochondrial Biogenesis
Official title: Procyanidin B2 Enriched Cocoa Effects on Mitochondrial Biogenesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Athletes
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to test how cocoa-rich procyanidin B2 affect the mitochondrial exercise adaptations.


Eligibility criteria: Inclusion Criteria:

* Men/Women
* Age between 18 and 45 years
* Aerobic power of oxygen consumption greater than or equal to 55 mL / kg / min

Exclusion Criteria:

* Smoke
* Any chronic disease
* Intake of nutritional or ergogenic supplements
* Chronic medication
* Cocoa allergy

Primary outcomes:
measure: Difference in mitochondrial number
timeFrame: 10 weeks
measure: Difference in exercise performance
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Villaviciosa de Odón
country: Spain
facility: Universidad Europea de Madrid
state: Madrid
Study officials:
affiliation: Universidad Europea de Madrid
name: Mar Larrosa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00986583: Effect of Succinylcholine on Patients Using Statins
Official title: Effect of Succinylcholine on Patients Using Statins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Succinylcholine
Statins
myalgias
statins with succinylcholine and pain
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2009-09-30
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Based on available mechanistic and clinical information, the investigators propose a nonrandomized study to evaluate the effect of succinylcholine in patients taking statins. The investigators' purpose is to evaluate the effect of succinylcholine on patients taking statins. Patients scheduled to undergo elective surgery (other then orthopedic, spinal, vascular or muscle) with planned endotracheal intubation will be approached regarding participation in the trial. Design of the study is complex because there is no way to randomize patients to statins or no statins and also no way to take them off the statins prior surgery. So statin use will not be randomized; confounding factors will be accounted for by stratification (every 10 years of age from 40-80 and gender) and statistical adjustment. The investigators propose to test the hypothesis that succinylcholine administration increases plasma myoglobin concentration more in patients who are on statins compared to patients who do not.


Eligibility criteria: Inclusion Criteria:

* Scheduled for elective surgery not involving orthopedic procedure, muscle and spinal surgery
* ASA Physical Status 1-3

Exclusion Criteria:

* History of liver failure
* History of renal failure
* History of neuromuscular disease
* Increased intraocular pressure
* Recent major burn
* Multiple trauma
* Susceptibility to or family history of malignant hyperthermia

Primary outcomes:
measure: Plasma Myoglobin Concentration
timeFrame: induction, 5 minutes after administration, 20 minutes and 24 hours post operatively
Secondary outcomes:
measure: Muscle Pain
timeFrame: 2 and 24 hours postoperatively
measure: Serum Potassium Concentration
timeFrame: At 5 and 20 min after succinylcholine
measure: Change in Plasma Creatine Phosphokinase (CK) Concentration From 2 to 24 Hours Postoperatively
timeFrame: 2 and 24 hours postoperatively
measure: Duration of Succinylcholine Block
timeFrame: intraoperative: from succinylcholine administration
measure: Fasciculation
timeFrame: postoperative
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Alparsan Turan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02477683: Pilot Evaluation of the FilmArray® Febrile Infant (FI) Panel
Official title: Pilot Evaluation of the FilmArray® Febrile Infant (FI) Panel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Fever
Lead sponsor: BioFire Diagnostics, LLC
Sponsor class: INDUSTRY
First posted: 2015-06-23
Enrollment: 1514
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients under the age of 3 with acute fever.

Brief summary: The purpose of this study is to collect data to support decisions made by BioFire regarding assay development, panel composition, and intended use for the final FilmArray FI reagent pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients under 3 years of age that present with acute fever.


Eligibility criteria: Inclusion Criteria:

* under age of 3
* has fever with no obvious focal infection
* written informed parental permission

Exclusion Criteria:

* parent/legal guardian unable to provide permission
* participation determined by a physician to be detrimental to patient health

Primary outcomes:
measure: Utility of multiplexed testing for pathogens in pediatric patients with acute fever
timeFrame: 15 months
Secondary outcomes:
measure: Epidemiology of pathogens in pediatric patients with acute fever
timeFrame: 15 Months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University School of Medecine
state: Indiana
city: Kansas City
country: United States
facility: Children's Mercy Hospitals & Clinics
state: Missouri
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
Study officials:
References:
Clinical trial NCT03256383: Plan for Testing Fingerstick Bloods on Magellan Systems
Official title: Plan for Testing Fingerstick Bloods on Magellan Systems
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lead Poisoning
Lead sponsor: Magellan Diagnostics
Sponsor class: INDUSTRY
First posted: 2017-08-22
Enrollment: 190
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: adults and children up to 18 years of age who are at risk of lead exposure, pregnant women who are at risk of lead exposure,

Brief summary: This study is to supplement our internal data that demonstrates the continued performance of capillary blood samples on Magellan's lead testing systems: LeadCare II, LeadCare Ultra (which have been cleared previously by FDA), and PediaStat, which is an upgraded LeadCare II instrument in development.


Eligibility criteria: Inclusion Criteria:

* healthy subjects who consent to a capillary blood collection

Exclusion Criteria:

* Patients are not currently taking chelating agents, e.g., penicillamine, succimer

Primary outcomes:
measure: Lead poisoning
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Brockton
country: United States
facility: Pediatric Associates, Inc.
state: Massachusetts
city: Hanson
country: United States
facility: Pediatrics Associates, Inc
state: Massachusetts
city: West Bridgewater
country: United States
facility: Pediatrics Associates, Inc
state: Massachusetts
Study officials:
name: Peter Rappo, MD
role: PRINCIPAL_INVESTIGATOR
References: