louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02464306: Fidaxomicin Versus Standard of Care Therapy in Solid Organ Transplant Recipients With Clostridium Difficile Infection
Official title: Fidaxomicin Versus Standard of Care Therapy in Solid Organ Transplant Recipients With Clostridium Difficile Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Clostridium Difficile Infection
Solid Organ Transplant
Keywords: recipients
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective study to assess the efficacy and safety of fidaxomicin in Solid Organ Transplant (SOT) recipients (heart, lung, kidney, liver, kidney-pancreas, and pancreas) with a first-episode of Clostridium difficile infection (CDI).

Detailed description: Patients will be treated with fidaxomicin 200 mg PO twice daily for 10 days. The rate of sustained clinical response (SCR; cure without recurrence at 30 days) will be assessed and compared to a historical cohort of SOT recipients who received standard of care therapy for CDI at our institution. The data for the historical control group will be collected under a separate IRB-approved protocol. Standard of care therapy will be considered oral or intravenous metronidazole and / or oral vancomycin. The study will be powered to show non-inferiority of fidaxomicin compared to standard of care treatment in SOT recipients.

Eligibility criteria: Inclusion Criteria:

* Age 18 or greater and up 85 years
* SOT recipient (lung, heart, kidney, liver, kidney-pancreas, pancreas)
* First episode of CDI

Exclusion Criteria:

* Receiving additional therapies with activity again C. difficile (oral bacitracin, fusidic acid, and/or rifaximin)
* Toxic megacolon
* Ileus or significant abdominal distension
* Hypotension with vasopressor requirement
* History of inflammatory bowel disease
* Pregnancy
* Decisionally challenged
* Prisoners
* \>4 doses of metronidazole for the treatment of C. difficile in the previous 7 days
* \>4 doses of oral vancomycin in the previous 7 days

Primary outcomes:
measure: The proportion of patients with a sustained clinical response (SCR), defined as clinical cure with no recurrence.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Kelly E Schoeppler, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05484336: Acute Effects of Spirulina on Postprandial Glycemic Responses and Arterial Blood Pressure
Official title: Acute Effects of Three Doses of Spirulina in Glucose Beverages on Postprandial Glycemic Responses, Arterial Blood Pressure, and Subjective Appetite Responses: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Potential Abnormality of Glucose Tolerance
Appetitive Behavior
Blood Pressure
Keywords: blood glucose responses
blood pressure
spirulina
subjective appetite
blood glucose concentrations
Lead sponsor: Agricultural University of Athens
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment
Primary purpose: OTHER

Brief summary: This study investigated the effects of three doses of spirulina in glucose beverages on postprandial glycemic responses, arterial blood pressure, and subjective satiety.

Detailed description: This study aimed to determine the effects of three different doses (4, 6 and 8 g) of spirulina in glucose beverages on postprandial glycemic responses, blood pressure, and subjective appetite responses in healthy young adults.

Eligibility criteria: Inclusion Criteria:

* healthy
* non-smokers
* men and women
* body mass index between 18 and 24.9 kg/m2
* normal blood pressure (systolic blood pressure \<120 mmHg and diastolic blood pressure \<80 mmHg)
* normal fasting blood glucose concentrations (\<100 mg/dL)

Exclusion Criteria:

* Medical conditions (e.g., cardiovascular diseases, diabetes mellitus, kidney or liver conditions, severe clinical depression, gastrointestinal disorders)
* Under medications known to affect glycemia (glucocorticoids, metformin, thiazide diuretics)
* Allergy to spirulina
* Pregnancy
* Lactation
* Competitive sports
* Alcohol abuse
* Drug dependency

Primary outcomes:
measure: Capillary blood glucose responses
timeFrame: 2 hours
measure: Blood pressure
timeFrame: 2 hours
Secondary outcomes:
measure: Subjective appetite ratings
timeFrame: 2 hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Agricultural University of Athens
state: Attica
Study officials:
affiliation: Agricultural University of Athens
name: Emilia Papakonstantinou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03071536: Furosemide Stress Test Predicting Early Graft Function in Kidney Transplantation
Official title: Furosemide Stress Test as a Marker of Postoperative Kidney Allograft Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Function
Kidney Transplant; Complications
Delayed Graft Function
Keywords: furosemide stress test
kidney transplantation
urine output
perioperation
delayed graft function
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
First posted: 2017-03-07
Enrollment: 180
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: Furosemide is an old drug that has been used frequently in the postoperative period of kidney transplantation, aiming to achieve adequate urine output. There is no previous study that directly evaluate the urine response to standardized dose of furosemide in the postoperative period. The objective is to measure the urine output after standardized dose of furosemide is delivered, as a biomarker to predict the graft function in perioperative period.


Eligibility criteria: Inclusion Criteria:

* Deceased donor kidney transplantation at KCMH
* informed consent is accepted

Exclusion Criteria:

* Known allergy to furosemide
* Surgical complication of allograft
* Urgently needed for dialysis (refractory hypervolemia, uremic symptoms, and hyperkalemia)

Primary outcomes:
measure: Urine output
timeFrame: 6 hours
Secondary outcomes:
measure: Delayed graft function
timeFrame: 7 days
measure: Creatinine reduction ratio
timeFrame: At postoperative day 0,7 and 14
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
Study officials:
affiliation: King Chulalongkorn Memorial Hospital and Chulalongkorn University
name: suwasin udomkarnjananun, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Udomkarnjananun S, Townamchai N, Iampenkhae K, Petchlorlian A, Srisawat N, Katavetin P, Sutherasan M, Santingamkun A, Praditpornsilpa K, Eiam-Ong S, Avihingsanon Y. Furosemide Stress Test as a Predicting Biomarker for Delayed Graft Function in Kidney Transplantation. Nephron. 2019;141(4):236-248. doi: 10.1159/000495765. Epub 2019 Jan 11.
Clinical trial NCT03020836: Evaluating Effective Methods for Referral for Smoking Cessation Counseling and High Blood Pressure Follow-up
Official title: Evaluating Effective Methods for Referral for Smoking Cessation Counseling and High Blood Pressure Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Smoking Cessation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 473
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Investigators conducted a clinic-based study to determine the magnitude of uncontrolled hypertension and current smoking in eye doctor's offices and sought to determine if referral to care results in actions taken by the patient.

Detailed description: Smoking and hypertension are two modifiable risk factors that are linked to highly prevalent chronic diseases such as diabetes and cardiovascular disease. The ophthalmology waiting room has the potential to be an effective point of intervention to provide referral to primary care in addition to health education on preventive health topics.

The investigators therefore, conducted a clinic-based study to determine the magnitude of uncontrolled hypertension and current smoking in eye doctor's offices and to determine if referral to care results in actions taken by the patient.

The investigators determined the proportion of patients who have elevated blood pressure. Patients were referred appropriately and the proportion of participants who followed the recommendation to meet with their primary care doctor for elevated blood pressure at 4-6 weeks and 8-10 weeks was determined. In addition, those who consented to be in the study and admitted to smoking cigarettes were offered smoking cessation assistance through a quit line. Investigators also followed up on cigarette smoking at 4-6 weeks and 8-10 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients \>18 years of age presenting to the glaucoma service and general eye service at Wilmer Eye Institute.

Exclusion Criteria:

* Non-English speakers
* Unable to provide written informed consent

Primary outcomes:
measure: Proportion of patients with elevated blood pressure
timeFrame: 1 day (at study clinic visit)
Secondary outcomes:
measure: Proportion of patients that are current smokers
timeFrame: 1 day (at study clinic visit)
measure: Proportion of patients with elevated blood pressure that sought referral care
timeFrame: From study visit to 10 weeks after
measure: Proportion of patients that were current smokers that sought referral quit line assistance
timeFrame: From study visit to 10 weeks after
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01528449: Babesia Testing in Blood Donors
Official title: Blood Donation Screening for Babesia Microti by Real-time Polymerase Chain Reaction (PCR) and by Indirect Flourescent Antibody (IFA) Assays
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Transfusion Transmitted Babesiosis
Keywords: babesia
blood donation
transfusion transmitted babesiosis
Lead sponsor: Imugen
Sponsor class: INDUSTRY
Collaborators: name: American National Red Cross
name: Memorial Blood Centers, Minnesota
name: Rhode Island Blood Center
First posted: 2012-02-08
Enrollment: 90116
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Both prospective and retrospective (look back) study of blood donors for laboratory evidence of babesia microti infection.

Two laboratory methodologies will be utilized:

1. - PCR, to look for the presence of B.microti in whole blood
2. - IFA, to look for significant titers of B.microti antibody

Detailed description: Retrospective study will involve archived specimens from blood donors whose units have already been released and transfused into recipients.

Prospective study will be real time and units testing positive by either PCR or IFA will be not released and will be disgarded, and the donors advised and deferred from further blood donation

Eligibility criteria: Inclusion Criteria:

* same as for donating blood

Exclusion Criteria:

* donor refusual to sign informed consent for this investigational babesia testing

Primary outcomes:
measure: number of blood donors testing positive for evidence of Babesia infection
timeFrame: goal is up to one year (all specimens by end 2012)
Secondary outcomes:
measure: the number of cases of transfusion transmitted babesia infection identified
timeFrame: goal is up to one year (all specimens by end 2012)
Other outcomes:
Locations:
city: Norwood
country: United States
facility: Imugen
state: Massachusetts
Study officials:
affiliation: Imugen Medical Director
name: Philip J Molloy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moritz ED, Winton CS, Tonnetti L, Townsend RL, Berardi VP, Hewins ME, Weeks KE, Dodd RY, Stramer SL. Screening for Babesia microti in the U.S. Blood Supply. N Engl J Med. 2016 Dec 8;375(23):2236-2245. doi: 10.1056/NEJMoa1600897.
Clinical trial NCT03260049: The Necessity and Optimal Time for Performing Pars Plana Vitrectomy in Acute Retinal Necrosis Patients
Official title: The Necessity and Optimal Time for Performing Pars Plana Vitrectomy in Acute Retinal Necrosis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Retinal Necrosis
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 30
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ARN patients

Brief summary: The records of patients who were diagnosed with ARN between April 2010 and February 2017 were analyzed.A retrospective review of the treatment options and outcomes of the these patients was performed.


Eligibility criteria: Inclusion Criteria:

* ARN was diagnosed according to the American Uveitis Society Diagnostic Criteria (1994)

Exclusion Criteria:

-

Primary outcomes:
measure: visual acuity
timeFrame: 1 year
Secondary outcomes:
measure: retinal detachement
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01875549: Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a LCD Stent
Official title: Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a Large Cell Niti-S (LCD) Stent
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obstruction of Biliary Tree
Cholangiocarcinoma
Hepatocellular Carcinoma
Malignant Lymphadenopathy
Gall Bladder Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 0
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: Internal biliary drainage is an useful method for a control of jaundice and cholangitis to patients who had a malignant hilar obstruction due to hepatocellular carcinoma, cholangiocarcinoma, gall bladder cancer or metastatic lymphadenopathy.

Bilateral biliary drainage is more physiologic but technically difficult to compared with unilateral biliary drainage specially related to conformability and flexibility between using stents.

There are no prospective clinical trials compared with these internal biliary drainage methods in hilar malignant obstruction using metal stent.

Therefore, the investigators want to compare the clinical outcome of two method: Unilateral biliary stent and Bilateral biliary stent


Eligibility criteria: Inclusion Criteria:

* Age\> 18
* diagnosis of malignancy in pathology or cytology
* jaundice(Total bilirubin)\> 2.0 mg/dL
* Diagnosed malignant hilar invasion to CT or other image finding

Exclusion Criteria:

* bleeding tendency(INR\>1.5)
* Pregnancy
* severe liver,kidney disease

Primary outcomes:
measure: Stent patency
timeFrame: up to 1year
Secondary outcomes:
measure: survival period
timeFrame: up to 1year
Other outcomes:
measure: complication
timeFrame: up to 1year
Locations:
Study officials:
affiliation: Division of Gastroenterology,Department of internal medicaion,samsung medical center,Sungkyunkwan University School of Medicine
name: Kwang hyuck Lee, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05908149: Gait Analysis in Patients With Hemiplegia Using Insole Splint.
Official title: Gait Analysis in Patients With Hemiplegia Using Insole Splint.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gait, Hemiplegic
Splints
EMG
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to compare the gait of patients with hemiplegia, with or without the use of insole splint. The main questions it aims to answer are:

Does the insole splint improve the gait of these patients? Does any difference exist in the use of muscles?

Participants will have to walk in the gait analysis' aisle with and without the insole splint, using wireless EMG device.


Eligibility criteria: Inclusion Criteria:

* Patients that can walk with or without the splint, having their first stroke episode at least two months ago and their hospitalisation period does not overcome six months, having also a diagnosis from a neurologist coming with a Brain CT-scan.
* Patients must have use the insole splint during physiotherapy sessions for at least 1 week before their inclusion in the trial.
* Patients must be able to communicate and fully understand the instructions given by the researchers.
* Researchers are going to try to have a sex ratio 50/50.
* Patients' age is going to be between 18-70 years.
* Functional Ambulation Category: FAC \> 2
* Modified Ashworth Scale of the affected lower Limb (MAS): MAS ≤2
* Normal Gait before the stroke.

Exclusion Criteria:

* Peripheral Neurological Damage.
* Past or ongoing orthopedic or reumatologic disease that bothers patient's gait.
* Past damage of the Central Nervous System.
* Dermatologic problems or human factors that limitate the use of insole splint.
* Patients must not have used intramuscular botox injection recently.
* Patients with low motivation and low perception are also excluded.

Primary outcomes:
measure: Gait speed
timeFrame: up to 6 months
measure: Gait cadence
timeFrame: up to 6 months
measure: Gait angles
timeFrame: up to 6 months
measure: Stride length
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina
Study officials:
References:
Clinical trial NCT00403949: A Study of Azelaic Acid (AzA) 15% in Topical Treatment of Mild to Moderate Perioral Dermatitis
Official title: A 6-week, Vehicle-controlled, Randomized, Double-blind, Parallel-group Multicenter Pilot Study of the Efficacy and Safety of Azelaic Acid (AzA) 15% Gel in the Topical Treatment of Mild to Moderate Perioral Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Perioral Dermatitis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2006-11-27
Enrollment: 48
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: The purpose of this study is to test the efficacy and safety of AzA 15% Gel in the treatment of mild to moderate perioral dermatitis.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of mild to moderate perioral dermatitis as diagnosed by the physician
* Investigator's Global Assessment (IGA) score at baseline of 2 or 3 (on scale from 0 to 4)
* 8 to 50 facial inflammatory lesions (papules, papulopustules, papulovesicles)

Exclusion Criteria:

* History of atopic dermatitis of the face
* Granulomatous perioral dermatitis
* Facial acne, rosacea, facial demodicosis
* Seborrheic dermatitis of the nasolabial fold, Lupus erythematosus
* The use of topical or systemic medications that could affect the course of treatment and/or evaluation
* Severe diseases likely to interfere with the conduct / planned termination of the study (e.g. cancer, cardiac infarct, unstable angina pectoris, uncontrolled diabetes)
* Use of fluorinated toothpaste
* Planned exposure to artificial or intensive natural UV light of the test area throughout the course of the study
* Use / planned use of cosmetic products (e.g. creams, moisturizers, make-up, fatty lipstick) in the test area during the course of the study
* History of or suspected hypersensitivity to any ingredient of the study drugs
* Participation in another clinical study 4 weeks prior to and/or during the conduct of this study

Primary outcomes:
measure: The sum score derived from the most important signs and symptoms of perioral dermatitis
timeFrame: Measurements and observations during the course of the study
Secondary outcomes:
measure: Intensity of single signs and symptoms
timeFrame: Measured at scheduled visits during the course of the study
measure: Safety outcomes measures will be all adverse events reported by the patients or observed by the investigator
timeFrame: Safety parameters recorded at scheduled visits during the course of the study
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Dülmen
country: Germany
city: Essen
country: Germany
city: Recklinghausen
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01319149: A Study of the Effects of Molecular Diagnostic Directed Wound Gels on Wound Care Outcomes
Official title: A Retrospective Study Of the Effects of Molecular Diagnostic Directed Wound Gels on Wound Care Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wounds
Keywords: molecular methods
Lead sponsor: Southwest Regional Wound Care Center
Sponsor class: OTHER
First posted: 2011-03-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with wounds who have been treated at Southwest Regional Wound Care Center.

Brief summary: A retrospective molecular diagnostic review on wound care outcomes. The time periods include March, April, May of 2010.The retrospective review would analyze the days of healing during the timeframe, upon the introduction of molecular diagnostic testing

Detailed description: The null hypothesis would be that the introduction of molecular methods did not statistically affect patient outcomes. To study this hypothesis, our chief information technologist would query the database for any patients who are admitted during that time period. This period of time designated is March, April and May 2010.

Eligibility criteria: Inclusion Criteria:

* Patients who have been treated at SWRWCC during the months of March, April, or May 2010.

Exclusion Criteria:

* Patients who were not treated at SWRWCC during the time frame of March, April or May 2010.

Primary outcomes:
measure: The retrospective review would analyze the days of healing during the timeframe, upon the introduction of molecular diagnostic testing.
timeFrame: 1 yr
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Southwest Regional Wound Care Center
state: Texas
Study officials:
affiliation: Southwest Regional Wound Care Center
name: Randall D Wolcott, M.D.
role: PRINCIPAL_INVESTIGATOR
References: