louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03193359: Open Label Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine
Official title: A Multicenter, Open-label, Safety, Tolerability and Efficacy Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Migraine Disorders
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2017-06-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is an open-label extension study to evaluate the safety, tolerability and efficacy of BOTOX® as headache prophylaxis in Chinese patients with chronic migraine who have successfully completed the double-blind study: 1313-301-008.


Eligibility criteria: Inclusion Criteria:

-Has successfully completed the double-blind study (1313-301-008).

Exclusion Criteria:

* Has met any of the withdrawal criteria in the double-blind study or has clinical significant abnormal laboratory or electrocardiogram (ECG) findings
* Headache attributable to another disorder (eg, cervical dystonia, craniotomy, head/neck trauma)
* Any medical condition that may put the patient at increased risk with exposure to Botulinum Toxin Type A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: 24 Weeks
measure: Percentage of Participants with AEs Leading to Discontinuation
timeFrame: 24 Weeks
measure: Change from Baseline in Vital Signs
timeFrame: Baseline, Week 24
measure: Change from Baseline in 12-Lead Electrocardiograms (ECGs) Parameters
timeFrame: Baseline, Week 24
measure: Change from Baseline in Clinical Laboratory Parameters
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change from Baseline in the Frequency of Headache Days during 28-Day Period Ending with Weeks 12 and 24
timeFrame: Baseline, Weeks 12 and 24
measure: Change from Baseline in Total Cumulative Hours of Headache Days during 28-Day period
timeFrame: Baseline, Weeks 12 and 24
Other outcomes:
Locations:
Study officials:
affiliation: Allergan
name: Arlene Lum
role: STUDY_DIRECTOR
References:
Clinical trial NCT02200159: Predictive Factors of Failure or Success of Sedation With Dexmedetomidine in ICU
Official title: Predictive Factors of Failure or Success of Sedation With Dexmedetomidine in ICU
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Requiring Sedation in ICU
Adult Patients
Patient Covered by French Health Care System
Keywords: Sedation
Dexmedetomidine
ICU
Delirium
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients ventilated requiring sedation in ICU with RASS objective more than -2

Brief summary: Research predictive factors of success or failure of a sedation with Dexmedetomidine in ICU

Detailed description: Prospective clinical study in ICU with sedated ventilated patients with dexmedetomidine, establishing incidence of success, failure of moderate sedation or failure of dexmedetomidine, to evaluate the effectiveness of this drug sedation in moderate sedation

Eligibility criteria: Inclusion Criteria:

-Adult patients ventilated requiring sedation in ICU with RASS objective more than -2

Exclusion Criteria:

* contraindication: intracranial lesion, hepatic failure
* pregnancy

Primary outcomes:
measure: Number of patients with failure of sedation with dexmedetomidine
timeFrame: at day 1
Secondary outcomes:
measure: Incidence of adverse event of dexmedetomidine
timeFrame: at day 1
measure: Incidence of delirium and use of other sedative drugs
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Jean-Michel CONSTANTIN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05506059: Heart Ultrasound by Emergency Medicine Residents as an Estimate of Heart Function
Official title: "BES2T" (Bedside E-point Septal Separation Test) for Emergency Medicine Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Volume
Cardiovascular Diseases
Lead sponsor: The Guthrie Clinic
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this research is to better understand the use of heart ultrasounds to estimate heart function.

Detailed description: This research involves ultrasounds of the heart by two different emergency medicine doctors who are residents in training. Results from the two doctors will be compared to see how similar they are. This research will help us understand if heart ultrasounds can be used to see how well the heart pumps blood and if similar results are obtained from different doctors.

The doctors will use ultrasound of the heart to measure E-Point Septal Separation (EPSS). EPSS is the distance between two parts of the heart, the mitral valve and the ventricular septum. EPSS is measured in millimeters (mm). EPSS can estimate left ventricular ejection fraction (LVEF) as a measure of how well the heart pumps blood.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers, or patients who come to the emergency department who may have a heart echocardiogram scheduled as part of their routine clinical care
* Age 18 or over
* Willing and able to provide informed consent

Exclusion Criteria:

* Pediatrics (age \<18 years old).
* No cardiac-altering intervention performed between examiners.
* Unable to obtain a parasternal long view with mitral valve anterior leaflet, interventricular septum and aortic root.
* Transthoracic echocardiogram (TTE) more than the next day after EPSS is performed (for secondary outcome).
* Female with known pregnancy.
* Prisoner
* Prior cardiac surgery

Primary outcomes:
measure: Mean change in millimeters between E-Point Septal Separation (EPSS) measurements of the heart by two physicians
timeFrame: During procedure
Secondary outcomes:
measure: Percent change in Left Ventricular Ejection Fraction (LVEF) estimated from ultrasound compared to a formal transthoracic echocardiogram.
timeFrame: During procedure
Other outcomes:
Locations:
city: Sayre
country: United States
facility: The Robert Packer Hospital
state: Pennsylvania
Study officials:
affiliation: The Guthrie Clinic
name: Dean Licurgo, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00138359: Mass Treatment T Solium Community Study
Official title: The Effect of a Single Control Intervention in the T Solium Life Cycle
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intestinal Parasitism
Keywords: T solium, cysticercus, pig triquina, solitaria, intestinal parasites, Niclosamide, tapeworms, Taeniasis
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2005-08-30
Enrollment: 4200
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigators from Cayetano Heredia University and Johns Hopkins University are doing this study. They want to see how people and pigs get infected with a parasite, called cysticercus (known as "pig triquina"). Cysticercus attacks the meat of pigs and the brains of people. In the intestine, the parasite is known as "solitaria". This study is to see how treatment in both people and pigs works to control the disease.

Detailed description: This is a prospective intervention study to determine the efficacy and persistence of effect over time of a single, chemotherapy intervention in both the human and porcine population. Four villages will be selected to be treated against T solium adult (in humans) and larval forms (in pigs), and two villages will receive no intervention and will serve as control villages. Pigs in control villages will be followed during 3 months only, and then the human and porcine populations will receive the intervention treatment. The effect of this intervention will be measured by the prevalence of infection in pigs and parasitic burden of infected pigs at month 3, 6, 9, and 12.

Eligibility criteria: Inclusion Criteria:

* All consenting individuals older than two years living in the study villages (6 endemic communities of the Northern coast of Peru)

Exclusion Criteria:

* Pregnancy (for antiparasitic treatment only).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Universidad Peruana Cayetano Heredia
Study officials:
References:
Clinical trial NCT00738959: Safety, Tolerability & PK of AZD0328 in Caucasian & Japanese
Official title: A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD0328 in Healthy Young Japanese and Caucasian Male Volunteers After Oral Single and Multiple Ascending Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: AZD0328
Japanese
Caucasian
pharmacokinetics
safety
tolerability
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-08-21
Enrollment: 64
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study will be performed to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of AZD0328 when administered to Japanese and Caucasian healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* first generation Japanese (both parents and grandparents are Japanese, the subject is born in Japan and left Japan less than 10 years ago) or Caucasian subjects.
* Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator.

Exclusion Criteria:

* History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the study.
* Participation in another study within 12 weeks before the first administration of the investigational product.
* Intake of any prescribed medicine or herbal remedies based on St John's Wort, except for occasional paracetamol and nasal adrenergic anticongestants, within 3 weeks before the first administration of the investigational product.

Primary outcomes:
measure: Safety variables (adverse events, vital signs, paper ECGs and 12-lead continuous digital ECGs including QT/QTc interval measurements
timeFrame: During the whole treatment period
Secondary outcomes:
measure: PK variables
timeFrame: Several samples during the study days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Södertälje, Sweden
name: Didier Meulien, MD
role: STUDY_DIRECTOR
affiliation: Richmond Pharmacology Ltd St George's University of London Cranmer Terrace, TootingLondon SW17 ORE UK
name: Ulrike Lorch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02220959: Is Preoperative Exercise Test in Morbid Obese Patients a Predictive Test for Extubation?
Official title: Is Preoperative Exercise Test in Morbid Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy a Predictive Test for Extubation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: morbid obesity surgery
walk test
exercise
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2014-08-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: the purpose of this study is to determine if 60 meter test done prior to surgery is a predictive in terms of extubation in morbid obese patients undergoing morbid obese surgery.


Eligibility criteria: Inclusion Criteria:

* patients between 18-60 years old
* patients with BMI \> 40
* patients undergoing Laparoscopic Sleeve Gastrectomy

Exclusion Criteria:

* patients with Chronic obstructive pulmonary disease (COPD), Asthma,
* patients with uncompensated heart failure
* Uncompensated diabetes mellitus
* Patients Who have orthopedic problems that effects the exercise test

Primary outcomes:
measure: Number of participants with successful extubation
timeFrame: postoperative 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cerrahpasa medical Faculty General surgery operation theatre
Study officials:
References:
Clinical trial NCT06148259: SGLT Inhibitors Versus DDP4 Inhibitors and Prostate in Patient With Diabetes
Official title: Comparison of Two Novel Anti Diabetes Medications Classes as Regard Prostate Symptoms in Patient With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Prostatic Hyperplasia
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study aims to compare the effect of two different classes of anti- diabetes medications on prostate volume and symptoms in elderly patients with diabetes mellitus

Detailed description: The study aims to compare the effect of two different classes of anti- diabetes medications on prostate volume and symptoms in elderly patients with diabetes mellitus The study compares sodium glucose cotransporter 2 inhibitors to Dipeptidyl peptidase 4 inhibitors in elderly patients with type 2 diabetes mellitus

Eligibility criteria: Inclusion Criteria:

* Patients with diabetes and benign prostatic hyperplasia should be on monotherapy with either SGLT inhibitor or DDP4 inhibitors

Exclusion Criteria:

* unable to consent to the blood sampling or ultrasound Any other diabetes control measure other than SGLT inhibitors or DDP 4 inhibitors

Primary outcomes:
measure: change in prostate volume
timeFrame: one year
measure: Change in prostate symptoms
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university hospitals
city: Cairo
country: Egypt
facility: Kasr Alainy University Hospitals
Study officials:
affiliation: Cairo University Kasr Alainy Faculty of Medicine
name: Tarek Abdelaziz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01370759: Feasibility Study to Evaluate the Performance of Flocculation-Adsorption System for Colon Cleansing Enhancement
Official title: Flocculation-Adsorption System for Colon Cleansing Enhancement: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: bowel prep
PillCam
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2011-06-10
Enrollment: 81
Sex: ALL
Minimum age (years): 23
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to demonstrate feasibility of enhancing colon cleansing.

Detailed description: To ensure the success of a PillCamTM Colon examination, as standard practice, patients are requested to adhere to a bowel preparation procedure.

The study is designed to evaluate the performance and contribution of a flocculation-adsorption system to colon cleansing.

Eligibility criteria: Inclusion Criteria:

* Subject's age is between 23-75 years.
* Subject is healthy.
* Subject agrees to sign the Informed Consent Form

Exclusion Criteria:

* Contraindication to capsule endoscopy
* Contraindication or allergy to any of the products and materials used for bowel preparation
* Subject is not able to provide written informed consent

Primary outcomes:
measure: Cleansing grading
timeFrame: within 10 days
Secondary outcomes:
measure: Distribution of time
timeFrame: within 10 days
measure: GI tract segment of capsule disintegration
timeFrame: within 10 days
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical center
Study officials:
affiliation: Rambam Health Care Campus
name: Ian Gralnek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02269059: Safety and Pharmacokinetics of MK-7680 in Participants With Hepatitis C (MK-7680-003)
Official title: A Multiple Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MK-7680 in Patients With Hepatitis C Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2014-10-20
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a two-part dose-finding trial of MK-7680 in participants with Hepatitis C Virus (HCV) infection of genotype (GT)1 (Part I) and GT3 (Part 2). The primary hypothesis is that daily administration of a safe and well tolerated dose of MK-7680 will produce a decrease in HCV viral load.

Detailed description: Parts 1 and 2 will each consist of 4 panels. In the first panel, a 200 mg dose of MK-7680 will be administered. In each of the following 3 panels, higher or lower doses of MK-7680 will be administered. Each panel will only begin once the safety and tolerability data from the preceding panel have been evaluated.

Eligibility criteria: Inclusion Criteria:

* Is in good health except for HCV infection
* Is male or is a female of non-childbearing potential
* Clinical diagnosis of HCV GT1 or GT3 with no evidence of mixed-GT or non-typeable infection

Exclusion Criteria:

* Has a history of clinically significant and not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic (excepting HCV infection), immunological, renal, respiratory, genitourinary, or major neurological abnormality or disease
* Has a history of cancer
* Has a history of significant multiple and/or severe allergies
* Is positive for hepatitis B or human immunodeficiency virus
* Has had major surgery, donated or lost 1 unit (500 mL) of blood within 4 weeks prior to screening
* Consumes more than 2 alcoholic beverages per day or is currently a regular user of any illicit drug(s) or has a history of alcohol/drug abuse within 12 months prior to screening
* Has chronic hepatitis not caused by HCV (e.g., nonalcoholic steatohepatitis \[NASH\])
* Has clinical or laboratory evidence of advanced or decompensated liver disease, or evidence of bridging or higher grade fibrosis

Primary outcomes:
measure: Change from baseline in HCV viral load
timeFrame: Day 1: predose, 2, 4, 8, 12, and 24 hours postdose; Days 3, 4, 5, and 6: predose; and Day 7: predose, 4, 12, 24, and 48 hours postdose
measure: Number of participants experiencing an adverse event (AE)
timeFrame: Up to 21 days
measure: Number of participants discontinuing from study therapy due to AEs
timeFrame: Up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04263259: Efficacy and Mechanisms of Mobile-Delivered Alcohol Attentional Bias Modification
Official title: Efficacy and Mechanisms of Mobile-Delivered Alcohol Attentional Bias Modification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol; Harmful Use
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-02-10
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy as well as psychological and neurobiological mechanisms of mobile-delivered alcohol attentional bias modification among heavy drinking adults.

Detailed description: By testing the efficacy and neurobiological mechanisms of behavior change (MOBC) following attentional bias modification among heavy drinking adults, the proposed study has the potential to unify dual process models and neurobiological models of addiction. The cognitive retraining will be delivered via mobile electronic devices to ensure the cost-effectiveness of these procedures, to allow a large amount of retraining to be delivered in an ecologically valid manner, and to facilitate broad dissemination of such procedures if found to be efficacious. Using an intensive longitudinal experimental design, subjects will be randomly assigned into one of 2 groups (attentional bias modification vs. attentional bias control). Ecological momentary assessment (EMA) data will be used to assess changes in cognitive and behavioral measures in situ, and functional magnetic resonance imaging (fMRI) scans before and after cognitive retraining will be used to examine neural changes in specific regions of interest (ROI).

Eligibility criteria: Inclusion Criteria:

* Alcohol Use Disorders Identification Test greater than or equal to 8
* right-handed

Exclusion Criteria:

* history of treatment for or diagnosis of alcohol use disorder/substance use disorder
* history of brain injury
* for females, currently pregnant
* any MRI safety contraindication

Primary outcomes:
measure: Alcohol Use Frequency
timeFrame: 4 weeks
measure: Alcohol Use Quantity
timeFrame: 4 weeks
measure: Negative Alcohol-Related Consequences
timeFrame: 4 weeks
Secondary outcomes:
measure: Attentional Bias to Alcohol
timeFrame: 4 weeks
measure: Alcohol Cue-Induced Neural Reward Circuit Activation
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Center on Alcoholism, Substance Abuse, & Addictions
state: New Mexico
city: Albuquerque
country: United States
facility: Mind Research Network
state: New Mexico
Study officials:
References: