louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00230958: Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment-Naive
Official title: Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Keywords: Viramidine
Ribavirin
Valeant
Hepatitis C
Pegylated interferon alfa-2b
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-03
Enrollment: 900
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: This purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before recieved treatment.

Detailed description: Compare the efficacy and safety of viramidine 600 mg BID versus ribavirin 1000/1200 mg/day, both drugs administered in combination with pegylated interferon alfa-2b to treatment-naive patients with chronic hepatitis C (CHC)

Eligibility criteria: Inclusion Criteria:

* Treatment-naive patients with compensated chronic hepatitis C.
* HCV RNA \>2000 copies/mL (780 IU/mL) as determined by NGI SuperQuant serum HCV RNA quantification, with a lower limit of detection of 100 copies/mL (39 IU/mL).

Exclusion Criteria:

* Severe neuropsychiatric disorders
* History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, opthalmologic disorders including severe retinopathy, or immune mediated disease
* Pregnant or breast-feeding patients

Primary outcomes:
measure: - Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period.
measure: - Safety: The proportion of patients with hemoglobin less than 10 g/dL at any time during treatment or at least 2.5 g/dL drop from baseline.
Secondary outcomes:
measure: - Efficacy: Undetectable plasma HCV RNA at treatment week 24
measure: - Efficacy: Undetectable or at least a 2-log drop from baseline at treatment weeks 12 and 24
measure: - Safety: Monitoring of adverse events
measure: - Safety: Monitoring of abnormal changes in laboratory parameters that are not disease-related
Other outcomes:
Locations:
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Ralph T. Doyle
role: STUDY_DIRECTOR
References:
Clinical trial NCT00141258: Pregabalin Epilepsy Add-On Trial
Official title: Pregabalin Add-On Titration Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Pregabalin (150 mg - 600 mg/Day) Using a Flexible, Optimized Dose Schedule in Subjects With Partial Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Partial Seizures
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 178
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: To evaluate the efficacy of pregabalin as adjunctive therapy, using a flexible, optimized dose schedule with dose adjustment based on clinical response and tolerability, compared to placebo in subjects with partial seizures


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of epilepsy with partial seizures (as defined in the ILAE Classification of Seizures) and be currently taking 1-3 AEDs
* Have a minimum of 4 partial seizures occurring over at least 2 days during the 6-week baseline with no 28-day period free of partial seizures

Exclusion Criteria:

* Have a treatable cause of seizures
* Are currently receiving treatment with CNS-active compounds (exception: single antidepressant, hypnotics, and standard AEDs), vigabatrin, Felbatol (felbamate), Neurontin (gabapentin)

Primary outcomes:
measure: Response ratio (RRatio or symmetrized percent change) for all partial seizures
Secondary outcomes:
measure: Responder rate, Percent change, Percent of SGTC responders, Seizure freedom measures, Change in number of seizure-free days (SFD) per a 28-day period, Analysis by seizure type, HADS, Weekly and endpoint mean sleep interference scores from DSIS, QOLIE-31
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Gwangju
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Incheon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01215058: Gastroprotective Agent Compliance in Patients at Risk Suffering From a Gastrointestinal(GI) Ulcer
Official title: Gastroprotective Agent Compliance in Patients at Risk Suffering From a Gastrointestinal Bleeding Ulcer or a Symptomatic Ulcer With Non-steroidal Anti-inflammatory Drug (NSAID) in France
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gastrointestinal Hemorrhage
Ulcer
Keywords: Compliance, France
Gastrointestinal bleeding ulcer or symptomatic ulcer with NSAID
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-10-05
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Hospital sample

Brief summary: The purpose of this study is to assess gastroprotective agent compliance in patients at risk suffering from a gastrointestinal bleeding ulcer or a symptomatic ulcer with NSAID.


Eligibility criteria: Inclusion Criteria:

* Patients at risk suffering from a gastrointestinal bleeding ulcer or a symptomatic ulcer confirmed by endoscopy

Primary outcomes:
measure: Gastroprotective agent compliance
timeFrame: At the end of 1 month
Secondary outcomes:
measure: Clinical characteristics of those ulcers with NSAID
timeFrame: At the end of 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Service gastro-enterologie et hepatologieCHRU Pontchaillou35033 RENNES cedex France
name: Jean-Francois Bretagne
role: STUDY_CHAIR
affiliation: Service Hepato-Gastroenterologie CHU Reims51092 REIMS cedex France
name: Gerard Thiefin
role: STUDY_CHAIR
affiliation: KantarHealth - France138, avenue Marx Dormoy92120 Montrouge cedex
name: Genevieve BONNELYE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02408458: Miromatrix Biological Mesh for Ventral Hernia Repair
Official title: A Prospective Post-Market Clinical Evaluation of Miromatrix Biological Mesh for Ventral Hernia Repair
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: Miromatrix Medical Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-03
Enrollment: 0
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: TREATMENT

Brief summary: This study is being conducted to gather long-term data of the performance of the Miromatrix Biological Mesh.

Detailed description: Miromatrix Medical Inc. has developed a new biologic mesh, called MIROMESH®. MIROMESH received FDA 510(k) clearance with an indication for reinforcement of soft tissue on March 31, 2014 under K134033. Miromatrix Biologic Mesh is a non cross-linked, acellular surgical mesh that is derived from the highly vascularized porcine liver. This study will serve to provide clinicians with high-quality clinical data in order to provide them with a higher degree of confidence when selecting MIROMESH for ventral hernia repair.

Eligibility criteria: Inclusion Criteria:

* between 18 and 80 years old on the day of study enrollment
* ventral or incisional hernia greater than 9 cm2 for which the physician anticipates ability to achieve midline fascia closure following a retro-rectus repair/component separation
* hernia classified as CDC class 1 or 2 preoperatively
* able and willing to sign the consent form and comply with all study visits and procedures
* commit to non-smoking for at least 4 weeks prior to procedure

Exclusion Criteria:

* sensitivity to porcine material
* scheduled for a concomitant procedure of a wound classified as other than clean
* immunocompromised or at risk of immunosuppression (i.e. be HIV positive, be experiencing organ rejection, be a recent or anticipated chemotherapy recipient) as determined by the Investigator
* BMI ≥40
* A1C level ≥10.0
* participating in another clinical study
* cirrhosis, and/or ascites
* diagnosed with a collagen vascular disorder
* American Society of Anesthesiology (ASA) Class 4 or 5
* allergic to tetracycline or kanacmycin
* life expectancy of less than 2 years at the time of enrollment
* any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements

Primary outcomes:
measure: Hernia recurrence requiring surgical intervention
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Kentucky
name: J. Scott Roth, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01043458: Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia
Official title: A Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of ABT-126 in Stable Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: Pharmacokinetics
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-01-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to investigate the process by which ABT-126 is absorbed, distributed, metabolized and eliminated by the body of stable schizophrenic volunteers receiving treatment with an atypical antipsychotic.


Eligibility criteria: Inclusion Criteria:

* Subject has signed informed consent;
* Current diagnosis of schizophrenia;
* Clinically stable on the same single second-generation (atypical) antipsychotic for the past 8 weeks;
* Meets study-specific criteria for Positive and Negative Syndrome Scale (PANSS);
* Females are not pregnant, not breast-feeding;
* Females are post-menopausal or surgically sterile or practicing birth control;
* Males are surgically sterile or agree to be sexually inactive or use barrier method of birth control

Exclusion Criteria:

* Diagnosis of schizoaffective disorder;
* Diagnosis with mental retardation;
* Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
* Acute psychosis hospitalization within past 6 months;
* Bipolar disorder, manic episode, dementia, obsessive-compulsive disorder, or drug-induced psychosis or current major depressive disorder;
* Current clozapine treatment;
* Suicidal ideation or behavior;
* BMI of 39 or greater;
* Relevant drug sensitivity or allergy;
* Positive hepatitis or HIV test result; positive urine screen for drugs of abuse or alcohol;
* Recent clinically significant illness/infection or surgery;
* Recent blood product transfusion, donation or loss of 5 mL/kg of blood;

Primary outcomes:
measure: Adverse Events
timeFrame: Duration of study
measure: ABT-126 levels in blood (plasma)
timeFrame: Pre-dose to 144 hours post-dose
measure: Clinical laboratory tests, vital signs and electrocardiogram (ECG)
timeFrame: Pre-dose to 72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Site Reference ID/Investigator# 25423
state: California
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 24322
state: Texas
Study officials:
References:
Clinical trial NCT04008758: Recruitment Maneuver Using Lung Ultrasound in Trauma Patients
Official title: Evaluation of Efficacy of Recruitment Maneuver Using Lung Ultrasound in Trauma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recruitment
Trauma
Keywords: recruitment
ultrasound
trauma
pulmonary contusion
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized prospective trial

1. st group is sono group using lung ultrasound
2. nd group is control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: In trauma patients, the incidence of pulmonary contusion is frequent. Recruit maneuver using lung ultrasound could be improve oxygenation in trauma populatioin, howevere, there is no previous study. The aim of this study is evaluation of the efficacy of lung recruitment using ultrasound in perioperative period in trauma patients.

Detailed description: In trauma patients, the incidence of pulmonary contusion is 17-75%. Pulmonary contusioin leads to atelectasis, lung consolidatioin. Finally it could results acute respiratory distress syndrome.

Lung ultrasound is non-invasive and available in anytime even during surgery. Previous studies showed recruitment maneuver using ultrasound improved postoperative oxygenation in pediatric cardiac surgery. In adults, recruitment maneuver not using ultrasound improved oxygenation after cardiopulmonary bypass. There is no study in adult trauma population.

The aim of this study is evaluation of the efficacy of lung recruitment using ultrasound in perioperative period in trauma patients.

Eligibility criteria: Inclusion Criteria:

* Who need surgery under general anesthesia due to trauma
* The position of the surgery is supine

Exclusion Criteria:

* Who has been ventilator care before the surgery
* Thoracic surgery
* Who had cardiopulmonary resuscitation
* Who has acute respiratory distress syndrome

Primary outcomes:
measure: arterial oxygen partial pressure / fractional inspired oxygen ratio at end of surgery
timeFrame: 2 hours
Secondary outcomes:
measure: Lung ultrasound score
timeFrame: 2 hours
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou university school of medicine
state: Gyeonggi-do
Study officials:
affiliation: Ajou University School of Medicine
name: In Kyong Yi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04501458: Western Kenya Integrated COVID-19 Response
Official title: Western Kenya Integrated COVID-19 Response Leveraging the Community Health Strategy, Youth, and Technology to Flatten the COVID-19 Curve and Improve COVID-19 Case Detection, Isolation and Management in Western Kenya
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Keywords: youth, community health, digital tools, capacity building
Lead sponsor: Surgical Systems Research Group
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
name: Tropical Institute of Community Health
First posted: 2020-08-06
Enrollment: 200000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: To respond to the COVID-19 pandemic, investigators will be deploying community health workers, equipped with mobile technology, and accompanied by youth to visit households door to door to screen for symptoms of COVID-19, isolate, test, and manage suspected cases of COVID-19. The community health workers and youth will educate households about preventive measures including frequent handwashing and home management of mild cases. Simultaneously, investigators will work with nurses, doctors, and clinical officers, to test and treat more severe cases of COVID-19 in health facilities. Our goals are: to visit every household in Siaya county covering a population of close to 1 million, and to train and support health workers working in 32 health facilities with oxygen capacity in Siaya to reduce the morbidity and mortality related to COVID19 and other conditions.


Eligibility criteria: Inclusion Criteria:

* Youth aged 18 to 30 years old.
* Active community health workers.
* Facilities with oxygen capacity.

Exclusion Criteria:

* Individuals younger than 18 or older than 30 years old.
* Inactive community health workers.
* Facilities without oxygen capacity.

Primary outcomes:
measure: Mortality
timeFrame: 3 months
measure: Number of confirmed COVID-19 cases in Siaya
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Surgical Systems Research Group/Tropical Institute of Community Health
Study officials:
affiliation: Surgical Systems Research Group
name: Neema Kaseje, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02695758: Local Intraoperative Analgesic Injection Versus Single Injection Interscalene Nerve Block in Patients Undergoing TSA
Official title: Local Intraoperative Analgesic Injection Versus Single Injection Interscalene Nerve Block in Patients Undergoing Shoulder Arthroplasty (TSA): A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis: Shoulder
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2016-03-01
Enrollment: 156
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: A non-blinded randomized controlled trial, in which participants undergoing primary reverse or total shoulder arthroplasty are randomly assigned to one of two treatment groups.


Eligibility criteria: Inclusion Criteria:

1. All individuals undergoing primary reverse and total shoulder arthroplasty by the shoulder service at Methodist Hospital or Rothman Specialty Hospital.

Exclusion Criteria:

1. Psychiatric illness as defined by co-morbid diagnosis of bipolar disorder or schizophrenia
2. Revision arthroplasty, arthroplasty for fracture
3. Unable/unwilling to consent for enrollment
4. Unable to complete postoperative pain survey
5. Known adverse drug reaction or allergy to the medications used
6. Chronic pain syndromes (including reflex sympathetic dystrophy, fibromyalgia, chronic diffuse musculoskeletal pain)
7. Patients taking long acting narcotic pain medications (including extended release narcotic pain medications and methadone).
8. Patients under the age of 18 years
9. Patients with history of hepatic disease
10. Pregnant women or women who are breastfeeding

Primary outcomes:
measure: Morphine and Morphine Equivalent consumption
timeFrame: 24 hours following surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06379958: Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects
Official title: A Phase 1, Open-label, 4-Part, Drug-Drug Interaction Study to Evaluate the Effects of Inhibition and Induction of CYP3A4 on the Pharmacokinetics of Leramistat, to Assess the Effect of Leramistat on the Pharmacokinetics of Simvastatin, and to Evaluate the Pharmacokinetic Interaction Between Leramistat and Upadacitinib (RINVOQ®) in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Modern Biosciences Ltd
Sponsor class: INDUSTRY
First posted: 2024-04-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A DDI study consisting of 4 parts conducted as an open label, fixed sequence study in healthy adult subjects.


Eligibility criteria: Principal Inclusion Criteria:

Healthy, adult, male or female of non childbearing potential 18 to 55 years of age.

Principal Exclusion Criteria:

History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.

History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.

Primary outcomes:
measure: leramistat: Area under the curve - AUC0-t
timeFrame: 8.5 Weeks
measure: leramistat: Area under the curve - AUC0-24h
timeFrame: 8.5 Weeks
measure: leramistat: Area under the curve - AUC0-inf
timeFrame: 8.5 weeks
measure: leramistat: Maximum observed concentration - Cmax
timeFrame: 8.5 weeks
measure: leramistat: Time of the maximum observed concentration - Tmax
timeFrame: 8.5 weeks
measure: leramistat:Elimination rate constant -Kel
timeFrame: 8.5 weeks
measure: leramistat: Half life - t½
timeFrame: 8.5 weeks
measure: leramistat: Plasma Clearance -CL/F
timeFrame: 8.5 weeks
measure: leramistat: Volume of distribution - Vz/F
timeFrame: 8.5 weeks
Secondary outcomes:
measure: Incidence of adverse event.
timeFrame: 8.5 weeks
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Celerion
Study officials:
References: