louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01047540: Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2
Official title: A Double-blind Randomized Placebo Controlled Dose-finding Trial to Investigate Different Doses of a New Antiviral Drug in Subjects With Genital HSV Type 2 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HSV-2
Lead sponsor: AiCuris Anti-infective Cures AG
Sponsor class: INDUSTRY
Collaborators: name: FHI 360
First posted: 2010-01-13
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of genital herpes


Eligibility criteria: Inclusion Criteria:

* Adult, Immunocompetent men and women in good health of any ethnic group
* History of recurrent episodes of genital herpes for at least 12 months
* Seropositive for Herpes Simplex Virus HSV Type 2
* Body Mass Index (BMI) between 18 and 35 kg/m2

Exclusion Criteria:

* Present episode of genital herpes
* Intake of systemic drug against HSV or any topical application against HSV within 7 days before randomization for the trial
* Intake of systemic corticosteroids, other immunomodulating agents or any investigational agent within 3 months before randomization for the trial
* Positive results in any of the virology tests for human immunodeficiency virus antibody (HIV-Ab), hepatitis C antibody (HCV-Ab), hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBc-Ab)

Primary outcomes:
measure: Efficacy of 4 Different Doses of AIC316 and Matching Placebo With Respect to the Suppression of Herpes Simplex Virus Replication (Shedding Rate)
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Cetero Research Miami Gardens
state: Florida
city: Indianapolis
country: United States
facility: Indiana University School of Medicine, Office for Research
state: Indiana
city: Portland
country: United States
facility: Westover Heights Clinic
state: Oregon
city: Houston
country: United States
facility: University of Texas Health Science Centre, Center for Clincial Studies
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Seattle
country: United States
facility: University of Washington, Virology Research Clinic
state: Washington
Study officials:
References:
citation: Wald A, Corey L, Timmler B, Magaret A, Warren T, Tyring S, Johnston C, Kriesel J, Fife K, Galitz L, Stoelben S, Huang ML, Selke S, Stobernack HP, Ruebsamen-Schaeff H, Birkmann A. Helicase-primase inhibitor pritelivir for HSV-2 infection. N Engl J Med. 2014 Jan 16;370(3):201-10. doi: 10.1056/NEJMoa1301150.
Clinical trial NCT06172140: Efficacy and Safety of Ciprofol for the Sedation in Patients Undergoing Hysteroscopy
Official title: Efficacy and Safety of Ciprofol for the Sedation in Patients Undergoing Hysteroscopy: A Prospective, Randomized, Non-inferiority Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ciprofol
Hysteroscopy
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Eligible patients undergoing hysteroscopy were randomly assigned in a 1:1 ratio to receive intravenous anesthesia with either propofol (2 mg/kg) or remifentanil (0.4 mg/kg).Continuous monitoring of pulse oximetry (SpO2), blood pressure (BP), heart rate (HR), expired gas partial pressure of carbon dioxide, integrated respiratory index (IPI), tidal volume (TV), respiratory rate (RR), and minute ventilation (MV) was performed.During induction, the MOAA/S score was assessed every 30 seconds. If the MOAA/S score remained \>1, a supplementary dose of 1/2 of the initial dose was injected within 10 seconds.If more than 5 supplementary doses were required within 15 minutes, it was considered that the painless hysteroscopy failed and propofol was used to enhance sedation.Continuous oxygen administration at a flow rate of 5 liters per minute was provided through nasal catheters until the patient was fully alert with a MOAA/S score of 5 and vital signs were stable.Observation indicators included: (1) the success rate of hysteroscopy;(2) induction time (MOAA/S ≤ 1 after the first dose);(3) full recovery time of consciousness;(4) operation duration;(5) number of additional anesthetics;(6) incidence of hypotension, hypoxemia, sinus bradycardia, delayed recovery, and injection pain;(7) respiratory parameters and minimum SpO2, IPI values before anesthesia, after induction, and after awakening.


Eligibility criteria: Inclusion Criteria:

* Voluntary signing of informed consent form
* Stable vital signs and qualified anesthesia outpatient evaluation
* No contraindications to anesthesia

Exclusion Criteria:

* Not willing to sign informed consent form
* Anaesthesia drug allergy
* Severe central nervous system diseases
* Severe hypertension and diabetes
* Mental disorders
* History of using psychotropic drugs in the past 3 months

Primary outcomes:
measure: Success rate of painless hysteroscopy
timeFrame: During procedure (The inspection is completed and the vaginal speculum is removed)
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Anesthesiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen Universit
state: Guangdong
Study officials:
References:
Clinical trial NCT01076140: Blood Pressure Effects of Nebivolol Versus Lisinopril in New Onset or Worsening Hypertension Induced by Bevacizumab
Official title: Comparative Blood Pressure Effects of Nebivolol Versus Lisinopril in Patients With New Onset or Exacerbated Hypertension Induced by Bevacizumab: a Crossover Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypertension
Keywords: Hypertension as a result of bevacizumab therapy
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2010-02-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to directly compare the blood pressure (hypertension) reduction effects of lisinopril and nebivolol in patients who develop new onset or worsening hypertension while treated with bevacizumab.


Eligibility criteria: Inclusion Criteria:

* Patients currently treated at the University of Mississippi Medical Center Oncology Clinic
* Patient is being treated with bevacizumab either alone or in combination with other agents for cancer
* Patient blood pressure is \>140 mmHg (systolic) or \> 90 mmHg (diastolic), either treated or untreated with medications for hypertension
* Patients may be currently on medications for hypertension (other than Beta blocker, ACEI, or ARB); these will be continued at the same dose throughout the study
* Patients should be \> 18 years of age
* Patients receiving bevacizumab therapy approximately every 2 weeks

Exclusion Criteria:

* History of ACEI or ARB induced angioedema or idiopathic/hereditary angioedema
* Patient currently treated with a Beta blocker, ACEI, or ARB or have a history of intolerance to a medication in any of these classes
* Hyperkalemia, defined as a potassium value of \>5 mEq/L
* Pregnancy or breastfeeding
* Severe renal impairment (eGFR \<30 mL/min)
* Moderate hepatic impairment as identified by physician
* Currently taking CYP2D6 inducers (rifampin, carbamazepine or dexamethasone) or inhibitors (bupropion, fluoxetine, paroxetine, duloxetine, etc.)
* History of clinically significant EKG abnormality which would contraindicate beta blocker use
* Recent stroke (\<6 months)
* Recent myocardial infarction (\<6 months)
* Congestive heart failure
* Severe asthma or COPD
* Diagnosed obstructive sleep apnea

Primary outcomes:
measure: The primary endpoint of the study will be changes in sitting systolic and diastolic blood pressure at the crossover and final visits.
timeFrame: 8 weeks
Secondary outcomes:
measure: The secondary endpoint of the study will be changes in heart rate at the end of the crossover and final visits.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
References:
Clinical trial NCT05879640: Sleep After Pediatric Critical Illness
Official title: Sleep Disturbances for Children After Critical Care: Pilot Sleep Education Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric
Critical Illness
Sleep Disturbance
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Before-after
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study tests a pilot educational sleep intervention for children after critical care hospitalization.

Detailed description: The investigators are conducting a before-after study evaluating an educational intervention delivered during hospitalization on sleep outcomes 1month after critical care hospitalization for children aged 6 to 18 years.

Eligibility criteria: Inclusion Criteria:

* Age 6 years to 18 years inclusive
* Inpatient consult to Pediatric Critical Care and Neurotrauma Recovery Program

Exclusion Criteria:

* Abusive trauma
* Child protective services custody
* Prisoners
* Pregnancy
* Non-English speaking caregivers

Primary outcomes:
measure: Sleep Disturbances Scale for Children
timeFrame: 1-month
Secondary outcomes:
measure: Pediatric Quality of Life Inventory Scale (PedsQL)
timeFrame: 1-month
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Cydni Williams, MD, MCR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03122340: Polyprenols (Ropren) in Acute Coronary Syndrome
Official title: Single-center Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Polyprenols (ROPREN) in Subjects With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Keywords: Acute Coronary Syndrome
Polyprenols
Cholesterol
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center double-blind, randomized, placebo-controlled study
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine efficacy and safety of polyprenols (ROPREN) using in patients with acute coronary syndrome

Detailed description: This study is randomized double blind placebo controlled. Patients with acute coronary syndrome taking standard therapy including atorvastatin 40 mg/day were randomized into 2 groups: group 1 takes Ropren 8 drops 3 times per day for 3 week, then 5 drops 3 times per day for 5 weeks; group 2 take placebo in the same dose regimen. The hepatoprotective, hypolipidemic, antiinflammatory, cognitive, antidepression functions evaluates after one and two - month therapy

Eligibility criteria: Inclusion Criteria:

* Acute coronary syndrome
* Informed consent received

Exclusion Criteria:

* Patient's incapacity to take accurately drops by oneself
* Cardiogenic shock

Primary outcomes:
measure: Сardiospecific enzymes
timeFrame: At 9 days after acute coronary syndrome
measure: Hepatic enzymes
timeFrame: At 2 months after acute coronary syndrome
measure: Inflammatory enzymes
timeFrame: At 2 months after acute coronary syndrome
measure: Cognitive Function
timeFrame: At 2 months after acute coronary syndrome
measure: Lipid spectrum
timeFrame: At 2 months after acute coronary syndrome
measure: Bilirubin
timeFrame: At 2 months after acute coronary syndrome
measure: Cognitive Function Anxiety
timeFrame: At 2 months after acute coronary syndrome
Secondary outcomes:
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Cardiology Research Institute
Study officials:
affiliation: Tomsk NRMC
name: Sergey V Popov, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Vyshlov EV, Tsoy EI, Sultanov VS, Trusov VB, Ryabov VV. Hypolipidemic and Hepatoprotective Effects of a Polyprenol-Containing Drug in Patients with Acute Coronary Syndrome. Bull Exp Biol Med. 2018 Jul;165(3):319-321. doi: 10.1007/s10517-018-4159-x. Epub 2018 Jul 12.
Clinical trial NCT05177640: Biodistribution and Dosimetry of 99mTc-Duramycin
Official title: Early Prediction of Tumor Response to Treatment: Translation of 99mTc-Duramycin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: dosimetry, biodistribution, safety, 99mTc-duramycin
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Molecular Targeting Technologies, Inc.
First posted: 2022-01-04
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Conduct a first-in-human study in healthy volunteers to show safety, biodistribution and dosimetry of \[99mTc\]Duramycin.

Detailed description: Monocenter, prospective microdosing study in healthy volunteers. Healthy volunteers will undergo a \[99mTc\]Duramycin whole-body planar and abdominal SPECT scan at different time points after one iv injection of the radiotracer (1 h, 2h, 3h, 6h and 24h), while vital signs, urine and faces analysis will be checked. Blood samples will be taken at 12 different time points: 9 blood samples for dosimetry study and 3 blood samples will be subjected to clinical laboratory chemistry (renal and liver function chemistry, hematology, and blood coagulation parameters).

Eligibility criteria: Inclusion Criteria:

* Males (n=4) or females (n=4) age 18 years or older
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Ability to give study-specific written informed consent.

Exclusion Criteria:

* Pregnant or lactating females (positive pregnancy test)
* Metal implants (e.g. pacemakers, osteosynthesis material)
* Body weight \> 100 kg
* Severe claustrophobia
* Abnormal kidney or liver function tests
* Unable to comply with study requirements

Primary outcomes:
measure: Determine the biodistribution of [99mTc]Duramycin.
timeFrame: 24 hours
measure: Determine the dosimetry evaluation of [99mTc]Duramycin.
timeFrame: 24 hours
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0"
timeFrame: 72 hours
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerpen
Study officials:
affiliation: University Hospital, Antwerp
name: Sigrid Stroobants, prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00851240: BTT-1023 in Rheumatoid Arthritis
Official title: A Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of Repeated Intravenous Doses of BTT-1023 in Patients With Rheumatoid Arthritis - a Double-blind Randomized Placebo-controlled Sequential Group Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
safety
Lead sponsor: Biotie Therapies Corp.
Sponsor class: INDUSTRY
First posted: 2009-02-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with adult-onset rheumatoid arthritis will be enrolled. They will be dosed with repeated intravenous doses of BTT-1023 or placebo. During the trial, the safety of the treatments and the pharmacokinetics of BTT-1023 will be assessed. The patient allocation to treatment groups will occur at random, and the actual treatment will not be revealed to the investigator or to the patient during the trial.


Eligibility criteria: Inclusion Criteria:

* adult-onset rheumatoid arthritis

Exclusion Criteria:

-

Primary outcomes:
measure: Incidence and intensity of adverse events
timeFrame: 17 wk
Secondary outcomes:
measure: Serum concentrations of the verum
timeFrame: 17 wk
measure: Disease activity
timeFrame: 17 wk
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Sofia, Bulgaria
Study officials:
affiliation: Biotie Therapies Corp.
name: Antero Kallio, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03616340: Efficacy of Intra-articular NSAID Versus Corticosteroid in the Treatment of Shoulder and Knee Conditions: A Randomized, Double-Blind, Prospective Study
Official title: Efficacy of Intra-articular NSAID Versus Corticosteroid in the Treatment of Shoulder and Knee Conditions: A Randomized, Double-Blind, Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Knee Arthritis
Shoulder Arthritis
Shoulder Impingement
Meniscus Lesion
Rotator Cuff Tear
Rotator Cuff Tear Arthropathy
Lead sponsor: OSF Healthcare System
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study will compare the efficacy of Triamcinolone versus Ketorolac for intra-articular injection of the knee and shoulder

Detailed description: This study will be a randomized prospective study comparing Triamcinolone to Ketorolac for injections in the knee and shoulder for a variety of orthopedic conditions. The investigators will monitor pain relief, length of pain relief, cost, and patient satisfaction after the injections

Eligibility criteria: Inclusion Criteria:

* knee and shoulder arthritis
* shoulder impingement
* rotator cuff tear

Exclusion Criteria:

* chronic pain management
* allergy to NSAIDs or steroids
* prior surgery
* kidney disease that would preclude NSAID administration

Primary outcomes:
measure: Pain level: VAS score
timeFrame: 0-6 months
measure: length pain relief
timeFrame: 0-6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00051740: Treating Thought Problems in Patients With Schizophrenia
Official title: Compensating for Cognitive Deficits in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2003-01-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare Cognitive Adaptation Training (CAT) to minimal schizophrenia treatment. This study will also determine whether the intensity of CAT can be reduced and still provide benefits to patients with schizophrenia.

Detailed description: Many schizophrenia patients have serious difficulties that affect their quality of life. Cognitive Adaptation Training (CAT) may improve adaptive functioning, quality of life, and rates of relapse in schizophrenia patients. CAT, which involves compensatory strategies or environmental supports, is tailored to each individual and is based on executive functioning levels and other factors.

Participants are randomly assigned to CAT, Minimal Environmental Supports (MES), or treatment as usual for 2 years. Participants receiving CAT will have a trained therapist make weekly visits to their home for 9 months. Over the following 3 months, the frequency of CAT visits will be slowly reduced to once a month. For the remaining 12 months of treatment, patients receive CAT only once a month.

Participants assigned to the MES group receive a generic set of supplies and equipment (calendar, alarm clock, watch, bus passes, etc.) at the beginning of the 2-year period. Each month, the supplies are replenished as necessary during the patient's scheduled clinic visit.

In all groups, assessments of adaptive function and quality of life occur at study start and at 3, 6, 9, 18, and 24 months.

Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia or schizoaffective disorder
* Treatment with an atypical antipsychotic medication
* Stable living environment
* Able to read, understand, and complete rating scales and neuropsychological testing
* Willing to participate in psychosocial treatments for schizophrenia that may involve home visits

Exclusion Criteria:

* History of significant head trauma, seizure disorder, or mental retardation
* Alcohol or drug abuse that could interfere with participation in the study
* Treatment by an ACT team
* History of violence in the past year
* Score \> 80 on the SOFAS
* Hospitalized in the past year

Primary outcomes:
measure: Primary
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Dawn I. Velligan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: