louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06535009: Study of ONO-7914 Alone and in Combination With ONO-4538 in Patients With Solid Tumors
Official title: A Phase I, Open-label, Uncontrolled, Dose Escalation Study to Evaluate the Tolerability and Safety of ONO-7914 Alone and in Combination With ONO-4538 in Patients With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-02
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is dose escalation study to evaluate the tolerability and safety of ONO-7914 alone and in combination with ONO-4538 in patients with advanced or metastatic solid tumors


Eligibility criteria: Inclusion Criteria:

1. Patients with advanced or metastatic solid tumor
2. Patients with ECOG performance status of 0 or 1
3. Patients with a life expectancy of at least 3 months

Exclusion Criteria:

1. Patients with severe complication
2. Patients judged to be incapable of providing consent for reasons such as concurrent dementia

Primary outcomes:
measure: Dose Limiting Toxicity
timeFrame: 28 days
measure: Adverse Events as assessed by CTCAE v5.0
timeFrame: Up to 28 days after the completion of treatment period
Secondary outcomes:
measure: Plasma concentration of ONO-7914
timeFrame: Up to 21 days after the first treatment
measure: Urine concentration of ONO-7914
timeFrame: Up to 24 hours after the first treatment
measure: Serum concentration of ONO-4538
timeFrame: Up to 28 days after the completion of treatment period
Other outcomes:
Locations:
city: Koto-ku
country: Japan
facility: Cancer Institute Hospital of JFCR
state: Tokyo
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References:
Clinical trial NCT01377909: HCV Treatment With Fluvastatin, Simvastatin to Improve Interferon Sensitivity
Official title: An Investigator-initiated Pilot Study Using Statins to Improve the Anti-HCV Response to Peginterferon Alfa 2-b and Ribavirin in Previous Non-responders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Keywords: chronic hepatitis C, interferon
Lead sponsor: Bader, Ted, M.D.
Sponsor class: INDIV
First posted: 2011-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Objective: The goal is to improve peginterferon sensitivity in previous poor responders. "Sensitivity" here means the host's ability to kill more HCV.

Design: Twenty poor responders to prior PIFN/RBV will be given 48 weeks of statin monotherapy. Veterans and civilians between the ages of 18 and 70 are eligible.


Eligibility criteria: Inclusion Criteria:

Hepatitis C positive by HCV RNA within 180 days. - No anti-HCV medicine within 30 days of screening

Exclusion Criteria:

* decompensated liver disease
* severe cardiac disease (ejection fraction \< 20% or uncontrolled angina)
* unexplained muscle pain at time of screening
* pregnancy
* renal insufficiency (creatine clearance \< 50 ml/min)

Primary outcomes:
measure: Improvement in peginterferon response as measured by change in HCV RNA levels
timeFrame: 48 weeks
Secondary outcomes:
measure: The response of interferon stimulated genes
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Veterans Administration Medical Center (VAMC)
state: Oklahoma
Study officials:
affiliation: VA Medical Center
name: Ted Bader, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06532409: Comparison of Efficacy of Oral Amoxicillin Versus Intravenous Ceftriaxone
Official title: Efficacy of Oral Amoxicillin in Comparison to Intravenous Ceftriaxone in Treatment of Uncomplicated Community Acquired Pneumonia (Cap) Among Children of Age 2-5 Years of Age
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Community-acquired Pneumonia
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 114
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The efficacy of oral amoxicillin is considered equal to that of ceftriaxone in community-acquired pneumonia among children. Also, there are some factors that contradict the usage of ceftriaxone, like antibiotic resistance, adverse reactions, drug cost, and the and the chances of IV trauma and infection, which is a major problem in developing countries. Therefore, this study was planned to determine the efficacy of oral amoxicillin compared with intravenous (IV) ceftriaxone in the treatment of uncomplicated ceftriaxone in community acquired pneumonia in children less than 5 years of age.

Detailed description: The efficacy of oral amoxicillin is considered equal to that of ceftriaxone in community-acquired pneumonia among children. Also, there are some factors that contradict the usage of ceftriaxone, like antibiotic resistance, adverse reactions, drug cost, and the and the chances of IV trauma and infection, which is a major problem in developing countries. Therefore, this study was planned to determine the efficacy of oral amoxicillin compared with intravenous (IV) ceftriaxone in the treatment of uncomplicated ceftriaxone in community acquired pneumonia in children less than 5 years of age.

Eligibility criteria: Inclusion Criteria:

* Children of both gender
* Aged from 2 to 5 years
* With fever \>37.5 C (99.5 F)
* Will be presented with symptoms and signs of uncomplicated community acquired pneumonia

Exclusion Criteria:

* Children requiring ICU care (having cyanosis SpO2 \< 85% requiring intubation within first day of admission or in state of shock)
* Children with conditions like congenital heart disease, chronic lung disease, chronic kidney disease, severe malnutrition, asthma, foreign bodies, sickle cell disease, and immunodeficiency
* Children with underlying anatomical disorders of the lung like pulmonary sequestration, tracheoesophageal fistula or congenital cystic adenoid malformation
* Children already on antibiotics
* Presence of any complication of community acquired pneumonia
* Patients having symptoms of multi-organ involvement/sepsis
* Hypersensitivity to Amoxicillin or Ceftriaxone
* Other co-existing infections like dengue, malaria, or measles

Primary outcomes:
measure: Free from fever
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Children Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT01501409: Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis
Official title: Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis : a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Aphthous Stomatitis
Keywords: Sodium lauryl sulfate (SLS)
recurrent aphthous stomatitis (RAS)
dentifrice
pain
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Sodium lauryl sulfate (SLS) is an anionic detergent that has been used as the major or sole surfactant in most dentifrices. But it is known to local irritating factor to oral mucosa and skin and results in many side effects. This study was to compare the effects of SLS-free dentifrice and SLS-containing dentifrice in patients with recurrent aphthous stomatitis (RAS).


Eligibility criteria: Inclusion Criteria:

* The volunteers had a history of regularly recurring oral ulcerations of at least 6 months duration, with more than one episode per month

Exclusion Criteria:

* already using an SLS-free dentifrice
* taking medications affecting oral ulcers (e.g., corticosteroids)
* having chronic oral mucosal disease (ex, lichen planus, pemphigus vulgaris, pemphigoid, and etc.)
* having allergies to food or medications
* being pregnant

Primary outcomes:
measure: Number of episodes
timeFrame: after 18 weeks
Secondary outcomes:
measure: Mean pain score
timeFrame: after 18 weeks
measure: Number of ulcers
timeFrame: after 18 weeks
measure: duration of ulcers
timeFrame: after 18 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Yonsei University dental hospital
name: Jeong-Seung Kwon
role: STUDY_DIRECTOR
References:
Clinical trial NCT04079556: Reducing Breast Cancer Risk in Korean American Women
Official title: Reducing Breast Cancer Risk in Korean American Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Secondhand Tobacco Smoke Exposure Reduction
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Korean Community Center of the East Bay
First posted: 2019-09-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goals of the study are to develop a culturally and linguistically appropriate intervention to reduce SHS exposure for LEP Korean women using a family-focused intervention approach targeting Korean Americans ages 18 and above in the greater San Francisco Bay Area, CA, and to evaluate efficacy of the proposed intervention. The study is a single group feasibility trial targeting a total of 4 lay health workers (LHW) and 24 dyads of LEP Korean women with self-reported SHS exposure at home and a male household smoker. The hypothesis is:

H. Can a family-based intervention approach reduce SHS exposure among Korean American women who live with a current smoker?


Eligibility criteria: Inclusion Criteria:

* self-identified as Korean or Korean American;
* Korean speaking;
* reside in the San Francisco Bay Area
* plan to stay in the area for the next 3 months
* for women participants, the participant must report having SHS exposure at home at least 1 day in the past 7 days and live in the same household as the smoker participant to form a dyad.
* for the smoker participants, they must be male and have smoked at least 1 cigarette daily in the past 7 days.
* provide a valid contact telephone number for pre- and post-intervention assessments

Primary outcomes:
measure: SHS exposure of non-smokers
timeFrame: 3-month
Secondary outcomes:
measure: Smoker's adoption of smoke-free rules
timeFrame: 3-month
measure: Smoker's Utilization of smoking cessation resources
timeFrame: 3-month
measure: Smoking Abstinence
timeFrame: 3-month
Other outcomes:
Locations:
city: San Leandro
country: United States
facility: Korean Community Center of the East Bay
state: California
Study officials:
affiliation: University of California, San Francisco
name: Janice Y Tsoh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05657756: Hand Dynamometer and Clinical Tests to Evaluate Neuromuscular Recovery in Atracurium vs Rocuronium
Official title: Hand Dynamometer and Clinical Tests to Evaluate Neuromuscular Recovery in Atracurium vs Rocuronium
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuromuscular Block Prolonged
Lead sponsor: Al Safwa University College
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: One of the common serious complications in the postoperative phase is Residual the neuromuscular blockade that confused the anesthesia medical team also patients may become uncomfortable, un ability to clear secretion, un-explanation of decreasing SPO2, increase respiratory effort and lead to an increase in the risk of respiratory complication. Most clinicians used clinical assessment to evaluate neuromuscular recovery such as a head lift for 5 seconds, Sustain leg lift, Tongue protrusion, teeth clenching, swallowing, Tidal volume 5 mL/kg, Handgrips Sustained for 5 seconds, and other clinical assessments in patients undergoing general anesthesia. A few studies have been discussing the utilization of hand dynamometers in the assessment of post-residual neuromuscular block. Our aim is to examine the neuromuscular recovery using a hand dynamometer after receiving Atracurium versus Rocuronium.


Eligibility criteria: Inclusion Criteria:

* all patient between 18-60 years old with ASAII under general anesthesia

Exclusion Criteria:

* all patient under 18 years old and over 60 years old
* prior administration of suxamethonium
* patient received magnesium, lithium, Quinidine, calcium channel blockers, local anesthesia

Primary outcomes:
measure: 100 patients were enrolled in our study, they are receiving muscle relaxants either Atracurium or rocuronium, and we recorded the muscle strength of the forearm in a postoperative location using an electronic hand dynamometer with a kilogram scale.
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Najaf
country: Iraq
facility: mohammed abdulzahra Sasaa
state: Adala
Study officials:
References:
Clinical trial NCT02254356: Zilver Flex Post-Market Study in Japan
Official title: Zilver PTX Post-Market Surveillance Study of Bare Metal Stents for Treating Femoropopliteal Artery Disease in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease (PAD)
Keywords: drug-eluting stent, paclitaxel-eluting stent, peripheral artery disease, peripheral vascular disease, superficial femoral artery, popliteal artery
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2014-10-01
Enrollment: 239
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Japanese post market clinical study of the Zilver Flex device.


Eligibility criteria: Inclusion Criteria:

* Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries

Exclusion Criteria:

-

Primary outcomes:
measure: Occurrence of stent fracture
timeFrame: 3 years
measure: Rate of adverse events
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Fukuoka Sanno Hospital
Study officials:
affiliation: Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA
name: Michael D Dake, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01473056: Study to Assess Safety,Tolerability,Pharmacokinetics & Antiviral Activity of JTK-853 in Hepatitis C Virus Genotype 1 Infected Subjects
Official title: Phase I,Randomized,Double-blind,Placebo-controlled,Multiple Dose Study Evaluating Safety,Tolerability,Pharmacokinetics and Antiviral Activity of JTK-853 in HCV Genotype 1 Infected Subjects,Followed by a Genotypic Resistance Monitoring Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C Virus Infection, Response to Therapy of
Keywords: Hepatitis C
JTK-853
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-17
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the safety, tolerability, pharmacokinetics and anti-viral activity of JTK-853 in hepatitis C virus genotype 1 infected subjects based on reduction in viral load (HCV RNA level) from baseline to end of treatment, followed by genotypic resistance monitoring for up to one year after study drug treatment.


Eligibility criteria: Inclusion Criteria:

1. Males and females infected with chronic hepatitis C virus (HCV) infection and genotype 1a or 1b
2. Subjects with a viral load (HCV RNA level) of ≥50,000 IU/mL
3. Subjects with a body mass index (BMI) of 18.0-36.0 kg/m2 (inclusive)

Exclusion Criteria:

1. Subjects should not have previously received a direct acting anti-HCV agent
2. Subjects should not previously have received pegylated interferon/ribavirin for a duration of more than two weeks

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: 1 week
measure: Maximum concentration (Cmax) of JTK-853 and metabolite M2
timeFrame: 1 week
measure: Time to reach maximum concentration (tmax) for JTK-853 and metabolite M2
timeFrame: 1 week
measure: Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and Metabolite M2
timeFrame: 1 week
measure: Trough concentration during multiple dosing prior to next dose (Ctrough) for JTK-853 and metabolite M2
timeFrame: 1 week
measure: Viral load change from baseline to end of treatment
timeFrame: 48 weeks
measure: Genotypic resistance assessment and viral load change from baseline over time
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
Study officials:
affiliation: Akros Pharma Inc.
name: Shoji Hoshino, D.V.M
role: STUDY_DIRECTOR
References:
Clinical trial NCT01690156: Trial on the Effects of Ultrasound Probe Position on Ultrasound-guided Nerve Blocks
Official title: Double Blinded Randomized Control Trial on the Effects of Ultrasound Probe Position on Ultrasound-guided Nerve Blocks
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: In-plane Ultrasound-guided Regional Anesthesia Performance
Keywords: In-plane
Ultrasound-guided regional anesthesia performance
Probe position
Needle visualization
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers naiive to ultrasound techniques

Brief summary: Ultrasound has been used to guide a needle to inject local anesthetics around nerves. This is usually done in the same plane as the ultrasound beam in America and is known as an in-plane technique. When done correctly, the entire needle is visualized on the ultrasound screen as it approaches the nerves which are also seen on the same screen the entire time. The ultrasound probe can be held perpendicular or parallel to the shoulders of the person performing the in-plane technique. Our hypothesis is that holding the ultrasound probe perpendicular to the shoulder is superior to holding the probe parallel to the shoulder during an in-plane ultrasound guided regional anesthesia technique.

Detailed description: Right handed volunteers with no prior exposure to ultrasound techniques are used in this study. They will be randomly assigned to be shown an instructional video on how to perform an in-plane ultrasound guided needling technique on a realistic simulation target. The two videos are identical with the exception of the probe position. A blinded assessor will time the volunteers performance behind a screen and note the duration in which the needle is not visualized in the ultrasound screen.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Right handed
* Aged 18 to 55

Exclusion Criteria:

* Any person who has prior knowledge about ultrasound imaging or regional anesthesia
* Any person who has prior experience with laparoscopy or biopsy
* Any person who has problems with depth of field or simple hand eye co-ordination task

Primary outcomes:
measure: Time taken to perform a simulated interscalene block
timeFrame: 1 hour
Secondary outcomes:
measure: Duration where the entire needle is not visualized when performing the simulated interscalene block
timeFrame: 1 hour
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Nicholas C Lam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06731556: Analgesic Effects of Intranasal Diclofenac Sodium, Ibuprofen, and Paracetamol in Pediatric Tonsillectomy Cases
Official title: Intranasal Diclofenac Sodium, Ibuprofen, and Paracetamol for Pain Relief After Pediatric Tonsillectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tonsil Disease
Pain Management
Intranasal Drug Administration
Keywords: Intranasal Spray
intranasal Analgesia
Diclofenac Sodium
Ibuprofen
Paracetamol
Tonsillectomy
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized study
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy and safety of intranasal Diclofenac Sodium, intranasal Ibuprofen, and intranasal Paracetamol for pain control following tonsillectomy in pediatric patients.

Detailed description: Postoperative pain management in pediatric tonsillectomy remains a challenge, with concerns about the safety and efficacy of available analgesic options. Intranasal administration of nonsteroidal anti-inflammatory drugs presents a promising alternative for effective pain relief with minimal side effects.

This prospective, randomized study evaluated the efficacy and safety of intranasal diclofenac sodium, intranasal ibuprofen, and intranasal paracetamol compared to intravenous paracetamol in pediatric patients following tonsillectomy. Sixty patients, aged 2 to 14 years, were divided into four groups to receive either intranasal paracetamol (Group 1), intranasal diclofenac sodium (Group 2), intranasal ibuprofen (Group 3), or intravenous paracetamol (Group 4). Pain was assessed using the CHEOPS, VAS, and Wong-Baker modified VAS scoring systems at various postoperative time points. Statistical analysis was performed using the Kruskal-Wallis and Dunn's tests.

Eligibility criteria: Inclusion Criteria:

-Pediatric patients who have undergone a tonsillectomy.

Exclusion Criteria:

* Chronic sinusitis
* Common cold or rhinitis
* Turbinate hypertrophy
* Nasal polyposis
* Deviated nasal septum
* Impaired mucociliary clearance
* Atrophic rhinitis

Primary outcomes:
measure: Children's Hospital of Eastern Ontario Pain Scale measurements
timeFrame: Pain levels were assessed at predefined time points (15, 30, 60, 120 minutes, and 2, 4, 6, 12 hours after surgery).
Secondary outcomes:
measure: VISUAL ANALOGUE Scale measurements
timeFrame: Pain levels were assessed at predefined time points (15, 30, 60, 120 minutes, and 2, 4, 6, 12 hours after surgery).
Other outcomes:
measure: Wong-Baker Facial Pain Scale (Modified VAS) measurements
timeFrame: Pain levels were assessed at predefined time points (15, 30, 60, 120 minutes, and 2, 4, 6, 12 hours after surgery).
Locations:
city: Istanbul
country: Turkey
facility: Ramazan Bahadır KÜÇÜK
Study officials:
References: