louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03612726: The Overall Survival of Patients With Unresectable HCC in Real-life
Official title: The Overall Survival of Patients Diagnosed With Unresectable Hepatocellular Carcinoma Under Real-life Clinical Practice in Asia Pacific Region
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Lead sponsor: Humanity & Health Medical Group Limited
Sponsor class: OTHER
Collaborators: name: Tokyo University
First posted: 2018-08-02
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Unresectable HCC who are treated under real-life clinical practice conditions in Asian Pacific Region

Brief summary: Liver cancer is the fifth most common cancer and the second most frequent cause of cancer-related death globally. Hepatocellular carcinoma represents about 90% of primary liver cancers and constitutes a major global health problem. The pattern of HCC occurrence shows a significant geographical imbalance, with the highest incidence rates in East Asia (more than 50% of the cases occurring in China).

The aim of this study is to investigate the overall survival (OS) of patients diagnosed with unresectable hepatocellular carcinoma under real-world practice conditions in Asia Pacific region.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of unresectable hepatocellular carcinoma
* Able to comprehend and provide written informed consent in accordance with institutional guidelines.

Exclusion Criteria:

* Patients not willing to participate and/or give their written informed consent.

Primary outcomes:
measure: Overall survival
timeFrame: Up to 5 years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to 5 years
measure: Time to progression (TTP)
timeFrame: Up to 5 years
measure: Duration of treatment
timeFrame: Up to 5 years
measure: Frequency and Severity of Adverse Events
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing 302 Hospital
city: Hong Kong
country: Hong Kong
facility: Humanity & Health Medical Group Limited
city: Tokyo
country: Japan
facility: Tokyo University
Study officials:
affiliation: Tokyo University
name: Masao Omata, PhD, MD
role: STUDY_CHAIR
affiliation: Humanity & Health Medical Group Limited
name: George Lau, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02438657: Ultrasound-guided Nerve Block: Determination of the Minimal Effective Volume of Local Anesthetic
Official title: Ultrasound-guided Median Nerve Block With Dextrose 5% Hydrodissection: Determination of the Minimal Effective Volume of Local Anesthetic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Surgery
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Ascending dose model
Primary purpose: TREATMENT

Brief summary: Ultrasound guidance can reduce the required local anesthetic volume for successful peripheral nerve block.

The aim of the study is to determine the minimum volume of local anesthetic to achieve an ultrasound-guided median nerve block with a dextrose 5% hydrodissection approach.


Eligibility criteria: Inclusion Criteria:

* aged 18 years from 18 to 80 years with an ASA (American Society of Anesthesiologists) physical status I-II
* elective hand ambulatory surgery with a maximum duration of 30 minutes involving the median nerve and performed with elbow nerve blocks

Exclusion Criteria:

* pregnant or lactating women,
* contra-indication to regional anesthesia
* diabetes mellitus,
* effective anticoagulation or antiplatelet therapy, laboratory evidence of abnormal bleeding
* neurological disease ( including carpal tunnel syndrome or neuromuscular disease detected by preoperative neurological examination in the median nerve)
* infection at the puncture site
* contra-indication to the administration of lidocaine, notably allergy
* contra-indication to the administration of lidocaine with epinephrine
* not speaking French

Exclusion from the study:

* patient having an intraneural injection of the median nerve defined by swelling appearance are excluded from analysis

Primary outcomes:
measure: Minimal effective volume of local anesthetic
timeFrame: 1 hour
Secondary outcomes:
measure: Nerve block onset time
timeFrame: 1 hour
measure: Success rate of the median nerve block
timeFrame: 1 hour
measure: Additional local anesthetic
timeFrame: 2 hours
measure: Duration of analgesia
timeFrame: 1 day
measure: Duration of the block
timeFrame: 1 day
measure: Complications
timeFrame: 1 month
measure: Block procedure time
timeFrame: One hour
Other outcomes:
Locations:
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque
city: Trappes
country: France
facility: Hopital privé de l'Ouest Parisien
Study officials:
affiliation: Centre Hospitalier de la Côte Basque, 64100 Bayonne, France
name: Eric Dufour, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dufour E, Jaziri S, Novillo MA, Aubert L, Chambon A, Kutz R, Vallee A, Fischler M. A randomized trial to determine the minimum effective lidocaine volume for median nerve block using hydrodissection. Sci Rep. 2022 Jan 7;12(1):52. doi: 10.1038/s41598-021-03660-7.
Clinical trial NCT04770857: Evaluation of Post-ERCP Pain as a Predictor for Post-ERCP Pancreatitis
Official title: Evaluation of Post-Post-Endoscopic Retrograde Cholangiopancreaticography Pain (ERCP) as a Predictor for Post-ERCP Pancreatitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post-ERCP Acute Pancreatitis
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients scheduled for ERCP for any reason at the study center will be asked for participation.

Brief summary: Pancreatitis is the most common complication after ERCP, although its frequency varies significantly depending on the study from \< 2% up to 40%.

Based upon data from studies that have included unselected patients, post-ercp pancreatitis (PEP) is mild, moderate, and severe in 45%, 44%, and 11% of cases, respectively. Dysfunction of the sphincter Oddi, female gender, younger age, previous history of pancreatitis, prolonged procedure time and pancreatic guidewire passages are well-known independent risk factors for PEP.

This study will assess whether the development of PEP can be predicted by Visual analogue scale (VAS) level 1 hour after ERCP.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Scheduled for ERCP for any reason

Exclusion Criteria:

* Absence of consent
* Language barrier
* No endoscopic advance to the papilla vateri
* Active pancreatitis at the time of the procedure
* Mental disability

Primary outcomes:
measure: Association between Pain 1 hour after ERCP
timeFrame: 1 hour
Secondary outcomes:
measure: Predictive value of VAS for PEP Predictive value of VAS for PEP
timeFrame: 1 hour
measure: Association between VAS level and severity of PEP
timeFrame: 1 hour
Other outcomes:
Locations:
city: Sankt Gallen
country: Switzerland
facility: Kantonsspital Sankt Gallen
Study officials:
References:
Clinical trial NCT03612557: A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects
Official title: A Phase 1, Open-label Study To Investigate The Pharmacokinetics And Safety Of A Single Intramuscular Injection Of Benzathine Benzylpenicillin In Japanese Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Benzathine benzylpenicillin
penicillin G benzathine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-08-02
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This will be an open label study to investigate the pharmacokinetics (PK) and safety of a single intramuscular injection of penicillin G benzathine in Japanese healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy female subjects (of childbearing or nonchildbearing potential) and/or male subjects
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg and \<100 kg.

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (history of penicillin hypersensitivity and/or a history of sensitivity to allergens).

Primary outcomes:
measure: Maximum observed plasma concentration for penicillin G (Cmax)
timeFrame: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
measure: Time to Cmax (Tmax)
timeFrame: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
measure: Area under the plasma concentration time curve from time zero to the time of the last measurable concentration (AUClast)
timeFrame: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
measure: Area under the plasma concentration time curve from time zero extrapolated to infinite time (as data permit)(AUCinf)
timeFrame: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
measure: Apparent clearance (as data permit) (CL/F)
timeFrame: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
measure: Apparent volume of distribution (as data permit) (Vz/F)
timeFrame: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
measure: Terminal half life (as data permit) (t1/2)
timeFrame: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Secondary outcomes:
measure: Number of Subjects experiencing an Adverse Event
timeFrame: Screening up to 28 days after last dose of study medication
Other outcomes:
Locations:
city: Hachioji-shi
country: Japan
facility: P-one Clinic, Keikokai Medical Corporation
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01501357: Effectiveness of Toothbrushing Techniques in Plaque Removal and Caries Lesion Control
Official title: Effectiveness of Toothbrushing Techniques in Plaque Removal and Caries Lesion Control in Erupting Primary Permanent Molars - Randomized Clinical Trial Abbreviated Over 24 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries
Keywords: caries
primary molars
plaque
toothbrushing
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 220
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to evaluate the effectiveness of cross-toothbrushing technique compared with anteroposterior and biofilm removal and control of caries lesions in first permanent molars.

Detailed description: 220 children between 5-7 years with at least one permanent molar erupting will be selected, with a maximum score of ICDAS 3. These children will be randomly allocated into two groups according to the technique adopted. The teeth will be evaluated by ICDAS, laser fluorescence (DIAGNOdent), QLF and subtraction radiography at baseline and after 15 days, 3, 6, 9,12,18,24 months.

Eligibility criteria: Inclusion Criteria:

* erupting primary permanent molar

Exclusion Criteria:

* caries ( ICDAS 4,5 and 6),
* enamel defects,
* sealant,
* restoration

Primary outcomes:
measure: dental caries
timeFrame: 24 months
Secondary outcomes:
measure: dental plaque
timeFrame: 24 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade de São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Mariana M Braga, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00735657: Anesthesia for Pars Plana Vitrectomy (PPV) With Insulin Needle
Official title: Anesthesia for PPV Using Insulin Needle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Disorders
Keywords: Efficiency
Pars
Plana
Vitrectomy
Lead sponsor: King Khaled Eye Specialist Hospital
Sponsor class: OTHER_GOV
First posted: 2008-08-15
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Periocular blockade with 12.5 mm needle is as effective as block with 25 mm needle for patients undergoing Pars Plana Vitrectomy.

Detailed description: The author wants to see the effect of short needle in patients undergoing retinal surgery.

Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing pars plana vitrectomy under local anesthesia

Exclusion Criteria:

* Patients allergic to local anesthetic solutions
* With local sepsis
* Serious impairment of coagulation
* Orbital abnormalities
* Unable to cooperate in maintaining a relatively motionless supine position
* Who refused the anesthetic technique

Primary outcomes:
measure: Efficacy of insulin needle.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Khaled Eye Specialist hospital
Study officials:
affiliation: KKESH
name: Waleed Riad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05149157: Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Official title: Search for Correlates of Recovery in the Patient Transcriptome (SCRIPT) (Malaria) Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Malaria
Keywords: Malaria
Recovery
Transcriptomics
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 240
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of any age with symptomatic malaria confirmed by asexual stage parasitaemia (of any Plasmodium species) on blood film

Brief summary: This observational research study aims to answer the question: 'Which aspects of human biology play an important role in recovery from symptomatic malaria?'

In particular, the researchers aim to identify human genes for which the level of gene activity reflects the patient's overall rate of recovery. The researchers believe this approach may reveal new targets for adjunctive therapies.

The researchers aim to recruit 240 people, of all ages, who have been diagnosed with symptomatic malaria at selected hospitals in London. Blood samples, urine samples, and clinical information will be collected over the 14 days following malaria diagnosis.


Eligibility criteria: Inclusion Criteria:

Patients of any age with symptomatic malaria confirmed by asexual stage parasitaemia (of any Plasmodium species) on blood film.

Exclusion Criteria:

Patients with asymptomatic malaria; Patients with congenital malaria; Patients with Plasmodium gametocytaemia only; Patients with known HIV; Patients who have received antimalarial treatment for symptomatic malaria in the 28 days prior to hospital presentation; Patients who explicitly deny consent.

Primary outcomes:
measure: Genes for which expression (level of gene activity) correlates with a 'composite recovery score'
timeFrame: Each study participant will be assessed over the 14 days following malaria diagnosis
Secondary outcomes:
measure: Genes for which expression (level of gene activity) correlates with rate of recovery for individual markers of tissue, organ, or organ system dysfunction
timeFrame: Each study participant will be assessed over the 14 days following malaria diagnosis
measure: Rate of recovery for individual markers of tissue, organ, or organ system dysfunction
timeFrame: Each study participant will be assessed over the 14 days following malaria diagnosis
measure: Sequences of clinical events predictive of recovery, as determined by Bayesian inference of dynamic pathways using the HyperTraPS statistical platform
timeFrame: Each study participant will be assessed over the 14 days following malaria diagnosis
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Aubrey Cunnington, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00565357: Silicone Earplugs for VLBW Newborns in Intensive Care
Official title: Silicone Earplugs for VLBW Newborns in Intensive Care: Feasibility, Sound Attenuation, and Outcomes From a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postnatal Growth
Keywords: Postnatal Growth
Postnatal Development
Noise
Neonatal Intensive Care Unit
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2007-11-29
Enrollment: 34
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was to determine the effects of individual noise reduction using silicone earplugs for very low birthweight newborns in neonatal intensive care on growth and development. The study hypothesis was that newborns who were randomized to the earplug group would be heavier than controls at 34 weeks post-menstrual age.


Eligibility criteria: Inclusion Criteria:

* birthweight between 401 and 1500 grams
* less than 1 week of age
* parental informed consent
* availability of research personnel

Exclusion Criteria:

* terminal illness
* congenital anomalies
* syndromes associated with hearing loss

Primary outcomes:
measure: Weight
timeFrame: 34 weeks post-menstrual age
Secondary outcomes:
measure: Length of stay in neonatal intensive care
timeFrame: hospital discharge
measure: Time on mechanical ventilator
timeFrame: hospital discharge
measure: Weight
timeFrame: 18 - 22 months of age
measure: Length
timeFrame: 18 - 22 months of age
measure: Frontal-occipital circumference
timeFrame: 18 - 22 months of age
measure: Bayley Mental Developmental Index
timeFrame: 18 - 22 months of age
measure: Bayley Psychomotor Developmental Index
timeFrame: 18 - 22 months of age
measure: ABR Hearing Screen
timeFrame: hospital discharge
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas Medical School at Houston
name: Robert E Lasky, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abou Turk C, Williams AL, Lasky RE. A randomized clinical trial evaluating silicone earplugs for very low birth weight newborns in intensive care. J Perinatol. 2009 May;29(5):358-63. doi: 10.1038/jp.2008.236. Epub 2009 Feb 5.
Clinical trial NCT03684057: Targeting Worry to Improve Sleep
Official title: Targeting Worry to Improve Sleep Using App-Based Mindfulness Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Sleep Disturbance
Keywords: Worry
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-09-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test an app-based mindfulness training program for worry to see if it can help individuals decrease worry and improve sleep.

Detailed description: In this study, 80 individuals with worry interfering with sleep will be randomized to receive Unwinding Anxiety or to Treatment as Usual (50/50 chance). The active intervention period will last 2 months, with an optional 2-month follow-up period in which the intervention remains available. Changes in mindfulness, emotional reactivity, cognition and sleep behavior at specified time points will be measured. The primary engagement targets will be non-reactivity and worry. The primary behavioral outcome target will be sleep.

Eligibility criteria: Inclusion Criteria:

* Score \> 40 on the Penn State Worry Questionnaire (PSWQ)
* Score ≥ to 40% on Worry Interfering with Sleep Scale (WISS)
* Owns a smartphone
* Willing to wear a sleep tracker for at least 1 week

Exclusion Criteria:

* Any usage of psychotropic medication: not on a stable dosage 6+ weeks
* Medical disorder of the severity that would interfere with ability to attend visits and complete study milestones
* Use of benzodiazepine or hypnotic sleep aid on as needed (i.e. prn)
* Known sleep disorder
* Psychotic disorder
* Post-traumatic Stress Disorder
* Severe depression (Score \> 3 on PHQ-2)
* Current shift work employment
* BMI \> 35
* Evening caffeine use
* Pregnant women

Primary outcomes:
measure: Change in Worry-related Sleep Disturbances
timeFrame: Baseline, 2 months
Secondary outcomes:
measure: Change in Worry
timeFrame: Baseline, 2 months
measure: Change in Total Sleep Time (TST)
timeFrame: Baseline, 2 months
measure: Changes in Non-reactivity
timeFrame: Baseline, 2 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Judson Brewer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gao M, Roy A, Deluty A, Sharkey KM, Hoge EA, Liu T, Brewer JA. Targeting Anxiety to Improve Sleep Disturbance: A Randomized Clinical Trial of App-Based Mindfulness Training. Psychosom Med. 2022 Jun 1;84(5):632-642. doi: 10.1097/PSY.0000000000001083. Epub 2022 Apr 14.