louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06196775: A Study of Cadonilimab Combined With AK112 as Second-line Therapy in Patients With Advanced Hepatocellular Carcinoma
Official title: A Single-arm, Single-center, Phase II Clinical Trial of Cadonilimab (Anti PD-1/CTLA-4) Combined With AK112 (Anti VEGF/PD-1) as Second-line Therapy in Patients With Unresectable Locally Advanced, Recurrent or Metastatic Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: cadonilimab (anti PD-1/CTLA-4 bispecific antibody)
AK112 ( anti VEGF/PD-1 bispecific antibody)
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of cadonilimab combined with AK112 as second-line therapy in patients with advanced hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* Histopathologically confirmed HCC
* Age 18-75 years old
* ECOG PS 0-1
* Child Pugh A-B7
* Patients who progressed on first-line standard system therapy (immunotherapy combined with Anti-angiogenesis targeting regimen) or with intolerable toxicity
* At least one measurable lesion (RECIST 1.1)
* Enough organ and bone marrow function
* Expected survival time≥12 weeks
* Sign a written informed consent and be able to comply with the visit and related procedures required by the study protocol

Exclusion Criteria:

* Severe complications due to primary liver disease
* No prior systemic therapy for advanced or metastatic primary hepatocellular carcinoma
* Malignant diseases other than primary hepatocellular carcinoma were diagnosed within 5 years prior to first administration
* Previous treatment with drugs that synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137)
* Autoimmune immune disease
* History of HIV
* Prognent women
* The presence of any serious or uncontrolled systemic disease
* Medical history or evidence of disease that may interfere with the test results, prevent participants from participating fully in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment. The Investigator considers that there are other potential risks that are not suitable for participation in the study.

Primary outcomes:
measure: Progression-Free-Survival
timeFrame: From the first drug administration up to two years
Secondary outcomes:
measure: Objective Response Rate
timeFrame: From the first drug administration up to two years
measure: Disease control Rate
timeFrame: From the first drug administration up to two years
measure: Overall survival
timeFrame: From the first drug administration up to two years
measure: Incidence of Adverse Events
timeFrame: From the first drug administration to within 90 days for the last dose
Other outcomes:
Locations:
city: Harbin
country: China
facility: Harbin Medical University Hospital
Study officials:
References:
Clinical trial NCT04249375: Integrating Pediatric Pharmacogenomic Testing Into the Canadian Health Care System
Official title: Integrating Pediatric Pharmacogenomic Testing Into the Canadian Health Care System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adverse Drug Reaction (ADR)
Keywords: Pharmacogenomics
Pediatrics
Adverse Drug Reactions
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Genome British Columbia
name: Genome Canada
name: Dynacare Laboratories, Inc.
First posted: 2020-01-30
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any individual who is currently on an analgesic, antibiotic and/or mental health medication that is part of the panels.

Brief summary: This project addresses the problem of adverse drug reactions in the three most frequently prescribed therapeutic classes of drugs in children: antibiotics, analgesics, and mental health medications.

We will conduct pilot testing of a pharmacogenomic testing panel and study how the tests and generated test results are utilized and understood by physicians, pharmacists, patients and their families.

Detailed description: The specific objectives are to:

1. Implement a pilot pharmacogenomics program to test medication safety and effectiveness of antibiotics, analgesics and mental health medication to enhance prescribing decision-making.
2. Develop data collection forms to collect necessary patient information from the prescribing physicians.
3. Develop pharmacogenomics reports to return results to physicians, pharmacists, patients and their families.
4. Determine how the tests and results are perceived and utilized by physicians, pharmacists, patients and their families.

Eligibility criteria: Inclusion Criteria:

* Participants will be enrolled if they can benefit from pharmacogenomic testing. This means their physician is considering the use of a drug that is part of the panels (analgesics, antibiotics, and mental health medication) or they are already using one.

Exclusion Criteria:

* Patients who do not speak or understand English.

Primary outcomes:
measure: 150 participants on analgesics, anti-infectives and psychotropics will be given pharmacogenomic recommendations for the risk of gene related adverse events prior to or during treatment.
timeFrame: June 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Children's and Women's Health Centre of British Columbia
state: British Columbia
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
References:
Clinical trial NCT00042575: Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression
Official title: Protocol F1J-US-HMBY Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Sad, blue, lack of energy, depressed, hopelessness, guilt
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2002-08-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Purposes of this Study are to determine:

The safety of duloxetine and any side effects that might be associated with it.

Whether duloxetine can help patients with major depression.

It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed.

Duloxetine might not have any good effects for you.


Eligibility criteria: Inclusion Criteria:

* You must be at least 18 years old.
* You must be diagnosed with major depressive disorder
* You must be able to visit the doctor's office once a week to once every 2 weeks for a total of 8 weeks.

Exclusion Criteria:

* You are a woman and are pregnant or breastfeeding.
* You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
* You have a history of alcohol or drug dependence or abuse within the past 6 months.
* You are allergic to the study drug or you have experienced allergic reactions when taking several medications at once.
* You have a serious medical illness.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Trumbull
country: United States
state: Connecticut
city: Lafayette
country: United States
state: Indiana
city: Gaithersburg
country: United States
state: Maryland
city: Belmont
country: United States
state: Massachusetts
city: Omaha
country: United States
state: Nebraska
city: Albuquerque
country: United States
state: New Mexico
city: Staten Island
country: United States
state: New York
city: Salt Lake City
country: United States
state: Utah
city: Bellevue
country: United States
state: Washington
Study officials:
References:
citation: Wohlreich MM, Mallinckrodt CH, Prakash A, Watkin JG, Carter WP. Duloxetine for the treatment of major depressive disorder: safety and tolerability associated with dose escalation. Depress Anxiety. 2007;24(1):41-52. doi: 10.1002/da.20209.
Clinical trial NCT05687175: Translation and Validation of Malay Version of painDETECT Questionnaire
Official title: Study to Translate and Determine the Validity and Reliability of Malay Version of painDETECT Questionnaire (PDQ-M)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropathic Pain, Nociceptive Pain
Lead sponsor: University Malaysia Sarawak
Sponsor class: OTHER
Collaborators: name: Persatuan Diabetes Malaysia
First posted: 2023-01-18
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have been diagnosed to have neuropathic or nociceptive pain by clinicians, with stable disease condition and pain duration of at least 4 weeks prior to recruitment.

Brief summary: The translation and cultural adaptation process of the English version of PDQ will be performed based on international guidelines. Subsequently, patients with neuropathic and nociceptive pain based on clinician's diagnoses will be recruited to complete three-type numeric rating scale (NRS) of pain followed by PDQ-M and SF-36 questionnaire. Patients' socio-demographic data and clinical characteristics will be reported using frequency for categorical variables and mean with standard deviation for continuous variables. Normality will be assessed using Shapiro Wilk test and histograms for continuous variables. Data will be compared between groups using chi-square test (for categorical variables) and t-test or Mann-Whitney's U test (for continuous variables). Suitability of PDQ-M data for factor analysis will be verified using the Bartlett's test of sphericity and the Kaiser-Mayer-Olkin (KMO) measure of sampling adequacy. Parallel analysis will performed to obtain the suitable factors. Construct validity will be investigated by exploratory factorial analysis (EFA) with varimax rotation. A factor loading of \>0.40 will be used to determine the items for each factor. The internal consistency of the questionnaire will be assessed using Cronbach's alpha test. A p value of \<0.05 is taken as statistically significant.


Eligibility criteria: Inclusion Criteria:

* able to read and understand the Malay language
* diagnosed to have neuropathic or nociceptive pain by clinician
* stable disease condition
* pain duration of at least 4 weeks

Exclusion Criteria:

* acute illness
* poor mental health status that prevents them from understanding or responding to the proposed questions
* cultural or language barrier

Primary outcomes:
measure: PDQ-M scores
timeFrame: 2-5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pulau Pinang
country: Malaysia
facility: Penang General Hospital
state: Penang
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Melaka
country: Malaysia
facility: Malacca General Hospital
city: Putrajaya
country: Malaysia
facility: Putrajaya Hospital
Study officials:
References:
Clinical trial NCT01068275: Lumbar Plexus Catheter Versus Femoral Nerve Catheter for Postoperative Pain After Anterior Cruciate Ligament (ACL) Repair
Official title: Lumbar Plexus Catheter Versus Femoral Nerve Catheter Versus Single-shot Femoral Block for Postoperative Pain Control After Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Keywords: anterior cruciate ligament
pain, postoperative
peripheral nerve catheter
nerve block
Children undergoing anterior cruciate ligament repair
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2010-02-12
Enrollment: 114
Sex: ALL
Minimum age (years): 11
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized trial comparing lumbar plexus catheter versus femoral nerve catheter (single-shot femoral block as control group) for postoperative pain control after anterior cruciate ligament repair in children (age 11-21). Primary outcome is pain scores for the first 72 hours. Secondary outcomes include opioid consumption, incidence of opioid side effects and quality of recovery (previously validated scale). Our hypothesis is that lumbar plexus catheter will provide superior pain control and overall quality of recovery compared to femoral nerve catheters.


Eligibility criteria: Inclusion Criteria:

* ASA physical status 1-2
* Age 11-21
* Undergoing anterior cruciate ligament repair

Exclusion Criteria:

* Patient refusal
* Coagulopathy
* Systemic infection or infection at needle insertion site
* Allergy to ropivacaine or opioids
* Taking chronic opioids
* Unavailable by phone

Primary outcomes:
measure: Postoperative pain scores
timeFrame: 72 hours
Secondary outcomes:
measure: Quality of recovery
timeFrame: 72 hours
measure: Opioid consumption
timeFrame: 72 hours
measure: Opioid side effects
timeFrame: 72 hours
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Felicia M Birch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06276075: The Impact of Erigo®Pro Therapy and Motor Imagery on the Balance of Stroke Patients.
Official title: The Influence of Therapy Enriched With the Erigo®Pro Table and Motor Imagery on the Body Balance of Patients After Stroke - a Randomized Observational Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke,
motor imaging,
Erigo®Pro tilt table,
balance,
physiotherapy
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 66
Sex: ALL
Minimum age (years): 38
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to examine the impact of motor imagery, Erigo®Pro tilt table intervention, and classic rehabilitation on the balance of people after a stroke.

Detailed description: DESIGN: randomized observational study. SETTING: A hospital Rehabilitation Department. POPULATION: Sixty-six post-stroke patients mean, 64.85 ± 18.62 years. METHODS: 66 stroke patients were randomly assigned to three groups (22 people each) with different therapies (conventional, with the addition of Erigo®Pro and enriched with motor imagery). The therapy duration was two weeks. Patients underwent assessment before and after completion of therapy. The study used the Trunk Stability Test, Berg Balance Scale to assess balance, as well as the Riablo device to measure static balance. Additionally, an evaluation of the superficial tension of the transverse abdominis and multifidus muscles was conducted.

Eligibility criteria: Inclusion Criteria:

1) patients 6-8 weeks post-stroke, 2) aged 38-85 years, mean, 3) males and females, 4) walking with or without assistance (modified Rankin scale = 3), 5) with slight neurological deficits (NIHSS ≤7).

Exclusion Criteria:

1) stroke up to six weeks after the episode, 2) epilepsy, 3) no possibility to sit and stand, 4) persistent deficit of speech and cognitive functions, lack of attention, 5) visual disturbances, 6) depression, 7) high or very low blood pressure, dizziness, malaise.

Primary outcomes:
measure: Trunk Control Test
timeFrame: two weeks
measure: Berg Balance Scale
timeFrame: two weeks
measure: RiabloTM device
timeFrame: two weeks
measure: RiabloTM device
timeFrame: two weeks
measure: Luna EMG
timeFrame: two weeks
measure: Luna EMG
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Military Institute of Medicine
state: Masovian District
Study officials:
affiliation: Military Institute of Medicine, Rehabilitation Clinic
name: Anna M Olczak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02559375: PAIN-LESS: Understanding and Alleviating Pain for Cancer Patients in Academic and Community Hospitals
Official title: PAIN-LESS: Understanding and Alleviating Pain for Cancer Patients in Academic and Community Hospitals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 466
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cancer Patients

Brief summary: This study will increase knowledge of patient preferences for pain treatments, and improve the ability to meet patients pain management needs. This study will assess patient attitudes towards underutilized treatments and identify technologies to increase awareness of such treatments. This study also demonstrate the feasibility of using the Penn Cancer Network in future clinical and cancer control research and better understand how to effectively raise patients awareness of supportive cancer services.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older; Have a primary diagnosis of cancer;
* Have a Karnofsky functional score of 60 or greater (i.e. ambulatory);
* Understand written English;
* Verbally indicate to the RA/RN that they feel physically well enough to complete a survey at the time of approach;
* Report experiencing nonzero pain (on a scale of 0-10) in the last seven days

Exclusion Criteria:

* An inability to understand the requirements of the survey

Primary outcomes:
measure: Number of subjects providing completed surveys
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Jun Mao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02405975: RCT Assessing the Impact of Online Training on Doctors' Prescribing for Older Patients
Official title: A Randomized Controlled Trial Assessing the Impact of an Online Educational Tool on Doctors' Knowledge and Confidence With Regards to Prescribing for Older Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Appropriateness of Prescribing in Older Patients
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2015-04-01
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study will assess, by means of a randomized controlled trial, the impact of an online educational tool, on doctors' knowledge and confidence with regards to prescribing for older patients.

Detailed description: Both control and intervention groups will complete assessments at baseline, 4 weeks post intervention and 8 weeks post intervention.

Differences in mean test scores will be the primary outcome measure.

Qualitative information exploring doctors' attitudes and confidence, pre and post intervention will also be collected and will be a secondary outcome

Eligibility criteria: Inclusion Criteria:

* Registered non-consultant hospital doctor working in one of the hospitals approved by the ethics board

Exclusion Criteria:

* Currently working as a consultant
* Having previously worked as a pharmacist

Primary outcomes:
measure: Difference in mean test scores
timeFrame: At baseline, 4 weeks post intervention and 8 weeks post intervention
Secondary outcomes:
measure: Doctors' confidence with regards to prescribing for older patients
timeFrame: At baseline, 4 weeks post intervention and 8 weeks post intervention
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Hospital
Study officials:
affiliation: University College Cork
name: Shane Cullinan, BPharm
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cullinan S, O'Mahony D, Byrne S. Use of an e-Learning Educational Module to Better Equip Doctors to Prescribe for Older Patients: A Randomised Controlled Trial. Drugs Aging. 2017 May;34(5):367-374. doi: 10.1007/s40266-017-0451-0.
Clinical trial NCT00634075: Clinical Assessment of Fish Oil-based Lipid Emulsion Infusions in Critical Patients With Severe Sepsis
Official title: Clinical Assessment of Fish Oil-based Lipid Emulsion Infusions in Critical Patients With Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Severe Sepsis
Keywords: Severe sepsis
Proinflammatory cytokines
ICU
Lead sponsor: Li Shin Hospital
Sponsor class: OTHER
First posted: 2008-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a fish oil-based lipid emulsion, enriched with ω-3 fatty acids, reduce proinflammatory cytokines and mortality rate in critically ill patients with severe sepsis.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to Li Shin Hospital's ICU with a main diagnosis of severe sepsis.

Exclusion Criteria:

* Age of ﹤15 years
* Pregnancy
* Patients treated with immunosuppressive drugs or the equivalent of hydrocortisone more than 300 mg daily
* Plasma triglyceride concentration of more than 400 mg/dl
* Infection with human immunodeficiency virus
* Anticipated rapid fatality from irreversible underlying disease or malignancy
* Severe hemorrhagic disorders
* Acute myocardial infarction
* Recent stroke (within 3 month)
* Suspected or proven pulmonary embolism
* Cirrhotic liver and/or acute hepatitis ( elevation of serum GOT or GPT \> 5 times of normal upper limit)
* Chronic renal failure (Cr \>3.5 mg/dl upon admission) or end stage of renal diseases
* Allergic reactions against fish or egg proteins.

Primary outcomes:
measure: All cause mortality
timeFrame: mortality rate on days 7 and 28.
Secondary outcomes:
measure: Lengths of ICU and hospital stay. Duration of mechanic ventilator requirement. Serial changing APACHE II and SOFA score. Changing of TNF-α, IL- 1β, IL-6, IL-8, and IL-10 levels. Incidence of hospital-acquired infection.
timeFrame: Days 0, 1, 3, 5, 7, 14 and 28.
Other outcomes:
Locations:
city: Pingjen
country: Taiwan
facility: Li Shin Hospital
state: Taoyuan County
Study officials:
affiliation: Department of Emergency & Critical Care Medicine, Li Shin Hospital
name: Boon-Siang Khor, MD
role: PRINCIPAL_INVESTIGATOR
References: