louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06927687: Study of ZG005 in Patients With Advanced Solid Tumors
Official title: A Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of ZG005 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Advanced Solid Tumor
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2025-04-15
Enrollment: 100
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: This is an open-label, multicenter, Phase II clinical trial, designed to evaluate the efficacy and safety of ZG005 in patients with advanced solid tumors who have previously failed or are intolerant to standard treatment.


Eligibility criteria: Inclusion Criteria:

* Fully understand the study and voluntarily sign the informed consent form.
* Male or female 18-75 years of age;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1;
* Life expectancy ≥ 12 weeks;
* Histologically or cytologically confirmed diagnosis of advanced solid tumors.

Exclusion Criteria:

* Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate that existence of the central nervous system(CNS) metastases;
* Any other malignancy within 5 years.

Primary outcomes:
measure: Objective response rate(ORR)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Adverse Event (AE)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
name: Jason Wu
role: STUDY_CHAIR
References:
Clinical trial NCT03658187: Assessment of the Acute Effect of IP
Official title: A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Assess the Acute Effect of IP on hGH Levels in Aging Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deficiency Growth Hormone
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2018-09-05
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is a nutraceutical system, consisting of oral tablet and an oral spray called Alpha GPC, which helps your body naturally restore the HGH levels.


Eligibility criteria: Inclusion Criteria:

* Males and females having age between 40-60 years (both inclusive)
* BMI ≥25 and ≤29.9 kg/m2
* FBS ≤ 120 mg/dl
* Serum hGH levels ≤0.94 ng/ml in females and ≤0.12 in males
* Thyroid Stimulating Hormone ≥ 0.35 and ≤ 5.55 mIU/ml

Exclusion Criteria:

* History of thyroid disorder (Hyper/Hypo).
* Smokers having at least 1 cigarette per day.
* Known hypersensitivity or allergy to one or more of the ingredients of the IP
* Participant suffering from primary or secondary insomnia with/without active treatment.
* Alcoholics as defined by consumption of more than 2 standard alcoholic drinks (more than 30 ml/ day) for past 3 months.

Primary outcomes:
measure: Change in the plasma human growth hormone (hGH) levels in aging individuals
timeFrame: Pre-dose: 0 hours and Post dose: 30, 60, 90,120 mins
Secondary outcomes:
measure: Change on Visual Analogue Score for Fatigue
timeFrame: From Day 0 to Day 1
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Vedic Lifesciences Pvt. Ltd
state: Opp Infinity Mall
Study officials:
affiliation: Vedic Lifesciences
name: Shalini Srivastava, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01622387: Radial Artery Versus Saphenous Vein Patency (RSVP) Trial - 10 Year Follow-up
Official title: Randomised, Controlled Trial Comparing Angiographic Patency of the Radial Artery Versus the Saphenous Vein Used as Free Aorto-coronary Grafts in Coronary Revascularisation (RSVP Trial) - 10-year Follow-up
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary artery bypass surgery
Arteries
Veins
Conduits
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During coronary bypass surgery, veins are taken from the leg and applied to the heart and aorta to 'bypass' narrowings in the coronary arteries. However using an artery in the chest, the internal mammary artery, means that the bypass lasts longer than using veins. The investigators recently showed that using an artery from the arm as a bypass vessel, the radial artery, also had less furring up than veins 5 years after surgery. Now the investigators would like to ask patients to come back for an angiogram 10 years following surgery.


Eligibility criteria: Inclusion Criteria:

* Included in the RSVP study
* Willing to attend for coronary angiography
* Willing to give written informed consent

Exclusion Criteria:

* Contraindication to coronary angiography
* participation in research project within previous 60 days
* unwilling to give written informed consent

Primary outcomes:
measure: Proportion of radial artery and saphenous vein grafts patent at 10 years
timeFrame: 10 years post surgery
Secondary outcomes:
measure: Angiographic visual grading
timeFrame: 10 years post surgery
measure: Patency (patent or complete occlusion, and secondary visual grading) of radial artery and internal mammary artery coronary bypass grafts
timeFrame: 10 years post surgery
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton & Harefield NHS Foundation Trust
Study officials:
affiliation: Imperial College London, and RBHFT
name: Peter Collins, MA, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Neil Moat, MD, FRCS
role: STUDY_DIRECTOR
References:
Clinical trial NCT05274087: Study to Evaluate the Effect of Different Warm-Up Times of Risankizumab Autoinjector (AI) on the Injection Pain Experiences in Healthy Volunteers
Official title: A Randomized, Double-Blind, Three-Period Crossover Study to Evaluate the Effect of Different Warm-Up Times of Risankizumab Autoinjector (AI) on the Injection Pain Experiences in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Risankizumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to assess the impact of different warm-up times of risankizumab autoinjector (AI) on the participant injection site pain experience in healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

- Body mass index (BMI) is \>= 18.0 to \<= 30.0 kg/m2.

Exclusion Criteria:

* Any findings in the medical examination that are deviating from normal and judged as clinically relevant by the investigator.
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
* Any evidence of a concomitant disease judged as clinically relevant by the investigator.
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, or psychiatric disease or disorder, or any other uncontrolled medical illness.

Primary outcomes:
measure: Change in Injection Site Pain Assessed Using Visual Analog Scale
timeFrame: Up to approximately 15 days
measure: Percentage of Participants Experiencing Adverse Events
timeFrame: Up to approximately 155 days
Secondary outcomes:
measure: Participant Rated Acceptability Assessed as Change in Self-Injection Assessment Questionnaire (SIAQ)
timeFrame: Up to approximately 15 days
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 223662
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05790187: Face Perception and Impact of Surgical Masks in Preterm Infants
Official title: Face Perception and Impact of Surgical Masks in Preterm Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Visual Preference With and Without Mask in Term Infant
Visual Preference With and Without Mask in Preterm Infant
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Laboratoire de Psychologie et NeuroCognition
First posted: 2023-03-30
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The preferences to masked and unmasked faces is relevant for premature newborns, since Covid-19, most of the faces that surround them during their hospitalization are masked. The Premask project is a continuation of the InfantMask and BabyMask studies (concerning infant and newborn), by studying the visual preferences to masked and unmasked faces of premature newborns.


Eligibility criteria: Inclusion Criteria:

* All preterm infants born before 32SA arriving at term (at≥37SA) hospitalized in the neonatology department of the pediatric hospital of Grenoble and approaching discharge will be included.

Of the potential participants meeting the inclusion criteria, those with at least 1 of the following exclusion criteria will not be eligible for inclusion in the study.

Exclusion Criteria:

* Parents not fluent in French
* Parents with no social security rights
* Patient with a syndromic disorder
* Abnormal neurological examination Invasive or non-invasive ventilation at the time of testing of babies requiring, at the time of testing at ≥37SA, non-invasive or invasive ventilatory support as well as labeled syndromic or ophthalmologic disease of prematurity (retinopathies).
* Infection requiring isolation
* Ophthalmologic impairment of prematurity (retinopathy)

Primary outcomes:
measure: proportion of visual fixation time to photos of masked/non-masked faces.
timeFrame: once, at term (at 37 weeks corrected age)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01556087: Distress Tolerance and Buprenorphine
Official title: Distress Tolerance and Reducing Early Relapse in Buprenorphine Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid Dependence
Keywords: opioids
distress tolerance
buprenorphine
Lead sponsor: Butler Hospital
Sponsor class: OTHER
First posted: 2012-03-16
Enrollment: 59
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: The investigators propose that inability to tolerate the distress of opioid withdrawal and the negative affect associated with early abstinence are key factors in early illicit opioid lapse and subsequent buprenorphine treatment drop-out. Our intervention aimed at increasing distress tolerance is designed to increase treatment adherence.


Eligibility criteria: Inclusion Criteria:

* initiating buprenorphine treatment (which requires meeting current criteria for a DSM-IV diagnosis of opioid dependence)
* plan to remain on buprenorphine for at least three months
* age between 18 and 65 years
* if female of childbearing potential -- must be using adequate contraception (an intrauterine device, oral contraceptive, depot contraceptive, a barrier method "every time," or hysterectomy) as assessed by the study physician
* has at least two persons they regularly contact and can provide contact information for them
* speaks English sufficiently to understand instructions and assessments.

Exclusion Criteria:

* current methadone maintenance treatment program participation
* medically necessary prescription opioid treatment (e.g., for chronic pain)
* current criteria for a DSM-IV diagnosis of substance dependence for sedative/hypnotic drugs, alcohol, stimulants, cocaine, inhalants, hallucinogens
* a diagnosis of organic brain disorder, bipolar disorder, schizophrenia, schizo-affective, schizophreniform, or paranoid disorder, or major depression (subjects who meet criteria for "substance-induced mood disorder," or dysthymia only will not be excluded)
* current suicidality on the Modified Scale for Suicidal Ideation
* use of daily psychotropic, antidepressant, or anxiolytic medication
* evidence of neuropsychological dysfunction as assessed by the study physician with confirmation with the Folstein Mini-Mental Status Examination
* anticipated major painful event (significant surgical procedure) in the coming 6 months
* probation/parole requirements that might interfere with protocol participation
* history of allergic reaction to buprenorphine or naloxone.

Primary outcomes:
measure: the Client Satisfaction Questionnaire-8
timeFrame: 4 months
measure: buprenorphine treatment adherence
timeFrame: 4 months
Secondary outcomes:
measure: distress tolerance persistence
timeFrame: 4 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT02848287: Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Children
Official title: Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Preschool-aged Children Undergoing Adenotonsillectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tonsillitis
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 84
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Emergence agitation (EA) is highly prevalent in children after surgery. Risk factors for EA are Eye, nose and throat (ENT) surgery, preoperative anxiety, postoperative pain. There are several preventive strategies but none of them completely prevent EA.

Topical application of ropivacaine can reduce post-tonsillectomy pain. Therefore, it might reduce the incidence of postoperative EA.


Eligibility criteria: Inclusion Criteria:

* American Society of anesthesiologist physical status class I/II
* tonsillectomy or adenotonsillectomy under general anesthesia

Exclusion Criteria:

* obstructive sleep apnea
* developmental delay attention deficit hyperactivity disorder, allergy to local anesthetics, convulsion disorder

Primary outcomes:
measure: Paediatric anesthesia emergence delirium scale (PAED) score at PACU admission
timeFrame: 1 min after postanesthesia care unit (PACU) admission
Secondary outcomes:
measure: Face legs activity cry consolability (FLACC) score
timeFrame: 1 min after postanesthesia care unit (PACU) admission
measure: PAED score 10 min after PACU admission
timeFrame: 10 min after postanesthesia care unit (PACU) admission
measure: PAED score 20 min after PACU admission
timeFrame: 20 min after postanesthesia care unit (PACU) admission
measure: PAED score 30 min after PACU admission
timeFrame: 30 min after postanesthesia care unit (PACU) admission
measure: FLACC score 10 min after PACU admission
timeFrame: 10 min after postanesthesia care unit (PACU) admission
measure: FLACC score 20 min after PACU admission
timeFrame: 20 min after postanesthesia care unit (PACU) admission
measure: FLACC score 30 min after PACU admission
timeFrame: 30 min after postanesthesia care unit (PACU) admission
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05170087: Radiomic Analysis for Predicting Treatment Response and Clinical Outcomes in Malignancies
Official title: Radiomic Analysis of CT and MRI Scans for Predicting Treatment Response and Clinical Outcomes in Patients With Breast, Brain, Head-neck and Gynecological Malignancies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Head and Neck Cancer
Brain Cancer
Gynecologic Cancer
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2021-12-27
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those treated with radiation at Odette Cancer Centre between 2010 and 2019 after being diagnosed with a breast, brain, head and neck, or gynecological malignancy.

Brief summary: In this study, the investigators aim to undertake a retrospective analysis of CT and MRI scans for patients undergoing radiation treatment to develop radiomic signatures to predict treatment response and clinical outcomes.

Detailed description: Imaging in oncology has widespread application with modalities like ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET) having a well-established role particularly in diagnosis, staging, assessment of treatment response, and surveillance. With the applications of radiomics in oncology, the potential of imaging as a non-invasive biomarker in treatment response, as well as genotypic characterization, has been recognized. Radiomics has the potential to tailor way towards precision oncology with the development of biomarkers that can guide personalized treatments. In this study, the investigators aim at developing CT and MRI radiomic signatures as potential biomarkers to predict treatment response and clinical outcomes for patients treated with radiation having breast, brain, head and neck, and gynecological malignancies.

Eligibility criteria: Inclusion Criteria:

* Breast, head and neck, brain, and gynecological malignancies
* Treated with radiation at Odette Cancer Centre between 2010 and 2019

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Development of imaging biomarkers in predicting treatment response for breast, brain, head-neck, and gynecological malignancies
timeFrame: 1 year
measure: Development of imaging biomarkers in predicting clinical outcomes (survival/toxicity) for breast, brain, head-neck, and gynecological malignancies
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Gregory Czarnota, Ph.D. M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01047787: Breathing Disorders in Patients With Congestive Heart Failure
Official title: Breathing Disorders in Patients With Congestive Heart Failure: Gender and Mortality Impact
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congestive Heart Failure
Keywords: Sleep apnea
Cheyne-Stokes Respiration
Congestive Heart Failure
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-01-13
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with CHF recruited from the outpatient Heart Failure Unit of the Heart Institute (Instituto do Coraçao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo)

Brief summary: The investigators prospectively evaluated 89 consecutive outpatients (29 female) with stable congestive heart failure. The presence of sleep disordered breathing (SDB) and Cheyne-Stokes respiration (CSR) while awake were investigated by overnight polysomnography. Males and females were similar in age, body mass index, and LVEF. Prevalence of SDB was higher in males than females. During follow up of 25±10 months, 27% of the population died. Nonsurvivors had lower LVEF (p=0.01), worse NYHA class (p=0.03) a higher proportion of CSR-awake (p\<0.001) than survivors.

Detailed description: Bakground: There is little information in sleep disordered breathing (SDB) in women with congestive heart failure (CHF). We studied consecutive CHF patients in order to compare SDB characteristics according to gender, and to determine overall mortality impact of SDB and Cheyne-Stokes respiration (CSR) while awake.

Methods: Eighty nine consecutive outpatients (29 female) with stable CHF (LVEF\<45%) were prospectively evaluated. The presence of SDB, as characterized by obstructive sleep apnea (OSA) and CSR during sleep, as well as CSR while awake before sleep onset, were investigated by overnight polysomnography.

Eligibility criteria: Inclusion Criteria:

* Patients with resting left ventricular ejection fraction (LVEF) of less than 45% as determined by echocardiography;
* Stable clinical condition as defined by no changes in drug therapy for at least one month before evaluation.

Exclusion Criteria:

* Patients with neurological, pulmonary, renal, musculoskeletal disease, unstable angina, primary valvular heart disease or previous diagnosis of sleep disordered breathing.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Rogerio S Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01635387: RAAS Inhibitor Drugs in Dialysis Patients
Official title: Upstream Use of Aliskiren in Hypertensive Haemodialysis Patients: Effects on Cardiovascular Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
End Stage Renal Disease
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
Collaborators: name: IRCCS San Raffaele
First posted: 2012-07-09
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypertensive haemodialysis patients are at high risk for cardiovascular events. This study was undertaken to ascertain whether the upstream of aliskirne, a direct renin inhibitor improves mortality and cardiovascular outcomes in these high-risk population.


Eligibility criteria: Inclusion Criteria:

* chronic kidney disease stage 5
* undergoing maintenance haemodialysis for a minimum of 3 months
* existing arterial hypertension or
* history of arterial hypertension or
* resting blood pressure ≥140/90 mmHg or
* antihypertensive medication
* man and female
* 18 years and older.

Exclusion Criteria:

* recent myocardial infarction (less than 3 months)
* atrial fibrillation/atrial flutter
* hypotension with systolic blood pressure of \<90 mmHg
* high-grade aortic stenosis
* left ventricular ejection fration \<50%
* known allergy to aliskiren
* severe disorders of liver function

Primary outcomes:
measure: time to first clinical event (among mortality from any cause, cardiac event including myocardial infarction, need for coronary angioplasty or coronary bypass surgery, ischaemic stroke, new-onset heart failure, new-onset atrial fibrillation)
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: