louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06237413: A Study of ZG2001 in Participants With KRAS Mutated Advanced Solid Tumours
Official title: A Phase I/II Dose Escalation Study to Evaluating the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG2001 Tosilate Tablets in Participants With KRAS Mutated Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Solid Tumor
KRAS Mutation-Related Tumors
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-02-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the tolerability, safety, effects, and pharmacokinetics of ZG2001 in Participants with advanced solid tumors that have a KRAS mutation.


Eligibility criteria: Inclusion Criteria:

* Participants who fully understood this study and voluntarily signed the informed consent form;
* Men or women ≥ 18 years old;
* Participants with a KRAS mutant solid tumor should have progressed on or are ineligible for all therapy(ies) known to confer clinical benefit.
* ECOG Performance Status (PS) 0 or 1;
* Life expectancy \> 3 months.

Exclusion Criteria:

* Received any SOS1 inhibitors;
* Participants with a known history of hypersensitivity reactions to the ingredients of the preparations used in this study;
* Other conditions that the investigator considers to be unsuitable for participation in this study.

Primary outcomes:
measure: Dose Limiting Toxicity (DLT)
timeFrame: Up to 21 Days
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Up to 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
name: Jason Wu
role: STUDY_CHAIR
References:
Clinical trial NCT01651013: Observational Study on Treatment of Metastatic Colorectal Cancer and the Role of K-Ras
Official title: Multicentered Observational Prospective Cohort Study on the Treatment of Metastatic Colorectal Cancer and the Role of Evaluating K-Ras
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Colorectal Cancer
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2012-07-26
Enrollment: 500
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: Patients at participating Institutes who are candidate for first-line treatment of metastatic colorectal cancer

Brief summary: The purpose of this study is to describe the treatments received and outcomes of patients with metastatic colorectal cancer, what percentage of these patients have K-Ras mutation of the tumor, and to describe the costs of treatments. Information will also be collected regarding risk factors, variables among treatment centers and patients, and explorative analyses will be done to try to identify factors that impact prognosis and factors that predict tolerability and response to treatment.


Eligibility criteria: Inclusion Criteria:

* Histologic diagnosis colorectal carcinoma
* Metastatic disease
* Signed informed consent

Exclusion Criteria:

* Prior treatment of metastatic colorectal cancer
* Refusal or incapability of providing informed consent

Primary outcomes:
measure: percentage of patients enrolled in a clinical trial
timeFrame: two years
measure: percentage of patients who undergo K-Ras mutation study
timeFrame: 2 years
measure: Percentage of patients with K-Ras mutation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
measure: metastatic colorectal cancer treatments used in clinical practice, according to participating center
timeFrame: 2 years
measure: patient outcome according to K-Ras status
timeFrame: two years
measure: estimated costs per treatment per center
timeFrame: 2 years
measure: disease outcome per patient per treatment received
timeFrame: 2 years
measure: factors that influence patient prognosis
timeFrame: 2 years
measure: predictive factors for response to treatment
timeFrame: 5 years
Locations:
city: Benevento
country: Italy
facility: A.O.G. Rummo
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico
city: Nocera Inferiore
country: Italy
facility: Ospedale Civile Umberto I
city: Rionero in Vulture
country: Italy
facility: C:R.O. Regione Basilicata Ospedale Giustino Fortunato
Study officials:
affiliation: National Cancer Institute, Naples
name: R. V. Iaffaioli, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: G. Nasti, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: M. C. Piccirillo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06826313: A Study of Intravenous VRT106 for Locally Advanced or Metastatic Solid Tumors
Official title: An Open-labeled Phase I Clinical Trial Evaluating the Safety, Tolerability, Biodistribution Characteristics, Biological EEffects, and Initial Efficacy of VRT106 for Injection in the Treatment of Locally Advanced/Metastatic Solid Tumors by Intravenous Administration
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Solid Tumors
Keywords: Solid Tumor
Oncolytic Virus
VRT106
Lead sponsor: Guangzhou Virotech Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Third Affiliated Hospital, Sun Yat-Sen University
First posted: 2025-02-13
Enrollment: 12
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: A Phase I Study of the Safety and Tolerability of VRT106 Administered Intravenously for Treatment of Patients With Locally Advanced or MetastaticSolid Tumors

Detailed description: To evaluate VRT106 for injection in patients with locally advanced/metastatic solid tumours for safety and tolerability, exploring the maximum tolerated dose (MTD)/maximum administered dose (MAD)/optimal bioavailable dose (OBD) and/or the recommended phase II clinical dose (RP2D) to provide a recommended dose for subsequent clinical trials.

Eligibility criteria: Inclusion Criteria:

1. Subjects voluntarily participate in the clinical study; fully understand and be informed about the study and sign the ICF; and are willing to follow and have the ability to complete all trial procedures.
2. Males and females are aged at 18-75 years (including borderline values) at the time of signing the ICF, male or female.
3. Subjects are histologically or cytologically confirmed to be intolerable or refractory to the standard systemic treatment.
4. Subjects have at least one measurable lesion.
5. ECOG score of 0 to 28 days prior to first dose of IMP.
6. An expected survival time of ≥ 12 weeks.
7. Have sufficient organ function.
8. Female patients of childbearing potential with a negative serum pregnancy test within 7 days prior to first dose of study drug.
9. Subjects of childbearing potential (males and females) agree to use effective birth control with their partner from signing informed consent to at least 90 days after the last dose.

Exclusion Criteria:

1. Subject has received any antitumor therapy within 4 weeks prior to the first dose of IMP.
2. Subject has previously received oncolytic virus or other gene drug therapy.
3. Subject has received treatment with other unlisted clinical investigational drugs/devices within 4 weeks prior to the first dose of IMP.
4. Subject is known to have an allergic reaction to any of the components of IMP.
5. Women who are breastfeeding.

Primary outcomes:
measure: Evaluate the safety and tolerability of escalating doses of VRT106 in Patients with advanced malignanttumors
timeFrame: About 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04352413: A Study of PLM60 in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First-Line Chemotherapy
Official title: An Open-label, Multi-center, Phase 2 Study of Liposome-entrapped Mitoxantrone Hydrochloride Injection (PLM60) in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First-Line Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open, multicenter phase II clinical study for PLM60. The primary aim of the study is to observe the initial efficacy of PLM60 in treatment of small cell lung cancer. The secondary aim is to explore the safety and PK characteristics of PLM60


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed diagnosis of SCLC;
2. Must have recurrence or progression after platinum-based first-line chemotherapy or chemoradiation therapy for the treatment of SCLC;
3. ECOG performance status 0\~2;
4. Measurable lesion according to RECIST v1.1;
5. Life expectancy ≥ 12 weeks;
6. Adequate organ function;
7. Signed informed consent from the patient.

Exclusion Criteria:

1. Radical surgical treatment for primary small cell lung cancer;
2. Any anti-tumor treatment received within 4 weeks before the first use of the study drug;
3. Untreated or symptomatic central nervous system (CNS) metastases;
4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
5. History of serious systemic diseases;
6. History of serious autoimmune diseases;
7. Those receiving treatment of adriamycin or other anthracyclines previously, with the total cumulative adriamycin (or adriamycin-equivalent) dose of \>360 mg/m2.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: Through study completion, an average of 2 year
Secondary outcomes:
measure: Duration of Response (DoR)
timeFrame: Through study completion, an average of 2 year
measure: Disease Control Rate (DCR)
timeFrame: Through study completion, an average of 2 year
measure: Progression Free Survival (PFS)
timeFrame: Through study completion, an average of 2 year
measure: Overall Survival (OS)
timeFrame: Through study completion, an average of 2 year
measure: Adverse Events
timeFrame: Through study completion, an average of 2 year
measure: Serious Adverse Events (SAEs)
timeFrame: Through study completion, an average of 2 year
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: Department of Medicine, CSPC Clinical Development Division
name: Kun Lou
role: STUDY_CHAIR
References:
Clinical trial NCT06493513: The Effect of 40 Hz Transcranial Stimulation on the Incidence of Emergence Delirium in Children
Official title: The Effect of 40 Hz Transcranial Stimulation on the Incidence of Emergence Delirium After Sevoflurane Anesthesia in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergence Delirium
Anesthesia
Children
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group: at the onset of anesthesia, the child received 40Hz transcranial stimulation for 1h.

Control group: at the start of anesthesia, the child did not receive any additional treatment.
Primary purpose: PREVENTION

Brief summary: Emergence delirium is a complex of perceptual deficits and psychomotor agitation most commonly seen in preschool children in the early post-anesthetic period. It increases the risk of bed falls, accidental catheter removal, surgical wound dehiscence, and delayed discharge in children. Exogenous 40 Hz stimulation can improve cognitive functioning. Therefore, the aim of this study was to explore the effect of 40Hz stimulation on the incidence of emergence delirium in children undergoing vascular malformation surgery under sevoflurane anesthesia.


Eligibility criteria: Inclusion Criteria:

1. Age 3-14 years old
2. ASA classification I or II
3. Proposed vascular malformation surgery under sevoflurane general anesthesia
4. Anesthesia duration\>1h
5. Obtaining informed consent

Exclusion Criteria:

1. Emergency surgery
2. Mental retardation
3. Neurological disorders with manic-like symptoms
4. Presence of severe kidney or liver disease, heart or respiratory disease
5. Autoimmune diseases
6. Vascular malformation of the head and face
7. Significant life changes in the 1 month prior to surgery

Primary outcomes:
measure: The incidence of emergence delirium
timeFrame: From extubation to 2 h after extubation and day 1, day 2, day 3 after surgery.
Secondary outcomes:
measure: The incidence of pain
timeFrame: Day 1, day 2, day 3 after surgery.
measure: The incidence of postoperative nausea and vomiting
timeFrame: Day 1, day 2, day 3 after surgery.
measure: Sleep quality
timeFrame: Day 1, day 2, day 3 after surgery.
Other outcomes:
Locations:
city: ZhengZhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
Study officials:
References:
Clinical trial NCT06180018: Modified TIP (Snodgrass) Using Interrupted Sutures in Hypospadias
Official title: Modified TIP (Snodgrass) Using Interrupted Sutures in Hypospadias
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypospadias
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 1
Sex: MALE
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Using interrupted sutures in TIP technique by Snodgrass in repair of hypospadias instead of continuous sutures


Eligibility criteria: Inclusion Criteria:

* Midshaft , distal ,
* coronal hypospadias

Exclusion Criteria:

-

Primary outcomes:
measure: Decreasing complications
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut
Study officials:
References:
Clinical trial NCT02606318: Adjusting Challenge-Skill Balance to Improve the Elderly's Quality of Life
Official title: Adjusting Challenge-Skill Balance to Improve the Elderly's Quality of Life: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Keywords: Occupational Therapy
Quality of Life
Lead sponsor: Harue Hospital
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 56
Sex: ALL
Minimum age (years): 62
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was to clarify the effects on health-related QOL of occupational therapy involving the adjustment of challenge-skill balance in the activity of elderly clients.

Detailed description: This study was single-blind, randomized controlled trial. Clients were randomly assigned by blocked randomization (block size 4) to either the experimental group (occupational therapy that included assessment and adjustment of the challenge-skill balance of the activities) or to the control group (occupational therapy as normally conducted at the day care center). Randomization was stratified by sex and EuroQol visual analogue scale, resulting in four layers. The primary outcome was change in health-related quality of life after 10 sessions of occupational therapy. Clients were assessed before the intervention (pre-test) and after the 10th session (post-test). Significant differences were observed in the EuroQol-5 Dimension (EQ-5D) score and in the Medical Outcome Study 8-Item Short-Form Health Survey (SF-8) scores for general health, physical functioning , and vitality.

Eligibility criteria: Inclusion Criteria:

* age \>60 years
* occupational therapy at the center for \>3 months

Exclusion Criteria:

* dementia
* visual impairment

Primary outcomes:
measure: Change in the EuroQol-5 Dimension questionnaire
timeFrame: Baseline and 10 weeks
measure: Change in the Medical Outcome Study 8-Item Short-Form Health Survey questionnaire
timeFrame: Baseline and 10 weeks
Secondary outcomes:
measure: Change in the Flow State Scale for Occupational Tasks questionnaire
timeFrame: Baseline and 10 weeks
measure: Change in the Canadian Occupational Performance Measure questionnaire
timeFrame: Baseline and 10 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Graduate School of Human Development and Environment
name: Tetsushi Nonaka, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010 Mar 24;8:18. doi: 10.1186/1741-7015-8-18.
citation: Hirao K, Kobayashi R, Okishima K, Tomokuni Y. Flow experience and health-related quality of life in community dwelling elderly Japanese. Nurs Health Sci. 2012 Mar;14(1):52-7. doi: 10.1111/j.1442-2018.2011.00663.x. Epub 2012 Jan 30.
Clinical trial NCT00097513: National Cooperative Growth Study (NCGS) of Optimal Nutropin AQ and Nutropin Dosing in Pubertal Growth Hormone-Deficient (GHD) Patients
Official title: National Cooperative Growth Study (NCGS) of Optimal Nutropin AQ and Nutropin Dosing in Pubertal Growth Hormone-Deficient (GHD) Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dwarfism, Pituitary
Keywords: Pubertal Growth Hormone Deficiency
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2004-11-25
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pubertal Growth Hormone Deficiency

Brief summary: This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech GH preparations to treat GH-deficient subjects with optimal GH dosing during puberty.


Eligibility criteria: Inclusion Criteria:

* Adolescent boys who are GH deficient and Tanner Stage 2 or greater (testes 3 mL or greater)
* Adolescent girls who are GH deficient and breast Tanner Stage 2 or greater
* Current treatment with GH dose of 0.4 to 0.7 mg/kg/wk
* Ability to keep follow-up appointments throughout the study
* Willingness to remain on therapy until epiphyseal closure is achieved
* Prior enrollment in NCGS Core Study 85-036

Exclusion Criteria:

* Treatment with non-Genentech GH preparation
* Closed epiphyses
* Active neoplasia
* Treatment with insulin for diabetes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: South San Francisco
country: United States
facility: Genentech Central Contact
state: California
Study officials:
affiliation: Genentech, Inc.
name: Barbara Lippe, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02206113: Sit to Stand Intervention for Allina Health Employees
Official title: A Sit-to-Stand Intervention for Allina Health Employees: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Quality of Life
Keywords: Standing workstation
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2014-08-01
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: A 16 week pilot study for Allina call center employees to look at the psychological outcomes and biological markers after an intervention of using a standing work station. There were two groups: group 1 received, and was instructed to use, the standing work station for all 16 weeks, group 2 was a wait-list control group and received, and was instructed to use, the standing work station for the second 8 weeks. Psychological outcomes were measured at weeks 0, 4, 8, 12, and 16. Biological markers were measured at weeks 0, 8, and 16.


Eligibility criteria: Inclusion Criteria:

* Allina Health Call Center Employee (75% or higher employee status)
* Aged 18 to 65 years
* Provide written informed consent

Exclusion Criteria:

* Unable to stand for 20 minutes continuously unaided
* Home based employees

Primary outcomes:
measure: Change in self-reported quality of life
timeFrame: Baseline, week 4, week 8, week 12, week 16
Secondary outcomes:
measure: Change in waist circumference
timeFrame: Baseline, Week 8, Week 16
measure: Change in number of minutes stood per day
timeFrame: Baseline, week 8, week 16
measure: Change in self-reported stress
timeFrame: Baseline, week 4, week 8, week 12, week 16
measure: Change in health promotion and lifestyle choices
timeFrame: Baseline, week 4, week 8, week 12, week 16
measure: Change in workplace productivity
timeFrame: Baseline, week 4, week 8, week 12, week 16
measure: Change in self-reported physical activity levels
timeFrame: Baseline, week 4, week 8, week 12, week 16
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline, Week 8, Week 16
measure: Change in body fat percentage
timeFrame: Baseline, week 8, week 16
measure: Change in resting heart rate
timeFrame: Baseline, week 8, week 16
measure: Change in blood pressure (systolic and diastolic)
timeFrame: Baseline, week 8, week 16
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Allina Health
state: Minnesota
Study officials:
affiliation: Allina Health
name: Jeffery Dusek, PhD
role: PRINCIPAL_INVESTIGATOR
References: