louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02489201: A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer
Official title: A Phase 1B Study of Donafenib Monotherapy in Advanced Oesophageal Cancer Progressing After Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Oesophageal Cancer
Keywords: donafenib
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2015-07-02
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label, one-center, noncomparative, two-stages phase 1B trial assessed the tyrosine kinase inhibitor donafenib tosylate tablets(400 mg/d,200mg bid) in patients with advanced, inoperable oesophageal cancer progressing after chemotherapy .

The primary endpoint is the safety.The secondary endpoints are tumor response and progression-free survival.

Detailed description: This open-label, noncomparative, two-part phase 1B trial recruited patients with advanced, inoperable oesophageal cancer. The primary objectives were to assess the safety for donafenib tosylate tablets .The secondary objectives were to estimate tumor response, progression-free survival, duration of response, and disease control rate (response plus stable disease); to evaluate changes in quality of life(QoL); This study is 2-stages designing. The investigators plan to enroll 19 patients in the first stage study. The investigators will start the secondary stage study if the disease control rate \>=8/19.

Eligibility criteria: Inclusion Criteria:

* All patients provided written, informed consent.
* Have histologically confirmed advanced oesophageal squamous-cell carcinoma, or type I/II Siewert junctional tumours.
* Have received up to two previous chemotherapy regimens( Platinum containing regimens \& Paclitaxel / docetaxel containing regimens).
* Have an Eastern Cooperative Oncology Group Performance status of 0-1.
* Have ability to swallow tablets.
* no contraindications to sorafenib or donafenib.
* Have either measurable or evaluable lesion on CT.

Exclusion Criteria:

* Patients with brain metastases.
* Patients receiving cytotoxic chemotherapy, immunotherapy or hormonal therapy, radiotherapy to site of measurable or evaluable disease within the previous 4 weeks.
* Patients had evidence of clinically active interstitial lung disease or abnormal blood results by predefined criteria (serum bilirubin \>1.5 times upper limit of reference range, aspartate or alanine aminotransferase\>2.5 times the upper limit of normal if no demonstrable liver disease) .

Primary outcomes:
measure: Number of participants with Adverse Events
timeFrame: 54 weeks
Secondary outcomes:
measure: Tumor response
timeFrame: 54 weeks
measure: Progression-free survival
timeFrame: 54 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Affiliated Cancer Center of Academy of Military Medical Sciences
Study officials:
affiliation: The Affiliated Hospital of Military Medical Science
name: Jianming Xu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05956301: Effects of Different Ventilatory Strategy During Bronchoscopy
Official title: Effects of Different Ventilatory Strategy During Bronchoscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bronchoscopy
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The execution of diagnostic-therapeutic investigations by bronchial endoscopy can expose the patient to hypoxemia. For this reason, oxygen therapy is administered at low or high flows during the course of bronchoscopic procedures.

Our study aim was to evaluate the efficacy and complications of High-flow nasal oxygen (HFNO) via Supraglottic jet oxygenation and ventilation (SJOV)during flexible bronchoscopy.


Eligibility criteria: Inclusion Criteria:

* need for bronchial endoscopy

Exclusion Criteria:

* life-threatening cardiac aritmia or acute miocardical infarction within 6 weeks need for invasive or non invasive ventilation presence of pneumothorax or pulmonary enphisema or bullae recent (within 1 week) thoracic surgery presence of chest burns presence of tracheostomy pregnancy nasal or nasopharyngeal diseases dementia lack of consent or its withdrawal

Primary outcomes:
measure: Compare the intraoperative oxygenation.
timeFrame: During bronchoscopy, an average of 0.5 hour.
Secondary outcomes:
measure: Arterial blood gases
timeFrame: At end of of bronchoscopy,an average of 0.5 hour after bronchoscope insertion.
measure: Assess the regional ventilation distribution by Electrical impedance tomography .
timeFrame: During bronchoscopy, an average of 0.5 hour.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05728801: Decoding the Cognitive Trajectory of Hong Kong SuperAgers: a Longitudinal Follow-up Study
Official title: Decoding the Cognitive Trajectory of Hong Kong SuperAgers: a Longitudinal Follow-up Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Age-related Cognitive Decline
Cognitive Deterioration
Dementia, Mild
Keywords: Cognitive maintenance
Cognitive ageing
Superagers
Cognition
Quality of life
Brain health
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 400
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High-performing elderly (SuperAgers) and the cases with normal ageing and neurocognitive disorder (NCD) will be re-invited in this study.

Brief summary: This is a prospective follow-up study conducted at the Department of Psychiatry, The Chinese University of Hong Kong. The participants, including high-performing elderly (SuperAgers), normal ageing elderly and neurocognitive disorder (NCD) patients will be re-invited from our previous cohort (2013-2014) (N=488).

Detailed description: Objectives: This study aims to investigate the cognitive changes in older adults with different cognitive statuses.

Eligibility criteria: Inclusion Criteria:

* SuperAgers are determined by the scores of global cognitive function. This ensured that the participants are divided by a measure relevant to the current study without directly biasing the results toward the domain of interest;
* Normal aging: the cases with the scores of cognitive performance within 1.5 standard deviation (SD) of age and education matched normative values derived from our cohort study, of which presented with HK MoCA score greater than 26 and CDR score equal to 0;
* NCD patients are deﬁned as: evidence of modest decline in one or more cognitive domains, which is set as ≥ 1.5 SD below the age- and education-adjusted normative scores; no interference with independence in everyday activities; and no comorbid major psychiatric disorders.

Exclusion Criteria:

* History of bipolar disorders or psychosis;
* History of major neurological deﬁcits including stroke, transient ischemic attack or traumatic brain injury;
* Comorbidities with depressive symptoms.

Primary outcomes:
measure: Global cognition will be measured by the Montreal Cognitive Assessment Hong Kong version (HK MoCA)
timeFrame: 2022-2024
measure: Complex attention will be measured by Attention Network Test (ANT)
timeFrame: 2022-2024
Secondary outcomes:
measure: Learning and memory will be measured by Word list learning test (WLLT)
timeFrame: 2022-2024
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Tai Po Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Hanna LU, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06273501: MRI and Magnetometer-guided Sentinel Lymph Node Detection in Vulvar Cancer
Official title: Preoperative MRI and Magnetometer-guided Intraoperative Sentinel Lymph Node Detection With Superparamagnetic Iron Oxide Nanoparticles (SPIO) in Patients With Vulvar Cancer - a Feasibility Study (POSVUC Pilot)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Vulvar Cancer
Lymph Node Metastasis
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the feasibility study is to evaluate whether SPIO-MRI and a magnetometer could be a potential substitute to the routine dual technique in pre-and intraoperative SLN localization. Secondary, to explore if SPIO-MRI could predict lymph node status in comparison to histopathological analysis.

Detailed description: Sentinel lymph node (SLN) biopsy is the routine procedure for nodal staging in early vulvar squamous cell carcinoma (VSCC) in the absence of clinical signs of lymph node metastasis. The gold standard technique for identifying SLN utilizes Technetium (Tc99m) lymphoscintigraphy and blue dye. An alternative method has emerged using superparamagnetic iron-oxide (SPIO) and magnetic resonance imaging (MRI).

This study aims to enroll 20 VSCC patients scheduled for the SLN procedure. Determination of the minimal dosage of SPIO required to avoid excessive MRI artifacts while still identifying the SLN. Intraoperative SLN detection with a magnetometer will be compared with the gold standard gamma probe.

As secondary objective, in addition to determining the SNL, MRI analysis of the nodal status will be evaluated for potential metastasis and compared to histopathological results.

Eligibility criteria: Inclusion Criteria:

Histologically confirmed primary VSCC \<4 cm, candidates for surgery with SLNB Age above 18

Signed and dated written consent before the start of specific protocol procedures.

ECOG performance status 0-2

Exclusion Criteria:

Contraindications for MRI such as electronic implants or severe claustrophobia

Hip replacement

Iron overload disease 4. Known hypersensitivity to iron or dextran compounds

Inability to understand given information and give informed consent or undergo study procedure

Primary outcomes:
measure: Sentinel lymph node identification
timeFrame: Within 30 days after SPIO injection.
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Department of Obstetrics and gynecology
Study officials:
affiliation: Department of radiology, Sahlgrenska University Hospital
name: Henrik Leonhardt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01657201: Study to Evaluate the Pharmacokinetic Properties of SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend)
Official title: A Randomized, Open-label, Two-Treatment, Two-Period, Two-Sequence, Cross-over Study to Evaluate the Pharmacokinetic Properties of SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend) in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Systemic Mycotic Infection
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2012-08-06
Enrollment: 59
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetic properties and safety of SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend).


Eligibility criteria: Inclusion Criteria:

* Healthy adults 20-45 years of age
* Weight of ≥ 60kg ≤ 90kg with BMI of ≥ 19 and \< 27 (BMI(kg/m2)= weight(kg)/{height(m)}2
* Voluntary written informed consent

Exclusion Criteria:

* History or presence of significant renal, neurologic, pulmonary, endocrine, hematology, oncology, urologic, cardiovascular, musculoskeletal or psychiatric disease
* Drug allergies to Voriconazole
* Recent history or evidence of drug abuse
* Recent participation(within 2 months) in other clinical studies
* Recent donation of blood(within 2months), plasma(within 1month) or transfusion(within 1month)

Primary outcomes:
measure: Pharmacokinetics parameters
timeFrame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h
Secondary outcomes:
measure: Pharmacokinetics parameters
timeFrame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h
measure: Safety
timeFrame: 16 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Research Institute, Seoul National University Hospital
Study officials:
References:
Clinical trial NCT00788801: Exploratory Positron Emission Tomography (PET) Study to Evaluate the Effects of ABT-614 on [11C]-(+)-PHNO Binding Potential to D3 Receptors in the Brain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-11-11
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is being done in healthy volunteers to help researchers understand how ABT-614 works in the human body, specifically in the brain. The PET imaging technique can be thought of as a way to take pictures of chemical changes in the brain. To take a PET scan (picture), a substance with low levels of radioactivity (radiotracer) has to be injected when you are in the PET camera. The radiotracer is only radioactive for a short period of time. In this study, PET is being used to measure how the study drug attaches to specific receptors in the brain. The radiotracer used in this study, \[11C\]-(+)-PHNO, is currently being used for studies in people at the CAMH PET Centre.


Eligibility criteria: Inclusion Criteria:

1. Body Mass Index (BMI) is 18 to 26 kg/m2, inclusive
2. A condition of general good physical health based upon the results of a medical history, physical examination, vital signs, laboratory profile, 12-lead electrocardiogram (ECG)

Exclusion Criteria:

1. Presence of a metal implant (i.e., aneurysm clip, metal fragments, internal electrical devices such as a cochlear implant, spinal cord stimulator or pacemaker) that would preclude a MRI scan
2. During the last year, a radiation exposure that on its own or in addition to the expected radiation from this study exceeds the allowed annual radiation exposition level (20 mV)
3. Use of tobacco or other nicotine-containing products within 6 months prior to Screening
4. Diagnosis of substance or alcohol disorder within 12 months prior to Screening
5. History of claustrophobia or feeling of inability to lie still on his back in the PET camera
6. History or presence of any neurological or psychiatric conditions

Primary outcomes:
measure: D3 receptor occupancy as estimated by measuring ABT-614 induced changes in [11C]-(+)-PHNO BP
timeFrame: At the approximate Tmax following a single dose of study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Site Reference ID/Investigator# 12201
state: Ontario
city: Toronto
country: Canada
facility: Site Reference ID/Investigator# 13961
state: Ontario
Study officials:
References:
Clinical trial NCT04863001: Use of Antiarrhythmic Drugs in Pediatrics
Official title: Adescriptive Study on the Use of Antiarrhythmic Drugs in Pediatrics Cardiology Unit Assiut University
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Antiarrhythmic Toxicity
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1- Patients' selection:- patients from 1 month age till 18 years on antiarrhythmic medications in Cardiology Unit Assiut University Hospital antiarrhytmic medications .

Brief summary: This study aims to describe the use of Cardiovascular Drugs in Pediatrics Cardiology unit Assiut University. As regard :

* indications of use .
* proper dosage.
* proper management of side effects of their use.

Detailed description: Arrhythmias occur in children and adolescents with congenital heart disease as well as those with structurally normal hearts. Antiarrhythmic medications primarily affect the ion channels in cardiac myocytes that are responsible for generating currents that create the action potential.

By altering the activity of these ion channels, the action potential is changed in an attempt to reduce the likelihood of sustained arrhythmias. There is awide range of antiarrhysmic drugs used in treatment Antiarrhysmics are therefore divided into five classes

Class I: Antiarrhythmics that affect sodium channels (slow depolarization) Class II: Drugs that counteract the sympathetic nervous system, predominantly beta-blockers Class III: drugs that affect the potasium channels ( prolong repolarization) Class IV: Drugs that affect calcium channels (Calcium channel blockers) Class V: Vagotonic drugs (Digoxin) and other miscellaneous drugs

Eligibility criteria: Inclusion Criteria:

* All Patients with Arrhythmic cardiac diseases admitted at cardiology unit Assiut University Hospital aged from 1 month to 18 years

Exclusion Criteria:

* ● Patients with diseases rather than arrhythmic cardiac diseases

Primary outcomes:
measure: descripe the use of antiarrhythmic drugs in pediatrics
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Podrid PJ. Antiarrhythmic drug selection. Annu Rev Med. 1987;38:1-17. doi: 10.1146/annurev.me.38.020187.000245.
Clinical trial NCT02879201: Continuous Venovenous Hemodiafiltration Versus Sustained Low-efficiency Hemodialysis for Critically Ill Patients With Acute Kidney Injury in Intensive Care Unit
Official title: Continuous Venovenous Hemodiafiltration Versus Sustained Low-efficiency Hemodialysis for Critically Ill Patients With Acute Kidney Injury in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital
Sponsor class: OTHER_GOV
First posted: 2016-08-25
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators conducted a comparison trial between SLED and CRRT in critically ill patients to evaluate the outcome for all cause mortality at 30 day . The secondary outcome were recovery of renal function, complications during therapy and duration of hospitalization.

Detailed description: The investigators performed a single center experience accumulated over 12 months since February 2009 with a continuous venovenous hemodiafiltration (CVVHDF) and hybrid technique named sustained low-efficiency dialysis (SLED). The primary end point was death from any cause by day 30. Intensive care unit (ICU) patients were eligible for inclusion when serum creatinine was \> 2 mg/dL, and renal replacement therapy (RRT) was initiated. The selected patients were treated with CVVHDF or SLED.

Eligibility criteria: Inclusion Criteria:

- The inclusion criteria were

1. AKI requiring RRT
2. Hemodynamic instability defined by systolic blood pressure ≤ 90 mmHg and/or diastolic blood pressure ≤ 60 mmHg
3. Patients requiring initiation to vasopressor support

Exclusion Criteria:

* Patients with pre-existing chronic kidney disease ( eGFR less than 30 mLmin/1.73m2) were excluded

Primary outcomes:
measure: All-cause mortality
timeFrame: 30 day
Secondary outcomes:
measure: Numbers of patients with abnormal laboratory values
timeFrame: 30 days
measure: ICU stay
timeFrame: 30 days
Other outcomes:
measure: Adverse events during treatment
timeFrame: 30 days
Locations:
city: Bangkok
country: Thailand
facility: Renal Unit, BMA Medical College and Vajira Hospital
Study officials:
References:
citation: Manns B, Doig CJ, Lee H, Dean S, Tonelli M, Johnson D, Donaldson C. Cost of acute renal failure requiring dialysis in the intensive care unit: clinical and resource implications of renal recovery. Crit Care Med. 2003 Feb;31(2):449-55. doi: 10.1097/01.CCM.0000045182.90302.B3.
Clinical trial NCT00600067: A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults
Official title: A Randomized, Double Blind Multicenter Study to Evaluate the Long-term Safety and Efficacy of VI-0521 Relative to Placebo in Providing and Maintaining Glycemic Control in Type 2 Diabetic Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Keywords: Diabetes
Type 2 Diabetes
Diabetes Mellitus
Metabolic Diseases
Glucose Metabolism Disorders
Glycemic Control
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
Collaborators: name: Synteract, Inc.
name: Sentrx
First posted: 2008-01-24
Enrollment: 130
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: The purpose of the study is to determine the long-term safety and efficacy of VI-0521 (phentermine/topiramate) compared to placebo in providing blood sugar control in Type 2 diabetic adults. Continuation of initial 6 month trial.


Eligibility criteria: Inclusion Criteria:

* Have completed the qualifying OB-202 trial
* If females of child-bearing potential, subjects must be using adequate contraception
* Provide written informed consent
* Be willing and able to comply with scheduled study visits, treatment plan, lab tests and other study procedures

Exclusion Criteria:

* Subjects who have developed one or more morbidities during the OB-202 trial that would pose a safety concern

Primary outcomes:
measure: HbA1c Change From Baseline Week 0 to Week 56
timeFrame: Baseline to 56 weeks
Secondary outcomes:
measure: Percent Weight Loss From Baseline to Week 56
timeFrame: Baseline to 56 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Los Angeles
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Spring Valley
country: United States
facility: Research Site
state: California
city: Walnut Creek
country: United States
facility: Research Site
state: California
city: Bethesda
country: United States
facility: Research Site
state: Maryland
city: Austin
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Richmond
country: United States
facility: Research Site
state: Virginia
Study officials:
affiliation: VIVUS LLC
name: Barbara Troupin, MD, MBA
role: STUDY_DIRECTOR
References:
citation: Garvey WT, Ryan DH, Bohannon NJ, Kushner RF, Rueger M, Dvorak RV, Troupin B. Weight-loss therapy in type 2 diabetes: effects of phentermine and topiramate extended release. Diabetes Care. 2014 Dec;37(12):3309-16. doi: 10.2337/dc14-0930. Epub 2014 Sep 23.