louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03851887: The Efficacy of Transarterial Chemoinfusion (TAI) Combine Stereotactic Body Radiation Therapy (SBRT) in Unresectable Hepatocellular Carcinoma (HCC)
Official title: The Efficacy of Transarterial Chemoinfusion (TAI) Combine Stereotactic Body Radiation Therapy (SBRT) in Unresectable Hepatocellular Carcinoma (HCC): A Prospective, Single-armed, Stage II Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 33
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 efiicacy of TAI combine SBRT in unresectable HCC


Eligibility criteria: Inclusion Criteria:

* older than 18 years old and younger than 75 years;
* ECOG PS≤1;
* proven advanced hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
* not previous treated for tumor;
* cannot accepted hepatectomy;
* the lab test could meet:

  * neutrophil count≥2.0×109/L;
  * hemoglobin≥100g/L;
  * platelet count≥75×109/L;
  * serum albumin≥35g/L;
  * total bilirubin\<2-times upper limit of normal;
  * ALT\<3-times upper limit of normal;
  * AST\<3-times upper limit of normal;
  * serum creatine\<1.5-times upper limit of normal;
  * PT≤upper limit of normal plus 4 seconds;
  * INR≤2.2;
* sign up consent.

Exclusion Criteria:

* cannot tolerate TAI or SBRT;
* known history of other malignancy;
* be allergic to related drugs;
* underwent organ transplantation before;
* be treated before (interferon included);
* known history of HIV infection;
* known history of drug or alcohol abuse;
* have GI hemorrhage or cardiac/brain vascular events within 30 days;
* pregnancy.

Primary outcomes:
measure: PFS
timeFrame: From date of randomization until the date of progression, assessed up to 36 months
measure: ORR
timeFrame: From date of randomization until the date of death, assessed up to 36 months
Secondary outcomes:
measure: OS
timeFrame: From date of randomization until the date of death from any cause, assessed up to 36 months
measure: DCR
timeFrame: From date of randomization until the date of death, assessed up to 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: SUN YAT-SEN University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT02152787: Comparison of Propofol 1mg/kg and Propofol 0.5mg/kg for Prevention of Emergence Agitation in Children Undergoing Strabismus Surgery During Sevoflurane Anesthesia
Official title: Comparison of Propofol 1mg/kg and Propofol 0.5mg/kg for Prevention of Emergence Agitation in Children Undergoing Strabismus Surgery During Sevoflurane Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Strabismus
Keywords: emergence agitation
propofol
strabismus surgery
children
elective strabismus surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-06-02
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The occurrence of emergence agitation (EA) in pediatric patients who have received sevoflurane anesthesia is a common postoperative problem. Among various strategies for reducing the incidence and severity of EA, the use of pharmacological agents at the end of anesthesia is thought to be the most convenient and easily applicable method in clinical situation. The one of typical agents that can be administered in this way is propofol. Previous studies demonstrated that the use of propofol 1mg/kg at the end of anesthesia could reduce the incidence of EA with low incidence of postoperative nausea and vomiting. However, it was also demonstrated that the use of propofol 1mg/kg at the end of anesthesia could delay the emergence time. The purpose of this study is to compare the preventive effect on EA and the emergence time between propofol 1mg/kg and propofol 0.5mg/kg administered at the end of sevoflurane anesthesia.


Eligibility criteria: Inclusion Criteria:

1. children (3-12 years old) scheduled for elective strabismus surgery undergoing general anesthesia.
2. ASA 1-2

Exclusion Criteria:

1. Patients with developmental disability, mental retardation, neurologic disorder, ongoing neurologic medication such as anticonvulsant, previously undergoing general anesthesia, a recent history of upper respiratory infection, parents difficult to read or understand the informed consent.

Primary outcomes:
measure: The incidence of the emergence agitation
timeFrame: from extubation up to 1 hour
Secondary outcomes:
measure: the emergence time
timeFrame: within the first 1hour after end of strabismus surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT00795587: Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring
Official title: Compared Effects of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Traumatic Brain Injury
Intracranial Hypertension
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2008-11-21
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Will an increase of the dose of mannitol improve the effects on neuromonitoring in patients suffering intracranial hypertension following traumatic brain injury?

Detailed description: traumatic brain injury intracranial hypertension 0,4 g/ kg vs 0,8 g/ kg (randomized) on 20 minutes monitoring: ICP, transcranial doppler, brain pO2, MAP, HR, diuresis, biology duration: 2 hours

Eligibility criteria: Inclusion Criteria:

* adults
* severe traumatic brain injury
* intracranial hypertension requiring mannitol administration

Exclusion Criteria:

* impeding neurosurgery
* hemodynamic or respiratory severe failure

Primary outcomes:
measure: intracranial pressure
timeFrame: 2 hours
Secondary outcomes:
measure: transcranial doppler
timeFrame: 2 h
measure: brain PO2
timeFrame: 2h
measure: MAP
timeFrame: 2h
measure: Heart Rate
timeFrame: 2h
measure: biology (blood gases, natremia, hematocrit)
timeFrame: 2h
measure: diuresis
timeFrame: 2h
measure: fluid requirement
timeFrame: 2h
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Universitary Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Gilles Francony, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00896987: Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies
Official title: An Open, Randomized, Multicenter Comparative Clinical Trial of Lamotrigine or Carbamazepine for Cognitive Function as Initial Monotherapy in Adult Untreated Epilepsies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Keywords: Epilepsy
lamotrigine
cognitive function
Lead sponsor: Korean Epilepsy Society
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2009-05-12
Enrollment: 121
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of anti-epileptic drugs' (AEDs) long-term treatment on cognitive function. This study is an open-label, randomized, multicenter comparative trial of lamotrigine versus carbamazepine. The planned enrollment is 100 patients.


Eligibility criteria: Inclusion Criteria:

* Age : 16\~60
* Seizure type was defined by MRI etc.
* Had more than 2 unprovoked seizures or 1 seizure with clear evidence for epilepsy (ex. positive in EEG or brain imaging)
* Need AED therapy and no AED medication for previous 1 year (exclude emergency medication for less than 2 weeks, baseline 4 weeks before)
* Is not pregnant by pregnancy test and is using contraceptive method
* Can report seizure diary by him/herself or his/her sick nurse
* Agreed to trial by written consent

Exclusion Criteria:

* Follow-up loss
* Canceled agreement
* Added other medication due to aggravated disease in 24 weeks
* Diagnosed as IGE
* Has progressive CNS disease by MRI or EEG
* Has serious systemic or psychological disease
* Under IQ 70
* Baseline lad data abnormality: Creatinine 2.0mg/dl or GOT/GPT 2 times higher than normal
* Abuse experience on alcohol or drugs
* Has experience on serious adverse event of any drug
* Previous experience on lamotrigine or carbamazepine
* Not suitable patients by investigator (uncooperative)
* Other reason which may interrupt the trial

Primary outcomes:
measure: To define the superiority of Lamictal in cognitive function comparing to carbamazepine in newly diagnosed adult partial epilepsy patients
timeFrame: 48 weeks
Secondary outcomes:
measure: Seizure outcome and tolerability
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Sang-Ahm Lee, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00651287: A Study to Evaluate the Efficacy and Safety of Quinapril or Quinapril Plus Hydrochlorothiazide in Patients With Mild to Moderate Hypertension
Official title: A 12-Week Open-Label, Uncontrolled Multicenter Study to Assess the Efficacy and Safety of Quinapril or Quinapril Plus Hydrochlorothiazide in Subjects With Mild to Moderate Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-02
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the response rate for the therapeutic goal (diastolic blood pressure (BP) less than 90 mmHg and systolic BP less than 140 mmHg) at Week 6 for quinapril 20 mg and at Week 12 for quinapril 20 mg, quinapril 40 mg, and quinapril 20 mg plus hydrochlorothiazide 12.5 mg; and to determine the mean decrease in diastolic and systolic BP measurements and the change in heart rate at Week 6 and Week 12 compared with baseline.


Eligibility criteria: Inclusion Criteria:

* A clinical diagnosis of mild to moderate primary hypertension ("Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, 6th report" Stage I or II)
* Sitting diastolic blood pressure between 90 mmHg and 109 mmHg and systolic blood pressure between 140 mmHg and 179 mmHg at the end of the no-treatment run-in period

Exclusion Criteria:

* Subjects with secondary hypertension
* Subjects with serious cardiac disease (including myocardial infarction in the last 3 months or decompensated heart failure)
* Subjects who do not accept to stop using any other antihypertensive treatment during the run-in period and the treatment period of the study

Primary outcomes:
measure: Response rate for the therapeutic goal (at Week 6 for 20mg quinapril and at Week 12 for 40mg quinapril and 20mg quinapril plus 12.5mg hydrochlorothiazide)
timeFrame: 12 weeks
Secondary outcomes:
measure: Mean decrease in diastolic and systolic BP measurements at Week 6 and at Week 12 compared to baseline
timeFrame: 12 weeks
measure: Change in heart rate at Week 6 and at Week 12 compared to baseline
timeFrame: 12 weeks
measure: Adverse events were recorded throughout the study
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cerrahpasa
country: Turkey
facility: Pfizer Investigational Site
state: Istanbul
city: Diyarbak R
country: Turkey
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05801887: Extracorporeal Shock Wave Therapy on Osteoblast-Like Cells In- Vitro Study
Official title: Extracorporeal Shock Wave Therapy on Osteoblast-Like Cells In- Vitro Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteosarcoma
Keywords: ESWT
Cell proliferation
Cell viability
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: test group - application of shockwave on osteoblast control group - No shockwave on osteoblast
Primary purpose: TREATMENT

Brief summary: The idea of treating different deformities or diseases in the maxillofacial region with Extracorporeal Shockwave Therapy (ESWT) has recently become popular. It has been widely used in medical practice for the management of urolithiasis, cholelithiasis and in haead and neck region for sialolithiasis. The present study 'Extracorporeal Shock Wave Therapy on Osteoblast-Like Cells In-vitro study' will be done to explore and evaluate the effect of shockwaves. Further, Osteoblast-like cells will be assessed for Cell - Cell interaction and Cell Viability. It will be assessed using a scratch assay, Mtt assay and ATP analysis.

Detailed description: Introduction:

Extracorporeal Shockwave Therapy (ESWT) has recently become popular. Shockwave has been widely used in medical practice for the management of urolithiasis, cholelithiasis and in haead and neck region for sialolithiasis.

Aim:

This study 'Extracorporeal Shock Wave Therapy on Osteoblast-Like Cells In-vitro study' will be done to explore and evaluate the effect of shockwaves. Further, Osteoblast-like cells will be assessed for Cell - Cell interaction and Cell Viability.

Methodology:

In this in-vitro study, 20 Osteoblast - like cells will be included. 10 samples to be considered for Control group and the remaining 10 samples considered as Test group. Extracorporeal shockwave will be applied to the Test samples. They will be further analysed using wound scratch assay which is used to assess Cell proliferative rate and scratch closure through live imaging. MTT assay and ATP assay used to determine Cell viability after exposure to shockwaves. The cell migration and cell viability after exposure to shockwaves will determine its effects on osteoblast-like cells.

Eligibility criteria: Inclusion Criteria:

* Cell cultures with a confluency of 70%-80%

Exclusion Criteria:

* Contaminated cell cultures

Primary outcomes:
measure: Scratch assay
timeFrame: 72hours
measure: MTT Assay and ATP analysis
timeFrame: 74hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Bengaluru
country: India
facility: Dr. Roxanne
state: Karnataka
Study officials:
References:
Clinical trial NCT02238587: The Effect of Ganoderma on Patients With Head-and-neck Cancer
Official title: The Effect of Gandoerma Spores Powder Capsules on the Post-treatment Life Quality and Immune Modulation of the Patients With Head-and-neck Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head-and-neck Cancer
Keywords: Gandoerma Spores Powder Capsules, head-and-neck cancer.
Lead sponsor: Chang Bing Show Chwan Memorial Hospital
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To study the effect of Ganoderma Spores Powder Capsules on the life quality and immunity status of the patients with head-and-neck cancer after complete treatment (including surgery and / or radiotherapy and/or chemotherapy)

Detailed description: Ganoderma is known to modulate immunity and improve health. However, the mechanism is not clear. We hypothesize that patients who have completed standard treatment with/without radiotherapy might require biological modifier such as Ganoderma to improve life quality and immunity status.

A total of 100 patients are randomized to study and control groups. In study group, Ganoderma Spores Powder Capsules are given to the patients for 6 weeks, In control group, only placebos are given during the same period. Then the patients in study and control groups are switched, Ganoderma Spores Powder Capsules and placebos are given for 6 weeks. The data pertaining to their Life quality are collected using Quality of Life Questionnaire after the first 6 weeks and the second 6 weeks. The immunity status is also studied at the same time.

Eligibility criteria: Inclusion Criteria:

* Patients with head-and-neck cancer after complete treatment for at least 3 months (including surgery and/or radiotherapy and/or chemotherapy)

Exclusion Criteria:

* Patients with head-and-neck cancer under treatment or within 3 months after treatment

Primary outcomes:
measure: Immune modulation such as tumor necrosis factors-α or interleukin-6
timeFrame: Change from baseline in cytokines at 6 months
Secondary outcomes:
measure: Life quality
timeFrame: Change from baseline in life quality at 6 months
Other outcomes:
Locations:
city: Changhua County
country: Taiwan
facility: Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
Study officials:
affiliation: Chang Bing Show Chwan Memorial Hospital
name: Kuender D. Yang, PhD
role: STUDY_DIRECTOR
affiliation: Chang Bing Show Chwan Memorial Hospital
name: Ching-Yeh Hsiung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00815087: Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC)
Official title: Efficacy of Functional Electrical Stimulation in Dysphagia of Nasopharyngeal Cancer Post Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dysphagia
Keywords: Nasopharyngeal carcinoma
functional electrical stimulation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-12-29
Enrollment: 20
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: The purpose of this study is to determine whether functional electrical stimulation is effective in the treatment of dysphagia due to nasopharyngeal cancer post radiotherapy

Detailed description: Nasopharyngeal carcinoma (NPC) patients usually underwent radiotherapy (RT) or chemoradiotherapy(CRT). There were some complications caused by RT, like dysphagia.

In recent studies, functional electrical stimulation (FES) was be used in neurologically dysphagia patients, and there were some positive effects with these studies. Hence, we decided applied FES to these NPC patients with dysphagia.

Eligibility criteria: Inclusion Criteria:

* Primary nasopharyngeal carcinoma
* Post radiation therapy
* Mild to severe dysphagia
* Never underwent swallowing therapy

Exclusion Criteria:

* Recurrent cancer
* Neurological or degenerate disease
* Total or partial laryngectomy
* Epilepsy
* With cardiac pacemaker

Primary outcomes:
measure: The Change From Baseline and Cut Point VFSS in Velocity of Displacement of Hyoid Bone at 1 to 3 Months
timeFrame: Averaged 2 months
Secondary outcomes:
measure: Questionnaire of Life Quality
timeFrame: 1 to 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Department of Physicale Medicine and Rehabilitation, National Taiwan University Hospital
name: Tyng-Guey Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04111887: Pilot Study Comparing Two Versions of Group Cognitive-behavioral Indicated Prevention Programs
Official title: Depression Prevention Programs: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of two depression prevention programs and a control brochure for college students. Participants may experience reductions in depressive symptoms and prevention of future depression.


Eligibility criteria: Inclusion Criteria:

* current student at the University of Oregon
* subthreshold symptoms of depression, as indicated by a CES-D depression screener score of 20 or greater

Exclusion Criteria:

* current diagnosis of major depression
* acute suicidal ideation requiring immediate mental health treatment

Primary outcomes:
measure: Change from baseline Depressive Disorder Diagnostic using the Kiddie Schedule for Affective Disorders and Schizophrenia at 6 weeks, 3 months and 6 months
timeFrame: Measured at baseline, 6 weeks, 3 months and 6 months
measure: Difference in attendance in Change Ahead vs Blues Program groups using group leader notes
timeFrame: Measured at each group therapy session (6 weeks in total).
measure: Difference in future onset of Major Depressive Disorder using the Kiddie Schedule for Affective Disorders and Schizophrenia
timeFrame: Measured at baseline, 6 weeks, 3 months and 6 months.
Secondary outcomes:
measure: Activity level
timeFrame: Measured at baseline, weeks 2,4 and 6.
measure: Emotions
timeFrame: Measured at baseline, weeks 2,4 and 6.
measure: Positive and negative thoughts
timeFrame: Measured at baseline, weeks 2,4 and 6.
measure: Assessments using writing samples
timeFrame: Measured at baseline and 6 weeks
measure: Depression and anxiety symptoms using the PHQ-9
timeFrame: Measured at baseline, 6 weeks, 3 months and 6 months
measure: Depression and anxiety symptoms using the GAD-7
timeFrame: Measured at baseline, 6 weeks, 3 months and 6 months
measure: Social adjustment in school, work, peer, spare time, and family domains
timeFrame: Measured at baseline, 6 weeks, 3 months and 6 months
measure: Negative life events
timeFrame: Measured at baseline
measure: Health care utilization
timeFrame: Measured at baseline, 6 weeks, 3 months and 6 months
measure: Negative automatic thoughts
timeFrame: Measured at baseline, 6 weeks, 3 months and 6 months
measure: Negative attributional style
timeFrame: Measured at baseline, 6 weeks, 3 months and 6 months
measure: Substance use
timeFrame: Measured at baseline (in intake screener), 6 weeks, 3 months and 6 months
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
References: