louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00040170: Vaccine Study of MVA-MUC1-IL2 in Patients With Prostate Cancer
Official title: Randomized Multicenter Phase II Study Evaluating Two Dosing Schedules of TG4010(MVA-MUC1-IL2) in Patients With Adenocarcinoma of the Prostate
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Keywords: Adenocarcinoma of the prostate
Lead sponsor: Transgene
Sponsor class: INDUSTRY
Collaborators: name: University of California, Los Angeles
name: The Cleveland Clinic
name: University of Arizona
First posted: 2002-06-25
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study involves the use of an experimental product, TG4010. The purpose of the study is to determine if TG4010 can stimulate the body's immune system to help it fight the cancer.

Detailed description: The experimental product, TG4010, is a modified vaccinia virus (already used in humans) into which two (2) genes have been placed. One gene is for a protein (MUC1) found in cancer cells. The second gene is for human interleukin 2 (IL2) which the body's immune system makes to help it fight cancer. The TG4010 is given as an injection under the skin (subcutaneous) once a week for six weeks followed by a schedule of every three weeks or every three weeks for the first twelve (12) weeks. If the therapy is working, it can be continued for up to 9 months until no further improvement or until the patient gets worse for as long as it is tolerated.

Eligibility criteria: Inclusion Criteria:

* Rising PSA after surgery or radiation for prostate cancer

Exclusion Criteria:

* Metastasis or local disease
* Prior hormone treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
References:
Clinical trial NCT04453670: Neuropathology in Adults Intensive Care Unit Patients With COVID 19
Official title: A Prospective Observational Autopsy Study of Neuropathology in Adults Intensive Care Unit Patients With COVID 19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID 19
Keywords: autopsy
coronavirus
brain
inflammation
Lead sponsor: University of Versailles
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients admitted to the ICU for severe COVID-19 and who died during their ICU stay and for whom family consent was obtained for performing autopsy

Brief summary: This is a single center observational autopsy study, conducted during the first wave of the coronavirus disease (COVID-19) pandemic in France. The main objective is to evaluate brain damages in patients who died from COVID-19 to inform the cause of death. Investigations include macroscopic and histology examinations, and virology analyses.

Detailed description: Setting: academic center designed as a referral center for patients with COVID-19 Design: single center observational autopsy study Participants: intensive care unit (ICU) adults who died from confirmed COVID-19 during the first wave of the pandemic in France.

Oversight: As per legal health authority requirement only patients with suspected or confirmed severe acute respiratory syndrome (SARS)- related to coronavirus 2 infection were admitted to the ICU. The department of pathology and forensic medicine is allowed by legal authority to perform autopsy of non-survivors from COVID-19 to inform the cause of death as per ministerial decree of July 12 2017 and March 28, 2020. In this context, of autopsy for medical purpose and public interest there is no requirement for institutional review board submission. However, consent from patients legal representative or closest relatives is required for autopsy.

Eligibility criteria: Inclusion Criteria:

* Adults
* admitted to the ICU
* confirmed COVID-19
* died during ICU stay

Exclusion Criteria:

* refusal from patient's legal representative or closest relative

Primary outcomes:
measure: detection of severe acute respiratory syndrome related to coronavirus-2 in brain tissues
timeFrame: From death up to five days
measure: quantification of inflammation, necrosis and hemorrhage in different brain areas
timeFrame: From death up to five days
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Hôpital Raymond Poincaré
Study officials:
affiliation: University Versailles SQY Unversité Paris Saclay
name: djillali annane
role: STUDY_CHAIR
References:
Clinical trial NCT03867370: Toripalimab in Combination With Lenvatinib as Neoadjuvant Therapy in Resectable Hepatocellular Carcinoma
Official title: A Phase Ib/II, Open-Label, Multi-Center Study Evaluating the Efficacy and Safety of Neoadjuvant Toripalimab Injection (JS001) or Toripalimab in Combination With Lenvatinib for Patients With Resectable Hepatocellular Carcinoma (HCC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Sponsor class: OTHER
First posted: 2019-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study will evaluate efficacy and safety of Toripalimab Injection (JS001) with or without Lenvatinib as a Neoadjuvant Therapy in patients with Resectable Hepatocellular Carcinoma (HCC)


Eligibility criteria: Confirmed by histopathological or cytological examination; The criteria for resectability is met; Has at least one evaluable lesion according to the RECIST 1.1 standard and has not received local treatment;

Exclusion Criteria:

Patients who previously received anti-programmed death receptor-1 (PD-1) antibody, anti-programmed death ligand-1 (PD-L1) antibody, anti-programmed death ligand-2 (PD-L2) antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies, including those who have participated in a JS001 clinical study;

Patients with a history of gastroesophageal varices or active cardia ulcers associated with a high risk of bleeding; Patients who have upper gastrointestinal hemorrhage within 1 year; Patients known to have fibrous layer HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC; Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Pathological response rate
timeFrame: Up to 2 months
Secondary outcomes:
measure: Objective response rate
timeFrame: up to 2 months
measure: Percentage of R0 resection
timeFrame: up to 8 months
measure: Time to operation
timeFrame: up to 8 months
measure: Progression free survival
timeFrame: up to 3 years
measure: Overall survival
timeFrame: up to 3 years
measure: Incidence of adverse events
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Zhongshan Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT05248542: The Effects of Virtual Reality/ Augmented Reality Usage on Oral Care Knowledge in Nursing Students
Official title: The Effects of Virtual Reality/ Augmented Reality Usage on Oral Care Knowledge in Nursing Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Oral Care
Knowledge, Attitudes, Practice
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study was to investigate the effects of virtual reality usage on oral care knowledge in nursing students. The participants were randomly assigned to virtual-reality experimental and control groups. The students in experimental group received a 30 minutes virtual reality (VR) training for elderly oral health care at the second week and the fourth week after the first time survey. All students self-administrated questionnaire three times at first date of consent form signed, immediately after each of the intervention for period of two weeks. Linear regression in generalized estimating equations (GEE) compare the differences between both groups.

Detailed description: A total of 50 first-year to third-year undergraduate nursing students were included from the Department of Nursing, Kaohsiung Medical University, Taiwan. The students were randomly assigned divided at random into two groups, control (n = 25) and experimental (n = 25).

Eligibility criteria: Inclusion Criteria:

1. undergraduate freshman, sophomore, and junior nursing students
2. those volunteered to participate in this study

Exclusion Criteria:

1. students with known negative effects of using VR devices, such as nausea, vomiting, etc.
2. those under 20 years of age who had not obtained the consent of a legal representative to participate in this study.

Primary outcomes:
measure: Knowledge of geriatric oral hygiene scale
timeFrame: through study completion, an average of 4 weeks
measure: Attitudes of geriatric oral hygiene scale
timeFrame: through study completion, an average of 4 weeks
measure: Self-efficacy of geriatric oral hygiene scale
timeFrame: through study completion, an average of 4 weeks
measure: Behavioral intention of geriatric oral hygiene scale
timeFrame: through study completion, an average of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
affiliation: Kaohsiung Medical University
name: Pei-Chao Lin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00702442: Role of Droperidol in Postoperative Vomiting
Official title: Role of Droperidol in Postoperative Vomiting: Phase IV Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vomiting
Keywords: Nausea, Vomiting
Vomiting episodes
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: AHEPA University Hospital
First posted: 2008-06-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Protocol title: Role of low dose droperidol in postoperative vomiting

Purpose: Evaluate the efficacy of droperidol to postoperative nausea and vomiting when administrated at the introduction to anesthesia, prior to surgery

Design: Prospective, randomized, placebo-controlled study

Patient Population: Male or female subjects 18 years of age or older who are scheduled for laparoscopic cholecystectomy

No. of Subjects: 100 patients divided into two groups, estimated up to 6 months to enroll

Duration of Treatment: Prior operation

Duration of Follow-up: Follow-up will be performed for 24 hours postoperatively

Endpoints: To evaluate the effectiveness of low dose droperidol when administered Prior surgery

Detailed description: In this prospective, randomized, placebo-controlled study, the researchers determined whether 0.625 mg (1/2 amp) IV droperidol given at the initiation of general anesthesia reduces the incidence of immediate and delayed post operative nausea and vomiting (PONV) in laparoscopic cholecystectomy population. One hundred patients receiving general anesthesia for laparoscopic cholecystectomy received droperidol 0.625 mg (1/2 amp) mg or placebo prior operation.

Eligibility criteria: Inclusion Criteria:

* Patient more than 18 years old
* Patients scheduled for laparoscopic cholecystectomy
* Informed consent obtained from the patient

Exclusion Criteria:

* Age \< 18 years old
* Contraindication to laparoscopic surgery
* Present a severe depressive syndrome
* Pregnancy women
* Trouble of cardiac rate
* Alcoholism
* Contra-indication for Droperidol prescription

Primary outcomes:
measure: Vomiting episodes
timeFrame: 24 hours
Secondary outcomes:
measure: Light nausea
timeFrame: 24 hours
measure: Control of nausea
timeFrame: 24 hours
measure: Anti-vomiting treatment
timeFrame: 24 hours
measure: Adverse events
timeFrame: 24 hours
measure: Modification of electrocardiograph
timeFrame: 24 hours
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: 3rd Department of Surgery, AHEPA University Hospital
state: Macedonia
city: Thessaloniki
country: Greece
facility: 3rd Department of Surgery, AHEPA University Hospital
Study officials:
affiliation: Associate Professor in Surgery
name: Isaak Kesisoglou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01747642: Safety and Efficacy of Oncoxin Plus Surafineb in Hepatocellular Carcinoma
Official title: Study to Evaluate Safety and Therapeutic Efficacy of a Combination Therapy of 'Oncoxin', a Nutritional Supplement and Surafenib, a Multikinase Inhibitor in Patients With Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Quality of Life
Keywords: Hepatocellular carcinoma
Oncoxin
Surafenib
Lead sponsor: Clinical Research Organization, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oncoxin in combination with Surafenib is safe and results in improved survival in patients with hepatocellular carcinoma (HCC)

Detailed description: To assess therapeutic efficacy and safety of Oncoxin plus Surafenib in hepatocellular carcinoma

To see if there is reduction in serum alpha fetoprotein level in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib

To see if there is reduction tumor size and or number in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib

To see if there is improvement of quality of life in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib

To see if there is improved survival in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib

Eligibility criteria: Inclusion Criteria:

* Patients with HCC irrespective of etiology, age, gender and status of underlying liver disease.
* Patients with HCC who are not suitable candidates for established modalities of treatment i.e. surgery and/or chemotherapy.
* Patients with HCC who have evidence of tumor metastasis
* Patients with HCC who are voluntarily unwilling to take established modalities of treatment i.e. surgery and/or chemotherapy.
* Patients with HCC in whom all possible treatment options have been exhausted.

Exclusion Criteria:

* Patients with HCC who are suitable candidates for established modalities of treatment i.e. surgery and/or chemotherapy.
* Patients with HCC who have no evidence of tumor metastasis
* Patients with HCC who are willing to take established modalities of treatment i.e. surgery and/or chemotherapy.
* Patients with HCC who are voluntarily unwilling to be included in the trial

Primary outcomes:
measure: Number of patients who have prolonged survival
timeFrame: 24 weeks
Secondary outcomes:
measure: Reduction in serum alpha-fetoprotein level and decrease in tumor size
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Farabi General Hospital
Study officials:
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: Mamun A Mahtab, MD, FACG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04826042: Effect of Contrast Medium on Optic Nerve Sheath Diameter
Official title: : Effect of Epidural Injection of Normal Saline or Contrast Medium on Optic Nerve Sheath Diameter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Optic Nerve Sheath Diameter
Keywords: optic nerve sheath diameter
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One method of indirect measurement of intracranial pressure is using optic nerve sheath diameter. There is no study whether equal volume of contrast medium injection has any increasing effect of optic nerve sheath diameter.

This study is designed to measure the changes of optic nerve sheath diameter and cerebral oxygenation when equal volume of contrast medium or normal saline was injected in epidural space.

Detailed description: Previous study showed that different volume of injections (1.0 ml/kg vs. 1.5 ml/kg) during caudal anesthesia showed siginifiant increase of optic nerve sheath diameter in group of high volumes. Increase of ICP can result in harmful effect including reduced cerebral flow and oxygen saturation. Also, increase of ICP can cause headache, syncope and transient loss of visual acuity. The proven and valid method of measuring ICP indirectly is using optic nerve sheath diameter. This study was designed to examine the changes of optic nerve sheath diameter and cerebral oxygenation when equal volume of contrast medium or normal saline was injected in epidural space.

Eligibility criteria: Inclusion Criteria:

* lung cancer
* liver cancer
* stomach cancer
* pancreas cancer
* gallbladder

Exclusion Criteria:

* coagulopathy
* infection
* previous spine fusion at thoracic level
* previous brain lesion

Primary outcomes:
measure: optic nerve sheath change during 4 time period
timeFrame: Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention
Secondary outcomes:
measure: cerebral oxygenation change during 4 time period
timeFrame: Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Ji Hee Hong
Study officials:
References:
citation: Hong JH, Park JH, Park KB. Comparison of Increase in the Optic Nerve Sheath Diameter between Epidural Saline and Contrast Medium Injections. Pain Physician. 2022 Mar;25(2):E263-E269.
Clinical trial NCT01344642: Qualitative and Quantitative HIV RNA Detection in Saliva Using the Oragene RNA Kit
Official title: Qualitative and Quantitative HIV RNA Detection in Saliva Using the Oragene RNA Kit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV
RNA
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: DNA Genotek (has supplied the kits)
First posted: 2011-04-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV monoinfected HIV-HCV co-infected HIV and HCV uninfected control

Brief summary: The purpose of this study is to determine if the Oragene.RNA kit is able to detect HIV RNA in saliva.

Detailed description: There is an important need for a rapid, non-invasive, sensitive and specific method for detection of HIV RNA, particularly in clinical settings in which patients at risk for HIV exposure are assessed and screened. A rapid and non-invasive method for quantitative testing of HIV RNA would be also valuable to monitor suppression of HIV RNA as a primary surrogate marker of combination antiretroviral therapy efficacy. An Ottawa-based biotech company (DNA Genotek Inc) has developed and sells to research and clinical labs world-wide a kit (Oragene� DNA Self-collection kit) that permits the collection, stabilization at room temperature, and purification of DNA present in saliva. They have recently developed a kit (Oragene��RNA) that is purported to stabilize RNA in saliva, a non-invasive source of a biological fluid.

Eligibility criteria: Inclusion Criteria:

* Four groups of 10 patients each will be recruited:

  * Controls (HIV and HCV seronegative by previous testing)
  * HIV seropositive with HIV RNA \&gt;1000 copies/mL and not on combination antiretroviral therapy. No concurrent HCV infection.
  * HIV seropositive with HIV RNA \&lt;50 copies/mL as a consequence of combination antiretroviral therapy use. No concurrent HCV infection.
  * HIV seropositive with HIV RNA \&gt;1000 copies/mL and not on combination antiretroviral therapy. HCV RNA positive and not on antiviral therapy.

Exclusion Criteria:

* Not fitting one of the 4 groups

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital, General Campus
state: Ontario
Study officials:
References:
Clinical trial NCT01477242: The Effect of Ondansetron During Intramuscular Ketamine Use in Children: A Trial in Emergency Department
Official title: The Effect of Oral Ondansetron During Intramuscular Ketamine Use in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sedation and Analgesia
Side Effect of Drug
Keywords: vomiting
anti-emetics
ketamine
sedation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Asan Medical Center
name: Myongji Hospital
First posted: 2011-11-22
Enrollment: 266
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the anti-emetic effect of oral ondansetron. For this evaluation, the investigators will perform a multi-center, double-blind, placebo-controled, randomized study. The investigators assumption is that oral ondansetron prior to intramuscular ketamine will reduce the occurrence of ketamine-induced vomiting.

Detailed description: Methods

* a multi-center, double-blind, placebo-controled, randomized study ( 4 tertiary hospital ED)
* survey for the occurrence of vomiting at ED and after discharge

Primary outcome

* the number of vomiting at ED and at home

Secondary outcome

* parent's satisfaction and ED length of stay

Eligibility criteria: Inclusion Criteria:

* children under 18 years of age
* children who are planned to admit ketamine intramuscular injection
* children with ASA classification class I or II

Exclusion Criteria:

* don't want to enroll to study
* children with condition of contraindication of ketamine (IICP, IIOP, psychosis, brain tumor, thyroid disease, porphyria)
* children with condition of contraindication of ondansetron (hypersensitivity to 5-HT3 antagonist, Long QT syndrome, severe liver failure, obstructive ileus)
* children under 3 months of age
* children whose weight are over 30 kg
* children managed by other drug with ketamine

Primary outcomes:
measure: vomiting at ED stay and 12 hours after discharge
timeFrame: the participants will be followed for the duration of ED stay (upto 24hr) and 12hours after discharge
Secondary outcomes:
measure: parent's satisfaction
timeFrame: satisfaction will be surveyed within 48hours after discharge
measure: length of emergency department stay
timeFrame: length of stay will be calculated upto 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Do Kyun Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: