louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02481089: Polymorphisms in Key Genes of Glycolytic Pathway: Influence on Radiosensitivity in Nasopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Carcinoma
Single Nucleotide Polymorphisms
Radiosensitivity
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: npc patients who can tolerable and agree for IMRT and concurrent chemotherapy

Brief summary: Warburg effect is an important feature of tumors,and genetic variation is one of the main factors of individual differences to radiotherapy treatment response for nasopharyngeal carcinoma(NPC). Through the previous work investigators found that the p53 codon72 (Pro/Arg) was related to the prognosis of NPC; Using the method of proteomics, investigators discovered glycolysis related gene such as PGK1, ALDOA，was associated with radiosensitivity.Thus,with all the previous work,investigators hypothesize that the key gene polymorphisms in glycolytic pathway, such as p53 , influence the glycolytic pathway,which leads to differences in radiosensitivity of NPC. This projects will include 600 cases of patients with NPC to detect common glycolytic key genes polymorphisms. Besides,investigators correlate these factors with their radiosensitivity and prognosis.Then, prediction model will be established, and validation of the prediction model will be done. Using enzyme-labeling instrument ，comet assay and clonogenic assay，cytological experiments will further investigate the influence of key gene polymorphisms on the glycolysis efficiency and mechanism of radiation sensitivity.Thus,investigators could provide theoretical basis of individualized treatment for NPC.


Eligibility criteria: Inclusion Criteria:

* pathological identified NPC
* KPS≥70
* tolerable and agree for IMRT and concurrent chemotherapy
* without severe other diseases
* informed consent

Exclusion Criteria:

* reject treatment
* cannot tolerate the treatment
* distant metastasis before treatment

Primary outcomes:
measure: progression free survival
timeFrame: up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan province tumor pospital
state: Hunan
Study officials:
References:
Clinical trial NCT03210389: A Clinical Trial of Chemotherapy With Lobaplatin and 5-FU in Recurrent Local or Distant Advanced NPC.
Official title: A Prospective, Single-arm, and Open Clinical Trial of Chemotherapy With Lobaplatin and 5-FU on Efficacy and Safety in Recurrent Local or Distant Advanced NPC.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent Nasopharyngeal Carcinoma
Keywords: Recurrent Nasopharyngeal Carcinoma
lobaptin
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of chemotherapy with Lobaplatin and 5-FU, in Recurrent Local or Distant Advanced Nasopharyngeal Carcinoma.


Eligibility criteria: Inclusion Criteria:

* NPC diagnosed by pathology, with measurable lesions and imaging results, such as MRI and CT. Patients with no other lesions but bone metastasis are excluded.
* Recurrent locally or distant advanced NPC (rT3-4N0-3M0-1)
* ECOG 0 or 1
* Expected survival ≥ 1 year
* Without dysfunction of heart, lung, liver, kidney and hematopoiesis
* Patients are voluntary and signed informed consent
* No other anti-tumor treatment (including steroid)

Exclusion Criteria:

* Allergy history to platinum
* Use of 5-FU in last 6 months
* Had major surgery in last 4 weeks, or the wound has not completely healed
* Toxicity from previous treatment is still ≥CTC AE grade 3
* History of other carcinoma in the past 5 years, except for treated carcinoma in situ of cervix, as well as basal cell carcinoma or squamous cell carcinoma of the skin
* Dysfunction of heart
* Bleeding ≥CTC AE grade 3
* Use of anticoagulant or vitamin K antagonists, except for small dose of aspirin and warfarin for prevention
* Patients participated in clinical trials of other drugs within last 4 weeks
* Mental illness

Primary outcomes:
measure: progression-free survival
timeFrame: 2 years after chemotherapy
Secondary outcomes:
measure: overall survival
timeFrame: 2 years after chemotherapy
measure: objective response rate
timeFrame: 2 years after chemotherapy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
name: Yun-fei Xia, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01678989: Evaluation of Brain MRI and Clinical Characteristics of Adolescents With Bipolar Disorder and Children of Parents With Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bipolar Disorder
Keywords: Bipolar disorder
Children
Cranial MRI
Lead sponsor: Turkish Psychiatry Association
Sponsor class: OTHER
First posted: 2012-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study, the cranial MRI findings and clinical features in adolescents with bipolar disorder and the same age and sex matched children who have parents with BD and healthy controls were investigated.

Brief summary: Genetic transition is important in the etiology of bipolar disorder (BD). So, evaluation of children of BD parents and diagnosed with and BD children whether or not brain has affected zones. These groups were compared to healthy controls and whether or not the mental health of children is influenced will be evaluated by the clinical investigation.

Detailed description: MRI studies in children at risk of BD, our understanding of the neurobiology of BD and abnormalities in the studied regions, regions that predispose to the development of our understanding of PBB will shed light on the etiology of the disorder. In this study, the cranial MRI findings and clinical features in adolescents with bipolar disorder and the same age and sex matched children who have parents with BD and healthy controls were investigated. Since there is few studies that evaluate these three groups, there is a need to increase our knowledge on this issue.

Eligibility criteria: Inclusion Criteria:

* Children with BD between the ages of 12-18
* Parents with BD who have children between the ages of 12-18
* Healthy children whose parents do not have BD
* Patients who does not have mental or organic disability to answer the questions
* Graduated from primary school

Exclusion Criteria:

* Patients who have mental or organic disability to answer the questions
* Patients who have a history of any chronic disease which is likely to affect the central nervous system
* Patients who have a contraindication for any first application for Magnetic Resonance Imaging (MRI)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University Medical Faculty Department of Child and Adolescent Psychiatry
Study officials:
References:
Clinical trial NCT04472689: Effects of Lidocaine Infusion on Quality of Recovery and Agitation After Functional Endoscopic Sinus Surgery
Official title: Effects of Lidocaine Infusion on Quality of Recovery and Agitation After Functional Endoscopic Sinus Surgery: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Polypous Rhinosinusitis
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The essential anesthesia requirements for FESS include airway management, considerations for facilitating surgical access, provision of a clear and still surgical field for precision surgery, assuring quick and non-stimulating emergence from anesthesia, and fast-tracking patients for discharge. Postoperative agitation, although short-lived, is potentially harmful to both patients and recovery room staff, it has a potential for self-injury by removing intravenous catheters, tubing, oxygen masks and nasal packs. Furthermore, very agitated patients can pose an immediate danger to operating theatre staff.

Detailed description: Lidocaine is an amino amide-type short-acting local anesthetic (LA). It has a short half-life, and a favorable safety profile, and is therefore the LA of choice for continuous IV administration, it has analgesic, and anti-inflammatory effects that are induced by reduction of cytokines production through inhibition of neutrophil activation, and the analgesia may persist even after plasma concentration reduction. It can blunt the pressor response to endotracheal intubation also systemic lidocaine was effective in producing controlled hypotension.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective functional endoscopic sinus surgery;
* ASA class I-II,
* aged (20-60 years).

Exclusion Criteria:

* Body mass index \>35 kg/m2
* History of allergic reaction to local anesthetic agents especially lignocaine.
* History of preoperative use of opioids.
* Patients with history of uncontrolled hypertension, A-V conduction block.
* History of sleep apnea.

Primary outcomes:
measure: quality of postoperative recovery
timeFrame: 48hours
measure: Emergence agitation
timeFrame: 30 minutes postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Rehab Abd Elraof Abd Elaziz
Study officials:
affiliation: Alexandria University
name: Rehab A. Abd Elaziz, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06293989: Efficacy and Safety of Intravenous Diazepam Given at 2 Different Doses Compared to Placebo in Acute Peripheral Vertigo
Official title: Efficacy and Safety of Intravenous Diazepam Given at 2 Different Doses Compared to Placebo in Acute Peripheral Vertigo: A Randomized Controlled Double Blinded Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Vertigo, Peripheral
Keywords: vertigo
diazepam
placebo
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 1000
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 prospective, randomised double-blind study that will be conducted in the emergency department of 3 university hospitals (FB Monastir, Sahloul Sousse, and FH Sousse) to compare the efficacy of two doses of diazepam (Valium®) and placebo for the relief of acute periphery vertigo in the ED

Detailed description: This is prospective, randomised double-blind study that will be conducted in the emergency department of 3 university hospitals (FB Monastir, Sahloul Sousse, and FH Sousse) to compare the efficacy of two doses of diazepam (Valium®) and placebo for the relief of acute periphery vertigo in the ED. The study should be reviewed and receive approval from the institutional review board. Principles of the Helsinki Declaration are considered All patients should provide their informed consent prior to enrollment.

Eligibility criteria: Inclusion Criteria;

* patients between 18 and 70 years of age
* a chief complaint of acute peripheral vertigo (APV) (sensation of spinning, which was worsened by movement and sudden in onset) were eligible if the treating emergency physician diagnosed an episode of vertigo that was peripheral in nature.

Exclusion Criteria: -Patients aged \> 70 years as central vertigo , -patients with a focal neurologic deficit, pregnancy, history of allergic reaction or contraindication to any of the test drugs, history of enrolment in a previous clinical drug trial,

* history of recent ingestion (within 24 hours) of a sedative, antihistamine, antipsychotic, or opioid,
* history of syncope or cardiac event, considerations of a central origin for vertigo -evidence of drug-induced vertigo or orthostatic hypotension -history of mental or neurological illness.

Primary outcomes:
measure: Visual analogue scale (VAS)-3H
timeFrame: 3 hours
Secondary outcomes:
measure: the Delta-VAS
timeFrame: 3 hous
measure: the time required to reach the resolution of the vertigo crisis
timeFrame: 3 hours
measure: Patients satisfaction
timeFrame: 3 hours
measure: number of patients with adverse effects
timeFrame: 3 hours
Other outcomes:
Locations:
Study officials:
affiliation: University of Monastir
name: Nouira semir, Pr
role: STUDY_DIRECTOR
References:
Clinical trial NCT03952689: Automatic Urine Output Measuring Device Performance Validation and Efficacy.
Official title: Automatic Urine Output Measuring Device Performance Validation and Efficacy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urine Output Decreased
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Observational, single arm test, self-controlled.
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the efficacy of Serenno Medical Automatic Urine Output measuring device in patients with indwelling urinary catheter hospitalized in the cardiac surgery intensive care unit.

Detailed description: In order to evaluate the efficacy of Serenno Medical Automatic Urine Output measuring device we will perform a non inferiority of study device in compare with Urinometer (with acceptance of 3% standard deviation), in patients hospitalized in the intensive care unit after cardiac surgery.

Secondary endpoints are to attribute and Identify urine output changes prior to early stage acute renal failure, and identifying urine output changes prior to fluid overload or dehydration.

Eligibility criteria: Inclusion Criteria:

* Subjects, aged \>18 years
* Patients hospitalized in the intensive care unit requiring an indwelling urinary catheter for urine output monitoring for at least 24 hours.

Exclusion Criteria:

* Known urological pathology including but not limited to nephrolithiasis, polycystic kidney disease, congenital abnormalities of the kidneys and or urinary tract, history of obstructive uropathy, advanced chronic kidney disease (stage 4) of any cause.
* Known pregnancy or lactating women.
* Cognitive and/or psychiatric impairment which may not allow cognitive signing on the informed consent unless patient has a legal representative that was appointed prior to patient enrollment.

Primary outcomes:
measure: Urine volume measurement.
timeFrame: 24 hours
Secondary outcomes:
measure: Acute renal failure detection by urine output measurement and creatinine level in the blood.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba medical center
Study officials:
affiliation: Sheba Medical Center
name: Eilon Ram, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05525689: Evaluating Technology Enabled Services in Perinatal Depression
Official title: Technology-Enabled Services to Support Care Mangers in Obstetrics Clinics to Treat Perinatal Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Perinatal
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2022-09-01
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators are evaluating a Technology Enabled Service (TES) to support the treatment of depression in the context of a collaborative care service in obstetrics clinics.

Detailed description: Investigators are evaluating a Technology Enabled Service (TES) to support the treatment of depression in the context of a collaborative care service in obstetrics clinics. The TES consists of digital technologies that connect patients to care managers remotely, providing tools for monitoring patient symptoms, communication, and delivery of a digital intervention. The intervention consists of a patient-facing app for assessment and self-management of depression.

Eligibility criteria: Inclusion Criteria:

* English speaking
* 18 years or older
* Referred to Northwestern Medicine COMPASS program for mental health care
* Currently pregnant or within 3 months of delivery
* Moderate to severe perinatal depression (defined as a PHQ-9 screen greater than or equal to 10)
* Owns a smartphone, has used smartphone in last 7 days

Exclusion Criteria:

* Experienced a pregnancy loss (miscarriage, termination, or stillbirth of the index pregnancy)
* Severe suicidality (as defined by the presence of a plan and intent to act on that plan)
* Not meeting the inclusion criteria described above

Primary outcomes:
measure: Depression
timeFrame: Continuous - Up to 12 weeks
Secondary outcomes:
measure: Anxiety
timeFrame: Continuous - Up to 12 weeks
measure: Satisfaction with care
timeFrame: Week 6, Week 12
Other outcomes:
measure: TWente Engagement with Ehealth Technologies Scale (TWEETS)
timeFrame: Week 6, Week 12
measure: Execution of Stepped Care
timeFrame: through study completion, an average of 12 weeks.
Locations:
city: Chicago
country: United States
facility: Prentice Women's Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: David Mohr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00152789: Normal Prostate: Oxygenation of the Prostate Gland in Men Undergoing Prostate Biopsy
Official title: Oxygenation of the Prostate Gland: a Polarographic Electrode Study in Men Undergoing Prostate Biopsy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2005-09-09
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is based on previous observation that, in men with localized prostate cancer, non-cancerous prostate tissue is hypoxic, and on the known contribution of hypoxia to the progression of cancer. Patients undergoing diagnostic prostate biopsy with serum prostate specific antigen (PSA) less than 10ng/ml and who have given informed consent will have oxygen measurements of the prostate and peri-prostatic tissue taken with the Eppendorf electrode at the time of biopsy. The oxygenation of normal prostate tissue will be compared to that of cancerous prostate tissue. In men with negative biopsies, the prostate tissue oxygen measurements will be compared with the peri-prostatic tissue oxygen measurements.


Eligibility criteria: Inclusion Criteria:

* Men due to undergo sextant prostate biopsy
* Serum PSA \<10 ng/ml

Exclusion Criteria:

* Previous diagnosis of prostate cancer
* Inability to give informed consent

Primary outcomes:
measure: Median pO2 and HP5 will be analyzed according to the presence or absence of tumour on biopsy
timeFrame: 7 years
Secondary outcomes:
measure: Median pO2 and HP5 for the prostate gland in each patient with negative biopsy result will be compared with the median pO2 and HP5 for peri-prostatic tissue.
timeFrame: 7 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Michael Milosevic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05563389: Statin Impact on Hepatic Decompensation
Official title: the Impact of Statin on Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Quality of Life
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the impact of statin on hepatic decompensation.

Detailed description: Cirrhosis is the late stage of liver damage and possess two phases:. The shift from compensated to decompensated cirrhosis is characterized by the onset of complications) which are associated with substantial morbidity and negative Impact on quality of life (QOL)Cirrhosis and its complications have a substantial economic, social, and personal impact on affected patients, as well as their families and caregivers

Eligibility criteria: Inclusion Criteria:

* cirrhosis adult both sex

Exclusion Criteria:

* renal insufficiency

Primary outcomes:
measure: impact on decompensation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
Study officials:
affiliation: assistant lecturer
name: khadija glal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03284489: Post Pancreatitis Complications Study (Based on a Prospective Data Base)
Official title: Prospective Cohort of Patients With Pancreatitis Hospitalized in West French Intensive Care Units
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pancreatitis
Keywords: Pancreatitis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2017-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pancreatitis hospitalized in ICU

Brief summary: The purpose of this observational epidemiological study is to investigate the management and the complications associated with pancreatitis. Datas will be analysed to answer pre-defined scientific projects and to improve management of these conditions.

Detailed description: Anonymous datas will be collected by study coordinators in a secured e-database.

Cross audit will be performed to check datas.

Eligibility criteria: Inclusion Criteria:

* pancreatitis

Exclusion Criteria:

* consent withdrawal

Primary outcomes:
measure: In ICU stay main complications
timeFrame: Within the 28 first days after ICU admission date
Secondary outcomes:
measure: Duration of Mechanical Ventilation
timeFrame: During ICU stay (up to 90 days)
measure: Length of ICU stay
timeFrame: During ICU stay (up to 90 days)
Other outcomes:
measure: Death
timeFrame: During ICU stay (up to 90 days)
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Tours
country: France
facility: Tours University Hospital
Study officials:
affiliation: Non-Affiliated
name: Karim Asehnoune, MD,PhD
role: STUDY_CHAIR
References: