louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01502540: Pain Prevalence After Major Craniotomy
Official title: Pain Prevalence After Major Craniotomy in Siriraj Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Craniotomy
Keywords: pain
craniotomy
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-12-30
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient undergoing cranitomy

Brief summary: Craniotomies are generally thought to be less painful than other operations. Indeed recent studies have confirmed that pain is a common problem during the postoperative phase following craniotomy.Pain not only causes discomfort, but it is also associated with other potential adverse events such as increased sympathetic activity and elevated systemic blood pressure. These events in turn may contribute to increased intracranial pressure. Some patients may also develop chronic pain.Potent opioids have been avoided due to its potential to cause respiratory depression and risk of masking pupillary signs. As a result postoperative craniotomy pain controls are usually inadequate.

In Siriraj hospital, there are 500-600 craniotomy patients per year. Still there are no definite guidelines for postoperative pain management in these patents due to lack of information about quality of postoperative pain control after craniotomy.

Objectives

Primary objective :

- To study incidence of moderate to severe pain during first 48 hours after craniotomy.

Secondary objectives :

* To determine risk factors for moderate to severe pain during first 48 hours after craniotomy
* To evaluate side effects and complications of postoperative craniotomy pain control
* To compare patient's expectation for pain management before and after surgery
* To determine patient's satisfaction for postoperative pain management


Eligibility criteria: Inclusion Criteria:

* Patient undergoing major craniotomy (supratentorial surgery and Infratentorial surgery)
* Age \> 18 years

Exclusion Criteria:

* Emergency or trauma
* Need postoperative ventilatory support
* Cannot communication
* Psychosis
* Not adherence to the treatment protocol
* History of using benzodiazepine or addictive substance

Primary outcomes:
measure: incidence of moderate to severe pain following major craniotomy
timeFrame: 48 hours
Secondary outcomes:
measure: risk factors of moderate to severe pain following craniotomy.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Sirilak Suksompong
Study officials:
affiliation: Mahidol University
name: Sirilak Suksompong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00517140: Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function
Official title: Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Cesarean Section
Uterine Rupture
Keywords: Pregnancy women with a scarred uterus due to previous caesarean section
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: Chinese University of Hong Kong
First posted: 2007-08-16
Enrollment: 262
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The incidence of caesarean section has reached 15-20% in most developed countries. Encouraging vaginal birth after caesareans section (VBAC) has been considered a key component of a strategy to reduce the caesarean section rate. Most medical literature has focused on the efficacy of VBAC in reducing the caesarean section rate and the physical safety of successful VBAC. However, 30%-40% of these women fail to achieve a vaginal delivery. Little is known about how the uncertainty of labour outcome and a failed VBAC impact on the psychosocial function of these women. We propose to study a cohort of women with a prior caesarean section and presenting with a subsequent pregnancy for care. After consent and recruitment, these subjects will be randomly assigned to have a repeat caesarean section or VBAC. The medical outcomes, overall satisfaction of the subjects with the care they received, and the short-term psychosocial function of these subjects will be studied. The result of this study will provide important information that would be useful in assisting women to decide the mode of delivery after a prior caesarean section.


Eligibility criteria: Inclusion Criteria:

All women who:

* Have one prior caesarean section
* No prior vaginal delivery and
* Agree for either vaginal delivery or elective caesarean section

Primary outcomes:
measure: pscyiatric morbidity
timeFrame: after delivery
Secondary outcomes:
measure: Psychosocial function
timeFrame: 3 and 6 months after delivery
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Obstetrics and Gynaecology, Prince of Wales Hospital
Study officials:
affiliation: Department of Obstetrics and Gynaecology, The Chinese Univerisity of Hong Kong
name: Tze Kin Lau, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02942667: Magnetic Resonance Imaging of Human Biometrics
Official title: Magnetic Resonance Imaging of Human Biometrics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Volunteers
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2016-10-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll up to 30 subjects at up to 5 study sites in the US.

Brief summary: The primary objective is to collect high quality MRI data (un-processed or processed) from participating subjects for Medtronic research purposes.


Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years of age
* Subject is willing and able to undergo study requirements

Exclusion Criteria:

* Subject has a medical condition that precludes the subject from participation
* Subject has any magnetizable foreign object (e.g. jewelry) which cannot be removed for the duration of the study
* Subject is claustrophobic
* Subject is unable to stand without assistance
* Subject requires sedation for MRI scans
* Subject is implanted with non-Magnetic Resonance conditional or other medical device:

  * Non-MRI conditional pacemaker, Implantable Cardiac Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT), or an implantable hemodynamic monitor
  * Metal clips (i.e. brain aneurysm clip)
  * Artificial heart valve
  * Implanted neural stimulator
  * Gastric capsule camera
  * Swan Ganz catheter
  * Stent
  * Inferior Vena Cava (IVC) filter
  * Orthopedic implant
  * Eye prosthesis
  * Vascular access port
  * Penile prosthesis
  * Intrauterine device
* Subject has a cochlear implant, middle ear prosthesis, or has had ear surgery
* Subject has ocular foreign bodies (i.e. metal shavings)
* Subject has any type of device held in place by a magnet (i.e. dentures)
* Subject has an insulin pump
* Subject has metal shrapnel
* Subject is pregnant or lactating
* Subject has magnetizable implant
* Subject requires legally authorized representative to sign Patient Informed Consent (PIC)/ Informed Consent (IC) form
* Subject has other contraindication for an MRI scan as defined by the study site

Primary outcomes:
measure: Collect High Quality MRI Data
timeFrame: Approximately 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
state: North Carolina
Study officials:
References:
Clinical trial NCT03777540: Gastric Cancer Surgery in Elderly Patients
Official title: Post-Operative Outcomes And Predictors Of Mortality After Gastric Cancer Surgery In The Very Elderly Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 236
Sex: ALL
Minimum age (years): 80
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 236 patients (181: 80-85 years old and 55: \>85 years old) underwent surgery for gastric cancer at the Sant'Orsola-Malpighi University Hospital in Bologna between 2010 and 2015.

Brief summary: Gastric cancer is most frequent after the fifth decade of life. Surgical risk is higher in aged population because of general health condition may affect the postoperative result. Aim of the study was to identify risk factors for post-operative mortality in octogenarian patients who underwent surgery for gastric cancer.

Detailed description: 236 patients (181: 80-85 years old and 55: \>85 years old) underwent surgery for gastric cancer at the Sant'Orsola-Malpighi University Hospital in Bologna between 2010 and 2015. The variables of the two groups of patients were compared.

Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed primary gastric cancer submitted to surgical treatment;
* Age \> 80 years.

Exclusion Criteria:

* Patients with histologically confirmed primary gastric cancer submitted to surgical treatment and age \< 80 years;
* Patients with histologically diagnosis of other neoplastic and non-neoplastic diseases submitted to surgical treatment.

Primary outcomes:
measure: Post-operative mortality In-hospital mortality was defined that occurred during hospitalization up to 90 days excluded post-operative mortality. Postoperative mortality
timeFrame: Up to 90-days
Secondary outcomes:
measure: Overall survival
timeFrame: Up to 5-years
Other outcomes:
Locations:
Study officials:
affiliation: University of Bologna
name: Bruno Nardo, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04023240: 68-Ga-FAPI PET Imaging in Malignancy
Official title: 68Ga-FAPI PET Imaging in Malignancy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This feasibility trial studies the use of gallium-68 (68Ga)-FAPI as the imaging agent for positron emission tomography (PET)/computed tomography (CT), collectively PET/CT, in patients with various cancers. PET uses a radioactive substance called 68Ga-FAPI, which attaches to cancer activated fibroblasts. The PET scanner takes pictures that capture where the radioactive drug is "lighting up" and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy tissue. CT uses X-rays to make a picture of areas inside the body. Using 68Ga-FAPI in diagnostic procedures, such as PET/CT, may allow doctors to identify smaller tumors than standard imaging.

Detailed description: PRIMARY OBJECTIVE:

To assess feasibility and biodistribution of PET imaging in malignancy using 68Ga-FAPI.

OUTLINE:

Patients receive 68Ga-FAPI intravenously (IV) and then undergo PET/CT approximately 1 hour later.

After completion of study, patients are followed up at 24-72 hours.

Eligibility criteria: Inclusion Criteria:

* Patient with current malignancy confirmed via pathology or imaging
* Patient must be \> 18 years old
* Patient must be willing and able to provide written informed consent for the trial
* Patient of reproductive potential will have a pregnancy test

Exclusion Criteria:

* Pregnant or breastfeeding

Primary outcomes:
measure: Feasibility of 68Ga-FAPI PET
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Hospitals and Clinics
state: California
Study officials:
affiliation: Stanford Universiy
name: Carina A Mari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03728140: Embryo Transfer With Self-spent Culture Medium
Official title: Can Embryo Transfer With Self-spent Culture Medium Improve Clinical Pregnancy Outcomes in Vitro Fertilization - Embryo Transfer Process?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: in Vitro Fertilization
Keywords: Embryo Transfer
Lead sponsor: Jinan Central Hospital
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 335
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Embryo Transfer With Self-spent Culture Medium or new Culture Medium in Vitro Fertilization - Embryo Transfer Process, to analyze which way can improve clinical pregnancy outcomes, is there a significant difference between the two?

Detailed description: Although some metabolites are present in self-spent culture medium, there are some embryonic exocrine factors secreted by embryo.These factors may have a positive impact on embryo implantation and subsequent development. So it is necessary to compare the two ways of embryo transfer with Self-spent Culture Medium or New Culture Medium in vitro fertilization - embryo transfer process.

The purpose of this study is to analyze which way can improve clinical pregnancy and birth outcomes, is there a significant difference between the two?

Eligibility criteria: Inclusion Criteria:

* Infertility female patients with tubal factors,
* Infertile female patients with spouse factors

Exclusion Criteria:

* Intrauterine adhesions,
* Endometriosis,
* Primary ovarian insufficiency，
* Infectious disease

Primary outcomes:
measure: Number of Participants Pregnant After 4 Weeks
timeFrame: 4 weeks
measure: Live Birth
timeFrame: 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Jinan Central Hospital Affiliated to Shandong University
state: Shandong
Study officials:
affiliation: Jinan Central Hospital
name: Yingchun zhang, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT02595840: Biomarker Study Accompanying the AIO-TRK-0114 Study (MARBLE)
Official title: Biomarker Study Accompanying the AIO-TRK-0114 Study (MARBLE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-small-cell Lung Cancer With Somatic EGFR Mutations
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2015-11-04
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, open-label, phase II study
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of afatinib maintenance with pemetrexed maintenance following induction therapy with platinum/ pemetrexed in patients with metastatic EGFR mutated non-small-cell lung cancer progressing after first-line treatment with afatinib as first tyrosine kinase inhibitor with respect to progression-free survival

Detailed description: Patients who have progressed after first-line treatment with afatinib as first tyrosine kinase inhibitor (TKI) will be screened while they are receiving second-line (induction) treatment consisting of cisplatin / carboplatin plus pemetrexed given in 21-day cycles. Patients who do not progress (i.e. complete or partial response, or stable disease - CR, PR or SD) after completion of at least three and not more than four chemotherapy cycles will be randomized (1:1 ratio) to receive maintenance therapy with either afatinib (40 mg/d or last tolerated dose during first-line treatment with afatinib as first TKI) or pemetrexed (500 mg/m2 or 375 mg/m2 if dose reduction was required every 21 days) until disease progression or treatment discontinuation because of patient decision or toxicity.

Eligibility criteria: Inclusion Criteria:

1. Participation in the AIO-TRK-0114 (MARBLE) study (EudraCT-No. 2014-001983-36)
2. Written informed consent

Exclusion Criteria:

1. Patients who do not meet the inclusion criterial of the AIO-TRK-0114 (MARBLE) study (EudraCT-No. 2014-001983-36)

Primary outcomes:
measure: Progression-free Survival in relation to exploratory biomarkers
timeFrame: until progression
Secondary outcomes:
measure: Overall Survival in relation to exploratory biomarkers
timeFrame: continuous assessment
measure: Objective response rate
timeFrame: Assessed every 6 weeks for 24 weeks, then every 9 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01728740: Bioequivalence Study for Acarbose / Metformin FDC
Official title: Randomized, Non-blinded Crossover Study to Establish the Bioequivalence Between Fixed Dose Combination (FDC) and Loose Combination of Acarbose and Metformin and to Investigate the Potential for a Drug-drug Interaction Following Single Oral Dosing in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type II
Keywords: Bioequivalence
Acarbose
Metformin
FDC
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-11-20
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI): 18 to 28 kg/m2 (inclusive)
* Results of Glycosylated Hemoglobin A1c (HbA1c) value are within the normal range (4.3-5.6%, inclusive)
* Results of the 75 g oral glucose tolerance test (OGTT) during screening show:

  * Blood glucose before OGTT \<110 mg/dL.
  * Blood glucose 1 hour after glucose loading \<180 mg/dL
  * Blood glucose 2 hours after glucose loading \<140 mg/dL

Exclusion Criteria:

* A history of relevant diseases of internal organs (diabetes mellitus, Ileus, Ileus-like symptoms, diseases that may significantly jeopardize body systems
* Febrile illness within 1 week before drug administration
* Family history of diabetes (within the second degree of relationship)
* Known drug hypersensitivity or idiosyncrasy
* Known severe allergies, non-allergic drug reactions, or multiple drug allergies
* Habitual medication including Chinese herbal drugs
* Intake of any drugs within 2 weeks of drug administration of period 1
* Regular daily consumption of more than 1 L of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form
* Donation of more than 150 mL of blood within 4 weeks before the screening examination
* Participation in another clinical trial within 4 weeks before the screening examination

Primary outcomes:
measure: Ratio of postprandial maximum concentration (Cmax) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)
timeFrame: within 4 hours after sucrose load
measure: Ratio of postprandial Area Under the Curve (AUC(0 4)) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)
timeFrame: within 4 hours after sucrose load
measure: Cmax of metformin
timeFrame: within 24 hours after dosing
measure: AUC(0-tn) of metformin
timeFrame: within 24 hours after dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01733940: Efficacy of Tegaderm-CHG® Dressing vs. Tegaderm-IV® Dressing
Official title: Efficacy of Tegaderm-CHG® Dressing vs. Tegaderm-IV® Dressing in the Reduction of Central Catheter Colonization in Patients of the Intensive Care Unit of the University "Gómez Ulla" Hospital.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Intravascular Catheter Colonization
Lead sponsor: Hospital Central de la Defensa Gómez Ulla
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Introduction: The vascular catheter-related bacteremia (BRC) is a major health problem in intensive care units. The use of dressings containing chlorhexidine gluconate (CHG) can decrease the catheters colonization, closely related to infection thereof.

Objective: To determine the efficacy of the dressing "Tegaderm CHG" dressings versus "Tegaderm IV" dressings in reducing the risk of colonization of central intravascular catheters in the intensive care unit (ICU).

Methods: Randomized controlled trial with blinding professional who reviews the main outcome. The study included patients over 18 years, indicating the central intravascular catheter implantation in the ICU or in the operating room, prior informed consent. Excluding subjects with positive blood culture at the time of catheter implantation.

The estimated sample size is 398 patients, with a confidence level of 95% and a statistical power of 80%. The study protocol was approved by the ethics committee of the hospital.

Be made prospectively followed subjects from study entry until catheter removal collecting information on age, sex, APACHEII, antibiotic therapy, duration of catheter insertion site and removal, reason for withdrawal and microbiological information.

For statistical analysis, a model is adjusted multivariate logistic regression, determining the interaction of variables with the likelihood ratio test and confusion by switching between the crude and adjusted effect greater than 10%.

Results and conclusions: The recruitment has started in November 2012 and is scheduled for completion in March 2013. This study will determine whether these new dressings are effective in our environment.


Eligibility criteria: Inclusion Criteria: over 18 years, indicating the central intravascular catheter implantation in the ICU or in the operating room, prior informed consent -

Exclusion Criteria:positive blood culture at the time of catheter implantation.

-

Primary outcomes:
measure: Incidence of intravascular central catheter colonization.
timeFrame: November 2012- March 2013
Secondary outcomes:
measure: Adverse effects of CHG Tegaderm ® dressings.
timeFrame: up to 4 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Central Hospital of the Defense
Study officials:
References: