louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02285556: The Diagnostic Assessment and Intervention Study of Amphetamine Type Stimulus
Official title: The Diagnostic Assessment and Intervention Study of Amphetamine Type Stimulus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amphetamine Addiction
Keywords: drug carving changes during rehabilitation
community
DNA
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this research is to inspire new medical ideas using brain image technology for the treatment of Amphetamine Type Stimulus addition, at the same time lowing the addition damage.

Detailed description: The study will increase the sample size based on the preliminary work,also, establish drug dependence induced craving associated environmental experiments , by using the multi-lead biofeedback instrument , CogState tester, event-related potentials Recorder and 3.0T high-field magnetic resonance imaging system to record the physiology , electrophysiology and brain changes during craving, taking a subjective self-assessment , clinical observations and physiological responses combined system to evaluate the ATS addiction degree.

Eligibility criteria: Inclusion Criteria:

* No previous history of any mental disorder meet the DSM-IV diagnosis
* aged 18-49 years old , men and women
* junior high school or higher education
* use of amphetamine-type substances time for more than one year
* cumulative use of amphetamines, substances dose of 50 grams or more.

Exclusion Criteria:

* Current or past had suffered neurological diseases
* exclusion of antisocial personality disorder and borderline personality disorder
* addicts in addition to other substances in tobacco , coffee, social drinking outside
* AIDS virus (HIV) detection positive patients .

Primary outcomes:
measure: the prevalence of ATS abuse or dependence characteristics and pathogenesis
timeFrame: Baseline
measure: the physiological psychology and cognitive impairment characteristic of ATS addicts,trends and ATS conducted cases.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Min Zhao, ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02080156: Impact of Continuous Positive Airway Pressure (CPAP) Therapy on Outcomes in Patients Undergoing Coronary Revascularization
Official title: Impact of Continuous Positive Airway Pressure Therapy on Outcomes in Patients Undergoing Coronary Revascularization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Ischaemic Heart Desease
Keywords: Obstructive Sleep Apnea
Percutaneous Coronary Intervention
Coronary Artery Bypass Graft
Mortality
Questionnaire
Biomarker
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 1200
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: Investigators assume that continuous positive airway pressure (CPAP) therapy can reduce the mortality, stroke rate and secondary coronary surgery in CAD with obstructive sleep apnea (OSA) patients after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABA) during postoperative follow-up of 3 years.

Detailed description: Investigators observe whether continuous positive airway pressure (CPAP) therapy can reduce the mortality, stroke rate and secondary coronary surgery in CAD with OSA patients after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABA) during postoperative follow-up of 3 years. During the 3 years, we randomize all enrolled patients to 2 groups separately beginning CPAP or no-CPAP intervention after sleep monitoring. Guidance for all patients during follow-up 1 week, 2 week, 1 month, 3 month. The follow-up procedure includes clinical assessments at three months, six months, one year, two and three years respectively.The primary outcome variables are prospectively being documented and are not subject to observer bias.Baseline comorbidity data, results of the sleep recordings, compliance with CPAP device, scores of the questionnaires as well as results of the blood analysis are performed and/or documented consecutively in separate files by research personnel blinded to the allocation of the study groups and/or unaware of the results of the concomitant outcomes.

Eligibility criteria: Inclusion Criteria:

* Angiography confirmed coronary heart disease (CHD) patients
* Underwent PCI or coronary artery bypass graft (CABG) in recent the week
* Signed informed consent
* Mild-to-moderate OSA（5≤AHI≤100)

Exclusion Criteria:

* OSA patients who has already started treatment
* Patients presenting mainly central apnea (≥ 50%)
* Respiratory insufficiency patients

Primary outcomes:
measure: Mortality
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: Capital Medical University Affiliated Beijing Anzhen Hospital
name: Yongxiang Wei, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02619656: A Trial of Supplemental CO2 Versus Room Air in Percutaneous Endoscopic Gastrostomy
Official title: Insufflation With Carbon Dioxide Reduces Pneumoperitoneum After Percutaneous Endoscopic Gastrostomy (PEG): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumoperitoneum
Keywords: PEG
CO2 insufflation
Room Air insufflation
pneumoperitoneum
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 35
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: The investigators hypothesize that using carbon dioxide for PEG placement versus using room air will decrease post-procedure pneumoperitoneum as well as improve post-procedure bloating/pain, and waist circumference.

Detailed description: Background and study aims: Pneumoperitoneum following PEG placement has been reported in up to 60% of cases, and while usually benign and self-limited, it can lead to evaluation for suspected perforation. This study was designed to determine whether using CO2 compared to ambient air for insufflation during PEG reduces post-procedure pneumoperitoneum.

Patients and Methods: Prospective, double blind, randomized trial of 35 consecutive patients undergoing PEG at a single academic medical center. Patients were randomized to insufflation with CO2 or ambient air. Primary outcome was pneumoperitoneum determined by left-lateral decubitus abdominal x-rays 30 min after PEG placement. Secondary endpoints included abdominal distention, pain, and bloating.

Eligibility criteria: Inclusion Criteria:

* Participants must be over the age of 18 and need a percutaneous endoscopic gastrostomy

Exclusion Criteria:

* None

Primary outcomes:
measure: Post-procedure pneumoperitoneum
timeFrame: left-lateral decubitus abdominal x-rays 30 min after PEG placement.
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah SOM
state: Utah
Study officials:
affiliation: University of Utah SOM
name: Christopher Murphy, MD
role: STUDY_CHAIR
affiliation: University of Utah SOM
name: John C Fang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03642756: Effects of Different Intra-arterial Catheter Size on Frequency of Optimal Dynamic Response in Radial Arterial Waveform
Official title: Effects of Different Intra-arterial Catheter Size on the Frequency of Optimal Dynamic Response in Radial Arterial Waveform
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Catheters
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 366
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to compare the effects of different intra-arterial catheter size on the frequency of optimal dynamic response in radial arterial waveform.


Eligibility criteria: Inclusion Criteria:

* patients who were scheduled for elective neurosurgery under general anesthesia
* patients with age of 20-79 and ASA class I-III
* patients who are needed to establish invasive arterial pressure monitoring

Exclusion Criteria:

* patients who refuted to be involved in the study
* patients with age of \<20 or \>80
* patients who had both arm saved
* patients who had a previous history of surgery on radial artery

Primary outcomes:
measure: The frequency of adequately damped arterial waveform
timeFrame: 1 minute after cannulation
Secondary outcomes:
measure: The difference of mean blood pressure between invasive blood pressure and non-invasive blood pressure
timeFrame: 1 minute after cannulation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Oh H, Choe SH, Kim YJ, Yoon HK, Lee HC, Park HP. Intraarterial catheter diameter and dynamic response of arterial pressure monitoring system: a randomized controlled trial. J Clin Monit Comput. 2022 Apr;36(2):387-395. doi: 10.1007/s10877-021-00663-7. Epub 2021 Feb 1.
Clinical trial NCT01539356: Hepcidin Levels in Preterm Infants
Official title: Hepcidin Levels in Preterm Infants Receiving Blood Transfusion and During Sepsis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Infants
Anemia of Prematurity
Neonatal Sepsis
Keywords: Hepcidin
Preterm Infants
Anemia
Sepsis
Ferritin
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2012-02-27
Enrollment: 62
Sex: ALL
Minimum age (years): 24
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm \< 38 weeks gestation Need of blood transfusion according to local Protocol. or signs and symptoms of sepsis

Brief summary: A recently isolated peptide hormone, hepcidin, is thought to be the principal regulator of iron homeostasis. Hepcidin acts by limiting intestinal iron absorption and promoting iron retention in reticuloendothelial cells. The aims of this study were to determine serum hepcidin levels in preterm infants who receive blood transfusion and preterm infants having sepsis, in order to assess possible relationships between hepcidin and serum iron, serum ferritin,in iron load situations.


Eligibility criteria: Inclusion Criteria:

* Preterm \< 38 weeks gestation
* Need of blood test for anemia or suspected sepsis

Exclusion Criteria:

* Major congenital anomalies
* Birth Asphyxia

Primary outcomes:
measure: Increase in Hepcidin levels by 30%
timeFrame: within 24-72 h
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Neonatal Intensive Care Unit
Study officials:
References:
citation: Muller KF, Lorenz L, Poets CF, Westerman M, Franz AR. Hepcidin concentrations in serum and urine correlate with iron homeostasis in preterm infants. J Pediatr. 2012 Jun;160(6):949-53.e2. doi: 10.1016/j.jpeds.2011.12.030. Epub 2012 Jan 28.
citation: Yapakci E, Tarcan A, Celik B, Ozbek N, Gurakan B. Serum pro-hepcidin levels in term and preterm newborns with sepsis. Pediatr Int. 2009 Apr;51(2):289-92. doi: 10.1111/j.1442-200X.2008.02688.x.
Clinical trial NCT03036956: The Prevalence of Sub Clinical Hypothyroidism During Early Pregnancy in Pakistan
Official title: The Prevalence of Sub Clinical Hypothyroidism During Early Pregnancy in Pakistan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subclinical Hypothyroidism
Keywords: subclinical hypothyroidism in pregnancy
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Dimension Research
First posted: 2017-01-31
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic/Private Clinic

Brief summary: The Precious study is likely to help determine the frequency (percentage) of subclinical hypothyroidism among pregnant women in Pakistan It will also help to determine the risk factors for developing subclinical hypothyroidism during pregnancy


Eligibility criteria: Inclusion Criteria:

* Subjects must meet all of the following criteria to be enrolled into the study
* Patient between 18-45 years of age; is pregnant and in First Trimester
* Patient willing to give blood sample for laboratory testing
* Patient willing to provide written authorization to obtain data for the study
* Exclusion Criteria:
* Patients suffering from any

  * Chronic Cardiac Disease - Chronic Cardiac Failure, Cardiac Arrhythmia
  * Hepatic Disorder : Cirrhosis
  * Renal Disease : Patients on dialysis and Transplant Therapy
  * Respiratory Disorder
* Subjects with history of non-thyroid malignancy
* Patient currently taking medication for hyperthyroidism
* Active systemic infection
* Patient with physical or mental impairment
* Patients on systemic steroid therapy or lithium therapy
* Patients in second or third trimester of pregnancy
* Patient not willing to give blood sample for laboratory testing
* Patient not willing to provide written authorization to obtain data for the study

Primary outcomes:
measure: Frequency of subclinical hypothyroidism in pregnant females
timeFrame: 12 months
Secondary outcomes:
measure: The risk factors that might be associated with subclinical hypothyroidism in all enrolled pregnant patients.
timeFrame: 12 months
Other outcomes:
Locations:
city: Hyderabad
country: Pakistan
facility: Isra University hospital
city: Islamabad
country: Pakistan
facility: Pakistam Insititute of Medical science
city: Karachi
country: Pakistan
facility: Atia Hospital Hospital
city: Karachi
country: Pakistan
facility: Boluvard Hospital
city: Karachi
country: Pakistan
facility: MediCell Hospital
city: Lahore
country: Pakistan
facility: Services Hospital
city: Lahore
country: Pakistan
facility: Sir Ganga Ram hospital
city: Muzafferabad, Azad Kashmir
country: Pakistan
facility: Welcare Medical Centre
city: Peshawar
country: Pakistan
facility: Lady Reading hospital
Study officials:
affiliation: Abbott
name: Raeefuddin Ahmed, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06384456: Topical TRanexamic Acid Vs. Placebo on Acute Postoperative Pain Following DRF Fixation
Official title: The Effect of Topical TRanexamic Acid Vs. Placebo on Acute Postoperative Pain Following Distal Radius Fracture Fixation: a Randomized Controlled Trial - the TRADR Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Distal Radius Fractures
Keywords: Distal Radius Fractures
acute pain
Topical tranexamic acid
Open Reduction and Internal FIxation
Placebo
Randomized Control Trial
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 90
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 goal of this study is to find out whether the use of topical tranexamic acid (TXA) into the surgical wound will result in less post-operative pain, less pain killer use, and better post-operative use of the wrist in people undergoing surgery for a wrist fracture compared to not using topical TXA (placebo).


Eligibility criteria: Inclusion Criteria:

* Patients undergoing open reduction internal fixation (Volar approach) for operative management of a distal radius fracture;
* Aged 18 or older;
* Provision of informed consent;
* Cognitive ability and English-language skills required to complete outcome measures.

Exclusion Criteria:

* Revision surgery or any additional operative management of ipsilateral wrist injury
* Distal radius fracture treated with a dorsal approach
* Known history of lymphedema or lymph node dissection in the operative extremity
* Known chronic pain conditions, fibromyalgia, or polymyalgia rheumatic
* Current user of opioids and/or on chronic opioids use
* Known allergic reaction to TXA
* Anticoagulant use not stopped in time for surgery as per thrombosis Canada guidelines (i.e. warfarin, acetylsalicylic acid, direct oral anticoagulants, etc.)
* Previous thrombotic stroke or thromboembolic disorders (i.e. known previous DVT, PE, or clotting disorders)
* Current pregnancy or breastfeeding
* Previous neurologic injury causing paralysis of affected shoulder/arm
* Severe cardio-respiratory disease (i.e. ASA Grade IV or higher).

Primary outcomes:
measure: acute post-op pain
timeFrame: 24 hours to 72 hours postoperatively
Secondary outcomes:
measure: opioid use
timeFrame: 1, 2, and 6-week post-surgery
measure: persistent pain
timeFrame: 1, 2, and 6-week post-surgery
measure: unscheduled hand-related procedures
timeFrame: 1, 2, and 6-week post-surgery
measure: Patient reported function
timeFrame: 1, 2, and 6-week post-surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT02091856: Internet-delivered Psychotherapy for Depression
Official title: Internet-delivered Cognitive-Behavioral Therapy for Depression: A Randomized Controlled Trial (PsiTOD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mild - Major Depression
Lead sponsor: West University of Timisoara
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2014-03-19
Enrollment: 79
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: Project aim: To compare the effectiveness and acceptability of a conventional and a religious internet-supported cognitive behavior therapy (iCBT) for depression in Romania.

Detailed description: Previous studies suggest that incorporating religious beliefs into conventional CBT appears to be helpful for religious individuals. In order to have two active comparable interventions the investigators added to the conventional CBT a similar set of exercises devised from the positive psychology paradigm.

Eligibility criteria: Inclusion Criteria:

* be fluent in Romanian
* be over 18 years
* have a diagnosis of current major depression disorder
* have access to an Internet connected computer

Exclusion Criteria:

* suicidal ideation
* ongoing psychological treatment for depression
* other primary disorder that need treatment
* obstacle to participation (i.e., long travel plans)
* recent change in psychiatric medication (i.e., during the last 6 weeks)

Primary outcomes:
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: Absolute values (average score) of Back Depression Inventory-II at 11 weeks (post-intervention)
measure: Beck Depression Inventory II (BDI-II)
timeFrame: Absolute values (average score) of BDI-II at 37 weeks (follow-up)
Secondary outcomes:
measure: Beck Anxiety Inventory (BAI)
timeFrame: Absolute values (average score) of Back Anxiety Inventory at 11 weeks (post-intervention)
measure: Quality of Life Inventory (QOLI)
timeFrame: Absolute values (average score) of QOLI at 11 weeks (post-intervention)
measure: Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
timeFrame: Absolute values (average score) of QIDS-SR after 11 weeks (post-treatment)
Other outcomes:
Locations:
city: Timisoara
country: Romania
facility: West University of Timisoara
state: Timis
Study officials:
affiliation: West University of Timisoara
name: Bogdan Tudor Tulbure, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02311556: Response of Brain Metastases After Gamma-Knife Radiosurgery Using Dynamic Susceptibility-weighted Contrast-enhanced Perfusion Magnetic Resonance Imaging
Official title: Assessment of Early Treatment Response of Brain Metastases After Gamma-Knife Radiosurgery Using Dynamic Susceptibility-weighted Contrast-enhanced Perfusion Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Brain Metastases
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is designed to evaluate whether advanced magnetic resonance imaging (MRI) techniques such as dynamic susceptibility-weighted contrast-enhanced perfusion MRI may be used to predict treatment response of brain metastasis after radiosurgery.


Eligibility criteria: Inclusion Criteria:

* Patient must have newly diagnosed brain metastases visible on brain MRI. A biopsy of the lesion is not required as long as the patient has a biopsy-proven malignancy elsewhere and a clinician deems the lesion to be metastatic.
* At least one brain metastasis must be ≥ 1cm to allow adequate quantitative imaging measurement for DSC-PMR.
* Patient must be clinically eligible for and elect to be treated with GK alone without WBRT.
* Patient must be ≥ 18 years of age.
* Patient must have Karnofsky Performance Status (KPS) of at least 60
* Patient may be part of other clinical trials (as long as no other local treatments beyond GK such as WBRT or other local therapy are indicated to the brain) or imaging studies.
* Patient or legally authorized representative must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Patient must not have any medical contraindications to MRI (e.g., unsafe foreign metallic implants, incompatible pacemaker, inability to lie still for long periods, severe to end-stage kidney disease or on hemodialysis).
* Patient must not be pregnant or breastfeeding.
* Patient must not have an estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2.
* Patient must not have melanoma.
* Patient must not have hemorrhagic lesions.

Primary outcomes:
measure: Time to local progression of each treated and evaluable brain metastasis
timeFrame: At time of radiosurgery and after radiosurgery (approximately 1 week)
Secondary outcomes:
measure: Radiation necrosis
timeFrame: Up to 1 year
measure: Complete response
timeFrame: Up to 1 year
measure: Elsewhere brain failure
timeFrame: Up to 1 year
measure: Clinical deterioration
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University of Medicine
name: Jiayi Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: