louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02846961: Anti CT-P13 Antibody in Moderate to Severe Inflammatory Bowel Disease
Official title: Occurrence of Anti-drug Antibody and Change of Drug Level for 1 Year After CT-P13 Therapy and Their Impact on Clinical Outcomes in Moderate to Severe Inflammatory Bowel Disease (OACIS Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Ulcerative Colitis
Crohn's Disease
Keywords: inflammatory bowel disease
biosimilar
anti-drug antibody
trough drug concentration
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 280
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate to severe inflammatory bowel disease who need to receive biosimilar CT-P13

Brief summary: The purpose of this study is to evaluate the development of anti-drug antibody to biosimilar CT-P13 and to assess the change of drug concentration for 1 year in patients with moderately to severe inflammatory bowel disease.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Crohn's disease or ulcerative colitis

Exclusion Criteria:

* Tuberculosis infection
* Allergy to CT-P13

Primary outcomes:
measure: Development of anti-drug antibody to CT-P13
timeFrame: one year
Secondary outcomes:
measure: Change of drug trough concentration
timeFrame: one year
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
affiliation: Sungkyunkwan University
name: Dong Il Park, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06722261: Single Case Research Design: Deaf Children's Language Outcomes
Official title: Single Case Research Design: Deaf Children's Language Outcomes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Language Development
Keywords: Sign Language
Deaf
Intervention
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2024-12-09
Enrollment: 8
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Eight deaf children in kindergarten to 3rd grade classes will be randomly selected for single case research. Their language skills will be monitored and assessed daily. Using a noncurrent multiple baseline design (Single Case Research Design or SCRD), Strategic and Interactive Signing Instruction (SISI) will be administered to two children in each of four classes.

Detailed description: A randomized selection method will be employed to select deaf children to participate in single case research. Two children will be selected from each age group between 5 and 10, making a total of eight students. Their language skills will be closely monitored and evaluated over the course of the year. Following the noncurrent multiple baseline design, in succession across 8 child participants in 4 classes, 2 SCRD participants in a class will begin receiving SISI while other children remain in the baseline for 3 weeks. Brainstorming occurs on Monday and the final sign language composition is shared on Friday. At the end of each day's intervention, child participants will independently narrate their expressed message recorded on videos. A score of 1 (applied correctly), 0.5 (applied but incorrectly), or 0 (omitted) will be given to their inclusion of target sign language skills, which is converted into percentages. If a child receives 100% on their target SL skill for 3 consecutive days (3 data points), Teacher 1 will select a new sign language skill to target. If the child receives 0% or 50% on their target sign language skill, Teacher 1 continues to focus on the same sign language skill.

Eligibility criteria: Inclusion Criteria:

* Deaf children in kindergarten to 3rd grade class in a school for the deaf

Exclusion Criteria:

* Non-deaf children

Primary outcomes:
measure: Sign Language Skills
timeFrame: From enrollment to the end of treatment 9 academic months later.
Secondary outcomes:
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee, Knoxville
state: Tennessee
Study officials:
References:
Clinical trial NCT01390883: Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal (Urology,Obstetrics,Gynecology)
Official title: Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal (Urology,Obstetrics,Gynecology)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-07-11
Enrollment: 475
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese patients undergoing abdominal surgery in urology, obstetrics and gynecology departments who are at high risk of venous thromboembolism

Brief summary: The purpose of this study is to collect and assess information on safety and efficacy of fondaparinux in patients undergoing abdominal surgery in urology, obstetrics and gynecology departments who are at high risk of venous thromboembolism.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing abdominal surgery in urology, obstetrics and gynecology departments

Exclusion Criteria:

* Patients with a history of hypersensitivity to the ingredients of fondaparinux
* Patients with bleeding (bleeding in important organs, sucn as retroperitoneal bleed)
* Patients with acute bacterial endocarditis
* Patients with severe renal impairment

Primary outcomes:
measure: The number of adverse events in Japanese patients treated with fondaparinux
timeFrame: 4 months at maximum
measure: Presence or absence of venous thromboembolism after treatment of fondaparinux
timeFrame: 4 months at maximum
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06497283: Binaural Sound for Remimazolam Maintenance
Official title: The Effect of Intraoperative Binaural Sound on Remifentanil Dose Required for General Anesthesia Using Remimazolam: a Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: General Anesthesia
Prostate Cancer Stage
Uterine Myoma
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is important to decrease the remifentanil dose for general anesthesia maintenance when using remimazolam. We will evaluate the effect of binaural sound on general anesthesia maintenance with remimazolam infusion.


Eligibility criteria: Inclusion Criteria:

1. Patients scheduled for general anesthesia
2. Patients aged 20-60
3. Patients with American Society of Anesthesiologist physical status classification 1-2
4. Patients with ideal body weight 50-80 kg

Exclusion Criteria:

1. Patients with hearing disability
2. Patients using opioids or sedatives in 1 week
3. Patients who are dependent for alcoholics or drugs
4. Patients with hypersensitivities to remimazolam or remifentanil
5. Patients with arrhythmia, cardiovascular disease, heart failure, or hypovolemia
6. Patients with liver failure

Primary outcomes:
measure: Intraoperative remifentanil dose
timeFrame: At anesthesia day 0
Secondary outcomes:
measure: Intraoperative remimazolam dose
timeFrame: At anesthesia day 0
measure: Pain score (0:no pain, 10:maximal pain)
timeFrame: At anesthesia day 0 and 1
measure: Electroencephalography
timeFrame: At anesthesia day 0
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
References:
Clinical trial NCT01254383: Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.
Official title: An Open Label Crossover Study In Healthy Older Male Subjects To Evaluate The Pharmacokinetics And Safety Of Sildenafil Following Fasted Administration Of An Orally Disintegrating Tablet Formulation Of Sildenafil Administered With Or Without Water Relative To Viagra® Oral Tablet With Water
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Erectile Dysfunction
Keywords: Bioequivalence Oral Dissolving Tablet
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-12-06
Enrollment: 36
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil.


Eligibility criteria: Inclusion Criteria:

* Otherwise healthy male subjects age 45 years or older with or without erectile dysfunction.

Body Mass Index (BMI) of 17.5 to 32.5 kg/m2.

Signed and dated informed consent document.

Exclusion Criteria:

* Evidence or history of clinically significant abnormalities
* Have baseline orthostatic hypotension
* Positive drug screen, excessive alcohol and tobacco use

Primary outcomes:
measure: AUC(0-t) of sildenafil.
timeFrame: Up to 1 month
measure: Cmax of sildenafil.
timeFrame: Up to 1 month
Secondary outcomes:
measure: AUC(0-inf) of sildenafil, if data permits.
timeFrame: Up to 1 month
measure: Half-life of sildenafil, if data permits.
timeFrame: Up to 1 month
measure: Tmax of sildenafil.
timeFrame: Up to 1 month
measure: Number of patients with adverse events.
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Damle B, Duczynski G, Jeffers BW, Crownover P, Coupe A, LaBadie RR. Pharmacokinetics of a novel orodispersible tablet of sildenafil in healthy subjects. Clin Ther. 2014 Feb 1;36(2):236-44. doi: 10.1016/j.clinthera.2013.12.010. Epub 2014 Jan 18.
Clinical trial NCT06031883: Efficacy of Adding Low Dose Ketamine or Fentanyl to Propofol-dexmedetomidine as Total Intravenous Anesthesia
Official title: Efficacy of Adding Low Dose Ketamine or Fentanyl to Propofol-dexmedetomidine as Total Intravenous Anesthesia for Patients Undergoing Craniotomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Patients Undergoing Elective Craniotomy
Lead sponsor: Minia University
Sponsor class: OTHER
Collaborators: name: Minia University Hospital
First posted: 2023-09-11
Enrollment: 40
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: OTHER

Brief summary: Efficacy of adding low dose ketamine or fentanyl to propofol-dexmedetomidine as total intravenous anesthesia for patients undergoing craniotomy in supra tentorial brain tumor

Detailed description: Efficacy of adding low dose ketamine or fentanyl to propofol-dexmedetomidine as total intravenous anesthesia for patients undergoing craniotomy in supra tentorial brain tumor surgery on brain relaxation score, hemodynamics, surgeon satisfaction score , total requirement of intra operative propofol and post operative analgesia

Eligibility criteria: Inclusion Criteria:

- Patients aged 18-70 years old ASA I - III with GCS 14-15 and BMI\<35 scheduled for elective craniotomy for resection of supratentorial masses

Exclusion Criteria:

* Patients will be excluded if they will refuse to give a written consent. Also patients with GCS \< 14 or having endocrine or blood diseases or sever cardiac disease or sever liver disease or renal failure and patients with uncontrolled hypertension or uncontrolled diabetes mellitus and patients have allergy to any of the study drugs.

Primary outcomes:
measure: Evaluation of brain relaxation score
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Eron
Study officials:
References:
Clinical trial NCT01568983: The Effects of Polyphenol-rich Berry Juice on Blood Pressure in Hypertensive Subjects
Official title: The Effects of Polyphenol-rich Berry Juice on Blood Pressure and Additional CVD Related Parameters in Pre-hypertensive Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pre-hypertension
Hypertension
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Fellesjuice AS
name: Nofima
First posted: 2012-04-02
Enrollment: 153
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the effects of berry juices containing different levels of polyphenols on blood pressure and other cardiovascular risk factors.

The study is a 12 week double blinded randomized controlled intervention trial. The subjects will be divided in three groups where one receives a placebo juice while the two other will consume 0.5 liter of juice containing different levels of polyphenols. Blood pressure will be monitored and blood samples will be taken.


Eligibility criteria: Inclusion Criteria:

* Pre-hypertension or hypertension systolic blood pressure in the 130-179 mmHg range and/or diastolic blood pressure in the 85-109 mmHg range)
* BMI 20-35 kg/m2
* Stable weight (change \<4 kg previous 12 weeks)

Exclusion Criteria:

* Regular use of blood pressure lowering agens
* Diabetes type I or II
* Smokers
* Allergy to grape, cherries, blueberries/bilberries, black currant, aronia
* Supplements for weight loss
* Changes in pharmacological treatment of hyperlipidemia or hyperglycemia (initiation, termination or changes in dosage) last 30 days prior to inclusion or during the study period (run-in and intervention)
* Participation in a drug trial during the previous 30 days

Primary outcomes:
measure: Systolic and diastolic blood pressure
timeFrame: Screening, baseline, 6 and 12 weeks
measure: Platelet aggregation
timeFrame: Baseline and 12 weeks
measure: Cardiovascular disease risk factors
timeFrame: Baseline and 12 weeks
measure: Diabetes related parameters in blood and urine
timeFrame: Baseline and 12 weeks
measure: Blood cell expression of stress-response and CVD related genes
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Polymorphisms in cardiovascular disease related genes
timeFrame: Baseline
measure: Whole genome transcription profiles and methylation patterns
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
affiliation: University of Oslo
name: Rune Blomhoff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06135883: Assessing Folic Acid in High-Risk Pregnancy for Neural Tube Defects
Official title: Evaluating Folic Acid Awareness and Usage in High-Risk Pregnant Women for Neural Tube Defects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neural Tube Defects
Folic Acid
Keywords: neural tube defects
folic acid
awareness
perinatology
pregnancy
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 267
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Singleton pregnant women over the age of 18 and under the age of 45 who have at least one of the risk factors for neural tube defects (family history, MTHFR gene mutation, birth history with aneuploidy, history of GDM or known DM).

Brief summary: Aim of this study is to investigate and statistically reveal the prevalence and awareness of folic acid usage in pregnant women who have at least one of the risk factors for neural tube defects, to express the level of knowledge of the determined population on this subject and to present ideas to increase awareness in the society.


Eligibility criteria: Inclusion Criteria:

* over 18 years
* Under 45 years of age
* Having at least one of the risk factors for neural tube defects (family history, MTHFR gene mutation, birth defect with aneuploidy, history of GDM or known DM) for Case Group.
* Singleton pregnant women

Exclusion Criteria:

* under 18 years old
* Above 45 years old
* Multiple pregnancies

Primary outcomes:
measure: High awareness level for high-risk pregnant women
timeFrame: up to 12 weeks
measure: Low awareness level for society, regardless of the risk situation
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Tascioglu City Hospital
state: Sisli
Study officials:
References:
Clinical trial NCT02196883: Steroid Injections Given at the "Level of MRI Pathology" Versus at the "Level of Clinical Symptoms" to See if One is More Effective Than the Other.
Official title: A Prospective, Randomized, Single Blind Study Comparing Transforaminal Epidural Steroid Injections at the Level of MRI Pathology vs Clinical Symptoms
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Radiculopathy
Spinal Stenosis
Intervertebral Disc Displacement
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2014-07-22
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients are being asked to participate in a research study because the patients are being treated for low back pain and the patients have decided to have an epidural steroid injection.

Low back pain has a tremendous impact on the individual and society. It not only affects the individuals quality of life, it also contributes to lost productivity and increased health care costs.

Epidural steroid injections (ESIs) are a common treatment option for many forms of low back pain. They have been used for low back problems since 1952 and are still being used as a non-surgical form of treatment for low back pain. The goal of the injections is reduction of pain, increased quality of life and improved function.

This study is being conducted to determine the outcomes of injections given at the "level of MRI Pathology" versus at the "level of clinical symptoms" to see if one is more effective than the other and to learn more about the characteristics of the two different injections.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Single level spinal stenosis.
* Single level radiculopathy with MRI findings at a different level than clinical pattern.
* Chronic low back pain with radicular symptoms of \> 4 weeks, but \< 6 months.
* Failure of conservative therapy to include physical and pharmacotherapy.
* Patient is at least 21 years of age.
* Patient is willing to be blinded to treatment until after the 3-month follow up visit.
* Patient is willing and able to review and sign the study's informed consent form.

Exclusion Criteria:

* Patient has a mental or physical condition that would invalidate evaluation results.
* Patient has had prior lumbar surgery at any level.
* Patient is pregnant.
* Patient has systemic infection or infection at the proposed injection site.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 2 weeks to 6months
Secondary outcomes:
measure: Short Form 36 Health Survey
timeFrame: 2 weeks to 6months
measure: Oswestry Disability Index
timeFrame: 2 weeks to 6months
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical Center
state: New York
Study officials:
References:
Clinical trial NCT00889083: Hepatic Mitochondrial Function in Sepsis
Official title: Evaluation of Hepatic Mitochondrial Function in Sepsis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sepsis
Peritonitis
Keywords: Sepsis
Peritonitis
Mitochondria
Liver
Lead sponsor: Institut d'Anesthesiologie des Alpes Maritimes
Sponsor class: OTHER
First posted: 2009-04-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: Multi-organ failure due to sepsis is a major cause of death in critically ill patients. But the mechanisms leading to this condition are not fully understood. Mitochondrial dysfunction has been shown in skeletal muscle of critically ill septic patients. Liver is very important in sepsis as it is responsible of the synthesis of several inflammatory proteins. Moreover hepatic failure is associated to a bad outcome.

The aim of this study is to evaluate the hepatic mitochondrial function in sepsis.


Eligibility criteria: Inclusion Criteria:

* Septic group : Peritonitis patients needing surgery
* Non septic group : Patients needing hepatic surgery

Exclusion Criteria:

* No liver biopsy performed

Primary outcomes:
measure: Mitochondrial complex activities
timeFrame: during surgery
Secondary outcomes:
measure: Quantification of adenine nucleotides
timeFrame: during surgery
measure: Quantification of oxidative stress markers
timeFrame: during surgery
measure: Correlation between SOFA score and mitochondrial complex activities
timeFrame: 28 days
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Carole Ichai, MD, PhD
role: STUDY_CHAIR
References:
citation: Brealey D, Brand M, Hargreaves I, Heales S, Land J, Smolenski R, Davies NA, Cooper CE, Singer M. Association between mitochondrial dysfunction and severity and outcome of septic shock. Lancet. 2002 Jul 20;360(9328):219-23. doi: 10.1016/S0140-6736(02)09459-X.
citation: Fredriksson K, Hammarqvist F, Strigard K, Hultenby K, Ljungqvist O, Wernerman J, Rooyackers O. Derangements in mitochondrial metabolism in intercostal and leg muscle of critically ill patients with sepsis-induced multiple organ failure. Am J Physiol Endocrinol Metab. 2006 Nov;291(5):E1044-50. doi: 10.1152/ajpendo.00218.2006. Epub 2006 Jun 27.