louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01907997: Effects of Systemic Lidocaine on Postoperative Quality of Recovery After Robot-assisted Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Cancer
Keywords: Systemic lidocaine, Intravenous lidocaine infusion, postoperative pain, quality of recovery, Robot-assisted thyroidectomy, thyroid cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Systemic lidocaine infusion may improve the patients' recovery quality and chronic post surgical pain after robot-assisted thyroidectomy


Eligibility criteria: Inclusion Criteria:

* Age between 20-65
* ASA class I and II
* Thyroid cancer patients who are scheduled for elective robot-assisted thyroidectomy

Exclusion Criteria:

* Allergy to local anesthetics or contraindication to use of lidocaine
* Pregnancy
* Severe cardiovascular disease
* Renal failure
* Liver failure
* Neurologic and psychologic disease
* Chronic treatment with analgesics

Primary outcomes:
measure: Quality of recovery 40(QoR-40) score
timeFrame: 24hours after operation day
Secondary outcomes:
measure: Assessing the presence of chronic postsurgical pain(CPSP)
timeFrame: 24hours after operation day
measure: aspect and site of CPSP
timeFrame: 24hours after operation day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei universiy college of medicine
Study officials:
References:
citation: Choi KW, Nam KH, Lee JR, Chung WY, Kang SW, Joe YE, Lee JH. The Effects of Intravenous Lidocaine Infusions on the Quality of Recovery and Chronic Pain After Robotic Thyroidectomy: A Randomized, Double-Blinded, Controlled Study. World J Surg. 2017 May;41(5):1305-1312. doi: 10.1007/s00268-016-3842-1.
Clinical trial NCT00716105: Effect of the Level of Dietary Protein on Infant Growth
Official title: Effect of the Level of Dietary Protein on Infant Growth and Body Composition in the First Year of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Nutrition
Keywords: Infant formula
Protein metabolism
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2008-07-16
Enrollment: 405
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether infants fed a formula with protein levels different than a standard infant formula have similar growth and development.


Eligibility criteria: Inclusion Criteria:

* Gestational age at least 37 weeks
* Singleton birth
* Birth weight between 2500g and 4500g
* Weight at enrolment is at or above the 5th percentile (CDC)
* Infant has been exclusively formula fed for at least the last 14 days
* Having obtained informed consent of legal representative

Exclusion Criteria:

* Congenital illness or malformation that affects infant feeding and/or growth
* Significant pre-natal and/or post-natal disease
* Suspected or confirmed allergy to cow milk protein
* In the investigators assessment, infant's family cannot be expected to comply with treatment (feeding regimen)
* Currently participating in another clinical trial

Primary outcomes:
measure: Mean weight gain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: The Samuel J. Fomon Infant Nutrition Unit Dept of Pediatrics, University of Iowa
state: Iowa
city: Oklahoma City
country: United States
facility: Department of Pediatrics University of Oklahoma Health Sciences
state: Oklahoma
Study officials:
affiliation: The Samuel J. Fomon Infant Nutrition Unit Dept of Pediatrics, University of Iowa
name: Ekhard E Ziegler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ziegler EE, Fields DA, Chernausek SD, Steenhout P, Grathwohl D, Jeter JM, Nelson SE, Haschke F. Adequacy of Infant Formula With Protein Content of 1.6 g/100 kcal for Infants Between 3 and 12 Months. J Pediatr Gastroenterol Nutr. 2015 Nov;61(5):596-603. doi: 10.1097/MPG.0000000000000881.
Clinical trial NCT00364897: Investigation of Clinical Outcome of ACL Reconstruction Utilizing Two Tibial Fixation Techniques, Concentric Tapered Interference Screws and Interference Screw and Sheath
Official title: Comparison Between Two Tibial Fixation Techniques in ACL Reconstruction
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Primary ACL Tears
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-08-16
Enrollment: 140
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Tibial fixation is the weak link when using soft tissue grafts and interference screws for fixation in a bony tunnel in ACL reconstruction. The Objective is to study two groups of patients undergoing double loop hamstring autograft ACL reconstruction and compare between the two tibial fixation devices: the tapered Deltascrew and the Intrafix screw and sheath .


Eligibility criteria: Inclusion Criteria:

* Males and females between ages 21 and 40 years.
* Primary ACL tears.
* Signed Informed consent.
* Availability during follow up period.

Exclusion Criteria:

* Additional meniscal injury requiring suture.
* Articular cartilage injury requiring surgical management.
* Concomitant ligament injuries to the same knee requiring surgery.
* Bilateral ACL injury.
* Revision ACL surgery.
* Concurrent fractures of the lower limbs caused by the same accident.
* Post operative wound infection.

  • Post operative nerve injury
* Cardiovascular compromise.
* Professional sports people.
* Soldiers on active military service.
* Patients actively seeking compensation for injury.
* Patients on other research protocols.
* Patients receiving medications which alter bone metabolism: corticosteriods, Calcitonin, Flourides, Biphosphonates, Vitamin D and its derivatives, Cytotoxic drugs.
* Non compliance. • Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Joseph Lowe, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03795805: After Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet
Official title: After Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Acute Kidney Injury
Tourniquets
Knee Osteoarthritis
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2019-01-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial
Primary purpose: PREVENTION

Brief summary: This study analize the incidence of acute renal failure after performing total knee arthroplasty with or without use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial

Detailed description: This study analize the incidence of acute renal failure after performing total knee arthroplasty with or without (using local intraarticular anesthesia) use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial

Eligibility criteria: Inclusion Criteria:

* Patients knee arthrosis
* Required a surgical treatment with Total Knee Arthroplasty

Exclusion Criteria:

* Not accept to be in the study
* Not signed consent form
* Not having blood sample for creatinin meassure

Primary outcomes:
measure: Creatinin before surgery
timeFrame: Creatinin before surgery
measure: Creatinin after surgery 1
timeFrame: Creatinin after surgery 1 at 24 hours
measure: Creatinin after surgery 2
timeFrame: Creatinin after surgery 2 at 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ciudad de México
country: Mexico
facility: UMAE Dr. Victorio de La Fuente Narvaez
Study officials:
affiliation: IMSS
name: Avelino Colin Vázquez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01035905: Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers
Official title: Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-12-21
Enrollment: 63
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of two different daily disposable contact lenses.


Eligibility criteria: Inclusion Criteria:

* Currently wear daily disposable, spherical, soft lens wearers (except the two study products) for at least the past 6 months.
* Habitually wear lenses for at least 8 hours per day and 4 days per week.
* Report 2 or more qualifying symptoms with current contact lenses.
* Able to achieve visual acuity of at least 20/40 in each eye with habitual and with study lenses at dispense.
* Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks immediately prior to enrollment.
* Currently enrolled in any clinical trial.
* Any use of ocular medications, exclusive of contact lens rewetting drops.
* History of corneal or refractive surgery.
* Cylinder correction greater than 1.00 D
* Current monovision contact lens wearers.
* Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Lens Awareness
timeFrame: 4 weeks of wear
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02861105: The Effect of LMWH on ICSI in Patients With Unexplained Infertility and Negative Immunological Markers
Official title: The Effect of LMWH on ICSI Outcome in Patients With Unexplained Infertility and Negative Immunological Markers; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Unexplained Infertility
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 716
Sex: FEMALE
Maximum age (years): 38
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of LMWH treatment in women with unexplained infertility and negative immunological markers undergoing ICSI.

Detailed description: Inclusion criteria:

1. patients undergoing 1st trial ICSI
2. unexplained infertility
3. negative immunological markers including ACL abs, LAC, ANA, ATA, AnitdsDNA

Exclusion criteria:

1. previous IVF/ICSI
2. Any cause of infertility
3. Suspected and/or unexpected poor response during ovulation induction
4. positive immunological markers
5. Age \> 40 years.

All participants will undergo IVF/ICSI cycle using the Long luteal phase protocol. the dose of gonadotropins will be calculated according to patient age and BMI. All patients will have 2-3 embryos transferred at D5 according to their age. the primary outcome will be LBR. secondary outcomes will include biochemical pregnancy rate and clinical pregnancy rate.

Eligibility criteria: Inclusion Criteria:

* age less than 38 years
* at least 12 months of infertility
* women with unexplained infertility

Exclusion Criteria:

* age more than or equals 38 years
* serum AMH level less than or equals 1 ng/ml
* patients of anticoagulant therapy
* immune-compromised patients
* patients with contraindications to low molecular weight heparin
* positive immunological markers
* patients with other than unexplained infertility
* male factor infertility
* refusal of participation
* patients with unexpected poor or over response during induction of ovulation

Primary outcomes:
measure: Live birth Rate
timeFrame: at delivery
Secondary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: at 7 weeks of gestation
measure: Biochemical Pregnancy Rate
timeFrame: 14 days after embryo transfer
Other outcomes:
Locations:
Study officials:
affiliation: Ain Shams University
name: Mostafa F Gomaa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00216905: Simultaneous Measurement of Electroencephalography (EEG) and Functional Magnetic Resonance Imaging (fMRI) in Patients With Alcoholism
Official title: Neurobiological Correlates of Disturbed Cognitive Function in Patients With Alcoholism - Simultaneous Measurement With EEG and fMRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcoholism
Keywords: Patients with alcoholism according to ICD-10 after detoxification
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with alcohol use disorder

Brief summary: Investigation of inpatients with alcoholism after detoxification with simultaneous Electroencephalography (EEG) and functional Magnetic Resonance Imaging (fMRI).


Eligibility criteria: Inclusion Criteria:

* Age of 18 or more
* Inpatient with alcoholism after detoxification.

Exclusion Criteria:

* Neurological disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Psychiatry, Ludwig-Maximilians-University
state: Bavaria
Study officials:
affiliation: Department of Psychiatry, Ludwig-Maximilians-University
name: Christoph Mulert, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00599105: Angiogenesis in Early Breast Cancer for Prognosis Prediction
Official title: Angiogenesis in Early Breast Cancer for Prognosis Prediction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Lesions
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2008-01-23
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will investigate the association of angiogenesis in breast cancer measured by magnetic resonance imaging and biomarkers with long-term prognosis of patients.


Eligibility criteria: Inclusion Criteria:

* Patient with a breast mass highly suspicious for malignancy from clinical, mammographic or sonographic examination.
* The study has been explained to the patient when she is scheduled for surgery.
* Healthy normal volunteers for imaging protocol optimization.

Exclusion Criteria:

* Pregnancy
* Patients with implanted surgical clips (hemostatic clips) or other ferromagnetic material,
* Patients engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or who may have imbedded metal fragments from military activities,
* Patients with metallic implants, because they may cause artifacts in diagnostic images due to magnetic field distortion,
* Patients with implanted prosthetic heart valves,
* Patients with pacemakers, neuro-stimulation devices,
* A breast mass with features of benign tumor
* The patients unwilling to participate in the study or fail to sign the consent form

Primary outcomes:
measure: To investigate whether breast cancer with a higher angiogenesis activity is associated with a unfavorable outcome.
timeFrame: 5 years from completion of enrollment
Secondary outcomes:
measure: To investigate whether angiogenesis of breast cancer is associated wit lymph node status
timeFrame: at completion of enrollment
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Center for Functional Onco-Imaging, University of California
state: California
Study officials:
References:
Clinical trial NCT03164005: The Effects of VEGF-B Signaling Pathway in Obesity and Metabolic Disease
Official title: The Effects of VEGF-B Signaling Pathway in Obesity and Metabolic Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Metabolic Disease
Keywords: VEGF-B
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects without metabolic diseases , subjects with metabolic diseases

Brief summary: The investigators will enroll about 120 subjects from the hospital's healthcare center. The investigators will collect the basic informations, blood pressure, body mass index, fasting blood glucose and fasting blood lipids of each subject. The investigators will collect the blood samples and then test them for fasting insulin levels, VEGF-B levels, the gene promoter region methylation status and the genomic protein methylation levels of the VEGF-B gene of the cells，and finally do the statistical analysis.

Detailed description: The investigators will enroll about 120 subjects from the hospital's healthcare center, and these 120 subjects will be divided into four groups: normal weight with or without metabolic diseases and obesity with or without metabolic diseases. Each group has 30 subjects. The investigators will collect the basic information(name, gender，age, medical history，family history, etc.), blood pressure, body mass index, fasting blood glucose and fasting blood lipids of each subject from the healthcare center. The investigators will collect the blood samples of each subject,separate the plasma and then test the fasting insulin, VEGF-B levels by ELISA. The investigators will separate the peripheral blood mononuclear cells from the blood, and then test the gene promoter region methylation status of the VEGF -B gene by PCR and the bisulfite-modified sequencing and test the genomic protein methylation level of the VEGF-B gene by chromatin immunoprecipitation assay(CHIP) and real-time quantitative PCR of the cells，and finally do the statistical analysis.

Eligibility criteria: Inclusion Criteria:

* NA

Exclusion Criteria:

* subjects with active history insulin treatment; and female participant pregnant at the time of recruitment.

Primary outcomes:
measure: Fasting insulin and blood VEGF-B levels
timeFrame: 3 days
Secondary outcomes:
measure: The methylation status of VEGF-B gene promoter region and VEGF-B genomic protein methylation level .
timeFrame: 7 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Endocrinology, Union Hospital,Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Department of Endocrinology, Union Hospital,Tongji Medical College, Huazhong University of Science and Technology
name: Chen Lulu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05631405: Efficacy of Dengue Infection With Warning Signs Treated With Dexamethasone (DengDex Study)
Official title: Efficacy of Dengue Infection With Warning Signs Treated With Dexamethasone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Dengue
Keywords: Severe Dengue
Dexamethasone
Steroid
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized double-blinded placebo-controlled trial is to learn about dexamethasone and the treatment of severe dengue population. The main question it aims to answer are steroid therapy may be effective in dengue.


Eligibility criteria: Inclusion Criteria:

* Laboratory confirmed Dengue infected patients (Positive NS1 Ag or anti-DENV IgM by Dengue Duo test)
* And still in febrile phase (Body temp\>37.5 C)
* Shock : Sys\<90mmHg or Narrow PP (\<20mmHg) orTachycardia (pulse\>100/min) with Hematocrit decreased ≥20 %
* Fluid accumulation and respiratory distress
* Severe bleeding
* Severe organ involvement

Exclusion Criteria:

* Severe dengue\> 24 hrs
* Dengue without warning signs
* Pregnancy
* Patient who receieved any steroid within 1 week

Primary outcomes:
measure: Mortality
timeFrame: 28 days
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 28 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn University
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
Study officials:
References: