louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04367155: Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy.
Official title: Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy. a Double-blind, Placebo-controlled Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Stones
Nephrolithiasis
Keywords: Tranexamic acid
percutanous nephrolithotomy
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: tranexamic acid during and after percutanous nephrolithotomy procedure
Primary purpose: TREATMENT

Brief summary: Efficacy of tranexamic acid on blood loss during percutaneous nephrolithotomy. a double-blind, placebo-controlled randomized clinical trial.

Detailed description: To evaluate whether intravenous tranexamic acid or tranexamic acid in the irrigation fluid in percutaneous nephrolithotomy (PCNL) in reducing bleeding during and after PCNL.

Eligibility criteria: Inclusion Criteria:

* Patient 18 years or older
* Stones ≥ 2 cm and/or mild to moderate hydronephrosis.

Exclusion Criteria:

* Age \<18 years or Pregnancy
* Bilateral simultaneous PCNL
* Morbid obesity (BMI \>40)
* Refuse to complete study requirements
* Untreated UTI
* Atypical bowel interposition by CT
* Tumour in the presumptive access tract area or Potential malignant kidney tumour

Primary outcomes:
measure: To assess the value of tranexamic acid
timeFrame: 12 months
Secondary outcomes:
measure: Hemoglobin drop post PCNL.
timeFrame: 12 months
measure: Requirement of blood transfusion post PCNL.
timeFrame: 12 months
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh faculty of medicine
state: Kafrelsheikh
Study officials:
affiliation: Lecturer of urology
name: Diaa Eldin Taha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00892255: Microwave Ablation of Resectable Liver Tumors
Official title: Microwave Ablation of Resectable Liver Tumors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hepatocellular Carcinoma
Liver Cancer
Keywords: Liver cancer
Tumors
Lead sponsor: St. Joseph Hospital of Orange
Sponsor class: OTHER
First posted: 2009-05-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for liver resection, either for primary or metastatic disease

Brief summary: The purpose of this protocol is to pathologically evaluate the destruction by microwave ablation of primary and metastatic liver tumors. The primary aim is to measure tissue destruction with the MedWaves Microwave Ablation/ Coagulation Ablation System.

Detailed description: Minimally invasive surgical alternatives are becoming more attractive for the treatment of malignancy.The goal is to reduce morbidity and mortality and increase the ability to treat patients in the outpatient setting. Image-guided ablation is becoming an attractive alternative because of its relative low cost, its ability to provide large regions of coagulative necrosis in a controlled fashion, and its relatively low toxicity. Although image-guided ablative techniques have been extensively investigated for the treatment of liver tumors, there has been limited experience with microwave ablation (MWA) in the liver. This study will evaluate the treatment effect of MWA in liver tumors. Patients undergoing planned surgical removal of liver tumors will have the tumors intra-operatively treated with MWA. The histological changes will be evaluated upon removal of the specimen.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary or metastatic liver cancer for which surgery is planned
* All participants need to be fully able to give informed consent

Exclusion Criteria:

* Mental or legal incompetence
* Impaired decision-making capacity
* Pregnant women may not participate

Primary outcomes:
measure: Measure of the tissue destruction with the MedWaves Microwave Ablation/ Coagulation Ablation System
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: The Center for Cancer Prevention & Treatment at St. Joseph Hospital
state: California
Study officials:
affiliation: St. Joseph Hospital of Orange
name: Hisham El-Bayar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04731155: Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction
Official title: Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Early PCSK9 Inhibitor on Ventricular Remodling
Lead sponsor: Shanghai Tong Ren Hospital
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 20
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: This is a prospect, multi-center, random study to investigate whether early offering PCSK9 inhibitor to acute myocardium infarction(AMI) can alleviate ventricular remodeling after primary percutaneous intervention(PPCI). Totally,twenty acute myocardium infarction subjects will be enrolled in this study after consent information. After randomization, the control group will receive standard therapy for AMI including PPCI. The experiment group will receive first PCSK9 inhibitor before PPCI, then twice a month until 3 months later. Six month after AMI, Myocardial salvage index will be used to evaluate ventricular remodeling. TnI peaking time and LDL control rates also will be recorded and compared.


Eligibility criteria: Inclusion Criteria:

1. Subject must be at least 18 years of age and less than 80 years old
2. Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for AMI and LAD should be the only culprit vessel.
3. Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure

Exclusion Criteria:

1. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
2. Known hypersensitivity or contraindication to study medications
3. Plan to receive revascularization in next six month.
4. Have received revascularization before.
5. Subjects with life expectation less than one year.
6. Subjects with active malignant tumor
7. subjects with severe liver or renal dysfunction（ALT \>5倍ULA，eGFR\<15ml/min/1.73mm2）
8. Other conditions which the investigators think not applicable to the study.

Primary outcomes:
measure: myocardial salvage index measured by MRI
timeFrame: one week after PPCI
measure: myocardial salvage index measured by MRI
timeFrame: six months after PPCI
measure: eject fraction measured by MRI
timeFrame: one week after PPCI
measure: eject fraction measured by MRI
timeFrame: six month after PPCI
Secondary outcomes:
measure: the change of serum level of TnI/T
timeFrame: 0,6 ,12,18 , 24 ,30,and 36 hours after PPCI
measure: LDL -C control rate
timeFrame: the first month after PPCI
measure: the serum lever of hsCRP
timeFrame: Baseline (before PPCI)
measure: the serum lever of hsCRP
timeFrame: one week after PPCI
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Tongren Hospital, Shanghai
state: Shanghai
city: Shanghai
country: China
facility: Shanghai tenth people's hospital
Study officials:
References:
Clinical trial NCT01188655: Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis
Official title: Observational Non-Interventional Study With Enbrel in Patients With Ankylosing Spondylitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spondylitis, Ankylosing
Keywords: Ankylosing Spondylitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-08-25
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient cohort in this non-interventional study will reflect the kind of patients seen in routine clinical practice and will not be specifically pre-selected as it is the case in clinical studies.

Brief summary: This observational study will be a documentation of the prescribing and administration practices of Enbrel® and their impact on ankylosing spondylitis patients outcome in a real life setting.

Detailed description: The study population will be described using standard descriptive statistics for demographic, clinical, medical, characteristics, as well as for standard health-related quality of life and functional disability questionnaires .

Eligibility criteria: Inclusion Criteria:

* Proven diagnosis of Ankylosing Spondylitisin accordance with local guidelines
* Patients treated as an outpatient

Exclusion Criteria:

* Patients who suffer from hypersensitivity to the active substance Etanercept or to any of the excipients of Enbrel®.
* Treatment with Enbrel® should not be initiated in patients with active infections including chronic or localised infections.
* Patients with sepsis or risk of sepsis should not be treated.

Primary outcomes:
measure: Percentage of Participants Achieving BASDAI 40 Response at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Change From Baseline in BASDAI at Week 12 and 24
timeFrame: Baseline, Week 12 and Week 24
measure: Change From Baseline in the BASFI at Weeks 12 and 24
timeFrame: Baseline, Week 12 and Week 24
measure: Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24
timeFrame: Week 12 and Week 24
measure: Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24
timeFrame: Week 12 and Week 24
measure: Mean Duration of Morning Stiffness
timeFrame: Week 12 and Week 24
measure: Change From Baseline in ASQoL at Week 12 and Week 24
timeFrame: Baseline, Week 12 and Week 24
measure: Percentage of Participants Without Enthesitis
timeFrame: Week 12 and Week 24
measure: Percentage of Participants Without Peripheral Arthritis
timeFrame: Week 12 and Week 24
measure: Mean Occiput-to-wall Distance at Week 12 and Week 24
timeFrame: Week 12 and Week 24
measure: Spine Agility Function by Schober Test
timeFrame: Week 12 and Week 24
measure: Spine Agility Function by Ott Test
timeFrame: Week 12 and Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00590655: Maintenance Programme After Weight Loss
Official title: Effect of Maintenance Programme on the Long Term Weight Reduction in Severely Obese Patients. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Morbid Obesity
Keywords: maintenance therapy
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Finnish Medical Foundation
First posted: 2008-01-10
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare a weight reduction programme with and without a maintenance programme in patients with severe obesity.


Eligibility criteria: Inclusion Criteria:

* BMI 35 kg/m2 or more
* Age 18-65 years

Exclusion Criteria:

* Type 1 diabetes
* Major alcohol problem
* Acute psychic disease, eating behavior, pregnancy, severe disease (cancer, unstable coronary disease, severe liver or kidney disease), or the patient has been in this treatment within the past 5 years

Primary outcomes:
measure: weight result
timeFrame: 2 years after weight loss phase
Secondary outcomes:
measure: quality of life and eating behavior
timeFrame: 2 years after active weight loss
Other outcomes:
Locations:
city: Vantaa
country: Finland
facility: Peijas Hospital
Study officials:
References:
citation: Pekkarinen T, Kaukua J, Mustajoki P. Long-term weight maintenance after a 17-week weight loss intervention with or without a one-year maintenance program: a randomized controlled trial. J Obes. 2015;2015:651460. doi: 10.1155/2015/651460. Epub 2015 Mar 30.
Clinical trial NCT04824755: Reduced ER-QOL in Families After Congenital Cataract Surgery
Official title: A Prospective Study on Assessments of the Eye-related Quality of Life, Functional Vision, and Their Determinants Using the PedEyeQ in Children After Congenital Cataract Surgery and Their Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prospective Cross-sectional Study
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 166
Sex: ALL
Minimum age (years): 0
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Children after congenital cataract surgery experience a lower quality of life and reduced functional vision. Their families have also been seriously affected. Investigators should pay more attention to them, and measures should be administered to families.


Eligibility criteria: Inclusion Criteria:

* visually not significant cataract, and ophthalmic surgery (incisional or laser) within one month

Exclusion Criteria:

* parents who were inability to communicate were also excluded

Primary outcomes:
measure: Gender of Child
timeFrame: through study completion, an average of half a year
measure: Parent/legal guardian Age
timeFrame: through study completion, an average of half a year
measure: Parent/legal guardian completing questionnaires
timeFrame: through study completion, an average of half a year
measure: Native Place
timeFrame: through study completion, an average of half a year
measure: Parent/legal guardian highest level of education
timeFrame: through study completion, an average of half a year
measure: Staging operation
timeFrame: through study completion, an average of half a year
measure: Postoperative timing
timeFrame: through study completion, an average of half a year
measure: Amblyopia treatment
timeFrame: through study completion, an average of half a year
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Ophthalmology and Optometry Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT01500655: Ultrasound-Guided Block of the Lateral Femoral Cutaneous Nerve in Pediatric Patients
Official title: Evaluation of Ultrasound-Guided Block of the Lateral Femoral Cutaneous Nerve in Pediatric Patients for Reconstructive Surgical Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: burn
skin graft donor site
analgesia for donor site
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-12-28
Enrollment: 19
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether either a peripheral nerve block under ultrasound (u/s) guidance of the lateral femoral cutaneous nerve (LFCN), versus an u/s guided block of the nerve followed by continuous catheter infusion of local anesthetic, offers better post-operative analgesia in pediatric burn patients undergoing reconstructive surgery, than the current analgesic regimen of subcutaneous local anesthetic infiltration.

Eligible subject, pediatric patients having reconstructive surgery for burns, having skin graft donor sites of the lateral thighs, will be randomized into three groups: control (having local infiltration of site), ultrasound guided nerve block, or ultrasound guided nerve block with catheter placement --fascia iliac.

Post-operative comfort will be assessed over the next 48 hours.


Eligibility criteria: Inclusion Criteria:

* going for reconstructive surgery requiring split thickness skin graft
* patient's donor site will be in distribution of lateral femoral cutaneous nerve
* age \>=2 and \<22
* patient emotionally/intellectually able to describe intensity of post-op pain using VAS or Wong- Baker faces scale.

Exclusion Criteria:

* potential block/catheter site infected or burned.
* intolerance/allergy to local anesthetics
* BMI \> 30
* American Society of Anesthesiologists (ASA) score \> 2

Primary outcomes:
measure: Visual Analog Pain Scale
timeFrame: Q4 hours,while awake, for 48 hours
Secondary outcomes:
measure: Narcotic use
timeFrame: 48 hours postoperative
Other outcomes:
Locations:
city: Boston
country: United States
facility: Shriners Hospital for Children
state: Massachusetts
Study officials:
affiliation: Partners Health Care
name: Erik S Shank, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05635955: Remimazolam Versus Propofol for Painless Abortion
Official title: Remimazolam Versus Propofol, in Combination With Esketamine for Painless Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anesthesia
Abortion Early
Lead sponsor: Maternal and Child Health Hospital of Hubei Province
Sponsor class: OTHER
Collaborators: name: The Hong Kong Polytechnic University
First posted: 2022-12-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the efficacy and safety of propofol vs. remimazolam in combine use of esketamine in women with early pregnancy undergoing painless abortion. The main questions it aims to answer are:

* whether remimazolam plus esketamine (R+E) has a better sedative and analgesic effectiveness than propofol plus esketamine (P+E).
* whether R+E has less adverse events than P+E.

Participants will be randomly allocated to two groups: R+E and P+E group.

* For those in group R+E: they will be administered with 0.3mg/kg remimazolam and 0.3mg/kg esketamine before the abortion surgery.
* For those in group P+E: they will be administered with 2mg/kg propofol and 0.3mg/kg esketamine before the abortion surgery.

We will compare R+E with P+E to see if the time to loss of conscious and time to recover from the sedation will be shorter and if there will be less severe adverse events in R+E.


Eligibility criteria: Inclusion Criteria:

* early intrauterine pregnancy less than 12 weeks confirmed by transabdominal ultrasound and blood HCG
* the American Society of Anesthesiologists (ASA) physical status ranked I-II
* competent to provide informed consent

Exclusion Criteria:

* chronic pain
* psychiatric disorders
* liver or kidney failure
* severe metabolic disorders
* poor respiratory functions
* cardiovascular diseases

Primary outcomes:
measure: Time to loss of consciousness
timeFrame: 5 - 30 minutes
Secondary outcomes:
measure: Success rate of sedation
timeFrame: Intraoperative period, 30 minutes - 1.5 hours
measure: Recovery time
timeFrame: Postoperative 30 minutes
measure: Mean arterial pressure (MAP)
timeFrame: Intraoperative period, 30 minutes - 1.5 hours
measure: Heart rate (HR)
timeFrame: Intraoperative period, 30 minutes - 1.5 hours
measure: Adverse events
timeFrame: Intraoperative and post-operation, 30 minutes - 1.5 hours
measure: Post-operative pain
timeFrame: Post-operation after fully awake, 30 minutes - 1 hour
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Maternal and Child Health Hospital of Hubei Province
state: Hubei
Study officials:
affiliation: Maternal and Child Health Hospital of Hubei Province
name: Na Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00562055: Double-Blind, Four Week Trial Of [S,S]-Reboxetine And Atomoxetine In Adults With Attention Deficit Hyperactivity Disorder.
Official title: Phase 2, Randomized, Double-Blind, Parallel-Group, Four Week, Efficacy And Safety Trial Of [S,S]-Reboxetine (PNU-165442g) And Atomoxetine In Adults With Attention Deficit Hyperactivity Disorder.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-11-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the safety and efficacy of \[S,S\]-reboxetine to atomoxetine in the treatment of adult patients with attention deficity-hyperactivity disorder.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Attention Deficit Hyperactivity Disorder according to DSM-IV criteria.
2. Score of 24 or higher on the Adult ADHD Investigator Symptom Rating Scale
3. Score of 4 or higher on the Clinician Global Impression - Severity scale

Exclusion Criteria:

1. Significant comorbid psychiatric diagnoses
2. Significant risk of suicidal or violent behavior

Primary outcomes:
measure: Adult ADHD Investigator Symptom Rating Scale - Total Score
timeFrame: 4 weeks
Secondary outcomes:
measure: Adult ADHD Investigator Symptom Rating Scale - Inattention Subscale Score
timeFrame: 4 weeks
measure: Adult ADHD Investigator Symptom Rating Scale - Hyperactivity/Impulsivity Subscale Score
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00916955: Genetic Modifiers for 22q11.2 Syndrome
Official title: Genetic Modifiers for 22q11.2 Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 22q11.2 Deletion Syndrome
Keywords: 22q11.2 deletion syndrome
velo-cardio-facial syndrome
congenital anomalies
mental illness
congenital heart disease
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
Collaborators: name: Albert Einstein College of Medicine
First posted: 2009-06-10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals with velo-cardio-facial syndrome confirmed by FISH

Brief summary: The purpose of the project is the determination of how the deletion of DNA from chromosome 22 at the q11.2 band causes the phenotypes observed in velo-cardio-facial syndrome (VCFS). In other words, the purpose remains genotype-to-phenotype matching. Current methods includes the use of whole genome chips and microarray analysis. Blood samples are collected for DNA from every patient who consents from the VCFS Center at Upstate Medical University. They are examined for phenotypic features consistent with our typical clinical evaluation. The information from these examinations will be entered anonymously into a database. Genomic information is then matched to clinical phenotype with appropriate statistical method applied.


Eligibility criteria: Inclusion Criteria:

* FISH confirmed diagnosis of 22q11.2 deletion syndrome

Exclusion Criteria:

* none

Primary outcomes:
measure: gene signal strength
timeFrame: 4 years
Secondary outcomes:
measure: physical phenotype
timeFrame: 4 years
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: VCFS International Center
state: New York
Study officials:
affiliation: Upstate Medical University
name: Robert J Shprintzen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Einstein College of Medicine
name: Bernice Morrow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shprintzen RJ, Higgins AM, Antshel K, Fremont W, Roizen N, Kates W. Velo-cardio-facial syndrome. Curr Opin Pediatr. 2005 Dec;17(6):725-30. doi: 10.1097/01.mop.0000184465.73833.0b.