louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02098486: Comparisons of Intravenous Ceftriaxone With Intravenous Moxifloxacin in ERCP
Official title: Antibiotic Prophylaxis for ERCP: a Comparison of Intravenous Ceftriaxone With Intravenous Moxifloxacin in the Prophylaxis of Cholangitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cholangitis
Keywords: Bile duct obstruction
Cholangitis
Moxifloxacin
Ceftriaxone
Sepsis
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2014-03-28
Enrollment: 86
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background and aims: The use of prophylactic antibiotics before endoscopic retrograde cholangiopancreatography (ERCP) is recommended by all major international gastroenterological societies, especially in the presence of an obstructed biliary system. Their use is intended to decrease or eliminate the incidence of complications following the procedure, namely cholangitis, cholecystitis, septicemia, and pancreatitis. However, there were a few reports concerning the dosage, duration and adopting antibiotics most suitable for this purpose. The aim of this prospective comparative study is to compare the occurrence rate of post-procedural complications, such as cholangitis, bacteremia and septicemia between intravenous moxifloxacin and ceftriaxone for the prophylactic use in patients with bile duct obstruction who will undergo therapeutic ERCP procedure.

Methods: In this prospective study, a total of 160 patients (calculated by IBM SPSS Sample Power, version 3.0) with bile duct obstruction due to variable causes (bile duct stones, benign or malignant stricture, etc) will be enrolled and randomly allocated to intravenous moxifloxacin and ceftriaxone group, respectively (using simple randomization program). Intravenous moxifloxacin (400 mg/day, infused more than 60 min) or ceftriaxone (2 g/day, diluted in 40 cc of 5% dextrose water, infused more than 30 min) will be given 90 minutes before ERCP procedure, and will be given to a patient for more than 3 days if the patient develops symptoms and signs of cholangitis or septicemia.


Eligibility criteria: Inclusion Criteria:

* patients with bile duct obstruction due to variable causes (bile duct stones, benign or malignant stricture, etc)

Exclusion Criteria:

* pregnancy
* hypersensitivity to moxifloxacin and/or ceftriaxone
* previous antibiotic exposure or theophyllin derivatives medication within 14 days of admission
* previous history of epilepsy
* previous history of endocarditis of valvular heart disease

Primary outcomes:
measure: cholangitis
timeFrame: 3 days
Secondary outcomes:
measure: 30 day mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sungkyunkwan University Kangbuk Samsung Hospital
Study officials:
affiliation: Sungkyunkwan University Kangbuk Samsung Hospital
name: Hong Joo Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01635686: Comparison the Safety and Pharmacokinetic Characteristics of DWP422 25 mg With Those of ENBREL 25MG PFS INJ. After Subcutaneous Injection in Healthy Male Volunteers
Official title: A Randomized, Double-blind, Single-dosing, Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of DWP422 25 mg With Those of ENBREL 25MG PFS INJ. After Subcutaneous Injection in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2012-07-09
Enrollment: 38
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED

Brief summary: The purpose of this study was to compare the safety and pharmacokinetic characteristics of DWP422 25 mg with those of ENBREL 25MG PFS INJ. after subcutaneous injection in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

1. Healthy males, 20 to 45 years of age the moment of screening
2. Body mass index is between 19.0 and 27.0 kg/m2

Exclusion Criteria:

1. Hypersensitivity response to the experimental and comparator drugs
2. The tuberculosis patient or latent tuberculosis patient

Primary outcomes:
measure: Etanercept levels in blood
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT04392986: Effect of Short-term Sunlight Exposure on Blood Pressure and Pulse Rate in Vitamin D3 Insufficient, Prehypertensive Patients
Official title: Effect of Short-term Sunlight Exposure on Blood Pressure and Pulse Rate in Vitamin D3 Insufficient, Prehypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunlight Exposure
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group parallel study
Primary purpose: PREVENTION

Brief summary: A three-period parallel (baseline, treatment, and post-treatment) design clinical research was conducted. All participants visited a clinical trial center of Korea University Anam Hospital for baseline measurement of clinical variables including ABPM and hematologic biomarkers (ACTH, aldosterone, norepinephrine, cortisol, and 25-hydroxyvitamin D3). After the baseline assessment, participants visited 'Cholipo beach' (Taean, Republic of Korea) for 3 nights and 4 days for the intervention (sunlight exposure program). After a week of wash-out period, post-treatment measurement was processed at Korea University Anam Hospital. Participants were prohibited from vigorous physical activity, alcohol drinking, and smoking during the study period. A normal-sodium diet (2800 mg/day)\[14\], caffeine and smoking restriction was suggested during the whole study period. To control the effect of circadian rhythm on endocrine blood tests and ABPM, we fixed sampling and monitoring start time at 10:00 am. All participants received the same measurements as they did in the baseline measurement during treatment and post-treatment periods.


Eligibility criteria: Inclusion Criteria:

* prehypertensive patients
* vitamin D insufficiency
* age 20-45

Exclusion Criteria:

* medical comorbidity other than prehypertension
* participant using medication
* Subjects with a history of cardiovascular, renal, hepatic, gastrointestinal, hematologic, psychological, or gastrointestinal abnormalities, taking any kind of medications

Primary outcomes:
measure: Blood pressure
timeFrame: 24 hours
measure: pulse rate
timeFrame: 24 hours
Secondary outcomes:
measure: Weight
timeFrame: 3 weeks
measure: Height
timeFrame: 3 weeks
measure: Age
timeFrame: 3 weeks
measure: 25-hydroxyvitamin D3
timeFrame: 3 weeks
measure: Aldosterone
timeFrame: 3 weeks
measure: Norepinephrine
timeFrame: 3 weeks
measure: ACTH
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References:
Clinical trial NCT00361686: Comparison of Tramadol vs Remifentanyl Patient Controlled Analgesia for Second Trimester Abortions
Official title: Randomized Double Blind Study Comparing Patient Controlled Analgesia With Tramadol vs. Remifentanyl for Women Undergoing 2nd Trimester Abortions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion,Induced
Keywords: tramadol
remifentanyl
patient controlled analgesia
abortion
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2006-08-08
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients undergoing second trimester abortions will recieve either patient controlled analgesia with either remifentanyl or tramadol for pain alleviation.

We beleive both to be equally effective for pain alleviation.

Detailed description: Women undergoing second trimester abortions will recieve patient controlled analgesia eith either tramadol or remifentanyl.

Patients will not know what they are recieving.

Patients in the tramadol goup will get a loading dose of tramadol and metocloparamide while the women in the remifentanyl group will be given a loading placebo.

Women will then be attached to one of the two patinet controlled analgesia protocols.

Throughout their laboring process they will be monitored for blood pressure, pulse, breathing rate, sedation score and nausea.

Additional medicatyion will be given for nausea.

If woman are still in pain the patient controlled analgesia settings will be set to deliver a higher dose. If the woman remains in pain, she will be given an additional per os medication.If this still does not alleviate pain, the option of epidural analgesia will be offered.

Eligibility criteria: Inclusion Criteria:

Woman undergoing 2nd trimester abortion -

Exclusion Criteria:

* Seizure disorder

  - \* Psychiatric disorder
* Inability to recieve patient controlled analgesia
* Allergy to tramadol or remifentanyl

Primary outcomes:
measure: Satisfaction
measure: VAS scores
measure: Nausea
measure: Sedation
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tiqvah
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Sharon Orbach-Zinger
role: STUDY_DIRECTOR
References:
Clinical trial NCT04517786: MINIject (MINI SO627) in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool
Official title: A Prospective, Open, Clinical Trial Analysing The Efficacy and Safety of MINIJECT (MINI SO627) In Patients With Open Angle Glaucoma Uncontrolled By Topical Hypotensive Medications Using A Single Operator Delivery Tool
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma, Open-Angle Glaucoma Eye
Keywords: Glaucoma
Medical device
MIGS drainage device
eye reduction IOP
Lead sponsor: iSTAR Medical
Sponsor class: INDUSTRY
Collaborators: name: International Drug Development Institute
First posted: 2020-08-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: MINIject SO627
Primary purpose: TREATMENT

Brief summary: The study will assess safety and performance in patients with open-angle glaucoma uncontrolled by topical hypotensive medications who had previously been implanted with a MINIject glaucoma implant.

Detailed description: The study will evaluate the efficacy and safety of MINI SO627 and IOP (Intra- ocular pressure) lowering effects with or without the use of glaucoma medications. The procedure will be a stand alone surgery. Patient follow up with several examinations up to 24 months after surgery.

The primary endpoint is the reduction in medicated mean diurnal IOP at 6 months follow up compared to medicated diurnal IOP at baseline visit.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
* Grade 3 or grade 4 according to Shaffer Angle Grading System.
* Glaucoma not adequately controlled by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21mmHg \< IOP \< 35 mmHg in the study eye at baseline visit.

Exclusion Criteria:

* Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shaffer Angle Grading System in the study eye.
* Neovascular glaucoma in the study eye.
* Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant in the stud eye.
* Prior glaucoma surgery in the study eye.

Primary outcomes:
measure: Change in medicated or unmedicated (without washout) mean diurnal IOP at 6 months follow-up
timeFrame: 6 month post surgey
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Maxivision Super Speciality Eye Hospital
city: Panamá
country: Panama
facility: Panama Eye Center
Study officials:
affiliation: iSTAR
name: Zubair Hussain, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03281486: "Hyaluronan" Formulation for Type 2 Diabetic Patients With Dry Mouth
Official title: Clinical Evaluation of the Efficacy of "Hyaluronan" Formulation for Dry Mouth in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Mouth
Xerostomia
Type 2 Diabetics
Lead sponsor: You First Services
Sponsor class: INDUSTRY
First posted: 2017-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: An increased incidence of dental caries in association with poorly controlled diabetes has also been reported, Xerostomia (dry mouth) has been reported to be a common complaint of patients with diabetes, Without adequate saliva production, both hard and soft tissues of the mouth can be severely damaged and become more susceptible to infections. This 9 week, cross-over group, randomized, single center, study will evaluate the efficacy of HA formulation in alleviating dry mouth in type 2 diabetic patients.


Eligibility criteria: Inclusion Criteria:

1. Patient should be above 18 years of age.
2. Patients who have been diagnosed with type 2 diabetes and have developed dry mouth or have worsening of pre-existing dry mouth condition.
3. Ability to attend visits at the research site
4. Patient should be able to read and/or understand and sign the consent form and be willing to participate in the research study
5. Agree to abstain from the use of any products for xerostomia other than those provided in the study.
6. Agree to comply with the conditions and schedule of the study.

Exclusion Criteria:

1. Subjects with open mouth sores at study entry.
2. Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia.
3. Subjects who are nursing, becoming pregnant or plan to become pregnant during the study period
4. Subjects currently on medication or treatment for dry mouth/xerostomia
5. Hypersensitivity to any of the following ingredients- HA ,xylitol and Sodium Benzoate.
6. Subjects with soft or hard tissue tumor of the oral cavity.
7. Presence of severe gingivitis.
8. Chronic disease with concomitant oral manifestations other than xerostomia
9. History of radiation therapy to head and neck
10. Subjects with conditions the investigator may feel will interfere with the study.

Primary outcomes:
measure: Relief from drymouth using VAS scoring
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Division of Endocrinology and Metabolism, Saint Louis University
state: Missouri
Study officials:
References:
Clinical trial NCT02180386: Effect of PlayStation Distraction in the Dental Setting
Official title: Effect of PlayStation Distraction on Children's Behavior and Pain in the Dental Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Global Behaviour Measure
Keywords: Audiovisual distraction
Pediatric dentistry
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2014-07-02
Enrollment: 34
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of the study was to assess whether the behavior, anxiety, and dental pain of pediatric patients during dental treatment improves when a video game is played as method of distraction.

Detailed description: global behavior Parental perception of patients' anxiety Patient's anxiety dental pain Heart Rate

Eligibility criteria: Inclusion Criteria:

* Patients aged 6-8 years.
* Patients who required a minimum of 2 visits for restorative treatment.

Exclusion Criteria:

* Patients with reduced audiovisual capabilities.
* Patients with psychological disorders.

Primary outcomes:
measure: Global behavior during the treatment
timeFrame: 14 days
Secondary outcomes:
measure: Parental perception of patient's anxiety
timeFrame: 14 days
measure: Self-reported anxiety during the treatment
timeFrame: 14 days
measure: Dental pain during the treatment
timeFrame: 14 days
measure: Heart rate during the treatment measures in different time points
timeFrame: 14 days
measure: Degree of acceptance of the distraction method by the pediatric patient
timeFrame: 14 days
Other outcomes:
Locations:
city: Sant Cugat del Valles
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
References:
citation: Ram D, Shapira J, Holan G, Magora F, Cohen S, Davidovich E. Audiovisual video eyeglass distraction during dental treatment in children. Quintessence Int. 2010 Sep;41(8):673-679.
citation: El-Sharkawi HF, El-Housseiny AA, Aly AM. Effectiveness of new distraction technique on pain associated with injection of local anesthesia for children. Pediatr Dent. 2012 Mar-Apr;34(2):e35-8.
Clinical trial NCT05588986: The Effect of Antenatal Corticosteroid on Umbilical Artery Doppler Velocimetry in IUGR
Official title: The Effect of Antenatal Corticosteroid Administration on Umbilical Artery Doppler Velocimetry in Pregnant Women Complicated With IUGR
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intrauterine Growth Restriction
Lead sponsor: Kocaeli University
Sponsor class: OTHER
Collaborators: name: Marmara University
First posted: 2022-10-20
Enrollment: 149
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women treated with antenatal corticosteroid due to a possible preterm delivery were divided into two groups as complicated and uncomplicated with IUGR.

Brief summary: The purpose of this study is to evaluate the effect of antenatal corticosteroid administration on umbilical artery Doppler velocimetry measurements in pregnancies complicated by IUGR.

Detailed description: This study was conducted with pregnant women who were likely to have preterm birth and were treated with antenatal corticosteroids. Betamethasone was used as an antenatal corticosteroid. UA Doppler measurements (PI, S/D ratio, RI) before antenatal corticosteroid administration and 24 and 48 hours after the last dose of corticosteroid administration were evaluated in pregnant groups complicated with IUGR and uncomplicated with IUGR and compared with each other.

Eligibility criteria: Inclusion Criteria:

pregnant women who were likely to have preterm delivery and were treated with antenatal corticosteroids.

Exclusion Criteria:

Pregnant women who had complicated pregnancy with fetal anomaly, who had multiple pregnancies, who left their pregnancy follow-up unfinished, and those under 18 years of age were excluded from the study.

Primary outcomes:
measure: systolic:diastolic ratio (S/D ratio)
timeFrame: 2018-2019
measure: pulsatility index (PI)
timeFrame: 2018-2019
measure: Resistive Index (RI)
timeFrame: 2018-2019
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Merve Demir
Study officials:
References:
Clinical trial NCT00327886: Managing Cyanosis Following Bidirectional Glenn Operation
Official title: A Retrospective Review of Postoperative Management of Cyanosis Following Bidirectional Glenn Operation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: pediatric
Glenn operation
Cyanosis
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2006-05-19
Enrollment: 150
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: The purpose of this retrospective study is to review the postoperative medical management of infants who underwent bidirectional Glenn operation from January 1, 2003 to December 31, 2005 who were significantly cyanotic.

Detailed description: Infants following bidirectional Glenn operation are at times significantly cyanotic. The medical management of significant postoperative cyanosis has changed with the advent of nitric oxide, sildenafil and bosentan. The purpose of this retrospective study is to review the postoperative medical management of infants who underwent bidirectional Glenn operation from Jan 1, 2003 to Dec 31, 2005 who were significantly cyanotic.

Summary of Procedures This is a retrospective study, therefore, the only procedure will be a chart review. I estimate the number of patients to be around 150, however, request permission to review the patient population in order to provide exact numbers. We request permission to review hospital charts from the time of bidirectional Glenn operation and the last clinic note within the dates Jan 1, 2003 to Dec 31, 2005.

We will assign each chart a unique study number and collect data of:

date of follow-up oxygen saturation during stay time since discharge 02 saturation at home home medications when discontinue medications

Eligibility criteria: Inclusion Criteria:

* Infants
* Bidirectional Glenn operation between 1/1/03-12/31/05
* Significant Cyanosis

Exclusion Criteria:

* Those who do not meet inclusion criteria.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Sibley Heart Center Cardiology, Children's Healthcare of Atlanta
name: Janet M Simsic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01596686: Comparison of Preparation Regimens for Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy Preparation
Lead sponsor: Clinical Hospital Colentina
Sponsor class: OTHER
First posted: 2012-05-11
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators intend to study the impact of two different preparation regimens for colonoscopy (PEG vs sodium picosulphate) on the quality of the endoscopy as well as patient tolerability.


Eligibility criteria: Inclusion Criteria:

* all patients undergoing colonoscopy

Exclusion Criteria:

* patient refusal to sign informed consent

Primary outcomes:
measure: colon preparation
timeFrame: 24 h
Secondary outcomes:
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Colentina Clinical Hospital
city: Timisoara
country: Romania
facility: Spitalul clinic judetean
Study officials:
References:
citation: Manno M, Pigo F, Manta R, Barbera C, Bertani H, Mirante VG, Dabizzi E, Caruso A, Olivetti G, Hassan C, Zullo A, Conigliaro R. Bowel preparation with polyethylene glycol electrolyte solution: optimizing the splitting regimen. Dig Liver Dis. 2012 Jul;44(7):576-9. doi: 10.1016/j.dld.2012.02.012. Epub 2012 Mar 26.
citation: Voiosu T, Ratiu I, Voiosu A, Iordache T, Schipor A, Baicus C, Sporea I, Voiosu R. Time for individualized colonoscopy bowel-prep regimens? A randomized controlled trial comparing sodium picosulphate and magnesium citrate versus 4-liter split-dose polyethylene glycol. J Gastrointestin Liver Dis. 2013 Jun;22(2):129-34.