louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02255877: ZIPS Study - Zip Incision Approximation vs. STAPLE
Official title: A Prospective, Non Blinded, Randomized Controlled Post Market Study Designed to Compare the Use of the Zip Surgical Skin Closure Device vs. Conventional Steel Staples for Skin Closure in Subjects Who Undergo a bi Lateral Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Arthroplasty, Replacement, Knee
Keywords: Bi lateral knee surgery
uni compartmental
Lead sponsor: ZipLine Medical Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study designed to evaluate the Zip Surgical Skin Closure device versus conventional steel staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi later total knee replacement.

Detailed description: This is a randomized, within patient control study aiming to enroll up to 25 subjects requiring bi lateral knee arthroplasty (unicompartmental or toal) at a single study center. Subjects will be followed for up for 6 weeks post surgery to evaluate wound healing and overall satisfaction of closure methods.

Eligibility criteria: Inclusion Criteria:

* Patients requiring epidermal closure after bi lateral total or partial (unicompartmental) knee arthroplasty;
* Patients willing to be evaluated at discharge and 6-weeks post op.

Exclusion Criteria:

* Known bleeding disorder not caused by medication
* Known personal or family history of keloid formation or scar hypertrophy
* Known allergy or hypersensitivity to non-latex skin adhesives
* Atrophic skin deemed clinically prone to blistering
* Any skin disorder affecting wound healing
* Any other condition that in the opinion of the investigator would make a particular patient unsuitable for this study

Primary outcomes:
measure: Effectiveness Outcome - Wound Healing
timeFrame: 6 weeks post surgery
Secondary outcomes:
measure: Surgeon Satisfaction with the Closure Method
timeFrame: At Discharge, 1-3 days post surgery
measure: Patient Pain
timeFrame: Throughout 6 week study period (Discharge, 2 week follow up and 6 week follow up (exit) visits.)
measure: Patient Satisfaction of Scars
timeFrame: At 6 week Follow up (exit) visit
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Orthopaedic Research Foundation
state: Indiana
Study officials:
affiliation: VP Marketing
name: Eric Storne
role: STUDY_DIRECTOR
References:
Clinical trial NCT04812977: Comparison of Intravitreal Anti-VEGF Versus Combination Therapy in Central Retinal Vein Occlusion
Official title: Comparison of Intravitreal Bevacizumab and Triamcinolone Acetonide With Intravitreal Bevacizumab Alone in Macular Edema Secondary to Central Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Retinal Vein Occlusion With Macular Edema
Keywords: central retinal vein occlusion
macular edema
intravitreal bevacizumab
Lead sponsor: Hayatabad Medical Complex
Sponsor class: OTHER_GOV
First posted: 2021-03-24
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effect of intravitreal-Bevacizumab and Triamcinolone with intravitreal-Bevacizumab alone on visual acuity and central foveal thickness in patients with macular edema secondary to central retinal vein occlusion.


Eligibility criteria: Inclusion Criteria:

* Subjects of either gender, age 40-80 years, having macular edema secondary to CRVO, Best-corrected visual acuity (BCVA) of less than or equal to 0.3 on Log MAR chart (Snellen equivalent of 6/12), Central foveal thickness CFT greater than or equal to 250 microns on Heidelberg Spectralis Spectral Domain Optical coherence tomography (SD-OCT) and clinical diagnosis of CRVO.

Exclusion Criteria:

* previously received laser treatment and/or intravitreal injection of any Anti-VEGF agent, having one eye, diagnosed case of glaucoma, family history of glaucoma, young patient, and anyone who has received any treatment for CRVO before presenting to us.

Primary outcomes:
measure: Visual Acuity
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Central Foveal Thickness
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Hayatabad Medical Complex
state: KPK
Study officials:
References:
citation: Yoshizawa C, Saito W, Kase M, Ishida S. Clinical Features of Central Retinal Vein Occlusion With Inflammatory Etiology. Asia Pac J Ophthalmol (Phila). 2012 Sep-Oct;1(5):270-6. doi: 10.1097/APO.0b013e318266de04.
citation: Lazic R, Boras I, Vlasic M, Gabric N, Tomic Z. Anti-VEGF in treatment of central retinal vein occlusion. Coll Antropol. 2010 Apr;34 Suppl 2:69-72.
Clinical trial NCT01327677: Safety Study of Analgesia After Craniotomy Surgery With End Tidal (ET) Carbon Dioxide (CO2) Monitoring
Official title: Post Craniotomy Analgesia Safety Monitoring With ET CO2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: pain management
opioid analgesic therapy
safety
craniotomy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2011-04-01
Enrollment: 137
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 research is being done to compare two methods of giving fentanyl, a narcotic often given to patients following brain surgery and determine if one method has more side effects than the other. Both of these methods are available in the postoperative treatment of pain. This research also is being done to determine if patients receiving narcotic pain medicine will benefit from additional monitoring of carbon dioxide levels. Since narcotic pain medicines can slow down breathing, The investigators want to see if measuring exhaled carbon dioxide levels will help identify a slower breathing rate and improve safety.

Detailed description: See brief summary

Eligibility criteria: Inclusion Criteria:

* Adult male and female, English speaking patients undergoing supratentorial craniotomy for tumor under general anesthesia at the Johns Hopkins Hospital will be eligible for this study.

Exclusion Criteria:

* pregnant women
* patients with post operative neurological changes
* patients who remain intubated post-operatively
* patients who require the use of concomitant administration of sedatives

  * patients who are unable to initiate a PCA bolus
  * patients who are unable to communicate verbally
  * patients who are allergic to fentanyl
* patients who have a history of narcotic abuse
* patients who have a history of chronic pain requiring opioids
* patients who have been in any investigational drug trial within 1 month of the treatment day
* patients who have chronic respiratory insufficiency

Primary outcomes:
measure: Respiratory Depression
timeFrame: up to 24 hours postoperatively
measure: Respiratory Depression
timeFrame: Up to 24 hours postoperatively.
Secondary outcomes:
measure: Hypoxia
timeFrame: up to 24 hours postoperatively
Other outcomes:
measure: Mean Fentanyl Consumption
timeFrame: up to 24 hours postoperatively
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Athir H Morad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04502953: Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele
Official title: Outcome of Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectocele
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We assumed that the technique of plication of the rectovaginal septum and rectal wall may factor in providing better and more sustained repair that confers more satisfactory improvement in symptoms. The present randomized study aimed to evaluate the outcome of TPR with vertical plication of the rectovaginal septum as compared to the horizontal plication with regards to improvement in ODS, recurrence of rectocele, postoperative complications and dyspareunia.


Eligibility criteria: Inclusion Criteria:

* Vertical plication of the rectovaginal septum was done

Exclusion Criteria:

* patients with ODS caused by conditions other than rectocele such as anismus and internal rectal prolapse
* patients with slow transit constipation.
* patients with recurrent rectocele after previous surgery.
* patients with pre-existing FI
* patients with associated anorectal pathology.

Primary outcomes:
measure: Complete cure of symptoms
timeFrame: 12 months after repair
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh H Emile
role: STUDY_CHAIR
References:
Clinical trial NCT01667653: Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment
Official title: A Randomized Parallel Group Study to Evaluate the Effect of a Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Antibiotic Therapy
Lead sponsor: Danisco
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
First posted: 2012-08-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is randomized, double-blind, placebo controlled, single centre; 21 days phase II clinical trial on healthy volunteers. Following baseline visit at the day of randomization, treatment with Augmentin 875mg for 7 days will be given. Concurrently and after antibiotic treatment subjects will also receive the study treatment, either probiotic or placebo. Daily Bowel Habit Diary will be completed by the subjects. The subjects will be asked to collect fecal samples for microbiological examination. The primary objective of the study is to evaluate the maintenance of intestinal microbiota composition during antibiotic treatment with Augmentin 875mg. Secondary objectives will be to evaluate the reduction in side effects associated with antibiotic use.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 to 50 years.
* Healthy as determined by laboratory results, medical history and physical exam
* Willing to give voluntary, written, informed consent to participate in the study

Exclusion Criteria:

* Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
* Body mass index ≥ 30 kg/m2
* Average number of formed bowel movements \> 3 per day or \< 3 per week
* Smokers
* Participation in a clinical research trial within 30 days prior to randomization
* Use of antibiotics within 60 days prior to randomization.
* Habitual use of pro- and/or prebiotic products.
* Follows a vegetarian or vegan diet
* Unstable medical conditions
* Any evidence of acute or chronic gastrointestinal disorder
* Alcohol use \> 2 standard alcoholic drinks per day and/or alcohol or drug abuse within past year
* Allergy or sensitivity to test product ingredients or antibiotic
* Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

Primary outcomes:
measure: Maintenance of intestinal microbiotic composition before, during and after antibiotic treatment with Augmentin 875mg
timeFrame: 3 weeks
Secondary outcomes:
measure: The influence of probiotics on side effects associated with antibiotic use
timeFrame: 3-weeks
Other outcomes:
Locations:
city: London/Ontario
country: Canada
facility: KGK Synergize Inc.
Study officials:
References:
Clinical trial NCT05351853: Metabolic Effects of Plant-based Diet
Official title: Metabolic Effects of Plant-based Diet on Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Diet
Fatty Liver
Insulin Resistance
Metabolic Syndrome
Healthy Lifestyle
Healthy Nutrition
Keywords: plant-based
metabolic
fatty-liver
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the metabolic effects of plant based diet on healthy young adults.

Detailed description: An internet announcement will be made and 60 participants who meet the eligibility requirements will be randomly selected. After being informed about study, all participants (60 omnivores) giving written informed consent will be assigned to the vegan and vegetarian groups of the study according to their preferences, while 20 participants will continue to be omnivores as the control group. At week 0 and 24, blood samples, urine samples, proton density fat fraction MRI evaluations and body composition analyze will be completed.

Eligibility criteria: Inclusion Criteria:

1. Being 18-40 years old,
2. BMI is 18-30 kg/m2,
3. Having no chronic diseases,
4. Not smoking

Exclusion Criteria:

1. Having chronic disease,
2. Being older than 40 years old or younger than 18 years old,
3. Smoking,
4. Alcoholism or drinking more than 140 gr/week of alcohol,

Primary outcomes:
measure: Change from Baseline Liver Steatosis at 6 months
timeFrame: At week 24 liver steatosis change will be compared between the groups.
Secondary outcomes:
measure: Change from Baseline Insulin Resistance at 6 months
timeFrame: At week 24 insulin resistance change will be compared between the groups.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University Medical Faculty
Study officials:
References:
Clinical trial NCT02360553: The Effect of ObeseGO! Towards Adolescent Obesity
Official title: The Effect of Internet Based Intervention (OBESEGO!) Towards Obesity Among Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Behavioral Change
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 47
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Adolescents nowadays is having most of their times other than school hours spending on screen by playing games, watching the movies and surfing the internet. Thus, it was suggested that Internet-based interventions have the potential for establishing healthy dietary style and physical activity that may persist in adulthood and reduce the risk of chronic disease. Preventing adolescent obesity requires an attitude of willingness by adolescents to implement healthy behaviors. By providing the health related activities in website, it would help the adolescents to spend time on screen by having something which can benefit them and improve their knowledge and attitudes.

Detailed description: This study done in improving the health promotion in Malaysia. It will be an evidenced in creating the most effective way in creating the awareness among adolescent. By having an effective health promotion it will help in reducing the prevalence of obesity and improving health among adolescents hence will reducing the comorbidities among adulthood.

Eligibility criteria: Inclusion Criteria:

* Students aged of 16 years old (adolescents) in secondary school in Kuala Lumpur who have BMI of more than 25 kg/m2, have one guardian or parent who willing to join the study and having access to internet at home were then selected to join this study

Exclusion Criteria:

* those who are having existing medical condition and having weight loss more than 2 kg in last two months

Primary outcomes:
measure: Body mass index
timeFrame: 3 months
Secondary outcomes:
measure: Waist Circumference
timeFrame: 3 months
measure: Body fat percentage
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02510053: Pharmacokinetics and Pharmacodynamics of Caspofungin (Cancidas ®) and Drug Tolerance of Fungi to Patients With an Invasive Fungal Infection in the Intensive Care Unit
Official title: PK-PD of Caspofungin (Cancidas ®) and Drug Tolerance of Fungi to Patients With an Invasive Fungal Infection in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Invasive Fungal Infection
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2015-07-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate pharmacokinetics(PK) and pharmacodynamics(PD) of Caspofungin in ICU patients after received a loading dose of 70mg followed by 50mg (35mg if Child-Pugh score is 7-9), 40 patients will be recruited. Blood samplings for PK analysis will be collected on day 4 in this study. Caspofungin plasma concentrations are measured by using solid phase extraction and reverse phase high-performance liquid chromatography. Safety analyses will be taken daily during the treatment of Caspofungin. Tests for drug tolerance of fungi and efficacy assessment (clinical and mycological responses) will be taken every 3 days by clinical and mycological tests.


Eligibility criteria: Inclusion Criteria:

* Patient is admitted to ICU with APACHE-II score more than 15
* Subject is 18 years old and older on the day of the first dosing
* Subject with evidence of proven or probable IFI defined by modified criteria of European Organization for Research and Treatment of Cancer(EORTC)

Exclusion Criteria:

* patient is known to be hypersensitive to caspofungin
* patient's Child-Pugh score is more than 9
* patient is prone to discontinue treatment result from lack of cost
* patient or their guardian refuse to sign a informed consent form
* patient concurrently receiving efavirenz, nevirapine, rifampin, systemic dexamethasone, phenytoin, carbamazepine, phenobarbital, or cyclosporine and other agents have influence on PK parameters of caspofungin
* patient is treated with caspofungin within 24 hours

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: day 4
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: day 4
Secondary outcomes:
measure: Drug-related adverse events
timeFrame: End of caspofungin treatment,an expected average of 20 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03759353: Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy
Official title: A Comparative Study Between Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Iron Deficiency Anemia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 98 pregnant women with iron deficiency will be randomized into two groups: lactoferrin group or ferrous sulfate group
Primary purpose: TREATMENT

Brief summary: The main drawbacks with oral iron are side-effects, poor compliance, and limited absorption from the gut. It has become very apparent gastrointestinal intolerance with oral iron therapy is dose related and common (up to 20% of patients), and this frequently leads to poor compliance.

Lactoferrin (formerly known as lactotransferrin) is a glycoprotein, and a member of a transferrin family, thus belonging to those proteins capable of binding and transferring iron. It represents an attractive and promising alternative to ferrous sulphate oral administration as pregnant women receiving lactoferrin did not experience any adverse effects.

This study aims to compare between lactoferrin and ferrous sulphate for therapy of iron deficiency in pregnant women.


Eligibility criteria: Inclusion Criteria:

* Pregnant women with single fetus.
* Second trimester (14-20weeks of gestation).
* Normal Hemoglobin level: more than10g\\dl.
* Serum ferritin less than 15 mcg / L

Exclusion Criteria:

* Other type than iron-deficiency anemia (thalassemia, hemolytic anemia ... etc.)
* Any other chronic diseases (bronchial asthma, renal or hepatic, hematological or cardiovascular diseases ... etc.)
* Having hypersensitivity to iron preparations.
* Treatment with any other iron preparation in the last month.
* History of peptic ulcer, oesophagitis or hiatal hernia.
* Medical disorders with pregnancy.
* Need for alternative parenteral route to blood transfusion when rapid increase is required (perioperative anemia-severe anemia in late pregnancy-postpartum anemia) .
* Bleeding in early pregnancy.
* Refusal to participate in the study.
* Family history of thalassemia-sickle cell anemia or malabsorption syndrome.
* Recent blood transfusion.
* Inflammatory bowel disease as intolerance of oral therapy but tolerated to parenteral route.

Primary outcomes:
measure: Change in serum ferritin level
timeFrame: 4 weeks
Secondary outcomes:
measure: Nausea and/or vomiting
timeFrame: 4 weeks
measure: Dyspepsia
timeFrame: 4 weeks
measure: Compliance to treatment
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain SHams Maternity Hospital
state: Abbaseya
Study officials:
affiliation: G Darwish
name: Ghada Mohamed, MBBCh
role: PRINCIPAL_INVESTIGATOR
References: