louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04316273: Colonic Duplication; Two Cases Report and Review of Literature
Official title: Colonic Duplication; Two Cases Report and Review of Literature
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 2
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients age group from 1 day till 18 years

Brief summary: Duplicated colon appendix are infrequent detected during surgical exploration. For Diagnosed cases, excision of the duplicated part is indispensable, due to risk of malignancy.

Detailed description: Alimentary tract duplication represents(ATD) 0.2% of all pediatric congenital malformations Which affect all gastrointestinal tracts (GIT) from the mouth to the anus.

ATD more common in with no familial or racial predilection. The ileum is the most common site (30%-35%) and the colon is the least common site (7%-20%).

The transverse colon is the most common site for colonic duplication. The duplicated part of GIT maybe in the mesenteric or anti-mesenteric side. It may has same vascular supply and mesentry or not(reported only in small bowel)..

Communication between the anomalous and actual enteric lumens may or may not be present.

Here in, two cases of colonic and anal duplication add to the knowledge with review of literature of duplicated colon in children.

Eligibility criteria: Inclusion Criteria:

1. Pediatric patients till age of 18 years old
2. All patients diagnosed with duplicated colon with or without symptoms
3. Patients with duplicated colon and other associated colorectal anomalies

Exclusion Criteria:

1. Patients \> 18 years with duplicated colon
2. All patients with duplication cyst

Primary outcomes:
measure: Post duplicated colon resection constipation by Bristol stool scale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Mohammed Hamada Takrouney
Study officials:
References:
citation: AbouZeid AA, Mohammad SA, Ibrahim SE, Fagelnor A, Zaki A. Late Diagnosis of Complete Colonic and Rectal Duplication in a Girl with an Anorectal Malformation. European J Pediatr Surg Rep. 2019 Jan;7(1):e47-e50. doi: 10.1055/s-0039-1692193. Epub 2019 Jul 5.
Clinical trial NCT05627973: Health Status of < 50 Year Old Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2020)
Official title: Health Status of < 50 Year Old Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2020)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Disease
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Sicknessfund Burgenland
name: Landesklinikum Sankt Polten
First posted: 2022-11-28
Enrollment: 991
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent isolated surgical aortic valve replacement in Austria above 18 years and below 50 years of age with no other concomitant heart surgery were included.

Brief summary: The overall project aim is to study outcomes following aortic valve replacement with either mechanical valves or bioprostheses by retrieving data from the main social security carriers in Austria for the years 2010-2020 in under 50 year old patients.

Detailed description: The purpose of this research project is to evaluate mortality (primary outcome) and incidence of heart attack, stroke, reoperation and first diagnosis of heart insufficiency, MACE (secondary outcomes) after aortic valve replacement in under 50 year olds. We aim to compare those outcomes between mechanical valves and bioprostheses.

Data will be retrieved from the main social security carriers in Austria (covering 98% of its population) from 2010-2020.

Eligibility criteria: Inclusion Criteria:

* isolated surgical aortic valve replacement in Austria

Exclusion Criteria:

* below 18 years of age
* above 50 years of age
* concomitant heart surgery

Primary outcomes:
measure: Overall mortality
timeFrame: 10 years
Secondary outcomes:
measure: reoperation
timeFrame: 10 years
measure: stroke
timeFrame: 10 years
measure: heart attack
timeFrame: 10 years
measure: heart insufficiency
timeFrame: 10 years
measure: MACE
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02366273: Diabetes and Psoriasis
Official title: Diabetes and Psoriasis: Study on Prevalence, Role of Inflammation and Insulin-resistance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Psoriasis
Keywords: Diabetes
Psoriasis
Inflammation
Insulin-resistance
Lead sponsor: University of Pavia
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Policlinico San Matteo di Pavia
First posted: 2015-02-19
Enrollment: 425
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with psoriasis

Brief summary: Patients with psoriasis will be evaluated. The investigators will collect personal history, concomitant diseases and in particular the presence of type 2 diabetes mellitus, impaired fasting glucose and impaired glucose tollerance. The aim of the study will be to evaluate if there is a correlation among inflammation, insulin-resistance and psoriasis.


Eligibility criteria: Inclusion Criteria:

* patients with psoriasis

Exclusion Criteria:

* NA

Primary outcomes:
measure: Evaluation of correlation between diabetes and psoriasis
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo Foundation
Study officials:
affiliation: University of Pavia - IRCCS Policlinico San Matteo Foundation
name: Giuseppe Derosa, MD, PhD, FESC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00031473: Ribavirin to Prevent RSV Pneumonia in Bone Marrow Transplant Patients
Official title: A Randomized Phase III Study to Evaluate the Safety and Efficacy of Ribavirin Inhaled Solution in Preventing Progression of Upper Respiratory Tract Respiratory Syncytial Virus Infection to RSV Pneumonia in Blood and Bone Marrow Transplant (BMT) Recipient
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Respiratory Syncytial Virus Infections
Keywords: Ribavirin
RSV
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2002-03-07
Enrollment: 90
Sex: ALL
Minimum age (years): 5
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the safety and effectiveness of ribavirin, administered as an aerosol, in preventing progression of upper respiratory tract RSV infection to RSV pneumonia in bone marrow and peripheral blood transplant recipients.

Detailed description: The study enrolls 90 transplant recipients with positive nasal/throat culture specimens for Respiratory Syncytial Virus (RSV) infection. Patients are randomized into one of two groups: investigational treatment or standard treatment.

Eligibility criteria: INCLUSION CRITERIA:

* 2 years of age or older.
* Are not pregnant or breast-feeding and agree to use a reliable birth control method for the duration of the study.
* Are a blood or bone marrow transplant recipient.
* Have evidence of upper respiratory tract infection.
* Have nasopharyngeal-throat samples positive for RSV.

EXCLUSION CRITERIA:

* Are known to be HIV positive.
* Have pneumonia.
* Require a ventilator to breathe.
* Are pregnant.
* Are breast-feeding and are unwilling to stop breast-feeding.
* Are receiving treatment with certain other drugs for RSV.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (CASG)
state: Alabama
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: J. Whitcomb Riley Hosp for Chldrn - Indianapolis
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital (Kansas City, MO)
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
References:
Clinical trial NCT01939873: The Effect Of Kristeller Maneuver On Maternal And Neonatal Outcome
Official title: A Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Secons Stage of Labor
Keywords: Kristeller maneuver; Second stage of labor;
Perineal laceration; Obstetrical outcome;
Neonatal outcome
Lead sponsor: Kayseri Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2013-09-11
Enrollment: 285
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The use of fundal pressure in management of the second stage of labor is controversial. The aim of this study is both to evaluate the effectiveness of fundal pressure in shortening the second stage of labor and to examine the related neonatal and maternal outcomes.

Detailed description: Patients will be randomly allocated to two groups by using a computer-generated random number chart: Kristeller maneuver intervention (study) group (n=140) and control group (n=140). Umbilical artery blood gas will obtained to assess the newborn's acid-base status. The umbilical artery levels of creatinine kinase, creatinine kinase with myocardial specific isoform, aspartate amino transferase, alanine amino transferase, lactate dehydrogenase and lactic acid will be measured. Length of episiotomy and length of vagina will be measured at 45 degrees from the midline. Each patient's vaginal laceration, cervical laceration, length of episiotomy and vagina before and after delivery and duration of the second stage of labor in minutes will be recorded. Neonatal information will include: infant birth weight, apgar scores, babies requiring pediatric help, and admission of neonatal intensive care units.

Eligibility criteria: Inclusion Criteria:

* Pregnants who were administered for delivery and signed informed consent form were included into the study.

Exclusion Criteria:

* Pregnant who required oxytocin augmentation, multiple gestations, pregnant with medical problems (such as asthma, thyroid, cardiac, liver, kidney disease, preeclampsia and diabetes), pregnant with previous caesarean and pregnant whose estimated fetal weight \<2500gr or \>4000gr were not included into the study.

Primary outcomes:
measure: vaginal laceration, cervical laceration, length of episiotomy and vagina before and after delivery
timeFrame: up to 6 months
Secondary outcomes:
measure: The umbilical artery levels of creatinine kinase, creatinine kinase with myocardial specific isoform, aspartate amino transferase, alanine amino transferase, lactate dehydrogenase and lactic acid were measured.
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Gökhan
Study officials:
References:
Clinical trial NCT02250573: An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery
Official title: An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Haemophilia B
Lead sponsor: Bio Products Laboratory
Sponsor class: OTHER
First posted: 2014-09-26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The main objectives of this study were to investigate the safety and efficacy of Replenine®-VF administered in appropriate dosage by bolus infusion to prevent bleeding and achieve haemostasis in subjects with haemophilia B undergoing surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects with moderate to severe haemophilia B undergoing major surgery requiring an in-patient stay of generally 5 to 10 days.

Exclusion Criteria:

-

Primary outcomes:
measure: Incremental recovery for Factor IX
timeFrame: 90 min post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej nad Matka I Dzieckiem, ul. Krysiewicza 7/8.
city: Bucharest
country: Romania
facility: Institutul National de Haemtologie, 2-8 Constantin Caracas Str.
city: Timisoara
country: Romania
facility: Spitalul de urgenta pentru copii "Louis Turcana", Str. losef Nemoianu 2.
city: Kirov
country: Russian Federation
facility: Kirov Research Institute of Haematology, 72 Krasnoarmeyskaya ul.
city: Moscow
country: Russian Federation
facility: Haematology Centre, Russian Academy if Medical Sciences, 4a Novozykovsky Proezed.
Study officials:
References:
Clinical trial NCT04312373: Efficacity of a Rigid Ankle Foot Orthosis for Persons With Ankle Osteoarthritis
Official title: Efficacity of a Rigid Ankle Foot Orthosis for Persons With Ankle Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Osteoarthritis
Keywords: Ankle Osteoarthritis
Ankle Foot Orthosis
Ankle Arthrodesis
Single Case Experimental Design
Lead sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from AOA

Brief summary: Ankle osteoarthritis (AOA) is a typical long-term complication of an ankle injury. Pain during walking is the main symptom that limits walking distance. Non-surgical treatments could be used to decrease pain. The gold standard treatment for end-stage OA is definitive surgical ankle arthrodesis.

The purpose of this study was to assess the effectiveness of a rigid ankle-foot orthosis (R-AFO) for walking pain in a population suffering from AOA.

Detailed description: This study used the SCED introduction/withdrawal methodology to assess the efficacy of R-AFO on pain and walking distance in the 2-minute walk test (2MWT). Each patient is his or her own comparator. During phase A, considered as the baseline, the patient performs the 2MWT without R-AFO. During phases B, considered as the introduction phases, the patient performs the tests with R-AFO. These tests are performed repeatedly and at regular intervals. The time of transition between phases has been randomized to have a minimum of 3 trials per phase.

At the end of each test, an visual analogue scale for the pain and the walking distance travelled during the 2MWT were recorded.

Eligibility criteria: Inclusion Criteria:

* primary or post-traumatic one-sided Ankle osteoarthritis (AOA)
* Able to walk at least two minutes

Exclusion Criteria:

* cardiovascular diseases
* respiratory diseases that prevent subjects from performing the walking tests
* neurologic or orthopaedic diseases which could affect their gait (excluding AOA)
* inability to understand study instructions

Primary outcomes:
measure: Evolution of the distance travelled during the 2MWT between each phase
timeFrame: 1 day, starting from the baseline
measure: Evolution of the Visual Analogue Scale (VAS) for walking ankle pain between each phase
timeFrame: The VAS was performed after each 2MWT. All 2MWT were completed in one day.
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Institut Régional de Médecine Physique et de Réadaptation
Study officials:
affiliation: Institut Régional de Médecine Physique et de Réadaptation
name: Jean Paysant, PhD-MD
role: STUDY_CHAIR
References:
Clinical trial NCT05090176: Title: Povidone-soaked Sutures Versus Ordinary Sutures for Reducing Surgical Site Infection
Official title: Title: Povidone-soaked Sutures Versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Efficacy Povidone Soaked Suture in Reducing Surgical Site Infection
Keywords: suture
povidone
surgical site infection
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 140
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: randomized control trial, double blind
Primary purpose: OTHER

Brief summary: To determine efficacy of using 3 minutes povidone-soaked suture in reducing surgical site infection during wound closure in elective surgery.

Detailed description: Participant recruitment and randomisation based on eligibility based on CONSORT.

Patient will get either package A or B which determine whether they are getting povidone-soaked suture or ordinary suture during wound closure.

Postoperative, follow up on D10 and D30 of patient well being and signs and symptoms of surgical site infection

Eligibility criteria: Inclusion Criteria:

* Age more than 12 years old
* Clean surgery or Clean- contaminated surgery
* Elective surgery

Exclusion Criteria:

* Age less than 12 years old
* Contaminated wound
* Dirty wound
* Allergy to povidone-iodine
* Pregnant
* Laparoscopic
* Emergency surgery

Primary outcomes:
measure: Povidone-soaked Sutures versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia
timeFrame: 6 months
Secondary outcomes:
measure: Povidone-soaked Sutures versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia
timeFrame: 6 months
measure: Povidone-soaked Sutures versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia
timeFrame: 6 months
Other outcomes:
Locations:
city: Kubang Kerian
country: Malaysia
facility: Universiti Sains Malaysia
state: Kelantan
Study officials:
affiliation: UNIVERSITI SAINS MALAYSIA- HEALTH CAMPUS
name: SITI HAFZAN ABD KARIM, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04676776: Assessing Use Of Mifepristone After Progestin Priming For Use As "Missed Period Pills"
Official title: Assessing Use Of Mifepristone After Progestin Priming For Use As "Missed Period Pills"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Missed Menstrual Period
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Cuidado Integral de la Mujer, Gineclinic, S.C.
First posted: 2020-12-21
Enrollment: 139
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Simon's two-stage design
Primary purpose: TREATMENT

Brief summary: This study will assess the effectiveness and acceptability of a 3-day missed period pill regimen.

Detailed description: Missed period pills (MPPs) are medications used for uterine evacuation among women with late menses who have not confirmed pregnancy status. Provision of MPPs could expand reproductive service options for individuals in a variety of settings. This study will collect data on the efficacy, safety, and acceptability of a 3-day missed period pill regimen among individuals with missed menses of 1-10 days

Eligibility criteria: Inclusion Criteria:

* Age 18-49 years
* General good health
* Does not want to be pregnant
* History of regular monthly menstrual cycles (±3 days)
* Missed menses of 1 to 10 days as verified by report of last menstrual period
* Sexual activity in the past month
* Willing and able to sign consent forms
* Willing to return for a follow-up visit
* Willing to provide a urine sample at enrollment and at follow-up

Exclusion Criteria:

* Known allergies or contraindications to mifepristone
* Symptoms of or risk factors for ectopic pregnancy, such as vaginal bleeding or spotting within the past week; unilateral pelvic pain or significant bilateral pelvic pain within the past week; prior ectopic pregnancy; prior permanent contraception or other tubal surgery
* Current use of an IUD, contraceptive implant or injectable

Primary outcomes:
measure: Efficacy of missed period pill regimen
timeFrame: Up to 28 days after administration of levonorgestrel
Secondary outcomes:
measure: Effectiveness of missed period pill regimen
timeFrame: Up to 28 days after administration of levonorgestrel
measure: Effectiveness at inducing return of menses within 10 days
timeFrame: Up to 10 days after administration of levonorgestrel
measure: Occurrence of treatment-emergent adverse events and/or side effects (safety and tolerability)
timeFrame: Up to 28 days after administration of levonorgestrel
measure: Acceptability of missed period pills
timeFrame: Up to 28 days after administration of levonorgestrel
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Cuidado Integral de la Mujer, Gineclinic, S.C
Study officials:
affiliation: Gynuity Health Projects
name: Beverly H Winikoff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Holly A Anger
role: STUDY_DIRECTOR
References: