louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01138891: Sonication of Explanted Breast Implants for Detection of Subclinical Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Implants, Breast
Keywords: Breast implants
capsular contraction
sonication
biofilm
Complications
surgery
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: University Hospital, Basel, Switzerland
name: Medical University Innsbruck
name: Clinic Löwencenter, Luzern, Switzerland
name: Clinic Birshof, Münchenstein, Switzerland
name: Crossklinik im Merian Iselin Spital, Basel, Switzerland
First posted: 2010-06-08
Enrollment: 121
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Five plastic surgery clinics in Switzerland participated in this study (Basel, Luzern, Dornach, Lausanne, Münchenstein).

Brief summary: Objective. Capsular contracture is a frequent complication after breast implantation with unclear etiology.

Summary Background Data: Microorganisms may trigger chronic periimplant inflammation with subsequent capsular fibrosis.

Study Hypothesis: The investigators hypothesize that with sonication adherent microorganisms can be detected on removed implants .

Methods: In a prospective multicentre study all breast implants explanted are collected to be analyzed by sonication. The resulting culture results are correlated with patient, surgical and implant characteristics.

Detailed description: The study is performed in order to find a correlation between the degree of capsular fibrosis and presence of biofilm bacteria on the surface of the implant.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or more
* Undergoing breast implant removal for any reason at one of the participating center
* Explantation of breast implant performed between February 2006 and March 2009

Exclusion Criteria:

* Obvious contamination of the breast implant in the operating room or during transportation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Plastic, Reconstructive & Aesthetic Surgery, Medical University, Innsbruck, Austria
name: Ulrich M Rieger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rieger UM, Pierer G, Luscher NJ, Trampuz A. Sonication of removed breast implants for improved detection of subclinical infection. Aesthetic Plast Surg. 2009 May;33(3):404-8. doi: 10.1007/s00266-009-9333-0. Epub 2009 Mar 26.
citation: Rieger UM, Mesina J, Kalbermatten DF, Haug M, Frey HP, Pico R, Frei R, Pierer G, Luscher NJ, Trampuz A. Bacterial biofilms and capsular contracture in patients with breast implants. Br J Surg. 2013 May;100(6):768-74. doi: 10.1002/bjs.9084. Epub 2013 Mar 6.
Clinical trial NCT01833091: Creating an Artificial Night on Physiological Changes in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Physiologic Changes
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 38
Sex: ALL
Minimum age (years): 30
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Effects of creating an artificial night on physiological changes, weight and feeding tolerance in preterm infants.

Introduction:Nowdays,with medical advances in intensive care increased chance of survival in premature infants.One of the major concerns exposure to high light levels in neonate \& subsequent it is increase in metabolism rate.So,this study was conducted to determine the effect of creating an artificial night on physiological changes, weight and feeding tolerance in preterm infants.

Methods: This is a randomized clinical trial dual group study, 38 preterm infants (gestational age of 30-34weeks)due to prematurity hospitalized at Ghaem NICU,were evaluated within 10 days. Infants were divided into two groups of 1200-1700 and 1701-2200g based on the weight and the weight of each group were randomized into artificial night(dark period was from 19 to 7 during incubator was covered with linen cloth \& light period was from 7 to 19 removed the cover) and control groups(continuous lighting). Mothers \& infants through questionnaires,interviews,observation \& document completion, changes in physiologic \& weight befor entering the study \& then physiologic changes twice a day,weight \& feeding tolerance were collected daily.Data were analyzed using spss v.16 software.


Eligibility criteria: Inclusion Criteria:

Premature newborn infants with gestational age of 30-34 weeks Birth weight of 1200-2200g Taking care and supervision in the incubator to measure weight and grow up Keeping the axillary temperature in the range of 36-37° C Keeping the heart rate in the range of 100 to 160 beats per minute Breast feeding through a nasogastric tube or gastric orally Healthy infants without congenital anomalies No history of taking specific drugs or alcohol by mother during the pregnancy. Mother's lack of addiction

Exclusion Criteria:

Illness of the infant (affecting with secondary sepsis, seizures; increased or decreased blood pressure, successive apnea, feeding intolerance or feeding stoppage) Starting phototherapy Discharge of the infant earlier than 10 days Parents' lack of consent with the study

Primary outcomes:
measure: effect of creating an artificial night on physiological changes, weight and feeding tolerance in preterm infants
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02480491: Study of Free DNA Content of Embryo Culture Medium as a Non-Invasive Tool for Embryo Assessment
Official title: Study of Cell Free DNA Content of Human Embryo Culture Medium as a Non-Invasive Tool for Embryo Assessment in ICSI Treatment Cycles
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Sadat City University
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2015-06-24
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICSI Treatment Cycles females

Brief summary: Study of Cell Free DNA Content of Human Embryo Culture Medium as a Non-Invasive Tool for Embryo Assessment in intra cytoplasmic sperm injection Treatment Cycles.

Detailed description: The aim of the present study is to determine whether cell free DNA content of the culture medium of the human embryo correlates with the quality and reproductive potential of embryos in ICSI cycles and, thus, to look for a new non invasive tool of assessing embryo quality beside morphological assessment. Determining a rapid, noninvasive method for the assessment of the developmental potential of embryos may be a great achievement

Eligibility criteria: Inclusion Criteria:

* third day embryos

Exclusion Criteria:

* less than third day embryos

Primary outcomes:
measure: correlations between levels of measured cell free DNA and embryo quality.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04127591: Differential Expression and Analysis of Peripheral Plasma Exosome miRNA in Patients With Myocardial Infarction
Official title: Differential Expression and Analysis of Peripheral Plasma Exosome miRNA in Patients With Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of myocardial infarction

Brief summary: The aim of this study is to determine the miRNA expression profile in peripheral blood exosomes of patients with myocardial infarction and to investigate its relationship with myocardial infarction.

Detailed description: Collect exosomes in peripheral blood of patients with myocardial infarction, compare the expression of miRNA with healthy volunteers, find out the miRNAs with significant differences, and explore its relationship with the development of myocardial infarction.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years ST elevation by ECG diagnostic of STEMI Evidency of coronary occlusion in coronariography Signed informed consent

Exclusion Criteria:

* Patients who will undergo immediate PCI Pregnant and lactating women Patients with mental disorders Patients are using other experimental drugs; Refusal to provide informed.

Primary outcomes:
measure: Determination of differential expression of miRNA by second-generation sequencing technology
timeFrame: Day 7
Secondary outcomes:
measure: Diagnostic value of the differential microRNAs evaluate by qPCR in patients of myocardial infarction
timeFrame: Day 7
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ethics Committee of Xinhua Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00733291: Evaluation of Daily Disposable Lenses With Multi-Purpose Solution (MPS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Daily disposable contact lenses
Multi-purpose disinfecting solutions
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-08-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate daily disposable lenses inserted out of the blister package versus daily disposable lenses inserted after a pre-soak in Multi-purpose solution FID 107027.

Detailed description: Corneal staining and subjective responses for ocular redness and comfort will be compared.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older.
* Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses.
* Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* History of hypersensitivity to any components of the multi-purpose solution.
* Evidence or history of ocular conditions as prescribed in protocol.
* One functional eye or a monofit lens
* Any slit-lamp finding score equal to 1 at Visit 1 of each study period.
* Significant corneal staining at visit 1 of each study period as prescribed in protocol.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Average Corneal Staining Area
timeFrame: After 2 hours of wear
measure: Total Corneal Staining Type
timeFrame: After 2 hours of wear
Secondary outcomes:
measure: Ocular Comfort
timeFrame: After 2 hours of wear
measure: Ocular Redness
timeFrame: After two hours of wear
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT02523391: Bioequivalence Study of Capsule and Tablet Formulations of TA-8995
Official title: A Phase I, Randomised, Open-label Cross-over Bioequivalence Study of Capsule and Tablet Formulations of TA-8995 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidaemia
Lead sponsor: Xention Ltd
Sponsor class: INDUSTRY
First posted: 2015-08-14
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the pharmacokinetics of capsule and tablet formulations of TA-8995 in healthy male subjects aged 18 to 55 years.


Eligibility criteria: Inclusion Criteria:

* Healthy males aged 18-55
* Body Mass Index (BMI) between 18.0 and 32.0 kg/m2, inclusive

Exclusion Criteria:

* Subject has a known hypersensitivity to any of the inactive ingredients of the study treatments.
* Subject has any other condition which, in the Investigator's opinion will interfere with the study.
* Subjects who are still participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) within 3 months or 5 half-lives (whichever is longer) prior to the first dose in this study.

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of TA-8995 capsule and tablet formulations
timeFrame: 72 hours
measure: Peak Plasma Concentration (Cmax) of TA-8995 capsule and tablet formulations
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit Ltd
Study officials:
References:
Clinical trial NCT03105791: The Effect of Patient Education on Opioid Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Injury
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Prospective, randomized clinical trial investigating the use of patient education on post-operative narcotic consumption


Eligibility criteria: Inclusion Criteria:

* Over the age of 18
* clinically indicated for an arthroscopic rotator cuff repair

Exclusion Criteria:

* Patients with irreparable rotator cuff tears
* allergic or sensitivity to the study medication
* history of gastrointestinal issues
* any evidence of glenohumeral arthritis
* inability to consent

Primary outcomes:
measure: Opioid Usage
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03165591: Open Label Immunotherapy Trial of Inoperable Pancreatic Cancer
Official title: Open Label Phase II Immunotherapy Trial of Inoperable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Pancreatic Cancer Non-resectable
Lead sponsor: Immunitor LLC
Sponsor class: INDUSTRY
First posted: 2017-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pancreatic cancer (PDA) is the most lethal form of cancer, and the fourth-leading cause of cancer-related death in the United States, with a survival rate of less than 7%.There are currently no treatments found to be effective for patients with advanced disease who are ineligible for surgery, a prognosis representing the majority of pancreatic cancer diagnoses. Pancreatic cancer is not amenable to chemotherapy as compared to other cancer types, leaving patients with practically no options except surgery.

We have made oral tableted therapeutic vaccine, V3-P, derived from pooled blood of patients with PDA in line with similar highly promising approach we have adopted for patients with hepatocellular carcinoma (HCC) and cholangiocarcinoma (CAA). Patients with PDA will be given one tablet per day of V3-P and followed up to see the outcome.

Detailed description: This study is an open label Phase II study aimed to recruit at least 20 patients with inoperable PDA and who are positive for CA19.9 pancreatic tumor marker. The presence of higher than normal levels of CA19.9 is the sole inclusion criteria. Patients will be given one tablet of V3-P daily and followed for three months.

Eligibility criteria: Inclusion Criteria:

* diagnosis of inoperable pancreatic cancer
* higher than normal of serum CA19.9 tumor marker levels (40 IU/ml)
* must be able to swallow tablets

Exclusion Criteria:

* negative for CA19.9
* pregnant, breast feeding women
* unwillingness to provide written consent

Primary outcomes:
measure: Effect of V3-P on tumor burden
timeFrame: 3 months
Secondary outcomes:
measure: Safety of V3-P
timeFrame: 3 months
measure: Effect of V3-P on sugar and bilirubin levels
timeFrame: 3 months
Other outcomes:
Locations:
city: Ulaanbaatar
country: Mongolia
facility: Immunitor LLC
city: Ulaanbaatar
country: Mongolia
facility: National Cancer Center
Study officials:
affiliation: Immunitor Inc.
name: Allen Bain, PhD
role: STUDY_CHAIR
References:
citation: Tarakanovskaya MG, Chinburen J, Batchuluun P, Munkhzaya C, Purevsuren G, Dandii D, Hulan T, Oyungerel D, Kutsyna GA, Reid AA, Borisova V, Bain AI, Jirathitikal V, Bourinbaiar AS. Open-label Phase II clinical trial in 75 patients with advanced hepatocellular carcinoma receiving daily dose of tableted liver cancer vaccine, hepcortespenlisimut-L. J Hepatocell Carcinoma. 2017 Apr 12;4:59-69. doi: 10.2147/JHC.S122507. eCollection 2017.
Clinical trial NCT00804791: Residence Time Evaluation of Marketed OTC Ophthalmic Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: dry eye
autofluorescence
residence time
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-12-09
Enrollment: 25
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: The objective of this study is to measure ocular surface residence time (in minutes) of two marketed OTC ophthalmic products in dry eye patients.


Eligibility criteria: Inclusion Criteria:

* Informed consent and HIPAA read, signed and dated before conducting any procedures.
* Adult volunteers diagnosed with mild to moderate dry eye. Criteria for diagnosis must include 2 of the 3 following characteristics: composite symptom score \> or = to 5 on modified Schein questionnaire; NaFl TFBUT \< or = to 7 seconds in either eye; or NaFl corneal staining sum score \> or = to 3 (using 0-15 point grading system).
* Able and willing to follow study instructions. 4) Best-corrected V.A. of 0.6 logMAR or better OU.

Exclusion Criteria:

* History or evidence of ocular or intraocular surgery in either eye w/i the past 6 months.
* History or evidence of serious ocular trauma in either eye w/i the past 6 months.
* History of intolerance or hypersensitivity to any component of the study medications.
* History or evidence of epithelial herpes simplex keratitis, vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva and/or eyelids, mycobacterial infection of the eye, and/or fungal disease of the eye.
* Use of concomitant topical ocular medications during the study period.
* Patients using systemic medications that may contribute to dry eye may not be enrolled unless they have been on a stable dosing regimen for a minimum of 30 days prior to Visit 1, and the dosing regimen must remain stable throughout the study period.
* Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe admininstration of the test article.
* Individuals unwilling to d/c contact lens wear during the study period. CL wear must have been d/c at least one week prior to Visit 1.
* Participation in an investigational drug or device study w/i 30 days of entering this study.
* Additionally, any subject may be declared ineligible for a valid medical reason.

Primary outcomes:
measure: Ocular Surface Residence Time
timeFrame: After 8 minutes, then every 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04750291: Management of Popeye Sign With Botulinum Toxin After Bicepstenotomy
Official title: Management of Popeye Sign With Botulinum Toxin After Tenotomy of the Long Head of the Biceps Tendon: a Double-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Popeye Syndrome
Keywords: tenotomy
long head of the biceps tendon
botulinum toxin
Lead sponsor: AZ Delta
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 20
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: Double-blinded randomized controlled trial with 20 people of whom 10 will receive a placebo infiltration and 10 an infiltration with botulinum toxin type A for cramping pain after arthroscopic tenotomy of the long head of the biceps tendon.

Detailed description: Title: Management of Popeye sign with botulinum toxin after tenotomy of the long head of the biceps tendon: a double-blinded randomized controlled trial Précis: Double-blinded randomized controlled trial with 20 people. Randomization in 2 arms of 10 people. 3 visits will be planned with a meantime of 3 months after the infiltration with botulinum toxin type A (BTX-A) or placebo that will be administered at the 2nd visit.

Objective: The primary objective is to assess the effectiveness of an infiltration with botulinum toxin in the biceps muscle after tenotomy of the long head of the biceps tendon for pain and disability reduction.

Endpoint: The primary endpoint is a pain reduction as measured by the Visual Analogue pain scale (VAS) and a reduced disability as measured by the quick DASH (Disabilities of the Arm, Shoulder and Hand).

Population: 20 people who underwent an arthroscopic tenotomy of the long head of the biceps tendon and are having post-operative pain in the biceps muscle.

Phase: 4

Number of Sites enrolling participants: single center study in AZ Delta Roeselare

Description of Study Agent: botulinum toxin type A (Botox®) 100 International Units by intramuscular injection

Study Duration: From March 2021 till December 2022

Participant Duration: 3 months

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Have had arthroscopic tenotomy of the long head of the biceps tendon without rotator cuff repair, acromioclavicular joint resection or glenoid labrum repair
* Having bicipital pain that started after the tenotomy

Exclusion Criteria:

* under 18 years of age
* over 65 years of age
* pregnancy or lactation

Primary outcomes:
measure: Pain change
timeFrame: 3 months
measure: Disability change
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roeselare
country: Belgium
facility: AZ Delta
Study officials:
affiliation: Orthopedie Roeselare AZ Delta
name: Bert Vanmierlo, MD
role: PRINCIPAL_INVESTIGATOR
References: