louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01754792: Effects of Pinitol on Hidrocarbonated Metabolism Parameters in Diabetic, Impaired and Normal Fasting Glucose Subjects
Official title: A Randomized, Double-blind, Placebo-controlled Study on the Influence of Pinitol on Carbohydrate, Lipid and Inflammatory Parameters, Endothelial Function and Oxidative Stress in Diabetic, Impaired and Normal Fasting Glucose Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Impaired Glucose Tolerance
Healthy
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2012-12-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to assess whether pinitol improves hidrocarbonated metabolism parameters, and evaluate its effect on oxidative stress and endothelial function in diabetic, impaired and normal fasting glucose subjects.

This was a 3-month randomised, controlled-placebo, parallel trial with a three-arm design. Patients were divided into three groups: diabetic (n=40), impaired fasting glucose (n=40) or normal fasting glucose subjects (n=40), receiving 4 g/day of pinitol/placebo.


Eligibility criteria: Inclusion criteria:

* Age range of 18-70 years.
* Normal fasting glucose subjects were diagnosed as fasting glucose \<100 mg/dl and HbA1c \<5.7%.
* Impaired fasting glucose subjects were diagnosed as fasting glucose between 100 and 125 mg/dl and/or HbA1c between 5.7 and 6.4%.
* Type 2 Diabetes subjects were diagnosed as basal plasma glucose ≥ 126 mg/dl, at least twice, or glucose levels 2 hours after 75 g oral glucose overload ≥ 200 mg/dl (American Diabetes Association)

Exclusion criteria:

* Morbid obesity
* Type 1 diabetes
* Heart, liver, thyroid or kidney untreated disease
* Neoplasic disease
* Hypertriglyceridemia (Triglycerides \>400 mg/dl),
* Use of drugs that can influence the inflammatory state or insulin sensitivity (NSAIDs, corticosteroids, antiTNFα) and
* Uncontrolled type 2 diabetes (HbA1c ≥ 8%) or with insulin or intestinal disaccharidase inhibitors (acarbose, miglyol,...) treatment.

Primary outcomes:
measure: To assess hidrocarbonated metabolism parameters before and after pinitol/placebo administration
timeFrame: 3 months
Secondary outcomes:
measure: To evaluate lipid parameters before and after pinitol/placebo administration
timeFrame: 3 months
measure: To evaluate inflammatory parameters before and after pinitol/placebo administration
timeFrame: 3 months
measure: To evaluate endothelial function before and after pinitol/placebo administration
timeFrame: 3 months
measure: To evaluate oxidative stress on mitochondrial function before and after pinitol/placebo administration
timeFrame: 3 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University Hospital Dr Peset
Study officials:
affiliation: Universtiy of Valencia
name: Antonio Hernandez, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04998292: Piezo-surgical Implant With Laser
Official title: Piezo-surgical Implant Placement With Laser
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Effect of Piezo-surgical Implant With Laser on Pain and Swelling in Patients With Missing Teeth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: split mouth study
Primary purpose: TREATMENT

Brief summary: Evaluation of the effect of laser with piezo-surgical device in dental implants


Eligibility criteria: Inclusion Criteria:

* Healthy subjects having good oral hygiene
* History of bilateral extractions in the lower molar area not less than 6 months ago.

Exclusion Criteria:

* Patients with debilitating diseases or bad oral hygiene,
* Patients with parafunctional habits and patients who are taking analgesics or with alcohol abuse.

Primary outcomes:
measure: Assessment of pain
timeFrame: 2 hours after surgery
measure: Assessment of pain using visual analog scale
timeFrame: 6 hours after surgery
measure: Assessment of pain using visual analog scale
timeFrame: 24 hours after surgery
measure: Assessment of pain using visual analog scale
timeFrame: 2 days after surgery
measure: Assessment of pain using visual analog scale
timeFrame: 3 days after surgery
measure: Assessment of pain using visual analog scale
timeFrame: 4 days after surgery
measure: Assessment of pain using visual analog scale
timeFrame: 7 days after surgery
Secondary outcomes:
measure: Swelling using swelling score system
timeFrame: 2 hours after surgery
measure: Swelling using swelling score system
timeFrame: 6 hours after surgery
measure: Swelling using swelling score system
timeFrame: 24 hours after surgery
measure: Swelling using swelling score system
timeFrame: 2 days after surgery
measure: Swelling
timeFrame: 3 days after surgery
measure: Swelling using swelling score system
timeFrame: 4 days after surgery
measure: Swelling using swelling score system
timeFrame: 7 days after surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mahmoud
Study officials:
References:
Clinical trial NCT01653392: BioThrax® (Anthrax) Vaccine in Pregnancy Registry
Official title: BioThrax® (Anthrax) Vaccine in Pregnancy Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Complications
Pregnancy Outcome
Congenital Abnormalities
Keywords: Maternal Mortality
Obstetric Labor, Premature
Eclampsia
Pre-Eclampsia
Abortion, Spontaneous
Diabetes, Gestational
Pregnancy, Ectopic
Hydatidiform Mole
Fetal death
Live birth
Still birth
Premature Birth
Sex ratio
Birth weight
Lead sponsor: Emergent BioSolutions
Sponsor class: INDUSTRY
Collaborators: name: Naval Health Research Center
First posted: 2012-07-31
Enrollment: 98
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Active duty female service members who received one or more doses of BioThrax® while pregnant, with the onset of pregnancy defined as the first day of the last menstrual period (LMP) All live born infants born to women who join the registry.

Brief summary: The purpose of this study is to determine if inadvertent receipt of the BioThrax vaccine during pregnancy is independently associated with adverse maternal, pregnancy, or infant health outcomes.

Detailed description: This study will use a convenience sample and passive referral to enroll participants.

For the maternal outcome portion of the study, pregnant active duty women who consent to join the registry are expected to complete several surveys over the course of their pregnancy, including an initial enrollment survey, a follow-up survey at or after the 20th week of pregnancy, and a post-delivery survey at two weeks after their delivery due date (unless a pregnancy loss is reported in the 20 week survey).

Outcomes among infants born to women enrolled in the Registry whose pregnancies result in a livebirth will be assessed with a survey during the post-delivery contact, again at 4 months of age, with a final follow-up when the infant reaches one year of age.

Eligibility criteria: Inclusion Criteria:

* Female active duty service member
* Received one or more dose of BioThrax while pregnant, with the onset of pregnancy defined as the first day of the last menstrual period.

Exclusion Criteria:

* Non-service member, non-active duty pregnant female.

Primary outcomes:
measure: Pregnancy Outcomes
timeFrame: Up to 44 weeks
measure: Maternal Outcomes
timeFrame: Up to 44 weeks
measure: Infant Outcomes
timeFrame: Up to 1 year of age
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Health Research Center
state: California
Study officials:
affiliation: Naval Health Research Center
name: Natalie Wells, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03780192: INSPIRON Sirolimus Eluting Stent Performance in Bifurcation Coronary Arteries Treated Using Provisional Technique
Official title: INSPIRON Sirolimus Eluting Stent Performance in Bifurcation Coronary Arteries Treated Using Provisional Technique
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bifurcation Lesion
Coronary Artery Disease
Lead sponsor: Scitech Produtos Medicos Ltda
Sponsor class: INDUSTRY
First posted: 2018-12-19
Enrollment: 80
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: All patients with bifurcation coronary artery disease with indication for drug eluting implantation.

Brief summary: Evaluate the efficacy of the Inspiron Sirolimus Eluting Stent on bifurcation coronary artery lesions, in order to preserve and not compromize the side branch using the provisional stent technique.


Eligibility criteria: Inclusion Criteria:

* Patients with coronary artery disease on bifurcation anatomy with indication of drug eluting stent implantation , on which the side branch is ≥ 2.5 mm diameter and ostial stenosis ≤50% (Medina 1-1-0, 1-0-0, 0-1-0).

Exclusion Criteria:

* Acute Myocardial Infarction (STMI);
* Chronic occlusion;
* Cardiogenic shock;
* Ejection fraction ≤ 20%;
* Thrombocytopenia (≤ 50 mil);
* DAPT contraindication;
* Life expectancy of less than 12 months.

Primary outcomes:
measure: Percentage of Stenosis
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: RS
Study officials:
References:
Clinical trial NCT06300892: Surgical Site Infections and the Microbiome: Understanding the Pathogenesis of Surgical Site Infections
Official title: Surgical Site Infections and the Microbiome: Understanding the Pathogenesis of Surgical Site Infections
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Open GI Surgery
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults over the age of 18 years, who are undergoing open abdominal surgery with a midline incision.

Brief summary: This is a prospective, observational study of patients undergoing open GI surgery. At the time of operation, samples will be collected from the incision site and GI tract. The study will follow patients up to 30 days postoperatively, monitoring for signs of SSI. Samples will be taken from all patients who develop SSI. Sequencing will be performed on a subset of samples based on our specific aims.

* Aim 1: conduct a case-control study of patients with SSI and age-, sex-, diagnosis-, and wound class-matched control patients without SSI, comparing microbiome alpha diversity and community composition with 16S RNA sequencing to determine the association with SSI.
* Aim 2: identify the strain of bacteria isolated from SSIs using shotgun metagenomic sequencing and determine whether the specific strain was present in the skin and gut at the time of operation.


Eligibility criteria: Inclusion Criteria:

* We will include adult patients (age ≥ 18 years)
* Undergoing open abdominal surgery during the study period.
* Open abdominal surgery will include any abdominal procedure entering the peritoneal cavity through a midline incision with a skin incision that is 5cm or greater.

Exclusion Criteria:

* Patients with planned minimally invasive surgery including laparoscopic or robotic surgery as these patients have lower rates of surgical site infections (SSIs). Patients who have a laparoscopic or robotic surgery converted to open surgery will be excluded.
* Appendectomy and cholecystectomy as these patients have lower risk of SSI.
* Vascular, gynecological, obstetric, urological or transplantation.
* Trauma patients.
* Patients without source control at the index operation including those with an open abdomen, no fascial closure, or temporary abdominal closure device (such as abthera dressing).
* Pediatric patients (age\<18 years).
* Patients who decline swab/specimen collection.

Primary outcomes:
measure: alpha diversity composition
timeFrame: Baseline, Day 30 post-op
measure: microbial community composition
timeFrame: Baseline, Day 30 post-op
measure: pathogenic strain of bacteria
timeFrame: Baseline, Day 30 post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jennifer Rickard
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05848492: Efficacy of Prophylactic Fluconazole Therapy in Preterm and Very Low Birth Weight Neonates in Preventing Invasive Fungal Infection.
Official title: Efficacy of Prophylactic Fluconazole Therapy in Preterm and Very Low Birth Weight Neonates in Preventing Invasive Fungal Infection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Invasive Candidiases
Lead sponsor: Services Institute of Medical Sciences, Pakistan
Sponsor class: OTHER_GOV
First posted: 2023-05-08
Enrollment: 110
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Invasive fungal infection is detecting candida species in blood, cerebrospinal fluid, or urine. Clinical signs of invasive candidiasis may include lethargy, temperature instability, feeding intolerance, apnea, hypotension, respiratory distress, abdominal distension, and thrombocytopenia. Fungal infection has been associated with an increased risk of retinopathy of prematurity and chronic lung disease. Preterm and low birth weight infants have an immature immune system that predisposes them to infections with bacteria, viruses, and fungi. These infants usually require prolonged admission in the neonatal unit and there is often a need for the administration of broad-spectrum antibiotics which predisposes them to colonization with fungi that may invade to cause systemic disease8. Other risk factors for the development of invasive fungal infection include endotracheal intubation, abdominal surgery, the presence of a central venous catheter, administration of H2 antagonists, and steroids. Infection with Candida species is the third most common cause of bloodstream infection in premature infants. Mortality in preterm infants due to invasive candidiasis is around 20% and can be as high as 50% in infants weighing \<1500g at birth. Invasive candidiasis is the second most common infectious cause of death in extremely preterm infants. The present study was conducted to determine the incidence of invasive candidiasis among preterm and very low birth weight infants in our neonatal unit and to evaluate the efficacy of prophylactic fluconazole in preventing invasive fungal infection. Based on the results of the present study institutional guidelines may be designed in our neonatal unit relating to antifungal prophylaxis in preterm and very low birth weight infants.


Eligibility criteria: Inclusion Criteria:

* Preterm babies born less than 34 weeks of gestation
* very low birth weight babies (weighing \< 1500 g at birth)
* Babies \<72 hours of age

Exclusion Criteria:

* Babies \>72 hours of life
* Syndromic babies
* Babies with suspected metabolic disorders

Primary outcomes:
measure: Invasive candidiases
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Hospital Lahore
state: Punjab
Study officials:
affiliation: Services Hospital, Lahore
name: M Tauseef Omer, MBBS FCPS Pediatrics
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01161992: Genomics of Primary Sclerosing Cholangitis (PSC)
Official title: P.R.O.G.R.E.S.S.: PSC Resource Of Genetic Risk, Environment and Synergy Studies.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Primary Sclerosing Cholangitis (PSC)
Keywords: Primary Sclerosing Cholangitis
PSC
Cholestatic Liver Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-07-14
Enrollment: 1500
Sex: ALL
Minimum age (years): 5
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are patients at Mayo Clinic and are seen in the department of Gastroenterology and Hepatology are recruited by mail and carry a diagnosis of Primary Sclerosing Cholangitis (PSC). Subjects who are not Mayo Clinic patients are encouraged to contact the study coordinator by phone or email to request enrollment.

Brief summary: Primary Sclerosing Cholangitis (PSC) is a progressive liver disorder of unknown cause. Current evidence suggests that genes, the genetic material we inherit from our parents, in combination with environmental factors, likely play an important role in the development of PSC.

This study is being done to investigate whether genes make people more likely to develop PSC. Discovery of these genes will help us to better understand how PSC developes and subsequently, to apply new approaches for its prevention, diagnosis and treatment.


Eligibility criteria: Inclusion Criteria:

* Men, Women, and Children between the ages of 5-90 with a history of PSC.
* PSC patients who have had a liver transplant are eligible.
* Family members (1st degree relatives) of enrolled PSC patients are eligible.

Exclusion Criteria:

* Individuals with no history of PSC or those unable to provide consent.

Primary outcomes:
measure: Mapping of Susceptibility Genes in Adult Chronic Cholestatic Liver Diseases
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Konstantinos N Lazaridis, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Juran BD, Atkinson EJ, Schlicht EM, Larson JJ, Ellinghaus D, Franke A, Lazaridis KN. Genetic polymorphisms of matrix metalloproteinase 3 in primary sclerosing cholangitis. Liver Int. 2011 Jul;31(6):785-91. doi: 10.1111/j.1478-3231.2010.02420.x. Epub 2010 Dec 7.
Clinical trial NCT00714792: Pilot Study: Is Overactive Bladder Caused by Subacute Urinary Tract Infections?
Official title: Pilot Study: Is Overactive Bladder Caused by Subacute Urinary Tract Infections?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 18
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Urogynecology clinic

Brief summary: The purpose of this study is to look for evidence of bacteria in the urine or bladder of people with overactive bladder. Because you do not have overactive bladder, your participation in this study will be used as a comparison to those who have overactive bladder.


Eligibility criteria: Inclusion Criteria:

* Urge urinary incontinence based on clinical history and bladder diary; subjects must have 3 or more urge incontinence episodes/day and 10 or more voids/day.
* 21 years or older
* Healthy volunteers for control subjects

Exclusion Criteria:

* Active cystitis performed on a catheterized urine specimen
* Known or suspected correctable etiology for her urge incontinence
* History of urinary tract stones, foreign bodies or malignancy
* History of recurrent Urinary Tract Infections
* Pregnant women, children
* Evidence of urge urinary incontinence or more than 1 episode of stress incontinence/day by control subject

Primary outcomes:
measure: Number of Subjects With Evidence of Bacteria in Urine Sample by Microbiologic Evaluation
timeFrame: within one week of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Urogynecology and Reconstructive Pelvic Surgery Center
state: New York
Study officials:
affiliation: University of Rochester
name: Michael K. Flynn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02292992: Lung Volume Change Between Noninvasive Positive Pressure Ventilation by Nasal Pillow and High Flow Nasal Cannula
Official title: The Difference of Lung Volume Change Detected by Electrical Impedance Tomography (EIT) Between Noninvasive Positive-pressure Ventilation (NIPPV) Support by Nasal Pillow and High Flow Nasal Cannula in Post-extubation Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Failure
Keywords: Electrical impedance tomography
Nasal Pillow Continuous Positive Airway Pressure(CPAP)
High Flow Nasal Cannula
extubation
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2014-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The difference of lung volume change will be monitored by electrical impedance tomography before and after use of noninvasive positive pressure ventilation by nasal pillow and high flow nasal cannula in post-extubation patients.

Detailed description: Electrical impedance tomography can effectively monitor the lung volume change in ICU patients who were under mechanical ventilator or noninvasive positive pressure ventilator support. Continuous positive airway pressure (CPAP) support by nasal pillow and high flow nasal cannula can improve inspiratory function in extubated patients . However, the extent of lung volume change or functional residual volume (FRC) change by using these two devices were never surveyed before in extubated patients. The investigators will check end-expiratory lung volume (EELV) ,anterior, medio-anterior, medio-posterior and posterior EELV by electrical impedance tomography after use of these two devices in extubated patients.

Eligibility criteria: Inclusion Criteria:

* \>20 y/o
* Any extubated patients after tolerating spontaneous breathing trial

Exclusion Criteria:

* Presence of tracheostomy
* Recent facial trauma
* Active gastro-intestinal bleeding
* Do-not-intubate status and
* Planned use of BiPAP after extubation.
* Patients with unstable spinal lesions or fractures.
* BMI\> 50
* Patients with a cardiac pacemaker
* Burn injury with skin defect

Primary outcomes:
measure: • End-expiratory lung volume (EELV) determined by electrical impedance tomography after high flow nasal cannula and nasal pillow CPAP
timeFrame: at day 1
Secondary outcomes:
measure: Anterior, medio-anterior, medio-posterior and posterior EELV at each time
timeFrame: at day 1
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
affiliation: +886975835770 l49428@mmh.org.tw
name: Lee Chao-Hsien, MD
role: PRINCIPAL_INVESTIGATOR
References: