louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06131567: Implantoplasty as Adjunct to Combined Surgical Therapy of Peri-Implantitis
Official title: Implantoplasty as Adjunct to Combined Surgical Therapy of Peri-Implantitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peri-Implantitis
Lead sponsor: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trials with paired number of subjects
Primary purpose: TREATMENT

Brief summary: Implantoplasty entails polishing of the implant surface during the surgical therapy of peri-implantitis. Given the controversy behind implantoplasty as surface decontamination method in the treatment of peri-implantitis, the goal of this clinical trial is to assess the clinical resolution and radiographic bone gain in peri-implantitis sites treated by means of reconstructive therapy (Inteross® + autogenous bone, Sigmagraft, CA, USA) + implantoplasty in combined defects when compared to the extent of implantoplasty along the exposed implant surface upon the clinical resolution and radiographic bone gain in peri-implantitis sites treated by means of reconstructive therapy (Inteross® + autogenous bone, Sigmagraft, CA, USA).


Eligibility criteria: Inclusion criteria

* All patients in age of 18 to 80, non-smokers
* With no presence of systemic disease or medication known to alter bone metabolism, and partial or complete edentulous patients that have no active periodontal disease.
* Peri-implantitis defined according to the EFP/AAP consensus meeting
* Combined defect configuration

Exclusion criteria:

* Pregnancy or lactation
* History of or current smokers
* Uncontrolled medical conditions,
* Cement-retained restoration
* Lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites.

Primary outcomes:
measure: Rate of disease resolution
timeFrame: 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: Centro de Implantologia Cirugia Oral y Maxilofacial
Study officials:
References:
Clinical trial NCT02470572: Evaluation of the Omnyx™ Integrated Digital Pathology System in the Primary Diagnosis of Surgical Pathology Specimens
Official title: Evaluation of the Omnyx™ Integrated Digital Pathology System in the Primary Diagnosis of Surgical Pathology Specimens
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Diagnosis of Surgical Pathology Specimens
Lead sponsor: Omnyx, LLC
Sponsor class: INDUSTRY
First posted: 2015-06-12
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A multi-site, randomized-read order, retrospective, paired-design evaluation of the Omnyx™ Integrated Digital Pathology (IDP) system with de-identified and previously signed-out cases from all major organ systems. Pathologist will read and diagnose cases on a conventional light microscope and on the Omnyx™ IDP system for Whole Slide Images (WSI) with a randomized read order. College of American Pathologists (CAP) cancer protocol checklists will be used to capture diagnostic reporting.

Diagnoses rendered by site Reading Pathologists will be captured on CAP checklists and compared directly to the Ground Truth (GT) diagnosis for both modalities.

Detailed description: Following the FDA issued guidance document, "Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable"- 2006, the specimens are surgical pathology samples from leftover human specimens from clinical cases, archived and previously signed-out across the majority of surgical pathology subspecialties

Eligibility criteria: Inclusion Criteria:

• All surgical pathology samples from pre-identified list provided by FDA

Exclusion Criteria:

* Gross evaluation only specimens (including hardware and specimens that do not require microscopic review for diagnosis)
* Immunofluorescence specimens
* Fluid-based specimens
* Intraoperative consultation specimens only (frozen preparation)
* Specimens from which a slide(s) fails quality control according to user manuals and training and issue(s) cannot be remediated at the time of procurement and over-labeling; this includes having too many labels such that slide damage or scanner failure is likely (as outlined in Omnyx user manuals).
* Specimens for which any slide (other than a blank) that should be in the case part cannot be located

Primary outcomes:
measure: Diagnosis of surgical pathology
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Omnyx, LLC
name: Michael Montalto, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00106704: Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)
Official title: A Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Glimepiride Alone or in Combination With Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-03-30
Enrollment: 441
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with Type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Patients with Type 2 Diabetes Mellitus with inadequate glycemic control

Exclusion Criteria:

* Patients with Type 1 Diabetes Mellitus

Primary outcomes:
measure: Change From Baseline in A1C at Week 24
timeFrame: Baseline and 24 Weeks
Secondary outcomes:
measure: Change From Baseline in FPG at Week 24
timeFrame: Baseline and 24 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Hermansen K, Kipnes M, Luo E, Fanurik D, Khatami H, Stein P; Sitagliptin Study 035 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab. 2007 Sep;9(5):733-45. doi: 10.1111/j.1463-1326.2007.00744.x. Epub 2007 Jun 26.
Clinical trial NCT01362504: Pro-adrenomedullin as a Prognostic Marker in Neonatal Sepsis
Official title: Zekai Tahir Burak Maternity Teaching Hospital Neonatal Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: Pro-adrenomedullin
Neonatal sepsis
Prognosis
Sepsis marker
Clinical sepsis
Proven sepsis
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2011-05-30
Enrollment: 80
Sex: ALL
Minimum age (years): 24
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm and term neonates with sepsis were enrolled in this study including 80 cases.

Brief summary: The aim of this study was to clarify the prognostic value of serum pro-Adrenomedullin level in neonatal sepsis. Eighty term and preterm neonates with sepsis were enrolled in this study. Eighty healthy matched neonates served as a control group.


Eligibility criteria: Inclusion Criteria:

* Clinical sepsis and/or proven sepsis.

Exclusion Criteria:

* Acute kidney injury
* Intracranial hemorrhage (Grade III and IV)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital, Neonatology Unit
Study officials:
References:
Clinical trial NCT00347204: Comparison of Acular LS Versus Nevanac for Pain Control in Eyes Undergoing PRK
Official title: Double Masked Evaluation of Acular LS Versus Nevanac for Postoperative Pain Control in Eyes Undergoing PRK
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myopia
Hyperopia
Keywords: PRK
laser vision correction
surface ablation
pain
wound healing
corneal haze
Lead sponsor: Center For Excellence In Eye Care
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2006-07-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the ability of two topical Nonsteroidal Anti-inflammatory drops (Acular LS \& Nevanac) to help control pain following Photorefractive Keratectomy (PRK).

Detailed description: Laser Vision Correction is the most commonly performed elective surgical procedure in the United States. Although Laser-Assisted in-situ Keratomileusis (LASIK) is the more popular technique, a growing number of surgeons have switched to surface ablation techniques, including PRK, LASEK and Epi-LASIK.1 With surface laser procedures, the corneal epithelium is removed by a variety of techniques (laser, manual debridement, diluted alcohol2,3, epi-keatome) prior to laser reshaping of the corneal stroma. Following the procedure, a contact lens is placed on the eye to promote epithelial regeneration. Due to the size of the epithelial defect, it can take between 3 to 6 days for the epithelium to regenerate. During this healing process, patients often complain of moderate to severe ocular pain, and delayed healing may result in an increased risk of infection or corneal haze4.

Over the past decade, a variety of methods have been used to assist with reducing pain following surface laser procedures. Topical Nonsteroidals have been shown in a number of studies to help reduce the degree of pain following PRK. Topical dilute tetracaine has also been shown to assist with the reduction of pain following PRK. Oral pain medications, such as Vioxx, Celebrex, and even Prednisone have been recommended as additional treatment options for pain control.

In October 2005, a new topical nonsteroidal anti-inflammatory drop, Nevanac, was approved by the FDA. Nevanac was approved with a a TID dosing schedule.

Acular LS is the current market leader for topical NSAID eye drops. Acular LS is typically used on a QID dosing schedule.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing PRK for myopia or hyperopia

Exclusion Criteria:

-

Primary outcomes:
measure: Prevention of postoperative discomfort on postoperative days 1 to 5 after PRK
measure: Best-corrected Visual acuity at all study visits
measure: Degree of corneal haze at all study visits
measure: Time to epithelial closure in each eye after PRK
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Center For Excellence In Eye Care
name: William Trattler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06348004: The Association Between Albumin Administration and Short-term Rebleeding Risk in Cirrhosis Patients With Acute Variceal Hemorrhage and Stable Hemodynamics
Official title: A Study on the Risk of Rebleeding Within 30 Days After Discharge in Patients With Cirrhosis and Acute Variceal Bleeding Following Short-term Albumin Infusion
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cirrhosis
Acute Variceal Haemorrhage
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cirrhosis patients with acute variceal bleeding who were admitted to the First Affiliated Hospital, Zhejiang University School of Medicine from January 2021 to October 2023.

Brief summary: The impact of albumin administration in cirrhotics with acute variceal hemorrhage (AVH) is controversial. We aim to investigate the short-term rebleeding risk associated with albumin administration in a retrospective study of hospitalized cirrhotics with AVH with stable hemodynamics. This retrospective analysis includes clinical data of cirrhosis patients with acute variceal bleeding admitted to our hospital from January 2021 to October 2023. Propensity score matching will be performed to account for potential confounders associated with albumin use for outcome analysis. According to the outcome, patients will be divided into rebleeding group and non-rebleeding group. To investigate the impact of albumin infusion on the rebleeding risk in the propensity-matched cohort, patients will be divided into albumin user group and albumin non-user group. The primary outcome is the rebleeding risk within 30 days after discharge.


Eligibility criteria: Inclusion criteria (1) Patients were diagnosed with liver cirrhosis with esophageal and gastric varices; (2) Patients were presented with any evidence or signs of acute upper gastrointestinal bleeding within 3 days before admission, including hematemesis, melena, and positive fecal occult blood. (3) Endoscopy or imaging data suggested the presence of AVB.

Exclusion criteria

(1) Patients with unstable hemodynamics (patients whose sBP\<90mmHg or heart rate \>120 bpm at admission). (2) Patients who were initially treated at other facilities but later transferred to our hospital without comprehensive medication records. (3) Ages \<18 years old or ages \>85 years old. (4) Patients with incomplete data.

Primary outcomes:
measure: The rebleeding risk within 30 days after discharge.
timeFrame: From enrollment to 30 days after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT05783804: Plaque Reversal With Early, Aggressive Lipid Lowering Therapy
Official title: Plaque Reversal With Early, Aggressive Lipid Lowering Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease Progression
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult (newly diagnosed) heterozygous FH patients between 18 and 50 years with non-calcificated plaque on coronary CT angiography and who are not optimally treated yet.

Brief summary: This study evaluates whether plaques in young patients with familial hypercholesterolemia (aged below 50 years) are susceptible to significant plaque regression with early, intensive lipid lowering therapy.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with heterozygous familial hypercholesterolemia
* Adult between 18 and 50 years old
* LDL cholesterol levels above 100 mg/dl (\>2.6 mmol/L) at inclusion

Exclusion Criteria:

* Renal insufficiency, defined as eGFR \< 30 ml/min
* History of atherosclerotic cardiovascular events
* Atrial fibrillation
* Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator
* Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.

Primary outcomes:
measure: CAD Progression
timeFrame: 40 Weeks
Secondary outcomes:
measure: Non-calcified plaque progression
timeFrame: 40 Weeks
measure: Calcified plaque progression
timeFrame: 40 Weeks
measure: Number of high-risk plaques
timeFrame: 40 Weeks
measure: Difference in Pericoronary Adipose Tissue Attenuation
timeFrame: 40 Weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC, location AMC
name: Erik SG Stroes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01063504: Teriparatide for Improved Knee Prosthesis Fixation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis of the Knee
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2010-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators will study how well knee joint prostheses become fixed to the bone when patients get teriparatide, compared to placebo. Measurements will use high resolution 3D radiography (radiostereometry, RSA).


Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of the knee planned for prosthesis surgery

Exclusion Criteria:

* Poor health, drugs affecting bone metabolism.

Primary outcomes:
measure: Migration as measured by RSA maximal total point motion.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Motala
country: Sweden
facility: Motala hospital
Study officials:
References:
Clinical trial NCT02357004: Mechanisms of Refractory Hypertension (Carvedilol)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypertensive
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this protocol is test whether patients with hypertension refractory to antihypertensive treatment have evidence of excessive sympathetic (i.e., nervous system) activity.

Detailed description: Refractory hypertension refers to high blood pressure that is failing conventional antihypertensive therapies. In a retrospective assessment of such patients in our clinic we observed that resting clinic heart rates were higher in patients with refractory hypertension compared to patients with controlled hypertension. This observation has led to the hypothesis that refractory hypertension is caused by excessive sympathetic output. This protocol is designed to test this hypothesis by comparing the BP response to carvedilol verses chlorthalidone in patients with refractory hypertension. If their extreme treatment resistance is neurogenic is etiology, a significantly larger BP response to carvedilol should occur compared to chlorthalidone.

Eligibility criteria: Inclusion Criteria:

* Uncontrolled clinic BP (\>140/90 mmHg)
* Receiving 5 or more antihypertensive agents including an ACE inhibitor or ARB, calcium channel blocker, and chlorthalidone 25 mg

Exclusion Criteria:

* Current use of an alpha or beta or combined alpha-beta antagonist
* Known allergy to alpha-beta antagonists
* CKD (eGFR \<40 ml/min/m2)
* MI, stroke or episode of CHF exacerbation within 3 months
* Bradycardia \<50 bpm; history of 2nd or 3rd degree heart block unless treated by a pacemaker
* Pregnant or breast-feeding women
* Known hypersensitivity to chlorthalidone or other sulfonamide-derived drugs

Primary outcomes:
measure: % of subjects who achieve BP control (<140/90 mm Hg)
timeFrame: 8 weeks after baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cardiology Department - University of Alabama at Birmingham
name: David A. Calhoun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00478504: Letrozole Versus Clomifene Citrate for Ovulation Induction
Official title: Double Blind Cross-over Randomized Controlled Trial Comparing Letrozole Versus Clomifene Citrate for Ovulation Induction in Women With Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Polycystic Ovarian Syndrome
Keywords: anovulation
ovulation induction,
polycystic ovarian syndrome
clomifene citrate
letrozole
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: University Hospitals of Derby and Burton NHS Foundation Trust
First posted: 2007-05-24
Enrollment: 159
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary aim of the study is to assess the efficacy of letrozole as an ovulation induction agent and to test the hypothesis that letrozole will generate better pregnancy rates with fewer multiple pregnancies and higher live birth rate than the current standard agent, clomifene citrate in anovular infertile women with polycystic ovarian syndrome.


Eligibility criteria: Inclusion Criteria:

1. Age: 18 - 39
2. BMI \< 36
3. Infertility due to anovulation
4. PCOS: At least two of the following diagnostic criteria of:

   1. Oligo/amenorrhoea
   2. Hyperandrogenaemia: biochemical (testosterone ≥2.5 nmol/l or free androgen index (FAI) ≥ 5) or clinical (acne/hirsutism) evidence
   3. USS evidence of PCO (either ≥12 follicles measuring 2-9 mm in diameter, or an ovarian volume of \> 10 ml)
5. No recent (within 6 months) treatment for induction of ovulation
6. Normal semen analysis (WHO 1999)
7. Proven patency of at least one Fallopian tube

Exclusion Criteria:

1. Inability to give informed consent
2. Contraindication to letrozole or clomifene citrate
3. Absence of any inclusion criteria

Primary outcomes:
measure: Pregnancy rate
timeFrame: 14 moths
Secondary outcomes:
measure: 1. Ovulation rate 2. Number of growing and mature follicles during treatment 3. Miscarriage rate 4. Live-birth rate 5. Multiple pregnancy rate 6. Endometrial thickness
timeFrame: 14 months
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
state: Derbyshire
Study officials:
affiliation: University of Nottingham and Derby Hospitals NHS foundation Trust
name: Saad Amer, MD, MRCOG
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amer SA, Smith J, Mahran A, Fox P, Fakis A. Double-blind randomized controlled trial of letrozole versus clomiphene citrate in subfertile women with polycystic ovarian syndrome. Hum Reprod. 2017 Aug 1;32(8):1631-1638. doi: 10.1093/humrep/dex227.