louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03193008: Current Value of Axillary Ultrasound in the Staging of Breast Cancer. Is BSGC Still Necessary?
Official title: Current Value of Axillary Ultrasound in the Staging of Breast Cancer. Is BSGC Still Necessary?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Breast Cancer
Axillary ultrasound
Sentinel lymph node biopsy
Axillary management
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2017-06-20
Enrollment: 1400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically confirmed breast cancer from January 2008 to December 2013

Brief summary: AUS/FNAC allows the identification of tumors without axillary tumor involvement, or with low axillary tumor burden, many of which do not benefit from SLNB, in the staging of early breast cancer.

Objective: To calculate the negative predictive value of AUS/FNAC in those patients with breast cancer who meet ACOSOG Z0011 criteria.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Tumors with ACOSOG Z0011 criteria, except positive SLNB (cT1-T2; cN0; breast-conserving surgery; Whole-Breast Radiotherapy)
* Axillary study with AUS/FNAC.
* SLNB/ALND (Gold-Standard).

Exclusion Criteria:

* Tumors without confirmation of axillary histologic status (No Gold-Standard)
* Tumor in pregnancy or breastfeeding.
* Tumors in the male.
* Tumors treated with neoadjuvant chemotherapy
* Tumors that do not meet ACOSOG Z0011 criteria.
* Tumors without axillary study using AUS/FNAC

Primary outcomes:
measure: Detection of axillary tumor burden by axillary ultrasound
timeFrame: Two weeks after the axillary surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Javier del Riego
state: Barcelona
Study officials:
References:
Clinical trial NCT03840408: Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer
Official title: Prospective Clinical Study of Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 1753
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lung cancer is the leading cause of cancer related mortality. Among them, non small cell lung cancer accounts for 85%. Only part of patients could be treated with radical surgery. Mitochondria-targeted system therapy combined with radiofrequency ablation could be an alternative treatment. Small sample clinical cases verified that this therapy could be an efficacy and safe treatment in a short period. The primary aim of this trial is to determine if the efficacy of mitochondria-targeted system therapy combined with radiofrequency ablation is comparable to that of standard surgical interventions for patients with non-small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* The patient can understand and voluntarily join the study, sign the informed consent form, and the compliance is good.
* Patients with single nodule.
* Before IIB period according to the eighth edition of the TNM staging period.
* No mediastinal lymph node metastasis.
* No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
* Eastern Cooperative Oncology Group performance status of 0 to 1
* Sufficient organ functions

Exclusion Criteria:

* Active bacterial or fungous infection.
* Simultaneous or metachronous (within the past 5 years) double cancers.
* Patients with contraindications to radiofrequency ablation and inability to complete treatment;
* Women during pregnancy or breast-feeding.
* Uncontrollable diabetes mellitus.
* Patients with severe heart, lung, kidney disease or other systemic diseases who have been judged to have a severe impact on survival or who are pre-assessed to be unable to tolerate thoracoscopic surgery

Primary outcomes:
measure: Disease-free survival
timeFrame: From the date of randomization until the date of first documented progression，assessed up to 60 months
Secondary outcomes:
measure: Overall survival
timeFrame: From the date of randomization until the date of death from any cause，assessed up to 60 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 10th People's Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00632008: Soluble Beta-glucan (SBG) as Treatment for Diabetic Foot Ulcers
Official title: A Randomised, Double-blind, Placebo-controlled Study to Determine the Efficacy of Soluble Beta-1,3/1,6-glucan in Chronic Foot Ulcers in Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Diabetic Foot Ulcers
Lead sponsor: Biotec Pharmacon ASA
Sponsor class: INDUSTRY
First posted: 2008-03-10
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the application of soluble beta-glucan (SBG) onto diabetic foot ulcers improves the healing of the ulcers.


Eligibility criteria: Inclusion Criteria:

* Type 1 or Type 2 diabetes mellitus
* Age ≥ 18 years
* One or more full-thickness ulcers at or below the level of the malleoli, which do not extend to tendon, joint, or bone
* The ulcer (or index ulcer, if appropriate) must have been present for at least 4 weeks prior to Day 0 but not longer than 2 years
* Ankle:brachial pressure index (ABPI) \>0.7, or the presence of two palpable pulses on the affected foot
* Ulcer area \>25 mm2 but \<500 mm2
* Written informed consent

Exclusion Criteria:

* Pregnancy, lactation or absence of adequate contraception for women with child bearing capacity
* ABPI \< 0.7
* Serum albumin \< 2.0 g/dL
* Gangrene on any part of the foot with the study ulcer
* Presence of signs of clinically significant foot infection on Day 0
* Chronic renal failure with calculated GFR \<30 ml/min
* Surgical procedure (other than debridement) on the foot with the study ulcer in the 28 days prior to Day 0
* HbA1c 12% or more
* Current alcohol or drug abuse
* Participation in other studies in the preceding 28 days
* An ulcer on a foot affected by acute Charcot osteoarthropathy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde Victoria
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
city: Manchester
country: United Kingdom
facility: North Manchester Hospital
city: Newcastle
country: United Kingdom
facility: Newcastle General Hospital
city: Northampton
country: United Kingdom
facility: Northampton General Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
Study officials:
affiliation: Nottingham City Hospital
name: William Jeffcoate, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04106908: Effectiveness and Tolerability of Eqwilate in Real-life Conditions
Official title: MOdalities of Use, effectiveNEss and TOlerability of Eqwilate® a Balanced combInatiON of VWF and FVIII in Von WillEbrand Patients in Real-life Conditions: the ONE-TO-ONE Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: VWD - Von Willebrand's Disease
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2019-09-27
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will involve patients (≥ 6 years of age) from the participating centres treated with Eqwilate® (either on-demand, as perioperative prophylaxis, or as prophylaxis) during the time inclusion period will be opened.

Brief summary: MOdalities of use, effectiveNEss and TOlerability of Eqwilate® a balanced combInatiON of VWF and FVIII in von WillEbrand patients in real-life conditions: the ONE-TO-ONE study


Eligibility criteria: Inclusion Criteria:

The study will involve patients (≥ 6 years of age) from the participating centres treated with Eqwilate® (either on-demand, as perioperative prophylaxis, or as prophylaxis) during the time inclusion period will be opened. Patients will be of any VWD type, previously treated or untreated.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Haemostatic Effectiveness of On-demand Treatment
timeFrame: 12 months
measure: Haemostatic Effectiveness of Perioperative Prophylaxis
timeFrame: 12 months
measure: Occurrence of Bleeding Episodes During Follow-Up
timeFrame: 12 months
Secondary outcomes:
measure: FVIII Levels
timeFrame: 12 months
measure: Productivity Loss
timeFrame: 12 months
measure: Volume of Blood loss
timeFrame: up to 1 week
measure: Immunogenicity Presence of inhibitors against VWF
timeFrame: 12 months
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen Study Site
city: Clamart
country: France
facility: Clamart Study Site
city: Paris
country: France
facility: Paris Study Site - Lariboisiere
city: Paris
country: France
facility: Paris Study Site - Necker
city: Rennes
country: France
facility: Rennes Study Site
city: Rouen
country: France
facility: Rouen Study Site
city: Saint-Denis
country: France
facility: Saint Denis Study Site - Pediatrie
city: Saint-Denis
country: France
facility: Saint Denis Study Site
city: Saint-Étienne
country: France
facility: Saint-Etienne Study Site
Study officials:
References:
Clinical trial NCT00511108: Sitagliptin and Pioglitazone Mechanism of Action Study in Type 2 Diabetes Mellitus (0431-061)
Official title: A Phase I Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Study the Safety, Efficacy, and Mechanism of Action of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet and Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: Type 2 Diabetes Mellitus (T2DM)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-08-03
Enrollment: 211
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A clinical study to determine the safety, efficacy and mechanism of action of sitagliptin alone and in combination with pioglitazone, in patients with type 2 diabetes mellitus who have inadequate glycemic (blood sugar) control.


Eligibility criteria: Inclusion Criteria:

* Patient has type 2 diabetes mellitus
* Male
* Female that is highly unlikely to become pregnant
* Patient is not on an antihyperglycemic agent (AHA) (hemoglobin A1c \[A1C\] 7-10%) or on oral single AHA or low-dose combination therapy (A1C 6.5-9.0%)

Exclusion Criteria:

* Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
* Patient has required insulin therapy within the past 12 weeks
* Patient is on or has been taking a Peroxisome Proliferator-Activated Receptor-gamma (PPAR -gamma) agent (i.e. Thiazolidinediones \[TZDs\]) within the prior 12 weeks of the screening visit.

Primary outcomes:
measure: Change From Baseline in Glucagon 3-hour Total Area Under the Curve (AUC) After 12 Weeks of Treatment
timeFrame: Baseline and 12 weeks
measure: Percent Change From Baseline in Index of Static Beta-cell Sensitivity to Glucose After 12 Weeks of Treatment
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change From Baseline in Glucose 5-hour Total AUC After 12 Weeks of Treatment
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Alba M, Ahren B, Inzucchi SE, Guan Y, Mallick M, Xu L, O'Neill EA, Williams-Herman DE, Kaufman KD, Goldstein BJ. Sitagliptin and pioglitazone provide complementary effects on postprandial glucose and pancreatic islet cell function. Diabetes Obes Metab. 2013 Dec;15(12):1101-10. doi: 10.1111/dom.12145. Epub 2013 Jul 19.
Clinical trial NCT05834608: Cerebral Regional Oxygenation with Manual Versus AutoFlow Ventilation
Official title: Cerebral Regional Oxygenation with Manual Versus Mechanical Ventilator Assisted Ventilation During Intravenous Induction in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxygen Deficiency
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 51
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric surgical patients aged 5-10 years scheduled for elective surgery.

Brief summary: Anesthesia induction is associated with hemodynamic imbalances that can affect the blood flow to major organs. Moreover it can result in deoxygenation as well. During standard anesthesia induction the patient is manually ventilated with a circle-valve-mask system until the effect of muscle relaxant shows of. Near-infrared spectroscopy (NIRS) is a modification of a well-known peripheral pulse oxymetry that is used in the detection of the regional oxygen saturation (rSO2) in organs, including brain, liver, muscle, and intestines. In this study we will compare the regional oxygenation status of the patients during anesthesia induction in which either standard manual ventilation or mechanical ventilator-assisted ventilation was performed. AutoFlow(R) mode of Draeger-Perseus mechanical ventilator will be used for the ventilator-assisted ventilation.


Eligibility criteria: Inclusion Criteria:

* American Society of Anaesthesiologists (ASA) physical status I-II

Exclusion Criteria:

* ASA III or above
* Congenital or traumatic brain injury
* Allergy to NIRS probe material
* Cardiac or vascular disease, including heart failure or hypertension
* Difficult mask ventilation and difficult intubation
* Thoracic surgery
* Head and neck surgery
* Emergency surgery
* Obesity

Primary outcomes:
measure: NIRS_-1
timeFrame: 60 seconds before induction.
measure: NIRS_0
timeFrame: At the start of anesthesia induction.
measure: NIRS_0.5
timeFrame: 30 seconds after the anesthesia induction.
measure: NIRS_1
timeFrame: 60 seconds after the anesthesia induction.
measure: NIRS_1.5
timeFrame: 90 seconds after the anesthesia induction.
measure: NIRS_2
timeFrame: 120 seconds after the anesthesia induction.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine
state: Pendik
Study officials:
affiliation: Marmara University Department of Anesthesiology and Reanimation
name: Tumay Umuroglu, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03164408: Orthopaedic Implant Removal
Official title: High Early Post-operative Complication Rate After Elective Aseptic Orthopedic Implant Removal of Upper and Lower Limb
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Implant Complication
Complication, Postoperative
Implant Site Infection
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 1545
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients in between scheduled period of time ( 2 years)

Brief summary: The necessity of orthopedic implant removal is under intense discussion and even if it is performed as an elective procedure, the risk of complications is present.

Aim of the study is to identify parameters responsible for an increased risk of early post-operative complications after elective aseptic orthopedic implant removal.


Eligibility criteria: Inclusion Criteria:

Elective aseptic orthopaedic Implant removal

Exclusion Criteria:

Arthroplasty present infection

Primary outcomes:
measure: Complications after implant Removal
timeFrame: 4 weeks postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Medical Center Mannheim
name: Arnold J Suda, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05098808: Artificial Intelligence in Diagnosing Dysphagia Patients
Official title: Classification of Dysphagia Patients at Risk of Aspiration Pneumonia Using Machine Learning Algorithms Incorporating Acoustic Features From Phonetic Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiration Disorders
Swallowing Disorder
Phonation Disorder
Stroke
Aspiration Pneumonia
Aspiration; Liquids
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 449
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: First ever stroke patients referred for swallowing disorders

Brief summary: In this prospective study we extracted acoustic parameters using PRAAT from patient's attempt to phonate during the clinical evaluation using a digital smart device. From these parameters we attempted (1) to define which of the PRAAT acoustic features best help to discriminate patients with dysphagia (2) to develop algorithms using sophisticated ML techniques that best classify those i) with dysphagia and those ii ) at high risk of respiratory complications due to poor cough force.

Detailed description: This study was prospective study, and patients who visited the department of rehabilitation medicine in a single university-affiliated tertiary hospital with dysphagic symptoms from September 2019 to March 2021 were included.Voice recording was performed at the enrollment with blinded assessment, where the participants first visited the rehabilitation department with chief complaints of dysphagia. The cough sounds were recorded with an iPad (Apple, Cupertino, CA, USA) through an embedded microphone.

From the acoustic files we extracted fourteen voice parameters that include the average value and standard deviation of the fundamental frequency (f0), harmonic-to-noise ratio (HNR), the jitter that refers to frequency instability, and the shimmer that represents the amplitude instability of the sound signal.

Machine learning algorithms and sophisticated deep neural network analysis will be performed.

Eligibility criteria: Inclusion Criteria:

- Inclusion criteria

1. Suspected swallowing disorder who were referred for swallowing assessment
2. Dysphagia attributable to brain lesion including stroke

Exclusion Criteria:

1. Participants who were unable to perform phonation
2. Participants who had no VFSS or standardized swallowing assessment results
3. Participants with no spirometric measurements

Primary outcomes:
measure: Functional Oral Intake Scale
timeFrame: during the intervention
measure: Cough strength
timeFrame: during the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine
state: Kyounggido
Study officials:
affiliation: The Catholic University of Korea
name: Sun Im, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02605408: Cataract Surgery in Indian Patients With or Without LenSx® Laser
Official title: A Phaco ± LenSx® Procedure Patients Registry in Indian Tertiary Medical Centers
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cataracts
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-11-16
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with cataracts who are receiving phacoemulsification (with or without LenSx® procedure) consecutively during the registry period

Brief summary: The purpose of this study is to record and analyze the profile and outcome of cataract patients receiving phacoemulsification (phaco) and artificial intraocular lens (IOL) implantation with or without femtosecond laser-assisted cataract surgery (FLACS) in Indian tertiary medical centers.

Detailed description: Legitimate patients will receive Standard of Care (SOC) phacoemulsification treatment for cataract and IOL implantation, with or without using LenSx® technology, with followup for 1 month using SOC postsurgical treatment.

Eligibility criteria: Inclusion Criteria:

* Agree to undergo phacoemulsification cataract surgery in at least 1 eye;
* Understand and sign an informed consent form;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Refuse to sign the informed consent form or have incomplete medical records;
* Contraindications for phacoemulsification treatment per Investigator discretion or listed in LenSx® Operator's Manual;
* Contraindications for anterior capsulotomy, phacofragmentation of the lens using the FLACS;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Completion rate of an anterior capsulotomy
timeFrame: Day 0, operative day
measure: Best Corrected Visual Acuity (BCVA)
timeFrame: Up to Day 30 postoperative
measure: Uncorrected Visual Acuity (UCVA)
timeFrame: Up to Day 30 postoperative
measure: Cumulative dissipated energy (CDE)
timeFrame: Day 0, operative day
measure: Total phaco + IOL time
timeFrame: Day 0, operative day
measure: Aspiration fluid (ml)
timeFrame: Day 0, operative day
measure: Success rate of IOL insertion
timeFrame: Day 0, operative day
measure: Completion rate of cornea incision
timeFrame: Day 0, operative day
measure: Laser procedure time from suction on to off
timeFrame: Day 0, operative day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon India Pvt. Ltd.
name: Head Medical Affairs, MD
role: STUDY_DIRECTOR
References: