louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06215976: The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer
Official title: The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Muscle-Invasive Bladder Carcinoma
Keywords: Metformin
cisplatin
nephroprotective effect
nephrotoxicity
bladder cancer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 78
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: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to evaluate the protective effect of metformin on nephrotoxicity of cisplatin in patients with bladder cancer. The main questions it aims to answer are:

* To determine protective effect of metformin on structural and functional kidney injury caused by cisplatin in patients with bladder cancer.
* To evaluate the safety of combining cisplatin and metformin on patients with bladder cancer


Eligibility criteria: Inclusion Criteria:

1. Non-diabetic adults of age between 18 to 65.
2. Chemotherapy naïve patients diagnosed with bladder cancer.
3. Patients with stable renal function: eGFR is above 60 ml/min/1.73 m2

Exclusion Criteria:

1. Patients with history of lactic acidosis.
2. Patients taking any nephrotoxic medication other than cisplatin (e.g., frusemide, NSAIDs, aminoglycoside or vancomycin).
3. Unstable renal function (defined as an increase in serum creatinine of 0.3 mg/dL or greater suddenly in 48 hours according to the acute kidney injury network (AKIN) classification
4. Patients with heart failure, acute myocardial infarction or cardiogenic collapse (shock).
5. Severe infection and sepsis.

   * Any infection requiring hospitalization.
   * Any infection leading to a need for oxygen, intubation, vasopressors or fluids to support blood pressure.
6. Alcohol intake.
7. Respiratory failure.
8. Severe hepatic impairment (Child-Pugh class C).
9. Patients with metastasis.

Primary outcomes:
measure: serum creatinine (SCr)
timeFrame: 12 week
measure: Human Neutrophil gelatinase-associated lipocalin (NGAL)
timeFrame: 12 week
measure: Cystatin C
timeFrame: 12 week
measure: Estimated glomerular filtration rate (eGFR)
timeFrame: 12 week
Secondary outcomes:
measure: FBG
timeFrame: 12 week
measure: HbA1C
timeFrame: 12 week
measure: Body weight
timeFrame: 12 week
measure: Body Mass Index
timeFrame: 12 week
measure: Blood pH
timeFrame: 12 week
measure: Blood Lactate Level
timeFrame: 12 week
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of pharmacy Cairo university
Study officials:
affiliation: faculty of pharmacy Cairo University
name: Samar Farid
role: STUDY_CHAIR
References:
Clinical trial NCT05772676: The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting
Official title: The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gastric Sleeve Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obesity
Nausea and Vomiting, Postoperative
Keywords: Laparoscopic Gastric Sleeve
Bariatric Surgery
Nausea and Vomiting, Postoperative
Aprepitant
Lead sponsor: Hospital General Tlahuac
Sponsor class: OTHER_GOV
First posted: 2023-03-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled clinical trial conducted in obese patients undergoing laparoscopic gastric sleeve surgery to assess the efficacy of Aprepitant (80 or 125 mg) in combination with a standard antiemetic regimen (Ondansetron + Metoclopramide + Dexamethasone) is presented vs placebo + the same standard regimen, evaluating postoperative nausea and vomiting by means of a specific scale (Rhodes index) for the assessment of nausea and vomiting
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the efficacy of Aprepitant + standard antiemetic regimen in reducing postoperative nausea and vomiting after laparoscopic gastric sleeve versus placebo + standard antiemetic regimen

Detailed description: After being informed about the study, all patients who provide written informed consent and meet the eligibility requirements will be randomized in a triple-blind manner (participant, evaluator, and investigator) in a 1:1 ratio to Aprepitant (80 or 125 mg) + standard antiemetic regimen (once two hours before surgery) or placebo + standard antiemetic regimen(once two hours before surgery).

The standard antiemetic regimen will be Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg

Eligibility criteria: Inclusion Criteria:

* 18 to 65 years old.
* Non-smokers.
* Obesity with BMI \> 30 kg/m2.
* Undergoing laparoscopic gastric sleeve.

Exclusion Criteria:

* Documented hypersensitivity to any component of the study regimen.
* Current treatment with: Orap (pimozide), Seldane (terfenadine), Hismanal (astemizole) or Propulsid (cisapride).
* Allergy to opioid drugs used in the anesthetic protocol.
* Drug or alcohol abuse.
* Chronic nausea and vomiting.
* Previous bariatric procedures.

Primary outcomes:
measure: Patient's postoperative nausea and vomiting evaluation at 0 hrs (Rhodes index)
timeFrame: 0 postoperative hours
measure: Patient's postoperative nausea and vomiting evaluation at 6 hrs (Rhodes index)
timeFrame: 6 postoperative hours
measure: Patient's postoperative nausea and vomiting evaluation at 12 hrs (Rhodes index)
timeFrame: 12 postoperative hours
measure: Patient's postoperative nausea and vomiting evaluation at 24 hrs (Rhodes index)
timeFrame: 24 postoperative hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital General Tlahuac
Study officials:
References:
Clinical trial NCT01764776: Effect of Hepatic Impairment on LDE225..
Official title: A Phase I, Open Label, Multi-center, Single Dose Study to Evaluate the Pharmacokinetics of LDE225 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Normal Hepatic Function
Impaired Hepatic Function
Keywords: LDE225
Pharmacokinetics
PK
Postmenopausal women
normal hepatic function
mild hepatic impairment
moderate hepatic impairment
severe hepatic impairment
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-01-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the pharmacokinetics and safety of 800 mg of LDE225 in subjects with impaired hepatic function and healthy subjects with normal hepatic function.


Eligibility criteria: Inclusion Criteria (all groups):

* Male and sterile or postmenopausal female age ≥18 to ≤70 years old.
* Normal Vital signs

Inclusion (group mild, moderate and severe hepatic impairment):

-Subjects with confirmed cirrhosis

Exclusion (all groups):

* Woman of childbearing potential and pregnant or lactating females or male not using condom
* Risk factors for torsades de pointes
* Clinically significant cardio-vascular disease
* severe or uncontrolled medical conditions
* Smokers consuming greater than 10 cigarettes or equivalent nicotine containing products per day.
* Use of investigational drugs (i.e. participation in any clinical investigation)

Exclusion for moderate, mild and severe groups:

* Symptoms or history of encephalopathy
* Clinical evidence of severe ascites

Exclusion Criteria:

-

Primary outcomes:
measure: LDE225A pharmacokinetic parameter Tmax
timeFrame: 8 weeks
measure: LDE225A pharmacokinetic parameter Cmax
timeFrame: 8 weeks
measure: LDE225A pharmacokinetic parameter AUClast
timeFrame: 8 weeks
measure: LDE225A pharmacokinetic parameter AUCinf
timeFrame: 8 weeks
measure: LDE225A pharmacokinetic parameter T1/2
timeFrame: 8 weeks
Secondary outcomes:
measure: Occurrence of abnormal safety laboratory parameters
timeFrame: 8 weeks
measure: Plasma protein binding of LDE225
timeFrame: 1 day
measure: Occurrence of changes in ECGs
timeFrame: 8 weeks
measure: Occurrence of adverse event
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Div. of Clinical Pharmacology
state: Florida
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Tel-Aviv
country: Israel
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06780176: A Study of Breast Cancer Risk Factors and Outcomes of People in Florida
Official title: Genomic and Non-Genomic Factors Associated With Breast Cancer Risk Factors and Outcomes in a Diverse South Florida Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Breast Neoplasms
Breast Diseases
Keywords: breast cancer
breast neoplasms
breast diseases
BIRADS
Memorial Sloan Kettering Cancer Center
24-372
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University of Miami treating clinicians will identify participants (anyone meeting inclusion criteria listed above) during their regularly scheduled visits (Breast radiology at time of initial biopsy, Surgery clinic visit, Medical Oncology clinic visit) or in the pre-operative waiting area prior to surgery.

Brief summary: The purpose of this study is to understand why different people have different risks and outcomes for breast cancer and non-breast cancer.


Eligibility criteria: Inclusion Criteria:

* Patients with BIRADS 0-5, seen in breast radiology clinic at University of Miami (UM), Sylvester Comprehensive Cancer Center (SCCC), Jackson Health Systems (JHS) for biopsy.
* Any new breast patient seen at UM/SCCC or JHS will be invited to participate in the study.
* Men and women 18 years of age and older are eligible to participate in the study.

Exclusion Criteria:

* Patients who are less than 18 years of age will be considered ineligible.
* Patients unable to complete the survey.

Primary outcomes:
measure: Clinical characteristic of participants (survey)
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles (Specimen Analysis only)
state: California
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All protocol activites)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Neha Goel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03901976: ZeroFall - Reliability Testing of Optical Sensor to Detect Bed Exit for Patients in Hospital
Official title: ZeroFall - Reliability Testing of Optical Sensor to Detect Bed Exit for Patients in Hospital
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Delirium of Mixed Origin
Lead sponsor: Philips Healthcare
Sponsor class: INDUSTRY
First posted: 2019-04-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: The study has several distinct phases:

* Silent Phase: The devices run in the background, activity is blinded for clinicians, settings are optimized by the research team.
* Run-In Phase: Bed exit notifications are turned on, notifications will be configurable for acceptability by clinical teams. Data extraction and data evaluation will be tested.
* Phase I: Data collection of bed exit data of sensors as well as data related to falls
* Phase II: Data collection of bed exit data with optimization of predictive algorithms
* Phase III: Data collection for validation using predictive data for early notification
Primary purpose: PREVENTION

Brief summary: Falls are one of the most common NHS adverse events. With an increasing number of frail elderly patients being admitted this risk is likely to increase. In order to be able to assist patients with bed exit in a timely manner monitoring might be of help. In ZeroFall we will test the reliability of monitoring devices to notify care givers if a patient is attempting to exit the bed.

Detailed description: In ZeroFall we intend to observe patients on risk of fall with two different devices during their hospital stay: The information from a no-touch optical sensing device that analyses movement and an under the mattress sensor that has already been used in a previous study at Bangor. Both are compatible with an existing monitoring system by Philips Healthcare and CE marked.

Eligibility criteria: Inclusion Criteria:

Adult patients with risk of fall more than 24 hours on the ward

Exclusion Criteria:

Patients with predominantly palliative needs

Primary outcomes:
measure: Number of true bed exit detections vs number of false bed exit detections
timeFrame: 12-15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangor
country: United Kingdom
facility: Ysbyty Gwynedd
state: Wales
Study officials:
affiliation: Ysbyty Gwynedd Hospital
name: Christian P Subbe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03297476: Clinical Application of Novel Panels for Early Precision Diagnosis and Relapse Prediction in High-risk Leukemia
Official title: Early Precision Diagnosis and Relapse Prediction Technology Development in High-risk Acute Leukemia and Clinical Application
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia, Acute
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with acute leukemia (newly diagnosis)

Brief summary: Based on the investigator's previous data on risk classification for acute leukemia,the investigators will design a set of panels to detect the gene expression and genomic variants (SNPs, mutation, insertion, deletion and fusion genes, etc), and identify the high-risk subtypes of acute leukemia, such as Ph-like acute lymphoblastic leukemia. Furthermore, the target therapy (Tyrosine Kinase Inhibitors,et.al) will be used to treat the identified patients. In addition, more sensitive minimal residual disease (MRD) detection technology will be designed and used to detect the MRD in patients to early predict the disease relapse.

Detailed description: patient eligibility criteria: newly diagnosed acute leukemia patients with clinical high-risk markers, reflactory and relapsed patients.

Eligibility criteria: Inclusion Criteria:

* Newly diagnostic acute lymphoblastic leukemia Be willing to start treatment

Exclusion Criteria:

* chronic leukemia

Primary outcomes:
measure: complete remission
timeFrame: From date of randomization or initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
measure: relapse
timeFrame: From date of randomization or complete remission until the date of first documented relapse from any cause, whichever came first, assessed up to 100 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Hematology, Zhongda Hospital Southeast University, Institute of Hematology Southeast University
state: Jiangsu
Study officials:
References:
Clinical trial NCT04190576: Minimally Invasive Ridge Augmentation
Official title: Subperiosteal Minimally Invasive Aesthetic Ridge Augmentation Technique With and Without Low Level Laser Therapy: A Comparative Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Bone Loss
Bone Density Increased
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups were made one test and control. The control group were treated with MINIMALLY INVASIVE RIDGE AUGMENTATION technique alone and the test group were treated with adjunctive low-level laser therapy for bone regeneration.
Primary purpose: TREATMENT

Brief summary: The present study is a human, prospective, randomised controlled clinical trial conducted to explore the outcome of a minimally invasive ridge augmentation technique with and without low level laser therapy. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

Detailed description: Twenty healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients.

All the patients were treated with subperiosteal minimally invasive aesthetic ridge augmentation technique. the test group of ten were given low level laser therapy as an adjunct. The clinical and radiographic parameters were recorded at baseline and six months postoperatively.

Eligibility criteria: Inclusion Criteria:

* Single or multiple edentulous sites with Seibert's class 1 defects corresponding to colognes 1 and 2
* ASA 1 and 2
* Patients with an esthetic concern
* Good oral hygiene

Exclusion Criteria:

* Seibert's class 2 defects
* ASA 3 and 4
* Osteoporosis
* uncontrolled diabetes
* immunosuppression
* radiation therapy and bisphosphonate therapy
* Gingival thickness less than 2 mm

Primary outcomes:
measure: Gain in Alveolar ridge width in millimeters
timeFrame: 6 months
Secondary outcomes:
measure: Change in Bone density in Hounsefield's units
timeFrame: 6 months
measure: Patient related outcomes of the surgical procedure in relation to 1) pain 2) discomfort and 3) swelling
timeFrame: one week
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Krishnadevaraya college of dental sciences
state: Karnataka
Study officials:
References:
Clinical trial NCT04161976: A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes Mellitus
Official title: A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of LY900027 in Patients With Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to learn more about a new formulation of insulin lispro when given by an insulin pump to participants with type 1 diabetes mellitus. The study will investigate how the body processes the drug and how the drug affects the body. Information about side effects will be collected. The study will last from six to 12 weeks for each participant.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of T1DM for at least 1 year
* Fasting C-peptide ≤0.30 nanomoles per liter (nmol/L)
* Bbody mass index between 18.5 and 33.0 kilograms per square meter (kg/m²)
* Participants should have a glycated hemoglobin of ≤9.0% at screening

Exclusion Criteria:

Primary outcomes:
measure: Pharmacokinetics (PK): Pharmacokinetics (PK): Area Under the Insulin Lispro Curve (AUC) 0 to 5 hours after Bolus Administration Prior to a Mixed Meal Tolerance Text (MMTT)
timeFrame: Day 1 through Day 10 in each dosing period
measure: PK: Maximum Observed Insulin Lispro Concentration (Cmax)
timeFrame: Day 1 through Day 10 in each dosing period
Secondary outcomes:
measure: Pharmacodynamics (PD): Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion
timeFrame: Day 1 through Day 10 in each dosing period
measure: PD: Total Daily Insulin Dose
timeFrame: Day 1 through Day 10 in each dosing period
measure: Duration Until Catheter Failure
timeFrame: Day -1 through Day 10 in each dosing period
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung
state: Nordrhein-Westfalen
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01274676: Carotid Stenting in Patients With High Risk Carotid Stenosis ("Soft Plaque")
Official title: Randomized Trial of Proximal-versus Distal Cerebral Protection on Micro Embolization During Carotid Artery Stenting in Patients With High Risk Lipid Palque
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Stenosis
Keywords: stenting
carotid plaque
stenosis
angioplasty
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
First posted: 2011-01-11
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Stenting is an alternative to traditional surgery in the treatment of carotid stenosis.The intra and/or postprocedural cerebral embolization remains the most frequent complication. Thanks to the systematic use of cerebral protection systems, these complications have reduced.A debate concerning which cerebral protective device should be more effective is still ongoing.


Eligibility criteria: Inclusion Criteria:

-patients with monolateral, significant, soft carotid stenosis

Exclusion Criteria:

* patients with controlateral carotid occlusion
* patients with critic stenosis of the external carotid

Primary outcomes:
measure: number of Microembolization signals (MES) detected with transcranal doppler
timeFrame: 6 different phases of carotid stenting (lesion wiring; predilation; stent crossing of the lesion; stent deployment; stent post dilation; device tetruieval/deflation
Secondary outcomes:
measure: Clinical success
timeFrame: In hospital and 30 days
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Centro Cardiologico Monzino, IRCCS
Study officials:
affiliation: Centro Cardiologico Monzino, IRCCS
name: Piero Montorsi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Montorsi P, Caputi L, Galli S, Ciceri E, Ballerini G, Agrifoglio M, Ravagnani P, Trabattoni D, Pontone G, Fabbiocchi F, Loaldi A, Parati E, Andreini D, Veglia F, Bartorelli AL. Microembolization during carotid artery stenting in patients with high-risk, lipid-rich plaque. A randomized trial of proximal versus distal cerebral protection. J Am Coll Cardiol. 2011 Oct 11;58(16):1656-63. doi: 10.1016/j.jacc.2011.07.015.