louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02489838: Lung Dose in Patients Treated With Yttrium-90 for Hepatocellular Carcinoma
Official title: Analysis of Lung Dose Using Volumetric Analysis in Patients Treated With Yttrium-90 Microsphere Radioembolization for Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Neoplasms
Keywords: Liver Neoplasma
Lung Radiation dose
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2015-07-03
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer Patients at the University of Rochester

Brief summary: To Calculate the amount radiation the lung receives in patients receiving Yttrium-90 for Liver Cancer.

Detailed description: To calculate the delivered lung dose using quantitative volumetric analysis in a cohort of patients with unresectable hepatocellular carcinoma who undergo selective internal radiation therapy (SIRT) with Yttrium-90 glass microspheres (TheraSphere®)-and compare this analysis to the lung dose estimated by established criteria. In addition, this study, will summarize the pre and post-treatment clinical data to describe the URMC Y-90 experience.

Eligibility criteria: Inclusion Criteria:

* Adults ≥ 18 years with no upper limit.-Receiving Y-90 Therasphere liver directed therapy
* Pathology proven diagnosis of hepatocellular carcinoma, metastatic colon cancer or other metastatic diseases to be treated with SIRT (Y-90)
* surgical resection not feasible at time of initiation of pre-treatment workup

  -\> 6 months projected life span
* ECOG 0-2

Exclusion Criteria:

* previous radioembolization of one or more liver lobes or segments without available treatment planning and procedural documentation ie. at another facility prior to URMC Y-90 radioembolization.

Primary outcomes:
measure: Lung dose measured with actual lung mass vs Lung dose measured with conventional method.
timeFrame: 1 month after treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Radiation Oncology, University of Rochester, Medical Center
state: New York
Study officials:
affiliation: Universtiy of Rochester
name: Alan Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05010538: Sarecycline Truncal Acne Safety and Efficacy Response
Official title: A Single Center, Phase 4, Open-label Prospective Case Series Study of the Safety and Efficacy of Sarecycline for 12 Weeks in Subjects Ages 9 and Over With Truncal Acne
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Sarecycline
Tetracycline
Truncal Acne
Lead sponsor: Arlington Research Center
Sponsor class: OTHER
Collaborators: name: Almirall, SAS
First posted: 2021-08-18
Enrollment: 10
Sex: ALL
Minimum age (years): 9
Maximum age (years): 50
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with moderate to severe truncal acne at a single center in Texas, USA.

Brief summary: The purpose of this study is to determine the efficacy and safety of oral sarecycline 1.5 mg/kg/day in truncal acne. Patients with moderate to severe acne vulgaris will be observed over a period of 12 weeks. Lesion counts, investigator's global assessments, photography, and safety measures will be assessed for the trunk and face.


Eligibility criteria: Inclusion Criteria:

* Male or female age 9 or above.
* Clinical diagnosis of moderate to severe truncal acne based on IGA

Exclusion Criteria:

* Known or suspected allergies or sensitivities to any components of the study drug.
* Any disorders that would preclude the use of tetracycline-class antibiotics or sarecycline.
* Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the trial results and/or put the subject at significant risk (according to the Investigator's judgment) if the subject takes part in the trial.

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Change from Baseline in Acne Severity Based on Investigator's Global Assessment Success
timeFrame: Baseline, Week 12
measure: Change from Baseline in Absolute Lesion Count
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Adverse Events and Adverse Events of Special Interest
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Arlington
country: United States
facility: Arlington Research Center
state: Texas
Study officials:
affiliation: Arlington Research Center
name: Angela Moore, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01018238: An Investigation of NNC 0151-0000-0000 in Subjects With Systemic Lupus Erythematosus (SLE)
Official title: A Multiple Dose, Randomised, Double-blind, Placebo-controlled, Multiple Site Study of Anti-C5a Receptor Antibody (NNC 0151-0000-0000) in Subjects With Systemic Lupus Erythematosus (SLE)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Inflammation
Systemic Lupus Erythematosus
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-11-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and signs of bioactivity of increasing repeated doses of NNC 151-0000-0000 in subjects with Systemic Lupus Erythematosus (SLE).

Detailed description: The trial was terminated before any patients were exposed to the trial drug based on new findings indicating that dose escalation with multiple doses should be performed in a different trial population.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of systemic lupus erythematosus (SLE)
* Disease duration: 6 months or longer
* Stable, mild to moderately active systemic lupus erythematosus (SLE)
* Receiving stable maintenance therapy

Exclusion Criteria:

* Significant Lupus Nephritis
* Active central nervous system (CNS) disease
* Significant arterial or venous thrombosis (blood clots) within 12 months prior to trial start
* Body weight of 260 lbs/120 kg or more
* History of alcohol or substance abuse
* History of cancer
* Infections
* Viral infections: HIV, Hepatitis B or C, Epstein-Barr Virus (EBV), Cytomegalovirus (CMV), Varicella-Zoster Virus (VZV), or Herpes Simplex Virus (HSV-1 or HSV-2)
* Tuberculosis
* Severe systemic bacterial, viral or fungal infections within the past 12 months prior to trial start
* Immunosuppressive and immune modulating therapy

Primary outcomes:
measure: Observed adverse events
timeFrame: From day -28 to day 113
Secondary outcomes:
measure: Number of adverse Events (including injection site reactions)
timeFrame: Every visit through study completion (Day 113)
measure: Pharmacokinetics: terminal half-life, trough values, serum concentrations
timeFrame: Day 1 through Day 113
measure: Pharmacodynamics: levels of serum, plasma, and urine markers, auto-antibodies
timeFrame: Day 1 through Day 113
measure: Clinical disease endpoints: Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), British Isles Lupus Assessment Group (BILAG), and Quality of Life by use of SF-36 (QOL)
timeFrame: Day 1 through Day 113
Other outcomes:
Locations:
city: Lake Success
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: New York
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06582238: Dentine Hypersensitivity Management KAP Study
Official title: Knowledge, Attitude and Practice for Management of Dentine Hypersensitivity Among Egyptian and Nigerian Dentists: A Cross-Sectional Comparative Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Dentin Sensitivity
Lead sponsor: Muhammad Modu
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2024-09-03
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Levels of Education

* Consultant/Fellow/Professor
* Specialist/Senior Lecturer
* Resident/Registrar/Post Graduate Student
* BDS

Brief summary: The study aims to assess and compare the knowledge, attitudes, and practices of Egyptian and Nigerian dentists on etiology, diagnosis, and management of DH. Also to identify if level of education, culture and environment have influence in the diagnosis and management of DH.

Detailed description: Diagnosis of dentin hypersensitivity is a challenge faced by dentists with different educational levels and the condition might be overlooked and not properly managed leading to persistent pain and poor quality of life for patients. Till the now, literature lacks rigorous guidelines for systematic diagnosis, prevention, categorization of severity and management of dentin hypersensitivity.

This study intends to spot the light on the current approaches adopted by dentists in Egypt and Nigeria towards diagnosis and management of Dentine Hypersensitivity. It also intends to compare the findings and identify the influence of geographic location, different educational levels, and degree of dental education in the management of Dentine Hypersensitivity

Eligibility criteria: Inclusion Criteria:

* Must be a Dentist
* Must be in clinical practice
* Must be practicing in Egypt or Nigeria
* Willingly CHOOSE to participate in the study

Exclusion Criteria:

* Dentists that choose NOT to participate in the study

Primary outcomes:
measure: Knowledge
timeFrame: 6 months
Secondary outcomes:
measure: Comparison
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
References:
Clinical trial NCT03046238: Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block in Breast Cancer Patients
Official title: Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block in Patient Undergoing Breast Cancer Surgery :A Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer Patients
Lead sponsor: South Egypt Cancer Institute
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To Evaluate the effect of addition of Dexmedetomedine to ultrasound guided modified Pecs block on post operative analgesia \& stress response in patient undergoing modified radical mastectomy.

Detailed description: 60 patients (age ≥29 years) who scheduled for modified radical mastectomy surgery under general anesthesia. Group I (Bupivacaine group): patients underwent modified radical mastectomy were given preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles on the interfasial plane, and 20 ml injected between the Pectoralis minor muscle and the serratus muscle.Group II (Bupivacaine + Dexmedetomidine group) : preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg) divided into 20 ml injected between the pectoralis muscles on the interfasial plane , and 10 ml injected between the Pectoralis minor muscle and the serratus muscle.

Eligibility criteria: Inclusion Criteria:

* ASA I - II patients
* weight 50- 100 kg)

Exclusion Criteria:

* a history of bleeding diathesis,
* relevant drug allergy
* opioid dependence,
* sepsis,
* those with psychiatric illnesses

Primary outcomes:
measure: morphine consumption mg/day
timeFrame: 48 HOURS
measure: Visual Analog Scale (VAS), scored from 0-10
timeFrame: 48 hours
Secondary outcomes:
measure: first request of analgesia
timeFrame: 48 hours
measure: level of stress hormones
timeFrame: 48 hours
measure: Adverse Events
timeFrame: 48 hours
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: South Egypt Cancer Institute, Assiut University, Assiut, Egypt.
Study officials:
affiliation: Assiut University
name: mohamad F mohamad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Institute, Anesthesia, Intensive Care, and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt.
name: Saher mohamad, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03343938: Evaluation of a Closed Assisted Reproductive Technology (ART) Station Versus an Open Flow Cabinet
Official title: Comparative Study Between Two Systems of Gamete and Embryo Handling: Closed Environment Versus Open System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ART
Keywords: Group embryo culture
Low oxygen tension
Closed station
Embryo handling
Lead sponsor: Vida Recoletas Sevilla
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: There is not yet a standardized system of human embryonic culture in vitro. In addition, technical improvements continually appear. The investigators recently carried out a study in which it shows that the grouped embryo culture at low oxygen tension (5% O2) in a benchtop incubator shows better success rates than individual culture at atmospheric oxygen tension (20% O2) in a conventional incubator. For these reasons, the investigators have decided to continue this research line to evaluate the efficacy of a new ART station with a closed environment in comparison of an open flow cabinet. This new system keeps a controled environment maintaining a carbon dioxide (CO2) concentration of 6% and a temperature of 37 degrees. A prospective randomized study will be carried out in which the manipulation of the gametes and pre-embryos of the patients will be carried out in open laminar flow cabinets or in a closed station that maintain the CO2 and temperature conditions.


Eligibility criteria: Inclusion Criteria:

* Signing a written consent to participate in the study.
* Blastocyst transfer:
* Patients using their own oocytes under 40 years.
* Patients using donated oocytes.

Exclusion Criteria:

* Preimplantation genetic screening patients.
* Severe male factor (spermatozoa of testicular or epididymal origin, patients with cryptozoospermia and patients with retrograde ejaculation)

Primary outcomes:
measure: Embryo quality
timeFrame: Through study completion, an average of two years
Secondary outcomes:
measure: Live birth rate per first embryo transfer
timeFrame: Through study completion, an average of two years
measure: Cumulative live birth rate
timeFrame: Through study completion, an average of two years
measure: Implantation rate
timeFrame: Through study completion, an average of two years
measure: Live birth rate of the first cycle per transferred embryo
timeFrame: Through study completion, an average of two years
Other outcomes:
Locations:
city: Seville
country: Spain
facility: IVI Sevilla
Study officials:
References:
Clinical trial NCT06112938: Alternative Treatment Strategies for Stenotrophomonas Maltophilia Pneumonia
Official title: Alternative Treatment Strategies for Stenotrophomonas Maltophilia Pneumonia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stenotrophomonas Maltophilia Infection
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a retrospective chart review study limited to only patients meeting inclusion and exclusion criteria. We plan to conduct the retrospective chart review of all patients identified during the study period that meet the inclusion and exclusion criteria.

Brief summary: Multi center, retrospective chart review of patients admitted to MHS hospitals from April 1, 2017 to March 31, 2022. Patients will be identified through the electronic medical record, and data from those that meet the study inclusion and exclusion criteria will be analyzed. Minimum inhibitory concentration (MIC) data will be interpreted per Clinical \& Laboratory Standards Institute (CLSI) standards to determine local patterns of resistance. Multivariable logistic regression will be performed to determine predictors of mortality for S. maltophilia isolates.

Detailed description: Stenotrophomonas maltophilia is an aerobic, non-fermenting, Gram-negative bacillus recognized by the World Health Organization as one of the leading multi-drug resistant nosocomial pathogens worldwide. The Investigators aim to examine differences in clinical outcomes and failure rates between standard and alternative treatment strategies such as minocycline (or moxifloxacin, ciprofloxacin, ceftazidime) alone or in combination with TMP-SMX, alternative TMP-SMX dosing regimens, or variations in durations of therapy for the treatment of S. maltophilia infections within Methodist Health System (MHS).

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* S. maltophilia isolated on respiratory or blood culture

Exclusion Criteria:

* Those that do not meet the inclusion criteria outlined in Section 4.1.

Primary outcomes:
measure: the difference in clinical failure rates between standard and alternative therapy
timeFrame: 30 days
Secondary outcomes:
measure: Clinical outcomes such as ICU LOS
timeFrame: 30 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Mathew Crotty, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00296738: 123I-MIBG SPECT/CT for Assessment of Cardiac Sympathetic Innervation
Official title: Quantitative 123I-MIBG SPECT/CT Assessment of Cardiac Sympathetic Innervation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Diseases
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2006-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients refered for neuroendocrine diseases

Brief summary: Myocardial scintigraphy with 123I-MIBG allows for visual and semi-quantitative assessment of sympathetic cardiac innervation using the hear to mediastinum ratio (HMR). Impaired cardiac MIBG clearance may occur in patients with congestive heart failure (CHF). The purpose of present study was to develop and validate a quantitative index for the assessment of cardiac MIBG uptake kinetics using SPECT/CT for diagnosis of CHF


Eligibility criteria: Inclusion Criteria:

* age\>40

Exclusion Criteria:

* none

Primary outcomes:
measure: The impact of the imaging modality on patient management
timeFrame: 2 years
Secondary outcomes:
measure: The impact on patient management
timeFrame: 2 years
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Shmuel Rispler, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01689038: Brain Imaging Study of F17464
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2012-09-20
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Assess the binding rate of F17464 to cerebral receptors in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Male healthy volunteers

Exclusion Criteria:

* Presence or positive history of severe medical illness or psychiatric conditions

Primary outcomes:
measure: Binding rate to cerebral receptors
timeFrame: up to 29 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
state: New York
Study officials:
References:
Clinical trial NCT04069338: Comparison of Lithotripsy Urolithiasis Machines
Official title: Randomized Controlled Trial Comparing the Storz Modulith SLX-F2 and Dornier Delta III Lithotripter Machines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Stone
Kidney Calculi
Ureteral Calculi
Ureterolithiasis
Urolithiasis
Keywords: Lithotripsy
Extracorporeal shockwave lithotripsy
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 6
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: A comparison on the outcomes of patients undergoing shockwave lithotripsy using the Storz machine versus the Dornier machine.

Detailed description: This is a single institution, prospective randomized controlled clinical trial comparing two lithotriper machines (the Storz Modulith LX-F2 and Dornier Delta III) in patients who are undergoing shockwave lithotripsy (SWL) as the primary management of their urinary stone. Patients record pain score on day of operation and post-operative day 1, and are followed for 1 month until they receive standard of care imaging at 1 month post-operatively.

Eligibility criteria: Inclusion Criteria:

- Cleveland Clinic Foundation patients planned for elective SWL with a preoperative CT performed

* Age ≥ 18 years old
* Male and female patients
* Patients of all ethnic backgrounds
* Stone size 5-15mm
* Stone location: Renal or proximal ureter
* Stone density: \< 1200 Hounsfield Units
* Skin to stone distance: \< 12cm
* Primary treatment for a solitary stone (must be previously untreated)

Patients must be capable of giving informed consent and must be capable and willing to enroll and participate fully with the study.

Exclusion Criteria:

* Prior treatment for specified stone

  * Multiple stones on treatment side (even if only one is treated)
  * Anticoagulated or history of coagulopathy
  * Prior ureteral stent placement
  * Technical problems/impossibility of localizing the stone on the day of intervention

Patients unable to give informed consent or unwilling to enroll or participate in the study will be excluded.

Primary outcomes:
measure: Stone free rate
timeFrame: Four weeks post operative
Secondary outcomes:
measure: Fluoroscopy time
timeFrame: Intra-operative
measure: Treatment Time
timeFrame: Intra-operative
measure: Pain Scores
timeFrame: Four days post-operative
measure: Complication Rates
timeFrame: One month post-operative
measure: Secondary Interventions required
timeFrame: One month post-operative
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Manoj Monga, MD
role: PRINCIPAL_INVESTIGATOR
References: