louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04603651: Expanded Access Program to Provide Bamlanivimab (LY3819253) for the Treatment of COVID-19
Official title: Expanded Access Information for Physicians for Bamlanivimab (LY3819253) Emergency Investigational New Drug [EIND]
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: COVID-19
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: AbCellera Biologics Inc.
First posted: 2020-10-27
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.


Eligibility criteria: Inclusion Criteria:

* Reside in a country where there are ongoing Lilly-sponsored clinical trials (currently this is only the United States)
* Present within 10 days of symptom onset
* Have severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) confirmed by reverse transcription polymerase chain reaction (RT-PCR) within the last three days
* Participants greater than or equal to (≥) 65 years of age OR
* Participants ≥ 12 years of age who weigh at least 40 kilograms AND have at least one of the following:

  * Cancer
  * Chronic kidney disease
  * Chronic obstructive pulmonary disease (COPD) or other chronic lung disease
  * Immunocompromised state (weakened immune system or on immunomodulatory medications)
  * Obesity (body mass index \[BMI\] of 35 or higher)
  * Serious heart conditions such as heart failure, coronary artery disease or cardiomyopathies
  * Sickle cell disease
  * Diabetes mellitus (Types 1 or 2)

Exclusion Criteria:

* Require hospitalization greater than (\>) 24 hours or hospice care. Residents in long term care or skilled nursing facilities that meet the inclusion criteria and are not on mechanical ventilation will be considered
* Bamlanivimab should not be used in patients hospitalized with severe COVID-19 respiratory disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Eli Lilly and Company
name: Contact Lilly at 1-800-LillyRx (1-800-545-5979)
role: STUDY_DIRECTOR
References:
citation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Clinical trial NCT06746051: A Study to Investigate How Respiratory Syncytial Virus (RSV) Infection Develops and Changes Over Time in Pediatric Participants
Official title: An Observational Study to Investigate Clinical Findings and Viral Load/Titer of Respiratory Syncytial Virus (RSV) Infection Over Time in Participants up to and Including 36 Months of Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: RSV Infections
Keywords: Respiratory Syncytial Virus Infections
Lower Respiratory Tract Disease (LRTD)
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-24
Enrollment: 100
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be enrolled at both inpatient and outpatient clinics.

Brief summary: The primary purpose of this study is to observe how viral load and titer change over time in participants with RSV and how data from hospitalized participants compares with data from non-hospitalized participants.


Eligibility criteria: Key Inclusion Criteria:

* Participant who is presenting within 5 days of onset of clinical signs at the time of informed consent.
* Participant is diagnosed with RSV within 5 days of sign onset.
* Participant's caregiver must be able to complete daily Observer Reported Outcomes (ObsROs) and collect nasal swabs

Key Exclusion Criteria:

* Participant is hospitalized for reasons other than RSV infection.
* Participant is considered by the PI to be immunocompromised, due to an underlying medical condition or medical therapy.
* Participant has or has had a confirmed respiratory infection with another clinically relevant viral/bacterial pathogen within 14 days of study enrollment.
* Participant underwent major surgery within 28 days prior to enrollment in the study or has planned major surgery within 15 days of expected study completion.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in RSV Viral Load Measurements
timeFrame: Day 1 to Day 21
measure: Change From Baseline in RSV Viral Titer Measurements
timeFrame: Day 1 to Day 21
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Shionogi
name: Shionogi Clinical Trials Administrator Clinical Support Help Line
role: STUDY_DIRECTOR
References:
Clinical trial NCT00834951: Adjuvant Low Dose Total Body Irradiation in Elderly Patients With Diffuse Large B-Cell Lymphoma
Official title: A Prospective Multicenter Phase II Study of MabThera (Rituximab) Plus 2 Weekly CHOP Followed by Low Dose Total Body Irradiation in Elderly Patients With Diffuse Large B-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Hodgkin's Lymphoma
Keywords: Diffuse large B-cell lymphoma
Elderly patients
Low dose total body irradiation
RCHOP14
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Rigshospitalet, Denmark
First posted: 2009-02-03
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the application of low dose total body irradiation following chemo-immuntherapy in elderly patients with aggressive with non-Hodgkin's lymphoma would be safe and potentially benecicial adjuvant therapy


Eligibility criteria: Inclusion Criteria:

* previously untreated, pathology verified aggressive non-Hodgkin lymphoma of the diffuse large B-cell type according to the WHO classification. Age between 60 years and 80 years.Positive for an anti-CD20 antibody. Good performance status and normal initial normal blood count.

Exclusion Criteria:

* Patients with previous lymphoma associated with immune suppression of any sort. Diagnosis or history of indolent lymphoma or other malignancies. Marked impairment of any vital organ such as the heart, lung, liver or kidneys.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05565651: Retrospective Study of Intestinal Microbiota in Association With Diabetes
Official title: Retrospective Study for the Characterization of the Intestinal Microbiota in Association With Pathologies and Diet in the Italian Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysbiosis Symptoms Linked to Pathology
Keywords: Microbiote
Dysbiosis
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 334
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 334 fecal samples from Lifebrain Cerba Healthcare Italian laboratory network were analyzed to perform a gut microbiota genetic test, accompanied by filling an attachment to provide a medical history useful for the interpretation of the results obtained and to provide a correct diagnosis using a specific test kit for the stool sample collection. The samples were collected from people aged between 2 and 87 years old.

Brief summary: The microbiota interacts with several human organs and influences the physiological process in the host. The predominant Phyla of species in the gut microbiota are Bacteroidetes (B) and Firmicutes (F), accounting for 60-80%, and Proteobacteria (P) and Actinobacteria (A) in minority. When some of the bacterial Phyla species are unbalanced, the pathological state of dysbiosis occurs. A laboratory index used for clinical analyzes is the F / B ratio \<0.8, which characterizes an intestinal dysbiotic state.

Many causes can affect the intestinal microbiota, thus altering it in a dysbiotic state, first of all the diet. In fact, dysbiosis can be characterized both by the severity with which it manifests itself and is also distinguished in putrefactive and fermentative dysbiosis.

Furthermore, the variation in the "normal" percentages of the Phyla is also related to some pathological alterations.

The aim of this study will be to monitor the population and heterogeneity of the microbiota in the Italian population. Knowing the complex implications of dysbiosis and the extensive data on it, this study will want to detail the state of the gut microbiota in the previously indicated population, focusing attention on peculiar profiles that could reflect a pathogenic spectrum or metabolic disturbances.

The study aims to investigate the diffusion and state of the microbiota in the Italian territory and if it occurs in association with certain pathologies and / or diet.


Eligibility criteria: Inclusion Criteria:

* Aged between 16 and 80 years old,
* Patients with completed questionnare
* Dysbiosis symptoms

Exclusion Criteria:

* Under 16 years old,
* over 80 years old,
* patients misidentified

Primary outcomes:
measure: Outcome percentage Phyla
timeFrame: 2020-2022
Secondary outcomes:
Other outcomes:
Locations:
city: Guidonia
country: Italy
facility: Lifebrain Cerba Healthcare laboratory network
state: Roma
Study officials:
References:
Clinical trial NCT02136251: Total Shoulder Replacement Outcomes With Autologous Bone Graft as Fixator for Glenoid Anchor Peg.
Official title: Five Year Outcome Follow-up of Glenoid Anchor Peg Component Fixation Utilizing Autologous Bone Graft in Total Shoulder Arthroplasty.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Arthritis
Keywords: Total Shoulder Arthroplasty
Glenoid anchor peg component fixation
Autologous bone grafting
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2014-05-12
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Orthopaedic Surgery clinic patients

Brief summary: We hypothesize that there will be a low incidence of glenoid loosening with a total shoulder arthroplasty using an anchor peg glenoid and autologous bone grafting. In addition, we suggest that the absence of radiolucent lines will correlate with excellent shoulder function.

Detailed description: This will be five year follow-up of glenoid anchor peg component fixation utilizing autologous bone graft in total shoulder arthroplasty. The purpose of this study is to investigate if the use of autologous bone graft around the anchor peg glenoid prosthesis correlates with better shoulder function. Subjects having had this surgery who are five years or more out from surgery will have computed tomography and three plain radiographs to monitor for bony apposition, radiolucent lines and component loosening. These testings are not a study intervention and are for monitoring purposes.

Eligibility criteria: Inclusion Criteria:

- Have had a total shoulder replacement with an anchor peg glenoid and autologous bone grafting at the Department of Orthopaedic Surgery at University of Nebraska and The Nebraska Medical Center five years or longer ago.

Exclusion Criteria:

* unable to comprehend the consent form information
* pregnant women

Primary outcomes:
measure: Evidence of lower incidence of glenoid loosening and absence of radiolucent lines confirmed by CT and radiographs.
timeFrame: 5 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Nebraska
name: Matthew Teusink, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02289651: Effectiveness of Pediatric Intubation
Official title: Comparison of the Venner(TM) A.P. Advance(TM) With the Macintosh Laryngoscope for Emergency Intubation in a Standardized Airway Manikin With and Without Chest Compressions by Nurses. A Randomized, Controlled Crossover Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrest
Keywords: intubation
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-11-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We hypothesized that the Venner videolaryngoscope (A.P. Advance™) is beneficial for intubation of pediatric manikins while performing CPR. In the current study, we compared effectiveness of the Venner videolaryngoscope (A.P. Advance™) and MIL laryngoscopes in child resuscitation with and without CC.


Eligibility criteria: Inclusion Criteria:

* Give voluntary consent to participate in the study
* minimum 1 year of work experience in nursing

Exclusion Criteria:

* Not meet the above criteria
* Wrist or Low back diseases

Primary outcomes:
measure: Success of intubation
timeFrame: 1 MONTH
Secondary outcomes:
measure: Intubation time
timeFrame: 1 MONTH
measure: POGO score
timeFrame: 1 MONTH
measure: Cormack-Lehane grading
timeFrame: 1 MONTH
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: Institute of Cardiology
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02754154: Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants
Official title: Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-04-28
Enrollment: 321182
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: Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using oral anticoagulants

Brief summary: The purpose of this study is to compare the risk of major bleeding event among nonvalvular atrial fibrillation patients treated with warfarin, apixaban, dabigatran and rivaroxaban.


Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years old as of the index date
* At least 1 diagnosis of atrial fibrillation in the 12 months prior to or on index date, identified by any medical claim
* At least one year of baseline period and continuous enrollment for at least 12 months prior to index date Individuals with NVAF who were using oral anticoagulants (i.e., warfarin, dabigatran, rivaroxaban and apixaban) within the study period beginning Jan 1, 2012 through December 31, 2013 or last date of the last data cut available at the time of execution of the study

Exclusion Criteria:

* Patients with evidence of valvular heart disease, thyrotoxicosis, pericarditis, mitral stenosis, Venous thromboembolism(VTE), heart surgery, and endocarditis during the baseline period any time prior to or on index date
* Patients with any evidence of pregnancy at any time during the baseline will be excluded

Primary outcomes:
measure: Time to "First Major" Bleeding event
timeFrame: Up to 25 months
Secondary outcomes:
measure: Time to "First Any" Bleeding event
timeFrame: Up to 25 months
measure: Major Bleeding-Related Healthcare Utilization
timeFrame: Up to 25 months
measure: Any Bleeding-Related Healthcare Utilization
timeFrame: Up to 25 months
measure: Major Bleeding-Related direct medical cost
timeFrame: Up to 25 months
measure: Any Bleeding-Related direct medical cost
timeFrame: Up to 25 months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04917354: Superb Micro-vascular Imaging for Evaluation of Hepatic Lesions
Official title: iBEAM-Based Superb Micro-vascular Imaging for Evaluation of Hepatic Lesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatic Lesion
Keywords: Superb Micro-vascular Imaging
Hepatocellular Carcinoma
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population consisted of patients (age:18-80 years) with visible hepatic lesion on US

Brief summary: Superb Micro-vascular Imaging (SMI) based on the iBeam platform is used to evaluate the blood supply of solid tumors. Compared with color Doppler technology, the sensitivity, accuracy and consistency of the ability of SMI to display blood flow are evaluated. Thus, the investigators will use Superb-Microvascular imaging (SMI, Toshiba, Japan) for diagnosing hepatic lesions, which enable to detect slow micro vascular flow inside the tumor

Detailed description: To evaluate the diagnostic accuracy of SMI (primary outcome) when applying on the hepatic lesion.

Each US findings during exam for patients with hepatic lesion were recorded by radiologist.

Sample size calculation according to the primary outcome.

Eligibility criteria: Inclusion Criteria:

1. Visible hepatic lesion on US
2. Agree to participate in the study
3. Accessible follow-up imaging or pathological results

Exclusion Criteria:

1. Pregnant women

Primary outcomes:
measure: diagnostic accuracy
timeFrame: 1 week preoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The second affilliated hospital of Zhejiang University school of medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT00202254: Multiple Sclerosis Rehabilitation Study
Official title: 'Functioning and Disability' and 'Quality of Life' in an Australian Community Cohort With Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Mulitple Sclerosis
MS
Lead sponsor: Melbourne Health
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The effects of routine rehabilitation in MS patients versus no rehabilitation.

Detailed description: Routine rehabilitation inervention in patients with MS. This comprises of medical and nursing input, physiotherapy, occupational therapy, speech pathology, neuropsychology, compared with a "control" group on the waiting list for rehabilitation intervention. Duration of intervention is 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of MS (Paty)- Community dwelling participants with known neurological and psychological deficits per EDSS groups.- Age 19-64 years.- Male and female participants.- Residing within 60kms of metropolitan Melbourne.- Have mobility problem.- Adequate cognition (KFS=2).

Exclusion Criteria:

* Patients residing in nursing home and other residential care.- Those with severe cognitive problems KFS\>2.-

Primary outcomes:
measure: Improvement in fatigue levels and psychological well being (depression, stress and anxiety) in MS patients. Outcome will be measured at 13 months since recruitment.
Secondary outcomes:
measure: - Improvement in function and activities of daily living ie. disability- Quality of life.- Carer Burder in multiple sclerosis.- Utilisation of health services.- 13 months follow up.
Other outcomes:
Locations:
Study officials:
affiliation: Melbourne Extended Care Rehabilitation Service
name: Fary Khan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00788554: LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein
Official title: LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein. A Randomised Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inguinal Hernia
Keywords: groin
inguinal
hernia
lichtenstein
TEP
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2008-11-11
Enrollment: 660
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 aim of this study is to compare laparoscopic total extraperitoneal and open mesh repair of inguinal hernia, with regard to hospital stay, postoperative pain, quality of life, postoperative recovery and return to daily activities, complications and recurrences


Eligibility criteria: Inclusion Criteria:

* informed consent
* age \> 18 years
* inguinal hernia(primary, recurrence or bilateral)
* elective procedure

Exclusion Criteria:

* Scrotal hernia
* Prostatectomy, Pfannenstiehl-incision, pre-peritoneal surgery in history
* Participation in other trial
* Pregnancy
* Communicative or cognitive restrictions

Primary outcomes:
measure: hospital stay
timeFrame: 7 days
measure: postoperative pain
timeFrame: 6 weeks
measure: return to work
timeFrame: 6 weeks
measure: quality of life
timeFrame: 5 years
Secondary outcomes:
measure: operating time
timeFrame: 1 day
measure: operating costs
timeFrame: 1 week
measure: complication
timeFrame: 1 month
measure: mortality
timeFrame: 5 years
measure: total costs
timeFrame: 1 month
measure: recurrence
timeFrame: 5 years
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid Holland
Study officials:
affiliation: Erasmus Medical Center
name: J.F. Lange, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: J.J. Jeekel, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eker HH, Langeveld HR, Klitsie PJ, van't Riet M, Stassen LP, Weidema WF, Steyerberg EW, Lange JF, Bonjer HJ, Jeekel J. Randomized clinical trial of total extraperitoneal inguinal hernioplasty vs Lichtenstein repair: a long-term follow-up study. Arch Surg. 2012 Mar;147(3):256-60. doi: 10.1001/archsurg.2011.2023.
citation: Langeveld HR, van't Riet M, Weidema WF, Stassen LP, Steyerberg EW, Lange J, Bonjer HJ, Jeekel J. Total extraperitoneal inguinal hernia repair compared with Lichtenstein (the LEVEL-Trial): a randomized controlled trial. Ann Surg. 2010 May;251(5):819-24. doi: 10.1097/SLA.0b013e3181d96c32.