louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06784570: Impact of Perioperative Levosimendan on Patients Undergoing Cardiac Surgery With Low Ejection Fraction
Official title: Impact of Perioperative Levosimendan on Patients Undergoing Cardiac Surgery With Low Ejection Fraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiac Surgery
Low Ejection Fraction
Keywords: levosemindan- low ejection fraction-cardiac surgery
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2025-01-20
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients divided into three groups according to type of surgery done : CABG alone, Valve alone and combined each group contains 80 patients, then each previous group is subdivided into LEVO group and TRAD group each subgroup contain 40 patients according to the type of inotropes used in each group either levosemindane (pre operative ) or other traditional adrenergic drugs :adrenaline ,noradrenaline ,dopamine and dobutamine
Primary purpose: PREVENTION

Brief summary: to compar levosemindan to other cardiac intropic medications that strengthen the heart in diffrent common adult heart surgery with patients with low ejection fraction(weak heart)

Detailed description: in this study show the effect of levosemindan use during coronary artery surgery ,heart valve surgery and combined coronary and valve surgery in comparison to other traditional medications with patients with low ejection fraction(weak heart)

Eligibility criteria: Inclusion Criteria:

1. Valve surgery
2. CABG surgery,
3. combined surgery
4. all patients Ejection Fraction less than 35 ٪ -

Exclusion Criteria:

1. Patients age ≤ 20-70 \< years
2. Aortic and redo surgery
3. any patients with Ejection Fraction more than 35 ٪ -

Primary outcomes:
measure: death through day 30,
timeFrame: 1 month (no scale for measurement as death may occured due to multible causes that be difficult to be identified and measured )
measure: Renal-replacement therapy
timeFrame: 1 month
measure: Perioperative myocardial infarction
timeFrame: 5 days
measure: Intra Aortic Ballon Pumb insertion
timeFrame: 5 days(no scale for measurement )
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: cardiothorathic surgery department -faculty of medecine-zagazig univeristy-Egypt
state: El Sharkia
Study officials:
References:
Clinical trial NCT05393570: Lifestyle Improvement for Teens With Bariatric Surgery
Official title: Partnering Lifestyle Intervention With Bariatric Surgery to Maximize Health Outcomes in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Adolescent
Bariatric Surgery Candidate
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-05-26
Enrollment: 75
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to Conduct a proof of concept study to assess feasibility, acceptability, and effectiveness of an Metabolic and bariatric surgery (MBS) -supported healthy lifestyle behavioral intervention among adolescent patients, their families, and their clinical team.


Eligibility criteria: Inclusion Criteria

* Must meet National Institutes of Health criteria to qualify for MBS for adolescents (BMI \>35 kg/m2 and at least one existing co-morbidity \[e.g. elevated blood pressure, hypercholesterolemia, etc.\] or a BMI\>40kg/m2).
* received psychological clearance for surgery

Exclusion Criteria:

* is not medically referred by a physician for bariatric surgery
* Refuses to participate in the study

Primary outcomes:
measure: Change in Health-related quality of life as measured by the HRQOL-14
timeFrame: 1 month Pre surgery and 6 months post surgery
measure: Change in Blood Insulin Levels
timeFrame: Pre surgery, 3 months post surgery, 6 months post surgery
measure: Change in Blood Lipid Levels as Assessed by Lipid Panel
timeFrame: Pre surgery, 3 months post surgery, 6 months post surgery
measure: Change in Blood Glucose Level
timeFrame: pre surgery, 3 months post surgery, 6 months post surgery
measure: Change in Diastolic Blood Pressure
timeFrame: pre surgery, 3 months post surgery, 6 months post surgery
measure: Change in Systolic Blood Pressure
timeFrame: pre surgery, 3 months post surgery, 6 months post surgery
measure: Change in HbA1c levels
timeFrame: pre surgery, 3 months post surgery, 6 months post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sarah E Messiah, Ph.D., MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03803670: Clinical Significance of Occult Central Nervous System Disease In Adult Acute Lymphoblastic Leukemia
Official title: Clinical Significance of Occult Central Nervous System Disease In Adult Acute Lymphoblastic Leukemia: A Multicenter, Retrospective Study From The Campus All/Gimema Network
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lymphoblastic Leukemia
Keywords: acute lymphoblastic leukemia
flow cytometry
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 241
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients affected by ALL underwent to diagnostic lumbar puncture

Brief summary: Central nervous system involvement at diagnosis remains an obstacle to a long-term cure of patients affected by acute lymphoblastic leukemia. The investigators have previously reported that flow cytometry (FCM) is better than conventional cytology (CC) in demonstrating the presence of leukemic cells in the patients'(pts) cerebrospinal fluid (CSF), especially in samples with low cell counts. In the framework of the national Campus ALL program aimed at improving the management of adult ALL patients in the context of the GIMEMA protocols, in the present study the investigators retrospectively evaluated the incidence of occult CNS positivity and its impact on outcome in 241 adult pts with newly diagnosed ALL from 13 centers.

Detailed description: Demographic and of laboratory data of 241 adult patients with ALL were retrospectively recorded. All patients underwent diagnostic lumbar puncture and each cerebrospinal fluid sample was examined by CC and FCM. The investigators identified patients with the only FCM positivity and the investigators correlated this condition with clinical and of laboratory data and with clinical outcome.

Eligibility criteria: Inclusion Criteria:

* ALL at onset
* Age \>18 years

Exclusion Criteria:

* ALL relapsed or refractory
* Age \<18 years

Primary outcomes:
measure: impact of occult CNS disease
timeFrame: 10 years
measure: impact of occult CNS disease on outcome
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Tor Vergata of Rome
name: Maria Ilaria Del Principe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Del Principe MI, Buzzatti E, Piciocchi A, Forghieri F, Bonifacio M, Lessi F, Imbergamo S, Orciuolo E, Rossi G, Fracchiolla N, Trappolini S, Neri B, Sarlo C, Zappasodi P, Dargenio M, Cefalo M, Irno-Consalvo MA, Conti C, Paterno G, De Angelis G, Sciume M, Della Starza I, Venditti A, Foa R, Guarini AR. Clinical significance of occult central nervous system disease in adult acute lymphoblastic leukemia. A multicenter report from the Campus ALL Network. Haematologica. 2021 Jan 1;106(1):39-45. doi: 10.3324/haematol.2019.231704.
Clinical trial NCT05341570: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-21668
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-21668 in Advanced Solid Tumor Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study is an open-label, single arm, dose escalation and dose expansion phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BPI-21668 in solid tumor patients. In dose escalation phase, biomarker status is not required, but in dose expansion phase patients are required to harbor PIK3CA mutation.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 and ≤70 years, male and female patients;
2. Life expectancy ≥ 12 weeks;
3. ECOG performance score 0-1;
4. Locally advanced or relapsed/metastatic solid tumor patients, who had disease progression after standard therapy, intolerable to standard therapy or for whom no standard therapy exists, PIK3CA mutation status is required for dose expansion phase;
5. Evaluable lesion required for dose escalation phase and measurable lesion as per RECIST 1.1 required for dose expansion phase;
6. Adequate organ function;
7. Signed informed consent.

Exclusion Criteria:

1. Prior use of PI3K、mTOR or AKT inhibitor;
2. Prior other malignant tumor;
3. Unstable, symptomatic primary CNS tumors/metastasis or leptomeningeal metastases ;
4. Type I or type II diabetes;
5. Inadequate wash-out of prior anti-cancer therapies;
6. Cardiac disorders;
7. Instable systemic diseases;
8. Acute or chronic pancreatitis;
9. Pregnancy or lactation;
10. Other protocol specified criteria.

Primary outcomes:
measure: The adverse events (AEs)
timeFrame: Through the Phase I, approximately 24 months
measure: Determine the Maximum Tolerated Dose (MTD)
timeFrame: Through the Phase I, approximately 24 months
measure: Determine the recommended Phase II dose (RP2D)
timeFrame: Through the Phase I, approximately 24 months
Secondary outcomes:
measure: Evaluate the pharmacokinetics of BPI-21668
timeFrame: Through the Phase I, approximately 24 months
measure: Determination of anti-tumor activity of BPI-21668
timeFrame: Through the Phase I, approximately 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Binghe Xu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00375570: Safety Study of ME-609 for Treatment of Herpes Simplex Labialis in Adolescents
Official title: An Open Label, Multi-Centre, Phase III, Subject Initiated Safety Study of ME-609 in Treatment of Recurrent Herpes Simplex Labialis in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Labialis
Lead sponsor: Medivir
Sponsor class: INDUSTRY
First posted: 2006-09-13
Enrollment: 254
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Purpose of this study is to evaluate the safety of ME-609 for the treatment of recurrent herpes labialis in adolescents.

Detailed description: The objective of the study was to evaluate the safety of ME-609 for the treatment of herpes labialis recurrences in immunocompetent adolescents, 12 - 17 years of age, following a 5-day treatment with 5-time daily topical administration.

Eligibility criteria: Inclusion Criteria:

* General good health
* History of recurrent herpes labialis with at two recurrences during the last twelve months

Exclusion Criteria:

* Treatment with systemic or topical antiviral agents or steroids within two weeks prior to inclusion
* Significant skin condition that occur in the area of herpes recurrences
* Nursing or/and pregnancy
* Immunosupressed state due to underlying disease (e.g. HIV infection or concomitant treatment (e.g. cancer chemotherapy)

Primary outcomes:
measure: Adverse Event
timeFrame: 3 weeks after last dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Medical Sciences, Dermatology and Venereology University Hospital, Uppsala, Sweden
name: Anders Strand, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05674370: A Study of the GRIP Influenza and SARS-CoV-2 POC Assays
Official title: Clinical Evaluation of the GRIP Influenza and SARS-CoV-2 Point-of-care Assays Using Fresh Patient Nasal Swab Samples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Influenza
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2023-01-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research is to determine if the use of a new device can accurately detect a virus infection.

Detailed description: GRIP has developed a novel, graphene-based detection system for potential use in point-of-care settings. This study will compare the performance of the GRIP device to routine PCR testing for detection of COVID-19 and influenza viruses. When patients present for routine testing for COVID-19 and influenza, they will also have a separate nasal swab collected that will be tested by the GRIP point-of-care device.

Eligibility criteria: Inclusion Criteria:

* Patients being tested for COVID 19 or Influenza

Exclusion Criteria:

* Patients \< 18 years of age

Primary outcomes:
measure: Positive Percent Agreement
timeFrame: One hour
measure: Negative Percent Agreement
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew Binnicker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00452270: Decongestant Effect, Timing of Effect and Impact on Sleep and General Well-Being of Xylometazoline in Subjects With a Common Cold
Official title: A Double-Blind, Randomized, Parallel Group, Placebo Controlled Study, Evaluating the Decongestant Effect, Time to Onset, Duration of Effect and Impact on Sleep and General Well-Being of Xylometazoline in Subjects With a Common Cold
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Common Cold
Keywords: Common cold, xylometazoline
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-03-27
Enrollment: 60
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 characterize the time profile of the decongestant properties of xylometazoline and to investigate its effect on sleep, general well-being and smell/taste.


Eligibility criteria: Inclusion Criteria:

* Over 18 years
* Have had moderate common cold symptoms for less than 36 hours.

Exclusion Criteria:

* Congested/runny nose for more than two continuous weeks in the previous 12 months
* Deviated septum or nasal polyps
* Recent use of antibiotics
* Recent sinusitis

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: To evaluate the decongestant effect of xylometazoline in subjects with
measure: common cold compared to placebo treatment by means of rhinomanometry over a period of 12 hours.
Secondary outcomes:
measure: To measure the peak subjective effect, time to onset of subjective relief of nasal obstruction
measure: and duration of relief of nasal obstruction
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Novartis Investigative Site
state: Wales
Study officials:
name: Novartis Investigative Site, Cardiff, Wales, UK
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06544070: Capillary Blood Accuracy
Official title: Capillary Blood Accuracy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer
Lead sponsor: Entia Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with a diagnosis of solid tumour cancer who are undergoing systemic anti-cancer therapy (SACT).

Brief summary: Entia is a health technology company that has developed a blood testing device called Entia Liberty, which analyses blood collected by a finger prick. Entia is sponsoring this research study to compare the results from Entia Liberty finger prick tests to results from the gold-standard laboratory analyser that tests blood from the arm, port, or PICC line.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old at the time of study entry
* Patients undergoing systemic anti-cancer therapy (SACT)
* Patients capable of providing written informed consent
* Patients undergoing routine Full Blood Count (FBC) laboratory blood tests as part of the standard of care

Additional inclusion criteria:

* Phase 1 (Longitudinal, low count data): Neutrophil Count ≤ 1.0 x109/L within 24 hours preceding consenting
* Phase 2 (Low count data): Neutrophil Count ≤ 1.5 x109/L within 24 hours preceding consenting

Exclusion Criteria:

* History or current diagnosis of haematological malignancy
* Inadequate use and understanding of the English language, requiring a translator

Primary outcomes:
measure: Validity of of the Liberty System for haematological parameters of interest: Hb, WBC, PLT, ANC
timeFrame: Through study completion, up to 8 days per participant.
measure: Reliability of of the Liberty System for haematological parameters of interest: Hb, WBC, PLT, ANC
timeFrame: Through study completion, up to 8 days per participant.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06464770: Optimizing Infection Prophylaxis Prior to Shoulder Surgery
Official title: Optimizing Infection Prophylaxis Prior to Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthroplasty Shoulder
Periprosthetic Joint Infection
Keywords: periprosthetic joint infection
cutibacterium
shoulder arthroplasty
chlorhexidine
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomization Option 1: Right shoulder, Test Group ; Left shoulder, Control Group Randomization Option 2: Right shoulder, Control Group ; Left shoulder, Test Group
Primary purpose: PREVENTION

Brief summary: The goal of this interventional study is to determine the amount of skin C. acnes reduction with increased pressure during the chlorhexidine gluconate, brand name ChloraPrep, application. The main question it aims to answer is:

Does changing the pressure applied during the ChloraPrep application impact the amount of C. acnes bacteria on the skin after one hour? Researchers will compare ChloraPrep applied at a pressure similar to a gentle wipe to ChloraPrep applied at a pressure similar to a massage to see if wash the amount of C. acnes on the skin after one hour is different.

Participants will have one shoulder washed with ChloraPrep using pressure meant to impact the dermal layer, similar to a gentle wipe, and the other shoulder washed with ChloraPrep using pressure meant to impact the subdermal layer, similar to a massage. Participants will have swabs taken of their skin before the ChloraPrep application and again one hour after application to look for the amount of C. acnes on the skin.


Eligibility criteria: Inclusion Criteria:

* English speaking

Exclusion Criteria:

* Self report very sensitive skin
* Allergic to chlorhexidine
* Used antibiotics in the last three months
* Used acne treatment in the last three months
* Wounds on your shoulders

Primary outcomes:
measure: Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Dermal Pressure
timeFrame: 60 Minutes After ChloraPrep Wash
measure: Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Subdermal Pressure
timeFrame: 60 Minutes After ChloraPrep Wash
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Jason Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04207970: Evaluating Adapted Structured Clinical Management for People With a Diagnosis of Personality Disorder
Official title: Evaluating Adapted Structured Clinical Management for People With a Diagnosis of Personality Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Personality Disorders
Lead sponsor: Camden and Islington NHS Trust
Sponsor class: OTHER_GOV
First posted: 2019-12-23
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with a diagnosis of Personality Disorder, under the care of Camden and Islington PDS.

Brief summary: Camden and Islington NHS Foundation Trust in London has a Personality Disorder Service (PDS) which offers a number of evidence-based interventions to people with a diagnosis of Personality Disorder. One team in the PDS, the Community Team, offers an adapted form of Structured Clinical Management (SCM; Bateman and Kravitz, 2013). As these adaptations are novel, this study aims to formally explore the effectiveness of this intervention, through a sample of clients under the team, with outcomes (proxy measures of distress such as inpatient admissions) pre- and post- intervention.


Eligibility criteria: Inclusion Criteria:

* Allocated to a care coordinator at the PDS for greater than one year (a reasonable time period for therapeutic rapport to form and the effect of the intervention to manifest).

Exclusion Criteria:

* No existing notes for one year prior to allocation.
* No primary diagnosis of Personality Disorder.

Primary outcomes:
measure: Proxy measures of client distress
timeFrame: One year pre-referral and one year post-allocation
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Camden and Islington Personality Disorder Service
Study officials:
affiliation: Camden and Islington NHS Trust
name: Andrew White
role: PRINCIPAL_INVESTIGATOR
References: