louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04633317: Aerosolized Colistin to Mechanical Ventilated Patients With Pneumonia
Official title: Aerosolized Colistin to Mechanical Ventilated Patients With CRGNB Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia, Bacterial
Lead sponsor: Chang Gung University
Sponsor class: OTHER
Collaborators: name: Chang Gung Memorial Hospital
First posted: 2020-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the effect of aerosolized colistin on to ventilated patients with carbapenem-resistant gram negative bacteria pneumonia. We hypothesize that adjunct aerosolized colistin, which achieve high drug concentrations in the airway, would more effectively treat the penumbra.

Detailed description: To treat respiratory infection of patients with mechanical ventilation, greater systemic antibiotic dose is required through the patient's venous injection. In this trial, patients with arbapenem-resistant gram negative bacteria pneumonia (CRGNB)were assigned to adjunct aerosolized colistin delivered by a jet nebulizer or a vibrating mesh nebulizer comparing to or standard intravenous injection by a randomizing protocol.

Need for a systemic antibiotic was determined by the clinical physician. Comparisons were made between standard care and study drug for their effects on bacteria eradiation, incidence of nephrotoxicity, and oxygenation.

Eligibility criteria: Inclusion Criteria:

* Patients received invasive mechanical ventilation \>48 hours
* Diagnosed with pneumonia caused by carbapenem resistance gram negative bacteria

Exclusion Criteria:

* pregnant or lactating women
* receiving colistin \> 3 days
* recurrent pneumonia caused by carbapenem resistance gram negative bacteria
* allergy to colistin or polymyxin B drugs
* immunocompromised, defined as neutropenia ANC\<500 cells/ul
* HIV positive
* received chemotherapy with 3 months
* renal function deficiency (creatinine clearance \< 30 ml/min)

Primary outcomes:
measure: Clinical pulmonary infection score
timeFrame: 7-10 days
Secondary outcomes:
measure: Ventilator pressure control level
timeFrame: 7-10 days
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Chiayi Chang Gung Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung University
name: Hui-Ling Lin, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03906617: Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine
Official title: Title of Project: Liposomal Bupivacaine (Exparel) Versus Bupivacaine And Dexamethasone Intercostal Nerve Blocks For Robotic Thoracic Surgery: A Prospective Randomized Single-Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Robotic Lung Surgery
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess analgesia after robotic lung surgery. Subjects will be randomized to receive wound infiltration and intercostal nerve block with either liposomal bupivacaine or bupivacaine/epinephrine + dexamethasone. Liposomal bupivacaine is a newer local anesthetic product and has not been compared to a combination of bupivacaine/epinephrine + dexamethasone in the context of pain control after robotic lung surgery.


Eligibility criteria: Inclusion Criteria:

* undergoing robotic wedge resection or lobectomy for lung mass(es)

Exclusion Criteria:

* emergency case
* history of opiate abuse
* chronic pain syndrome
* intravenous drug use
* chronic use of oral steroids
* pregnancy
* imprisonment
* body weight lower than 70 kg
* liver failure
* uninsured patients
* non-verbal patients or patients who are unable to rate their pain on a visual analogue pain scale
* history of allergic reaction to any of the drugs used in the study: bupivacaine, liposomal bupivacaine, dexamethasone

Primary outcomes:
measure: Visual Analogue Scale pain scores
timeFrame: 24 hours post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
Study officials:
References:
Clinical trial NCT05735717: MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies
Official title: Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha/Beta Depletion (A/B TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults With Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hematologic Malignancy
Acute Leukemia
Remission
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
AML
TP53
Intrachromosomal Amplification of Chromosome 21
Cytogenetic Abnormality
CNS Leukemia
Minimal Residual Disease
Myelodysplasia
Juvenile Myelomonocytic Leukemia
Somatic Mutation
PTPN11 Gene Mutation
N-RAS Gene Amplification
Neurofibromatosis 1
NF1 Mutation
CBL Gene Mutation
Monosomy 7
Chromosome Abnormality
Fetal Hemoglobin
Keywords: Bu
Flu
G-CSF
GFSR
aGVHD
HCT
MAC
Mel
PBSCT
PTLD
RECIST
TCR
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 150
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase II, open-label, prospective study of T cell receptor alpha/beta depletion (α/β TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies


Eligibility criteria: Inclusion Criteria:

* Histological confirmation of hematological malignancies
* Acute leukemias
* Acute Myeloid Leukemia (AML) and related precursor neoplasms
* Favorable risk AML is defined as having one of the following:
* Acute lymphoblastic leukemia (ALL)/lymphoma
* Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features.
* Age 60 years of age or younger at the time of consent
* Karnofsky performance status ≥ 70% or Lansky play score 50% for ≤16 years of age.
* Adequate organ function

Exclusion Criteria:

* Pregnant or breastfeeding.
* Active uncontrolled infection within 1 week of starting preparative therapy
* Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR.
* Any prior autologous or allogeneic transplant
* CML blast crisis
* Active central nervous system malignancy

Primary outcomes:
measure: Determine the rate of GVHD after alpha beta TCR depletion
timeFrame: 85 months
Secondary outcomes:
measure: Transplant engraftment
timeFrame: 42 days
measure: Graft Failure
timeFrame: 100 days
measure: Non-relapse mortality (NRM)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Cancer Center
state: Minnesota
Study officials:
affiliation: University of Minnesota Masonic Cancer Center
name: Margaret MacMillan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03454217: Impact of Tramadol and Oxycodone on Sleep Apnea
Official title: Impact of Tramadol and Oxycodone on Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Apnea
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2018-03-05
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: Postoperative pain is usually treated with opioids. Among them, oxycodone is popular in the daily practice as it is administered orally and is easily titrated. However, side-effects include increase duration and frequency of apneic episodes. Some authors believe that tramadol has less impact on these apneic episodes during the first postoperative night, based on a trial that reported conclusive results only during the first 2 postoperative hours. The objective of this randomized controlled trial is to compare the effect of postoperative pain treatment of oxycodone with tramadol on apneic episodes during the first and third postoperative nights.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for orthopaedic surgery on the lower limb under a spinal anaesthesia
* physical status I-III

Exclusion Criteria:

* planned surgical duration more than 3 hours
* contraindication to spinal anaesthesia
* severe respiratory disease
* patient treated for sleep apnea syndrome
* allergy to tramadol or oxycodone

Primary outcomes:
measure: Apnea hypopnea index while lying supine
timeFrame: Postoperative night 1
Secondary outcomes:
measure: Apnea hypopnea index in another position than supine
timeFrame: Postoperative night 1
measure: Mean pulse oxymetry
timeFrame: Postoperative night 1
measure: Apnea hypopnea index while lying supine
timeFrame: Postoperative night 3
measure: Apnea hypopnea index in another position than supine
timeFrame: Postoperative night 3
measure: Mean pulse oxymetry
timeFrame: Postoperative night 3
measure: Pains scores (numeric rating scale)
timeFrame: Postoperative day 0, 1, 2 and 3
measure: Opioid (oxycodone or tramadol) consumption
timeFrame: Postoperative day 0, 1, 2 and 3
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
state: Vaud
Study officials:
affiliation: University of Lausanne Hospitals
name: Eric Albrecht
role: PRINCIPAL_INVESTIGATOR
References:
citation: Albrecht E, Pereira P, Bayon V, Berger M, Wegrzyn J, Antoniadis A, Heinzer R. The Relationship Between Postoperative Opioid Analgesia and Sleep Apnea Severity in Patients Undergoing Hip Arthroplasty: A Randomized, Controlled, Triple-Blinded Trial. Nat Sci Sleep. 2022 Feb 25;14:303-310. doi: 10.2147/NSS.S348834. eCollection 2022.
Clinical trial NCT02191917: A Study of Respiratory Muscle Strength in Patients With Late-onset Pompe Disease (LOPD)
Official title: A Study of Respiratory Muscle Strength, Including Effort-Independent Measures, in Subjects With Late-Onset Pompe Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Late-onset Pompe Disease
Lead sponsor: BioMarin Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 8
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: Fifteen subjects were planned for enrollment; there were no screening failures; 8 subjects were enrolled. Two subjects were enrolled from 701-301 and the remaining 6 subjects enrolled directly into 701-201 (no parent study)

Brief summary: Study 701-201 is a study in patients with late-onset Pompe disease (LOPD). The study will test respiratory muscle strength initially and again after 24 weeks in subjects treated or not treated with BMN 701 .


Eligibility criteria: Inclusion Criteria:

* Willing and able to provide written informed consent, after the nature of the study has been explained, and prior to any study-related procedures
* Documented diagnosis with late-onset Pompe disease - At least 18 years of age at study entry
* Willing and able to comply with all study procedures

Exclusion Criteria:

* Requires ventilatory support while awake and in the upright position
* Concurrent disease, medical condition, or extenuating circumstance that, in the opinion of the investigator, might compromise patient well-being, study completion, or data collection
* Allergy to tools or procedures used for respiratory muscle testing

Primary outcomes:
measure: Maximal Inspiratory Pressure (MIP)
timeFrame: Baseline, Week 28
Secondary outcomes:
measure: Maximal Expiratory Pressure (MEP)
timeFrame: Baseline, Week 28
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: BioMarin Pharmaceutical
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05493917: A Real-world Study to Evaluate the Safety and Immunogenicity of a Third-dose Booster After Two Doses of an Inactivated COVID-19 Vaccine
Official title: A Real-world Study to Evaluate the Safety and Immunogenicity of a Third-dose Booster After Two Doses of an Inactivated COVID-19 Vaccine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Vaccine Reaction
Keywords: inactive vaccine
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 2000
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: Recruit and screen subjects who have completed 2 doses of the new coronavirus vaccine for more than 6 months and voluntarily receive a third dose of the vaccine

Brief summary: This project is a prospective observational real-world study, recruiting and screening subjects who have completed 2 doses of the COVID-19 vaccine for more than 6 months and receive the third dose of the vaccine voluntarily into the clinical cohort of this study. Subjects received a third dose of the COVID-19 vaccine will be enrolled in the study and followed up for 1 year at baseline (day 0) before vaccine injection, 28 days after injection, 90 days, 270 days after injection. On the 365th day, blood samples were collected for the detection of anti-SARS-CoV-2 antibodies and other related indicators to evaluate the immune protection effect.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years old, gender is not limited;
* Subjects who completed the second dose of COVID-19 inactivated vaccine for more than 6 months and received the third dose of the same vaccine

Exclusion Criteria:

* allergic to the active ingredients of the SARS-CoV-2 vaccine, any of the inactive ingredients, the substances used in the production process, or those who have had allergies during previous vaccination of similar vaccines;
* those who have had severe allergic reactions to vaccines in the past (such as acute allergic reactions, angioedema, respiratory Difficulties, urticaria, angioedema or abdominal pain);
* Receiving other research drugs within 3 months ;participating in other research vaccines Or subjects in clinical trials of research drugs;
* other conditions that the investigator judges are not suitable for this clinical trial;

Primary outcomes:
measure: Geometric mean titers (GMTs)
timeFrame: Day 28±3 after the third dose of vaccine injection
Secondary outcomes:
measure: Geometric mean titers (GMTs)
timeFrame: Day 90±7, Day 180±7, Day 270±7, Day 365±7 after the third dose of vaccine injection
measure: IgG
timeFrame: Day 28±3, Day 90±7, Day 180±7, Day 270±7, Day 365±7 after the third dose of vaccine injection
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Infectious department of Huashan Hospital, Fudan University
Study officials:
References:
Clinical trial NCT05058417: Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis
Official title: Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Sadat City University
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled study evaluating empagliflozin tablets administered daily for 8 weeks. The purpose of the study is to evaluate the efficacy and safety of empagliflozin in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using Mayo score for ulcerative colitis activity. Calculation of the score requires patients to undergo colonoscopy at the start of the study and at week 8.


Eligibility criteria: Inclusion Criteria:

* Patients with mild or moderate ulcerative colitis newly diagnosed by colonoscopy and biopsy according to Mayo endoscopic scoring of ulcerative colitis.
* Adults (males and/or females) with age range from 18 to 65 years old.
* Patients on treatment with 5-aminosalisylic acid (5-ASA)

Exclusion Criteria:

* Patients with severe ulcerative colitis according to Mayo endoscopic scoring of ulcerative colitis.
* Treatment with systemic or rectal steroids.
* Treatment with immunosuppressants.
* Previously failed treatment with a sulphasalazine.
* Known hypersensitivity to any of study drugs.
* Hepatic and renal dysfunction.
* Pregnancy and lactation.
* History of colorectal carcinoma.
* History of complete or partial colectomy.
* Patients with diabetes mellitus
* Patients with history of lactic acidosis
* Patients with disease states associated with hypoxemia including cardiorespiratory insufficiency
* Positive stool culture for enteric pathogens, positive stool ova and parasite exam.

Primary outcomes:
measure: Expression of colonic (NF)-κB proteins
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Faculty of Pharmacy
state: Menoufia
Study officials:
References:
Clinical trial NCT00789217: Penicillin Skin Testing in Patients With History of Allergic Reactions to Betalactams
Official title: The Comparative Results of Penicillin Testing in Patients With History of Allergic Reactions to Betalactams Between Using In-house Penicillin Test Preparation and Commercial Available Penicillin Testing Kit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Penicillin Allergy
Keywords: Penicillin
Beta-Lactams
Allergy
Hypersensitivity
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Mahidol University
First posted: 2008-11-11
Enrollment: 63
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to compare the readings of skin testing results in patients with suspected penicillin allergy between in-house penicillin test preparation and commercial available penicillin testing kit.

Detailed description: The results of skin test with immediate reading will be compared between alkali-treated penicillin G and DAP reagents from Diater

Eligibility criteria: Inclusion Criteria:

1. Patients with history of hypersensitivity reactions to betalactams; penicillin, aminopenicillins, and cephalosporins
2. 15-65 years of age

Exclusion Criteria:

1. On antihistamine/ cannot discontinue antihistamine before the test
2. Having asthma exacerbation
3. Being pregnant
4. Suffering from severe systemic disease/ in bad health

Primary outcomes:
measure: The skin testing results of in-house penicillin skin test and Penicillin G Sodium compared to commercial penicillin testing kit
timeFrame: 1 year
Secondary outcomes:
measure: Clinical correlation and side effects
timeFrame: 1 year
measure: Correlations between Penicillin skin test result with specific IgE and/or basophil activation test
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Jettanong Klaewsongkram, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wangrattanasopon P, Ruxrungtham K, Chantaphakul H, Buranapraditkun S, Klaewsongkram J. Alkali-treated penicillin G solution is a better option than penicillin G as an alternative source of minor determinants for penicillin skin test. Allergy Asthma Proc. 2012 Mar-Apr;33(2):152-9. doi: 10.2500/aap.2012.33.3496.
Clinical trial NCT06639217: Comprehensive Nursing Care Protocol for Women With Pelvic Organ Prolapse and Urinary Incontinence: A Global Perspective
Official title: Comprehensive Nursing Care Protocol for Women With Pelvic Organ Prolapse and Urinary Incontinence: A Global Perspective
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: women prolapse -Care Protocol
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Pelvic organ prolapse is the descent of pelvic structures into the vagina due to ligament or muscular weakness. Pelvic organ prolapse (POP) is subcategorized according to the compartment of descent. Cystocele characterizes anterior wall herniation, rectocele refers to the posterior vaginal wall descent, and vaginal vault prolapse characterizes the descent of the uterus, cervix, or apex of the vagina. They can occur either singly or in combination

Detailed description: this study aimed to investigate the effectiveness of a comprehensive nursing care protocol provided for nurses who provide direct care for women with pelvic organ prolapse and urinary incontinence in gynecological in patients departments, Mansoura University Hospital, Mansoura University on their knowledge and practices as well as its impact on the women quality of life.

Eligibility criteria: Inclusion Criteria:

* All available nurses assigned for bed side care in the previous study settings and fulfilled the following inclusion criteria:

  * Age 20≥ 60 years
  * Willing to participate in the study
  * Both sex

Exclusion Criteria:

* nurses did not assign for bed side care in the previous study settings and not fulfill the inclusion criteria

Primary outcomes:
measure: Nurses knowledge structured interview
timeFrame: 3 months
measure: Nurses Observational Practices Checklist
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Al Manşūrah
country: Egypt
facility: Basma Wageah Mohamed Mohamed Elrefay
state: الدقهلية
Study officials:
References: