louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01414569: Dexamethasone for Pain After Shoulder Surgery
Official title: High Dose Dexamethasone as Pain Treatment After Arthroscopic Shoulder Surgery: A Randomised, Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Shoulder Impingement Syndrome
Arthritis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Horsens Hospital
name: Central Denmark Region
name: The Hede Nielsen Family Foundation
name: The Danish Rheumatism Association
First posted: 2011-08-11
Enrollment: 97
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: The purpose of this study is to determine if a dose of 40 mg dexamethasone is more effective as pain treatment than the currently used dose of 8 mg after arthroscopic shoulder surgery.


Eligibility criteria: Inclusion Criteria:

* Arthroscopic subacromial decompression and/or acromioclavicular resection
* General anaesthesia
* Daysurgery, Horsens Hospital

Exclusion Criteria:

* Incompetent
* Pregnant
* Age under 18 or over 90 years
* Allergy toward dexamethasone
* Diabetes
* Active gastric ulcer
* Untreated hypertension
* Glaucoma
* Daily use of glucocorticoids or strong opioids
* Daily use of analgesics for unrelated illness
* Myasthenia gravis
* Mitochondrial disorders

Primary outcomes:
measure: Pain score by numeric rating scale
timeFrame: At 8 hours postoperatively
Secondary outcomes:
measure: Use of analgesics
timeFrame: During hospital stay, about 4 hours
measure: Pain score by numeric rating scale
timeFrame: At about 8 a.m. on the first postoperative day
Other outcomes:
Locations:
city: Horsens
country: Denmark
facility: Horsens Hospital
Study officials:
affiliation: Aarhus University, Horsens Hospital
name: Karen T Bjørnholdt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital
name: Kjeld Søballe, Prof. dr.med.
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Lone Nikolajsen, ph.d., MD
role: STUDY_CHAIR
References:
citation: Bjornholdt KT, Monsted PN, Soballe K, Nikolajsen L. Dexamethasone for pain after outpatient shoulder surgery: a randomised, double-blind, placebo-controlled trial. Acta Anaesthesiol Scand. 2014 Jul;58(6):751-8. doi: 10.1111/aas.12333. Epub 2014 May 13.
Clinical trial NCT04157569: CtDNA After Chemotherapy in Elderly Patients With Acute Leukemia
Official title: Monitoring Circulating Tumor DNA After Chemotherapy in Elderly Patients With Acute Leukemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Leukemia
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
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 include old AML patients with somatic mutations

Brief summary: This study will monitor CtDNA After Chemotherapy in Elderly Patients With AL

Detailed description: This study will use droplet digital PCR (ddPCR) method to quantify peripheral blood plasma mutant allele frequency (MAF) in elderly acute leukemia patients after chemotherapy to evaluate the clinical value of CtDNA .

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Male
* not pregnant female
* patients \>=60 years old
* Diagnosis of acute leukemia

Exclusion Criteria:

* Pregnancy
* HIV positive
* patients \>=100 years old

Primary outcomes:
measure: cumulative incidence of relapse(CIR)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: overall survival (OS)
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Navy General Hospital
Study officials:
affiliation: Navy General Hospital, Beijing
name: Liren Qian, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04812769: Electronic Consultation for AD/ADRD Residents Experiencing Infectious Diseases
Official title: Electronic Consultation for AD/ADRD Residents Experiencing Infectious Diseases
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alzheimer's Dementia
Nursing Homes
Antibiotics
Dementia
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Advarra
name: National Institute on Aging (NIA)
name: Brown University
First posted: 2021-03-24
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two participating nursing homes will be assigned to the intervention. One participating nursing home will serve as a control.
Primary purpose: PREVENTION

Brief summary: Pilot study to evaluate the feasibility of a pilot embedded pragmatic cluster randomized controlled trial to reduce the duration of antibiotic therapy and number of antibiotic prescriptions in nursing home residents with AD/ADRD.

Detailed description: The overall objective of the proposed investigation is to assess the feasibility of a pilot embedded pragmatic cluster randomized controlled trial (ePCT) to reduce the duration of antibiotic therapy and number of antibiotic prescriptions among nursing home residents with AD/ADRD. With the support of three independently owned and operated nursing homes that are unaffiliated with an academic medical center, we have developed the multicomponent intervention, eCARE-ID (Electronic Consultation for AD/ADRD Residents Experiencing Infectious Diseases). eCARE-ID consists of three components: 1) Tele-ID video clinical consultation services for nursing home residents; 2) electronic consultation (e-consultation) services for healthcare personnel at participating nursing homes; and 3) Tele-ID video antibiotic stewardship services for healthcare personnel including pharmacists at participating nursing homes.

Eligibility criteria: Inclusion criteria - residence in a participating nursing home

Exclusion criteria:

- Not willing to consent to the study

Primary outcomes:
measure: Duration of antibiotic therapy in nursing home residents
timeFrame: 6 months
Secondary outcomes:
measure: Number of antibiotic prescriptions in nursing home residents
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Manisha Juthani-Mehta, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04221269: Suicide Prevention Intervention for Schizophrenia-Spectrum Disorders
Official title: Post-Hospital Suicide Prevention Intervention for Patients With Schizophrenia-Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Suicide
Keywords: psychiatric hospitalization
suicide prevention
psychosis
psychosocial intervention
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: American Foundation for Suicide Prevention
First posted: 2020-01-09
Enrollment: 30
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 current project is a pilot randomized controlled trial to test the Coping Long-term with Active Suicide Program for schizophrenia-spectrum disorders (CLASP-S) for patients following a psychiatric hospitalization. Participants will be assigned to enhanced treatment as usual (ETAU) alone vs CLASP-S plus ETAU. Participants complete assessments at baseline during their psychiatric hospitalization and at 3 months (mid-treatment) and 6 months (post-treatment) following discharge. The primary aim is to assess the feasibility and acceptability of CLASP-S. The secondary aim is to estimate the effects of CLASP-S on reducing suicidal thoughts and behaviors relative to ETAU.


Eligibility criteria: Inclusion Criteria:

* suicidal thoughts or behaviors prior to hospital admission
* diagnosis of a schizophrenia-spectrum disorder
* receiving pharmacotherapy
* 18 years or older
* speaks/reads English

Exclusion Criteria:

* psychosis due to substance use or medical condition
* lack of phone access
* discharge to long-term facility

Primary outcomes:
measure: Client Satisfaction Questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Columbia Suicide Severity Rating Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Brandon Gaudiano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02856269: Zinc Supplementation and Cardiovascular Risk in HIV
Official title: Zinc Supplementation and Cardiovascular Risk in HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Inflammation
Keywords: Zinc
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2016-08-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pilot open labeled randomized double arm trial, studying zinc supplementation to prevent HIV comorbidities that are linked to inflammation. Patients will be given zinc gluconate 45 mg capsule once daily in one arm, and 90 mg zinc gluconate in the other arm for 16 weeks.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this pilot study is to determine whether zinc supplementation significantly affects immune activation in HIV-infected subjects.

Detailed description: Zinc is a dietary supplement with compelling preclinical evidence for potential health benefit that could be expanded not only to the entire HIV population, but also to other inflammatory conditions that share many facets of HIV infection, namely the persistent intestinal barrier dysfunction, monocyte activation and heightened inflammation state.

Eligibility criteria: Inclusion Criteria:

* HIV-1 infection
* Age ≥18 years
* Zinc level ≤0.75 mg/L
* Receiving a stable antiretroviral regimen with no plans to change during study
* Documentation of an HIV-1 RNA level of ≤400 copies/mL
* No diarrhea or nausea/vomiting for the last month

Exclusion Criteria:

* Pregnancy/lactation
* Presence of inflammatory condition
* Regular use of agents that may affect inflammation in the last 3 months. The regular use of NSAIDS, aspirin, or statins will be allowed as long as dose has been stable for the last 3 months and is not expected to change during the study.
* Presence of active neoplastic diseases requiring chemotherapy and/or use of immunosuppressive drugs
* Known cardiovascular disease
* Uncontrolled diabetes
* Allergy or intolerance to zinc sulfate.
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 2.5 x Upper limit of normal (ULN)
* Hemoglobin \< 9.0 g/dL
* glomerular filtration rate (GFR) \< 50 mL/min

Primary outcomes:
measure: Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP)
timeFrame: Baseline and 16 Weeks
Secondary outcomes:
measure: Percentage of Participants That Reached the Zinc Sufficient Level After Treatment
timeFrame: 16 Weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Grace McComsey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05147168: Quality of Life of Pancreatic Cancer Patients:Psychometric Validation of Chinese Version in Taiwan
Official title: Quality of Life of Pancreatic Cancer Patients:Psychometric Validation of Chinese Version of the EORTC QLQ-PAN26 and EORTC QLQ-C30 in Taiwan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer
Keywords: Quality of life
Psychometric Validation
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2021-12-07
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pancreatic Cancer

Brief summary: This study will investigate the reliability and validity of Chinese version of the quality of life scale in EORTC QLQ-PAN26 and EORTC QLQ-C30 on pancreatic cancer patients in Taiwan

Detailed description: 1. Verify the reliability and validity of Chinese version of the EORTC QLQ-C30 Quality of Life Scale and the chinese version of the EORTC QLQ-PAN26 Quality of Life Scale.
2. Verify the construct validity of the Chinese version of the EORTC QLQ-PAN26 Quality of Life Scale, perform factor analysis, test-retest reliability, and known group validity
3. Verify the criterion related validity of Chinese version of the EORTC QLQ-C30 Quality of Life Scale and the SF-36 Quality of Life Scale

Eligibility criteria: Inclusion Criteria:

1. Paitent who aged over 20, with clear consciousness, is capable of communicating with Chinese.
2. Pancreatic Cancer patients(stage I.II.III.IV)
3. The subject who agrees and is willing to participate in the research after explaining the purpose of the research.

Exclusion Criteria:

1. Patient who is younger than 20 years old, illiterate, or is unable to cooperate with intervention measures.

Primary outcomes:
measure: Quality of Life (EORTC QLQ-C30 )
timeFrame: baseline
measure: Quality of Life (EORTC QLQ-PAN26 )
timeFrame: baseline
measure: Quality of Life (EORTC QLQ-PAN26 )
timeFrame: 2nd or 3rd week after recruited
measure: Quality of Life(SF-36)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Hui-Mei Chen, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03409068: C2-C4 Compartment Block Versus Block of Costagliola, in TEAC
Official title: The Effectiveness of C2-C4 Compartment Block Versus Block of Costagliola, in the Control of Persistent Postoperative Pain in Patients Undergoing Carotid Thromboendarterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Somatic Pain
Neuropathic Pain
Keywords: Carotid thromboendarterectomy
Carotidodynia
Lead sponsor: San Salvatore Hospital of L'Aquila
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: C2-C4 compartment block compared to the Costaiola block, in the control of persistent postoperative pain (somatic and neuropathic) in patients undergoing carotid thromboendarterectomy

Detailed description: A comparative analysis will assess the somatic pain (scores ≥4 on the NRS scale) and neurapathic pain (by the Lindblom roller and Von Frei hair tests) between group A (block group of the C2-C4 compartment ) and the control group B (block group according to Costagliola), during the 3 months after surgery.

Eligibility criteria: Inclusion Criteria:

* patients undergoing to carotid thromboendarterectomy

Exclusion Criteria:

* ASA status: 4
* pregnancy
* BMI \> 39,99
* neurological impairment
* neck anatomical abnormalities
* status of sepsis
* coagulopathy
* neck cancer
* neck infections

Primary outcomes:
measure: somatic pain
timeFrame: 3 mounths after surgery
Secondary outcomes:
measure: Opiates request
timeFrame: 3 mounths after surgery
measure: Pregabalin request
timeFrame: 3 months
measure: Neuropathic pain
timeFrame: 3 months
Other outcomes:
Locations:
city: Avezzano
country: Italy
facility: SS Filippo and Nicola Academic Hospital of Avezzano
state: L'Aquila
Study officials:
affiliation: SS Filippo and Nicola Academic Hospital of Avezzano
name: Emiliano Petrucci, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05994768: 18F-FDG Tomography and Labeled Leukocyte Scintigraphy
Official title: Comparison of the Performance of 18F-FDG PET/CT With That of Labeled Leukocyte Scintigraphy in the Follow-up of Malignant Otitis Externa.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Otitis Externa
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent an 18F-FDG positron emission tomography examination and a labeled leukocyte scintigraphy before and after antibiotic therapy in the case of management of an malignant otitis externa.

Brief summary: The study will aim to show that there is a superiority of 18F-FDG PET/CT compared to labeled leukocyte scintigraphy in patients with a malignant otitis externa.

Detailed description: The management of malignant otitis externa (MEO) is a major issue in patients who are often polypathological and fragile. Appropriate antibiotic therapy must be started quickly after the diagnosis is made and followed for a period of at least 6 weeks. Imaging plays a major role in assessing the extent of the infection and especially healing, after 6 weeks of antibiotic therapy. The persistence of an infection at the end of the treatment, observed in imaging, will allow a change of antibiotic line. This study consists in studying in a population affected by an OEM, the performance of PET/CT with 18F-FDG compared to scintigraphy with labeled leukocytes. The usefulness of the latter in the follow-up of the pathology after antibiotic therapy has already been proven in the literature. The study will aim to show that there is a superiority of 18F-FDG PET/CT compared to labeled leukocyte scintigraphy.

Eligibility criteria: Inclusion Criteria:

* patients with malignant otitis externa who received a 18F-FDG positron emission tomography and a labelled leukocyte scintigraphy

Exclusion Criteria:

* patients who refuse to have their imaging data used

Primary outcomes:
measure: 18F-FDG positron emission tomography
timeFrame: one day
measure: Labeled leukocyte scintigraphy
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre les Nancy cedex
country: France
facility: Verger Antoine
Study officials:
References:
Clinical trial NCT01303068: Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF
Official title: Detection of Pseudomonas. Aeruginosa in the Airways of Patients With Cystic Fibrosis Using of Aerosolized 13C-urea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: CF
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2011-02-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if inhaled urea can be used to detect the presence of Pseudomonas Aeruginosa in the lungs

Detailed description: Dose Escalation study

Eligibility criteria: Inclusion Criteria:

* Patients with CF aged 18 years and above colonized with P. aeruginosa
* Normal subjects ages 18 and above without CF or p. aeruginosa

Exclusion Criteria:

* for patients and volunteers will include the presence of asthma, allergic rhinitis, pregnancy, a history of gastric or duodenal ulcer, smoking, and a baseline FEV1 less than 60% of predicted normal value and a pulmonary exacerbation within the last 2 weeks as defined by use of systemic antibiotic

Primary outcomes:
measure: The Primary Objective is to Assess the Safety of 13C Urea Administered by Inhalation.
timeFrame: 6 hours
Secondary outcomes:
measure: The Secondary Objective is to Assess the Kinetics of 13C Carbon Dioxide Production by Measuring the Isotopic Ratio of 13C to 12C in Exhaled Carbon Dioxide.
timeFrame: 5 minutes post inhalation
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: UNM
name: Hengameh Raissy, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00255268: CMAB vs IMAB in Metastatic Prostate Cancer
Official title: Longitudinal, Randomized, Open and Prospective Clinical Trial to Evaluate the Efficacy of Continuous vs Intermittent Maximum Androgen Blockade (CMAB vs IMAB) With Goserelin-Bicalutamide Combination in the Treatment of Hormonal naïve With Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Metastatic Prostate Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-18
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy, safety and survival of two treatment regimens: Continuous Intermittent Maximum Androgen Blockade, using goserelin and bicalutamide in patients with prostate cancer. Primary endpoint is time to progression. Fifteen patients will be evaluated. QoL evaluation is also included.


Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of D2 of Adenocarcinoma,
* Naivety to treatment
* Valuable bone metastasis

Exclusion Criteria:

* Hematological, liver or renal toxicity Grade IV
* Severe and active infections

Primary outcomes:
measure: Time to progression
Secondary outcomes:
measure: Safety
measure: Quality of Life
Other outcomes:
Locations:
city: Metepec
country: Mexico
facility: Research Site
city: Mexico City
country: Mexico
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Mexico Medical Director, MD
role: STUDY_DIRECTOR
References: