louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05151796: Continuation of Aspirin Before Isolated Heart Valve Surgery
Official title: Effect of Continuation of Aspirin Before Isolated Heart Valve Surgery on Postoperative Bleeding and Transfusion: a Single-center Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Isolated Heart Valve Surgery
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing isolated heart valve surgery at the University Hospital of Liege (Belgium)

Brief summary: Whether or not continuing aspirin up to de day before surgery increases the risk of bleeding and/or prevents thrombo-embolic complications remains debated. The investigators retrospectively investigated the whether continuing aspirine within 5 days of isolated heart valve surgery increased the risk of bleeding.


Eligibility criteria: Inclusion Criteria:

* Isolated heart valve surgery

Exclusion Criteria:

* Antiplatelet agent other than aspirin or anticoagulant not discontinued preoperatively
* Emergent or salvage surgery
* Surgery for endocarditis
* Use of NSAIDs within 48 hours before surgery

Primary outcomes:
measure: The number of units of packed red blood cells transfused anytime during the hospital stay
timeFrame: 30 days
Secondary outcomes:
measure: Chest tube drainage
timeFrame: 24 hours
measure: Surgical revision for bleeding
timeFrame: 24 hours
measure: Any thrombo-embolic complication
timeFrame: 30 days
measure: Transfusion of any type of blood product
timeFrame: 30 days
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU of Liege
state: Liege
Study officials:
affiliation: CHU of Liège
name: Vincent Bonhomme, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04766996: PROUD Study - Preventing Opioid Use Disorders
Official title: PROUD Study - Preventing Opioid Use Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anesthesia
Opioid Use
Keywords: Hip replacement
Opioid free
Perioperative period
Team work
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Matched Prospective Case with Retrospective Control Study and Staff Survey
Primary purpose: TREATMENT

Brief summary: The objective of this study is to pilot an opioid free anesthetic protocol for patients undergoing total hip replacement.

Detailed description: The objective of this study is to pilot an opioid free anesthetic protocol for patients undergoing total hip replacement. The study team identified alternative pharmacologic methods to block pain pathways to reduce or even eliminate the need for opioids in the intra- and postoperative periods, with the goal of decreasing or eliminating exposure to opioids. A secondary objective is to assess two core competencies for interprofessional collaborative practice (Interprofessional Communication and Teams; and Teamwork) within the interprofessional care team implementing the opioid free protocol.

Eligibility criteria: Inclusion Criteria Intervention group:

* Prospective study participants undergoing unilateral total hip replacement surgery between the months of February through May, 2021

Inclusion Criteria Control:

* Retrospective controls selected from the Emory Healthcare System Clinical Data Warehouse that underwent unilateral total hip replacement surgery between the months of February through May, 2020

Inclusion Criteria Professional Staff:

* All staff that participate in the implementation of the opioid free surgical protocol.

Exclusion Criteria:

* Participants that do not speak English will not be eligible for participation in the study.
* Individuals less than 18 years of age will not be included for participation in the study.
* Individuals with cognitive impairment or the inability to provide informed consent will not be included in the study.

Primary outcomes:
measure: Total Post-operative Opioid Requirements With Non-opioid Drug Regimen
timeFrame: Up to 5 weeks
Secondary outcomes:
measure: Nebraska Interprofessional Education Attitude Scale (NIPEAS) Score for Professional Staff Arm
timeFrame: Prior to protocol implementation (baseline), halfway through the recruitment period (2 months) and after the last participant has been discharged from the hospital (4 months)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Orthopaedic and Spine Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Wiltse Nicely, PhD, CRNA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01034696: Pain Prevalence and Risk Factors Among Sarcoma/Melanoma Oncology Patients in an Outpatients Setting
Official title: Pain Prevalence and Risk Factors Amongst Sarcoma/Melanoma Oncology Outpatients. A Baseline, Cross Sectional Study Towards a Pain Free Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma
Melanoma
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2009-12-17
Enrollment: 250
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: Participants attending sarcoma and melanoma out patients clinics at the Royal Marsden Hospital.

Brief summary: The primary objective of this research project is to estimate the number of patients with sarcoma or melanoma attending an outpatients clinic that are in pain or have unmet pain needs.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of sarcoma or melanoma cancer
* Able to respond to an assessment in written English.
* Able to provide informed consent to participate in the study.

Exclusion Criteria:

* Patients whose health would be compromised by participation in the study

Primary outcomes:
measure: The proportion of patients with significant pain and the proportion of patients with a negative score on the pain management index (PMI)
Secondary outcomes:
measure: Proportion of patients with neuropathic pain.
measure: Potential predictors of pain. The variables tested as potential risk factors will be age, tumour type, gender and treatment type.
measure: We will also seek to identify potential predictors of pain intensity in patients that do have pain. In addition to the risk factors already mentioned above, duration and cause of pain will also be tested in this case as potential pain predictors.
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Dr John Williams
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02592096: Pazufloxacin Mesilate Ear Drops Clinical Trial Protocol
Official title: A Single Dose Phase I Clinical Study of Pazufloxacin Mesilate Ear Drops for the Patients With Otitis Media
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Otitis Media
Keywords: safety and bioavailability
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
First posted: 2015-10-30
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the safety, tolerance, dynamic percolation model of single dose usage pazufloxacin mesilate ear drops for patients with acute suppurative otitis media or chronic suppurative otitis media


Eligibility criteria: Inclusion Criteria:

1. Aged 18-65 years old, both gender;
2. Patients with acute or chronic suppurative otitis media, need to be treated partially by antimicrobial agents;
3. Written informed consent form.

Exclusion Criteria:

1. Allergic to quinolones antibiotics or severe allergic constitution;
2. Not able to collect otorrhea during the trial;
3. High severity with the need of combined antibiotics treatment;
4. Induced by pathogens, e.g.: fungus, virus (myringitis bullosa);
5. Combined otitis externa (e.g.: ear cellulitis, mumps), intracranial or extracranial complication (meningitis, cerebral abscess, thrombophlebitis of sigmoid sinus, Bezold's abscess, ear subperiosteal abscess);
6. Severe disease of cerebral, cardiopulmonary, renal hepatic, circulatory system;
7. Life-threatening disease, e.g.: malignant tumor or AIDS.
8. Renal hepatic dysfunction (ALT, AST ≥ 1.5 times of normal maximum level, Cr \> normal maximum level);
9. Confirmed or suspected of alcohol/drug abuse record;
10. Neurological or psychiatric disease leading to inability of cooperation or not willing to follow the protocol or instruction;
11. Feminine patients who are in gestational, lactation period or having a birth plan in short-term;
12. Enrolled into other clinical trial in the past 3 months;
13. Not suitable for this trial according to investigator's judgment;

Primary outcomes:
measure: safety and tolerance of pazufloxacin mesilate ear drops
timeFrame: 24 hours
Secondary outcomes:
measure: PK of pazufloxacin mesilate ear drops
timeFrame: 24 hours
measure: PK of pazufloxacin mesilate ear drops
timeFrame: 24 hours
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
Study officials:
affiliation: Qingdao Municipal Hospital
name: Weiguo Cue, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04168996: Individualized Discharge Planning in Patients With Rib Fracture
Official title: Effectiveness of an Individualized Discharge Planning on, Functionality and Quality of Life in Different Severity Rib Fracture Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rib Fractures
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with rib fractures may develop pneumonia and even respiratory failure requiring critical care, ventilator management, and hospitalization. Discharge planning is a broad range of time-limited services designed to ensure healthcare continuity, avoid preventable poor outcomes among at-risk populations, and promote the safe and timely transfer of patients care.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria were to be patients hospitalized due to fractures ribs due to falls, traffic accidents, and aggression.

Exclusion Criteria:

* Exclusion criteria were an inability to provide informed consent, the presence of psychiatric or cognitive disorders, progressive neurological disorders, or inability to cooperate. Patients who had experienced hospitalization in the Intense Care Unit were also excluded.

Primary outcomes:
measure: Lung Injury Score (LIS).
timeFrame: Change during the hospitalization, after a week, and after 6 months follow up
measure: EuroQol-5D (EQ-5D)
timeFrame: Change during the hospitalization, after a week, and after 6 months follow up
measure: Barthel Index
timeFrame: Change during the hospitalization, after a week, and after 6 months follow up
Secondary outcomes:
measure: Blaylock Risk Assessment Screening Score (BRASS)
timeFrame: Change during the hospitalization, after a week, and after 6 months follow up
measure: Early Screen for Discharge Planning (ESDP)
timeFrame: Change during the hospitalization, after a week, and after 6 months follow up
measure: Newcastle Satisfaction with Nursing Scales (NSNS)
timeFrame: Change during the hospitalization, after a week, and after 6 months follow up
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Faculty of Health Sciences. University of Granada.
state: Andalucia
Study officials:
References:
citation: Granados Santiago M, Valenza MC, Prados Roman E, Lopez Lopez L, Munoz Vigueras N, Cabrera Martos I, Cebria I Iranzo MA. Impacts of tailored, rehabilitation nursing care on functional ability and quality of life in hospitalized elderly patients after rib fractures. Clin Rehabil. 2021 Nov;35(11):1544-1554. doi: 10.1177/02692155211022734. Epub 2021 Jun 6.
Clinical trial NCT05795296: Efficacy and Safety of Fruquintinib With Sintilimab as First-line Therapy in Gastric Cancer
Official title: Clinical Study of Fruquintinib in Combination With Sintilimab as a First-line Therapy in Gastric Adenocarcinoma/Adenocarcinoma of Esophagogastric Junction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Stomach Neoplasms
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to explore the efficacy and safety in patients with gastric adenocarcinoma or adenocarcinoma of esophagogastric junction. The main questions it aims to answer are:

* Does this therapy have a promising efficacy?
* Does this therapy have a manageable toxicity? Participants will receive fruquintinib plus sintilimab as first-line therapy for gastric cancer.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological confirmed advanced, recurrent, of metastatic gastric adenocarcinoma or adenocarcinoma of esophagogastric junction;
* ECOG PS: 0-2;
* Adequate hepatic, renal, heart, and hematologic functions;
* At least one measurable lesion (according to RECIST1.1);
* Haven't received any systematic treatment for the cancer involved;
* Expected survival \> 12 weeks;
* Contraception until 6 months after the study termination;
* Signed informed consent.

Exclusion Criteria:

* Her-2-positive gastric cancer, or exposed to any immune checkpoint inhibitor;
* Participated in another study;
* Immunodeficiency;
* Received allograft；
* Unmanageable hypertension, diabetes, or coronary disease;
* Have difficulty in taking medicine, or active bleeding;
* Pulmonary tuberculosis, or interstitial lung disease that needs steroid therapy;
* Infection of HIV, HBV, HCV, or other unmanageable infection;
* Other malignant tumor history;
* Allergic to the test drug;
* Other diseases which will affect the results of this study;
* Received resection of stomach;
* Taking anti-tumor traditional Chinese Medicine;
* Severe active bleeding.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 12 months
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 12 months
measure: Disease Control Rate (DCR)
timeFrame: 12 months
measure: Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
affiliation: RenJi Hospital
name: Shuiping Tu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01672996: Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Abdominal CECT in Healthy Volunteers
Official title: A Phase 1/2, Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Contrast-Enhanced Abdominal Computed Tomography in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: Use in Abdominal
Contrast Enhanced
Computed Tomography
Optimize concentration
dosage of Ioforminol Injection
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Physician Reference Laboratory
name: Quintiles, Inc.
First posted: 2012-08-27
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To optimize both the Ioforminol concentration and dosage(s) for CECT of the abdomen. To evaluate the safety and tolerability of low concentration Ioforminol Injections. Study recruits healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females between 18 and 50 years of age.
* The subject has a maximum abdominal circumference of 120 cm or less.

Exclusion Criteria:

* The subject has known Grade 3 or 4 allergic reaction/hypersensitivity to either iodine or any iodinated-based contrast agent or with history of multiple allergies (i.e., foods, pets, medications, etc).
* The subject has chronic renal insufficiency (estimated glomerular filtration rate \[eGFR\] \<60 mg/dL) as measured at the screening visit.
* The subject is pregnant or breast-feeding.
* The subject has suspicion or diagnosis of hyperthyroidism or autonomously functioning thyroid nodule confirmed by T3, T4, and/or thyroid-stimulating hormone.
* The subject has severe liver or hematologic diseases (sickle cell disease or multiple myeloma), or immunodeficiency.
* The subject is taking metformin (e.g., Glucophage®) therapy.

Primary outcomes:
measure: Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).
timeFrame: Within 5 minutes after administration for either Ioforminol or Iopamidol.
measure: Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).
timeFrame: Within 5 minutes after administration for either Ioforminol or Iopamidol.
Secondary outcomes:
measure: Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE).
timeFrame: Up to 72 hours for safety monitoring post Ioforminol and Iopamidol administration.
Other outcomes:
Locations:
city: Princeton
country: United States
facility: GE Healthcare
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: Rubin Sheng, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00185016: Women Abuse and the Role of the Family Doctor.
Official title: Women Abuse and the Role of the Family Doctor. Testing an Intervention in a Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Improved Recognition of Partner Abuse
Gender Differences in Discussing Partner Abuse
Abused Women's Expectations,Experiences
Abused Women's Health Care Utilisation
Keywords: intimate partner abuse
gender
education
attitude
family doctor
health care utilisation
abused women
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Theia Foundation, Zilveren Kruis Achmea
First posted: 2005-09-16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: The study tested a training to improve recognition of abused female patients in family practice.Effect measures of the training were: number of reported cases wherein the doctor suspected and discussed partner abuse and the number of non-obviuos reasons to suspect partner abuse.We assumed that following a training would improve the recognition of abused women.

Secondary to this trial we explored gender differences of family doctors in discussing partner abuse and we interviewed women recently identified by their family doctor. Medical histories of recently identified abused women were studied to assess health problems and health-care utilisation.


Eligibility criteria: Inclusion Criteria:women consulting in family practice, age 18 years and older -

Exclusion Criteria:we excluded only for the interviews: women who were assessed by their family doctor to be in danger because of the abusive situation, women with a psychiatric condition.

-

Primary outcomes:
measure: number of reported cases wherein a doctor suspected and discussed partner abuse.
Secondary outcomes:
measure: number of cases with non-obvious symptoms wherein a doctor suspected partner abuse.
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre
Study officials:
affiliation: Radboud University Medical Centre Nijmegen
name: Toine LM Lagro-Janssen, PhD/MD/FP
role: STUDY_CHAIR
affiliation: Radboud University Medical Centre, Nijmegen
name: Sylvie H Lo Fo Wong, MD/FP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05808816: "Lactobacillus Crispatus M247, LSIL and Microbiota"
Official title: Interventional Study on Efficacy of Lactobacillus Crispatus M247 in Patients Affected by HPV Low-grade Preneoplastic Cervical Lesions and Evaluation of Vaginal Microbiota Changes Before and After Oral Supplementation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vaginal Flora Imbalance
ASC-US
LSIL
HPV Infection
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients affected by ASC-US/ low-grade HPV cervical lesions will be randomly assigned to treatment arm vs control arm. The treatment arm will include the characterization of the vaginal microbiota at enrollment (T0), 4 months of oral treatment with Lactobacillus Crispatus M 247 (1 buccal stick Die), characterization of the vaginal microbiota at 1 month post treatment (T5 m). The vaginal microbiota will be evaluated by Danagene microbiome vaginal DNA KIT-XMICROGem (XBIOGem) test, with amplification of the variable regions of the 16S ribosomal RNA gene, using the MICROBIOTA kit (CE-IVD - ARROW diagnostics) and second generation sequencing technologies (NGS on Illumina MiSeq platform). The control arm will provide for the characterization of the vaginal microbiota at the same timescales. Patients will be given a medical history questionnaire at T0 and T5m


Eligibility criteria: Inclusion Criteria:

* Pap smear ASCUS or L-SIL
* HPV test + (HPV-HR e/o HPV-LR)

Exclusion Criteria:

* Hormonal therapy (OC, ring, patch, implant)
* Pregnancy status
* Immunosuppressive therapies
* Ongoing HPV vaccination

Primary outcomes:
measure: To evaluate the efficacy of Lactobacillus Crispatus M247 oral supplementation to change the genetic profile of the vaginal microbiota of patients with low-grade lesions from HPV, by XBIOGem test.
timeFrame: 5 months
Secondary outcomes:
measure: Cytological regression and microbiological clearance of HPV infection
timeFrame: 5 months
measure: Evaluate the applicability in clinical practice of the XBIOGem test in the characterization of the vaginal microbiota in this type of patient
timeFrame: 24 months
measure: Evaluation of the role of anamnestic factors on the characterization of vaginal microbiota
timeFrame: 24 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: RM
Study officials:
References: