louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03686943: Iatrogenic Drug Risk in People Over 75, With or Without Cognitive Disorders, From an Inventory of Their Family Pharmacy
Official title: Iatrogenic Drug Risk in People Over 75, With or Without Cognitive Disorders, From an Inventory of Their Family Pharmacy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Elderly
Iatrogenic Drug Risk
Keywords: Elderly
Iatrogenic drug risk
Family pharmacy
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 0
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient over 75 years seen with the mobile extra hospital geriatric team

Brief summary: Many hospitalizations or emergency room visits are due to problems of iatrogenic medication, especially in elderly patients who are very often polymedicated. Moreover, they are more at risk because of fragility. This has an important socio-economic impact. It therefore seems important to act upstream of these adverse events and a review of the drugs available in the homes of elderly patients seems a good starting point.


Eligibility criteria: Inclusion Criteria:

* Patient over 75 years with or without cognitive disorders

Exclusion Criteria:

* Refusal to participate

Primary outcomes:
measure: Iatrogenic drug risk in patients' homes
timeFrame: At the inclusion (baseline)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Tours
name: Julie BOURGUEIL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06007443: Pain Related Variables
Official title: Association Between Pain Related Variables in Patients With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Neck Pain
Musculoskeletal Pain
Pain Modulation
Cortical Plasticity
Conditioned Pain Modulation
Temporal Summation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 46
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: SCREENING

Brief summary: Chronic neck pain is a common problem among the general population. Patients with chronic neck pain used health care services twice as much as the population on average, mainly due to intense pain intensity. It is well-known that pain intensity depends on the association of pain processing in several levels of central pain processing.

Identifying the association between conditioned pain modulation, temporal summation, and somatosensory representation, all represent separate central pain processing, will provide an opportunity to develop treatment strategies.


Eligibility criteria: Inclusion Criteria:

* pain in the back of the neck region
* pain longer than 3 months
* pain intensity at least 3 based on the visual analog scale

Exclusion Criteria:

* vertebra fracture
* fibromyalgia
* chronic fatigue syndrome
* surgery to the neck or shoulder
* radicular pain
* neurologic deficit due to disk hernia
* spinal stenosis

Primary outcomes:
measure: pressure pain threshold
timeFrame: 'baseline'
Secondary outcomes:
measure: temporal summation
timeFrame: 'baseline'
measure: conditioned pain modulation
timeFrame: 'baseline'
measure: tactile acuity
timeFrame: 'baseline'
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT02559843: Effects of Pomegranate Juice on Oxidative Stress in Patients With type2 Diabetes
Official title: Effects of Pomegranate Juice Consumption on Glycemic Control, Lipid Profile, Oxidative Stress and Blood Pressure in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Type 2
Keywords: pomegranate
diabetes
oxidative stress
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Diabetes mellitus a chronic diseases, is the most common and important metabolic disease in human. Increased free radicals production due to hyperglycemia produces oxidative stress which worsens the disease and its complications. Pomegranate juice has antioxidant and antiatherosclerotic properties. The present study was planned to evaluate the effects of pomegranate juice consumption on glycemic control, lipid profile,blood pressure and oxidative stress in patients with type 2 diabetes


Eligibility criteria: Inclusion Criteria:

* Age of 40-65 years
* Body Mass Index 18.5-30
* Fasting blood glucose ≥ 126 mg/dl

Exclusion Criteria:

* Smoking
* insulin for blood glucose control
* taking estrogen or progesterone (if female)
* Taking antioxidant supplements
* suffering from any other chronic diseases
* Participants are also excluded if they missed more than 10% of their pomegranate juice packs

Primary outcomes:
measure: total antioxidant capacity
timeFrame: 6 weeks
Secondary outcomes:
measure: fasting blood glucose
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: NNFTRI clinic
Study officials:
References:
Clinical trial NCT01608243: Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts
Official title: Investigation of the Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adults With House Dust Mite-associated Allergic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
House Dust Mite Allergy
Lead sponsor: Stallergenes Greer
Sponsor class: INDUSTRY
First posted: 2012-05-31
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety of different doses of sublingual tablets of house dust mite allergen extracts in adults with house dust mite-associated allergic asthma.


Eligibility criteria: Inclusion Criteria:

* Written informed consent.
* Male or female patient from 18 to 50 years.
* Diagnosed asthma with medical history consistent with HDM-induced allergic asthma.
* Positive SPT to House Dust Mites(HDM)and HDM-specific IgE serum value ≥ 0.7 kU/L.
* Stable asthma treatments.
* Spirometry with best FEV1 \> 70% of the predicted value.
* Spirometry with reversibility of FEV1 of ≥ 12% and ≥ 200 mL.
* Asthma Control Test™ (ACT) score ≥ 20.

Exclusion Criteria:

* Current smoker or former smoker with \> 10 pack/year history.
* Co-sensitisation to any allergen possibly leading to clinically relevant respiratory allergy likely to significantly change the symptoms of the patient throughout the treatment period.
* Patient with a past or current disease, which as judged by the Investigator, may affect the patient's participation in or the outcome of this study.
* Patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study.
* Female patient pregnant or breast-feeding/lactating.
* Female patient of childbearing potential not using a medically accepted contraceptive method.
* Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
* Patient who received allergen immunotherapy for HDM in the last 10 years.
* Ongoing treatment by immunotherapy with another allergen.

Primary outcomes:
measure: Safety, tolerability as indicated by adverse events and safety laboratory evaluation
timeFrame: 10 dosing days
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Arnaud de Villeneuve
Study officials:
affiliation: CHU Arnaud de Villeneuve, Montpellier, France
name: Pascal Demoly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01254838: Novel Peptide Vaccination for Patients With Advanced Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Cell Carcinoma
Lead sponsor: Iwate Medical University
Sponsor class: OTHER
Collaborators: name: Human Genome Center, Institute of Medical Science, University of Tokyo
First posted: 2010-12-07
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to evaluate the safety and CTL reaction of novel peptide vaccination for advanced renal cell carcinoma


Eligibility criteria: Inclusion Criteria:

DISEASE CHARACTERISTICS advanced renal cell carcinoma which already showed resistance to standard treatments

PATIENTS CHARACTERISTICS

1. Patients who showed resistance to hormonal therapy and chemotherapy
2. Histological diagnosis is adenocarcinoma
3. HLA-A\*0201/0206
4. ECOG performance status of 0 to 2
5. Age ≥ 20 years, ≤80 years
6. WBC≥ 2,000/mm³, ≤12000/mm³ hemoglobin≥ 8.0g/dl Platelet count ≥ 70000/mm³ AST, ALT ≤100 IU/l Total bilirubin ≤ 1.5 mg/dl Creatinine ≤ 1.0 mg/dl PaO2≥ 70mmHg
7. life expectancy ≥ 3months
8. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
2. Breastfeeding
3. Patients willing to childbearing ( Refusal or inability to use effective means of contraception)
4. Serious infections requiring antibiotics
5. Concomitant treatment with steroids or immunosuppressing agent
6. Other malignancy difficult to control.
7. Decision of unsuitableness by principal investigator or physician-in-charge

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 2 years
Secondary outcomes:
measure: CTL reaction
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Department of Urology, Iwate Medical University
name: Tomoaki Fujioka
role: STUDY_CHAIR
References:
Clinical trial NCT03704038: Electrical Impedance Tomography Guided Assessment of Optimum PEEP Levels During Mechanical Ventilation in Lateral Decubitus Position
Official title: Electrical Impedance Tomography Guided Assessment of Optimum PEEP Levels During Mechanical Ventilation in Lateral Decubitus Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation
Bioelectrical Impedance
Keywords: PEEP
Electrical impedance tomography
Mechanical ventialtion
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Goal of this study is to determine optimal PEEP levels for patients undergoing surgery in lateral decubitus position. Patients will be randomized into 3 groups - PEEP 0, 5 and 10 mbar. Endotracheal anesthesia will be conducted with propofol, fentanyl, rocuronium and sevoflurane/O2/air gas mixture.

Patients with preexisting lung disease, organ transplants and disseminated malignant disease will be excluded.

Demographic data - age, weight, height, ASA status, smoking history will be recorded. EIT measured parameters - tidal variation ratio of nondependent and dependent lung, regional end-tidal and end-expiratory lung impedances as well as horizontal and vertical centers of ventilation will be recorded and calculated at 3 time points - before anesthesia induction, 5 minutes after lateral positioning of the patient and 90 minutes after lateral positioning. ABGs will be sampled to calculate aA gradient and Horovitz quotient at those time points as well as measured hemodynamic parameters (HR, BP, CI, SVI).

Primary endpoints for the study are nondependent/dependent tidal variation ratios measured at predefined time points and changes in ABGs. Secondary endpoints are number of postoperative pulmonary complications (defined as new onset of pneumonia during 28 days of followup), length of hospital stay and changes in hemodynamic parameters.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for nephrectomy, adrenalectomy or urterotomy surgery which will be performed in lateral decubitus position
* signed informed consent form

Exclusion Criteria:

* preexisting moderate to severe obstructive (GOLD score \> 1) or restrictive lung disease (FVC \< 85%)
* history of organ transplant
* disseminated malignant disease
* pregnancy

Primary outcomes:
measure: Change of nondependent / dependent tidal variation
timeFrame: Baseline, 10 and 90 minutes post lateral positioning
Secondary outcomes:
measure: Change of a-A gradient
timeFrame: Baseline, 10 and 90 minutes post lateral positioning
measure: Duration of hospital stay
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
state: Grad Zagreb
Study officials:
affiliation: Anesthesiologist and Critical Care specialist
name: Andrej Šribar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04879238: Tailoring a Mindful Intervention to Enhance Opioid Treatment
Official title: Tailoring a Mindful Intervention to Enhance Opioid Treatment Outcomes in a Community Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Keywords: Medication Assisted Treatment
Lead sponsor: University of Connecticut
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Yoga and Mindfulness intervention
Primary purpose: TREATMENT

Brief summary: The main aim of this study is to better understand whether yoga can be blended with mindfulness as an additional intervention for people receiving medication assisted treatment at a Hartford-based community agency. If this program is acceptable to participants, then additional studies can allow us to determine its impact on stress and cravings. This intervention, developed by the researchers, is called BEING.

Detailed description: This study is a micro-trial of our mindful yoga intervention, BEING, tailored to the MAT clients. This study adapts an existing manualized program of yoga and mindfulness intervention (BEING) for MAT participants. Particularly important is addressing potential challenges and concerns regarding acceptability and feasibility of implementation in vulnerable males with substance dependence. We are enlisting the support of a mindful yoga expert with experience in related populations (i.e., previously incarcerated male veterans with mental health issues) in the adaptation process. This study is designed primarily to test the feasibility of the implementation of the intervention. We cannot draw statistically valid conclusions about the impact the intervention on outcomes, given the overall study design. We plan to collect participant feedback on whether or not the intervention is acceptable. We also want to evaluate the availability, accessibility, acceptability and feasibility of collecting certain measures that would be collected in a subsequent adequately powered treatment study.

Eligibility criteria: Inclusion Criteria:

* Receiving Medication Assisted Treatment 18 years or older Released from incarceration within the past year Currently receiving services from the partnering community agency English speaking

Exclusion Criteria:

* Under 18 years old Non-English Speaking Current incarcerated Not receiving Medication Assisted Treatment Not receiving services from the partnering community agency

Primary outcomes:
measure: Acceptability
timeFrame: 3 months following pre-test
measure: Adherence (self report)
timeFrame: 3 months following pre-test
measure: Adherence (record review)
timeFrame: 3 months following intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Community Renewal Team
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Michael Fendrich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06007638: A Single and Multiple Ascending Dose Study of LY3876602 in Healthy Participants
Official title: A Randomised Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3876602 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-08-23
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to evaluate the safety, tolerability and PK of LY3876602 after administering it as single ascending doses and, following a data review, proceeding to multiple ascending doses in healthy participants. Blood tests will also be performed to check how much LY3876602 gets into the bloodstream and cerebrospinal fluid (CSF) and how long it takes the body to eliminate it.

Following the screening visit for Part A, the study will last up to approximately 20 weeks., and a subgroup of participants will consent to CSF collections The study will last up to approximately 28 weeks for Part B. All participants will consent to CSF collections.


Eligibility criteria: Inclusion Criteria:

* Male and female participants who are overtly healthy as determined by medical evaluation
* Have a body mass index with the range of 18 and less than or equal to (≤) 32 kilograms per square meter (kg/m²)
* Male or female participants of nonchildbearing potential

Exclusion Criteria:

* Have a family history, defined as a parent or first-degree relative, of genetic neurodegenerative disorders
* Have allergies to diphenhydramine, epinephrine, or methylprednisolone
* Have serious or unstable medical conditions,
* History of skin wounding within 14 days of screening or current skin infection
* Are unwilling to stop alcohol consumption 48 hours prior to each dosing
* Have active or latent tuberculosis
* Participants in the cohorts undergoing lumbar puncture have an allergy to local anesthetics

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline up to 28 weeks
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3876602
timeFrame: Predose up to 28 weeks
measure: PK: Maximum Observed Drug Concentration (Cmax) of LY3876602
timeFrame: Predose up to 28 weeks
measure: PK: Half-life (t1/2) of LY3876602
timeFrame: Predose up to 28 weeks
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: ICON Early Phase Services, LLC
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06179238: Urinary Catheter Self-care Management
Official title: Education Given to Patients With Urinary Catheters on Urinary Catheter Self-care Management and Urinary Tract Infection Impact on Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Diseases
Lead sponsor: Kastamonu University
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: It is important for healthcare professionals to be sensitive to the needs of patients undergoing urinary catheterization. Patients and their relatives should be educated, guided and supported by nurses and other healthcare professionals. The aim of this study was to determine the effect of education given to patients with urinary catheterization on urinary catheter self-care management and urinary tract infection status. is planned as an experimental research.

Detailed description: The most important risk factor in the development of healthcare-associated infections of the urinary system is the insertion of a urinary catheter. Because when a urinary catheter is inserted, the possibility of developing daily bacteriuria inthe patient increases. Urinary catheter application can cause the development of fungal infections as well as bacterial infections in the patient. Although most of these infections are asymptomatic and do not pose a threat, symptomatic serious infections rarely occur. may occur. There is a risk of catheter-associated urinary tract infection in both long and short-term catheterization. This risk increases as the duration of catheterization increases. According to the Nursing Regulation published in 2011 in our country, the initiatives in this direction are expected to be continued by nurses. Therefore, in this study, the knowledge and practices of patients with urinary catheter will be examined and the effect of the education given on urinary catheter self-care management and urinary tract infection status will be evaluated. It is thought that the results of the study will guide patients with urinary catheters and nurses who provide care about the care and education of patients.

Eligibility criteria: Inclusion Criteria:

* Volunteer to participate in the study
* Urinary catheterization
* Being conscious
* To be able to do self-care

Exclusion Criteria:

* Not volunteering to participate in the study
* Lack of awareness
* Inability to take care of themselves

Primary outcomes:
measure: The Urinary Catheter Self-Care Management Scale
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kastamonu
country: Turkey
facility: Kastamonu Training and Research Hospital
Study officials:
References: