louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05831254: The Effect of Health Literacy Education in Adults (HELP-e-Pulse)
Official title: Comparison of the Effects of European Health Literacy Based Education and E-Pulse Education on the Level of Health Literacy in Adults Aged 45-64: a Randomized Controlled Study with Active Control Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Literacy
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 140
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The world's elderly population is increasing. It is possible to prepare for the old age period by starting to develop the level of Health Literacy (HL) in the 45-64 age group. In this context, this study is planned to be conducted as a randomized controlled study with an active control group in order to compare the effect of European Health Literacy-based education and e-Pulse education (HELP) on the level of health literacy in adults aged 45-64 with insufficient-limited health literacy. The study was planned to include a total of 140 participants from the intervention group (HELP) (n:70) and the active control group (e-Pulse) (n:70). Interactive group training consisting of six modules and 90 minutes each will be given to the HELP group. Individual e-Pulse instruction will be given to the active control group. European Health Literacy Scale scores will be considered as the primary outcome of the research. Scores from the eHealth Literacy Scale will be considered as the secondary outcome of the research.


Eligibility criteria: Inclusion Criteria:

* Being aged 45-64 and above and being literate,
* Having a score of 33 or less on the European Health Literacy Scale (insufficient, limited and problematic health literacy)
* Being able to use a smart phone, tablet or computer,
* Having agreed to voluntarily participate in the study.

Exclusion Criteria:

• Those who do not speak Turkish

Primary outcomes:
measure: European Health Literacy Scale
timeFrame: Baseline-Second month
Secondary outcomes:
measure: eHealth Literacy Scale
timeFrame: Baseline-Second month
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Soğuksu Yaşlı Evi
Study officials:
References:
Clinical trial NCT05046054: The Effect of Transcutaneous Electrical Nerve Stimulation on Pain During Propofol Injection
Official title: The Effect of Transcutaneous Electrical Nerve Stimulation on Pain During Propofol Injection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transcutaneous Electrical Nerve Stimulation
Pain
Propofol Adverse Reaction
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: TENS YW-5000 (YoungWon Medical Co, Korea)
Primary purpose: PREVENTION

Brief summary: Propofol, an intravenous sedative agent, frequently produces pain during injection. This study was designed to investigate whether transcutaneous electrical nerve stimulation could reduce pain during propofol injection.

in minimizing propofol injection pain.

Detailed description: Twenty min after transcutaneous electrical nerve stimulation, the electrodes were removed and propofol 0.5 mg/kg was administered at the rate of 0.5 ml/sec using syringe pump. Propofol injection pain was evaluated by a study blinded anesthesiologist using a four point scale: 0=no (negative response to questioning), 1=mild pain (pain reported only in response to questioning without any behavioral sings), 2=moderate pain (pain reported in response to questioning and accompanied by a behavioral signs or pain reported spontaneously without questioning, 3=severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal or tears).

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* American Society of Anesthesiologists physical status classification \> 3
* Patient with a history of allergy to drugs
* Patient who takes opioid, sedative, anticonvulsant
* Patient with a history of neurologic disease and psychological disorders
* patient with skin problem
* Patient with pacemaker or electric medical device
* pregnancy

Primary outcomes:
measure: pain during propofol injection
timeFrame: 15 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National university hospital
Study officials:
affiliation: Kyungpook National University Hospital
name: Younghoon Jeon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03898154: Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures
Official title: The Effect on Wrist Range of Motion With Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Distal Radius Fracture
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 200
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 purpose of this investigation is to compare functional outcome measures and range of motion for patients receiving glucocorticoid (GC) injections versus those not receiving GCs for the treatment of distal radius fractures. The investigators hypothesize that patients who receive GC will have improved ROM and functional outcome measures compared to patients who do not receive GC. In addition, this study aims to determine if there is a difference in rates of complications and postoperative pain control between the GC and non-GC groups. In order to accomplish these aims, the investigators will conduct a prospective, randomized, controlled investigation.


Eligibility criteria: Inclusion Criteria:

* Patient 18 years of age and older.
* Patients undergoing ORIF with VP fixation of an acute, isolated DRF with or without associated distal ulna fracture and with or without associated carpal tunnel release

Exclusion Criteria:

* Worker's compensation patient
* Non-operatively treated fractures
* Open fractures
* Preoperative neurovascular injury
* Coexisting fractures or injuries
* Diabetes mellitus
* Allergy or contraindication to GCs
* Associated non-orthopedic injury that would prohibit the administration of GCs
* Patients currently incarcerated
* Pregnant patients

Primary outcomes:
measure: QuickDASH
timeFrame: 0-12 months
measure: Visual Analog Scale Pain Score
timeFrame: 0-12 months
measure: PROMIS Pain Interference
timeFrame: 0-12 months
measure: PROMIS Self-Efficacy Manage Symptoms
timeFrame: 0-12 months
measure: PROMIS Upper Extremity
timeFrame: 0-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Woodbine
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Liam Dwyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02422654: Taste Evaluation of Different Liquid Formulations With Eliglustat
Official title: A Single-blind, Randomized, Unbalanced Crossover Design With 5 Vehicles, 5 Periods, and 5 Sequences, Repeated-doses (With no Ingestion) Study to Assess the Palatability of Eliglustat Prototype Liquid Formulations in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gaucher Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2015-04-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary Objective:

The purpose of this study is to assess the palatability of eliglustat prototype liquid formulations in healthy subjects.

Detailed description: The total duration of the study for each subject will be approximately 5 weeks (screening period from Day -28 to Day -2, treatment period of 3 days, and follow-up call on Day 5).

Eligibility criteria: Inclusion criteria :

* Healthy male and female subjects, 18 to 55 years of age, inclusive.
* Normal smell and taste ability to discriminate odor and flavor differences.

Exclusion criteria:

* Poor metabolizer phenotype status for CYP2D6 (predicted based on genotype).
* Subject who has smoked within 3 months of inclusion.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability
timeFrame: Each day for 3 days immediately post expectorating the sample
measure: Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability
timeFrame: Each day for 3 days 5 minutes post expectorating the sample
measure: Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability
timeFrame: Each day for 3 days 15 minutes post expectorating the sample
measure: Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability
timeFrame: Each day for 3 days 30 minutes post expectorating the sample
Secondary outcomes:
measure: Subject's taste preference questionnaire from most preferred to least preferred of the 5 different liquid formulations
timeFrame: up to 3 days
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Investigational Site Number 840001
state: Indiana
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT01131754: Heparin 100U/L for Prevention of PVC Complications
Official title: STUDIO CLINICO RANDOMIZZATO SULL'UTILIZZO DI EPARINA PER LA PROFILASSI DELLA TROMBOFLEBITE DA CATETERE VENOSO PERIFERICO
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Venous Catheter Complications
Occlusion
Phlebitis
Ecchymosis
Keywords: Peripheral venous catheter complications
PVC occlusion
PVC phlebitis
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2010-05-27
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Flushes with saline solution are used for maintaining patency of peripheral intermittent intravenous catheters in many institution based on the results of previous studies showing that 10 U heparin/mL is not better than saline in this respect. The latest meta-analysis investigated also safety and efficacy of heparin concentrations of 100 U/ml used as an intermittent flush, but no firm conclusion was reached because of limitations of the few available studies.


Eligibility criteria: Inclusion Criteria:

* requiring i.v. therapy for an expected duration longer than five days
* admitted to the 3rd medical ward of IRCCS Policlinico San Matteo

Exclusion Criteria:

* bleeding tendency
* platelet count less than 100 x 109/L
* coagulation defects
* previous adverse reaction to heparin
* programmed cytotoxic therapy
* inability to give an informed consent

Primary outcomes:
measure: Phlebitis or Occlusion
Secondary outcomes:
measure: Ecchymosis
measure: Heparin induced thrombocytopenia
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Medicina 3 - IRCCS Policlinico San Matteo
Study officials:
References:
Clinical trial NCT01233154: Effect of a L. Paracasei Strain on Grass Pollen Allergic Rhinitis Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2010-11-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Various studies in animal and humans have shown a potential beneficial effect of probiotics consumption on allergy. However few studies exist that document their efficacy for upper airways allergies such as allergic rhinitis. The objective of this study is to investigate the effect of short-term oral administration of a L. paracasei or of a blend of 2 probiotics (L. acidophilus + B. lactis) on a nasal provocation test (NPT) with grass pollen, performed out of the pollen season. Adult volunteers with allergic rhinitis are enrolled in a randomized, double-blind study, based on two 4-weeks cross-over periods of product consumption separated by a washout period of 6-8 weeks. Objective and subjective clinical parameters of NPT as well as systemic and nasal immunological markers are compared before and after each treatment.


Eligibility criteria: Inclusion Criteria:

* age 18-40 years old
* history of allergic rhinitis during the latest grass pollen season confirmed by a positive skin prick test to grass pollen (wheal diameter \> 3mm) and a positive response to a NPT with grass pollen (combined nasal reaction threshold \<= 10000 standardized quality units/ml at the screening phase

Exclusion Criteria:

* any medical condition that could influence the study (pregnancy, viral or bacterial airway infection, active allergic rhinitis)
* uncontrolled asthma (peak expiratory flow \<20% of volunteer's best personal value)
* treatment with antihistamine or antibiotic treatment less than two weeks before enrolment or during the trial

Primary outcomes:
measure: Nasal reaction threshold when provocation test with allergens
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
Study officials:
References:
citation: Perrin Y, Nutten S, Audran R, Berger B, Bibiloni R, Wassenberg J, Barbier N, Aubert V, Moulin J, Singh A, Magliola C, Mercenier A, Spertini F. Comparison of two oral probiotic preparations in a randomized crossover trial highlights a potentially beneficial effect of Lactobacillus paracasei NCC2461 in patients with allergic rhinitis. Clin Transl Allergy. 2014 Jan 6;4(1):1. doi: 10.1186/2045-7022-4-1.
Clinical trial NCT02145754: Culture Media for Borrelia Burgdorferi Sensu Lato
Official title: Comparison of Two Culture Media for Cultivation of Borrelia Burgdorferi Sensu Lato
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erythema Migrans
Keywords: erythema migrans
Lyme borreliosis
Borrelia burgdorferi
skin culture
culture media
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: University of Ljubljana School of Medicine, Slovenia
First posted: 2014-05-23
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose of this study is to compare effectiveness of two different culture media for cultivation of Borrelia burgdorferi sensu lato from skin specimens obtained from patients with erythema migrans.


Eligibility criteria: Inclusion Criteria:

* erythema migrans in patients \> 18 years

Exclusion Criteria:

* pregnancy or lactation
* taking antibiotic with antiborrelial activity within 10 days
* erythema migrans localized on face or neck

Each patient (235 subjects) provided two skin samples (470 skin samples).

Primary outcomes:
measure: Detection of Borrelia Burgdorferi Sensu Lato by Microscopy in Dark Field (Positive vs. Negative)
timeFrame: weekly examination during 9 weeks of cultivating for individual specimen
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana, Department of Infectious Diseases
Study officials:
affiliation: UMC Ljubljana
name: Franc Strle, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Ljubljana School of Medicine, Slovenia
name: Eva Ruzic-Sabljic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02290054: Auriculotherapy for Prevention of Postoperative Urinary Retention
Official title: Auriculotherapy for Prevention of Postoperative Urinary Retention in Men Receiving Postoperative Epidural Analgesia After Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia, Epidural
Keywords: analgesia, epidural
urinary retention
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2014-11-13
Enrollment: 53
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Urinary retention is a common complication of epidural analgesia. Auriculotherapy could prevent this complication. This study will be performed among men receiving thoracic epidural analgesia after thoracic surgery.


Eligibility criteria: Inclusion Criteria:

* patients scheduled to a lung surgical procedure and thoracic epidural analgesia

Exclusion Criteria:

* Abnormalities of the external ear
* Dialysis or end stage renal failure
* Abnormal urinary tract
* Incapacity to self assessment of comfort and anxiety,
* Contra-indication to total intravenous anesthesia

Primary outcomes:
measure: bladder catheterization
timeFrame: 24 hours
Secondary outcomes:
measure: Comfort
timeFrame: 24 hours
measure: Anxiety
timeFrame: 24 hours
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
state: Hauts de Seine
Study officials:
affiliation: Hopital Foch
name: Mireille Michel-Cherqui, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Michel-Cherqui M, Szekely B, Lemoyne F, Feliot E, Gayat E, Fischler M. Auriculotherapy in the prevention of postoperative urinary retention in patients with thoracotomy and thoracic epidural analgesia: A randomized, double-blinded trial. Medicine (Baltimore). 2019 Jun;98(23):e15958. doi: 10.1097/MD.0000000000015958.
Clinical trial NCT06778954: Ropivacaine-Poloxamer 407 Gel for Pain Control After Open Gastrectomy
Official title: Prospective Randomized Controlled Trial of Ropivacaine-Poloxamer 407 Based Gel Application on Postoperative Pain After Open Gastrectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single Blind Randomized controlled
Primary purpose: TREATMENT

Brief summary: The study evaluates the efficacy of Ropivacaine-Poloxamer 407 hydrogel in reducing postoperative pain following open gastrectomy.


Eligibility criteria: Inclusion Criteria:

1. Patients with a histologically confirmed diagnosis of gastric adenocarcinoma prior to surgery.
2. Patients who have undergone a complete surgical resection (R0 resection).
3. Patients with an ASA (American Society of Anesthesiologists) score of 3 or below.
4. Patients aged 20 years or older.

Exclusion Criteria:

1. Patients under 19 years of age.
2. Presence of ascites or peritoneal metastasis.
3. Patients who have undergone preoperative chemotherapy or radiotherapy.
4. Diagnosis of malignancies other than gastric cancer.
5. Uncontrolled diabetes, autoimmune diseases, hypertrophic scars, or keloid history affecting wound healing.
6. History of allergy or adverse reactions to Ropivacaine or other local anesthetics.
7. Pregnant women.
8. Patients with preoperative chronic pain conditions, including CRPS.
9. Patients with long-term preoperative use of opioid analgesics.
10. Patients with psychiatric disorders deemed likely to interfere with study participation.
11. Patients with severe liver disease, renal disease, or arrhythmia.

Primary outcomes:
measure: Total fentanyl consumption within 72 hours postoperatively.
timeFrame: Total fentanyl consumption within 72 hours postoperatively.
Secondary outcomes:
measure: Pain intensity scores (NRS) at rest and during movement.
timeFrame: Pain intensity: Measured at 24, 48, and 72 hours postoperatively.
measure: Time to first flatus and bowel movement.
timeFrame: Bowel function: Time to first flatus and bowel movement recorded until discahrge (within 6 days)
measure: Occurrence of postoperative nausea and vomiting (PONV).
timeFrame: PONV: Assessed daily for 72 hours.
measure: Wound healing assessment, including seroma and infection rates.
timeFrame: Wound healing: Evaluated at regular intervals until first outpatient day (within 14 days)
measure: Length of hospital stay.
timeFrame: Hospital stay: up to 1 month
measure: Quality of recovery (QoR-15).
timeFrame: QoR-15: Measured at baseline and 72 hours postoperatively.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
Study officials:
References:
Clinical trial NCT00330954: Gene Expression Profiling in Type 1 Diabetes
Official title: Gene Expression Profiling in Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Keywords: viral response genes
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2006-05-29
Enrollment: 64
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female subjects 7-14 years of age

* New onset T1DM
* Five years post onset of T1DM

Brief summary: One of the goals of the Kansas City Diabetes Consortium is to identify and characterize genes and their products that are associated with T1DM. Characterization of such genes and their products can aid in developing new tools for risk assessment, development of new prevention strategies and monitoring progression of disease.

Study design: Descriptive, basic science pilot study. The results of this pilot study will be used to help design a much larger study to address the importance of viral response and autoimmune diabetes.

Detailed description: The hypothesis is that viral responsive genes are up-regulated prior to the onset of symptoms of Type 1 Diabetes (T1DM) and may correlate with increased expression of interferon alpha.

Both genetic and environmental factors contribute to risk of development of T1DM. There are a number of conflicting reports associating viral infections and T1DM in genetically susceptible individuals and causality has not been proven. Viruses may not have a large role in the initiation of islet cell autoimmunity but more of a role in acceleration of the disease leading to overt symptoms. There are no studies describing viral responsive gene expression in these individuals.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects 7-14 years of age
* New onset T1DM
* Five years post onset of T1DM
* Participant in the TrialNet initiative and either antibody positive or antibody negative sibling control
* Body weight sufficient to tolerate an additional 15ml (1 tbsp) blood loss

Exclusion Criteria:

* Subjects who do not meet the criteria above
* Subjects who have received steroids or other immunosuppressive therapy within the 6 months prior to enrollment into the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Karen Kover, PhD
role: PRINCIPAL_INVESTIGATOR
References: