louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06455228: Long Peripheral Intravenous Catheter Insertion Site and Catheter-related Complications in Antimicrobial Therapy
Official title: Long Peripheral Intravenous Catheter Insertion Site and Catheter-related Complications in Antimicrobial Therapy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Antimicrobial
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 90
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: This study applies long PIVCs to patients undergoing antimicrobial therapy, and compares the effects of different placement sites, aiming to provide a reference basis for patients undergoing antimicrobial treatment to select the optimal placement site, thus reducing complications, prolonging catheter retention time, and alleviating the patient's pain.

Detailed description: This study investigates the use of long PIVCs in patients undergoing antimicrobial therapy, and compares the effects of different insertion sites. The aim is to provide evidence-based recommendations for the optimal placement site for long PIVCs in antimicrobial treatment, with the goals of reducing complications, prolonging catheter retention time, and alleviating patient discomfort.

Eligibility criteria: Inclusion Criteria:

* ① estimated time of intravenous infusion ≥1 week; ② age: ≥18 years; ③ antimicrobial therapy was only used for treatment during hospitalization, with a pH value of 5-9 and osmotic pressure \&lt; 900 mOsm/L; and ④ patients were conscious and able to communicate normally; ⑤ the catheter-to-vessel ratio is less than 45%.

Exclusion Criteria:

* ① a history of radiotherapy, thrombosis, and trauma at the catheterization site and ② plans to discharge with a catheter during the study duration.

Primary outcomes:
measure: Incidence of catheter-related complications
timeFrame: After insertion of catheter
Secondary outcomes:
measure: Puncture success rate with one-attempt
timeFrame: After insertion of catheter
measure: The procedure time
timeFrame: After insertion of catheter.
measure: Indwelling catheter duration
timeFrame: After insertion of catheter
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: Zhao Linfang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05913128: Comparison Between Glandular Urethral Disassembly Versus Tubularized Incised Plate for Primary Distal Hypospadius Repair
Official title: Comparison Between Glandular Urethral Disassembly Technique Versus Tubularized Incised Plate Technique for Primary Distal Hypospadius Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glandular Urethral Disassembly
Tubularized Incised Plate
Distal Hypospadius Repair
Keywords: Glandular Urethral Disassembly, Tubularized Incised Plate, Distal Hypospadius
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 86
Sex: MALE
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized clinical trial
Primary purpose: TREATMENT

Brief summary: To compare Glandular Urethral Disassembly technique versus Tubularized Incised Plate technique for Primary Distal Hypospadius Repair

Detailed description: Aim of study to compare glandular Urethral Disassembly technique versus Tubularized Incised Plate technique for Primary Distal Hypospadius Repair

Eligibility criteria: Inclusion Criteria:

* Primary Distal Hypospadius

Exclusion Criteria:

* secondary Distal Hypospadius Recurrent Hypospadius

Primary outcomes:
measure: Hospital stay
timeFrame: up to14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Faculty of medicine
state: Qalubia
Study officials:
affiliation: faculty of medicine
name: Ahmed AE Abdel Fattah, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01391728: Active Lifestyle All Your Life-an Intervention Programme for Preventing Fall Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frequency of Accidental Falls
Participation
Self-rated Health
Occupational Gaps
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2011-07-12
Enrollment: 138
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the project is to formulate, implement and evaluate a new type of activity-orientated, evidence-based prevention programme to prevent fall injuries among elderly people. The question examined by the study is whether the intervention programme can:

* significantly reduce accidents and incidents involving falling among the participants,
* influence variables such as satisfaction with life, confidence in one's own ability and a feeling of involvement,
* be shown to be cost effective in terms of the use of resources. The intervention programme - Active lifestyle all your life - is being developed in and for primary care for the cost effective prevention of fall injuries among elderly people using a method that results in continued active life. The aim is to ensure that the elderly person is able to continue living an active life with commitment and involvement, which can in itself prevent fall injuries. This presupposes a knowledge of how to avoid fall injuries and the measures and aids that are available to prevent such injuries. The programme will also provide the participants with a social community in self-supporting groups which, by their own efforts but also with social support, are able to continue some of the activities provided through primary care.


Eligibility criteria: Inclusion Criteria:

* 65 or older
* Fall injury in the form of radius fracture or other minor documented fall injury, or one or more fall incidents reported in the last six months (reported to a district nurse in the 75-year discussion)

Exclusion Criteria:

* Cognitive impairments
* Documented psychiatric problems that make participation in organized group activity impossible
* Considerable difficulties in speaking and understanding Swedish

Primary outcomes:
measure: Accidental falls
timeFrame: Two Years (2010-2012)
Secondary outcomes:
measure: Participation Self-Rated health Self efficacy
timeFrame: Two Years (2010-2012)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References:
Clinical trial NCT03301428: Educational Tools to Improve Beliefs About Pain and Reduce Pain-related Disability
Official title: Effectiveness of Different Educational Tools to Improve Beliefs About Pain and Reduce Pain-related Disability in Patients With Chronic Low Back Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Beliefs
Disability Physical
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 300
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: This trial aims at comparing the effectiveness of different didactic tools developed for patients with chronic pain to correct misbeliefs and improve disability in patients with chronic low back pain

Detailed description: This trial aims at comparing the effectiveness of different didactic tools (an educational website vs a booklet) developed for patients with chronic pain to correct misbeliefs and improve disability in patients with chronic low back pain.

Participants of the 2 experimental groups will be invited to use the tool they receive during a one-month period.

Eligibility criteria: Inclusion Criteria:

* individuals with non-specific persistent low back pain (pain \> 6 months) who had their pain assessed by their general practitioner or a specialist within the last 3 months

Exclusion Criteria:

* specific low back pain,
* educational treatment (back school, cognitive-behavioral, pain neurosciences education) in progress or planned during the study period
* previous consultation of the didactic tools investigated in the present study
* nerve root compromise,
* recent spinal surgery (\<3 months)
* not fluent in French
* no regular access to a computer and the internet
* present follow-up by a psychiatrist

Primary outcomes:
measure: Pain Beliefs Questionnaire
timeFrame: Change from baseline to the three-month follow-up
measure: Roland-Morris Disability Questionnaire
timeFrame: Change from baseline to the three-month follow-up
Secondary outcomes:
measure: Brief-Illness Perception Questionnaire
timeFrame: Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up
measure: Back-PAQ questionnaire
timeFrame: Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up
measure: Pain intensity
timeFrame: Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Liege University Hospital
Study officials:
affiliation: Liege University Hospital
name: Christophe Demoulin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05068128: Combined Flow and Pressure Study of Craniospinal Dynamic
Official title: Combined Flow-pressure Study of Cerebrospinal Circulation Using CSF Perfusion Tests and Phase-contrast MRI - Reversible Dementia Substudy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intracranial Pressure
Cerebral Blood Flows
Infusion Test
Phase Contrast MRI
Hydrocephalus
Dementia
Keywords: Intracranial pressure
cerebral blood flows
infusion test
Phase contrast MRI
Hydrocephalus
Dementia
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: University Hospital, Caen
name: University Hospital, Brest
First posted: 2021-10-05
Enrollment: 73
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected active hydrocephalus (HA) known as "normal pressure" and with Flow MRI and CSF infusion test.

Brief summary: Normal pressure hydrocephalus (NPH) can cause a type of dementia. However, this type of dementia is the only one that is reversible. To treat this dementia it is necessary to evacuate the accumulation of CSF from the brain to another body cavity using a device called a shunt. But the implantation of this shunt is only effective when the cause of the pathology is an alteration of the normal circulation of the CSF. To diagnose these patients, morphological MRI and lumbar puncture are standard approaches used but remain perfectible in diagnostic terms.

The main objective is to build a new model of the interaction of intracranial pressures and fluids in order to obtain a new parameter allowing to obtain information on the cerebral biomechanics.


Eligibility criteria: Inclusion Criteria:

* age \> 55 years
* Patients with suspected active hydrocephalus (HA) known as "normal pressure":
* Ventricular dilatation: Evans index \> 0.3
* Patients with cognitive impairment, and/or gait disorders and/or urinary incontinence or a combination of these three symptoms.
* Absence of other neurological diseases that could cause ventriculomegaly.
* Information and collection of the patient's non opposition

Exclusion Criteria:

* All patients with neurological disease other than active hydrocephalus will be excluded.
* Individuals who cannot tolerate an MRI examination
* All individuals with implants, pacemakers, prostheses and ferromagnetic objects
* Patients under guardianship, curators or safeguard of justice

Primary outcomes:
measure: Variation of number of MRICP parameters according of CSF accumulation
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Salouël
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT02240628: Combining Placing a Synera Patch With Propofol/Lidocaine Mixture to Decrease Pain With IV Propofol Injection
Official title: In Children, Placing a Synera Patch for Intravenous Access Combined With Administration of a Propofol-Lidocaine Mixture Decreases Pain Associated With Propofol Intravenous Injection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain on IV Injection of Propofol.
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2014-09-15
Enrollment: 76
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective is to evaluate if combining placing the Synera patch and using Propofol /Lidocaine mixture will further decrease the pain associated with the IV injection of Propofol.

Detailed description: Commonly, anesthesiologists inject Propofol, a sleeping medication, intravenously to induce general anesthesia.Propofol injection is commonly associated with burning pain. In a previous onsite study we concluded that placing a Synera patch at least 30 minutes before placing the IV decreased the pain associated with the Propofol injection. Also,a study documented that adding Lidocaine to the Propofol decreases the pain associated with propofol injection. In our study here we are trying to evaluate if combining the use of both the Synera patch and the Propofol-Lidocaine mixture will further decrease the pain associated with the IV Propofol injection.

All children will receive a Synera Patch, it will be placed on the dorsum of both hands for at least 30 minutes.All Children will be Sedated with P.O Versed.

22 g IV will be started either in the holding area or in the OR. Children will be randomized into groups using a computer generated randomization list:- Group 1 will receive Propofol -Lidocaine mixture. Group 2 will receive Propofol-Saline mixture. An independent blinded observer and an anesthesia member will independently evaluate pain on Propofol injection according to pain scale.

1. No pain.
2. Mild Pain (associated with facial expression of pain).
3. Moderate Pain(Pulling the arm).
4. Severe Pain (screaming).

Eligibility criteria: Inclusion Criteria:

* Healthy Children 6-17 yrs.
* Scheduled to receive general anesthesia for an elective procedure.
* ASA classification 1-2

Exclusion Criteria:

* Children with Skin disease and/or Skin infections.
* Allergy to Propofol, Lidocaine or tetracaine.

Primary outcomes:
measure: Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection.
timeFrame: During propofol injection.
Secondary outcomes:
measure: Pain Intensity
timeFrame: During Propofol injection.
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: samia khalil, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02605928: Use of BIP-Needles in Rheumatologic Injections
Official title: INJ-INAR-01 Use of BIP-Needles in Rheumatologic Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intra-articular Injections
Keywords: Arthritis
Bioimpedance
Glucocorticoid
Intra-articular injection
Needle Guidance
Lead sponsor: Injeq Ltd
Sponsor class: INDUSTRY
First posted: 2015-11-17
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study focuses on needle guidance in rheumatologic operations - glucocorticoid injections inside joint capsules specifically. The main purpose of the study is to assess and validate the clinical feasibility and performance of Bioimpedance Probe (BIP) Needles and assess the benefits, drawbacks and risks related to use of the BIP Needles.

Detailed description: Clinical device investigation

Eligibility criteria: Inclusion Criteria:

* Adult patients having an inflammatory rheumatic disease requiring an intra-articular glucocorticoid injection.

Exclusion Criteria:

* Exclusion criteria are the same as generally for intra-articular glucocorticoid injections (e.g. bacterial infection or recent surgical operation relating the joint).
* In addition for not giving (or not capable to give) the consent personally for any reason is an absolute exclusion criterion.
* In addition pregnant women are excluded

Primary outcomes:
measure: True Positive Detection of Synovial Fluid Marked in Case Report Form
timeFrame: During intra-articular injection
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital, Clinic of Rheumathology
state: HUS
Study officials:
affiliation: Helsinki University Hospital, Clinic of Rheumathology
name: Riitta Luosujärvi, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00988728: Efficacy & Safety of SCH 900435 in Schizophrenia (Study P06079)(WITHDRAWN)
Official title: A Multicenter, Randomized, Parallel-Group, Double-blind, Fixed-Dose, 28-Day Trial to Assess the Efficacy and Safety of SCH 900435 Compared With Placebo, Using Olanzapine as an Active Control in Subjects With an Acute Exacerbation of Schizophrenia (GUEST - Glycine Uptake Inhibitor Efficacy and Safety Trial, Phase 2, Protocol No. P06079)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-10-02
Enrollment: 0
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 study is to assess whether SCH 900435 (Org 25935) 16 mg twice daily is more effective than placebo in the treatment of patients with schizophrenia, using olanzapine 15 mg once daily as active control.


Eligibility criteria: Inclusion Criteria:

* Subjects eligible to participate:

  * present a substantial and recent exacerbation of schizophrenia
  * have responded positively to treatment with an antipsychotic other than clozapine in the past
  * are without adequate treatment for their symptoms, or willing and capable to stop concurrent medication, which appears inadequate to treat their condition, prior to participation

Exclusion Criteria:

* Schizoaffective disorder;
* single episode of schizophrenia in partial remission
* concomitant use of antidepressants, mood-stabilizers (including anticonvulsants) or long-acting sedatives
* substance abuse or dependence (excluding nicotine and caffeine)
* uncompensated medical illness (including clinically relevant eye disorder)

Primary outcomes:
measure: The change from baseline of the Positive and Negative Symptoms Scale (PANSS) (total score)
timeFrame: 4 weeks (Day 28)
Secondary outcomes:
measure: Change from baseline in PANSS positive and negative subscale scores (in this order) as compared to olanzapine
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01001728: SuPr Study (Supine Versus Prone Treatment Position in Breast Radiotherapy)
Official title: A Randomised Trial Investigating the Prone Treatment Position as a Method of Sparing Healthy Tissues in Women Prescribed Breast Radiotherapy (SuPr Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast Cancer
Radiotherapy
Prone position
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2009-10-27
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomised, two-arm, non-blinded crossover study investigating the impact of treatment position (prone versus supine) upon reproducibility of tumour bed position in patients undergoing breast radiotherapy following excision of early breast cancer.

Detailed description: To establish whether or not the prone (face down) position reduces exposure of healthy tissue to radiation when compared to the supine position. To compare patient comfort and acceptability in each of the prone and supine positions. To perform a time and motion study for radiotherapy planned and delivered in each of the prone and supine positions.

Eligibility criteria: Inclusion Criteria:

* Complete microscopic excision of early stage invasive ductal or lobular carcinoma (pT1-3b N0-1 M0) with breast preservation.
* Paired titanium clips marking anterior, posterior, and radial walls of excision cavity
* Breast cup size C or above
* Recommendation for whole breast radiotherapy
* No requirement for nodal irradiation
* Ability to lie prone on breast board
* For left-sided breast cancer patients, cardiac and LAD doses must be ≤10% greater than those predicted for the supine position.
* For all patients, the following absolute dose constraints should be met: ≤5% of heart volume to receive 18Gy and ≤10% of ipsilateral lung volume to receive ≥20Gy
* Age ≥18
* PS ≤1
* No previous radiotherapy to the affected breast
* No concomitant herceptin
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
* Written informed consent given according to ICH/GCP before registration/ randomisation.
* Patients can only be randomised into this trial once.

Primary outcomes:
measure: Interfraction reproducibility of tumour bed position (Reproducibility of tumour bed position in supine versus prone positions compared using the difference in mean daily displacement in tumour bed centre of gravity over a course of radiotherapy in 3D).
timeFrame: End of radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Professor John Yarnold
role: PRINCIPAL_INVESTIGATOR
References: