louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06661954: Comparison of Sacral Interface Pressure in Healthy Volunteers on Two Dynamic Pressure-Prevention Support Surfaces
Official title: Sacral Interface Pressure Mapping of Hospital Bed Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteer
Pressure Distribution
Keywords: Pressure Injury
Pressure Mapping
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the research study is to investigate the peak sacral interface pressures of two separate hospital bed systems in the supine and 30 degrees head-of-bed elevation position.


Eligibility criteria: Inclusion Criteria:

* non-disabled
* can walk \& stand independently
* can visit UAB SIM Lab once for 45 to 60 minutes

Exclusion Criteria:

-skin breakdown or compromising skin conditions

Primary outcomes:
measure: Peak Sacral Pressure
timeFrame: 5-15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Rachel Cowan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06234254: Reducing Adult Inpatients Anxiety With Virtual Reality Meditation
Official title: Reducing Adult Inpatients Anxiety With Virtual Reality Meditation: A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Virtual Reality
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to evaluate if non-invasive, distracting devices (virtual reality) can decrease anxiety and improve affect and satisfaction in adult, hospitalized patients.


Eligibility criteria: Inclusion Criteria:

* between age 18-99
* hospitalized at Stanford Health Care
* english-speaking

Exclusion Criteria:

* significant cognitive impairment or inability to consent
* current nausea
* visual problems or currently using corrective glasses that are incompatible with the virtual reality headset
* a history of severe motion sickness
* a history of seizures cause by flashing light
* clinically unstable or require immediate/urgent intervention

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Before and Immediate after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Health Care (SHC)
state: California
Study officials:
affiliation: Stanford University
name: Thomas Caruso
role: STUDY_DIRECTOR
References:
Clinical trial NCT02382354: Remifentanil for the I-gel and Laryngeal Mask Airway Insertion
Official title: Comparison of the Effect-site Concentration of Remifentanil for Insertion of the I-gel and Laryngeal Mask Airway During Propofol Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Supraglottic Airways for General Anesthesia
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 41
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Structural differences of supraglottic airway devices could influence the different compressive forces in the oropharyngeal cavities, and require different depth of anesthesia. The addition of remifentanil during propofol anesthesia facilitates the insertion of laryngeal mask airway (LMA) with minimal adverse hemodynamic disturbances. This study was designed to determine the effect-site concentration of remifentanil in 50% of patients (EC50) and 95% of patients (EC95) for successful i- gel insertion, and compare those for LMA insertion during propofol target-controlled infusion (TCI).

Detailed description: Anesthesia was induced with propofol TCI at the effect-site concentration of 5 μg/ml, and the predetermined effect-site concentration of remifentanil was started simultaneously. The remifentanil concentration was determined using modified Dixon's up-and-down method (initial concentration: 3.0 ng/ml, step size: 0.5 ng/ml). Five minutes later, i- gel or LMA insertion was attempted. The response of the patients to the insertion of LMA was classified as either 'movement' or 'no movement'.

Eligibility criteria: Inclusion Criteria:

* ASA I-II patients undergoing general anesthesia for short elective surgery (\<2 hr)

Exclusion Criteria:

* G-E reflux
* obesity (BMI\>30)
* anticipated difficult airway

Primary outcomes:
measure: successful insertion of i-gel and LMA
timeFrame: from 5 min after anesthetic induction to 1min after device insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University hospital
Study officials:
affiliation: Ajou University School of Medicine
name: Jong Yeop Kim, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06047054: Incidence Rate and Risk Factors of Malnutrition in ICU
Official title: Incidence Rate and Risk Factors of Malnutrition in Patients Admitted to Surgical Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malnutrition
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cases who will admitted to the surgical intensive care unit

Brief summary: To assess the incidence of malnutrition in surgical Intensive Care Unit by NUTRIC score. To determine the different risk factors of malnutrition

Detailed description: To assess the incidence of malnutrition in surgical Intensive Care Unit by NUTRIC score. To determine the different risk factors of malnutrition by assessment of the type of nutrition, caloric adequacy, and actual caloric intake, laboratory Investigations twice weekly

Eligibility criteria: Inclusion Criteria:

* Adult patients who will be admitted to surgical ICU.
* Both sexes.

Exclusion Criteria:

* • Referral from another hospital or other ICU

Primary outcomes:
measure: Assess incidence rate of malnutrition in ICU
timeFrame: From the date of randomization until the date of ICU discharge or death, assessed up to 4 months
Secondary outcomes:
measure: Correlation of risk factors with malnutrition in ICU
timeFrame: From the date of randomization until the date of ICU discharge or death, assessed up to 4 months
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine - Zagazig University
Study officials:
affiliation: Faculty of medicine, Zagazig University Hospitals
name: Naglaa Abdelhaleem, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lew CCH, Yandell R, Fraser RJL, Chua AP, Chong MFF, Miller M. Association Between Malnutrition and Clinical Outcomes in the Intensive Care Unit: A Systematic Review [Formula: see text]. JPEN J Parenter Enteral Nutr. 2017 Jul;41(5):744-758. doi: 10.1177/0148607115625638. Epub 2016 Feb 2.
Clinical trial NCT00632554: The Efficacy of Three Months-prednisolone Therapy for Chronic Eosinophilic Pneumonia
Official title: Phase 4, Randomized Study of Three Months-prednisolone Therapy in the Treatment of Chronic Eosinophilic Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Eosinophilic Pneumonia
Chronic Disease
Lead sponsor: Hamamatsu University
Sponsor class: OTHER
First posted: 2008-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A comparison of 3 months-prednisolone administration with 6 months-prednisolone therapy in the treatment of chronic eosinophilic pneumonia. Three months-prednisolone administration may be as effective as 6 months-therapy.


Eligibility criteria: Inclusion Criteria:

* Biopsy-proven chronic eosinophilic pneumonia

Exclusion Criteria:

* Patients who received oral glucocorticosteroid (more than 10 mg)
* Immunosuppressive drug

Primary outcomes:
measure: Efficacy of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia
timeFrame: Three years
Secondary outcomes:
measure: Safety of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia
timeFrame: Three years
Other outcomes:
Locations:
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine
Study officials:
affiliation: Hamamatsu University
name: Kingo Chida, MD, PhD
role: STUDY_CHAIR
References:
citation: Oyama Y, Fujisawa T, Hashimoto D, Enomoto N, Nakamura Y, Inui N, Kuroishi S, Yokomura K, Toyoshima M, Yamada T, Shirai T, Masuda M, Yasuda K, Hayakawa H, Chida K, Suda T. Efficacy of short-term prednisolone treatment in patients with chronic eosinophilic pneumonia. Eur Respir J. 2015 Jun;45(6):1624-31. doi: 10.1183/09031936.00199614. Epub 2015 Jan 22.
Clinical trial NCT05751954: Influence of Weight-bearing Mechanical Axis on Foot and Ankle in Patients Following Total Knee Arthroplasty
Official title: Influence of Weight-bearing Mechanical Axis on Foot and Ankle in Patients Following Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Knee Artroplasty
Keywords: weight-bearing mechanical axis
total knee arthroplasty
Lead sponsor: Clinic for Orthopedics Lovran
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This comprehensive scientific research will investigate the influence of the weight-bearing mechanical axis on foot and ankle following total knee arthroplasty. Few studies have monitored the outcome of surgical treatment using similair methods, and consequently the aim of this study was to evaluate the change in upper and lower leg load by analyzing radiographic recordings and pedobarographic measurements after the implantation of total knee endoprosthesis. In addition to objective instruments, knee and foot questionnaires will be used to describe the functional outcome of the operation of the subjects. The practical contribution of this research lies in the prediction of possible changes in the joints of the feet depending on the type of knee deformity (varus / valgus). Our research will consist of: analysis of postero-anterior radiographs of the lower extremity (weight-bearing) preoperatively and at the follow-up three months postoperatively, pedobarographic analyzes preoperatively and at the control examination three months postoperatively, analysis of personal data (age, gender, weight and height, operated side) and completion of functional standardized questionnaires (AOFAS, KOOS) preoperatively, and at the screening three months postoperatively.


Eligibility criteria: Inclusion Criteria:

* knee varus or valgus deformity 5 degrees or more

Exclusion Criteria:

* previous surgery which included corrective osteotomies, osteosynthesis or arthrodesis of the knee, ankle and foot.

Primary outcomes:
measure: Weight-bearing mechanical axis
timeFrame: 1 year
Secondary outcomes:
measure: Pedobarographic analysis
timeFrame: 1 year
Other outcomes:
Locations:
city: Lovran
country: Croatia
facility: Clinic for Orthopeadics and Traumatology Lovran
state: Primorsko-Goranska
Study officials:
References:
Clinical trial NCT01699854: Capsaicin Patch 8 % for the Treatment of Persistent Pain After Inguinal Herniotomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Persistent Pain After Inguinal Herniotomy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 50
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: In the present study the investigators intend to investigate analgesic and sensory effects of a capsaicin patch 8 %(Qutenza) in patients with severe post-herniotomy pain and sensory abnormalities in the skin.


Eligibility criteria: Inclusion Criteria:

* Patients ASA (American Society´s of Anesthesiology´s classification) scores I-III
* Severe post-herniotomy pain for more than six months and with severe pain (numerical rating scale \[NRS\] 0-10 points) during rest or during movement \> 5.

Exclusion Criteria:

* History of an allergic reaction or intolerance to capsaicin or vehicle ingredients in the patches
* Severe cardiac impairment, e.g., NYHA (New York Heart Association) Class ≥ III
* Inflamed or injured skin at the application site
* Signs of cognitive impairment
* Known drug or ethanol abuse

Primary outcomes:
measure: Pain change capsaicin vs. placebo patch treatment
timeFrame: Pain intensity assessed at baseline and at 1,2,3 months follow-up
Secondary outcomes:
measure: Changes in AAS (Activities Assessment Scale) score
measure: Changes in HADS (Hospital Anxiety and Depression Scale) score
measure: Changes in QST (Quantitative sensory testing)
measure: Changes in sleep (Sleep Interference Scale) score
measure: Changes in S-LANSS (Leeds self-assessment of neuropathic symptoms and signs)
measure: Changes in intraepidermal nerve fiber density
measure: Subgroup analysis for pain change(summed pain intensity differences (SPID) capsaicin patch vs. placebo are made for patients with thermal hypoesthesia and thermal normo/hyperesthesia
measure: Changes in PCS (Pain Catastrophizing Scale) score
Other outcomes:
measure: interim analyses
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Copenhagen Ø
Study officials:
References:
citation: Bischoff JM, Ringsted TK, Petersen M, Sommer C, Uceyler N, Werner MU. A capsaicin (8%) patch in the treatment of severe persistent inguinal postherniorrhaphy pain: a randomized, double-blind, placebo-controlled trial. PLoS One. 2014 Oct 7;9(10):e109144. doi: 10.1371/journal.pone.0109144. eCollection 2014.
Clinical trial NCT01305733: Local Infiltration Analgesia During Total Knee Arthroplasty
Official title: Local Infiltration Analgesia During Total Knee Arthroplasty - Reduced Opiate Consumption and Faster Mobilisation Postoperatively - Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Pain relief
Lead sponsor: Coxa, Hospital for Joint Replacement
Sponsor class: OTHER
First posted: 2011-03-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate whether local infiltration analgesia (LIA) will reduce oxycodone consumption during the first 48 postoperative hours in patients undergoing total knee arthroplasty (TKA).

Detailed description: The goal of LIA is to gain an effective and safe pain control during the first postoperative days. The study is a single-center, randomized controlled trial, which will be performed in Coxa Hospital for Joint Replacement in Tampere, Finland. The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline with occasional variations if the patient is unusually small, very elderly, infirm or has a history of significant intolerance to analgesics or anesthetic agents. The RKA mixture is diluted with normal saline. Total volume of the solution is 100 ml depending on the size of the wound. The normal saline injection are used in the control group in the same manner than in the RKA group.

Eligibility criteria: Inclusion Criteria:

* Patients requiring primary TKA for primary OA
* Patients aged 75 years or less
* Patients suitable for all applicable devices

Exclusion Criteria:

* Rheumatoid arthritis or other inflammatory diseases
* Patients requiring bone grafting during surgery
* Unwilling to provide informed consent
* BMI \> 35
* ASA \> 3
* Renal dysfunction
* Allergic to ASA
* Previous high tibial osteotomy or previous osteosynthesis
* \> 15 degrees varus / valgus malalignment
* Physical, emotional or neurological conditions which would comprise the patient´s compliance with postoperative rehabilitation and follow-up (e.g. drug or alcohol abuse, serious mental illness, general neurological conditions such as Parkinson, MS, etc.)
* Known sensitivity to materials in the devices

Primary outcomes:
measure: oxycodone consumption during the first 48 postoperative hours
timeFrame: 48 hours
Secondary outcomes:
measure: functional outcome after TKA
timeFrame: 1 year
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Coxa - hospital for joint replacement
state: Pirkanmaa
city: Tampere
country: Finland
facility: COXA
state: Pirkanmaa
Study officials:
affiliation: Coxa, Hospital for Joint Replacement
name: Antti Eskelinen, M.D., Ph.D
role: STUDY_DIRECTOR
affiliation: Coxa, Hospital for Joint Replacement
name: Mika Niemeläinen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04774133: The Immunodynamic Effect of Radiotherapy in Prostate Cancer Patients.
Official title: Radioinduced Modifications of Lymphocyte Subpopulations Involved in Resistence and Escape Mechanisms to Radiation Therapy of Localized Prostate Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostatic Neoplasm
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: Paola Nisticò
name: Iole Cordone
name: Adriana Faiella
name: Paola Trono
name: Serena Masi
name: Roberta Merola
name: Anna Antenucci
name: Maria Laura Foddai
name: Maria Consiglia Ferriero
name: Diana Giannarelli
name: Paolo Di Ridolfi
First posted: 2021-03-01
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Radiotherapy has an important role in the treatment of prostate cancer both as curative treatment and postoperative or salvage ones. Several studies demonstrated a significant reduction of lymphocytes during RT but there are only a few studies monitoring these cells in the treatment of prostate cancer. This study will enroll 50 patients with hystologically proven prostate cancer who will undergo to radiotherapy according to Institutional protocols.

This study aims to evaluate the effect of RT on immuno-regulatory B, NK, T, B and T lymphocyte subpopulations (Breg and Treg) and plasma cells, quantitative / qualitative changes,their correlations with the clinical course of the disease and acute and late toxicity. In parallel, using multicolor panels (12 colors) we will evaluate the expression of inhibitory checkpoints and TGFβ signaling.

The final objective is to identify new therapeutic targets to be combined with RT.


Eligibility criteria: Inclusion Criteria:

* Histologically documented prostatic cancer
* Indication to perform radiotherapy treatment
* Age over 18 years
* Informed consent

Exclusion Criteria:

* Hematological diseases
* Autoimmune diseases
* Previous neoplasias
* Prior chemotherapy or other therapies that may have violated the hematopoietic organs
* Patient's refusal to undergo periodic blood samples

Primary outcomes:
measure: to quantify the variation in lymphocyte subpopulations T, NK, B, Breg and Treg,
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: IRCSS Regina Elena
Study officials:
affiliation: IFO
name: Giuseppe Sanguineti
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01483833: Efficacy Study of Iferanserin to Treat Hemorrhoids
Official title: Protocol for the Study of the Effects of S-MPEC (Iferanserin) in Patients With Hemorrhoids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hemorrhoids
Lead sponsor: Ventrus Biosciences, Inc
Sponsor class: INDUSTRY
First posted: 2011-12-01
Enrollment: 121
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: To evaluate the safety and efficacy of topical 0.5% S-MPEC cream vs. placebo cream (applied twice daily for 14 days) in the treatment of Grade I - III hemorrhoids.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Diagnosis of grade I - III hemorrhoids with bleeding episodes of at least every other day during the last two weeks before enrollment in the study.
* Patients signing the Informed Consent form.

Exclusion Criteria:

* Patients with protruding or irreducible hemorrhoids (grade IV).
* Patients with anal fistulas, periproctitis or hemorrhagic diathesis
* Patients with current history of Type I or Type II diabetes mellitus.
* Patients with severe hepatic, renal or cardiovascular disorders.
* Patients with any type of infectious disease.
* Patients who have been involved with another experimental drug trial within the past 30 days.
* Patients presently diagnosed with cancer.
* Patients who have known alcohol and drug abuse.
* Patients who require the use of suppositories.
* Patients with blood or urine laboratory values outside the normal limits or those with values considered abnormal in the opinion of the investigator.

Primary outcomes:
measure: Assessment of hemorrhoid bleeding
timeFrame: Day 7 and 14
Secondary outcomes:
measure: Assessment of bleeding, hemorrhoid size, other hemorrhoid symptoms, and physician evaluation of hemorrhoids.
timeFrame: 14 days
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Prof. Alexander Herold, MD
Study officials:
References:
citation: Herold A, Dietrich J, Aitchison R. Intra-anal Iferanserin 10 mg BID for hemorrhoid disease: a prospective, randomized, double-blind, placebo-controlled trial. Clin Ther. 2012 Feb;34(2):329-40. doi: 10.1016/j.clinthera.2011.12.012. Epub 2012 Jan 11.