louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03590236: Graded Exposure Therapy in Chronic Pelvic Pain
Official title: Graded Exposure Therapy in Women With Chronic Pelvic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pelvic Pain
Keywords: women
chronic pelvic pain
fear avoidance
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 60
Sex: FEMALE
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: Chronic pelvic pain (CPP) is considered as nonmalignant recurrent or continuous pain related to the structures of the pelvis. The objective of this study was to evaluate the effects of graded exposure therapy in women with chronic pelvic pain.

Detailed description: Chronic pelvic pain (CPP) is considered as nonmalignant recurrent or continuous pain related to the structures of the pelvis. This condition lasts at least 6 months, and many times is associated with negative cognitive, emotional, sexual and behavioral consequences.In addition to the high economic cost, CPP is also costly in emotional and psychological suffering. This clinical trial aims to evaluate the effects of a program based on graded exposure therapy in women with chronic pelvic pain.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic pelvic pain
* Moderate fear of movement

Exclusion Criteria:

* Other clinical diagnosis.
* Men
* Other pathology such as neurological disease.
* Cognitive impairment.

Primary outcomes:
measure: Fear-avoidance behaviors
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Pain assessed by the Brief Pain Inventory
timeFrame: Baseline, 6 weeks
measure: Disability
timeFrame: Baseline, 6 weeks
measure: Activity performance
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Department of Physical Therapy
Study officials:
affiliation: Universidad de Granada
name: Marie CArmen Valenza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ariza-Mateos MJ, Cabrera-Martos I, Ortiz-Rubio A, Torres-Sanchez I, Rodriguez-Torres J, Valenza MC. Effects of a Patient-Centered Graded Exposure Intervention Added to Manual Therapy for Women With Chronic Pelvic Pain: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 Jan;100(1):9-16. doi: 10.1016/j.apmr.2018.08.188. Epub 2018 Oct 9.
Clinical trial NCT02048436: Perminova Respiratory Effort Accuracy Validation 09-12-2013-Rev 2
Official title: Perminova Respiratory Effort Accuracy Validation 09-12-2013-Rev 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Rate Accuracy Test
Keywords: Respiratory Rate
Lead sponsor: Clinimark, LLC
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy Male or female, ages 18-45

Brief summary: The purpose of this study is to validate the accuracy of the Perminova N4 Monitoring system Respiration Rate technology.

Detailed description: After IRB Approval, eighteen volunteer test subjects will be entered into an accuracy study that is designed to validate accuracy of the respiratory rate technology of the Perminova N4 Monitoring system (Device Under Test). The subjects will be selected to represent a range of body types including small, average, muscular, and large with a range of BMI's.

A range of stable respiratory rates will be elicited from each volunteer test subject. The rates will be approximately 5, 10, 15, 20, 25, 30, 35 and 40 breaths per minute; with some natural variation from these exact numbers.

Each subject will be instrumented with an open system mask that allows for measurement of the end tidal carbon dioxide (EtCO2) respiratory rate and tidal volume. The EtCO2 monitor will be used as the Accuracy Reference Device (Reference) in this study. Performance of the currently released ECG Impedance Respiratory Rate monitor (Acceptance Standard) will be used to establish the acceptance criteria in this study by comparing to Reference.

Eligibility criteria: Inclusion Criteria:

* male
* female
* 18-45
* range of physiques
* healthy

Exclusion Criteria:

* injury to sensor area
* skin inflammation
* implanted devices such as pacemakers
* pregnant

Primary outcomes:
measure: Respiratory Rate of test subject as compared to end tidal CO2
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Clinimark Laboratory
state: Colorado
Study officials:
References:
Clinical trial NCT02997436: First Approach for Aspirin Misuse Objective Screening
Official title: Asa Test ; un Nouvel Outil Dans le dépistage du Traitement Par Aspirine ? (This Official Titre is in French and Contains no Spelling Error. English Translation for it Would be : "ASA-test. A New Tool for the Screening of Aspirin Treatment")
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2016-12-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: prospective interventional study. The aim is to analyse the effect of usual ongoing treatments over the microvascular cutaneous response to galvanic current application (Current induced vasodilation ; CIV) on the forearm of subjects referred for ultrasound investigations due to suspicion of peripheral artery disease. Hypothesis is that the use of aspirin (even at low dose) abolishes the response .

Detailed description: At admission eligible patients are proposed to participate. Written consent is signed after complete oral and written explanation of the protocol is signed.

No register of non-included patients will be kept. In included patients, in parallel to the routine ultrasound investigation for which the patient is referred, microvascular investigation will be performed as explained later in arm description.

Usual ongoing treatments are obtained by history and recorded. The end of the visit is the end of the participation of the subjects.

Eligibility criteria: Inclusion Criteria:

* subjects referred for investigation of peripheral arterial disease.
* Affiliation to the French National healthcare system
* French speaking patients
* Ability to stand still for half a minute.

Exclusion Criteria:

* pregnancy
* inability to understand the study goal
* Patients protected by decision of law

Primary outcomes:
measure: correlation of treatments to CIV response.
timeFrame: 10 minutes after the second period of current application
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: UH Angers
Study officials:
affiliation: UH Angers
name: Marie-Sophie Fernandez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UH Angers
name: Pierre Abraham, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UH Angers
name: Philippe Bouye, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UH Angers
name: Valmont Richard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UH Angers
name: Vincent Azzola, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03983941: IPACK Versus Popliteal Sciatic Nerve Block in ACL Reconstruction
Official title: Comparison of Postoperative Analgesic Efficacy of Adductor Canal Block With IPACK Versus Adductor Canal and Popliteal Sciatic Nerve Block in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anterior Cruciate Ligament Tear
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 7
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective study comparing femoral nerve block plus sciatic nerve block to femoral nerve block plus infiltration of the posterior knee capsule (IPACK) in patients undergoing arthroscopic anterior cruciate ligament reconstruction. Femoral nerve block via the adductor canal (FNB-AC) with IPACK may provide effective analgesia while avoiding the motor block involved with sciatic nerve block. The lack of motor block is important to facilitate postoperative ambulation and physical therapy.


Eligibility criteria: Inclusion Criteria:

* Patients less than 21 years of age
* American Society of Anesthesiologists physical status I and II
* Undergoing elective anterior cruciate ligament reconstruction

Exclusion Criteria:

* They are unable or unwilling to take part in the study
* History of allergy to any of the medications administered for the nerve block
* Contraindication to peripheral nerve block
* Patients who are unable to understand instructions or questions related to the study or the families required language interpretation
* Patients who consume opioid medications for more than three days per week for more than a month prior to surgery

Primary outcomes:
measure: Average Post-operative Pain Score
timeFrame: Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours
Secondary outcomes:
measure: Number of Opioid Doses Administered
timeFrame: Intra-operative and up to 48 hours post-discharge, an average of 48 hours
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT04579341: Probiotics Supplementation Effect on Glucose Homeostasis in Children With Type 1 Diabetes
Official title: The Effect of Probiotics Supplementation on Glucose Homeostasis, Lipid Profile and Interleukin (IL)-21 and IL-22 Levels in Children With Type 1 Diabetes: A Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 70
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Probiotics influence immune homeostasis, through altering gut microbiota. The efficacy of probiotics in diabetes has been shown in preclinical settings as well as in human trials. Interleukin (IL)-21 and IL22 have been implicated in the pathogenesis of T1D. Objectives: to assess the effect of oral supplementation with probiotics on glycemic control as well as IL-21 and IL-22 levels in children with T1D. Methods: This randomized-controlled trial study included 70 children with T1D. Enrolled children aged 5-18 years with disease duration \> 1 year. They were randomly assigned into two groups; intervention group (group A) who received oral probiotics containing Lactobacillus acidophilus La-14 (108 CFU) 0.5 mg once daily. The other group (group B) did not receive any supplementation and served as a control group. Both groups were followed-up for 6 months with assessment of fasting blood glucose (FBG), HbA1c, IL-21 and IL-22 levels.


Eligibility criteria: Inclusion Criteria:

* T1D

Exclusion Criteria:

* other types of DM

Primary outcomes:
measure: glycemic control
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Ramses
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Amira Adly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05771441: Effects of Neck Stabilization Exercise With Heat Therapies
Official title: Effect of Heat Therapies on Pain, Functional Status, Range of Motion, and Disability in Patients With Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: hot pack
exercise
ultrasound therapy
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, we aimed to determine the effects of heat therapies and neck stabilization exercises on pain, disability, range of motion, and mood of NP patients.

Detailed description: Chronic non-specific neck pain (NP) has become one of the main causes of disability in the adult population around the world.Several treatment options used like; exercise, manual therapy, electrotherapy, and hot treatments etc. In this study, we aimed to determine the effects of heat therapies and neck stabilization exercises on pain, disability, range of motion, and mood of NP patients.100 patients with NP will be included.Patients will be randomyl assigned to 4 groups and will receive a total of 3 weeks of treatment. Patients' pain levels (visual analogoue scale VAS), quality of life (short form 36), mood (Beck deppression inventory BDI), range of motion, and neck disability index were evaluated prior to treatment, at 6th and at 12th weeks.

Eligibility criteria: Inclusion Criteria:

Patients with chronic neck pain

Exclusion Criteria:

* sensory deficit on neck area, servical disc pathologies, neurological deficit, malignity, secondary causes for neck pain, active inflammation, arthritis on the neck area, serious mental health problems, pregnancy, spine surgery, and having received treatment to the cervical region in the last 6 months

Primary outcomes:
measure: change from baseline VAS (visual analog scale) at 6th and 12th week
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Change from baseline quality of life (short form 36) at 6th and 12th week
timeFrame: up to 12 weeks
measure: Change from baseline shoulder range of motion (ROM) at 6th and 12th week
timeFrame: up to 12 weeks
measure: Change from baseline Beck depression inventory (BDI) at 6th and 12th week
timeFrame: up to 12 weeks
measure: Change from baseline neck disability index (NDI) at 6th and 12th week
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Hilal Yeşil
state: Afyon
Study officials:
References:
Clinical trial NCT00037141: Safety/Tolerability Study of Alcohol Injection for Treatment of BPH (Enlarged Prostate)
Official title: Evaluation of the Safety and Tolerability of Transurethral Alcohol Injection for the Treatment of BPH (Enlarged Prostate)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Disease
BPH
Benign Prostatic Hyperplasia
Benign Prostatic Hypertrophy
Keywords: Prostate
BPH
Prostatitis
Lead sponsor: American Medical Systems
Sponsor class: INDUSTRY
First posted: 2002-05-17
Enrollment: 150
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multi-center, prospective randomized dosing and safety research study. A maximum of 150 men will be enrolled in the study. Qualifying patients will receive one of three possible doses of the study drug. Symptoms will be evaluated before treatment, and then 1-week, 1-month, 3-months, and 6-months following treatment.


Eligibility criteria: Eligible patients are 50 to 80-year-old men who have experienced some or all of the following urinary symptoms for at least 6 months:

* frequent or urgent need to urinate
* difficulty starting their urinary stream
* interruption of their urinary stream
* feeling of incomplete emptying of bladder after urinating
* interruption of sleep due to the urge to urinate

Patients should have tried oral medication for their condition in the past, and be willing to discontinue any current BPH medications for a period of time before undergoing study treatment. They should be in good general health and have no previous surgery, or other procedure(s) intended to reduce prostate size.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02946541: A Clinical Trial to Investigate the Efficacy and Safety of Evogliptin
Official title: A Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial to Investigate the Efficacy and Safety of Evogliptin After Oral Administration in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Diet and Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: DA-1229
evogliptin
DPP-IV inhibitor
Suganon
DPP-4 inhibitor
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-10-27
Enrollment: 160
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 is a randomized, double-blind, placebo-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin after oral administration in patients with type 2 diabetes who have inadequate glycemic control on diet and exercise.

Detailed description: 1. Evogliptin 5mg Group: Administration with Evogliptin 5mg for 0-52 weeks.
2. Placebo Group: Administration with Placebo for 0-24 weeks, and with Evogliptin 5mg for 24-52 weeks.

Eligibility criteria: Inclusion Criteria:

* Subjects with 6.5%≤HbA1c≤10.0% at screening
* Subjects untreated with oral hypoglycemic agents within 6 weeks prior to screening
* Subjects with 6.5%≤HbA1c≤10.0% at Visit 2
* Subjects with 20kg/m2≤BMI≤40kg/m2 at screening

Exclusion Criteria:

* Subjects with fasting plasma glucose≥270mg/dL at screening
* Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
* Subjects with history of myocardial infarction, cerebral infarction within 6 months prior to screening
* Subjects with ALT and AST 2.5 times or higher than upper normal range

Primary outcomes:
measure: HbA1c
timeFrame: Change from baseline at 24 weeks
Secondary outcomes:
measure: fasting plasma glucose
timeFrame: Change from baseline at 24 weeks
measure: HbA1c response rate
timeFrame: Change from baseline at 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
Study officials:
affiliation: Kangdong Sacred Heart Hospital
name: Doo Man Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04527341: Postoperative Delirium in Cardiac Surgery ICU
Official title: Study on Visual Assessment System and Stratified Management Program for Postoperative Delirium After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Delirium
Keywords: postoperative delirium
cardiac surgery
Intensive care unit
risk assessment
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged above 18 who are admitted to surgical ICUs after cardiac surgery will be screened for eligibility.

Brief summary: Postoperative Delirium (POD) is a common complication in patients after cardiac surgery, which is associated with short-term prognosis and long-term quality of life. Due to the lack of specific treatment, prevention is the most effective strategy to reduce delirium. Risk assessment greatly contributes to guide prevention by stratifying the risk of the POD. However, the high-quality risk assessment tools are still sparse, and the combination of risk assessment and stratified prevention has not been applied to the management of delirium after cardiac surgery. In the previous work, we found the predictive value of preoperative cardiac function on POD, and found a critical value. On the basis of previous research, this project will learn from previous studies on risk factors of POD, and deeply explore potential predictors. Furthermore, we will develop and validate POD risk prediction model, and then develop it into a visual evaluation system. In addition, based on the theory of risk management and risk assessment tools, using the concepts and methods of evidence-based medicine, the risk assessment system and stratified management program of POD will be formed and evaluated by expert discussion meetings. It is expected that the risk assessment system and stratified management program constructed by this project could simply and quickly screen high-risk patients and carry out timely intervention, so as to reduce the incidence of POD, improve patients' prognosis and the quality of life after cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Aged above 18
* Patients after cardiac surgery
* Admitted to ICU after surgery

Exclusion Criteria:

* Preoperative delirium or dementia patients
* Unable to fully participate in delirium testing, including blind, deaf, illiterate or inability to understand Chinese
* Undergoing surgery procedures do not require admission to SICU
* Transfer to ICU from wards after surgery

Primary outcomes:
measure: Incidence of postoperative delirium
timeFrame: up to 5 days postoperatively
Secondary outcomes:
measure: Severity of postoperative delirium
timeFrame: up to 5 days postoperatively
measure: duration of postoperative delirium
timeFrame: up to 5 days postoperatively
Other outcomes:
Locations:
Study officials:
References: