louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00333372: To Evaluate the Efficacy of Z-338 in Subjects With Functional Dyspepsia
Official title: To Evaluate the Efficacy of Z-338 in Subjects With Functional Dyspepsia, Focusing on the Assessment of Subjective Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Functional Dyspepsia
Lead sponsor: Zeria Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2006-06-05
Enrollment: 440
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To Evaluate the efficacy of Z-338 in subjects with Functional Dyspepsia, focusing on the assessment of subjective symptoms in order to further determine the optimal dosage and efficacy parameters for PhaseIII clinical trials.


Eligibility criteria: Inclusion Criteria:

* Postprandial fullness, upper abdominal bloating and/or early satiety should be at least moderate for 2 days or more at the 7 days at Visit 1
* upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiety, nausea, vomit and belching should be at least moderate for at least 2 symptoms for 2 days or more at the 7 days at Visit 1

Exclusion Criteria:

* subjects taht heartburn should be the most bothersome symptom
* Subjects presenting with primary complaints relieved by stool movements (IBS)
* Subjects with diabetes by treatment
* Subjects taht heartburn should be more than moderate

Primary outcomes:
measure: General impression at last visit
Secondary outcomes:
measure: General impression at each week
measure: Individual symptom score
Other outcomes:
Locations:
city: Sendai
country: Japan
facility: Tohoku University
Study officials:
affiliation: Tohoku University Hospital
name: Michio Hongo, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05811572: Investigation of Pelvic Floor Muscle Strength in Low Back Pain
Official title: Investigation of Pelvic Floor Muscle Strength in Women With Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain, Mechanical
Pelvic Floor Muscle Weakness
Non-specific Low Back Pain
Disability Physical
Pain
Keywords: Non-specific low back pain
perinometer
Pelvic Floor Muscle
Disability
Pain
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Women with and without non-specific low back pain

Brief summary: To evaluate the effect of pelvic floor muscle strength on women with non-specific low back pain


Eligibility criteria: Inclusion Criteria:

* being a woman
* 18-50 years old
* BMI≤30

For The NSLBP Group:

* diagnosed with non-specific low back pain by a specialist physician,
* have low back pain for at least 3 months,
* have no pain radiating to the leg,
* have low back pain 3 or higher on the visual analog scale (VAS, 0-10 scale)

Exclusion Criteria:

* have a somatic or psychiatric disorder,
* have signs and symptoms associated with other conditions such as nerve root compression (at least 2 of these symptoms: weakness, reflex changes or loss of sensation associated with the same spinal nerve),
* have had previous spinal surgery or are scheduled for surgery,
* Pregnant
* have neurological and pelvic inflammatory diseases

Primary outcomes:
measure: pelvic floor muscle strength
timeFrame: 1 day
Secondary outcomes:
measure: Roland morris disability questionnaire
timeFrame: 1 day
measure: Visual analog scale
timeFrame: 1 day
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Bandırma Onyedi Eylül University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Study officials:
References:
Clinical trial NCT06172972: Atraumatic Care Practice From the Child and Parent Perspective
Official title: Atraumatic Care Practice From the Child and Parent Perspective
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse's Role
Keywords: child
fear
pain
phlebotomy
distraction methods
atraumatic care
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 219
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is important for pediatric nurses to apply atraumatic care while providing care to children and their families. Pediatric nurses should use methods appropriate for the child's age and developmental period within the scope of atraumatic care.

Detailed description: The use of atraumatic care approaches such as supporting the active participation of the family in the care of the child, using therapeutic communication techniques with parents and children during procedures, providing emotional support, reducing pain during painful procedures, using techniques to distract the child's attention during medical procedures, informing parents about the procedures to be performed on their children, and supporting parents and teaching techniques to cope with stress is recommended to be used by the nurses.

Eligibility criteria: Inclusion Criteria:

* being able to speak Turkish
* being between 5-10 years of age
* having no visual, intellectual or neurological disabilities
* having the phlebotomy procedure carried out with a single attempt
* not having a disease that causes chronic pain
* being accompanied by either mother or father during the procedure
* not taking painkillers or sedating drugs before the phlebotomy procedure

Exclusion Criteria:

* being younger than 5 years or older than 10 years
* having visual, audio, or speech impairments
* having a disease that causes chronic pain
* with a history of sedative and analgesic use within 24 h prior to admission
* filling out the data collection forms incompletely

Primary outcomes:
measure: Children's Fear Scale
timeFrame: baseline, pre-intervention and immediately after the intervention
measure: Wong-Baker Faces Pain Rating Scale
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Assessment of Parental Satisfaction-Visual Analog Scale
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Hatice Uzşen
state: Atakum
Study officials:
affiliation: Ondokuz Mayıs University
name: Esra Tural Büyük, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02638272: Early Outcomes of Radical Debridement Versus no Debridement Under Different Surgical Procedures
Official title: Outcomes of Radical Debridement Versus no Debridement Under Different Surgical Procedures for the Treatment of Thoracic and Lumbar Spinal Tuberculosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Tuberculosis
Lead sponsor: The Second Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2015-12-23
Enrollment: 74
Sex: ALL
Minimum age (years): 14
Maximum age (years): 67
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Whether radical debridement is necessary for the treatment of thoracic and lumbar tuberculosis is still questionable. The objective of this prospective randomized study was to compare the outcomes of radical debridement versus no debridement under different surgical procedures for the treatment of thoracic and lumbar tuberculosis.

Detailed description: Seventy-four thoracic and lumbar tuberculosis patients with a neurological function of grade D and E underwent surgeries from January 2009 to January 2014. All patients were divided into group A and group B by taking the drawing of lots. In group A, radical debridement, bone graft and instrumentation were performed. In group B, isolated posterior instrumentation without debridement were performed in all cases and drainage of iliopsoas abscess via laparoscopy in 2 cases. The operative time, blood loss, visual analogue score (VAS), erythrocyte sedimentation rate (ESR), kyphotic angle, Frankel grading, fusion rate and complications were evaluated.

Eligibility criteria: Inclusion Criteria:

1. Frankel grading was grade D and E
2. Severe back pain
3. Abscess combined with high pressure symptoms
4. Larger sequestrum formation or sinus
5. Significant spinal instability.

Exclusion Criteria:

1. Frankel grading was grade A,B and C
2. Conservative treatment

Primary outcomes:
measure: The operative time in minutes
timeFrame: 5 years
measure: blood loss in milliliter
timeFrame: 5 years
measure: erythrocyte sedimentation rate (ESR) in mm/h
timeFrame: 5 years
measure: kyphotic angle in degree
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04330872: An Investigation Into The Impact Of Enteric Coated Of Aspirin In Patients With Newly Diagnosed Ischemic Stroke.
Official title: An Investigation Into The Impact Of Enteric Coated Of Aspirin In Patients With Newly Diagnosed Ischemic Stroke. Non-randomized Interventional Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke, Ischemic
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2020-04-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Uncertainty remains regarding the impact of enteric-coated (EC) aspirin as it relates to the reduction of CV risk. We hypothesize that EC formulation based on the previous report may blunt aspirin response as evidenced by reduced Thromboxane A2 (TXA 2) levels in diabetic patients.


Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed ischemic stroke who are just about to start aspirin.
2. No prior history of cardiovascular morbidity (including ischemic heart disease, chronic kidney disease, peripheral vascular disease) 3-18- 75 years.

4-Patients with ischemic stroke who underwent reperfusion intervention (catheter-directed thrombolysis and/or thrombectomy) regardless of the time of presentation (i.e within or outside the therapeutic window as the managing stroke deem fit.

Exclusion Criteria:

1. Concomitant antiplatelet therapy (irrespective of the duration of the treatment).
2. Patients on any prostaglandins related medications (non-steroidal anti-inflammatory drugs, misoprostol, and other ant secretory drugs among others).
3. Any salicylate-containing supplements.
4. Patients on the NG tube will be excluded from the study

Primary outcomes:
measure: Incidence of Aspirin non-responders.
timeFrame: At "Day 3"
Secondary outcomes:
measure: Incidence of Gastrointestinal bleeding consequent upon aspirin therapy.
timeFrame: After three daily aspirin doses ( at "Day 3")
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
References:
citation: Elshafei MN, Imam Y, Alsaud AE, Chandra P, Parray A, Abdelmoneim MS, Obeidat K, Saeid R, Ali M, Ayadathil R, Mohamed MFH, Abdallah IM, Mohammed S, Akhtar N, Danjuma MI. The impact of enteric coating of aspirin on aspirin responsiveness in patients with suspected or newly diagnosed ischemic stroke: prospective cohort study: results from the (ECASIS) study. Eur J Clin Pharmacol. 2022 Nov;78(11):1801-1811. doi: 10.1007/s00228-022-03391-2. Epub 2022 Sep 19.
citation: Elshafei MN, Imam Y, Mohamed MFH, AlSaud AE, Ahmed MS, Obeidat K, Saeid R, Ali M, Abdallah IM, Parray AS, Danjuma MI. An investigation into the impact of enteric coated of aspirin in patients with newly diagnosed ischemic stroke (ECASIS). Medicine (Baltimore). 2020 May;99(20):e20307. doi: 10.1097/MD.0000000000020307.
Clinical trial NCT02422472: Comparison of Ultrasound Guided Peripheral IV Placement With and Without Use of a Guidewire
Official title: Comparison of Ultrasound Guided Peripheral IV Placement With and Without Use of a Guidewire
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult Peripheral IV Access
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 70
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 compare ultrasound guided peripheral IV placement with and without the use of a guidewire. Patients in the Emergency Department with difficult peripheral IV access (as defined by 2 failed attempts by nursing staff) will be consented and randomized to standard ultrasound guided peripheral IV placement or ultrasound guided peripheral IV placement with modified seldinger technique using a guidewire.


Eligibility criteria: Inclusion Criteria:

* Difficult peripheral IV access (2 failed attempts by nursing staff)
* Prior history of difficult IV access and patient request for ultrasound guided IV

Exclusion Criteria:

* Need for emergent access or central venous access
* Inability to provide informed consent

Primary outcomes:
measure: First attempt success rate
timeFrame: 60 minutes
Secondary outcomes:
measure: Overall success rate
timeFrame: 60 minutes
measure: Number of skin punctures
timeFrame: 60 minutes
measure: Complications including hematoma, IV infiltration, catheter dislodge
timeFrame: 3 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Heidi Kimberly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06440772: Portal Vein Pulsatility Index to Assess Fluid Intolerance
Official title: Assessing Fluid Intolerance Using Portal Vein Pulsatility Index Post-Passive Leg Raising Test in Fluid Responders: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Congestion
Keywords: congestion
portal vein pulsatility
ultrasound
fluid responsiveness
fluid tolerance
Lead sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 50
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: Mechanically ventilated postoperative adult patients after cardiac surgery within 6 hours after intensive care unit admission.

Brief summary: This study uses the portal vein pulsatility index (PVPI) to assess fluid intolerance amongst fluid responders.

Detailed description: This prospective observational study aims to use the portal vein pulsatility index (PVPI) to assess fluid intolerance in fluid responders. The investigators will enroll mechanically ventilated postoperative adult patients within 6 hours of ICU admission after cardiac surgery. Patients will undergo a Passive Leg Raising (PLR) test and Left Ventricular Outflow Tract (LVOT) recording using transthoracic echocardiography. The main objective is to predict fluid intolerance after a fluid challenge of 7 ml/kg Ringer Lactate over 10 minutes in initially tolerant fluid responders.

Eligibility criteria: Inclusion Criteria:

* Informed consent.
* Mechanically ventilated patients within 6 hours after ICU admission following surgery who are considered for fluid administration to optimize haemodynamics.
* Sinus rhythm.

Exclusion Criteria:

* A condition known to interfere with portal vein flow assessment or interpretation (liver cirrhosis or chronic hepatic disease, suprahepatic or portal vein thrombosis).
* Any mechanical circulatory support.
* Cardiac transplant.
* Poor transthoracic echocardiographic window.

Primary outcomes:
measure: Fluid Intolerance
timeFrame: 10 minutes after 7 ml/kg Ringer's Lactate
Secondary outcomes:
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases
Study officials:
affiliation: "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases
name: Cosmin Balan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases
name: Serban-Ion Bubenek-Turconi, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT05768672: The Sense of Small and Inhibition in Obesity
Official title: Investigating the Relationship Between the Sense of Smell and Cognitive Inhibition in Obesity: a Behavioural Experiment.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Keywords: obesity
smell
food
cognitive inhibition
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
Collaborators: name: Università degli Studi di Trento
First posted: 2023-03-14
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with obesity will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy)

Brief summary: The aim of this research is to verify whether inhibitory control ability is different between a group of individuals with obesity and a group of individuals with normal weight in the presence of olfactory stimuli, different for valence, edibility (food versus no-food), and caloric density (high-calorie vs low-calorie content) of foods associated with odours.


Eligibility criteria: Inclusion criteria:

* Right-handed
* diagnosis of obesity (i.e., the level of body mass index (BMI) higher or equal to 30).

Exclusion criteria:

* Concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders.

Primary outcomes:
measure: Error %
timeFrame: baseline
Secondary outcomes:
measure: Interference Error
timeFrame: baseline
Other outcomes:
Locations:
city: Piancavallo
country: Italy
facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe
state: VCO
Study officials:
affiliation: IRCCS Istituto Auxologico Italiano
name: Sofia Tagini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00784472: Visceral Pain From the Upper Urinary Tract - a Trial on the Effect of Morphine and Oxycodone in Patients Undergoing PCNL
Official title: Visceral Pain Originating From the Upper Urinary Tract - a Randomized Controlled Trial on the Effect of Morphine and Oxycodone in Patients Undergoing Percutaneous Nephrolithotomy (PCNL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Stones
Keywords: PCNL
oxycodone
morphine
visceral pain
Lead sponsor: Fredericia Hosptial
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
First posted: 2008-11-04
Enrollment: 55
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 investigate the effect of oxynorm versus morphine after operation for kidney stone (PCNL). In addition the relationship between pain symptoms and referred sensory and trophic changes will be examined in the patients before and after the operation.Finally a blood sample is analysed to investigate pharmaca-genetics.

Detailed description: Primary outcome: the amount of opioid (morphine or oxynorm) used the first 4 hours postoperatively.

Secondary outcome: side effect to the opioids, pain score, pain threshold to electrical stimulation and pressure before and after operation, pharmacogenetics, size of referred pain area.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Indication for PCNL

Exclusion Criteria:

* Malignant disease in the upper urinary tract
* Allergy to morphine or oxycodone
* Use of opioids the last 48 hours before PCNL
* Pregnancy
* Nursing mothers
* Present JJ-stent in the ureter
* Previous urinary stone disease on the opposite site

Primary outcomes:
measure: Amount of analgetics used
timeFrame: four hours postoperatively
Secondary outcomes:
measure: Side effects
timeFrame: four hours postoperatively
Other outcomes:
Locations:
city: Fredericia
country: Denmark
facility: Hospital Little Belt, Fredericia
Study officials:
affiliation: Hospital Little Belt, Fredericia
name: Palle Osther, Professor
role: STUDY_CHAIR
affiliation: Hospital Little Belt, Fredericia
name: katja Venborg Pedersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05520372: Autologous Immune Enhancement Therapy (AIET) for Cancer Patients
Official title: Evaluating Safety and Quality of Life of Cancer Patients Treated by Autologous Immune Enhancement Therapy (AIET) in Vinmec International Hospitals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Patients With Cancer
Lead sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a retrospective study that included 60 cancer patients who underwent autologous NK cell and CD8 T cell therapy between January 2016 and December 2021

Detailed description: The dysfunction and reduced proliferation of peripheral immune cells including CD8 T and NK cells have been observed in both aging and cancer patients, thereby challenging the immune cell therapy in these subjects. Therefore, we evaluated the growth of these lymphocytes in elderly patients with several types of cancer and the correlation of peripheral blood (PB) indexes to the expansions. This is a retrospective study that included 60 cancer patients who underwent autologous NK cell and CD8 T cell therapy between January 2016 and December 2021. By optimizing the antiviral and tumor surveillance ability of both NK cells and CTLs through serial steps from isolation and expansion, followed by re-infusion of these activated cells back to the patient body, AIET has become a promising, cutting-edge method in detecting and eliminating cancer cells. The study aimed to evaluate the safety and effectiveness of 60 cancer patientsreceiving AIET.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 - 75
* Patients have been diagnosed with cancer.
* Patients signed the written informed consent form.

Exclusion Criteria:

* Severe health conditions such as serious infection, autoimmune diseases, or using any anti-rejection drugs

Primary outcomes:
measure: Number of Adverse events and serious adverse events (AEs or SAEs)
timeFrame: up to the 36-month period following treatment
Secondary outcomes:
measure: Changes in health-related quality of life of patients
timeFrame: up to the 36-month period following treatment
measure: Survival time of patients in this study
timeFrame: up to the 36-month period following treatment
measure: Changes in Symptoms of patients using MD Anderson Symptoms Inventory Gastrointestinal Cancer Module (MDASI )
timeFrame: up to the 36-month period following treatment
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vinmec Research Institute of Stem Cell and Gene Technology
Study officials:
affiliation: Vinmec Research Institute of Stem Cell and Gene Technology
name: Liem Nguyen Thanh, PhD
role: PRINCIPAL_INVESTIGATOR
References: