louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06391268: Emotional Freedom Technique (EFT) on Pain and Stress Levels in Fibromyalgia (FMS)
Official title: "Investigation of the Effect of Self-Applied Emotional Liberation Technique on Pain and Stress Levels in Fibromyalgia Patients"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia,
Emotional free technique
pain
stress
comfort
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: Buca Seyfi Demirsoy State Hospital
First posted: 2024-04-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Determination of Subjective Units of Discomfort (SUD) (The researcher scores the distress felt on a scale between zero and ten points).
2. Setup (The general structure of the setup sentence is "Despite this .........., I deeply and completely accept myself.")
3. Clicking the meridian points in sequence
4. Nine Gamut procedure (some eye movements, mumbling and counting while clicking on the Gamut point in the hand).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The main aim of the study was to investigate self-administered emotional to determine the effect of the freedom technique on pain and stress levels.

The sub-objectives of the study are as follows:

1. To determine the effect of self-administration of EFT on pain level.
2. To determine the effect of self-administered EFT on stress level.
3. To determine the effect of EFT self-administration on comfort level.

Detailed description: HYPOTHESES OF THE RESEARCH

H 1 : Between the pain levels of patients with and without self-administered EFT there is a difference.

H 2 : There is a difference between the stress levels of patients who apply EFT to themselves and those who do not. there is a difference.

H 3 : Comfort levels of patients with and without self-administered EFT there is a difference.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of fibromyalgia
* Can speak and understand Turkish
* Have time and place orientation
* No psychiatric illness,
* No vision and hearing problems.

Exclusion Criteria:

* Unstable medical condition
* Non-cooperative individuals

Primary outcomes:
measure: Comparison of the self-EFT group
timeFrame: up to 24 weeks
measure: INVESTIGATION OF THE EFFECT OF SELF-APPLIED EMOTIONAL FREEDOM TECHNIQUE ON PAIN AND STRESS LEVELS IN FIBROMYALGIA PATIENTS
timeFrame: INVESTIGATION OF THE EFFECT OF SELF-APPLIED EMOTIONAL FREEDOM TECHNIQUE ON PAIN AND STRESS LEVELS IN FIBROMYALGIA PATIENTS
Secondary outcomes:
measure: Control grouup
timeFrame: up to 24 weeks
measure: Control grouup
timeFrame: The application areas of the thesis are from non-pharmacological treatments to complementary therapies.
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Buca Seyfi Demirsoy Training and Research Hospital
Study officials:
References:
Clinical trial NCT00629668: Genetic Polymorphisms of TNF-α Promoter and HBV Genotype on Outcome of HBV-Related Chronic Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Liver Disease
Hepatocellular Carcinoma
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2008-03-06
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The prognosis of Hepatitis B virus (HBV)infection varies from minimal progressive liver disease to cirrhosis or hepatocellular carcinoma (HCC).Both viral and host genetic factors contribute to disease severity. Cytokine gene polymorphism has been regarded affecting prognosis of disease. By detecting HBV genotyping and tumor necrosis factor-alpha polymorphism, this study aime to assess their effects and interaction on disease severity of HBV-related chronic liver disease and HCC.


Eligibility criteria: Inclusion Criteria:

* HBV-positive patients

Exclusion Criteria:

* HBV-negative patients

Primary outcomes:
measure: cytokine gene polymorphism
timeFrame: years
Secondary outcomes:
measure: cytokine gene polymorohism on severity of disease
timeFrame: years
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Assistant Professor of Clinical Laboratory
name: Jen-Eing Jeng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04001868: Sub Occipital Inhibition Technique on Postural Balance
Official title: Immediate Effect of Sub Occipital Inhibition Technique on Postural Balance: Stabilometric Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Movement Disorders
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the present study the investigators want to verify if the inhibition of the suboccipital muscles improves the postural balance in subjects with cervical pain objectified by stabilometry.


Eligibility criteria: Inclusion Criteria:

* Individuals who suffer neck pain for at least 3 months
* Come to receive physiotherapy treatment at Clinica Osteomed (NRS: 8415-CV), Elche, Alicante, Spain.
* Age between 18 and 65 years old.
* Sign the informed consent.

Exclusion Criteria:

* Suffering or having suffered pathologies of the postural control system (postural sensors, central nervous system or locomotor system)
* Presenting deformities or orthopedic injuries in the lower limbs or rachis
* Presenting pain at the moment of study
* Present contraindications to the intervention under study
* Have received physiotherapy treatment in the last six months
* Have undergone surgical treatment of any kind.

Primary outcomes:
measure: Surface of the ellipse open eyes
timeFrame: Postintervention immediate
measure: Surface of the ellipse closed eyes
timeFrame: Postintervention immediate
Secondary outcomes:
measure: Mean of the oscillation on the X axis and on the Y axis.
timeFrame: Preintervention and Postintervention immediate.
measure: Speed of the oscillation on the X axis and on the Y axis
timeFrame: Preintervention and Postintervention immediate.
measure: Average speed of the oscillation
timeFrame: Preintervention and Postintervention immediate.
measure: Length of oscillation
timeFrame: Preintervention and Postintervention immediate.
Other outcomes:
Locations:
city: Moncada
country: Spain
facility: Ceu Cardenal Herrera University
state: Valencia
Study officials:
References:
Clinical trial NCT05472168: Impact of Olfactory Odour StimulatioN on Energy EXpenditure
Official title: SNEEX - Impact of Olfactory Odour StimulatioN on Energy EXpenditure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: In this preliminary short-term study it is investigated, whether a short olfactory stimulation with distinct odours impacts energy expenditure in patients with obesity and lean patients.


Eligibility criteria: Inclusion Criteria:

* • Age 18-55 years

  * Obesity (BMI ≥30 kg/m2) and Lean (BMI 18-25 kg/m2)
  * Written informed consent
  * Normosmia (defined by sniffing Sticks test)

Exclusion Criteria:

* • Chronic or acute sinusitis

  * Surgical intervention of the nasal cavity or the paranasal sinus
  * Known allergy to odors used in the study
  * Smokers
  * Current illicit drug abuse including daily marijuana and cannabidiol (CBD) consumption (alcohol ≤2 drinks per day allowed)
  * Any kind of severe chronic disease (e.g. severe heart failure, active cancer disease)
  * Diabetes mellitus
  * Treatment with insulin sensitizing drugs including Glucagon-like Peptide (GLP)-1 analogues within the last 3 months
  * History of neurodegenerative diseases, severe head trauma
  * Severe renal impairment (e.g. estimated glomerular filtration rate \<30 ml/min/m2)
  * Known liver cirrhosis or other severe liver impairment
  * Use of any kind of decongestant more than twice a week
  * Use of cortisone-containing nasal spray within the last 3 months
  * Acute upper respiratory tract infection
  * Uncontrolled dysthyroidism
  * Uncontrolled hypertension
  * Regular use of psychopharmaceutic drugs
  * Study participants aims to start a new diet or exercise program during the study
  * Bariatric surgery
  * Pregnancy/Lactation
  * Onset of climacteric symptoms within one year (e.g. hot flashes and/or diaphoresis) OR initiation of hormonal replacement therapy in the last three months
  * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
  * Participation in an interventional study within the last 3 months

Primary outcomes:
measure: Change in Energy Expenditure
timeFrame: 6 hours
Secondary outcomes:
measure: Energy Expenditure, Additional Odours
timeFrame: 6 hours
measure: Heart Rate
timeFrame: 6 hours
measure: Blood Pressure
timeFrame: 6 hours
measure: Metabolic Parameters
timeFrame: 6 hours
measure: Glucose Levels
timeFrame: 6 hours
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
References:
Clinical trial NCT03570268: Preventing Falls and Participation Restrictions in Neurological Diseases
Official title: Educational and Exercise Intervention to Prevent Falls and Participation Restrictions in Subjects With Neurological Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Parkinson Disease
Stroke
Keywords: Falls prevention
Education
Neurological disease
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2018-06-26
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: A randomized open clinical trial to assess the added value of a comprehensive rehabilitation program on fall prevention and improve participation and activities of daily living. Baseline assessment, 6-month experimental intervention (experimental group) vs. usual rehabilitation programs and assessment at end of treatment and six months after treatment will be performed.

Detailed description: 90 patients will be randomly patients will be stratified by disease type and randomized separately.

The trial will be organized in Baseline assessment (clinical characteristics; fall predictors, chosen among the variables found to predict falls in the observational study), experimental intervention (experimental group) vs. usual rehabilitation programs (control group) and assessment at end of treatment and six months after treatment.

The aim of the treatment will be the prevention of falls.

Eligibility criteria: Inclusion Criteria:

Patients with stroke, Parkinson's disease and Multiple Sclerosis residing in the centers' catchment areas, requiring rehabilitation, and releasing a written informed consent.

Exclusion Criteria:

1. Cognitive impairment (Minimental State Examination score \<21); 2. Major depression; 3. Severe joint/bone disorder interfering with mobility, 4. Aphasia if interfering with understanding the aims of the study and self-administered tests; 5. relapses in the previous three months (MS); 6. Stroke occurred in least four weeks before study entry.

Primary outcomes:
measure: Change of Percentage of fallers
timeFrame: Change from Baseline percentage of fallers at 6 months.
Secondary outcomes:
measure: Change of Participation level
timeFrame: Change from Baseline partecipation at 6 months.
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione Don Gnocchi ONLUS
Study officials:
References:
Clinical trial NCT06718868: Evaluation of the Effect of Pectoral Nerve Block II on Acute and Chronic Pain in Patients Undergoing Oncological Breast Surgery
Official title: Evaluation of the Effect of Pectoral Nerve Block II on Acute and Chronic Pain in Patients Undergoing Oncological Breast Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Carcinoma
Chronic Pain
Keywords: Oncological breast surgery, PECS II Block, chronic pain, acute pain
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 128 patients who met the inclusion criteria were included in the study.

Brief summary: The aim of this observational study is to evaluate the effect of Pectoral Nerve Block II (PECSII) on the development of pain in the acute and chronic periods in female patients over the age of 18 who underwent oncological breast surgery. The main questions it aims to answer are:

Is PECSII blockade applied to patients undergoing oncological breast surgery effective on acute pain scores compared to the non-blockade group? Is there a difference between the group with block and the group without block in terms of the development of chronic pain in the evaluation made at the 3rd month after surgery? The analgesia method applied to the patients will be recorded in the patient files and acute and chronic pain scores will be evaluated. Chronic pain score evaluation will be made by telephone survey.


Eligibility criteria: Inclusion Criteria:

* Patients who will be operated under general anesthesia
* ASA score I-II-III patients
* Non-pregnant patients
* Patients who agreed to participate in the study

Exclusion Criteria:

* Patients with coagulopathy
* Patients who underwent bilateral mastectomy
* Patients with chest wall anomalies
* Patients with neuropathic pain before surgery
* Patients who did not agree to participate in the study

Primary outcomes:
measure: Evaluation of the effect of PECSII block on the development of chronic pain in patients undergoing oncological breast surgery
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Tascıoglu Education and Research Hospital
Study officials:
affiliation: Prof. Dr. Cemil Tascioglu Education and Research Hospital
name: Serap Karacalar, Prof.
role: STUDY_DIRECTOR
affiliation: Prof. Dr. Cemil Tascioglu Education and Research Hospital
name: İrem Erkan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02883868: Stromal Demarcation Line: is it Predictive for Cross-Linking Efficiency?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Progressive Keratoconus
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients treated with CXL between March 2014 and March 2015 were included

Brief summary: To assess the association between stromal demarcation line after collagen crosslinking (CXL) for progressive keratoconus and mid-term (6 month) refractive, topographic and clinical outcomes of CXL

Detailed description: All consecutive patients treated with CXL between March 2014 and March 2015 were included. They all underwent the same procedure: accelerated-CXL protocol (10 minutes UVA irradiation with 9 mW/cm2 intensity), irradiation device (IROC UV-X™ 2000, Medeuronet). One month after the procedure, AS-OCT examination was performed in all patients (RS-3000, NIDEK). The visibility of the stromal demarcation line was scored (0: not visible line; 1: visible line, but measurement not clearly defined; 2: clearly visible line) and its depth was measured centrally at anytime it was possible. Changes in best corrected visual acuity (BCVA), spherical equivalent (SE), Kmax and thinnest pachymetry, were studied preoperatively and at 6 months

Eligibility criteria: Inclusion Criteria:

* patients treated with CXL

Exclusion Criteria:

-

Primary outcomes:
measure: visibility of the stromal demarcation line
timeFrame: month 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02093572: Effect of Skipping Breakfast on Metabolic Function
Official title: Effect of Skipping Breakfast on Metabolic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skipping Breakfast
Circadian Rhythms
Keywords: Clock genes
Metabolism
Insulin sensitivity
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-03-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to test the hypothesis that the disruption of the "normal" (three meals a day) eating pattern and prolonged overnight fasting caused by skipping breakfast: i) alters the expression of specific clock genes and clock gene targets involved in regulating adipose tissue lipolysis (breakdown or destruction); ii) increases basal adipose tissue lipolytic (breakdown) activity and plasma free fatty acid (FFA) concentrations; iii) reduces skeletal muscle insulin sensitivity; and iv) increases daylong plasma glucose, FFA, and insulin concentrations. The investigator will do this by studying healthy, lean persons either randomized to consume either 3 standard meals per day or omit breakfast and consume 2 meals per day without changing daily calorie intake (skipping breakfast group).


Eligibility criteria: Inclusion Criteria:

* Males \& females
* 18-55 years old
* BMI between 18.5 - 29.9 kg/m²
* Sleeps \>7 hours/night
* Normally consume 3 meals/day, including breakfast

Exclusion Criteria:

* Pregnancy, lactating or breastfeeding
* Diabetes
* Sleep disorders
* Significant organ dysfunction
* Shift or nighttime workers
* Smokers
* Breakfast skippers
* People who regularly sleep \<7 hours/night
* Consume excess amounts of alcohol
* Medications that could alter the results of this study

Primary outcomes:
measure: Determine the effect of skipping breakfast on basal adipose tissue lipolytic activity and skeletal muscle insulin sensitivity
timeFrame: 3 weeks
measure: Determine the effect of skipping breakfast on 24-hour plasma substrate, hormone concentrations and intramyocellular fatty acid mediators of lipotoxicity.
timeFrame: 3 weeks
measure: Determine the effect of skipping breakfast on the diurnal expression of clock genes and downstream metabolic targets involved in regulating adipose tissue lipolytic activity and skeletal muscle insulin action.
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jun Yoshino, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yamaguchi S, Moseley AC, Almeda-Valdes P, Stromsdorfer KL, Franczyk MP, Okunade AL, Patterson BW, Klein S, Yoshino J. Diurnal Variation in PDK4 Expression Is Associated With Plasma Free Fatty Acid Availability in People. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1068-1076. doi: 10.1210/jc.2017-02230.
Clinical trial NCT05282069: A Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder
Official title: A Multicenter, Double-blind, Placebo-controlled and Active-reference, Randomized, Parallel, Therapeutic Confirmatory Clinical Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-16
Enrollment: 607
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of DA-8010 in patients with overactive bladder for 12 weeks as double-blind, placebo-controlled and active-reference study, and also will evaluate the long-term safety of DA-8010 for 52 weeks in patients with overactive bladder as open-label study.


Eligibility criteria: Inclusion Criteria:

Main Inclusion at Screening (Visit 1):

* Men and women 19 years or older with OAB symptoms for ≥ 3 months.
* Subject who is willing and able to complete the voiding diary correctly.
* Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study

Exclusion Criteria:

Main Exclusion at Screening (Visit 1):

* Clinically significant stress urinary incontinence or mixed urinary incontinence where stress is the predominant factor
* Subject who has Injury or neurodegenerative disease which is able to effect on lower urinary tract and nerves
* Subject with diabetes insipidus, urinary stone, urinary tract infection, interstitial cystitis, recurrent urinary tract infection, pelvic organ prolapse or neurogenic bladder
* Clinically significant benign prostatic hyperplasia at the discretion of the investigator
* Had bladder or lower urinary tract surgery within 12 months from the screening visit
* Medical history of malignant tumor in urinary system or pelvic organs
* \>150 mL of post-void residual volume in the screening test

Primary outcomes:
measure: Change from baseline in the mean number of micturitions per 24 hours at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline in the mean number of micturitions per 24 hours at 4 and 8 weeks
timeFrame: 4 and 8 weeks
measure: Change from baseline in the mean number of urinary urgency(Grade 2, 3, 4) per 24 hours at 4, 8 and 12 weeks
timeFrame: 4, 8 and 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References: