louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04843384: The Effect of Reiki on Anxiety, Stress, and Comfort
Official title: The Effect of Reiki on Anxiety, Stress, and Comfort Levels Before Gastrointestinal Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reiki
Gastro-Intestinal Disorder
Lead sponsor: Mardin Artuklu University
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Upper gastrointestinal (GI) endoscopy is a procedure that is used in the examination, diagnosis, and treatment of the esophagus, stomach, and duodenum. With developments in present-day technology, it is safe and widely used. This study's aim is to determine the effect of Reiki when applied before upper gastrointestinal endoscopy on levels of anxiety, stress, and comfort. This single-blind, randomized, sham-controlled study was held between February and July 2021.

Detailed description: Anxiety and stress are problems that are often seen in patients undergoing upper GI endoscopy, and managing them is an important step in calming the patient and thereby reducing complications.The results of this study will contribute to the literature in forming a basis for other studies on the topic. The aim of this study is to evaluate the effects of the application of Reiki and sham Reiki on anxiety, stress, and comfort levels in patients undergoing upper GI endoscopy.

Eligibility criteria: Inclusion criteria

* patients who were having an upper GI endoscopy for the first time,
* patients who were age 18 or over,
* patients who had not previously had Reiki or sham Reiki (SR),
* patients who did not have a history of an operation in the previous six months,
* patients who were not using anxiolytic, hypnotic, or sedative drugs,
* patients who had no cognitive or effective problems or any hindrance in communication,
* patients who was literate, and who agreed to take part in the study.

Exclusion criteria

* patients who had an upper GI endoscopy with more than one elective condition,
* patients who was undergoing an emergency upper GI endoscopy,
* patients who were using anxiolytic, hypnotic, or sedative drugs,
* patients who had taken an opioid analgesic before the procedure,
* patients who completed the data collection forms incorrectly or incompletely,
* patients who had previously had Reiki or SR,
* patients who had a runny nose, fever, cough or any complaint of breathing difficulty,
* patients who were not literate and who did not wish to voluntarily participate.

Primary outcomes:
measure: Visual Analog Scale for Stress (VASS)
timeFrame: "Average of 1 year"
measure: State Anxiety Inventory (SAI)
timeFrame: "Average of 1 year"
measure: Short General Comfort Questionnaire (SGCQ)
timeFrame: "Average of 1 year"
Secondary outcomes:
Other outcomes:
Locations:
city: Mardin
country: Turkey
facility: Hediye Utli
Study officials:
affiliation: Mersin University
name: Birgül VURAL DOĞRU, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06378684: To Evaluate the Safety and Pharmacokinetic Interactions in Healthy Volunteers
Official title: A Randomized, Open-label, Multiple-dose, 6×3 Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of JW0104 and C2207 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2024-04-22
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The objective is to evaluate the safety and Pharmacokinetic Interactions after adminitration drug(Treatment A or B or A+B) in Healthy Volunteers

Detailed description: Pharmacokinetic Interactions: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

Safety: All adverse events are summarized in terms of the number of subjects, expression rate, and number of expressions of adverse reactions by treatment group.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Subjects does not meet the Inclusion Criteria

Primary outcomes:
measure: Cmax,ss
timeFrame: Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)
measure: AUCτ,ss
timeFrame: Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trial Center, Severance Hospital
Study officials:
affiliation: Severance Hospital
name: MinSoo Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02663284: Evaluation of the Physiodoloris Pain Monitor in Patients With Complex Regional Pain Syndrome
Official title: Evaluation of Non-invasive Monitor of Physiodoloris Pain in Patients With Complex Regional Pain Syndrome Treated by Nerve Block (Prospective Monocenter Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Regional Pain Syndrome
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A French University team (M. Jeanne, MD, and M. LOGIER, Ph D) have developed a pain assessment tool based on the analysis of the variability heart rate which evaluates the Analgesia Nociception Index (ANI). This index is intended to give a quantification of pain.

The aim of the present study is to assess the validity of the ANI parameter in patients with Complex Regional Pain Syndrome treated with a nerve block (reversible pain).


Eligibility criteria: Inclusion Criteria:

* patients suffering from a Complex Regional Pain Syndrome of the upper or lower limb

Exclusion Criteria:

* contra-indication of a nerve block,
* contra-indication of the use of the pain monitor

Primary outcomes:
measure: Evaluation of ANI before the peri-neural block
timeFrame: 5 minutes
measure: Evaluation of pain before the peri-neural block
timeFrame: 5 minutes
Secondary outcomes:
measure: Evaluation of ANI after the peri-neural block
timeFrame: 10 minutes
measure: Evaluation of pain after the peri-neural block
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Coquelles
country: France
facility: Clinique des 2 Caps
Study officials:
affiliation: Hopital Foch
name: Marc Fischler
role: STUDY_CHAIR
References:
Clinical trial NCT06399484: In Patients With Carpal Tunnel Syndrome, Median Nerve Conduction is Evaluated After Nerve Mobilizations
Official title: Immediate Effect of Median Nerve Mobilization on Neural Conduction in Patients With Carpal Tunnel Syndrome: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 30
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 project is linked to the line of research on carpal tunnel syndrome, of the PhysiUZerapy research group, belonging to the University of Zaragoza. Within this line, the biomechanical and physiological effect of the proposed technique has been investigated, both in healthy subjects, in cadavers and in patients with carpal tunnel syndrome (CTS), resulting in the reading of 2 doctoral theses, the publication of 9 articles in high-impact journals. and the patent for a splint for the treatment of pathology. This project aims to provide information that is still lacking on the immediate effect of these techniques in patients with CTS. For this, there will be three groups of patients from the Lozano Blesa University Clinical Hospital distributed randomly. In two of the groups, sliding and neural tension techniques will be carried out (case group). The remaining group (control group) will be taken as a reference by performing a placebo treatment. Before and after carrying out these techniques, electrophysiological data will be collected to be able to compare them. This comparison is based on highlighting the differences between the data before the techniques and after, as well as between the case group and the control group.


Eligibility criteria: Inclusion Criteria:

* Being over 18 years
* Present carpal tunnel syndrome diagnosed by electroneurogram
* Have understanding and communication skills
* Give consent to participate in the study

Exclusion Criteria:

* Have received previous surgery on the hand or wrist
* Present a severe limitation of movement in any of the joints of the affected upper limb
* Not signing the informed consent

Primary outcomes:
measure: Distal motor latency (APB) (ms)
timeFrame: Before and immediately after the intervention
measure: Motor amplitude (APB) (mV)
timeFrame: Before and immediately after the intervention
measure: Median motor velocity (m/s)
timeFrame: Before and immediately after the intervention
measure: Median sensory conduction (digit II) (13 cm) (m/sec)
timeFrame: Before and immediately after the intervention
measure: Sensory amplitude (µV)
timeFrame: Before and immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
Study officials:
References:
Clinical trial NCT05040984: Predictors Affecting Long-term Use of Solifenacin or Mirabegron in Women With Overactive Bladder Syndrome
Official title: Predictors Affecting Long-term Use of Solifenacin or Mirabegron in Women With Overactive Bladder Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overactive Bladder Syndrome
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 500
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with overactive bladder syndrome, who received Solifenacin or Mirabegron as the initial treatment.

Brief summary: A retrospective analysis of medical records at Far Eastern Memorial Hospital from January 2008 to May 2020 about female patients with overactive bladder syndrome, who received Solifenacin or Mirabegron as the initial treatment. Factors affecting persistence of OAB medications will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Women with overactive bladder syndrome received solifenacin or mirabegron as the initial treatment

Exclusion Criteria:

* \<20 year-old

Primary outcomes:
measure: Predictors of persistence of mirabegron versus solifenacin use
timeFrame: 13 years
Secondary outcomes:
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT04715984: Corticostriatal Contributions to Parkinson's Disease Cognitive Impairment
Official title: Corticostriatal Neurophysiology in Parkinson's Disease Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Deep Brain Stimulation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to learn more about the brain activity underlying Parkinson's disease cognitive impairment. The investigators will utilize neural recordings from corticostriatal structures performed during deep brain stimulation surgery to measure neural activity underlying nonmotor symptoms of Parkinson's disease.


Eligibility criteria: Inclusion criteria:

* Scheduled to undergo deep brain stimulation surgery under local anesthesia at Vanderbilt University Medical Center
* Planned clinical electrode trajectory that contacts caudate
* Age greater than or equal to 40
* Diagnosis of Parkinson's disease
* Able to participate in intraoperative testing
* English speaking

Exclusion criteria:

* Age less than 40
* Not able to participate in intraoperative testing (for example unable to comprehend instructions or follow directions)
* Movement disorder other than Parkinson's disease

Primary outcomes:
measure: Changes in caudate DLPFC beta coherence
timeFrame: Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours
measure: Changes in gambling task performance with neural stimulation
timeFrame: Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours
Secondary outcomes:
measure: Change in beta power with neural stimulation
timeFrame: Baseline to end of deep brain stimulation (DBS) surgery, approximately 3-4 hours
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Sarah Bick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03010384: Contact to a Physician Specialized in Social Medicine and Return to Work
Official title: Contact to a Physician Specialized in Social Medicine and the Impact on Return to Workforce in Patients Suspected of Disc Herniation? - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Return to Work
Musculoskeletal Disease
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 443
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to investigate the impact of a rehabilitation program including a physician specialized in social medicine parallel to treatment for suspected spinal disc herniation.

Detailed description: In a two-year time period (2011 to 2012) 443 patients of suspected of disc herniation and risk of low work ability - based on questionnaires participated in a randomized control trial. The patients were randomized to either the intervention group (n=220) or control group (n=223). The intervention group were invited to the Department of Social Medicine two to four weeks after their first contact to Department of Rheumatology for a consultation with a physician specialized in social medicine. Together with the patient a return-to-work (RTW) schedule was made to ascertain the need for contact to the workplace (to adjust work functions), municipality, general practitioner or short-term supportive consultations with a psychologist. Throughout the intervention, the patients received their usual treatment from the Department of Rheumatology like patients from the control group. Outcome was return to the work force at one year follow up using information from a national registry.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 and \< 60 years old,
* not receiving disability pension and not on maternity leave.
* sick leave over the past year for more than ten days
* low self-rated work ability for the next two years
* health anxiety

Exclusion Criteria:

-

Primary outcomes:
measure: Return to Work (register based information)
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02382484: Impact of Pacing Site and AV Delay on Blood Pressure in Hypertensive Patients
Official title: Impact of Pacing Site and AV Delay on Blood Pressure in Hypertensive Patients: An Acute Study in Patients Undergoing an Electrophysiology Study or Pacemaker Implant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension Resistant to Conventional Therapy
Lead sponsor: BackBeat Medical Inc
Sponsor class: INDUSTRY
First posted: 2015-03-06
Enrollment: 19
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: The purpose of this study is to test whether the A-V sequential pacing strategy shown to effectively reduce blood pressure in a dog model of hypertension also reduces blood pressure acutely in patients with hypertension (systolic blood pressure greater than 140 mmHg) despite medical treatments.


Eligibility criteria: Inclusion Criteria:

1. Patient has hypertension with systolic blood pressure \>140 mmHg despite at least one antihypertensive medication.
2. Patient has a clinical indication for a pacemaker or an electrophysiology study involving introduction of transvenous electrophysiology catheters to the right atrium and/or right ventricle.
3. Patient is willing and able to provide informed consent

Exclusion Criteria:

1. Patient is in atrial fibrillation at the time of the study
2. Patient has an ejection fraction less than 45%
3. Patient has a history of symptomatic heart failure, regardless of EF
4. Patient is undergoing an ablation procedure for a bypass track (WPW)
5. Patient has a history of resuscitation from ventricular fibrillation or sustained ventricular tachycardia

Primary outcomes:
measure: Change of blood pressure upon initiation of pacing with AV delays of 2 ms
timeFrame: Approx. 5 minutes after initiating pacing with the respective AV delay
measure: Change of blood pressure upon initiation of pacing with AV delays of 20 ms
timeFrame: Approx. 5 minutes after initiating pacing with the respective AV delay
measure: Change of blood pressure upon initiation of pacing with AV delays of 40 ms
timeFrame: Approx. 5 minutes after initiating pacing with the respective AV delay
measure: Change of blood pressure upon initiation of pacing with AV delays of 80 ms
timeFrame: Approx. 5 minutes after initiating pacing with the respective AV delay
measure: Assessment of any adverse effects
timeFrame: Over a 24 hour period following the acute tests
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University
Study officials:
affiliation: The Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University
name: Bing Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06255184: Effect of Serenity Therapy on Symptoms Distress, Coping Styles, and Emotional Regulation Among Geriatric Patients Undergoing Hemodialysis: a Randomized Controlled Trial
Official title: Effect of Serenity Therapy on Symptoms Distress, Coping Styles, and Emotional Regulation Among Geriatric Patients Undergoing Hemodialysis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Geriatric Patients
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Our research aims to examine the effect of the serenity therapy on symptoms distress, coping styles, and emotional regulation among geriatric patients undergoing hemodialysis. This study highlights the following question: what is the effect of the serenity therapy on symptoms distress, coping styles, and emotional regulation among geriatric patients undergoing hemodialysis.

Detailed description: In order to conduct this study, a randomized controlled trial research design was followed. The selected sitting for this study was the hemodialysis unit of the National Medical Institute at Damanhur city, El-Behaira Governorate, Egypt. Geriatric patients who were recruited for this study, meet the following inclusion criteria; being sixty years or more, scheduled for two or three weekly hemodialysis sessions for a minimum of three months, and having previously undergone hemodialysis for at least six months.

Eligibility criteria: Inclusion Criteria:

* Being sixty years or more
* Scheduled for two or three weekly hemodialysis sessions for a minimum of three months
* Having previously undergone hemodialysis for at least six months.

Exclusion Criteria:

* having kidney transplant or peritoneal dialysis, hearing or vision disorders that could impede communication, previous participation in serenity therapy program, and getting psychiatric or psychosocial treatment

Primary outcomes:
measure: Hemodialysis Symptoms Distress-22 scale
timeFrame: 3 months
measure: Coping Orientation to Problems Experienced Inventory
timeFrame: 3 months
measure: The Emotion Regulation Questionnaire
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Damanhur
country: Egypt
facility: Hemodialysis unit of the National Medical Institute
state: El-Behaira Governorate, Egypt.
city: Alexandria
country: Egypt
facility: Faculty of Nursing, Alexandria university
Study officials:
References:
Clinical trial NCT01287884: Correlation of Arterial Blood Gas (ABG) and Venous Blood Gas (VBG) in the Undifferentiated Critically Ill Patient
Official title: Correlation of Arterial Blood Gas (ABG) and Venous Blood Gas (VBG) in the Undifferentiated Critically Ill Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Needing Blood Gases
Keywords: ABG
VBG
pH
pCO2
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2011-02-02
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this study is to identify a correlation between the pH and pCO2 in arterial and venous blood. The secondary objectives include a correlation of pulse oximetry and arterial pO2 along with subgroup analyses of specific patient populations such as congestive heart failure, chronic obstructive pulmonary disease, diabetic ketoacidosis, pneumonia, overdose, and trauma.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older Signed consent Patient in the ED or ICU Have a disease state that necessitates obtaining an ABG Have a disease state that necessitates pulse oximetry monitoring

Exclusion Criteria:

* Any contraindication to arterial or venous blood draw Prior enrollment in the study during the current hospitalization Pregnancy Prisoners

Primary outcomes:
measure: Degree to which pH and pCO2 correlate between ABG and VBG
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: Eli Zeserson, MD
role: PRINCIPAL_INVESTIGATOR
References: