louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00539786: The Proton Pump Inhibitor (PPI) Test for the Extraesophageal Manifestation of GERD
Official title: Clinical Usefulness of Proton Pump Inhibitor Test for Identifying Gastroesophageal Reflux Disease in Patients With Extraesophageal Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Keywords: Patients with extraesophageal manifestation of gastroesophageal reflux disease
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2007-10-05
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: PPI test;empirical trial with high-dose proton-pump inhibitors (PPIs) has been shown to be a sensitive tool for diagnosing patients with GERD. However, this diagnostic strategy has not been well established in patients with extraesophageal manifestation of GERD. In this study, we aim to see the relevance of PPI test in diagnosing GERD in patients with extraesophageal symptoms.


Eligibility criteria: Inclusion Criteria:

* Patients with extraesophageal manifestation symptoms of GERD

Exclusion Criteria:

* laryngeal, pharyngeal, liver, lung, renal, or hematological disorders
* a history of gastrointestinal surgery, and a history of connective tissue disorders.
* patients with duodenal or gastric ulcers as well as other significant lesions, such as gastric cancer, esophageal cancer, or subepithelial tumors more than 1 cm observed on the upper endoscopy

Primary outcomes:
measure: Symptom responders after PPI trials
timeFrame: 2 weeks after PPI trials
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan University School of Medicine
state: Gangnam-gu
Study officials:
affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Poong-Lyul Rhee, MD. Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02158286: Paracetamol Absorption Technique as a Method for Measuring Gastric Tube Outlet
Official title: Validation of Paracetamol Absorption Technique as a Method for Measuring Gastric Tube Outlet to Golden Standard, to Scintigraphy. A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal and/or Cardia Cancer
Esophagectomy
Gastric Pull-up Reconstruction
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2014-06-06
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients where it had past at least two years since they had underwent an Ivor Lewis esophagectomy with gastric pull-up reconstruction.

Brief summary: Retention of the gastric tube after esophagectomy is a clinically important problem, and there is a need of a simple method to evaluate emptying rate from the gastric tube after esophagectomy. Scintigraphy is the golden standard of measuring emptying rate from the gastric tube. In non-operated patients, paracetamol clearance technique have been widely used for measuring gastric emptying rate. There is no validation however if paracetamol clearance technique can be used for measuring emptying rate of the gastric tube. The investigators aim of this pilot- study is to validate paracetamol clearance technique to scintigraphy for measuring emptying rate from the gastric tube and to evaluate if there is a correlation between symptoms of retention and quality of life with the emptying rate.


Eligibility criteria: Inclusion Criteria:

* Patients where it had past at least two years since they had underwent an Ivor Lewis esophagectomy with gastric pull-up reconstruction.
* no signs of recurrence
* \>18 years of age

Exclusion Criteria:

-

Primary outcomes:
measure: Validate paracetamol clearance technique to scintigraphy for measuring emptying rate from the gastric tube
timeFrame: Up to 12 months
Secondary outcomes:
measure: Evaluate if patient with symptoms of slow emptying rate from the gastric tube also have slow emptying rate measured with scintigraphy.
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Surgery
Study officials:
References:
Clinical trial NCT06557486: The Effects of Mindfulness-Based Stress Reduction Program for Family or Caregivers of Children With Motor Disabilities
Official title: The Effects of Mindfulness-Based Stress Reduction Program on the Psychological and Physiological Stress of Family or Caregivers of Children With Motor Disabilities Due to a Neurological Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress, Psychological
Stress, Emotional
Stress
Lead sponsor: Universitat de Lleida
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 80
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 present study aims to investigate the effect of a mindfulness-based program on perceived stress, severity of anxiety, parents'/caregivers' quality of life and their children, cortisol and IL-6 blood concentrations.


Eligibility criteria: Inclusion Criteria:

* Not having attended previously a mindfulness course
* A score equal to or greater than 23 points at the PSS.
* \>18 years old
* Children \<18y with motor/physical disability due to a Neurological disorder.
* Spanish/Catalan speaking

Exclusion Criteria:

* Currently using drugs or any kind of medication related to stress, depression, anxiety or sleeping pills, such as steroid medicines.
* Regular meditation practice (once a week in the past 12 months)
* Diagnose of hypertension stage 2
* Pregnancy in the case of mothers
* Present hyperthyroidism
* Primary adrenal insufficiency syndromes such as Cushing syndrome or Addison disease
* Present any kind of infection or inflammation process, different from the interestingly to the present study that could differ the results

Primary outcomes:
measure: Perceived Stress
timeFrame: baseline, two months (through study completion), and follow-up of one month
measure: Cortisol levels
timeFrame: baseline and two months (through study completion)
Secondary outcomes:
measure: Severity of clinic anxiety
timeFrame: baseline, two months (through study completion), and follow-up of one month
measure: Sleep Quality
timeFrame: baseline, two months (through study completion), and follow-up of one month
measure: Quality of Life assessment
timeFrame: baseline, two months (through study completion), and follow-up of one month
measure: Blood pressure
timeFrame: baseline, two months (through study completion), and follow-up of one month
measure: Resting Heart rate
timeFrame: baseline, two months (through study completion), and follow-up of one month
measure: Respiratory rate
timeFrame: baseline, two months (through study completion), and follow-up of one month
measure: Interleukin 6 (IL-6)
timeFrame: baseline and two months (through study completion)
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Claudia Arumi
Study officials:
References:
Clinical trial NCT04966286: The Effectiveness of Applying Multimedia on Self-Care and Quality of Life in Patient With Enterostomy
Official title: The Effectiveness of Applying Multimedia on Self-Care and Quality of Life in Patient With Enterostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multimedia Learning Education
Self-care
Quality of Life
Enterostomy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This report was an effective evaluation of using multimedia educational program for self-care and quality of life in patients with a stoma at postoperative and established a simple threshold for enterostomy self-care skills.

Detailed description: In a systematic review, evaluated the effectiveness of multimedia education program (MLEP) and confirmed that MLEP reduced cost significantly and improved patient participation in enterostomy care and self-care ability. However, research was insufficient for whether a multimedia education program (MLEP) interventions can improve patient self-care and quality of life.

Eligibility criteria: Inclusion Criteria:

* Age ≧ 20
* Operation with ostomy

Exclusion Criteria:

* Dementia, mental illness, and central nervous system diseases
* Unable self-care
* Visual or hearing impairs

Primary outcomes:
measure: self-care ability
timeFrame: One and a half years
Secondary outcomes:
measure: Promote quality of life
timeFrame: One and a half years
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Hsing Fang Ko
Study officials:
References:
Clinical trial NCT04795986: First Clinical Evaluation of HEARO Robotic Cochlear Implantation Surgery in Austria
Official title: First Clinical Evaluation of HEARO Robotic Cochlear Implantation Surgery in Austria
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Deafness
Keywords: cochlear implantation
robotic surgery
automated inner ear access
automated middle ear access
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: MED-EL Elektromedizinische Geräte GesmbH
First posted: 2021-03-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant.

Brief summary: To demonstrate the efficacy of a minimally invasive direct cochlear access via the HEARO procedure in cochlear implantation.

Detailed description: The HEARO procedure involves a robot which drills the access to the cochlear in cochlear implantation.

The study is an observational study of the first implementation in clinical routine in Austria.

Eligibility criteria: Inclusion Criteria:

* Adult cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant.

Exclusion Criteria:

* Age under 18 years

  * Pregnant women
  * Facial recess size does not allow a minimum distance of 0.4mm from the planned trajectory to the facial nerve and 0.3mm to the chorda tympani
  * Vulnerable or mentally retarded candidates
  * Invalid or withdrawn informed consent

Primary outcomes:
measure: efficacy of cochlear access
timeFrame: at implantation
Secondary outcomes:
measure: electrode array insertion outcomes
timeFrame: at implantation
measure: Safety of cochlear access
timeFrame: at implantation
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: HNO Klinik am AKH Wien
state: Wien
Study officials:
References:
Clinical trial NCT05306886: Investigation of the Effect of Specially Designed Insoles for Flat-footed Patients
Official title: Investigation of the Effect of Specially Designed and 3D Printed Insoles on Physical Activity Levels, Balance and Functional Performances
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flat Foot [Pes Planus] (Acquired), Unspecified Foot
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In our study, it was aimed to investigate the effect of insoles specially designed for each patient and printed with 3D printers on the physical activity levels, balance and functional performances of those patients.

Detailed description: Our study, B.A.İ.B.Ü. İzzet Baysal Physical Therapy Training and Research Hospital and Fizyotermal Corp. It will be carried out as a dual center on individuals between the ages of 18-45 who apply to our clinic. It will be carried out by selecting 48 people who are suitable for the study among the flat-footed patients who applied to the clinics.

Patients will be evaluated before they start using the insoles, and immediately after using it , also after wearing the insoles for 8 weeks.

Patients will be randomized according to the order of their arrival at the clinic.

Eligibility criteria: Inclusion Criteria:

* 1. Having a minimum 5 degree subtalar pronation angle while standing,
* 2. A minimum score of +6 from the Foot Posture Index (API) scale
* 3. Being between the ages of 18-45
* 4. Not having received any treatment from the foot area in the last 6 months
* 5. To have cognitive competence

Exclusion Criteria:

* 1. End of volunteering
* 2. Having a history of surgery of the lower extremity
* 3. Being an active athlete
* 4. Being pregnant or diagnosed with malignancy
* 5. Having a dysfunction such as severe neurological involvement, immobility, cooperation deficits that will limit physical activity
* 6. Lower extremity inequality greater than 1 centimeter (cm)
* 7. Having a different orthopedic disease that may affect lower extremity biomechanics
* 8. Receiving a different treatment for pes planus

Primary outcomes:
measure: The Physical Activity Assessment Questionnaire (IPAQ) Short Form
timeFrame: Eight weeks
measure: Flamingo Balance Test and Y Balance Test
timeFrame: Eight weeks
Secondary outcomes:
measure: Standing Long Jump Test
timeFrame: Eight weeks
measure: 10 Meter Walk Test
timeFrame: Eight weeks
measure: Shuttle Running Test
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University Faculty of Health Science
state: Merkez
Study officials:
affiliation: Abant Izzet Baysal University
name: Ramazan Kurul
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02392286: Corticosteroid Dosage for Crohn's Disease Flare
Official title: A Prospective, Randomized Trial Comparing the Efficacy of Body-weight Based Versus Fixed Corticosteroid Dosage on Remission in Patients With Moderate to Severe Crohn's Disease Flares
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Crohn's Disease
Inflammatory Bowel Disease
Keywords: Corticosteroid
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-03-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective randomized comparative effectiveness trial designed to compare fixed dosing and weight-based dosing of corticosteroids in patients with Crohn's disease flares.

Detailed description: * Determine if weight-based corticosteroid (1mg/kg daily) induces remission at a greater rate than fixed corticosteroid dosage.
* Determine if weight-based corticosteroid is associated with greater rate of adverse events than fixed corticosteroid dosage.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Established diagnosis of Crohn's disease
* Diagnosis of Crohn's flare
* Decision by treating gastroenterologist to start corticosteroid therapy

Exclusion Criteria:

* Patients in whom corticosteroid therapy is contraindicated: immunocompromised (active cancer on chemotherapy or radiation treatment), severe liver disease (decompensated cirrhosis, active alcoholic hepatitis), end-stage renal disease on dialysis, AIDS or AIDS-defining illness; myocardial infarction within the past year; NYHA Class 4 heart failure
* Patients on systemic corticosteroid therapy currently or within the past 8 weeks
* Patients not on stable doses of immunomodulators or biologics for at least 8 weeks
* Infectious colitis (e.g., C. difficile, CMV, HSV)
* Systemic infections (bacteremia, fungal infections)
* Fulminant Crohn's disease
* Patients who require imminent surgery
* Abscess
* Pregnancy
* Weight \<35 kg

Primary outcomes:
measure: Number of Participants in Remission at End of 2 Weeks
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of Participants With Response at End of 2 Weeks
timeFrame: 2 weeks
measure: Number of Participants With Response or Remission at End of 1 Week
timeFrame: 1 week
measure: Number of Participants With Response or Remission at End of 4 Weeks
timeFrame: 4 weeks
measure: Number of Participants With Response or Remission at End of 12 Weeks
timeFrame: 12 weeks
measure: Number of Participants With Corticosteroid-associated Side Effects
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University, Section of Digestive Diseases
name: Loren Laine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02891486: Analysis of the Incidence of Post-Operative Wound Infections After Spine Surgery
Official title: Analysis of the Incidence of Post-Operative Wound Infections After Spine Surgery - a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Keywords: spinal surgery, surgical site infection
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 6959
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18 years of age or older undergoing a spinal operation.

Brief summary: Post-operative wound infections can prolong hospital stays, increase rates of readmission to the intensive care unit, and increase the costs of treatment significantly. This study will conduct a prospective chart review of all patients undergoing elective spinal surgery on both the neurosurgery and orthopedic spine services at two facilities on an academic campus. The investigators will collect the data of those patients who develop post-surgical infections. This data will then be analyzed and compared to published data from other studies. The aim of this investigation is to passively collect this infection data, which may ultimately provide needed baseline incidence rates using current and standard protocols.

Detailed description: This is a chart review study.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Patients undergoing elective spinal surgery on either the neurosurgery and orthopedic spine services
* Patients who develop post-operative wound infections within 90 days of surgery

Exclusion Criteria:

* Patients younger than 18 years of age
* Patients who are not undergoing elective spinal surgery on either the neurosurgery and orthopedic spine services
* Patients who do not develop post-operative wound infections within 90 days of surgery

Primary outcomes:
measure: Number of patients who develop a surgical site infection (SSI)
timeFrame: 90 days following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Allan D Levi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00704886: A Randomized Controlled Trial of Using Video Images in Dementia
Official title: A Randomized Controlled Trial of Using Video Images in Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: dementia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Foundation for Informed Medical Decision Making
First posted: 2008-06-25
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: BACKGROUND: Advance care planning (ACP) is the process in which patients plan for future medical care under circumstances of impaired decision-making. Video is an underutilized medium that can assist clinicians in discussions of future health states, such as the state of advanced dementia. Video may enable patients to visualize the future by concisely providing complex information vital for ACP. This study will examine whether the use of video could facilitate a more comprehensive understanding of advanced dementia and inform clinician-patient discussions about the level of care a patient would want in the event of advanced dementia.

RESEARCH PLAN: We propose to conduct a randomized trial studying ACP for 200 elderly subjects using a video depiction of a patient with dementia compared to the traditional verbal narrative. Specific aims 1 and 2 assess the effect of a video of advanced dementia on the clinical decision making of elderly subjects compared to the traditional verbal narrative.

Detailed description: Outcome measures were what subjects wanted if they had advanced dementia.

Eligibility criteria: Inclusion Criteria:

* Over 64

Exclusion Criteria:

* Can't speak English

Primary outcomes:
measure: preferences
timeFrame: at time of interview
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH
state: Massachusetts
Study officials:
affiliation: MGH
name: Angelo Volandes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Volandes AE, Paasche-Orlow MK, Barry MJ, Gillick MR, Minaker KL, Chang Y, Cook EF, Abbo ED, El-Jawahri A, Mitchell SL. Video decision support tool for advance care planning in dementia: randomised controlled trial. BMJ. 2009 May 28;338:b2159. doi: 10.1136/bmj.b2159.