cyrilzakka/clinical-trials huggingface dataset:
Zemedy Application for Irritable Bowel Syndrome

The purpose of the study is investigate the effectiveness of Zemedy, a mobile application that enables the digital delivery of a CBT program to people with IBS.

Irritable bowel syndrome (IBS) is defined as having recurrent abdominal pain associated with defecation or a change of bowel habits. The pathophysiology of IBS can be looked through the biopsychosocial model of disease which is defined by the complex interplay between genetic, cultural, environmental, and psychosocial factors.

Treatment of IBS is multifaceted and ranges from exercise to dietary restrictions, however, psychological treatments to target the gut-brain axis such as cognitive-behavior therapy (CBT) have also been shown to be an effective therapy, and aims to address the psychological and environmental stressors that contribute to the symptoms. Therefore the purpose of the study is investigate the effectiveness of Zemedy, a mobile application that enables the digital delivery of a CBT program to people with IBS.

CBT has been shown to reduce the severity of intractable IBS symptoms by as much as 70%. The investigators hope to learn whether the Zemedy mobile application is effective in the reduction of IBS. This will be measured based on their IBS Symptom Severity Scores (SSS) at week 8 compared to baseline.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients \>=18 years old.
2. Meet Rome IV criteria for IBS for at least 6 months. No restrictions on type of IBS.
3. English proficiency (in order to understand use of the application.
4. Patient must be on a stable regimen for IBS for at least 30 days.
5. Patients must own a smartphone (iOS or Android) in order to participate in the CBT application.

Exclusion Criteria:

1. Laboratory or imaging evidence of an alternative explanation of patient's symptoms.
2. Active gastrointestinal disease such as Crohn's disease, ulcerative colitis, history of complete colon resection, acute infection, or any disease that precludes participation in CBT application.
3. Patient already undergoing cognitive behavioral therapy.
4. Psychiatric hospitalization within 10 years.
5. Current or past diagnosis of a major mental illness such as schizophrenia, bipolar disorder, personality disorder or substance abuse.
6. Active (within the past 3 months) suicidal ideation.
7. Prisoners or other detained individuals.
8. Adults unable to consent.
9. Pregnant people.
Open Versus Close Chain Exercise Effects With Lifestyle Modification and Education in Knee Osteoarthritis

A randomized clinical trial will be conducted in Gujranwala and 24 patients with grade 3 knee OA will be recruited. After consent, patients will be randomly allocated into 2 groups by lottery method. Group A will do close kinetic chain exercises, including static cycling, lifestyle modification, and patient education. Group B will do open kinetic chain exercises including quadriceps drills with lifestyle modification and patient education. A total duration of 12 weeks with 3 sessions per week will be given. Outcome measures Assessment will be done at 0 weeks, 4 weeks, 8 weeks, and 12 weeks.

Osteoarthritis is a clinical syndrome characterized by joint pain, varying degrees of functional impairment, and a poor quality of life and in 21st century It is predicted that the number of persons over 65 would double placing a heavy burden on healthcare systems and caregivers' resources. For individuals with knee OA, open kinetic chain (OKC) and closed kinetic chain (CKC) exercises have been recommended thus far. The distal segment of the body components can move freely during OKC exercise since it is not bound, but remain static on the ground during CKC exercise.

A single-blinded randomized clinical trial will be conducted at Al-Raee Trust Hospital Gujranwala and 24 patients of both genders and age of 50-70 years with grade 3 knee OA (according to Kellgren and Lawrence classification system based on plain x-rays) will be recruited. After taking written consent, patients will be randomly allocated into 2 groups by lottery method. Group A will be treated with close kinetic chain exercises including static cycling with lifestyle modification and patient's education and group B will be treated with open kinetic chain exercises including quadriceps drill with lifestyle modification and patient's education about 30 minutes per session including 10 min of walking as a warm up for total duration of 12 weeks with 3 sessions per week. Outcome measures such as pain, disability and health status will be assessed by NPRS, WOMAC and OAKHQOL respectively. Assessment will be done by therapist at 0 week, 4 weeks, 8 weeks and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* • Both genders

  * With Grade 3 of Knee Osteoarthritis (Kellgren-Lawrence scoring)
  * Mild-to-moderate pain on NPRS
  * Age 50-70 years old
  * Available three times a week for over 3 months

Exclusion Criteria:

* • Having Knee surgery in the past 6 months

  * Having Acute symptomatic KOA
  * Having Any muscular, joint or neurological conditions that affect lower limb function
  * Conducting another structured exercise programme specifically for KOA during this study period
  * Having Motor neuron disorders such as Alzheimer's and Parkinson's diseases.
Dialysis Geriatric Care Model

The objectives of this study are to refine the dialysis care model with key stakeholder input and conduct a pilot randomized controlled trial (RCT) to obtain evidence critical to inform a definitive RCT.

The investigators designed a new dialysis care model that includes a centralized geriatric team that uses information from the Geriatric screen for OLder Dialysis patients (GOLD) to develop individualized recommendations for geriatric syndrome management based on the patient's priorities. The study population is older adults receiving hemodialysis and dialysis staff. The investigators will have patient participants complete the care model and undergo geriatric evaluation. This phase will be referred to as refinement aim 1. The investigators will then assess agreement of each GOLD instrument with its corresponding geriatric evaluation. The investigators will assess acceptability and feasibility of the care model through surveys and interviews with patients and dialysis staff to complete refinement aim 2. Once the new dialysis care model is redefined, the investigators will conduct the third phase, pilot RCT (geriatric care model vs. usual care) and assess geriatric problem management at 4 months, as well as, patient reported outcomes, physical function, and health care utilization at intervals up to 12 months. The analyses will include 1) measure of agreement using Cohen's kappa, 2) qualitative rapid analyses, 3) descriptive statistics from acceptability and feasibility surveys, 4) descriptive statistics from pilot RCT data, and 5) tests for difference in geriatric problem management between treatment and control groups. The study does not involve activity from participants that would exceed normal or routine care so there are negligible physical, financial, or legal risks.

Eligibility Criteria:
Patient Inclusion Criteria:

* community-dwelling dialysis patients 55 and older
* may have cognitive impairment; however, patients with severe cognitive impairment will require a caregiver present to participate in the study (mini MoCA \<6)

Patient Exclusion Criteria:

* advanced dementia
* non-English speaking
* nursing home residents
* hospice enrollees
Clinical Performance of the AtbFinder® Test System for Selection of Antibiotic Therapy in Persons With Cystic Fibrosis

This prospective case-control study was planned to evaluate the efficacy of antibiotic therapy selected with the AtbFinder® in persons with cystic fibrosis.

This pilot study entitled "Clinical Performance of the AtbFinder® diagnostic test system for selection of antibiotic therapy in persons with cystic fibrosis " was designed to demonstrate the clinical performance of antibiotics selected with the AtbFinder® for the treatment of lung infections in persons with cystic fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cystic fibrosis based on sweat chloride levels = or \> 60, or genetic testing showing 2 pathogenic mutations.
* Ability to provide a clinical sample (expectorated sputum, throat culture or bronchoalveolar lavage) prior to the start of the antibiotic treatment.
* Prior treatment of a pulmonary exacerbation with systemic antibiotics in the preceding year.

Exclusion Criteria:

* Inability to meet any of the above inclusion criteria.
* Systemic therapy with an antibiotic or corticosteroids in the 3 weeks preceding enrollment in the study, except those on chronic inhaled antibiotics.
* Primary or secondary (drug- or condition-induced) immune compromise.
* Creatinine \> 2 x upper limit of normal for age.
* Previous participation in this study in the prior 28 days.
A Pilot Study for the Evaluation of the Safety and Performance of a Combined OCT System

The novel Coaxial Optical Coherence Tomography (OCT) System is designed to visualize both structures of the retina and choroid.

The purpose of this research is the safety and evaluation of a combined coaxial optical coherence tomography (OCT) system, to image diseases of the posterior and anterior segment of the eye.

Background and Rationale:

Many posterior segment ocular diseases involve the retinal and choroidal vasculature. A new technology to noninvasively and simultaneously visualize vascular pathology is of utmost importance to reduce patient exposure to different diagnosis methods like e.g. fluorescence angiography. The novel Coaxial Optical Coherence Tomography (OCT) System is designed to visualize both structures of the retina and choroid.

Furthermore, it may be used to image other structures of the eye.

Objective(s):

The purpose of this research is the safety and evaluation of a combined coaxial optical coherence tomography (OCT) system, to image diseases of the posterior and anterior segment of the eye. This device may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as Glaucoma, Diabetic Retinopathy or Age-Related Macular Degeneration. Measurements are compared to normal controls.

Measurements and procedures:

After screening, all participants will undergo a scanning procedure on the same day.

Only one eye of each participant will be scanned with the investigational device. For patients, the eye showing the disease will be chosen, for healthy volunteers, the left or right eye will be scanned according to a randomisation list.

The image quality is rated by the investigator and an independent assessor on a VAS (visual analogue scale). A subgroup of each stratum will have a comparative measurement of the choroid thickness against a SS-OCT (swept-source-OCT) device (Topcon) and a retina thickness against the Spectralis data. The subgroup will consist of half planned sample size. The measurement is taken from one eye, ie. every second participant per stratum will be attributed to the thickness measurement subgroup. The endpoint is a true/false criterion on whether the measurement of the retina and choroid thickness was successful. The thickness is measured in μm. The measurement is considered a "success" if the value is no more than +/- 10% off the reference measurement.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with healthy eye, or has been diagnosed already with eye disease
* Patients \> 18 years of age
* Informed Consent as documented by date and signature

Exclusion Criteria:

* Clinically significant concomitant disease that impair measurement
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, late stage Alzheimer disease, etc. of the participant,
* Subjects using implanted electronic medical devices (e.g. cochlear implant, pacemaker, defibrillator, infusion pump).
* Participation in another study with investigational drug within the 30 days preceding and during the present study
Arterial Blood Pressure and Cardiac Arrest

To describe and measure diastolic and systolic femoral arterial pressure during medical cardiac arrest.

To define baseline measures. To describe and measure arterial blood pressure after placement of an ITD device.

To observe the diastolic pressure immediately prior to return of spontaneous circulation.

To quantify and describe the effects of intravenous adrenaline on arterial blood pressure in cardiac arrest.

Cardiac arrest is a complex disorder whose outcome is reliant on a huge number of factors. Moreover, many interventions are time critical, therefore an intervention that may be lifesaving if given early, may have no benefit if instigated further in the disease course. For these reasons' studies involving cardiac arrest are incredibly difficult to carry out and interpret. Many of the interventions carried out during cardiac arrest are aimed at improving blood pressure and thereby increasing the amount of blood and oxygen delivered to the myocardium in the hopes of achieving a return of spontaneous circulation (ROSC). However current data on what a 'normal' blood pressure, based largely upon non-invasive measurement, during cardiac arrest is severely limited, making comparison and evaluation of interventions extremely difficult. This provides the basis for this study in order to prospectively collate and describe data from invasive blood pressure monitoring during adult, medical cardiac arrest in the pre-hospital environment.

3. Research Question/Aim(s) To measure and describe femoral arterial pressure during cardiac arrest with mechanical CPR by a LUCAS device. 3.1 Objectives Primary objective To quantify and describe baseline arterial systolic blood pressure as measured by an invasive femoral line in adult patients suffering medical cardiac arrest in the pre-hospital setting. This will be defined as a line of best fit for systolic blood pressure superimposed on the arterial trace during a 3 minute period.

Secondary Objectives

* To quantify and describe baseline arterial diastolic blood pressure as measured by an invasive femoral line in adult patients suffering medical cardiac arrest in the pre-hospital setting. This will be defined as a line of best fit for diastolic blood pressure superimposed on the arterial trace during a 3 minute period.
* To quantify and describe arterial blood pressure after the placement of an ITD device over a 3 minute period.
* To quantify and describe the effect of intravenous adrenaline on blood pressure as administered in line with ALS guidelines (every 3-5 mins) in adult patients in cardiac arrest.
* To document the diastolic blood pressure of those patients that achieve return of spontaneous circulation (ROSC) following out of hospital cardiac arrest.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18years) in medical cardiac arrest
* Deemed suitable to attempt resuscitation.

Exclusion Criteria:

* Prisoners
* \<18years
* Pregnancy
* Traumatic cardiac arrest
* Arrest caused by hypovolaemia, tension or tamponade as determined by the clinical team on scene
* Inability to secure a patent airway.
Pompe Lactation Sub-Registry

The objective is to determine if alglucosidase alfa is present in breast milk from mothers with Pompe Disease being treated with alglucosidase alfa and to measure breast milk production and composition in women with Pompe Disease who receive alglucosidase alfa.


Eligibility Criteria:
Inclusion Criteria:

* Must be enrolled in Pompe Registry (NCT00231400)
* Must be pregnant and intend to breast-feed or be currently lactating and receive at least one infusion of alglucosidase alfa while lactating
* Provide a signed Patient Information and Authorization form to participate in the sub-registry prior to any sub-registry-related assessments are performed
* Agree to adhere to the sub-registry guidelines for antibody testing and recommended schedule of assessments.

Exclusion Criteria:

* Patients will be excluded from this sub-registry if they have received an investigational drug (excluding alglucosidase alfa in regions where alglucosidase alfa is not commercially available) within 30 days prior to Visit 1 breast milk collection
A Study of Low-level Light Therapy Using Photo-activated Modulation Ameliorates Cognitive Deficits

The primary objective of this study is to confirm and compare the effect of methods of Low-level light therapy (LED-T) in the mild cognitive impairment.

Total 168 patients were recruited and randomized to receive either real or sham-LED-T. Real experimental groups were divided into three groups; CA group, VA group, CA+VA dual group. Each group received LED-T (30 min) once a day for 30 days. Each groups LED-T positioned at following locations;

* CA group on the superior border of the thyroid cartilage, and anterior to the sternocleidomastoid muscle based on Korea traditional therapy called Inyoung(ST9)
* VA group on the upper abdomen, spinous process of the 2nd cervical vertebra upper margin based on Korea traditional therapy called CunChu
* CA+VA dual group on the CA position (ST9), and VA position (BL10) The patients were initially evaluated at baseline, immediately, 4wks after intervention.

Study type : Interventional Study Phase : Not provided Study Design : Allocation : Randomized Intervention Model : Parallel Assignment Masking : Single Blind (Investigator) Primary Purpose : Treatment, intervention Condition : Mild cognitive impairment, Health subjects

Intervention :

* Low-level light therapy device (Peak wavelength:610nm, Power intensity: 1.7mW/cm2, Energy density: 2.0J/cm2, Skin-adhesive light-emitting probes: spot size, 1cm diameter),
* Parameters : Neuroimaging assessement: fMRI, SPECT, Neuropsychological behavioral assessment: SNSB; Seoul Neuropsychological screening battery, K-MoCA, Corsi-block test, K-MBI, K-ADL, GDS, EQ-5D, Neurophysiological assessment: MEP, Motor evoked potential, Gene test(BNDF, ApoE)

Study Arms

* Experimental : Sham control group and real stimulation group.
* In each group, total sessions of the Low-level light therapy (LED-T) was done for intervention was followed after that.
* Subjects received LED-T (30 min) once a day for 30 days.
* The sham control group was kept without LED-T

Eligibility Criteria:
Inclusion Criteria:

1. Subjects ages older than 55 years old
2. Subjects who has K-MoCA assessment score less than 23
3. Subjects who understand the purpose of the study and acquired the consent of the subjects or caregiver

Exclusion Criteria:

1. Subjects who have K-MMSE less than 19
2. Subjects who have pre-existing and present-existing neurological diseases as CNS lesion
3. Subjects who have psychiatric disease such as depression, schizophrenia, bipolar disease, or dementia
4. Subjects who is estimated as not appropriate for the study by the investigators
Kinesiotaping With and Without Combined Chain Exercises in Patients With Knee Osteoarthritis

Knee osteoarthritis is a major public health issue because it causes chronic pain, reduces physical function and diminishes quality of life. Aging of the population and increased global prevalence of obesity are anticipated to dramatically increase the prevalence of knee osteoarthritis. Knee osteoarthritis is characterized by complex multifactorial joint pathology and is the most common form of joint disorder in the world. Chronic knee osteoarthritis leads to marked weakening of the quadriceps femoris muscle, which is the extensor and stabilizer of the knee and atrophy of this muscle result knee pain and functional impairment. Quadriceps muscle weakness and atrophy have been reported to contribute to functional impairment and pain in patients with knee osteoarthritis and quadriceps strengthening can be achieved through open kinetic chain exercises and close kinetic chain exercises. Close kinetic chain exercises are modeled as, in which a movement in a joint simultaneously produces movements in other joints of the extremity. Open kinetic chain exercises and close kinetic chain exercises form the combined chain exercises. Kinesiotaping with these exercises to improve the patients suffering with knee osteoarthritis. The aim of this study will be to compare the effects of kinesiotaping as an adjunct to combined chain exercises compared with only kinesiotaping on pain, range of motion and quality of life in the management of individuals with knee osteoarthritis.

This study will be randomized control trial. Patients will be recruited into two groups by simple random assignment. Non probability consecutive sampling technique will be used. Data will be collected from patients of grade 2 knee osteoarthritis patients by using NPRS for pain, Goniometer for ROM and SF-36 for quality of life will be used before and immediate after the treatment. Those who will meet the inclusion criteria will be recruited. Group 1 will be treated with kinesiotaping and combined chain exercises and the Group 2 will be treated with only kinesiotaping on knee OA patients. Total intervention will be given for four weeks for three sessions per week.The subject attended physical therapy and kinesiotaping will assess for pain, range of motion and quality of life at baseline and after 4 week of intervention. After collecting data from defined study setting, data will be entered and analyzed by using Statistical Package for the Social Sciences (SPSS) for Windows software, version 25.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients.
* Patients age between 40 years- 60years.
* Patients with Grade II knee osteoarthritis.

Exclusion Criteria:

* Patients with allergic reaction to tape or any skin problems
* Patients with history of injection at the knee.
* Patients with surgical intervention at the knee
A Safety and Immunology Study of a DNA Trivalent Influenza Vaccine

The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to cause particular immune responses in the body.

Influenza is a contagious disease of the upper airways and the lungs. It rapidly spreads around the world in seasonal epidemics, killing hundreds of thousands of people and having high economic consequences due to healthcare costs and lost productivity. Each year governments recommend groups who are at risk of influenza or its complications to receive influenza vaccination. Current vaccine supply is not sufficient to meet the demand if this recommendation were to be taken up by all. This study is part of the clinical development of a particle mediated epidermal delivery (PMED) trivalent DNA vaccine for the prevention of influenza.This study will investigate the safety and tolerability of this vaccine as well as assess the humoral and cellular immunogenicity of the vaccine in healthy subjects.

Eligibility Criteria:
Ages Eligible for Study:

* 18 Years - 50 Years
* Genders Eligible for Study: Both
* Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

* Healthy adult volunteers (women must be of non child-bearing potential)
* Provided written informed consent

Exclusion Criteria:

* No significant concomitant illness
* No allergy to gold
* No immunosuppression due to disease or treatment
* No previous flu vaccination in 2005 or 2006
Mitochondrial Dysfunction and Insulin Resistance in Skeletal Muscle

The purpose of the study is to evaluate the link between insulin resistance and alterations in skeletal muscle mitochondrial redox homeostasis


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥25 and \<40 kg/m2
* Fasting plasma glucose ≥ 5.6 mmol/L or HbA1c ≥ 5.7%
* HOMA2-IR \> 1.4
* VO2max \<45 ml/kg/min

Exclusion Criteria:

* Treatment with \>2 antidiabetic medications
* Insulin usage
* Chronic disease deemed by the study responsible medical doctor to interfere with any part of the study
* Chronic use of prescription medicine deemed by the study responsible medical doctor to interfere with any part of the study
* Smoking