cyrilzakka/clinical-trials huggingface dataset:
Prospective, Randomized Study of the Impact of a Education Program for Patients Suffering From Low Back Pain

According to the WHO, therapeutic education is intended to help patients acquire or maintain the skills they need to optimally manage living with a chronic disease. Low back pain is frequent and therapeutic education could be a promising option.

The purpose of the study is to evaluate the impact of a therapeutic education program for patients suffering from low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Low back pain
* Treatment with transcutaneous electrical nerve stimulation (TENS)

Exclusion Criteria:

* Contra-indication of TENS
* Patients with mental disorders
* Lack of autonomy or patients living alone at home without help
* Concomitant inclusion in another research on the treatment of pain
PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia

To investigate dose-response efficacy and safety in hemodialysis patients with hyperphosphatemia.


Eligibility Criteria:
Inclusion Criteria:

* Patients age 20 or older, regardless of gender.
* Receiving stable maintenance hemodialysis 3 times a week.
* Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start.

Exclusion Criteria:

* Patients having history of a pronounced brain / cardiovascular disorder.
* Patients having severe gastrointestinal disorders.
* Patients having severe hepatic disorders.
Safety Study of Lifitegrast to Treat Dry Eye

The purpose of the study is to evaluate the safety of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye as assessed by ocular and non-ocular adverse events when administered BID for approximately 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to read, sign and date the informed consent and HIPAA documents
* Willing and able to comply with all study procedures
* Be at least 18 years of age
* Patient-reported history of dry eye in both eyes
* A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period

Exclusion Criteria:

* Any ocular condition that, in the opinion of the Investigator, could affect study parameters including, but not limited to, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy
* Unwilling to avoid wearing contact lenses for 24h prior to Visit 1 and for some duration during the study
* Any blood donation or significant loss of blood within 56 days of Visit 1
* Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.
* Use of any prohibited medications during the appropriate pre-study washout period and at any time during the study unless otherwise specified
* Any significant illness that could interfere with study parameters
* History of laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to Visit 1, and/or any other ocular surgical procedure within 12 months prior to Visit 1; or any scheduled ocular surgical procedure during the study period.
* Known history of alcohol and/or drug abuse
* Subjects with Dry eye secondary to scarring or destruction of conjunctival goblet cells (as with Vitamin A deficiency)
A Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis

The main purpose of this study is to describe the efficacy and safety of LY3454738 in adult participants with moderate-to-severe atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

* Are candidates for systemic therapy.

ISA specific:

* Have moderate-to-severe AD, defined as meeting all of the following criteria, at the first dosing visit:

  * EASI score greater than or equal to (≥)16
  * vIGA-AD score ≥3, and
  * ≥10% of BSA involvement (per EASI BSA).
* Have applied at least 1 emollient every day for at least 2 weeks before the day of the first dose of study intervention in this ISA and agree to daily use of at least 1 emollient continuously throughout the study.

Exclusion Criteria:

ISA specific:

* Have, in the screening period, any of the skin conditions, infections, or medical conditions listed under master IMMB.
* Are currently being treated with topical or systemic therapy
* Recent treatment with experimental (biologics and/or small molecules) - doesn't apply for subset of participants who must have been exposed to biologics and/or small molecules.
Effects of Home-based Physical Activity in Saudi Arabian Type-2 Diabetes Mellitus Patients.

The World Health Organization ranks Saudi Arabia as having the 7th highest rate of type-2 diabetes in the world. This therefore makes diabetes the most challenging health problem facing Saudi Arabia. Importantly, physical activity has been shown to improve disease symptoms and overall health in patients with type-2 diabetes. However, findings relating to the prevalence of physical inactivity in the Saudi population confirm that a sedentary lifestyle is on the rise, within physical inactivity levels in adults being 80.5%. Therefore, interventions aimed at reducing physical inactivity using bespoke modalities pertinent to Saudi Arabia are clearly warranted.

The purpose of this research project is to undertake a feasibility randomised control trial, examining the effects of a 12-week home-based physical activity programme on HbA1c, blood lipids, fasting glucose and other indices of health-related quality of life in Saudi Arabian adults with type-2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Clinically established diagnosis of type-2 diabetes for at least 12 months
* Previously sedentary
* Knowledgeable about hypoglycemia
* Aged over 18 years
* Capacity to give informed consent.

Exclusion Criteria:

* Cognitive impairment precluding consent or participation
* Pregnancy
* Additional medical conditions that prevent safe physical activity (e.g. severe arthritis or advanced heart failure)
* Enrolment in any other clinical trial designed to influence type-2 diabetes symptoms.
Comparison of Ascorbic Acid and Grape Seed Extract in Oxidative Stress Induced by on Pump Heart Surgery

Study aimed to compare the effect of grape seed extract and ascorbic acid in oxidative stress induced by on pump coronary artery by pass grafting surgery.

This study aimed to compare the effect of grape seed extract and ascorbic acid in oxidative stress induced by on pump coronary artery by pass grafting surgery.

There are three groups in the study. 75 candidate of coronary artery by pass grafting surgery were assigned random allocation on the groups (25 in each group).

1. Control
2. GSE (100 mg/6h - PO, 24h before surgery)
3. Vit C (25 mg/kg in pump circulation during surgery)

Eligibility Criteria:
Inclusion Criteria:

* Candidates for elective CABG surgery with pump for first time
* 3VD

Exclusion Criteria:

* High risk patients
* Those who need another heart surgery beside CABG
* Urgent patients
* Diabetics
* Ischemic time more than 120 min
Pacing Activity Self-management for Patients With Chronic Fatigue Syndrome

Given the lack of evidence in support of pacing self-management for patients with chronic fatigue syndrome (CFS), it is examined whether physical behavior and health status of patients with CFS improve in response to a pacing self-management program. The effects of pacing will be compared with those observed when applying relaxation therapy to patients with CFS.

Given the lack of evidence in support of pacing self-management for patients with chronic fatigue syndrome (CFS), it is examined whether physical behavior and health status of patients with CFS improve in response to a pacing self-management program. The effects of pacing will be compared with those observed when applying relaxation therapy to patients with CFS.

According to the power calculation, 36 patients fulfilling the 1994 Centre for Disease Control and Prevention criteria for the diagnosis of chronic fatigue syndrome (CFS) will be randomized to either 3 weeks of pacing activity self-management or relaxation therapy. Both treatment groups will receive 3 weekly sessions spread over 3 consecutive weeks. All treatments will be delivered by occupational therapists or physiotherapists. One treatment session lasts for about 45 minutes each.

Outcome measures include the Canadian Occupational Performance Measure (COPM), Medical Outcomes Short Form 37 Health Status Survey (SF-36), Checklist Individual Strength (CIS), CFS Symptom List and autonomic activity at rest and following 3 activities of daily living (writing a standardized test on a laptop computer, ironing, and climbing 26 flights of stairs). For measuring autonomic activity, the Nexus 10 device (Mind Media, the Netherlands) will be used. Skin conductance, body temperature, heart rate, blood volume pressure and heart rate variability will be measured continuously in real time during a 2 minutes period, with the patient sitting on a chair (back supported and hands resting on legs). Electrodes will be placed on the left hand in all patients.

Eligibility Criteria:
Inclusion Criteria:

* adult
* age range between 18 and 65 years of age
* female gender
* willing to sign informed consent form
* fulfilling the 1994 Centre for Disease Control and Prevention criteria for the diagnosis of chronic fatigue syndrome

Exclusion Criteria:

- Not fulfilling each of the inclusion criteria listed above.
Study of the Antipodal Capsular Fold and Its Potential Role in Antero-inferior Glenohumeral Instability

In schoulders instabilty, the soft tissue has not been the subject of histological studies, as has the "bare area" or zone devoid of cartilage, the exact role of which in glenohumeral biomechanics is unknown. This research is based on the hypothesis that the antipodal lesions are constant, underestimated and that an architectural disorganization at the capsulo-ligament level could contribute to the instability of the shoulder. The aim of this study is therefore to better characterize these lesions which could be the subject of a complementary stabilization procedure even in the absence of a humeral notch

Surgery for unstable shoulders sometimes involves repairing lesions that promote instability. These lesions are identified on imaging before surgery and then during the operation, but they are macroscopically inconsistent on genuine unstable shoulders. While the importance of posterior capsuloligamentous structures (soft tissue) in antero-inferior stability has been the subject of biomechanical studies, the soft tissue has not been the subject of histological studies, as has the "bare area" or zone devoid of cartilage, the exact role of which in glenohumeral biomechanics is unknown. However, this research is based on the hypothesis that the antipodal lesions are constant, underestimated and that an architectural disorganization at the capsulo-ligament level could contribute to the instability of the shoulder. The aim of this study is therefore to better characterize these lesions which could be the subject of a complementary stabilization procedure even in the absence of a humeral notch.

Eligibility Criteria:
Inclusion Criteria:

Instability Group

* Patient, male or female, over 18 years old and up to 40 years old
* Patient operated for antero-inferior shoulder instability
* Subject affiliated or beneficiary of a social security scheme
* Patient having signed the free and informed consent comparativ group
* Patient, male or female, over 18 years old and up to 40 years old
* Patient operated for a reason other than unstable shoulder
* Subject affiliated or beneficiary of a social security scheme
* Patient having signed the free and informed cons

Exclusion Criteria:

* History of surgery on the affected shoulder
* Capsuloligamentous disease (Ehler Danlos)
* History of instability (dislocation, subluxation) in witnesses
* Patient participating in another clinical study
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision;
* Pregnant, breastfeeding or parturient woman;
* Patient hospitalized without consent.
Examining The Efficacy Of Scapular Exercises On Pain And Function İn Patients With Lateral Epicondylitis

We aimed to investigate the effect of scapular exercises on pain and functioning in patients with lateral epicondylitis to achieve a more accurate result by using little-used EMG between scapula and elbow muscles in the literature besides ongoing classical measurements and evaluations.

Thirty patients who participated in the study were randomly divided into two groups. First group (n=15), conventional physiotherapy program and exercise, second group (n=15), in addition to the conventional physiotherapy program and exercises, scapula exercises were applied. Patients were evaluated before and after treatment by VAS, algometer, hand dynamometer, EMG, UEFS, PRTEE and DASH questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Cases diagnosed with lateral epicondylitis by the physician and decided to receive conservative treatment
* Not receiving NSAID or other medical treatment
* Untreated Lateral Epicondylitis for the last 6 months
* Cases with age range 18-75
* Patients with pain and tenderness for at least 3 months

Exclusion Criteria:

* People with pacemakers or cardiac arrhythmias
* Tumoral disease
* Pregnant women
* Head and neck, elbow, scapula joint pathologies
* Acute infection
* Nerve or nerve root compression
* Other musculoskeletal problems
6x3 Crossover, Bioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy Volunteers

A Randomized, Open Label, Single Subcutaneous Dose 6x3 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability among Different Eutropin Formulations in Healthy Volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between the ages of 19 or more and less than 40 years (19 =\< age \< 40) on the day of screening
* Negative findings in serum / urine hCG test or Subjects who are not pregnant or lactating in women

Exclusion Criteria:

* Administered other drug(s) in other clinical study within 180 days prior to the day of screening
To Evaluate the Efficacy and Safety on Blood Pressure In Patients With Hypertension Diagnosed Congestive Heart Failure

To compare and evaluate the efficacy and safety of Candemore tab. versus Atacand tab. on blood pressure in patients with hypertension diagnosed congestive heart failure

This is an open label, randomized, active drug comparative, Parallel group, Multi-center, phase IV study. Patients receive candemore tablet or atacand tablet. Initial dose is 4mg/day or 8mg/day. Every 2 weeks, patients take double dose if patients blood pressure is measured SBP ≥ 100mmHg and DBP \> 60mmHg. Maximum dose is 16mg/day.

Eligibility Criteria:
Inclusion Criteria:

* willing and able to provide written informed consent
* age 20 years or older
* patient with congestive heart failure, taking treatment medicine and NYHA grade II\~III
* patient with hypertension, taking treatment medicine or SBP ≥ 140mmHg or DBP ≥ 90mmHg at the screening visit

Exclusion Criteria:

* Known or suspected secondary hypertension(ex. aortic coactation, primary hyperaldosteronism, renal artery stenosis, pheochromocytoma, cushing syndrome, polycystic renal disease)
* blood creatinine level ≥ 2.5mg/dl
* blood potassium level \> 5.5mEq/L
* blood SGOT, SGPT level ≥ maximum normal range X3 or patient with sever hepatic dysfunction, cholestasis
* pregnant or breast-feeding
* premenopausal women not using adequate contraception
* patient has history about hypersensitivity or taboo of investigational product
* patient with lactose intolerance or Lapp lactase deficiency or glucode-galactose malabsorption
* administration of other study drugs within 1 month prior to screening
* history of ischemic heart disease(ex. angina pectoris, myocardial infarction) within the last 3 months
* in investigator's judgement
FR01 and FR20 IUS (Intrauterine System) Wearing Study

The aim of the study is to evaluate two different placebo intrauterine systems, placebo FR01 and FR20 with different types of inserters, for wearing comfort, insertion/removal ease and pain compared to a placebo T-frame intrauterine system.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Female subject
* Age 18-40 years (inclusive)
* History of regular cyclic menstrual periods at baseline (cycle length 21 to 35 days)
* Women using any COC (combined oral contraceptive) for contraception with a monthly regimen before the study entry.
* Confirmed uterine sound depth of 6 to 10 cm

Exclusion Criteria:

* Pregnancy or lactation
* Sterilized
* Nulliparous
* Congenital or acquired uterine anomaly
* Vaginal or cesarean delivery within 8 weeks prior to insertion
Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Ulcerative Colitis (UC) ≥ 3 months prior to screening
* Active UC confirmed by endoscopy
* Moderately active UC defined as a modified Mayo score of 4 to 6 and an endoscopic score ≥ 2 and rectal bleeding score ≥ 1
* Received a surveillance colonoscopy within 12 months before baseline

Exclusion Criteria:

* Severe extensive colitis
* Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease
* Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
* Hospitalization for exacerbation of UC requiring intravenous steroids within 12 weeks prior to or after screening
pRedicting the Long-term rEsponse of High Frequency sPinal cOrd sTimulation in Patients With Failed Back Surgery Syndrome.

The aim of the current retrospective study is to predict responders for HF10-SCS therapy by only using baseline data. Data collected through clinical practice until June 2020 will be used in this retrospective analysis.


Eligibility Criteria:
Inclusion Criteria:

* FBSS patients treated with high frequency spinal cord stimulation implantation.
Effect of Emotional Freedom Technique on Symptoms in Dysmenorrhea

1. Reducing symptoms with EFT in young women suffering from dysmenorrhea
2. Improving the quality of life of young women suffering from dysmenorrhea
3. Raising women's awareness for EFT
4. Reducing healthcare costs for dysmenorrhea

Primary dysmenorrhea, the most common form of dysmenorrhea, is a problem characterized by pain that begins in the lower abdomen before or with menstruation, lower back pain and pain radiating to the legs. The Emotion Freedom Techniqu has become a manualized method that has led to uniform application research, education, and clinical practice. EFT is a brief intervention that combines exposure, cognitive therapy, and somatic stimulation of acupressure points on the face and body. It has been reported in the literature that EFT, a "needle-free and emotional" form of acupuncture, reduces or eliminates dysmenorrhea symptoms and premenstrual complaints.

Eligibility Criteria:
Inclusion Criteria:

* • Being a female student at Karabük University Faculty of Health Sciences

  * Being between the ages of 18-25
  * Voluntarily agrees to participate in the study,
  * T.R. to be a citizen,
  * Not having any chronic disease,
  * Those whose symptom complaints are 5 or above according to the VAS scale

Exclusion Criteria:

* • Leaving the study at any time,

  * Having any diagnosed psychiatric disorder.
  * Not having secondary dysmenorrhea pathology
Comparison of Robot-assisted Gait Training According to Gait Speed in Participants With Stroke

Comparison of the experimental group that applied the speed of the robot-assisted gait training constantly and the control group that applied the gradual increase of the speed of the robot-assisted gait training.


Eligibility Criteria:
Inclusion Criteria:

* Hemiplegic patients secondary to first cerebrovascular accidents
* Functional ambulation category score ≥ 3

Exclusion Criteria:

* History of surgery of affected lower limb
* Fracture of affected lower limb
Clinical Evaluation of FreeO2 (Version 4) in All Patients Receiving Oxygen

Evaluation of automatic titration of oxygen with a new version of FreeO2 (V4)

In the previous studies, the investigators used many times automatic titration of oxygen on spontanous breathing patient (FreeO2 device) with a prototype develop in our lab in collaboration with Laval university. In this study, we want to evaluate the new version of the FreeO2 device (V4)

Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years old
* Patient receiving oxygen between 1 to 6 lpm for medical pathology
* Admitted to a medical service for less than 72 hours (emergency room not included)

Exclusion Criteria:

* Unreliable SpO2 signal
* Emergency or intensive care hospitalization
* Absence of NIV or intubation criteria at baseline
* Sleep apnea not paired
* Long-term Oxygen Therapy
* Active delirium and cognitive impairment preventing informed consent
Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation

The aim of the present study is to assess whether left atrial roof ablation adds any benefit in the arrhythmia-free probability after paroxysmal atrial fibrillation ablation.


Eligibility Criteria:
Inclusion Criteria:

* Drug-refractory paroxysmal atrial fibrillation

Exclusion Criteria:

* Hypo or hyperthyroidism
* Implantable defibrillation or pacemaker implanted
* Moderate or severe mitral valve disease or mitral prosthetic valve
* Ejection fraction less than 30%
* Left atrial anteroposterior diameter more than 50 mm.
* Previous atrial fibrillation ablation
* Left atrium thrombus
* Current infective disease or sepsis
* Pregnant women
* Current unstable angor
* Acute myocardial infarction in last 3 months
* Atrial fibrillation secondary to ionic disturbance, thyroids disease or secondary to any other reversible or non cardiovascular disease
* Reduced expectancy of life (less than 12 months)
* Patient participating in another clinical study that investigates a drug or device
* Psychologically unstable patient or denies to give informed consent