cyrilzakka/clinical-trials huggingface dataset:
Evaluating Collagen Cross-Linking (CCL) Treatment in Norway

The purpose of this study is to assess safety, efficacy and stability of riboflavin-UV induced cross-linking of corneal collagen in reducing the progression of keratecatasia and in improving visual acuity. This is the first Norwegian study concerning CCL.

The technique of corneal collagen cross-linking consists of photopolymerization of stromal fibers by combined action of a photosensitizing substance, riboflavin and ultraviolet type A rays (UVA) from a solid-state UVA Source. Photopolymerization increases the rigidity of corneal collagen and its resistance to keratectasia. It has been used to stop progression of keratectasia.

Corneal transplantation has been the only available option so far for treatment for keratectasia in its advanced stage in Norway. The method of CCL using riboflavin and UV light is technically simple and much less invasive than corneal transplantation and it treats and prevents the underlying pathophysiological mechanism. It also does not reduce the chances for a successful corneal transplantation, in case that would still be necessary after CCL.

The purpose of this study is to assess safety, efficacy and stability of riboflavin-UV induced cross-linking of corneal collagen in reducing the progression of keratecatasia and in improving visual acuity. This is the first Norwegian study concerning CCL.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 20 to 45 years
2. Progressive keratectasia (primary or secondary) in an advanced stage
3. Decreased best corrected visual acuity bellow 20/40, which cannot be further improved by use of soft contact lenses
4. Rigid contact lenses are either not tolerated or do not improve visual acuity
5. No previous eye surgery (except for laser refractive surgery)
6. All patients must provide written informed consent to become a study subject
7. Subjects able to return for scheduled follow-up examinations according to this protocol

Exclusion Criteria:

1. Corneal thickness \< 400 µm at thinnest position
2. Keratometric - readings above 60 diopters
3. Other active ocular disease than keratectasia
4. Herpes keratitis
5. Previous ocular surgery (other than laser refractive surgery)
6. Patients who were immunocompromised, pregnant or who had atopic syndrome, connective tissue or autoimmune disease
7. Patients with known sensitivity to study medication
8. Subjects with intraocular pressure \> 23 mmHg by Goldmann applanation tonometry, a history of glaucoma, or glaucoma suspects
9. Subjects who intent to participate in other ophthalmic clinical trails during this clinical investigation
Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera

The prospective multicenter observational cohort study will be offered consecutively to any patient with primary or secondary myelofibrosis or with Polycythemia Vera who has initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. The main purpose is to assess adherence to ruxolitinib using the ARMS questionnaire. Each individual patient will be administered the questionnaire at the first convenient opportunity, regardless of when ruxolitinib is started, and again after 4, 8, 12, 24, and 48 weeks, in conjunction with drug procurement.

The prospective multicenter observational cohort study will be offered consecutively to any patient with primary or secondary myelofibrosis or with Polycythemia Vera who has initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. Laboratory tests and histologic, cytogenetic, molecular, and radiologic investigations performed by the patient and collected for study will be conducted in accordance with clinical practice, independent of the patient's participation in the study. In particular, data related to systemic symptoms and splenomegaly will be collected at diagnosis and disease reassessments performed in the context of normal clinical practice. These data will be collected at the first administration of the ARMS questionnaire and again after 12, 24, and 48 weeks. If performed, any additional assessments will also be recorded. Each individual patient will be administered the questionnaire (ARMS) at the first convenient opportunity, regardless of the time of initiation of ruxolitinib, and again after 4, 8, 12, 24, and 48 weeks, in conjunction with drug procurement. If in-person data collection is not possible, the mode of data collection by telephone interview will be adopted. The minimum expected duration of individual patient observation is 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients diagnosed with Primary Myelofibrosis or secondary to Essential Thrombocythemia/Polycythemia Vera or diagnosed with Polycythemia Vera who are in the treatment with ruxolitinib therapy in accordance with normal clinical practice
* Obtaining informed consent for data collection and processing
* The Patient must come to the in-person visit at least once, an occasion on which informed consent to 'study membership will be offered

Exclusion Criteria:

* None
Entarik Feeding Tube System Placement in Adult ICU

The purpose of this study is to evaluate the safety and effectiveness of the Entarik Feeding Tube System in an adult ICU patient population for the administration of nutrition, fluids and medications.


Eligibility Criteria:
Inclusion Criteria:

* Must be able to swallow tabletsAt least 18 years old
* Able to provide informed consent or ability to have a legally authorized representative provide informed consent
* Adults in the ICU requiring an 8Fr, 10Fr, or 12Fr NG tube. The size of the feeding tube should be determined clinically, and the Entarik Feeding Tube should only be placed if that size is appropriate.
* Suitable to start enteral (gastric but no post-pyloric) feeding
* Anticipated to receive enteral feeding (either bolus or continuous feeds) for more than 6 hours and conclude the enteral nutrition while in the care of the ICU. If enteral nutrition has already been initiated, indicated for replacement of an NG feeding tube Note: Both subjects on a ventilator (non-invasive or invasive ventilation) or not requiring a ventilator are eligible for this study.

Exclusion Criteria:

* inability to receive a feeding tube including subjects with known history of issues such as esophagitis or strictures, frequent nose bleeds, basilar skull fracture or GI bleeding disorders
* Known major upper airway malformation
* Known major GI abnormality, upper GI malignancy, or partial gastric resection
* History of gastroparesis
* Currently pregnant
* NPO status - expected to remain NPO for the following 72 hours.
* Patient needs an MRI in the immediate future (e.g., 6-12h) where placement of the feeding tube (non-MRI compatible) is going to mandate replacement with standard feeding tube
* Critically ill, facing imminent death
* Deemed unsuitable for enrollment in study by the investigator based on subject's history (e.g., active anticoagulation therapy) or physical examination
OnQ Pain Pump Effectiveness in Post Operative Pain Control in Bariatric Patients

This study will assess the efficacy of OnQ pain catheters in pain reduction in the bariatric surgical population and seeks to identify if a quantifiable improved post-operative course occurs in patients receiving a catheter filled with local anesthetic versus that achieved by patients who receive a catheter filled with injectable saline.

This study will assess the efficacy of OnQ pain catheters in pain reduction in the bariatric surgical population. Approximately 12 to 15 weight reduction surgeries are performed at William Beaumont Army Medical Center each month. It is the current practice that each patient receiving the laparoscopic gastric sleeve or laparoscopic Roux-en-Y gastric bypass receive an OnQ pain catheter during the surgery to reduce post-operative pain. There have been limited studies to quantify the efficacy of these devices. This study will seek to identify if a quantifiable improved post-operative course occurs in patients receiving a catheter filled with local anesthetic versus that achieved by patients who receive a catheter filled with injectable saline.

Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for Bariatric surgery
* Consents to be in protocol
* No local anesthetic allergy
* Will be having sleeve gastrectomy
* Doesn't have extensive scarring of abdominal wall that would prevent placement of OnQ catheter

Exclusion Criteria:

* declines to participate
IBD Disease Course of Infliximab-naïve IBD Patients Treated With Subcutaneous Infliximab CT-P13 Remsima®

CURRENT STATE OF KNOWLEDGE IN VIEW OF THE RESEARCH About the condition under investigation Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are chronic diseases characterized by relapsing and remitting episodes.

About comparator strategies/procedures Infliximab in its Intravenous (IV) form was the first biotherapy to be approved to treat IBD. Biosimilars of intravenous (IV) infliximab have been shown to be non-inferior to the reference product in patients with IBD, to induce and maintain clinical response

Recently, the subcutaneous (SC) formulation of the infliximab biosimilar CT-P13 (CT-P13 SC) has been shown to be non-inferior on CT-P13 concentration at week 22 to the IV formulation of CT-P13 (CT-P13 IV). These results were based on 66 patients treated with CT-P13 SC, and larger studies are needed to better assess IBD disease course of patients treated with CT-P13 SC in real-life setting.

The study assesses in real-life setting the IBD disease course of infliximab-naïve IBD patients treated with subcutaneous infliximab. This study will look at the clinical and biological outcomes of people who take subcutaneous infliximab.

The study will enroll approximately 120 participants with an indication for iv infliximab.

All participants will receive 1 intravenous infusion on Day 1 and Week 2, followed by 1 SC injection on Week 6 and then 1 SC injection every 2 weeks for up to Week 48.

Switch to subcutaneous infliximab (Remsima® SC) at week 6 will be proposed as part of standard of care.

This multi-center trial will be conducted in hospitals of Assistance Publique - Hôpitaux de Paris (AP-HP). The overall time to participate in this study is 48 weeks. Participants will make approximately 5 visits to the clinic.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Crohn's disease or ulcerative colitis (confirmed by clinical evaluation and a combination of endoscopic, histological, radiological, and/or biochemical investigations according to European guidelines)
* Starting infliximab as standard of care (originator or biosimilars)
* with or without concomitant immunosuppressive agent and/or steroids use at infliximab initiation
* Patients agreeing to participate

Exclusion Criteria:

* Patients not eligible to infliximab according to standard of care screening
* Previous exposure to infliximab: originator or biosimilars
* Participation in another interventional study
* No coverage by the French health insurance
The Effect of Melatonin on Postoperative Delirium in Elderly ICU Patients

Delirium in older patients is associated with increased mortality and health care costs. And delirium is frequent in intensive care unit (ICU). Circadian rhythm alteration is one of the most important risk factor for developing delirium. In this study, investigators will investigate the effect of administration of melatonin on postoperative delirium in elderly ICU patients.

Randomly selected patients of the melatonin group are given 5mg of melatonin in the evening from the day before surgery to the the 5th postoperation day. In contrast, patients in the control group are given placebo.

Primary outcome of this study is the incidence of postoperative delirium measured by ICD-SC (Intensive Care delirium Screening Checklist). And secondary outcome includes intra-procedural hemodynamics measured by amount of used vasopressors, heart rate and blood pressure, total amount of sedatives, total amount of analgesics, duration of mechanical ventilation, duration of ICU stay.

Thus, investigators perform this study to investigate the relationship between delirium and circadian rhythm.


Eligibility Criteria:
Inclusion Criteria:

* older than 50 years old
* patients who admitted to ICU after surgery

Exclusion Criteria:

* Subjects are ineligible if they have cognitive dysfunction,
* disabling mental change disorder,
* alcohol addiction,
* dementia,
* cerebrovascular accident,
* transient ischemic attack,
* carotid artery stenosis,
* autoimmune disease,
* patients who are unable to communicate or speak Korean,
* emergent operation
Intratumoral phIL12 GET

Electroporation provides non-viral gene delivery method for plasmid DNA. Its clinical application was already proven in preclinical and in clinical trial in treatment of melanoma skin metastases with plasmid coding IL-12, in USA. Intratumoral gene transfer of plasmid coding for IL-12 has proven safe end effective, having good local tumour control and some evidence indicates on abscopal effect. The EU directives recommend the use of plasmids without the gene for antibiotic resistance. For this purpose we constructed plasmid coding for IL-12 in accordance with the EU regulatory requirements.

In the proposed study we intend to study the safety and tolerability of the constructed plasmid, phIL12, in treatment of basal cell carcinomas in patients with operable tumors in head and neck region. The study is designed as exploratory, dose escalating with the aim to determine the dose of plasmid that produces IL-12 expression in the tumours with best biological activity, infiltration of the immune cells and no toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed, previously untreated cutaneous basal cell carcinoma located in head and neck region.
* Solitary tumors, with largest diameter up to 3 cm, in the region where curative surgery is feasible.
* Age 18-years or older.
* Life expectancy \> 3 months.
* Physical performance in accordance with the Karnofsky scale ≥ 70 or \< 2 in accordance with World Health Organization (WHO) scale.
* The patient must be capable of understanding the treatment procedure and possible adverse events, which may arise during treatment.
* The patient must be capable of signing the informed consent to participate in the clinical study (voluntary and conscientious consent after education).
* Prior to inclusion in the trial, the patient must be presented at a multidisciplinary advisory team meeting.

Exclusion Criteria:

* Known malignancy elsewhere in/on the body.
* Lesions not suitable for treatment with GET (invasion into the bone, infiltration of large vessels).
* A life-threatening infection and/or severe heart failure and/or liver failure and/or other life-threatening systemic diseases.
* Significantly reduced lung function, which requires the determination of DLCO. Patients should not be treated if DLCO is abnormal.
* Treatment with immunosuppressive drugs, steroids and other drugs that would affect poor wound healing.
* Age under 18-years.
* Major disruptions in the coagulation system (who does not respond to the standard therapy - replacement of vitamin K or freshly frozen plasma).
* A chronic decline in the kidney function (creatinine \> 150 µmol/L).
* Epilepsy.
* Pregnancy and breast-feeding.
* The patient's incapability of comprehending the purpose or course of the trial, or not agreeing to be included in the trial.
* Patients unwilling or unable to comply with the protocol requirements and scheduled visits.
Whole Body Vibration Therapy in a Participant With Multiple Sclerosis Related Balance Deficits - A Case Study

The purpose of this investigation is to determine the effect of Whole Body Vibration Therapy (WBV) on balance in a participant with multiple sclerosis (MS) related balance deficits as measured by the NeuroCom Balance Master, the Sapphire IIME EMG Device and the Kurtzke Expanded Disability Status Scale (EDSS) and the Berg Balance Score.


Eligibility Criteria:
Inclusion Criteria:

Logan student, staff, or faculty or general public with a minimal of 2 year history of diagnosed Multiple Sclerosis (MS)

Exclusion Criteria:

1)visual or vestibular condition that would affect balance; 2) Non-Ms related systemic illness that would have an adverse effect on balance; 3) Local infection, acute inflammation, injury, tumors or other malignancy, recent wounds, diabetes; 4) Any unstable joints of the lower extremity, recent hip and knee joints or fitted hip or knee pins, bolts and/or plates; 5) Acute thrombosis; 6) Severe migraine, epilepsy; 7) Serious cardiovascular disease, wearing a pacemaker; Any Spinal manipulation within 48 hours; 8) Acute disc herniation, discopathy or spondylolysis; 9) Prescription or herbal muscle stimulants, relaxants, etc. that could affect balance; 10) Any implanted device or prosthesis or intrauterine IUD type of device; 11) Pregnancy
The Effect of Phonophoresis in Subacromial Impingement Syndrome.

Subacromial impingement syndrome (SIS) is a dysfunction caused by an impingement of the rotator cuff tendon between the head of the humerus and the acromion as a result of changes in the subacromial space. The patients' symptoms, such as pain, limited joint mobility and reduced strength, may lead to a diagnosis of SIS. The conservative treatment of individuals with SIS is includes analgesics and non-steroidal anti-inflammatory drugs (NSAIDs), steroid injections and physiotherapy. Ultrasound therapy is one of the common physiotherapy applications for SIS, but its effectiveness is controversial. Phonophoresis is a combination of ultrasound therapy and medical therapy. In phonophoresis, a medicine in gel form is used as a transmitter with ultrasound instead of the aquatic conductor gel. It was hypothesized that ultrasound waves favoring the penetration of an anti-inflammatory drug would lead to an improved response to the treatment of SIS. However, the effectiveness of ultrasound modes (pulsed or continuous) can be used in phonophoresis is debatable. The purpose of this study is to determine the effect of ultrasound therapy, pulsed mode ultrasound and continuous mode ultrasound phonophoresis in patients with SIS.


Eligibility Criteria:
Inclusion Criteria:

* to be diagnosed as shoulder impingement syndrome,
* shoulder pain for at least one month,
* VAS score over 40mm.

Exclusion Criteria:

* grade III supraspinatus tendon injury,
* major shoulder trauma,
* diabetes mellitus,
* hipotiroidizm,
* adhesive capsulitis,
* cardiac pacemaker
* physical therapy or local injection to the shoulder at last six month
* serious cervical pathologies.
Validity and Reliability of the Thai KASRP

Pain is a very common symptom. Pain was found to be a major cause for visiting a doctor. It accounted for 40% of the primary care visits. Pain is also the leading cause of Emergency Department visits. Physicians have a significant role for assessment and management of various kinds of pain.

Knowledge and attitude of doctors (as well as other health care providers) affect their pain management. A survey study using The Knowledge and Attitudes Survey Regarding Pain (KASRP) questionnaire performed in Malaysia revealed that 41.7% of respondents had scores less than 60% regarding pain knowledge. It also revealed that male medical officers had better performance than female medical officers. Anesthesiologist showed the highest mean score. Authors of this study concluded that there is a lack of knowledge and attitude on assessment and management of pain. A similar survey study was performed in Jordan to evaluate health care providers' knowledge and attitudes by using the KASRP. Even doctors had more pain knowledge in comparison to nurses, both of them demonstrated a low level of knowledge and negative attitudes in terms of pain management. A survey study from Iran showed that less than half of health care providers who volunteered to complete a study questionnaire had correct response. Only 9.3% of them thought that they had received sufficient teaching regarding pain and its management.

The Knowledge and Attitudes Survey Regarding Pain (KASRP) The Knowledge and Attitudes Survey Regarding Pain (KASRP) 2014 is a 39-item questionnaire. It comprises of 22 true or false questions and 17 multiple choice questions. Its purpose is to measure knowledge and attitudes of health care providers in regard to pain. It is principally useful as a pre- and post-test measure and can be utilized to rate learning outcomes following educational programs on pain. The KASRP tool was developed in 1987 and has been used extensively since then until present. It has been revised over several years to reflect changes in pain management practice. Its content validity has been established by review of pain specialists. The content of the KASRP tool is derived from standards of pain management such as the American Pain Society (APS), the World Health Organization (WHO), and the National Comprehensive Cancer Network Pain Guidelines. Its construct validity has been established by comparing scores of nurses at various levels of expertise such as students, new graduates, oncology nurses, graduate students, and senior pain experts. The tool was identified as discriminating between levels of expertise. Test-retest reliability was established (r \> 0.80) by repeat testing in a continuing education class of nursing staffs (n = 60). Internal consistency reliability was established (alpha r \> 0.70) with items reflecting both knowledge and attitude domains.

Eligibility Criteria:
Inclusion Criteria:

* Health care providers

Exclusion Criteria:

* None
Balance in People With Frozen Shoulder

The aim of this study was to investigate the balance characteristics of patients with Frozen Shoulder.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers aged 40-65 years,
* Diagnosed with unilateral Frozen Shoulder, Frozen Shoulder stage 2-3,
* Pain lasting more than 3 months,
* No mental or cognitive impairment
* At least 25% movement limitation in at least 2 movement planes and
* Able to cooperate.

Exclusion Criteria:

* Who had a neurological, rheumatic, cardiac and active malignant diseases
* Who had a history of surgery, trauma, and fracture
* Who had comorbid conditions that would affect balance

The control group consisted of healthy subjects who were not diagnosed with Frozen Shoulder and did not have a chronic disease that would affect balance between the ages of 40-65.