cyrilzakka/clinical-trials huggingface dataset:
NOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for the Treatment of Dry Eye

Study is to assess the safety and efficacy of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Cationic Emulsions QD compared to vehicle for the treatment of the signs and symptoms of dry eye after a 3 month treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Male and female 18 years and older
* Diagnosis of dry eye in both eyes

Exclusion Criteria:

* Contraindications to the use of the study medications
* Known allergy or sensitivity to the study medications or their components
* Female currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test
* Have participated in an investigational drug or device study within 30 days of Visit 1
LipoAerosol© Inhalation After Tracheostomy

Patients after tracheostomy represent a substantial part in the ear nose throat clinic. Long-term intubated patients in intensive care units also profit from tracheostomy due to an improved respiratory toilet. However, after tracheostomy patients demonstrate shunt ventilation bypassing the sinonasal and pharyngeal system. The physiological moistening, cleaning and warming of the breathing air fail resulting in a respiratory inflammation. Beside a variety of supportive medical devices no general recommendation exists at present. Recently, we demonstrated the beneficial application of local phospholipids in Sjoegren's syndrome and antineutrophil cytoplasmatic antibody associated sinonasal vasculitis.

In the current monocentric, two-armed, double-blinded, randomized parallel group study we would like to evaluate the beneficial application of LipoAerosol© when compared with standard physiologic saline inhalation. LipoAerosol© is a licensed, tradable medical device and will be applied as part of its intended use. Liposomal inhalation solution provides moistening, cleaning and warming of the upper and lower respiratory tract and supports the natural moistening film in airway irritations and diseases.

Blood parameter (leucocytes and c reactive protein) and tracheobronchial secretion (Lymphocyte subpopulation, c reactive protein, lactate dehydrogenase, granulocyte macrophage colony stimulating factor, interferon γ, interleukins 10, 12 (p70), 13, 1β, 2, 4, 5, 6, 7, 8, tumor necrosis factor α) will be collected 1, 3, and 10 days after tracheostomy. In addition, medical examination records the number of suction maneuver (0 points: none; 1 point: 5-10x/d; 2 points: 10-20x/d; 3 points: \>20x/d), flexible-optical assessment of tracheo-bronchial redness (0 point: none; 1 point: peristomal; 2 points: tracheal; 3 points: tracheo-bronchial) and flexible-optical assessment of mucous congestion (0 point: none; 1 point: fluent; 2 points: tenacious; 3 points: barky).

Subjective estimation of the respiratory impairment will be analyzed via visual analogue scale (Subjective overall impairment, coughing frequency, breathlessness, mucous congestion, color of sputum, consistency of sputum). The study is designed without any additional invasive or incriminating clinical examination.

Aim of the study is to maintain the functional integrity of the tracheo-bronchial system after tracheostomy using LipoAerosol© resulting in a general therapeutic recommendation.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≤24h after tracheostomy and regular patient's consent

Exclusion Criteria:

* No regular patient's consent
* Known allergy for ingredients
* Patients \>24h after tracheostomy
* Patients with acute or imminent sepsis
* Patients with existing bronchopulmonary inflammation
* Patients with immunosuppressive therapy
* Patients with poorly adjusted pulmonary disease
* Patients with chronic respiratory insufficiency
Nu-DESC DK: The Danish Version of the Nursing Delirium Screening Scale

Delirium is one of the most common complications among elderly hospitalized patients, postoperative patients and patients on intensive care units. The reported prevalence is between 11 and 80 %. Delirium is associated with a high morbidity and threefold higher 6-month mortality. The Nursing-Delirium Screening Scale (Nu-DESC) is a screening tool with a high sensitivity and specificity.

The purpose of this study is to translate the Nu-DESC to danish and evaluate afterwards its feasibility and understanding by different medical staff.

Material and methods:

The Nu-DESC will be translated after International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines to Danish by permission of the original author.

The evaluation will be performed, by filling out evaluation forms, where the feasibility and understanding will be rated on a 6 step Likert scale.

Translation of the original tool and evaluation of understanding and feasibility by medical staff.

Eligibility Criteria:
Inclusion Criteria:

* Medical staff working in the recovery room or orthopedic ward

Exclusion Criteria:

* Medical staff from other wards
Proprioceptive Training and Low Back Pain

Proprioceptive weighting changes may explain differences in postural control performance. Deficits in proprioception are found in a subgroup of patients with low back pain.

The aim of the study is to clarify whether proprioceptive training has a positive effect on proprioceptive postural control in individuals with recurrent low back pain.


Eligibility Criteria:
Inclusion Criteria individuals with low back pain:

* Age: 18-45 years old
* At least 1 year of low back pain with/without referred pain in buttock/thigh
* At least 3 episodes of disabling low back pain
* At least a score of 20% on the Oswestry Disability Index
* Willingness to sign the informed consent

Exclusion Criteria:

* History of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant
* One of the following conditions: Parkinson, multiple sclerosis, stroke, history of vestibular disorder, respiratory disease, pregnancy
* Radicular symptoms
* Not Dutch-speaking
* Strong opioids
* Neck pain
* Smoking history
Comprehensive Exercise Training Program During Hospitalization for an Acute CF Exacerbation

This protocol was designed to assess if when subjects with CF are admitted to the hospital for a pulmonary exacerbation if a comprehensive exercise program (moderate to high intensity aerobic, resistance, flexibility and balance exercises) was superior to our "usual care intervention (30 min/day of self selected mode and intensity of exercise) in improving aerobic capacity, muscle strength/power, flexibility and balance.

This protocol was designed to assess if when subjects with CF are admitted to the hospital for a pulmonary exacerbation if a comprehensive exercise program (moderate to high intensity aerobic, resistance, flexibility and balance exercises) was superior to our "usual care intervention (30 min/day of self selected mode and intensity of exercise) in improving aerobic capacity, muscle strength/power, flexibility and balance.

The experimental group will participate in the following regime:

Day 1 - Evaluation including standardized tests and measures: If Day 1 is a M,W, F, day 2 will constitute: aerobic exercise between 20-30 minutes based on patient tolerance using the appropriate RPE scale (13-15 on Borg with patients ages 13-21, and 6-8 on pictoral CERT with patients ages 6-12)to ensure correct intensity. Choices will include treadmill, stationary bike, game bike, or ambulating at varying intensities throughout hospital; Balance Activities: Standing on bosu ball while performing UE activity (throwing, catching with another ball, Frisbee, etc.). Standing on one leg or B LE's will be determined by patients currently level.

If Day 1 is a Tuesday or Thursday, day 2 will constitute: 5-10 minutes of aerobic activity at warm up level (11-13 on Borg, and 4-6 on PCERT)x resistance training for UE: biceps, triceps, lattisimus, rhomboids/mid-trap, thoracic expansion exercises, and other muscles based on patient needs; resistance training for LE: quadriceps, hamstrings, gluteals (especially maximus and medius), and other muscles depending on patient need, core and abdominal strengthening, Stretches for flexibility depending on the patients individual needs: Thoracic expansion stretches will be done with every pt. supine and sidelying. Stretches are held for 10 seconds and repeated 10 times, Hamstring stretches will be performed if pt unable to reach line with sit and reach test.

Eligibility Criteria:
Inclusion Criteria:

* age 6 to 21 years
* admission for an acute Cystic fibrosis (CF) exacerbation
* forced expiratory volume in 1 s (FEV1) of \< 60% of predicted at admission

Exclusion Criteria:

* medically unstable as deemed by the attending physician
* had completed both arms of the present study
Perception of Objects and Natural Scenes in People With Vision Loss (ACTIVIS)

The loss of central vision causes difficulty not only in reading but also in faces recognition, and in particular in the identification of facial expression, objects or spaces. These visual deficits have been mainly studied in relation with reading, which is the main complaint of these kind of patients. However, there are not enough data regarding perception of objects and spaces in this population. Then, the objectives are to study the visual-spatial abilities in individuals with vision loss, and altered cognitive processes, (2) to develop clinics tools for early detection and quantification of visual-spatial deficits and (3)to understand the capacities of normal peripheral vision in order to test the possibility of potential training for use of peripheral vision when central vision is impaired by an ophthalmic pathology.


Eligibility Criteria:
Inclusion Criteria cases:

* Patients with eye disease causing loss of central or peripheral vision
* French speakers
* Age between 18 and 90 years old
* Written consent
* Health insurance

Inclusion Criteria controls:

* Sex and age matched controls (+/- 5 years)
* French speakers
* Normal visual examination with visual acuity of min 9/10

Exclusion Criteria:

* Psychiatric disease or neurological pathologies
* Communication difficulties (deafness / mutism)
* Drug treatment altering concentration
* Mental deterioration with MMS \<24
* Alcoholism or addiction to drugs
* Persons under guardianship
A Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus Receiving Sitagliptin

The objectives of the study is to evaluate the efficacy and safety of DS-8500a compared with placebo in patients with type 2 diabetes mellitus (T2DM) receiving sitagliptin.

In patients with type 2 diabetes mellitus being treated with sitagliptin, efficacy and safety of DS-8500a are to be evaluated after 28-day multiple oral administration of DS-8500a at 25 or 75 mg, in a double-blind, placebo-controlled, parallel-group comparison study.

Eligibility Criteria:
Inclusion Criteria:

* Japanese patients with type 2 diabetes
* Patients aged ≥ 20 years at the time of informed consent
* Patients who have been treated with sitagliptin 50 mg monotherapy for the treatment of type 2 diabetes mellitus
* Patients who have HbA1c ≥ 7.0% and \< 9.0%

Exclusion Criteria:

* Patients with type 1 diabetes mellitus or with a history of diabetic coma, precoma, or ketoacidosis
* Patients receiving or requiring treatment with insulin
* Patients with a body mass index (BMI) of \< 18.5 kg/m2 or ≥ 35.0 kg/m2
* Patients with clinically evident renal impairment (estimated glomerular filtration rate \[eGFR\] of \< 45 mL/min per 1.73 m2) or clinically significant renal disease
* Patients with fasting plasma glucose ≥ 240 mg/dL
A Prospective Study of the Effect of Treatment of First Time Traumatic Shoulder Anterior Dislocation by Immobilization in External Rotation on the Incidence of Recurrent Dislocation

Dislocation of the glenohumeral joint of the shoulder is a common orthopedic clinical problem. The majority of the dislocations are anterior (about 95%) while the rest are posterior and inferior. After reduction of the initial dislocation, the treatment's goal is to prevent recurrent dislocations. In spite of treatment, the recurrence rate is 80-90% in the population aged 18-29. There is an age-related decrease in the recurrence rate, with the only 2-3% for ages 60-70. It has been calculated that 1 in 200 soldiers in the Israeli Army between the ages of 17 and 33 suffers from recurrent shoulder dislocations \[1\].

The traditional treatment for primary (first-time) shoulder anterior dislocation has been immobilization of the shoulder in internal rotation in a soft dressing called universal shoulder immobilizer (USI) for 3-6 weeks. However, there is a lack of evidence-based information to demonstrate the effectiveness of this treatment. Posterior dislocations are immobilized in external rotation. Work presented previously in the Orthopaedic Research Society and more recently at the American Academy of Orthopaedic Surgeons suggests that immobilization of the shoulder after reduction of anterior dislocation is best in external rotation and not in internal rotation. MRI studies have shown that the labral tear, which is the hallmark of most traumatic anterior dislocations, is best reduced to its anatomical position when the shoulder is immobilized in external and not in internal rotation. Preliminary data indicates that immobilization in external rotation of the primary traumatic shoulder dislocations may lower the incidence of reoccurrence.

The traditional shoulder immobilizer is a generic bandage produced by several companies. In the current study, the investigators will use a USI distributed by Uriel® company (Uriel #87), which can be modified to hold the shoulder in external rotation.


Eligibility Criteria:
Inclusion Criteria:

* Male, age 18-29
* Diagnosis of anterior traumatic dislocation of the shoulder
* First time dislocation with no history of prior shoulder instability before the present episode
* Immobilization placed within 48 hours of the acute shoulder dislocation
* Subject will be in available for 2 years of follow-up
* Signed informed consent

Exclusion Criteria:

* Mechanism of injury - motor vehicle accident
* Associated fracture of tuberosities or glenoid
* Known Collagen disorder
* Additional conditions that prevent inclusion of patient according to the physician's decision
Comparison of Dexmedetomidine and Midazolam for Intra-op Sedation in TIVA in Children Undergoing Inguinal Hernia Repair

To compare dexmedetomidine and midazolam for intra-op sedation in TIVA in children undergoing inguinal hernia repair. The results of the study if found significant will guide the anesthetist in appropriate choice and dose of sedative drug with highest efficacy and minimum side effects to avoid post operative adverse effects associated with anesthesia


Eligibility Criteria:
Inclusion Criteria:

* Male and female paediatric patients In age range neonates to 15 years
* Planned for elective inguinal hernia repair
* Patients with uncomplicated hernia With ASA class I or II

Exclusion Criteria:

* Patients undergoing emergency inguinal repair
* Patients with ASA class III,IV,V or VI
* Patients present with complicated hernia
* Patients with BMI above 40kg/m2
* Patients with any allergy to anesthesia
* Patients with coagulopathy
* Patients with narcotic/opioid addiction
tDCS and Physical Therapy in Stroke

The purpose of this study is to determine whether a painless and noninvasive procedure called transcranial direct current stimulation (tDCS) combined with a method of physical therapy called constraint-induced movement therapy improves motor function in patients with chronic stroke. Research in healthy subjects has shown that when tDCS is combined with motor learning tasks, there is an increase in learning as compared to motor learning tasks only. The tDCS procedure sessions will be compared to sham (fake) procedure sessions, which is also called placebo stimulation. This study is double blind, which means neither the subjects nor researchers analyzing motor function will know if participants are receiving real tDCS stimulation or placebo. Only the person performing the procedure will know which one participants are receiving. Only by comparing the tDCS procedure to a sham (placebo) procedure can we understand if the tDCS actually improves motor function.

We hypothesize that tDCS will enhance the effects of constraint-induced movement therapy on motor recovery in chronic stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* First time clinical ischemic or hemorrhagic cerebrovascular accident (radiologically confirmed)
* Demonstrates adequate balance while wearing a hand restraint on the unaffected arm
* Ability to stand from a sitting position and ability to stand with or without upper extremity support
* Stroke onset at least 6 months prior to study enrollment

Exclusion Criteria:

* Significant pre-stroke disability
* Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing
* Excessive pain in any joint of the paretic extremity
* A terminal medical diagnosis consistent with survival of less than 1 year
* Advanced liver, kidney, cardiac, or pulmonary disease
* Coexistent major neurological or psychiatric disease (including epilepsy)
* A history of significant alcohol or drug abuse in the prior 3 years
* Use of neuropsychotropic drugs - such as antidepressants
* Patients may not be actively enrolled in a separate intervention study targeting stroke recovery
* Patients may not have already received constraint-induced movement therapy and/or tDCS treatment for stroke
A Double Blinded Study to Examine the Effect of Alpha Agonist Ointment on Fecal Incontinence in Patients With Idiopathic Fecal Incontinence

The purpose of this study is to assess the effect and safety of alpha agonist ointment on fecal incontinence severity in patients with idiopathic fecal incontinence.

This is a double blinded cross over study. Approximately 40 subjects will be participating in this 4 weeks study. A screening visit will be used to determine eligibility for the study. Patients found eligible will receive alpha agonist ointment or placebo ointment for 2 weeks. This will be followed by a second 2 weeks treatment cycle in which:

* patients previously treated with alpha agonist will be treated with placebo.
* patients previously treated with placebo will be treated with alpha agonist.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent.
* Male or female subjects 18 to 65 years of age.
* Fecal incontinence score over 8.
* The patient is able to understand the treatment and is willing to comply with the prescribed regimen.

Exclusion Criteria:

- Has a clinically significant history or presence of any of the following conditions:

* Known allergy to the API.
* Porphyria.
* Glaucoma.
* Pregnancy or lactation.
* Active or past history of cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities;
* Type 1 diabetes mellitus;
* Insulin treated type 2 diabetes mellitus.
* Renal insufficiency.
* Liver insufficiency.
* Malignant disease within 5 years of screening;
* Has hypertension (sitting blood pressure over 140/90 mmHg at screening)
* History of rectal surgery.
* History of HIV, hepatitis B, hepatitis.
* Has used, in the last four weeks, drugs that may affect blood coagulation, such as Aspirin (at a dose above 250 mg/day), Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine.
* Use of tricyclic or monoamine-oxidase inhibitors.
* Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula., infection or space occupying lesion.
* Unable to understand the use instruction for the ointment, as judged by the investigator.
Serum Lactate in Acute Mesenteric Ischemia

Background: Acute mesenteric ischemia is a vascular emergency with high mortality because of ambiguous symptomatology and a lack of early diagnostic markers. Lactate dehydrogenase has been described as a mortality biomarker and bowel necrosis length too. Nevertheless, the association between them has been mildly studied. Our objective was to evaluate the association between serum lactate admission levels, bowel necrosis extension, and mortality. Additionally, we performed a mortality characterization.

Materials and Methods: A retrospective cross-sectional study was designed. We reviewed patients' clinical records with acute mesenteric ischemia that attended a hospital between 2012 and 2018. We compared serum lactate admission levels with bowel necrosis length and mortality. A receiver operating characteristic curve was performed on the last association. As post hoc analysis, a classification and regression tree on mortality was fitted.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years of age
* Required urgent laparotomy with a postoperative diagnosis of acute mesenteric ischemia
* Attended the private academic hospital, between 2012 and 2018
* Had a registered serum lactate dehydrogenase at admission

Exclusion Criteria:

* Secondary causes of AMI
* Chronic intestinal ischemic
* Patient records with no description of the serum lactate dehydrogenase or extension of intestinal necrosis