cyrilzakka/clinical-trials huggingface dataset:
Cool vs Room-temperature Artificial Tears

Background and Objective: To evaluate the efficacy of cooled versus room temperature artificial tears in reducing post intravitreal injection (IVI) ocular discomfort.

Patients and Methods: Patients receiving IVI were randomized to either cooled or room temperature tears intervention groups. Both groups rated their ocular discomfort following IVI before intervention and again after administration of cooled or room temperature tears.


Eligibility Criteria:
Inclusion Criteria:

* Patients were eligible if they were receiving standard intravitreal injections for their exudative age-related macular degeneration, cystoid macular edema, diabetic macular edema, proliferative diabetic retinopathy, retinal vein occlusion with macular edema, or retinal neovascularization.

Exclusion Criteria:

* Inability or lack of willingness to participate in the study
* Active ocular infection including infectious uveitis
* First time receiving intravitreal injection
* Those who reported never having ocular discomfort following intravitreal injections on the pre-injection questionnaire
* Less than 18 years of age
DE-111 Against Timolol Ophthalmic Solution 0.5%

DE-111 ophthalmic solution will be evaluated for superiority in comparison with Timolol ophthalmic solution 0.5%, in IOP(intraocular pressure ) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Safety will be compared and evaluated as well.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary open angle glaucoma or ocular hypertension
* Provided signed, written informed consent
* 20 years of age and older
* If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study

Exclusion Criteria:

* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
* Presence of any abnormality or significant illness that could be expected to interfere with the study
General Anesthesia vs. Local Anesthesia in Stereotaxy

Examination of stress level in general anesthesia in comparison to local anesthesia in stereotactic biopsy

Stereotactic biopsy is routinely performed under local or general anesthesia. The advantage of local anesthesia might be reduction in cardiac and pulmonal complications, reduction of surgical time, and reduction of hospital stay. On the other hand it has been postulated that intraoperative seizures are avoided by general anesthesia and that brain tumor surgery is perceived in the public as psychological and physical stress.Therefor we postulate that patients undergoing stereotactic biopsies in local anesthesia show a higher stress level than patients operated under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* planned stereotactic biopsy
* age \> 18 years

Exclusion Criteria:

* pregnancy
* anxiety disorder
* impaired consciousness
Catheter Ablation of Arrhythmias to Improve CRT Response

The purpose of this study is to test if catheter ablation is better than medication therapy at treating arrhythmias originating from the upper and/or lower chambers of the heart in order to allow the heart to beat properly.


Eligibility Criteria:
Inclusion Criteria:

* Heart failure patients with CRT-D or CRT-P greater than 3 months
* Bi-ventricular pacing less than 94% of the time
* 3 months after CRT-D or CRT-P implantation an EF improvement less than 5%
* Presence of one of the following arrhythmias and eligible for catheter ablation:
* Atrial fibrillation
* Atrial flutter
* Supraventricular tachycardia
* Premature ventricular contraction burden greater than 30% in a 24-hour period
* Ventricular tachycardia

Exclusion Criteria:

* Estimated survival less than one year
* Patient unable to make scheduled follow up visits at treating center
* Participating in another investigational study
Operative Versus Non-operative Treatment of Recalcitrant Plantar Fasciitis - A Randomized Study

The purpose of the study is to examine whether patients with heel spurs for more than 6 months, who have been treated conservatively, have better effect of surgery than further conservative treatment. The study is performed as a randomized trial with the inclusion of 32 patients divided between open plantar fasciectomy and conservative treatment.

The primary endpoint is Self-Reported-Foot-And-Ankle Score (SEFAS-score) after 24 months.

Secondary endpoints includes: Pain (Visual analogue score) at first step, rest and activity after 3, 6, 12 and 24 months, SEFAS-score after 3, 6 og 12 months, changes in gait after 6 months (measured with gait-analysis). All endpoints are measured at inclusion.

The power calculation is based on the assumption that surgical treatment gives an improvement in SEFAS-score of 10 points (SD 7.9) after 24 months when compared to conservative treatment together with an alpha-value of 5 % and a beta value of 90 %.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Isolated plantar fasciitis through more than 6 months
* Ultrasonic verification of diagnosis (plantar fascia \>4 mm)
* Ability to follow the post-operative- and conservative plans
* Able to give informed consent.

Exclusion Criteria:

* Previous surgical treatment of plantar fasciitis or surgery around the heel
* Rheumatic disease
* Diabetes
* Dementia
* Neuropathy
* Known alcohol abuse
* Pareses/paralysis of the affected extremity.
PiCCO ASSESSMENT IN PATIENTS WITH SEPTIC SHOCK

Sepsis is the result of a complex pathological process which involves an intravascular inflammatory state, loss of vascular tone, endothelial injury, extravascular leakage, and often inefficient myocardial contractility. These affect the cardiovascular homeostasis as well as the regional perfusion and tissue oxygenation of patient. The importance of early cardiovascular support in septic patients is the reason why, for about fifteen years, the implementation of standardized resuscitation protocols has been emphasized.

The Surviving Sepsis Campaign Guidelines (SSG) recommend an initial fluid resuscitation followed by use of a vasoactive agent such as norepinephrine for the treatment of patients with septic shock. To understand the impact of the hemodynamic support provided by the resuscitation strategy, the assessment of surrogate clinical parameters is pivotal. According to the current guidelines, the increase of mean arterial pressure (MAP) above 65 mmHg represents the threshold in defining patients as "stable".

Although this strategy has been well established, its impact on the actual hemodynamic profile of the septic patient, remains a subject of ongoing controversy. In this scenario, the transpulmonary thermodilution technique (TPTD) allows invasive assessment of the patient hemodynamic profile in terms of fluid responsiveness, vasomotor status, or global cardiac efficiency. By using this technique, several studies highlighted a wide variability in the individual response of patients undergoing cardiovascular stabilization guided by SSG. This suggests that the implementation of a "customized" resuscitation protocol based TPTD derived parameters rather than resuscitation strategy guided by a fixed mathematic model, could be preferred. However, in daily clinical practice, the use of this advanced hemodynamic monitoring system in not routinely used, though it is often reserved in case of failure of the initial SSG-resuscitation protocol.

The investigators supposed that, even if the initial resuscitative efforts were successful in achieving the SSG targets i.e. by restoring the MAP \> 65 mmHg, this could still be inadequate in some patients. Accordingly, the investigators hereby will report the hemodynamic profile of patients with septic shock admitted in ICU.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* admitted in ICU with diagnosis of septic shock

Exclusion Criteria:

* Contraindication at the insertion of the PiCCO catheter; conditions able to bias the transpulmonary thermodilution technique results (atrial fibrillation, extracorporeal membrane oxygenation, valvular disease and/or cardiomyopathy
* Pre-existing respiratory and cardiovascular pathologies
* Pre-existing kidney pathologies
InterGard Synergy Post-Marketing Surveillance Study

The purpose of the study is to assess the performance and safety of the InterGard Synergy vascular graft.

Study of the device in patients with aneurysmal and occlusive disease of the abdominal aorta and peripheral arteries.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring an InterGard Synergy Vascular Graft

Exclusion Criteria:

* Patients with contra-indications per InterGard Synergy Vascular Graft
* Patients with current graft infection
* Patients with a known allergy to collagen, triclosan or silver acetate
* Patients who require urgent or emergent surgery
The Brain and Lung Interaction (BALI) Study

The purpose of this study is to understand the relationship between intracranial pressure and airway pressures during mechanical ventilation. This study is a single-center, prospective cohort study to be conducted at Beth Israel Deaconess Medical Center. The investigators will recruit patients with severe brain injury (GCS 8 or less) who receive intracranial pressure monitoring and mechanical ventilation as part of their routine medical care. The primary endpoint is the change in intracranial pressure as a function of positive end-expiratory pressure. There is only one study encounter with safety monitoring for up to 24 hours after. No additional follow up is required.


Eligibility Criteria:
Inclusion Criteria:

- Patients with severe brain injury (GCS 8 or less) who receive both mechanical ventilation and intracranial pressure monitoring as part of their standard medical care will be considered eligible.

Exclusion Criteria:

* Patients with esophageal varices
* Patients with esophageal trauma
* Patients with recent esophageal surgery
* Patients with coagulopathy (Platelets \< 80k or INR\> 2 )
* Other contraindication for esophageal manometry
* Patients who are receiving PEEP greater than 15 cmH2O within 24 hours prior to enrollment
* Intracranial hypertension (defined as ICP greater than 20 mmHg) within 48 hours prior to enrollment
* Decompressive hemi-craniectomy

Cessation Criteria: Study related ventilator adjustments and measurements will be stopped at any point during the intervention and ventilator settings will be returned to the pre-intervention settings under the following conditions:

* If ICP increases above 20mmHg, regardless of the duration of the event.
* If systolic blood pressure decreases below 90mmHg, regardless of the duration of the event.
* If systolic blood pressure increases above 180mmHg, regardless of the duration of the event.
Rhinitis, Cognition and Driving Performance

This study investigates the effects of Allergic Rhinitis (AR) on driving ability and memory functions. Our group has previously shown that patients suffering from AR symptoms perform less well on tasks requiring sustained attention compared to non symptomatic controls. Car driving is a typical behavior that is susceptible for changes in sustained attention and might therefore become worse under conditions when patients suffer from AR symptoms. We will compare the driving performance of untreated, symptomatic AR patients with the performance of symptomatic patients that have been treated with either a systemic AR medication (a pill) or a topical medication (nasal spray)


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers known with Seasonal Allergic Rhinitis
* Experienced drivers holding a license
* 21- 45 years of age

Exclusion Criteria:

* Asthma or other chronic illness
* current psychoactive medication
* History of drug abuse
A Study to Investigate the Safety Tolerability Pharmacokinetics, and Pharmacodynamics of Inhaled and Intravenous GSK2862277 in Healthy Volunteers

This will be a 3 part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of GSK2862277 administered via inhalation (IH) or intravenous (IV) routes in healthy subjects.

Part 1 of this study will involve an initial assessment of safety, tolerability and pharmacokinetics of GSK286227, via single escalating intravenous doses, compared to a predecessor molecule, GSK1995057. After completion of Part 1 an interim data review will occur which will assess key comparability criteria to inform progression to Part 2 of the study.

Part 2 of the study will involve single doses of GSK2862277 at a level predicted to be at or close to therapeutic dose levels. Part 2 will investigate both intravenous and inhaled routes of administration, in sequential manner, respectively. An interim data review will also occur after completion of Part 2, where all data accumulated previously will be assessed to examine appropriateness to progress to Part 3.

Part 3 of the study will involve 5 days of repeat dosing via both inhaled and intravenous routes using the same dose administered in Part 2.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
* Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
* Subject is positive at screening for HAVH autoantibodies against GSK1995057 (Part 1 only).
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
* A positive pre-study drug/alcohol screen.
* A positive test for human immunodeficiency virus (HIV) antibody.
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.

Exclusion Criteria:

* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
* A positive pre-study drug/alcohol screen.
* A positive test for human immunodeficiency virus (HIV) antibody.
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day
Impact of Nutrition Labels on Consumer Purchasing Intentions

The purpose of this interventional study is to compare the impact of four different Front-Of-Pack (FOP) nutrition labels on purchasing intentions. This study is nested in the ongoing web-based prospective observational NutriNet-Santé cohort study, including on December 2014 around 150,000 participants. The investigators will perform a five-arm randomized trial where participants will be subjected to different FOP nutrition label formats: Guidelines Daily Amount (GDA), Multiple Traffic Lights (MTL), 5-Color Nutrition Label (5-CNL), Green Tick (Tick) and a 'no label' condition. The impact of front-of-pack nutrition labels on the nutritional quality of the shopping cart will be assessed. Participants from the NutriNet-Santé cohort study will be randomly assigned to one of these five experimental conditions according to their sociodemographic characteristics.

Purchasing intentions will be assessed using an experimental web-based supermarket designed to look like a regular online grocery store. The supermarket includes 269 unique products divided into 4 categories: dairy products, processed meat/delicatessen, savory and breakfast/sugary products. Each category is then separated into specific products families like yogurt, milk, cheese, etc. for the dairy products category. Inside a food family, the selection of foodstuffs will be made to obtain a representative sample of the products commonly sold in French supermarket. For each type of products, at least two variants are proposed. Products are retailers or manufacturers branded. Categories of products that are not usually bought each week, or which are likely to be bought from different sources are not included on the web-based supermarket.

Participants are asked to simulate a shopping situation: they have to select a week worth of food for their family among proposed products. If the user is not able to find a product he/she usually buy, the instruction is to select similar product among proposed ones.

Information provided for each product is: name, price and the picture with the FOP label/or not according to the experimental condition to which the participant is allocated. A brief explanation of the FOP label used is also given.


Eligibility Criteria:
Inclusion Criteria:

* Being a participant of the NutriNet-Santé cohort study
* Completing the preliminary questionnaire about nutrition knowledge and purchasing habits
* Completing online shopping in the experimental supermarket

Exclusion Criteria:

* Not going shopping usually
* Having a difference greater than 400€ between the price of their shopping cart versus their usual weekly shopping cart budget
* Having aberrant body mass index (i.e. \>55 or \<11 for women and \<13 for men)
Study of the Effect of Food on the Bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers

This is an open-label, single-dose, two period crossover study to evaluate the effect of food on the bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult, male or female, 18-60 years of age, inclusive
* Nonsmoker who has not used nicotine containing products for at least 3 months
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs
* If of reproductive age, willing and able to use a medically highly effective form of birth control 4 weeks prior to first dose, during the study and for 30 days following last dose of study medication
* Capable of giving informed consent and complying with study procedures.

Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition or disease
* History of any illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study
* History or presence of alcohol or drug abuse within the past 2 years
* Presence or history of significant gastrointestinal, liver or kidney disease, or any other condition that is known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects
* History of prolonged QT syndrome or a QTc interval with Fridericia's correction (QTcF) \> 450 msec for males or QTcF \> 470 msec for females
* Abnormal liver function at screening
* Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug
* Positive results for coronavirus infection (COVID-19) at screening or check-in (Day -1)
* Positive drug or alcohol results at screening
* Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
* Participation in another clinical study within 30 days prior to, and 30 days after the first dosing
Effect of a Healthy Food Voucher on Blood Glucose Control in People With Type 2 Diabetes or Prediabetes

This randomized controlled trial (RCT) will determine if access to a voucher for healthy foods reduces blood sugar levels among people living on a low income who have type 2 diabetes or elevated blood sugar.


Eligibility Criteria:
Inclusion Criteria:

* hemoglobin A1c 6.0 to 11.0
* report food insecurity or financial insecurity

Exclusion Criteria:

* live with a current study participant
* life expectancy \< 6 months
* multiple life-threatening allergies to common foods
* require total parenteral nutrion
* blood dyscrasia that interferes with hemoglobin A1c interpretation
* hemoglobin A1c \>11
A Novel Non Invasive Brain Stimulation Based Treatment for Chronic Low Back Pain (CLBP)

Neuropathic pain results from damage to or dysfunction of the peripheral or central nervous system, rather than stimulation of pain receptors. Diagnosis is suggested by pain out of proportion to tissue injury, dysesthesia (eg, burning, tingling), and signs of nerve injury detected during neurologic examination. Although neuropathic pain responds to opioids, treatment is often with adjuvant drugs (eg, antidepressants, anticonvulsants, baclofen, topical drugs). Neuropathic pain (e.g. phantom limb pain, CRPS, postherpetic neuralgia, postsurgical pain syndromes, CLBP etc.) remains a challenging condition to treat because it is commonly refractory to classical pharmacological and to surgical treatment approaches. Chronic low back pain (CLBP) is a widespread and costly problem for which few interventions are effective. An increased focus on the study of the nervous system and its involvement in pain disorders has documented complex neuronal activity and structural changes at a peripheral, as well as at spinal cord and cortical levels indicating a neuropathic element in CLBP. Accumulated evidence suggests that neuropathic pain in general and CLBP specifically might be associated to brain cortical plastic changes. Thus an ideal rehabilitative approach should aim to reverse them. In line with this idea, the investigators suggest an innovative noninvasive intervention aimed at alleviating neuropathic pain. New rehabilitative approaches have been proposed to try and reverse this cortical reorganization. Results of several studies have shown that motor cortex stimulation with epidural electrodes or repetitive transcranial magnetic stimulation (rTMS) or transcranial direct stimulation (tDCS) are effective in reducing pain in patients with central pain refractory to treatment. Transcranial direct current stimulation (tDCS) is an easily applied and safe technique by which brain activity can be modulated noninvasively and can decrease pain in patients with refractory central pain. The investigators hypothesized that focal-tDCS treatment personally customized to each patients basal neuronal network properties would result in both acute and long term pain relief for neuropathic pain patients.


Eligibility Criteria:
Inclusion Criteria:

1. age 18 to 70
2. CLBP as defined by the European guidelines

Exclusion Criteria:

1. Acute low back pain (duration of less than 6 months
2. Neurological illness causing structural brain damage (e.g. Stroke, TIA)
3. Psychiatric disease other than mood disorders
4. Current chronic use of medications with pro-epileptic properties
5. Known alcohol dependency
6. Use of alcohol within the previous 24 hours
7. History of loss of consciousness
8. Epilepsy or epilepsy in a first degree relative
9. Medical implants
10. Pregnancy
11. Illicit drug use or within the previous month