cyrilzakka/clinical-trials huggingface dataset:
Predicting Rehabilitation Outcomes in Bilingual Aphasia Using Computational Modeling

The purpose of this investigation is to implement a computational model that can predict and optimize training and cross-language generalization patterns for bilingual persons with aphasia (BPA). The proposed work will determine the best possible treatment program for each individual patient even before they are rehabilitated. In addition, the computational model allows specification of variables such as age of acquisition, language exposure/proficiency, impairment and their systematic influence on a range of language rehabilitation outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Any number of years of education
* Bilingual: speaking both Spanish and English (or Chinese and English) with any degree of language proficiency prior to stroke
* Aphasia secondary to a left-hemisphere stroke (diagnosed by a neurologist on the basis of clinical CT/MRI imaging or medical reports)
* Aphasia resulting from stroke or dementia
* Naming deficits must be present with concurrent lexical/semantic impairment
* Visual and auditory acuity sufficient for all assessment and treatment procedures
* Ability to understand study and follow study procedures for the entire length of the study

Exclusion Criteria:

* Premorbid history of speech/language disorder
* Proficient in more than just Spanish and English (or Chinese and English)
* Overt, behaviorally noticeable, attentional limitations that interfere with completing the experimental tasks
* Active medical disease that may compromise participation (e.g., cancer undergoing acute treatment, unstable diabetes, renal or hepatic insufficiency, fluctuating systemic immunological disease such as systemic lupus erythematosis, etc.)
* Currently taking medications that are known to exert significant effects on cognitive processes, such as neuroleptics, steroids, anticholinesterase inhibitors, etc.
* Current drug or alcohol use or dependence that would interfere with adherence to study requirements, in the opinion of the principal investigator
* Inability or unwillingness of individual to give written informed consent
* Diagnosed with mental illness other than active depression
* Neurological condition other than that which resulted in aphasia
VIBATIV Pregnancy Registry

The purpose of this registry is to evaluate the outcome of pregnancy in women exposed to VIBATIV at any time during pregnancy. There are no mandated physician visits for the registry.


Eligibility Criteria:
Inclusion Criteria:

* Female patients who were exposed to VIBATIV at any time during pregnancy
* Outcome of pregnancy is unknown at the time of enrollment
Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis

Observational studies among critically ill patients have shown strong associations between vitamin D deficiency and adverse outcomes, including increased length of stay, infection, and mortality. It is unknown whether vitamin D deficiency contributes directly to adverse outcomes or whether it is simply a biomarker of severity of illness or overall health status. However, vitamin D plays a key role in host defense, largely by stimulating production of the anti-microbial peptide cathelicidin (LL-37). We will test the hypothesis that administration of activated vitamin D (calcitriol) will increase serum levels of cathelicidin.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18
* Severe sepsis or septic shock
* Central venous catheter (for blood drawing)

Exclusion Criteria:

* Serum calcium ≥ 10.0 mg/dl or phosphate ≥ 6.0 mg/dl, assessed within previous 48 hours
* Current or recent therapy (within previous 7 days) with nutritional vitamin D at doses \>1,000 I.U. per day or activated vitamin D at any dose
* History of solid organ or bone marrow transplant, primary parathyroid disease, metabolic bone disease, or sarcoidosis
* Expected to die or leave the ICU within 48 hours
* History of hypersensitivity or any allergic reaction to calcitriol
* End stage renal disease
* Acute Kidney Injury receiving intermittent renal replacement therapy
* Enrolled in a competing study
* Pregnancy
REDEXAM - Reducing Painful Eye Examinations in Preterm Infants

More than 8000 babies born \>8 weeks early or weighing less than 1500g at birth in the United Kingdom annually are at risk of a serious eye problem - retinopathy of prematurity (ROP). Less than 1 in 10 need treating, but to identify these all of them require eye examinations 1-2 weekly from 5 weeks. These tests are uncomfortable, upsetting for families, and cost considerable time and money.

There is now a new urine test that might help identify babies with the highest risk of developing significant ROP. This cheap test appears to predict which babies need treatment and could avoid invasive eye examination in thousands of babies. The test has so far only been used in 136 babies. It accurately predicted ROP, but 136 babies cannot change practice. We need to test more babies including in the UK. This study is designed to test \>300 UK babies to see how accurately urine levels of NTproBNP predict development of ROP needing treatment.

We will also pool our data with other researchers across Europe testing the same test to identify the best 'cut'-off' value for this test. In the future babies with urine levels of this chemical lower than this cut-off level would not need invasive eye examinations.

If this test works as we hope it will many babies will avoid repeated painful eye tests, and their families will be saved the stress of watching this being done, by replacing these with a simple easy cheap pain free urine test. There will be substantial savings in health care costs that could be used to improve other aspects of care. In resource poor settings without an expert ophthalmologist babies could be screened for ROP that currently cannot be screened.

We hope to demonstrate this to be a family-friendly, achievable intervention that positively impacts on the lives of babies and families experiencing neonatal intensive care.

See protocol

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants \<1500g or \<32 weeks gestation

Exclusion Criteria:

* Separate ocular pathology
Safety Study on IdeS in Healthy Volounteers

This is a first in man study to assess safety and tolerability of the IgG cleaving enzyme Immunoglobuli G degrading enzyme of streptococcus pyogenes (IdeS).

A phase I study (11-HMedIdeS-01, EudraCT no. 2012-000 969-21) first in man single ascending dose study in 29 healthy subjects to investigate if IdeS is safe and well tolerated in doses up to 0.24 mg/kg body weight (BW).

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and sign informed consent
* BMI 19-30

Exclusion Criteria:

* Clinically significant disease
* Positive HIV, hepatistis B or C

  * Drug abuse
* Smoking
* Use of medication except paracetamol
The Usefulness of Visuprime in Cataract Surgery

This is a multicentre, post-market, open label, randomized, placebo-controlled prospective study exploring the performance of Visuprime in improving ocular surface homeostasis and reducing conjunctival bacterial load in patients receiving cataract surgery, as an addon treatment to postoperative standard terapy. The study will consist on 3 visits: Visit 1 (day -3 from surgery), Visit 2 (day 0, surgery), and Visit 3 (day 7 from surgery). Patients will be enrolled after having signed the informed consent form prior to any other study procedure and after inclusion/exclusion criteria check. At each visit all study procedures will be performed according to the clinical investigation plan requirements. Patients will be enrolled at Visit 1 and randomized with a 1:1 ratio to 2 groups:

GROUP A: patients receiving Visuprime eyedrop BID from day -3 to week 1. After surgery, patients will be also given standard postoperative treatment consisting on unitdose desametasone eyedrop + levofloxacin eyedrop, both given four times daily (QID) from day 0 (after surgery) to the end of the study.

GROUP B: patients receiving placebo eyedrop (the vehicle of Visuprime, i.e. isotonic buffered saline solution) BID from day -3 to week 1.

After surgery, patients will be also given standard postoperative treatment consisting on unitdose desametasone eyedrop QID + levofloxacin eyedrop QID from day 0 to the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old patients, male and female
* Previous diagnosis of cataract requiring surgery
* Wishing to participate in the study and able to sign the ICF
* No topic ophthalmic medication, including lubricating eyedrops administration for at least 4 days before screening visit.

Exclusion Criteria:

* Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g.rheumatic disease)
* Previous participation on this study for the fellow eye
* Increased risk of complicated cataract surgery according to the investigator assessment (for example presence of dilation less than 6 mm, pupil decentration, pseudoexfoliation, areas of iris atrophy, sublussation or lussation of the lens, complete cataract, sac instability, iridodonesis, systemic disease limiting intraoperative patient cooperation)
* Coexisting corneal diseases
* Past or active conjunctivitis - any type
* Past ocular surface burns
* Keratinization of the eyelid margin
* Sjogren syndrome
* History of corneal trauma
* Pregnant and lactating women
* Inability to self-administer study medications
* Know allergic sensitivity to any of the devices ingredients, or any other type of allergy
* Participation in a clinical trial during the 3 months prior to the beginning of the study.
Influence of Food on the Bioavailability of Two Doses of Telmisartan/HCTZ Fixed-dose Combination in Japanese Healthy Male Volunteers

To investigate the relative bioavailability and pharmacokinetics of the fixed-dose combination tablets (telmisartan 40 mg/HCTZ 12.5 mg and telmisartan 80 mg/HCTZ 12.5 mg) after food intake in comparison with those in the fasting state in healthy Japanese male volunteers


Eligibility Criteria:
Inclusion Criteria:

Healthy males according to the following criteria:

1. Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead ECG (electrocardiogram), clinical laboratory tests
2. Age ≥20 and Age ≤35 years
3. Body weight ≥50 kg
4. BMI ≥18.0 and BMI ≤25.0 kg/m2 (Body Mass Index)
5. Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation.

Exclusion Criteria:

1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
2. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
3. Chronic or relevant acute infections
4. Any clinical relevant findings of the laboratory test deviating from normal
5. Positive result for either hepatitis B surface (HBs) antigen, anti Hepatitis C virus (HCV) antibodies, syphilitic test or human immunodeficiency virus (HIV) test
6. History of surgery of gastrointestinal tract (except appendectomy)
7. History of relevant orthostatic hypotension, fainting spells or blackouts
8. Known hypersensitivity to any component of the formulation (telmisartan and hydrochlorothiazide), or to any other angiotensin II receptor blocker (ARBs), any other thiazides, or thiazide derivatives (e.c. sulfonamide derivatives like a chlorthalidone)
9. Intake of drugs with a long half-life (≥24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
10. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 7 days prior to administration or during the trial
11. Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational drug prior to administration
12. Smoker (≥20 cigarettes/day)
13. Alcohol abuse (60 g or more ethanol/day: ex. 3 middle-sized bottles of beer, 3 gous (equivalent to 540 mL) of sake)
14. Drug abuse
15. Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
16. Excessive physical activities (within 1 week prior to administration or during the trial)
17. Intake of alcohol within 2 days prior to administration
18. Inability to comply with dietary regimen of study centre
19. Inability to refrain from smoking on trial days
20. Subjects judged to be inappropriate by the investigator or the sub-investigator
Viviant 20mg Special Investigation (Regulatory Post Marketing Commitment Plan)

In this survey, to collect the safety and efficacy information of Bazedoxifene in daily medical practice will be examined. In addition, the necessity of special Investigation and post-marketing clinical studies will be examined, while investigating unexpected adverse drug reactions during the survey period and understanding of the status of frequency of adverse drug reactions in daily medical practice.

All the subjects whom an investigator prescribes the first Bazedoxifene (Viviant) Tablets should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

* Post menopausal women subjects with Osteoporosis who has no experience of use of Bazedoxifene.

Exclusion Criteria:

* Subject with present or past venous thromboembolism such as deep venous thrombosis, pulmonary embolism, or retinal venous thrombosis
* Subject in long-term immovability (postoperative recovery, long-term bed rest)
* Subject with antiphospholipid antibody syndrome
Development and Evaluation of mHealth Solutions to Monitor and Involve Cardiometabolic Patients in Self-care

To develop, using barcode systems and virtual pillbox (TuMedicina and Alice), an App aimed at patients and carers of patients with cardiometabolic diseases as the main diagnosis, over 45 years of age, who have one or more pathologies and use one or more drugs on a daily basis and to analyze their effectiveness in terms of achieving therapeutic objectives, self-efficacy and self-efficacy in self-care or provision of care (as the case may be), healthy behavior, therapeutic compliance and safe use of medication.

In order to achieve the objective of this study, an experimental study will carry out on patients with cardiometabolic and respiratory diseases and their caregivers. A participation of 100 patients and 85 caregivers is planned. The aim is for them to use the mobile application developed over three months in order to evaluate their health improvement comparing several clinical and analytic parameters before and after the use of the App, and also evaluating the satisfaction of the participants.

Eligibility Criteria:
Inclusion Criteria:

* Cardio-metabolic disease, respiratory disease or neurologic disease

Exclusion Criteria:

-
The Effects of High-definition Transcranial Direct Current Stimulation on Balance Control in Older Adults With Chronic Low Back Pain

The goal of this clinical trial is to investigate the effects and mechanisms of high-definition transcranial direct current stimulation over left dorsolateral prefrontal cortex on chronic low back pain and balance in older adults. The main questions it aims to answer are:

Primary hypothesis 1: Active stimulation would have greater improvement in pain and balance, reduced left dorsolateral prefrontal cortex activation than sham stimulation.

Primary hypothesis 2: Active stimulation would have enhanced functional connectivity than sham stimulation.

Primary hypothesis 3: The balance improvement would be related to reduced pain, decreased left dorsolateral prefrontal cortex activation, enhanced functional connectivity, attention, and/or executive function.

Participants will be randomly received a single-session of high-definition transcranial direct current stimulation (active or sham stimulation). Before and immediately after the intervention, balance (semi-tandem stance and timed up-and-go test (TUG)) and cognitive (attention and executive function) tests will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Aged 60-85 years;
* With non-specific chronic low back pain that has no definitive diagnosis but lasted for at least 3 months, typically occurs in the area between the lower rib margins and the buttock creases;
* With an average pain intensity over the last week to be ≥ 3 on an 11-point numerical rating scale (NRS) anchored with "no pain" at zero and "worst pain imaginable" at 10;
* Have normal cognitive function (Hong Kong Montreal Cognitive Assessment ≥ 22);
* Who agree to sign an informed consent form.

Exclusion Criteria:

* Inability to ambulate without assistance from another person or tools (e.g., canes or walkers);
* Having specific causes of low back pain (e.g., spinal stenosis, lumbar disc herniation, spondylolisthesis, recent vertebral fracture, spinal infection);
* Having other acute or overt musculoskeletal conditions in other parts of the body (e.g., fractures, severe pain, multiple joint pain (e.g., knee pain));
* History of lumbar or lower extremity surgery;
* Receiving LBP treatment within the past one month or at present;
* Have never received non-invasive brain stimulation (e.g., transcranial direct current stimulation, repetitive transcranial magnetic stimulation, and transcranial alternating current stimulation) before.
A Telehealth Advance Care Planning Intervention in Those With Mild Cognitive Impairment or Unrecognized Dementia

The purpose of this study is to pilot test a telehealth Advance Care Planning (ACP) intervention among those with either mild cognitive impairment (MCI) or unrecognized dementia. Our goal is to pilot-test and evaluate a pragmatic Telehealth ACP intervention among patients with either the diagnosis of mild cognitive impairment (MCI) or unrecognized dementia.

Telehealth has the potential to overcome barriers related to timing and travel restraints and to provide patients and their caregivers with an opportunity to discuss their goals, values, and priorities for their healthcare within their home setting. Recent studies have demonstrated patients' willingness to use telehealth and have shown that it can play an integral role in dementia care management.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of recognized or probable Mild cognitive impairment (MCI) or mild dementia determined by either ICD10 diagnostic codes or electronic health record (EHR) Risk of Alzheimer's and Dementia Assessment Rule (eRADAR)
* Have decisional capacity according to their primary care physician (PCP) to complete ACP
* Completed visit with their PCP within the past 12 months
* Affiliated with an Accountable Care Organization.
* English-speaking

Exclusion Criteria:

* Moderate to severe hearing loss that would preclude participating in a video or telephone intervention
* No phone number available for patient.
* Lives in a long-term care facility
A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RG1662 in Healthy Subjects

The study is being conducted to investigate the effect of itraconazole treatment in the pharmacokinetics of RG1662. It is also to evaluate the exposure of RG1662 vs. QTc response relationship and the safety and tolerability of RG1662 when given in combination with itraconazole in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers
* Ages 18 to 60 years, inclusive
* A body mass index (BMI) between 18 to 32 kg/m2, inclusive
* Agreement to comply with study restrictions

Exclusion Criteria:

* History of epilepsy, convulsions or significant head injury or electroencephalogram (EEG) abnormalities
* Electrocardiogram (EGC) or vital signs abnormalities
* Significant history of drug allergy, as determined by the Investigator, or a known hypersensitivity to any of the ingredients of any of the study treatments
* Use of any drugs or substances that are known to be substrates, inducers or inhibitors of CYP3A4 within 30 days of the first dose administration
* Pregnant or lactating
* Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
Genetic Study of Immunodeficiency: Search for New Genetic Causes for Primary Immunodeficiencies

Individuals with suspected primary immunodeficiency will be studied and the results compared with healthy controls. Primary immunodeficiency may manifest as recurrent, severe or unusual infections as well as signs and symptoms of immune dysregulation such as autoimmunity or lymphoproliferation.

Patients with a suspected immunodeficiency will be identified and invited to participate. Upon agreement, an additional blood sample will be collected when they have their routine bloods taken. If the study participants undergoes anaesthesia for any other reason, a small skin biopsy will be taken as well. Additional samples including blood samples or mouth swabs will be taken from healthy family members. Blood from healthy controls will only be taken when there is a clinical need for blood sampling (or when the study participant is already anaesthetised for any other reason) and not for research purposes only.

Eligibility Criteria:
Inclusion Criteria:

* Patient with suspected PID, healthy relative or healthy volunteer
* consent

Exclusion Criteria:

* none
13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.

This study will compare the immune responses of the infants who have been given 13vPnC in the mutidose vial formulation to the immune reponses of the infants who have been given 13vPnC in the single-dose syringe formulation.

It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all infants who are vaccinated.


Eligibility Criteria:
Inclusion Criteria:

* Aged 42 to 70 days at enrollment.
* Determined by medical history, physical examination, and clinical judgment to be eligible for the study
* Weight of 3.5 kg or greater at the time of enrollment

Exclusion Criteria:

* Previous vaccination with licensed or investigational pneumococcal vaccine.
* A previous anaphylactic reaction to any vaccine or vaccine-related component.
* Contraindication to vaccination with pneumococcal conjugate vaccine.
* Receipt of blood products or gamma-globulin since birth
Ropivacaine Hypobaric Spinal Anaesthesia in Traumatic Hip Surgery

This is a prospective, monocentric, randomized study, comparing the effectiveness and tolerance of four different dosages of hypobaric ropivacaine for unilateral spinal anaesthesia during traumatic femoral neck surgery in the elderly.


Eligibility Criteria:
Inclusion Criteria:

* older than 70
* dorsal decubitus surgery
* ASA score 1, 2, 3
* MMS score \> or equal to 25

Exclusion Criteria:

* local anesthetic allergy
* spinal anaesthetic exclusion
* MMS score lower than 25