cyrilzakka/clinical-trials huggingface dataset:
Effects of Titrated Oral Tolvaptan 15-60 mg Once Daily (QD) on Cognitive and Neurological Function in Elderly Hyponatremic Patients

Demonstrate an improvement in the composite scores of validated neurocognitive tests in elderly subjects with chronic sub-clinical (i.e., asymptomatic) hyponatremia.

Subjects will be randomized, with stratification by baseline sodium \<130 or ≥ 130 mEq/L\[mmol/L\] to receive either tolvaptan 15 mg tablet or matching placebo tablet at doses of 15, 30 or 60 mg for 21 days. During this period, fluid restrictions should be loosened or suspended, until the subject's response to therapy can be evaluated, typically over the first few days of therapy. Fluid restriction may be reinstituted at any time in subjects whose sodium fails to improve or worsens with study therapy. A forced-titration up to 60 mg of study drug by day 3 to 7 will be based on the subject's serum sodium Subjects entering the study with a serum sodium concentration less than 130 mEq/L\[mmol/L\] may be fluid restricted if necessary at the discretion of the Investigator. Subjects should be monitored closely during the first 24 hours of treatment for dosing titration. The total dosing duration will be up to 21 days (plus 3 day treatment window). Subjects will return to the clinic on Day 22 (+3 days) for assessments and will complete a follow-up visit on Day 28 (+2 days).

Eligibility Criteria:
Inclusion Criteria:

* Women and men 50 years of age or older.
* Serum Sodium ≥123 and ≤ 134 mEq/L \[mmol/L\]at screening and baseline.
* Subjects with serum sodium concentrations ≥118 and ≤122 mEq/L\[mmol/L\] at screening and baseline may be entered into the trial based on consultation and approval from the study medical monitor.

Exclusion Criteria:

* Conditions or history which may present a safety concern to the subject or their offspring or extreme susceptibility to hypotension with sudden fluid loss (aquaresis).
* Hyponatremia that is acute, easily reversible, artifactual, or due to a condition not associated with vasopressin excess or likely to respond to aquaretic therapy.
* Conditions associated with an independent imminent risk of morbidity and mortality.
* Conditions which may confound the assessment of endpoints, history of poor compliance, participation in a clinical trial believed by the PI or Sponsor likely to confound endpoint assessments.
* Conditions which may confound primary endpoints of cognitive function.
Comparison of Cariostatic Effect of Nano-Silver Fluoride Versus Silver Diamine Fluoride

This study will be conducted to test the cariostatic effect of Nano Silver Fluoride in a comparison to Silver Diamine Fluoride in a group of preschool children.

Silver Diamine Fluoride has offered a non-invasive and easily performed method to manage dental caries in very young children.Studies shows that SDF has been proven to arrest caries in cavitated lesions and to prevent caries in sound teeth as Fluoride is effective in enhancing the remineralization of dental hard tissue and silver ion acts as an antibacterial agent. However, It was found that silver causes staining to the dental tissues with a black discoloration, which can be considered to be a main drawback specifically, when it is used on anterior teeth. Nano-silver fluoride varnish preparation showed high efficacy in arresting caries progression in primary teeth without causing black discoloration to the tissues.Silver diamine fluoride (SDF) .

Benefits for patient:

1. Non-invasive treatment leading to reduce patient anxiety and stress.
2. No drilling and filling.
3. Protects against further caries progression.

Benefits for the practitioner:

1. Provide alternative treatment options.
2. Pain-free procedure that facilitates child management and saves time.

Benefits for the community:

1. Increasing overall oral health
2. Provides more information by testing new material
3. To provide better service quality.

Eligibility Criteria:
Inclusion Criteria:

* Children aged from 3 to 5 years
* clinical diagnosis of active dentinal caries in primary teeth
* Co-operative participants and free of any systemic diseases

Exclusion Criteria:

* Children whose parents refuse to sign consent
* Primary teeth with pulp involvement, pain, mobility, abscess, sinus, fistula; or discoloration related to tooth non-vitality.
Mesalamine for Uncomplicated Diverticular Disease: a Randomized, Double-blind, Placebo-controlled Study

The purpose of this study is to determine whether mesalamine is effective in the treatment of uncomplicated diverticular disease by reducing the pain.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diverticular disease with acute pain without serious complications
* Lower abdominal pain of moderate or severe intensity at least during the last 4 days before study inclusion

Exclusion Criteria:

* Chronic inflammatory bowel disease
* Fever or other signs of serious complications.
NACER II: Reducing Prenatal Exposures to Household Air Pollution in Rural Guatemala Through a Gas Stove/Behavior Intervention to Improve Neonatal Health

Greater efforts are needed to bring affordable, clean stoves and adaptive behavioral strategies to the millions of households worldwide that continue to burn solid cooking fuels using inefficient stoves. Two of the leading causes of infant mortality, preterm birth and pneumonia, are associated with high exposures to household air pollution during pregnancy and early infancy. The proposed study will assess the feasibility and acceptability of an introduced liquid petroleum gas stove, complemented by two alternative approaches to delivering tailored behavioral change interventions, among pregnant women and their neonates.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman less than 20 weeks gestation
* Does not smoke cigarettes
* Uses an open fire or deteriorated woodstove for cooking
* Purchases wood
* Intends to stay in the study area for at least one year
* Uses Ministry of Health clinics for routine prenatal care
* Has a mobile phone
* Primary person responsible for cooking in the household
* Able to give Informed Consent

Exclusion Criteria:

* Multiple pregnancy (eg twins)
* Identified as a high-risk pregnancy by physician
* Regularly taking prescription medication
* Smokes cigarettes
* Routinely carries a child less than 2 years old on their back
Study of 3 Doses of ARD-0403 in Testosterone Deficient Men

The purpose of this study is to determine which dose, if any, results in testosterone levels within the normal range for men.


Eligibility Criteria:
Inclusion Criteria:

* Testosterone deficiency
* Normal BMI

Exclusion Criteria:

* Previous treatment with testosterone replacement therapy within 4 weeks
* Moderate-severe benign prostatic hypertrophy, or prostatic cancer
* Haematocrit \>50%
Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the Knee

Patients with knee pain due to Osteoarthritis (OA) experiencing sub-optimal pain relief from their current analgesic regimen will participate in a pilot clinical trial to evaluate the effectiveness and tolerability of the Lidoderm Patch compared with placebo in treating knee pain from OA.


Eligibility Criteria:
Key Inclusion criteria:

* Male or female patients ≥37 years with moderate-to-severe OA related pain in one knee
* Body mass index (BMI) ≤40 kg/m2
* Symptomatic OA of the index knee diagnosed with a functional capacity of II or III according to ACR criteria classification Note: Patients with symptomatic contralateral knee OA with persistent pain ≤2 cm on a 0-10 cm PI-NRS for ≥2 months will be allowed to participate.
* Unchanged dose of analgesic medication for OA for at least 4 weeks prior to screening and for the duration of the study
* Able and willing to complete all paper and e-diary assessments required by protocol

Key Exclusion criteria:

* Pain in any joint other than the index joint that could interfere with the patient's assessment of pain in the index joint
* Compromised integrity of the intact, superficial skin layer
* A grade 1 or 4 Kellgren and Lawrence score on radiographic examination
* Recent injury to either knee causing pain and interference with daily activities (eg. walking)
* Recent surgery/procedure to either knee causing pain that could interfere with study assessments of pain, function, and QoL
* Known hypersensitivity or allergy to lidocaine, local anesthetics of the amide type, or any component of the product
Influenza Vaccine Revaccination in Ambulatory Elderly Subjects

This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years.

Primary Objective:

To describe the safety profile for all subjects.

Secondary Objective:

To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.

Subjects who previously participated in study FID29 will be invited to participate in this revaccination study. They will be assigned to 1 of 3 groups based on the group they were previously randomized to and the vaccine received in study FID29.

Eligibility Criteria:
Inclusion Criteria :

* Aged ≥ 65 years on the day of vaccination
* Enrolled in and completed study FID29 and received the correct vaccine for the group to which they were randomized
* Informed consent form signed and dated
* Able to attend all scheduled visits and to comply with all trial procedures
* Subject is medically stable.

Exclusion Criteria :

* Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the trial vaccination
* Planned participation in another clinical trial during the present trial period
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
* Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
* Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
* Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
* Receipt of any vaccination in the 4 weeks preceding the trial vaccination
* Planned receipt of any vaccine in the 4 weeks following the trial vaccination
* Known human immunodeficiency virus (HIV), hepatitis B (HBs) antigen, or Hepatitis C seropositivity.
* Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine
* Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination
* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
* Neoplastic disease or any hematologic malignancy, (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, as well as subjects who have a history of neoplastic disease and who have been disease free for ≥ 5 years).
* Personal or family history of Guillain-Barré Syndrome.
Evaluation of Wearable Vest for Lung Monitoring

This was the pilot study of the EU funded research and innovation project WELMO (Wearable Electronics for Effective Lung Monitoring) -Grant agreement number: 825572. The clinical trial involved patients suffering from a variety of respiratory pathological conditions and examined the ease-of-use and efficacy of the WELMO system, comprising a sensors vest for thorax auscultation and recording of Electric Impedance Tomography (EIT) signals and transmitting those on the cloud for review by physicians. The study recruited and briefly monitored 27 patients who underwent brief training and subsequent wearing of the sensors vest for 15-20 minutes, after manual auscultation, spirometry and oximetry. The collected data were transmitted wirelessly to a tablet and then securely to the cloud for review by attending physicians. The usability of the system, the quality of the obtained signals and the validity of the results were evaluated.

The study recruited and briefly monitored 27 patients at the outpatient department and the medical ward of the Pulmonology Department of "G. Papanikolaou" General Hospital of Thessaloniki, Greece, as well as the 1st Intensive Care Unit of the same Hospital. Patients were recruited during their hospitalization or at the outpatient setting and informed consent was obtained before participation. They were examined with spirometry, manual auscultation of the thorax and where necessary, with chest X-ray or CT scan. They wore the WELMO sensors vest for a period of 15-20 minutes during which they performed tidal and deep breathing, cough and spirometry maneuvers and changes of posture. At the end of the study, they were requested to fill in a questionnaire about comfort and usability of the vest.

Patients from various thoracic disease categories were included from both sexes and aged 18-90 years. The study was approved by the bioethics committee of the Hospital and personal data protection provisions were in place. The obtained signals (lung sounds and EIT signals) were examined for consistency with conventionally obtained medical data and the usability, comfort, patient acceptance and practicality of the WELMO vest was assessed.

Eligibility Criteria:
Inclusion Criteria:

* Age \>16 years
* Suffering from respiratory disease
* Outpatient at Pulmonology Department of G Papanikolaou Hospital
* Hospitalized at Pulmonology Department of G Papanikolaou Hospital
* Hospitalized at 1st ICU of G Papanikolaou Hospital

Exclusion Criteria:

* Age \<16 years
* Skin allergies or broken skin
* Unwilling to provide informed consent
Assessment of Cognitive Functioning as it Relates to Risk for Suicide in Veterans With HIV/AIDS

The purpose of this project is to gather pilot data related to exploring relationships between cognitive impairment and/or psychiatric distress and suicidal thoughts and/or behaviors in Veterans with Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS). To achieve this goal, a neuropsychological battery will be administered to Veterans with HIV/AIDS.


Eligibility Criteria:
Inclusion Criteria:

* Veterans between ages 18 to 65
* Have a diagnosis of HIV/AIDS confirmed via medical record
* Currently receiving or eligible to receive physical and/or mental health care through the VA Eastern Colorado Health Care System

Exclusion Criteria:

* Acute intoxication via alcohol or other illicit drugs at time of assessment as determined by observation and/or interview.
* Psychosis at time of interview as determined by observation and/or interview.
* Poor Test of Memory Malingering (TOMM) performance (scores below 25 on Trial 1 or scores lower than 45 on Trial 2)
* Current status as a prisoner
Functional Outcome in Midshaft Clavicle Fracture, Treated With Superior Versus Anteroinferior Reconstruction Plate

The purpose of this study was to evaluate the functional outcome in patients with a midshaft clavicle fracture treated with to different techniques. the first one was placing a 3.5mm reconstruction plate in the superior side of the clavicle and the second one placing the same 3.5mm reconstruction plate in the anteroinferior side of the clavicle. the patients had the same rehabilitation program and evaluated with functional scores at 30, 60, 90 and 365 days after surgery. biomechanical studies have demonstrated more stable construct using an anteroinferior plate in clavicle fractures and we were trying to find out if it has a clinical relevance in patients with midshaft clavicle fractures.

The purpose of this study was to evaluate the functional outcome in patients with a midshaft clavicle fracture treated with to different techniques.

the first technique was placing a 3.5mm reconstruction plate in the superior side of the clavicle and the second one placing the same 3.5mm reconstruction plate in the anteroinferior side of the clavicle.

the patients had the same rehabilitation program and evaluated with Disabilities Arm Shoulder and Hand functional outcome score and Visual Analogue Score for pain at 30, 60, 90 and 365 days after surgery.

biomechanical studies have demonstrated more stable construct using an anteroinferior plate in clavicle fractures and we were trying to find out if it has a clinical relevance in patients with midshaft clavicle fractures.

Eligibility Criteria:
Inclusion Criteria:

* traumatic fracture
* ao 15 b1 and 15 b2
* no previous shoulder lesions
* no further 7 days fractures
* closed fracture

Exclusion Criteria:

* calcium diseases
* Previous shoulder pain
* other fractures associated
Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment

The purpose of this research study is to compare the outcomes of pneumatic retinopexy with the outcomes of vitrectomy (with or without scleral buckle) for the management of retinal detachment, in terms of anatomical success, functional success and impact on patient quality of life.

Rhegmatogenous retinal detachment (RRD)is an acute, sight threatening condition, with an incidence of approximately 10 per 100,000 population. Both of the treatments under investigation are widely used and accepted by vitreoretinal surgeons, but randomised, prospective comparison of the two techniques has not been reported in the scientific literature to date. Currently, the management decisions surrounding primary retinal detachment are grounded on a weak evidence base. The findings of this study will allow vitreoretinal surgeons and their patients to select the most appropriate intervention for that individual, in an informed and holistic manner.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with acute rhegmatogenous retinal detachment
* Single retinal break OR group of breaks no larger than one clock hour (30°)
* All break/s in detached retina between 8-4 o'clock
* No significant proliferative vitreoretinopathy

Exclusion Criteria:

* Inferior breaks in detached retina
* Inability to read English language
* Age \< 18 years
* Mental incapacity
* Previous vitrectomy (index eye)
* Previous retinal detachment (index eye)
* Inability to maintain the post-operative posturing
* Inability to carry out detailed examination of peripheral retina due to media opacity
Pharmacogenomics and Post-Operative Nausea and Vomiting

The Researchers overall goal is to evaluate the benefit and utility of preemptive genotypic data to guide post-operative nausea and vomiting treatment in the bariatric surgical population. The hypothesis is that using genotypic variation in CYP2D6 to select the appropriate 5HT3 serotonin receptor antagonist to treat PONV will decrease rates of PONV in the bariatric surgical population.


Eligibility Criteria:
Inclusion Criteria

* A Mayo Clinic patient scheduled to undergo any bariatric surgical procedure, including Roux-en-Y gastric bypass, sleeve gastrectomy, or duodenal switch.
* Patient age 18 or above.
* Patients must understand and provide written informed consent and HIPAA authorization prior to initiation of any study-specific procedures.
* Patient is willing to engage in a medication adjustment as part of their clinical visit (when needed).

Exclusion Criteria

* Patient with uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.
* Patients that deny access to their medical records for research purposes will not be included in this study. Also any patient who will be unable to have genetic testing at minimum of 1 week prior to scheduled surgery or with allergies to ondansetron or granisetron.
* Any patient with prior genetic testing that is readily available in the medical record will be excluded from this study.
* Any patient that is pregnant
Endoscopic Dacryocystorhinostomy Prospective Research

Endoscopic dacryocystorhinostomy (EN-DCR) is an effective procedure when treating saccal and postsaccal obstructions of the nasolacrimal pathway. The benefit of silicone tubing after DCR is still controversial. We conducted a prospective, randomized study in order to evaluate 1) the necessity of bicanalicular silicone tubes after primary EN-DCR, 2) efficacy of the perioperative Mitomycin C for the prevention of adheesion and re-stenosis of rhinostomy site in revision EN-DCR, 3) the subjective symptoms and QoL changes before and after DCR-operation.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age \> 18), ASAI-III, and were scheduled for primary or revision lacrimal pathway surgery due to recurrent or chronic watering eyes or conjunctival discharge.
* Patients were excluded if they had previous nasolacrimal surgery, malignancy in the paranasal sinuses, nasal cavity, or lacrimal pathway, presaccal obstruction, pregnancy or lactation, or mental disability.

Exclusion Criteria:

* Malignancy in the paranasal sinuses, nasal cavity, or lacrimal pathway, presaccal obstruction, pregnancy or lactation, or mental disability.
Genetics and Mechanisms of Rheumatoid Arthritis

The study is aimed at revealing genetic background in rheumatoid arthritis (RA). For that purpose samples of DNA will be collected from 500 RA patients and similar number of controls from whole Slovakia. Variations in several genes associated with RA will be evaluated. The second aim is to assess functional changes in immune cells from selected patients and their evaluation together with genetic background. The project has observational character without any intention to change the treatment of RA patients.


Eligibility Criteria:
Inclusion Criteria:

* rheumatoid arthritis or healthy

Exclusion Criteria:
Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2016-2017 Season

This prospective annual release study is designed to evaluate the safety of 1 new influenza virus vaccine strain to be included in FluMist Quadrivalent for the 2016-2017 influenza season

This prospective, randomized, double-blind, placebo-controlled release study will enroll approximately 300 healthy adults 18 to 49 years of age. Eligible subjects will be randomly assigned in a 4:1 fashion to receive a single dose of monovalent vaccine or placebo by intranasal spray. Randomization will be stratified by site. This study will be conducted at 3 sites in the United States of America. Each subject will receive 1 dose of investigational product on Day 1. The duration of study participation for each subject is the time from study vaccination through 180 days after study vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 through 49 years
* Written informed consent
* Subject available by telephone
* Ability to understand and comply with the requirements of the protocol, as judged by the Investigator

Exclusion Criteria:

* Concurrent enrollment in another clinical study up to 180 days after receipt of investigational product (Day 181)
* History of hypersensitivity to any component of the vaccine, including egg or egg protein or serious, life threatening, or severe reactions to previous influenza vaccinations
* Any condition for which the inactivated influenza vaccine is indicated, including chronic disorders of the pulmonary or cardiovascular systems (example \[eg\], asthma), chronic metabolic diseases (eg, diabetes mellitus), renal dysfunction, or hemoglobinopathies that required regular medical follow-up or hospitalization during the preceding year
* Acute febrile (greater than \[\>\] 100.0 degrees Fahrenheit \[F\] oral or equivalent) and/or clinically significant respiratory illness (example, cough or sore throat) within 14 days prior to randomization
* Any known immunosuppressive condition or immune deficiency disease, including human immunodeficiency virus infection, or ongoing immunosuppressive therapy
* History of Guillain-Barré syndrome