cyrilzakka/clinical-trials huggingface dataset:
Initial Test of the Time to Talk CARDIO (Creating a Real Dialogue In the Office) Program

This research focuses on communication practices between patients and health care professionals, like nurses, doctors, or physician assistants. The goal is to help improve communication about heart health issues.

This pilot (or Beta) study is designed to test our ability to recruit an appropriate sample of participants, and determine our ability to deliver and evaluate the effects of a web-based intervention. The investigators hypothesize that exposure to the intervention will result in measurable changes in self-reported knowledge, attitudes and behavior regarding communication between patients and health care professionals.

Participants in this research study are being recruited from the people who currently receive care at the Richmond Family Health Center of the Oregon Health \& Science University. People who participate in this study will be between 55 and 70 years old, speak English as their preferred language, and have one of several possible diagnoses related to heart health. These could include, for example, hypertension, diabetes, asthma, or obesity.

Additionally, the investigators are recruiting a small number of health care professionals from the Richmond Family Health Center. Their participation will be similar to but separate from the participation of patients.

All participants will take two web-based surveys. Some participants will use a web-based tool that hopes to help improve communication between health care professionals and patients.

The surveys contain questions that explore the knowledge, attitudes, and behaviors of participants related to heart health and communication between health care professionals and patients.

Data analysis will focus upon identifying any changes that occurred in knowledge, attitudes, or behaviors with respect to health communication after using the web-based tool, as well as learning about what influences the quality and nature of communication between health care professionals and the patients they serve.


Eligibility Criteria:
Inclusion Criteria:

* Age 55-70 years
* English is preferred language
* Has one or more chronic cardiovascular-related diagnosis or risk factor
* Has an appointment with Primary Care provider within 2 weeks of enrollment

Exclusion Criteria:

* Inadequate vision or hearing to complete on-line assessment
Azithromycin in the Treatment of M. Avium Complex Lung Disease

To determine the safety and efficacy of azithromycin in the treatment of lung infection with M.avium complex and M. abscessus lung disease.

To study the safety and efficacy of azithromycin in combination treatment for M. abscessus and MAC lung disease

Eligibility Criteria:
Inclusion Criteria:

* Meet American Thoracic Society criteria for nontuberculous lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; abnormal CXR consistent with M. avium lung disease; absence of other lung pathogens (except for the coexistence of M. abscessus).
* Age 18 and older
* Pretreatment isolate of M. avium complex available for MIC determination

Exclusion Criteria:

* History of macrolide allergy
* Received macrolide therapy in last two months
* Children less than 18 years of age
* If a menstruating female, not pregnant and on adequate birth control
Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease

The goal of this interventional investigation is to compare BUFY02 with TRB02 in the treatment of patients with dry eye disease. The main questions it aims to answer are:

* Is BUFY02 non-inferior to TRB02 in terms of signs of DED?
* Is BUFY02 non-inferior to TRB02 in terms of symptoms of DED?

Participants will be asked to:

* Visit the trial site at 4 different timepoints
* Use the allocated study treatment everyday until the end of the study (during 3 months)
* Be examined by the investigator
* Complete several questionnaires
* Return unused study treatment.

Researchers will compare BUFY02 to TRB02 to see if both study treatments provide similar effects on signs and symptoms of the disease, together with comparable safety.


Eligibility Criteria:
Inclusion Criteria include:

* At least a 3-month documented history of bilateral dry eye syndrome needing artificial tears;
* At least one eye with Oxford score ≥ 4 and ≤ 9;
* At least one objective sign of tear deficiency (in at least one eligible eye);
* Having a health insurance.

Exclusion Criteria include:

* Wear of contact lenses starting within the last 2 months;
* Best-corrected visual acuity (BCVA) \< 1/10;
* Severe DED with one of the listed conditions:
* Severe blepharitis;
* Seasonal allergy;
* Any issues of the ocular surface not related to DED;
* History of ocular trauma, infection or inflammation not related to DED;
* History of ocular surgery, including laser surgery;
* Unstable glaucoma;
* Use of artificial tears with preservative within the last 2 weeks;
* Systemic (enteral or parenteral) or local (topical) use of one of the listed medications:
* Known hypersensitivity to any constituent of the study treatments;
* Pregnancy or breastfeeding;
* Participation in another clinical study within the last 90 days;
* Legally restricted autonomy, freedom of decision and action.
Paracetamol and Glutathion

Paracetamol is one of the most widely used analgesics in the world especially for chronic pain in the elderly. The metabolism of paracetamol occurs in the liver and involves the use of glutamyl-cysteinyl-glycine (Glutathione (GSH)). Medications such as paracetamol, may reduce the reserves of GSH because it is used for detoxification and elimination. It is well known that the concentration of GSH decrease after administration of paracetamol in humans and animals.

Aging is associated with decreased concentration of GSH in cells and tissues. In the elderly, a decrease of GSH concentration in plasma or red blood cells is associated with decreased physical and mental health.

We wish here to determine, in subjects aged over 70 years, the blood concentration of glutathione (GSH) and urinary loss of cysteine in the detoxification of paracetamol, when taking paracetamol treatment repeated.

Paracetamol is one of the most widely used analgesics in the world especially for chronic pain in the elderly. The metabolism of paracetamol occurs in the liver and involves the use of glutamyl-cysteinyl-glycine (glutathione (GSH)). Medications such as paracetamol, may reduce the reserves of GSH because it is used for detoxification and elimination. It is well known that the concentration of GSH decrease after administration of paracetamol in humans and animals.

Aging is associated with decreased concentration of GSH in cells and tissues. In the elderly, a decrease of GSH concentration in plasma or red blood cells is associated with decreased physical and mental health.

We wish here to determine, in subjects aged over 70 years, the blood concentration of glutathione (GSH) and urinary loss of cysteine in the detoxification of paracetamol, when taking paracetamol treatment repeated.

Eligibility Criteria:
Inclusion Criteria:

* Elderly patients over 70 years and treated for over two weeks by oral paracetamol, 3 grams per day (Doliprane ® 1000 mg) as part of their usual care.
* Male and female.

Exclusion Criteria:

* Subject to compliance with the prescribed drug therapy is questionable.
* Subject taking the N-acetyl-cysteine.
* Renal or hepatic disease.
Effects of the T12-L1 Vertebral Manipulation on Body Temperature, Arterial Tension and Cardiac Frequency

Single-blinded Randomized Controlled Trial conducted amongst a sample of healthy subjects divided into two different groups: the experimental treatment will consist in bilateral T12-L1 vertebral manipulation, whereas the control group will receive a sham intervention consisting solely in applying tension without properly manipulating. Body temperature, arterial tension and cardiac frequency will be measured before and after the intervention. Changes in the aforementioned variables will be measured.

The current study will correspond to a single-blinded Randomized Controlled Trial with two arms, conducted amongst a sample of healthy subjects, who will be divided into two different groups: the experimental treatment will consist in bilateral T12-L1 vertebral manipulation, whereas the control group will receive a sham intervention consisting solely in applying tension without properly manipulating. Three different variables will be measured prior to and after the intervention: body temperature, arterial tension and cardiac frequency, to subsequently calculate possible changes in the variables, with the aim of establishing the effect of the manipulation and/or sham treatment.

Eligibility Criteria:
Inclusion Criteria:

* Both genders;
* Over 18 years of age;
* Minimal amount of exercise per week: 1 hour/week;
* Covid-related aspects: Negative antigen-test 24 hours before the test or negative PCR 48 hours before the test.

Exclusion Criteria:

* Surgical intervention in the 5 years previous to the study;
* Any acute or chronic medical condition;
* Any pharmacological treatment;
* Osteosynthetic implants.
Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD)

An increasing literature shows that omega-3 fatty acids provide numerous health benefits, including a variety of psychiatric symptoms and disorders including stress, anxiety, cognitive impairment, mood disorders (major depression and bipolar disorder) and schizophrenia. Omega-3 fatty acids may additionally represent a promising treatment strategy in patients with PTSD. Moreover, given its beneficial cardiovascular effects, adjunctive omega-3 fatty acids may also benefit the general health status of these veterans, who frequently present with a variety of comorbid medical disorders.

See brief summary

Eligibility Criteria:
Inclusion Criteria:

1. Veterans 18-65 years of age, any ethnic group, either sex.
2. Ability to participate fully in the informed consent process.
3. Current diagnosis of PTSD .
4. No anticipated need to alter medications for the 10-week duration of the study.

Exclusion Criteria:

1. Serious unstable medical illness, history of traumatic brain injury (TBI) with loss of consciousness greater than 30 minutes, or history of cerebrovascular accident, prostate or breast cancer.
2. Current active suicidal and/or homicidal ideation, intent or plan.
3. Use of aspirin, warfarin or other anticoagulant therapy, as omega-3 fatty acids may increase bleeding time. Other concomitant medications for medical conditions will be addressed on a case-by-case base and determined if exclusionary.
4. Regular use of omega-3 fatty acid supplementation within the last 3 months (cod liver oil, other fish oil, flaxseed).
5. Regular consumption of more than one serving of fatty fish per week.
6. Substance dependence within the last 4 weeks (other than nicotine dependence).
7. Current Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition other than TBI.
8. Female patients who are pregnant or breast-feeding.
9. Known allergy to study medication.
The Effect of OPCSP on Adherence and Clinical Outcomes Among Patients With Rheumatic Diseases

This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic diseases.The purpose of this study is to evaluate:

1. rates of medication adherence in the OPCSP program compared with usual care in an integrated health care system.
2. total direct costs and clinical outcomes in the OPCSP program compared with usual care in an integrated health care system.

This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic diseases.Three types of rheumatic diseases were included in the study, Systemic lupus erythematosus (SLE), Ankylosing spondylitis (AS), and Rheumatoid Arthritis(RA). The purpose of this study is to evaluate:

1. rates of medication adherence in the OPCSP program compared with usual care in an integrated health care system.
2. total direct costs and clinical outcomes in the OPCSP program compared with usual care in an integrated health care system.

Eligibility Criteria:
Inclusion Criteria:

* Willingness of the subject to participate in the study, proven by signing the informed consent;
* Systemic lupus erythematosus (SLE), as defined by meeting at least 4 of 11 classification criteria of American College of Rheumatology for the classification of systemic lupus erythematosus, either sequentially or coincidentally. The 4 criteria doesn't need to be present at the time of study enrollment;
* Patients fulfilled the American College of Rheumatology criteria for RA and AS;

Exclusion Criteria:

* Patients who are unwilling to sign the inform consent;
* Pregnancy or lactation
Citrate Versus Heparin for the Lock of Non-tunneled Hemodialysis Catheters in Patients Hospitalised in ICU

After obtaining written informed consent and inclusion, patients will be randomised into 2 groups for the type of dialysis catheter lock:

* The first group will have a citrate lock
* The second group will have a heparin lock Patients will be stratified according to the centre and type of Renal Replacement Therapy (RRT) continuous or intermittent.

The daily surveillance of patients will not be different from the usual surveillance of patients on Renal Replacement Therapy.

The hemodialysis catheters used will be specific Renal Replacement Therapy catheters.

The decision to withdraw the catheter will be made by the investigator and based on clinical criteria (complications related to the catheter, termination of Renal Replacement Therapy...)


Eligibility Criteria:
Inclusion Criteria:

* Patients aged \> 18 years
* Requiring RRT for acute renal insufficiency
* For which a 1st non-tunneled catheter is placed
* In the jugular or femoral position
* After written informed consent has been obtained from the patient, a member of the family or a person of trust

Exclusion Criteria:

* Patient presenting active poorly controlled bleeding
* Known allergy to citrate
* Acute liver failure (Prothrombin level \<30%)
* Thrombopenia \< 30 000/mm3
* Known or suspected heparin-induced thrombopenia
* Known systemic bacterial infection at the time the catheter is placed
* catheter in the subclavicular position
* Persons not affiliated to a national health insurance scheme
* Pregnant women
* Adults under guardianship
Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients

The purpose of this pivotal Phase 1/3 study is to determine the pharmacokinetic (PK) parameters, the hemostatic efficacy, and the safety of BAX 326, a recombinant factor IX, in previously treated patients (PTPs) with severe and moderately severe hemophilia B.


Eligibility Criteria:
Main Inclusion Criteria:

* Participant is 12 to 65 years old at the time of screening
* Participant and/or legal representative has/have provided signed informed consent
* Participant has severe (factor IX (FIX) level \< 1%) or moderately severe (FIX level 1-2%) hemophilia B (based on the one stage activated partial thromboplastin time (aPTT) assay), as tested at screening at the central laboratory
* Participant is previously treated with plasma-derived or recombinant FIX concentrate(s) for a minimum of 150 exposure days (EDs) (based on the participant's medical records); if a verifiable, documented history is unavailable, the participant can be enrolled if s/he has 100-150 EDs to any FIX product that are not fully documented and has participated in Study 050901 for at least 50 EDs to Immunine prior to enrollment (not valid for US and Japan).
* Participant has no evidence of a history of FIX inhibitors
* If the participant is to receive prophylactic treatment, the participant is willing to receive prophylactic treatment over a period of 6 months.
* If the participant is to receive on-demand treatment, the participant has ≥12 documented bleeding episodes requiring treatment within 12 months prior to enrollment and is willing to receive on-demand treatment for the duration of this study.

Main Exclusion Criteria:

* The participant has a history of FIX inhibitors with a titer ≥0.6 Bethesda Units (BU) (as determined by the Nijmegen modification of the Bethesda assay or the assay employed in the respective local laboratory) at any time prior to screening
* The participant has a detectable FIX inhibitor at screening, with a titer ≥0.6 BU as determined by the Nijmegen modification of the Bethesda assay in the central laboratory
* The participant's weight is \< 35 kg or \> 120 kg
* The participant has a history of allergic reaction, eg, anaphylaxis, following exposure to FIX concentrate(s)
* The participant has a known hypersensitivity to hamster proteins or recombinant furin (rFurin)
* The participant has ongoing or recent evidence of a thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC)
AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia

The purpose of this study is to test the effectiveness of the study drug, AEGR-733 alone and in combination with the medication, atorvastatin (Lipitor), on cholesterol in volunteers with moderately high cholesterol.

Recent studies suggest more intensive cholesterol lowering treatment for people at very high risk of a heart attack, specifically for patients who have heart disease plus major risk factors. Available medications used alone at even the highest approved doses are not expected to reach these new target recommendations for cholesterol in a large number of subjects. Thus, the development of new medications that can provide additional cholesterol lowering may be beneficial.

This study tests the effectiveness of different doses of the study drug, AEGR-733 alone and in combination with the approved cholesterol lowering drug, atorvastatin (Lipitor), on cholesterol. Volunteers will be randomized to one of 6 different study treatments and will take the assigned medication (3 capsules daily) for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women between the ages of 18 and 70 years.
2. Elevated LDL cholesterol based on risk factors for cardiovascular disease or presence of cardiovascular disease

Exclusion Criteria:

1. Women who are pregnant, lactating, planning to become pregnant, or women of childbearing potential who have not successfully been using acceptable contraceptive methods over the previous 3 months, e.g., intrauterine device (IUD) and barrier method plus spermicide.
2. Uncontrolled hypertension
3. History of chronic kidney problems
4. History of liver disease
5. Positive for Hepatitis B or Hepatitis C.
6. Any major surgical procedure occurring less than 3 months ago
7. Cardiac insufficiency
8. History of a malignant cancer (other than basal cell or squamous cell carcinoma of the skin that has been removed) within the previous 5 years.
9. Regular alcohol use \>1 drink per day.
10. Regular consumers of grapefruit juice, or currently taking the following medications: cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone.
11. Use of other cholesterol lowering medications that cannot be stopped.
12. Heart attack or stroke within the previous 6 months
13. Diabetes Mellitus
14. Body mass index (BMI) ≥ 40 kg/m2.
15. Significant gastrointestinal symptoms, such as irritable bowel syndrome.
16. Current use of fish oils, niacin, and herbal weight loss products that cannot be stopped.
Carbon Dioxide Investigation

The investigational device enables monitoring of EtCO2, FiCO2 and respiration rate values.

The purpose of this clinical study is to collect parameter raw data for development, evaluate the operational and functional features of the investigational device as well as ease of use of the system.


Eligibility Criteria:
Inclusion Criteria:

* Adults and pediatric patients that are endotracheally intubated, tracheostomized or have a laryngeal mask or similar
* Tolerate airway adapter dead space of 6.7 ml
* Are above 10 kg
* 2 years of age of older
* Able to provide written informed consent or have a LDR to provide written informed consent
* Are being cared for in hospital unit and are expected to remain in the unit for the duration of the study procedure

Exclusion Criteria:

* Are known to be pregnant
* Are breastfeeding
* Are suffering from infection(s) or immunocompromised patients that require isolation.
* PI or designee decision due to subject health condition
Reactogenicity, Safety, and Immunogenicity of Covid-19 Vaccine Booster

Preliminary data suggest that inactivated vaccine-induced neutralizing antibodies against SARS-CoV-2 decrease at six months after vaccination. Observational, unpublished data also indicate that vaccine effectiveness against Covid-19 wanes over time. Thus, the investigators aimed to determine the reactogenicity, safety, and immunogenicity of a homologous or heterologous booster of SARS-CoV-2 vaccines among people already immunized with an inactivated SARS-CoV-2 vaccine. The study focuses on the elderly population and healthcare workers.


Eligibility Criteria:
Inclusion Criteria:

* Full immunization with CoronaVac (2 doses; 0,28) prior to April 15, 2021
* Being a resident of any of the eligible Nursing Homes (located in the Metropolitan Region of Chile)
* Healthcare workers of one of the eligible Nursing Homes.
* Healthcare workers of Hospital de Urgencia Asistencia Publica (HUAP, Santiago, Chile)

Exclusion Criteria:

* Prior history of Covid-19
* Not able to consent
A Multi Focal Visual Outcome Study Using Different Near Additions

A multi-centre non-randomized clinical investigation to assess multifocal visual outcomes using different near additions, for the treatment of aphakia after cataract removal.


Eligibility Criteria:
Inclusion Criteria:

* Age-related cataract patients undergoing cataract surgery where the cataractous lens has been removed by phacoemulsification, with circular tear capsulotomy, leaving the posterior capsule intact
* Patients requiring primary IOL implantation
* Patients with a potential corrected visual acuity of 20/40 or better on clinical assessment
* Patients with normal anterior segments - apart from cataracts
* Subjects with clear intraocular media other than cataract

Exclusion Criteria:

* Pre-existing pathology or physiology, which may be aggravated by the implant, or may render the implant ineffective and that could potentially cause future acuity losses to a level of 0.5 or 20/40 or worse in either eye. This includes the following:

  * Microphthalmia
  * Corneal decompensation or Endothelial Insufficiency
  * Pseudo exfoliation
  * High myopia
  * Pars planitis
* Patient with greater than 1 dioptre of pre-operative corneal astigmatism
* Subjects who are expected to require retinal laser treatment
* Previous intraocular and/or corneal surgery
* History of uveitis, glaucoma, proliferative diabetic retinopathy or IDDM, pseudoexfoliation, macular degeneration that may affect potential best corrected visual acuity of 20/40 or better
* Operative complications of posterior capsular rupture, zonular dehiscence, incomplete continuous curvilinear capsulorhexis, severe iris /corneal trauma and inability to achieve secure placement in the designated location
* Subjects using a systemic medication that is known to cause ocular side effects
* Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days
* Subjects who have only one eye with potentially good vision
* Patients who are not willing to cooperate in the 6-months follow-up period
* Children under the age of 18 years