cyrilzakka/clinical-trials huggingface dataset:
IConquerMS™ - a Patient-Powered Research Network for Multiple Sclerosis

iConquerMS™ is a research initiative developed by and for people with multiple sclerosis (MS) to contribute their health data and ideas to advance and accelerate research into MS. iConquerMS welcomes adults with MS and others interested in advancing MS research, children and teens with MS and their family members (via iConquerMS Kids \& Teens) and MS caregivers (via iConquerMS Caregivers) to participate.

The purpose of this study is to create a Multiple Sclerosis Patient-Powered Research Network (MS-PPRN) that includes at least 20,000 people with multiple sclerosis (MS) who contribute data on their health and other topics. Survey data will be made available to research scientists who are studying MS and similar diseases. Our goal is to use this data to answer questions that researchers and people with MS have regarding the disease, including its causes, treatments, and other topics.

While the MS-PPRN is focused on enrolling people with MS, people without MS are also welcome to participate in this research study. Adults are invited to participate via iConquerMS, while children and teens are invited to participate via iConquerMS Kids \& Teens. Adults who are MS caregivers may participate via the dedicated iConquerMS Caregivers site.

This study will be conducted online via the iConquerMS.org website. This is an ongoing study and will last for an indefinite period of time.

Eligibility Criteria:
Inclusion Criteria:

* 21 years of age or older at the time of informed consent or under 21 with parental consent and participant assent.

Exclusion Criteria:

* Unwilling or unable to provide informed consent.
The Efficacy of Influenza Vaccine in Reducing Cardiovascular Events in Patients With Coronary Artery Diseases

Influenza vaccine reduces the cardiovascular events in post-myocardial infarction (MI) patients and in those with stable angina (SA).

A connection between infectious processes and atherosclerosis is repeatedly reported \[1\]. Acute respiratory infection was found to be associated with myocardial infarction (MI) \[2,3\] and a number of epidemiological studies found that mortality attributable to cardiovascular diseases is increased during influenza epidemics \[4\]. Naghavi et al \[5\] in a case-control study of patients with coronary artery disease (CAD) found that vaccination against influenza was negatively associated with the development of new MI during the same influenza season. While some clinical trials found influenza vaccine effective in secondary prevention of cardiovascular adverse events \[6,7\], a large trial \[8\] failed to approve such an efficacy. Furthermore, a recent review of published trials on the subject concluded that frailty selection bias and use of non-specific endpoints such as all cause mortality have led cohort studies to greatly exaggerate vaccine benefits and that the remaining evidence base is currently insufficient to indicate the magnitude of the mortality benefit of the vaccination program \[9\].

This study aims to assess the efficacy of vaccine in secondary prevention of cardiovascular events in MI and stable angina (SA) patients using specific endpoints including reliable quantitative tools.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosis of acute, evolving or recent MI (after recovered the acute phase) as defined by:

  1. Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following:

     * Ischemic symptoms
     * Development of pathologic Qwaves on the ECG
     * ECG changes indicative of ischemia (ST segment elevation or depression); OR
     * Coronary artery intervention (e.g., coronary angioplasty).
  2. Pathologic findings of an acute MI \[12\]
* Patients with stable angina pectoris and documented coronary artery stenosis (angiography).

Exclusion Criteria:

* Any acute disease
* Chronic liver or kidney diseases
* Conditions accompanied by immunosuppression (like organ transplantation, HIV)
* Diagnosed malignancy
* Incubation with influenza vaccine within the past 5 years
* Any psychological disease that interferes with regular follow-up
* Congestive heart failure (Killip class IV)
* Unstable angina, and contradictions of vaccine incubation (like egg allergy).
Telemonitoring of Patients Admitted in Hospital at Home With Acute Decompensated Heart Failure - Pilot Study

"La Casa nel Parco" (CANP) Project is a multidisciplinary project funded by the European Union and Regione Piemonte aimed to explore innovative technology application in the care of older subjects. In this context, MONTEROSA is a monocentric randomized controlled open-label clinical trial evaluating the use of a telemonitoring/telemedicine (TM) suite (including a sphygmomanometer, pulse oximeter, weight scale, thermometer, glucometer, electrocardiograph) as a support to the routine clinical care of patients admitted to a Hospital at Home service for acute decompensated heart failure.

The main objective of the study will be to evaluate the impact of TM on number of daily physician's visits. Secondary objectives will be to evaluate the impact of TM on number of daily nurse visits, on overall in-hospital mortality and on patient's and caregiver's quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted in Hospital at Home with signs and/or symptoms of new-onset or decompensated heart failure, according with the definition of 2016 European Society of Cardiology (ESC) guidelines on Heart Failure
* Written informed consent signed by both the patient and the main caregiver

Exclusion Criteria:

* Main caregiver with low IT skills (e.g. unable to use a smartphone);
* Patient in whom body weight or accurate daily urine output cannot be measured
* Patient with history of neoplastic/degenerative disease and with estimated life expectancy less than 3 months
* Patient with decompensated liver cirrhosis (Child-Pugh score B o C)
The Effect of Nicardipine on Kidney Function During Orthognathic Surgery Under Hypotensive Anesthesia

Since nicardipine is known to protect kidney function, nicardipine infusion will result in better renal parameters measured in this study.


Eligibility Criteria:
Inclusion Criteria:

* healthy adult patients undergoing hypotensive anesthesia

Exclusion Criteria:

* patients with any co-morbidity
Implementation and Impact of an Online Tool Used in Primary Care to Improve Income Security

We will evaluate the acceptability, feasibility and impact of an online tool that helps patients identify financial benefits that they are entitled to at six clinic sites over a three month period. We will answer the following questions: Is an online tool that addresses income security feasible and acceptable to clinicians? Can such a tool be integrated into regular clinic workflow? What is the patient perspective on the tool and what is the short-term impact?

Addressing the social determinants of health of patients has been identified as a key way to achieve health system goals. However, few evidence-based interventions exist. This study emerges from an ongoing collaboration between family physicians, researchers and a charitable financial literacy organization. This study aims to answer the following questions: Is an online tool that addresses income security feasible and acceptable to clinicians? Can such a tool be integrated into regular clinic workflow? What is the patient perspective on the tool and what is the short-term impact? We will recruit six primary care sites in Toronto and Winnipeg that serve low-income communities. We will introduce clinicians to screening for poverty and increasing access to additional income sources via government benefits. Following an initial orientation session, health providers will be encouraged to use the tool with any patient seen. The health provider and patient will complete the online tool together, generating a tailored list of financial benefits, along with local community resources to assist with obtaining these benefits. A brief survey on this experience will be administered to patients after they complete the tool, as well as a request to contact them in one month. Those who agree to be contacted will be interviewed on whether the intervention impacted their knowledge and ability to access benefits. We will administer an online survey to providers and conduct provider focus groups at each site at the end of study. An advisory group made up of patients living on low incomes and representatives from community agencies will support this study. An online tool could help health providers in improving the income security of their patients. Strengths of this study include that it involves a diverse set of clinics and that the tool has been implemented pragmatically, in the real world of busy primary care clinics. Limitations include the convenience sampling method, that the selected clinics may not be representative of all primary care providers and the relatively short follow-up period. Our findings will provide insight into the potential of electronic tools that assist providers address the social determinants of health.

Eligibility Criteria:
Inclusion Criteria:

* Used the online income tool with their health provider
* Able to provide consent
* Able to converse in English
* Able to be reached by telephone or email

Exclusion Criteria:

- None
Wearable Device to Increase Physical Activity Amongst Adults With Pain

This protocol is for a pragmatic mixed methods randomized parallel-group exploratory feasibility trial to examine all facets of a proposed future phase III trial on the use of wearable device to increase physical activity and possibly reduce pain amongst middle-aged people with musculoskeletal (MSK) chronic pain. The feasibility study is intended to answer the following research questions:

Question 1 Evaluate the acceptability of all aspect of the study design of wearable devices as an intervention to increase physical activity in middle-aged adults with musculoskeletal chronic pain.

Question 2: Is it feasible and acceptable to use wearable devices as an intervention to increase physical activity in middle-aged adults with musculoskeletal chronic pain? Question 3: How can using wearable device promote physical activity effectively in middle-aged adults with musculoskeletal chronic pain?

Participants will be recruited from a National Health Service (NHS) pain clinic and randomised on a ratio1:3 into control group (standard care) and intervention group (standard care combined with wearable device). The feasibility study will last for 18 months, participants involvement will be for 24 weeks. Patients in both groups can participate in any physical activity, including planned, structured, and repetitive bodily movement exercise or occupational and recreational PA. Qualitative semi-structured interview will be conducted at baseline and week-12, while outcome measures will be conducted at baseline, 4-week, 8-week,12-week, and 24-week for all participants to examine their pain, physical activity, and their responses to the trial. Qualitative interview will be conducted for stakeholders which include clinicians and service managers after all patient data has been collected. This study has the potential to make an original contribution to provide key data on the feasibility, acceptability, and effectiveness of using wearable technology to support physical activity intervention for middle-aged adults with musculoskeletal chromic pain.


Eligibility Criteria:
Inclusion Criteria:

* Patient of any gender identity 40-65 years old.
* Willingness to participate in the trial.
* Able to understand and speak sufficient English to engage during interviews.
* They have self-reported persistent or recurrent musculoskeletal pain for three months or longer.
* Participants will be receiving treatment for musculoskeletal chronic pain.

Exclusion Criteria:

* Palliative patient.
* Patients of any gender identity younger than 40-year-old or older than 65-year-old.
* Patients that are dependent on alcohol or drugs.
* Involvement with other ongoing studies.
* Patients unable to complete the questionnaires as judged by the researcher.
A Study to Evaluate Safety and Tolerability After Oral Dosing of AZD1656 in Healthy Volunteers

The purpose of this study is to assess safety and tolerability of AZD1656 after single ascending oral doses in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Clinically normal physical findings and laboratory values as judged by the investigator including negative test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to hepatitis C virus.

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the Investigational Product
* History of psychiatric or somatic disease/condition that may interfere with the objectives of the study, as judged by the investigator
Inspiratory Muscle Training in Patients With End Stage Renal Failure

This study will investigate whether inspiratory muscle training in patients with end stage renal failure can improve strength and function.

Patients with chronic renal failure commonly have weak respiratory muscles leading to problems in everyday activities and respiratory infections.

This project aims to investigate if threshold inspiratory muscle training improves the strength, everyday function and participation of patients on haemodialysis. Forty eight patients will be recruited in a randomized controlled trial of inspiratory muscle training vs sham training.

Outcome measures include the maximal inspiratory pressure and the Frenchay activities index. Initial data will be collected by a blinded assessor; the patients will train at 40 % of initial maximal inspiratory pressure for six weeks and be reassessed. If the inspiratory muscle training is effective, it will improve both the physical and functional components of the patient's lives and be recommended for all renal patients.

Eligibility Criteria:
Inclusion Criteria:

* documented chronic renal failure
* attending either haemodialysis or pre-dialysis clinic
* age 18
* English speaking
* no prior experience with inspiratory training devices.

Exclusion Criteria:

* lung collagen disorders
* renal diseases associated with autoimmune pulmonary diseases
* current pleural effusion
* pulmonary oedema
* decreased conscious level
* behavioural disturbances
* unable or refused to give consent
* taking medications that influence respiratory muscle function (e.g. steroids or cyclophosphamide)
Effect of Nasaleze on Nasal Challenge With Allergen

The objectives of this protocol are:

1. to confirm the inhibitory effect of Nasaleze on the immediate response to nasal challenge with antigen, and
2. to show that inhibition of the immediate response to nasal challenge with antigen by Nasaleze inhibits subsequent inflammatory events.


Eligibility Criteria:
Inclusion Criteria

1. Males and females between 18 and 45 years of age.
2. History of grass and/or ragweed allergic rhinitis.
3. Positive skin test to grass and/or ragweed antigen.
4. Positive response to screening nasal challenge.

Exclusion Criteria:

1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
2. Pregnant or lactating women.
3. Upper respiratory infection within 14 days of study start.
4. FEV1\<80% of predicted at screening for subjects with history of mild asthma.
TAmoxifen Versus LIdocaine Cream. A Randomized Clinical Trial for Reducing Pain and Discomfort During Mammography

This is a double-blind placebo-controlled randomized clinical trial to test the use of tamoxifen or lidocaine for diminishing the pain and discomfort while performing mammography, intending to include 450 patients distributed between the three groups.

This is a double-blind placebo-controlled randomized clinical trial to test the use of tamoxifen or lidocaine for diminishing the pain and discomfort while performing mammography, intending to include 450 patients distributed between the three groups.

Inclusion criteria:Patients presenting mastalgia with a prior indication for mammography who is over 40 years old, undergoing their radiological examination at the university hospital of the Federal University of Goias. The only patients who were not included were those who did not wish to participate in the study.

The patients will receive:

* Group 1:Five capsules containing 20mg of tamoxifen plus one sachet containing gel placebo;
* Group 2: Five capsules containing placebo and one sachet containing lidocaine gel at 4%;
* Group 3: Five capsules containing placebo plus one sachet containing gel placebo.

Mammography procedures: The mammography at the university hospital was carried out using a high-resolution mammograph with mean compression in each plane of approximately 800 newtons.

All the patients will undergo at least four imaging views: one craniocaudal and one mediolateral oblique plane for each breast. When necessary, complementary imaging will be used, including selective compression, magnification or other methods.

Control variables:

* Patient's age in completed years at the time of the study;
* Time within the menstrual cycle;
* Menopausal status;
* Use of oral contraceptives;
* Use of hormone replacement therapy;
* Previous history of mastalgia;
* Number of cups of coffee drunk per day;
* Bra size;
* Weight and height, for body mass index (BMI): weight in kilograms and height in meters, according to information provided by the patient at the time of the study;
* Any previous mammographic examination.

Dependent variables:

The pain will be used to measure according to the linear visual analog pain scale. Discomfort will be recorded into four possible categories according to the patient's opinion: no discomfort, uncomfortable, very uncomfortable or intolerable.

Ethical matters:

This study was approved by the Research Ethics Committee of the university hospital of the Federal University of Goias and it will be conducted in accordance with the ruling principles of the Helsinki Convention.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mastalgia in the mastology program with age 40 who have indication for mammography.

Exclusion Criteria:

* Patients who do not wish to participate in the study
* Patients who underwent prosthetic silicone implants
* Patients who mammoplasty (breast reduction or mastopexy) were submitted
* Pregnant women
* Patients allergic to tamoxifen or to lidocaine, heart disease, or patients with a history deep vein thrombosis.
Randomized Trial on Robotic Assisted Resection for Rectal Cancer

Hypothesis: the bladder and sexual functions can be better preserved in patients with robotic assisted rectal surgery

This is a randomized trial comparing the bladder and sexual function of patients who undergo laparoscopic and robotic assisted rectal resection for rectal cancer.

This is a randomized trial comparing the bladder and sexual function of patients who undergo laparoscopic and robotic assisted rectal resection for rectal cancer

The primary objective of this study is to compare the bladder and sexual functions of patients who undergo laparoscopic and robotic assisted resection for rectal cancer through a randomized controlled trial.

The secondary outcome measures include

1. The operative outcome in terms of the complication rate, hospital stay and reoperation of the two groups;
2. The quality of life of the patients and the cost of the two groups
3. The quality of the resected specimens
4. The local recurrence rates at two years after the surgery

Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven new case of rectal cancer with the lower border within 15 cm from anal verge
2. Age \>18 years
3. Informed consent obtained
4. American Society of Anesthesiologist class 1-3
5. No contraindication to laparoscopic surgery
6. Acceptable operating risk

Exclusion Criteria:

1. Locally advanced fixed tumor with the need for exenterative surgery
2. Severe cardiac or pulmonary comorbidity rendering pneumoperitoneum hazardous
3. Multiple previous operations with the anticipation of dense peritoneal adhesions
4. No informed consent
Haptoglobin Phenotype, Vitamin E and High-density Lipoprotein (HDL) Function in Type 1 Diabetes

The purpose of the study is to determine whether the function of the good cholesterol (HDL cholesterol) as well as its subfractions (via NMR spectroscopy) is altered among people with type 1 diabetes and a variation in the Haptoglobin gene and to evaluate whether vitamin E supplements may improve this function.

Persons with type 1 diabetes are at a much greater risk for heart disease compared to the general population. Among individuals with diabetes, those with a specific variation in a genetic marker called Haptoglobin (approximately 43% of persons with type 1 diabetes) are at even greater risk compared to those not carrying this genetic variation. A genetic marker or a "gene" is information inherited from parents (a blueprint) about the structure and functions of cells in the body that make up the color of our hair and eyes and may influence the way our bodies respond to certain stimuli such as an illness, or infection.

In this project we are seeking to understand what some of the mechanisms may be that put persons with type 1 diabetes and this variation in the Haptoglobin gene at greater risk for heart disease. Specifically, we will assess whether this gene variant affects the function of the good cholesterol (HDL cholesterol) and its subfractions (via NMR spectroscopy), which is thought to help against heart disease development. We also seek to evaluate whether vitamin E supplements may improve this function. If results indicate that vitamin E is beneficial and improves the function of HDL cholesterol, the next question to be answered would be whether vitamin E would also help reduce the risk of heart disease itself in these persons. To answer the latter, a large clinical trial would have to take place. In this research project we will therefore also evaluate whether such a trial would be feasible and whether individuals with type 1 diabetes would be interested in participating in a long, 4-5 year, clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with type 1 diabetes residing in the Pittsburgh, PA area (members of the Allegheny Count or Children's Hospital of Pittsburgh/Epidemiology of Diabetes Complications Registries)
* 30 years old or older
* with diabetes duration greater than 10 years or less than 10 years but with a history of heart disease

Exclusion Criteria:

* Allergy to vitamin E
* Stroke, MI within the past 6 months
* Unwillingness/inability to limit antioxidant supplement use to study-provided supplements