cyrilzakka/clinical-trials huggingface dataset:
Tricuspid Regurgitation Study

The effect of cardiac pacing leads on tricuspid regurgitation is unclear. This study will determine whether using a smaller diameter leads and an alternate position in the ventricle, the proximal septum, will reduce tricuspid regurgitation than larger leads placed in the apex.

Leads are commonly placed in the right ventricular apex. It is not known whether placing similar leads higher on the septum where there will be less redundancy or pressure on the septal leaflet will change the extent and severity of tricuspid regurgitation following pacemaker/ICD implantation. Data has shown that right ventricular pacing can give rise to right ventricular dysfunction, which in turn may give rise to enlargement of the right ventricle and cause tricuspid regurgitation.

The study will answer the clinically relevant questions on device lead-related tricuspid regurgitation.

This study is a single center prospective study at the Mayo Clinic, Rochester. The study will enroll 200 eligible subjects and follow for 12 months. 50 pacemaker subjects will be randomized to right ventricular apex pacing 50 pacemaker subjects will be randomized to right ventricular septum pacing 50 pacemaker subjects will be randomized to left ventricular pacing via coronary sinus 50 ICD subjects will be enrolled with right ventricular apex pacing.

A baseline heart failure assessment and Two Dimensional echocardiography will be performed before device implant.

A Two Dimensional echo will be performed 24 hours after device implant. If significance TR is present a Three Dimensional echo will be performed. At 12 months post implant heart failure assessment and Two Dimensional echo will be performed.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of either sex

  * Patient is recommended to receive a pacemaker or an ICD
  * Provide informed consent

Exclusion Criteria:

* Pregnant or breastfeeding women
* Congenital heart disease
* Pre-existing moderate or severe TR
* An existing pacemaker or defibrillator
* Pulmonary hypertension
* Pacemaker dependence
* Unable to give informed consent
* Not feasible for patient to be followed up at Mayo Clinic
* Acute myocardial infarction within 7 days
Observational Study of Blinatumomab

An observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices.

The primary objective of this study is to characterize the safety of Blincyto in routine clinical practice. Blincyto effectiveness, medication errors, and utilisation; and select healthcare resource use while using Blincyto will also be described. Safety and effectiveness of Blincyto in specified subgroups of patients will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

- Medical records of patients initiating Blincyto after country-specific reimbursement in routine clinical practice will be eligible for extraction.

Exclusion Criteria:

* Medical records of patients who have participated in Blincyto clinical trials will be excluded since their treatment will be prescribed by the study protocol unless the patient is receiving new Blincyto treatment outside the clinical trial.
* Medical records of patients participating in other Amgen non-interventional prospective studies in which safety endpoints are collected will be excluded.
* Medical records of patients who have received Blincyto via an expanded access/compassionate use program will be excluded.
* In countries where patient informed consent is required for access to their medical records, any patient who does not provide informed consent will be excluded.
CT 5400 RT System Application Clinical Study

The purpose of this study is to assess the satisfaction of the common functions, the operation convenience, and the whole system stability, and the safety of CT 5400 RT System.


Eligibility Criteria:
Inclusion Criteria:

* 18≤ Age ≤ 75 years old
* Subjects with Clear consciousness; Subjects can cooperate and act autonomously
* Subjects agree to participate in this clinical study and sign the subject's informed consent
* Women subjects of childbearing age should have a negative pregnancy test and should have no plans to become pregnant in the next 6 months

Exclusion Criteria:

* Subjects who do not have full capacity for civil conduct;
* Women subjects who are pregnant or in lactating phase;
* Subjects who have had a CT scan within one year;
* Subjects with a history of allergies or asthma, severe hepatic and renal insufficiency or hyperthyroidism in which are considered as contraindication for CT contrast-enhanced examination;
* According to the opinion of the investigator: any situation that may affect the evaluation of the results or expose subjects into health risk;
* Subjects with mental disorders who cannot cooperate with the examination
Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer

This research study is evaluating a behavioral intervention designed to help people with advanced lung cancer manage dyspnea (i.e., breathlessness or shortness-of-breath).

Many individuals with advanced lung cancer experience debilitating breathlessness at some point during the course of their illness. Unfortunately, few interventions exist to treat this distressing symptom of cancer.

The purpose of this study is to test the efficacy of a brief behavioral intervention may help relieve breathlessness in individuals with advanced lung cancer. Participants will have a 50/50 chance of receiving the behavioral intervention or standard care. The principal investigator of the study, Dr. Joseph Greer, is a licensed clinical psychologist who has trained oncology nurses in how to deliver the behavioral intervention. The oncology nurses will meet with participants during their outpatient oncology appointments, such as chemotherapy infusions, to review the behavioral skills that may help with breathlessness. This intervention involves no medications but rather teaches patients skills for breathing control and relaxation of the body.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of either NSCLC, SCLC, or mesothelioma, not being treated with curative intent
* Self-reported shortness of breath (a score of 2 or greater on the Modified Medical Research Council Dyspnea Scale)
* Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 2 (symptomatic and in bed \<50% of day)
* The ability to read and respond to questions English
* Primary cancer care at the Massachusetts General Hospital (MGH) Cancer Center or Dana-Farber Cancer Institute (DFCI)
* Age \>18 years

Exclusion Criteria:

* Cognitive or psychiatric conditions prohibiting study consent or participation.
* A treating clinician who reports that the patient is inappropriate for the study
Effects of SIMEOX on Airway Clearance in Cystic Fibrosis

This study will investigate the contribution of SIMEOX technology on the effectiveness of bronchial drainage.

This is a crossover study to evaluate the contribution of SIMEOX on the effectiveness of bronchial drainage (verified by the amount of sputum secretions, the rheology of sputum secretions and the subjective sensation of ease of sputum) in patients with cystic fibrosis.

Patients will perform, in randomized order (1) a 30-min session of autogenic drainage, (2) a 30-min session of autogenic drainage with the SIMEOX device. Sputum will be collected during and after the session. The two sessions will be performed with minimum washout time of 24 hours.


Eligibility Criteria:
Inclusion Criteria:

* Adults with cystic fibrosis
* Chronic bronchorrhea, able to expectorate by themselves
* Hospitalized

Exclusion Criteria:

* Regular use of SIMEOX,
* Difficulties in understanding instructions,
* Severe cardiac comorbidity.
Optical Detection of Malignancy During Percutaneous Interventions

Investigation of application possibilities of optical spectroscopy within the field of oncology. Optical spectroscopy enables the possibility to specifically differentiate between different (human) tissues. The hypothesis is that incorporation of this technique into existing medical devices (e.g. biopsy needle) would enlarge the accuracy and reliability of these devices. The purpose is to improve and speed up the diagnostics and therapy of the malignancies.

Primary Objective:

In this observational study the investigators aim to evaluate whether optical spectroscopy can correctly diagnose malignant tissue in the existing clinical workflow of percutaneous interventions in lung, liver, and breast.

Secondary Objective:

During the measurement procedure, possible improvements of the measurement hardware will be recorded. Analysis of this documentation will provide information for possible alterations of hardware design for improved clinical applicability in the future. Special attention will be paid to observe how the procedure fits in the standard workflow of the radiologist.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a suspicious lesion in lung or liver who are scheduled for a standard core biopsy procedure
* Patient planned for percutaneous RFA of colorectal liver metastasis
* Written informed consent
* Patients ≥ 18 years old
* Breast patients with a BIRADS score 4 or 5

General Exclusion criteria:

* Patients who have higher risk of bleeding
* Patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy

Breast Specific Exclusion criteria:

* Patients who have a history of breast cancer and/or who have received prior chemotherapy, endocrine therapy, or radiation therapy
* Patients who have breast implants
* Patients needing a stereotactic breast biopsy (i.e. non palpable-, ultrasound opaque lesions)
Effect of Mass Deworming on Child Growth

The purpose of the study was to determine whether periodical mass deworming improves growth in children below six years of age.

Many children in developing countries get slowed growth because of heavy loads of intestinal helminths. Quite often treatment is not sought because there may not be any obvious symptoms. Slowed growth may manifest as low weight for age or low height for age.

The objective of the study was to estimate the effectiveness of the delivery of an anthelmintic drug through a community child health program on the weight gain of preschool aged children.

Design: This was a cluster randomized controlled trial in 48 parishes in Eastern Uganda. All 48 parishes were participating in a new program for child health; 24 were randomly assigned to offer to children an additional service of anthelmintic treatment. The intervention was 400 mg of albendazole added to the standard services at child days over a 3 years period. All children were offered the drug and the main outcome measure was weight gain.

Results: A total of 27,995 children were recruited into the 2 arms of the study with 14,940 in the treatment arm and 13,055 in the control arm. The intervention arm got an increase in weight gain of about 10% (166 grams per child per year (CI: 16-316) above expected weight gain when treatment was taken twice a year and an increase of 5% when treatment was received approximately annually.

Conclusion: The inclusion of deworming in regularly scheduled health services appears practical and capable of increasing child growth.

Eligibility Criteria:
Inclusion Criteria:

* children 1-6 years

Exclusion Criteria:

-
Electroconvulsive Therapy (ECT) for Elderly Patients With Major Depression

ECT (electroconvulsive therapy) is mostly given to patients between the age of 60 - 85 years. There is limited evidence on the efficacy and cognitive side-effects of right unilateral (RU) and bifrontal (BF) electrode positions, the placements that are considered safe for the elderly. As far as the investigators know no randomized controlled trials (RCTs) have yet been published describing this population treated with BF or RU ECT. Non-demented depressed patients will be randomized to either method (n = 2x36). Symptom intensity, global cognitive function and biomarkers will be related to 20 healthy comparators. Testing, evaluation of depression and blood-tests are done before ECT-treatment, after a series of 6-16 ECT and 3 months after terminated ECT-treatment.

Patients are assessed with Mini Mental Status Examination. Postictal reorientation time is measured. There is also a weekly rating of depression depth during the series. After the 6th ECT; Mini Mental Status Examination For a subgroup of patients; extensive blood-test samples are taken on the day of the 6th ECT.

Some of the patients receive continuation-ECT once monthly after the series. In these months patients receive treatment as usual (naturalistic observation).

Eligibility Criteria:
Inclusion Criteria:

* Major depression, either unipolar or bipolar.
* Competent to give informed consent.
* Passing a thorough physical examination

Exclusion Criteria:

* Previous ECT non - response
* ECT given during last 6 months
* Ongoing substance abuse
* Rapid cycling bipolar or schizoaffective disorder
* Parkinsons disease
* Cognitive impairment (MMSE \< 24/30)
AZD9668 Relative Bioavailability

This clinical study will aid future formulation development and optimisation of AZD9668 tablets by evaluating possible effects of minor changes to the formulation and process on the rate and extent of absorption.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study-specific procedures
* female subjects may be of non-child bearing potential (i.e. post menopausal or surgically sterile) or of child bearing potential
* Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 calculated from height and weight at the screening visit; minimum weight 50 kg.
* Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol, cotinine and negative test results for Hepatitis B surface antigen, antibodies to Hepatitis C virus and antibodies to HIV-1/2 at the screening visit
* Be a none smoker or ex-smoker who has stopped smoking for \>6 months prior to visit 2 (pre-entry)

Exclusion Criteria:

* Any clinically significant disease or disorder (eg infections/viral disease, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment), which in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the absorption, distribution, metabolism and excretion of drugs.
* Any clinically relevant abnormal findings in physical examination, vital signs, clinical chemistry, haematology, urinalysis, which, in the opinion of the investigator, may put the subject at risk because of his/her participation in the study
* Any ECG abnormality (including cardiac arrhythmia) which in the opinion of the investigator may put the subject at risk
Implementation of a Web Based Real Time Clinical Decision Support Tool.

In the developed world critical illness is routinely treated in an intensive care unit (ICU) by highly specialized physicians, nurses and support staff. This model of intensive care is spreading rapidly to low and middle income countries and as it spreads, challenges and limitations to this model arise. In resource-poor settings, inadequate human resources, training, and equipment all present barriers to safe and effective use of life-saving procedures. The advances in medical informatics and human factors engineering have provided tremendous opportunity for novel and user-friendly clinical decision support (CDS) tools that can be applied in a complex and busy hospital setting. Real-time data feeds and standardized patient care tasks in a simulated acute care environment have been proven to have a significant advantage of a novel interface (compared to a conventional) in reducing provider cognitive load and errors. Currently researchers within the investigator's research group have developed and are pilot testing a simple electronic decision support tool: CERTAIN (Checklist for Early Recognition and Treatment of Acute Illness). This tool has been successfully tested and validated in simulated settings and is being implemented as pilot study in 18 countries. Worldwide infant and early childhood mortality continues to be very high partly due to the inability to recognize and respond aggressively to critical illnesses. Investigators expect that adaptation of the algorithms from CERTAIN has potential to be a powerful tool to improve on the medical care of children in developing countries. Investigators aim in this project is 1) to develop a pediatric adaptation of CERTAIN (CERTAINp) and 2) to implement it into clinical practice in resource-poor settings and evaluate the impact of the tool on the processes and patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* All pediatric patients (\< 18 years) admitted for the first time to the participating PICUs will be included.

Exclusion Criteria:

* Not critically ill, admitted for low risk monitoring, planned PICU admission for routine post operative surveillance for less than 24 hours after uncomplicated surgery, readmission and transfer from outside PICU.
A Study of Delavirdine Used Together With Other Anti-HIV Drugs in HIV-Infected Patients

The purpose of this study is to see if it is safe and effective to give delavirdine (DLV) in combination with two or three other drugs to HIV-infected patients. The drugs to be used in combination with DLV are zidovudine (ZDV), indinavir (IDV), and lamivudine (3TC).

In this open-label pilot study, patients are randomized to 1of the following 4 arms for 24 weeks:

Arm 1 (40 patients): DLV plus ZDV plus IDV. Arm 2 (40 patients): DLV plus IDV plus 3TC\*. Arm 3 (40 patients): DLV plus ZDV plus IDV plus 3TC. Arm 4 (40 patients): ZDV plus IDV plus 3TC.

* Dose determined by body weight. Patients may opt to continue on study for 24 additional weeks at the discretion of the investigator.

Eligibility Criteria:
Inclusion Criteria

Prior Medication:

Allowed:

Less than 1 month prior treatment with zidovudine.

Exclusion Criteria

Prior Medication:

Excluded:

* Prior indinavir.
* Prior lamivudine.
* Prior protease inhibitors.
* Prior non-nucleoside reverse transcriptase inhibitors.
* 1 month or more prior zidovudine.

  1. HIV-1 positive.
* CD4 coun tis above 50.
* HIV-1 RNA levels greater than 20,000.
Safety and Efficacy of ThisCART7 in Patients With Refractory or Relapsed T Cell Malignancies

This is a single dose escalation study to evaluate the safety and clinical activity of ThisCART7(Allogeneic CAR-T targeting CD7) in patients with refractory or relapsed CD7 positive T cell malignancies.

This is a single-center, nonrandomized, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART7 in patients with refractory or relapsed CD7 positive T cell malignancies, such as T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma and T-cell Non-Hodgkin Lymphoma. The dose range is 0.5-6 x 10\^6 cells per kg body weight.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with relapsed and refractory CD7 + T cell hematologic malignancies (including, but not limited to, T-cell leukemia, extranodal NK/ T-cell lymphoma nasal, peripheral T-cell lymphoma, enteropathy associated T-cell lymphoma and anaplastic T-cell lymphoma, etc.);
2. No alternative treatment options deemed by investigator;
3. Measurable or detectble disease at time of enrollment;
4. Age 18-70 years old, no gender and race limited;
5. Eastern cooperative oncology group (ECOG) performance status of ≤2;
6. Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO);
7. Estimated life expectancy \> 12 weeks deemed by investigator;
8. Serum creatinine ≤ 1.5 upper limit of normal (ULN);
9. Serum ALT/ AST ≤ 5 upper limit of normal (ULN);
10. Signed informed consent form (ICF).

Exclusion Criteria:

1. Women in pregnancy or lactation;
2. Uncontrolled infection;
3. Active hepatitis B virus or hepatitis C virus infection;
4. Concurrent use of corticosteroids or other immunosuppressant medications for chronic disease;
5. Prior treatment with an allogeneic stem cell transplant within 100 days;
6. Grade 2-4 Active graft versus host disease;
7. History of HIV infection;
8. With central nervous system involvement;
9. Patients combine with other disease cause neutrophil count (ANC) \< 750/uL or PLT\< 50,000/uL.
A Study to Assess the Impact of Pneumococcal Conjugate Vaccination Programme on the Carriage of Pneumococci

A study taking swabs from the back of the nose (nasopharynx) to look at carriage of pneumococci.


Eligibility Criteria:
Inclusion Criteria:

* Born in a cohort eligible for routine or catch up pneumococcal conjugate vaccination (i.e. date of birth since 4th September 2004) or a family member where a child is eligible and has been enrolled
* Written informed consent given by the subject's parent/ legal guardian as well as assent from the child after the nature of the study has been explained to them or
* Written informed consent given by the subject after the nature of the study has been explained to them

Exclusion Criteria:

* Moderate to severe disability.
* Cerebral palsy, syndromes and neurological disorders affecting swallowing.
* Ear Nose and Throat disorders affecting the anatomy of the ear,i.e.malformed ears.
* Confirmed or suspected immunodeficiency (congenital or acquired).
* On immunosuppressive therapy.
Post-Marketing Safety Study in ST-Segment Elevation Myocardial Infarction (STEMI) Participants Undergoing Primary Percutaneous Coronary Intervention (PCI) Procedure With VISIPAQUE® as the Contrast Medium

The purpose of this study is to prospectively observe the incidence rate of acute kidney injury (AKI), major adverse renal and cardiovascular events (MARCE) in participants who were diagnosed with ST-segment elevation myocardial infarction (STEMI) and have completed primary percutaneous coronary intervention (PCI) procedure following an injection of iso-osmolar contrast medium iodixanol (Visipaque) during the in-hospital period and up to 30 days post-PCI follow-up period. The study will provide a better safety profile of Visipaque as the contrast medium in PCI procedure.


Eligibility Criteria:
Inclusion Criteria:

Participants may be included in the study if they meet all of the following criteria:

* The participant is over 18 years' old
* The participant with ST segment elevation myocardial infarction (STEMI) diagnosis has completed primary percutaneous coronary intervention (PCI) procedure and Visipaque was used as the contrast medium in the procedure
* The participant completed pre-procedural serum creatinine (SCr) test at the same hospital where PCI procedure was conducted, and the SCr test should be conducted with the same methodology before and after the procedure
* The participant has signed and dated the written informed consent form

Exclusion Criteria:

Participants must be excluded from participating in this study if they meet any of the following criteria:

* The participant has any contraindications to Visipaque (e.g., manifest thyrotoxicosis, history of serious hypersensitivity reaction to iodinated contrast media)
* The participant is pregnant or lactating
* The participant has been previously enrolled in this study
* The participant is currently under renal dialysis
* The participant presents with a terminal (life expectation \<1 month), serious, or life-threatening disease, or any medical or psychiatric condition, or any condition where study participation may compromise the management of the participant
* The participant has other reasons that in the judgement of the investigator is unsuitable for participation in the study