cyrilzakka/clinical-trials huggingface dataset:
Clinical Significance of 64-slice Multidetector Coronary CT Angiography to Evaluate the Prevalence and Severity of Coronary Artery Disease in Renal Transplant Recipients

The aim of this study is to evaluate the clinical usefulness of 64-slice multidetector coronary CT angiography (MDCTA) in renal transplant recipients who had no previous coronary artery disease (CAD). Primary endpoint is to assess the prevalence and severity of coronary artery disease in patients post-transplant 6 to 12 months. CAD can be diagnosed noninvasively with similar accuracy of coronary angiography using MDCTA. Early detection and intervention of CAD may provide survival benefit in renal transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 40 yrs
2. renal transplant recipient at post-transplant 6 to 12 months
3. stable graft renal function: CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation ≥45 mL/min/1.75m2
4. patients who had no previous CAD

Exclusion Criteria:

1. unstable graft renal function
2. History of acute kidney injury within 3 months
3. Allergic history to contrast agent
4. Irregular heart beat
5. Multiorgan transplant recipients
6. Pregnancy
7. Patients who do not consent to this study
An Extended Follow-Up Study of the HPV Vaccine Delayed Booster Trial

This is an extended follow-up study to follow-up study participants who received 1 booster dose of Gardasil 9 in the "HPV vaccine delayed booster trial." This was a prospective, single-arm, open-label, non-randomized, phase IIa trial among 9-11 year-old girls and boys to determine the immunogenicity after a single dose of the nonavalent HPV vaccine (Gardasil 9) over 24 months, with a delayed booster dose at 24 months and an optional booster at 30 months after the first dose. Participants provided blood specimens at 6, 12, 18, 24, and 30 months after the first dose. Serologic geometric mean titers (GMT) of the nine vaccine types (HPV 16/18/ 6/11/31/33/45/52/58) were measured at each time point. One hundred and thirty-three (133) participants received one booster dose at month 24 and elected not to receive the second booster at month 30.

For this follow-up study, we anticipate that we will be able to accrue 120 participants from the original study who received just one booster dose. Participants who received one booster dose of Gardasil 9 will be contacted to return to the clinic to provide blood specimens at 48 (±3), 60 (±3), and 72 (±3) months after the priming dose. Serologic geometric mean titers (GMT) of the nine vaccine types (HPV 16/18/ 6/11/31/33/45/52/58) will be measured at each time point.


Eligibility Criteria:
Inclusion Criteria:

* Study participants who received one booster dose of Gardasil 9 at month 24 and elected not to receive the second booster at month 30 in the original "HPV vaccine delayed booster trial"
* Ability to understand and the willingness to sign a written informed consent document by the legal representative(s) of the participant.
* Ability to understand and the willingness to sign a written assent document by the participant.

Exclusion Criteria:

- Has received any HPV vaccine dose from an external source at any point during or after participation in the HPV vaccine delayed booster trial.
Study on the Safety and Effectiveness of Risperidone Treatment of Acute Psychotic Patients

The purpose of this study was to evaluate the safety of risperidone treatment in acute psychotic patients that require an admission into emergency department. The effectiveness of risperidone in controlling acute psychotic symptomatology and incidence, severity and risk of psychomotor agitation in acute psychotic patients was also studied.

Antipsychotic drugs are key treatment for the acute psychotic symptoms experienced by schizophrenic, schizoaffective disorder and schizophreniform disorder patients. In the last years, atypical antipsychotics having fewer side effects than conventional neuroleptics, have been introduced into clinical practice. There is not an agreement about what type of drugs should be used in an emergency situation (acute psychotic patient). The aim of this observational, prospective study was to evaluate the impact of a treatment regimen with the atypical antipsychotic drug, risperidone, as first line treatment in acute psychotic patients that requested an admission into the hospital. Effectiveness of risperidone treatment was measured by Positive and Negative Syndrome Scale (PANSS) agitation sub scale, Brief Psychotic Rating Scale and days of in-patient period. Aggressive behavior was rated using Staff Observation Aggression Scale (SOAS) and Visual Analogic Scale for agitation and anxiety. Safety was evaluated collecting elicited adverse events. Observational study - Risperidone, 3-6 mg per day, orally, during the study period (in-patient period for each patient).

Eligibility Criteria:
Inclusion Criteria:

* Acute Psychotic symptoms in Schizophrenia
* Schizoaffective disorder and Schizophreniform disorders in patients that required an admission into a hospital and in which physicians considered the use of risperidone as treatment under clinical practice

Exclusion Criteria:

* Pregnant or lactating patients
* Patients with psychiatry pathology other than Schizophrenia or schizoaffective disorder
* Patients with neurology pathology except Parkinsonism induced by neuroleptics
* Patients with other severe concomitant pathology
* Patients treated with risperidone in the last 30 days
Measurement of Cerebral and Peripheric Tissue Oxygenation in Anemic Preterm Infants Who Underwent Blood Transfusion

Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral oxygenation in newborn infants. Using this technique we investigated the relationship between changes in cerebral oxygenation and hemodynamics, and changes in some physiological variables during blood transfusion in anaemic preterm infants.


Eligibility Criteria:
Inclusion Criteria: \<32 gestational age and/or \<1500gr.,\>30th day preterm infants -

Exclusion Criteria:sepsis,shock,severe intracranial hemorrhage,NEC,abdominal and cranial surgery

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An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis

Primary Objective:

To evaluate the efficacy of dupilumab (SAR231893/REGN668) in the treatment of bilateral Nasal Polyposis (NP) by assessment of the endoscopic nasal polyp score (NPS) in comparison to placebo.

Secondary Objectives:

To evaluate effect of dupilumab with regards to:

* symptoms of sinusitis,
* sinus computed tomography (CT) scan,
* NPS in the sub-group of participants with co-morbid asthma,
* Safety and tolerability.

Screening period (4 weeks) + Randomized Treatment Period (16 weeks) + Post-Treatment Period (16 weeks) = 36 weeks.

To ensure at least 28 participants with co-morbid asthma needed for subgroup analysis, recruitment of NP participants without co-morbid asthma would stop when approximately 28 participants without asthma were randomized.

Eligibility Criteria:
Inclusion criteria: participants with:

* A minimum bilateral nasal polyp score of 5 out of a maximum score of 8 (with a unilateral score of at least 2 for each nostril) despite completion of a prior intranasal corticosteroid (INCS) treatment for at least 8 weeks before screening.
* Presence of at least two of the following symptoms prior to screening: nasal blockade/obstruction/congestion or nasal discharge (anterior/posterior nasal drip); facial pain/pressure; reduction or loss of smell.

Exclusion criteria:

* Participants \<18 or \>65 years of age.
* Sinonasal outcome test (SNOT-22) \<7.
* Participants who had taken other investigational drugs or prohibited therapy for this study within 2 months before screening or 5 half-lives, whichever was longer:

  * Burst of systemic corticosteroids within the 2 months before screening or were scheduled to receive systemic corticosteroids during the study period for another condition
  * INCS drops within 1 month prior to screening
  * Monoclonal antibody (mAB) and immunosuppressive treatment
  * Anti-immunoglobulin E (IgE) therapy (omalizumab) within 130 days of Visit 1
  * Leukotriene antagonists/modifiers unless participant was on a continuous treatment for at least 30 days prior to Visit 1.
* Participants who had undergone any nasal surgery (including polypectomy) within 6 months before screening or have had more than 5 sinonasal surgeries in the past of which maximal 2 were surgeries changing the lateral wall structure of the nose.
* Participants with asthma having:

  * Forced Expiratory Volume (FEV1) ≤ 60%, or .Asthma exacerbation requiring systemic (oral and/or parenteral) steroid treatment or hospitalization for \>24 hours for treatment of asthma, within 3 months prior to screening or were on a dose of greater than 1000 microgram (mcg) fluticasone or an equivalent INCS.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
High-Speed Resistance Training Program in Independent Older Adults

The aims of the present investigation are: a) to determine the effects of a 16-weeks high-speed resistance training program on health parameters in independent older adults; and b) to verify the durability of the effects after 6 and 12 months after the intervention.

The present investigation will last a total of 18 months. More specifically, Two weeks for initial assessments, then the 16-weeks training program. After that, there will be a 1-year follow-up.

Regarding the training program, it consists in a high-speed resistance training program of 16-weeks, with three sessions per week (Mondays, Wednesdays, and Fridays) of 50-60min, each session being comprised of five-six exercises, two-three sets, and six-ten reps/exercise. The following exercises are used during the intervention period in pneumatic machines: incline bench press, squat in multipower or with dumbbell, leg extension, seated low row, leg press, calf raise, chest fly and lat pull down.

The intensity is gradually increased after each session in accordance with the movement velocity (\>1.3 to 0.75 m/s) representing approximately 20% to 60% of one repetition maximum. Participants execute the exercises rapidly and explosively making all repetitions for each shortening phase (concentric phase) performed as quickly as possible with the lengthening phase of the muscle (eccentric phase) being controlled for 2-3 s. The velocity of the concentric phase in each exercise is monitored through a BEAST™ sensor (Beast Technologies, Brescia, Italy).

Participants unavailable to participate in the intervention period will be allocated to the control group. These participants continue their usual activity without engaging in any resistance training or beginning a new exercise program during the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants of both genders;
* Aged 65 years old or more;
* Can walk and perform daily tasks independently and autonomously.

Exclusion Criteria:

* People with cognitive impairment;
* People with neurodegenerative diseases;
* People with diabetes disease;
* People with heart/respiratory pathology or use of pacemakers;
* People with musculoskeletal injuries in the 6 months before the study;
* People with active oncology disease;
* People with an uncontrolled hypertension (\>90 mmHG; \>150 mmHg);
* People participate in other supervised exercise program;
* Paeople who refuse to sign the informed consent.
Healthy Lifetime - Phase 2

HealthyLifetime (HL) is a person-centered program that enables older adults to maximize health and optimize functioning - the necessary requisite to successfully remaining independent in their preferred home setting as long as possible, i.e., to age in place.

HL seeks to intervene early in the aging process when individuals have the best chance for longer term benefits of changing their health behavior, as a means to stave off functional decline, and minimize the onset or exacerbation of chronic conditions. And, for individuals who are experiencing any of the barriers described above, our HL program's Nurse Coaches are prepared and experienced in helping them achieve their highest level of functioning and self-care capacity, while integrating and collaborating with, but not duplicating, their medical services such as primary care, specialty care, and case management or medical social services. While the latter medically oriented services support clinical management, they do not focus on helping older adults maximize health and function by building self-care capacity, long term health behavior change capacity and the functional resilience necessary to sustain or regain independent living.

Eligibility Criteria:
Inclusion Criteria:

* Be able to read, speak English and hear - but may use glasses or hearing aids, if needed;
* Be able to tell us their age, their date of birth, address, and phone number, as well as write down and explain their health problems;
* Have their own computer or iPad (Tablet) with an Internet connection, a working camera and microphone. and
* Be able to use their computer/tablet to connect to video chat sessions like Zoom in a private space in their home or a private room.

Exclusion Criteria:

* People who, in the last month, have used the Emergency Room (ER) or stayed in the hospital.
* Are not verified users of Medicaid Home Help services \[we will check with the Michigan Department of Health and Human Service to verify that you receive these services using your name, date of birth, and Medicaid identification number\];
* Have a new major health problem that they are seeing a doctor about more than once per month;
* Have been told their illness is not curable;
* Cannot remember their name, date of birth or their health problems;
* Cannot use glasses or a hearing aid to see or hear well enough to read materials on the computer or talk to the nurse easily; and,
* Do not have, or cannot use, a computer, iPad or other device with the Internet at home to use Zoom (e.g., internet streaming).
To Investigate Effects GSK561679 on Part of the Body's System That Controls the Balance of Many of the Hormones.

A study to investigate the effects GSK561679 on part of the body's system that controls the balance of many of the hormones (including cortisol).


Eligibility Criteria:
Inclusion:

* Healthy male subjects
* non-smoker
* normal ECG

Exclusion:

* shift workers
* vegetarians
* persons who travel distances
* persons participating in a psychology or psychiatry course
Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma

The primary purpose of this study is to determine the safety and feasibility of delivering HDMTX in an outpatient setting.

High Dose Methotrexate (HDMTX) is an integral part of osteosarcoma therapy whose main toxicities include myelosuppression, mucositis, nephrotoxicity, and hepatitis. In order to deliver HDMTX therapy safely, patients require urinary alkalinization, hydration, monitoring of renal function, therapeutic drug monitoring, and leucovorin rescue. Due to the required supportive care needs, HDMTX has historically been given as an inpatient. In some centers however, HDMTX is being given safely as an outpatient in order to reduce health care costs, improve patient quality of life and to deliver timely therapy with limited inpatient chemotherapy beds available.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 6 years of age;
* Localized or metastatic osteosarcoma;
* Adequate renal function (GFR \> 70 ml/1.73m2) prior to each cycle;
* No grade III/IV renal toxicity, mucositis or vomiting with most recent prior inpatient MTX cycle;
* Parent and/or patient must be able to provide written consent, and complete Patient Flow Sheets in English.

Exclusion Criteria:

* Patients, in the opinion of the primary healthcare team, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal.
* Pregnant females
* Breastfeeding females
Outcomes of Neonatal Resuscitation

The primary objective of this study is to describe mortality of newborns who received basic, advanced or no neonatal resuscitation immediately after birth at Shoklo Malaria Research Unit.

This is a retrospective, descriptive study of hospital records will be conducted. The existing dataset of newborns of ≥28 weeks gestation delivered at Shoklo Malaria Research Unit clinics from January 2008 to December 2015 will be analysed.

In the dataset, 15224 newborns fulfill the inclusion criteria and therefore they will all be analysed with IBM SPSS Statistics 22 for Windows.

Descriptive statistics will be used to define: a) the proportion of newborns alive at 24 hours, 7 days, 28 days, and at 1 year, following resuscitation at SMRU birthing rooms and b) the number of newborns requiring basic and advanced resuscitation.

Measurements of correlation coefficient will be used to compare Shoklo Developmental test scores and developmental milestones attained at 1 year in resuscitated and non-resuscitated infants. The Pearson correlation coefficient will be used if the relationship between two variables is found to be linear.

Antenatal, perinatal and postnatal characteristics associated with neonatal resuscitation will be defined by logistic regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* Liveborn singletons birthed at SMRU
* ≥28 weeks gestation

Exclusion Criteria:

* Stillborn infants
* Liveborn infants birthed at home or in the Thai hospital
* Major congenital abnormalities
A Study of Step-up in Bronchial Asthma as a New End Point in Asthma Control (SURFE)

The goal of this observational study is to learn about the frequency needed for stepping-up treatment in patients with mild and moderate bronchial asthma. The main questions this study aims to answer are:

* What is the frequency and duration in which patients of asthma need to step up their treatment?
* Can the criteria described in this study be applied and validated to test need for step up of asthma treatment? Participants will follow the treatment they are already receiving according to established guidelines and will be asked for regular visits for examination and spirometry. They will record symptoms score, each time they use the prescribed rescu inhaler, and morning and evening peak expiratory flow.


Eligibility Criteria:
Inclusion Criteria:

1. Able to give written informed consent.
2. Age above 12 years.
3. Ability to use study inhalers correctly, use e-diary, and comply with study procedures and visits.
4. Confirmed diagnosis of mild or moderate asthma asthma (based on GINA defined asthma control on a maximum of maintenance low dose ICS/LABA combination).
5. Pre-bronchodilator ≥FEV1 60%.
6. Reversibility test ≥12% or 200 ml from baseline.
7. Non-smoker.
8. For female subjects, non-pregnant and administer efficient contraception if in childbearing period.

Exclusion Criteria:

1. Severe asthma exacerbation in last 3 months.
2. Use of any systemic corticosteroids in last 12 weeks.
3. Use of depot systemic steroids in last 12 weeks.
4. Any concurrent respiratory disease as bronchiectasis, COPD, lung fibrosis, ...
5. Current or known history of tuberculosis in any organ.
6. Current malignancy or any history of malignant disease for the past 5 years.
7. Subjects receiving any medications with known drug interaction with study medications.
8. Use of beta-blockers including eye drops.
9. Any significant concurrent disease as cardiac, hepatic, renal, ...
10. Current or history of alcohol or drug abuse.
11. Current or history of significant psychiatric disease.
12. Current or history of significant immunodefieciency.
13. History of receiving any biological therapy for asthma for the last 3 years or currently eligible for any biological therapy for asthma.
14. Subjects under any immuno-modulating therapy including biological therapy for any other indication. Subjects may be allowed to participate after 5 times half-live of the concerned drug.
15. Any known allergy or contraindication to any of the study medications.
A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy Smokers

Study to determine the safety and effectiveness of silver salt in Ariva® Silver Wintergreen Lozenge on discouraging smoking, by its imparting an unfavorable taste to the smoker when tobacco is smoked.

Each subject will be given an Ariva® Silver Wintergreen lozenge or an Ariva® Wintergreen lozenge on a random basis.

Once the lozenge has dissolved in the mouth, subjects will smoke one of their own cigarettes, and will answer questions about the experience and their craving for a cigarette.

After a washout period, each subject will repeat the steps with the second type of lozenge.

Eligibility Criteria:
Inclusion Criteria:

* healthy adult smoker
* smoking for at least 5 years
* smoking at least one (1) pack of cigarettes a day
* interest in quitting smoking

Exclusion Criteria:

* known allergy to silver or silver salts
* pregnant or breast-feeding
* current drug or alcohol abuse, and/or history of drug or alcohol dependence within 3 months of study
Early Detection of Broken Hearts in Cancer Patients

The early detection of BVZ or Sunitinib mediated cardiotoxicity using cardiac biomarkers and novel Transthoracic Echocardiogram (TTE) techniques may allow one to adjust treatment and/or administer prophylactic cardioprotective agents, prior to the development of irreversible cardiac dysfunction. We hypothesize that cardiac biomarkers, TVI/strain-derived indices will be able to accurately detect subtle cardiac injury at a time when conventional Left Ventricular Ejection Fraction (LVEF) remains normal in BVZ or Sunitinib mediated cardiotoxicity. Additionally, we hypothesize that Endothelial Function Test (EndoPAT) testing can detect early BVZ or Sunitinib mediated endothelial dysfunction.

A total of 100 individuals (50 receiving BVZ and 50 receiving Sunitinib) will be prospectively enrolled . (80 at Mayo Clinic \[80 receiving BVZ, Sunitinib ,or Pazopanib\] and 20 at St. Boniface General Hospital (SBGH)). Patients receiving either BVZ 5mg/kg iv ,Sunitinib 50 mg po daily, or Pazopanib for advanced Metastatic carcinoma will be screened for potential eligibility in the study. For metastatic renal cancer treatments, Sunitinib doses are (oral) 50 mg once a day for 4 weeks followed by a two week off period. The six week cycle is then repeated. In case of toxicities observed with the dose, a 25% reduction in the daily dose during the "on" period is performed (37.5 mg). Patients will be studied at 7 time points: i) Baseline; ii) Day 1; iii) Day 5; iv) 4-6 weeks ; v) 3 months; vi) 6 months after the initiation of both drugs (BVZ and Sunitinib) ; and vii) 12 months after the initiation of BVZ drug only (Figure 1). Three visits (baseline, 4-6 weeks , and 3 months) are considered part of standard clinical care, and four visits are for research. At each visit, in addition to standard of care provided by the Oncologist, blood will be drawn to measure high sensitivity troponin-T (hsTnT) and Natriuretic-proBNP. The patients will also undergo a TTE with tissue velocity imaging (TVI), strain and left ventricular opacification (LVO) and myocardial perfusion at each time point. EndoPAT test will also be performed at baseline, and 3 months. The baseline, 4-6 weeks, and 3 month visits will be part of your standard clinical care and followup.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with advanced cancer
2. Treatment plan includes BVZ ,Sunitinib, or Pazopanib
3. Ages 18 - 90 years old -

Exclusion Criteria: Left Ventricular EF \< 50%

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