cyrilzakka/clinical-trials huggingface dataset:
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics ，Pharmacodynamics of Oral SHR2150 in Healthy Subjects

The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics of SHR2150.

will consist of 50 healthy subjects, 5 groups. The purpose of this part is to explore the safety, tolerability ,pharmacokinetics and pharmacodynamics of single doses of SHR2150 capsule in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent.
2. Aged 18\~45.
3. Body weight ≥ 50 kg for male; ≥ 45 kg for female, body mass index (BMI) between 18 to 28 kg/m2 ( Including boundary value) .
4. Vital signs, physical examination, laboratory results are within normal range or considered not clinically significant.
5. Female subjects (including partner) of childbearing potential must be using a medically acceptable form of birth control.

Exclusion Criteria:

1. Currently suffering from cardiovascular, liver, kidney, digestive, nervous, blood, thyroid or mental diseases.
2. Have severe infection, severe trauma or major surgical operations within 3 months. Plan to receive surgery during the trial and within two weeks after the end of the trial..
3. 12-ECG test have clinical significant abnormality or the QT interval (QTc) \> 450 ms(male)/QTc)\> 460 ms(male) or\<300ms(female).
4. Screening for infectious diseases is positive (Including HBsAg, Anti-HCV, TPPA, Anti-HIV)
5. Suspected allergy to any ingredient in the study drug.
6. Have any drug that inhibits or induces liver metabolism within 1 month.
7. Any condition or disease that affects the absorption, metabolism, and/or excretion of the study drug judged by the investigator;
8. Treatment with immunosuppressant or interferon-containing drugs within 6 months of study drug administration;
9. Participated in clinical trials of any drug or medical device within 3 months before screening, or within 5 half-lives before screening;
10. Treatment with live(attenuated) vaccine within 2 months before taking the study drug or during the study or within 1 months after administration;
11. Had donated blood or blood transfusion≥ 200 mL within 1 months before taking the study drug or had donated blood or blood transfusion≥ 400 mL within 3 months prior to screening;
12. The average daily smoking ≥ 5 cigarettes within three months; the average daily alcohol intake in a month exceeds 15 g (15 g alcohol is equivalent to 450 mL beer or 150 mL wine or 50 mL low-alcohol);
13. Keep smoking, drinking alcohol or consuming caffeinated foods or beverages (more than 8 cups, 1 cup = 250 mL) 2 days before taking the study drug and during the study; and those who have special dietary requirements and cannot follow the unified diet;
14. History of drug abuse , drug dependence or drug screening test is positive;
15. Pregnant or lactating women;
16. Other conditions that the investigator believes the subject is not suitable.
Fimasartan Blood Pressure Lowering After Acute Stroke

This study evaluates the effectiveness of fimasartan-based antihypertensive treatment and prognosis in post-acute phase of ischemic stroke or transient ischemic attack patients. All participants will receive fimasartan, and the investigators will follow them up for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke or transient ischemic attack occurs after 7 days to 3 months.
* Mean blood pressure measured 3 times at the first visit (Visit 1) should be over 140 mmHg for systolic blood pressure or 90 mmHg for diastolic blood pressure
* Suitable for administration of fimasartan
* The life expectancy should be over 6 months.

Exclusion Criteria:

* Patients already treated with antihypertensive medications
* Hemorrhagic stroke patients
Effective Measurement of Risperidone Treatment Outcome for Persons With Borderline Personality Disorder

The objective of Study A is to evaluate the efficacy of risperidone on the 4 behavioral dimensions of Berderline Personality Disorder (BPD)in an open label trial:mood swings, impulsivity, thing difficulties and disturbed relationships. The secondary objective of this study (Study B)is to validate a self-report measure of clinical symptoms specific to the treatment of patients with BPD, the UAB Borderline Rating Scale(BRS).

Study A: An open-label, prospective trial of the efficacy and safety of risperidone in the treatment of BPD.The study is 8 weeks in duration, with a screening visit and follow-up visits at the end of Weeks 1,2,3,4,6, and 8. 20 female patients, 19 years or older will be recruited. A full medical and psychiatric history will be taken and a physical exam will be performed by a sstudy physician. A psychosocial assessment will be conducted during the screen.

Study B: The ofjective is to validate the UAB BRS by administering the BRS and other neuropsychological instruments as repeated measures over a 6 week period to 40 patients with BPD.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of BPD

Exclusion Criteria:

* Any other Axis I diagnosis except dysthymia, PTSD, or generalized anxiety disorder;substance abuse within a month; unstable medical illness.
MR-simulation in Radiotherapy for Prostate Cancer

To assess the feasibility of acquiring an MR scan in the radiotherapy treatment position as part of the patient's radiotherapy pathway and incorporating the data into our radiotherapy planning systems, so that it can be potentially used to reduce healthy tissue exposure to radiation. Subsequently, the protocols and procedures established can be used to put the technique into routine clinical practice.

Conventional radiotherapy treatment planning uses computed tomography (CT) scans to provide an accurate 3-D picture of the local anatomy. This helps the planners to maximise the radiation dose delivered to the prostate, whilst minimising the dose to surrounding normal tissue. Magnetic resonance imaging (MRI) scanning is an established diagnostic imaging technique that provides even clearer images of the local anatomy. However, until recently the technology hasn't existed to allow us to perform MRI scans with patients "set-up" in the position required to plan and deliver radiotherapy to the prostate. This study is being performed to assess methods that may allow us to incorporate MRI scans into the radiotherapy planning process, which may further increase the accuracy of the treatment, reducing the irradiation of surrounding normal tissue and minimising toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Written, voluntary, informed consent
* Age ≥ 18
* ECOG Performance Status ≤ 2
* Life expectancy \> 12 months
* Histologically proven carcinoma of the prostate
* Radical radiotherapy +/- hormones indicated as the primary treatment modality
* Staging diagnostic MRI of the prostate need to be available for comparison.
* Adequate organ function and absence of other major concurrent illness, allowing

Exclusion Criteria:

* Inability to provide informed consent
* Impaired renal function (serum creatinine of \> 200)
* Severely impaired liver function
* Patients with allergies or contra-indications to the gadolinium contrast agent that may be used in the study
* Severe claustrophobia or inability to tolerate MRI scans
* General contra-indications to MRI including cardiac pacemakers and defibrillators, metallic prosthetic devices, aneurysm clips and metal fragments in the eyes, as defined in MRI safety departmental protocols
* Serious inter-current conditions or other non-malignant illnesses that are uncontrolled or whose control may be affected by participation in this study
* Any patient who has urinary or faecal incontinence
* Status greater than or equal to 3
A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab

This study is open to people with hidradenitis suppurativa (HS) who have completed another study with spesolimab (study 1368-0098 (NCT05819398) or study 1368-0100).

The purpose of this study is to find out how well people tolerate spesolimab and whether it helps people with HS in the long-term. For about 1.5 years, participants get spesolimab injections under the skin every 2 weeks.

Participants are in the study for about 2 years. During this time, participants have 41 visits. 24 visits are done at the study site. 17 visits can be done by video call at the participant's home. At study visits, doctors check the severity of the participant's HS and collect information on any health problems of the participants.


Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
2. Participants must be within the defined Residual Effect Period corresponding to 16 weeks since last spesolimab administration.
3. Participants who have completed treatment in the parent hidradenitis suppurativa (HS) spesolimab trial (1368-0098 (NCT05819398) or 1368-0100) without premature discontinuation and are willing and able to continue treatment in this trial.
4. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.

Exclusion Criteria:

1. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
2. Use of any drug considered by the investigator likely to interfere with the safe conduct of the trial since the last visit of the parent trials.
3. Use of immunomodulatory biologics or investigational agents since the last visit of the parent trials.
4. Participants who require / intend to use certain restricted medications such as immunomodulatory biologics or other investigational drugs/devices during the course of the trial.
5. Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis. The corresponding laboratory tests will be performed at Visit 1. A participant can be re-screened if the participant was treated and is cured from the acute infection.

Further exclusion criteria apply.
Leukemia Stem Cell Detection in Acute Myeloid Leukemia

Most patients with acute myeloid leukemia (AML) achieve complete remission (CR) following induction chemotherapy. However, a large majority subsequently relapse and succumb to the disease. Currently, cytogenetics and molecular aberrations are the best prognostic indicators; however, these factors cannot prognosticate accurately for individual patients. Overall, the majority of patients with favorable or intermediate-risk AML will experience relapse. Prognosis after relapse is dismal with a five-year overall survival rate of less than 10%. A leukemia stem cell (LSC) paradigm may explain this failure of CR to reliably translate into cure. This study is undertaken to determine whether the presence of LSCs has prognostic value as well as to determine whether the presence of LSCs has predictive value. This study has an observational component, whereby we intent evaluate whether the presence or absence of LSCs is prognostic. This study also has an interventional component in which it uses LSC status to determine whether favorable and intermediate risk AML patients in CR receive consolidation with chemotherapy or allogeneic HCT.


Eligibility Criteria:
Inclusion Criteria:

1. Must have previously signed the specimen procurement protocol consent associated with the leukemia stem cell assay ("Step 1 informed consent") prior to starting AML therapy.
2. Age 18 years and older
3. New diagnosis of AML, other than APL, confirmed by bone marrow aspirate/biopsy and reviewed by an institutional hematopathologist
4. Completion of induction therapy, as defined by the Investigator and post-induction bone marrow biopsy.

Exclusion Criteria:

1. Any debilitating medical or psychiatric illness that would preclude ability to follow study procedures.
2. Indeterminate leukemia stem cell assay results at diagnosis.
True Continuous ECG Monitoring (TCEM Study)

The purpose of this study is to compare short term (up to 48 hours) traditional cardiac rhythm monitoring using a standard ambulatory Holter monitor versus long term (up to 14 days), continuous ambulatory cardiac rhythm monitoring using a new device cleared by the FDA (Zio® Patch), iRhythm Technologies, Inc., San Francisco CA) in patients with suspected cardiac arrhythmias.

This is a prospective, observational study of patients seen in the Holter lab at Scripps Green Hospital and other Scripps Clinic locations. Only patients who have indications for traditional cardiac rhythm monitoring will be enrolled in the study. Patients 18 years or older with suspected arrhythmias capable of providing informed consent will wear both a traditional Holter monitor for up to 48 hours and a Zio® Patch for up to 14 days. Both devices will be initiated at the same time as they do not interfere with one another. This will also allow a direct comparison of the same initial up to 24 hour monitoring period between the two devices. As the Zio® Patch is worn for up to 14 days instead of only 24 hours, it will be assessed if in the physician's opinion (referring physician), waiting for the extended time hinders being able to provide medical care and/or diagnosis for the patient.

Eligibility Criteria:
Inclusion Criteria:

* Are being seen in the outpatient office for evaluation, treatment, or follow-up of arrhythmias;
* Have a medical history for which ascertaining whether asymptomatic arrhythmias is occurring could be helpful in their treatment plan;
* Are capable of giving informed consent; assessed by the investigator or the Study Coordinator;
* Are 18 years of age or older;
* Able to comply with long term continuous monitoring ECG device.

Exclusion Criteria:

* Have known skin allergies, conditions, or sensitivities (e.g. allergy to adhesives, psoriasis) as the Zio(R)Patch should not be used on patients with known skin allergies, conditions, or sensitivities; or
* Are receiving pacing therapy (e.g., from a pacemaker); or
* Are anticipated to receive or require external cardiac defibrillation during the monitoring period; or
* Are anticipated to be exposed to high frequency surgical equipment during the monitoring period.
Virtual Reality (VR) Based Mindfulness Practice in Relieving Stress in Postgraduate Students

University students, especially graduate students, are constantly striving to achieve their goals, and their performance is constantly being evaluated, which creates a plethora of stressors, such as tests, a large amount of content to be learnt, lack of time, getting poor marks, and living up to their expectations. Mindfulness has been demonstrated to benefit one's emotions in a 'non-judgement' way. Evidence suggests that VR-based mindfulness practice may help individuals maintain present-moment awareness and block out distractions and may be more effective than conventional mindfulness approaches. The current pilot study aims to test the feasibility and acceptability of VR-based mindfulness practices in graduate students.

A three-arm, assessor-blinded pilot randomised controlled trial (RCT) will be implemented. Participants will be randomly assigned to either mindfulness group, VR mindfulness group and control group. Participants will be randomised at a 1:1:1 ratio to the intervention groups or control group. Block randomization will be conducted by an independent research assistant using randomly varying block sizes of 4 and 6 to avoid selection bias. This study aims to test the feasibility, acceptability, and preliminary effects of the VR-based mindfulness practice in improving stress for graduate students.

Specific objectives are as follows:

1. To investigate the feasibility and acceptability of the VR-based mindfulness practice in improving stress for graduate students
2. To investigate the preliminary effects of VR-based mindfulness practice in improving stress for graduate students
3. To understand the user experience of mindfulness practice in VR

Eligibility Criteria:
Inclusion Criteria:

1. aged 18 or over;
2. enrolled in graduate programme at the Chinese University of Hong Kong;
3. experienced stress: the score of perceived stress scale more than 13;
4. able to speak and write in English

Exclusion Criteria:

1. diagnosed with psychiatric disorders;
2. currently taking psychotropic medication;
3. have history of photosensitive epilepsy or previous experience of severe simulator sickness;
4. receiving or have just completed other psychological interventions (e.g. stress management, mental health support, peer support, etc) within the last six months will be excluded; or
5. history of seizures and motion sickness.
Modifiable Predictors of Neural Vulnerabilities for Obesity

The purpose of this study is to examine how certain factors in childhood and adolescence relate to neural vulnerabilities for obesity in young adulthood. It is hypothesized that specific individual and environmental factors will significantly predict neural vulnerabilities for obesity.

Studies aimed at elucidating neural vulnerability factors for obesity - including high food reward sensitivity and poor food regulation - hold particular promise. However, relatively little is known about the modifiable factors that contribute to these neural vulnerabilities, thus precluding the development of potentially powerful interventions to promote healthy long-term weight trajectories. Further, the limited research in this area lacks critical developmental and environmental context. The current proposal addresses these gaps by examining the roles of selected modifiable cognitive (executive control), behavioral (diet, sleep), affective (negative affect), and environmental (obesogenic environment) factors throughout childhood and adolescence in predicting emerging neural vulnerabilities for obesity during the pivotal transition to young adulthood. The specific aims are to: 1) Determine the impact of executive control development across childhood and adolescence on food reward sensitivity and regulation in young adulthood; 2) Determine the impact of a set of behavioral and affective factors in adolescence (i.e., diet, sleep, negative affect) on food reward sensitivity and regulation in young adulthood; and 3) Explore the impact of the obesogenic environment encountered in adolescence on food reward sensitivity and regulation in young adulthood.

Eligibility Criteria:
Inclusion Criteria:

* Age 19 years or older
* Previous participation in the Preschool Problem Solving Study OR lived in Lancaster County, NE for at least part of high school

Exclusion Criteria:

* Contraindications for functional magnetic resonance imaging (fMRI):
* metal in body
* pregnancy
* braces
* non-removal piercings
* hair extensions
* As of 8/13/21, for individuals who were not in the Preschool Problem Solving Study but are invited to participate in the current study because they lived in Lancaster County for at least part of high school, the maximum age for eligibility is 20 years of age.
Seasonal Trends in Pneumococcal Carriage in COPD Patients

Patients suffering from chronic obstructive pulmonary disease (COPD) commonly get exacerbations of their illness which have many potential triggers including infection. The most common cause of lung infection/pneumonia is an organism named Streptococcus pneumoniae. In Ireland a 13-valent pneumococcal conjugated vaccine (PCV-13) was recently introduced into the childhood vaccination programme. This study aims to investigate the carriage rate of S. pneumoniae in COPD patients over one year and to determine if isolates of S. pneumoniae found within the COPD population would be covered by the PCV-13 vaccine.

This study aims to determine the potential contribution of S. pneumoniae to the morbidity of patients with COPD in Ireland and if the PCV-13 has potential for reducing infective exacerbations in this cohort. A group of 150 COPD patients are being monitored at quarterly intervals over one year. At each study visit patients report changes to COPD-related medication, recent hospitalisations and exacerbations and provide a sputum sample (or pharyngeal swab if not possible) which is assessed for the presence of S. pneumoniae.

The specific objectives of the study are:

1. To monitor the carriage rate of pneumococci in a cohort of Irish patients with COPD during and outside periods of acute exacerbation over a one year period.
2. To assess the COPD exacerbation rate amongst this group of patients.
3. To monitor changes in the proportion of patients positive for pneumococci carriage over a full season and to document those patients intermittently or permanently colonised.
4. To characterise S. pneumoniae isolates carried by COPD patients in terms of their genetic evolution, comparison with strains in other countries, and antimicrobial susceptibility.
5. To assess the proportion of colonised COPD patients that would be covered by current and future pneumococcal vaccines.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age.
* Have a clinical diagnosis of COPD.
* Have a forced expiratory volume at one second/forced vital capacity (FEV1/FVC) ratio \< 80%.

Exclusion Criteria:

* Patients too unwell.
Prospective Study of Cerebrovascular Accidents (CVA) in 3 French Cities (Besançon, Cayenne and Tours)

The objective of this study is to specify the typology of CVA in French Guiana by prospectively comparing consecutive strokes observed at each of the three study sites (Cayenne, Tours, Besançon)

CVA is a public health problem that is managed in a codified manner by the Neurovascular Units (NU). In Cayenne, in the absence of a NU, strokes are managed directly in the emergency room by 24-hour telemedicine provided by the neurovascular team at the Besançon University Hospital. The vascular neurologist can perform a clinical examination remotely in a dedicated examination room and has access to magnetic resonance imaging by image transfer. The Tours and Besançon university hospitals each have a regional reference NU. The coordinating investigator of the study is the head of the neurology department of the Tours University Hospital, currently on an extended mission in Cayenne. The initial emergency management of a person with stroke who is hospitalized is comparable between the three regions studied.

Epidemiological studies show disparities in stroke mortality and vascular risk factors between French regions. The stroke mortality rate in French Guiana in 2013 (72 per 100 000 population per year) was twice that of metropolitan France. The standardized prevalence rate of diabetes in French Guiana is 7.1% of the population compared with 4.4% in metropolitan France, and the prevalence of hypertension is twice as high among women in the French Guiana West Indies compared with metropolitan France. There are twice as many obese persons (BMI\>30) in Guyanese women compared with metropolitan France.

We propose a prospective observational study based on the following hypothesis:

The average age of stroke occurrence, its type (ischemic or hemorrhagic), the vascular territories involved, the vascular risk factors, and the pre-hospital and intra-hospital management times will be superimposable between two metropolitan regions but different in French Guyana.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a diagnosis of Cerebral Vascular Accident confirmed on MRI

Exclusion Criteria:

* Age under 18 years
* Absence of MRI