cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Co-administrated BR1018B and BR1018C

The purpose of this clinical trial is to evaluate the efficacy and safety of co-administrated BR1018B and BR1018C in patients with essential hypertension and primary hypercholesterolemia


Eligibility Criteria:
\<Inclusion Criteria\>

Screening Visit (V1)

* Patients with essential hypertension and primary hypercholesterolemia
* If patients are being treated with antihypertensive/antihyperlipidemic drugs at screening, they should be determined to be medically reasonable by investigator about discontinuing existing antihypertensive/antihyperlipidemic drugs during the clinical trial
* Patients under the following criteria at screening:

  * Patients who meet a fasting triglyceride (TG) \< 400 mg/dL and LDL-C ≤ 250 mg/dL
  * Patients who meet the following criteria, depending on whether antihypertensive drugs were administered within the last 4 weeks

    1. Naïve : 140 mmHg ≤ MSSBP \< 180 mmHg and MSDBP \< 110 mmHg
    2. Use antihypertensive drugs : 130 mmHg ≤ MSSBP \< 180 mmHg and MSDBP \< 110 mmHg

Baseline Visit (V2)

* Patients who meet the following criteria of blood pressure measured in selected reference arm at baseline (According to the clinical situation of each subject, Follow the blood pressure standards(Refer to 2022 The Korean Society of Hypertension Guideline))

  * 140 mmHg(or 130 mmHg) ≤ MSSBP \< 180 mmHg
  * MSDBP \< 110 mmHg
* Patients who meet fasting serum lipid profile test levels (LDL-C and TG) correspond to cardiovascular risk and risk factors at baseline (Refer to 2022 Korean Guidelines for the Management of Dyslipidemia (the 5th edition))

\<Exclusion Criteria\>

* Patients with a difference of SiSBP ≥ 20 mmHg and SiDBP ≥ 10 mmHg in blood pressure measured three times on both arms at screening(V1)
* Patients with blood pressure results showing MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg at screening(V1, both arms) and baseline(V2, selected reference arm)
* Patients with a history of secondary hypertension or suspected secondary hypertension; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, renal hypertension, pheochromocytoma, Cushing's syndrome and polycystic kidney disease, etc.)
* Patients with a history of secondary hyperlipidemia or suspected hyperlipidemia; (e.g., Chronic renal failure, nephrotic syndrome, dysproteinemia, obstructive liver disease, Cushing's syndrome, hypothyroidism, etc.)
* Patients with hyportensive shock
* Patients with orthostatic hypotension accompanied by symptoms
Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of SUI in Chinese Men Undergone Robotic Radical Prostatectomy

This is a prospective, randomized trial to evaluate the efficacy and safety of High-Intensity Focused Electromagnetic (HIFEM) Technology in the treatment of stress urinary incontinence compared with standard of care in Chinese men who had undergone robotic radical prostatectomy.

This is a prospective randomised control trial of consecutive patients with prostatectomy to have either standard of care versus HIFEM assisted pelvic floor exercise. Randomization will be performed for patients when the subject has completed the informed consent for study participation. Randomization will be performed in 1:1 ratio into 2 arms: HIFEM assisted (BTL EMsella) pelvic floor muscle training (Arm A) plus Standard of care or Standard of care (Arm B).

Eligibility Criteria:
Inclusion Criteria:

* Undergone robotic radical prostatectomy
* Able to carry out 1-hour pad test
* Voluntary participation and signing of the informed consent form

Exclusion Criteria:

* Pre-existing stress urinary incontinence
* Post-void residual urine greater than 200ml
* Active urinary tract infection
* Urethral or bladder fistula
* History of pelvic irradiation
* Neurological condition (Spinal cord problems, stroke with poor neurological recovery, epilepsy, Parkinson disease, multiple sclerosis)
* Previous surgery for SUI
* Concurrent medication with diuretics, serotonin-norepinephrine reuptake inhibitors or any other medication known to worsen incontinence
* Condition contraindicated for electromagnetic therapy i.e. Arrhythmia, on a pacemaker or implanted metallic device; Coagulopathy or on anticoagulant
Find the Adequate Dose of Nalbuphine for Laparoscopic Cholecystectomy

This study evaluate the adequate dose of mutonpain for laparoscopic cholecystectomy in the management of post operative pain. The investigators will randomize patients into three groups to compare the analgesia effects and side effects.

Nalbuphine is a FDA approved noncontrolled drug of opioid. And it had been applied for post operative pain for different surgeries, claiming that less nausea and vomiting with the same analgesic effect when comparing with morphine.

However, several studies concerning post pain management usually used nalbuphine 0.15-0.3 mg/kg for laparoscopic cholecystectomy. If the analgesic effect of nalbuphine is similar with morphine, less nalbuphine injection could reduce the side effects of opioid.

The investigators will randomize patients into three groups of different initial nalbuphine dose for post laparoscopic cholecystectomy surgical pain, and set patient control analgesia machine with nalbuphine for further pain management. If the pain or side effects of opioid were intolerable, the investigators will change pain medications into NSAIDs or other adequate medications to comfort the patient.

The primary outcome were numerical rating pain score and consumption of nalbuphine. The secondary outcomes were nausea, vomiting, pruritus and satisfactory score, and if any other medications use.

Eligibility Criteria:
Inclusion Criteria:

* patient accept laparoscopic cholecystectomy
* age:20-80 years old

Exclusion Criteria:

* nalbuphine allergy
* chronic pain
* active liver disease that would affect metabolization of nalbuphine
* patient who had regular pain medications
* patient who could not cooperate to the evaluation of the survey
* dementia or other psychiatric disease
Families Preventing Diabetes Together

The current study proposes to study the feasibility and acceptability of the Families Preventing Diabetes Together Intervention among 40 families who have one parent diagnosed with type 2 diabetes and at least 1 child between the ages of 5-14 years of age. Successful recruitment, measurement and randomization of patients and their families will provide data for our aim of assessing feasibility. Patient and family participation in the intervention and feedback via the post-intervention surveys will provide data for our aim of acceptability.

The current study is a randomized controlled trial with 40 families. Twenty families will be randomly assigned to receive usual care consisting of diabetes education delivered through Fairview Health Services. An additional 20 families will be randomized to a family-based, in-person program that focuses on nutrition education, the development of meal planning and cooking skills and promotion of healthful eating for families; the program will augment usual care and diabetes education received from Fairview Health Services for the parent with diabetes. Parents with diabetes who are randomized to the intervention group will also participate in one goal-setting phone call with intervention staff at one point during the intervention program.

Adult patients and their families will be recruited in two ways:

1. from Fairview Health Service's clinics in the North metropolitan area with the assistance of Fairview Health Service diabetes educators, and
2. through MyChart messages informing them about the study.

Adults between the ages of 25 and 55 years who have a diagnosis of Type 2 diabetes, who have participated in at least some diabetes education through Fairview Health Services, and who have at least one child between the ages of 7-12 years of age will be invited to participate in the study. Successful recruitment, measurement and randomization of patients and their families will provide data for our aim of assessing feasibility. Patient and family participation in the intervention and feedback via the post-intervention surveys will provide data for our aim of acceptability.

Eligibility Criteria:
Inclusion Criteria:

* Parent with Type 2 diabetes
* At least 1 child between the ages of 7-12
* Parent has completed at least some Diabetes Education through Fairview Health System

Exclusion Criteria:

* Parent with Type 2 diabetes does not speak or read in English
* No parents with Type 2 diabetes or no children ages 7-12 years
* Parent with Type 2 diabetes has not completed at least some Diabetes Education
Observational Study of Correction of Anaemia With Darbepoetin Alfa at QM Dosing Interval in Patients With CKD Not on Dialysis

To describe anaemia correction via haemoglobin measurements taken throughout observation period in ESA naive patients with chronic kidney disease initiated on darbepoetin alfa QM

Darbepoetin alfa (Aranesp) is a long-acting ESA approved for treatment of anaemia in CKD patients, and may be administered once a week (QW), once every two weeks (Q2W) or once a month (QM) for correction and for maintenance in CKD patients not on dialysis. Prescribing information for darbepoetin alfa was updated in August 2013 (in EU and Australia), to incorporate the option for correction at QM dosing frequency in CKD patients not on dialysis. There is very little published literature describing QM correction in a real-world setting.

Data obtained from this study are intended to contribute to filling a literature gap and to provide a robust source of information for physicians.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥18 years of age.
2. Patients with CKD:

   1. Not on dialysis at time of darbepoetin alfa initiation at QM dosing frequency.
   2. Hb \<10g/dL immediately prior to initiation of darbepoetin alfa at QM dosing.
   3. Commenced darbepoetin alfa at QM dosing frequency during or after August 2013.
   4. Received at least three consecutive doses of darbepoetin alfa at QM dosing frequency, being the initiation dose and two further doses at QM dosing frequency.
3. Patient or patient's legally acceptable representative has provided informed consent, if applicable according to local requirements.

Exclusion Criteria:

1. Treatment with an ESA within 14 weeks prior to initiation of darbepoetin alfa.
2. Patient was enrolled in an interventional device or drug study at any time during the 46-week data observation period or within 30 days prior to commencement of the data observtion period.
Goal-Directed Resilience Training to Mitigate Chronic Pain in Former Football Players

The investigators propose to test a pilot study that teaches resilience skills to former football players who experience chronic pain. The purpose of this study is to see if learning resilience skills makes a difference in how former players manage chronic pain. This pilot study may advance methods to improve the well-being and quality of life of former players affected by pain.

This pilot study seeks to test the efficacy of a resilience skills training intervention for former football players who experience chronic pain. Chronic pain threatens quality of life, and the culture of elite athletes is poorly adapted to the chronic condition of pain. Innovative strategies that are both culturally acceptable and effective are needed to address the needs of players who may have a reluctance to engage traditional treatment approaches.

The overarching goal is to strengthen the capacity for former football players to maintain adaptive engagement in valued activities despite chronic pain. Responding to recent findings from the Harvard Football Player Health Study (HFPHS) that identified pain as a significant challenge, we propose a pilot study that tests a resilience skills training intervention with former football players who currently experience chronic pain.

This proposed study builds on previous work conducted at Morehouse School of Medicine engaging retired professional football players and ongoing resilience intervention research involving veteran and community-based populations. The specific aim of this study is to test an intervention to decrease chronic pain and co-morbid symptoms and improve a broader adaptive level of functioning through Goal-Directed Resilience Training (GRIT) for chronic pain in a sub-sample of Atlanta-based former players.

The investigators hypothesize the following:

1. GRIT training intervention versus control training will be associated with reduced chronic pain and related symptoms of insomnia, anxiety, depression, improved emotional functions, and improved neurocognitive functions.
2. Improved self-reported physical health, quality of life, personal relationships, and personal growth will be evident for intervention versus control participants.

This pilot study has the potential to advance strategies to improve the well-being and functional status of former players impacted by pain.

Eligibility Criteria:
Eligibility Criteria

Inclusion Criteria:

* Former football player between 18 - 65 of age
* Player has passed pre-selection and are referred by Harvard Football Players health study
* Potentially diverse racial \& ethnic identities.

Exclusion Criteria:

* Active suicidality or suicidal intent requiring greater than outpatient level of care (Columbia Suicide Severity Rating Scale - CSSRS)
* High risk drinking of alcohol (based on scoring guidelines of AUDIT-C)
* Active psychosis (Psychosis Screener)
* Inability to participate in a small group setting (self-reported inability to regulate constructive social interaction in small group setting
* Inability to meet projected attendance requirements.
Study on the Efficacy and Safety of QLM1016 in Schizophrenia

The study will evaluate the antipsychotic efficacy of QLM1016 in a multicenter, randomized, double-blind, parallel controlled study in patients diagnosed with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* male or female subjects, ages 18-65 inclusive, with a clinical diagnosis of schizophrenia
* PANSS total score ≥ 70 and ≤ 120，Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms: delusions, hallucinatory behavior, conceptual disorganization, and unusual thought content
* CGI-S score ≥ 4

Exclusion Criteria:

* Currently, meet DSM-5 diagnostic criteria for other psychiatric disorders ( for example schizoaffective disorder, schizophreniform disorder, bipolar I and II disorder; pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders；
* known or suspected borderline or antisocial personality disorder or other psychiatric disorders of sufficient severity to interfere with participation in the study
A Phase III Clinical Trial Assessing the Immunogenicity and Safety of Lyophilized Live-Attenuated Varicella Vaccine in Healthy Subjects Aged 13 to 55 Years

Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Adolescents and adults Aged 13-55 Years: A Phase III, Randomized, Double-Blind, Active-Controlled Study


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals aged between 13 to 55 years who are permanent residents; Have obtained informed consent from the volunteer and/or their legal guardian, and signed the informed consent form; The volunteer and/or their legal guardian can comply with the requirements of the clinical trial protocol; Axillary temperature ≤37.0°C.

Exclusion Criteria:

* Females aged 18 to 55 years with a positive urine pregnancy test, pregnant women, women who are breastfeeding, or women planning to become pregnant within the next 3 months; Have a history of varicella vaccination, a history of chickenpox, or a history of herpes zoster infection; Allergic to known components of the study vaccine, or a history of severe allergic reactions to any vaccination; A history of epilepsy, seizures, or convulsions, or a family history of psychiatric disorders; Individuals with immunodeficiency, undergoing immunosuppressive therapy (e.g., oral corticosteroids), or having HIV-related immunocompromised status, or having close family members with congenital immune diseases; Have congenital malformations, developmental disorders, or severe chronic diseases (such as Down syndrome, diabetes, sickle cell anemia, neurological disorders, Guillain-Barré syndrome); Known or suspected concurrent diseases including: respiratory diseases, acute infections, or active chronic diseases, cardiovascular diseases, skin diseases, severe hypertension, or during treatment for malignant tumors; Diagnosed with coagulation dysfunction (such as coagulation factor deficiencies, coagulopathies, platelet abnormalities) or significant bruising or coagulation disorders; Have received blood products in the past 3 months; Have received live attenuated vaccines in the past 14 days or subunit or inactivated vaccines in the past 7 days; Have had various acute diseases or acute exacerbations of chronic diseases in the past 7 days; Have had a fever (axillary temperature ≥38.0°C) in the past 3 days; Any other factors deemed by the investigator as unsuitable for participation in the clinical trial.
A Study of JNJ-73763989 in Adult Participants With Renal Impairment

The purpose of this study is to evaluate the pharmacokinetics (PK) of a single subcutaneous (SC) dose of JNJ-73763989 in adult participants with renal impairment compared with healthy participants with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

* Must have stable renal function defined as a less than (\<) 20 percent (%) change in serum creatinine concentrations between screening and Day -1
* Concomitant medications should be stable for the previous 1 month and throughout the duration of the study
* Women, except for postmenopausal women, must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and urine (beta-hCG) pregnancy test on Day -1
* Must sign an informed consent form (ICF) indicating they understand the purpose of, and procedures required for the study and are willing to participate in the study
* Participants with kidney disease without dialysis using benzodiazepines, tricyclic antidepressants, and prescription opiates with a positive urine test for drugs prescribed by their physician may be included following prior discussion with the sponsor

Exclusion Criteria:

* Have kidney disease requiring dialysis
* Renal transplants, systemic lupus erythematosus, or participant with malignancy
* Known allergies, hypersensitivity, or intolerance to JNJ-73763989 or its excipients
* Received an experimental drug (including investigational vaccines) or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the administration of the study drug is scheduled
* Preplanned surgery or procedures that would interfere with the conduct of the study
Study to Demonstrate the Lot-to-lot Consistency and to Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate

The purpose of this phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility Criteria:
Inclusion Criteria:

* A male or female age 60 years or older at the time of the vaccination.
* Subjects who the investigator believes can and will comply with the requirements of the protocol
* Written informed consent obtained from the subject.
* Free of an acute aggravation of the health status as established by clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
* Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
* History of hypersensitivity to a previous dose of influenza vaccine.
* History of confirmed influenza infection within the last 12 months.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
* Acute disease at the time of enrolment