cyrilzakka/clinical-trials huggingface dataset:
A Safety Study of Ginkgolides Meglumine Injection in the Treatment of Ischemic Stroke.

The aim of this study is to evaluate the safety of Ginkgolides Meglumine Injection in the treatment of ischemic stroke with Syndrome of Intermingled Phlegm and Blood Stasis.

Ginkgolides Meglumine Injection was jointly developed by China Pharmaceutical University and Jiangsu Kanion Pharmaceutical Co., Ltd. Its pharmacal ingredients are ginkgo lactones , ginkgo lactone B, ginkgo lactone K, etc; Excipients for meglumine, citric acid, sodium chloride. It is used to treat stroke (mild-to-moderate cerebral infarction) in recovery phlegm and Syndrome of Intermingled Phlegm and Blood Stasis.

The aim of this study is to evaluate the safety of Ginkgolides Meglumine Injection in the treatment of ischemic stroke with Syndrome of Intermingled Phlegm and Blood Stasis.

Eligibility Criteria:
Inclusion Criteria:

* patients according to diagnostic standards on western medical ischemic stroke;
* patients according to diagnostic standards on Chinese medical attack to meridians;
* patients according to differentiation standards on syndrome of intermingled phlegm and blood stasis;
* 2 weeks to 6 months after attack;
* Age between 18-80 years;
* patients must volunteer to participate in this study and sign the informed consent form.

Exclusion Criteria:

* patients accompanying unconsciousness or severe dementia;
* ALT, AST≥2 times of upper limit of normal;
* patients with other severe diseases such as disease in circulatory system, hematopoietic system, digestive system, endocrine system etc;
* patients allergic to Ginkgo biloba drugs，Meglumine and meglumine agents;
* patients who are pregnant, lactating or planning for pregnancy;
* patients with insanity;
* patients who are not suitable for clinical trial under doctors' consideration;
* patients with Merge bleeding after infarction or patients with hemorrhagic tendency;
* patients with lower extremity venous thrombosis;
* patients who have participated in other clinical trial within 1 month.
CLEARI (Clinical Efficacy Assessment on Recurrent Upper-Respiratory Tract Infections) Study

The purpose of this study is to assess the efficacy and safety of J022X ST for prevention of Recurrent Upper-Respiratory Tract Infections (RURTI) compared to placebo in children of younger age who develop infectious diseases more frequently than other children of this age in general.


Eligibility Criteria:
Key Inclusion Criteria:

Patients with all the following criteria will be eligible for inclusion in Year 1:

* Children, male or female
* Aged 3 to 4 years
* Children known for recurrent URTIs in the past year (based on medical recording or reported history)
* Children at risk for URTI in the physician's opinion (e.g. absence of breastfeeding, hospitalization in the previous year, tonsillectomy or adenoidectomy, parental smoking, daycare institution or nursery school, early schooling, prematurity, low weight at birth, malnutrition, failure to thrive).

Patients with all the following criteria will be eligible for randomisation in Year 2:

* Children, male or female
* Aged 4 to 5 years
* Suffering from RURTI, i.e. at least 6 URTI episodes medically confirmed, with a maximum of 18, during the Year 1 of the study.

Key Exclusion Criteria:

Presence of diseases (Chronic suppurative otitis media, acute broncho-pulmonary infection, Immune deficiency or disorders, surgery of respiratory tract, cystic fibrosis...) or treatments (chronic use of corticosteroids, bronchodilators, ...) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study
Shift Worker Intervention for Sleep Health

The aim of this study is to pilot test a comprehensive, personalized, media-augmented telehealth intervention ("SWISH") designed to improve sleep health among shift workers.

Night shift nurses with insomnia who meet all study criteria will receive insomnia therapy, modified for shift workers that is designed to improve sleep health among shift workers by targeting shift workers' unique sleep health problems which manifest during both sleep and wake. Participants will be randomized to either SWISH, a multicomponent behavioral intervention based on cognitive behavioral therapy for insomnia that is individually administered via telehealth across approximately weekly sessions that range in length from 30-60 minutes, or delayed treatment control, which will involve weekly assessments but no active treatment until the delay period is over, at which point they will be offered the intervention. The therapy will be conducted over telehealth by interventionists trained in behavioral sleep medicine.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Any gender; Ages 18-65
* Currently employed as a nurse or nursing staff member (e.g., CNA) in the United States
* Currently have shift work schedules (i.e., stable night shift or rotating shifts that include nights, \>=2 nights/week) and have worked shift work \>=2 nights/week for at least 3 months
* Expect to have a shift work schedule \>=2 nights/week over the next 6 months
* endorse poor sleep, as evidenced by T-score \>=60 on the PROMIS Sleep Disturbance OR Sleep-Related Impairment measure
* Have daily access to the internet on a smartphone, table, or computer; and
* Can read and write in English.

Exclusion Criteria:

* Conditions which make study treatment likely to be ineffective. For example, current chronic use of medications that interfere with sleep, alcohol or substance use disorder, or thought disorder (as determined by DIAMOND psychiatric interview), unstable sleep or medical conditions that necessitate additional medical care not provided by study treatments (e.g., known untreated sleep apnea).
* Presence of safety risk or condition in which study participation may result in increased risk to safety (e.g., elevated risk for suicide, self-reported uncontrolled seizure disorder, history of manic or hypomanic episode, current pregnancy),
* Currently receiving non-pharmacological treatment for insomnia (e.g., cognitive behavioral therapy for insomnia) and/or current unstable hypnotic/alerting medication use OR
* Currently participating in other research studies with substantial overlap in terms of methods/procedures (e.g., PI's ongoing study "Piloting an Adaptation of Cognitive Behavioral Therapy for Insomnia for Shift Workers (CBTI-Shift)"
Breaking Down Care Process and Patient-level Barriers to Arteriovenous Access Creation Prior to Hemodialysis Initiation

More than 80% of individuals in the U.S. start maintenance hemodialysis (HD) with a central venous catheter, despite substantial evidence that starting HD with an arteriovenous (AV) access improves quality of life, lowers mortality, and decreases healthcare costs. Health system- and patient-level barriers contribute to low rates of AV access creation prior to HD initiation. Evidence-based, pre-dialysis interventions to improve these low rates and associated clinical outcomes are lacking.

A Vascular Access Navigation and Education Quality Improvement Program will be implemented in the Geisinger Danville, PA chronic kidney disease clinic. Individuals who choose to participate in a research sub-study of the program will complete questionnaires to assess their vascular access care knowledge and confidence before and after participation in the quality improvement program.


Eligibility Criteria:
Inclusion Criteria

Patients:

* Receive care at the Geisinger Danville Nephrology Clinic
* Age ≥ 18 years
* eGFR ≤ 25 mL/min/1.73 m and 2-year kidney failure risk score \>10% based on kidney failure risk equation, or nephrologist recommendation for vascular access
* Participation in the Vascular Access Navigation and Education Quality Improvement Program

Providers: Professional involved in dialysis vascular access care (e.g., nephrologist, surgeon, kidney disease clinic nurse, etc.) at Geisinger in Danville, PA

Exclusion Criteria

Patients:

* Too far into the vascular access creation process to benefit from the intervention (e.g. completed vascular access surgery appointment or has a surgery appointment scheduled within the next 4 weeks),
* Inability to consent, or
* Inability to complete interviews in English

Providers: None
Sleep IntervEntion as Symptom Treatment for ADHD

Up to 72% of adolescents with ADHD portray sleep problems. The most common sleep difficulties in adolescents with ADHD are initial insomnia, nocturnal awakenings, non-restorative or restless sleep. These difficulties seem to be causally related to increased ADHD symptom impairment, oppositional and depressive symptomatology, and functional impairments in daily life, resulting in a vicious circle of sleep problems and impairment. Thus, reducing sleep problems is an important intervention target. However, to date there is no evidence-based cognitive behavioral sleep treatment available. Sleep-focused treatments need adaptation towards this developmental phase/disorder for effectiveness, as ADHD and sleep problems are bi-directional. Therefore, a blended treatment targeting the core deficits integrating motivational interviewing, planning skills and sleep interventions is needed. Thus, the aim of this project is testing the short and 3 months follow-up effectiveness of the blended CBT sleep intervention in adolescents with ADHD.


Eligibility Criteria:
Inclusion Criteria:

1. Attending secondary education and between 13-17 years old
2. prior diagnosis of ADHD (any presentation) and confirmation of DSM-5 criteria of ADHD in current study
3. Displaying sleep problems for at least 3 nights per week for at least 3 months

   1. sleep onset latency of at least 20-30 minutes
   2. and/or wake after sleep onset greater than 30 min
   3. and/or an average sleep time of less than 7 hours
   4. and at least one poor sleep hygiene practice
   5. and experienced distress as indicated by parent/guardian and/or adolescent.
4. estimated IQ≥80
5. stable ADHD medication use at least 4 weeks before start of treatment and no dose or medication type changes planned during active treatment

Exclusion Criteria:

1. the following comorbidities: sleep-breathing disorder, restless leg syndrome, narcolepsy, conduct disorder, depressive disorder with suicide risk or active suicidality, autism spectrum disorder, or substance use disorder, with an exception for nicotine
2. acute crisis situation at home
3. physical problems that interfere with sleep (e.g. pain) or medical disorders and related medication that could affect sleep
4. participation in a behaviorally based sleep intervention in the 6 months prior to our study
5. currently taking pharmacological medication for sleep (including melatonin), anxiety or depression. Participation will be allowed after a two-week wash-out period of the medication
Usability Evaluation of a Portable Oxygen Concentrator

This study evaluates how well an individual can put together and use a Portable Oxygen Concentrator (POC) by following the instructions in the User Manual.

The Belluscura X-PLO2R Portable Oxygen Concentrator (POC) is intended for the provision of supplemental oxygen to patients with chronic pulmonary diseases, such as Chronic Obstructive Pulmonary Disease (COPD), and for a patient requiring supplemental oxygen, as prescribed by a physician. The purpose of this study is to evaluate if the X-PLO2R POC can be used by the intended users without serious errors or problems for the intended use and under the expected use conditions. Specifically, the study is to evaluate if potential users of the device can correctly, safely and effectively set-up, activate and operate the X-PLO2R POC to receive the required supplemental oxygen; if the intended user can understand and apply the information contained in the Belluscura X-PLO2R Quick Start Guide and User Manual; and to identify any and all use difficulties, problems and errors made during device assembly and operation, and to subsequently mitigate each identified instance of use error through device and/or materials modification, and to subsequently evaluate the effectiveness of each modification.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older.
* Male or female.
* Suitable for supplemental oxygen use from a suitably qualified and licensed medical professional.
* Voluntarily signed subject consent form.

Exclusion Criteria:

* Company employee.
* Former human factors study participants.
Facial Patterns and Masticatory Symmetries

The purpose of this study is to evaluate chewing side preference, and lateral asymmetry of occlusal contact area and bite force of individuals with different craniofacial patterns

Dolichofacial subjects presents poorer mechanical advantage, less efficiency in masticatory muscles during mastication and in generating bite force, smaller occlusal contact area and masticatory capacity when compared to brachyfacial individuals.

Wide, bilateral chewing cycles were related to better masticatory performance, however, unilateral chewing was reported to be very common in population, and it has been associated to lateral asymmetry on bite force and occlusal contact area.

It has been reported that dolichofacial subjects need greater muscular effort during mastication when compared to meso and brachyfacial subjects. This may cause functional overloading of weaker masticatory muscles, and may lead to functional asymmetries.

Eligibility Criteria:
Inclusion Criteria:

* Full dentition, good general and oral health

Exclusion Criteria:

* Facial deformities
* Severe malocclusion
* History of signs and symptoms of temporomandibular disorder
* History of parafunctions
* History of maxillofacial surgery or jaw injuries and orthodontic treatment concluded in the last 2 years
Molecular Imaging of Prostate-Specific Membrane Antigen Using Labeled Technetium-99m BQ0413

The study should evaluate the biological distribution of \[99mTc\]Tc-BQ0413 in patients with prostate cancer.

The primary objective are:

1. To assess the distribution of \[99mTc\]Tc- BQ0413 in normal tissues and tumors at different time intervals.
2. To evaluate dosimetry of \[99mTc\]Tc- BQ0413.
3. To study the safety and tolerability of the drug \[99mTc\]Tc- BQ0413 after a single injection in a diagnostic dosage.

The secondary objective are:

1. To compare the obtained \[99mTc\]Tc- BQ0413 SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in prostate cancer patients.

The overall goal is to study the effectiveness of SPECT imaging prostate cancer patients Using technetium-99m labeled BQ0413.

Phase I of the study:

Biodistribution of \[99mTc\]Tc-BQ0413 in patients with prostate cancer.

The main objectives of the study:

1. To evaluate the distribution of \[99mTc\]Tc-BQ0413 in normal tissues and tumors in patients with prostate cancer at different time intervals.
2. To evaluate dosimetry of \[99mTc\]Tc-BQ0413 based on the pharmacokinetic parameters of the drug after a single intravenous administration.
3. To study the safety of use and tolerability of the drug \[99mTc\]Tc-BQ0413 after a single intravenous administration in a diagnostic dosage.

Additional research tasks:

1. To conduct a comparative analysis of the diagnostic information obtained in the visualization of prostate cancer by SPECT using \[99mTc\]Tc-BQ0413 with data obtained by CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) research of postoperative material.

Methodology:

Open-label, exploratory, single centre study. The subjects will receive a single injection of the labeled tracer.

Eligibility Criteria:
Inclusion Criteria:

* Subject is \> 18 years of age
* Clinical and radiological diagnosis of prostate cancer with histological verification.
* White blood cell count: \> 2.0 x 10\^9/L
* Haemoglobin: \> 80 g/L
* Platelets: \> 50.0 x 10\^9/L
* Bilirubin =\< 2.0 times Upper Limit of Normal
* Serum creatinine: Within Normal Limits
* Blood glucose level not more than 5.9 mmol/L
* Subject is capable to undergo the diagnostic investigations to be performed in the study
* Informed consent

Exclusion Criteria:

* Active current autoimmune disease or history of autoimmune disease
* Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening)
* Known HIV positive or chronically active hepatitis B or C
* Administration of other investigational medicinal product within 30 days of screening
* Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
Validation of a Portable Sleep Device in Patients With Co-existing Medical Illnesses

The standard sleep study for diagnosing obstructive sleep apnea (OSA) in patients with co-existing illness is by conducting an attended polysomnography (PSG) with more than 7 channels for recording physiological parameters in the sleep center, as recommended by international guidelines. However the guidelines are more than 10 year old without update. With the growing and aging of the population, there is a need to explore if portable monitoring devices could be used in this group of population, so this group of patients can be managed in a timely manner. Portable monitoring devices have been used widely in patients without significant co-existing illness. These devices record at least 4 physiological parameters for diagnosing OSA and can be performed in an unattended setting e.g. at home because of the simplicity. This can shorten the waiting time for making a diagnosis using PSG.

Eighty patients suspected of OSA, with stable co-existing illnesses, will be recruited for the study. Informed consent will be signed before participation. They will be offered a standard attended PSG in the sleep center. A portable monitoring device "Nox T3" will be hooked up to the patients concurrently during the PSG.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients suspect of OSA (with or without symptoms) of age between 18 to 80 years old, with or without significant comorbidities.
* Patients consent of concurrent use of both type I and or type III devices at the same time in hospital setting.

Exclusion Criteria:

* Pregnant patients.
* Patients refuse to have both type I and type III devices used concurrently.
* Patients with any co-existing medical illnesses which are unstable. "Unstable" is defined as:
* Any recent hospital admission within 1 month before the schedule of sleep study
* Any recent change of medication within 1 month before the schedule of sleep study
* Any change in patient conditions requiring medical attention within 1 month before the schedule of sleep study.
Study to Evaluate the Pharmacokinetics (PK), Safety, and Efficacy of B/F/TAF in Human Immunodeficiency Virus (HIV)-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters

The primary objective of this study is to evaluate the steady state PK of bictegravir (BIC) and confirm the dose of BIC/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed dose combination (FDC) in HIV-1 infected, virologically suppressed pregnant women in their second and third trimesters.


Eligibility Criteria:
Key Inclusion Criteria:

* The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
* With singleton pregnancy, at least 12 weeks but not more than 31 weeks pregnant at the time of screening
* Agree not to breastfeed for the duration of the study
* Currently on a stable antiretroviral regimen for ≥ 6 months preceding the screening visit
* Documented plasma HIV-1 ribonucleic acid (RNA) levels of \< 50 copies/mL for ≥ 6 months preceding the screening visit and have HIV-1 RNA \< 50 copies/mL at the screening visit
* Have no documented or suspected resistance to FTC, Tenofovir (TFV), or integrase strand-transfer inhibitors (INSTIs) including, but not limited to, the reverse transcriptase resistance mutations K65R or M184V/I
* Have a normal ultrasound, completed locally prior to the Day 1 visit, with no evidence of any fetal malformation or structural abnormality affecting either fetus or placenta
* Normal maternal alfa-fetoprotein level at the screening visit

Key Exclusion Criteria:

* Have chronic hepatitis B virus (HBV)
* Have active hepatitis C virus (HCV) infection
* An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Laboratory, Cellular and Molecular Determinants of Clinical Success in Diabetic Patients With Critical Limb Ischemia

The ECAD-CLI is an investigator-driven, prospective, single-center study. The aim of the study is to prospectively collect clinical, laboratory, angiographic, cellular and molecular variables related to prognosis and outcome in patients with diabetes mellitus and critical limb ischemia.

All consecutive patients admitted to Maria Cecilia Hospital will be enrolled in the ECAD-CLI study. According to interventional management of the patient the following data and samples will be prospectively collected and related to outcome:

* medical history, cardiovascular risk factors, clinical presentation
* information related to angiography of peripheral arteries. An independent core-lab will review angiographies to assess extent and severity of peripheral artery disease
* information related to medical treatment, including antithrombotic agents, antimicrobics and any treatment to permit wound healing
* blood sample to obtain DNA, RNA and serum
* patient undergoing surgery and/or debridement for wound/ulcer due to diabetic foot disease will receive biopsy for specimen collection
* atherosclerotic plaque sample in patients undergoing atherectomy for the treatment of the peripheral artery disease All clinical variables and information obtained from blood/tissue samples will be related to outcome.

Any adverse events will be judged by an independent blinded committee.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of diabetes mellitus in treatment with oral agents and/or insulin
* diagnosis of critical limb ischemia requiring medical and/or interventional treatment

Exclusion Criteria:

* dialysis
* diagnosis or suspicion of malignancy
* life expectancy \<1 year
* inability to guarantee clinical follow-up
Mindfulness Based Compassionate Living in Recurrent Depression

Since a few years, Mindfulness Based Cognitive Therapy (MBCT) has been used as treatment for patients suffering from recurrent depression. Though a number of studies show that MBCT is effective in this population and MBCT reduces the chances of relapse/recurrence in recurrent depressive patients, the chance of a new depression developing after end of treatment is still considerable. Ergo, there is room for improvement.

Especially the development of a non-judging or compassionate attitude towards all experience seems to mediate the treatment effect. It is therefore our expectation that a follow-up intervention that focuses specifically on self-compassion could prove very useful in elaborating on the effects of MBCT.

The research question of this research is therefore: what is the effect of compassion training in people suffering from recurrent depression who have already received MBCT training?


Eligibility Criteria:
Inclusion Criteria:

1. Recurrent depression according to the DSM-IV criteria.
2. Having participated in an MBCT training (\>= 4 sessions)

Exclusion Criteria:

1. One or more previous (hypo)manic episodes according to DSM-IV criteria.
2. Primary psychotic disorder, e.g. schizophrenia or delusions.
3. Clinically relevant neurological conditions (e.g. brain trauma or dementia) or somatic conditions (e.g. cancer, AIDS) that could be related to the depression.
4. Current alcohol and/or drug abuse.
5. Use of high dosages of benzodiazepines.
6. Recent electro convulsive therapy (ECT) (less than 3 months ago).
7. Problems impeding participating in a group, such as severe borderline personality disorder.
8. No prior experience with MBCT.
9. Problems impeding completing the questionnaires, such as cognitive dysfunctions (only assessed if suspected).
10. Subnormal intelligence (IQ \< 80) (only assessed if suspected).