cyrilzakka/clinical-trials huggingface dataset:
8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding

The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm expanded polytetrafluoroethylene(ePTFE)-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.

For the prevention of recurrent esophageal variceal bleeding, previous clinical studies and meta-analysis show that patients treated with transjugular intrahepatic portosystemic shunt (TIPS) have lower rebleeding rates compared with endoscopic therapy. However, TIPS is associated with higher rates of portosystemic encephalopathy and does not show survival benefit. TIPS with a small-diameter may achieve sufficient portal decompression and reduce the incidence of hepatic encephalopathy. The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm ePTFE-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.

Eligibility Criteria:
Inclusion Criteria:

1. Cirrhosis
2. Patients who had bled from esophageal varices (≥5days and ≤28days)
3. Child-Pugh B or Child-Pugh C≤13

Exclusion Criteria:

1. THE presence of gastric varices
2. Non-cirrhotic portal hypertension
3. Portal vein thrombosis
4. The history of hepatic encephalopathy
5. Total bilirubin ≥51.3 umol/L
6. Previous treatment of TIPS or surgery
7. Proven malignancy including hepatocellular carcinoma
8. Contraindications to TIPS、EVL or propranolol
9. End-stage renal disease under renal replacement therapy;
10. Cardiorespiratory failure
11. Pregnancy or patients not giving informed consent for endoscopic procedures
Impact of Surgical Management for Relapse After Conversion Hepatectomy for Initially Unresectable Colorectal Liver Metastasis

For patients with initially unresectable colorectal liver metastasis (IU-CRLM) receiving effective conversion therapy, disease relapse after conversion hepatectomy is common due to the extensive tumor load. Yet, few studies have focused on the assessment and management of relapse after conversion hepatectomy for IU-CRLM. This study aimed to investigate the impact of surgical management for relapse after conversion hepatectomy in IU-CRLM.


Eligibility Criteria:
Inclusion Criteria:

* initially unresectable colorectal liver metastasis (IU-CRLM)
* received conversion therapy
* underwent conversion hepatectomy

Exclusion Criteria:

* the histologic type of CRLM was not called adenocarcinoma
* uncontrollable extrahepatic metastases, such as peritoneal, bone, brain metastasis
* history of previous hepatectomy
* the primary tumor was not resected or palliative resection
* R1 or R2 liver resection
A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)

The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.


Eligibility Criteria:
Inclusion Criteria:

* Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy.
* Confirmed diagnosis of ER positive breast cancer
* No prior systemic anti-cancer therapy for advanced ER+ disease.
* Postmenopausal women
* Measurable disease as per Response Evaluation Criterion in Solid Tumors \[RECIST\] or bone-only disease
* Eastern Cooperative Oncology Group \[ECOG\] 0-2
* Adequate organ and marrow function
* Patient must agree to provide tumor tissue

Exclusion Criteria:

* Confirmed diagnosis of HER2 positive disease
* Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
* Known uncontrolled or symptomatic CNS metastases
* Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ≤ 12-months from completion of treatment.
* Prior treatment with any CDK 4/6 inhibitor.
4Hz Transcranial Alternating Current Stimulation for Patients With Mild Alzheimer's Disease

The goal of this study is to explore the efficacy and safety of 4Hz transcranial alternating current stimulation (tACS) in patients with mild Alzheimer's disease (AD). The study will recruit 40 individuals with mild AD, and the participants will be randomized to either a 4 Hz tACS group or a sham stimulation group. Both groups will undergo 30 one-hour sessions across 3 weeks (21 days). At the end of the intervention and 3-month follow-up, all subjects will repeat the baseline assessments.

Background: Recently, transcranial alternating current stimulation (tACS), which could interact with ongoing neuronal activity, has emerged as a potentially effective and promising treatment for Alzheimer's disease (AD), and the 4Hz frequency was suggested to improve working memory Methods: The proposed study is a double-blinded, randomized controlled trial that will include 40 individuals with mild AD, and the participants will be randomized to either a 4Hz tACS group or a sham stimulation group. Both groups will undergo 30 one-hour sessions in 3 weeks (21 days). The outcome measures will be assessed at baseline, end of intervention and 3 months after the first session. Primary outcome is global cognitive function, assessed by the 11-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog), and the second outcomes include changes in other neuropsychological assessments, structural MRI, resting electroencephalogram (EEG) and simultaneous EEG-functional MRI (fMRI).

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with informed consent;
2. 45-75 years of age;
3. At least 6 years of education;
4. AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) guidelines;
5. Clinical Dementia Rating Scale (CDR)=1.0;
6. Positive findings in amyloid PET imaging or amyloid protein levels in CSF;
7. On a stable dose of cholinesterase inhibitors (e.g. donepezil or rivastigmine) as defined as 6 consecutive weeks of treatment at an unchanging dose, and without any intentions to modify the dosage during the observation period.

Exclusion Criteria:

1. Current or past history of any neurological disorder other than dementia, such as epilepsy, stroke, progressive neurologic disease (e.g. multiple sclerosis), poorly controlled migraines or intracranial brain lesions; and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment;
2. Contraindication for undergoing MRI or receiving tACS;
3. Eczema or sensitive skin;
4. Familial AD;
5. Depression or other psychiatric disorders;
6. Abnormal brain structural magnetic resonance imaging (MRI) scan, including hydrocephalus, stroke, structural lesions, etc. that would potentially confound the outcome;
7. Severe cardiovascular/pulmonary disorders;
8. Other conditions, in the investigator's opinion, might not be suitable for the study.
Reducing Asthma Disparities by Improving Provider-Patient Communication

The purpose of this study will be to assess the impact of a culturally-sensitive, patient-focused asthma communication instrument (ACCI) designed to enhance provider-patient communication by prompting and guiding providers in assessments of disease severity and discussion of adherence behaviors with minority patients with asthma.

Improving communication between health care providers and their patients is the critical first step in efforts designed to reduce asthma-related health disparities in urban areas. Improving communication will help providers tailor asthma therapies to their patients' needs, and help providers and patients to overcome barriers (e.g., concerns about adverse effects) to adherence with those asthma treatment plans.

Eligibility Criteria:
Inclusion Criteria:

* are able to provide informed consent;
* report physician-diagnosed asthma;
* report asthma symptoms and/or use of short-acting reliever medication at least twice weekly in the past month.

Exclusion Criteria:

* state they do not have asthma;
* have mild intermittent disease
* no recent evidence of disease activity.
In-vivo Efficacy Study of Patient Pre-operative Preps

The purpose of this study is to determine the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

The primary efficacy is evaluated by demonstration that the product provides a lower bound of the 95% confidence interval of percent responders that is greater than or equal to 70%.

On the abdominal sites, a responder is defined as a subject with a 2-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

On the inguinal sites, a responder is defined as a subject with a 3-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of any race
* Subjects in good general health
* Minimum skin flora baseline requirements on abdomen and groin

Exclusion Criteria:

* Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test areas
* Topical antimicrobial exposure within 14 days prior to screening and treatment days
* Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days
Deprescribing in Patients Living with Dementia with Caregiver and Provider Nudges

The objectives of this study are to demonstrate the feasibility of implementing a deprescribing nudge intervention using pragmatic methods, confirm that outcomes can be feasibly measured and evaluated at scale in a subsequent embedded pragmatic clinical trial (ePCT), and explore representativeness of persons living with dementia and care partners identified.

The PCP nudge will consist of: a 'pre-commitment' EHR nudge triggered when a PCP opens a patient encounter (i.e., prompt to first have a discussion and then later deprescribe) and a brief message within the in-basket prior to upcoming visits including information about their patient. The patient living with dementia (PLWD)/care partner nudge will include an electronic message delivered prior to upcoming visits (in their primary language recorded in the EHR) that includes a recommendation for the PLWD (and care partner, if available) to discuss medications with the PCP at the visit.

Eligibility Criteria:
Primary care providers will be the primary unit of identification and randomization.

Primary care providers inclusion criteria:

* Providers within Brigham and Women's Hospital primary care practices
* Having prescribed at least one of the high-risk medications of interest

Eligible patients will be identified through this providers within the health care system.

Patient inclusion criteria:

* At least 65 years of age
* Prescribed at least 90 pills of one of the high-risk medications of interest in the last 180 days in the EHR system, which most guidelines consider chronic use, and have a diagnosis of dementia in the EHR.
Local Study of Akatinol Memantine in VaD in Russia

The study evaluates the clinical efficacy and safety of Akatinol Memantine 20 mg (single-doses) vs. Akatinol Memantine 10 mg (double-doses) in patients suffering from moderate and moderately severe vascular dementia.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from the patient or his/her legal representative if the patient is declared incapable by a court decision.
* Understanding of study procedures and willingness to abide to all procedures during the course of the study by the patient or his/her legal representative.
* Male and female patients from 50 to 85 years of age (inclusive) suffering from moderate and moderately severe vascular dementia.
* Mini-Mental State Examination (MMSE) Test total scores of 10 to 20.
* Hachinski's Ischemic Score (HIS) of 7 or higher point.
* Availability in the anamnesis of instrumental confirmation of the diagnosis (data methods of neurovisualization - CT or MRT).
* For females: menopause or inability to conceive due to other reasons (hysterectomy, etc.).
* Availability of a relative or legal representative who lives with the patient, monitors him/her and cares for the patient.

Exclusion Criteria:

* Alzheimer's disease or secondary types of dementia.
* Epilepsy, seizures, schizophrenia, other psychoses, bipolar disorder, alcoholism, drug abuse (including the history thereof).
* Other clinically significant neurological or psychiatric disorders.
* Severe depression (Hamilton score, HAM-D \> 18 points).
* Severe, unstable or decompensated physical disease (including clinically significant laboratory abnormalities) potentially affecting the trial findings.
* Contraindications to oral drug intake during the time period determined by the study protocol.
* Known hypersensitivity to the investigational product or any of its ingredients.
* Administration of nootropic, anti-dementia and typical antipsychotic drugs, tricyclic antidepressants, long-acting benzodiazepines, NMDA receptor antagonists (amantadine, ketamine, dextromethorphan) for 1 month before the enrollment and during the study.
* For females: pregnancy and breastfeeding.
* Evidence or suspicion that the patient might not comply with the study directive.
* Any reason or contraindication which in the investigator's opinion precludes participation in the study.
* Patient is direct relative of an employee of the study site or Merz Pharma LLC.
* Previous participation in this clinical study.
* Participation in another clinical trial within the last 12 weeks prior to screening or ongoing participation in a study.
An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Routine Care

The HS-1000 device, an investigational intracranial monitoring device, has the potential to safely and quickly diagnose and assess stroke (and potentially other neurologic conditions) with minimal discomfort to patients. HS-1000 has the capability to establish cerebral hemodynamic measurements in suspected stroke within minutes, assist with appropriate management of stroke, and also provide an objective diagnostic tool for clinicians to monitor recovery.

A prospective study will be conducted on patients with suspected stroke and/or acute neurologic changes treated at the Armenia Republican Medical Center. Male and Female patients over the age of 18 will be eligible for enrollment into the study. Eligible patients or their legally authorized representative (LAR) will be approached for consent to participate in the study. An initial recording session using the HeadSense HS-1000 device will be obtained upon admission to the hospital. During the admission, 2-4 additional recording sessions with the HS-1000 will be completed.

The end-point of the study is to collect up to 30-minute recording with up to 5 sessions of adequate quality for analysis from up to 200 subjects. This data will be correlated with clinical findings obtained during the patient's diagnosis and treatment course. An ease-of-use questionnaire will be administered to the HS-1000 device operator(s) to obtain information regarding the function and workflow aspects of using the HS-1000 in an acute setting to improve assessment, diagnosis and treatment after stroke. The data obtained from the HS-1000 recordings will be analyzed to establish specific waveform patterns correlated with brain physiology after stroke.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, \> 18 years of age
* Subjects with suspected stroke and/or acute neurologic changes admitted to Armenia Republican Medical Center
* Subject or legally authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol
* Subject or legally authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study

Exclusion Criteria:

* Local ear infection
* Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
* Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
* Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g., mental condition)
Visual Outcomes and Patient Satisfaction With Implantation of the Clareon Monofocal IOL With the New Clareon Manual Monarch IV IOL Delivery System

To evaluate visual outcomes, in-the-bag placement and patient satisfaction in patients implanted with either Clareon monofocal or Clareon monofocal toric IOLs with the Monarch IV inserter and targeted for emmetropia.

This study is a single-arm clinical evaluation study of visual performance and patient satisfaction, after successful bilateral cataract surgery. Subjects will be assessed pre- operatively, operatively and at 1 month and 3 months post-operatively. Clinical evaluations will include measurement of bilateral visual acuity, manifest refraction, and IOLSAT questionnaire.

Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes.

* Adult cataract surgical patients over the age of 45 with visually significant bilateral cataracts (glare visual acuity 20/40 or worse with BCVA testing), with planned cataract extraction using phacoemulsification, clear corneal incision and Clareon monofocal or Clareon toric with Monarch IV.
* Able to provide written informed consent for participation in the study.
* All eyes will be in the range of availability for Clareon monofocal and Clareon toric with Monarch IV.
* Expected visual potential of 20/25 Snellen (0.10 logMAR) or better in each eye.

Exclusion Criteria:

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* Visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery.
* History of neovascular AMD, diabetic macular edema, unstable proliferative diabetic retinopathy, geographic atrophy, branch retinal artery or branch retinal vein occlusion, central retinal artery or central retinal vein occlusion, moderate to severe epiretinal membrane, severe dry eye.
* History of intraocular infection including HSV keratitis, VZV keratitis, endophthalmitis.
* History of previous ocular surgery, including corneal refractive surgery, eye trauma or retinal detachment surgery.
* History of rheumatoid arthritis, ocular cicatricial pemphigoid, or Steven's Johnson Syndrome.
* History of glaucoma.

The principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD)

The primary purpose of this study is to evaluate the pharmacokinetics and safety of Zuranolone in adolescents (ages 12 to 17 years) with MDD.

This study was previously posted by Sage Therapeutics. In December 2024, sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Inclusion Criteria:

* Participant meets Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime DSM-5 (KSADS-PL DSM-5) criteria for MDD.
* Participant has a Children's Depression Rating Scale-Revised (CDRS-R) total score greater than or equal to 40 at screening and Day 1.
* Participant's parent/caregiver is able to attend all scheduled study visits, oversee administration of study drug and complete assessments per the protocol.
* Participant has a body weight greater than or equal to 20 kg and a body mass index greater than fifth percentile and less than ninety-fifth percentile for age at Screening.
* Participant is a post-pubertal (has experienced menarche) female (sex assigned at birth), 12 to 17 years of age, inclusive, at the time informed consent/assent is obtained.

Exclusion Criteria:

* Participant has a history of psychosis, bipolar disorder, autism, seizures, or other restricted comorbid psychiatric or neurological conditions and has treatment-resistant depression.
* Participant has a known diagnosis of intellectual disability or is unable to communicate with the study investigator or research team.
* Participant has a history of suicidal behavior or is currently at risk of suicide in the opinion of the investigator.
* Participant has a recent history of Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) alcohol or drug use disorder or has clinically significant alcohol or drug misuse as judged by the investigator.

Note: Other protocol-defined inclusion/exclusion criteria may apply.
Effects of Non-invasive Brain Stimulation in Impulse Control Disorders

The goal of this project is to study the effect of noninvasive brain stimulation on decision-making and on brain activity in impulse control disorders.


Eligibility Criteria:
Inclusion Criteria:

* Impulse control disorders according to DSM-IV criteria

Exclusion Criteria:

* Other psychiatric disorders
* Contraindication to Non-invasive brain stimulation and MRI
Genetic Variation in the Transporters and Hypoglycemic Agents

Type 2 diabetes have become a major global health problem. Currently, metformin is used as first-line therapy in combination with lifestyle changes, and sitagliptin can be added to metformin in case of insufficient glycemic control by metformin alone, and fixed-dose combination of sitagliptin and metformin is available.

In clinical practice, inter-individual variations in response to sitagliptin and metformin treatment are commonly found, which may reflect inter-patient differences in disposition of these medications.

Sitagliptin and metformin are known as substrates of some transporters (P-gp, OAT3, OCT1 and OCT2) and some functional variations of these transporters were reported. This study is designed to clarify the effect of these transporter variants on response to sitagliptin and metformin in type 2 DM patients.


Eligibility Criteria:
Inclusion Criteria:

* Newly Diagnosed Type 2 Diabetes Patients
* 20-80 years old
* Taking sitagliptin and metformin for more than 3 months

Exclusion Criteria:

* Taking other oral hypoglycemic agents
* Taking medications can induce or inhibit transporters