cyrilzakka/clinical-trials huggingface dataset:
Bilateral Single-Electrode VO Combined With STN-DBS for Treating Meige Syndrome

Meige syndrome is a rare and debilitating movement disorder characterized by blepharospasm, oromandibular dystonia, and cervical muscle contractions, often refractory to pharmacological therapies. Deep brain stimulation (DBS), initially developed to treat essential tremor and Parkinson's disease, has been explored in recent years as a potential treatment for various dystonias, including Meige's syndrome. This clinical study aims to evaluate the safety and efficacy of bilateral single-electrode ventralis oralis (VO) nucleus stimulation combined with subthalamic nucleus deep brain stimulation (STN-DBS) in patients with Meige syndrome.

While deep brain stimulation (DBS) targeting the subthalamic nucleus (STN) or the globus pallidus interna (GPi) has shown moderate efficacy, incomplete symptom relief and high stimulation thresholds with associated side effects remain significant limitations. Emerging evidence suggests that dual-target neuromodulation combining STN with ventralis oralis (VO) nucleus stimulation may synergistically modulate hyperactive basal ganglia-thalamocortical circuits, potentially enhancing therapeutic outcomes.The study will involve patients diagnosed with Meige syndrome who are eligible for DBS therapy. Participants will be randomly assigned to one of two groups.The primary outcome measure is the improvement in motor symptoms, assessed using the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) before and after treatment. Secondary outcomes will include changes in quality of life, anxiety and depression scores, and any adverse effects related to the DBS procedure.The results of this study will be used to guide future clinical trials and inform the treatment options for patients with Meige syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Must meet the clinical diagnostic criteria for Meige syndrome
* Only includes patients with: Blepharospasm-type Meige syndrome and Blepharospasm with lower jaw muscle dystonia-type
* All patients must have undergone at least one year of systematic and standard treatment prior to surgery

Exclusion Criteria:

* History of neurological diseases other than Meige syndrome
* Severe cognitive impairment
* Severe psychiatric disorders
TIPOPS (Telemedicine vs In Person Oncology Patient Surveillance)

This research study is comparing telemedicine and face-to-face visits to understand patients' experiences with telemedicine versus face to face visits and to understand when it is and is not appropriate to conduct visits remotely

This study is a prospective randomized trial of telemedicine (TM) versus face-to-face (F2F) visits for follow up care of patients with either early-stage breast or prostate cancer.

This study does not involve investigational drugs or devices but does involve survey data collection from participants about their experiences of care.

After an initial in-person routine visit, participants will be randomly assigned to either telemedicine or face-to-face care delivery for their next routine visit.

It is anticipated participants will be in the study for about 6 months depending on the timing of their routine care appointments.

It is expected that 360 people will take part in this research study

Eligibility Criteria:
Inclusion Criteria:

* For breast cancer participants: Early-stage breast cancer defined as Stages I-IIIA at diagnosis or localized prostate cancer defined as Stages I-III
* For breast cancer participants: participant has completed definitive treatment for early stage breast cancer including surgery, radiation, chemotherapy, anti-HER2 antibody treatment. Participant may or may not be taking oral anti-estrogen treatment such as tamoxifen or an aromatase inhibitor
* For prostate cancer participants: participant is on active surveillance or has undergone definitive surgery for localized prostate cancer
* Participant is on a surveillance follow up visit schedule occurring at every three to seven month intervals
* Willingness and ability to use Patient Gateway portal
* Participant has access to an electronic device that can support a video and audio virtual visit platform (for example, laptop computer, desktop computer, smart phone)
* Participants can be women or men
* Age ≥ 18 years

Exclusion Criteria:

* Patients whose next visit requires cytotoxic chemotherapy, radiation therapy, anti-HER2 antibody therapy or investigational cancer agents are ineligible
* Patients with distant metastatic breast cancer
* Patients with locally advanced or metastatic prostate cancer
* Patients treated by radiation therapy for prostate cancer
* Patients whose next visit requires a prostate biopsy
* Prisoners
* Non-English speaking patients (non-English speaking patients will be excluded from the trial given the challenges of delivering telemedicine with the use of medical interpreters. There are also logistical challenges in obtaining the study endpoints, which are largely survey based, with non-English speakers as well as the possibility that study endpoints will be influenced by the presence of a medical interpreter during a visit).
Severe Cutaneous Adverse Reactions in Thailand

The multicenter registry of patients with severe cutaneous adverse reactions among tertiary medical institutes in Thailand to study clinical characteristics, etiologies, therapeutic outcomes, quality of life, and the values of in vitro drug allergy diagnosis for the confirmation of the causative drugs

Patients with severe cutaneous adverse reactions (Steven-Johnson Syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis, and generalized bullous fixed drug eruption) among six tertiary medical institutes in Thailand will be recruited to study clinical characteristics, etiologies, therapeutic outcomes, quality of life, and the values of using laboratory techniques for the confirmation of the causative drugs

Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilled criteria of probable or definite cases of SJS, TEN, DRESS, or AGEP according to RegiSCAR validation criteria as well as patients diagnosed with GBFDE

Exclusion Criteria:

* Patients later confirmed to have other diagnosis than diseases mentioned above or have no sufficient data for the registry
Effect of Sildenafil for Sustained PAH After MV Surgery (SUPERIOR Trial)

The purpose of this study is to determine whether Sildenafil is effective in the treatment of sustained pulmonary artery hypertension after corrected mitral valve disease.


Eligibility Criteria:
Inclusion Criteria:

* New York Heart Association Functional class (NYHA Fc) ≥ 2 dyspnea which was sustained till one year after the previous mitral valve surgery (repair or replacement)
* TR Vmax ≥ 3.5m/s by echocardiography
* Normal left ventricle ejection fraction (EF ≥ 50%)
* Pulmonary vascular resistance ≥ 3 Wood Unit or diastolic pressure gradient ≥ 7mmHg by cardiac catheterization

Exclusion Criteria:

* Other valve disease more than moderate degree (ex. aortic stenosis, aortic regurgitation)
* Liver cirrhosis
* Chronic renal failure with serum creatinine ≥ 1.7mg/dL
* Lung disease (ex. chronic obstructive pulmonary disease, Asthma)
* Thyroid dysfunction
* Other causes which can lead to pulmonary hypertension
HBRN: Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B

This is an ancillary to the NIDDK-sponsored treatment trials titled: Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B (NCT01369212) and Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B (NCT01369199).

This study will examine the balance between immune regulatory and effector responses in hepatitis B-infected participants enrolled in the HBRN's clinical trials (NCT01369212 and NCT01369199) to define natural history and treatment outcome.

Aim 1. Therapeutic HBV suppression will enhance antiviral immune effector responses and reduce immune inhibitory factors in participants with chronic hepatitis B. This study will also examine if antiviral therapy has a durable effect in host immune phenotype and define the immunological effect of interferon-alpha (IFNα) therapy in chronic HBV participants.

Aim 2. Antiviral immune effector and regulatory responses before, during and/or after therapy can predict long term therapeutic response.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent for participation in the ancillary study

Exclusion Criteria:

* Children under 18 years of age
* Pregnant women
* Participants with anemia (Hgb\<10 or Hct\<30)
* Participants with active medical conditions such as congestive heart failure or chronic lung disease requiring oxygen, active coronary artery disease with unstable angina, sepsis and renal failure
* Participants with significant medical conditions, autoimmune disease or immunosuppression
Phase II Study of Sorafenib + Carboplatin and Docetaxel in First Line Treatment of Stage IIIB/IV NSCLC

This is an open-label, single institution, phase II study of Sorafenib in combination with docetaxel and carboplatin in patients with advanced non-small cell lung cancer. Docetaxel and carboplatin will be given on day 1 of every three week cycle. Patients will take Sorafenib twice a day on the 1st day of treatment and continue to take the medication every day until progression of disease, prohibitive toxicity, or patient withdrawal from the study. Chemotherapy courses will repeat every 21 days in the absence of disease progression or unacceptable toxicity for a total of four cycles.

Patients will be monitored after every two cycles (6 weeks) for tumor response, stability, or progression by radiographic imaging studies. The primary goal of this study is to determine the clinical response rate of this regimen in patients with advanced lung cancer. Secondary endpoints include time to progression, overall survival, and toxicity. Blood levels of ERK-phosphorylation, activated caspase 3, cyclin D1, anti -cIAP2, p-Akt, and Mcl1 activity will be measured at the beginning, middle and end of therapy to help identify predictors of drug response and toxicity during the first cycle of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed NSCLC with clinical or radiological evidence of advanced disease (Stage IIIB/IV)
* Uni-dimensionally measurable disease
* Age =\> 18 years
* ECOG performance status of 0-1
* Life expectancy \> 3 months

Exclusion Criteria:

* Small-cell or mixed histologies including a small cell component
* Prior chemotherapy, biotherapy, radiotherapy to an area of measurable disease
* Patients with peripheral neuropathy grade =\> 2
Rivaroxaban Estimation With Warfarin in Atrial Fibrillation Patients With Coronary Stent Implantation Study (REWRAPS)

Antiplatelet therapy is indispensable for the prevention of stent thrombosis in patients who underwent coronary artery stenting. Similarly, anticoagulant therapy is essential for the prevention of cardiogenic embolism including cerebral infarction in AF patients. However, the combined antithrombotic therapy has been reported to increase the risk of major bleeding for AF patients after coronary stenting, New anticoagulant drugs that hardly interact with other drugs and do not need frequent blood tests have become commonly used. The purpose of this study is to assess the hypothesis that Rivaroxaban is non-inferior to Warfarin in the efficacy and safety for AF patients after coronary stenting


Eligibility Criteria:
Inclusion Criteria:

Clinically stable atrial fibrillation (AF) patients who underwent coronary artery stenting more than one year ago and are treated or are scheduled to be treated with anticoagulant drug (regardless of the type of stents and AF).

Those who are willing to cooperate with us in the study. Those who can sign the informed consent document that is approved by the ethics committee of the medical institution participating in the study.

Exclusion Criteria:

Those in whom the package inserts state anticoagulant drugs are contraindicated for use Those who are scheduled to undergo percutaneous coronary intervention or catheter ablation for AF. Those who have to continuously undergo dual antiplatelet due to a past history of stent thrombosis during the distant stage after stenting. Those who have undergone prosthetic valve replacement for valvular disease. Those who the physician in charge judges are ineligible for the study due to serious pathological conditions. Those who are not willing to participate in the study.
Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule

This is a booster study in 2 groups of healthy children less than 3 years old to measure the reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine, when given as a booster or as a two-dose catch-up vaccination.

This protocol posting deals with objectives and outcome measures of the booster phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00338351).

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

Eligibility Criteria:
Inclusion Criteria:

* Male or female between, and including, 18-21 months of age at the time of vaccination.
* Subjects who previously participated in the primary study and received 3 doses of study or control vaccines during the primary study.
* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
* Written informed consent obtained from the parent or guardian of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the booster doses of study vaccines, or planned use during the study period (active phase and extended safety follow-up).
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month (30 days) before the booster doses of vaccine(s) and during the active phase of the study (up to the follow-up visit (Visit 3)).
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
* Acute disease at the time of enrolment.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster doses of study vaccines.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* A family history of congenital or hereditary immunodeficiency.
* Major congenital defects or serious chronic illness.
* Administration of immunoglobulins and/or any blood products within the last 3 months prior to booster or follow-up vaccination or planned administration during the active phase of the study.
Exercise Training and Glucose Metabolism in Aging

Diabetes and its associated complications affect more than 20 million Americans, and the prevalence of type 2 diabetes and impaired glucose tolerance rises dramatically with age such that 40% of Americans over age 60 are affected. In older adults, glucose metabolism may be affected by reduced skeletal muscle capillary supply, which limits insulin, glucose, and oxygen delivery to skeletal muscle. Reduced capillary supply to skeletal muscle is found in older individuals with impaired glucose tolerance and we hypothesize that this is due to reduced vascular growth factor expression, and chronic inflammation. Further, we hypothesize that reversal of a sedentary lifestyle through aerobic exercise training will increase insulin signaling and vascular growth factor expression, as well as decrease inflammation, to increase capillary supply to skeletal muscle, which contributes to improved glucose metabolism in older adults. This study will: 1) Determine the mechanisms underlying reduced skeletal muscle capillarization in older adults with impaired glucose tolerance; and 2) Determine the effect of aerobic exercise training-induced increases in skeletal muscle capillarization on glucose metabolism in older adults.


Eligibility Criteria:
Inclusion Criteria:

* Age 50-75 years
* Non-smoker \>2 years
* Body mass index = 18-35 kg/m2

Exclusion Criteria:

* History of CAD or cerebrovascular disease that would preclude exercise
* Implantable defibrillator
* Active cancer
* Chronic pulmonary, thyroid, renal, liver, or hematological disease
* HIV positive or prone to malnutrition
* Sickle cell anemia
* Type 1 diabetes, or currently on medication to treat type 2 diabetes
* Poorly-controlled type 2 diabetes
* Poorly-controlled hypertension
* Taking medications including: beta-blockers, oral steroids, warfarin, certain statins, hormone replacement therapy (HRT), oral contraceptives (OCP), thiazolidinediones (TZD), or chronic steroids or nonsteroidal analgesics (NSAIDS) that may not be safely discontinued temporarily for specific procedures (i.e. for 72 hours prior)
* Allergic to lidocaine or heparin
* Recent weight change (\>5kg in 3 months)
* Currently pregnant or nursing
* Physical impairment limiting exercise
* Dementia or unstable clinical depression
A Randomized Controlled Trial Assessing the Efficacy of Lianhua Qingwen as an Adjuvant Treatment in Patients With Mild Symptoms of COVID-19

COVID-19 virus remains in infected patients for extended periods of time. A great resource burden is placed on the healthcare system and society at large to isolate COVID-19 patients for prolonged periods. Thus, being able to increase the rate of viral clearance, thus reducing the duration of COVID-19 infection, would allow patients to be discharged earlier to free up resources for those who require it. The investigators designed a randomized controlled trial, investigating the use of Lianhua Qingwen, a TCM treatment, in COVID-19 infected patients with mild symptoms. The investigators hypothesize that the use of Lianhua Qingwen will increase the proportion of patients who test negative for COVID-19 after 8 days of TCM treatment when compared to the group of patients provided with standard care and placebo. Patients will be recruited from community isolation facilities, and have onset of symptoms within 5 days prior to admission to the isolation facility. The trial also evaluates the time taken for relief of clinical symptoms associated with COVID-19 and assesses the safety of the TCM treatment given to patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥21 years
2. Positive laboratory test for COVID-19 by RT-PCR methods
3. Presenting with at least one symptom (symptoms include fever, dry cough, sore throat, nasal congestion, malaise, headache, muscle pain, anosmia, and diarrhoea)
4. Length of time between date of onset of symptoms and the date of recruitment should not exceed 5 days to ensure that trial participants are in the early stages of infection
5. No clinical or radiographic evidence of pneumonia
6. Able to provide informed consent

Exclusion Criteria:

1. Individuals with underlying primary diseases such as cardiovascular, respiratory, liver, renal, diabetes, hepatitis A/B/C, gout or endocrinological diseases and neurological disorders which put them at a higher risk of developing severe disease
2. Individuals with compromised immune systems such as malignant tumors, organ or bone marrow transplants, HIV, or have taken immunosuppressants in the past three months.
3. Women who are pregnant or on lactation.
4. Individuals with mental illness.
5. History of allergy to any drug or food, or herb ingredient observed in this trial.
6. Individuals who are deemed not able to comply with trial procedure or follow-up
Effect of Short-term Oxygen During CPET in GUCH

In a randomized, sham-controlled crossover trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with grown-up congenital heart disease.


Eligibility Criteria:
Inclusion Criteria:

* GUCH, stable medication for at least 4 weeks.

Exclusion Criteria:

* instable status, pregnancy, clinically relevant concomitant diseases, inability to follow the study procedures
The Effect of Essential Oil Inhalation Patches on Perceived Burn-out & Stress on an Inpatient Medical-surgery Unit.

The purpose of this clinical study is to compare the use of an essential oil inhalation patch in medical surgical nurses on perceived burn-out and stress.

The main question is can essential oil inhalation patches decrease perceived burn-out and stress.

Participants will

* Take part in the study over 30 days, alternating weeks, resulting in each participant using six patches over six shifts.
* Complete anonymous Perceived Stress Survey (PSS) before the study begins and at the conclusion of the study.
* Participants will also complete a (different) survey after two weeks.

Essential Oil inhalation patches are a nonpharmacological option that is worn by the nursing staff on an inpatient medical-surgical unit to determine the efficacy of patch on staff perceived stress \& burn-out levels. Each participant will wear a new patch during six work shifts. Location is on chest or the ID badge area where it can be easily accessed to. The patch provides up to 8 hours of aromatic support. The patches use a unique patented technology that slows the release of the aromatic molecules while maintaining the purity and vitality of the essential oil. The FDA approved medical adhesive patches are roughly 1x1" in size, and are inhalation only- no contact of essential oils on skin. The patch is portable and discreet. No overwhelming aroma for others. The patch has directions for use on package with an expiration date. Used for a non-specific purpose for stress reduction environment for this study.

Eligibility Criteria:
Inclusion Criteria:

* Full time employee (Nurse, LPN, or LNA) working on L3WD and L4WC
* At least 18 years of age

Exclusion Criteria:

* Pregnant/breastfeeding or planning to become pregnant