cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Edoxaban in Thoracoscopic Ablation

The aim of this study is to compare the safety and efficacy of edoxaban and warfarin for prevention of stroke during a 6-month follow up after total thoracoscopic ablation.

In Korea, 5% of patients older than 65 years and 10% of patients older than 80 have a history of atrial fibrillation (AF), which is often associated with sudden death and stroke. Medication and percutaneous radiofrequency catheter ablation are commonly used treatment modalities. Pharmacotherapy is primarily symptomatic treatment; moreover, the effect of conversion to a normal rhythm is minimal, and mainly aimed at stabilizing heart rate. Catheter ablation is associated with a high incidence of recurrence in chronic AF, and it is difficult to treat left atrial appendage, thereby preventing discontinuation of anticoagulation therapy post procedure. Thoracoscopic ablation is known to be a less invasive and more effective modality to treat patients with chronic atrial fibrillation. However, anticoagulation therapy is mandatory in the early postoperative period due to intracardiac thromboembolism associated with atrial stunning despite conversion to a sinus rhythm and resection of the left atrial appendage. Further investigation would be required to assess the efficacy and safety of novel oral anticoagulants such as edoxaban compared to that of warfarin for stroke prevention during the early postoperative period (6 months) after a thoracoscopic procedure. The need to maintain a constant level of blood coagulation and the potential development of complications such as hemorrhages are drawbacks associated with the use of warfarin. While novel oral anticoagulants such as edoxaban do have a role in atrial fibrillation, data regarding their effectiveness and incidence of complications after arrhythmia surgery do not exist. In this study, we will compare warfarin and edoxaban with respect to safety and efficacy, after they are used for 6 months following thoracoscopic ablation in patients with chronic atrial fibrillation

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years or older (not exceed 80 years old).
2. Elective thoracoscopic ablation.
3. Presence of atrial fibrillation (paroxysmal, persistent, long-standing persistent).

Exclusion Criteria:

1. Chronic obstructive pulmonary disease (COPD).
2. History of pulmonary tuberculosis.
3. Other cardiac comorbidities including valvular disease, coronary artery disease.
4. Congenital heart anomalies except for atrial septal defect.
5. Known, clinically important anemia or thrombocytopenia.
6. Pregnancy or lactation.
7. Malignancy.
8. Intracardiac mass or thrombus
9. Life expectancy less than 1 year.
Observational Study for Non-motor Symptoms and Treatment in Parkinson's Disease Patients

This study is implemented to identify factors having an impact on improvement or exacerbation of non-motor symptoms, to provide information contributing to development of medical care in this field and improvement of patients' QOL, and to clarify the association between the use of istradefylline and non-motor symptoms or QOL.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have wearing off under treatment with levodopa-containing drugs administered at least three times daily
* Patients who have at least one non-motor symptom as a complication
* Patients at least 20 years of age at the time of consent
* Patients who have given written consent
* Patients who are receiving outpatient care

Exclusion Criteria:

* Patients with dementia or a score of 23 or less on the Mini-Mental State Examination (MMSE)
* Patients, in the opinion of the investigator or subinvestigator, having conditions impairing the proper assessment of the MDS-UPDRS or PDQ-8 (e.g., patients who are receiving treatment for malignant tumor)
Bryostatin-1 in Treating Patients With Recurrent Non-Hodgkin's Lymphoma

Phase II trial to study the effectiveness of bryostatin-1 in treating patients with recurrent non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

OBJECTIVES:

I. Determine the response to bryostatin 1 (BRYO) administered weekly for 3 weeks in patients with relapsed non-Hodgkin's lymphoma.

II. Assess the toxic effects of this treatment. III. Establish the correlation between PKC isoenzyme activity and BRYO function in lymphoma cells and normal lymphocytes.

IV. Determine the pharmacokinetic profile of BRYO and its relationship to pharmacodynamics.

OUTLINE:

Single-Agent Chemotherapy/Differentiation Therapy. Bryostatin 1, BRYO, NSC-339555.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed non-Hodgkin's lymphoma
* Working formulation low-, intermediate-, and high-grade histologies eligible
* Mantle cell and marginal zone lymphoma eligible
* Relapse after at least 1 doxorubicin-containing regimen required
* No more than 2 prior chemotherapy regimens
* One prior biologic therapy in addition to the 2 prior chemotherapy regimens allowed
* No prior bone marrow transplantation
* Ineligible for treatment on higher priority protocols
* Patients eligible for bone marrow transplantation may be treated to reduce tumor bulk
* Bidimensionally measurable disease required
* No history of primary or metastatic CNS disease

PATIENT CHARACTERISTICS:

* Age: Any age
* Performance status: Zubrod 0-2
* Life expectancy: Greater than 12 weeks
* Absolute neutrophil count at least 1,000/mm3
* Platelet count at least 100,000/mm3
* Bilirubin no greater than 1.8 mg/dL
* Transaminases no greater than 2.5 times normal
* Creatinine no greater than 1.5 mg/dL OR creatinine clearance greater than 70 mL/min
* No HIV antibody
* No serious intercurrent illness
* No pregnant or nursing women
* Effective contraception required of fertile patients throughout study and for 1 year thereafter

PRIOR CONCURRENT THERAPY:

-At least 4 weeks since prior therapy (6 weeks since mitomycin) and recovered
Ultrasound-Guided Erectro Spinae Plane Block Versus Stellate Ganglion Block for Patients With Upper Limb Acute Herpes Zoster Pain.

Herpes zoster (HZ) is a painful, eruptive, viral condition results from reactivation of the latent varicella zoster virus after the primary infection. The selection of an effective analgesic method in the acute phase of herpes zoster can decrease the incidence of postherpetic neuralgia by reducing neural sensitization. The stellate ganglion is present in 80% of the general population and is composed of the inferior cervical ganglion and the first thoracic ganglion fusion. It lies anterior to the neck of the first rib and extends to the inferior aspect of the transverse process of C7. The erector spinae plane (ESP) block has been reported to provide diffuse and effective analgesia in the cervical, thoracic, and lumbar regions.

Especially for elderly patients, when cell-mediated immunity wanes, common symptoms of HZ appear, primarily as pain in a dermatomal distribution with a burning, sharp pain sensation (paresthesia) and itching, in addition to development of a vesicular rash. The selection of an effective analgesic method in the acute phase of herpes zoster can decrease the incidence of postherpetic neuralgia by reducing neural sensitization. The sympathetic fibers for the head, neck, heart, and upper limbs arise from the first thoracic segments, ascend through the sympathetic chain, and synapse in the superior, middle, and inferior cervical ganglions. The stellate ganglion is present in 80% of the general population and is composed of the inferior cervical ganglion and the first thoracic ganglion fusion. It lies anterior to the neck of the first rib and extends to the inferior aspect of the transverse process of C7. The erector spinae plane (ESP) block has been reported to provide diffuse and effective analgesia in the cervical, thoracic, and lumbar regions.

Eligibility Criteria:
Inclusion Criteria:

* patients over the age of 21 with upper limb herpetic eruption lasting shorter than a week along with moderate to severe pain who got adequate antiviral medications

Exclusion Criteria:

* We will exclude patients who refuse to participate, those who are taking anticoagulant medications, have secondary bacterial infections of the dermatome, those who have an allergy to local anesthetics or serious disease of the heart ( e.g. heart block), lung, kidneys and those who had a history of neck surgery, such as thyroid cancer.
Study on the Correlation Between Neurotrophic Factors and the Condition of Stroke Patients

Stroke is currently the most common disabling disease, which often leads to impairment of sensory, motor, speech and psychological functions, resulting in a reduced quality of life for patients. Therefore, post-stroke functional rehabilitation, especially the rehabilitation of physical function and psychological condition, is particularly important for patients to rejoin society. Acupuncture can promote the functional recovery of patients and facilitate the rehabilitation of limb function, thus improving the quality of survival of post-stroke patients.

Neurotrophic factors are diverse, most of which are mainly derived from neuronal cells in the central nervous system and are involved in a variety of neurological functions such as cell growth, differentiation and plasticity, thus promoting recovery of multiple functions after stroke. Many studies have found that different interventions affect the prognosis of stroke patients differently, e.g., long-term acupuncture increases serum levels of brain-derived neurotrophic factor in stroke patients and also has better outcomes than controls in post-stroke neurological recovery and the development of post-stroke psychiatric disorders.

This study investigated the effects of different therapeutic measures on patients' functional recovery and neurotrophic factors by setting up a controlled and blinded trial design, which could not only provide clinical evidence for the effectiveness of relevant therapeutic measures, but also verify the clinical value of certain neurotrophic factors (e.g., predicting outcome, assessing condition, and preventing adverse events).


Eligibility Criteria:
Inclusion Criteria:

* Symptom recognition to admission ≤ 72 hours
* Clear imaging evidence
* Diagnosis of spontaneous cerebral hemorrhage by an immobilized physician according to relevant guidelines; pre-onset mRS score ≤ 1

Exclusion Criteria:

* This onset was caused by traumatic and violent factors
* History of previous intracranial surgery
* Previous cerebrovascular accident
* Previous speech disorders and limb movement disorders
* Participation in other trials in the last three months.
Star Excursion Balance for Patellofemoral Pain Syndrome

Patellofemoral pain syndrome (PFPS) is a common and painful musculoskeletal condition that affects physically active young adults and causes pain front of the knee. Patients with PFPS has bilateral impairment in proprioception, as well as more in the affected knee than the normal; also the decrease of muscular strength, range of motion, and neuromuscular control are known to result with impaired static and dynamic balance.This study aimed to investigate the efficacy of a-four week YDT balance exercises on pain, quality of life and functional state in patients with PFPS with impaired balance.

Patellofemoral pain syndrome (PFPS) is a common and painful musculoskeletal condition that affects physically active young adults and causes pain front of the knee. Patients with PFPS has bilateral impairment in proprioception, as well as more in the affected knee than the normal; also the decrease of muscular strength, range of motion, and neuromuscular control are known to result with impaired static and dynamic balance. We aimed to investigate the efficacy of a-four week YDT balance exercises on pain, quality of life and functional state in patients with PFPS with impaired balance.

Patients with PFPS diagnosed will included in the study. Participants will randomized into the YDT exercise group (n = 24), the KAT 2000 exercise group (n = 24) and the combined exercise group (n = 24). Before the study, all groups of patients will given exercises such as quadriceps, vastus medialis oblique (VMO), hip abductor, extensor and external rotator strengthening exercises. All patient groups received balance training for four weeks, three days a week.

Pain intensity will be measure on Visual Analog Scale (VAS). Functional capacity will be evaluated by using the Western Ontario McMaster Osteoarthritis Index (WOMAC) and Kujala Patellofemoral Score (KPS). Static balance performance will be evaluated by using Kinesthetic Ability Trainer 2000 (KAT 2000) and dynamic balance performance will be evaluated by using Berg Balance Scale (BBS) and KAT 2000. The quality of life will assessed using Nottingham Health Profile (NHP).

Eligibility Criteria:
Inclusion Criteria:

* Between 20 -50 years
* Retropatellar pain
* Positive Clark test, J finding, increased Q angle, positive patellar compression and comphrension test
* Mild or moderate Berg Balance Scale Scores
* body mass index \<30
* Mini mental state test score \>24

Exclusion Criteria:

* Effusion on patellefemoral site
* Severe neurologic disease
* Trauma history
* Lower extremity surgery history
* Lower extremity fracture history
* severe vitamin B12 deficiency
* another disease led to balance deficit
Hardware Preservation in Management of Infected Non United or Delayed United Fractures of Long or Short Bones by Debridement and Local Calcium Sulfate Loaded by Antibiotics

* Diagnosis of infection based on elevated serum markers of infection (ESR, CRP), discharging sinus, preoperative radiographs suggestive of bone infection and radiological findings . \[6\]
* infected nonunion mean the bone has previous fracture , the bone not healed may be one of the reasons it didn't heal because there is sub-acute infection , there is low grade colonization into the bone or around the wound preventing the bone from healing , it different from infected fracture which occur fairly acutely. \[6, 7\]
* Infected nonunion treated with systemic antibiotics alone, without using local antibiotic delivery systems associated with higher recurrence and reoperation rates. \[7\]
* This led to the development and use of medical-grade calcium sulfate (CS), CS facilitates osseous healing in an osteoconductive fashion by filling the bone void and preventing fibrous tissue


Eligibility Criteria:
Inclusion Criteria:

* Patient at any age and of any sex with infected non united fracture of long or short bones

Exclusion Criteria:

* Presence of previous vascular injury or pathological fracture
* Refusal to participate
* Inability to provide informed consent
* Allergy or sensitivity to vancomycin or tobramycin
* Patient with impaired renal function
* Patient with hypercalcemia
Assessment of Combined CCM and ICD Device in HFrEF

The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%).

Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years.


Eligibility Criteria:
Inclusion Criteria:

Individuals must meet all the following:

1. Patient is aged 18 years or older;
2. Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure ;
3. Patient has HFrEF (LVEF ≤40%);
4. Patient is on GDMT for heart failure;
5. Patient has a Class I or Class II indication for an ICD
6. Patient has a reasonable expectation of meaningful survival of \> 1 year;
7. Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred;
8. Patient is willing to give informed consent, available for scheduled study follow-up visits, and able to complete all testing described in the study protocol at the investigational site location.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Patients should not have severe AI or AS, and should not have MS; additionally, patients undergoing DE testing should not have severe MR;
2. Patients who have undergone mitral valve repair or clip within 90 days prior to study consent;
3. Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;
4. Prior heart transplant or ventricular assist device;
5. Implanted mechanical tricuspid valve;
6. PR interval greater than 375ms or advanced AV block;
7. In situ S-ICD, pacemaker, or CRT device;
8. Indicated for CRT;
9. End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer);
10. Indicated for permanent bradyarrhythmia pacing;
11. Unstable angina pectoris within 30 days prior to study consent;
12. Pregnant or planning to become pregnant during the study;
13. Participating in another cardiac investigational device or drug study at the same time (or within 30 days prior to study consent); Note: Registries and other observational studies are acceptable.
14. Other criteria that preclude Optimizer INTEGRA CCM-D implantation and/or CCM therapy, as determined by Investigator.
Functional Outcomes of Knee Protheses for Malignant Tumours of Bone

The placement of mega knee prosthesis is a necessity after a large tumor resection and oncological. These mega knee prostheses implanted in the context of oncological surgery have been very few evaluated in the literature.

Active knee extension is essential in order to walk properly. The study propose the evaluation of this prosthesis by checking the possibility of locking of the prosthetic joint and thus the possibility of active walking.

A more in-depth, isokinetic analysis at 1 year of follow-up will also be done in an exploratory manner, as the literature has no data on this subject.


Eligibility Criteria:
Inclusion Criteria:

* Patient with MUTARS® modular reconstruction prostheses following primary or secondary knee bone malignancy with minimal follow-up of one year,
* Cardiological follow-up including at least one ECG and a clinical examination of less than 1 year (ability to perform the isokinetic test),
* Written informed consent from patient,
* Socially insured patient,
* Patient willing to comply with all study procedures and study duration.

Exclusion Criteria:

* - Underage,
* Less than a one-year follow-up after surgery (stability of results is not achieved if follow-up is less than one year),
* Meniscal lesion knee healthy side,
* Prosthetic surgery of the knee healthy side,
* Patient with an unbound fracture,
* Patient without cardiological follow-up,
* Pregnant or breastfeeding woman,
* Inability to receive information, consent and participate in the whole study,
* No social insurance cover,
* No written consent,
* Person under judicial protection or deprived of liberty.
Radioembolization With Yittrium-90 for Intermediate and Advanced Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the fifth most-common cancer worldwide and the second most-common cause of cancer mortality. Liver resection is the first-line curative treatment for huge HCC. The 5-year overall survival (OS) rates after hepatic resection were range from 25% to 45%. Transarterial chemoembolization (TACE) is the major treatment option for the unresectable primary or secondary liver malignancies. Yittrium-90 (Y-90) is a pure beta-emitter, without any toxic effect or immune rejection. There are ample data that support the use of Y-90 microspheres for primary and metastatic liver tumors. The aim of our study was to compare the clinical outcome of radioembolization with Y-90 and TACE and provide a new strategy for the treatment of intermediate and advanced hepatocellular carcinoma with portal vein thrombus by conduting a randomized trial.


Eligibility Criteria:
Inclusion Criteria:

1. Child-Pugh class A or B liver function;
2. Preoperative ECOG criteria score of 0-2;
3. Patients preoperatively diagnosed of hepatocellular carcinoma according to chest computed tomography (CT) and/or magnetic resonance imaging (MRI);
4. Tumor number ≤5 and the sum of largests tumor diameter ≤15 cm;
5. The expected survival time \>6 months.

Exclusion Criteria:

1. Other anticancer treatment before treatment
2. Patients with apparent major organs (i.e. cardiac, pulmonary, cerebral and renal) dysfunction, which may affect the treatment of liver cancer
3. Patients with other diseases that may affect the treatment of this treatment
4. History of other malignant tumors
5. Patients who are participating in other clinical trials
6. Pregnant, lactating women
Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder

The aim of this study is to determine if a single dose of psilocybin administered with motivational enhancement therapy (MET) can reduce heavy drinking in patients with an alcohol use disorder (AUD).

The primary objective of this study is to determine if psilocybin administered with a standardized psychotherapeutic intervention, motivational enhancement therapy (MET), can reduce heavy drinking in a patient population with an alcohol use disorder (AUD). Patients with an AUD will be randomly allocated to either a high dose (25mg; active treatment) or a low dose (1mg; active control) psilocybin arm. All participants will receive 5 sessions of MET, starting at 24hrs post-dosing. Heavy drinking will be assessed as percent heavy drinking days using the Time Line Follow Back (TLFB) at baseline and 1-, 4-, and 12-weeks post-dosing.

A total of 128 male and female patients between the ages of 22-65 with a moderate to severe AUD diagnosis will be recruited from the community. Participants will undergo a thorough screening procedure and eligible participants will be randomly allocated to the high (N=64) or low (N=64) psilocybin doses. All participants will complete a baseline session consisting of clinical, behavioral, and neuroimaging measures. Following the single dosing session, participants will complete 5 weekly MET sessions. Neuroimaging measures will be assessed again at 1-week post-doing. Clinical and behavioral outcomes will be measured at 1-, 4-, and 12-weeks post-dosing

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-5 AUD criteria of at least moderate severity
* Meets heavy drinking requirements (heavy drinking days, number of drinks) in past 30 days
* Desire to decrease alcohol consumption
* Limited lifetime hallucinogen use

Exclusion Criteria:

* Severe or moderate substance use disorder other than alcohol or nicotine in past 6 months
* Diagnosis of schizophrenia, bipolar disorders or first-degree relative with diagnosis
* Active suicidal ideation or serious attempt within past 3 years
* Currently pregnant, nursing, or trying to become pregnant
* Any notable abnormality on ECG, physical exam, or routine medical blood laboratory test