cyrilzakka/clinical-trials huggingface dataset:
An Observational Real World Study on the Efficacy and Safety of Toripalimab Injection Combined With TACE in the Treatment of Extrahepatic Cholangiocarcinoma

This is an open-label, single-arm, multicenter phase II clinical study to preliminarily observe and evaluate the efficacy and safety of Toripalimab combined with TACE in the treatment of extrahepatic cholangiocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years and \< 75 years
* both men and women
* ECOG performance status score 0-2 points
* Child-Pugh score ≤ 7 points
* Expected survival ≥ 12 weeks
* Patients with histologically or cytologically confirmed extrahepatic cholangiocarcinoma, patients with obstructive jaundice need to return to normal after drainage
* At least one measurable lesion \[spiral CT scan ≥ 10 mm (CT scan slice thickness no greater than 5 mm)\] (RECIST Version 1.1)
* Vital organ function meets the following requirements: a. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; b. Platelets ≥ 75 × 109/L; c. Hemoglobin ≥ 8 g/dL; d. Serum albumin ≥ 2.8 g/dL; e. Bilirubin ≤ 3 ULN, ALT/AST ≤ 2.5 UILN; if there is liver metastasis, ALT/AST ≤ 5 times ULN; f. Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault, see Appendix III); g. Normal thyroid function. h. Adequate cardiac function, 2-dimensional cardiac ultrasound examination of the score (LVEF) \> 50%
* No history of serious drug allergy
* Women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test before enrollment
* The subject voluntarily participates in this study. Sign the informed consent form, with good compliance and cooperation in follow-up

Exclusion Criteria:

* Known to be allergic to recombinant humanized PD-1 monoclonal antibody drugs and their components
* Presence of any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; complete remission of asthma in childhood, no intervention after adulthood can be included; patients with asthma requiring bronchodilators for medical intervention can not be included)
* Patients are using immunosuppressive agents, or systemic hormone therapy to achieve the purpose of immunosuppression (dose \> 10 mg/day prednisone or other effective hormones), and continue to use 2 times before enrollment
* Pregnant or lactating women
* Other malignant tumors have been diagnosed within 5 years before the first use of the study drug, except for effectively treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma and/or effectively resected in situ cervical cancer and/or breast cancer
* Patients prone to infection and poor blood glucose control
* Incomplete important imaging examination and incomplete record of adverse reactions
* Previous surgery, chemotherapy, targeted, radiotherapy and immune-related therapy
* Other conditions that the investigator judges may affect the conduct of the clinical study and the judgment of the study results
Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.

Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection.

This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123. This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be eligible if they were randomized to study A3051123.

Exclusion Criteria:

* Participation in study A3051123 ceased (ie, withdrew consent, lost to follow-up, etc) prior to final visit of study A3051123.
Efficacy and Safety of Letrozole vs. Letrozole Plus Zoledronic Acid as Endocrine Therapy Before Surgery in Postmenopausal Patients With Breast Cancer

This study will evaluate the safety/efficacy of zoledronic acid when given by intravenous infusion every 4 weeks in addition to letrozole as endocrine therapy in postmenopausal patients with hormone responsive breast cancer

Open-label, multicenter, randomized phase II trial over approx 6.5 months of neoadjuvant treatment with letrozole with or without zoledronic acid in postmenopausal patients with primary breast cancer. A total of approximately 850 patients were originally planned to be enrolled; primary study endpoint was the objective response rate (according to modified RECIST criteria) after 6 months of treatment. After the core study, patients willing to participate were followed-up for further 5 years.

Eligibility Criteria:
Inclusion criteria:

* Postmenopausal women with primary invasive breast cancer, histologically confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive
* Clinical Stage T1c (Size ≥ 1.5 cm), T2, T3, T4a, b, c, N0 or N1, M0 (TNM Classification). According to the modified RECIST criteria, tumors of size ≥ 1.5 cm are considered measurable by mammography and can be determined as target lesions).
* Tumor measurable by mammography, sonography and clinical examination.
* Adequate bone marrow, renal and hepatic function
* Good health status (ECOG Performance status of 0, 1 or 2)

Exclusion criteria:

* Prior treatment with letrozole or bisphosphonates. Prior and concomitant anti-breast-cancer treatments such as chemotherapy, immunotherapy / biological response modifiers (BRM's), endocrine therapy other than letrozole (including steroids), and radiotherapy. Patients who have received hormone replacement therapy (HRT) will NOT be excluded, provided that HRT is discontinued at least 2 weeks prior to entry into the study.
* Patients with unstable angina, or uncontrolled cardiac disease (e.g. Class III and IV New York Heart Association's Functional Classification, see Appendix 9) or uncontrolled endocrine disorders.
* Evidence of inflammatory breast cancer or distant metastasis.
* Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures. Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants).
* History of diseases with influence on bone metabolism, such as Paget's disease, Osteogenesis Imperfecta, and primary or secondary hyperthyroidism within the 12 months prior to study entry

Other protocol-defined inclusion/exclusion criteria may apply
Healthy Eating, Activity and Reduction of Teen Stress

The goal of this study is to develop and pilot test a telehealth behavioral weight control intervention for adolescents from a low-income background that combines facets of mindfulness training with behavioral weight control. We aim to examine biological (e.g., weight) and behavioral (e.g., emotional eating, mindfulness) changes as a result of a 12-session mindfulness-based weight control intervention compared to a 12-session standard behavioral weight control intervention.

The overarching aim of this study is to pilot and refine a novel Mindfulness-Based Weight Control (MBWC) intervention to improve weight management outcomes among adolescents (ages 13-18) who are overweight or obese and from a low-income background. First, we will pilot (open-trial) the MBWC intervention, with a focus on decreasing emotional eating, in an adolescent population. Second, we will conduct a randomized controlled trial of the 12-week MBWC intervention vs. a 12-week standard behavioral weight control intervention among adolescents who are overweight or obese and compare outcomes of the MBWC and control interventions. All components of this telehealth intervention will be delivered via HIPAA-compliant videoconferencing software. We are interested in examining change in biological and behavioral variables (e.g., body mass index normed for age and biological sex; perceived stress; eating and activity patterns; psychological function related to weight management) post-intervention and at three-month follow-up. Treatment satisfaction/treatment acceptability will be evaluated at the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. 13-18 years old
2. BMI in the overweight or obese range (≥ 85th%ile for age and sex)
3. speak English

Exclusion Criteria:

1. use of medications that have recently resulted in a change in eating or weight
2. cognitive impairment/developmental delay such that study procedures would be inappropriate
3. major psychiatric disorder (e.g. clinically severe depression, psychosis, anorexia nervosa, bulimia nervosa)
4. current participation in a weight loss program
5. pregnant or breastfeeding
6. medical condition known to impact weight or that would otherwise prevent participation
Goal Attainment Scaling in Upper Limb Spasticity Treatment

Patients after stroke with upper limb spasticity treated with botulinum toxin-A (BTX-A) will be included in this two-part study. In the first part, goal attainment scaling and comprehensive assessment of motor functioning will be performed before BTX-A application and after two weeks. In the second part, the patients will be randomised into a test group performing prescribed regular exercise for two weeks and a control group exercising at their own discretion during the same period, whereby the patients' health-related quality of life will be assessed at the beginning and end of the two-week period.

Goal setting will be performed by the patient together with the physician according to the SMART principle (specific, measureable, achievable, realistic, time bound). The goals will be classified according to the International Classification of Functioning, Disability and Health. Goal attainment will be assessed using the Goal Attainment Scale - Light. Comprehensive assessment of motor functioning will address range of motion, spasticity, pain, degree of motor disability and degree of dependence in daily activities. The prescribed exercises for the test group will be passive or active, depending on spasticity of the impaired upper limb. Both groups will keep an Exercise Diary during the second part of the study.

Eligibility Criteria:
Inclusion Criteria:

* patient's or caregiver's approval
* ischemic or hemorrhagic stroke diagnosed using head CT/MRI
* at least one upper limb muscle spasticity (MAS ≥ 3)
* candidate for BTX-A treatment or already given BTX-A in the past
* patient's or caregiver's capability for goal attainment protocol cooperation (Mini Mental Examination ≥ 24 points)

Exclusion Criteria:

* aphasic patients without caregiver's presence
* other neurological or musculoskeletal diseases that could affect the treatment outcome
A Study to Evaluate ONO-4474 in Patients With Pain Due to Osteoarthritis of the Knee

The purpose of this phase 2, randomised, double-blind, placebo controlled, parallel group, multicentre study is to investigate the efficacy, safety, tolerability and pharmacokinetics of a compound ONO-4474 in patients with moderate to severe pain due to osteoarthritis of the knee following 4 weeks of oral administration of ONO-4474.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic OA of the knee for ≥3 months diagnosed prior to screening as per American College of Rheumatology clinical criteria.
* Radiographic evidence of tibiofemoral OA of index knee (Kellgren-Lawrence grade 2-3), as confirmed at screening.
* Moderate to severe index knee pain due to OA requiring use of analgesic medication.
* Willing to discontinue use of all analgesic medication (aside from rescue medication) during the study.

Exclusion Criteria:

* Presence of, or history of,

  1. any inflammatory arthritis (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative spondylarthropathy, septic arthritis, previous diagnosis of pseudogout in target joint with proven crystals on joint aspiration or elevated C-Reactive Protein (CRP) at time of knee arthritis flare),
  2. RPOA, osteonecrosis, osteoporotic fracture or any other painful joint disease other than OA,
  3. Secondary causes of OA; other rheumatologic or musculoskeletal conditions (e.g., rheumatoid arthritis, fibromyalgia, septic arthritis, congenital abnormality).
* Orthopaedic surgery of a lower extremity or any major surgery within the previous 6 months prior to Visit 1 or has plans for surgical intervention during the study.
* Symptomatic hip OA.
* A history of partial or complete joint replacement surgery in the index knee at any time or anticipating knee surgery during the study period.
* Significant knee injury or any knee surgery (including arthroscopy) in the index knee within 6 months prior to screening.
* Uncontrolled diabetes.
Imaging of Dissection of the Descending Aorta

Patients with dissection of the descending aorta will be followed up according to a precise timeline.

NMR baseline A PET Scanner will be performed minimum 3 months post dissection 6 months and every year during three years after PET scanner : CT scanner and blood sample

Eligibility Criteria:
Inclusion Criteria:

* 18 years
* Seen for dissection of the descending aorta
* Dissection of the descending aorta within the last three months
* Affiliation to social security
* Signed informed consent

Exclusion Criteria:

* intervention programmed in relation with dissection of the descending aorta
* Pregnant female
* Adults without legal capacity
Evaluation of Electrical Nerve Stimulation (TENS) Therapy for Pain Relief Following Total Knee Arthroplasty (TKA)

Evaluation of Electrical Nerve Stimulation (TENS) Therapy for Pain Relieft Following Total Knee Arrhtoplasty (TKA)

A prospective, randomized postmarket trial to assess the efficacy of the Select TENS™ Pain Management System, a transcutaneous electrical nerve stimulation (TENS) device, for reducing pain and narcotics requirement in patients managed with a total knee arthroplasty (TKA). This will be a placebo-controlled study involving 116 patients undergoing primary unilateral TKA procedures; 58 patients will be randomly selected to be treated postoperatively with an active TENS unit and the other 58 patients will be randomly selected to be treated with the placebo TENS unit (control group). Patients will be enrolled at two sites within the Cleveland Clinic Health System (Main Campus and Lutheran Hospital). Both treatment and control groups will receive a femoral nerve catheter, standard during a primary TKA. It is hypothesized that TENS (in combination with a femoral nerve catheter) can reduce narcotic usage, reduce pain, and allow for a quicker return to function following TKA.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing unilateral primary total knee arthroplasty
* Patients who are between the ages of 18-85 years
* Patient has signed informed consent

Exclusion Criteria:

* Patients who live \>100 miles from the Cleveland Clinic main campus (9500 Euclid Ave., Cleveland, OH 44195)
* Patients who will not receive a femoral nerve catheter for surgery
* Patients who are not planned to be discharged directly home following surgery
* Patients who have used a TENS device in the past
* Preoperative daily use of narcotics (i.e., high tolerance)
* Already enrolled in another research study, including the present study for contralateral knee
* Patients with a history of epilepsy
* Patients with a cardiac pacemaker
* Patients who are a risk for poor compliance or have a poor understanding of the use of the TENS device
* Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.
Prostatectomy Adaptive Radiation Therapy (ART)

This study will ultimately aim to evaluate the side effects of treatment by asking 20 subjects to receive post-operative radiotherapy for prostate cancer with the treatment plan adapted after the first week of treatment to account for changes in the target shape. These patients will be asked to complete toxicity scores and a quality of life questionnaire at the start and completion of treatment, and at 3 months 1, 2 and 5 years from the start of radiotherapy. These results will be used to determine the feasibility of the proposed approach, and obtain early estimates of improvements in uncertainty margin requirements for this population of patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of adenocarcinoma of the prostate after radical prostatectomy AND
* Clinical stage pT3, pT4, or pT2 with positive margin OR
* Any p-Stage with a persistently elevated post-operative PSA \> 0.05 ng/ml OR
* A delayed rise in PSA post-operatively

Exclusion Criteria:

* Inflammatory bowel disease or other contraindications to radiotherapy
* Prior pelvic radiotherapy
* Previous cytotoxic chemotherapy
* Radiological or pathologic evidence of nodal metastases.
* Planned radiotherapy to pelvic lymph nodes
* Evidence of systemic metastases on imaging.
* Prosthetic hip replacement
* No signed informed consent
The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Anxiety and Insomnia

The study examined the effects of adding the sleep aid eszopiclone to Lexapro on mood and levels of the neurotransmitters glutamate, glutamine, and GABA in women with depression, anxiety, and insomnia. Specifically, the objective was to determine the role of glutamate, glutamine, and GABA in mediating the response the to the combined treatment. The hypothesis was that levels of glutamine and glutamate will be increased in women receiving eszopiclone compared to those receiving placebo. The antidepressant effect of the medication combination and its effect on sleep status was also assessed.


Eligibility Criteria:
Inclusion Criteria:

* Female aged 18 to 55 years and regularly menstruating.
* Meets DSM-IV criteria for unipolar major depression.
* Insomnia severity index score \> 10.
* Hamilton Anxiety scale score \> 15.
* Hamilton Depression scale score \> 17.
* Capable of providing informed consent.
* Has an established residence and phone.

Exclusion Criteria:

* Meets DSM-IV criteria for schizophrenia, schizoaffective disorder or other axis I or II diagnosis except co-morbid anxiety disorder and insomnia.
* Actively abusing substances or alcohol; or has met DSM-IV criteria for substance dependence in the past month.
* Pregnancy.
* Use of benzodiazepines or other sedative-hypnotics, beta blockers, calcium channel blockers, antidepressants, antipsychotic medications, lithium or other medication which in the opinion of the investigator could alter glutamate or GABA activity in the brain.
* A medical condition, which in the opinion of the investigator could possibly affect the individual's brain levels of Glu and GABA.
* Participation in a research protocol that included administration of medication within the past 3 months.
* Cigarette smoking.
* Subject has known allergic sensitivity to any of the study to escitalopram, eszopiclone or zopiclone.
* Clinically significant suicidal ideation or risk of suicide as evidenced by formulation of a plan or steps taken to act on those feelings.
* History of clinically significant hepatic impairment.
* Subject is taking a potent cytochrome p450 3A4 inhibitor medication (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) and is unwilling or it is clinically contraindicated to stop the medication.
Aspiration in Acute Respiratory Failure Survivors

The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe.

The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe. Patients are asked to be in this study because they had problems breathing on their own and therefore needed the help of a machine called a ventilator. In order for this ventilator to push air into the lungs, patients need a tube placed in the throat called an endotracheal tube. The process of placing this endotracheal tube was called intubation. The tube has now been removed, which is a process called extubation. Sometimes, people who have had endotracheal tubes can have difficulty swallowing food and liquids for a period of time. This disease is called post-extubation dysphagia (PED). PED is a serious condition and may result in food or liquid going from the mouth into the lungs. This could cause further lung problems. Given this risk, doctors sometimes suggest that patients with PED either avoid eating or drinking, or get a feeding tube. Currently, nobody knows how often patients develop PED, why they develop it, or the best method to detect it. Standard care involves clinicians making educated guesses. This study looks to determine if watching the patient swallow, both with and without a small camera, is an accurate method for detecting PED.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be eligible to participate in the study if they meet all of the following criteria:

  1. Admission to a University of Colorado Hospital ICU
  2. Mechanical ventilation support through an endotracheal tube for greater than 24 hours

Exclusion Criteria:

* Subjects will be ineligible to participate in the study if they meet any of the following criteria

  1. Age less than 18 years
  2. Contraindication to enteral nutrition administration
  3. Diagnosis of an acute or pre-existing central nervous system disorder (excluding a seizure disorder)
  4. Pre-existing dysphagia
  5. Previous surgery of the head, neck, or esophagus
  6. Previous cancer of the head or neck
  7. The presence of a tracheostomy
  8. The presence of nasal or pharyngeal trauma or bleeding
  9. Clinical team believes one of the protocols would be harmful to an individual patient
  10. Expected survival less than 3 months
  11. Pregnancy
  12. Imprisoned at the time of admission, anytime during the hospitalization, or anytime during the followup period
  13. Inability to give informed consent and proxy unavailable.
Impact of Liwen Procedure in Obstructive Hypertrophic Cardiomyopathy on Arrhythmias

The goal of this observational study is to learn about the occurrence of various arrhythmias ( tachyarrhythmia and bradyarrhythmia ) during or after Percutaneous Intramyocardial Septal Radiofrequency Ablation. The main questions it aims to answer are:

* To investigate the occurrence of various arrhythmias ( tachyarrhythmia and bradyarrhythmia ) during procedure and its relationship with clinical characteristics and procedural parameters
* To analyze the changes of 12-lead electrocardiogram and 24-hour dynamic electrocardiogram before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation and their relationships with clinical characteristics and procedural parameters


Eligibility Criteria:
Inclusion Criteria:

1. Subject with symptoms that limit daily activities (New York Heart Association functional class \>II, exercise-induced syncope) despite adequate medical treatment or when medical treatment is not tolerated
2. Subject with a peak LVOT gradient≥50 mm Hg
3. Subject volunteers for the Liwen procedure and received the procedure at the Hypertrophic Cardiomyopathy Center of Xijing Hospital.

Exclusion Criteria:

1. Subject with a peak instantaneous Doppler LVOT gradient of \<50 mm Hg
2. Subject with an indication for septal reduction therapy and other lesions requiring surgical intervention (e.g., mitral valve repair/replacement and papillary muscle intervention)
3. Subject has end-stage heart failure