cyrilzakka/clinical-trials huggingface dataset:
Zanubrutinib and Lenalidomide as Maintenance Therapy in DLBCL

The goal of this phase 2 trial is to test the safety and efficacy of zanubrutinib and lenalidomide as maintenance therapy in patients with DLBCL.

The investigators will evaluate safety and efficacy of zanubrutinib and lenalidomide as maintenance therapy in patients with diffuse large B-cell lymphoma post complete remission and have completed planed courses of chemotherapy . Event-free survival (EFS), progression-free survival (PFS), overall survival (OS), adverse events (AEs) will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed Diffuse Large B Cell Lymphoma according World Health Organization (WHO) classification;
* Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
* Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;
* Patient is willing and able to adhere to the study visit schedule and other protocol requirements;
* Patient has recieved complete remission and has completed planed courses of chemotherapy
* Meet the following lab criteria: Absolute Neutrophil Count (ANC) ≥ 1,5 x 10\^9/L (≥ 1 x 10\^9/L if bone marrow (BM) involvement by lymphoma)；Platelet ≥ 75 x 10\^9/L (≥ 50 x 10\^9/L if BM involvement by lymphoma)； Hemoglobin ≥ 8 g/dL. Anticipated life expectancy at least 3 months

Exclusion Criteria:

* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;
* Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy;
* Pregnant or lactating women
Effectiveness and Neural Mechanism of Naoan Dripping Pills for Migraine

This is a randomized, double-blind, placebo-controlled clinical trial. Its main purpose is to investigate the effects and neural mechanism of Naoan dripping pills on migraine patients by utilizing fMRI and DTI method, as well as headache evaluation measures such as responder rate, headache duration, PRO scale, etc.

Naoan dripping pills, which is a Chinese patent medicine proved effectively in treating migraine on clinic, but its neural mechanism remains unknown. This study is expected to validate the effectiveness and explore its neural mechanism by fMRI and DTI so as to provide evidence for physicians to promote the appropriate use of Naoan dripping pills treatment for migraine patients. Patients will be randomly assigned to either Naoan dripping pills group or placebo group, they will receive Naoan dripping pills/Placebo treatment for 12 weeks. Clinical evaluation will be performed at baseline, every 4 weeks during treatment and the follow-up week(16 weeks) . MRI scans are performed at baseline, and 12 weeks later. Responder rate (defined as the percentage of subjects in a treatment group with 50 % or greater reduction in attack frequency during treatment compared with the baseline period) and fMRI and DTI imaging changes after treatment are defined as primary outcome. In addition, 10 healthy controls will also undergo MRI scanning at baseline to determine abnormal brain activity and structure in migraine patients.

Eligibility Criteria:
Inclusion Criteria:

* Subject has migraine without aura or with typical aura according to criteria of the International Headache Society (IHS)
* Subject has been diagnosed with qi deficiency syndrome and/or blood stasis syndrome in TCM
* Subject has onset of migraine occurring before age 50
* Subject has a history of migraine headaches for at least 1 year
* In recent 3 months, subject has 2 to 8 headache attacks every 4 weeks
* Age ≥ 18 years and ≤ 65 years
* Right-handers
* Subject has signed informed consent

Exclusion Criteria:

* Subject takes painkillers more than 10 days a month for headache attacks
* Subject who was／is in possess of Naoan dripping pills therapy but the treatment is ineffective
* Allergic to Naoan dripping pills
* subject's taken, within 12 weeks before enrollment, migraine prevention drugs drugs such as β-blocker, calcium channel inhibitor，Anti-epileptic drugs，antidepressants or 5-HT receptor blocker
* Alcohol or drug abusers
* Subject suffers from other primary headaches as specified by IHS criteria
* Subject has medical condition such as severe heart disease, stroke, kidney disease, liver disease, hepatic or renal impairment, hematologic disease
* Subject has psychological or mental disorder, Hamilton Anxiety Scale（HAMA）≥7，Hamilton Depression Scale（HAMD）≥7
* Subject has language impairment or cognitive impairment, unable to read, understand or record information in study diaries and questionnaires
* Pregnant or breast feeding subjects
* Subjects with contraindications for undergoing MRI scans (e.g. Claustrophobic, patients with heart pacemaker )
Non-Invasive 3D Mapping for Identifying Origin and Preferential Propagation of Ventricular Arrhythmias

This study will measure the diagnostic sensitivity and specificity of the Medtronic CardioInsight wearable 252 electrode vest in predicting the chamber of origin of premature ventricular complexes (PVCs) and compare its diagnostic accuracy with the standard 12- lead ECG.

Until recently, the only non-invasive diagnostic modality to help identify the location of ventricular arrhythmias was the 12 lead ECG. The Medtronic CardioInsight wearable vest is a recently FDA approved diagnostic modality noninvasive, single beat cardiac mapping system that provides 3D electroanatomic maps of the ventricular chambers. CardioInsight projects unipolar signals collected from a 252-electrode vest to cardiac chambers imaged with a non-contrast CT of the chest. The created non-invasive 3D electroanatomical maps can be evaluated by the physicians pre-procedurally but also during the actual electrophysiology study (EPS).

The technology has been approved by FDA for non-invasive mapping of any arrhythmias, however there is little evidence on its value in predicting the origin of ventricular arrhythmias and its proven diagnostic superiority over the standard 12-lead ECG.

With this study the investigators seek to assess the sensitivity and specificity of CardioInsight in predicting the chamber of origin of ventricular arrhythmias and compare its diagnostic accuracy with the standard 12-lead ECG. The study will include thirty patients with ventricular arrhythmias undergoing EPS and ablation. The day of the procedure patients will be fitted with the CardioInsight vest and undergo a non-contrast CT chest. Spontaneous arrhythmias will be recorded and noninvasive 3D maps will be created prior and during the EPS. The non-invasive maps will be used, per operator discretion, in designing mapping and ablative strategies during the EPS. The true origin of the arrhythmia will be determined during the EPS. In addition, the investigators will perform threshold pacing from common site of idiopathic ventricular arrhythmias. The 12-lead ECGs and non-invasive maps will be stored for off line review and analysis.

Non-invasive maps, as well as ECGs of spontaneous arrhythmias and pacemaps will be evaluated off line by 2 electrophysiologists blinded to the results of the EPS. The sensitivity and specificity of the 12 lead ECG, as well as the non-invasive maps, in predicting the site of origin of the ventricular arrhythmias and pacemaps will be calculated and compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients with PVCs or VT requiring EPS for:
* Symptomatic arrhythmias
* High PVC burden
* Presence of cardiomyopathy
* Risk stratification to determine which patients to offer ablative vs medical therapy and for ICD implantation if deemed high risk for sudden cardiac death.

Exclusion Criteria:

* Patients in acute coronary syndrome
* Patient with congestive heart failure in acute decompensation
* Patients in rapid atrial fibrillation
* Patients requiring persistent ventricular pacing
* Patient who refuse to undergo EPS
Anterior Cruciate Ligament Reconstruction Made With Hamstring Tendon And Quadriceps Tendon Autografts

Anterior cruciate ligament reconstruction (ACLR) is one of the most common procedure all around the world, however optimal graft source for ACLR still remains controversial. Although Quadriceps tendon (QT) is the least used and least studied autograft, it could be an appropriate and good alternative for ACLR. If investigaters use the same surgical technique, and exert the same rehabilitation methods they may have better results than hamstring tendon (HT) autografts.

Investigators enrolled 36 patient and randomized them to different group (HT, QT). at the first evaluation examination findings noted, PROMs (patient reported outcome measurements) questioned, thigh circumference measured, flexor and extensor thigh muscle strength recorded with help of Humac CYBEX Norm (CSMI, 2004) device. After these examinations and preparations all patients operated by the same surgeon who is familiar with both technique. The same surgical technique and fixation method used for both groups. At 1st year follow-up all evaluations PROMs (İKDC,lysholm,VAS) and measurements repeated. Back to the sports rates and postoperative complications compared between HT-QT.

Eligibility Criteria:
Inclusion Criteria:

diagnosed primary ACL rupture willing to involve study

* lesser than Outerbridge 2 cartilage lesions, non-buckethandle meniscus injuries

Exclusion Criteria:

more than one ligament injury greater than outerbridge 3 cartilage injury buckethandle meniscus injuries re-ruptures bilateral injuries previous knee surgery any disease affecting muscle strength

-
Prospective Observational Study and Biobank CKIO

Prospective observational study and biobank in all persons referred to CKIO

* Patient involvement and quality of life
* Population characteristics regarding hormone levels, safety parameters and clinical outcome before and after gender affirming hormone treatment.

This is a prospective observational cohort study including all patients referred to the Center of Gender Identity Odense. The purpose is to follow patients yearly to observe patient reported outcomes and control the quality and effects of the clinical treatment.

Eligibility Criteria:
Inclusion Criteria:

* All Individuals with gender dysforia who are referred to Center of Gender Identity Odense
* Age 18+

Exclusion Criteria:

°There are no exclusion criteria
Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

The primary purpose of this study is to determine the impact of maximizing patient and primary care provider (PCP) activation on breast cancer surveillance rates among women previously treated with chest radiotherapy (RT) for a childhood cancer. This is an 18-month, 3-arm randomized controlled trial using a smartphone intervention with data being collected at baseline and 18-months through patient and provider surveys and medical record review. Eligible women treated for a childhood cancer with chest RT will be randomly sampled from the Childhood Cancer Survivor Study (CCSS) and randomly selected to one of three groups: control, patient activation (PA) using a smartphone-based intervention, or patient activation + primary care provider activation (PA+PCP) which will include physician materials about breast cancer risk in this population along with guidelines for breast cancer surveillance. Participants in all groups will receive mailed targeted print materials as an educational resource about their previous chest radiation and breast cancer screening recommendations. The primary outcome is a medical record confirmed breast MRI and mammogram with the goal of increasing the rate of women completing the national guideline-based recommended combination of breast MRI and mammogram. This study will test the hypothesis that women in the PA and PA+PCP groups will have significantly higher rates of breast cancer surveillance (breast MRI and mammogram) than women in the control group. In addition, the hypothesis that women in the PA+PCP group will have significantly higher rates of breast cancer surveillance than women in the PA group will also be tested.


Eligibility Criteria:
Inclusion Criteria:

Eligible participants will include women who:

* Were diagnosed with a childhood cancer prior to the age of 21 years;
* Were treated with ≥ 10 Gy of chest RT (recent revision with a lower dose threshold);1
* Do not have a history of breast cancer;
* Have not had both a breast MRI and mammogram in the previous 24 months;
* Do not have a contraindication to MRI (i.e., pacemaker);
* Are 25 years of age or older at time of enrollment;
* Have an interval from their chest RT to the time of enrollment of at least 8 years;
* Have a smartphone;
* Are English-speaking.

Participants will be selected from women in the Childhood cancer Survivor Study (CCSS) cohort.
Study of Oral Anthocyanins on Insulin Resistance

Dietary strategies for alleviating the metabolic complications such as diabetes associated with obesity are actively being pursued as alternatives to pharmaceutical interventions The genus Vaccinium (e.g. blueberry, blaeberry, cranberry) has been used traditionally as a source of folk remedies for established diabetic symptoms, primarily as leaf or stem infusions or decoctions. Berries from this family such as blaeberry (BL) and blueberry (BB) are enriched in anthocyanins, polyphenolics recognized for their ability to provide and activate cellular antioxidant protection, inhibit inflammatory gene expression, and consequently protect against oxidant-induced and inflammatory cell damage and cytotoxicity. The association of obesity with adipose tissue stress, macrophage recruitment, and inflammatory gene expression suggests that eating edible berries from this genus might provide an effective alternative or supplementary intervention to attenuate obesity- associated inflammation and the associated insulin resistance.

The aim of this study is to determine the effects of anthocyanin supplementation in the form of a concentrated blaeberry extract on insulin resistance and inflammation particularly in the adipose tissue following a three week supplementation period.


Eligibility Criteria:
Inclusion Criteria:

* Obese male subjects (BMI \> 30)
* Aged \> 40 and \< 70 years of age
* Type 2 diabetes; subjects controlling their diabetes by diet alone or with impaired glucose tolerance
* All the obese subjects will have a waist circumference over 40 inches
* All subjects must live the Aberdeenshire area of Scotland

Exclusion Criteria:

Medical exclusion criteria:

* Chronic illness, including:

  * thromboembolic or coagulation disease,
  * unregulated thyroid disease,
  * kidney disease,
  * hepatic disease,
  * severe gastrointestinal disorders,
  * pulmonary disease (e.g. chronic bronchitis, COPD),
* Alcohol or any other substance abuse,
* Eating disorders,
* Psychiatric disorders (including severe depression, lithium treatment, schizophrenia, severe behavioural disorders),
* Skin conditions on the abdomen,
* Allergy to skin dressings,

Medication exclusion criteria:

* Oral steroids,
* Tricyclic antidepressants, neuroleptics,
* Anticoagulants,
* Digoxin and antiarrhythmics,
* Chronic use of antiinflammatories (e.g. high doses of aspirin, ibuprofen),
* Insulin, Sulphonylureas, Thiazolidinediones (glitazones), metformin
Toripalimab Plus Neoadjuvant Chemotherapy Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

This Phase II non-randomized study is to determine the efficacy and toxicity of neoadjuvant toripalimab plus chemotherapy followed by chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma.

This Phase II non-randomized study is to determine the efficacy and toxicity of neoadjuvant toripalimab plus chemotherapy followed by chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma.

All patients were planned to receive 2 cycle of toripalimab plus paclitaxel/nedaplatin as neoadjuvant therapy. Then they all receive radical dose of chest radiation and concurrent chemotherapy of capecitabine (PO 1000 mg/m2, bid, d1-d14, q3w).

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed esophageal squamous cell carcinoma
* patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* unresectable T1-4 N0-3 M0-1 confirmed by CT or MRI (M1 only includes patients with lymph node metastasis in the supraclavicular region)
* ECOG performance status 0-1
* no previous chest radiotherapy, immunotherapy or biotherapy.
* hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
* serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
* bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
* FEV1 \>0.8 L
* CB6 within normal limits
* patients and their family signed the informed consents

Exclusion Criteria:

* previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ
* contraindication for chemotherapy
* women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
* women who has the probability of pregnancy without contraception
* tendency of hemorrhage
* in other clinical trials within 30 days
* addicted in drugs or alcohol, AIDS patients
* uncontrollable seizure or psychotic patients without self-control ability
* severe allergy or idiosyncrasy
* not suitable for this study judged by researchers
Study Comparing Full-dose Radiotherapy Versus Reduced Dose in the Management of Bone Metastasis in Patients With Breast Cancer Receiving Zoledronic Acid

The aim of this prospective, randomized, open-label, multicentric clinical study is to assess the effícacy and tolerability of zoledronic acid 4 mg IV infused over 15 minutes every 4 weeks for a total of 6 infusions, in combination with standard or reduced dose radiotherapy in patients with breast cancer and metastatic bone disease associated with pain.


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged ≥ 18 years.
* Histologically confirmed diagnosis of breast cancer with at least one bone metastases.
* Radiologically documented solitary or multiple osteolytic or osteoblastic lesions in axial skeleton or in the extremities in which radiotherapy is indicated.
* Pain and/or analgesic score ≥ 3 (see section 3.5.2) at the bone site to be irradiated.
* ECOG performance status ≤ 2.
* Life expectancy more than 6 months.

Exclusion Criteria:

* Patients in whom the target lesion(s) is not detectable by conventional techniques (i.e. X-rays MRI or CT scan).
* Presence of pathological fracture in the target lesion(s).
* Prior irradiation of the painful area(s) to be irradiated.
* Known hypersensitivity to zoledronic acid or other biphosphonates.
* Previous treatment with bisphosphonates for the current disease; any treatment with biphosphonates for other indications should anyway have been discontinued at least two years before randomization into the study.
* Skeleton-related complications (e.g., pathological fractures, orthopedic intervention to treat or stabilize an osteolytic defect, spinal cord compression) during the last 3 weeks prior to the first infusion of trial medication.
* Change in anticancer therapy within the 2 weeks prior to screening assessments and/or test treatment start.
* Patients with severe renal function (serum creatinine \> 400 umol/l or \> 4.5 mg/dl or calculated creatinine clearance ≤ 30 ml/minute) or with prior renal transplantation. Creatinine clearance will be calculated using the following formula:

Creatinine clearance = (140-age\[yr\])(body weight \[kg\]) x 0.85 (72) (serum creatinine \[mg/dL\]) or Creatinine clearance = (140-age\[yr\])(body weight \[kg\]) x 0.85 (0.814) (serum creatinine \[µmol/L\])

* Corrected (adjusted for serum albumin) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/L).
* Patients with clinically symptomatic brain metastases
* Bone metabolism disorder, e.g. Paget disease, primary hyperparathyroidism
* Serious intercurrent illness other than breast cancer that can interfere with the evaluation of the effect of the therapy.
* Pregnancy and lactation.
* Women of childbearing potential not on an effective form of contraception.
* Known history or present abuse of alcohol or drugs (accepted social alcohol usage will not exclude the patient)
* Patients who, in the opinion of the investigator, are unlikely to cooperate fully during the study.

Other protocol-defined inclusion/exclusion criteria may apply.
Evaluation of the Clinical Efficacy and Safety of BriTurn Injection or BrisTurn Prefilled Injection

This study evaluate clinical efficacy and safety in adult patients administered BriTurn injection or BrisTurn Prefilled injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium.

This study evaluate clinical efficacy and safety in adult patients administered BriTurn injection or BrisTurn Prefilled injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium.

* Efficacy: Time (minutes) for Train-Of-Four (TOF) ratio to reach 0.9 (90%)
* Safety: whether bradycardia and resulting cardiac arrest occur or whether bronchospasm occurs

Eligibility Criteria:
Inclusion Criteria:

* Adults over 19 years of age
* Subject administered BriTurn Injection or BrisTurn Prefilled Injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium

Exclusion Criteria:

* Pregnant women or nursing women
* Subject to prohibition according to the permission of BriTurn Injection or BrisTurn Prefilled Injection
A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney

The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.

The study has two primary endpoints. The first primary completion date is anticipated to be reached July 2022 (DFS in Part A). The second primary completion date is anticipated to be reached July 2024 (DFS in Part B).

Eligibility Criteria:
Inclusion Criteria:

* Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy
* Pathologic tumor, node, and metastasis (TNM) staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, (a, b, c), G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0
* Post-nephrectomy tumor shows renal cell cancer (RCC) with a predominantly clear cell histology, including participants with sarcomatoid features
* Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
* Women must agree to follow methods of contraception, if applicable

Exclusion Criteria:

* Participants with an active known or suspected autoimmune disease
* Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
* Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
* History of allergy or hypersensitivity to study drug components
* Participants with a condition requiring systemic treatment with corticosteroids
* Participants who have received a live/attenuated vaccine within 30 days of first treatment

Other protocol-defined inclusion/exclusion criteria apply