cyrilzakka/clinical-trials huggingface dataset:
A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma

This is a multicenter, open-label study to evaluate the safety and efficacy of C-CAR088 in patients with relapsed or refractory multiple myeloma. The phase Ib part of this study is to determine the recommended phase 2 dose (RP2D) of C-CAR088 in the targeted patient population.

The study includes the following sequential procedures: Screening, Apheresis and C-CAR088 manufacturing, Baseline testing, Lymphodepletion, C-CAR088 infusion, and Follow-up Visit. Two dose levels of C-CAR088 will be tested during the phase Ib part to determine RP2D, which will be further evaluated during the phase II part.

Eligibility Criteria:
Inclusion Criteria

* ≥ 18 years of age, male or female patients
* Relapsed or refractory multiple myeloma
* Have been treated with ≥ 3 prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory drug, and had progressed during or within 12 months post the last treatment.
* Had measurable disease as defined by any of the following criteria:

  * Serum M protein ≥ 0.5g/dL
  * Urine M protein ≥ 200mg/24h
  * Serum free light chain (sFLC): abnormal κ/λ ratio with involved sFLC ≥ 100mg/L
* Adequate liver, renal, bone marrow, and heart function
* Eastern cooperative oncology group (ECOG) 0-1

Exclusion Criteria

* Any known allergies to the components or excipients of the C-CAR088 cell product
* Prior allogeneic hematopoietic stem cell transplantation (HSCT) at anytime, or autologous stem-cell transplantation (ASCT) within 12 weeks prior to apheresis
* Central nervous system (CNS) involvement
* Stroke or convulsion history within 6 months prior to signing informed consent form (ICF)
* Plasma leukemia
* Autoimmune disease, immunodeficiency or diseases requiring immunosuppressants treatment
* Uncontrolled active infection; active hepatitis B virus (HBV), hepatitis C virus (HCV) infection; HIV or syphilis infection
* Severe heart, liver, renal or metabolism disease
* Inadequate wash-out time for previous anti-tumor treatments prior to apheresis
* Previous CAR-T cell treatment, genetically modified T-cell therapies or BCMA-directed treatment history
* History or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial
Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

This is an efficacy study of Bromfenac Ophthalmic Solution in cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years of age who are scheduled for unilateral cataract surgery

Exclusion Criteria:

* Have known hypersensitivity to bromfenac or to any component of the investigational product
Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Primary Axillary Hyperhidrosis

This study is intented to evaluate the efficacy and safety of MEDITOXIN compared to placebo in treatment of primary axillary hyperhidrosis.


Eligibility Criteria:
Inclusion Criteria:

* adult patients aged from 20 to 65, with persistent bilateral primary axillary hyperhidrosis

Exclusion Criteria:

* those who have secondary hyperhidrosis
* those who have systemic neuromuscular junction disorders
* women who are pregnant or lactating
Tenofovir in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus

Immunoprophylaxis failure of hepatitis B virus (HBV) leading to vertical transmission remains a concern and has been reported in approximately 8-15% of infants born to hepatitis B e antigen (HBeAg) positive mothers with high levels of HBV DNA. Maternal HBV DNA \> 6log10 copies/mL (or \>200,000 IU/mL) is the major risk for the mother-to-child transmission. Prior observational studies have shown that antiviral therapy including lamivudine or telbivudine use during late pregnancy can safely reduce the rate of vertical transmission in this special population compared to untreated patients.

Tenofovir Disoproxil (TDF), a pregnancy category B medication, reduces HBV DNA and normalizes serum alanine aminotransferase (ALT) in chronic hepatitis B patients (CHB) with few adverse effects. Two aspects on tenofovir use in pregnancy will be evaluated prospectively in this study:

1. The data on its tolerability and safety in HBeAg+ pregnant women with HBV DNA \> 6log10 copies/mL (or \> 200,000 IU/mL) during late pregnancy and infants.
2. Its efficacy in the reduction of HBV vertical transmission rate.

Eligible mothers will be randomized (1:1) to either TDF-treated group or untreated group with about 100 subjects in each arm. The treatment group will receive TDF starting at week 30-32 of gestation until week 4 postpartum; follow up will continue until post-partum week 28 and infants age of 28 weeks. Untreated group will receive the standard of care with similar follow-up schedule as the treatment group.

Eligibility Criteria:
Inclusion Criteria:

* documented CHB infection with HBsAg positive \> 6 months
* HBeAg+ CHB pregnant women
* gestational age between 30-32 weeks
* HBV DNA \> 6 log10 copies/mL (or \>200,000 IU/mL)
* both mother and father of the child are willing to consent for the study

Major Exclusion Criteria:

* co-infection with hepatitis A, C, D, E, HIV-1 or sexually transmitted disease (STD)
* decompensated liver disease or significant co-morbidity
* history of abortion, or diagnosis of fetal defect, or congenital malformation in prior pregnancy
* antiviral used within six months prior to this pregnancy, or history of renal or tubular function impairment due to adefovir.
* requirement for other medication during pregnancy to manage other chronic disease(s) or concurrent treatment with immune-modulators, cytotoxic drugs, or steroids
* the biological father of the child had CHB
* clinical signs of threatened miscarriage in early pregnancy
* evidence of hepatocellular carcinoma
* maternal alanine aminotransferase (ALT) \> or = 5 x upper limit of normal (U/mL), or Total Bilirubin \> or = 2, or glomerular filtration rate (GFR) \< 100, or Albumin \< 25 g/L
* evidence of fetal deformity by ultrasound examination
* patient is participating other clinical study
Worksites, Occupational Nurses and Cholesterol Change

To study the relative effectiveness of teaching occupational nurses to conduct cholesterol screening, counseling and referral events (SCOREs) in their own worksites versus using an external organization to implement these programs. Also. to study the relative effectiveness of face-to-face behavior change counseling following the cholesterol measurement versus automated feedback of essentially the same individualized educational material.

DESIGN NARRATIVE:

The research design was a 2 x 2 design with repeated measures at six and 12 months after the baseline measurement and treatment application. The investigators tested the relative effectiveness of two major dimensions of blood cholesterol change programming in worksites of 250 - 800 employees with at least one occupational nurse. The overall design was 2 x 2 with 10 of 25 worksites randomly assigned to an Internal Condition and 10 worksites assigned to an External Condition. In the Internal Condition, occupational nurses were trained by project staff to implement the SCOREs and were given Reflotron portable dry chemistry analyzers to measure cholesterol. In the External Condition, the SCORE was conducted by an external organization (project staff). Five (5) worksites from each of the above conditions had the educational session of the SCORE delivered face-to-face \[Face-to-Face condition (FF)\] by either the nurse or project staff, depending on the condition (Internal + FF or External + FF). The other 10 worksites had this education delivered by a microcomputer/optical scanner (the RT 2000) that read the participant's risk factor and self-reported eating pattern information and delivered a print-out with recommendations that were prioritized and individualized for the participant (RT intervention was delivered by the nurse or project staff depending on the condition (Internal + RT or External + RT). All SCORE participants in the above 20 worksites also received a self-help nutrition change kit. This cross design allowed testing for possible interaction effects.

Another group of five worksites was also included which served as a comparison group for the External Condition. The employees in this group received a screening and education experience similar to the usual type of program offered by external, commercial screeners with minimal written education materials and no individualized feedback (Usual Care External Condition). The primary dependent variables included measured blood cholesterol, weight, other CHD risk factors, and self-reported eating pattern. Change were assessed six and 12 months after the SCOREs were conducted. A wide range of other variables including process, cost and mediating variables were assessed through the project period.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Lenalidomide in Combination With R-GemOx in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma

The purpose of this study is to investigate efficacy and safety of Lenalidomide in combination with R-GemOx as first-line treatment of elderly patients with Diffuse large B cell lymphoma.

Gemcitabine and Oxaliplatin(GemOx) shows effective activity in patients with relapsed diffuse large-cell lymphoma and other solid tumors. The purpose of this study is to investigate efficacy and safety of Lenalidomide in combination with R-GemOx as first-line treatment of elderly patients with Diffuse large B cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

1. The histopathologic diagnosis was DLBCL (except primary mediastinal large B cell lymphoma, primary central lymphoma, HIV related lymphoma).
2. Age older than 70 years or older than 60 years with Eastern Cooperative Oncology Group(ECOG) performance status(PS) ≥ 2;
3. Expected survival ≥ 12 weeks;
4. At least a measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm);
5. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements;
6. All patients must agree to take effective contraceptive measures during the trial measures

Exclusion Criteria:

1. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons
2. Patients known to have varicella or herpes zoster virus infection
3. Previous exposure to any anti-tumor therapy
4. Poor hepatic and/or renal function, unless these abnormalities were related to the lymphoma
5. Poor bone-marrow reserve, defined as neutrophil count less than 1.5×109/L or platelet count less than 75×109/L, unless caused by bone marrow infiltration
6. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within past 12 months
7. New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome#acute heart failure#severe ventricular arrhythmia
8. Central nervous system (CNS) or meningeal involvement
9. Known sensitivity or allergy to investigational product
10. Major surgery within three weeks
11. Patients receiving organ transplantation
12. Patients with secondary tumour, excluding cured (5 years without relapse) in situ Non-melanoma skin cancer. superficial bladder cancer, in situ cervical cancer, Gastrointestinal intramucous carcinoma and breast cancer
13. Presence of Grade III nervous toxicity within past two weeks
14. Active and severe infectious diseases
15. Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment
16. In any conditions which investigator considered ineligible for this study.
17. Histologic transformation
Locoregional Administration of TIL and Lymphodepletion in Patients With Melanoma and Liver Metastases

Evaluate the safety and tolerability of treatment with autologous tumor infiltrating lymphocytes (TIL) administered via hepatic arterial infusion and preconditioning with percutaneous hepatic perfusion in patients with liver metastases (but not restricted to) of malignant melanoma


Eligibility Criteria:
Inclusion Criteria:

* Patient is willing and able to provide written informed consent and comply with study procedures. Written informed consent must be signed and dated before the start of specific protocol procedures.
* Patient must have a histologically/cytologically confirmed diagnosis of:
* stage IV uveal melanoma with or without any previous systemic therapy OR
* stage IV cutaneous melanoma with confirmed progression following at least one or two prior systemic therapies including a programmed cell death protein-1 (PD-1) inhibitor with or without a CTLA-4 inhibitor; and if BRAF V600 mutation-positive, also a BRAF inhibitor or a BRAF inhibitor in combination with a MEK inhibitor.
* Measurable disease by computed tomography (CT) per RECIST 1.1 criteria with at least one target lesion identified in the liver and where the distribution pattern of metastasis is predominantly engaging the liver as judged by the investigator.
* At least one resectable lesion in the liver (or aggregate of lesions resected) of a minimum size of 0.5 cm in diameter post- resection to generate TILs.
* ECOG performance status of 0 - 1.

Exclusion Criteria:

* Life expectancy of less than 3 months.
* Reduced renal function defined as S-Creatinine \>=1.5xULN or Creatinine Clearance \< 40 mL/min, calculated using the Cockroft and Gault formula.
* Reduced hepatic function (defined as ASAT, ALAT, bilirubin \> 3\*ULN and PK- INR \> 1.5) or medical history of liver cirrhosis or portal hypertension.
* Hemoglobin \<90 g/L or platelets \<100x109/L or neutrophils \<1.5x109/L
* Use of live vaccines four weeks before or after the start of study.
* Infection of human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), hepatitis B or hepatitis C.
* Active autoimmune disease.
* A condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \>10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
* Concomitant therapy with any other anti- cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications or use of other investigational drugs.
* Has a known additional malignancy of other diagnosis that is progressing or requires active treatment.
* A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator
The Efficacy of Salvage BGD With autoSCT Consolidation in Advanced Classical HL Patients Not Responding to ABVD

The objective of the study is evaluation of efficacy of Bendamustine, Gemcytabine, Dexamethasone (BGD) salvage therapy with autologus stem cell transplantation (ASCT) consolidation in advanced classical Hodgkin lymphoma patients not responding to ABVD therapy.

Treatment regimen:

Bendamustine (B) 90 mg/m2 iv day 1, 2 Gemcytabine (G) 800 mg/m2 iv day 1, 4 Dexamethasone (D) 40 mg iv/po day 1,2,3,4

Course of treatment every 21-28 days, 4 courses of treatment max; next round of treatment may be given if ANC\>1000/μl and PLT\>75000/μl. Up to 7-day delay is permitted.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed Classical Hodgkin's Lymphoma treated with ABVD regimen with PET scan/CT performed before, during and after treatment, and also one of the following:

  * positive result (Deauville 4 and 5) of early PET scan after 2 ABVD courses
  * disease progression or relapse after first-line ABVD treatment or ABVD and radiotherapy combination treatment
* No contraindications for salvage chemotherapy and ASCT
* At least one measurable malignancy
* ECOG performance status ≤ 3
* Written signed and dated informed consent prior to any study procedures being performed

Exclusion Criteria:

* Non-Classical Hodgkin's Lymphoma
* Other than ABVD first-line treatment, preceding patient's inclusion
* Lack of PET scans performed in accordance with inclusin criteria during ABVD treatment
* Transformation of Hodgkin's Lymphoma
* Central Nervous System (CNS) Metastases
* Contraindications for ASCT or lack of patient's consens for the procedure
* Second malignancy - active or cured less than 5 years prior
* Uncontrolled diabetes
* Hepatic impairment (bilirubin concentration ≥ 1.5 x ULN, SGOT \> 5 x ULN), if non-realted to the lymphoma or Gilbert's syndrome
* HIV infection
* Active HBV or HCV infection. Subjects who have had Hepatitis B and are abHBC positive, need to undergo HBV DNA test using a Polymerase Chain Reaction (PCR) technique and be applied appropriate preventive treatment.
* Pregnancy or lactation
* Hypersensitivity to any of the drugs
* Lack of written informed consent
Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

This is a prospective, randomised, multicenter, no placebo-controlled, open label study for evaluating the efficacy and safety of pyrotinib in women with residual invasive HER2-positive breast cancer after neoadjuvant chemotherapy plus anti-HER2 target therapy. The main purpose is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer based on the 1-year trastuzumab standard adjuvant treatment with or without pertuzumab.


Eligibility Criteria:
Inclusion Criteria:

* Female, Aged ≥18 and ≤70 years;
* Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ) ;
* Completed neoadjuvant therapy, including chemotherapy and trastuzumab;
* Residual invasive disease was detected pathologically in the surgical specimen of the breast or axillary lymph nodes after completion of neoadjuvant chemotherapy;
* Been or being treated for early breast cancer with standard of care duration of trastuzumab;
* Adjuvant treatment regimen needs to be determined before randomization;
* Duration from Random time to the last use of trastuzumab≤1 year.
* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
* Required laboratory values including following parameters:ANC: ≥ 1.5 x 109/L; Platelet count: ≥ 100 x 109/L; Hemoglobin: ≥ 9.0 g/dL; Total bilirubin: ≤ 1.5 x upper limit of normal, ULN; ALT and AST: ≤ 1.5 x ULN; BUN and creatine clearance rate: ≥ 50 mL/min; LVEF: ≥ 50%; QTcF: \< 470 ms
* Signed informed consent form (ICF) .

Exclusion Criteria:

* Metastatic disease (Stage IV) ;
* Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;
* Progressive disease during neoadjuvant therapy;
* Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;
* Treated or treating with anti-HER2 TKI, including but not limited to pyrotinib, lapatinib and neratinib.
* Less than 4 weeks from the last clinical trial;
* History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation;
* Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial;
* Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test;Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period;
* Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.
Safety and Performance Study of the INGEVITY Lead

The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.

The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads

Eligibility Criteria:
Inclusion Criteria:

* Subject is willing and capable of providing informed consent
* Subject has a Class I or II indication for implantation of a single(VVI (R) only) or dual chamber pacemaker or a CRT-P system according to the ACC/AHA/HRS, or ESC guidelines
* Subject is willing and capable of participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
* Subject is age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

* Subject has or has had any pacing or ICD system implants
* Subject has a sensitivity to dexamethasone acetate (DXA)
* Subject has a mechanical tricuspid heart valve
* Subject is enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries
* Subjects with documented permanent or persistent AF where the physician intends to implant dual chamber pulse generator (single chamber VVIR pulse generators in these subjects is acceptable)
* Subject is currently on the active heart transplant list
* Subject has documented life expectancy of less than 12 months
* Women of childbearing potential who are or might be pregnant at the time of study enrollment or INGEVITY Lead implant
* Subjects currently requiring dialysis