cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors

This is a first-in-human (FIH), multicenter, open-label Phase I study to evaluate the safety, tolerability, PK profile, immunogenicity, and preliminary efficacy of BA1302 in patients with advanced solid malignancies. The study includes a dose-escalation phase (Part A) and a dose-expansion phase (Part B).


Eligibility Criteria:
Inclusion Criteria:

* 1. Metastatic or unresectable solid malignancy that is histologically or cytologically confirmed. Patients who have progressed on or after standard therapy, or are intolerant of standard therapy, or have no appropriate standard therapy available.

  1. Part A: Advanced malignant solid tumors;
  2. Part B: Metastatic melanoma, Advanced breast cancer, Advanced Non-small cell lung cancer (NSCLC), Advanced pancreatic adenocarcinoma.
* 2.Participants should be able to provide adequate tumor tissue for biomarker analysis
* 3.ECOG Performance Status ≤ 1.
* 4.Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1)

Exclusion Criteria:

* 1. Malignant disease within 5 years prior to the first dose of investigational drug other than that being treated in this study. Except completely resected basal cell carcinoma, cutaneous squamous cell skin carcinoma and papillary thyroid carcinoma and completely resected carcinoma in situ of any type.
* 2. Received any chemotherapy, radiotherapy, targeted therapy, cell therapy, immunotherapy, ADC medication or other anti-cancer treatment within 28 days prior to the first dose.
* 3.History of severe hypersensitivity reactions to any ingredient of study drugs.
* 4.Pregnant or lactating women.
* 5.Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results.
PD-1 Antibody in Addition to BACE in Patients With NSCLC: A Randomised Controlled Trial

This is a randomized controlled trial to determine the efficacy and safety of PD-1 Antibody in addition to Bronchial Arterial Chemoembolization in stage III-Ⅳ NSCLC patients who failed, refused or ineligible to receive standard treatments.

Bronchial artery chemoembolization (BACE) is a technique of drug delivery and embolization performed via injecting anti-tumor drugs with drug carriers and implanting the embolization agents into the tumor feeding artery, promoting the clinical outcomes of patients and providing a palliative treatment option for patients with NSCLC. while the short-term effect of BACE is good, it is easy to relapse and metastasize.

The rapid development of immunotherapy checkpoint inhibitors represented by PD-1/L1 monoclonal antibody has changed the treatment pattern of NSCLC. The publication of early research data repeatedly verified the long-term survival benefit characteristics of PD-1/L1 in NSCLC.

Based on this research and clinical practice, we designed this trial to determine the efficacy and safety of PD-1 antibody in addition to Bronchial Arterial Chemoembolization in stage III-Ⅳ NSCLC patients who failed, refused or ineligible to receive standard treatments.

Eligibility Criteria:
Inclusion Criteria:

1. Patient age between 18 and 75
2. Signed Informed Consent Form.
3. Confirmed TNM stage is III-Ⅳ of NSCLC ，and failed, refused or assessed ineligible to receive conventional treatments (surgery, chemoradiotherapy, chemotherapy )； Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
4. Adequate hematologic and end-organ function.
5. Expected life span \> 3 months.
6. Be able to provide fresh or archival tumor tissues for PD-L1 expression in tumor cells

Exclusion Criteria:

1. Prior treatment targeting PD-1, PD-L1 or CTLA-4.
2. Prior therapies of interventional therapy (I seed implantation, Ablation, BACE).
3. Harboring EGFR sensitizing mutation or ALK gene translocation
4. History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline.
5. With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.
6. Symptomatic central nervous system metastasis
7. Known HIV infection, participants with untreated chronic hepatitis B, active vaccination treatment.
8. Prior allogeneic stem cell transplantation or organ transplantation
9. Active autoimmune diseases or history of autoimmune diseases that may relapse.
10. With conditions requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone or equivalent) or other immunosuppressive medications
11. Known to be hypersensitive to contrast agent;
12. Pregnant or breastfeeding women;
13. Other protocol defined Inclusion/Exclusion criteria may apply
A Phase 2 Study of ASC-J9 Cream in Acne Vulgaris

The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating acne.

Subjects with acne were randomized to one of four treatment groups for twice daily topical dosing to the face for 12 weeks. Assessments of acne status were performed at Baseline, Weeks 2, 4, 8 and 12 and then 4 weeks after the last dose of study drug.

Eligibility Criteria:
Inclusion Criteria:

* At least 12 years of age.
* Facial acne, with:

  20 -100 inflammatory facial lesions 20 -100 noninflammatory facial lesions No more than 2 nodules/cysts on the face

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Skin diseases other than acne vulgaris
* Use of oral retinoids within 6 months of Baseline Visit
* Unwilling to discontinue all other treatments for facial acne
* Unwilling to avoid excessive swimming/sun exposure and use of cosmetics
Efficacy of a Clinical Algorithm for the Selection of Peripheral Venous Catheters

The aim of this observational study is to investigate the complications associated with peripheral venous catheterization based on whether a correct or incorrect catheter was used according to a clinical algorithm in patients admitted to an acute care unit. The main question it seeks to answer is:

• Are there fewer complications associated with catheterization when a correct catheter choice is made? Data from patients admitted to the acute care units of the sponsoring study center will be reviewed.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to acute care hospital wards.
* Carriers of a peripheral venous catheter.
* With the study evaluation criteria documented in their medical records.

Exclusion Criteria:

* Admitted to gynecology, obstetrics, and pediatrics wards.
* Admitted to the emergency department and intensive care units
miPlan: A Trial of miPlan Intervention vs. Standard of Care

Using our experience in digital media, behavior theory, client-centered interventions, and family planning, we have prototyped a digital application ("app")-miPlan-to be used in the clinic waiting room prior to a contraceptive visit. The goal of this research is to refine the app and conduct a randomized controlled trial of the miPlan intervention vs. standard care. The aim of this study is to understand miPlan's impact. The primary outcome is LARC uptake at clinic discharge. The secondary outcomes are contraceptive use at discharge, self-efficacy and decisional balance for highly effective contraception post-app use, contraceptive satisfaction, and intention to continue method use. The research will consist of baseline activities as well as a three-month follow-up call.

Using our experience in digital media, behavior theory, client-centered interventions, and family planning, we have prototyped a digital application ("app")-miPlan-to be used in the clinic waiting room prior to a contraceptive visit. The goal of this research is to refine the app and conduct a randomized controlled trial of the miPlan intervention vs. standard care contraceptive counseling. The aim of this study is to understand miPlan's impact in terms of contraceptive knowledge, intentions and behaviors. The primary outcome is LARC uptake, which will be measured via chart review at clinic discharge, i.e. immediately following a patient's family planning visit. The secondary outcomes are contraceptive use at discharge (measured via chart review immediately following patient's family planning visit), self-efficacy and decisional balance (both measured via adapted validated scales for each) for highly effective contraception post-app use (measured immediately following intervention and prior to contraceptive counseling session), contraceptive satisfaction (measured at 3 months post baseline), and intention to continue method use (measured at 3 months post baseline). The research will consist of baseline activities as well as a three-month follow-up call.

Eligibility Criteria:
Inclusion Criteria:

* African American or Latina female and sexually active with a male partner(s) within the past 6 months,
* age 15 to 29 years
* present for contraception initiation
* English speaking

Exclusion Criteria:

* not currently pregnant or intending pregnancy within the next 6 months
* and not currently using LARC
* not highly intending LARC at enrollment
Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC

Concurrent cisplatin-based chemotherapy plus radiotherapy increased the risk of treatment-related death and severe acute toxicity. The survival benefit of adding concurrent chemotherapy to intensity modulated radiation in patients with locoregionally advanced nasopharyngeal carcinoma is unclear. Gemcitabine plus cisplatin chemotherapy combine with radiotherapy was effective and well tolerated by patients with locoregionally advanced NPC.

The purpose of this study is to compare gemcitabine plus cisplatin induction chemotherapy combine intensity-modulated radiotherapy with or without concurrent cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to reevaluate the value of concurrent cisplatin when 4 cycles induction chemotherapy (gemcitabine+cisplatin) and IMRT is used.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO 2005) histologically type).
* A Karnofsky performance status of at least 80;
* Tumor staged is according to the 7th American Joint Commission on Cancer edition as Stage III：T1-2N2M0, T3N0-2M0 Stage IVa：T4N0-2M0 Stage IVb：Any T、N3.
* Adequate marrow: a WBC ≥3.5×109 l-1; a platelet count ≥100×109 l-1; and hemoglobin levels ≥100 g/l.
* Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
* Adequate renal function: a creatinine clearance rate of at least 60 mL/min.
* Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

* WHO Type keratinizing squamous cell carcinoma.
* Age \>65 years or \<18 years.
* Distant metastasis,
* Treatment with palliative intent.
* Pregnancy or lactation.
* a history of previous radiotherapy in the nasopharyngeal region or previous chemotherapy.
* history of renal disease, unstable cardiac disease requiring treatment.
The Multi-Center Clinical Study of Tang Shen Prescription on Type 2 Diabetic Kidney Disease in Early Stage

This study is a randomized, double-blinded, placebo-controlled clinical trial on type 2 diabetic Kidney Disease in early stage ( microalbuminuria excretion rate = 20-200mg/min) to evaluate the therapeutic effect of tang shen prescription. 632 participants will be recruited for the study, all of whom had type 2 diabetes, serum creatinine concentrations is normal, and no evidence of non-diabetic renal diseases. The subjects will be randomized to treatment with either tang shen prescription or placebo.

This study is a randomized, double-blinded, placebo-controlled clinical trial on type 2 diabetic Kidney Disease in early stage ( microalbuminuria excretion rate = 20-200ug/min) to evaluate the therapeutic effect of tang shen prescription.632 participants will be recruited for the study, all of whom had type 2 diabetes, serum creatinine concentrations is normal, and no evidence of non-diabetic renal diseases. The study will last for 24 weeks. Subjects will be randomly divided into two groups, either tang shen prescription or placebo，and both of them would be performed on a basic treatment which includes diabetes education, diabetic diet, rational control of blood glucose, and losartan at 50 mg daily, study group take tang wang prescription. Measurements of microalbuminuria excretion rate, albumin-to-creatinine ration, glomerular filtration rate (GFR), serum creatinine concentrations will be tested monthly, and quantity of 24h urinary protein per three months.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of type 2 diabetic Kidney Disease in early stage;
2. Aged 30-70;
3. Signed the informed consent.

Exclusion Criteria:

1. Non-diabetic renal disease, such as gout, essential hypertension, tumors, and chronic kidney disease which may cause proteinuria or microalbuminuria.
2. Cardiovascular disease、hepatopathy、kidney disease and hematopoietic disease et al, the serum transaminase was two times larger than the normal valuet、serum creatinine concentration greater than the upper limit of normal value and psychiatric disease.
3. Women with Pregnancy or prepare for pregnancy or lactating.
4. Degree of renal failure have developed to the stage of hypoxemia and uremia.
5. Patients participate in other clinical researchers within a month.
6. Patients have been treated with the angiotensin receptor blocker (ARB) drugs to treat diabetic kidney disease except for losartan within a month.
7. Patients have been treated with angiotensin-converting enzyme inhibitors (ACEI) drugs to treat diabetic kidney disease within a month.
8. Systolic blood pressure over 160mmHg or diastolic blood pressure over 100mmHg.
9. Patients with diabetic ketosis, ketoacidosis and severe infections within a month.
10. Patients addicting alcohol, psychoactive substances within 5 years.
11. According to the researcher's judgment, there are other diseases or situations that can reduce the possibility of entering the group or complicate the group, such as frequent changes in the working environment and unstable living environment.
Diagnosis and Therapy of Vulnerable Atherosclerotic Plaque

The aim of the present study is to examine the atherosclerotic plaque stability using in vivo and in vitro techniques and to investigate the influence of exercise, anti-diabetic, lipid-lowering and cannabinoids receptor antagonists on atherosclerotic plaque texture in patients with cardiovascular risk and animals prone to atherosclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Carotid atherosclerosis
* Femoral atherosclerosis
* Cardiovascular risk

Exclusion Criteria:

* Heart failure
* Renal disease
* Liver disease
* Life-threatening diseases
Jugular Venous Flow Neurosurgical Patients

Our hypothesis is that there will be a decrease in internal jugular venous flow in the park bench position when compared to the supine position. There will also be a change in blood flow between the right and left internal jugular veins in the park bench position. In particular, there will be a greater reduction of flow on the dependent side. However, the internal jugular venous flow will be the same in both the prone and supine positions.

The different positions used in neurosurgery for better accessibility to the operating field (park bench, prone) can impact cerebral venous drainage due to the effects of internal jugular venous outflow of blood, and may increase intracranial pressure. Excessive neck flexion and rotation in the park bench position, or flexion in the prone position, may lead to kinking or twisting of the internal jugular vein. This has been hypothesized as the major cause of disturbed venous drainage during surgery and may lead to neck swelling, brachial plexus injury, macroglossia (swollen tongue), delayed airway obstruction, and increases in intracranial pressure in postoperative patients. Optimal brain perfusion is best in the neutral position of the head, but surgery cannot always be performed in this position. Thus, we look to measure the internal jugular venous flow at different positions, as there have been few studies looking at this important contributing factor.

Eligibility Criteria:
Inclusion Criteria:

* Adult neurosurgical patients who are above the age of 18
* Patients undergoing neurosurgery requiring general anesthesia and placement in either in prone or park bench position for surgical accessibility

Exclusion Criteria:

* Lack of informed consent
* Patients undergoing surgical procedures only in the supine position
* Patients needing a central venous catheter in the neck
Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia

The study is designed to determine the effects of an investigational drug Monofer in subjects with non-dialysis dependent chronic kidney disease (NDD-CKD) subjects and with iron deficiency anaemia (IDA).


Eligibility Criteria:
Inclusion Criteria:

1. Men and women, aged more than 18 years.
2. Subjects diagnosed with NDD-CKD with MDRD calculated eGFR between 15-59 mL/min.
3. Hb \< 11.0 g/dL (6.80 mmol/L)
4. Either or both of the following iron stores indicators below target {Serum ferritin \< 100 ug/l and Transferrin saturation (TfS)\<20%}.
5. Life expectancy beyond 12 months by Principal Investigator's judgement.
6. Willingness to participate after informed consent and any authorization as required by local law ( e.g. Protected Health Information \[PHI\] for North America).

Exclusion Criteria:

1. Anaemia predominantly caused by factors other than renal impairment or iron deficiency (according to Principal Investigator's judgment).
2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis).
3. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulphate or any excipients of the study drug.
4. Subjects with history of multiple allergies.
5. Decompensated liver cirrhosis or active hepatitis (Alanine Aminotransferase (ALT) \> 3 times upper normal limit).
6. Active acute or chronic infections ((assessed by clinical judgment), supplied with White Blood Cells (WBC) and C-Reactive Protein (CRP)).
7. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
8. Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product (5 days): Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches).
9. Extensive active bleeding necessitating blood transfusion.
10. Planned elective surgery during the study.
11. Participation in any other clinical study within 3 months prior to screening.
12. Known intolerance to oral iron treatment.
13. Untreated B12 or folate deficiency.
14. I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit.
15. ESA treatment within 8 weeks prior to screening visit.
16. Serum ferritin \> 500 µg/L.
17. Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study or interfere with study drug evaluation. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
18. Body weight \< 30 kilograms.
Comparison of Adhesive Glue With Skin Suture for Repair of Episiotomy

Surgical repair of perineal lesions after delivery is frequently associated with pain and discomfort interfering with the normal activities of the puerperium. The aim of this study was to compare perineal skin repair after episiotomy with adhesive glue versus a subcuticular suture, regarding the incidence of pain and wound complications.


Eligibility Criteria:
Inclusion Criteria:

* vaginal delivery
* episiotomy performed
* no further perineal or vaginal lesions present

Exclusion Criteria:

* previously existing local infections or lesions
* body mass index \> 35 (Kg/m2)
* severe pulmonary disease
* collagen disease
* known immunodeficiency
* diabetes mellitus
* immunosuppressive treatment
Increasing Treatment Efficacy Using SMART Methods for Personalizing Care

The proposed study will determine the feasibility, tolerability, and acceptability of a study that tests: 1) personalized treatment delivery (i.e., module sequencing and treatment discontinuation timing) aimed at increasing the efficiency of care, and 2) the research protocol designed to evaluate the effects of this personalized care. A sample of 60 participants with heterogeneous anxiety disorders (and comorbid conditions, including depression) will be enrolled in a pilot sequential multiple assignment randomized trial (SMART). Patients will be randomly assigned to one of three sequencing conditions: transdiagnostic treatment administered in its standard module order, module sequences that prioritize capitalizing on relative strengths, and module sequences that prioritize compensating for relative weaknesses. Next, after 6 sessions, participants will be randomly assigned to either continue or discontinue treatment to evaluate post-treatment change at varying levels of target engagement. This proposal will enable us to 1) test the feasibility, acceptability, and tolerability of the research protocol, treatment sequencing conditions, and early treatment discontinuation, 2) determine whether a preliminary signal that capitalization or compensation module sequencing improves treatment efficiency exists, and 3) explore preliminary associations between core process engagement at treatment discontinuation and later symptom improvement. The proposed study, and the subsequent research it will support, will inform evidence-based decision rules to make existing treatments more efficient, ultimately reducing patient costs and increasing the mental health service system's capacity to address the needs of more individuals.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of at least one anxiety disorder, trauma- or stressor-related disorder, or obsessive-compulsive disorder
* fluent in English
* medication stability

Exclusion Criteria:

* concurrent therapy
* psychological condition that would be better addressed by alternative treatments
* have received more than 5 sessions of cognitive behavioral therapy in the past 5 years