cyrilzakka/clinical-trials huggingface dataset:
China Salt Substitute Study

Cardiovascular disease is a leading cause of death and disability worldwide, and blood pressure is a leading determinant of this risk. To date, strategies for blood pressure lowering have focused on drug treatment but dietary interventions such as reducing sodium intake and increasing potassium intake may also be effective. Such interventions may be particularly suitable for low- and middle-income countries in which significant dietary changes may be more easily achieved. This study will test the effect of a salt substitute on blood pressure, among individuals at high-risk from cardiovascular disease in Northern China.

This randomised trial will clearly identify whether a low-sodium, high-potassium salt-substitute is a feasible means of lowering blood pressure in high-risk individuals in rural China. The randomised design and the large size (n=600) will ensure that the results are reliable and precise. The 12-month duration will address the long-term practicability of the intervention strategy. The study is being conducted because salt-substitute-based blood pressure lowering may be particularly appropriate for rural populations in low- and middle-income countries. First, sodium intake is often very high. Second, the salt-substitute can be easily incorporated into the diet because most food is prepared and eaten at home. Third, the intervention can be provided at very low cost.

Comparisions: Low sodium high potassium salt (65% sodium chloride, 25% potassium chloride, 10% magnesium sulphate) compared to normal salt (100% sodium chloride).

Eligibility Criteria:
Inclusion Criteria:

Participant inclusion will be based upon the presence of:

* A doctor-confirmed high risk of future vascular disease defined as a history of any one of:

  * Stroke or transient ischaemic attack
  * Hospitalisation for management of any acute coronary syndrome
  * Surgery or angioplasty for peripheral vascular disease
  * Treated diabetes and age 55 years or older
  * Systolic blood pressure \>160mmHg
* Estimated daily sodium intake of 260mmol/24hrs (about 15g/24hrs of NaCl) or above and expectation that at least 50% of daily dietary salt intake can be replaced with the salt-substitute. This will be estimated through interview of the potential participant and the individual responsible for daily food preparation (if this is not the patient) using a structured questionnaire.
* Provision of informed consent

Exclusion Criteria:

Potential participants will be excluded if:

* they are on potassium-sparing medication
* there is an established history of significant renal impairment that would preclude the use of the salt-substitute in the opinion of the responsible physician.
* there is any reason why either the salt-substitute or normal salt are definitely indicated or definitely contra-indicated.
Trial of Tumor Vaccine Used for Adjuvant Therapy in Post Radical Operation Patients With Lung Cancer

Tumor vaccines may make the body build an immune response to kill tumor cells. This research study is evaluating a new type of tumor vaccine termed as "Neoantigen Tumor Vaccine". The purpose of this phase I/II trial study is to assess the safety and effectiveness of neoantigentumor vaccine in post radical operation patients with stage IIIA lung cancer.

Outline: After successful vaccine manufacturing, patients receive neoantigen tumor vaccine hypodermically (5 injections for each 3 days and then 1 injection for each 3 months till recurrence or up to 2 years). Treatment continues in the absence of disease recurrence and metastasis or unacceptable toxicity.

Patients are followed for 2 years or up to the absence of disease recurrence and metastasis.

Projected accrual: A total of 30 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 70 years, Male or Female
* Histological or cytologically diagnosis of lung adenocarcinoma
* After surgical treatment (lobectomy and systematic lymph node dissection)
* Pathological stage IIIA (According to the IASLC Lung Cancer Staging (eight Edition))
* Postoperative standard treatment (platinum-based double-drug adjuvant treatment with or without chemotherapy) or no adjuvant treatment
* Have potential dynamic tumor biomarkers
* Able and willing to give witnessed, written informed consent form prior to receiving any study related procedure, agree to participate in long-term follow-up for up to 3 years

Exclusion Criteria:

* Age \< 18 or\< 70 years
* Lung squamous cell carcinoma, small cell lung cancer, large cell lung cancer
* Without surgical treatment
* Pathological stage I、II、IIIB、IIIC or IV (According to the IASLC Lung Cancer Staging (eight Edition))
* Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study vaccine
* Drug or alcohol abusers
* Pregnant or breast-feeding patients
* History of immunodeficiency disease or autoimmune disease
* Patients with chronic disease which is undergoing immune reagents or hormone therapy
* Concurrent other medical condition that would prevent the patient from undergoing protocol-based therapy
* Lack of availability of a patient for immunological and clinical follow-up
Safety Study of Imexon Treatment of Patients With Metastatic or Disseminated Malignancy

AMP-011 is a Phase 1 study designed to extend the understanding of the toxicity and pharmacology of imexon by investigating a schedule of daily treatment for 5 days every three weeks. The objective of the study is to determine the maximally tolerated dose, the pharmacokinetics, and the toxicity of the drug on the designated schedule.


Eligibility Criteria:
Inclusion Criteria:

* Previously treated malignant disease of any type.
* Prior treatment; at least one prior regimen required.
* Able to perform the activities of daily living.
* Off prior cancer therapy for at least 4 weeks.
* If female, neither pregnant nor nursing.
* Willing to use contraceptives to prevent pregnancy.
* No other serious illnesses.
* No other active malignancy.
* No serious infections.
* No other current drug therapy for the cancer.
* Blood counts and blood chemistries in or near normal range.
* Prior radiation is permitted.

Exclusion Criteria:

* No active brain metastases.
Reduced Nicotine Cigarette Purchasing Decisions

The goal of this project is to experimentally evaluate how expectations about reduced-nicotine cigarettes as well as actual nicotine content interact to determine behavioral and subjective response for these novel products.


Eligibility Criteria:
Inclusion criteria:

* 21 years or older
* Smoke five or more cigarettes per day for the past six months
* Biological confirmation of cigarette use: have an expired carbon monoxide (CO) level of more than 8 ppm and a urinary cotinine level of more than 100 ng per milliliter at screening

Exclusion criteria:

* Intention to quit smoking in the next 30 days
* Weekly use of nicotine-containing products other than machine-manufactured combustible cigarettes
* Serious medical or psychiatric disorder precluding participation by study physician guidance
* Positive urine screening for illicit drugs other than cannabis or current substance use disorder
* Women who are pregnant, plan to become pregnant, or are breast-feeding
* Medical contraindications to receiving tobacco products
Device to Reduce Surgery Site Contamination - Spine

The objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g. bacteria) present at a surgery site during spinal procedures.

The Air Barrier System is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the Air Barrier System can reduce the presence of airborne colony-forming units at the surgery site during spinal procedures.

Eligibility Criteria:
Inclusion Criteria:

* Candidate for instrumented posterior lumbar interbody fusion

Exclusion Criteria:

* Prior history of infection
* Revision surgery
* Screens positive for MRSA
Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance

The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen (functional monotherapy) in people with human immunodeficiency virus (HIV) (PWH) with multi-drug resistance (MDR).


Eligibility Criteria:
Key Inclusion Criteria:

* Adult aged ≥ 18 years (at all sites) or adolescent aged ≥ 12 and weighing ≥ 35 kg (at sites in North America and Dominican Republic)
* Currently receiving a stable failing ARV regimen for \> 8 weeks
* Have HIV-1 RNA ≥ 400 copies/mL at screening
* Have multidrug resistance (resistance to ≥2 agents from ≥3 of the 4 main classes of ARV)
* Have no more than 2 fully active ARV remaining from the 4 main classes that can be effectively combined to form a viable regimen
* Able and willing to receive an OBR together with lenacapavir
* No Hepatitis C virus (HCV) ongoing infection

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Evaluation of HPGD and SCLO2A1 Expression in Clear Cell Renal Cell Carcinoma Patients

This study aims to investigate the role of HPGD in clear cell renal cell carcinoma (ccRCC). Specifically, it will focus on HPGD's impact on proliferation, epithelial-mesenchymal transition (EMT), and prognosis. The study will analyze gene expression data from clinical samples and use techniques like RT-qPCR, Western blotting, and immunohistochemistry to assess HPGD expression levels. Additionally, the research will explore the relationship between HPGD and patient survival outcomes. By elucidating HPGD's contribution to cancer progression, the study seeks to identify potential therapeutic targets for improving renal cancer treatment.

This study is designed to comprehensively explore the role of 15-hydroxyprostaglandin dehydrogenase ( HPGD) in clear cell renal cell carcinoma development and progression. HPGD has been implicated in various cancers, with evidence suggesting its involvement in tumorigenesis, EMT, and poor prognosis. However, its specific function n clear cell renal cell carcinoma (ccRCC) is still unclear. This research will analyze clinical samples, including tumor tissues and normal adjacent tissues, to evaluate HPGD expression through a combination of advanced laboratory techniques such as quantitative real-time PCR (qRT-PCR), Western blotting, immunohistochemistry (IHC) and RNA sequencing.

Furthermore, HPGD-interacting proteins were predicted using STRING and TCGA data, followed by PCR, Western blot validation, and IHC. Mechanistically, HPGD positively correlated with the solute carrier organic anion transporter 2A1 (SLCO2A1), and SLCO2A1 knockdown partially attenuated the tumor-suppressive effects of HPGD overexpression..

This study underscores the tumor-suppressive role of HPGD in ccRCC, highlighting its capacity to hinder cell proliferation and EMT via its interaction with SLCO2A1. Targeting the HPGD-SLCO2A1 axis may offer a promising novel therapeutic approach for ccRCC management.

Eligibility Criteria:
Inclusion Criteria:

Adults aged 18 years or older. Histologically confirmed diagnosis of clear cell renal cell carcinoma . Measurable disease as per RECIST criteria. Adequate organ function as defined by laboratory tests (e.g., liver, kidney, and hematologic function).

HPGD expression level determined via biopsy or previous analysis. Written informed consent provided.

Exclusion Criteria:

History of other malignancies within the past 5 years, excluding non-melanoma skin cancer or in situ carcinoma.

Prior treatment with HPGD inhibitors or similar targeted therapies. Active or uncontrolled infections. Pregnant or breastfeeding women. Known autoimmune disorders or conditions requiring immunosuppressive therapy. Inability to comply with the study protocol or procedures.
A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)

The objective of this study is to evaluate the efficacy and/or safety of multiple therapies in patients with early-stage resectable NSCLC. Cohort B1 is a phase II cohort that will evaluate the safety, and efficacy of alectinib in combination with up to four cycles of platinum-based chemotherapy in the adjuvant setting post complete surgical resection. Cohort B2 is a phase II cohort that will evaluate the efficacy and safety of perioperative alectinib in combination with chemotherapy in the neoadjuvant setting.


Eligibility Criteria:
Inclusion Criteria Cohort B1:

* Complete resection of the primary NSCLC with negative margins
* Confirmed stage II to select stage IIIB (T3N2) NSCLC of non-squamous (adenocarcinoma) histology
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1

Inclusion Criteria Cohort B2:

* Evaluation by the operating attending surgeon and involved medical oncologist prior to study enrollment to verify study eligibility for complete surgical resection with curative intent
* Pathologically and/or histologically confirmed Stage II-IIIA and IIIB (T3N2 only) NSCLC of non-squamous (adenocarcinoma) histology

Inclusion Criteria Cohorts B1 and B2:

* Documented ALK fusion

Exclusion Criteria Cohort B1:

* NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation
* Prior exposure to any systemic anti-cancer therapy

Exclusion Criteria Cohort B2:

* NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation
* Known sensitivity to any component of alectinib, pemetrexed, cisplatin, or carboplatin
* Prior exposure to any systemic anti-cancer therapy

Exclusion Criteria Cohorts B1 and B2:

* Pregnancy or breastfeeding, or intention of becoming pregnant during the study
Left Atrial Appendage Occlusion Study III Extended Follow Up

LAAOS III Extension is a longer term follow-up of an international cohort study of patients who were enrolled in the Left Atrial Appendage Occlusion Study (LAAOS III) trial.

The association between atrial fibrillation and heart failure has been well established. Although the causal relationship between the two clinical entities has not been fully elucidated, atrial fibrillation is believed to cause heart failure via several mechanisms: 1) increased heart rate resulting in shorter diastolic filling time and lower cardiac output; 2) reduced atrial contraction contribution to left ventricular filling, lowering cardiac output; and 3) tachycardia-induced cardiomyopathy from myocardial ischemia, myocardial energy depletion, and abnormal calcium regulation leading to left ventricular dilatation and reduced ejection fraction. These processes occur over time. It is also established that the left atrial appendage is a source of atrial natriuretic peptide, and it has been hypothesized that removal of the appendage might impair renal clearance of salt and water, increasing the risk of heart failure. A recent non-randomized study has supported this hypothesis. In LAAOS III, we did not observe an increase in hospitalization for heart failure, either early after surgery or during the 3.8 years of follow-up. However, an adverse impact on heart failure may appear over a longer follow-up period. We need to ensure we examine this patient population for the long-term impact of left atrial appendage occlusion on heart failure hospitalization to ensure we fully appreciate the benefit-risk balance of this intervention.

The extended follow-up of the LAAOS III trial aims to assess whether, in patients with a history of atrial fibrillation undergoing cardiac surgery for another indication, concomitant left atrial appendage occlusion decreases the risk of death and stroke on top of usual care including anticoagulation without increasing re-hospitalization for heart failure at a mean follow-up of 8 years.

Eligibility Criteria:
Inclusion Criteria:

* Participant was enrolled in the LAAOS III trial
* Participant has provided written informed consent

Exclusion Criteria:

* Participant did not undergo the index LAAOS III cardiac surgery
* Participant underwent heart transplant
Reduction of Post-operative Endodontic Pain

To determine the effect of intraligamentary injection of Lornoxicam on the intensity of post-operative endodontic pain in the tooth with symptomatic irreversible pulpitis.

sixty qualified samples (initial estimate which will be come more accurate after the pilot study on 6 patients) will be divided randomly in three groups which all of them will have an inferior Alveolar injection and before the beginning of the treatment the primary group will receive an injection of 0.4 mL ( 0.2 mL in mesio buccal and 0.2 mL in disto buccal) of Lornoxicam and the second group will be injected with 0.4 mL of normal saline( 0.2 mL in mesio buccal and 0.2 mL in disto buccal) ,in third group we will only pretend the injection but actually there is no substance injected ,making the patient believe that there was an injection . Then the patients' pain will be evaluated with visual Analogue Scale analysis (VAS) 0-170 mm in time intervals of 6, 12, 24 and 48 hours after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* healthy (ASA I, II);
* Patients with first or second mandibular molars who need endodontic treatment;
* Vital tooth without a history of past endodontic treatment;
* Patients with clinical evidence of irreversible Pulpits with moderate to severe pain;
* Patients without pre apical lesion and periodontal ligament enlargement more than 0.75-1mm on the x-ray images;
* Patients in the age group of 18-65 years old

Exclusion Criteria:

* Pregnant or nursing;
* necrotic tooth;
* Patients with allergy or contraindication toward non-opioid or opioid painkillers such as aspirin or NSAIDs;
* People who have a history of acute peptic ulcer, during the past 12 months;
* People who have bleeding problems or have been taking anticoagulant drugs over the past month;
* Patients who have taken opioid or non opioid or steroid pain killers, antidepressants or sedative drugs.
Application of ICG in Lymph Node Dissection During Radical Resection of Rectal Cancer With Preserved Autonomic Nerves Around LCA and IMA

Indocyanine green NIR imaging is valuable for lymph node dissection in D3 radical surgery for rectal cancer. It can guide the intraoperative improvement of lymph node dissection based on the preservation of LCA and peripheral autonomic nerves of IMA. This not only reduces the occurrence of postoperative complications and promotes rapid postoperative recovery, but also provides a more precise and individualized comprehensive treatment plan for patients after surgery. In addition，this trial also demonstrated that ICG is safe and feasible for use in rectal cancer

The pathological data of 96 patients with rectal cancer from September 2020 - July 2022 were collected from the First Hospital of Qinhuangdao City.In 51 of these patients, ICG was injected preoperatively via anoscope or anal dilator in the mucosal layer around the tumor, and surgical treatment was performed after visualization. The surgical approach was performed by laparoscopic radical rectal cancer with an intermediate approach step.The IMA root is treated with low ligation of the IMA, while lymph node dissection is performed while preserving the autonomic nerves around the IMA. The other 45 patients were not injected with ICG, and the procedure was performed as before.The occurrence of postoperative complications was recorded, and the detection of lymph nodes was also compared between the two groups, as well as the intraoperative situation and postoperative recovery.

Eligibility Criteria:
Inclusion Criteria:

1. The preoperative colonoscopic pathological diagnosis was clearly rectal cancer and no malignant tumor in other sites.
2. Good preoperative general condition, no serious cardiopulmonary, hepatic, renal or other major comorbidities before surgery
3. Radical rectal cancer surgery with preservation of LCA and peripheral autonomic nerves of IMA in patients
4. No contraindications to surgery
5. No history of ICG or iodide allergy

Exclusion Criteria:

-
Evaluation of Diagnostic HIV Ag/Ab Combo Assay

To test blood specimens using a new investigational test that detects antigen and antibody to human immunodeficiency virus (HIV). Results will be compared to an approved HIV antibody test and supplemental testing performed to determine HIV status.

All specimens collected under separate specimen collection protocols or obtained from specimen suppliers will be provided to the clinical sites performing the investigational HIV test.

This includes 6252 specimens collected from normal healthy individuals (7B5-02-05Z01-01: Collection of Specimens Used in Abbott Laboratories In Vitro Diagnostic HIV and Hepatitis Assays Clinical Studies)and from specimen suppliers. 588 specimens from HIV-infected pediatric subjects and 448 pregnant females at risk for HIV infection collected under protocol (7B5-02-05Z01-02: Collection of Pediatric and Pregnant Female Specimens Used in the Abbott Laboratories In Vitro Diagnostic HIV Assay)and from specimen suppliers. All specimens were previously collected and frozen, except for a subset of 586 specimens from normal healthy population and 55 specimen from pregnant females at risk for HIV infection which were collected under separate specimen collection protocols and tested as fresh specimens during the study.

In addition, 83 specimens that were HIV antigen positive, 1121 specimens that were HIV-1 antibody positive, 201 specimens that were HIV-2 antibody positive, and 1409 specimens from US at risk for HIV infection or from HIV-2 endemic area were all obtained from specimen suppliers, except for 11 pediatric specimens collected under a separate protocol (7B5-02-05Z01-02: Collection of Pediatric and Pregnant Female Specimens Used in the Abbott Laboratories In Vitro Diagnostic HIV Assay).

Eligibility Criteria:
Normal Healthy Population:

Inclusion Criteria:

* Apparently healthy individual at the time of enrollment as affirmed by the subject

Exclusion Criteria:

* HIV infection as affirmed by the subject

Pregnant Female Population at Risk for HIV Infection:

Inclusion Criteria:

* Subject is a pregnant female
* Subject has risk factor for HIV infection

Exclusion Criteria:

* HIV infection as affirmed by the subject

HIV-1 Positive Pregnant Female Subjects

Inclusion Criteria:

* Subject is a pregnant female in first, second, or third trimester
* Subject must have documented HIV infection

Exclusion Criteria:

* None

HIV-1 Positive Pediatric Subjects

Inclusion Criteria:

* Subject must be 2 years to 16 years of age
* Subject must have documented HIV infection (e.g., Western blot positive or HIV RNA positive/detectable)

Exclusion Criteria:

* None