cyrilzakka/clinical-trials huggingface dataset:
SJG-136 in Treating Patients With Advanced Solid Tumors

This phase I trial is studying the side effects and best dose of SJG-136 in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as SJG-136, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PRIMARY OBJECTIVES:

I. To determine the toxicities, pharmacokinetic profile and the recommended phase 2 dose of SJG-136 in patients with an advanced solid tumor.

SECONDARY OBJECTIVES:

I. To determine preliminary efficacy data and evaluation of correlative markers of DNA damage and apoptosis in peripheral blood lymphocytes.

OUTLINE: This is an open-label, dose-escalation study.

Patients receive SJG-136 intravenously (IV) over 20 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SJG-136 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed solid tumor

  * Advanced disease, defined as metastatic or unresectable disease
* Measurable indicator lesions
* Standard curative or palliative measures do not exist or are no longer effective
* Previously treated CNS metastases allowed provided patient has completed local therapy AND corticosteroids have been discontinued for at least 4 weeks
* No known leptomeningeal metastases
* Performance status - ECOG 0-2
* Performance status - Karnofsky 60-100%
* More than 3 months
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ 1.0 mg/dL
* AST and ALT ≤ 2.5 times upper limit of normal
* Creatinine \< 1.4 mg/dL
* No congestive heart failure
* No recent myocardial infarction
* No unstable angina
* No uncontrolled hypertension
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection
* No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drug
* No other significant medical history, unstable medical condition, or unstable systemic disease that would preclude study participation
* At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas and 8 weeks for UCN-01)
* At least 4 weeks since prior radiotherapy
* No prior radiotherapy to ≥ 25% of hematopoietic bone marrow
* Recovered from all prior therapy
* At least 4 weeks since prior investigational anticancer drugs
* No other concurrent investigational agents
* No concurrent combination antiretroviral therapy for HIV-positive patients
A Prospective Randomized Controlled Study of Radiotherapy and the Concurrent Three-week and Single-week TP Chemotherapy for Advanced Cervical Squamous Cell Carcinoma and the Correlation Between HPV Classification and Sensitivity.

the main purpose for this experiments are as follows: 1. Patients with stage ⅡB-ⅢB cervical squamous cell carcinoma who received full dose radiotherapy will be randomly assigned to the combined TP regimen weekly treatment group and 3-week treatment group for the short-term efficacy and safety observation; 2. All enrolled patients will be tested for HPV subtype infection; the relationship between the sensitivity and curative effect of concurrent radiotherapy and chemotherapy will be analyzed, and at the end of the test, HPV subtypes will be tested again and changes will be analyzed to provide more clinical evidence for the reasonable comprehensive treatment and precision medical treatment of advanced cervical squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. The patient participated in this study voluntarily and all volunteers will sign the informed consent.
2. New cervical squamous cell carcinoma cases between 18 and 70 years old;
3. Clinical stages: stage ⅡB-stage ⅢB;
4. PS score is less than 2 points;
5. Expected survival is over 3 months;
6. Blood routine: Hb≥70g/L, WBC≥3.5×10\^9/L, ANC≥1.5×10\^9/L, PLT≥80×10\^9/L
7. Serum ALT and AST≤2×ULN; serum creatinine≤1.5×ULN;
8. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the trial;
9. Patients who can comply with the trial protocol (judged by the investigator).

Exclusion Criteria:

1. Active or uncontrolled serious infection;
2. Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatments;
3. A history of immunodeficiency, including HIV positive or other acquired congenital immunodeficiency diseases;
4. Chronic renal insufficiency and renal failure;
5. Pregnant woman;
6. Myocardial infarction, severe arrhythmia and congestive heart failure ≥2 (New York Heart Association (NYHA) classification);
7. Patients receiving targeted therapy and pelvic artery embolism;
8. Those who have had arterial/venous thrombosis within 6 months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism;
9. Those who have received radiotherapy for malignant pelvic tumors in the past;
10. Patients with autoimmune system diseases such as systemic lupus erythematosus;
11. Patients with comorbidities who need to take drugs with severe liver and kidney damage during treatment, such as tuberculosis;
12. Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent;
13. Those with concomitant diseases or other special circumstances that seriously endanger the safety of patients or affect the completion of the study.
Clinical and Genetic Investigation of the Association Between Primary Aldosteronism and Thyroid Cancer

Aldosterone excess can cause oxidative stress leading to DNA damage in vitro and in vivo. Single case reports demonstrated a coincidence of primary aldosteronism (PA) with different malignancies. A higher prevalence of thyroid nodules and non-toxic multinodular goiter was described in patients with PA compared to those with essential hypertension (EH). A single study showed an association between PA and papillary thyroid cancer (PTC), but without a paired control group. Objective: To assess PA prevalence in a transversal cohort of patients with PTC and EH compared to a paired control group with HT.

Primary aldosteronism (PA) is the most frequent cause of endocrine hypertension, with an estimated prevalence of 20% among individuals with resistant hypertension. PA is associated with an increased risk of malignancy, probably due to aldosterone effects in promoting cell proliferation. Recently, a high prevalence of PA was demonstrated in patients with essential hypertension (EH) and papillary thyroid cancer (PTC), similarly to the prevalence of PA among individuals with resistant EH. In addition, abnormalities in thyroid ultrasound (non-toxic multinodular goiter) are more common in PA patients when compared to controls. Despite of this initial evidence, the link between PA and PTC remains to be elucidated. Then, the aim of this study is to investigate the clinical and genetic aspects of the association between PA and PTC. The specific aims are: 1) To evaluate the prevalence of PA in a transversal cohort of patients with EH and PCT; 2) To investigate thyroid ultrasonography abnormalities in PA patients; 3) To perform exome sequencing (blood DNA) in patients with PA and PTC paired with tumor tissue; and 4) To conduct functional studies of the novel genetic variants identified by exome sequencing. To achieve this goal, the investigators will employ the following techniques: next-generation sequencing, bioinformatic analysis, real-time PCR and immunohistochemistry. In this project, the investigators expect to establish the prevalence of PA among patients with EH and PTC, and to identify new genetic targets involved in the association between PA in PTC.

Eligibility Criteria:
Inclusion Criteria:

* All patients with PTC and EH regardless of hypertension severity

Exclusion Criteria:

* Patients who were using medications that secondarily increase blood pressure levels were excluded
* Did not agree to participate
Effect of Manipulation on Coccydynia

The aim of this study was to investigate the efficacy of manipulation combined with exercise as a treatment for patients with coccydynia.

Subject: Coccydynia is a painful condition characterized by inflammation and discomfort in the coccyx region, commonly known as the tailbone. It can significantly affect an individual's quality of life by impairing their ability to sit, stand, or engage in daily activities. Various treatment approaches have been explored to alleviate the symptoms of coccydynia, including manipulation techniques and exercise interventions. However, to date, there is a scarcity of research investigating the combined effects of manipulation and exercise for patients with coccydynia.

Purpose: The purpose of this study is to evaluate the efficacy of combining manipulation techniques with exercise interventions for patients diagnosed with coccydynia, a painful condition affecting the coccyx region. Despite the debilitating impact of coccydynia on daily activities and quality of life, there is a limited understanding of the optimal treatment approach for this condition. This study aims to address this knowledge gap by investigating the potential benefits of combining manipulation and exercise in managing coccydynia.

Eligibility Criteria:
Inclusion Criteria:

* chronic (3 months) coccydynia
* age over 25 and under 60 years
* no ongoing antidepressant treatment
* no medicolegal litigation or occupational-accident etiology

Exclusion Criteria:

* undergoing an operation aimed at the anal area
* those with additional diseases such as radiculopathy etc.
EDRN Prostate MRI Biomarker Study

The commercialization of MRI fusion biopsies has resulted in a dramatic increase in the use of MRI imaging for prostate cancer. How best to use MRI in the initial prostate biopsy setting given the availability of validated prostate cancer early detection markers is uncertain.This study will allow investigators to determine if prostate MRI is superior to validated panel of laboratory biomarkers (e.g. PCA3, PSA and TMPRSS2:ERG) in the initial biopsy setting.

The primary aim of this study is to see if the addition of prostate MRI to a panel consisting of PSA, PCA3, TMPRSS2:ERG will significantly improve specificity for high-grade prostate cancer by 10%. The subsequent exploratory aims will 1) create an optimal panel of urine, blood and tissue biomarkers that will select those cases most likely to benefit from a MRI targeted biopsy, 2) directly compare PSA and urinary biomarkers with MRI to determine which ones are value added in the setting of initial biopsy, 3) evaluate changes in these biomarkers and MRI to determine if longitudinal changes predict subsequent high-grade prostate cancer, and 4) optimize MRI imaging to improve test performance. Importantly, this study will create a unique, prospective, cohort that will become the foundational reference set for of a range of future biomarker studies.

Eligibility Criteria:
Inclusion Criteria:

* Men with suspected but undiagnosed prostate cancer
* To be scheduled/scheduled for biopsy as routine clinical care

Exclusion Criteria:

* Inability to obtain blood and urine per SOP or conduct an attentive DRE
* Unable to undergo/tolerate a prostate MRI or failure to conduct the MRI
* Prior diagnosis of prostate cancer
* Prior prostate MRI unless being used as Index MRI (in this case index MRI can be one year prior to consent date)
* Participating in clinical trial for prostate disease
* Prior prostate surgery such as TURP, TUNA, TUMT, HOLEP, REZUM, UROlift
* Prior PCA3, TMPRSS2:erg or MIPS panel performed for clinical purpose
Study of Talabostat in Advanced Melanoma

The purpose of this study is to assess the antitumor activity and safety of talabostat in patients with metastatic melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed melanoma that is metastatic (unresectable Stage IV per AJCC 2002)
* Patients with measurable disease defined as at least one measurable index lesion with clearly defined margins
* ECOG Performance Status of 0, 1, or 2
* Expected survival ≥12 weeks
* Written informed consent

Exclusion Criteria:

* More than 1 prior chemotherapy or biotherapy regimen for Stage IV melanoma
* Radiation therapy to \>50% of the bone marrow. Patients must not have had prior radiotherapy to index lesions unless they have clearly progressive disease in this site or there is measurable disease outside the area of prior radiation.
* Clinically significant laboratory abnormalities
* CNS metastases
* Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
* The need for chronic (i.e., \>7 days) oral or intravenous corticosteroid therapy
* Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
* Patients who are within 30 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for melanoma. Patients must have recovered from all of the side effects of treatment in order to be enrolled.
* Pregnant or lactating women.
E-health Literacy in Athletes

e-health literacy in athletes is very important. The aim of this study was to determine the level of e-health literacy in athletes and to examine the relationship between age, gender, sports branches and injury sites.


Eligibility Criteria:
Inclusion Criteria:

* volunteering to participate in the training,
* being an athlete for at least 2 years.

Exclusion Criteria:

* having any vision and hearing problems
Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

This clinical trial is designed to evaluate the performance, comfort, and usability of a new nasal pillows mask for the treatment of obstructive sleep apnea (OSA) in a home environment.


Eligibility Criteria:
Inclusion Criteria:

* Are ≥22 years of age
* Weigh ≥66 lbs
* Have been formally diagnosed with OSA by a physician
* Have an AHI ≥5 on a diagnostic night
* Have been prescribed PAP therapy to treat OSA by a physician
* Are an existing nasal pillows mask user
* Have been using a nasal pillows mask for ≥3 months prior to enrolment into the study
* Are compliant with PAP therapy for ≥4 hours per night for 70% of nights
* Are fluent in spoken and written English
* Possess the capacity to provide informed consent

Exclusion Criteria:

* Are intolerant to PAP therapy
* Possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
* Are currently diagnosed with respiratory disease or CO2 retention
* Are pregnant or think they may be pregnant
* Have an IPAP pressure of \>25 cmH2O
* Persons who use a PAP therapy machine for the delivery of medicines, except O2
* Use a PAP therapy machine that does not possess data recording capabilities to capture AHI and leak information that is accessible to OSMI
Immune Responses to Autologous Langerhans-type Dendritic Cells Electroporated With mRNA Encoding a Tumor-associated Antigen in Patients With Malignancy: A Single-arm Phase I Trial in Melanoma

This study is being done to see if the investigators can help the immune system to work against melanoma.

A dendritic cell is another type of white blood cell. It has most, if not all, of the proteins needed to make T cells work to destroy cancer cells. However, dendritic cells do not normally have the cancer proteins on their surface. The challenge then is to combine the antigens with dendritic cells to make a vaccine. The investigators think that the body's T cells might then react against the tumor and help destroy it.

This study will see if altered dendritic cells will make T cells work against tumor cells. The dendritic cells will be made in a lab and will carry the antigens. These cells then will be injected under the skin.

In this study, the investigators are trying to help the body make a stronger immune response against the cancer. The patient will get the same kind of dendritic cell vaccine used in the earlier study, but with one major difference. The dendritic cells will contain messenger-RNA (mRNA). Cells use mRNA to make proteins. The mRNA will be put into dendritic cells by a laboratory method called electroporation. The mRNA is never given to the patient directly. This mRNA will help the dendritic cell make a tumor antigen like what the cancer expresses. The dendritic cell can then put this tumor antigen on its surface so that the body could make a stronger immune response against the tumor.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of melanoma, AJCC stage IIB, IIC, III, or IV (MIa), with histologic confirmation by the Department of Pathology at MSKCC.
* Patients must be HLA-A\*0201 positive, based on high resolution DNA level typing.
* Expected survival of greater than 3 months.
* Karnofsky performance status of 70 or higher
* All patients should have undergone surgical treatment appropriate to their stage of disease
* Patients may not have received chemotherapy, immunotherapy, or radiation within a minimum of 28 days (minimum of 42 days for nitrosoureas or mitomycin) before participation in this protocol.

Exclusion Criteria:

* Pregnant or lactating women because of unknown risks to the fetus or infant.
* Patients requiring systemic corticosteroids or comparable exogenous immunosuppressive agent(s) (no exclusion for use of NSAIDs).
* Patients with a known immunodeficiency (e.g., infection with HTLV-1,2, HIV-1,2; etc.).
* Patients with coexisting autoimmune diseases, except vitiligo.
* Patients with baseline impairments of hematologic, hepatic, or renal function (CTCAE v4.0 \> grade 1, ANC \< 1500, hgb \< 10.0 g/dl, plts \< 75,000/ul, AST \> 3x ULN, creatinine \> 1.5xULN), all assessed within four weeks of study entry.
* Patients with organ allografts.
* Patients who are status post splenectomy or status post splenic irradiation.
* Patients with a history of documented pre-existing retinal/choroidal disease.
Topical GW842470X In Adults Patients With Moderate Atopic Dermatitis

The purpose of this study is to investigate the clinical efficacy of 3% (w/w) GW842470X cream applied to involved skin of adult patients with moderate atopic dermatitis using the Eczema Area Severity Index (EASI) assessment of disease severity and to investigate the safety of and tolerability of 3% GW842470X cream on diseased skin of adult patients.


Eligibility Criteria:
Inclusion criteria:

* Moderate atopic dermatitis patients (IGA=3).
* The disease involvement must be \>5% of body surface area.
* Female patients of child-bearing potential must use an appropriate method of contraception.

Exclusion criteria:

* Patients with any active skin disease other than atopic dermatitis will not be eligible.
* Patients who have had systemic treatment for atopic dermatitis or other topical or transdermal treatments (such as nicotine, hormone replacement therapies) within 14 days prior to first application of study medication and/or topical treatment with tar, any corticosteroid, topical immunomodulators or oral treatment with any corticosteroids within 10 days prior to first application and/or oral anti-histamines within 5 days of the first dose.
Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden

This is a prospective, randomized pilot study of patients who will undergo either early or late incisional laser therapy after breast reduction surgery to alleviate scar burden at NYU Langone Medical Center. The purpose of this study is to see how well carbon dioxide (CO2) laser therapy works at preventing scar formation after surgery.CO2 laser therapy is currently being used by dermatologists and plastic surgeons to help with scarring after acne and to rejuvenate the face; its benefits are now being explored by medical professionals in dermatology and cosmetic surgery to prevent scarring after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients of all ethnic origins will be considered, although certain ethnic groups will be preferentially excluded more than others such as black and South Asian patients due to our exclusion criteria related to darker skin individuals (see below).
* Patients undergoing bilateral breast reduction surgery

Exclusion Criteria:

* Males will be excluded from this study as male patients rarely undergo breast reduction surgery. When males do undergo breast reduction surgery for gynecomastia, it is often unilateral, and is performed with several techniques and incision types that are not typical employed during female breast reduction. Thus, for this study, only female patients will be considered (see below).
* Any patient enrolled in this study who shows evidence of delayed wound healing, dehiscence, or post operative infection at the first post operative visit will be excluded
* Patients with darker skin (Fitzpatrick IV and above), which is a well-known contraindication to laser therapy
* Pregnant patients
* Patients who have had prior breast surgery
* Patients who have had prior chest/breast irradiation
* Patients with the following diseases which interferes with wound healing: prior hypertrophic scarring/keloids, type I or type II Diabetes Mellitus, autoimmune diseases/collagen vascular diseases
* Patients who are active smokers
* Patients using blood thinners that cannot be stopped
* Patients who have used aspirin within a week of the procedure date