cyrilzakka/clinical-trials huggingface dataset:
Reasons for Changing HOrmonal Therapy of Advanced Breast Cancer

Breast cancer is the leading type of cancer in women. Although big advance in diagnostics and treatment of early and breast cancer has been made in recent years breast cancer still has a significant mortality rate. A number of treatment modalities exist for postmenopausal women with advanced breast cancer. The treatment modality is chosen based on patient and tumour characteristics. Hormonal treatment is preferred and recommended in women with hormone sensitive breast cancer (ESMO, CECOG and NCCN guidelines). Tumor markers are an established method of monitoring systemic therapies in various cancers. Tumor markers CA 15-3 and CEA are used in clinical practice to monitor treatment efficacy of metastatic breast cancer. Blood levels of tumor markers are widely used to assess response/progression to treatment and guide therapy change. Treatment efficacy is assessed by imaging methods in clinical studies. Change of therapy in clinical study is usually done when progression based on RECIST criteria is found. Hormonal treatment has slower onset of effect compared with chemotherapy that can last several weeks. Also when a new therapy is started spurious early rises may occur. Therefore rising levels of tumor markers during the first weeks of new hormonal therapy are not necessarily sign of progression and should not be the only guidance for treatment change. Evidence of treatment efficacy form clinical studies and treatment change is based on imaging techniques.


Eligibility Criteria:
Inclusion Criteria:

* Women with at least two finished lines of hormonal treatment for advanced breast cancer Tumor markers (CEA. CA15-3) values available at the time of onset and discontinuation of therapy Imaging methods results available at the time of onset and discontinuation of therapy

Exclusion Criteria:

* None
Clinical Implementation of TNM-immunoscore in Resected Non-small Cell Lung Cancer

The purpose of this study is to validate TNM-Immunoscore in resected non-small cell lung cancer.

The main aim is to validate the most promising T-cell marker candidates from earlier studies in a prospective multicenter study to establish a prognostic TNM-Immunoscore.

The investigators will include around 1000 stage I-IIIA patients from various centers in Scandinavia. The investigators will also collect demographic and clinicopathological data, blood and tissues in a database and biobank. Candidate T-cell markers will be analyzed by immunohistochemistry for validation and by other methods for exploration of their impact on prognosis

Eligibility Criteria:
Inclusion Criteria:

* resectable NSCLC
* Age 18 and above
* no other malignancy last 5 years
* informed consent

Exclusion Criteria:

* multiple tumor foci
* preoperative chemo- or radiotherapy
* non-NSCLC histology
* no tissue available for study
* metastasis
Development of a Rapid and Accurate Diagnostic Assay for Tuberculosis

This study evaluates new technique for diagnosis of tuberculosis. Among patients who are suspected with tuberculosis, participants will be tested conventional method including Xpert TB/RIF assay, and new diagnostic technique using homobifunctionalImidoesters compounds.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are suspected with pulmonary tuberculosis, tuberculosis meningitis, tuberculosis peritonitis, tuberculosis pleurisy

Exclusion Criteria:

* Under 18 years
CD4 in Combination With CHOP in Treating Non-cutaneous Peripheral TCell Lymphoma

Evaluation of CD4 in combination with CHO chemotherapy in subjects with nodal involvement of non cutaneous Tcell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* study is closed to enrollment

Exclusion Criteria:

* study is closed to enrollment
MRI-guided Single Dose Preoperative Radiotherapy in Low-risk Breast Cancer

This study aims to evaluate the pathologic response at 12 months after single dose preoperative partial breast irradiation in early stage breast cancer patients. Furthermore, the aim is to collect data on response monitoring. Patient-reported outcome measures and treatment-induced toxicity will be evaluated.

In this multi-center single arm interventional cohort study 70 patients will be treated with single dose preoperative partial breast irradiation (PBI). Breast conserving surgery will be performed 12 months following PBI to assess pathologic response. Response monitoring following PBI includes MRI (3T and 7T), liquid biopsies and biopsy of the irradiated tumor.

Results from this trial can change the current treatment of patients with early stage breast cancer. The single dose PBI can be of benefit for all patients who are suitable for postoperative PBI according to current guidelines. If pathologic complete response can be accurately predicted by (one of) the abovementioned response monitoring modalities, the need for surgery will become disputable. Moreover, in patients without expected pathologic complete response, the burden of radiotherapy can be minimized from 3-4.5 weeks of radiotherapy to a single dose of radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* WHO performance scale ≤2.
* Females at least 50 years of age with unifocal cT1N0 breast cancer or females at least 70 years of age with unifocal cT1-2(maximum 3 cm)N0 breast cancer on mammography, ultrasound and MRI.

  * Patients with an indication for chemotherapy or immunotherapy according to Dutch National Oncoline Guidelines or own hospital protocols are not eligible. Patients with an indication for endocrine therapy are eligible.
  * Tumor size as assessed on MRI.
* On tumor biopsy:

  * Bloom-Richardson grade 1 or 2.
  * Non-lobular invasive histological type carcinoma.
  * LCIS or (non-extensive) DCIS is accepted.
  * ER positive tumor receptor.
  * HER2 negative tumor.
* Tumor-negative sentinel node.
* Adequate communication and understanding skills of the Dutch language.

Exclusion Criteria:

* Legal incapacity.
* BRCA1, BRCA2 or CHEK2 gene mutation.
* Previous history of breast cancer or DCIS.
* Other type of malignancy within 5 years before breast cancer diagnosis. Patients with adequately treated malignancy longer than 5 years before breast cancer diagnosis are eligible for inclusion. For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span to breast cancer diagnosis is required for inclusion.
* Collagen synthesis disease.
* Signs of extensive DCIS component on histological biopsy or imaging.
* Invasive lobular carcinoma.
* MRI absolute contraindications as defined by the Department of Radiology.
* Nodal involvement with cytological or histological confirmation.
* Indication for treatment with (neo-)adjuvant chemotherapy.
* Non-feasible dosimetric RT plan.
Effect of Betablocker or Aldosterone Antagonist Therapy on Patients With Liver Cirrhosis

The study´s purpose is to investigate the effect of beta blockade or aldosterone antagonist therapy on oxygenation, peripheral and cardiac hemodynamics and humoral systems, in patients with liver cirrhosis.

Cardio-pulmonal complications to patients with liver cirrhosis and portal hypertension determine the patients' prognosis. Most patients have hemodynamical changes in circulation with increased cardiac output and decreased systolic function in stress. Endothelial dysfunction is a parameter for bad prognosis in cardiovascular disease. The Renin-angiotensin-aldosterone-system plays an important role in natrium and volume regulation. Descriptions of changes in the peripheral circulation and oxygenation have been deficient up to now.

Patients with liver cirrhosis and portal hypertension are betablockers and/or aldosterone antagonists routine treatment - effects on peripheral hemodynamics and oxygenation in relation to central hemodynamic changes are deficient.

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis
* Clinical indication for treatment with betablocker or aldosterone antagonist
* Must not have been treated earlier with betablocker or aldosterone antagonist
* Must have been alcohol abstinent for more than 4 weeks

Exclusion Criteria:

* Gastrointestinal bleeding in the last 2 weeks
* Encephalopathy \> grade 1
* Acute medical conditions
* Malignant disease
* Pregnancy
A Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS)

This study will compare the efficacy and safety of unesbulin plus dacarbazine versus placebo plus dacarbazine in participants with unresectable or metastatic, relapsed or refractory LMS who have received at least 1 prior line of systemic therapy.


Eligibility Criteria:
Key Inclusion Criteria:

* Histological or cytological confirmation of LMS arising at any anatomic site except bone sarcoma, unresectable or metastatic, relapsed or refractory disease measurable per RECIST 1.1 criteria
* Disease progression on previous treatment before screening or intolerability to other oncology treatments
* Participants with liver metastases may be enrolled
* Participants with well-controlled asthma or chronic obstructive pulmonary disease may be enrolled.
* Toxicity from prior therapies recovered to Grade ≤1 or participant's baseline, except for alopecia. In addition, endocrinopathies associated with prior immunotherapy-based treatments that are well controlled on replacement medication are not exclusionary.
* At least 1 prior systemic cytotoxic or targeted therapy regimen for LMS, which may include but is not limited to single-agent doxorubicin or other anthracycline, doxorubicin plus ifosfamide, trabectedin, pazopanib, or gemcitabine with or without docetaxel.
* At least 4 weeks since prior surgery and recovered in the opinion of investigator

Key Exclusion Criteria:

* Received temozolomide or dacarbazine at any time
* Any other systemic anticancer therapy including investigational agents ≤3 weeks before initiation of study treatment. Additionally, participants may not have received radiation ≤3 weeks before initiation of study treatment.
* Known intolerance to dacarbazine or one or more of the excipients in unesbulin.
* Co-existing active infection or any co-existing medical condition likely to interfere with study procedures
* Gastrointestinal disease or other conditions that could affect absorption. Active peptic ulcer disease, active gastritis, or previous history of gastric perforation within the last 2 years
* Major surgery, open biopsy, or significant traumatic injury that has not recovered, in the opinion of the investigator, within 28 days of baseline
* Immunization with a live vaccine within 30 days before starting study drug due to the risk of serious and life-threatening infections.
* Prior malignancies, other than LMS, that required treatment or have shown evidence of recurrence (except for non-melanoma skin cancer or adequately treated cervical carcinoma in situ, prostate cancer in situ or any other low risk malignancy that is approved by the medical monitor) during the 5 years before initiation.
* Prior or ongoing clinically significant illness, medical or psychiatric condition, medical history, physical findings, electrocardiogram (ECG) findings, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant, or alter the absorption, distribution, metabolism, or excretion of the study drugs, or could impair the assessment of study results.

Note: Other inclusion and exclusion criteria may apply.
Safety and Dose-Finding Study of DTX301 (scAAV8OTC) in Adults With Late-Onset Ornithine Transcarbamylase (OTC) Deficiency

This is a Phase 1/2, open-label, single arm, multicenter, safety and dose finding study of DTX301 in adults with late-onset OTC deficiency. The primary objective of the study is to determine the safety of single intravenous (IV) doses of DTX301.

Eligible participants will receive a single IV infusion of DTX301. Dose escalation will be conducted according to a model that uses the collected data to predict the safety profile of the dose in order to determine the optimal biological dose (OBD). The decision to proceed to the next dose cohort will be made after the data monitoring committee (DMC) has evaluated the safety data for all participants in a dosing cohort. Participants will be followed for 52 weeks after dosing. After completion of this study, participants will be asked to enroll in a 4-year extension study to evaluate the long term (a total of 5 years) safety and efficacy of DTX301.

This study was previously posted by Dimension Therapeutics, which has been acquired by Ultragenyx.

Eligibility Criteria:
Key Inclusion Criteria:

1. Males and females ≥18 years of age with documented diagnosis of late onset (defined as first manifestation of signs and symptoms at ≥1 month of age) OTC deficiency, confirmed via enzymatic, biochemical, or molecular testing
2. Documented history of ≥1 symptomatic hyperammonemia event with ammonia ≥100 µmol/L.
3. Subject's OTC deficiency is stable as evidenced by either a) no clinical symptoms of hyperammonemia OR b) an ammonia level \<100 µmol/L within the 4 week period preceding the Screening visit.
4. On ongoing daily stable dose of ammonia scavenger therapy for ≥4 weeks.
5. Males and all females of childbearing potential must be willing to use effective contraception at the time of administration of gene transfer and for the 52 weeks following administration of DTX301

Key Exclusion Criteria:

1. At Screening or Baseline (Day 0), plasma ammonia level ≥ 100 μmol/L for patients who historically maintain normal ammonia levels; OR plasma ammonia level ≥ 200 μmol/L for patients who historically are not able to fully control ammonia levels with baseline management; OR signs and symptoms of hyperammonemia.
2. Liver transplant, including hepatocyte cell therapy/transplant.
3. History of liver disease
4. Significant hepatic inflammation or cirrhosis
5. Serum creatinine \>2.0 mg/dL.
6. Participation in another investigational medicine study (including another gene transfer trial) within 3 months of Screening
7. Pregnant or nursing

Note additional inclusion/exclusion criteria may apply, per protocol.
Decreasing Edema with Platysma Exercises Following Third Molar Extraction Surgery

This study will investigate the effects of a platysma muscle exercise on edema following third molar extraction surgery.

The investigators hypothesized that, during the muscle contraction of the platysma, the vascular structures will be subjected to a pump effect, leading to an increase in venous circulation. Additionally, due to its connection to the fascia, the investigators propose that platysma contractions may mobilize the fascia and stimulate the lymph nodes, thereby improving interstitial fluid flow. This could lead to an effective treatment option for decreasing edema after third molar tooth extraction. Therefore, this study aims to investigate the effects of platysma exercises applied after third molar tooth extraction on edema while observing the differences on pain and trismus.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-40,
* Those requiring impacted third molar extraction
* Those with no systemic health conditions, were included in the study
* Those who accepted to participate in the study

Exclusion Criteria:

* Those who had systemic diseases
* Those who were taking medications that could interfere with inflammation, or healing,
* Those who were pregnant or breastfeeding,
* Those who had infections or pathologies involving teeth 38 and 48,
* Those who were unable to comply with postoperative recommendations or required therapeutic interventions outside the study protocol
Registry Protocol for Tracking Trial Subjects After VTI-206 Study Completion

VTI-207 (NCT01452295) is designed to follow subjects, both treated and control, for five years after their completion of study participation in protocol VTI-206 (NCT00973817) to gather information relating to the incidence of liver transplant, the incidence and type of cancer (if any), and survival.

Vital Therapies, Inc. (VTI) is conducting clinical trial VTI-206 in which subjects with acute on chronic hepatitis (AOCH) and acute alcoholic hepatitis (AAH) are treated with the ELAD system to assess the safety and efficacy of this therapy. The ELAD system incorporates cloned immortalized human liver cells (C3A cells). A hypothetical risk exists that, over an extended period of time, there may be an increased incidence of tumor in subjects treated with ELAD.

The company is also collecting data related to whether a patient received a liver transplant and on survival.

Eligibility Criteria:
Inclusion Criteria:

* Subjects participating in the VTI-206 clinical trial.

Exclusion Criteria:

* Subjects not participating in the VTI-206 clinical trial.
Observational Cohort Study Evaluating the Effectiveness of an Educational Program (NGAYDAUTIEN) in Combination With Perindopril and Amlodipine Single-Pill Combination in Hypertensive Patients naïve of Antihypertensive Treatments.

The primary objective is to assess the change of systolic blood pressure from baseline after a 6-month follow up for hypertensive patients initiating Viacoram® plus an educational program (NGAYDAUTIEN) in comparison to hypertensive patients initiating other antihypertensive drugs (except single pill combination).


Eligibility Criteria:
Inclusion Criteria:

1. Aged of at least 18 years (without upper limit of age)
2. Diagnosis of grade 1 or grade 2 hypertension
3. Naïve of treatment:

   * newly diagnosed hypertension and without treatment with antihypertensive effect for at least 3 months
   * previously diagnosed but without treatment with antihypertensive effect for at least 3 months
4. Patients follow-up within the scope of the current medical practice and in the same health centre during the 6-month period

Exclusion Criteria:

1. Previously attended to the Ngay Dau Tien educational program for HBP management
2. Plan to be hospitalized for other medical conditions during the next 6 months
3. Plan to move/relocate during 6-month follow-up
4. Have a severe disease (i.e. cirrhosis, end-stage renal disease ...)
5. Are unlikely to cooperate in the study
6. Arm 1: patient having contra-indication to take Viacoram® according to SmPC
7. Arm 2: patient showing interest in attending NDT educational program.
An Evaluation of the Medtronic Gatekeeper System in the Treatment of SUBJECTS With Gastroesophageal Reflux Disease (GERD)

The purpose of the study is to demonstrate the intended use of the Gatekeeper Reflux Repair System to provide symptomatic relief is subjects with gastroesophageal reflux disease.

The purpose of the study is to demonstrate the intended use of the Gatekeeper Reflux Repair System to provide symptomatic relief is subjects with gastroesophageal reflux disease

Eligibility Criteria:
Diagnosis and main criteria for inclusion:

* Subjects diagnosed with GERD with symptomatic improvement on PPIs.
* Subjects who have demonstrated a baseline 24 Hour pH ≥ 4% time with pH ≤ 4.0.
* Subjects with a baseline GERD-HRQL heartburn score of ≤11 on PPI and ≥ 20 off PPI.

Diagnosis and main criteria for exclusion:

* Extensive Barrett's Esophagus (\> 2 cm).
* Esophagitis (LA Classification Grades C or D).
* Previous history of gastroesophageal surgery, anti-reflux procedures, or gastroesophageal or gastric cancer.
* Large hiatal hernia (\> 3 cm).
* Current complaints of clinical dysphagia evidenced by greater than one occurrence per month.
* Esophageal strictures
* Esophageal or gastric varices
QUILT-2.013: First-Line Treatment for Extensive Stage Small Cell Lung Cancer

This trial is titled "A Phase 1b/2 trial of AMG 479 or AMG 102 with Platinum-Based Chemotherapy as First-Line Treatment for Extensive Stage Small-Cell Lung Cancer (SCLC)."

Part 1, the phase 1b portion of this study, is a multicenter, open-label investigation to identify safe dose levels of either AMG 102 or AMG 479 in combination with etoposide plus cisplatin or carboplatin in subjects with previously untreated extensive stage SCLC.

Part 2, the phase 2 portion of this study, is a multicenter, double-blind, 3-arm investigation to evaluate overall survival of either AMG 102 or AMG 479 in combination with platinum-based chemotherapy.


Eligibility Criteria:
Key Inclusion Criteria

* Histologically or cytologically confirmed SCLC
* Extensive disease, defined by at least one of the following:
* No limited disease (ie, no disease confined to the ipsilateral hemithorax, which can be safely encompassed within a tolerable radiation field)
* Extrathoracic metastases
* Malignant pericardial or pleural effusion
* Contralateral hilar adenopathy
* Measurable or nonmeasurable disease, as defined by modified RECIST
* Eastern Cooperative Oncology Group (ECOG) status 0 or 1
* ≥18 years old
* Life expectancy (with therapy) ≥3 months
* Adequate hematologic, hepatic, coagulation, renal, and metabolic function
* Diabetes, if present, must be controlled, with glycosylated hemoglobin (HbA1C) ≤ 8% and fasting glucose levels ≤160 mg/dL

Key Exclusion Criteria

* Prior chemotherapy, chemoradiation, or investigational agent for SCLC
* Prior radiotherapy to \>25% of the bone marrow
* Symptomatic or untreated central nervous system metastases (with exceptions)
* Currently or previously treated with biologic, immunologic or other therapies for SCLC
* Current serious or nonhealing wound or ulcer
* History of prior concurrent other malignancy (with exceptions)
* Thorombosis or vascular ischemic events within the last 12 months such as DVT, PE, TIA or MI
* Any clinically significant medical condition other than cancer (eg, cardiovascular disease or COPD), which could interfere with the safe delivery of study treatment or risk of toxicity