cyrilzakka/clinical-trials huggingface dataset:
A Comparison of Clarithromycin-based and Furazolidone-based Bismuth-containing Regimens for H. Pylori Eradication

We aim to assess and compare the effectiveness of clarithromycin- and furazolidone-based regimens as primary therapies in eradicating H. pylori.

Helicobacter pylori plays a pivotal role in many diseases such as peptic ulcer disease and MALT lymphomas. And the prevalence of H. pylori is increasing in some parts of the world.

However, the eradication becomes increasingly difficult due to the growing antibiotic resistance. Bismuth-containing quadruple regimens are now recommended to serve as first-line therapies. Bismuth-clarithromycin-containing and bismuth-furazolidone-containing quadruple regimens are both in the list of the first regimens. And recent antimicrobial susceptibility tests showed us that the clarithromycin was increasingly resisted while furazolidone remained hardly resisted. The comparison between the effects of bismuth-clarithromycin-containing and bismuth-furazolidone-containing quadruple regimens is not so clear.

Eligibility Criteria:
Inclusion Criteria:

* Patients, aged between 18 and 75years old, with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

Exclusion Criteria:

* Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.
Pazopanib + Vinorelbine in Non Small Cell Lung Cancer (NSCLC) and Breast Cancer

The purpose of this study is to determine the highest dose of Vinorelbine and Pazopanib that can be given together without causing severe side effects. Also, this study will evaluate what effects (good and bad) that the treatment has on patients and their cancer.

This study involves an investigational drug called pazopanib in combination with the chemotherapy drug vinorelbine. An investigational drug is a drug that has not been approved by the U.S. Food and Drug Administration (FDA) for use in the United States. Vinorelbine has been FDA approved to treat patients with NSCLC and breast cancer. Pazopanib is a vascular endothelial growth factor inhibitor, which means it may prevent the tumor from growing its own blood vessels thereby interfering with the growth of the tumor. Participants in this study will be assigned to one of three groups with each group receiving a higher dose of vinorelbine and pazopanib than the previous group. Vinorelbine will be given through a needle in the vein on days 1 and 8 of each 21 day study treatment cycle. Pazopanib is a pill which will be taken by mouth every day during the 21 day study treatment cycle.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients must have diagnosis of breast cancer or non small cell lung cancer
* Patients must have evaluable disease
* Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study.
* Patients must have given signed, informed consent prior to registration on study.

Exclusion Criteria:

* Patients must not be pregnant and/or lactating.
* Patients must not be receiving any other investigational agents.
* No prior exposure to vinorelbine or other VEGF inhibitors as treatment for metastatic disease
* Patients must not have received prior therapy (including radiation, surgery, and/or chemotherapy) within 30 days
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib or vinorelbine.
* Patients cannot have received more than 2 prior chemotherapy regimens for lung cancer or 3 prior chemotherapy regimens for breast cancer. This criterion can be discussed further with the study doctor.
* Must not have uncontrolled illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmic, psychiatric illness/social situations that would limit compliance with study requirements.
An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis

This clinical trial examines an investigational scan (64Cu-DOTA-trastuzumab positron emission tomography \[PET\]/magnetic resonance imaging \[MRI\]) in imaging patients with HER2+ breast cancer that has spread to the brain (brain metastasis). Diagnostic procedures, such as 64Cu-DOTA-trastuzumab PET/MRI, may help find HER2+ breast cancer that has spread to the brain and determine whether cancer in the brain takes up trastuzumab, which may predict for response to trastuzumab deruxtecan (the standard of care chemotherapy).

PRIMARY OBJECTIVES:

I. Evaluate the feasibility of 64Cu-DOTA-trastuzumab PET imaging in patients with HER2+ breast cancer metastatic to the brain.

II. Evaluate if HER2+ breast cancer patients with brain metastasis who are responders to fam-trastuzumab deruxtecan have higher maximum standardized uptake value (SUVmax) (minimum over all lesions in the brain) than non-responders.

SECONDARY OBJECTIVE:

I. Evaluate if the minimum SUVmax of all quantifiable lesions in a given patient is associated with time to progression in the brain.

OUTLINE:

Patients receive trastuzumab intravenously (IV) over 15 minutes on day 0. Patients then receive 64Cu-DOTA-trastuzumab IV and then undergo PET/MRI scan on day 1. Patients undergo repeat brain MRI every 6 weeks for 24 weeks and then every 9 weeks until disease progression. Patients then receive trastuzumab deruxtecan IV every 21 days in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Documented informed consent of the participant and/or legally authorized representative
* Women with documented metastatic HER2 positive breast cancer (American Society of Clinical Oncology \[ASCO\] College of American Pathologist \[CAP\] guidelines) who have brain metastases
* Age \> 18 years
* Eastern Cooperative Oncology Group (ECOG) 0-2
* Patients with leptomeningeal disease will be considered eligible
* Planned therapy with fam-trastuzumab deruxtecan
* Left ventricular ejection fraction (LVEF) \> 50%
* Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L
* Platelets \> 100 x 10\^9/L
* Hemoglobin \> 9 g/dL
* Total (T.) bilirubin \< 3 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 x ULN
* Creatinine clearance \> 30 ml/min (by Cockcroft-Gault formula)
* Activated partial thromboplastin time (aPTT) \< 1.5 x ULN
* Prior therapy for central nervous system (CNS) disease is allowed, but at least 1 lesion \> 1.5 cm is evident on MRI

Exclusion Criteria:

* Need for immediate local intervention for brain metastases
* Noninfectious interstitial lung disease or pneumonitis requiring glucocorticoids
* Clinically significant corneal disease
* Myocardial infarction \< 6 months before, congestive heart failure (CHF), unstable angina, or serious cardiac arrhythmia
Consumption of 4D Dietary Supplement on Perceptual-Cognitive and Visual-Motor Performance

The purpose of this investigation is to determine if supplementation with the 4D dietary supplement impacts perceptual-cognitive and visual-motor skills in healthy individuals.

Multi-ingredient supplements (MIS) have been reported to positively impact various aspects of performance. While caffeine alone has been shown to improve aerobic performance, resistance training (such as bench press), reaction time and sprint performance, it has also been suggested that it lacks the ability to improve cognition. Therefore, the purpose of this investigation is to examine the effects of a caffeine containing MIS on measures of cognition and reaction time, with the intent of providing additional benefits to athletic performance.

This study will utilize a randomized, double-blind, placebo-controlled design. Following two familiarization trials, participants will complete two testing visits. During these visits, they will complete baseline assessments, consume either the 4D dietary supplement or a taste matched placebo, and rest for 45 minutes. Reaction time, cognition assessments (visual tracking speed), and reactive agility performance will be assessed following the rest period.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between the ages of 18-40 years old
* Determined to be healthy by the MHQ and PAR-Q+

Exclusion Criteria:

* Any response of "yes" on the PAR-Q+
* Daily caffeine consumption greater than 200 mg
Compression Bandages in Upper Limb Lymphedema

Despite different types of bandages are using in the lymphedema treatment, numerous of them have not been directly compared. The aim of this study is to compare the efficacy of five different kinds of bandages on limb volume and lymphedema-related symptoms. It was also measured as secondary variables the comfort of the bandage related by the participants and the directly cost of each kind of bandage during the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Women after breast cancer surgery undergoing upper limb lymphedema not previously treated
* Having more than two centimeters between two adjacent measurements between the lymphedematous and the contralateral upper limb
* The presence of heaviness, tension or fovea in the affected limb
* More than six months post-surgery or radiation to eliminate the possibility of being a post-chirurgical oedema

Exclusion criteria will be:

* Bilateral breast cancer surgery
* Only hand lymphedema
* Active cutaneous infection
* A loco-regional cancer recurrence
* The impossibility of complete all the physical therapy sessions
* A primary lymphedema
* Women with lymphedema symptoms like thickness and heaviness in the upper limb but without a difference of two centimeters in two adjacent points
* Any contraindication to physiotherapy
Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.

This study is a randomized, multicenter, open-label, active control study to evaluate the safety and efficacy of AT-1501 compared with tacrolimus in the prevention of rejection in patients undergoing kidney transplantation. Up to 120 de novo kidney transplant recipients will receive rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy, and will be randomized 1:1 to receive either AT-1501 or tacrolimus.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age
* Recipient of their first kidney transplant from a living or deceased donor
* Agree to comply with contraception requirements during and for at least 90 days after the last administration of study drug

Exclusion Criteria:

* Induction therapy, other than study assigned rATG, planned as part of initial immunosuppressive regimen
* Currently treated with any systemic immunosuppressive regimen, including immunologic biologic therapies
* Currently treated with corticosteroids other than topical or inhaled corticosteroids
* Will receive a kidney with an anticipated cold ischemia time of \> 30 hours
* Will receive a kidney from a donor that meets any of the following:

  * 5a. Donation after Cardiac Death (DCD) criteria; Or
  * 5b. Kidney Donor Profile Index (KDPI) of \> 85%; Or
  * 5c. Is blood group (ABO) incompatible
* Medical conditions that require chronic use of systemic corticosteroids or other immunosuppressants
* History of a thromboembolic event, known hypercoagulable state, or condition requiring long term anticoagulation
* Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening
Motor Learning of Stroke Patients in Virtual Environments

The aim of this study is to assess the motor learning of patients with chronic stroke in virtual environments. Half the patients will undergo conventional therapy and half virtual reality training using virtual game. The study will also include healthy individuals matched for age, sex, schooling and hand laterality.

Stroke is the main cause of long-term disability in adults and motor learning is vital for recovering from motor sequelae. A number of approaches have been proposed to promote motor learning, including virtual reality, which simulates a real world environment and is based on the assumption that skills acquired in a virtual world will be transferred to the real world. Virtual reality induces use-dependent plastic changes in response to stimulation of higher motor areas, recruiting the memory system containing stored motor programs. As such, these interactive interventions of virtual reality are based on the idea that stimulating the action processing system activates the cortical areas involved in movement execution.

These game characteristics allow activation of the mirror neuron system during the execution or observation of actions. Recent evidence suggests an important role for this neuron system in the improvement or motor recovery of patients. In this respect, observing an action in association with physical training may enhance the effects of motor training on the recovery of patients with stroke.

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with the first episode of stroke, confirmed by medical imaging examination, unilateral brain injury, lesion time of at least 6 months;
* Right-handed and able to complete the assessment instruments;
* Individuals with affected upper limb movement skills, such as drinking water from a glass;
* Subjects able to remain in the orthostatic position, with or without gait assistive device.

Exclusion Criteria:

* Unilateral neglect and uncorrected primary auditory or visual impairment.
Does Optical Coherence Tomography Optimise Results of Stenting

Optical Coherence Tomography (OCT) is a recent imaging modality that yields cross-sectional images with a resolution 10 times greater than that of intravascular ultrasound (IVUS). OCT uses a near-infra-red light source to obtain images of the interior walls of the coronary arteries and is increasingly used to evaluate vulnerable atherosclerotic plaques and assess placement and response to stenting. - To date, no study has evaluated whether optical coherence tomography (OCT) contributes to optimizing percutaneous coronary intervention (PCI) and stenting.

The DOCTORS study is a randomized, open label study to evaluate whether OCT-guided angioplasty would provide useful clinical information beyond that obtained by angiography, and whether this information would subsequently modify physician behavior and treatment choices. In particular, we will evaluate the impact of changes in procedural strategy resulting from the use of OCT on the value of fractional flow reserve (FFR) obtained after angioplasty and stent implantation of a lesion responsible for non-ST segment elevation acute coronary syndromes.


Eligibility Criteria:
Inclusion Criteria:

Patients aged 18 to 80 years inclusive, admitted for acute coronary syndrome (ACS) with the following symptoms :

* Clinical signs of ischemia (chest pain) at rest lasting for at least 10 minutes in the previous 72 hours;
* AND at least one of the following two criteria :

  * New ST segment depression ≥1 mm or transitory ST segment elevation (\<30 minutes) (≥1 mm) on at least 2 contiguous leads of the ECG; OR
  * Elevation (\>upper limit of normal, ULN) of cardiac enzymes (CK-MB, Troponin I or T).

AND Presenting an indication for coronary angioplasty with stent implantation of the target lesion considered to be responsible for the ACS.

AND Written informed consent.

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from the study:

* Left main stem disease
* Presence of coronary artery bypass grafts
* Cardiogenic shock or severe hemodynamic instability
* Severely calcified or tortuous arteries
* Persistent ST segment elevation
* One or more other lesions considered angiographically significant and located on the target vessel
* Severe renal insufficiency (creatinine clearance ≤30 mL/min)
* Bacteraemia or septicaemia
* Severe coagulation disorders
* Patients who refuse to sign the informed consent form
Modulation of Biomarkers in Patients With Flesh-eating Bacterial Infections After With Hyperbaric Oxygen Treatment

The purpose of this study is to investigate the effects of hyperic oxygen treatment on the immune response in patients with necrotizing soft tissue infections

Necrotizing soft tissue infections (NSTI) is a complex, multi-factorial disease and the bacteria show a diverse microbial etiology. The exentisive inflammatory response caused by these bacteria is thought to be a main course of death. In Denmark, most NSTI patients are treated with hyperic oxygen therapy (HBOT). However, the effects of HBOT have never been investigated in NSTI patients.

Location: Copenhagen University Hospital, Rigshospitalet, Denmark.

Design: Observational cohort study.

Cohort: NSTI patients in Denmark treated with HBOT.

Biomarkers: Cytokines, acute-phase proteins, vasoactive biomarkers and other inflammatory biomarkers.

Sample size calculation: The investigators expect a mean IL-6 concentration before HBOT of 3500 pg/ml (standard deviation 1500 pg/ml) and consider a reduction of 800 pg/ml to be clinically relevant. With an alpha = 0.05 and a power of 80%, 112 patients will be required.

Data: The Danish Data Protection Agency has approved the processing of personal data for the NSTI patients (J. no. 30-0900).

Ethics: The trial will adhere to the Helsinki Declaration and the Danish law. The National Ethics Committee and the Regional Scientific Ethics Committee of Copenhagen have approved the study (CVK-1211709 and H-2-2014-071).

Analysis: Biomarker analyses will be performed once the recruitment of patients has ended.

Eligibility Criteria:
Inclusion criteria:

* Necrotizing soft tissue infection based on surgical findings
* Admitted to/planned to be admitted to the ICU at Rigshospitalet and/or operated for NSTI at Rigshospitalet
* Receving a minimum of 1 HBOT

Exclusion criteria:

* Patients who at the operating theatre were categorized as a non-NSTI patient
Ankle-Brachial Index to Predicte All-Cause and Cardiovascular Mortality in Framingham Risk Score Patients

Framingham Risk Score (FRS) included age, gender, body mass index (BMI), cigarette smoking, blood pressure, total cholesterol (TC), LDL-cholesterol (LDL-C) and diabetes mellitus (DM). Previously, Framingham cohort study and other study has confered patients with medium or high FRS had worse prognosis. However, the score list was tending to over-estimate risk in medium FRS or under-estimate risk in high FRS patients . For this reason, ACC/AHA cholesterol guidelines also recommend the use of additional markers to improve atherosclerotic cardiovascular disease (ASCVD) risk assessment and medical decision making.

Meanwhile, the ABI, which was the ratio of systolic pressure at the ankle to that in the arm, was quick, easy and used to diagnosis and assess the severity of peripheral artery disease (PAD) in the legs. Several research have shown its low value as an indicator of general atherosclerosis and independently risk associated with cardiovascular events in prospective studies . In addition, ABI aggressively modified risk factors and accelerated the adverse prognosis of ASCVD. However, whether FRS or ABI, were all related to participants and race. And, most studies were from western countries, lack of Asian date, especially aimed at risk prediction model research. Therefore, this research was aimed to validate incorporating ABI and relevant Framingham risk variables whether could improve prediction all-cause mortality and cardiac mortality in medium and high Framingham risk score (FRS) patients.

The study is a longitudinal cohort study. The first cross-sectional survey was conducted in 2011.

Eligibility Criteria:
The inclusion criteria:

1. Patients were age older than or equal to 18 years
2. Patients with medium and high Framingham risk score，namely, Framingham Risk Score (FRS) 10%-20%,or FRS \> 20%.
3. All participants gave written informed consent to this study, which was approved by the ethics committee of Tongji University.

Exclusion Criteria:

1. Patients were suffering from mental illness.
2. Life expectancy of patients were less than 1 year.
A Phase 1 Trial of OPB-111077 in Combination With Bendamustine and Rituximab in Patients With r/r DLBCL

To investigate the tolerability and safety of OPB-111077 in combination with bendamustine and rituximab in patients with r/r DLBCL.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a definite diagnosis of Diffuse large B-cell lymphoma(DLBCL)
* Patients who have received at least initial standard treatment
* Patients with measurable lesions (based on International Working Group \[IWG\] 2014 criteria)
* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1

\<Only for dose-expansion stage\>

* Patients who are pathologically diagnosed as CD20 positive lymphoma
* Patients who have a history of being treated with 1 to 5 regimens of previous chemotherapy for the underlying disease

Exclusion Criteria:

* Patients who are candidates for autologous or allogeneic hematopoietic stem cell transplantation
* Patients who were refractory to initial standard treatment
* Patients who have a history of bendamustine administration and are intolerant to bendamustine
* Patients with central nervous system (CNS) involvement of lymphoma or with a history of CNS involvement of lymphoma
* Patients diagnosed with DLBCL transformed from low-grade B-cell non-Hodgkin's lymphoma (NHL)

\<Only for dose-expansion stage\>

- Patients who have a history of rituximab administration and are intolerant to rituximab
Change in NLR and Survival Among Advanced Lung Cancer Patients Receiving ICIs With Immunomodulator

The main objective of this study is to evaluate the change of neutrophil to lymphocyte ratio (NLR) after 6-week treatment of immune checkpoint inhibitors (ICIs) with or without immunomodulatory drugs and recognize the effect of post-treatment NLR and overall survival in advanced lung cancer patients by retrospective review.

In recent years, the therapeutic strategies for lung cancer have been enriched with small molecular targeted therapy and immunotherapy. In this retrospective study, we will observe the change in NLR and explore its possible association with survival among advanced lung cancer patients receiving Immune checkpoint inhibitors (ICIs) with and without such immuno-modulator, Astragalus Polysaccharide Injection. It can be used to understand the relationship between NLR values and the survival rate of lung cancer patients after ICIs treatment. Physicians can refer to this result to give patients the suitable treatment recommendations.

Eligibility Criteria:
Inclusion Criteria

* Aged 20 years and older.
* Patients who have been given a diagnosis of lung cancer.
* Previously advanced lung cancer patients first treated with ICIs from Oct 1, 2015 to Oct 31, 2019.

Exclusion Criteria

* Patients who have no hematological laboratory data available at baseline (within 3 days prior to ICI treatment) and the 6th week (± 2 weeks) after ICI treatment initiation.