cyrilzakka/clinical-trials huggingface dataset:
Ultrasound-guided Stellate Ganglion Block for Treatment of Chronic Migraine in Adult

To assess the 6-months effects and safety of stellate ganglion block(SGB) for Chronic Migraine (CM) patients who failure to undergo preventive therapy and are seeking a more suitable non-pharmacological therapy.

The investigators aim to investigate whether the stellate ganglion block(SGB) is better than traditional medication treatment and provides medical evidence for the clinical application and promotion of SGB to provide a minimally invasive, safe, and effective treatment for patients with chronic migraine(CM) who failed to receive standardized drug treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 65 years;
2. Diagnosed with CM according to the International Classification of Headache Disorders, 3rd (ICHD-3) criteria \[Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211\].
3. not received prior prophylactic migraine treatment or, due to lack of efficacy or tolerability, had failed or had not been suitable for up to three previous prophylactic treatments from the following: Metoprolol/propranolol, amitriptyline, and flunarizine.

Exclusion Criteria:

1. BMI \<15 kg/m2 or \>35 kg/m2；
2. Previous SGB treatment；
3. History of other neurological disorders；
4. History of severe cardiopulmonary, hepatic or renal dysfunction；
5. History of allergies to any of the study drugs；
6. Patients with chronic use of opioids；
7. Preoperative coagulation abnormalities (activated partial thromboplastin time greater than 1.5 time normal value)；
8. Infection or mass near the puncture site；
9. Neck anatomic structural changes (caused by radiotherapy or surgery);
10. Pregnant or breast feeding;
11. Psychological disorders;
12. Refusal to sign informed consent.
64 Cu-DOTA-alendronate PET Imaging in Localizing and Characterizing Breast Calcifications in Participants Before Undergoing Mastectomy

This early phase I pilot trial studies how well 64Cu-DOTA-alendronate positron emission tomography (PET) imaging work in localizing and characterizing breast calcifications (small calcium deposits) in participants before undergoing mastectomy. Diagnostic procedures, such 64Cu-DOTA-alendronate PET, may detect calcification and help doctors predict cancer associated calcification within breast tissue.

PRIMARY OBJECTIVES:

I. To evaluate the uptake (maximum standardized uptake value \[SUVmax\]) of 64Cu-DOTA-alendronate in female patients with biopsy-proven malignant breast calcifications.

SECONDARY OBJECTIVES:

I. To compare uptake of 64Cu-DOTA-alendronate on PET -computed tomography (CT) with histology after mastectomy.

OUTLINE: This is a dose-escalation study of 64Cu-DOTA-alendronate.

Participants receive 64Cu-DOTA-alendronate intravenously (IV) and undergo PET/CT imaging 60 minutes after injection. Participants with sufficient levels of residual radioactivity may undergo repeat imaging on day 1 as determined by the study team.

After completion of study , participants are followed up for 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of calcifications on mammogram
* Biopsy confirmed malignancy associated calcifications in at least one breast
* Biopsy confirmed benign calcifications in at least one breast (same or contralateral breast)
* Planned total mastectomy for treatment
* Ability to provide informed consent
* Negative serum pregnancy test
* No evidence of impaired hepatic or kidney function

Exclusion Criteria:

* Participants who do not have residual calcifications present on mammogram following biopsy
* Concurrent malignancy other than non-melanoma skin cancer
* Patients with known metastatic disease
* Patients who have received prior treatment for the current breast cancer
* Patients currently using oral bisphosphonate therapy
* Patients with injection of other radioactive material within 90 days
* Inability to provide informed consent
* Pregnant or lactating patients
* Patients with impaired kidney function (creatinine \>= 1.3 mg/dL or \< 0.6 mg/dL)
Prevention With Chloroquine in Health Personnel Exposed to Infection With Coronavirus Disease 2019 (COVID-19) (TS-COVID)

The purpose of this study is to assess the efficacy and safety of chloroquine prophylaxis on the incidence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections in healthcare workers exposed to patients with confirmed Coronavirus Disease 2019 (COVID-19)

Single arm study in which healthcare workers were actively invited to participate. Possible participants were asked to complete a questionnaire to determine eligibility for study entry and to identify risk factors for infection, severe infection, or adverse events associated with chloroquine use.

Volunteers who meet the eligibility requirements received chloroquine 150mg base at days 0, 15, 30, 45, 60, 75. Cumulative incidence and incidence rate of COVID-19 at days 30,60 and 90 were calculated. Presence of Immunoglobulin G (IgG) antibodies against SARS-Cov-2 was evaluated at the beginning, at the end and at any moment if they become infected with this virus.

In addition, patients were asked to complete a survey evaluating adverse effects and COVID-19 symptoms at day 0 and weeks 2,4,6,8,10, and 12.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic healthcare workers and contractors who work in Fundacion Valle del Lili

Exclusion Criteria:

* To have two or more of the following symptoms 14 days previous to the initial assessment: cough, dyspnea, odynophagia, fatigue, weakness, fever \>38 degrees °C
* History of close contact (less than two meters) with a person with probable or confirmed COVID-19 without adequate protection during the last 14 days
* History of one the following diseases in treatment at inclusion in the study: cardiac arrhythmias, epilepsy, kidney disease, seizures
* Treatment with concomitant medications: tamoxifen, quinine, cyclosporine, amiodarone, digoxine, anticonvulsivants
* Having recently taken chloroquine or hydroxychloroquine in the last two weeks
* Known hypersensitivity to chloroquine or hydroxychloroquine
Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced HCC

Sorafenib ,an oral multikinase inhibitor targeting several tyrosine-kinase receptors with antiangiogenesis and antiproliferation of HCC, is the first approved target therapy for HCC.

Zoledronic acid is used for treatment of bone metastasis of diverse malignant cancer. Emerging data suggest that zoledronic acid may also exhibit anticancer properties.

The objectives of the study is to evaluate the safety of Sorafenib combined with Zoledronic Acid and to evaluate overall survival and time to progression.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features
* patient with unresectable primary hepatocellular carcinoma
* Child-Pugh Class A or B, score ≤ 7
* ECOG score 0-2
* Expected survival time not less than 12 weeks
* At least one tumor nodule with one uni-dimension of ≥ 1 cm
* Peripheral platelet of or more than 50×10(9)/L
* Peripheral hemoglobin of or more than 85g/L
* Peripheral albumen of or more than 28g/L
* Total bilirubin ≤3.0mg/dl
* ALT and AST ≤ 5.0 x the upper limit of normal
* Serum amylase ≤ 1.5x the upper limit of normal
* Serum creatinine ≤ 1.5x upper limit of normal
* PT-INR\<2.3 or PT prolong no more than 4s of normal

Exclusion Criteria:

* Congestive heart failure \> NYHA class 2
* History of active coronary disease( except myocardial infarction more than 6 months ago)
* Receive anti-arrhythmia treatment(except β-receptor blocker,calcium channel blocker and digoxin)
* uncontrollable hypertension
* Active clinically serious infections (\> 2 NCI-CTC Version 3.0)
* History of HIV infection
* Inclined to hemorrhage or active hemorrhage with 1 month
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
* Pregnant or breast-feeding.Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolling in this portion of the study
* Known or suspected allergy to any agent given in association with this trial
* Concomitant anti-cancer therapy (except immunotherapy and Chinese traditional treatment)
* Surgical operation within 4 weeks prior to enrolling in this portion of the study
Functional Neuroimaging of Cortical Plasticity in the Human Visual System

The study's objective is to measure changes in human visual cortex organization that may arise as a result of injury to the visual pathways. Subjects with retinal or cortical injury will be studied and compared to appropriate controls. Functional magnetic resonance imaging methods are used to monitor cortical topography in time. The main aims of the study are to determine: 1) what are the patterns of cortical reorganization that are seen spontaneously after injury, and 2) whether rehabilitative training can promote adaptive reorganization enhancing recovery.


Eligibility Criteria:
Inclusion Criteria:

* Stable lesion of the visual pathways resulting in a visual field scotoma.

Exclusion Criteria:

* Inability to undergo magnetic resonance imaging,
* Inability to comply with basic instructions,
* Inability to perform the behavioral tasks required,
* Patients with chronic progressive neurological or psychiatric disorders,
* Patients that are pregnant, or breast feeding.
Immunological Biomarkers in Tuberculosis Management

Tuberculosis (TB) is the leading cause of death by infectious disease in the world, responsible for 1.6 million deaths in 2017. The treatment of active TB requires at least a 6-month combined antibiotic regimen and can cause heavy side effects. As a consequence, treatment adherence is not optimal, particularly in primary care settings. Rapid and reliable monitoring of anti-TB treatment adherence and efficacy is critical to provide adequate patient care and curb relapse episodes and acquired drug resistance.

Investigators propose to evaluate the performance in terms of diagnosis accuracy and outcome prediction of four new biomarkers of active TB: 1) a double IGRA (Interferon Gamma Release Assay) including QuantiFERON-Gold Plus® and HBHA; 2) a whole blood transcriptomic analysis of mRNA (messenger Ribonucleic acid) expression of a panel of 150 genes; 3) a whole blood proteomic analysis; 4) an ex vivo immunophenotyping using flow and mass cytometry to characterize the lymphocyte populations.


Eligibility Criteria:
Inclusion Criteria:

Adult ≥ 18 year-old

* Patients having given written consent
* Patients accepting a follow up ≥ 6 months
* Proven active tuberculosis (positive direct examination and/or PCR)
* Latent tuberculosis infection assessed by positive IGRA

Exclusion Criteria:

* Malignant solid tumor
* Malignant hemopathy
* Solid organ transplantation or hematopoietic stem cell transplantation
* Immunosuppressive treatments (i.e. biologics, calcineurin inhibitors, corticosteroids)
* Auto-inflammatory disease
* Chronic liver diseases
* Chronic infection with HIV, HCV (hepatitis C virus) or HBV (hepatitis B virus)
* Antimycobacterial treatment initiated \> 7 days
* Pregnancy or breastfeeding
* Refusal to participate to the study
* Persons deprived of their liberty by judicial or administrative decision
* Protected adults
* Patients not affiliated to health-care social security
* The homeless
Haemodynamic Effects of Apelin Agonists and Antagonists in Man in COPD With Raised Pulmonary Artery Pressures

The investigators are interested in studying how Pulmonary Hypertension occurs. A substance called 'apelin', that naturally occurs in the body has been shown to have an important role in heart disease. Previous studies have shown that it can make blood vessels get wider, and help blood flow around the body and thus improve the way the heart and lungs work.

The investigators are looking to recruit both healthy and COPD pulmonary hypertension patients to study 3 types of apelin. The purpose of this study is to help the investigators understand how Pulmonary Hypertension occurs which may will help with the development of future treatments.

The purpose of this study:

To investigate the physiological role of apelin in the cardiovascular system in patients with COPD with raised pulmonary artery pressures.

Study Aim and hypotheses:

The primary objective is to test the above hypotheses using forearm blood flow and systemic infusions of apelin peptides.

Hypotheses:

1. Apelin agonists are vasodilators in human resistance vessels and this effect will be altered in patients with pulmonary hypertension.
2. Apelin peptides improve right ventricular and pulmonary haemodynamics in patients with elevated pulmonary artery pressures.

Study 1a - A validation dose study of 3 apelin agonists performed in healthy volunteers and COPD patients with elevated pulmonary artery pressures.

Study 1b- A validation dose study of apelin receptor antagonist, in healthy volunteers and COPD patients with elevated pulmonary artery pressures.

Study 2a - To define the haemodynamic response to apelin agonists in healthy volunteers and evaluate the response.

Study 2b - To investigate the haemodynamic response to 3 apelin agonists in COPD patients with elevated pulmonary artery pressures.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

  * Aged 18 to 70 years
  * Non-smoker (\<1 cigarette per week)
  * If female, postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test COPD patients with estimated Pulmonary Artery Pressure (PAP) on echo \>25mmHg
  * Clinical diagnosis of COPD as per standard criteria
  * Between 18 and 70 years
  * If female, postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test

Exclusion Criteria:

* pre-existing:

  * Systemic Hypertension (sustained BP \>160/100mmHg)
  * Ischaemic Heart Disease
  * Primary valvular heart disease
  * Significant left ventricular failure
  * Active malignancy
  * Renal disease (Creatinine \>180 µmol/L)
  * Neurological disease
  * Diabetes mellitus
  * BMI \>35, BMI \<17
  * Pregnancy
  * Use of vasoactive medication or NSAIDS/aspirin within 48 hours of study.
  * Current involvement in other research studies, other than observational/non-interventional
  * Known HIV
COVID-19: SARS-CoV-2-CZ-PREVAL-II Study

The aim of the SARS-CoV-2-CZ-PREVAL-II Study is to quantify the prevalence of participants with antibodies against SARS-CoV-2 and/or cell immunity against SARS-CoV-2 in specific subjects cohorts.

The aim of the SARS-CoV-2-CZ-PREVAL-II Study is to quantify the prevalence of participants with antibodies against SARS-CoV-2 and/or cell immunity against SARS-CoV-2 in four specific cohorts: participants with chronic illness, healthy volunteers participating in the Study of the Czech Academy of Science, healthcare workers, and healthy volunteers that participated in the "Herd Immunity Study SARS-CoV-2-CZ-Preval" in May 2020.

The primary aim of the study is to estimate the number of people with anti-SARS-CoV-2-antibodies, i.e., people with COVID-19 history, or with vaccination against COVID-19.

Antibodies test will focus on two main proteins of virus SARS-CoV-2: S-protein and N-protein.

The secondary aims of the study are:

* quantitative analysis of cellular immunity and the other relevant markers,
* estimation of the proportion of participants with asymptomatic COVID-19 infection
* quantification of anti-SARS-CoV-2 antibodies and cell immunity according to individual risk factors.

Eligibility Criteria:
Inclusion Criteria:

* signed Informed consent
* willingness to complete the study questionnaire
* demographic criteria - age 18 years old and more
* clinical criteria - without acute health problems
* time criteria - sample collection in the defined period time

Exclusion Criteria:

* none
Lumigan® in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

This is an observational study of Lumigan® 0.01% (bimatoprost) treatment in clinical practice for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary open angle glaucoma or ocular hypertension
* Prescribed Lumigan®

Exclusion Criteria:

* None
Karolinska Cardiorenal Theme-centre and StockholmHeartbank

Chronic kidney disease (CKD) affects 10-18% of the adult population and is becoming recognized as one of the most serious disorders causing increased risk for cardiovascular disease and death. In patients with ischemic heart disease 26% have increased creatinine, which rises to 40% if patients also have diabetes mellitus. Risk increases as renal function diminishes, and just slowing the rate of decline in renal function would have a tremendous impact on health and morbidity. This association is commonly termed the Cardiorenal Syndrome, though it is caused by a much more complex interplay between major pathogenetic pathways such as glucose metabolism and diabetes, systemic and tissue inflammation, tissue metabolism, coagulation, mineral metabolism, sympathetic activation, renin-angiotensin-aldosterone system activation, endothelial dysfunction, lipid metabolism, fetal programming etc.

Karolinska Institutet recently merged basic and clinical researchers in all these fields, creating a Karolinska Kardiorenal Theme Centre; ultimately aiming to explore the syndrome and provide improved care for the individual patient.

The investigators road to success:

* Creating a Biobank (blood, DNA, plasma) from the majority of all hosptalized patients with ACS in Stockholm county - Stockholmheartbank.
* This Theme Center include all teaching hospitals associated with Karolinska Institutet; Danderyd University Hospital, Karolinska University Hospital and Södersjukhuset University Hospital. Together theses hospitals serve as emergency hospitals for 1.9 million people. The investigators are aiming at creating a biobank from all patients admitted for an acute coronary event (about 2.300/yr), which is a unique asset for molecular and genetic research as well as observational and intervention studies.
* The investigators have access to the National registry with 100% coverage, that contains data on all patients admitted to Stockholms coronary care units since 1995.
* To ensure translation in to clinical practice, most of the researchers are also MD:s, and several are clinically active.
* The clinical network facilitates the development of novel therapies and translational research.
* Steering groups for Education and a Clinical Practice implementation program.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to one of the four major emergency hospitals in Stockholm, for an acute coronary event.
* All patients admitted to one of the four major emergency hospitals in Stockholm, for an elective coronary angiography

Exclusion Criteria:

* Severe hemodynamic instability with the need of inotropic therapy and at the same time anemia with haemoglobin \<1.1 g/dL
Thyroid and Cortisol Hormone Response to Sepsis

Thyroid and cortisol hormone response to sepsis

Sepsis is dysregulated host response to infection that results in life-threatening organ dysfunction. Virtually every body system can be affected by this syndrome to greater or lesser extents.

Endocrine alterations are well characterised in sepsis with variations in circulating blood levels and/or receptor resistance.

In response to any psychological or physical stressor, there is widespread neurohormonal activation to adapt body with the stressor. Production and secretion of stress hormones increase to modulate behaviour Many studies have been performed investigating specific hormonal perturbations such as critical illness-induced corticosteroid insufficiency ,all of which are associated with worse outcomes and poor of body inflammation. However, the endocrine system as a whole has been largely overlooked as a fundamental contributor to the integrated host response to sepsis thyroid axis is affected during sepsis with decreased pituitary release of thyroid stimulating hormone (TSH) and inhibition of the peripheral conversion of thyroxine (T4) by 5-deiodinase to the much more metabolically active triiodothyronine (T3). High cortisol levels also inhibit this enzymatic conversion.

Eligibility Criteria:
Inclusion Criteria:

* The study will include Adults (≥18 years), both genders
* septic patients admitted to critical care unit

Exclusion Criteria:

* thyroid disease
* hypopituitarism
* Addison disease
* Cushing syndrome)
A Study of IMC-A12 (Cixutumumab) With and Without Other Standard Chemotherapies in Participants With Lung Cancer Who Have Not Received Chemotherapy Before

The purpose of this study is to determine the number of participants whose cancer shrinks or disappears after treatment on the study.

Participants with Stage IIIb or IV non-small cell lung cancer (NSCLC) who have not received previous chemotherapy will be stratified, based on disease histology (squamous versus \[vs.\] nonsquamous).

Eligibility Criteria:
Inclusion Criteria:

* Has histologically or cytologically confirmed, Stage IIIb - IV NSCLC
* Has metastatic disease
* Has a tumor measurable according to Response Evaluation Criteria in Solid Tumors (RECIST)
* Has adequate hematologic function
* Has adequate hepatic function
* Has adequate renal function
* Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation

Exclusion Criteria:

* Has uncontrolled brain metastases
* Has leptomeningeal disease
* Has received previous chemotherapy for NSCLC (participants who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization)
* Receiving any other investigational agent(s)
* Has a history of treatment with other agents targeting the insulin-like growth factor (IGF) or the epidermal growth factor (EGF) receptor
* Has a known allergy / history of hypersensitivity reaction to any of the treatment components
* Has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range \[fasting glucose \<160 milligrams per deciliter (mg/dL) or below the upper limit of normal (ULN) and hemoglobin A1C≤ 7%\] and that they are on a stable dietary or therapeutic regimen for this condition
* Has an uncontrolled intercurrent illness
* Pregnant or lactating
* Has a history of another primary cancer, with the exception of: a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 3 years
* Has superior vena cava syndrome contraindicating hydration
* Has current clinically-relevant coronary artery disease (New York Heart Association III or IV) or uncontrolled congestive heart failure
* Has any National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version (v) 3.0 Grade ≥2 peripheral neuropathy
* Has significant third space fluid retention, requiring repeated drainage
What is the Potential Impact of Reviewing Post-procedure Images With Patients Following Interventional Spine Procedures.

The purpose of this study is to explore the impact of spine physicians reviewing post-procedural fluoroscopic images with patients. The outcome measure to be assessed will be the potential impact the patient satisfaction and the patient's global impression of change (PGIC) 2 weeks after the spine procedure.


Eligibility Criteria:
Inclusion Criteria:

* Lumbosacral radiculopathy symptoms
* Received transforaminal epidural steroid injection

Exclusion Criteria:

* Patients who will be sedated for transforaminal epidural steroid injection
* Unable to read or understand English-language survey