cyrilzakka/clinical-trials huggingface dataset:
Single Ultra-high Dose Stereotactic Body Radiation Therapy for Early Lung Cancer

The goal of this prospective single-arm phase II study is to study the efficacy and safety of stereotactic body radiotherapy (SBRT) for early lung cancer. The main questions it aims to answer are:

How effective is this regimen of SBRT for early lung cancer? How safe is this regimen of SBRT for early lung cancer?

The goal of this prospective single-arm phase II study is to study the efficacy and safety of stereotactic body radiotherapy (SBRT) for early lung cancer. This study intends to enroll 100 participants in 2 years. The participants enrolled will receive single fraction of ultra-high dose stereotactic body radiotherapy (SBRT) (30Gy/1F).

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent;
2. Male or female aged ≥ 18 years and ≤ 75 years;
3. patients with early stage lung cancer confirmed by pathology or clinical MDT;
4. The physical state score (ECOG PS) of the eastern tumor cooperative group was 0 \~ 1;
5. Expected survival time ≥3 months;
6. Laboratory results during screening must meet the following requirements:

   1. Blood routine: neutrophil absolute count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 100 × 109/L, hemoglobin (HGB) ≥ 90 g/L (no blood transfusion or erythropoietin dependence within 7 days);
   2. Liver function: total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were less than 2.5 times ULN in subjects without liver metastasis, and ALT and AST were less than 5 times ULN in subjects with liver metastasis.
   3. Renal function: serum creatinine (Cr) ≤1.5 times ULN or Cr clearance ≥60 mL/min (Cockcroft-Gault formula), and urine protein (UPRO) \&lt on routine urine test; 2+ or 24 h urinary protein quantification \&lt; 1g;
   4. International standardized ratio (INR) ≤1.5 times ULN and partial prothrombin time (PTT) or activated partial thrombin time (APTT) ≤1.5 times ULN during the 7 days prior to treatment;
7. For female subjects of reproductive age, urine or serum pregnancy tests should be negative within 3 days prior to receiving the first fraction of SBRT. If the urine pregnancy test results cannot be confirmed negative, a blood pregnancy test is requested;
8. Compliance with the research protocol is expected to be good.

Exclusion Criteria:

1. currently participating in an interventional clinical trial;
2. any unstable systemic disease, including but not limited to active infection, congestive heart failure \[New York Heart Association (NYHA) class ≥ II\], severe arrhythmia requiring medical therapy, liver, kidney, or metabolic disease; Type I and type II respiratory failure;
3. other malignancies within 5 years before randomization, except adequately treated cervical carcinoma in situ, basal cell or squamous skin cancer, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, or papillary thyroid cancer;
4. women who are pregnant or breastfeeding or who plan to become pregnant or breastfeeding during the study period;
Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy

We plan to examine the feasibility, acceptability, preliminary quit rates, overall nicotine exposure and adverse effects of the nicotine inhaler for smoking cessation in pregnancy.

Subjects in this pilot study are healthy pregnant women who wish to quit smoking. They will set a quit date and use the nicotine inhaler for 4 weeks. They will receive behavioral counseling in addition to the inhaler for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 13-26 weeks pregnant
* Smoking at least 5 cigarettes per day the preceding 7 days
* Motivated to quit smoking (at least 7 on a 10 pt. scale)
* Able to speak English
* Intend to carry pregnancy to term
* Stable residence

Exclusion Criteria:

* Current drug or alcohol abuse or dependence (other than methadone maintenance
* Twins or multiple gestation
* Unstable psychiatric disorder
* Unstable medical problems
* Known congenital abnormality
* High risk pregnancy
18F-FDG PET/CT in Diagnostic Patients of Disorder of Consciousness

Clinical examinations are difficult to discriminate between vegetative state and minimally conscious state. the diagnostic and prognostic usefulness of neuroimaging methods has not been established in a clinical setting. we will do a forward study of PET imaging in disorders of consciousness patients, and validate with clinical assessments with the coma recovery Scale-Revised(CRS-R).

Every patient need to be conducted the PET/CT scanning two times.The first time is resting state.The second time is stimulated state by watching a vedio.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of disorder of consciousness

Exclusion Criteria:

-
Prospective Registry of European Hemophilia B Patients Receiving BeneFIX® for Usual Use

This is an open-label multi-center Registry in patients with hemophilia B receiving BeneFIX. All patients who begin treatment with BeneFIX in European Union countries, will be eligible for participation. Patient demographics will be collected at baseline for all patients. A baseline FIX activity and Bethesda assay for inhibitor based on historical data should be recorded if available. Adverse events as defined in the protocol will also be reported on the appropriate forms. Data will be collected from patients on an ongoing basis to ensure that information is being captured for each patient being treated with BeneFIX.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Hemophilia B scheduled to begin treatment with BeneFIX are eligible for Registry enrollment

Exclusion Criteria:
Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects

This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in Chinese hemophilia B subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia B (FIX activity: more than 5%, 1-5%, or less than 1%, respectively)
* Subjects with previous exposure to FIX replacement therapy
* If HIV positive, documented CD4 count more than 200/µL within 6 months of study entry

Exclusion Criteria:

* Diagnosed with any bleeding disorder in addition to hemophilia B
* Current FIX inhibitor or history of FIX inhibitor (defined as \>ULN of the reporting laboratory)
* Subject has no history of exposure to FIX products (previously untreated patient \[PUP\])
* Subject is currently utilizing primary FIX prophylaxis
* Subjects anticipating elective surgery that may be planned to occur in the 6 months following study entry
* Treated with immunomodulatory therapy within 30 days prior to study entry or planned use for the duration of their study participation
* Participated in another investigational drug or device study within 30 days prior to study entry or planned participation for the duration of their study participation
* Subjects with a known hypersensitivity to hamster protein
* Significant hepatic or renal impairment (ALT and AST \>5 x ULN, bilirubin \>2 mg/dL or serum creatinine \>1.25 x ULN)
* Prothrombin Time \>1.5 x ULN
* Platelet count \<80,000/µL
* Pregnant or breastfeeding women
* Unwilling or unable to follow the terms of the protocol
* Any condition which may compromise the subject's ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation, in the opinion of the Investigator or Sponsor
Polyphenols and Endothelial Function

To determine whether fruit juice rich in polyphenols might increase exercise capacity and memory in healthy sedentary subjects.Both parameters might be improved because of the anti-oxidant effects of polyphenols.


Eligibility Criteria:
Inclusion Criteria:

* sedentary

Exclusion Criteria:

* diabetes
Endometriosis and Pain

Endometriosis is a condition affecting about 10% of childbearing age women. It can begin a few months to a few years after puberty. It causes abdominal and pelvic pain that can be extremely debilitating, affecting the quality of patients life by affecting sexuality and fertility. Psychological repercussions are very important and underestimated. Patient care focuses most often on the "organ pathology treatment ".

This study proposes to evaluate a multidisciplinary patient care by insisting on anatomo-physiological pain management, psychological and bodily, in the perioperative phase.

The main objective is to evaluate benefit of psychological and corporal group management on the overall quality of life of patients with severe endometriosis in terms of endometriotic damage and/or functional and painful repercussions, requiring surgery, before or after this study


Eligibility Criteria:
Inclusion Criteria:

* Patients \>=18 years
* Patients with deep endometriosis according to the CNGOF (collège national des Gynécologues et Obstétriciens Français) and/or chronic pain related to endometriosis according to doctor's evaluation and to the definitions of IASP (International Association for the Study of Pain) and HAS (French National Authority for Health) in treatment failure despite appropriate medical or surgical management of endometriosis
* Patients with social security
* Patients willing to come to all study visits
* Patients who signed their informed consent

Exclusion Criteria:

* Patients unable to participate in group care:

  * Patients with social phobia assessed during the inclusion interview
  * Patients with psychiatric disorders of a psychotic nature: delirium, hallucination, incoherent thoughts
  * Patients with behavioral disorders of hetero-aggressive or self-aggressive type oPatients with a handicap that prevents them following the physical and psychological group sessions (speech disorders, hearing, visual or practical)
* Pregnant women
* Patients planning a change (stop, start) during the study of their psychological management in their current care path.
* Patients planning a change (stop, start) during the study of their treatment by non-medicinal techniques (auriculo-acupuncture, relaxation and self-hypnosis, transcutaneous neurostimulation by TENS)
* Patients suffering from other severe or chronic somatic diseases associated with endometriosis
* Patients with cognitive disorders
* Patients with analgesics addiction (psychoactive substances, morphine substances, etc.)
* Patients protected by law (under guardianship / trusteeship)
* Patients participating in another interventional research that may interfere with the protocol results
Evaluating the Use of Educational Videos in Newly Diagnosed Patients in a Medical Oncology Sarcoma Clinic

This study aims to evaluate how sarcoma-specific educational videos improve patients' knowledge of their disease and treatment options before their first clinic appointment.

Participants will watch four educational videos before their first appointment with a medical oncologist. Participants will be asked to complete surveys to assess their understanding of sarcoma and its treatment options before and after their first medical oncology clinic appointment.


Eligibility Criteria:
Inclusion Criteria:

1. Signed written and voluntary informed consent.
2. Have histologically documented advanced metastatic sarcoma, or is a caregiver of a patient with histologically documented advanced metastatic sarcoma.
3. Age ≥ 18 years.
4. Have not received any previous systemic treatment for sarcoma, or is a caregiver of a sarcoma patient who has not received any previous systemic treatment for sarcoma.
5. Willing/able to complete questionnaires.
6. Able to read and write in English.

Exclusion Criteria:

1. Inability to provide informed consent.
2. Previously seen by a medical oncologist for their sarcoma.
Distance and Intermediate Visual Acuity in Patients With Implanted Monofocal Negative Aspheric Intraocular Lens

To get the visual outcomes for distance and intermediate and binocular defocus curve in patients with implanted monofocal intraocular lens Clareon (IOL; model SY60CL; Alcon Vision LLC) at 3 months after the surgery.

The goal of refractive cataract surgery is to remove the opacity, or cataract and to produce the desired refractive outcome. In most cases, the desired outcome is an emmetropic eye, or an eye that sees 20/20 Snellen for distance vision post-surgery with the implant of a monofocal IOL. This, however, does not offer much in the way of intermediate and near vision. The increased desire for simultaneous distance, intermediate and near vision has increased the popularity of multifocal IOLs (MIOLs). However MIOLs provide visual acuity for all distances, they has occurence of optical phenomena such as glare and halo and lower contrast sensitivity. Extended depth of focus (EDOF) lens should provide distance vision as good as monofocal lens and intermediate vision better than monofocal but without or with less appearance of optical phenomenon or decreased contrast sensitivity.

This study is prospective, multi-center, conducted from 10/2022 to 08/2023 in the Ophthalmology department of Faculty Hospital Kralovske Vinohrady in Prague, in Eye Center Prague and Eye Clinic SOMICH (Karlovy Vary). The research protocol was explained to all participants and informed consent was signed before enrolling patient to the study. The study was approved by the Ethics Committee of Faculty Hospital Kralovske Vinohrady and will enrolled up to 100 patients with presence of cataract in both eyes.

Bilateral clear corneal phacoemulsification and IOL implantation is performed by two experienced surgeon using the same technique in both eyes. The surgical process involved topical anesthesia, superior 3-step clear corneal incision (2,2mm), 5,0mm curvilinear capsulorhexis, phacoemulsification, bilateral irrigation- aspiration and implantation of monofocal aspheric intraocular lens (Clareon Alcon vision LLC).

Patients are scheduled for visit at 3 months after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* presence of cataract in both eyes
* no other ocular pathology affecting visual acuity
* bilateral phacoemulsification cataract surgery was arranged for both eyes
* corneal astigmatism up to 0,5 cylinder (measured by IOL Master biometry)
* dioptric power of both selective lens within 1,5 D range in one patient
* selecting IOL power between 15 D and 28 D power range

Exclusion Criteria:

* complicated cataract
* corneal opacities or irregularities
* amblyopia
* anisometropia
* coexisting ocular pathologies
* glaucoma
* history of ocular surgery
* refusal or unable to maintain follow-up
Predicting the Development of Myocardial Depression in Acute Neurological Patients

The purpose of this study is to assess the levels of serum catecholamines associated with myocardial depression (MD) in patients with acute neurological injury.

The purpose of this study is to investigate the level of plasma catecholamines, associated with myocardial depression (MD) as noted on Transthoracic ECHO (TTE) by evidence of wall motion abnormalities (WMA) with or without drop in ejection fraction or symptomatic heart failure (HF). Takotsubo syndrome (TTS) is commonly diagnosed after the onset of HF once patients become symptomatic. The investigators intend to study whether early MD can be detected by identifying certain levels of plasma catecholamines and whether the level correlates with severity of myocardial depression. Identification of early MD changes can lead to alteration of management strategies and may help prevent worsening of HF. Highly selected patients with Subarachnoid Hemorrhage (SAH) or Acute Ischemic Stroke (AIS) requiring induced hypertension with the use of norepinephrine infusion will be recruited to enroll in this pilot study. This group of patients are expected to have high circulating catecholamines and are more likely to develop MD. Given the prevalence of TTS in females and elderly, 10 female patients \>50 years admitted to the neuro ICU with diagnosis of either AIS or SAH will be enrolled. Patients with history of coronary artery disease, smoking, poorly controlled diabetes with HbA1c \>8 and uncontrolled hypertension will be excluded. Patients with poor ECHO windows will also be excluded. Baseline plasma catecholamine levels, transthoracic ECHO(TTE), Troponin T, EKG and BNP will be obtained and will be followed daily through the study duration.

Eligibility Criteria:
Inclusion Criteria:

* female patients \>50 years admitted to the neuro ICU with diagnosis of either acute ischemic stroke or subarachnoid hemorrhage
* Only patients predicted to be on norepinephrine infusion for at least 48 hrs will be selected.

Exclusion Criteria:

* patients with known history of heart failure will be excluded
* Patients with history of coronary artery disease, smoking, poorly controlled diabetes with HbA1c \>8 and uncontrolled hypertension will be excluded.
* Patients with poor ECHO windows will be excluded
Tolerability, Safety and Pharmacokinetic Study Of Mianhuahua Flavonoids Tablets in Healthy Adult Subjects

The purpose of this study is to determine the safety and tolerability, and to evaluate the pharmacokinetic characteristics of Mianhuahua Flavonoids Tablets after oral administration in healthy adult subjects.

1. Dose-escalation study of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults to assess the safety and tolerability.
2. Multiple-dose study of Mianhuahua Flavonoids Tablets in healthy adults to assess the safety and tolerability.
3. Dose-escalation study of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults to evaluate the pharmacokinetic characteristics
4. Multiple-dose study of Mianhuahua Flavonoids Tablets in healthy adults to evaluate the pharmacokinetics characteristics

Eligibility Criteria:
Inclusion Criteria:

* Male or female, between 18 and 45 years of age, Body Mass Index (BMI) between 19～24 kg/m2, Weight \> or = 50kg
* In good health as judged by the investigator
* Agreed to take effective contraceptive measures during the test and within 6 months after the last drug administration
* Signed informed consent form and fully understood the contents, process and possible adverse reactions of the test

Exclusion Criteria:

* Pregnancy and lactation
* History of kinds of food or drug allergy, or suffering from allergic diseases or allergic constitution
* Presence (in screening stage) or history of the acute/chronic organic diseases or clinical manifestations: Including but not limited to blood system, renal disease, liver disease, endocrine system, respiratory system, digestive system, cardiovascular system, nervous system, mental disease, or any disease and physiological conditions interfering with the results of the test
* with a clinically significant abnormality in routine serological detection: including Hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infected
* History of abuse of drugs, or the result of drug abuse test is positive
* Alcohol intake more than 2 units (1 unit is equal to 12 ounces or 360 ml beer, 5 ounces or 150 ml liquor, 1.5 ounces or 45 ml distilled spirits ) per day on average within 3 months before the test, or the result of alcohol test is positive
* Smoking more than 5 cigarettes per day, or using quite amount of nicotine products within 3 months before the test, or unable to stop smoking during the test
* Excessive consumption of xanthine soda drinks, more than four cups or bottles per day
* With major surgical operations and blood or blood component transfusion within 4 weeks before the test
* Severe blood loss or blood donation more than 400ml within 2 months before the test
* Participation in other drug trials within 3 months before the test
* Usage of any drugs within 2 weeks before the test, or within 5 times of drug eliminated half-life or pharmacodynamics half-life; Vaccination within 4 weeks before the test; Acceptance of biological agents within 4 months before the test
* Be otherwise unsuitable for the study, in the opinion of the Investigator.
Screening for Inherited Heart Disease

Genetically inherited heart diseases like hypertrophic cardiomyopathy (HCM) are conditions affecting the heart passed on to family members by abnormalities in genetic information. These conditions are responsible for many heart related deaths and illnesses.

Presently, there are several research studies being conducted in order to improve the understanding of disease processes and symptoms associated with genetically inherited heart diseases.

This study is designed to determine the eligibility of patients diagnosed with or suspected to have inherited heart disease to participate in these research studies.

Patients with hypertrophic cardiomyopathy (HCM) and other inherited cardiac diseases are being studied under several research protocols to determine their pathogenesis and clinical manifestations. The purpose of this protocol is to determine the eligibility of patients with known or suspected inherited heart conditions for our research protocols.

Eligibility Criteria:
INCLUSION CRITERIA

Subjects and family members known or suspected to have inherited a cardiac disease such as HCM.

EXCLUSION CRITERIA

Patients with cardiac conditions that are not known to be inherited.
Impact of 3-year Lifestyle Intervention on Postprandial Glucose Metabolism: the SLIM Study

To evaluate the effect of a 3-year diet- and exercise lifestyle intervention, based on general public health recommendations, on glucose tolerance, insulin resistance and metabolic cardiovascular risk factors in Dutch subjects with impaired glucose tolerance (IGT).

Objective To evaluate the effect of a 3-year diet- and exercise lifestyle intervention, based on general public health recommendations, on glucose tolerance, insulin resistance and metabolic cardiovascular risk factors in Dutch subjects with impaired glucose tolerance (IGT).

Research design and methods 147 IGT subjects (75 male, 72 female) were randomized to the intervention group (INT) or control group (CON). 106 subjects (52 INT, 54 CON) completed 3 years of intervention. Annually, glucose, insulin and FFA concentrations were determined during fasting and after an oral glucose tolerance test, in addition to measurements of body weight, serum lipids, blood pressure and maximal aerobic capacity.

Eligibility Criteria:
Inclusion Criteria:

* caucasion,age 40-70, mean 2hr glucose 7.8-12.5 mmol/l, mean fasting blood glucose below 7.8

Exclusion Criteria:

* known type 2 diabetes, mean 2hr glucose \>12.5 mmol/l, mean fasting blood glucose \> 7.8 mmol/l, chronic illness that makes 5-year survival improbable, interferes with glucose tolerance or makes participation in a lifestyle intervention impossible, medication known to interfere with glucose tolerance, participation in a vigorous exercise and/or diet program