cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024)

To assess the safety of a vaccine in healthy adults prior to the release of the trivalent vaccine (FluMist).

The primary study objective is to assess the safety of a monovalent vaccine of a new 6:2 reassortant in healthy adults prior to the release of the trivalent vaccine (FluMist). Safety will be demonstrated by similar fever rates (oral temperature ≥101°F) in vaccine and placebo recipients.

Eligibility Criteria:
Inclusion Criteria:

* 18-64 years of age (not yet reached their 65th birthday);
* In good health;
* Available by telephone;
* Ability to understand and comply with the requirements of the protocol; and
* Signed informed consent.

Exclusion Criteria:

* Any condition, other than age, for which the inactivated influenza vaccine is indicated, including: chronic disorders of the pulmonary or cardiovascular systems, including asthma; chronic metabolic diseases (including diabetes mellitus) renal dysfunction, or hemoglobinopathies which required regular medical follow-up or hospitalization during the proceeding year;
* Acute febrile (\>100.0°F oral) illness or clinically significant respiratory illness within the 14 days prior to enrollment;
* Hypersensitivity to egg or egg protein;
* Signs or symptoms of any immunosuppressive or immune deficiency disease, including HIV infection, or ongoing immunosuppressive therapy; or an immunosuppressed individual living in the same household;
* Participation in another investigational trial within one month prior to enrollment or expected enrollment in another investigational trial during this study; and
* Any condition that in the opinion of the investigator, might interfere with the vaccine evaluation.
ThromboAblation in Acute Myocardial Infarction

1. Assess whether excimer laser coronary atherectomy (ELCA) before direct infarct-related artery (IRA) stenting results in improved reperfusion success in patients presenting with acute ST wave elevation myocardial infarction (STEMI) and angiographically evident thrombus.
2. Validate an ELCA technique for the treatment of STEMI, at high-volume centers experienced in the treatment of acute myocardial infarction (AMI).


Eligibility Criteria:
Inclusion Criteria:

Electrocardiographic inclusion criteria: (baseline 12-lead ECG recorded at 25 mm/second upon arrival at investigational center)

* STEMI within 12 hours of symptom onset, with ≥ 2 mm ST segment elevation in two or more leads and minimum ≥ 3 mm ST segment elevation in one lead.

Angiographic inclusion criteria after crossing with guidewire:

* IRA is a native coronary artery; and,
* Reference vessel diameter 2.5 - 4.0 mm; and,
* TIMI 0 or 1 flow with any TIMI thrombus grade; or,
* TIMI 2 or 3 flow with TIMI thrombus grade 3 or greater

Exclusion Criteria:

* Patient unwilling or unable to give informed consent
* Previous MI in the distribution of the current IRA
* Previous CABG
* Contraindications to PCI

  * allergy(s) to intended study medications
  * contraindicated for stent implantation
* Active bleeding or coagulopathy
* Patient in cardiogenic shock (\<90mmHg SBP and/or requiring IABP or vasopressors)
* Known left ventricular ejection fraction (EF) \<30%
* Fibrinolytic administered before PCI
* Renal insufficiency (creatinine \>2.0mg/dl)
* Current vitamin K antagonist therapy or known INR \>1.5
* Known thrombocytopenia - platelets \<100,000 cell count
* Patient has Left Bundle Branch Block (LBBB) or pacemaker rhythm
* Known history of hemorrhagic stroke (CVA or TIA) \<2 years before screening
* Known or suspected pregnancy
* Current cancer disease
* Comorbidity where survival is anticipated to be \<1 year.
* No future patient cooperation expected
* Patient is participating in another clinical study
* Patient \<18 years of age
Safety Study of Autologous Stem Cell in Liver Cirrhosis

It is a fase I/II clinical study to evaluate feasibility, safety and kinetics of cellular therapy with bone marrow-derived mononuclear cells (ABMMC) in patients with liver cirrhosis. All the patients have moderate liver disfunction and a waiting time expectancy of liver transplantation longer than 12 months due their low MELD score. The ABMMC are labeled with 99mTc and infused through the hepatic artery. Scintigraphy is performed 2 and 24 hours after infusion. Patients are submitted to frequent clinical, laboratorial and image evaluation during the follow up period of 12 months.

A one year clinical trial was conducted. Patients had moderate liver dysfunction and a liver transplant was not expected to occur earlier than 12 months, due to low MELD scores. Hepatocellular carcinoma (HCC) and hepatic artery or portal vein thrombosis were excluded by color Doppler ultrasonography (DUS) and 3-phase computed tomography (CT). Under local anesthesia, 100 mL of bone marrow were aspirated from the posterior iliac crest. ABMMC were isolated by density gradient centrifugation in Ficoll-Hypaque gradient, 10% of the cells were labeled with SnCl2-99mTc, and a small fraction was used for cell counting and viability analysis. ABMMC were delivered preferentially in the common hepatic artery by celiac trunk catheterism. Total body scintigraphy (TBS) was performed 3 hours after infusion. Patients were submitted to frequent clinical, biochemical and imaging evaluation during follow up.

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis of any origin
* Moderate liver disfunction (Child-Pugh Score=7-10)

Exclusion Criteria:

* Waiting time expectancy of liver transplant shorter than 12 months
* Ongoing hepatic encephalopathy
* Clinically detectable ascitis
* Severe coagulation disorder (INR\>2,0 or platelets count \< 40.000)
* Diagnosis or strong suspicion of cancer (except basocellular)
* Pregnancy or intention to become pregnant during the next 12 months
* Moderate or severe co-morbidity
* Current participation in another clinical trial
This Study in Healthy Men and Women Tests Whether BI 409306 Has an Effect on the ECG (Thorough QT Study)

The primary objective of this trial is to assess the effect of BI 409306 on the QT/QTc interval in healthy male and female volunteers as measured by the QTcF change from baseline compared with placebo.

Secondary objectives are to show the assay sensitivity of the trial, by reproducing the typical effect of the positive control moxifloxacin on the QT/QTc interval, and to assess the effect of BI 409306 on heart rate.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead single Electrocardiogram (ECG) and 12-lead Holter Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 50 years (incl.)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and local legislation
* Male subjects, or female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion:

  * Use of adequate contraception, e.g. non-hormonal intrauterine device plus condom
  * Sexually abstinent
  * A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
  * Surgically sterilised (including hysterectomy)
  * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion Criteria:

* Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Chronic or relevant acute infections
* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
* Further exclusion criteria apply
Sleep Disordered Breathing and Gestational Hypertension

Sleep disordered breathing (SDB) is a common problem in the adult population. By conservative estimates, 4% of the adult female population has SDB. SDB is a recognized cause of hypertension and treating SDB can improve blood pressure control in people with hypertension. More recently, research efforts have looked at SDB as a possible cause of pregnancy induced hypertension (PIH), a condition which complicates 10% of pregnancies. Traditionally, the best way to assess SDB required patients to spend a night sleeping in the Sleep Laboratory. This is inconvenient and for pregnant women often impossible to arrange, considering the short time frame that exists between time of PIH diagnosis and eventual delivery. Researchers at the University of Saskatchewan are now looking at whether an adequate sleep assessment can be performed at the bedside - either in a patient's home or on the hospital ward. The researchers will also look at different treatment options for sleep apnea, to see if these can improve blood pressure control in this patient population, and delay the need for early delivery. The information from this study may result in a detailed sleep assessment becoming part of the complete assessment of women with PIH. There is an association between sleep disordered breathing (SDB) and gestational hypertension (GHTN). Treatment for the SDB may represent an effective addition to the management of the cardiovascular and metabolic perturbations of GHTN We plan to assess women whether treating SDB with one of two methods will improve the management of GHTN. We will also assess if one method is more effective than the other.


Eligibility Criteria:
Inclusion Criteria:

* Women with singleton pregnancies who have the diagnosis of gestational hypertension.

Exclusion Criteria:

* Inability to comply with study parameters
* Delivery expected within 48 hours
Impact of Using a Cuffed Endotracheal Tube on Limiting the Risk of Airway Fire

The purpose of this study is to evaluate the impact of using a cuffed endotracheal tube (ETT) on the oxygen concentration in the oropharynx during adenoidectomy, tonsillectomy, or adenotonsillectomy. The study hypothesis is that inflation of the cuff on the ETT will eliminate contamination of the oropharynx with the inspired anesthetic gases and decrease the oxygen concentration in the oropharynx.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing adenoidectomy, tonsillectomy, or adenotonsillectomy.

Exclusion Criteria:

* Airway anomalies or cardiac conditions that have the potential for a complicated anesthesia induction.
Salvage HIFU for Local Recurrence in the Prostatic Bed After Prostatectomy and External Beam Radiation Therapy : Preliminary Results

Retrospective monocentric analysis performed on patients treated with salvage HIFU for isolated macroscopic recurrence in the prostatic bed after radical prostatectomy and salvage or adjuvant EBRT. The oncological outcomes (treatment failure-free survival, progression-free survival), the adverse events and urinary incontinence will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* patient treated by S-HIFU for a single recurrence within the prostatic bed after an initial RP with curative intent with or without lymphadenectomy followed by salvage or adjuvant EBRT (with or without pelvic lymph node irradiation) combined or not with ADT;

  * life expectancy of ≥10 years;
  * histological local recurrence (positive biopsy),
  * negative metastatic evaluation (All patients underwent multiparametric MRI (mpMRI) to confirm the relapse in the prostatic bed and Choline PET/CT to exclude metastasis (lymph node, visceral or bone metastasis).
  * the use of ADT at BF after S-EBRT was not an exclusion criterion (ADT was introduced by the centre referring the patient).
  * no limits were placed on prostate cancer characteristics, PSA (value, doubling time (PSA-DT)), Gleason score and location of suspected recurrence in relation to the sphincter.

Exclusion Criteria:

* patients who do not meet the inclusion criteria
Pilon Fracture Reduction and Functional Outcome

This prospective case series will essentially examine the influence of reduction quality on the primary functional outcome (as assessed using the FAAM) of patients with pilon fractures treated with plate fixation.

The plates used in this trial can be chosen according to the preferences of the surgeon.

A prospective case series to examine the influence of reduction quality on the primary functional outcome (as assessed using the FAAM) of patients with pilon fractures treated with plate fixation. Radiological parameters including single/combined alignment and various articular measurements will also be validated according to their reliability. The sensitivity of the effects of reduction quality on functional outcome, and an extended evaluation of patient-rated functional and social outcomes as well as their outcome expectations will also be assessed as part of the secondary study aims.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Patients with a unilateral intraarticular pilon fracture of the distal tibia classified according to AO: AO 43 - B1, B2 and B3 (partial intraarticular) AO 43 - C1, C2 and C3 (total intraarticular)
* Definitive fracture fixation with a plate within 4 weeks after accident (Temporary fixation with an external fixator, cast or traction is allowed)
* Signed written informed consent (by the patients) and agreement to attend the planned FU evaluations

Exclusion Criteria:

* Contralateral fracture of the distal half of the tibia/fibula/talus
* Pathologic fracture
* Severe Polytrauma: Injury Severity Score (ISS) \> 28
* Preexisting severe vascular disease (chronic venous insufficiency, chronic arterial occlusive disease)
* Drug or alcohol abuse
* American Society of Anesthesiologists (ASA) class V and VI
* Inability to walk independently prior to injury event
* Neurological and psychiatric disorders that would preclude reliable assessment
Effect of Jianpi Huatan Decoction on Advanced Colorectal Cancer

This study will take progression-free survival and overall survival as the main evaluation indexes, to evaluate the Efficacy of Jianpi Huatan Decoction in the Treatment of Advanced Colorectal Cancer. Decision Trees and Discriminant Analysis will be used to analyze the characteristics of dominant population combined with clinical data of patients. DNA methylation of the subjects will be detected to study the methylation characteristics of the preponderant population of Jianpi Huatan Decoction.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with colorectal cancer with clear pathological diagnosis and Western medicine diagnostic criteria.
2. TNM classification of stage IV disease according to National Comprehensive Cancer Network (NCCN) Guidelines.
3. Expected survival time is over 3 months.
4. The age of 18 years old or more.
5. According to the efficacy evaluation criteria for solid tumors (RECIST 1.1), there are measurable lesions.
6. Chemotherapy and/or targeted therapy are planned.
7. Signed informed consent.

Exclusion Criteria:

1. History of previous or combined malignancies except non-melanoma skin cancer, cervical cancer in situ, or bladder cancer (Tis and T1) received adequate treatment in the five years prior to screening.
2. Combined with severe heart, liver, lung and kidney disease.
3. Patients have intestinal obstruction can't take decoction and need intravenous high-energy nutrition. Patients have malabsorption syndrome or other disease affecting gastrointestinal absorption or have active peptic ulcer disease.
4. Any unstable condition or condition that may endanger patient safety and compliance with research, such as pregnancy, depression, manic-depressive disorder, obsessive-compulsive disorder, or schizophrenia.
5. The expected survival time is less than 3 months.
6. The researchers determine that they were not suitable for the study.
Effect of Saccharomyces Cerevisiae in LDL Cholesterol

The aim of the study is to evaluate the effect of the consumption of a food supplement (live saccharomyces cerevisiae) on lipidic profile in moderate hypercholesterolemic subjects.


Eligibility Criteria:
Inclusion Criteria:

* Moderate hypercholesterolemia (LDL cholesterol between 1.3 and 1.9 g/L) with maximum 1 associated cardiovascular risk factor.

Exclusion Criteria:

* Total cholesterol \> 3.5 g/L (on an empty stomach)
* Triglycerides \> 3 g/L (on an empty stomach)
* Familial hypercholesterolemia (IIa type)
* Diabete mellitus treated or not
* Subjects having consumed drugs known for their impact on lipid metabolism (statines, ezetimibes, colestyramin, fibrate...) in the month before beginning if the study and/or susceptible to consume such drugs during the study
* Subjects having consumed food supplements or functional foods known for their impact on cholesterolemia (phytosterols, phytostanols, policosanols, beta-glucans...) in the month before the study and/or susceptible to consume such products during the study
* Subjects having consumed probiotics food supplements in the month before the study and/or susceptible to consume such products during the study
* Subjects following a low diet regimen (intakes \< 1500 kcal/day) in the month before the study and/or susceptible to start such a regimen during the study
* Food behaviour disorders diagnosed
* Subjects with rare serious diseases (rare digestive diseases, renal failure, cardiovascular diseases, tumor...) or having endure a serious surgery
* Subjects having endure bariatric surgery or having a gastric bypass in place
* Pregnant or lactating women
* Women willing a pregnancy Excessive alcohol consumption
* Susceptible to modify their tobacco consumption before the end of the study
Pilot Study to Evaluate the Self-Management of Gait, Speech, and Dexterity Symptoms in Parkinson's Disease Using a Smartphone Application

The purpose of this study is to evaluate the impact of a smartphone application that delivers at-home therapy exercises on patients' self-management of gait, speech, and dexterity symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects at least 30 years of age or older,
* History of idiopathic Parkinson's Disease (Hoehn and Yahr stage of II-IV),
* Normal joint range of motion in both legs,
* Able to walk independently for 10 feet with or without an assistive device,
* Parkinson's gait and mild to moderate speech impairment,
* No history of vestibular disease,
* No evidence of dementia (MMSE ≥24),
* Clear benefit from Levodopa,
* Agrees to Beats Medical Application Privacy Policy and Terms of Use,
* Access to an iPhone 7 or higher to use the Beats Medical applications.

Exclusion Criteria:

* Medical condition for which exercise is contraindicated,
* History or evidence of neurological deficit other than Parkinson's Disease that could interfere, such as previous stroke or muscle disease,
* History or evidence of orthopaedic or muscular problems,
* Subject is currently enrolled in a study to evaluate an investigational drug or device,
* Subject unable or unwilling to provide informed consent,
* Vulnerable populations as deemed inappropriate for the study by site Principal Investigator,
* History of falls in the past 6 months,
* Pregnancy,
* Current or previous use of the Beats Medical Parkinson's application.
Validation of Optical Device for Aortic Pulse Wave Velocity Measurement

Existing techniques available for capturing reliable aortic pulse wave velocity measurements and estimating aortic stiffness are costly and require technical expertise. The purpose of this research is to investigate an oximeter device performance as a stand-alone aortic pulse wave velocity (PWV) measurement instrument. By validating this device and its measurements against the gold-standard method of carotid-femoral readings, we aim to demonstrate that the proposed method is an comparably effective in terms of the metrics (Mean difference, standard deviation, correlation, etc.) outlined by the Artery Society Guidelines.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* History of cardiovascular disease
* Not in sinus rhythm/arrhythmia
* Pacemaker
* Impalpable arterial pulse
* Use of blood pressure medication
* Systolic blood pressure \> 140
* Use of vasoactive medication
* Use of cholesterol medication
* Diabetes diagnosis
* Smokers
* BMI \> 30 kg/m2
* Pregnancy