cyrilzakka/clinical-trials huggingface dataset:
Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension

A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population.


Eligibility Criteria:
Inclusion Criteria:

* At least 55 years of age.
* Previously untreated or treated hypertension.
* For patients \>= 60 years, evidence of at least one CV disease or target organ damage, or for patients 55-59 years evidence of at least two CV diseases or target organ damage from two different organ systems as defined in the protocol.

Exclusion Criteria:

* Allergy to any of the drugs administered in this trial.
* Current angina pectoris (ie, no anginal event requiring NTG within 1 month prior to Visit 1).
* Secondary hypertension.
* Refractory hypertension defined as SBP \>= 180 mmHg and/or DBP \>= 110 mmHg unresponsive to triple-drug regimens of sympatholytics, diuretics and vasodilators.
* History of symptomatic heart failure (NYHA classes II-IV) or ejection fraction \< 40%.
* Myocardial infarction, coronary revascularization (CABG or PCI), unstable angina within one month of Visit 1.
* Stroke or transient ischemic event (TIA) within 3 months of Visit 1.
* Significant obstructive valvular cardiovascular disease or any valvular disease expected to lead to surgery during the course of the study.
* Evidence of hepatic disease (AST or ALT values \>= 2 X upper limit of normal).
* Impaired renal function (serum creatinine \>= 2.5 mg/dL (221 µmol/L)).
* Baseline serum potassium of \> 5.2 meq/L not on potassium supplements.
* History of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the last 5 years.
* History of clinically significant auto immune disorders such as Systemic Lupus Erythematosus.
* Significant non-cardiovascular illness or condition likely to result in death prior to trial completion, e.g., major organ transplant (life expectancy \<5 years).
* Significant cardiovascular disease such as an aortic aneurysm ≥ 6 cm, likely requiring surgical intervention during the course of the study.

Other protocol-defined exclusion criteria applied to the study.
Vibration Response Imaging (VRI) in Management and Evaluation in Patients With Pleural Effusion

The primary purpose of this study is evaluate the VRI device's accuracy in diagnosis of pleural effusion (in comparison to chest x-ray and ultrasonography), and to assess the pleural effusion location and size. The VRI system uses pressure sensors (electronic stethoscopes) to record the energy created by the airflow in the lungs during breathing.

The accumulation of excess fluid in the pleural cavity of the lungs, known as pleural effusion, is a common clinical condition that may be the result of trauma or disease. Diagnosis and management of pleural effusion can be done by X-Ray or ultrasound; however X-Ray emits radiation, requires a special room and expert personnel, while ultrasound requires a high level of expertise to perform and analyze. The VRI device is non-invasive and radiation free. The VRI device is a simple method to image the lungs in a regional manner to examine changes that occur during pleural effusion.

Comparison: X-ray and ultrasonography evaluations of pleural effusion, compared to VRI acoustic imaging evaluations.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to read, understand, and provide written Informed Consent;
* Male or Female in the age range of 18-85 years;
* Subject is suspected to have pleural effusion;
* Body mass index (BMI) \> 21.

Exclusion Criteria:

* Chest wall deformation;
* Spine deformation (including severe scoliosis);
* Hirsutism;
* Potentially contagious skin lesion on the back;
* Skin lesion that would interfere with sensor placement;
* Cardiac pacemaker or implantable defibrillator;
Safety,Tolerability and Pharmacokinetic Study of Recombinant Human Interferon Alfa 2B in Chronic Hepatitis C Patients (HM10660A)

The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of HM10660A in subjects with chronic hepatitis C(HCV).

* To evaluate the repeat-dose pharmacokinetics (PK) of HM10660A when given by weekly, biweekly, and monthly subcutaneous (SC) injection.
* To evaluate the repeat-dose pharmacodynamics (PD) of HM10660A when given by weekly, biweekly, and monthly SC injection.
* To explore the antiviral activity of HM10660A at Week 4, Week 12, and Week 24.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 to 65 years old, inclusive
* Willing and able to provide written informed consent.
* Previously untreated HCV infection with HCV RNA \> 75,000 IU/mL at screening.
* HCV genotype 1a or 1b.
* Body mass index (BMI) between 18 and 38 kg/m2.
* Willing and able to comply with the protocol and available to complete the study schedule of assessments.

Exclusion Criteria:

* Pregnant women or women who may wish to become pregnant during the course of the study.
* Males and females of reproductive potential who are unwilling to use 2 forms of effective birth control throughout the duration of study treatment and for at least 6 months after the last dose of RBV. One method should include a condom with spermicide for males. Males must agree to refrain from sperm donation for at least 6 months after the last dose of RBV.
* Evidence of infection or co-infection with a non-genotype 1 HCV strain.
* Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
* Lactating females
Improving Aphasia Using Electrical Brain Stimulation

Language and communication are essential for almost every aspect of human life, but for people who have aphasia, a language processing disorder that can occur after stroke or brain injury, even simple conversations can become a formidable challenge. Speech and language therapy can help people recover their language ability, but often requires months or even years of therapy before a person is able to overcome these challenges. This research will investigate non-invasive brain stimulation as a way to enhance the effects of speech and language therapy, which may ultimately lead to better and faster recovery from stroke and aphasia. The investigators hypothesize that participants with aphasia who receive speech and language therapy paired with active electrical brain stimulation will improve significantly more on a language comprehension task than those who receive speech and language therapy paired with sham stimulation.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older.
2. No diagnosis of neurological disorder (other than stroke).
3. No diagnosis of psychiatric disorder.
4. No seizure within the past 6 months.
5. Not pregnant.
6. In chronic phase of recovery, defined as at least 6 months post-stroke.
7. Not undergoing speech and language therapy targeting auditory comprehension or attention for the duration of the study.
8. No metal implants in the head.
9. No unhealed skull fractures.
10. Onset of aphasia related to left hemisphere stroke.
11. Damaged brain tissue from stroke does not overlap with left hemisphere dorsolateral prefrontal cortex.
12. Mild to moderate aphasia.
13. Cognitive ability minimally within functional limits.
14. Able to pass vision and hearing screening (with use of corrective aids if needed; eyeglasses, hearing aids).
15. Willing to allow audio-recording of study sessions.

Exclusion Criteria:

1. Younger than 18 years old.
2. Diagnosis or history of neurological disorder other than stroke.
3. Diagnosis or history of psychiatric disorder.
4. History of seizures within the past 6 months.
5. Pregnant.
6. \<6 months post-stroke (however, if this is only exclusionary criterion met, participant can be re-evaluated at the 6-month mark if still interested in the study)
7. Currently undergoing speech and language therapy targeting auditory comprehension or attention.
8. Metal implants in the head.
9. Currently has a skull fracture.
10. Onset of aphasia related to etiology other than left hemisphere stroke.
11. Damaged brain tissue includes left hemisphere dorsolateral prefrontal cortex.
12. No aphasia or severe aphasia.
13. Cognitive ability below functional limits.
14. Unable to pass vision and/or hearing screening with use of corrective aids.
15. Unwilling to allow audio-recording of study sessions.
Heart and Lung Function Monitoring System

The investigator goal is to test a new device to see if it can provide continuous and simultaneous monitoring of heart and lung function.

The purpose of this study is to evaluate and guide progress in the development of a new instrument that may provide continuous, integrated monitoring of heart and lung function.

Eligibility Criteria:
Inclusion Criteria:

* Adult's ≥ 18 years old

Exclusion Criteria:

* Wounds, surgical incisions at the site of sensor placement
Electrochemoterapy With Bleomycin for the Treatment of Unresectable Pancreatic Cancer

Electrochemotherapy is a type of electroporation that allows the delivery of drugs to the cells through the local creation of pores in the cell membrane. The electric pulses can be applied directly to the neoplastic cells, allowing for the local concentration of a possible chemotherapeutic agent administered through the bloodstream. This technique does not use heat nor other thermal energies and it is performed using special needles/electrodes linked to a generator ("porator").

In this study this technique will be applied on unresectable pancreatic cancer, already submitted to neoadjuvant treatment and still unresectable, through laparotomy. Bleomycin will be the chemotherapeutic agent.


Eligibility Criteria:
Inclusion Criteria:

* Radiologic confirmation of locally advanced pancreatic cancer by at least contrast enhanced CT of chest and abdomen (with the upper abdomen scanned according to a dedicated 3mm slice multiphase pancreatic tumor protocol), performed maximum 4 weeks prior to the procedure
* Cytohistological diagnosis of pancreatic cancer
* Age \> 18 and \< 80
* Stable disease after chemotherapy (no tumor progression, no oncomarkers (Carbohydrate Antigen 19-9 \[CA 19-9\] or Carcinoembryonic antigen \[CEA\]) increase
* Performance Status 0 sec. ECOG (Eastern Cooperative Oncology Group)
* Written informed consent

Exclusion Criteria:

* Resectable pancreatic cancer as assessed by multidisciplinary meeting
* Stage IV disease
* Patients receiving fenitoin, phosphofenitoin or living vaccines
* Pregnancy
* Progressive disease (either dimensional and not only by stage)
* \< 18 years old and \> 80
Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia

RATIONALE: Monoclonal antibodies, such as alemtuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with Waldenstrom's macroglobulinemia.

OBJECTIVES:

* Determine the objective response in patients with Waldenstrom's macroglobulinemia treated with alemtuzumab.
* Determine the time to treatment failure in patients treated with this drug.
* Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive alemtuzumab IV over 2 hours on days 1, 3, and 5 of weeks 1-6 (course 1) in the absence of disease progression or unacceptable toxicity. Patients with a complete response undergo observation. Patients with stable disease or a minor or partial response receive an additional course of alemtuzumab, administered as in course 1, on weeks 7-12.

Patients are followed every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of Waldenstrom's macroglobulinemia (lymphoplasmacytic lymphoma)

  * Immunoglobulin (Ig) M, IgG, and IgA paraprotein
  * Measurable monoclonal paraprotein
* Failed at least 1 prior first-line therapy (alkylator agent, nucleoside analogue, or rituximab)
* CD52-positive tumor determined by either bone marrow immunohistochemistry or flow cytometry

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* ECOG 0-2

Life expectancy

* At least 6 months

Hematopoietic

* Absolute neutrophil count ≥ 500/mm\^3
* Platelet count ≥ 25,000/mm\^3

Hepatic

* SGOT ≤ 2.5 times upper limit of normal (ULN)
* Bilirubin ≤ 2.5 times ULN

Renal

* Creatinine ≤ 2.5 mg/dL (\> 2.5 mg/dL allowed if due to disease)

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective double-method contraception during and for 6 months after study participation
* No serious comorbid disease
* No uncontrolled bacterial, fungal, or viral infection
* No other active malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics
* No prior alemtuzumab
* More than 3 months since other prior monoclonal antibody therapy

Chemotherapy

* See Disease Characteristics
* More than 21 days since prior chemotherapy

Endocrine therapy

* More than 21 days since prior steroid therapy

Radiotherapy

* More than 21 days since prior radiotherapy

Surgery

* Not specified
Can Dexmedetomidine For Procedural Sedation In Knee Arthroplasty Reduce Postoperative Pain? A Randomized Control Study

Dexmedetomidine has been often used for procedural sedation. It has also has been shown to have a pain sparing effect. Therefore the investigators propose that if Dexmedetomidine is used for sedation in total knee replacements done under spinal anesthetic, the patients will have less pain up to 24 hours after the procedure.

Randomization will occur prior to patient being brought into operating room (by pharmacy or by the anesthesia research coordinator). A third anesthetist not involved in the project will mix up the syringe based on instructions in an opaque envelope, and provide the syringe to the attending anesthetist.

The current standard of care entails patients receiving a midazolam bolus for sedation during the operation. The investigators propose to substitute a syringe of dexmedetomidine or saline to be run as an infusion throughout the case for sedation. A midazolam bolus will be available at anesthetist discretion to achieve a moderate sedation score as defined by the American Society of Anesthesia.

Standardized Medication Protocol

Pre-op:

Tylenol and Naproxen

Spinal:

Marcaine .75%, 1.7cc (12.75mg) Fentanyl 10 micrograms

Sedation

1. st arm- Dexmedetomidine, drawn up into a 50cc syringe of saline, thereby making it 5ug/ml.
2. nd arm- Receives Normal Saline syringe

Plan for bolus of 0.5microgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr (Can be titrated from 0.2-0.7 microgram per kg per hr to achieve moderate sedation as defined by the ASA

Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.

Post op- Initial setting of patient-controlled-analgesia pump to be set at morphine 1 mg, lockout of 8 minutes, to be increased to 1.5 mg with lockout of 6 minutes if pain not controlled. The investigators will increase the pump dose by 0.5 mg/dose/1 hr until pain controlled.

Risks The most common treatment-emergent adverse reactions for dexmedetomidine, occurring in 2% of patients in both ICU and procedural sedation studies, include- Hypotension, Bradycardia and Dry mouth. To minimize the risks to participants, an anesthesiologist will always be present in the room while the infusion is running, will monitor the patient, and will be allowed to treat as they see fit any of these risks.

Data Collection Data collection will be performed primarily by Ian Chan, anesthesiology resident.

Primary Outcome:

Total morphine consumption in the first 24 hours

Eligibility Criteria:
Inclusion Criteria:

* Total Knee arthroplasty American Society of Anesthesiologist score of 1-3 Age 18-85 Elective total knee arthroplasty under spinal anesthetic.

Exclusion Criteria:

* Contraindication to Dexmedetomidine. (second or third degree heart block, renal or hepatic dysfunction) Contraindication to Spinal Anesthetic Pain being treated by opioids prior to operation Contraindication to premedication Previous total knee arthroplasty
A Device for Screening of Fall Risk in the Elderly

This study evaluates the screening accuracy of a device (OAK) in assessing fall risk in the elderly, compared to the assessment provided by the Algorithm for Fall Risk Assessment of the Centers for Disease Control and Prevention (CDC).

The OAK device is a technologic system, based on virtual reality. It allows to quickly perform a fall risk assessment integrating clinical indexes of the Brief-BESTest (The Balance Evaluation System Test), and kinematic and posturgraphic indexes. The participants interact with the OAK device through simple exercises, then the device provides an assessment of their functional mobility, equilibrium and postural reactions.

Falls are a serious problem among the elderly. Most falls do not cause death, but 20%-30% of falls result in serious injuries representing a significant source of morbidity and mortality. Good evidence shows that many falls can be prevented. Thus, identifying people with risk of falling is crucial. The aim of this study is the evaluation of the screening accuracy of a device (OAK) in assessing fall risk in the elderly.

Participants are recruited at IRCCS Galeazzi Orthopedic Hospital in Milan, among outpatients and healthy volunteers. A brief questionnaire is administered in order to collect data relevant to the CDC Algorithm for Fall Risk Assessment. Then, participants are assessed through the OAK device. The OAK assessment is evaluated in terms of performance, accuracy (in comparison to the CDC Algorithm for Fall Risk Assessment) and safety.

Eligibility Criteria:
Inclusion Criteria:

* Able to walk without walking aids.
* Signed informed consent.

Exclusion Criteria:

* Neurological, musculoskeletal and orthopaedic disorders limiting mobility function and equilibrium. Psychiatric disorders. Any other medical condition limiting mobility function, as diabetes, obesity, serious ocular disorders (e.g. glaucoma), vestibular disorders (e.g. labyrinthitis) and proprioceptive disorders (e.g. ataxia).
* Pacemaker.
* Surgical interventions for orthopaedic disorders (e.g. knee or hip prosthesis) during the previous 6 months.
* Drug intake altering coordination and equilibrium (e.g. anti-epileptic, sedative-hypnotic drugs).
* Pregnancy.
Clinical and Biological Anti-aging Efficacy of a Cosmetic Cream

The aim of the study is to determine the efficacy of the investigational product "Cream " :

* on skin network after 56 days of daily application
* on biological parameters linked to cellular communication involved in senescence
* on sebum composition (metagenomics and metabolomics analysis)

This study will be conducted as a monocentric, randomized (for side of product application on forearms), open trial.

4 visits are planned:

* Visit 1 - Inclusion (D1)
* Visit 2 - Follow-up visit (D29), a window of +72 hours is allowed for this evaluation,
* Visit 3 - End of the application period (D57), a window of +72 hours is allowed for this evaluation
* Visit 4 - Follow-up visit (D7 post-biopsies +/- 24h)

For a subject completing the study, the theoretical investigational product application will be 56 consecutive days up to 59 days maximum.

The study duration for each subject will be 67 days maximum.

Eligibility Criteria:
Inclusion Criteria:

* sensitive skin (declaratory judgment)
* face skin type: combination to normal skin
* presenting wrinkles and/or finelines on the whole face
* displaying saggy skin on the face (loss of firmness)
* presenting a lack of skin radiance, dull complexion and an inhomogeneous skin on the face

Exclusion Criteria:

Related to the treatment/product:

* having had any surgery, chemical or significant invasive dermo-treatment on the experimental area considered by the Investigator liable to interfere with the study data
* having undergone techniques with aesthetic aim on study areas (chemical peel, mechanical dermabrasion, laser, pulsed flash lamp etc.) or having made injections of anti-wrinkle products (collagen, hyaluronic acid, botulinic toxin etc.)
* having applied products with an anti-aging action (Retinoic acid, retinol, retinaldehyde, A.H.A. etc.)
Comparative Bioavailability in Healthy Elderly Volunteers

A randomised four way crossover design in which each subject will receive two dose levels of TRx-0037 and two doses of TRx-0014 over approximately a four week period in randomised order.


Eligibility Criteria:
Inclusion Criteria:

* Male and female 55 and over
* No clinically important abnormal physical finding
* No clinically significant lab results
* Normal ECG, Normal BP and HR,BMI between 19 and 32
* Weight 50 to 100 kg, Able to communicate
* Provide written informed consent
* Non smokers
* Males to use contraception
* Females to be surgically sterile or post menopausal

Exclusion Criteria:

* Administration of any IMP other than study drug within 12 weeks before entry
* Use of any prescribed meds, St John's wort, over the counter meds as described in the protocol
* Surgical or medical condition that might interfere with IMP
* History of drug or alcohol abuse
* Clinically significant allergy requiring treatment
* Loss of greater than 400ml of blood within 12 weeks.
* Serious adverse reaction or hypersensitivity to any drug
* Prescence of Hep B, Hep c or HIV-1 or HIV-2 at screening
* Presence of G6PD at screening
* History of methaemoglobinaemia
* Partner who is pregnant of lactating
* Positive Pregnancy test
Serum Neuroglobin and HIF-1α in Acute Ischemic Stroke

Neuroglobin has shown rich neuroprotective effects against cerebral ischemia and hypoxia, and therefore has the potential to impact outcomes after acute ischemic stroke. Hypoxia inducible factor (HIF)-1α is neuroprotective in several models of experimental brain injury and is increased in brain after acute cerebral infarction in humans and experimental animals.The investigators sought to examine the changes in serum neuroglobin and HIF-1α concentrations in patients with acute ischemic stroke during the initial 96-h period after stroke and assessed the relation between them and the relation of them to prognosis of such patients with acute ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute ischemic stroke
* Admission within 12 hours

Exclusion Criteria:

* Lacunar infarction
* Cerebral hemorrhagic infarction
* Epilepsy or epileptic persons
* History of neurological diseases, myocardial infarction, renal and hepatic abnormalities and metabolic diseases
* Contraindications to antiplatelet treatments
* Serial blood samples could not be obtained
Study of ZG005 in Combination With Paclitaxel＋Platinum-based ± Bevacizumab in Patients With Advanced Cervical Carcinoma

This is a multicenter, open-label phase I/II study for the first-line treatment of advanced cervical cancer.


Eligibility Criteria:
Inclusion Criteria:

* Fully understand the study and voluntarily sign the informed consent form.
* Female 18-70 years of age;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
* Life expectancy ≥ 3 months.

Exclusion Criteria:

* Patients were deemed unsuitable for participating in the study by the investigator for any reasons.