cyrilzakka/clinical-trials huggingface dataset:
Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma

This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients with metastatic renal cell cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic renal cell carcinoma (mRCC) with histological or cytological confirmation of clear cell carcinoma or a component of clear cell
* Patients must have received one and only one prior VEGF-targeted therapy and one and only one prior mTOR inhibitor therapy in the metastatic setting. One VEGF targeted therapy (e.g. sunitinib, or pazopanib, or axitinib, or tivozanib or bevacizumab) and one prior mTOR inhibitor therapy (everolimus, or temsirolimus or ridaforolimus)
* Prior cytokines therapy and prior vaccines in the adjuvant setting is permitted.
* Patients must have had disease progression on or within 6 months of stopping the last therapy.
* Patients must have at least one measurable lesion at baseline (by RECIST Criteria Guidelines v1.1) assessed by Computer Tomography (CT) Scan or Magnetic Resonance Imaging (MRI).
* Karnofsky performance status ≥ 70%
* Patients must have the following laboratory values:

  * Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
  * Platelets ≥ 100 x 109/L
  * Hemoglobin (Hgb) \> 9 g/dL
  * Serum total bilirubin: ≤ 1.5 x ULN
  * ALT and AST ≤ 3.0 x ULN (Patients with known liver metastases: AST and ALT ≤ 5.0 x ULN)
  * Serum creatinine ≤ 1.5 x ULN

Exclusion Criteria:

* Patients who have previously received sorafenib therapy in the neoadjuvant, adjuvant or metastatic setting.
* Patients who have previously received Dovitinib or brivanib in the neoadjuvant, adjuvant or metastatic setting.
* Patients with brain metastases. Radiological imaging (e.g. CT or MRI scan) of the brain is required at screening/baseline
* Patients with another primary malignancy within 3 years prior to starting study treatment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix
* Patients who have received the last administration of an anticancer targeted small molecule therapy ≤ 2 weeks prior to starting study treatment (e.g. sunitinib, pazopanib, axitinib, everolimus, temsirolimus), or who have not recovered from the side effects of such therapy
* Patients who have received the last administration of nitrosurea or mitomycin-C ≤ 6 weeks prior to starting study treatment, or who have not recovered from the side effects of such therapy
* Patients who have undergone major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) ≤ 4 weeks prior to starting study treatment or who have not recovered from side effects of such therapy
* Patients with a history of pulmonary embolism (PE), or untreated deep venous thrombosis (DVT) within the past 6 months
* Patients with concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study

Other protocol-defined inclusion/exclusion criteria may apply
Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Patients With Stage II Hypertension

The purpose of this study is to evaluate the blood pressure lowering effects of a valsartan/amlodipine combination treatment and amlodipine monotherapy for the treatment of stage II hypertensive patients (MSSBP ≥ 160 mmHg).


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Moderate to severe high blood pressure. This is defined as a systolic pressure (the top number) greater than or equal to 160 mmHg and less than 200 mmHg.

Exclusion Criteria:

* History of allergy or hypersensitivity to ARBs, CCBs, thiazide diuretics
* Inability to stop all prior blood pressure medications safely
* Systolic BP ≥ 200 mmHg and/or diastolic BP ≥ 120 mmHg
* Controlled blood pressure (systolic BP \< 140 mmHg) taking more than 3 antihypertensive medications at screening
* Systolic BP ≥ 140 mmHg and \< 180 mmHg taking more than two antihypertensive medications at screening
* Systolic BP ≥ 180 mmHg taking more than one antihypertensive medication at screening
* History of stroke, angioplasty, coronary artery bypass graft surgery, heart attack or unstable angina
* Type 1 diabetes
* Poorly controlled Type 2 diabetes
* History of heart failure
* Arrhythmia
* Significant valvular heart disease
* Active gout
* History of autoimmune diseases
* History of multiple drug allergies
* Liver disease
* Pancreatic injury within 1 year of screening
* Evidence of kidney impairment or history of dialysis
* Any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of any drug. This could include currently active gastritis, ulcers, or gastrointestinal/rectal bleeding, or urinary tract obstruction.
* Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, would be excluded UNLESS they are post-menopausal, surgically sterile OR are using acceptable methods of contraception. The use of hormonal contraceptives is not allowed
* Pregnant or nursing (lactating) women
* History of malignancy of any organ system within the past five years
* Any severe, life-threatening disease within the past five years
* History of drug or alcohol abuse within the last 2 years.

Other protocol-defined inclusion/exclusion criteria may apply
The Effect of Therapeutic Climbing on Muscle Strength, Tone and Balance in Hemiplegic Children

The goal of this randomised controlled trial is to learn about the effect of therapeutic climbing in hemiplegic children. The main questions it aims to answer are:

Does climbing affect muscle strength and tone? What is its connection between normative data drawn from healthy children? How can it affect balance?

Participants (children) will be asked to complete an series of movements used in sports climbing, such as inside-flag, back-flag and horizontal traverse, while hanging on an in-door climbing wall.


Eligibility Criteria:
Inclusion Criteria:

* Children from 4 to 16 years old
* Children with Hemiplegia
* Evaluated as Level 1 on GMFCS

Exclusion Criteria:

* Botulinum toxin injection in last 6 months
* Surgery in the last 1 year (myofascial lengthening etc.)
* Children with poor cognitive skills (not following instructions etc.)
Testing of INSTI™ HIV-1 Antibody Test Kit in Volunteer Subjects at Risk for HIV Infection

Each year up to 22 million persons in the US are tested for HIV. Currently available "rapid" tests do not provide test results for at least 30 minutes from the collection of serum and plasma from the subject. Providing accurate test results in less than a minute would make it easier to make timely decisions about treatment and counselling.

This study will compare results of an experimental rapid test to existing standards to determine if the test can reliably and accurately diagnose HIV in less than one minute.

The primary objective is to determine if INSTI™ performed with finger-stick whole blood, venous whole blood, and plasma demonstrates at least 98.0% sensitivity and specificity compared to an FDA-approved HIV testing algorithm.

The study will have two parts. The first part of the study will be conducted in institutions where HIV testing is routinely performed and where HIV counseling is offered \[i.e. point of care (POC) centers\]. The second part of the study will be conducted in a central laboratory that routinely conducts laboratory-based HIV testing using an FDA-licensed HIV-1 ELISA and Western blot test.

Geographically diverse POCs will be selected in the USA. Approximately 15-20 POCs are planned. Approximately 2,500 subjects will participate in the study including 1,500 subjects with unknown HIV status and 1,000 seropositive subjects. Across these POC sites, voluntary testing of 1500 subjects with unknown HIV status is planned with at least 500 of these subjects being high risk. Samples will be obtained from consenting subjects in the voluntary testing population including high-risk and known HIV 1 seropositive individuals.

Each subject is to receive an INSTI™ on finger-stick blood and parallel HIV testing of EDTA-treated venous whole blood and plasma samples will be conducted at a central laboratory.

The results of INSTI™ will not be given to the subject. The subject will be given the results of the POC HIV test only, per their standard of care procedures. Subsequent subject care decisions will NOT be based on the results of INSTI™.

Eligibility Criteria:
Inclusion Criteria:

* Unknown HIV status who are undergoing voluntary testing for HIV infection in a POC clinic setting or known HIV seropositive subjects willing to be re-tested.
* Ability to give proper informed consent, or have legal parent or guardian provide consent.
* Willingness to participate in a POC standard of care HIV counseling and testing program and receive POC standard of care test results
* Willingness to provide the necessary volume of whole blood collected through venous blood draw and finger stick (approximately 10 ml)

Exclusion Criteria:

* Subject self-report of history of multiple myeloma
* Subject self-report of history of long-term anti-retroviral therapy with known low or non-existent antibody titre (sero-inversion)
Camelia Sinensis for Basal Metabolism and Body Composition

Camellia Sinensis leaf extract contributes to increasing energy expenditure and calorie consumption by increasing thermogenesis. The purpose of this study is to evaluate the efficacy of Camellia Sinensis on basal metabolism and body composition in overweight women or with obesity in postmenopause.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopause
* Overweight or obesity class I-II (Body Mass Index 25-39,9 Kg/m2)

Exclusion Criteria:

* Changes in heart rhythm
* Intolerance or allergy to components
* Obesity class III (Body Mass Index \> 40 Kg/m2)
Dose Response Study of a Fermented Yogurt on the Immune System and Gut Health

The purpose of this study is to determine the dose-response effect of a yogurt containing a combination of bifidobacterium Lactis (BB-12) and Lactobacillus Acidophilus (LA-5) and green tea extract on markers of the immune system and gut health in healthy subjects. We hypothesize that the response of the immune function will be dose-dependent of the probiotics found in the fermented yogurt.

There is an increasing list of food containing probiotics on the market. Several studies have emphasized the health benefits of single probiotics, particularly on the immune system. However, it is unclear how a combination of two different probiotics complemented with green tea extract can beneficially modify markers of the immune.

The aim of this study is to determine the dose-response effect of a yogurt containing a combination of bifidobacterium lactis (BB-12) and Lactobacillus Acidophilus LA-5 and green tea extract on immune system in healthy subjects. More specifically, this randomized, parallel placebo controlled study will investigate the impact of increasing doses (109 and 1010) of these probiotics on phagocytosis activity, oxidative metabolism and on the antipneumococcics antibody specific serotype response S. pneumoniae vaccination. Finally, this study will also examine the effect of increasing dose of these probiotics on intestinal microflora and blood lipids.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 55 years
* Healthy individuals, non-smokers
* BMI between 18 and 35 kg/m2
* Stable weight (+/- 5kg) for 3 months before randomisation
* Agree to receive a vaccine Pneumovax 23®

Exclusion Criteria:

* Pregnant or lactating woman
* Previous history of cardiovascular disease
* Diabetes
* Kidney or liver disease
* Gastrointestinal disorders or diseases
* Endocrine disorders or diseases
* Allergy
* Subjects taking hypolipidemic drugs, antidepressant, medication for high blood pressure, for inflammation or auto-immune diseases.
* Subject who have receive antipneumococcics vaccine in the year before randomisation.
A Web-based Digital Distance Visual Acuity Test

Primary objective of this study is the development and validation of a web-based application for the examination of the distance visual acuity of normal- and low-vision patients.

Present study aims to develop and validate a web-based digital distance visual acuity test (Democritus Distance Vision Test - DDVIT). DDVIT is an application, which will be easily accessed through a simple internet connection. This application will provide the possibility of a simple but reliable examination of patients, establishing a commonly accepted way of measuring the distance visual acuity among rural doctors, general practitioners and ophthalmologists.

Specifically, present study aims to develop a new online distance visual acuity test (DDVIT) according to the standards of the Early Treatment Diabetic Retinopathy Study (ETDRS) test and to evaluate the level of agreement between the two visual acuity tests, as well as the test-retest reliability of the online DDVIT visual acuity test.

The first part of the study is the development of the online visual acuity test (letters, numbers, symbols) including the following smart features:

1. Adjustment of the font size according to the size of the computer screen used for the examination
2. Real time calculation of the patient-screen distance through a face detection system
3. Automatic calculation of the reading time of each line (each logMAR)
4. Entering the number of patient's reading errors for each line
5. Automatic calculation of the visual acuity in the following score units:

   * Number of Letters (max 85)
   * Visual Acuity Score (max 100)
   * logMAR
   * Decimal
   * Snellen Fraction

The calculation of various reading parameters resulting from the aforementioned features (visual acuity score in different units, reading duration (in sec) and number of errors for each slide (line), patient-screen distance for each slide) will be performed after the end of the examination. Except for the html format, a file in the format of Microsoft Excel and Pdf are also generated.

The second part of this study is the clinical validation of the DDVIT visual acuity test. In this part, the reading acuity measured with the DDVIT and ETDRS test are compared.

All the comparisons will take place in two groups: a) a Normal Vision Group (NVG), and b) a Low Vision Group (LVG) in order to estimate the visual acuity in a population with a wide range of vision.

Eligibility Criteria:
Inclusion Criteria:

* Patients of our outpatient ophthalmology clinic
* Age between 18 to 75 years

Exclusion Criteria:

* Dyslexia
* Attention-deficiency
* Former diagnosis of mental and/or psychiatric diseases
* Inability to cooperate
Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents

This proposed project will be an open-label, split face, randomized controlled pilot study. Up to 60 patients with diffuse facial actinic keratosis will be enrolled in the study. The purpose of this study is to understand the change in skin appearance throughout 5-FU treatment course and to examine whether a topical corticosteroid and moisturizer can decrease severity and duration of skin inflammation after 5-FU treatment course.

The purpose of this study to understand the change in skin appearance during and after the course of 5-FU cream in patients with AK, and compare how the appearance of skin inflammation changes with the use of topical corticosteroids and moisturizers.

Eligibility Criteria:
Inclusion Criteria:

* Male and female, at least 18 years of age
* Subject must have a diagnosis of actinic keratosis (at least 5 lesions on each side of the face)
* Able to comprehend and read the English language

Exclusion Criteria:

* Subjects who do not fit the inclusion criteria
* Concurrently have other inflammatory skin conditions.
* Prior known allergy to any components to of 5FU cream, topical steroid ointment or vaseline.

  • Subject who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures (i.e.: compliant with using 5-FU cream, topical corticosteroid or moisturizers
* Those that are prisoners or cognitively impaired.
Acupoint Selection Based on Meridian Theory in Primary Insomnia of Liver Depression and Spleen Deficiency Type

The classical literature combined with modern medicine to select acupoints, in order to intervene in the autonomic nerve function of the superior cervical sympathetic ganglion as an opportunity, put forward the meridian acupoints mainly to reconcile the head orifices Ying Wei, acupuncture treatment of primary insomnia clinical research. Heart rate variability ( HRV ), Pittsburgh sleep quality index ( PSQI ), polysomnography ( PSG ) and the MOS item short from health survey ( SF-36 ) were observed. Insomnia Severity Index ( ISI ), Dysfunctional Beliefs and Attitudes about Sleep Scale 16 ( DBAS-16 ), GABA, Glx and other secondary indicators were used to clarify the clinical short-term and long-term efficacy of different acupoints in the treatment of patients with primary insomnia and the intervention effect on HRV.

In this randomized controlled trial, 96 patients with insomnia of liver depression and spleen deficiency type were selected from the Third Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine. All patients will be randomly assigned to the control group or the acupuncture group.

MAIN OUTCOME MEASURES : Pittsburgh Sleep Quality Index ( PSQI ) was used to measure sleep quality, and 36-Item Short Form Health Survey ( SF-36 ) was used to measure quality of life. Secondary outcomes included the Insomnia Severity Index ( ISI ), Sleep Dysfunction Beliefs and Attitudes Scale 16, DBAS-16, GABA and Glx.

Eligibility Criteria:
Inclusion Criteria:

* In line with the diagnostic criteria of insomnia of liver depression and spleen deficiency type in traditional Chinese medicine :
* In line with the Western diagnostic criteria for insomnia ;
* 18 ≤ age ≤ 40 years old, male or female ;
* patients with a course of more than two weeks ; Note: The above criteria must be met for inclusion in this study.

Exclusion Criteria:

* Insomnia caused by a variety of organic diseases, neurological or psychiatric disorders
* Pregnancy, lactation or drug allergy
* There are more serious primary diseases such as cardiovascular and cerebrovascular diseases, gastrointestinal diseases, endocrine system diseases, or psychiatric patients.
* Patients with coagulation dysfunction and bleeding tendency.
Impact of Hyperoxia During Cardiopulmonary

The hypothesis implies that this work is the use of hyperoxia during cardiopulmonary bypass by his heart preconditioning effect is associated with a lower incidence of cardiac arrhythmias (atrial fibrillation, tachycardia or ventricular fibrillation) and lesions of myocardial ischemia-reperfusion injury in cardiac surgery postoperative.


Eligibility Criteria:
Inclusion Criteria:

* Major patient ≥ 18 years
* Patient operated cardiac surgery for myocardial revascularization (CABG) or surgical correction of valvular or combined surgery (CABG and valve disease) or ascending aortic surgery
* Signed Consent
* Affiliation to social security

Exclusion Criteria:

* Permanent atrial fibrillation
* Cordarone therapy,
* Pregnant woman
* Patient under guardianship or trusteeship or private public law
* Internal pacemaker
* Hypothermia,
* Patient refusal,
* Cardiac surgery without extracorporal circulation (ECC),
* Participation in another study.
Study of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian Countries

This study will be conducted with the aim of investigating the efficacy, safety and tolerability of 10 mg/day Vortioxetine in Asian patients compared to an approved active comparator (venlafaxine extended release 150 mg/day).


Eligibility Criteria:
Inclusion Criteria:

* The patient suffers from recurrent MDD as the primary diagnosis according to DSM-IVTR™ criteria. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI)
* The patient has a MADRS total score ≥26
* The patient has a CGI-S score ≥4
* The reported duration of the current MDE is ≥3 months.

Other inclusion criteria may apply.

Exclusion Criteria:

- The patient meets any of the exclusion criteria listed in the protocol or, in the investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any reason.
Comparative Evaluation of Diffusion Weighted MRI And Ultrasonography In The Detection of Breast Lesions

This study aims to conduct a comparative evaluation of Diffusion Weighted MRI (DW-MRI) and Ultrasonography (US) in detecting breast lesions. Breast cancer remains a leading cause of cancer-related deaths among women worldwide, necessitating efficient and accurate diagnostic methods. Ultrasonography, a commonly used imaging modality, provides valuable insights into breast lesions but has limitations in sensitivity and specificity.

Diffusion Weighted MRI, on the other hand, shows potential for higher accuracy in identifying malignant versus benign lesions due to its ability to assess tissue cellularity and integrity non-invasively. This research will involve a specified number of female participants within a defined age range, focusing on the comparative effectiveness, sensitivity, and specificity of DW-MRI and US. The findings are expected to contribute valuable insights into optimizing breast cancer diagnostic protocols, ultimately aiding in earlier detection, better patient outcomes, and possibly reducing the need for invasive biopsy procedures.

Eligibility Criteria:
Inclusion Criteria:

* Women with suspected breast lesions
* Breast feeding woman
* Referred for MRI examination.
* Age 18 years or older
* Ability to provide informed consent.

Exclusion Criteria:

* Contraindications to MRI or contrast agent
* Previous breast Implant
* Early Pregnancy

Exclusion criteria

\*
Oral Bioavailability and Bioactivity of Prenylflavonoids From Hops

The prenylflavonoids 6-prenylnaringenin (6-PN) and 8-prenylnaringenin (8-PN) are secondary plant substances, almost exclusively found in hops (Humulus lupulus). Both compounds have known potential biological properties, but poor bioavailability due to their low oral absorption and retention. Our study followed a single dose (500 mg 6- or 8-PN), placebo controlled, randomized, double-blind, three armed crossover study design with ≥2-week washout periods. Plasma, PBMC and urine samples were collected at intervals up to 24 h after intake. Investigators investigated the safety, pharmacokinetics and impact of oral prenylflavonoids on the function of cells of the immune system.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers with blood chemistry values within normal ranges
* Age: 18-45 years
* BMI: 19-25 kg/m2

Exclusion Criteria:

* Pregnancy or lactation
* Alcohol and/or drug abuse
* Use of dietary supplements or any medications, except contraceptives
* Any known malignant, metabolic and endocrine diseases
* Previous cardiac infarction
* Dementia
* Participation in a clinical trial within the past 6 weeks prior to recruitment
* Physical activity of more than 5 h/wk
A Single Ascending Dose Study of R1671 in Patients With Mild Intermittent Asymptomatic Asthma.

This 8 arm study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of R1671 or placebo in patients with mild, intermittent, asymptomatic asthma. Patients will be randomized to receive placebo or R1671, at a starting dose of 0.0015mg, by intravenous infusion; this dose will be escalated in subsequent groups of patients after a satisfactory assessment of the data from the previous dose. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-50 years of age;
* mild, intermittent, asymptomatic asthma;
* history of asthma for \>=6 months;
* non-smokers.

Exclusion Criteria:

* females of childbearing potential, or lactating;
* history of immunologically medicated disease;
* systemic antineoplastic or immunomodulatory treatment in past 6 months.