cyrilzakka/clinical-trials huggingface dataset:
Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults - T705US316

The purpose of this study is to determine if favipiravir is effective in reducing the time to resolution of influenza symptoms.

The purpose of this study is to determine if a 5-day regimen of favipiravir reduces the time to alleviation of influenza symptoms, resolution of fever, and viral shedding, in subjects with uncomplicated influenza compared to no treatment (e.g. placebo).

Eligibility Criteria:
Inclusion Criteria:

* At time of enrollment has 2 or more of the following symptoms (moderate to severe in intensity) that began 48 hours or less prior to the anticipated start of dosing with study medication: cough, sore throat, headache, nasal congestion, body aches and pains, fatigue
* Has a fever at the first visit or in the 6 hours prior if antipyretics were taken, defined as: ≥ 38.0°C (≥ 100.4°F) if \< 65 years old; or ≥ 37.8°C (≥ 100.0°F) if ≥ 65 years old
* Tests positive for influenza A or B during the 48 hours between onset of symptoms and anticipated dosing with study medication as confirmed by RAT or PCR testing (study or non-study procedure); or per Investigator and Medical Monitor discretion in the event there is a known influenza outbreak circulating in the community or the subject has been in close contact with a person who was recently confirmed to have laboratory-confirmed influenza
* Willing to adhere to strict contraceptive measures throughout study and for 3 months following last dose of study medication

Exclusion Criteria:

* Female subjects who are pregnant, currently breast-feeding, or have a positive pregnancy test at Screening
* Has taken an anti-influenza drug, or received any live attenuated influenza vaccine within 4 weeks prior to signing the informed consent
* Has underlying chronic respiratory disease; includes bronchial asthma if currently experience asthma symptoms, requires current asthma treatment, or has had an asthma attack in the past year
* Is suspected of having bacterial respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or infiltrate in lung observed on chest x ray, or is on antibiotics for pulmonary disease) at start of study
* Has a history of gout or is under treatment for: gout or hyperuricemia; hereditary xanthinuria; hypouricemia or xanthine calculi of the urinary tract
* Has a history of hypersensitivity to an anti-viral nucleoside-analog drug targeting a viral RNA polymerase
* Current use of adrenocorticosteroids (except topical preparation) or immunosuppressive drugs
* Has an allergy or contraindication to use of acetaminophen (paracetamol)
* Has a serious chronic disease, history of alcohol or drug abuse within preceding 2 years, psychiatric illness not well controlled (not on stable regimen \> 1 year), or is deemed by the Investigator to be ineligible for any reason
* Previously participated in a clinical trial of favipiravir (T-705)
* Has renal insufficiency requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD)
Metabolic Response to Infliximab in Pediatric Ulcerative Colitis

The metabolic response to ulcerative colitis, including increased proteolysis and lipolysis and changes in energy expenditure, plays a significant role in the resulting malnutrition from which these patients suffer. Tumor necrosis factor-alpha (TNF-alpha), a pro-inflammatory cytokine, has been found to be elevated in children with ulcerative colitis. TNF-alpha has been incriminated in the mechanism of weight loss in many different chronic diseases, and causes net protein and lipid catabolism. Anti-TNF-alpha antibody (infliximab) has been proven to be an effective therapy for ulcerative colitis.

The purpose of this study is to determine changes in protein and lipid metabolism, as well as resting energy expenditure, before and after therapy with anti-TNF-alpha antibody (infliximab) in children with ulcerative colitis. Performing this study will better define the changes in nutrition status observed in these children following remission of active ulcerative colitis, and potentially lead to changes in medical and nutritional management of these children


Eligibility Criteria:
Inclusion Criteria:

* Male and female children between the ages of six and eighteen years of age
* Endoscopic or histologic evidence of ulcerative colitis
* Active ulcerative colitis determined by primary pediatric gastroenterologist to require anti-tumor necrosis factor-alpha antibody (infliximab) therapy
* Colitis symptom score ≥2
* Screening laboratory tests that meet the following criteria (obtained within 4 weeks of enrollment):

  1. Hemoglobin \>8.0 g/dL
  2. White blood cell count \>3.5 x 109/L
  3. Neutrophils \>1.5 x 109/L
  4. Platelets \>100 x 109/L
  5. Aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase levels within 3 times the upper limit of normal.
  6. PPD skin test with skin induration \<5 mm.
  7. Signed written consent from the parent/legal guardian and assent from the child to be obtained prior to enrollment.

Exclusion Criteria:

* Female subjects who are pregnant, nursing, or planning pregnancy.
* Concomitant diagnosis or history of congestive heart failure.
* Serious infection in the 3 months prior to enrollment.
* History of prior or current active or latent tuberculosis.
* Immune deficiency syndrome, including documented human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
* History of systemic lupus erythematosus.
* A transplanted organ.
* Known malignancy or history of malignancy within 5 years of enrollment.
* History of demyelinating disease.
* History of substance abuse.
* History of diabetes mellitus.
* Poor tolerability of venipuncture or lack of venous access during the study period.
* A live virus vaccination within 3 months of enrollment.
* Prior history of infliximab infusion or any other therapeutic agent targeted at reducing tumor necrosis factor-alpha (TNF-alpha).
* Hypersensitivity to any murine proteins or other component of the product.
* Inability to comply with study procedures
Hematopoietic Stem Cell Transplantation in Myeloma

The treatment assignment is based on the presence or absence of an HLA-identical sibling donor (Genetic Randomisation, NOT formal Randomisation). Patients with suitable HLA-identical sibling donors are offered a tandem transplant approach consisting of standard autografting nonmyeloablative radiotherapy and allografting. Patients without HLA-identical siblings are treated with standard double autologous transplantation as per Institutional guidelines or enrolled in other treatment programs approved by local IRBs.This is a multi-center study. The Division of Hematology of University of Torino at the S.G.B. Hospital, Torino, Italy, is the co-ordinating Center.


Eligibility Criteria:
Inclusion Criteria:

* Durie-Salmon stage IIA-IIIB multiple myeloma;
* Age \> 18 and ≤ 65 years;
* previously untreated myeloma;
* presence of a sibling (potential donor);
* bilirubins \< twice normal;ALAT and ASAT \< four times normal;
* left ventricular ejection fraction \> 40%;
* creatinine clearances \> 40 mL/min;
* Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) \> 40% and/or need for continuous oxygen supplementation;
* Karnofsky performance status \> 60%;
* patients must give written informed consent;

Exclusion Criteria:

* Age \> 65 years
* previously treated myeloma;
* absence of a sibling (genetic randomisation cannot be applied);
* Karnofsky performance status score \< 60%
* HIV-infection;
* pregnancy;
* Refusal to use contraceptive techniques during and for 12 months following treatment
* patients unable to give written informed consent

PS. Informed consent is obtained from each patient according to the Institutional Review Boards of the participating centers. The study is conducted according to the Declaration of Helsinki.
Validation of the Dynamometer LABIN

The main objective of this work is to validate the dynamometer LABIN in comparison with the technique of gold-standard reference JAMAR, in a healthy population.

The infringement of the prehension is frequent and impacts on the social and professional quality of life of the patients. There are numerous instruments measuring the strength of prehension. The JAMAR is a mechanical, hydraulic dynamometer, exploring in kilograms the maximal strength of the prehension. It is at present Gold Standard for the measure of the strength of prehension. There is for the moment no electronic known instrument exploring the endurance of the strength of prehension during an effort of tightening. This parameter would indeed be interesting for the exploration in geriatrics and in the neuromuscular pathologies.

This study justifies itself by the fact that the dynamometer LABIN should allow the evaluation of the muscular endurance of the strength of hand as complement of the peak of strength

Measure of the strength of prehension with JAMAR and LABIN according to the following protocol:

* Position: the subject sits comfortably on a chair without armrests, feet put on the ground, the pond at the bottom of the seat, the hips and the knees in 90 ° of flexion, shoulder in adduction and neutral rotation, the elbow bent in 90 °, forearm in neutral position, the wrist between 0 and 30 ° of extension and between 0 and 15 ° of slope ulnaire. The dynamometer is vertically presented and in front of the forearm to maintain the standardized positions.
* Test: regulation of the zero by making a vacuous acquisition during 5 seconds. The order "Jamar then Labin" or Labin then Jamar is chosen by randomization. The operator encourages the subject to every test. The subject does not see the curve displaying.
* Test: 3 clampings of a handle of a dynamometer LABIN by the right hand during 5 seconds, with a break of 30 seconds between the tests. After 2 minutes of break the subjects make 3 clampings with a left hand. After that , the same session is realized with the dynamometer JAMAR

The order "Jamar then Labin" or Labin then Jamar is chosen by randomization. The operator encourages the subject to every test. The subject does not see the curve displaying.

Total duration of participation in the study for the patient: 30 minutes

Main analysis: the calculation of the coefficient of correlation (Pearson or Spearman with regard to the statistical distribution), coefficient of linen concordance and the coefficient of intra-classy correlation.

Eligibility Criteria:
Inclusion Criteria:

* Age : \> 20 years and \<60 years
* Professionally active
* Right-handed(right-wing) or left-handed person
* Volunteer
* Subjects have given its consent in writing to participate in the study

Exclusion Criteria:

* Subjects with a trauma or surgery of the upper limb
* Subjects with a diabetes
* Subjects with a dysthyroïdie
* Subjects with a neurological disease
* Subjects with a syndrome canalaire of the upper limb
* Subjects with a cutaneous disorders(confusions) of the cognitive upper
CHANCE - Candesartan in Hypertrophic Cardiomyopathy

The primary hypothesis of the study is that treatment with AT1-R antagonist in patients with nonobstructive form of HCM will be first save, second will cause regression of myocardial hypertrophy.

Patients will be randomly assigned in 1:1 ratio either to candesartan (target dose 32 mg once daily) or matching placebo. The initial dose of the study drug will be 8 mg once daily. Study drug dose will be then doubled as tolerated every 2 weeks while aiming for a target dose of 32 mg once daily. Monitoring of blood pressure, serum creatinine, serum potassium and pressure gradient in LV outflow tract will be performed during dose increase. Patients will be observed clinically at 3, 6, and 12 months after the maintenance dose was reached. Exercise tolerance will be assessed by bicycle ergometry, presence of malignant arrhythmias by Holter monitoring, extent of LV hypertrophy by 2-dimensional echocardiography, and LV outflow tract pressure gradient by Doppler echocardiography at baseline and 12-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* HCM defined on the basis of echocardiographic criteria showing a nondilated, hypertrophied left ventricle (any wall thickness \> 15 mm) in the absence of known causes of LV hypertrophy hypertension or valvular disease

Exclusion Criteria:

* Hypertrophic obstructive cardiomyopathy defined as presence of resting gradient in left ventricular outflow tract ³30 mmHg or in righ ventricular outflow tract ³15 mmHg at Doppler echocardiography;
* Atrial fibrillation;
* Treatment with ACE inhibitors or AT1-R antagonists any time in the past;
* Contraindications to AT1-R antagonists;
* Coronary artery disease, renal failure, hepatic disorders or serious intercurrent illness limiting survival; and
* Poor echocardiographic image quality.
Validation of Myocardial Perfusion Imaging

The new cadmium-zinc-telluride (CZT) technology is a powerful tool for cardiac nuclear medicine. The increased photon counting sensitivity of camera can be used to explore novel protocols like dual isotope (rapid stress Tl-201/rest Tc-99m protocol for use with high-speed SPECT MPI). The use of dual isotope imaging is very interesting because this imaging combines the use of thallium-201 with technetium-99m agents permitting optimal image resolution and simultaneous assessment of viability, all with an exam duration of approximately 20 minutes. However, no study compares stress thallium-201/rest technetium-99m sequential dual isotope high-speed myocardial perfusion imaging versus invasive coronary angiography. The investigators report here the first validation of high-speed protocol with dual isotope for myocardial perfusion imaging using invasive coronary angiography as the standard of reference.

The new cadmium-zinc-telluride (CZT) technology is a powerful tool for cardiac nuclear medicine. Indeed, recent clinical validation studies of CZT technology have documented a scan time reduction and low radiation dose without degradation of myocardial perfusion imaging in comparison with standard dual detector cameras. The increased photon counting sensitivity of camera can be used to explore novel protocols that may offer advantages over standard protocols used for Myocardial Perfusion Imaging. Berman et al. showed that rapid stress Tl-201/rest Tc-99m protocol for use with high-speed SPECT MPI has offered the superior qualities of Tl-201 for stress imaging and of the Tc-99m agents for rest imaging can be preserved. Nuclear medicine presents the most level of scientific validation for diagnosis and prognosis of coronary artery disease. A lot of studies have compared performance of standard dual detector cameras vs. Invasive Coronary Angiography. Fiechter et al. reported the first validation of ultrafast dedicated cardiac gamma camera with CZT versus invasive coronary angiography. But he used a novel hybrid SPECT /CT device and 99m-Tc-tetrofosmin pharmacological stress/rest examination. However, no study compares stress thallium-201/rest technetium-99m sequential dual isotope high-speed myocardial perfusion imaging versus invasive coronary angiography. Moreover, diagnosis performance of this high-speed protocol versus fractional flow reserve for stenosis evaluation is unknown.

The investigators report here the first validation of high-speed protocol with dual isotope for myocardial perfusion imaging using invasive procedures (coronary angiography and fractional flow reserve) as the standard of reference.

Eligibility Criteria:
Inclusion Criteria:

* Stable angina
* Cadmium-zinc-telluride gamma camera SPECT with dual isotope imaging
* Coronarography

Exclusion Criteria:

* Pregnant woman
* Patient with terminal illness,
* Terminal Renal failure
* Allergy to iodine
A First-in-Human Study to Assess Single and Multiple Doses of NXC736 in Healthy Participants

This is a randomized, double-blind, placebo- controlled, single and multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NXC736 after oral administration in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males aged between 19 and 55 at screening
* Those whose weight is between 55 and 90 kg and BMI is between 18.0 and 30.0
* Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
* Signed informed consent form

Exclusion Criteria:

* Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
* Those who have gastrointestinal diseases or past history of gastrointestinal diseases that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
* A person who shows any of the following results in vital signs at the time of screening

  * Systolic blood pressure below 90 mmHg or above 140 mmHg
  * diastolic blood pressure less than 50 mmHg or greater than 90 mmHg
  * Pulse rate less than 50 beats per minute or more than 90 beats per minute
* A person who exhibits any of the following results from a 12-lead ECG test at the time of screening:

  * PR \> 210 msec
  * QRS complex \> 120 msec
  * QTcB \> 450 msec
* A person who exhibits any of the following results in a clinical laboratory examination at the time of screening ;

  * glomerular filtration rate (eGFR, CKD-EPI) \< 60 mL/min/1.73 m2
  * WBC count \< 3500/μL
  * Absolute neutrophil count (ANC) \< 1500/μL
  * AST/ALT \> 1.5 X ULN
* Those who have a history of tuberculosis infection or who have confirmed positive tuberculosis infection as a result of the Quantiferon TB-Gold test and Chest X-ray performed at the screening test
* Persons with acute infectious diseases including herpes virus infection, herpes simplex, and herpes zoster

Other protocol-defined inclusion/exclusion criteria may apply.
Study of Polyfunctionality of Anti-tumor T Lymphocytes in Cancerology: Potential Biomarker for Emerging Immunotherapies

Purposes of this study are :

* Characterization of polyfunctionality of anti-tumor T lymphocytes using in vitro inhibition of PD-1/PDL-1 pathway
* Study and comparison of polyfunctionality of anti-tumor T lymphocytes in cohorts of patients with melanoma, lung cancer and renal carcinoma. This cancers are chosen because of use of anti-PD-1 or anti-PDL-1 antibodies
* Comparison of this technique with IFN-γ Elispot assay for detection and quantification of anti-tumor T lymphocytes after in vitro blockade of PD-1/PDL-1 pathway.

In this study an immunomonitoring of specific responses of T lymphocytes to tumor-associated antigens based on detection of intracellular cytokines through flow cytometry, after stimulation with all-tumor antigens and blockade of PD-1/PDL-1 interaction is used. Peripheral blood mononuclear cells of patients with cancers are stimulated with 4 telomerase-peptides or peptides overlapping the entire sequence of survivin.

This project studies the frequency and role of polyfunctionality of anti-tumor T lymphocytes in cancerology with an in vitro technique detecting polyfunctional T lymphocytes with a better sensitivity based on removal of an inhibitory PD-1/PDL-1 pathway. It is a flow cytometry protocol with various theoretical advantages in terms of reproducibility and dynamic monitoring of functionality of different sub-populations of polyfunctional anti-tumor T lymphocytes. Moreover, it allows the study of molecular mechanisms involved in proliferation of polyfunctional anti-tumor T lymphocytes with the possibility to sort sub-populations.

The use of all-tumor antigens allows the use of this technique to evaluate the presence and prognostic or predictive value of this biomarker in various cancers.

Detection of polyfunctional anti-tumor T lymphocytes can be a biomarker of anti-tumor lymphocytic adaptive immunity and a potential eligibility or efficacy criteria for new immunotherapies, such as anti-PD-1 or anti-PDL-1 treatments.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by melanoma (LyteloMel), lung cancer (TeloCap) or renal carcinoma (EMIR) from cohorts of medical oncology department of CHRU Besançon (France)

Exclusion Criteria:

-
Hospital Discharge Oral Nutrition Support Trial

To investigate the effect of different strategies for managing malnutrition in the community


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Age 50 years and over
* Able to eat and drink without the need for altered texture fluids
* Identified at risk of disease related malnutrition
* Competent to provide written informed consent
* Willingness to take part in the study and to follow the study protocol

Exclusion Criteria:

* Individuals unable to eat or drink
* Chronic renal disease requiring dialysis
* Galactosaemia
* Dysphagia
* Normally or going to be residing in an institution e.g. care home upon discharge from hospital
* Palliative care
* Cancer (active treatment)
* Liver failure
* Poorly controlled diabetes
* Diagnosed lactose intolerance
* Participation in other clinical trials currently or in the previous 4 weeks
* Due to be discharged to an area out of the hospital region
* Requiring tube or parenteral nutrition
* Due to be discharged from hospital on oral nutrition support recommended by a Dietitian
Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy Volunteers

This study is being conducted to evaluate the safety of KetoNaph ophthalmic solution in healthy adult subjects and in pediatric subjects with a history or family history of ocular allergy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects less than 18 years of age, have either a history or family history of ocular allergy.
* ocular health within normal limits, including a calculated best-corrected visual acuity of 0.3 logMar or better, in each eye. For subjects under 10 years old who are developmentally unable to use the ETDRS chart, visual acuity will be made using the LEA symbols. For these subjects, 20-foot Snellen equivalent units of 20/63 or better in both eyes will be required.

Exclusion Criteria:

* Contraindications or sensitivities to the use of any of the investigational product(s) or their components.
* Subjects less than 18 years of age that have had symptoms and/or signs of allergic conjunctivitis/rhinitis and/or treatment with topical or systemic anti-allergy therapy, or have had a history of ragweed hypersensitivity during the 21-day period prior to visit 1.
* Surgical intervention within three months prior to Visit 1 or during the refractive surgery within the past 6 months.
* A known history of retinal detachment, diabetic retinopathy, or active retinal disease;
* An active ocular infection (bacterial, viral or fungal
* Use of any topical ophthalmic agents other than investigational products during study participation or within 5 days of beginning study treatment.
* Current or anticipated use of contact lenses during study participation or within 5 days of beginning study treatment.
* Current, prior (within 14 days of beginning study treatment) or anticipated use of systemic corticosteroids, and/or any other systemic medications which the Investigator feels may confound study data or interfere with the subject's study participation. Prior (within 21 days of beginning study treatment), current or anticipated use of any topical (including nasal) or systemic anti-allergy medications.
* Intraocular pressure (IOP) that is less than 5 mmHg or greater than 22 mmHg or have a normal IOP with a diagnosis of glaucoma.