cyrilzakka/clinical-trials huggingface dataset:
Phase ll Study of HEC585 in Patients With IPF

A Phase ll Study to evaluate the efficacy and safety of various doses of HEC585 Tablets in patients with idiopathic pulmonary fibrosis


Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in this clinical study and sign the ICF before the study begins;
* Aged 40-80 (including 40 and 80) ;
* Female or male subjects with child-bearing potential who agree and promise to take effective contraceptive measures;
* Diagnosed with IPF according to the Official ATS/ERS/JRS/ALAT Clinical Practice Guideline for IPF Diagnosis (2018);
* FEV1/FVC ≥ 0.7;
* FVC ≥ 45% predicted;
* DLCO corrected for Haemoglobin (Hb) ≥ 30% predicted of normal;
* In the opinion of the Investigator, subjects are willing and able to comply with the protocol requirements and attend the visit.

Exclusion Criteria:

* In the opinion of the Investigator, subjects underwent significant deterioration in IPF within one month before randomization;
* Interstitial lung disease caused by other known causes;
* Any bacterial, viral, parasitic or fungal infection that needs to be treated at screening;
* Expected to receive lung transplantation during the study;
* Expected survival is less than 6 months;
* History of tumors within 5 years before screening (except for localized cancers such as basal cell carcinoma);
* Moderate to severe hepatic insufficiency (Child-Pugh grade B or C, see Appendix 4);
* History of unstable or worsening heart disease within 6 months before screening;
* Cannot perform 6MWT or PFT;
* Allergic to any component of HEC585 Tablets or pirfenidone tablets;
* Participated in other clinical study and received the last dose within 3 months before screening;
* Pregnant or breastfeeding;
* History of smoking within 3 months before screening or are unwilling to quit smoking during the study;
* Subjects often drink alcohol within 6 months before the screening (drink more than 21 units of alcohol a week), or refuse to reduce alcohol intake during the study;
* History of drug abuse within 6 months before the screening;
* Family or personal history of QT prolongation syndrome;
* Any condition that, in the opinion of the investigator, would compromise the safety or compliance of the subject, or prevent the subject from completing the study.
* TBil \> 1.5 × ULN or AST or ALT \> 2 × ULN;
* CLcr \< 50 mL/min;
* Human immunodeficiency virus (HIV) antibody is positive;
* Uncontrolled hepatitis B virus infection or hepatitis C virus infection;
* QTcF \> 480 ms.
* Subjects have received any of the following treatments within 28 days before randomization:

  1. Any cytotoxic drug or immunosuppressant
  2. Therapeutic drugs for IPF, including but not limited to pirfenidone, nintedanib, prednisone at \> 15 mg/d or other glucocorticoids of the equivalent dose, N-acetylcysteine at \> 600 mg/d.
  3. Moderate and strong inhibitor or strong inducer of CYP1A2.
  4. Strong inducers or strong CYP3A4 inhibitors.
Phase 1/1b Study of Rilotumumab in Japanese Subjects With Advanced Solid Tumors or Advanced or Metastatic Gastric or GEJ

This is an open label phase 1/1b study of Rilotumumab in Japanese subjects with advanced solid tumors or metastatic gastric esphagogastric (GEJ) adenocarcinoma.


Eligibility Criteria:
Key Inclusion Criteria:

* Japanese subjects with pathologically confirmed unresectable locally advanced or metastatic carcinoma which is refractory to standard therapies or for which there is no standard therapy (Part 1 only)
* Japanese subjects with pathologically confirmed MET-positive (fulfilling the MET IHC criteria as defined by validated IVD \[in vitro diagnostic\]) unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma (Part 2 only)
* Eastern Cooperative Oncology Group (ECOG) Performance Status (0 or 1)
* Availability of archival tumor tissue (Part 2 only)
* Evaluable (measurable or non-measurable) disease by RECIST 1.1 criteria
* Able to tolerate infusions and take oral medications (Part 2 only)

Key Exclusion Criteria:

* Previous systemic therapy (including chemotherapy, biologic, immunotherapy, or investigational therapy) for locally advanced or metstatic gastric or GEJ adenocarcinoma (Part 2 only)
* Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemotherapy to enrollment (Part 2 only)
* Squamos cell history (Part 2 only)
* Known HER2-overexpressing unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma (Part 2 only)
* Resectable disease or suitable for definitive chemoradiation
* Subjects who have persistent gastric outlet obstruction, complete dysphagia or are dependent upon jejunostomy for feeding (Part 2 only)
* Known central nervous system metastases
Appetite Response to Exercise- Versus Energy Restriction-induced Energy Deficit in Adolescents With Obesity.

The aim of the present study is to compare the effect of iso-energetic energy deficits induced by exercise or dietary restriction on energy intake and appetite feelings in adolescents with obesity

The present study will compare the nutritional response to an energy deficit of 400 kcal induced once by realisation of an acute exercise set at moderate intensity and once by a dietary restriction imposed at lunch (compared with a control condition). 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (CON); ii) one session with an exercise-induced energy deficit (Def-EX); iii) one session with an energy restriction-induced energy deficit (Def-EI).

Their ad libitum energy intake will be assessed during dinner time. Appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* BMI percentile \> 97th percentile according to the french curves.
* ages 12-16 years old
* Signed consent form
* being registered in the national social security system
* no contraindication to physical activity

Exclusion Criteria:

* Previous surgical interventions that is considered as non-compatible with the study.
* Diabetes
* weight loss during the last 6 months
* cardiovascular disease or risks
Contralateral Effects of Russian Current on Adolescent Athlete

The strength loss associated with immobilization causes long term decreases in performance and loss of hours of participation for athletes during rehabilitation period to regain a competitive form. Therefore, reducing such effects throughout the immobilization period is highly preferable. Cross-educational strength transfer to the inactive muscle by means of unilateral strength training may provide an opportunity to avoid strength loss and atrophy.

After injury and/or surgery, neuromuscular electrical stimulation is widely used to train muscles and enhance muscle strength. and some studies have found it to be superior to voluntary exercise after immobilization . One of the preferred common NMES techniques for muscle strengthening is the Russian current (RC) It stimulates almost all muscle motor units to contract synchronously, resulting in a greater muscle hypertrophy. While some studies exist to confirm the efficacy of this current in the Russian language, there is very little evidence to support its use in English literature. The aim of our study is to investigate the effectiveness of cross education of Russian current on the strength of the contralateral inactive biceps and triceps muscles of the affected elbow in pediatrics athletes to decrease some of the negative effects of immobilization on muscle tissue and enhance recovery.

Eligibility Criteria:
Inclusion Criteria:

* 1 year experience in tennis training
* diagnosis of tennis elbow

Exclusion Criteria:

* Any contraindication to the application of electrotherapy
* upper limb surgery
Non-invasive Quantification of Liver Iron With MRI

The purpose of this study is to validate magnetic resonance imaging as a biomarker of hepatic iron concentration (HIC). Excessive accumulation of iron in the body is highly toxic, specifically in the liver. Accurate, non-invasive assessment of HIC is needed for diagnosis, quantitative staging and treatment monitoring or hepatic iron overload.

Excessive accumulation of iron in the body can result from abnormal intestinal absorption in hereditary hemochromatosis or repeated intravenous blood transfusions (ie: transfusional hemosiderosis). Excess body iron is highly toxic, and requires treatment aimed at reducing body iron stores. Measurement of body iron stores is critical for detection of iron overload, staging its severity and monitoring of iron-reducing therapies that are often extremely expensive (\>$40,000/year) and carry their own toxicities. MRI has been shown to be very sensitive to the presence of iron. The investigators have developed an MRI-based method for rapid iron quantification (for instance, whole liver in a single breath-hold). The purpose of this work is to validate this new method using the FDA-approved Ferriscan technique (Resonance Health, Claremont, Australia) as a reference standard.

Eligibility Criteria:
Inclusion Criteria:

* Controls: 18 years or older with no known history of iron overload or liver disease.
* Patients: 10 years or older with known or suspected iron overload

Exclusion Criteria:

* Patients with contraindications to MRI (eg. pacemaker, contraindicated metallic implants, claustrophobia, etc) and pregnant females (as determined by self-report during MRI safety screening) will be excluded.
* For control subjects, those with known liver disease will be excluded.
Clinical Study to Evaluate the Possible Efficacy and Safety of L- Carnitine and Sildenafil in Children Having Beta Thalassemia With Increased Tricuspid Regurgitant Jet Velocity

This study aims to investigate the possible efficacy and safety of L_Carnitine and Sildenafil on patient with Beta thalassemia complicated with increased Tricuspid Regurgitant Jet Velocity


Eligibility Criteria:
Inclusion Criteria:

* Children with Beta thalassemia major who have increased TRJV more than 2.5m/s.
* Children age from 6-18 years

Exclusion Criteria:

* Others hemolytic anemia

  * Young age before 6 years of age
  * Allergy to Sildenafil or L-carnitine
  * Patient with documented causes of pulmonary hypertension rather than caused by Beta thalassemia.
  * Hepatic dysfunction: serum Alanine Aminotransferase (ALT) 3X.
  * Renal dysfunction: Creatinine level greater than or equal to 1.2 mg/dl.
Pain Perception by the Chronic Renal Patient at the Time of Vascular Access Cannulation.

Pain in patients under hemodialysis affects chronic renal patients' quality of life. Distraction has been effective in controlling pain induced by the insertion of needles. Once applied adequately, distraction promotes endorphins' release, with efficacy in acute pain. This study aims to evaluate pain perception while puncturing the hemodialysis device using an anti-stress ball as a distraction strategy.


Eligibility Criteria:
Inclusion Criteria:

* adults over 18 years old
* able to read and write
* vascular access by a fistula or arteriovenous prosthesis, cannulated with a 15G needle
* vascular access at least with month old

Exclusion Criteria:

* patients under 18 years
* can't be able to read and/or write
* usage of topical anesthetics before treatment
* vascular access by a fistula or arteriovenous prosthesis, cannulated with smaller or larger 15G needles
* vascular access under one-month-old
Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants

The primary objective of this study is to evaluate the effect of filgotinib on a mixed organic anion transporting polypeptide/cytochrome P450 3A (OATP/CYP3A), OATP/ breast cancer resistance protein (BCRP), and OATP substrates using phenotypic probes.


Eligibility Criteria:
Key Inclusion Criteria:

* Be a nonsmoker. The use of nicotine or nicotine-containing products must be discontinued 90 days prior to the first dose of study drug.
* Have a calculated body mass index (BMI) of greater than or equal to (≥) 19.0 and less than or equal to (≤) 30.0 kilogram per meter square (kg/m\^2) at screening.
* Have a creatinine clearance (CLcr) ≥ 90 milliliters per minute (mL/min) (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at screening and upon admission.
* Female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at clinic admission.
* Male participants must be surgically sterile.
* Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
* Screening laboratory evaluations and 12-lead electrocardiogram (ECG) evaluations must be without clinically significant abnormalities as assessed by the investigator.
* Have liver biometric tests such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin below the upper limit of normal at screening.
* Must be willing and able to comply with all study requirements.
* Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs.
* Participants must not have donated blood within 56 days of study entry or plasma within 7 days of study entry and must refrain from blood donation from clinic admission, throughout the study period, and continuing for at least 30 days following the last dose of study drug.

Key Exclusion Criteria:

* Positive serum pregnancy test (Female participants).
* Lactating female.
* Have received any investigational drug/device within 30 days prior to study dosing (or within 5 half-lives of the drug, whichever is longer).
* Have current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance or participant safety, or a positive drug or alcohol test at screening or admission.
* Have a positive test result for human immunodeficiency virus type 1 (HIV-1) antibody, hepatitis B virus (HBV) surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at screening.
* Have positive Coronavirus Disease 2019 (COVID-19) Real-Time Reverse.
* Transcriptase-Polymerase Chain Reaction (RT-PCR) testing on screening and admission.
* Have poor venous access that limits phlebotomy.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
OBSERVATIONAL STUDY on VIRAL SHEDDING and IMMUNOLOGICAL RESPONSE of OROPOUCHE VIRUS

This is a single-center observational study, whose primary objective is to describe the immune response to Oropouche Virus (OROV) during the study period and the duration of viral RNA shedding, only for sequential samples, by RT-PCR in different matrices.

This is a study with retrospective and prospective enrollment.

Eligibility Criteria:
Inclusion Criteria:

* patients resulted positive to the RT-PCR for OROV;
* informed consent to the participation to the study and to personal data's treatment and/or donation of residual samples to Tropika Biobank;
* patients ≥ 18 years old.

Exclusion Criteria

• lack of signed informed consent.
Investigation of New Intermittent Catheters in Healthy Volunteers

Investigation of non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.

The CP322 study investigated a novel non-CE marked intermittent catheter for males and females, designed in two different variants, Variant 1 and Variant 2, respectively. The study was conducted in Denmark and was a randomized, single blinded, cross-over investigation comparing the two new variant catheters with a comparator catheter in 30 adult healthy volunteers.

For each participant, the study thus contained three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 30 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). There were 4-14 days between the test visits.

Eligibility Criteria:
Inclusion Criteria:

* Minimum 18 years of age and with full legal capacity
* Written informed consent and signed letter of authority and secrecy agreement given
* Willing to comply with not using analgesics 1 up to 24 hours prior to catheterization visits
* Urine Multistix negative for erythrocytes (hematuria)

Exclusion Criteria:

* Participation in any other clinical investigations during this investigation
* Known hypersensitivity towards any of the test products
* Symptoms of urinary tract infection (UTI) (Investigators judgement)
* Pregnancy or breastfeeding
Study of Galunisertib in Healthy Participants

The study involves a single dose of galunisertib taken by mouth by Japanese participants and non-Japanese participants. The study will evaluate the relationship between the effect of the study drug on the electrical activity of the heart, as measured by electrocardiogram (ECG) and how much of the study drug gets into the blood stream and how long it takes the body to remove it. Ths study will last about 42 days for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy male or female Japanese or non-Japanese participants, as determined by medical history and physical examination.
* Male participants: Must agree to use a reliable method of birth control for 12 weeks after receiving the dose of study drug, OR be at least 6 weeks post-vasectomy with documentation of sperm-free ejaculate.
* Female participants: Women not of child-bearing potential may participate, and include those who are:

  * Infertile due to surgical sterilization; or
  * Postmenopausal.
* All female participants must test negative for pregnancy at screening.
* Have a body mass index (BMI) of 18.5 to 32.0 kilogram per meter square (kg/m²), inclusive at screening.
* Have clinical laboratory test results within normal reference range.
* Are able and willing to give signed informed consent.

Exclusion Criteria:

* Have participated, within the last 3 months, in a clinical trial involving an Investigational Product (IP). If the previous IP has a long half-life, 3 months should have passed.
* Have known allergies to galunisertib-related compounds or any components of the formulation, or history of significant atopy.
* Have a personal or family history of long QT syndrome, heart failure, hypokalemia, or sudden death.
* Have a personal history of unexplained syncope within the last year.
* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study or affects or confounds the corrected QT (QTc) analysis (the ECG waveform morphology or rhythm are incompatible with reliable measurement of ECG intervals), or have QTcF greater than (\>) 450 milliseconds (msec).
* Have an abnormal blood pressure as determined by the investigator.
* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the IP; or of interfering with the interpretation of data.
* Have serum magnesium and potassium values outside of the normal reference range.
* Show evidence of human immunodeficiency virus (HIV) infection, hepatitis C or hepatitis B.
* Intend to use over-the-counter or prescription medication (including herbal medications) within 14 days prior to dosing.
* Have donated blood of more than 500 milliliter (mL) within the last month
* Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females).
New Tools for the Diagnosis, Prognosis and Treatment Follow-up in Chagas Disease

Chagas disease is endemic to Latin America, and is of emerging importance in non-endemic countries because migration of people infected with T. cruzi. Current methods for diagnosis of T. cruzi infection are not ideal. Existing drugs for treatment are very limited, produce severe side-effects, and their effectiveness cannot be properly evaluated. Reliable biomarkers for prognosis, early diagnosis and effectiveness of treatment will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Patients from endemic areas (Latin America)
* Older than 18 years old and younger than 50
* With serological confirmation of Chagas Disease infection with two different techniques
* Indeterminate or initial cardiac form
* No previously treated for Chagas Disease

Exclusion Criteria:

* Co-morbidity: previous cardiac disease from other aetiology (ischemic, alcoholic or hypertensive), active inflammatory or immunology diseases for another agent. Hepatic disfunction
* Pregnancy or lactation
Can Steerable Capsule Endoscopy Enhance Gastric Emptying?

Small bowel wireless capsule endoscopy is the investigation modality of choice for suspected diseases of the small bowel. The procedure is safe and noninvasive, the main risk being capsule retention occurring in approximately 2% of procedures. Other problems such as incomplete examinations occur in 10-20% of procedures. Reasons include delayed gastric emptying, slow small bowel transit, faulty equipment and poor bowel preparation.

Some protocols identify the capsule position 30 minutes after ingestion using a 'realtime' viewer. If the capsule remains in the stomach, mobilisation is encouraged followed by an intramuscular prokinetic injection if this fails. This approach has disadvantages since an intramuscular injection is uncomfortable for patients. Additionally metoclopramide, commonly used for this purpose, has a risk of acute dystonic reactions particularly in young patients.

Recently a handheld magnet (Intromedic Ltd.) has been developed to enable control of the capsule in the upper GI tract. We propose that this could be used, alongside positional changes, to expedite capsule transit through the stomach thus improving completion rates and avoiding the risks of unnecessary medication. We wish to undertake a randomised controlled study comparing a standard protocol for small bowel capsule endoscopy against a hand held magnet and positional change protocol to enhance gastric emptying of the wireless capsule.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20 years or over
* Patients attending hospital for small bowel endoscopy examination

Exclusion Criteria:

* Patients under the age of 20 years
* Patients with a permanent pacemaker, or implantable cardioverter-defibrillator
* Patients with any electronic/magnetic/mechanically controlled devices
* Patients that are pregnant
* Patients who are unable to understand or speak English
A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)

The objective of this trial is to determine the effect of linaclotide on abdominal girth in IBS-C participants with the baseline symptoms of abdominal bloating and an increased abdominal girth.


Eligibility Criteria:
Inclusion Criteria:

• Patient meets protocol criteria for diagnosis of IBS-C, abdominal pain, abdominal bloating and abdominal girth

Exclusion Criteria:

* Patient has history of loose or watery stools
* Patient has both clinically significant findings and unexplained clinically significant alarm symptoms
* Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain
* Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments