cyrilzakka/clinical-trials huggingface dataset:
Study to Compare Bioavailability of GLPG1972 Given as 2 Different Tablet Formulations Versus an Oral Solution

This study is a Phase I, randomized, open-label, cross-over study with 4 single-dose treatments of GLPG1972 to compare the bioavailability of the oral wet granulation (WG) tablet relative to an oral solution and to the oral direct compression (DC) tablet after single dose intake in healthy male subjects and to evaluate the effect of food on the bioavailability of the WG oral tablet.


Eligibility Criteria:
Inclusion Criteria:

1. Male between 18 and 50 years of age, inclusive,
2. A body mass index (BMI) between 18-30 kg/m², inclusive, weight of at least 50 kg.
3. Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and laboratory findings.
4. Discontinuation of all medications except occasional paracetamol at least 2 weeks or 5 half-lives prior to the first study drug administration.
5. Non-smokers and not using any nicotine-containing products.
6. Negative urine drug screen and alcohol breath test.
7. Current sexually active male agrees to use adequate contraception
8. Willing to consume a non-vegetarian high-fat and high-calorie breakfast
9. Able and willing to sign the ICF

Exclusion Criteria:

1. Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug
2. Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or any history of hepatitis from any cause with the exception of hepatitis A.
3. History of or a current immunosuppressive condition
4. Symptoms of clinically significant illness in the 3 months before the initial study drug administration.
5. History of malignancy within the past 5 years
6. Clinically relevant abnormalities detected on ECG regarding either rhythm or conduction (e.g. QTcF \>450 msec, or a known long QT syndrome).
7. Presence of abnormal liver function
8. Renal function with an estimated creatinine clearance \<80 ml/min based on the Cockcroft-Gault formula.
9. Presence of any condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
10. Clinically relevant abnormalities detected on "vital signs"
11. Dietary requirements precluding participation.
12. Significant blood loss including blood donation or had a transfusion of any blood product within 12 weeks
13. Hemoglobin level \<7.5 mmol/L (12 g/dL).
14. Active drug or alcohol abuse within 2 years prior to the initial study drug administration.
15. Current (2 weeks before screening) and planned uninterrupted consumption of large quantities (\> 6 cups) of coffee
16. Administration of an injectable drug within 30 days prior to the initial study drug administration.
17. Concurrent participation, or participation in a drug/device study within 8 weeks or 5 half-lives of the drug or within 6 months for biologicals
18. Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff
Determination of Perioperative Acute Kidney Injury Incidence

In the last few years, acute renal injury (AKI) definition has been significantly changed. In the light of the data obtained from multicenter international studies, acute renal injury was redefined according to RIFLE, AKIN and KDIGO criteria. The common criteria of all three criteria in acute renal failure is the increment of level of creatinine as 0.3 mg/dL or 50 % increment of respective basal value of serum creatinine.

In the current study, older than 40 years patients with no specific gender, who will stay at least one night in hospital will be included and cardiovascular and urological surgery patients and patients with known renal insufficiency will be excluded. It was aimed to measure serum creatinine levels in all included patients at baseline and up to 24h after surgery and will be determined acute kidney injury incidence and risk factors according to new criteria.


Eligibility Criteria:
Inclusion Criteria:

* older than 40 years
* no gender specified
* patients who will stay at least one night in hospital
* patient with normal renal function

Exclusion Criteria:

* patient with renal dysfunction and cardiovascular, urological surgery patients
Evaluation ctDNA in Patients of Non-Small-Cell Lung Cancer Following Resection

Circulating tumor DNA (ctDNA) is a promising biomarker for noninvasive assessment of cancer burden. In this study, PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline. Investigators also applied ctDNA dynamic monitoring using PEAC technology in early stage NSCLC patients with driver mutations positive at baseline, to evaluate the feasibility and their potential clinical application.

Circulating tumor DNA (ctDNA) is a promising biomarker for noninvasive assessment of cancer burden. Advances in DNA sequencing technologies and our understanding of the molecular biology of tumours have resulted in increased interest in exploiting ctDNA as a tool to facilitate earlier detection of cancer and thereby improve therapeutic outcomes by enabling early intervention. In this study, PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline. Investigators aim to evaluate whether driver gene mutations detected by PEAC can replace tissue testing results in patients with stage I to Ⅲ NSCLC. Investigators also applied ctDNA dynamic monitoring using PEAC technology in early stage NSCLC patients with driver mutations positive at baseline, to evaluate the feasibility and their potential clinical application.

Eligibility Criteria:
Inclusion Criteria:

* Postoperative histopathological diagnosis of TNM stage I to III NSCLC with R0 resection;
* No adjuvant chemotherapy, radiotherapy, targeted drug therapy or biotherapy after surgery;
* Men or women of age ≥18 years and \<75 years old;
* Eastern Cooperative Oncology Group (ECOG) behavior status score 0 to 1.

Exclusion Criteria:

* Patients with other cancers other than NSCLC within five years prior to this study;
* Who can not get enough tumor histological specimens (non-cytological) for analysis;
* Human immunodeficiency virus (HIV) infection;
* NSCLC mixed with patients with small cell lung cancer;
* Pregnant or lactating women;
* There is a clear history of neurological or mental disorders, including epilepsy or dementia;
* Conditions that investigators think is not suitable for inclusion.
Clinical Trial to Evaluate the Bioavailability and Safety of AGSAV301

The purpose of this study is to evaluate the bioavailability and safety of AGSAV301 tablet in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Adult males 20 to 40 years at screening.
* body weight ≥ 45kg and within ± 20% of the ideal body weight : Ideal body weight = (height \[cm\] - 100) x 0.9
* Be able to collect blood for study and visit for follow-up period
* Subject who agrees to participate in this study and give written informed consent

Exclusion Criteria:

* Have history of significant hepatic, renal, gastrointestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hematologic, cardiovascular diseases
* Have a gastrointestinal disease(ex : Crohn's disease, gastrointestinal ulcer)or surgery(except for Appendectomy, Hernia repair) affected the absorption of medications
* Inappropriate in Screening test (interview, vital sigh, BP, 12-lead ECG, laboratory test etc.)
* Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of amlodipine or valsartan
* drug abuse, or have a history of drug abuse showed a positive for the screening test on urine : amphetamine, barbiturate, cocaine, opiates, benzodiazepines, cannabinoids, methadone etc.
* Subject who takes herbal medicine within 30 days, ethical drug within 14 days, OTC within 7 days before the beginning of administration of investigational drug
* Unusual diet affected the absorption, distribution, metabolism, excretion of medications
* Subject who treated with any investigational drugs within 60 days before the administration of investigational drug
* Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days
* Subject who takes inhibitors and inducers of drug metabolizing enzyme (Barbiturates etc.) within 30days
* Subject who have taken habitually caffeine (caffeine \> 5 units/day)
* Subject who have drunken habitually (alcohol \> 21 units/week, 1 unit = pure alcohol 10ml)or who are unable to quit drinking during this study or smoker
* positive for Hepatitis B, Hepatitis C, HIV or Syphilis
* Blood Pressure is not in the range of "140 \> sitting SBP ≥ 90mmHg, 90 \> sitting DBP ≥ 60mmHg"
* Pulse rate is not in the range of "95 \> sitting Pulse Rate ≥ 45bpm (beats per minute)"
* AST, ALT, total bilirubin over twice of reference range
* Subjects deemed ineligible by investigator based on other reasons
Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Patients With Acute Sickle Cell Crises?

The purpose of this study is to determine whether IV acetaminophen can decrease the need for subsequent opioid administration in the acute management of sickle cell crisis pain in the pediatric emergency room.

This is a single-center, prospective, randomized, double-blinded, controlled study in an academic urban pediatric emergency department of children with sickle cell disease presenting with acute sickle cell crisis pain between ages of 4 to 16 years, with a pain score of 6/10 or higher on the Wong-Baker modified FACES pain scale. In order to detect a difference of 0.2 mg/kg in cumulative dosage of morphine (at our institution, 0.3 mg/kg morphine deems an inpatient admission for parenteral pain management) with 80% power and alpha of 0.05, we calculated a sample size of 33 patients in each group. All patients will receive IV ketorolac and IV morphine. Patients will be randomized to receive IV acetaminophen or IV saline (volume-equivalent). Pain scores will be obtained at baseline, and again at 30 minutes, 60 minutes, 90 minutes, and 120 minutes after medication administration. Cumulative morphine dosing, rates of admission, and rates of adverse effects of morphine will also be analyzed. Our primary objective is to decrease the need for subsequent opioid administration. Our secondary objectives are to determine if IV Acetaminophen decreases pain score at 30 minutes, 60 minutes, 90 minutes, and 120 minutes, decreases the rate of admissions, and decreases the rate of adverse effects from opioids.

Eligibility Criteria:
Inclusion Criteria:

* Any patient age 4-16 years with sickle cell disease who presents the Pediatric ER with acute sickle cell pain crisis with a pain of 6/10 or higher

Exclusion Criteria:

* Patient with fever (38C or 100.4F)
* Patient less than age 4 years
* Patient greater than age 16 years
* Patient with hypersensitivity/allergy to either morphine, NSAIDs, or acetaminophen
* Patient received acetaminophen within the past 4 hours
* Patient with known liver disease or renal disease
* Patient not requiring IV morphine (pain score 5/10 or less)
* Patient enrolled in the study within the past 72 hours
Individualized Precise Localization of rTMS on Primary Motor Area

Parkinson's disease (PD) patients have some problem with self-initiated movement task. Compared with health controls, task meta-analysis found that PD patients showed abnormal activation in pre-supplementary motor area (pre-SMA) and putamen. And the functional connectivity has already been reported between pre-SMA and putamen in 2013. Repetitive Transcranial Magnetic Stimulation (rTMS) is a sage and painless technique to activate cortical areas. The deep brain structure can be activated via stimulating superficial cortex by rTMS. For investigating the mechanism of self-initiated movement, this project is using functional magnetic resonance imaging (fMRI) to individualize the precise localization in motor area and combining rTMS to activate putamen.

Healthy subject is recruiting in this project. High and low frequency rTMS will be performed, respectively. For the l-Hz sessions (low frequency), stimulation is delivered at 100% of the subject's resting motor threshold at 1 Hz continuously over 30 min for a total of 1,800 pluses. The 10-Hz stimulation is delivered at 100% of the subject's resting motor threshold via 60 trains of 3-s 10-Hz rTMS (30 pulses per train).

Eligibility Criteria:
Inclusion Criteria:

* There are activation in motor area during the task fMRI
* The head motion less than 2 mm in translation or 2 degrees in rotation in any direction during the resting-state fMRI

Exclusion Criteria:

* Without any neuropsychiatric conditions
* No head injury or history of epilepsy
* Not on any medications
Resolution of Sickle Cell Leg Ulcers With Voxelotor

This study is a Phase 3, multicenter, randomized, placebo-controlled study to evaluate the efficacy of voxelotor and standard of care for the treatment of leg ulcers in participants with sickle cell disease. The study is divided into a 5 study periods: Screening, Run-in, Randomized Treatment, Open-label Treatment, and Follow-up/End of Study (EOS).

The study will be conducted in approximately 80 eligible participants at approximately 20 global clinical trial sites.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants with documented diagnosis of SCD (HbSS, HbS/β0 thalassemia)
2. Age 12 years and older
3. At least 1 cutaneous ulcer(s) on the lower extremity (leg, ankle, or dorsum of foot) that meets the following criteria:

   * Duration: ≥ 2 weeks and \< 6 months at Screening, and
   * Size: \> 2 cm2 prior to randomization
4. Written informed consent (≥ 18 years) or parental/guardian consent and participant assent (≥ 12-17 years) per IEC policy and requirements, consistent with ICH guidelines

Exclusion Criteria:

1. Target ulcer(s) healed by ≥ 25% during the standard of care run-in period prior to randomization
2. Active infection/purulence at ulcer site, or exposed tendon or bone at the ulcer site, based on Investigator's clinical judgment
3. Current osteomyelitis at or near the ulcer site
4. Known vascular abnormalities that would preclude healing in the opinion of the Investigator (eg, pre-existing severe arterial insufficiency in the affected limb)
5. Serum albumin \< 2.0 g/dL
6. RBC transfusion within 60 days of initiation of study drug
7. Receiving regularly scheduled RBC transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) during the study
8. Planned elective surgery within the next 6 months
9. Anemia due to bone marrow failure (eg, myelodysplasia)
10. Absolute reticulocyte count \< 100 × 109/L
11. Screening alanine aminotransferase (ALT) \> 4 × upper limit of normal (ULN)
12. Severe renal dysfunction (estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73 m2 by Schwartz formula) or is on chronic dialysis
13. Clinically significant bacterial, fungal, parasitic, or viral infection that requires therapy

Other protocol-defined Eligibility Criteria that apply
Quality of Life Study of Helixate NexGen

The aim of this study is to describe Health Related Quality of Life (HRQoL) in adolescents and adults with Hemophilia A treated prophylactically or on-demand with Helixate NexGen. The study will also assess the kinds of determinants, including key transitional life events, that might impact HRQoL in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Haemophilia A patient
* Severely (\<1%) and moderately (1-5%) affected
* On treatment with Helixate NexGen
* Ability to read and understand study materials (patient information and data protection form, patient-related questionnaires)
* Signed data protection form; if patient is \<18 years of age, legal guardian must also give written consent by signing the data protection form

Exclusion Criteria:

* Presence of inhibitors
* Abuse of recreational drugs or alcohol interfering with the every-day-life in the opinion of the physician
* Advanced stage human immunodeficiency virus (HIV) infection (CD4 cell counts \<200/cmm, multi-drug resistance, presence of AIDS related signs or symptoms)
* Symptomatic liver disease (cirrhosis, ascites, esophageal varices)
* Concomitant or planned interferon therapy
* Malignancies on or off treatment
Effects of Specific Pelvic Stabilization Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain Women

Postpartum women with PPGP receiving specific pelvic stabilization exercise training with transabdominal sonography-guided Biofeedback would have better improvements on muscle functions, physical functions, pain, and disability compared to the regular pelvic stabilization exercise group


Eligibility Criteria:
Inclusion Criteria:

* postpartum : ≥ 3 months
* pregnancy-related pelvic pain
* pain location is located between posterior iliac crest and gluteal fold
* Clinical screening test for pelvic pain :

ASLR : positive and SI joint ≥ 2 (+ symphysis ≥ 1)

Exclusion Criteria:

* lumbar or pelvic surgery
* other causes of pelvic pain (such as fractures)
* Radiculopathy
* other health problems, such as cancer, cardiovascular disease, rheumatism , etc
* daily activities limited , unable to complete the experiment
* communication disorders
* mental disorder
* pregnancy
* have been trained in stable muscle strength in the past.
LMA I-Gel Versus LMA Protector During Minor Urological Procedures Under General Anesthesia in Adult Patients

This will be a randomized comparative study comparing the two supraglottic devices i-gel and Protector, intraoperatively, during minor urological procedures under general anesthesia in adult patient.

This randomized comparative study aims to evaluate the effectiveness, safety, and unwanted effects of two laryngeal mask airway devices, the iGel and the Protector. The study will involve adult patients during minor urological procedures under general anesthesia. Participants will be divided into two groups: in one group will be inserted the iGel laryngeal mask airway, while in the other group will be inserted the Protector laryngeal mask airway.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* Patients older than 18 years
* Procedures in supine and lithotomy position

Exclusion Criteria:

* Tumors or anatomical anomalies of the upper airway
* Known history of difficult intubation
* Limited mouth opening less than 2cm
* Decreased compliance of the lungs or the thoracic cage
* Need of mechanical ventilation after the surgery
Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain

For cancer patients with inadequate pain relief, a switch to an alternative opioid is the preferred option for symptomatic improvement. However, multiple opioids are often simultaneously administered for anecdotal reasons.

The present study isdesigned to assess the analgesic profiles of two different strategies in chronic cancer pain: the opioid rotation from oxycodone to transdermal fentanyl and the combination of oral oxycodone and transdermal fentanyl.

Patients with uncontrolled cancer pain despite treatment of oral morphine equivalent ≥100 mg/d will be randomly assigned to oral opioids to transdermal fentanyl (rotation group) or oral oxycodone plus fentanyl (combination group). Patients answer a questionnaire that included pain severity (0 to 10) and interference items at baseline and after one week. Primary outcomes are change in pain score and treatment success.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Uncontrolled Pain That Required Stronger Opioid Therapy Than They Have Been Taking
* Histologically Confirmed Solid Cancer
* Aged Over 18 Years
* Admitted in a Palliative Cancer Care Unit

Exclusion Criteria:

* Uspected to Have Narcotic Abuse, Clinically Relevant CO2 Retention or Had an Active Skin Disease
* Inability to swallow oral medication, and impaired sensory or cognitive function
* Patients who had an active infection, uncontrolled central nervous system involvement, or on antitumor therapy of any kind
Abdominal Aortic Junction Tourniquet (AAJT-S) for Non-compressible Torso Haemorrhage

This study seeks to evaluate the feasibility of a Abdominal Aortic Balloon Occlusion of the Aorta (AAJT-S) in exanguinating trauma patients with non-compressible truncal haemorrhage in the emergency room and the pre-hospital setting.

The study is designed as a prospective observational study to accomapany the impementation of this device in clinical routine. However, the device has already been used in the emergency room and AAJT-S application is no study specific intervention.

Eligibility Criteria:
Inclusion Criteria:

* aged, or believed to be aged, 18 years or above,
* confirmed or suspected life-threatening lower body trauma (i.e. signs of inadequate perfusion of tissues, tachycardia, hypotension, suspected blood loss)
* is thought to benefit from trauma resuscitation with AAJT-S or REBOA zone III

Exclusion Criteria:

* suspected additional bleeding source proximal to the umbilicus, or
* known or suspected pregnancy at presentation, or
* known abdominal aortic aneurysm
Trial of IRE in Cholangiocarcinoma

The purpose of this study is to test any good and bad side effects of surgery using IRE to treat cancer of the bile duct.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Capable of providing written and oral informed consent in English
* Locally advanced disease based on preoperative work-up demonstrating that the tumor is unresectable due to portal vein, hepatic artery, and/or bile duct involvement, insufficient hypertrophy response of the future liver remnant after portal vein embolization, or patients not able to tolerate major liver surgery
* Found to be unresectable intraoperatively based on vascular, biliary, or lymph node (N2) involvement upon exploratory laparotomy
* Patients will be assessed for chemotherapy prior to treatment with IRE, but given the common problem of recurrent cholangitis, some patients will not be candidates for chemotherapy until after IRE is performed.

Exclusion Criteria:

* Locally advanced PHC eligible and accepted for liver transplantation evaluation
* PHC with \> 5 cm extension along the common hepatic duct or common bile duct on preoperative imaging or intraoperative ultrasound
* Metastases to peritoneum, liver or other organs confirmed by percutaneous biopsy, staging laparoscopy or intraoperative frozen section
* Lymph node metastases beyond N2 stations, confirmed by intraoperative frozen sections or radiographic diagnosis
* History of cardiac disease:

  * Congestive heart failure (NYHA class \>2)
  * Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening)
  * Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers are permitted)
* Any implanted stimulation device (defined as implantable cardiac device and a pacemaker)
* Uncontrolled hypertension (blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen)
* Uncontrolled infections (\> grade 2 NCI-CTC, version 3.0)
* Epilepsy
* Both narrowing (sclerosis) of the main portal vein and a reduced diameter of either the common hepatic artery, celiac trunk or superior mesenteric artery of \>50%
Tumor Antigen-sensitized DC Vaccine As an Adjuvant Therapy for Esophagus Cancer

The aim of this single center, single arm and prospective study is to explore the safety and efficacy of tumor antigen-sensitized DC vaccine in postoperative adjuvant treatment of esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diagnosis of esophageal squamous cell carcinoma；
* Immunotherapy for preoperative；
* Karnofsky performance status 0-1;
* The postoperative pathological stage is (y) Pt + and / or N + M0 according to AJCC 8th
* Function of the main organs is normal;
* Edition Patient's written informed consent

Exclusion Criteria:

* Tumor emergencies;
* Abnormal coagulation function;
* Contagious diseases, such as HIV, HBV, HCV infection;
* Mental disorders;
* Concomitant tumors;
* Immunological co-morbidities