cyrilzakka/clinical-trials huggingface dataset:
To Compare the Pharmacokinetics and Safety After a Single Dose Administration of IN-G00002 and IN-R00002 in Healthy Adult Volunteers

To compare the pharmacokinetics and safety after a single dose administration of IN-G00002 and IN-R00002 in healthy adult volunteers

A randomized, open-label, single-dose, crossover study

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers aged ≥ 19 years at screening
* Body weight \> 60kg and Body mass index (BMI) in the range of 18.0 and 30.0 kg/㎡
* Subjects who do not have congenital or chronic diseases requiring treatment and have no pathological symptoms or findings as a result of physical examination
* Determined by the investigator to be eligible for study participation based on the results of screening tests (clinical laboratory tests, vital signs, physical examination, 12-lead ECG) conducted according to the IP characteristics
* Subjects who decided to participate in the study and signed informed consent form voluntarily after receiving detailed explanation of the study and fully understanding

Exclusion Criteria:

* Subjects who have taken the drug which can induce or inhibit drug metabolism enzyme within 4 weeks prior to the 1st IP administration
* Subjects who have participated in any other clinical study or bioequivalnece study within 6 months prior to the 1st IP administration
* Subjects who have donated whole blood within 8 weeks prior to the 1st IP administration or have donated blood components or received transfusion within 2 weeks prior to the 1st IP administration
* Pregnant(positive urine HCG) or breastfeeding women if female
* Subject who have continued drink of alcohol within 1 month prior to the 1st IP administration (female: \> 14 glasses per week, male \> 21 glasses per week)
* Subjects with a presence and a history of surgery or gastrointestinal diseases which might significantly change absorption of medicines
* Pregnant(positive urine HCG) or breastfeeding women if female
* Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* Subjects or spouses (or partners) are unable to use an effective method of contraception (e.g., correctly placed intrauterine device, sterilization surgery (vasectomy, tubal ligation, etc.), barrier method (spermicide and condom, a concomitant use of contraceptive diaphragm, vaginal sponge or cervical cap)), throughout the study
* Subjects who are judged ineligible for the clinical study by the investigator due to reasons other than the above inclusion/exclusion criteria.
Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula

The purpose of this study is to evaluate the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula

A Phase I clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Subjects with Crohn\&amp;#39;s disease or complex perianal fistula diagnosed at least 6 months earlier according to the Chinese Consensus Opinion on the Diagnosis and Treatment of Inflammatory Bowel Diseases (Beijing, 2018).Subjects with active perianal fistula and non active luminal CD defined by a CDAI ≤ 200.
3. For patients with perianal fistula, 1≤ the number of internal openings ≤2, and 1≤ the number of external openings ≤3, the fistula of the patient needs to be drained smoothly
4. All subjects and their partners were not planning to have a child from screening to the end of the trial and agreed to use effective non-drug contraception during the trial.
5. ECOG score 0\~1, ASA grade I\~II
6. Subjects failed to respond to adequate treatment with any of the conventional antibiotics, immunomodulatory drugs (including steroids), anti-tumor necrosis factor-α (TNF-α) monoclonal antibodies and other biological agents.

Exclusion Criteria:

1. Subjects with active infection evaluated by the investigator.
2. Subjects with Crohn\&amp;amp;amp;#39;s disease requiring immediate therapy.
3. Subjects with abscess or collections \&amp;amp;amp;gt;2 cm.
4. Subjects with rectal and/or anal stenosis and/or active proctitis.
5. Subjects who treated with systemic steroids in the 4 weeks prior to stem cells administration.
6. Subjects with abnormal laboratory results: liver function: total bilirubin \&amp;amp;amp;gt;=1.5 × ULN, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \&amp;amp;amp;gt;=2 × ULN; renal function: creatinine clearance below 60 mL/minute calculated using Cockcroft-Gault formula or by serum creatinine \&amp;amp;amp;gt;=1.5 × upper limit of normal (ULN).
7. Subjects with malignant tumors or a history of malignant tumors.
8. Subjects with severe, progressive, uncontrolled hepatic, hematological, gastrointestinal (except Crohn\&amp;amp;amp;#39;s disease), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases.
9. Serum virology test (HBeAg, HCV antibody, HIV antibody, Treponema pallidum antibody) positive.
10. Subjects allergic to Human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic drug
11. Subjects who has received stem cells therapy.
12. Subjects who has major surgery or severe trauma within 6 months prior to the screening period.
13. Subjects who has received any investigational drug within 3 months prior to the screening.
14. Subjects deemed inappropriate by the investigator to participate in this clinical trial.
15. The female participant who is pregnant, or is lactating.
16. Not suitable for PET/CT examination.
17. Participants considered inappropriate to participate in this clinical trial
A Retrospective Review of Rib Fracture Pain Management at a London Major Trauma Centre

Thoracic epidural analgesia (TEA) is widely considered to be the current gold standard treatment for rib fracture pain and is used in the Imperial invasive treatment pathway for rib fractures. However, TEA are often contraindicated due to other injuries or the use of anticoagulant medications, which also contraindicates other invasive nerve block techniques e.g. paravertebral catheters. A number of case reports have reported the safe use of alternative techniques such as Serratus Anterior Blocks (SAPB) and Erector Spinae Blocks (ESPB) and the anaesthesia community has taken them up widely based on this relatively limited evidence. In view of this, Womack et al recently published a large retrospective review examining the safety and efficacy of ultrasound guided paravertebral catheter analgesia techniques in rib fracture management along with small numbers of ESPBs. However, this data did not report the analgesic efficacy, patient reported pain relief or respiratory complications.The goal is to advance this body of evidence by reviewing our larger data set concerning the use of TEA and alternative regional techniques such as ESPB and SAPB. This comprehensive review will benefit patients by documenting the efficacy and safety of these techniques for clinicians managing rib fracture patients.

Primary Objective The primary objective is to examine whether novel fascial plane blocks, e.g. SAPB and ESPB, are effective pain relief modalities in patients with rib fractures - the proportion of patients with a reduction in pain.

Secondary Objectives

The investigators review the safety profile and complications of TEA and alternative analgesic techniques such as ESPB and SAPB used for rib fracture management in our trauma centre. In particular the effects of regional anaesthesia techniques on:

1. Opioid use
2. Nausea \& vomiting
3. Respiratory complications
4. Intubation \& non-invasive ventilation (NIV)
5. ICU admission for respiratory complications

The investigators will assess the duration of use and complication profile of regional anaesthetic techniques, including infection, analgesic failure and damage to other structures during insertion e.g. the lung.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \> 18 years of age presenting with traumatic rib fractures in a major trauma centre over the past 5 years
* Meet the criteria for the Imperial College Healthcare NHS Trust 'Invasive rib fracture management pathway'

Exclusion Criteria:

* Under 18 years old
* Prisoners
* Pregnant
* Private patients
* Meet the criteria for the Imperial College Healthcare NHS Trust 'Non-invasive rib fracture management pathway'
Medication Strategies for Treating Aggressive Behavior in Youth With Attention Deficit Hyperactivity Disorder

This study will assess whether adding a mood stabilizer, divalproex sodium, to stimulant treatment is more effective than stimulant treatment alone in reducing aggressive behavior among children with attention deficit hyperactivity disorder (ADHD).

ADHD is one of the most common childhood mental disorders. It often causes impaired functioning in multiple areas, including home, school, and peer relationships. Additionally, children with ADHD often develop aggressive behavior, which is not usually adequately suppressed by standard stimulant treatments for ADHD. In order to address this problem, many physicians prescribe multiple medications at once. There is no clinical evidence, however, proving that this method is safe and effective. This study will assess whether adding a mood stabilizer, divalproex sodium, to stimulant treatment is more effective than stimulant treatment alone in reducing aggressive behavior among children with ADHD.

Participants in this double blind study will first receive open label stimulant treatment for ADHD and a comorbid disruptive behavior disorder. Participants whose aggressive behavior subsides with stimulant treatment alone will not proceed into the next phase of the study. Participants whose ADHD symptoms lessen from the treatment but whose aggressive behavior persists will be randomly assigned to receive either divalproex sodium or placebo in addition to their stimulant treatment for 8 weeks. Study visits will be held weekly for 11 to 16 weeks. At these visits, aggression levels and medication side effects will be assessed. Families will also meet with the researchers to discuss the child's progress, and attend behavioral counseling with a therapist. Participants who did not continue into the second phase of the study will be asked to return to the study site for a follow-up visit 8 weeks following the end of the first phase.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ADHD
* Diagnosis of opposition defiant disorder or conduct disorder
* Score that exceeds the study threshhold on the standardized scale of aggressive behavior

Exclusion Criteria:

* Current psychosis
* Current major depression
* Current pervasive developmental disorder
* Current obsessive compulsive disorder
* Any other anxiety disorder as primary diagnosis
* Mental retardation
SGC Stimulation, Perioperative Vascular Reactivity, and Organ Injury in Cardiac Surgery

The goal of this mechanistic clinical trial is to learn about the effects of medications called soluble guanylyl cyclase stimulators on vascular function and markers of kidney and brain injury in patients having heart surgery. The main questions it aims to answer are:

1. Does soluble guanylyl cyclase stimulation improve blood vessel function compared to placebo?
2. Does soluble guanylyl cyclase stimulation decrease markers of kidney injury and brain injury compared to placebo?

Participants will be randomized to a soluble guanylyl cyclase stimulator called vericiguat or placebo, and researchers will compare vascular function and markers of brain and kidney injury to see if vericiguat improves vascular function and reduces markers of injury.

This will provide important information to determine the underlying reasons that patients have some kidney and brain function problems after having heart surgery.

Patients undergoing elective cardiac surgery will be randomized to the soluble guanylyl cyclase stimulator vericiguat versus placebo before surgery through the day of surgery and vascular function will be quantified using ultrasound and direct assessment of arterial relaxation ex-vivo. Markers of brain and kidney injury will be measured in plasma and urine.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Elective open-heart surgery, defined as surgery on the heart or aorta that requires sternotomy or thoracotomy

Exclusion Criteria:

1. Intolerance to vericiguat
2. Use of other soluble guanylyl cyclase stimulators or current use of phosphodiesterase-5 inhibitors
3. Pregnancy or breast feeding. Pregnancy will be excluded in women of child-bearing potential by a urine or serum beta hcg test
4. Renal replacement therapy within 30 days prior to screening
5. Estimated glomerular filtration rate \<15 ml/min per 1.73 m2 per Chronic Kidney Disease Epidemiology collaboration (CKD-EPI) equation at time of screening
6. Systolic blood pressure less than 120 mmHg at the time of screening
7. Prior kidney transplantation
8. History of significant liver dysfunction (defined as Child-Pugh class C)
9. Surgery scheduled to be performed with circulatory arrest
10. Surgery scheduled to correct a major congenital heart defect
11. Extracorporeal membrane oxygenation (ECMO) prior to surgery
12. Active systemic infection or surgery for infectious endocarditis
13. Ventricular assist device or intraaortic balloon pump support prior to surgery
14. Prisoners
The Effect of Analgesia Based Sedation Protocol on Brain Function of Critical Care Patients

Benzodiazepines is a commonly uesd sedative medication,there are many reports that Benzodiazepines is associated with delirium ,but using of analgesia reduces benzodiazepines requirements .The purpose of this study is to determine whether analgesia based sedation protocol reduces the incident of delirium.


Eligibility Criteria:
Inclusion Criteria:

* Signing a consent form
* postoperative patient
* Requirement for mechanical ventilation and anticipate time of mechanical ventilation more than 24 hours
* Requirement for sedation
* Age more than 18 and less than 85 years old

Exclusion Criteria:

* Unstable blood circulation
* Heart rate less than 50 beats per minute
* II ° ～ III ° atrioventricular conduct block
* Intracranial lesions 、neurosurgical intervention and mental disability inability to cooperate;
* Receipt of antipsychotics 、hypnotic drugs before surgery ;
* Alcohol abuse;
* Liver failure class Child-Pugh C;
* Acute Respiratory Distress Syndrome;
* Acute or chronic renal failure;
* Other severe diseases ,septic shock;
* Receipt of neuromuscular blocking drug;
* Pregnancy and nursing woman;
* Allergy to investigational drug or other contraindication.
OmegAD (Omega-3 and Alzheimer's Disease)

Memory loss and difficulties with thinking associated with Alzheimer's disease (AD) may be due to a deficiency in the brain of a fatty acid named DHA. The aim of this trial is to see if dietary supplementation with a preparation, rich in DHA, will halt cognitive impairment in AD patients


Eligibility Criteria:
Inclusion Criteria: Alzheimer's disease with MMSE 15-30, living in own homes, treated with stable dose of acetylcholine esterase inhibitor for \>3 months and remaining on that treatment for the study period

Exclusion Criteria: Already treated with omega-3 fatty acids, NSAIDs, warfarin, being an alcohol abuser, suffering from serious concomitant disease or not having a caregiver
Safety Study of TRK-820 for Patient With Hemodialysis

The purpose of this study is to observe pharmacokinetics and safety of nalfurafine hydrochloride in patients receiving hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic renal failure who receive dialysis three times a week on a regular basis and do not expect an important change in treatment nor a rapid change in conditions
* Patients aged 20 years or older
* Patients whose post-dialysis BMI measured at the nearest time before the singing day is in the range of 70 \~ 130 %
* Patients who can understand and follow instructions and participate in the study during the entire study period
* Patients who signed the informed consent form before participating in the study

Exclusion Criteria:

* Patients who have confirmed malignant tumor
* Patients with cognitive impairment including depression, schizophrenia and dementia
* Patients with hepatic cirrhosis as a complication
* Patients with drug allergy to opioids
* Patients with drug dependency or allergic disease (including skin response to UV radiation)
* Patients who participated in other study and received the investigational drug within 1 month before the signing day
* Patients who participated in other TRK-820 study within 4 weeks before the signing day
* Pregnant or lactating women or premenopausal women of childbearing potential who do not conduct contraception
* Patients who received any of the following drugs within 2 weeks before Day 1

  1. Azole antifungal agents

     1. Ketoconazole
     2. Fluconazole
     3. Itraconazole
     4. Clotrimazole
  2. Macrolide antibiotics

     1. Erythromycin
     2. Midecamycin
     3. Josamycin
     4. Roxithromycin
     5. Clarithromycin
     6. Triacetyloleandomycin
  3. Ritonavir
  4. Cyclosporine
  5. Nifedipine
  6. Cimetidine
  7. Amiodarone
* Patients who had the following drinks and foods within 2 weeks before Day 1

  1. Foods and drinks containing grape fruit juice
  2. Food and drinks containing St. John's wort
* Patients who participated in other clinical study during the period between the singing day and hospitalization (Day 1)
* Patients who smoked and drank from three months before the signing day
* Patients who are ineligible for the clinical study for other reasons at the investigator's discretion
Prediction Value of PANX1 in Infection Post Liver Transplantation

The purpose of this study is to determine prediction value of PANX1 expression in infection post liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* patients underwent liver transplantation.

Exclusion Criteria:

* re-transplantation
* multiorgan transplantation
* living donors or split-liver donors liver transplantation
Tackling Dry Socket Via Laser Therapy in Smokers

This study examines the efficiency of diode laser therapy to manage dry sockets after tooth extraction.

The study compares the efficiency of diode laser therapy and using only alveogyl to accelerate the healing of dry sockets after tooth extraction in smokers. Smoker patients with dry sockets were enrolled randomly into two different groups. Group 1 received dual wavelength laser diode therapy, three times per week. While group 2 received only a topical application of alveogl. The treatment lasted for two consecutive weeks. The treatment efficiency was evaluated by measuring the volume of the socket using the syringe method. The pain level was measured by the visual analog scale.

Eligibility Criteria:
Inclusion Criteria:

* Smokers patient

Exclusion Criteria:

* Females on contraceptives.
* Diabetic patients
* Hepatitis C virus patients
* Patients on corticosteroids
* Patients with renal diseases
* Anemic patients
Study of Coronary Calcium Score as a Marker of Post-radiation Vascular Dysplasia in Adults Treated During Childhood for Cancer With Mediastinal Irradiation

To measure coronary calcium score in adults treated during childhood or adolescence for irradiation cancer in the heart and / or anthracycline area and compare them to determine whether irradiation of the heart area is associated with increased calcium score after adjustment for other cardiovascular risk factors (age, sex, smoking, dyslipidemia, obesity, diabetes, high blood pressure and renal failure).


Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years of age or older,
2. Treated for cancer during childhood, adolescence or young adulthood (≤25 years),
3. Treated with irradiation of the heart area (≥20% of ≥5Gy heart rate) and / or anthracycline (cumulative dose of doxorubicin equivalent ≥300mg/m\^²),
4. In complete remission of their pediatric cancer for at least 10 years,
5. Patient affiliated to a social security scheme or beneficiary of such a scheme,
6. Patient Information and Signed Informed Consent.

Exclusion Criteria:

1. Perspective less than 10 years,
2. Persons deprived of liberty or guardianship (including trusteeship),
3. Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons,
4. Pregnant women.

Inclusion criteria for extension cohort:

1. Patients 30 years of age or older,
2. Treated for cancer during childhood, adolescence or young adulthood (≤25 years),
3. Treated with irradiation of the heart area (≥20% of ≥5Gy heart rate),
4. In complete remission of their pediatric cancer for at least 10 years,
5. Patient affiliated to a social security scheme or beneficiary of such a scheme,
6. Patient Information and Signed Informed Consent.

Exclusion criteria for extension cohort:

1. Persons deprived of liberty or guardianship (including trusteeship),
2. Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons,
3. Pregnant women.
Diet Composition - Metabolic Regulation and Long-term Compliance

This study will compare a high-protein/low-carbohydrate diet (modified paleolithic diet, MPD) with a diet high in slow carbohydrates (Nordic Nutrition Recommendations, NNR). The diets will be compared with respect effects on weight reduction, metabolic regulation, and long-term compliance to the diet regimes. Seventy-two postmenopausal overweight healthy women have been recruited and will be followed for two years.

The following variables will be studied:

* Anthropometry
* DEXA
* OGTT
* Liver fat content measured with 1H-MRS
* Hepatic 11β-HSD1 activity, measured with cortisone/cortisol conversion test


Eligibility Criteria:
Inclusion Criteria:

* Female
* Postmenopausal
* BMI\>28

Exclusion Criteria:

* Disease
* Gravidity
* Smoking
* Prescribed medication
2 Regimens of Lactulose for Colonoscopy Preparation in Adults

The purpose of the study is to determine the efficacy of 2 regimens of lactulose as a preparation for colonoscopy.

A full-dose regimen of lactulose for oral solution, where all dosing is completed the evening prior to the colonoscopy procedure, will be studied and compared to a split-dose regimen, where three doses are taken on the prior evening, and one dose is taken the morning of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring bowel evacuation for colonoscopy.

Exclusion Criteria:

* Patients with galactosemia (galactose-sensitive diet).
* Patients known to be hypersensitive to any of the components of lactulose for oral solution.
* Patients with an abnormality on screening blood work or vital sign assessments that, in the Investigator's judgment, may pose a significant risk including those pertaining to dehydration or electrolyte shifts.
* Patients with a history of impaired renal function.
* Patients with current or recent history of hypotension, as defined by the Investigator.
* Patients with a history of long Q-T syndrome.
* Patients with a history of a failed bowel preparation.
* Patients with severe constipation, defined as those patients taking daily prescription or over-the-counter laxatives.
* Patients with possible bowel obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, ileus or previous colonic surgery.
* Patients on lactulose therapy or receiving any treatment for chronic constipation.
* Be pregnant or nursing.
* Patients with known large polyps or flat polyps (i.e. polyps requiring electrocautery or argon plasma coagulation).
* Patients less than 18 years of age.
* Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]) and agree to abide by the study restrictions.
* Be otherwise unsuitable for the study, in the opinion of the Investigator.