cyrilzakka/clinical-trials huggingface dataset:
Outcomes of Liver Transplantation in Low Weight Children After Reducing the Lateral Segment of a Living Donor, Adapting the Shape and Size of the Graft to the Needs of the Recipient

The shortage of organs has always been a problem in pediatric liver transplants due to the lack of donors with an adequate size. Different techniques of hepatic reduction have been described that allow to use larger organs in the pediatric population. However, in these techniques the maximum reduction achieved by segments 2 and 3 is excessive for low-weight children. Since 1997 the liver transplantation group at Hospital Italiano de Buenos Aires has developed and practiced a technique called hepatic hyper-reduction, which consists in reducing the lateral segment of a living donor, adapting the shape and size of the graft to the needs of the recipient. The investigators have performed approximately 50 pediatric liver transplants with live donors in low weight children in whom the hyper-reduction technique has been applied. The aim of the present study is to describe postoperative morbidity and mortality and analyze overall and graft survival.


Eligibility Criteria:
Inclusion Criteria:

* \< or = 17 years old.
* Having undergone live donor liver transplantation.
* Having received hyper-reduced liver grafts
* At the Liver Transplantation Unit of the Hospital Italiano de Buenos Aires
* Between June 1997 and April 2018

Exclusion Criteria:

* \> 17 years old.
* Cadaveric liver transplant
* Whole liver grafts.
Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis

Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis

Data collection including medical history, operative procedure data, and follow-up data every six months while using the HeRO Graft for dialysis, including:

* Post-operative complications for HeRO Graft implantation
* Length of time between insertion and use of HeRO Graft
* Incidence of thrombosis
* Hospitalizations
* Incidence of infections and other adverse event occurrence
* Mortality
* Hemoglobin
* Kt/V
* pre-dialysis blood pressure
* post-dialysis blood pressure
* blood flow rate and
* dialysis flow rate

Eligibility Criteria:
Inclusion Criteria:

* All patients eligible for HeRO Graft for dialysis access
* Age greater than 18 years old
* Able to give informed consent

Exclusion Criteria:

* Subjects with any kind of disorder that compromises the ability of the subject to give informed consent and/or to comply with the study procedures;
* Any medical condition that in the opinion of the investigator may pose a safety risk to a subject in the study or which may interfere with study participation.
SB-681323 In Subjects With Rheumatoid Arthritis

The purpose of this research is to find out how effective and safe SB-681323 will be in the treatment of RA when it is added to standard anti-rheumatic treatments.


Eligibility Criteria:
Inclusion Criteria:

* Females cannot be pregnant or lactating.
* Must use defined contraceptive methods if of child-bearing potential.
* BMI range: 18.5-35.0 kg/m2.
* Diagnosis of RA (rheumatoid arthritis) according to revised 1987 American College of Rheumatology (ACR) criteria.
* If other RA-medication is used: Disease-Modifying Anti-Rheumatic Drug (DMARDS) must be stable for at least 8 weeks before first trial visit.
* If other oral anti-RA therapies are used, these must have been stable at least 4 weeks before first trial visit.
* If Methotrexate medication is used as RA-therapy, Folate supplement must be taken with stable red cell folate levels.
* Must give informed consent.
* Must abstain from alcohol during the trial participation.

Exclusion Criteria:

* Non-responder on biological RA treatment.
* Has a positive alcohol screen.
* Any history of liver disease.
* Positive Hepatitis B surface antigen or Hepatitis C antibody result within 3 months of screening.
* Have any significant disease that places the subject at unacceptable risk as a participant in this trial.
* Acute infection.
* History of active tuberculosis.
* History of repeated or chronic infection.
* History of malignancy.
* History of HIV or other immunosuppressive diseases.
* Participated in a clinical trial within the last 3 months for non-biological therapies and 6 months for biological therapies.
* Uncontrolled diabetes or psoriasis.
Measurement of Ocular Tensional Fluctuation by Triggerfish Lens Before and After Cataract Surgery in Patients With Exfoliative Glaucoma

Glaucoma is a very frequent disease in Brittany. In glaucoma the retinal ganglion cells and their axons slowly die with visible changes at the optic nerve head (cupping). Without early diagnosis and effective treatment or with delayed treatment decrease of visual acuity or blindness become.

In secondary pseudoexfoliation glaucoma grayish-white deposits of abnormal proteins are found on all surfaces of eye irrigated by the aqueous humor. The deposits of PEX material inside the trabecular meshwork decrease aqueous humour outflow and the intraocular pression raise. The exfoliation material is found on the surface of the lens capsule with frequent developement of nuclear cataract . After cataract surgery the intra ocular pressure (IOP) decrease.

Some recent study have found decreasing ocular volume variation associated to IOP fluctuation in night after cataract surgery in normal pressure glaucoma patients. In our study we want see if it's the same thing in pseudoexfoliation glaucoma patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult
* Exfoliative glaucoma
* Patient who need cataract surgery
* Patient agree with study

Exclusion Criteria:

* Monophtalm patient
* Patient with bleb after glaucoma surgery
* Terminal glaucoma
* Herpes
* One year control impossible
Transcranial Magnetic Stimulation in Children With Stroke

This is a pilot study of repetitive transcranial magnetic stimulation (rTMS) to test tolerance and efficacy in children who have hemiparesis from acquired or presumed perinatal stroke.

The investigators will begin to test the hypothesis that rTMS will be tolerated and will result in improved hand strength and mobility when compared with sham stimulation.

Aim 1: To determine whether 1 Hz rTMS applied to the hemisphere opposite the infarct (contralesional or healthy hemisphere) is tolerated by children ages 6-18 years who have chronic motor sequelae from a stroke.

Aim 2: To determine whether 8 sessions of inhibitory 1 Hz rTMS to the contralesional healthy hemisphere improves grip strength and hand mobility when compared with sham stimulation in controls.

Eligibility Criteria:
Inclusion Criteria:

1. A history of ischemic or hemorrhagic stroke at least 6 months prior to recruitment, and causing current unilateral motor impairment of hand function (scoring 1-3 on a modified Ashworth scale; scale explained in Appendix).
2. Cerebral infarction spares the transcallosal pathways.
3. Cerebral injury confirmed by brain MRI or CT
4. Ages 6-18 years inclusive.

Exclusion Criteria:

1. The presence of an implanted device such as a pacemaker, vagal nerve stimulator, or recently implanted cardiovascular stent; arterial aneurysms; arteriovenous malformations; obstructive hydrocephalus.
2. Infarction of the cortical motor areas.
3. Presence of a brain tumor or suspected neurodegenerative disease.
4. Intractable epilepsy or a history of poorly controlled epilepsy.
5. Current use of medications that may lower seizure threshold (such as specific antipsychotics, specific antidepressants, amphetamines)
6. Hand function limited to rigid flexion or extension (score = 4 on the modified Ashworth scale)
7. Disorders causing hallucinations, delusions, or excessive anxiety or depression.
8. Pre-existing chronic pain syndromes including intractable headache and chronic daily headache.
9. Pregnancy.
10. Any sensorimotor or cognitive impairment that prevents valid responses on study measures.
11. Bilateral strokes (cerebral injuries) involving motor cortex and/or corpus callosum
12. All patients and parents must be naïve regarding the effects and sensations of rTMS (i.e., patients and/or parents with prior exposure to TMS will be excluded).
13. Subject has had a recent neurosurgical procedure involving the brain.
14. Subject suffered traumatic brain injury that places the subject at risk of seizures.
A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)

This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered with pravastatin in patients with low or relatively low HDL-C levels. Patients will be randomised to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or placebo po daily, for 12 weeks.All patients will also receive pravastatin 40mg po daily for 12 weeks.The anticipated time on study treatment is 3 months and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients 18-75 years of age;
* dyslipidemic patients with low or relatively low HDL-C levels during treatment with pravastatin.

Exclusion Criteria:

* women who are pregnant, breastfeeding, or of child-bearing potential;
* morbid obesity;
* uncontrolled hypertension;
* poorly controlled or insulin-treated diabetes;
* high creatinine levels or history of statin-associated myopathy.
Out-of-Hospital Randomized Comparison of Video-assisted Endotracheal Intubation

This research project examines the effectiveness of different video laryngoscopes in a out-of-hospital emergency intubation. Since in preclinical airway management severe incidents with esophageal failures of intubation may partly happen or rather endotracheal Intubation may completely fail, it is of great importance to evaluate alternative ways of endotracheal intubation in out-of-hospital emergency medicine. Video laryngoscopy has been proven in everyday clinical practice and may clinically be superior in most situations when compared to endotracheal Intubation using a conventional laryngoscope. No data exist, if different video laryngoscope types perform differently in the out-of-hospital setting. The investigators hypothesize that there would be no difference with regard to intubation time, intubation success, and intubation morbidity between different models of video laryngoscopes.


Eligibility Criteria:
Inclusion Criteria:

- All adult emergency patients, age 18 years and older for whom a preclinical emergency intubation is necessary

Exclusion Criteria:

* Age under 18 years
* Laryngoscopy according to the algorithm of airway management not being indicated
Neurocognitive Follow-Up (FU) Study

This is a follow-up study of a recently completed trial (17.14.INF) evaluating the growth of pre-term infants. Enrolled children will undergo neurocognitive assessments at 18- and 24-months of corrected age (CA).

This is a follow-up study of a recently completed multi-center, prospective, single-arm, open-label interventional trial (17.14.INF - Alprem RTF: NCT03728764) evaluating the growth of pre-term infants receiving a two-stage PTF feeding system while in the neonatal care unit and continuing until 30 days post-discharge.

Enrolled children will undergo neurocognitive assessments at 18- and 24-months of corrected age (CA). The timing of the cognitive assessments aligns with routine check-up visits and reflect the period at which developmental delays may first become evident.

Eligibility Criteria:
Inclusion Criteria:

1. Infants / children born prematurely who were enrolled into the original clinical trial and who are less than 24 m of CA.
2. Having obtained his / her parents' (or his or her legally accepted guardian written informed consent and having evidence of personally signed and dated informed consent document indicating that the child's parent(s) / legal guardian has been informed of all pertinent aspects of the study.

Exclusion Criteria:

1. Infants identified retrospectively as not meeting the inclusion or exclusion criteria for the original study.
Phase 2 Study on Use of a Combination of Pemetrexed in Patients With Advanced Gastric Carcinoma

Pemetrexed has shown an anti-tumor activity in advanced gastric cancer patients in a previous study, while cisplatin is widely used in the combination chemotherapy of gastric cancer. Pemetrexed has shown synergy with cisplatin in preclinical models and in various human cancers. The introduction of vitamin supplementation has made treatment with pemetrexed plus cisplatin safe and well tolerated. The present phase 2 study is an effort to determine the efficacy and safety of the combination of pemetrexed and cisplatin in Korean patients with gastric carcinoma who had no prior palliative chemotherapy for advanced disease. The patients, who will give their consent for participating in this study, will be screened for their eligibility and on meeting pre-defined study eligibility criteria, they will receive an intravenous therapy of the combination of pemetrexed and cisplatin for number of times that in the opinion of their treating physician is appropriate for them. A response rate of 30% is considered as the minimum activity level of interest for this patient population.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of adenocarcinoma of the stomach
* Stage IV disease not amenable to curative surgery.
* Disease status must be that of measurable disease as defined by RECIST criteria
* Performance Status of 0 or 1 on the ECOG Scale and adequate organ function.
* Signed informed consent from patient

Exclusion Criteria:

* Prior palliative chemotherapy for advanced disease.
* Known or suspected brain metastasis or Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
* Concurrent administration of any other tumor therapy
* Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of ALIMTA plus cisplatin.
* Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone.
Efficacy and Safety of Nicotine-Qbeta Vaccine in Smokers

The purpose of this study is to help smokers quitting by vaccinating them with CYT002-NicQb. Upon vaccination, the smoker will generate antibodies directed against free nicotine. The antibodies will bind nicotine and prevent its passage into the brain. The successfully vaccinated smoker will have no reward effect after smoking, thus braking the vicious circle of nicotine addiction.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age 18 to 70 years
* Smokers: \> 10 and ≤ 40 cigarettes per day and smoking history of more than 3 years
* Fageström Test for Nicotine Dependence (FTND) score ≥ 5
* Female participant must meet one of the following criteria: a) no reproductive potential due to menopause, hysterectomy, bilateral oophorectomy, or tubal ligation; b) agrees to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 12 additional months after the last immunization

Exclusion Criteria:

* Pregnant or nursing
* History of severe allergy or immunological disorders
* Blood donation within previous 30 days
* Surgery within previous 30 days
* Use of investigational drugs within previous 60 days
* Significant cardiovascular disease:

  * angina pectoris
  * congestive heart failure
  * clinically significant murmurs
  * previous angioplasty or coronary artery bypass surgery
* Active infectious disease:

  * WBC \> 12 000 cells/µL
  * Seropositivity for Hepatitis B and C
  * History of risk behavior to acquire HIV
* Significant hepatic disease
* Significant renal disease
* Significant hematological disorder
* Significant pulmonary disease
* History of malignancy
* Autoimmune disease
* Organic neurological disorder or significant psychiatric disorder
* Use of psychoactive drug within one month before enrolment
* Abuse of drugs or alcohol
* Subjects using any concomitant medications due to chronic illness which bears a high risk of fluctuation in disease activity or exacerbations during a 12-months period such as coronary heart disease, asthma, severe COPD, chronic rheumatoid disease, diabetes, etc. should be excluded.
* Obesity: BMI \> 35 kg/m2
* Use of concomitant nicotine replacement treatment (NRT) at screening or visit 1
* Any planned surgical intervention during the study period
A Trial to Assess the Efficacy and Safety of Morinidazole in Patients With Appendicitis

To assess the efficacy, safety, tissue distribution of target organ and Population Pharmacokinetic (PPK) of morinidazole and sodium chloride injection with surgery in patients with suppurative or gangrenous appendicitis

Acute appendicitis is among the most common cause of acute abdominal pain. In patients with complicated acute appendicitis, postoperative, broad-spectrum antibiotics are always recommended. Metronidazole, a member of the nitroimidazole drug class, is included in the regimens recommended for improving anaerobic bacteria coverage. The sideeffects of metronidazole include a metallic taste, nausea, transient neutropenia, and peripheral neuropathy. Antimicrobial resistance to metronidazole has emerged after several decades of worldwide use of the drug. Morinidazole, a National Class I Antimicrobial, is a new type of third-generation nitroimidazole antimicrobial that is used for treating amoebiasis, trichomoniasis, and anaerobic bacterial infections, and which exhibits greater activity and less toxicity than metronidazole.

Morinidazole and Sodium Chloride Injection used in pelvic inflammatory disease or appendicitis cases had been approved by CFDA in 2014. This phase 4 study is to assess the efficacy, safety, tissue distribution of target organ and Population Pharmacokinetic (PPK) of morinidazole in patients with suppurative or gangrenous appendicitis.

Eligibility Criteria:
Inclusion Criteria:

* 18 and 65 years old
* A diagnosis of suppurative or gangrenous appendicitis based on:

  1. metastatic right lower abdominal pain
  2. lower abdominal tenderness and/or rebound tenderness
  3. pyrexia (axillary temperature ≥ 37.5 °C), a WBC \> 10\*109/L on routine blood examination
  4. Voluntary signing of written informed consent

Exclusion Criteria:

* patients with an allergy to nitroimidazole
* patients with a history of antibiotic therapy within the last 48 hours
* patients with any condition likely to require broad spectrum antibiotics
* patients who can not evaluate the efficacy or difficult to complete the desired course of treatment
* ALT and / or AST ≥ 1.5 times the ULN, and / or serum creatinine ≥ the ULN
* patients with severe systemic diseases likely to affect therapy (e.g., cardiovascular abnormalities, unstable angina, high blood pressure, severe neuropathy, or epilepsy)
* patients with other diseases or use other drugs which may interfere with the efficacy or safety of the drug
* patients who participated other clinical trials within 6 months before the start of the trial
* Pregnant women, breastfeeding women, women of childbearing age without effective contraceptive
Concomitant Therapy of H. Pylori

If we compare eradication rate of Helicobacter pylori divided to 4 groups: amoxicillin, rabeprazole, clarithromycin(AOC), amoxicillin, rabeprazole, metronidazole(AOM), treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days(sequential), amoxicillin, clarithromycin, metronidazole, rabeprazole(concomitant), then the eradication rate of concomitant group will be the highest.

* Subject: The patient of gastritis, gastric ulcer, and duodenal ulcer infected with Helicobacter pylori
* 170 subjects per group
* Eradication regimens are as follows: AOC group, treated with amoxicillin, rabeprazole, clarithromycin for 7 days; AOM group, treated with amoxicillin, rabeprazole, metronidazole for 7 days; sequential group, treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days; concomitant group, treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days

Eligibility Criteria:
Inclusion Criteria:

* patients infected with Helicobacter pylori

Exclusion Criteria:

* cancer
* pregnancy
* formerly treated with eradication
Topical Capsaicin for Cyclical Vomiting

This is a phase 2 randomized controlled trial testing the effect of topical capsaicin for the relieve of nausea and vomiting.


Eligibility Criteria:
Inclusion Criteria:

* suspected cyclical vomiting syndrome / cannabinoid hyperemesis
* active severe nausea or vomiting in the emergency department

Exclusion Criteria:

* pregnant women, children \< 18 years, no prior history of similar symptoms, suspected surgical or infectious cause of symptoms, suspected hepatitis or pancreatitis, allergy to capsaicin or hot peppers, chronic use of prescription antiemetic in prior 24 hours, abdominal pain alone (without nausea or vomiting)
A Study to Evaluate the Pharmacokinetics and Safety of BR3409 and Co-administration of BR3409-1 and BR3409-2 in Healthy Volunteers Under Fasting Conditions

The purpose of this clinical study is to evaluate the pharmacokinetics and safety of BR3409 and co-administration of BR3409-1 and BR3409-2 in healthy volunteers Under Fasting Conditions


Eligibility Criteria:
Inclusion Criteria:

* Those have body mass index (BMI: weight(kg)/the square of {height(m)}) within the range of 18.0 to 30.0 at screening visit.

  * For men, Those who weigh 55 kg or more
  * For women, Those who weigh 50 kg or more
* Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.
* Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\*(Except for hormone drugs) from the date of consent to 56 days after the last administration and disagree to provide their sperm or ovum.

  * Methods of contraception accepted in clinical trial: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.

Exclusion Criteria:

* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days before the first administration date or have taken drugs concerned about affecting this clinical trial within 10 days before the first administration date. (However, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)
* Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months before the first day of administration. (However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
* Those who have a medical history of gastrointestinal resection or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
* In the case of a female subject, those suspected pregnancy or pregnant woman, lactating woman.