cyrilzakka/clinical-trials huggingface dataset:
A Study of Aflibercept in Combination With FOLFIRI in Patients With Second-Line Metastatic Colorectal Cancer in Japan

Primary Objective:

To assess efficacy aflibercept + 5-fluorouracil (5-FU)/levofolinate/irinotecan (FOLFIRI) by objective response rate (ORR).

Secondary Objective:

To assess the following:

* safety profile;
* progression free survival (PFS);
* overall survival (OS);
* pharmacokinetics (PK);
* immunogenicity.

Screening was up to 24 days. Treatment period was continued until DP, unacceptable toxicity, or participant's refusal. Follow up period was continued until death, participant's refusal, or end of study, whichever came first.

This trial was conducted in Japan, where the International Nonproprietary Name (INN) designation for the study molecule is "aflibercept" and this term is therefore used throughout the synopsis. In the US, the US proper name is "ziv-aflibercept".

Eligibility Criteria:
Inclusion criteria:

* Histologically or cytologically proven adenocarcinoma of the colon or rectum.
* Metastatic disease that was not amenable to potentially curative treatment.
* Participants with measurable disease.
* One prior chemotherapeutic regimen (containing oxaliplatin) for metastatic disease.
* Participants who relapsed within 6 months of completion of oxaliplatin-based adjuvant chemotherapy were also eligible.

Exclusion criteria:

* Prior therapy with irinotecan.
* Less than 28 days elapsed from prior radiotherapy, prior surgery, or prior chemotherapy to the time of registration.
* Unresolved toxicity (grade \>1) from prior anticancer therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status \>1.
* Brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis.
* Other prior malignancy.
* Pregnant or breast-feeding women.
* Uncontrolled hypertension.
* Inadequate bone marrow function, liver function, or renal function.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Effect of Recombinant Human Interferon α-2b Spray on Herpangina

This is a multicenter, open，randomized controlled trial aiming to evaluate the effectiveness of recombinant human interferon α-2b spray compared with ribavirin treatment on pediatric patients with herpangina.


Eligibility Criteria:
Inclusion Criteria:

Subjects should meet all of the following:

1. meet the diagnostic criteria for pediatric herpangina;
2. ages 1-7 years, no limitation for gender;
3. within 72 hours of onset;
4. the main organs (heart, liver, kidney and lung) function normally;
5. follow up according to requirements and be hospitalized for observation;
6. the guardian is fully informed and signed informed consent.

Exclusion Criteria:

Subjects should be excluded if meet any of the following:

1. have allergy history of interferon;
2. heart failure, respiratory insufficiency,liver and kidney dysfunction or severe malnutrition and other serious disease, or immunodeficient;
3. children with epilepsy or other neurological disorders;
4. other pathogens exist at the same time;
5. the researchers believe that it is not appropriate to participate in this study.
Ability of a Molecule (Prima) to Restore Physiological Differentiation in Epithelium Expressing Gene p63

Ectodermal dysplasia associated with p63 is a rare disease which, in addition to limbic abnormalities, primarily affects the skin and cornea. The most common forms are called Ectrodactyly, Ectodermal dysplasia, palate Key for cleft lip and palate (EEC) and Ankyloblepharon, Ectodermal dysplasia, cleft lip and palate (AEC). Apart from symptomatic treatment, no cure is available. To understand the molecular defects associated with this disease and to identify therapeutic tools, a research team modelized the disease by reprograming EEC and AEC patient fibroblasts in pluripotent stem cells (iPSC), then induced iPSC differentiation in patients and controls epidermal (skin) and limbic (cornea) cells and demonstrated that the mutated cells can reproduce in vitro the abnormalities observed in patients.

P63 gene belongs to the family of p53 gene. The functions of the two proteins are very similar. Data suggest that molecule Prima could reactivate the p63 protein mutated in patients and thus alleviate skin defect healing and limbic regeneration.


Eligibility Criteria:
Inclusion Criteria:

* Patient with genetic pathology of the ocular surface
* Age ≥ 7 years

Exclusion Criteria:

* Agonal glaucoma
* low vision mostly related to retinal pathology
* Pregnant or breast-feeding patient
Cognitive Behavioural Therapy (CBT) and Recreational Activity for Autism Spectrum Disorders (ASD)

The purpose of this study is to determine if adults with autism spectrum disorder and with normal intelligence improve from 36 sessions (1 calendar year) of group treatment with Cognitive Behavioural Therapy or recreational activity in groups with 6-8 participants.

The purpose of this study was to compare two group interventions for psychiatric patients with Autism spectrum disorder and normal intelligence: Cognitive Behavioural Therapy developed to suit adults with Autism spectrum disorder, and recreational activity, enabling social interaction. The recreational activity intervention served as a low-impact option, easily organised within the community. It is not a placebo; rather it controls for the positive effects that come out of a structured social environment and group setting. The investigators hypothesized that both interventions would lead to improvement in quality of life, well-being and relief in psychiatric symptoms, with a greater effect in the Cognitive Behavioural Therapy intervention compared to recreational activity. A cumulative follow-up was made, within 5 1/2 years after the start of the treatments. Additional questions adapted to the patient group were added at this 5 1/2 year time point.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of autism spectrum disorders
* Normal intelligence as assumed by mainstream schooling
* Acceptance of a group setting
* Being able to transport themselves to the clinic (with or without support)

Exclusion Criteria:

* Current substance abuse
* Current psychosis
Peer Comparison Feedback on Opioid Prescribing

We aim to determine if descriptive normative feedback of peer prescribing reduces opioid analgesic prescribing by emergency medicine providers

State-based Prescription Drug Monitoring Programs (PDMPs) are being implemented to reduce prescription drug abuse and diversion. On August 24, 2016, Pennsylvania initiated its mandated PDMP. In prior research, we found that ED providers reduced opioid prescribing by 17% immediately after PDMP went live. Still, there is variability between providers in the frequency of opioid prescribing even after PDMP initiation. Changing clinician prescribing behavior is difficult, but recent research has shown that using peer comparisons can assist behavior change (Meeker D et al., JAMA, 2016). In this study, we will randomize a convenience sample of ED providers to receive either their opioid prescribing history data with peer comparative data or without peer comparative data. We will examine the effect on immediate perceived norms as well as impact on opioid prescribing in the subsequent 3 months. Results could inform behavioral feedback to alter clinician prescribing behaviors

Eligibility Criteria:
Inclusion Criteria:

* Emergency medicine provider
* Writes 10 or more opioid prescriptions per month (on average)

Exclusion Criteria:

* none
A Study of LY2181308 Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia

The purpose of this study is to understand the safety profile of LY2181308 sodium administered in combination with idarubicin and cytarabine to patients with relapsed or refractory acute myeloid leukemia (AML).


Eligibility Criteria:
Inclusion Criteria:

* Patients who have a diagnosis of acute myeloid leukemia that is relapsed or refractory to at least 1 prior treatment for leukemia, or patients with chronic myeloid leukemia (CML) who are in myeloid blast crisis which have failed at least 1 previous tyrosine kinase inhibitor (TK1). A baseline bone marrow assessment is required less than or equal to 96 hours prior to the first dose of study drug.
* Must have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, cancer related hormone therapy, or other investigational therapy for at least 21 days for myelosuppressive agents (such as cytarabine, daunorubicin, and gemtuzumab ozogamicin) or 14 days for non-myelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (such as neurotoxicity, diarrhea, and mucositis) except for residual myelosuppression and alopecia. Hydroxyurea is permitted to control the peripheral blast cell count, but must be stopped at least 24 hours before study drug administration.
* Must have adequate organ function.
* Females must have a negative pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.
* Patients must be at least 18 years old.

Exclusion Criteria:

* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a non-myelosuppressive or myelosuppressive agent, respectively.
* Patients with acute promyelocytic leukemia (APML).
* Major surgery within 4 weeks of study enrollment.
* Patients with serious pre-existing medical conditions (at the discretion of the investigator). Because of the known cardiac toxicity of anthracyclines, patients with pre-existing ejection fraction (EF) less than or equal to 45% should not participate in this study. No patient should exceed the maximum exposure of anthracycline doses (for example, idarubicin greater than 120 mg/m²).
* Patients with a second malignancy that could affect the interpretation of the results.
* Patients with leukemic involvement of the central nervous system (CNS) by spinal fluid cytology or imaging.
* Patients with known coagulopathy or bleeding disorder, other than leukemia related thrombocytopenia. Patients with severe of life threatening bleeding refractory to platelet transfusions are also excluded.
* Concomitant anticoagulant therapy (with the exception of heparinized saline to maintain the patency of central venous catheters).
* Women who are pregnant or breast feeding.
* Patients with a known hypersensitivity to oligonucleotides, idarubicin, and/or cytarabine.
Retinal Neurodegenerative Signs in Alzheimer's Diseases

A few studies suggest that patients suffering from neurodegenerative diseases (such a multiple sclerosis or Alzheimer's disease (AD)) show decreased thickness of the retinal nerve fiber layer (RNFL), indicating axonal degeneration. High-definition spectral domain optical coherence tomography (SD-OCT), performed without radiation in a few seconds per eye, offers a precise and standardized estimation of this parameter, which could constitute a biomarker for cerebral axonal degeneration. These RNFL deficits might even be the earliest sign of AD, prior to damage of the hippocampal region that impacts memory.

Besides, some associations of AD with some degenerative diseases of the eye (glaucoma, microvascular abnormalities, age-related macular degeneration (AMD)) have also been reported.

It therefore seems interesting to determine whether RNFL thickness, and other ocular parameters, may give some indications for a better detection of AD and cognitive decline in the elderly.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for AD cases:
* Diagnosis of probable AD, defined according to the NINCDS-ARDRA criteria51
* Light to moderate severity of the disease, defined by a MMSE score \>10 (global evaluation of cognition)
* Patient aged 50 years or more
* Patient benefiting from social insurance

Inclusion criteria for controls:

* Absence of suspicion of dementia, based on normal performance according to age and educational level at neuropsychological testing defined as:
* Free recall ≥17 and total recall ≥40 for the Free and Cued Selective Reminding Test (Grober and Buschke test 52) MMSE ≥ norm for age and educational level (defined by mean - 1 SD)
* Isaac's set test ≥ norm for age and educational level (defined by mean - 1 SD)
* Matched to age and gender of the cases
* Patient benefiting from social insurance

Exclusion Criteria:

Exclusion criteria for all patients :

* History of Parkinson's disease or other neurodegenerative disorder
* History of Horton's disease
* History of inflammatory neuropathies (in particular Devic's disease, multiple sclerosis)
* History of vascular ischemic neuropathies and chronic intracranial hypertension
* History of pituitary tumors
* Presence of diseases (systemic and/or ocular diseases) or behavioural or cognitive symptoms incompatible with eye examination
* Known diabetes
* Person under tutorship or curatorship, person unable to express consent

Additional exclusion criteria for AD cases:

* Dementia of other cause than AD
* Severe AD, defined by MMSE score ≤ 10

Additional exclusion criteria for controls:

* Presence of dementia, of whatever cause
Efficacy of AEMCOLO (Rifamycin SV MMX) in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)

Open label interventional randomized pilot study utilizing two dosing regimens of AEMCOLO. The goal of this study is to evaluate effectiveness of a novel antibiotic, AEMCOLO (Rifamycin SV MMX) in the treatment of Small intestinal bacterial overgrowth (SIBO).


Eligibility Criteria:
Inclusion Criteria:

* Symptoms compatible with SIBO
* A positive breath test for either hydrogen predominant, methane predominant or mixed SIBO

Exclusion Criteria:

* History of diabetes mellitus,
* Diarrhea predominant irritable bowel syndrome (IBS-D),
* Symptomatic bowel obstruction,
* Diverticulitis and/ or adhesions,
* Autoimmune disorder,
* Immunosuppression by medication or disease,
* Pregnant or breast feeding,
* The use of antibiotics, probiotics or prebiotics within the previous 30 days,
* Known hypersensitivity to rifamycin, any of the other rifamycin class antimicrobial agents (e.g. rifaximin), or any of the components of AEMCOLO.
Comparison of Prasugrel and Clopidogrel in Low Body Weight Versus Higher Body Weight With Coronary Artery Disease

The 5-milligram (mg) dose of prasugrel in low body weight (LBW) patients with coronary artery disease produces a pharmacodynamic response within the same therapeutic range as 10-mg dose in higher body weight (HBW) patients.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a history of stable coronary artery disease who are not currently indicated for treatment with a thienopyridine (that is, prasugrel, clopidogrel, or ticlopidine)
* Provision of written informed consent
* For women of child-bearing potential only (that is, women who are not surgically or chemically sterilised and who are between menarche and 1 year post menopause), test negative for pregnancy (based on a urine or serum pregnancy test to be performed before randomisation) and agree to use a reliable method of birth control during the study

Exclusion Criteria:

* Unstable coronary artery disease
* Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft Surgery (CABG) within the previous 90 days
* History of refractory ventricular arrhythmias within the last 6 months; an implanted defibrillator device; congestive heart failure within 6 months prior to screening; major surgery, or severe trauma, fracture or organ biopsy within 3 months prior to enrollment
* Any planned surgical procedure or any coronary revascularisation (surgical or percutaneous) planned within 60 days following randomisation
* Any known contraindication to treatment with an antiplatelet agent
* Significant hypertension at the time of screening or randomisation
* Clinically significant out-of-range values for platelet count or haemoglobin at screening, in the investigator's opinion, or results of clinical laboratory tests at the time of screening that are judged to be clinically significant for the study population, as determined by the investigator
* Prior history or presence of significant bleeding disorders, abnormal bleeding tendency, or personal history of coagulation or bleeding disorders.
* Prior history or clinical suspicion of cerebral vascular malformations, intracranial neoplasm, Transient Ischemic Attack (TIA) or stroke.
* Prior history of thrombocytopenia or thrombocytosis
* Use of antiplatelet agents (besides aspirin) within 10 days prior to screening; the use (or planned use) of heparin, oral anticoagulants, or fibrinolytic agents within 30 days of screening; or subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDS) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study
Effect of Water Intake on the DNA Adducts Formation

The main purpose of the study is to assess the effect of water intake on the formation of 4-ABP DNA adducts.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects 20 to 45 years old (bound included)
* Smoker with at least 15 cigarettes/day
* Subjects with body mass index between 18 and 27kg/m2 (bound included)
* Subjects with a 3-meal diet (breakfast, lunch, dinner)
* Subjects who have an easy daily access to internet
* Subjects able to communicate well with the investigator and willing to comply the requirement of the study
* Subjects who have signed the form of informed consent and are registered to the French national welfare system

Exclusion Criteria:

* Subjects presenting evidence or history of severe or acute disease which could affect the results of the study or the vital status
* Subject practising physical activity in an intensive way according to the investigator judgment.
* Subject with a history of metabolic disease or with acute or chronic gastrointestinal disease except appendicectomy
* Subjects with diagnosed urinary tract disease
* Subjects with diagnosed lung or respiratory disease
* Subjects consuming regularly more than 3 units of alcohol per day
* Subjects who take drugs or presenting drug addiction (cannabis, opioids, amphetamines.)
* Subjects presenting a situation interfering with the outcomes of the study according to the investigator opinion
* Subjects working with painting, dry cleaning, dyes, pesticides, aluminium or alphalt
* Subjects who eat charcoaled food more than three meals/week
* Subjects with a vegetarian diet
* Subjects under local or general treatment which can modify measurements performed in the study, in particular the assessment of the hydration status (diuretic intake, or treatment interfering with metabolism and nutrition behaviour)
* Subjects planning to stop or reducing smoking or change their cigarette brand within the next 3 months
* Subjects in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject
* Subjects currently in a exclusion period following participation in another clinical trial
* Subjects having received 4500 euros indemnities for participation in clinical trials in the 12 previous months (including participation in the present study)
Appraisal of MDCO-157 and Plavix® Pharmacokinetics and Pharmacodynamics in Healthy Volunteers With an Evaluation

Following a first, dose ascending study that enrolled 144 normal healthy volunteers (NHVs), this study, to be conducted in approximately 36 NHVs, will provide pertinent information in determining the dose-response of MDCO-157 for platelet aggregation inhibition and P2Y12 receptor inhibition effects and in selection of doses that match the antiplatelet effects of 300 mg PLAVIX® ®. The study will also provide additional data for pharmacokinetics (PK), safety and tolerability of single doses of MDCO-157.


Eligibility Criteria:
Inclusion Criteria

* Healthy males or females 18 to 45 years of age, inclusive.
* Provide written informed consent for genetic testing and written informed consent for the study before initiation of any study related procedures
* Affiliated to the French social security system
* Screening and baseline Fridericia's correction (QTcF) interval \< 450 msec and baseline heart rate between 50 and 100 bpm (inclusive)

Exclusion Criteria:

* Known or suspected hypersensitivity or allergy to clopidogrel, Captisol, PLAVIX® , or its excipients
* Body mass index \<20 or \> 30 kg/m²
* Inability to communicate with the investigator or comply with study related procedures, or high likelihood of being lost to follow up
* Known or suspected pregnancy or lactating female
* Medical history, physical examination including 12-lead ECG or laboratory evaluation conducted at the screening visit with results indicative of any disease or condition which might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk
* Tobacco product use within the last 6 months prior to dosing
* Platelet count \< 150,000/µL
* A personal or family history of coagulation or bleeding disorders or reasonable suspicion of vascular malformations
* Active pathological bleeding such as peptic ulcer or intracranial hemorrhage
* Positive screen for Hepatitis B (Hepatitis B Surface Antigen HBsAg), Hepatitis C (Hepatitis C Antibody), or HIV (anti-HIV 1/2)
* Received an investigational drug within a period of 30 days or 5 half-lives, whichever is longer, prior to enrollment in the study
* Use of aspirin, other non-steroidal anti-inflammatory drugs, CYP3A4 inhibitors (ketoconazole), CYP2C19 inhibitors (eg, omeprazole) or other drugs known to affect platelet function or coagulation within 14 days prior to receiving study drug (MDCO-157 or oral clopidogrel)
* Grapefruit within 10 days prior to receiving study drug (MDCO-157 or PLAVIX®)
* Use of any over-the-counter medication, including herbal products, within 7 days prior to administration of study drug (MDCO-157 or PLAVIX®), except for up to 2 grams of acetaminophen per day for up to 3 days for pain control
Serratus Anterior Plane Block Versus Intercostal Block

Pain after thoracotomy is the most severe pain experienced by the patient. Good pain control after the operation provides comfortable respiration and reduces the development of chronic pain and complications.

we aimed to compare SAPB with IBregarding postoperative visual analog scale (VAS) scores and analgesic consumption in patients undergoing thoracotomy operation.

Patients who underwent thoracotomy operation in our hospital between May 2016 and June 2017 were examined. A retrospective evaluation was made of the data that was retrieved from the records of a total of 49 patients aged 18-75 years, ASA I-III, who were applied with Intercostal (IB) or Serratus anterior plane(SAPB) for a thoracotomy operation. The patient information was retrieved from the patient records and anesthesia block forms. The data were examined in respect of age, sex, height, weight, ASA, operation type, operating time, the amount of postoperative analgesic consumption, VAS at 1.,2.,4.,6.,12.,24. hours and complications (atelectasis, nausea, vomiting, hypotension and bradycardia).

Statistical analysis was performed using the SPSS program for Mac, version 17.0 (SPSS,Chicago,IL). Descriptive statistics are presented as mean and SD, and as the number of cases (n) and the corresponding percentage (%) for nominal variables. T tests were performed for normally continuous variables. The Mann-Whitney U test was used for non-parametric variables. A value of p \< 0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

1. Thoracotomy operation
2. a.Serratus anaterior plane block b.Intercostal block

Exclusion Criteria:

1. missing data
2. written consent
3. rethoracotomy