cyrilzakka/clinical-trials huggingface dataset:
Deductive Reasoning and Math Learning Difficulty

Most studies to date that have examined the factors underlying math achievement in children have focused on basic numerical knowledge. Yet, math skills are clearly not limited to basic numerical knowledge and recent behavioral studies suggest a relationship between math and deductive reasoning skills. The goal of this study is to determine the neural mediators of this relationship using functional magnetic resonance imaging. The investigators will ask children from 8 to 14 to complete a standardized math achievement test, and measure their brain activity while they process deductive arguments. The investigators will then correlate brain activity during reasoning to individual math skills to identify the brain regions in which activity during reasoning is modulated by math skill.


Eligibility Criteria:
Inclusion Criteria:

* Girl or boy between 8 and 14
* Right-handed
* Affiliated to the French social security
* Whose parents gave informed consent

Exclusion Criteria:

* Neurological disorders
* Psychiatric disorders
* Birth complications requiring admission into neonatal intensive care unit
* Medication affecting central nervous system processing
* Significant hearing impairment
* Uncorrected visual impairment
* Non-native French speaker
* Contraindications for MRI
Fecal Microbiota Transplantation for C Diff Infection

The objective of this study is to provide treatment with Fecal Microbiota Transplantation (FMT) to patients with recurrent or refractory Clostridium difficile infection (CDI). It has been shown that good bacteria (like that found in the stool from a healthy donor) attack Clostridium difficile in multiple ways: they make substances that kill Clostridium difficile - and they attach to the surface of the colon lining, which prevents the Clostridium difficile toxin (poison) from attaching.

FMT involves infusing a mixture of saline and stool from a healthy donor into the bowel of the patient with CDI during a colonoscopy.

The method used to deliver the FMT will depend on individual characteristics of the subject and is at the discretion of the treating physician. FMT may be administered by the following methods.

* Colonoscopy: This method allows full endoscopic examination of the colon and exclusion of comorbid conditions (such as IBD, malignancy or microscopic colitis) which may have an impact on subject's treatment or response to therapy.
* Sigmoidoscopy: This method still allows infusion of the stool into a more proximal segment of the colon than an enema, but may not require sedation. This method may be beneficial in subjects who are elderly or multiparous and who may have difficulty retaining the material when given as enema. Sigmoidoscopic administration eliminates the additional risks associated with colonoscopy in subjects who may not have a clear indication for colonoscopy.
* Retention enema: This method may be preferable in younger subjects who have already had recent endoscopic evaluation, in subjects who prefer not to undergo endoscopy or in subjects with significant co morbidities and may not tolerate endoscopy.

The physician will administer 300-500 mL of the fecal suspension in aliquots of 60 mL, through the colonoscope or sigmoidoscope or 150 mL via retention enema. In cases of colonoscopic delivery, the material will be delivered to the most proximal point of insertion.

The subject is encouraged to retain stool for as long as possible.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years old.
2. Subject has recurrent or relapsing CDI defined as:

   * At least three episodes of mild-to-moderate CDI and failure of a 6-8 week taper with vancomycin with or without an alternative antibiotic (e.g., rifaximin, nitazoxanide, fidaxomicin). OR
   * At least two episodes of severe CDI resulting in hospitalization and associated with significant morbidity. OR
   * Moderate CDI not responding to standard therapy (vancomycin) for at least a week. OR
   * Severe C. difficile infection with toxic megacolon, not responding to standard therapy or the use of IVIg.
3. Subject is willing and able to provide informed consent.
4. If a female of childbearing potential, subject has agreed to use an acceptable form of birth control for up to 4 weeks after FMT treatment.

Exclusion Criteria:

1. Subject is pregnant.
2. Subject is unable to comply with study requirements.
Teenage Passenger Influences on Driving Performance of Teenage Drivers

This study, conducted at the University of Massachusetts at Amherst, will examine how male teenage driving performance varies in the presence or absence of male teenage passengers. It will explore what information teen drivers and their passengers use when making decisions that affect their performance on the road.

Male drivers under 18 years of age who have a Junior Operator's or Full License and have driven at least once in the month before enrolling in the study may be eligible to participate.

In a university laboratory, participants sit in a 1995 Saturn sedan and operate the controls of the car just as they would those of any other car, during simulated drives in urban, suburban and rural areas. They are fitted with a head-mounted eye tracker that records their point of gaze in real time. On one drive, the subject drives alone; on another, a male passenger rides along. After the drives, the subject fills out some questionnaires.

The purpose of this research is to examine how male teenage driving performance varies in the presence or absence of high versus low risk accepting male teenage passengers. Driving performance includes attention and risk measures including eye glance behaviors, speed management, following distance, closing speed and gap acceptance. To what extent does driving performance vary as a product of the male teen passenger risk- acceptance compared with no passenger present?

Eligibility Criteria:
* INCLUSION CRITERIA:

Only male driver and passengers

Under the age of 18

Having a provisional or full license (i.e. allowing driving without supervision)

Having driven in the past 3 months

Having normal or corrected-to-normal vision (i.e. contact lenses or eye glasses are accepted)

EXCLUSION CRITERIA:

Females

Motion sickness
In Vitro Functional Modulation of Monocyte-derived Dendritic Cells of Patients With Cancer by Peptides

The purpose of this study is to evaluate in vitro the potential of peptides, to modify, phenotypically and functionally, the monocyte-derived dendritic cells of patients with metastatic cancer.

The DCs will be generated in vitro from peripheral blood mononuclear cells (PBMCs) which will be obtained from 30 ml of peripheral blood collected from each patient with metastatic cancer by venipuncture in heparin tubes.

The cellular viability, the expression of maturation biomarkers and the presence of several cytokines will be evaluated by flow cytometric assays after the culture period of DCs exposed to the peptides.

An interim analysis is programmed with the first 10 patients. If an effect is demonstrated the study will include an additional number of subjects sufficient to ensure adequate comparison with other commercially available peptides.

Eligibility Criteria:
Inclusion Criteria:

1. Signature of the Informed Consent Form before the performing of any procedures related to the study;
2. Age ≥18 years;
3. Histologically confirmed metastatic malignant neoplasia;
4. Results of laboratorial exams in the first 6 weeks before the blood sample collection within the following values:

   * White blood cells ≥ 3.000/μL;
   * Platelet count ≥ 100,000/mm³;
   * Hemoglobin \> 10g/dL;
   * Serum aspartate aminotransaminase (AST), alanine aminotransferase (ALT) and alkaline phosphatase \< 2.5 x upper limit of normal (ULN);
   * Serum creatinine \< 1.5 x upper limit of normal (ULN);
5. Karnofsky performance status ≥ 70%.

Exclusion Criteria:

1. Presence of autoimmune disorders or conditions that require systemic treatment with immunosuppressant medications or systemic corticosteroids;
2. Received any systemic chemotherapy or radiotherapy within 15 days prior to the blood sample collection;
3. Received any immunotherapy within 4 weeks prior to the blood sample collection;
4. Known history of positive serology for HIV (human immunodeficiency virus).
A Clinical Study of Curcuminoids in the Treatment of Oral Lichen Planus

A phase 2 randomized, placebo-controlled, double-blind trial of a two week course of curcuminoids in oral lichen planus will be conducted. 26 consecutive, eligible patients with OLP presenting to the oral medicine clinic at the University of California, San Francisco, will be enrolled. Study subjects will be randomized to receive either placebo or curcuminoids 6000mg/day for 2 weeks in three divided doses of 2000mg three times/day. Measurement of signs, symptoms, periodontal status and blood tests including complete blood count, liver enzymes, serum c reactive protein and serum interleukin-6 levels will be done at baseline and at the end of 2 weeks. A side-effects questionnaire will be administered at the 2-week follow-up.

The Numeric Rating Scale (NRS) will be used to measure symptoms and the Modified Oral Mucositis Index (MOMI) to measure clinical signs of OLP. Primary outcome is change in symptoms from baseline. Secondary outcomes are change in clinical signs, occurrence of side-effects, change in serum C-reactive protein and serum interleukin-6 levels.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to the UCSF oral medicine clinic diagnosed with either the atrophic or the erosive form of oral lichen planus
* Study subjects must have a symptom score between 3 to 8 at the time of entry into the study. (Range of scale: zero to ten with zero being no symptoms and ten being the worst imaginable symptoms.
* Study subjects will have discontinued systemic and/or topical steroids and/or curcuminoids for at least 2 weeks before entry into the study.

Exclusion Criteria:

* Pregnancy, lactation or unwillingness to use an effective method of contraception. An attempt will be made to ascertain the date of the last menstrual period among eligible pre-menopausal women. If pregnancy cannot be ruled out, a pregnancy test will be provided to the women before enrollment into the study. - Patients younger than 21 years of age.
* Patients who cannot return for a follow-up visit at two weeks after enrollment.
* Patients who have a medical contraindication to discontinuation of systemic steroids eg. those on long term corticosteroid therapy. - Patients with a history of gastro-esophageal reflux disease, gastric / duodenal ulcers, or gallstones.
* Patients with elevated liver enzymes;
* Patients on anticoagulants or antiplatelet medications.
* Patients undergoing orthodontic treatment.
* Patients who don't read, speak or understand English.
Short Term Oral Iron Supplementation in Systolic Heart Failure Patients Suffering From Iron Deficiency Anemia

The purpose of this study is to determine the efficacy of Ferrous Sulphate (FS) tablets in improving iron stores and functional capacity in HF patients with Iron Deficiency Anemia (IDA).

The investigators conducted a double blind randomized controlled trial (RCT) enrolling 54 Heart Failure (HF) patients (LVEF \< 50%) with IDA (Ferritin \< 100 ng/mL or 100-300 ng/mL with Tsat \< 20%) at outpatient clinic of National Cardiovascular Center Harapan Kita from January to July 2016. Patients were randomized 1:1 to received FS or placebo for 90 days, the investigators then evaluated the change in 6-Minute Walking Test (6MWT) distance as primary end-point and changes on N-Terminal-pro Brain Natriuretic Peptide (NT-proBNP) and post 6MWT serum lactate levels as secondary end-points.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 year old
* Systolic heart failure patients without clinical sign of decompensation at outpatient clinic
* New York Heart Association (NYHA) functional class II-III able to perform 6MWT
* LVEF \< 50%
* On heart failure therapy
* Haemoglobin (Hb) \< 13 gr/dL (male); Hb \< 12 gr/dL (female) and \> 8 gr/dL
* Ferritin \< 100 µg/L or Ferritin 100-300 µg/L dengan Transferrin saturation (Tsat) \< 20%
* Agree to participate

Exclusion Criteria:

* History of : active bleeding,infection, malignancy, haematological abnormality, peptic ulcer
* History of myocardial revascularization (CABG/PCI) within 3 month
* Acute Coronary Syndrome (ACS), stroke,Transient Ischemic Attack (TIA) within 3 month
* Know to have allergic reaction to Ferrous sulfate
* History of intravenous iron administration within 1 month
* Permanent Pace Maker(PPM)/Implantable Cardiac Defibrillator (ICD)/Cardiac Resynchronization Therapy (CRT)
* estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73m2
* NT-proBNP \> 4000 pg/ml (for patients without baseline data) or decreased level of NT-proBNP \< 30% from baseline
* Increase level of serum alanine aminotransferase (ALT)/ serum aspartate aminotransferase (AST)\> 3x normal value
* Moderate to severe primary valvular heart disease
* Congenital heart disease
* Right heart failure due to primary pulmonary hypertension, cor pulmonale, Chronic Thrombo-Embolic Pulmonary Hypertension (CTEPH)
A Preemptive Epidural Ropivacaine for Postoperative Pain Relief in Degenerative Lumbar Spine Surgery

This prospective randomized study aims to evaluate the effectiveness of epidural injection of ropivacaine on the relief of pain in patients undergoing laminectomy.

Total 60 patients will be randomized into one of two groups (groupC or groupI) based on Excel number generation.

Patients in group C will receive no medication intraoperatively, and patients in group I will receive epidural injection of 0.1% ropivacaine 10ml before skin incision.

Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4,12,24,48 hour postoperatively.

Patients in group I will receive 0.1% ropivacaine 10 ml before skin incision under guide of C-arm.

Eligibility Criteria:
Inclusion Criteria:

* laminectomy

Exclusion Criteria:

* r/o infection
* reoperation
* mental change
* allergy to local anesthetics
Split-dose Versus Single-dose Polyethylene Glycol Regimen for Capsule Endoscopy

To compare the small bowel cleanliness for wireless capsule endoscopy using two different Polyethylene Glycol administration schedules (before the wireless capsule endoscopy ingestion versus in a split-dose fashion).

The image quality obtained from the wireless capsule endoscopy improves its diagnostic yield. The amount of visualized mucosa is in direct correlation with the diagnostic yield. Nonetheless, frequently, the quality of the image obtained is hampered by the presence of bubbles, debris, bile and enteric fluid. Therefore many efforts have been putted in order to eliminate this factor such as the use of prokinetics, simethicone and bowel purgatives. The latter (namely the polyethylene glycol - PEG - solution) has accumulated evidence and is, therefore, recommended by the last European guidelines. Usually, the cleansing starts and finish in the day before the capsule endoscopy ingestion.

We hypothesized that, similarly to what had become evidence to large bowel cleansing, a shorter gap between the polyethylene glycol intake and the exam could provide a better capsule endoscopy image quality and therefore gauging our diagnostic yield.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients referred to our institution for CE during the study period

Exclusion Criteria:

* inpatients, bedridden, patients with clinical evidence of active bleeding, past history of abdominal surgery, abdominal or pelvic radiation therapy, occlusion, bowel perforation (suspected or confirmed), use of oral iron replacement therapy, severe cardiopulmonary, renal or hepatic disease, pregnancy, hypersensitivity to any components of the preparation, patients that didn't complete the preparation protocol, patients with incomplete enteroscopies (a complete enteroscopy is defined by the visualization of the mucosa from the duodenal bulb to the cecum), patients enrolled in other clinical studies and patients who didn't signed informed consent.
A Phase 2 Trial of AMG 706 or Bevacizumab in Combination With Chemo for Advanced NSCLC

The purpose of this study is to estimate the difference in objective response rates between each paclitaxel/carboplatin plus AMG 706 arm (Arm A and B) and paclitaxel/carboplatin plus bevacizumab arm (Arm C) in subjects with advanced non-squamous NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Men or women 18 years or older with histologically or cytologically confirmed advanced non-squamous NSCLC (unresectable stage IIIB with pericardial or pleural effusion or stage IV/recurrent)
* Measureable disease per RECIST criteria modified
* ECOG performance status of 0 or 1
* Ability to take oral medications
* Competent to give written informed consent

Exclusion Criteria:

* Current or prior history of CNS metastases
* Any prior chemotherapy for advanced NSCLC
* History of pulmonary hemorrhage or gross hemoptysis within 6 months prior to randomization
* Prior targeted therapies
* Known history of allergy or hypersensitivity to paclitaxel or carboplatin
* History of arterial or venous thrombosis within 52 weeks prior to randomization
* History of bleeding diathesis or non-pulmonary bleeding within 14 days prior to randomization
* Peripheral neuropathy \> grade 1 per CTCAE Version 3.0
* Myocardial infarction, cerebrovascular accident, grade 2 or greater peripheral vascular disease, transient ischemic attack, congestive heart failure, percutaneous transluminal coronary angioplasty/stent, ongoing arrythmias requiring medication or unstable angina within 52 weeks prior to randomization
* Any kind of disorder that compromises the ability of the subject to comply with the study procedures
* Uncontrolled hypertension as defined by resting blood pressure \> 150/90 mm Hg. Anti-hypertensive medications are allowed if hypertension is stably controlled at the time of randomization.
* Participation in therapeutic clinical trials or currently receiving other investigational treatment(s) within 30 days prior to randomization
* Pregnant or breast feeding women
* Known to be HIV, hepatitis B surface antigen, or hepatitis C positive
Prevention of Early Postoperative Decline

The purpose of this trial is to determine whether using a brain training program in the time leading up to as well as after heart surgery will reduce confusion and cognitive loss that can occur after surgery.

Randomized, controlled pilot study with a convenience sample of 45 adult cardiac surgical patients. The main intervention to be studied will be the use of a neurocognitive training program (Lumosity) for 10 days preoperatively, and then for four weeks postoperatively. The prescribed regimen of training will focus on the areas of cognitive function most commonly affected in the postoperative period, including working memory, attention, and processing speed. Patients in the control arm will undergo current standard cardiac surgical postoperative care and will be asked to refrain from obtaining a Lumosity account.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing cardiac surgery age 60-90
* Cardiac surgery scheduled at least 10 days from enrollment
* High school education level or equivalent

Exclusion Criteria:

* Preexisting psychiatric illness
* History of cerebrovascular event or seizure
* Non English speakers
* Baseline severe cognitive dysfunction including Alzheimer's, Parkinson's, or other severe forms of dementia
* Significant visual impairment
* Enrollment in another study involving cognition
A Study to Assess the Amount of LY3074828 That Gets Into the Body When Given With LY9999QS, in Healthy Participants

The purpose of this study is to look at the amount of the study drug, LY3074828, that gets into the blood stream and how long it takes the body to get rid of LY3074828 when given together with LY9999QS compared to LY3074828 alone. The tolerability of the different formulations will also be evaluated and information about any side effects experienced will be collected.

Screening is required within 28 days prior to the start of the study. For each participant the total duration of the clinical trial will be approximately 13 weeks, not including screening.


Eligibility Criteria:
Inclusion Criteria:

* Have venous access sufficient to allow for blood sampling and administration of investigational product
* Have clinical laboratory test results within normal reference range for the investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

Exclusion Criteria:

* Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females)
* Must not show evidence of active or latent tuberculosis (TB)
* Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 1 month of screening, or intend to during the study
* Must not be immunocompromised
* Must not have known hypersensitivity to hyaluronidases
* Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
* Must not have significant allergies to humanised monoclonal antibodies
* Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or sever post treatment hypersensitivity reactions
* Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
* Must not have had breast cancer within the past 10 years
Double Anaerobic Threshold in Athletes

During an incremental cardiopulmonary exercise test (CPET) performed with a ramp protocol, it is very important to determine the anaerobic threshold, defined as the point at which the metabolism switches from being predominantly aerobic to also being anaerobic. The anaerobic threshold can be determined invasively, by identifying the increase in blood lactates with an arterial sampling, or, more commonly, non-invasively by three methods: the V-slope method, the ventilatory equivalents method and by using end-expiratory oxygen and carbon dioxide pressure (PETO2 and PETCO2 respectively). Normally, the anaerobic threshold is determined by the first method and the other two are used to confirm the value. The finding of different anaerobic threshold values using these three methods has been reported anecdotally in the past, while a prevalence of 11% in a healthy population has recently been described. Regular training, particularly that aimed at endurance sports, is able to shift the anaerobic threshold to higher exercise intensities. At present, the physiological reasons for the presence of a double threshold are unclear.

The aim of the study is to identify the anaerobic threshold by means of the V-slope method and by means of the ventilatory equivalents method in athletes who have performed an incremental ramp CPET at the laboratories of the investigating centres, to assess in how many athletes a double threshold is present and to try to interpret the physiological/ pathophysiological significance of this finding.

In this retrospective and prospective observational study, healthy male and female athletes who have had a cardiopulmonary test at our laboratories from 2007 to the present (retrospectively recruited) and prospectively recruited until the calculated sample size is reached will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* no major present or past illnesses, no ongoing treatment
* At least 2 training sessions per week.

Exclusion Criteria:

* Current illnesses and treatments for any physical condition that could potentially alter performance
* Subjects who have performed a submaximal test (RER \< 1.05)
* CPET during which the AT determination is poorly assessable, i.e. due to changes in respiration.
* obese subjects (BMI \>30)