cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI

The aim of this project is to evaluate the effects of the anticonvulsant drug lamotrigine (trade name Lamictal) on neuropathic facial pain or neuralgia using functional magnetic resonance imaging (fMRI).

Currently there are no pharmacological agents that can control neuropathic pain akin to the efficacy of antibiotics for bacterial infection. All current neuropathic pain drugs have approximately the same efficacy of less than 30% in controlled trials, and many of these drugs do not have known mechanisms of action. fMRI studies may provide insight into how brain circuitry is altered by chronic pain, and how these drugs act on altered circuitry. The trigeminal system in particular offers unique advantages for studying such alterations, including a large central representation and high degree of somatotopy. The administration of lamotrigine to neuropathic pain patients in conjunction with fMRI will allow us to compare subjective ratings of pain with objective measures of neural activity during increased conditions of allodynia/hyperalgesia.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years of age
* Right-handed non-smokers
* Diagnosed with facial pain
* Continuous pain for more than 3 months
* Spontaneous pain greater than 3 of 10
* Allodynia to brush greater than 5 of 10

Exclusion Criteria:

* Medications
* Depression
* Significant medical problems
* Claustrophobia
* Abnormal EKG
* Significant drug or alcohol history
* Positive drug screen
* Weight greater than 285 lbs
* History of allergy to anticonvulsants
* Tattoos with metallic ink on upper body
* Any neurostimulator devices, or metal cochlear, ocular, or cardiac implants or other metal near vital areas
* Exposure to shrapnel or metal filings
* Other metallic surgical hardware
Should we Repair Ischemic Mitral Regurgitation?

The purpose of this study is to assess whether adding mitral valve repair to coronary artery bypass grafting improves outcome in patients with ischemic mitral regurgitation.


Eligibility Criteria:
Inclusion Criteria:

* Stable coronary artery disease
* Patient accepted for coronary artery bypass surgery
* Ischemic mitral regurgitation

Exclusion Criteria:

* Acute coronary syndrome within 30 days
* Organic valvular heart disease
* Need for other than CABG and mitral valve repair cardiac surgical procedure
A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.

This 2-arm study will investigate the safety and tolerability of oseltamivir for the treatment of influenza in immunocompromised participants and characterize the effects of oseltamivir in immunocompromised participants on the development of resistant influenza virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be randomized to receive either conventional dose (30 milligrams \[mg\] to 75 mg twice daily orally \[po\], depending on age and weight) or double dose (60 mg-150 mg twice daily po depending on age and weight) olseltamivir for 10 days. Nasal and throat swabs will be taken, and safety evaluations made, at intervals during the study. The anticipated time on study medication is 10 days and the anticipated time on study is 40 days.


Eligibility Criteria:
Inclusion Criteria:

* Rapid diagnostic test, PCR, or viral culture positive for influenza in the 96 hours prior to first dose
* Immunocompromised participants with primary or secondary immunodeficiency
* Symptoms suggestive of influenza-like illness
* Use of an effective contraceptive, as specified by protocol; women of childbearing potential cannot be pregnant or breastfeeding

Exclusion Criteria:

* Influenza vaccination with live attenuated vaccine in the 2 weeks prior to randomization
* Antiviral treatment for influenza in 2 weeks prior to randomization
* Severe hepatic impairment
* Any current renal replacement therapy
* Any gastrointestinal disorders which may interfere with the absorption of oseltamivir
* Participation in a study with an investigational drug from 4 weeks prior to study start until study end
Using the Digital EEG Spectral Analysis in Assessing Neuroelectrical Processing Abnormalities in Autism

Individuals with Autism Spectrum Disorder will have abnormal DESA® results. Our objective is to use neuroelectrical measures to determine the degree of processing abnormalities in individuals with Autism. The study will survey processing patterns and will locate and evaluate the degree(s) of abnormalities for further study. The abnormal results of comprehensive neuroelectrical evaluations of individuals with Autism when compared to the normative database will provide objective, verifiable, neurophysiological information with which to form novel approaches to the disorder.

The research method will be: gathering, analyzing and utilizing data.

We will observe research subjects through neuroelectrical instrumentation, then, compare results to retrospective information collected from research subjects and a normative database.

A qualified neurologist thoroughly familiar with electrophysiology will interpret the data, and analyze it to explore the abnormalities.

The hypothesis will be evaluated.

We will, then, utilize the results to find data-based forms of treatment for those with the disorder.

Eligibility Criteria:
Inclusion Criteria:

* The study will include children between the ages of five and eighteen, adults from the age of nineteen to twenty-five, and those with the diagnosis of Autism and Autism Spectrum Disorders.

Exclusion Criteria:

* those with mental retardation
* those with any other neurological disorder
* those that cannot sit in a chair for one hundred and fifty minutes
* those that have been previously diagnosed with a seizure disorder
* those who are blind and/or deaf
* those who are not ambulatory
* those who cannot understand English
* those that are not a resident of Los Angeles County
Relative Energy Deficiency in Rowers

This study aims to learn about relative energy deficiency in male and female rowers at the end of the direct sport preparation phase of the annual training cycle. The main questions:

- How will energy intake influence leptin, cortisol levels, mood, gut discomfort, and permeability? The observational study involves male and female rowers from the Polish rowing team.

Participants will perform 2000 meter ergometer test and 6000 ergometer test in annual training cycle. Researchers will compare outcomes from both tests.


Eligibility Criteria:
Inclusion Criteria:

* Membership in Polish Rowing Team,
* minimum five years of training,
* total training time minimum of 240 minutes,
* filling out a food diary,
* finishing 2000-meter ergometer test.

Exclusion Criteria:

* Probiotics within the last three months,
* prebiotics within the last three months
* antibiotic therapy within the last three months,
* dietary regime,
* gastrointestinal diseases.
Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile

The inclusion of breakfast cereals enriched with omega-3 for female users of a pharmacy who had some lipidic profiles to the limit is highly conditioned by their nutritional acceptance. The main objective is to assess the effect of breakfast cereals intake with omega-3 on women lipid profile values to the limit, users of a pharmacy in Elche and in this way reduce the small dyslipidemia.

The investigators performed an intervention including 133 women (age 25-70 years). Participants were randomly and single-blind distributed into three groups: Group 1 (n=38) consumed cereal with omega-3 (Cw-3 + D), cereal (C) and diet (D), Group 2 (n=38). Volunteers consumed (C) + (D) and Group 3 (n=37) consumed only diet. All groups followed a limit levels-cholesterol diet. Circulating total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and glucose were determined at the beginning and end of a 30-day test.

Statistical analysis was carried out using STATGRAPHICS Centurion XV software (StatPoint Technologies, Inc. Warrington, VA, USA); likewise, significance was defined at p ≤ 0.05. Data are reported as mean ± standard error of the mean (sem). Intra-group statistical comparisons were performed using the following hypothesis tests, both parametric and non-parametric: t-test, sign test and signed rank test for paired samples. Inter-group statistical comparisons were performed using the one-way analysis of variance and the Kruskal-Wallis hypothesis tests. Also, Fisher's least significant difference (LSD) Multiple Range Test and Tukey's honestly significant difference (HSD) were used in order to determine which means were significantly different from the others. In addition, Generalized Multiple Regression was used to statistically analyze the relationships between the variations in the lipid profile and the different factors included in the study.

Eligibility Criteria:
Inclusion Criteria:

* voluntarily participation
* ages between 25-70 years
* undergoing dyslipidemia
* with no pharmacological treatment
* cholesterol (250-300 mg/dL)
* triglycerides (160-175 mg/dL)

Exclusion Criteria:

* subjects undergoing any pharmacological treatment that may influence lipid metabolism
* lipid levels outside the range of those specified in the inclusion criteria
* subjects that were deemed to be unlikely to complete the treatment or to cooperate fully at the investigator´s discretion.
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer

The purpose of this pilot is to provide credible performance estimate information in order to conduct a subsequent pivotal reader study.

This clinical research is a retrospective, pilot, multi-reader, multi-case (MRMC) study with an enriched sample of 100 breast screening or diagnostic cases which were selected from the library of mammograms collected under Fujifilm protocol FMSU2013-004A (all subjects previously provided written informed consent agreeing their image data and supporting documentation could be used for future research and investigations). Approximately 6 qualified radiologists will independently perform two reads on all (approximately 100) cases. Each reader will read each case both as a FFDM (Full Field Digital Mammography) read, and a DBT (Digital Breast Tomosynthesis) plus S-View (Synthesized View) read on the ASPIRE Bellus II workstation.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects participating in FMSU2013-004A protocol with known clinical status

Exclusion Criteria:

* Female subjects that did not have known clinical status in FMSU2013-004A
A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis

The study consists of two phases: The first portion of the study is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given as a single agent orally once daily in subjects with Chronic Idiopathic Myelofibrosis (CIMF) regardless of their JAK2 mutational status. The second portion of the study is a Phase 2 study to define the efficacy and safety profile of single agent SB1518 at the recommended dose in subjects with CIMF.


Eligibility Criteria:
Inclusion Criteria

* Subjects with CIMF (including post ET/PV MF) requiring therapy, including:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Men of reproductive potential who can agree to practice effective contraception during the entire study period and for one month after the last study treatment
* Women of child-bearing potential who have a negative pregnancy test within 14 days prior to the first dose of study drug and can agree to practice effective contraception during the entire study period and for one month after the last study treatment, unless documentation of infertility exists
* Subjects who are able to understand and willing to sign the informed consent form

Exclusion Criteria

* Subjects with uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. Subjects receiving antibiotics for infections that are under control may be included in the study unless the antibiotic is a CYP3A4 inducer/inhibitor
* Subjects known to be HIV-positive
* Subjects with known active hepatitis A, B, or C, or latent hepatitis B
* Women who are pregnant or lactating
* Subjects with prior radiation therapy to more than 20% of the hematopoietic marrow (prior radiation to spleen is allowed)
Evaluation of Rapid Virologic Response Among HCV Patients Treated With PegIntron and Rebetol in Brazil (Study P05427)

The objective of the study is to evaluate, in each group, the number of participants who achieve rapid virological response (RVR) after 4 weeks treatment with PegIntron and Rebetol. The study will also assess whether RVR is a reliable predictor of sustained virologic response (defined as undetectable viral load at 24 weeks post-treatment).


Eligibility Criteria:
Inclusion Criteria:

* Willing to participate in the study and sign the Informed Consent Form
* Established HCV infection, confirmed by molecular biology test (positive qualitative polymerase chain reaction \[PCR\] test)
* Can be treatment-naïve, have retreatment, or co-infected with HIV
* Be under treatment with PegIntron in combination with ribavirin, starting up to 14 days before the screening visit

Exclusion Criteria:

* Participants who have not confirmed their willingness to participate in the study or have refused to sign the Free and Informed Consent Form
* Prior treatment with PegIntron (combined with ribavirin or not)
* History of alcohol abuse in the past 6 months
* Decompensated liver disease
* Severe heart disease
* Decompensated thyroid disorder
* Neoplasia
* Type 1 diabetes mellitus - uncontrolled or hardly controlled
* Seizures - uncontrolled
* Primary immune deficiency
* Men and women not using appropriate contraceptive methods
* Pregnancy or lactation
* For participants co-infected with HIV: HIV-related opportunistic disease in the past 6 months or CD4 count lower than 200 cells/mm\^3
Effect of Probiotics on Infant's Fecal Microbiota Composition

Randomized clinical trial to evaluate the effect of two probiotic strains which belong to Bifidobacterium Longum and Pediococcus pentosaceus species on fecal microbiota composition in healthy infants. Secondary outcomes comprise evaluation of anthropometric growth, digestive tolerance, sleeping habits, incidence of functional gastrointestinal disorders, incidence of gastrointestinal and respiratory infections, allergic reactions and safety and tolerability of the product.

Double-blind, randomized, placebo-controlled clinical trial to determine the effect of the probiotic strains Bifidobacterium longum and Pediococcus pentosaceus on fecal microbiota composition in infants. Healthy babies with ages comprised between 60 and 90 days who meet inclusion and exclusion criteria will be randomized 1:1:1 to one of the following study groups: one group will receive Bifidobacterium longum, another group will receive Pediococcus pentosaceus and the other one will receive placebo for 3 months. Other study outcomes comprise anthropometric growth, frequency and consistency of the stools, digestive tolerance, wellbeing, number, type and duration of infections and functional gastrointestinal disorders, and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants
* Age between 1 and 90 days
* Gestational age between 37 and 42 weeks
* Appropiate birth weight for gestational age (between P10 and P90)
* APGAR test score for birth normal at 1' and 5' of 7-10
* Whose parents accept the follow-up of the study procedures and sign the informed consent

Exclusion Criteria:

* Infants participating in other clinical study
* Fed with infant formula containing probiotics or other aliments or food supplement based in probiotics 4 weeks prior the start of the study
* Infants who have taken antibiotics 4 weeks prior the start study
* Infants with cow's milk protein allergy, lactose intolerance or other digestive diseases
* Mother's pathological background and during gestation: neurologic disorders, matabolopaties, diabetes mellitus type 1, chronic disease (hypothyroidism), maternal malnutrition
* Acute congenital or acquired diseases which can interfere with the growth and the normal feeding of the infant
* TORCH complex infections
* Every other diseases related with the immune system
* Parents who can not accomplish the follow-up of the study (medical criterium)
HA35 Treatment the Gingival Discomfort as Well as Gingival Redness and Bleeding of Patients With Periodontitis

The main objective of this study is to research the treatment of 35 kDa hyaluronan fragment HA35 for Mild periodontitis and associated with gingival discomfort or itchiness.

In this study, tissue permeable 35 kDa low molecular hyaluronan fragment HA35 was freshly manufactured using pharmaceutical grade hyaluronidase PH20 injection (State Drug Administration H31022111) and joint cavity HA injection (State Drug Administration H20174089) mixed at room temperature for 20 min.

In this study, 20 patients, 8 males, and 12 females, with a mean age of 47±15 years, were selected from the outpatient clinic of the Department of Dentistry. All had mild periodontitis and were associated with gingival discomfort or itchiness. Injection treatment was performed using freshly manufactured 35 kDa hyaluronan fragment HA35. The study was an open-label clinical trial in which no information was withheld from the participating investigators. A pre- and post-treatment controlled study approach was used, whereby the investigator injected 35kDa hyaluronan fragment HA35 into the periodontal pocket in a single dose of 100 mg. The distribution of injection amount was determined by the location of gingival inflammation. The clinical effects of gingival discomfort or itching, redness and swelling, and bleeding from the probing were observed and recorded in patients before and after 7 days of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Mild periodontitis and associated with gingival discomfort or itchiness.
2. Patient \> 18 years old.
3. Systemically healthy individuals

Exclusion Criteria:

1. Patients who take Anticoagulants or Antiplatelet Agents
2. Pregnant or breastfeeding women
3. Patient having expressed his opposition to participate in the research.
Efficacy of Suction Enabled Retraction Device

This is a prospective randomized controlled trial of the Suction-Integrated Surgical Tissue

Elevator \& Retractor \[SISTER\] device to assess:

* Effects on operative time and efficiency of exposure in open lumbar spine cases.
* Effect on total blood loss during the exposure part of the operation.
* Rate of clogging of suction device.

The device, Suction-Integrated Surgical Tissue Elevator \& Retractor \[SISTER\], is shaped like a Cobb elevator but also has a hollow core allowing suction tubing to be connected. Thus, a single hand can be used to retract and suction at the same time while the other hand separates soft tissue from the bones with electrocautery. This set up which is proposed to be more efficient will be evaluated in this study.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Patients undergoing lumbar one to sacral one open instrumentation
* Surgery performed by the Departments of Neurological Surgery and Orthopedics at the University of MIami Miller School of Medicine

Exclusion Criteria:

* Less than 22 years old
* Procedure does not involve instrumentation
* Prior lumbar spine surgery involving more than one level
* BMI less than 20 or greater than 35
* Known bleeding conditions ( ex. Factor V Leiden, Von Willebrand)
* Routinely taking anticoagulation medicine (ex. aspirin 325 mg/day, Plavix)
* Operative cases where a single surgeon performs both sides of exposure
* Pregnant women
* Prisoners
* Adults unable to consent
Effect of Progesterone Levels on 15th Day After Embryo Transfer in Early Miscarriage < 7 WG or Evolving Pregancy Rates

Progesterone level has been studied at days before embryo transfert. But, progesterone blood level has not been studied 15 days after embryo transfert. The aim of this study is to study progesterone level impact at 15 days after embryo transfert on evolving pregnanies or early miscarriages.


Eligibility Criteria:
Inclusion criteria:

* ART program in Montpellier hospital
* age \>18 years old
* Blood progesterone level 15 days after embryo transfert
* Pregnancy development know

Exclusion criteria:

- non uterine pregnancy
HKI-272 Ketoconazole Drug Interaction Study

To investigate a potential pharmacokinetic drug interaction between HKI-272 and ketoconazole when co-administered.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.
Effectiveness of Carbohydrate Counting Method With Mixed Meals

In a randomized, cross-over designed study, the investigators examined the effectiveness of the carbohydrate counting method after consumption of mixed meals typical of the Greek cuisine with various protein and fat contents in a sample of people with type 1 diabetes (DM1). The investigators also tried to further explore the effects of additional extra virgin olive oil (11 ml) on the glycemic response.

A total of 20 adults with type 1 diabetes on intensive insulin therapy consumed three mixed meals at noon between 1200 and 1300 hours, with and without the addition of 11 ml extra virgin oil, in random order. One week before entering the study, participants kept a detailed 7-day weighed food record with fingerprick blood glucose measurements pre-and-2hour post-meals for calculation of their carbohydrate (g) to insulin (units) ratio. Moreover, the individual correction factor was calculated. Thereafter, insulin requirements for the test meals were calculated based on the carbohydrate content of each dish and according to the personalised carbohydrate to insulin ratio. Postprandial glycemia was measured in capillary blood glucose samples at 30min intervals over 195min. For 24hr before each testing session, participants were asked to refrain from the consumption of alcohol and to maintain their usual physical activity pattern. On the day of testing, subjects were asked to consume their usual breakfast and abstain from food for at least 2 hours before their appointment. If blood glucose was \>7.2 mmol/l at 1200, insulin was administered based on the individualised correction factor. If blood glucose was \>10 mmol/l at the beginning of the testing session, insulin was administered to correct it and the subject was asked to return on another day. if hypoglycaemia occurred (defined as blood glucose level \<3.8 mmol/l), the test session was stopped, the event was recorded and the patient treated appropriately. The on target 2hour postprandial blood glucose level was set between 3.9 and 10 mmol/l. Anthropometric measurements (body weight, waist and hip circumferences) were performed at every visit.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 diabetes
* Intensive insulin therapy
* HbA1c \< 10%
* \>2 years with diabetes

Exclusion Criteria:

* Food allergies
* Diabetic neuropathy
* Kidney disease
* Hematological disturbances
* Liver disease
* Uncontrolled hypo- or hyperthyroidism
* Arrhythmia
* Heart disease
* Cancer
* Serious mental illness