cyrilzakka/clinical-trials huggingface dataset:
Efficacy of EGFR TKIs in Patients With Rare EGFR-mutated NSCLC

Lung cancer is the leading cause of cancer-related death worldwide and is well known to remain a major health problem. Non-small-cell lung cancer (NSCLC) constitutes more than 80% of all the cases of lung cancer.

Today, NSCLC can be defined by various molecular criteria. Especially, somatic mutations within the epidermal growth factor receptor (EGFR) gene itself were discovered in a subset of NSCLC patients.

Two activating EGFR mutations are in-frame deletion in exon 19 and the substitutions for L858R in exon 21, which account for 85% of all clinically important mutations related to EGFR TKI sensitivity.

Besides two activating EGFR mutations, other EGFR mutations in NSCLC have been discovered. G719 and L861 are reported to have intermediate sensitivity to EGFR TKI. And in-frame insertions within exon 20 and T790, which are known to be resistant to EGFR TKIs.

However, there are still other EGFR mutations such as E709 and S768 as well as doublet EGFR mutations are also observed. These rare mutations have not been fully described and data on their correlation with response to EGFR-TKIs are still unclear.

Research hypothesis Rare EGFR mutations of unknown clinical significance in NSCLC patients, which are distinguish from mutations such as deletion in exon 19, L858 and insertion in exon 20, have some possibility of EGFR TKI sensitivity.

Rationale for conducting this study It has an opportunity to be shown the efficacy of EGFR TKIs in patients with rare EGFR mutation in large number of patients in Korea (Asia) during the short period.


Eligibility Criteria:
Inclusion Criteria:

1. Histological confirmed non-small cell lung cancer (NSCLC), Stage IIIB or stage IV, between January 1, 2008 to December 31, 2011
2. Confirmed EGFR rare mutations (EGFR mutation except both exon 19 deletion and exon 21 L858R) using direct DNA sequencing
3. Experiences of treatment with EGFR TKIs.
4. at least one measurable and/or evaluable lesion according to RECIST criteria (version 1.1)

Exclusion Criteria:Subjects should not enter the study if any of the following exclusion criteria are fulfilled: EGFR wild type, EGFR exon 19 deletion alone, EGFR L858R alone
Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2

This is a four arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.

Participants with chronic tinnitus will be provided with a CE marked neuromodulation device. Participants are randomized to one of four different treatment arms. The treatment period is intended for 12 weeks of use. Based on the clinical investigation plan, participants are informed that their stimulation settings can change between the first and second halves of the treatment period and that the differences may be perceptually noticeable. Differences in tinnitus severity scores will be compared between and within treatment arms.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years of age
* Ability to read and understand English
* Willing and able to provide informed consent
* Willing to commit to the full duration of the study
* Baseline Tinnitus Handicap Inventory (THI) score of \>= 38 points
* Subjective tinnitus of 3 months to 10 years
* Maximum AC pure-tone audiometry hearing loss of 80 dB HL in any test frequency in the set {2,3,4,6,8}kHz or 40 dB HL in the set {250,500,1000}Hz either unilaterally or bilaterally
* Baseline Minimum Masking Level (MML) of 20 to 80 dB HL
* Tonal tinnitus

Exclusion Criteria:

* Diagnosed with objective tinnitus
* Commenced usage of hearing aid within the last 90 days
* Cases where pulsatility is the dominant feature of tinnitus
* Patients whose tinnitus cannot be masked during Minimum Masking Level (MML) assessment
* Meniere's disease
* Significantly severe Loudness Discomfort Level (LDL, less than 30 dB SL)
* Depression or neuro-psychological condition, previously diagnosed or identified from the State-Trait Anxiety Inventory (STAI) with score greater than 120
* Diagnosed with somatic tinnitus resulting from head or neck injury
* Temporomandibular Joint Disorder (TMJ)
* Current or previous involvement in medico-legal cases
* Pregnancy
* Oral piercings
* Neurological condition that may lead to loss of consciousness (e.g. epilepsy) or is considered to be the dominant feature of the tinnitus, as assessed by audiologist or ENT consultant
* Severe cognitive impairment based on Mini Mental State Examination (MMSE, less than 20)
* Patient with a pacemaker or other electro-active implanted device
* Have used Neuromod Devices products in the past
* Participants currently prescribed drugs for a central nervous system pathology, i.e. epilepsy, Multiple Sclerosis (MS), Parkinson's, bi-polar disorder
* The site Principal Investigator does not deem the candidate to be suitable for the study for other reasons not listed above
* Self-reporting episodes of auditory hallucinations
* Abnormal Otoscopy as assessed by the Audiologist, including active Otitis Media, perforation and hearing loss that is identified as completely conductive
* Abnormal Tympanometry as assessed by the Audiologist
Evaluation of Efficacy and Safety of Goff Transpancreatic Septotomy vs. Double Wire Technique for Achieving Biliary Access in Technically Challenging ERCPs

Randomized, prospective study evaluating efficacy and safety of Goff transpancreatic septotomy vs. double wire technique for achieving biliary access in patients who fail initial cannulation at ERCP.

Selective placement of a guidewire into the bile duct (biliary cannulation) during endoscopic retrograde cholangiopancreatography (ERCP) is necessary for performing therapeutic biliary procedures. The success rate for biliary cannulation by experienced endoscopists during ERCP is approximately 85% with standard cannulation techniques. Inadvertent placement of the guidewire into the pancreatic duct rather than the bile duct often occurs when attempting selective biliary cannulation in technically challenging cases. When this occurs repeatedly, other approaches may be used to facilitate selective biliary cannulation, but there are few prospective studies evaluating the efficacy and safety of these approaches. Here the investigators evaluate two approaches for technically challenging biliary cannulation: one involving maintenance of a wire in the pancreatic duct, followed by repeat attempt at biliary cannulation (double wire technique) and one involving a small incision in the septum adjacent to the pancreas followed by repeat attempt at biliary cannulation (transpancreatic septotomy). This study is a prospective randomized trial comparing the rate of cannulation success, procedure duration and complications following these two approaches.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and older
2. Patient has a clinical indication for ERCP
3. Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

1. Age \<18
2. Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
3. Complex post-surgical anatomy e.g. Billroth type II anatomy, Roux-en-Y-gastrojejunostomy
4. Prior sphincterotomy or balloon dilation of ampulla
5. Thrombocytopenia, coagulopathy, or indication for ongoing anti-coagulation therapy
6. Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
A Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid

This trial is a phase III study to evaluate the efficacy , tolerability, and safety of Bempedoic Acid Tablets in patients with hyperlipidemia not adequately controlled by Statins.


Eligibility Criteria:
Inclusion Criteria:

* 1. 18 years and older, male or female.
* 2. 18 kg/m2 ≤Body Mass Index (BMI) ≤35 kg/m2.
* 3. Participants must agree to use reliable contraception from the screening day until 30 days after the last dose, and must not donate sperm or eggs for assisted reproduction purposes.
* 4. Fully understand the purpose and requirements of the study, voluntarily participate in the clinical trial, and sign a written informed consent form, capable of completing the entire study process.

Exclusion Criteria:

* 1. Known allergy to any component of the investigational drug or its excipients, or a history of allergic diseases (e.g., asthma, urticaria, eczema) or allergic constitution.
* 2. Fasting triglycerides (TG) ≥ 5.64 mmol/L (≥ 500 mg/dL) at screening.
* 3. History of malignant tumors prior to screening.
* 4. History of drug, alcohol, amphetamines, or other drug abuse.
* 5. Participation in other clinical studies and use of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of the drugs (whichever is longer).
* 6. Pregnant or breastfeeding females, or those with a positive human chorionic gonadotropin (HCG) pregnancy test.
* 7. Any other factors that the investigator believes makes the participant unsuitable for the study.
Predictors of Aortic Root Dilatation in Tetralogy of Fallot Patients

* To predict vulnerable patients for aortic root dilatation in TOF patients using CT as a reliable imaging modality, thus aiding early intervention, and identifying those who will require strict follow-up.
* To assess the prevalence of TOF patients who developed aortic root dilatation, and those who were complicated with dissection, AR, and aneurysm, through collecting data from a large center (Aswan Heart Centre).
* To investigate the relationship between age at repair and the diameter of aortic root.

Tetralogy of Fallot (TOF) occurs in approximately 3 to 5 of every 10,000 live births and is the most common cyanotic congenital heart defect and it exhibits four main features. These features are pulmonary stenosis, right ventricular hypertrophy, overriding aorta and ventricular septal defect. Moreover, since the survival of patients with congenital heart diseases has improved significantly in recent decades, long-term complications should be monitored cautiously. One of these complications is aortic root dilatation, attributed to increased and altered flow through the overriding aorta and an uneven sharing of conotruncal tissue between the aorta and pulmonary artery, particularly in patients who have not undergone early repair.

Despite the concern that TOF patients may harbor aortopathy that can lead to aortic regurgitation, aortic aneurysms, and, potentially, aortic dissection, the scope of the problem remains uncertain. Prevalence estimates of aortic root dilatation have ranged from 15% to 87% with the use of various criteria. Moderate to severe aortic regurgitation (AR) has also been reported in up to 12.5% of adults with TOF and dilated aortic roots. The incidence of aortic dissection and surgical intervention remains unknown. Moreover, features associated with aortic dilatation are not fully understood. Therefore, correlating and predicting vulnerable patients and identifying possible risk factors for aortic root dilatation in TOF patients, will enable more cautious follow-up and earlier intervention, thus decreasing possible morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* All patients with TOF who either underwent or have not yet had surgical correction.
* All patients with Fallot-type DORV.
* Patients should have survived until discharge and have at least one echocardiography and CT with full data related to one or more anatomic subcomponents of the aortic root, either before surgery or during follow-up, regardless of specific duration post repair.

Exclusion Criteria:

- Patients who have contraindication for conducting cardiac CT scan. For instance, dye sensitivity, pregnancy, CKD, in addition to patients who have factors that interfere with CT image quality as metallic objects within the chest (e.g. Pacemaker).
The Effect of In-vitro Myoinositol Supplementation of Human Sperm on the Outcome of Cryopreservation

The objective of this study is to evaluate the effect of in-vitro myoinositol supplementation of human sperm on the outcome of cryopreservation.

Sperm cryopreservation is considered the most valuable and used way to preserve male reproductive function. Unfortunately, osmotic effects of freezing and thawing during the cryopreservation process negatively affect sperm morphology and motility .

Myoinositol is the most biologically important form of inositol in nature. In male reproductive system, myoinositol appears to regulate sperm motility, capacitation and acrosomal reaction.

The objective of this study is to evaluate the effect of in-vitro myoinositol supplementation of human sperm on the outcome of cryopreservation.

Eligibility Criteria:
Inclusion Criteria:

* Infertile men with normal or abnormal semen analysis

Exclusion Criteria:

* Azoospermic samples
Telerehabilitation in Mild Cognitive Impairment

The main aim of the study is to evaluate the efficacy of the Virtual Reality Rehabilitation System (VRRS) compared to usual care treatment for patients with Mild Cognitive Impairment (MCI). Moreover, we will assess the possibility to prolong the beneficial effects of the treatment with an innovative telerehabilitation system. In the second phase of the present study we aim to evaluate the short and long term effects induced by the treatment of active (anodal) transcranial Direct Current Stimulation (tDCS) applied to the left dorsolateral prefrontal cortex combined with VRRS compared to placebo tDCS stimulation combined with VRRS.

The effects of the intervention on outcome variables will be assessed using a randomized controlled trial design with five groups. The investigators will assess the effects of VRRS system and of the implementation of the at-home treatment on the quality of life, cognitive and functional abilities.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MCI, defined according to standard criteria (Petersen et al., 2011)
* Mini Mental State Examination (MMSE) ≥24
* Education ≥ 5 years
* All of the subjects will have normal or corrected-to-normal vision and will be native Italian speakers.
* All participants reported subjective memory complaints and objective memory impairment, but no impairment of function in daily life.

Exclusion Criteria:

* visual perception disorder and/or hearing loss
* history of major psychiatric disorders
* any contraindication for tDCS such as a history of seizures, major head trauma, past brain surgery, a brain metal implant or a pacemaker.
Intraoperative Optical Coherence Tomography - Normals

Optical Coherence Tomography (OCT) image data will be evaluated for image quality and used to test post-processing algorithms to improve detection sensitivity for ophthalmic diseases.

Optical coherence tomography (OCT) is an established technology for ophthalmic diagnosis which can perform noncontact, noninvasive, real time, cross-sectional imaging of the retina and anterior eye. OCT has displaced ophthalmoscopy and stereo-photography as the gold-standard for clinical assessment and documentation of retinal microanatomy including thickness, cystoid structures, subretinal fluid and retinal traction. Despite these benefits, new technologies can still benefit patients including increasing the resolution, imaging speed, and contrast of OCT technologies. Since 2013, Dr. Tao's group has worked to develop and translate new ophthalmic imaging technologies.

The goal of this proposal is to develop novel OCT technology for improved diagnostic sensitivity in ophthalmology. Specifically, we will develop novel OCT imaging and image-processing methods to improve imaging speed and quality. Successful completion of this project will improve clinical diagnostics of ophthalmic diseases. Pre-clinical validation of system performance and ergonomics is a valuable step is clinical imaging technology development. The aim of this project is to performance system iterations on next-generation ophthalmic OCT imaging technologies over current-generation imaging systems on healthy adult volunteers prior to clinical translation. While system resolution, contrast, and speed can be (and will be) evaluated using calibration standards and phantoms, in vivo human imaging in healthy subjects is necessary to establish a baseline for system performance and image quality prior to clinical translation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults (\>18 years) with no pre-existing ophthalmic conditions

Exclusion Criteria:

* Children or adults unable to consent
* Any volunteers with history of ocular disease/injury
Targeting the Right Ventricle in Pulmonary Hypertension

This study is looking to see if giving ranolazine to subjects on stable pulmonary hypertension specific therapies but with right ventricular dysfunction (RVEF \<45%) would improve their outcome. This study is accompanied by a baseline comparison of the metabolic profiling/microRNA/iPS cells of subjects with and without right ventricular dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic pulmonary hypertension based on one of the following criteria: Idiopathic pulmonary arterial hypertension, Familial pulmonary arterial hypertension, pulmonary hypertension associated with connective tissue disease, chronic thromboembolic pulmonary hypertension-nonsurgical/distal vessel disease or patients who are reluctant to go to surgery within a 6-month period and are willing to participate, simple congenital such as repaired atrial septal defect or ventricular septal defect or unrepaired small atrial septal defect or ventricular septal defect with persistent and out of proportion pulmonary arterial hypertension, group 3 patients who have a component of pulmonary arterial hypertension, pulmonary arterial hypertension caused by conditions affect the veins and small vessels of the lungs, sickle cell disease, group 5 pulmonary hypertension such as polycythemia vera, essential thrombocythemia, sarcoidosis, or vasculitis, or metabolic disorder.
* WHO functional class II, III, or IV
* Mean pulmonary artery pressure \>25 mmHg at rest
* Pulmonary capillary wedge pressure or left ventricular end diastolic pressure \< 15 mmHg
* Baseline 6-minute walk test distance \> 50 meters
* Stable on baseline existing PH specific therapy for 12 weeks with no dosage change within 28 days prior to screening.

Exclusion Criteria:

* Previous treatment with or prior sensitivity to ranolazine
* Any family history of corrected QT interval prolongation, congenital long QT syndrome, or receiving drugs that prolong the corrected QT interval
* Parenchymal lung disease showing total lung capacity \< 50% of predicted OR forced expiratory volume at one second/forced vital capacity \< 50%
* Portal hypertension associated with liver disease
* Left sided heart disease including any of the following: moderate or greater aortic or mitral valve disease, Any left ventricle cardiomyopathy, Left ventricular systolic dysfunction defined as an ejection fraction \< 50%, Symptomatic coronary artery disease
* Uncontrolled hypertension
* Uncontrolled diabetes
Randomized Trial of the Effects of Musical Training on Child Development in the Venezuela Orchestra Program (El Sistema)

This study evaluates Venezuela's National System of Child and Youth Orchestras, better known as "El Sistema".

The randomized control trial was conducted in 16 music centers in Venezuela between May 2012 and November 2013, with a population of 6-14 year olds seeking entry to the program. During an application period (May-July 2012), 2,603 guardians (the experimental cluster) applied on behalf of 2,999 6-14 year olds. Approximately half of the guardians were randomly offered early admission in September 2012, with the rest offered admission in September 2013. Baseline and follow-up data were collected on outcomes which will be explored for full-group and specific sub-groups (children with less educated mothers, and boys or girls exposed to violence).

Eligibility Criteria:
Inclusion criteria:

* Excess demand in 5 geographic areas: 24 music centers across the 5 states were identified as the experimental sites based on the likelihood of having excess demand by families in the 2012-13 academic year.
* Apply protocol: Experimental sites agreed to accept written applications from guardians between May 7 and July 8, 2012 (without informing guardians of admission decisions until after randomization). Directors consented to participate in the experiment and received training in the experimental protocol. Children were eligible to apply if they would be 6 to 14 years old on September 1, 2012. Sites received applications from 2,603 guardians on behalf of 2,999 children.

Exclusion criteria:

* Music center level: Two sites were excluded because their directors declined to follow the experimental protocol, and six were excluded because of insufficient demand to carry out randomized experiment.
* Child/guardian level: By prior agreement, each site director could award early admission to a small number of applicants (no more than 5% of positions). In eight sites, 85 children (of 74 guardians) were excluded from the study because they entered through these positions allotted to site directors. Children were also lost from study if parental consent and child assent not given.
Gluten Free Diet in People With Schizophrenia: A Pilot Study

Background: Celiac disease is an immune-mediated reaction to gluten, presenting with diarrhea, weight loss, abdominal complaints and a range of less common associated neurologic and psychiatric symptoms. Evidence of a link between schizophrenia and celiac disease dates back to 1961. Recent evidence shows that 5.5% (age adjusted) of persons with schizophrenia participating in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study had a level of antibodies to tTG that is consistent with a diagnosis of celiac disease (compared to 1.1% of the comparison sample). An unexpected finding was that 23.4% (age adjusted) of the CATIE sample had antibodies to gliadin (compared to 2.9% of the comparison sample). It is hypothesized that a gluten free diet in people with schizophrenia who have Celiac disease or gluten sensitivity will have improvement in symptoms and quality of life.

Objectives: The aim of this proposed pilot study is to establish the feasibility of a initiating and maintaining a Gluten-free diet in these two groups. For this study The investigators will identify 8 individuals who have positive assays to tTG antibodies and confirmed celiac disease (N=4), or positive assays for anti-gliadin antibodies (N=4). The investigators plan to consent at least 2 subjects from each group and ask them to participate in a two-week open label treatment of a gluten free diet. The groups are;

1. Celiac disease (positive tTG antibody); and
2. Positive assay on Antigliadin antibodies


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be of either gender and of any race, with an age range of 18 55.
* Subjects will meet DSM-IV (APA, 1994) criteria for either schizophrenia or schizoaffective disorder. A best estimate diagnostic approach will be utilized in which information from the Structured Clinical Interview for DSM-IV (First et al, 1997) is supplemented by information from family informants, previous psychiatrists, and medical records to generate a diagnosis.
* Subjects will be required to have celiac disease (positive tTG antibody) or have gluten sensitivity (positive or AGA antibodies).
* Must be clinically stable and on the same antipsychotic for at least two months with an unchanged dose for the prior four weeks.
* Participants must complete the Evaluation to Sign Consent with a score of 10/12 or higher.

Exclusion Criteria:

* Pregnant or lactating women will be excluded. Pregnancy will be determined by pregnancy test. Lactating will be determined by participant report.