cyrilzakka/clinical-trials huggingface dataset:
10-Propargyl-10-Deazaaminopterin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of 10-propargyl-10-deazaaminopterin in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

OBJECTIVES: I. Determine objective response rate, duration of response, and time to disease progression in patients with stage IIIB (pleural or pericardial disease) or stage IV non-small cell lung cancer treated with 10-propargyl-10-deazaaminopterin as first line or second line chemotherapy. II. Determine the toxicity of this drug in this patient population. III. Determine duration of survival in these patients. IV. Determine quality of life of these patients.

OUTLINE: Patients receive 10-propargyl-10-deazaaminopterin IV on days 1 and 15. Treatment repeats every 4 weeks in the absence of unacceptable toxicity or disease progression. Quality of life is assessed at the beginning of each course. Patients are followed every 8 weeks for disease progression.

PROJECTED ACCRUAL: A total of 19-39 patients will be accrued for this study within 12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed stage IIIB (pleural or pericardial disease) or stage IV non-small cell lung cancer Measurable or evaluable indicator lesion that has not been irradiated Pleural effusions, bone metastases, brain metastases, elevated serum enzymes, and abnormal radionucliotide scans are unacceptable as sole indicator lesions No clinically significant pleural effusions or ascites No grade III or IV edema No prior pneumonectomy No symptomatic or uncontrolled brain or leptomeningeal involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 Hemoglobin at least 10 g/dL Platelet count at least 160,000/mm3 Hepatic: Bilirubin no greater than 1.0 mg/dL AST no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No unstable cardiac disease requiring treatment Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other concurrent active cancer No history of significant neurologic or psychiatric disorders, including psychotic disorders, dementia, or seizures No active uncontrolled infection No other serious illness or medical condition

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy OR Progression after stable disease or initial response to 1 prior chemotherapy regimen, including 1 preoperative or adjuvant chemotherapy regimen Endocrine therapy: Concurrent steroids allowed if dose is stable Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: No prior antifolates At least 7 days since prior folic acid supplements
Pharmacokinetics of Oseltamivir in Newborns and Infants

Oseltamivir dosing in infants \< 3 months of age is based on a single pharmacokinetic study in 20 infants from a single center. This dataset is limited by a lack of robustness, because only 1 sample was collected from each participant. The investigators obtained two blood samples each from infants receiving oseltamivir after obtaining informed consent from the infant's parents. The investigators propose to analyze the blood samples to determine the amount of oseltamivir in the infant's blood. Measurement of these values will increase the understanding of the absorption and elimination of oseltamivir in preterm and term infants, and improve our ability to provide the correct doses to this high risk population.


Eligibility Criteria:
Inclusion Criteria:

* All neonates and infants in the NICU at St. Louis Children's Hospital who received oseltamivir for treatment of or exposure to influenza virus type A were considered eligible for this study.
Assessment of Stroke Volume and Cardiac Output in Response to Varying Heart Rates

The investigators will seek to determine the effects of different heart rates on both stroke volume and cardiac output using non-invasive hemodynamic assessments. In order to safely manipulate the HR, the investigators will study patients with permanent pacemakers in whom heart rate manipulation can be done in a safe and non-invasive manner.

Permanent pacemakers have sometimes been used to treat patients with recurrent vasovagal syncope. This is because patients with vasovagal syncope often experience bradycardia at the time of their syncope. Unfortunately, pacemakers are often ineffective in preventing syncope.

Classical cardiovascular hemodynamics would suggest that increasing the heart rate (HR; via pacemaker) should increase the cardiac output (CO). This is because:

CO = HR x Stroke volume (SV).

The assumption is that the SV is fixed during manipulation of the HR. However, this might not be the case. As the number of beats per minute (HR) increases, the cardiac cycle length (R-R interval \[RRI\]) shortens, as a function of simple math. This means that the time in cardiac systole shortens, and the time in cardiac diastole shortens. Since cardiac diastole is when the heart fills up with blood, faster HR can be associated with decreased cardiac filling times. This, in turn, could compromise the SV. However, there is a paucity of data as to what happens to SV and CO at different HR. Further, it is possible that these effects will be different when a person is lying down supine versus when a patient is upright (when stroke volume will be lower).

The investigators will seek to determine the effects of different HR on both SV \& CO. In order to safely manipulate the HR, they will study patients with permanent pacemakers in whom HR manipulation can be done in a safe and non-invasive manner.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years (inclusive)
* Implanted permanent pacemaker or implanted defibrillator capable of atrial and ventricular pacing
* LV ejection fraction \>50%

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Clinical need for a cardiac resynchronization device
Metabolomic Profiling of Eosinophilic Esophagitis

A prospective longitudinal, observational study of adolescent and adults that will identify novel metabolites associated with dysphagia in Eosinophilic Esophagitis (EoE).

In this study, the investigators seek to understand whether a metabolomic profile obtained from esophageal samples correlate with the symptom of dysphagia in adolescent and adults. The investigators hypothesize that intraluminal secreted metabolite(s) will change during episodes of dysphagia. The aim of the study will be to use a novel method of producing esophageal luminal samples, the esophageal string test, to capture esophageal metabolites when a patient is and is not experiencing dysphagia.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with Eosinophilic Esophagitis (EoE) and seen either at Children's Hospital Colorado or University of Colorado Hospital for scheduled outpatient clinical assessment or upper GI endoscopy

Exclusion Criteria:

* Acute food impaction at time of study
* Recent (within 2 months) use of systemic steroids
* Other known esophageal disease or esophageal injury (e.g. tracheoesophageal fistula, congenital stricture, caustic injury)
* known other inflammatory bowel disease
* inability to swallow the EST
Maxillofacial Rehabilitation Using Motor Imagery vs Sham After Orthognathic Surgery

Dento-maxillary dysmorphoses are defined as an anomaly in the relative growth of the maxilla and/or mandible. They lead to functional disorders (i.e., disturbances in chewing or oral communication) and aesthetic issues with psychological repercussions on self-esteem, affecting the quality of life of these patients. The multidisciplinary treatment involves orthodontics (duration = 18-24 months), orthognathic surgery involving the maxillary and/or mandibular bone (at 12 months), immediately followed by physiotherapy (duration = 3 months). One main goal after surgery is the recovery of month opening to restore an appropriate orofacial function. Motor imagery (mental rehearsal of a movement without actually moving) is effectively used in athletes and in rehabilitation mainly neurological but so far has not been investigated in maxillofacial rehabilitation. Considering that the effectiveness of rehabilitation is increased when physical and mental practices are combined, this leads to propose this study aiming to investigate whether the addition of motor imagery of the maxillofacial region to maxillofacial physiotherapy (based on a practice of physical therapeutic exercises) modifies the recovery of maximum mouth opening, other ranges of motion, jaw function, and quality of life in patients after orthognathic surgery compared to the addition of a control cognitive task \[watching a non-emotional content film or filling out a crossword or Sudoku grid\] to maxillofacial physiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Volunteer after orthognathic surgery of the mandible alone or concurrently with the maxilla.
* Consent to participate to the study after receiving clear, loyal and appropriate information.
* Aged ≥ 18 years.
* Health care beneficiary

Exclusion Criteria:

* Patient who has undergone maxillary surgery alone (e.g., LeFort I) or genioplasty. Indeed, both of these surgeries typically have a favorable and rapid recovery without the need for maxillofacial physiotherapy.
* Patient unable to imagine a maximum mouth opening movement (i.e., score = 1, no mental image / no sensations) on the 5-point Likert scale used during the administration of the Tongue Month Imagery Questionnaire (TMIQ).
* Ongoing participation in another research that aim to evaluate an intervention likely to improve the neurological or functional recovery introducing an experimental bias.
* Patients not undergoing rehabilitation in the study centers.
* Patients under guardians, curators, or legal protection.
* Pregnant or lactating patients.
Biomarkers Predictive of Thymic Evolution and Therapeutic Response At 2 Years in Patients with a First Psychotic Episode

Psychosis is a severe, common, and disabling psychological disorder. An epidemiological study conducted in England reported an incidence of 34 new cases per 100,000 person-years, with a peak between 16 and 19 years of age. Following a first psychotic episode, two clinical evolutions are possible: thymic psychosis (17%) and non thymic psychosis (83%). The first includes bipolar disorders with a psychotic component and major depressive disorders with a psychotic component; the second, other psychotic disorders, mainly schizophrenia. One of the major difficulties encountered is the frequent impossibility of specifying the type of psychosis at the beginning of the psychotic episode. However, these disorders require different therapies, particularly medication. This leads to a delay in diagnosis with a high risk of relapse.

The semiological study of these diseases being carried out within the framework of interviews, it seems interesting to be able to record these and to obtain a quantitative and objective measurement through the study of language. The use of machine learning has made it possible to distinguish patients with schizophrenia from those with bipolar disorder by graphical analysis of language in a more efficient way than with clinical scales.Moreover, it is possible to identify linguistic markers: thus, an alteration of syntactic structures and prosody would be more present in non-thymic than in thymic psychoses.

Paraclinical markers are also emerging. In particular, the link between inflammation and mental disorders.For example, an increase in IL-8 has been found only in thymic psychoses.

In this context, it seems essential to be able to distinguish these disorders as early as possible through the combined use of clinical and paraclinical markers, and to be able to better understand their pathophysiology.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a first episode of psychosis,
* Aged between 15 and 30 years,
* Able to consent and having signed a consent form (parental consent for minors).

Exclusion Criteria:

* Introduction or increase of antipsychotic and/or antidepressant and/or thymoregulatory treatment in the last month,
* Mother tongue other than French,
* Psychotic episode due to an organic disorder,
* Psychotic episode induced by the use or withdrawal of toxic substances with severe dependence ,
* Intellectual deficit,
* Chronic inflammatory disease,
* Immunomodulatory treatment,
* Contraindication to MRI,
* Pregnant or breastfeeding woman,
* Patient under court protection, guardianship, curatorship or deprived of liberty.
The Effect of Transcranial Direct Current Stimulation (tDCS) in Addition to Tinnitus Retraining Therapy (TRT) for Treatment of Chronic Tinnitus Patients

The aim of this study is to evaluate the added effect of tDCS to TRT within patients with chronic, non-pulsatile tinnitus. Patients were randomised in two groups namely, TRT and real tDCS and the second one is TRT with sham tDCS. Evaluations took place at the start of therapy, at the end of the counselling and at last a follow-up visit will be planned after 84 days of the start of the therapy. Subjective outcome measurements such as Tinnitus Functional Index and Visual Analogue Scales of loudness are the primary outcome measurement. Secondary outcome measurements are the Hospital Anxiety and Depression Scale, hyperacusis questionnaire and psychoacoustic measurements.


Eligibility Criteria:
Inclusion Criteria:

* Duration of tinnitus \> 6 months
* Maximum loudness of tinnitus on the VAS ≥ 4
* TFI score ≥ 25

Exclusion Criteria:

* Pregnancy
* Psychiatric disorders
* Pace maker or defibrillator
* Pulsatile tinnitus
* Acoustic Neurinoma
* CVA
A Pilot Project for Multifidus Muscle Evaluation in Patients With Multiple Sclerosis

This research study plans to evaluate if multifidus muscle dysfunction is associated with back pain in patients with Multiple Sclerosis (MS).

Since the multifidus muscle helps to stabilize the lumbar spine, the investigators hope to learn if there is dysfunction and/or atrophy of this muscle in MS patients who also have back pain. The main objective is to study if it is possible to do a home-exercise program in patients with MS younger then 50 years old and who do not need any assistance to walk. Another objective is to further characterize the multifidus function in those patients. This will be by by measuring the size of muscle at the beginning and end of the study, and also by physical exam. As an exploratory aim, the investigators would like to evaluate the relation between compliance with the home-exercise program and the change in the size of the multifidus muscle and the change in pain.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis by an UAMS neuro-immunologist of relapsing-remitting MS or primary progressive MS or secondary progressive MS
* Age between 18 years old and 50 years old on consent
* Complain of low back pain or severe axial back pain
* English-speaking

Exclusion Criteria:

* Patients that also have the diagnosis of thoracic or lumbar radiculopathy or history of prior thoracic or lumbar spinal surgery.

Patients that are currently pregnant EDSS over 5.5 or less than 1.0 Patient younger than 18 years old or older than 50 years old Knee total extension of less than 100 degrees
Reliability of the Neurophysiology of Pain Questionnaire in the Neck Pain the Cross-validation Study

The aim of this study is to study the validity and reliability of the Modified Pain Neurophysiology Questionnaire in patients with neck pain. After the ethics committee approval, women and men in Turkey will be invited to the research via online advertisements (researchers' facebook, instagram, twitter accounts). The scale will be translated from English to Turkish by two people who are fluent in Turkish and English. A single Turkish translation will be obtained with a common opinion from these two Turkish translations. In ten trial phases, a preliminary assessment will be conducted with 15 participants to test the intelligibility of the scale. If there are participants who think that there is a problem with the intelligibility of the scale, they will be asked to explain which items they have problems understanding and why. After individuals are informed with the online voluntary consent form, participants will be asked to complete the Modified Pain Neurophysiology questionnaire. Modified Pain Neurophysiology scale questions and questions in the data collection form will be prepared through the google surveys application and will be sent to the participants via Whatsapp, Facebook, Instagram and e-mail. Participants will fill out the survey forms online. In order to evaluate the validity of the Modified Pain Neurophysiology questionnaire, the pain subscale of the SF-36 scale, which has been validated in Turkish, will be used (McHorney, Ware, Lu, and Sherbourne, 1994), (Kocyigit et al., 1999). Scales after 15 days to assess test-retest reliability will be repeated.


Eligibility Criteria:
Inclusion Criteria:

* be between the ages of 18-65
* Having neck pain complaints for the last 3 months
* Adult individuals who agreed to participate in the study. Their mother tongue is Turkish.

Exclusion Criteria:

* Not answering all the questions
Study on the Efficacy and Safety of Oral Probucol Tablets in Patients With Hyperlipidemia - Post-Marketing Surveillance

The primary objective of this post marketing surveillance (PMS) is to determine the safety and efficacy of probucol in lowering the level of serum cholesterol in the blood.

This nationwide post marketing surveillance targets to recruit a total of 3,000 patients with hyperlipidemia. Duration of treatment is 60 days. The usual starting dose for Lorelco is 500 mg administered daily, divided into two (2) doses (250mg BID) and given after meals. The dose may be adjusted according to the patient's age and condition. Lipid serum test will be obtained at Day 0 (Baseline). In subjects requiring antihyperlipidemics that fulfill the inclusion criteria, Lorelco 250 BID will be started. There will be 2 follow-up visits after baseline on Day 30 and Day 60. Both lipid serum tests and ECG will be done on these 2 follow-up visits. During each visit the investigator will assess the subject's vital signs and symptoms and check for any adverse events.

The primary outcome of measure is the percentage reduction or increase in total cholesterol and triglycerides from baseline values at Week 0 to Week 4 and Week 8 using the following scale:

Total Cholesterol Triglycerides

1. Markedly reduced
2. Moderately reduced
3. Slightly reduced
4. Unchanged
5. Increased Reduction of ≥ 15% Reduction of ≥ 10% but \< 15% Reduction of ≥ 5% but \< 10% Change of \< 5% Increase of ≥ 5% Reduction of ≥ 30% Reduction of ≥ 20% but \< 30% Reduction of ≥ 10% but \< 20% Change of \< 10% Increase of ≥ 10% The percentage change on the last week of treatment will be the final evaluation.

The secondary outcome is measured by the changes in symptoms and vital signs. Using the following scale:

1. Markedly Improved
2. Improved
3. Slightly Improved
4. Unchanged
5. Aggravated
6. Unknown (not assessable)

Safety will be measured by the incidence of adverse events to be collected.

Overall efficacy and safety will be evaluated to assess the usefulness of Lorelco using the following scale:

1. Very useful
2. Useful
3. Somewhat useful
4. Not useful
5. Unfavorable
6. Unknown (not assessable)

Eligibility Criteria:
Inclusion Criteria:

Diagnosed with hyperlipidemia including familial hypercholesterolemia and xanthoma.

Exclusion Criteria:

None
Immune Response To Intranasal Influenza Vaccination

This research during the last decade has focused on the kinetics of the systemic and local immune response to parenteral influenza vaccine in humans. The investigators have shown that normally high numbers of influenza specific antibody secreting cells (ASC) are present in the nasal mucosa of healthy adults but upon parenteral vaccination the numbers remain stable. However, a rapid transient increase in specific ASC is observed in the tonsils and peripheral blood after parenteral vaccination. In the tonsils, this is associated with a significant decrease in both naïve/effector (CD45RA+) and memory (CD45RO+) CD4+ cells upon vaccination. In this study the investigators will extend our work to investigate the characteristics of influenza-specific T- and B-cells induced locally and systemically after intranasal vaccination in man.

The clinical trial will be an open study. All subjects eligible for tonsillectomy at Haukeland University Hospital within the specified age range (children: 2 to less than 18 years old and adults \>18-59 years old) will receive an invitation to join the study. The primary endpoints of the trial are the evaluation of the systemic and local immune response after live attenuated influenza vaccine. The vaccine specific immune response will be assessed through the induction of specific local and systemic antibody and cellular immune responses, and analyses of the epitopes to which the response is directed. Furthermore the capacity of the vaccine to elicit cross reactive and long lasting immunity will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children (age range ≥2 and \<18 years old) or adults (\>18-59 years old) as concluded from the medical history, physical examination, and clinical judgment) scheduled for tonsillectomy ;
* Signed informed consent from the subject or both parents/ both guardians and from subjects aged 12 years and older;
* Subjects or guardians able to understand and comply with the study protocol and complete the Adverse Event Form:
* Subjects able to attend the scheduled visits.

Exclusion Criteria:

* Persons with a history of anaphylaxis or serious reactions to any vaccine;
* Person with known hypersensitivity to any of the vaccine components (e.g. gelatin, gentamicin, eggs or egg proteins (e.g. ovalbumin);
* Persons who are pregnant
* Persons who have had a temperature \>38oC during the previous 72 hours;
* Persons who have had an acute respiratory infection during the last 7 days;
* Persons who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids;
* Persons with severely immunocompromised family members;
* Persons with severe asthma or active wheezing.