cyrilzakka/clinical-trials huggingface dataset:
Study of Temozolomide in the Treatment of Brain Metastasis From Non-small-cell Lung Cancer (Study P02143)

Brain metastases from solid tumors are diagnosed in more than 300,000 patients annually. Nonsmall cell lung cancer accounts for the majority of CNS mets. Treatment with whole brain radiation and steroids will improve neurologic symptoms in about 50% of patients although survival is short. This study will test the safety and efficacy of temozolomide in combination with radiation therapy in the treatment of patients with brain mets form nonsmall cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologic confirmation of non-small-cell lung cancer
* Stable systemic disease
* Maximum of one prior chemotherapy regimen for metastatic systemic disease
* Radiotherapy for local control or palliative bony lesions is allowed
* Karnofsky of greater than or equal to 70%
* Adequate hematologic, renal and liver function

Exclusion Criteria:

* Patients eligible for surgery of the brain
* Any previous chemotherapy for the brain metastasis
* Chemotherapy within 4 weeks or previous temozolomide
* Prior radiotherapy to the brain
* Radiation therapy to greater than 50% of the bone marrow
* Insufficient recovery from previous therapies
* Active nonmalignant systemic disease
* Inability to take oral medication
* Pregnant or nursing women
* Non use of adequate contraceptive techniques, negative urine pregnancy test is required
* Known AIDS related illness
Prochlorperazine Versus Prochlorperazine & Ketorolac in Treatment of Pediatric Migraine in the Emergency Department

The aim of this study is to evaluate whether the use of prochlorperazine and ketorolac in combination lead in a larger reduction in pain score compared to prochlorperazine alone when treating pediatric migraine in the Emergency Department (ED). Our hypothesis is that this combination of medications treats not only the pain but also the associated gastrointestinal symptoms of migraine. The main outcome of this study is the reduction in the patient's pain score at 60 minutes from administration of the study medications. Secondary outcomes include the number of patients achieving complete resolution of the headache while in the ED, the number of patients requiring additional treatment interventions by the treating physician, the number of patients with resolution of the associated symptoms like nausea, vomiting, photophobia and phonophobia, the recurrence of headache in the 48-72 hours after discharge, and side effects of the medications.


Eligibility Criteria:
Inclusion Criteria:

1. patient aged 8-18 years presenting to Akron Children's Hospital (ACH) ED with complaint of headache
2. patient has an established diagnosis of migraine without aura or as established by history meets the criteria for migraine headache as defined by the International Criteria for Headache Disorder -II in 2004 a. At least 5 episodes of headache b. The headache should last between 1-72 hours c. The headache should include two of the following: i. Unilateral location, though may be bifrontal or frontotemporal in location but should not be occipital ii. Pulsing quality iii. Moderate to severe pain iv. Aggravation by or causing avoidance of routine physical activity d. One of the following symptoms should accompany the headache i. Nausea or vomiting ii. Photophobia or phonophobia e. The headache should not be attributed to another disorder based on history, physical and/or laboratory information.

Exclusion Criteria:

1. Patients with a contraindication to receiving prochlorperazine, ketorolac, diphenhydramine, or naproxen
2. Patients unable to complete the pain scale.
3. Patients on medications that will have a drug-drug interaction with the study medication including prochlorperazine, ketorolac, diphenhydramine or naproxen.
4. Patients with any medical condition that may be contributing or associated with the current headache such as concussion or trauma
5. Female patients with a positive urine HCG point of care test
6. Patients with diagnosis of or suspected to have chronic daily headaches defined as a headache lasting at least 4 hours for more than 15 days a month for the past 3 months.
7. Patients who received prochlorperazine or ketorolac in the past 48 hours.
8. Patients who had previously been randomized in this study in the past 3 months.
Heart Ultrasound by Emergency Medicine Residents as an Estimate of Heart Function

The purpose of this research is to better understand the use of heart ultrasounds to estimate heart function.

This research involves ultrasounds of the heart by two different emergency medicine doctors who are residents in training. Results from the two doctors will be compared to see how similar they are. This research will help us understand if heart ultrasounds can be used to see how well the heart pumps blood and if similar results are obtained from different doctors.

The doctors will use ultrasound of the heart to measure E-Point Septal Separation (EPSS). EPSS is the distance between two parts of the heart, the mitral valve and the ventricular septum. EPSS is measured in millimeters (mm). EPSS can estimate left ventricular ejection fraction (LVEF) as a measure of how well the heart pumps blood.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, or patients who come to the emergency department who may have a heart echocardiogram scheduled as part of their routine clinical care
* Age 18 or over
* Willing and able to provide informed consent

Exclusion Criteria:

* Pediatrics (age \<18 years old).
* No cardiac-altering intervention performed between examiners.
* Unable to obtain a parasternal long view with mitral valve anterior leaflet, interventricular septum and aortic root.
* Transthoracic echocardiogram (TTE) more than the next day after EPSS is performed (for secondary outcome).
* Female with known pregnancy.
* Prisoner
* Prior cardiac surgery
Macrolide Maintenance Therapy in Chronic Obstructive Pulmonary Disease

To assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the preceding year of inclusion can decrease the exacerbation rate in the year of treatment.

COPD is characterized by progressive development of airflow limitation that is poorly reversible. Because of a poor understanding of COPD pathogenesis, treatment is mostly symptomatic and new therapeutic strategies are limited. There is a direct relationship between the severity of the disease and the intensity of the inflammatory response.One of the hypothesis for persistent airway inflammation is that the presence of recurrent infections is responsible for this condition.

Macrolide antibiotics have a bacteriostatic as well as anti-inflammatory properties. This clinical trial will investigate whether maintenance treatment with macrolide antibiotics during 1 year in people with 3 or more exacerbations in the preceding year of inclusion can decrease the exacerbation rate in that same year of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD according to GOLD criteria (FEV1/FVC\<70%), classification into GOLD I (FEV1 70-100% predicted), GOLD II (FEV1 50-70% predicted), GOLD III (FEV1 30- 50% predicted) or GOLD IV (FEV1 ≤ 30% predicted)
* Age ≥ 18 years
* Three or more exacerbations of COPD in one year for which a course of prednisone and/or antibiotic therapy was started
* Clinically stable during 1 month. Patients have to be free of COPD exacerbation or respiratory tract infection within a month prior to involvement in the study and they should not have received a high dose of systemic glucocorticoids or antibiotics in this period
* Informed consent

Exclusion Criteria:

* Use of antibiotics or high dose of systemic steroids within a month prior to involvement in the study.
* Addition of inhalation steroids to the patient's therapy regimen, shortly before entering the study.
* Pregnant or lactating women.
* Allergy to macrolides.
* Liver disease (alanine transaminase and/or aspartate transaminase levels 2 or more times the upper limit of normal).
* Asthma, defined as episodic symptoms of airflow obstruction which is reversible with bronchodilators, assessed with lung function testing.
* Presence of a malignancy which is clinically active.
* Bronchiectasis.
* Malignancy of any kind for which the subject is under treatment or is being monitored as part of follow up after treatment.
* Heart failure.
* Use of drugs which can adversely interact with macrolides and for which therapeutic monitoring cannot be undertaken.
ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions

The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD).


Eligibility Criteria:
Inclusion Criteria

* Participant has documented diagnosis of MDS according to World Health Organization (WHO) 2016 that meet IPSS-R classification of very low, low, or intermediate-risk disease, (intermediate-risk of ≤ 3.5 IPSS-R score) confirmed via bone marrow aspirate and:.

  i) \< 5% blasts in bone marrow and \< 1% blasts in peripheral blood.
* Participant is not transfusion dependent (NTD) based on IWG2018 criteria.
* Participant is erythropoiesis-stimulating agent naive. Participants may be randomized at the investigator's discretion if the participant received no more than 2 prior doses of epoetin alfa, epoetin alfa biosimilar, or darbepoetin alfa, with the last dose at least 8 weeks prior to randomization.
* Participant has a baseline endogenous serum erythropoietin (sEPO) level of ≤ 500 U/L.
* Participant has symptoms of anemia:.

  i) Participant records a severity score of "moderate" or greater on at least 1 PGI-S item of fatigue, weakness, shortness of breath, or dizziness performed during the screening period.
* Participant has a baseline Hb concentration prior to randomization of ≤ 9.5 g/dL. The baseline Hb will be calculated using the mean of the two lowest available Hb measurements within 16 weeks prior to randomization and must include at least one central lab Hb reading done within the screening period (no more than 35 days before randomization). The two Hb measurements must have been performed at least seven days apart. Hb levels less than 21 days following RBC transfusion should not be used. Split samples for local assessments are not required.

Exclusion Criteria

* Participant with secondary MDS (that is, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
* Participant with known history of diagnosis of AML.
* Participant with history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis within 6 months prior to randomization.
* Participant with a history of pure red cell aplasia and/or antibody against erythropoietin.
* Other protocol-defined Inclusion/Exclusion criteria apply.
The Influences of Watching a Movie Clip of Normal Walking on Measurable Walking Parameters Among Post-Brain-Stroke Patients as Opposed to the Influences of a Control Movie Clip Showing Backwards Walking

The study will include 20 subjects who will be randomly divided to two groups: a ten person group being the study group and a ten person group acting as a control group (each group will include a similar number of females and males as the other group). In addition, the physiotherapy treatments at the rehabilitation center, the study group will gain an intervention consisting of 12 therapy sessions, administered for 12 consecutive days (apart of weekends). The intervention will include 6 minutes of watching a movie clip alternately showing a healthy man and a healthy woman at their sixties, walking while being filmed from various angles. Immediately after watching, the subject will perform 6 minutes of walking, under the experimenters supervision, but without his or hers intervention. Immediately following the walking, the whole procedure will be repeated (watching a clip and walking).

The control group will undergo 12 treatments of the same nature, but will watch the movie clip shown backwards, so that the people filmed will seem to walk backwards (it was established that watching a reversed action does not activate the MNS system activated by a regular execution of the activity \[Celnik et al., 2008\]), followed by 6 minutes of walking under the experimenters supervision, then watching the movie again and walking again.

The person performing the examinations will be blinded as to the division of the subjects to the study group and the control group. After performing the previously noted examinations needed to participate in the research, the subjects found fit will be examined before the beginning of the intervention, at its end and then three months after its conclusion. The examinations will include smart step and walking parameters.


Eligibility Criteria:
Inclusion Criteria:

* People after a first ischemic or hemorrhagic stroke, up to 60 days following the event.
* A FAC (Functional Ambulation Category) score test result of 2 or 3, in order to ensure basic mobility, even if still requiring supervision.
* A NIHSS (National Institutes of Health Stroke Scale) score of 3 to 18.
* Patients suffering from the following will not be part of the study:

  * Significant neglect (a BIT score under 129 in the conventional tests).
  * Hemianopsy as determined upon a clinical examination by a rehabilitation physician.
  * Clarity of vision problem, determined upon an SC based examination.
  * Significant cognitive decline (a Mini mental test score of under 24).
  * Aphasia which prevents understanding the signing a Helsinki form.

Exclusion Criteria:

* Patients participating in concurrent researches will not participate
To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet

Assess the effect of renal function on the blood levels of DCV, ASV, BMS-791325.

IND Number: 79,599/101,943

Primary Purpose: Other - Phase 1 Clinical Pharmacology study to determine the effect of renal impairment on the exposure of DCV, ASV, BMS-791325 (fixed dosed combination) and BMS-791325 given in multiple doses

Fixed dose combination (FDC)

Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325 (DCV 3DAA FDC)

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Subjects in Group A must be in good health and have normal renal function
* Subjects in Groups B-E may have clinical, Electrocardiogram (ECG) and laboratory findings consistent with their degree of renal dysfunction
* Women of childbearing potential (WOCBP) and male participants must agree to follow the required contraceptive methods

Exclusion Criteria:

* Subjects in Group A must not have any significant acute or chronic illnesses
* Subjects in Groups B-E must not have uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, and/or neurological disease within 6 months of screening
* Subjects in Groups B-E may not have evidence of rapidly deteriorating renal function, defined as a screening creatinine clearance (CLcr) which has decreased from a previous CLcr by 50% within the last 3 months
* Prior exposure to DCV, ASV or BMS-791325 within 3 months prior to study drug administration
Diabetes Support Project: Couples Intervention

Research has shown that diabetes affects both the patient and family, and that support from family and partners helps diabetes patients manage their illness better. However, diabetes programs rarely involve the partner. The purpose of this study is to test an intervention that helps partners and patients who have type 2 diabetes better support each other. The intervention will be delivered over the telephone to reach more people. Our hypothesis is that an intervention that targets the couple has a greater effect on health and well-being of patients than one that targets the individual patient alone.

Diabetes is a serious illness that affects an estimated 7% of the US population, and is associated with life-threatening and disabling complications. Research has shown that diabetes affects both the patient and family, and that support from one's spouse has been found to be the most important source of support during illness episodes. Research clearly shows that marital interaction, i.e., how the support is given and received, impacts both marital quality and health functioning. Despite the acknowledged importance of social support, the vast majority of chronic illness interventions target the individual patient. Telephone counseling has been effectively used to enhance feasibility and target patients with many illnesses, and has many benefits including low cost, decreased subject burden, and the ability to reach a broader population. This study proposes a study of a telephone-administered behavior change that promotes couples communication and collaboration.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes
* A1c level is \>=7.5%
* Age of target subject and spouse/partner is 21 years or older
* Married or together for \> 1 year
* Able to speak, read, and hear English
* Have a telephone

Exclusion Criteria:

* History of diabetes-related medical complications
* History of active psychosis or dementia
Tongue Strength in Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease with a poor prognosis that occurs in adults 64 years on average. Its prevalence is 4 to 6/100 000 inhabitants.

Swallowing disorders occur during evolution and involve the prognosis of patients in the short term by the association of dysphagia with severe malnutrition, and aspiration. The issue of phoniatric monitoring is to detect early onset of the swallowing disorders to develop strategies for respiratory protection, food adapted to disturbances, and speech therapy.

The objective of this study is to compare the tongue force in patients with amyotrophic lateral sclerosis at the time of diagnosis and at the onset of swallowing disorders compared to healthy subjects, with the dynamic palatography device developed in the Laboratoire Parole et Langage (UMR 7309, CNRS-Université Aix-Marseille, Aix-en-Provence), which allows the measurement of the strength and duration of the pression of the tongue on the palate.


Eligibility Criteria:
Inclusion Criteria:

* Adults and legally responsible/ valid medical insurance
* patients : ALS diagnostic already announced
* healthy subjects : EAT-10 score\<2

Exclusion Criteria:

* Non pregnant and non baby feeding
* Presence of risk factor or suspicion of Creutzfeld Jacob Disease
* Allergy/intolerance to the glueing paste
* Antecedent of pathology of the aerodigestive tract
* Other neurologic disease
* Morphologic anomaly of the aerodigestive tract
* Excessive gag reflex
The Effects of Whole Food Intervention on Mucositis in Patients Treated for Thoracic Cancer

This study will evaluate whether a Whole Food Intervention reduces the frequency or severity of esophagitis in patients receiving treatment for non-small cell lung cancer.

The Whole Food Intervention consists of yogurt, butter, honey, vanilla, and glutamine with 3 portioning cups, equal to approximately 12 ounces, taken daily before starting radiation therapy.

The proposal is a one center, open label, randomized pilot study to evaluate the safety, tolerability and compliance of a Whole Food Intervention with Standard of Care for patients with non-small cell lung cancer. The primary objectives are:

1. To determine whether patients will use a Whole Food Intervention 4-6 times daily, and
2. To determine whether the Whole Food Intervention will reduce the incidence of grade 2 or greater esophagitis from 75% historically seen to 25% .
3. To determine whether Whole Food Intervention will reduce the incidence of treatment breaks from \>19% to \< 10% (see section 9 for comments)

This Whole Food Intervention will be taken by mouth before the start of radiation therapy, with or without chemotherapy and for the entire treatment therapy.

Esophagitis-related pain and reduction of oral intake will be quantified by using validated assessment tools. Weight loss or gain, diarrhea, constipation or no change in bowel function and the use of conventional medication for radiation-induced esophagitis will be recorded. Chart review and patient questionnaires will be used to establish whether a treatment break or dose reduction for radiation of chemotherapy was required due to radiation esophagitis-related symptoms. Complete Chemistry Profile and Complete Blood Count will be extracted from the patients' medical oncologist's or radiation oncologist's records. The patient will continue to use standard esophagitis therapies if desired as prescribed by the treating oncology physician.

The Whole Food Intervention consists of yogurt, butter, honey, vanilla, and glutamine with 3 portioning cups, equal to approximately 12 ounces, taken daily before starting radiation therapy. A questionnaire will be used to record symptoms and doses taken. The patient will continue to use standard esophagitis therapies as prescribed by the treating oncology physician.

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed diagnosis of thoracic carcinoma
* Scheduled to undergo continuous daily course of radiation therapy with or without chemotherapy
* No other serious concurrent medical illness as determined by the Principle Investigator
* Absolute neutrophil count ≥ 500/mm3
* Platelet count ≥ 50,000/mm3
* No history of insulin-dependent diabetes mellitus
* No prior hypersensitivity reaction to compound components

Exclusion Criteria:

* Dislike of the available forms of the WFI
* Allergy or food intolerance relevant to the ingredients
* Lack of access to refrigerated storage for the WFI
* Inability or unwillingness to participate twice a week
* Inability to swallow
* Undergoing treatment for HIV with HIV medications
* Ongoing alcohol and/or drug abuse