cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Efficacy of Aprepitant (MK0869) for Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients

Aprepitant was approved in 2003. The drug works to lessen the amount of nausea and vomiting that cancer patients experience after treatment. Aprepitant has been well-studied in adults, but not in children. Data from adult studies has shown aprepitant to be safe. It has also been shown to be effective in lessening the amount of nausea and vomiting that adult patients experience. Because aprepitant has been shown to be safe and effective, the investigators have been using it in pediatric patients at this hospital as standard of care. The investigators will be surveying patients already receiving aprepitant for prevention of chemotherapy-induced nausea and vomiting to determine the amount of nausea and vomiting they experience. The investigators will also be surveying these patients to determine what their appetite is like and if they experience any disruptions in activities of daily living. The investigators are also going to be assessing any side effects these patients experience from receiving aprepitant.

This will be a prospective, observational study conducted at WVU Children´s Hospital. The study will be conducted over a one-year period until data from 20-40 patient encounters is obtained. There will be no randomization and no control group. Information will be collected from all patients who meet the study´s inclusion criteria. Patients will be given a survey to complete at baseline, on all days of chemotherapy, and for five days after the conclusion of chemotherapy using the BARF Scale and a 4-point Likert scale. The information collected from the survey will include the incidence and severity of nausea and emesis, evaluation of appetite, activities of daily living, and rescue medications used for acute CINV. The specific chemotherapy regimen that each patient receives will be recorded. Any data identifying the patient will be de-identified after all pertinent data is collected. Descriptive statistics will be used to analyze data.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is between the ages of 1-17 years
2. Patient has a confirmed malignancy
3. Patient is receiving highly or moderately emetogenic chemotherapy
4. Receiving aprepitant as part of an anti-emetic regimen
5. Patient's legally-authorized representative understands and voluntarily signs the written informed consent prior to any study-specific procedures. A copy of the signed informed consent form will be retained by the treating institution.
6. Patient ≥7 years of age understands and voluntarily signs the written informed assent form prior to any study specific procedures. A copy of the signed informed assent form will be retained by the treating institution.

Exclusion criteria:

1. Pregnant or breast feeding
2. Concomitant use of pimozide, terfenadine, astemizole, or cisapride
3. Child-Pugh score \> 9
4. Receiving IV fosaprepitant
Integrated Behavioral Intervention for Cigarette Smoking and Binge Drinking in Young Adults

RATIONALE: Nicotine patches and behavioral therapy may help reduce cigarette smoking and binge drinking in young adults. PURPOSE: This randomized clinical trial studies nicotine patches with or without behavioral therapy in reducing cigarette smoking and binge drinking in young adults.

OBJECTIVES: I. To evaluate the efficacy of Integrated Intervention that targets both cigarette smoking and binge drinking on the cigarette smoking behavior of young adult smokers at 6-month follow-up. II. To evaluate the efficacy of Integrated Intervention that targets both cigarette smoking and binge drinking on binge drinking behavior of young adult smokers. III. Examine the effect of Integrated Intervention on several possible mediators of change corresponding to mechanisms that have been proposed to account for the relationship between cigarette smoking and alcohol use. These mediators include cravings to smoke, perceived similarity to the typical smoker, and self-efficacy for smoking abstinence. OUTLINE: Patients are randomized to 1 of 2 treatment arms.All patients receive nicotine patch therapy in weeks 4-11. ARM I: Patients attend behavioral sessions for smoking and binge drinking cessation over 30 minutes once weekly in weeks 1-6. ARM II: Patients attend behavioral sessions for smoking cessation over 30 minutes once weekly in weeks 1-6.After completion of study treatment, patients are followed up at weeks 12, 16, 20, and 24.

Eligibility Criteria:
Inclusion Criteria: - Smoked an average of \>= 10 or more cigarettes per day during the past 6 months - Binge drank on an average of \>= 2 occasions per month during the past 3 months - Able to participate fully in all aspects of the intervention and keep all scheduled appointments - Willing to participate in 6 months of follow-up - Willing to stop smoking and use nicotine patch therapy - Willing to refrain from participating in additional smoking interventions for the duration of the study - Provide written informed consent Exclusion Criteria: - Current (past 90 days) alcohol dependence as assessed by the Structured Clinical Interview for DSM-IV Axis I Disorders, Alcohol Dependence Module - Current (past 12 months) non-nicotine or alcohol drug dependence as assessed by a Drug Abuse Screening Test-20 score of \>= 6 - Current elevation of depressive symptoms (past 2 weeks) that would be indicative of clinical depression as assessed by a Beck Depression Inventory-II score of \>= 20 - Current use (past 30 days) of nicotine containing medication or frequent use (\> 10 occasions per month) of tobacco products other than cigarettes - Current use (past 30 days) of any other smoking cessation treatment involving behavioral or pharmacological interventions - Any medical condition that would preclude use of the nicotine patch including current unstable angina, recent history (past 30 days) of myocardial infarction or stroke, history of severe skin allergies, or evidence of severe chronic dermatosis - Currently pregnant or breast feeding, or likely to become pregnant during the nicotine patch phase
Tailored Music Therapy for Dementia

This study evaluates the effect and process of individualized music therapy for home-dwelling persons with mild to moderate dementia. The music therapy is administered individually and includes a close caregiver. Memory of familiar music is found to be retained in persons with dementia. It is assumed to facilitate autobiographical memories and stimulate interaction with significant others. Based on time series analyses we will use statistical process control to evaluate when and how change occur.

Dementia is often followed by complicating symptoms such as anxiety, depression, agitation, hallucination and sleep disorders. The progression of dementia can threaten the relationship between the person with dementia (PWD) and their relatives. One reason is the possible loss of reciprocity and a mutual supportive relationship. This may influence the quality of life in both the PWD and their relatives and increase the caregiver-burden. The music therapy in this intervention is focusing on increasing positive emotions, increasing reciprocity and stimulating communication.

The 1st, 5th and 10th music therapy-session is video-recorded. The first 5 recorded minutes before the sessions will provide a baseline of the observed primary outcomes throughout the session. Videos are analyzed to examine changes in social communication behavior and emotional well-being. Time-series analysis of the observations will be conducted, enabling us to evaluate potential effects of the therapeutic interventions and to find out when, why and to what extent changes unfold in real time. The pre-post measures are secondary. The project is a merging and further development of two recent music therapy designs. (Articles cited in the references.)

Eligibility Criteria:
Inclusion Criteria:

* The patient is diagnosed with Dementia of the Alzheimer's type, Vascular Dementia, Dementia with Lewy bodies, Parkinsons's Disease Dementia (ICD-10 criteria)
* The severity of the cognitive impairment is within the range of 0,5 - 2 when assessed with The Clinical Dementia Rating Scale (CDR)
* A caregiver chosen by the patient commits to involvement in the treatment as a collateral (i.e. spouse, child, grandchild, sibling, close friend)
* Use of psychotropic medication has been stable during the past 2 weeks
* The PWD is able to answer simple self-report questionnaires on their own or when interviewed by a trained professional
* Informed consent is obtained from patients and caregiver
* The PWD's are living in their home, in assisted living facilities or only periodical living in care homes.

Exclusion Criteria:

* Severe dementia(a score of 3\> on CDR).
* Severe aphasia
* Frontotemporal dementia
* Comorbid diagnosis of bipolar disorder, diagnosis of schizophrenia and related disorders
* Changes in psychotropic medications in the past 2 weeks. If so, the medication needs to be stable before pre-assessment is undertaken
* Severe psychotic symptoms or serious risk of suicide
* Permanent living arrangement in nursing home, or planned temporary stay during the treatment period
Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 1

The purpose of this study was to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Acuvue Moist contact lenses.

Subjects were expected to attend 3 study visits and wear study lenses for approximately 14 - 20 days (7 - 10 days for each product).

Eligibility Criteria:
Key Inclusion Criteria:

* Able to understand and sign an Informed Consent Form that has been approved by an Institutional Review Board.
* Willing and able to attend all scheduled study visits as required per protocol.
* Current wearer of spherical soft contact lenses.

Key Exclusion Criteria:

* Any ocular condition that contraindicates contact lens wear.
* Previous or current habitual wearer of ACUVUE® MOIST or DAILIES TOTAL1® contact lenses.
A Phase II Study to Evaluate the Efficacy and Safety of SHR-1314 in Lupus Nephritis

To demonstrate the efficacy of SHR-1314 at Week 12 in subjects with proliferation lupus nephritis in terms of improvement of 24h UPCR, compared to placebo. The study will also assess the safety and tolerability of SHR-1314 in the patient population over the study period.


Eligibility Criteria:
Inclusion Criteria:

1. Chinese adult pts (18-65yr), Male or Female
2. BMI≥18 kg/m2 and ≤ 35kg/m2
3. Confirmed diagnosis of LN, renal biopsy report data is within 3-months prior to the date of ICF is first signed

   3.1 Biopsy-proven proliferative lupus nephritis Class III or Class IV, either with or without the presence of Class V, using the 2003 ISN/RPS criteria.

   3.2 24h UPCR ≥ 1 at screening.

   3.3 24h UPR ≥ 1.0 g/d，≤ 3.5 g/d.

   3.4 eGFR \> 45ml/min/1.73m2.
4. SLEDAI-2K≥8.

Exclusion Criteria:

1. Significant medical Problems like myocarditis, pericarditis, severe manifestations of neuropsychiatric SLE (NPSLE)
2. Subjects who have previously treated by both CYC and MMF (or other forms of mycophenolate)
3. With a hHistory of using 60 mg/d prednisolone (or equivalent dose) for more than 3 months prior to Baseline
4. History of inflammatory bowel disease or have other ongoing active autoimmune diseases
5. Required management of acute or chronic infections within the past 8 weeks.
6. At screening, history or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
7. History of congestive heart failure (New York Heart Association \[NYHA\] functional classification ≥III), cerebro-cardiovascular events, or serious bleeding events at screening and / or randomization that in the judgement of the Investigator prevents the subject from participating in the study.
8. History of depression and/or suicidal ideation or any suicidal behavior based on an assessment using the Columbina Suicide Severity Rating Scale (C-SSRS) at screening and baseline . The subjects will be exluded if any answer to question is "yes" in the questionnaire orare clinically judged by the investigator to be at risk for suicide
9. Receipt of any IL-17/IL-17R targeted therapy within the past year.
10. Those who have participated in any clinical study for any drug or medical device within 3 months before screening.
11. Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
12. All subjects will be tested for tuberculosis status using IGRA and X-ray test. Subjects with active or latent tuberculosis will be excluded
13. History of severe allergic reaction to contrast agents or biological medicines.Current drug or alcohol abuse or dependence.
14. History of severe allergic reaction to contrast agents or biological medicines.Current drug or alcohol abuse or dependence.
15. Pregnant or nursing..
Brief Intervention for Sleep Medication Misuse Among Elderly

Randomized controlled trial to evaluate effectiveness of behavioral Brief Intervention administered by General practitioners (GPs) versus business as usual on use of Z-hypnotics by elderly patients in primary care.

Two armed study with controlled masked first part over 6 months. Active arm is with Brief Intervention for inappropriate use of Z-hypnotics among elderly with intervention delivered by trained GPs. Control arm is for patients handled by their (non-trained) GPs with business as usual (BAU). Main outcome is 6 weeks after intervention with additional data collection points after 6 months (blinded) and long-term follow-up to 12 months (open). After 6 months there will be an open single crossover as BAU GPs will then also receive training in the Brief Intervention method.

Baseline assessments are limited to self reports and automatic sleep assessment with actigraphy to avoid assessment effects. Follow-up at main outcome time point is in person, some outcomes are also by telephone assessment and compared to baseline prior to intervention (e g Actigraphy assessment.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported use of Z-hypnotics \> 4 days per week and \> 4 weeks

Exclusion Criteria:

* diagnosis of dementia,
* diagnosis of psychosis,
* diagnosis of major depression,
* diagnosis of delirium,
* unable to give informed consent,
* insufficient Norwegian language capacity to complete tests
Electrical Impedance Myography of Neck and Low Back Pain

The purpose of this study is to assess neck and low back pain using Electrical Impedance Myography (EIM) in order to develop an algorithm to aid primary care providers (PCPs) in the diagnosis of neck/back pain. Secondary goals include the refinement of EIM technology and associated software of ease-of-use and interpretation by PCPs and staff.


Eligibility Criteria:
1. Radiculopathy Subjects:

   Inclusion Criteria:
   * Age 21-80 years old
   * History consistent with radiculopathy based on clinical, radiologic, and standard electrophysiological criteria, as determined by spine expert (Dr. John Keel)

   Exclusion Criteria:
   * Age under 21 or over 80
   * History of a generalized neuromuscular condition, except for mild polyneuropathy or common mononeuropathies (e.g., carpal tunnel syndrome, ulnar neuropathy at the elbow)
   * History of moderate-to-severe ongoing medical conditions producing generalized disability, such as advanced cardiac or renal disease
   * Metal spine implants of any type
2. Musculoskeletal Back Pain Subjects:

   Inclusion Criteria:
   * Age 21 to 80 years old
   * Low back or neck pain without evidence to suggest neuropathic component; i.e., without radiation of pain, sensory loss or weakness

   Exclusion Criteria:
   * Age under 21 or over 80
   * History of sciatica or cervical radiculopathy
   * History of a generalized neuromuscular condition, except for mild polyneuropathy or common mononeuropathies (e.g., carpal tunnel syndrome, ulnar neuropathy at the elbow)
   * History of moderate-to-severe ongoing medical conditions producing generalized disability, such as advanced cardiac or renal disease
   * Metal spine implants of any type
3. Undiagnosed Lower Back or Neck Pain Subjects:

Inclusion Criteria:

* Age 21 to 80 years old
* Major complaint of lower back or neck pain

Exclusion Criteria:

* Age under 21 or over 80
* Recent (\<6 month) history of similar symptoms that has been evaluated
* History of a generalized neuromuscular condition, except for mild polyneuropathy or common mononeuropathies (e.g., carpal tunnel syndrome, ulnar neuropathy at the elbow)
* History of moderate-to-severe ongoing medical conditions producing generalized disability, such as advanced cardiac or renal disease
* Metal spine implants of any type
Barriers in the Process of Achieving Informed Consent From Critically Ill Patients

The study will explore barriers in the process of achieving informed consent from critically ill patients

The barriers will be divided into four major categories:

* Practical barriers
* Medical barriers
* Legal barriers
* Ethical barriers

Eligibility Criteria:
Inclusion Criteria:

* Patients considered for inclusion in the NORIDES study

Exclusion Criteria:

* None
Serum Antimullerian Hormone Levels Among Epileptic Patients

The production of AMH starts in granulosa cells before birth and the levels within the serum decreases towards the menapouse. The levels of AMH do not change throughout the menstruation cycle hovewer, it can be affected in cases related to body mass index (BMI), polycyctic ovarian syndrome (PCOS). The lower levels of AMH had been documented after ovarian surgery, radiotheraphy and chemotheraphy. AMH is a member of Transforming Growth Faktor β (TGF- β ) and it has receptors in brain structures including hyppocammpus. It is highly active neurophysiologically and it has a protective effect against N-methyl-D -aspartate related neuronal injury that is demonstrated both in vivo and in vitro studies. As a result, being a neuroactive hormone; AMH may have an effect on seizures within epileptic patients or serum AMH levels may be effected in epileptic patients when compared with healthy ones.


Eligibility Criteria:
Inclusion Criteria:

* Healthy and epileptic volunteer females
* Ages between 12-18
* After menarche

Exclusion Criteria:

* ovarian surgery,
* history of radiotherapy
* history of chemotherapy,
* before menarche
Function of Inner Ear Such as Balance and Perception of Verticality in Children With Idiopathic Scoliosis

The purpose of this study was to evaluate vestibular function in children with idiopathic scoliosis as a possible cause of etiopathogenesis of its diagnose.


Eligibility Criteria:
Inclusion Criteria:

* idiopathic scoliosis

Exclusion Criteria:

* operation of the spine
* neurological disease
* hearing problems
A Study to Evaluate the Effect of Cholestyramine on LOXO-783 in Healthy Participants

The main purpose of this study is to conduct blood tests to measure how much LOXO-783 is in the bloodstream and how the body handles and eliminates LOXO-783 when administered alone or in combination with cholestyramine in healthy participants. The study will also evaluate the safety and tolerability of LOXO-783 with and without cholestyramine. Participation could last up to 63 days including screening period.


Eligibility Criteria:
Inclusion Criteria:

* Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease
* Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

Exclusion Criteria:

* Females who are lactating or of childbearing potential
* Clinically significant history of any drug sensitivity, drug allergy, or food allergy
Improving Adherence to Home Blood Pressure Monitoring With Pharmacist Support

The purpose of this research study is to evaluate the impact of monitoring blood pressure from home everyday with pharmacist support.

High blood pressure is very common and increases risk of heart, kidney, brain, and eye disease. It is important to diagnose and treat high blood pressure to reduce risk of these complications. Getting blood pressure checked only when someone sees a doctor is not the best way to diagnose high blood pressure or to make sure blood pressure is well managed. Checking blood pressure at home gives a better idea of whether someone's blood pressure is normal or too high.

As part of their usual blood pressure monitoring, participants will be given an Omron 3 series or 5 series blood pressure monitor which has been cleared by the US Food and Drug Administration and validated to meet accuracy and performance requirements. For one month, participants will monitor their blood pressure once a day and then return the device to the clinic at the end of the study. Participants will text their blood pressure result to the American Heart Association's Check, Change, Control (CCC) secure online tracker.

As part of the research study, participants will also be randomized to either receive or not receive weekly check-in phone calls from a pharmacist to review their blood pressures and the number of times they tested in that week. Approximately 50 individuals will participate in this study. Participation in this study will last 1 month.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Uncontrolled hypertension (BP \> 130/80 mm Hg)

Exclusion Criteria:

* non-English speaking patients
* patients without a mobile phone or texting capability
Gemcitabine/Platinum Containing Regimens as Preoperative Chemotherapy for Patients With Non Small Cell Lung Cancer

To study the efficacy and tolerability of gemcitabine/platinum chemotherapy in non small cell lung cancer


Eligibility Criteria:
Inclusion Criteria:

* Histologically of cytologically confirmed non small cell lung cancer
* No prior chemotherapy or radiation
* No prior malignancy

Exclusion Criteria:

* Pregnant or breastfeeding
* Serious concomitant systemic disorder
Carboplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Nasopharyngeal 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 carboplatin and paclitaxel in treating patients with locally recurrent or metastatic nasopharyngeal cancer.

OBJECTIVES: I. Estimate the response and toxicity of carboplatin in combination with paclitaxel in patients with locally recurrent or metastatic nasopharyngeal carcinoma.

OUTLINE: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. This cycle is repeated every 3 weeks. Patients may receive 6-8 cycles of therapy in the absence of toxicity and disease progression. Patients are followed every 3 months for the first 2 years, every 6 months for the next 3 years, and yearly thereafter.

PROJECTED ACCRUAL: 30 eligible patients will be accrued in approximately 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed locally recurrent or metastatic nasopharyngeal carcinoma that is not curable with resection or radiation therapy Bidimensionally measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 3.0 mg/dL Other: No active infections Serum calcium within institutional normal range No history of hypercalcemia Prior malignancy other than nasopharyngeal carcinoma allowed No concurrent malignancy Not pregnant or lactating Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy allowed Chemotherapy: No prior chemotherapy for metastatic or recurrent disease Prior induction or adjuvant chemotherapy concurrent with radiation therapy allowed No prior treatment with paclitaxel Endocrine therapy: Not specified Radiotherapy: See Chemotherapy Surgery: Not specified