cyrilzakka/clinical-trials huggingface dataset:
Pediatric Quality of Life Among Population With Body Mass Index (BMI) Greater Than or Equal to 85%

We are currently experiencing an epidemic of obesity in the Pediatric Population. This epidemic affects many areas including quality of life.

We have been conducting a nutrition and exercise program since 2003. We have noticed that many of the participants seem to have a better quality of life after finishing the one year program compared to when they started. We would like to objectively quantify this improvement using a validated questionnaire at the beginning and at the end of the study. Questionnaires will be given to participants and to their caretakers at the same time. There will be two groups in the study: one intervention (minimum attendance of 4 sessions) and one control group.

We are currently experiencing an obesity epidemic in the Pediatric population. The latest National Health and Nutrition Examination Survey (NHANES) data indicates that 16.5% has a BMI greater than or equal to 85% \< 95% and 17.1% has a BMI greater than or equal to 95%. The quality of life of children who are obese has been shown to be lower than that of children with cancer. Health related quality of life measurements have emerged as an important health outcome in clinical trials, clinical practice improvement strategies, and healthcare services research and evaluation. We have conducted a behavioral nutrition and exercise program since 2003. The name of the program is Teens, Empowerment, Exercise, Education, Nutrition (TEEEN) Program. We meet once a month on a Saturday afternoon for four hours. During this time we cover: registration (monitoring of sedentary activities and liquid choices; motivational interview, exercise testing); exercise; educational interactive lectures; didactic games and projects. We have noticed that participants seem to have a better quality of life after participating in the program compared to baseline. We would like to objectively quantify this subjective finding. We will be using the Pediatric Quality of Life Inventory Version 4.0 (PedsQL(TM)4.0) questionnaire which has been validated in the pediatric population. We will have an intervention and a control group. Both participants and their caretakers will be given a questionnaire at the beginning and at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Ages 10-20
* BMI greater or equal to 85%
PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer)

To estimate the effect of second-line panitumumab monotherapy on objective response in patients with metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed squamous cell carcinoma of head and neck (SCCHN) of oropharynx, oral cavity, hypopharynx, or larynx with at least 1 measurable lesion using computed tomography (CT) or magnetic resonance imaging (MRI) scan
* Diagnosis of recurrent disease determined to be incurable by surgery or radiotherapy
* Karnofsky Performance Status (KPS) score ≥ 60% at screening
* Men or women age ≥18 years
* Adequate hematologic, electrolyte and hepatic functions and negative pregnancy test

Exclusion Criteria:

* Subject received \> 1 chemotherapy regimen for the treatment of metastatic or recurrent disease
* Concomitant chemotherapy for recurrent disease administered solely for the purpose of radiation sensitization during re-irradiation will not be counted towards this chemotherapy regimen
* Nasopharyngeal carcinoma, salivary gland and primary skin SCCHN, or symptomatic central nervous system (CNS) metastases
* History of interstitial lung disease, significant cardiovascular disease, or another primary cancer
* Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic hepatitis B infection
* Known allergy or hypersensitivity to any component of panitumumab
* Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, panitumumab, cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib) for recurrent or metastatic disease with the following exceptions:

  * Prior EGFr inhibitor therapy is allowed if received as part of prior multimodality treatment (eg, as radiation sensitizer) and completed \> 24 weeks prior to randomization
  * Subjects who received no more than one dose of cetuximab and discontinued prior to progression due to documented severe infusion reaction are eligible.
* Significant thromboembolic event ≤ 8 weeks prior to enrollment
* Subjects not recovered from all previous acute radiotherapy-related toxicities
* History of severe skin disorder that in the opinion of the investigator may interfere with study conduct
* History of any medical, or psychiatric condition, or laboratory abnormality that may interfere with the interpretation of study results
* Subject is currently in a clinical trial ≤ 30 days prior to enrollment
* Subjects requiring use of immunosuppressive agents however corticosteroids are allowed
* Man or woman of child-bearing potential who do not consent to use adequate contraceptive precautions during the course of the study
* Female subject who is pregnant or breast-feeding
* Subject requiring major surgery using general/spinal anesthesia ≤ 28 days prior to enrollment, or minor surgery ≤ 14 days prior to enrollment.
Activities for Cognitive Enhancement of Seniors

Cognitive aging and cognitive decline are important public health concerns in an aging US population. The investigators will conduct a randomized controlled trail among healthy older adults to assess effects of several innovative activities on remediation of age-related cognitive decline.

ACE-Seniors is designed as a single-site trial of four randomly assigned interventions, Tai Chi exercise, autobiographical writing, both Tai Chi and autobiography (dual intervention), and general health education. Participants are relatively healthy adults aged 70 years or older, who are not regular practitioners of Tai Chi or regular writers. They are without medical or neurological disorders that would substantially limit the ability to participate in study interventions, without dementia or mild cognitive impairment, relatively sedentary, able to walk unassisted, and able to score 4 or better on the Short Physical Performance Battery. Interventions are administered over a 6 month period of time, with similar exposure times among the four groups. The prespecified primary endpoint is derived from a composite neuropsychological measure, based on three tests of executive function and three tests of episodic memory. The planned sample size is 96 (24 per group). Intention-to-treat analysis will include all eligible participants who complete baseline assessments.

Eligibility Criteria:
Inclusion Criteria:

* 70 years of age or older.
* No other household member already enrolled.
* In reasonably good health: no serious cognitive problem; free of any condition that would limit your ability to participate in Tai Chi classes (a moderate intensity exercise), in Qigong exercises, in a writing program, or in a seminar series.
* Not presently engaged in a regular exercise program; not presently engaged in Tai Chi Qigong or another form of Eastern exercise; and not a regular writer.
* Not now engaged in research to enhance cognitive skills.
* Willing to travel to Stanford for ACE-Seniors program classes. Planning to be in the area during most of the coming year;
* Willing to be assigned randomly (by chance) to one of the ACE-Senior activities.

Exclusion Criteria:

* Failure to meet inclusion criteria.
Adjunctive Bright Light Therapy in Patients With Bipolar Depression and Eveningness

This is a randomized placebo-controlled trial to examine the efficacy of six-week bright light therapy as adjunctive treatment for patient with bipolar depression and eveningness.

This randomized placebo-controlled trial aims to evaluate the efficacy of adjunctive BLT in addition to their maintenance treatment in reducing depressive symptoms. The second aim of the study is to explore the effects of BLT on sleep-wake changes and the sleep disturbances.

Method: Each eligible participant will be randomized to either i) bright light therapy (BLT) or ii) inactive negative ion generator (placebo) treatment for 30-minutes daily at their habitual wake time for a total of six weeks. Participants will be evaluated at baseline, 2nd, 4th and 6th week for depression and insomnia symptoms. Actigraphy will be done at baseline and in the last week of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-65 years.
2. Is capable to give informed consent.
3. Meeting the diagnostic criteria of bipolar depression (including both bipolar I and II disorders) by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V), Disorders (SCID-V).
4. a score 20 or above representing current moderate or severe episode of major depression and a score of at least 1 on items H1 or H2 on the Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement (SIGH-ADS), corresponding to at least moderate severity.
5. A score of 41 or less by the Morningness-Eveningness Questionnaire which represents eveningness.
6. On a stable dose of antimanic treatment for bipolar disorder for at least four weeks.

Exclusion Criteria:

1. Major Depressive Disorder fulfilling the Seasonal Pattern Specifier of the DSM-V (Seasonal Affective Disorder).
2. A past history of rapid-cycling within the past twelve months or a Young Mania Rating Scale more than 12 at screening
3. A current or past history of schizophrenia, mental retardation, organic mental disorder; or current substance use disorder.
4. Presence of psychotic symptoms or substantial suicidal risk as judged by the clinician and/or screening instruments.
5. Presence of contraindications to bright light therapy: for example, history of light induced migraine/ epilepsy; current use of photosensitizing medications such as St. John's wart; presence of eye disease: e.g. retinal blindness, severe cataract, glaucoma, and photosensitive skin condition e.g. systemic lupus erythematosus
6. Significant medical condition/ hearing impairment/ speech deficit leading to incapability of completing clinical interview.
7. Regular shift-workers or trans-meridian flight in the past 3 months or during study
8. Enrolment in another clinical trial of an investigational medicinal product or device.
9. Receiving regular psychotherapy.
Chronic Lung Allograft Dysfunction MRI Study

This studies purpose is to confirm the efficacy and efficiency of using OE-MRI and MRI with hyperpolarized gas techniques and Iodinated contrast CT scan, this will enhance understanding of CLAD pathophysiology. Moreover, this project is foundational to performing additional studies to establish if novel MRI imaging can serve as an objective confirmatory diagnostic tool for CLAD in post-transplant patients.

This studies purpose is to confirm the efficacy and efficiency of using OE-MRI and MRI with hyperpolarized gas techniques and Iodinated contrast CT scan, this will enhance understanding of CLAD pathophysiology. Moreover, this project is foundational to performing additional studies to establish if novel MRI imaging can serve as an objective confirmatory diagnostic tool for CLAD in post-transplant patients.

This observational imaging study will use 3T UTE MRI with varying oxygen levels (room air vs. 100% oxygen) to evaluate lung ventilation using oxygen enhanced imaging, in 50 healthy normal subjects (age 18-80).

Subjects will have vital signs taken, complete questionnaires and have pulmonary function test (spirometry) done, Iodinated contrast CT scan and standard of care CT scans, in addition to one MRI session that will include 6 series of scans. The MRI scans will be taken in supine position (laying on back) and include breathing room air and 100% oxygen. OE-MRI will be done in addition to MRI scans with Xenon-129.

Eligibility Criteria:
All subjects-Inclusion Criteria:

* Ages 18-80
* English Speaking Subjects
* Willingness and ability to provide informed consent
* Non-smoker

Lung transplant patients-inclusion criteria:

* \>/= 6 months from lung transplant
* History of bilateral lung transplant

CLAD-free patients-inclusion criteria:

* Stable spirometry with FEV1 \> 90% of baseline value (average of 2 best values) and forced mid-expiratory flow (FEF) (25-75) \> 75% of baseline
* Total Lung Capacity (TLC) \> 90 % of baseline
* Post-transplant chest radiograph without significant abnormality
* No evidence of on-going lung infection or allograft rejection

Early CLAD patients-inclusion criteria:

* FEV1 \< 80% of baseline value (average of 2 best values)
* Follow up 6-months or decline in lung function (20% decrease in FEV1 without evidence of infection or acute rejection)

Exclusion Criteria:

* SAO2 drops below 90% (in absence of mechanical failure) during normal tidal breathing
* Unilateral diaphragm paralysis
* Evidence of acute illness on day of study
* Evidence of restrictive lung disease
* Dependence on supplemental oxygen
* History of cardiac disease
* Pregnancy (self-declared)
* Lactating women
* Participants with metal objects in their body
* Known contraindication to MRI examination
* Systolic blood pressure reading of \< 100 mmHg or \> 200 mmHg
* Diastolic blood pressure reading of \<60 mmHg or \> 100 mmHg
BACE Trial Substudy 2 - FarmEc Substudy

A second sub-analysis of the BACE trial will include a detailed cost-effectiveness study.

Our multicenter randomized trial executed in one country will provide an excellent tool for more precise health economic assessments. In a first approach, rough estimates on savings of direct costs in the entire study cohort will be made by taking into account the Flemish average costs for a single hospitalization day at a respiratory ward, for a day at intensive care, for an emergency visit, for a home physician contact and for an antibiotic-steroid course. A more detailed cost-effectiveness and cost-utility analysis at 3 and 9 months interval will only be performed in case significant clinical benefits are found in favor of the active treatment.

For this purpose medical resource use data will be collected retrospectively via hospital invoices (direct costs including drugs, physician visits, laboratory tests, technical exams, medical imaging, hospital stay) but also prospectively via patient diaries, to cover direct and indirect costs during the entire outpatient period, and will be linked to EQ5D scores.

Patient will have to give informed consent that additional to the clinical evaluation, invoices will be collected. However, individual patients can still opt out for these analyses (sub-study) and only participate in the medical intervention study (main study).

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of COPD by medical doctor (based on clinical history OR pulmonary function test)
* Smoking history of at least 10 pack-years (10 pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, etc.)
* Current hospitalization for potential infectious AECOPD treated with standard therapy
* History of at least one exacerbation during the last year (prior to the current hospital admission) for which systemic steroids and/or antibiotics were taken
* ECG at admission

Exclusion Criteria:

* Mechanical or non-invasive ventilation at moment of randomization (D1)
* Long QT interval on ECG (QTc \> 450msec for males or \> 470msec for females)
* History of life-threatening arrhythmias
* Myocardial infarction (NSTEMI or STEMI) less than 6 weeks before start of study drug
* Unstable angina pectoris or acute myocardial infarction (NSTEMI or STEMI) at admission
* Drugs with high risk for long QT interval and torsade de pointes (amiodarone, flecainide, procainamide, sotalol, droperidol, haldol, citalopram, other macrolides)
* Documented uncorrected severe hypokalemia (K+ \< 3.0 mmol/L) or hypomagnesemia (Mg2+ \< 0.5 mmol/L)
* Chronic systemic steroids (\> 4 mg methylprednisolone /day for ≥ 2 months)
* Actual use of macrolides for at least 2 weeks
* Allergy to macrolides
* Active cancer treatment
* Life expectancy \< 3 months
* Pregnant or breast-feeding subjects. Woman of childbearing potential must have a pregnancy test performed and a negative result must be documented before start of treatment
US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy

To compare the efficacy of USG-guided bilateral External oblique intercostal (EOI) block with Erector spinae plane block (ESPB) for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both External oblique intercostal fascial plane block and Erector spinae plane block are effective in providing post-operative analgesia.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2,
* patients with the American Society of Anesthesiologists (ASA) physical status I/II,
* Patients scheduled for elective laparoscopic cholecystectomy.

Exclusion Criteria:

* Allergy to local anaesthetics,
* Infection at the site of injection,
* Coagulopathy,
* Chronic pain syndromes,
* Prolonged opioid medication,
* Patients who received any analgesic 24 h before surgery.
Esketamine Combined Pregabalin and Duloxetine for Postherpetic Neuralgia

To assess the 1-week effects and safety of esketamine in combination with pregabalin and duloxetine to relieve pain in patients with postherpetic Neuralgia(PHN).

The investigators aim to investigate whether or not esketamine combined with pregabalin and duloxetine to relieve pain in patients with PHN, and seek a rapid, effective and safe treatment for refractory patients with PHN

Eligibility Criteria:
Inclusion Criteria:

1. Ages more than 18 years;
2. Pain present for more than 3 months after healing of a herpes zoster skin rash;
3. Has an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0= no pain, 10= worst possible pain)；
4. Failed to respond to or tolerate the effective dose of pregabalin monotherapy.

Exclusion Criteria:

1. Obstructive sleep apnoea syndrome;
2. Those who receive interventional treatments;
3. A history of systemic immune diseases, organ transplantation, or cancers;
4. A history of severe cardiopulmonary, hepatic or renal dysfunction;
5. A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;
6. Currently using monoamine oxidase inhibitors (MAOIs);
7. Having untreated angle-closure glaucoma;
8. Those suffering from increased intracranial pressure；
9. Comorbid hyperthyroidism or phaeochromocytoma;
10. Suspected or confirmed history of drug abuse;
11. Having contraindications to esketamine, pregabaline or duloxetine;
12. Communication difficulties;
13. Women who are preparing for pregnancy, in the pregnancy or lactation period.
Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients

A Phase 1b/2, open-label, multicenter study to determine the recommended phase 2 (RP2D) of ABT-101in solid tumor and to explore antitumor activities of ABT-101 in patients with HER 2 mutated non-small cell lung cancer (NSCLC)

This study will be conducted in two parts:

Part 1: Dose- Escalation, Phase 1b, is designed to determine the RP2D. Patients with solid tumor will be enrolled into a dose finding study scheme with the assessment of dose-limiting toxicities (DLTs). DLT assessment will be conducted during treatment cycle 1

Part 2: Dose- Expansion, Phase 2, will evaluate the safety and efficacy of ABT-101 at the dosage and dosing regime determined in Phase 1b. Phase 2 will enroll NSCLC patients with HER2 mutations

Study participation for all patients includes screening period, treatment period and safety/ follow-up period. Patient will received study treatment until progressive disease or any other discontinuation or withdrawal criterion is met

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥ 20 years or adult age as per local regulations, at time of informed consent
* Histologically or cytologically confirmed advanced solid tumor (Part 1) or NSCLC with HER2 mutations as determined by the central result (Part 2)
* For patients in Part 2 only: Patients has measurable disease per RECIST 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Part 1), 0 to 2 (Part 2)
* Appropriate candidate for experimental therapy
* Adequate organ function

Exclusion Criteria:

* Known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
* For patients in Part 2 only: Previously treated with EGFR or HER2 TKIs.
* Serious acute or chronic infections
* Received a live-virus vaccination
* Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose.
* Not recovered from prior- treatment toxicities to Grade ≤1
* Major surgery within 28 days prior to the study treatment
* Concurrent malignancy within 2 years prior to first dose
* History or presence of clinically relevant cardiovascular abnormalities. QTcF ≥ 470 ms
* Significant gastrointestinal disorder(s) that could interfere with absorption of ABT101
* Known to have a history of alcoholism or drug abuse
Microfluidic Device to Diagnose Leptomeningeal Metastasis in Breast Cancer

This study will prospectively enroll 36 evaluable subjects with breast cancer who are undergoing workup for clinical suspicion of leptomeningeal metastasis (LM). Neuroimaging consisting of MRI of the brain or total spine (or both, as clinically indicated) will be obtained in all patients. Patients will also undergo a lumbar puncture and standard CSF evaluation, which may consist of intracranial pressure measurement, CSF protein, glucose, white and red cell analysis, infectious cultures, as well as conventional cytopathologic analysis (cytocentrifuge). An additional CSF sample will be obtained for evaluation of CSF CTCs by OncoCEETM technology and cell-free DNA (recommended amount: 1 tube, 10 mL) at the time of lumbar puncture.

Leptomeningeal metastasis (LM) is a condition in which cancer cells seed the meninges and may go on to invade the brain parenchyma, spinal cord, cranial nerves or peripheral nerves. It is a devastating complication of breast cancer, and is often considered in the differential diagnosis when patients with breast cancer present with new neurologic symptoms. It was previously thought to be a rare occurrence, but autopsy series have shown the true overall incidence to be up to 8%. In fact, while the incidence of meningeal metastasis from other malignancies has decreased, the opposite is true of breast cancer, in which clinical evidence suggests an increasing incidence.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18 years or older) patients, with invasive breast cancer, of all racial and ethnic origins
* Undergoing lumbar puncture for clinical or radiographic suspicion of leptomeningeal metastasis
* Provide study-specific informed consent
* Patients with unequivocal or suspicious MRI findings.
* Of those with a definitive diagnosis of LM (i.e. positive CSF cytology), 10 evaluable patients will be accrued.

Exclusion Criteria:

* Prior CSF fluid which identified malignant cells after 10 evaluable patients with positive CSF are accrued.