cyrilzakka/clinical-trials huggingface dataset:
IMPT Dose Escalation for NSCLC (HyDose)

In this randomized controlled trial, the aim is to test the hypothesis that proton therapy dose escalation using a heterogeneous simultaneous boost on the primary tumor as part of chemoradiotherapy for locally advanced non-small-cell lung cancer is safe, i.e. does not result in an increase in severe toxicity compared to standard-dose proton therapy. Secondarily, the goal is to estimate the treatment effect size, if any.

In the intervention group, patients will receive intensity-modulated proton therapy dose escalation to the primary tumor up to 74.0 Gy or 64.0 Gy (RBE of 1.1) in 25 fractions, depending on proximity to the mediastinal envelope. In the control group, patients will receive 60.0 Gy intensity-modulated proton therapy in 25 fractions.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven stage III NSCLC
* Planned for CCRT and adjuvant immunotherapy (intention to treat)
* Primary tumour volume outside of mediastinal PRV (i.e., mediastinal envelope + 5 mm) ≥60% of total primary tumour volume (true for 75% of patients in preliminary analysis), for sufficient dose escalation

Exclusion Criteria:

* Chemotherapy not given concurrently with radiotherapy
* Upfront decision that adjuvant immunotherapy is not possible
* Primary tumour overlapping ≥40% with mediastinal PRV
MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation

Cardiac rehabilitation is a medically recommended program for patients with certain heart conditions. It includes exercise training, health education, and counseling. Unfortunately, many patients do not participate in cardiac rehabilitation. Some find it challenging to attend the in-person sessions. This study aims to compare two methods of delivering cardiac rehabilitation: in-person and through telehealth. The investigators want to know if the effects of these two programs are alike and if certain individuals benefit more from one program over the other.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Eligible for cardiac rehabilitation

   1. Diagnosis within 1 year prior to consent

      * Myocardial infarction
      * Percutaneous coronary intervention
      * Coronary artery bypass
      * Heart valve repair or replacement
      * Heart transplant
   2. Chronic stable angina, or
   3. Chronic systolic heart failure (ejection fraction ≤ 35%)
   4. Referred to cardiac rehabilitation by a doctor or advanced practice provider for another indication that is covered by the participant's insurance, such as heart failure with preserved ejection fraction or aortic surgery.
3. Willing to be randomized to in-person or telehealth cardiac rehabilitation
4. Able to communicate in English or Spanish

Exclusion Criteria:

1. Unstable arrhythmias which may make unmonitored exercise unsafe (e.g., history of ventricular tachycardia not on medical therapy and without an implantable cardioverter defibrillator)
2. Unsafe for patient to participate in the opinion of the investigator
3. Hospice
4. Unable to consent for self
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers

Background:

Infections in the lower respiratory tract (lungs) are the leading cause of death from infectious disease worldwide. This was true even before the COVID-19 pandemic. Respiratory viruses are still a major health threat. Many of these viruses infect people by penetrating the thin skin that lines the nose. These viruses can also spread easily to other people when they multiply in the tissues that line the nose. Researchers want to learn more about what these viruses do inside the nose, how they get from the nose to the lungs, and how they spread from person to person.

Objective:

To collect cell samples from inside the noses of healthy people. These cells will be stored for use in future research on respiratory diseases.

Eligibility:

Healthy volunteers aged 18 years and older.

Design:

Most participants will have 1 visit on 1 day. They will be asked questions. Those who have a runny nose, coughing, congestion, or fever will be asked to wait up to 21 days before participating.

Participants will be given a slender swab with small bristles at the end. They will rub the inside of their nose with the swab. A clinic staff member will be present to help, if needed.

Participants will provide their name, age, and sex. This information will be encoded so that only certain researchers will know the participants identities.

Participants will not be contacted again....

Study Description:

This is a repository protocol with prospective sample collection to provide samples needed for future studies of the pathogenesis of emerging respiratory viruses. Nasal brushings will be collected from approximately 100 healthy volunteers at RML and stored in the LV to be made available for future research studies that will be conducted under separate protocols, as applicable.

Primary Objective:

To obtain nasal epithelium brushes from healthy volunteers for 1) establishment of upper respiratory tract organoids, 2) assay validation, and 3) use for research into the pathogenesis of emerging respiratory viruses.

Eligibility Criteria:
* INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

* Aged \>=18 years.
* Able to provide informed consent.
* Willing to allow biological samples and data to be stored for future research.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this

study:

* History of respiratory symptoms including but not limited to runny nose, coughing, congestion, and/or fever within the past 14 days.
* NIH and laboratory staff with direct involvement in the operation or maintenance of the repository are excluded from participation.
* An individual who has any condition that, in the judgment of the investigator, may put them at undue risk or make them unsuitable for participation in the study will be excluded.
The Effects of a Train High, Sleep Low Strategy

The investigators will examine the long-term effects of a combined training and diet intervention that, acutely, increases fat oxidation during exercise. This is done with a 4 week intervention study with moderately trained cyclists. Performance is tested pre and post intervention and muscle biopsies are obtained.


Eligibility Criteria:
Inclusion Criteria:

* 18-45 years
* VO2-max\>55 ml/kg/min
* No smokers
* Training 6 hours per week (cycling)
* Training experience for more than 3 years.

Exclusion Criteria:

* Less than 2 g carbohydrate/kg/day
Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity

Quantify the efficacy and cost of nonoperative treatment modalities used for adult spinal deformity.

1. Identify disease burden associated with adult spinal deformity (ASD) using quality adjusted life year (QALY) analysis.
2. Identify disease burden of specific demographic and radiographic features associated with ASD.
3. Compare disease burden of ASD to other musculoskeletal and non-musculoskeletal diseases.
4. Identify efficacy of specific nonoperative treatment modalities to treat ASD and identify specific clinical and radiographic features of ASD responsive to nonoperative treatment modalities.
5. Compare QALY and ICER values for different ASD nonoperative treatment modalities to previously established QALY and ICER for values for operative and nonoperative treatment modalities for degenerative hip and knee disease, coronary artery disease, insulin dependent diabetes, and hypertension.
6. Evaluate the cost and work hours associated with data collection and minimum 85% patient follow up.
7. Evaluate patient characteristics associated with poor patient compliance for study follow up including demographic, radiographic and HRQOL values and for reasons for cross-over to operative treatment for ASD.
8. Establish standardized data collection methodology for economic based outcome studies based upon patient demographics and HRQOL values.

Eligibility Criteria:
Inclusion Criteria:

1. Age 40-75 years of age at the time of enrollment.
2. ODI ≥30
3. Adult degenerative or idiopathic lumbar scoliosis 10-40° as measured by the Cobb angle technique
4. Sagittal plane deformity by SRS Schwab classification with at least one modifier ++ or two modifiers + and associated coronal cobb of at least 10 degrees

Exclusion Criteria:

1. Adult degenerative or idiopathic scoliosis with a curvature of the spine measuring \<10 degrees or \>40 degrees
2. Diagnosis of scoliosis other than degenerative or idiopathic (i.e. neuromuscular, congenital, etc.)
3. Cardiopulmonary disease or comorbidities that preclude surgical intervention
4. Patient not deemed surgical candidate by treating surgeon
5. Patient unwilling to commit to monthly phone interviews or completion of necessary questionnaires or inability to return for defined follow up time points. Patients unwilling to comply with study protocol will not be offered enrollment into the study, regardless of meeting inclusion criteria.
Investigation of the Putative Correlation Between Involuntary Psoas Activity During Passive Flexion of the Trunk at the Hips

Passive flexion of the trunk (relative to the legs) may be accompanied by contraction of the psoas muscles, even when the subject has been told not to contract any muscles. The psoas contraction is involuntary and cannot be controlled by the subject. This lack of passivity might be concomitant with lower back pain: the impairment may be present when lower back pain is present and/or absent when lower back pain is absent.

The study's primary objective is thus to determine the sensitivity and/or specificity of a clinical test for impaired hip flexor passivity in cases of lower back pain during passive flexion of the trunk (from the supine position,).

The secondary objective is to show that a negative test (after administration of correcting measures) is correlated with a decrease in pain (i.e. pain intensity and the functional repercussions of pain).


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 30
* Social security coverage
* Ability to understand the study's objectives, procedures and risks and to provide informed, written consent
* Having been informed about the results of the prior clinical examination.

Exclusion Criteria:

* Past or concomitant infectious or cancerous diseases of the spine
* Vertebral osteosynthesis
* Acute neck or arm pain (recurrent dislocations of the glenohumeral joint, trauma in the previous 12 months, etc.)
* Lower back pain with irradiation of pain below the buttocks
* Known specific lower back pain or pain for which a differential diagnosis suggests an inflammatory, traumatic, cancerous or infectious cause
* Subjects under legal guardianship
* Known pregnancy
* Simultaneous participation in another biomedical research study of a drug or medical device.
Efficacy of NicVAX in Smokers Who Want to Quit Smoking

The purpose of this study is to determine whether vaccination with NicVAX will result in a higher continuous abstinence rate than vaccination with placebo in smokers who want to quit smoking. In addition, two different formulations and dosing schedules will be studied, to select the dose and dosing schedule which generates the highest level of anti-nicotine antibodies. The primary study period is 12 months, which was extended by amendment to include up to 2 years of observations.

Cigarette smoking is responsible for over 400,000 (1 out of every 5) deaths in the United States each year. Most smokers are aware of the health consequences and want to quit, but have difficulty doing so. Only 3-5% of smokers who quit on their own are successful. Since the vast majority of those who attempt to quit will fail, the need for better approaches to smoking cessation is clear and urgent. A safe and effective means of blocking the effects of nicotine would be of considerable interest as a potential treatment for tobacco use. Vaccination to produce nicotine-specific antibodies may be viewed as an alternative method of blocking nicotine effects. Nicotine is a small molecule that does not elicit an immune response in animals of humans. In order for the immune system to respond to this hapten, nicotine can be combined or bound to a larger molecule in a unique manner so that an immune response is mounted against nicotine. Nabi Biopharmaceuticals has developed a conjugate vaccine (NicVAX) that consists of 3'-aminomethylnicotine bound to Pseudomonas aeruginosa exoprotein A, an exotoxin that has been made non-toxic by an amino acid deletion. Subjects will be randomized to one of four treatment groups.

Within each treatment group, 75 subjects will be randomized in a 2:1 ratio (NicVAX:Placebo), yielding a total of 50 active and 25 placebo subjects for each treatment group. There will be 12 subjects enrolled in a fifth open label arm to evaluate immunogenicity. A quit date will be set at the end of week 7 or at the end of week 5, depending on the dosing schedule. Continuous abstinence will be measured between the end of week 18 and the end of week 26.

Eligibility Criteria:
Inclusion Criteria:

* Smokes at least 15 cigarettes per day
* Wants to quit smoking
* Good general health
* Negative pregnancy test prior to study entry
* Carbon monoxide level greater than 10 ppm

Exclusion Criteria:

* Prior exposure to NicVAX or any other nicotine vaccine
* Known allergic reaction to alum or any of the components of the vaccine
* Use of steroids, immunosuppressive agents or other medication that might interfere with an immune response
Pleuroscopy First Versus Thoracentesis First in Patients with Suspected Malignant Pleural Effusions

This is a randomized control trial of patients with suspected malignant pleural effusions to compare whether patients who have a thoracentesis or pleuroscopy (pleural biopsy) obtain an adequate biopsy, achieve a diagnosis, and begin cancer-directed therapy faster.

This is a randomized control trial of patients with suspected malignant pleural effusions comparing patients who undergo either pleuroscopy or thoracentesis as the first diagnostic test. Both procedures are considered standard of care for this diagnosis but it is unknown which one provides more adequate biopsy samples and achieves faster diagnosis and shorter time to oncologic treatment. Currently, most patients undergo thoracentesis first and, if this is inadequate for diagnosis, they then undergo pleuroscopy for further biopsy samples. This study seeks to assess whether patients who undergo pleuroscopy as the first test obtain adequate biopsy samples and a faster path to further oncologic care compared to patients who undergo thoracentesis first. Patients will be recruited and randomized in a 1:1 manner.

Ultrasound is routinely used prior to the procedure and a chest x-ray is done after the procedure. Any other imaging will be determined by clinic need only. No imaging will be done for research purposes. No additional samples will be collected other than what is necessary for diagnostic purposes. In patients who have a non-diagnostic thoracentesis, the participants will be referred for pleuroscopy as the next diagnostic step. In the rare case that pleuroscopy does not achieve adequate diagnosis, the next step would be a liquid biopsy (non-invasive serologic testing for oncologic markers.) The need for liquid biopsy in participants in this study will be determined on a case-by-case basis depending on the clinical concern for malignancy.

Eligibility Criteria:
Inclusion Criteria:

* Referral for diagnostic pleural procedure.
* Age ≥ 18 years.
* Suspected malignant pleural effusion (Suggestive radiologic appearance (based on computed tomography or positron emission tomography) OR suspected cancer with associated effusion.)

Exclusion Criteria:

* Inability to provide informed consent.
* Needs emergent drainage.
* Pleural effusion is known to be malignant.
* Suspected transudative, infectious or inflammatory effusion etiology.
* Having prior inconclusive/non-diagnostic thoracentesis or pleuroscopy.
* Patient is deemed by the clinical team to be more appropriate for VATS biopsy.
* Terminally ill patients in whom a diagnosis will not change management, or who is unlikely to be a candidate for oncological treatment due to significant comorbidities.
* Pregnancy
Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP Malignancy

Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP Malignancy.

The most important outcome in the management of HBP malignancies is survival. Since the application of ERAS (enhanced recovery after surgery), the improvement of QOL(quality of life) has been known as one of important factor for the management of HBP malignancies as well as survival, and the improvement of QOL, itself, affect the survival.

There are several reports that perioperative rehabilitation affect positively for the outcome of surgery and QOL in surgical patients. However, in the HBP field, there are rarely studied for this concept.

This study aim to investigate that the application of rehabilitation program for the surgery of HBP malignancies affect on short-term outcome and lead the improvement of QOL.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old or \<80 years old
* ECOG 0-2
* resectable HBP malignancies or premalignant lesions which should be required GI resection and anastomosis
* open surgery
* no distant metastasis
* no functional disturbance in bone marrow; WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/mm3
* no functional disturbance in liver; AST less than 5 times upper limit of normal
* no function disturbance in kidney; Creatinine no greater than 1.5 times upper limit of normal
* informed consent

Exclusion Criteria:

* distant metastasis (+) or recurred HBP tumor
* active or uncontrolled infection
* alcohol or other drug addiction
* already enrolled patient in other study which affect this study
* pregnant or the possibility of pregnancy (+)
* uncontrolled cardiopulmonary disease
* moderate to severe comorbidity which affect on the quality of life and nutritional status (liver cirrhosis, end stage renal disease, heart failure, etc.)
* previous history of major gastrointestinal surgery (gastrectomy, colectomy, etc.)
* previous history of neurological or musculoskeletal diseases which is impossible to allow investigator's order
A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease

The purpose of this study is to demonstrate that CNTO 328 when administered in combination with best supportive care (BSC) is superior to BSC in terms of durable tumor and symptomatic response (complete response or partial response) among patients with Multicentric Castleman's Disease.

This is a multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), double blind (neither investigator nor the participant knows the treatment that the participant receives), placebo controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study), study to assess the efficacy and safety of CNTO 328 plus BSC compared with BSC in patients with symptomatic Multicentric Castleman's Disease. The study mainly consists of 3 phases, including: the screening phase (majority of assessments performed within 28 days of first dose), the treatment phase (blinded and unblinded), and the follow up phase. In the blinded treatment phase, approximately 78 patients will be randomly assigned in 1:2 ratios to either of 2 treatment groups, ie, Placebo + BSC, or CNTO 328 + BSC. Participants receiving placebo + BSC during blinded treatment period who do not respond and have treatment failure will have the option to crossover and receive siltuximab + BSC during unbllinded treatent period. The follow up phase will be 3 months after last dose of study medication and the survival will be followed up until the study ends. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, patient-recorded temperature, and physical examination will be monitored throughout the study. The total study duration will be 5 years after the last patient starts study medication.

Eligibility Criteria:
Inclusion Criteria:

* Measurable and symptomatic Multicentric Castleman's Disease
* Adequate organ function as assessed by laboratory values evaluated by the investigator to determine eligibility prior to treatment
* Eastern Cooperative Oncology Group performance status of 0, 1, or 2
* Corticosteroids dose that does not exceed 1 mg/kg/day of prednisone, and has remained stable or decreased over the 4 weeks before treatment

Exclusion Criteria:

* Human Immunodeficiency Virus or Human Herpes Virus-8 positive
* Skin lesions as sole measurable manifestation of Multicentric Castleman's Disease
* Previous history of lymphoma
* Malignancies, except for adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or cancer other than lymphoma, from which the patient has been disease-free for 3 or more years
* Concurrent medical condition or disease that may interfere with study participation
* Prior exposure to Interleukin-6 or Interleukin-6 receptor targeted therapies
Development and Validation of a Quality of Life Instrument for Actinic Keratosis

Actinic keratoses (AKs) are some of the most common lesions seen by dermatologists. Flesh colored to erythematous, these lesions often present with scaling or crusting in sun damaged regions of the body. While they are physically visible and often palpable, these changes can also result in psychosocial changes in patients, including embarrassment about their skin or reduction in leisure activities to avoid further sun exposure. At the same time, AKs are known to progress in a significant number of cases to squamous cell carcinoma (SCC), a concern in terms of its metastatic potential.

The primary purpose of developing this questionnaire is to examine how well it can potentially identify patients with actinic keratoses. However, since AK is associated with significant detriment to quality of life for validity/reliability assessment, the investigators propose to give a compilation of four self-assessment questionnaires (not specific to AK but validated for skin health in general) to subjects with at least one actinic keratosis and age- and sex- matched participants without AKs, defined as the control population. These will include the SKINDEX-16, the DLQI and the Skin Health Calculator, as well as a questionnaire composed of items specific to predisposition to AKs to be able to better assess the discriminatory power of the questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 years or older being seen in a dermatology clinic
* Informed consent of participation must be given by subject

Exclusion Criteria:

* Inability to complete all study questionnaires.
* Subjects who are unable to read and write English