cyrilzakka/clinical-trials huggingface dataset:
Assess the Seroconversion Status of Health Care Workers Suspected or Confirmed Cases of COVID-19 Patients

A large number of Health Care Workers (HCWs) would be potentially getting exposed to COVID19. Some of them would be asymptomatic or may get subclinical symptoms. Our HCW would have higher exposure and possibly higher seroconversion either symptomatic or with clinical symptoms than the general population. This study is aimed to understand the rate of seroconversion states at different stages of exposure. It is crucial to collect baseline immune status and the early immunological changes that might occur in asymptomatic or symptomatic health care workers and to compare that with the suspected or confirmed cases by following them for six weeks.

This prospective observational, longitudinal study is being conducted at Max Super Specialty Hospital, Saket, New Delhi. Below mentioned are the study objectives-

Primary Objectives

* To determine the extent of infection in the healthcare workers (HCW) of a tertiary care hospital in India, by determining the seropositivity
* To compare immune changes that might occur in healthcare workers who are asymptomatic or symptomatic with the proven positive cases in OPD or IPD at Max hospital.

Secondary Objectives

* To determine the fraction of asymptomatic or subclinical infections
* To understand the seroconversion status at different stages of exposure to front line HCW

The study population would include all employees of Max Hospitals, Delhi-NCR, who have been tested for COVID-19. Samples and data of the COVID positive patients admitted in the hospital will also be collected and OPD patients coming to the hospital for COVID-19 testing will be one of the study subsets.

Eligibility Criteria:
Inclusion Criteria:

* Healthcare workers of Max Hospital, irrespective of age and gender OR
* COVID-19 positive patients admitted in the hospital OR
* Out-patients getting tested for COVID-19

Exclusion Criteria:

* Refusal to give informed consent, or contraindication to venipuncture.
Randomized Controlled Clinical Trial of Weight Loss Programs in Obese Persons

The purpose of this study is to compare two approaches to a diet and exercise-based weight loss program.

The high prevalence of obesity and its medical consequences make it one of the most important public health issues in the United States today. Few interventions have been consistently successful at reducing obesity. This trial will test an intervention program that lasts 22 weeks, with 16 evening sessions and one weekend day. Participants will be randomized to one of two arms. Both arms will receive diet and exercise intervention elements. The study aims for gradual weight loss, with a calorie target that will maintain ideal body weight, rather than a more calorie restricted diet. The exercise component is based around increasing walking. The arms will compare methods for producing long-lasting behavior change.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+ years old
* BMI \> 30-45
* Waist circumference \> 102 cm (men) or \> 88 cm (women)
* Live in San Francisco Bay Area and able to attend more than 16 classes and up to 12 assessment visits in San Francisco over an 18 month period

Exclusion Criteria:

* Inability to provide informed consent
* Age \< 18
* A substance abuse, mental health, or medical condition that, in the opinion of investigators, will make it difficult for the potential participant to participate in the group intervention
* Type I or II Diabetes or fasting glucose ≥ 126 mg/dl or hemoglobin A1c ≥ 6.5; those with HbA1c between 6-6.5% may complete an OGTT to rule out diabetes (glucose \<200 mg/dl)
* Use of systemic (oral or IV) corticosteroids in the 6 months prior to enrollment or severe autoimmune disorders or other conditions (e.g. rheumatoid arthritis, lupus), that are likely to require these medications
* Use of immunosuppressive or immunomodulating drugs or chronic or acute conditions that would require the use of such medications
* A history of known coronary artery disease (CAD), or typical or atypical anginal chest pain requires a letter from the participant's physician that he or she has been adequately evaluated and that a moderate exercise program is appropriate
* Non English speaker
* Pregnant or planning to get pregnant in the next 12 months, breastfeeding or less than 6 months post-partum
* Initiation of new class of psychiatric medications in past 2 months
* Currently on a specific weight loss diet
* For influenza vaccine administration: a prior allergic reaction to the influenza vaccine or eggs. These participants can be included in the trial but will be excluded from participation in influenza vaccination.
* Active bulimia or strong history of bulimia
* Current use of weight loss medications or supplements such as amphetamine-based drugs that are believed to have some effect on weight
* History of or planned weight loss surgery
* Untreated hypothyroidism: TSH \> 4mU/mL (or the upper limit of normal reference defined by the lab doing the assay)
To Compare Blood and Urine Concentrations of Mirabegron (YM178) in Healthy Poor or Extensive Metabolizers for CYP2D6 and to Assess the Effect of Mirabegron on the Metabolism of Metoprolol

The study aims to compare blood and urine concentrations of mirabegron (YM178) in healthy poor or extensive metabolizers for CYP2D6 and to evaluate if blood levels of metoprolol change whilst being dosed at the same time with daily miragebron.

The study is an open label, single center study. All subjects are genotyped for CYP2D6 before the study. Genotype expression is confirmed by dextromethorphan phenotyping.

Part I: The pharmacokinetic profile of a single dose of YM178 is compared in 8 healthy male subjects genotyped and phenotyped as poor metaboliser (PM) for CYP2D6 and in 8 healthy male subjects genotyped and phenotyped as extensive metaboliser (EM) for CYP2D6.

Part II: The effect of YM178 on the model substrate of CYP2D6 metoprolol is evaluated, using a cross-over design, in 12 healthy male subjects genotyped and phenotyped as EM for CYP2D6.

Eligibility Criteria:
Inclusion Criteria:

For Part I:

* Subject genotyped and phenotyped for CYP2D6
* Body weight between 60 and 100 kg and Body Mass Index less than or equal to 30 kg/m2

For Part II:

* Subject genotyped and phenotyped as extensive metaboliser for CYP2D6
* Body weight between 60 and 100 kg and Body Mass Index less than or equal to 30 kg/m2

Exclusion Criteria:

* Known or suspected hypersensitivity to β-adrenergic receptor agonists or constituents of the formulations used
* Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug
* Any clinically significant history of upper gastrointestinal symptoms (such as nausea, vomiting, abdominal discomfort or upset, or heartburn) in the 4 weeks prior to admission to the Research Unit
* Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic
* Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests
* QTc intervals of \>430 msec
* Abnormal pulse rate measurement (\<40 or \>90 bpm) taken by manual counting at the pre-study visit after subject has been resting in supine position for 5 min
* Abnormal blood pressure measurements taken at the pre-study visit after subject has been resting in supine position for 5 min as follows: systolic blood pressure \<95 or \>160 mmHg; diastolic blood pressure \<40 or \>95 mmHg
* Positive orthostatic test at screening i.e. any symptoms of dizziness, light-headedness etc. and/or a fall of ≥ 20 mmHg in systolic blood pressure after 2 min standing (preceded by 5 min. supine rest) and/or an increase in pulse rate of ≥ 20 bpm
* Regular use of any prescribed or OTC drugs except paracetamol up to 3 g/day, in the 4 weeks prior to admission to the Research Unit OR any use of such drugs in the 2 weeks prior to admission to the Research Unit
Neurostimulation and Electromyographic Assessment of the TetraGraph (NEAT) In Patients (NEAT-3)

TetraGraph is a newly developed EMG-based, quantitative, battery-powered neuromuscular monitoring system intended for daily clinical use. The primary aim of this clinical investigation is to examine the applicability (ease of use, equipment need, etc.), repeatability (precision or internal consistency) and performance (signal quality, accuracy of outcome, voltage of stimulation output before and during a stimulus) of the Tetragraph device in patients undergoing elective surgeries requiring neuromuscular blockade.

The TetraGraph will be tested in 50 consenting patients undergiong elective surgeries requiring neuromuscular blockade. The left of right hand of the patients will be randomly studied. After the induction of anesthesia but before the administration of muscle relaxant train-of-four (TOF) stimulation will be started with 30 mA current intensity, 0.2 msec pulse duration at 20 sec intervals. The stimulation will be left to run until extubation. The TetraGraph device will be set not to show measurement results on the screen but save them on the SD card for later analysis. This way TetraGraph will not influence clinical decisions and patient care. During the operations we will record the number of muscle twitches in return to stimulation, the time and dose of muscle relaxant and opioid administration, the time of use of electrocautery and the skin temperature.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older.
2. American Society of Anesthesiology (ASA) physical status I-III criteria (Table I).
3. Subject has provided written informed consent.

Exclusion Criteria:

1. Presence of an underlying neuromuscular disease.
2. Presence of renal or hepatic disease.
3. Subject has open skin sores in the locations needed for electrode application (forearms).
4. Patient is taking anti-seizure medication
5. Patient is taking oral anti-cholinesterase (e.g., therapy for myasthenia gravis)
6. Magnesium sulfate administration is required
Biomarkers for Diagnosis of Lung Cancer

The study goal is to collect blood samples from individuals at risk for lung cancer in order to identify protein markers for diagnosis of lung cancer in the Chinese population.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years of age
* Patients referred to pulmonologists, oncologists, or thoracic surgeons for diagnosis of suspicious pulmonary nodules as either lung cancer or benign and undergoing bronchoscopic biopsy
* Patients will be enrolled if the result of the bronchoscopic biopsy is a diagnosis of NSCLC or benign pulmonary nodule
* Cases: Patients with untreated non-small cell lung cancer, i.e. primary lung adenocarcinoma or squamous cell carcinoma of early
* Computed tomography or X-Ray is available and shows a suspicious pulmonary nodule
* A biopsy or surgical resection to clarify the nature of the lung nodule is available (NSCLC or benign, including histological diagnosis) in both groups
* Controls: Patients must be available for a 6 month follow-up to confirm benign diagnosis
* A serum and plasma sample was collected prior to any treatment of the lung nodule beyond biopsy
* No other cancer diagnosis in the last 5 years excluding non-melanoma skin cancer
* Patients must be fully informed of the investigational nature of the procedure and sign an informed consent.

Exclusion Criteria:

* Prior treatment for lung cancer by chemotherapy or surgery (excluding biopsy)
* Patients with benign nodules who are not able or willing to have a 6-month follow-up visit to confirm benign diagnosis
* Diagnosis or treatment of other cancer in the last 5 years excluding non-melanoma skin cancer. In the judgment of the clinical investigator, patients who are likely to be non compliant or uncooperative during the study.
Pilot Functional Imaging Study to Evaluate Mechanisms Underlying Chronic Pain in Breast Cancer Patients

The purpose of this study is to better understand why some women with breast cancer develop chronic pain.

Women with breast cancer who either have chronic pain or who do not have chronic pain will be asked to enroll. Those who participate will have pictures taken of their brain using MRI when they are lying still and also when pressure is being applied to their thumbnails. These pictures will be compared to patients without breast cancer who do not have pain and to those who have other types of pain, such as fibromyalgia. By taking and analyzing these pictures the investigators hope to understand more about why breast cancer survivors develop pain after their diagnosis and treatment. In the future the investigators hope to better treat the pain or possibly even prevent the pain from occurring in the first place.

Eligibility Criteria:
Inclusion Criteria:

* Breast Cancer Survivor with and without chronic pain
* Able to undergo MRI
Continued Evaluation of Patients With Parkinson's Disease Who Previously Received BRT-DA01

This is a multicenter study to evaluate the safety and clinical outcomes of BRT-DA01 in subjects with PD who previously received BRT-DA01 in the Phase 1 Study MSK-DA01-101.No investigational therapy will be administered in this study.

All subjects who received BRT-DA01 transplantation in Study MSK-DA01-101 (ie, parent study) will be asked to enroll in Study BRT-DA01-501. Subjects enrolled in this study are to be monitored for safety and clinical outcomes through 5 years post-BRT-DA01 transplantation. For individual participating subjects, the Baseline visit for the BRT-DA01-501 study will be defined as the last observation recorded in the parent study.

Eligibility Criteria:
Inclusion Criteria:

* Subject received BRT-DA01 in Study MSK-DA01-101 (ie, parent study) and will have completed or discontinued the parent study
* Subject must be willing and able to provide written informed consent for the BRT-DA0-501 study in accordance with applicable regulations and guidelines and to comply with all study visits and procedures

Exclusion Criteria:

* No exclusion criteria
Neuropathic Pain and It's Relation to Sleep Quality in Knee Osteoarthritis

The primary aim is to investigate the frequency and severity of neuropathic pain and its association with night pain in patients with knee osteoarthritis. For this purpose a progressive longitudinal study design was planned. The secondary aim is to investigate the relationship between night pain and neuropathic pain and sleep quality.

Osteoarthritis (OA) is the most common form of arthritis in the world. Classically, OA presents with joint pain and loss of function; however, the disease is clinically very variable and can present merely as an asymptomatic incidental finding to a devastating and permanently disabling disorder.

The severity of knee pain caused by osteoarthritis, often does not correlate with the degree of degenerative changes in the joint. In patients reporting night pain, this may be related to inflammation, but in the absence of clinical and laboratory findings of inflammation, it is not possible to explain night pain only by the degree of joint damage. The existence of a relationship between night pain and neuropathic pain may be a guide in looking for neuropathic pain in patients who have night pain and experience this pain severely and thus for planning an appropriate treatment for the patient.

Patients with stage 2-4 knee OA will be evaluated in terms of demographic variables and outcome measurement parameters specified in the case report form. The relationship between neuropathic pain scores and knee pain severity will be sought. It will be studied whether there is a difference in outcome measurement parameters between those with neuropathic pain and those without. Correlation analysis will be performed between sleep quality score and pain intensity scores. The determinants of sleep quality will be evaluated by regression analysis.

American College of Rheumatology criteria will be recruited. Demographics and disease related variables will be recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Having a clinical diagnosis of knee osteoarthritis according to the American Rheumatology Association/ACR criteria 2. Knee OA is of Kellgren-Lawrence stage 2-4 3. The participant gives signed consent

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Exclusion Criteria:

Exclusion Criteria:

1. Having diabetes mellitus 2. Chronic kidney failure 3. Hypothyroidism 4. Presence of orthopedic disability (such as implant, prosthesis, contracture, shortness) in the lower extremity 4. Neurological diseases that can cause neuropathic pain 5. Presence of fibromyalgia 6. Malignancy 7. Pregnancy 8. Neurological deficit in the lower extremity 9. Drug use that may cause neuropathy (colchicine, etc.) İn the last 3 months 10. Drug use (antidepressant, antipsychotic, antiepileptic) due to sleep disturbance or widespread pain in the last 3 months.

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Music During Labor Epidural Placement and Patient Satisfaction

Patient satisfaction is becoming increasingly important to hospital administrators as a metric for quality of patient care services because it is now being linked to reimbursements (Maher 2015). Patient satisfaction is a complex problem, and may be affected by a variety of factors. A recent study found that higher patient satisfaction was associated with patients who received music therapy during their hospital stay (Mandel 2014). Given that music may positively affect patient satisfaction, we are designing a study to examine the effects of patient-preferred music on patient satisfaction in women undergoing labor epidural placement.

PROCEDURES STEP-BY-STEP

1. Once enrolled in the study, patient will be randomized to either:

   * The intervention group (music played on a portable speaker system), or
   * The control group (no music).
2. Prior to epidural placement, patients in both groups will be asked to answer one question about their music preference: "What is your favorite music? You can name an artist, genre, album, or any other identifier"

   • If patient preferred music is not available on the Pandora app, other apps will be searched (Spotify, Youtube, itunes Radio, etc.)
3. If patients are randomized to the intervention group, the investigator will create a station in the Pandora music app using the patient's preferred music. Volume will be initially set on low and portable speaker system placed within 3 feet of the patient (in order to ensure that she can hear the music). The music will be started and volume will then be adjusted to the patient's preference, avoiding music that is too loud but ensuring it is loud enough so the patient can hear it.
4. At that point, epidural placement will begin. Patients will receive an epidural in the normal fashion. Music will be continued throughout the duration of the epidural placement procedure, unless the patient requests that it be discontinued earlier.
5. If patients are randomized to the control group, no music will be played.
6. One hour after epidural placement, the patient will be asked to fill out the patient satisfaction survey to assess their satisfaction with the epidural placement. All patients from both the intervention and control group will be asked to complete the survey.
7. Data (see below) will be collected from the chart at time of enrollment and at time of study completion.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women in labor

   • Healthy pregnant women in labor requesting epidural labor analgesia
2. \>30 weeks gestation
3. Ages 18 - 45

Exclusion Criteria:

1. Any patient who refuses
2. Women with impaired decision-making capacity
3. Patients who are deaf or extremely hard of hearing (if patients wear a hearing aid and can hear with it, then patients are still eligible to be in the study)
Assessing the Patient Experience in Cancer Care

Communication is an important component of comprehensive cancer care impacting patient satisfaction, adherence, and quality of life. The wide array of issues addressed in cancer clinical interactions makes communicating about a broad range of topics (including quality of life, communication, symptom control, complementary/alternative therapies, costs, treatment burden, prognosis, anxiety, side-effects, sexual function, palliative care options, etc.) especially interesting and potentially challenging. Some of these topics may not be routinely addressed in the clinical interaction or may require consultative support from other members of the comprehensive cancer care team. One frequently overlooked critical element in research on communication between cancer clinicians, their patients, and their primary care clinicians is describing real-time consultations between patients and their clinicians. These interactions provide rich material for assessing key psycho-social dynamics and identifying issues that patients find important in their care. In order to devise systems of care that optimize the patient experience, it is critical that clinicians and researchers understand, appreciate, and systematically characterize the richness and complexity of the decision-making process in routine cancer consultations between cancer patients and their treating clinicians. This study seeks to assess the patient experience in cancer care by observing patients and their physicians in their clinical interactions and following them for several months to see how their care went. By describing in-depth the conversations and experiences of patients in these clinical interactions, this study will lay the foundation for practice-based interventions to optimize patients' interactions with their cancer care teams.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Histological confirmation of: brain, breast, endocrine, gastrointestinal, genitourinary, gynecological, head/neck, lung, melanoma, or sarcoma malignancies.
* Speak English or Spanish
* Not enrolled in hospice
* In any of the following phases of the cancer control continuum: initial diagnosis, initial treatment, early survivorship, or recurrence.
* Provide written informed consent

Exclusion Criteria: