cyrilzakka/clinical-trials huggingface dataset:
Effect of COVID-19 Pandemic on Pediatric Cancer Care

Observational cohort study to assess the effects of COVID19 on pediatric cancer care in Egypt and the Arab World through a survey applied to pediatric oncologists who will be interviewed either directly or through the internet to assess the effect of COVID 19 on pediatric cancer care

Corona viruses are single stranded enveloped RNA viruses with helical capsids. They infect wide variety of hosts including humans and animals. Coronavirus disease 2019 (COVID-19) was first described in December 2019 in Wuhan, the capital of China's Hubei province. A novel corona virus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified as the causative organism. On 30 Jan 2020, WHO declared COVID-19 as a Public Health Emergency of International Concern (PHEIC). Subsequently on 11 March 2020, WHO declared COVID-19 as a pandemic. On April 30, 2020; 3,239,220 confirmed cases were diagnosed across the globe with 228,860 deaths. The united states has the highest number of cases followed by spain and Italy. The first confirmed case of COVID-19 in Egypt was reported on 14 February 2020. As of April 30, 2020, there have been 5,537 confirmed cases, 1381 recovered and 392 deaths The overall global incidence of cancers in children aged 0-14 years is 140·6 per million, whereas, It's 130.9 per million in Egypt. Although cancer is a rare disease among children and adolescent, It's one of the leading causes of death. The prognosis of childhood cancer has significantly improved over the past decades with 5-year survival rates improved from 58% in the mid-1970 to around 83% in 2008-2014.

Little is known about the effects of COVID-19 on children with cancer. Children with cancer face numerous challenges during COVID-19 pandemic. Children with cancer are immunocompromised because of cancer or anti-cancer therapy. They have to be hospitalized to receive their anti-cancer therapy. The major problem we-as pediatric oncologist- face nowadays is how to organize pediatric cancer care in the COVID-19 ERA.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric oncologists working in cancer centers in Egypt and the Arab world during COVID 19 pandemic

Exclusion Criteria:

* Pediatric oncologists not caring for patients during COVID 19 pandemic
Effect of Yoga@Work Program

Employees working in IT industry are prone to develop musculoskeletal pain,specifically back, neck and shoulder pain. This study evaluates the effectiveness of work-site yoga intervention, Yoga@work on neck and shoulder pain in IT employees.


Eligibility Criteria:
Inclusion Criteria:

* IT companies employee
* Full time employment
* Neck and Shoulder Pain
* pain of at least 3 months duration
* able to comply with intervention schedule

Exclusion Criteria:

* Pregnancy
* Refuse to give informed consent
* spinal fracture
* recent cervical spine or shoulder surgery
* recent (3 months) chemotherapy/radiotherapy/ intervention
Influence of Sensorimotor Treatment in the Balance of Soccer

This study presents the hypothesis that the sensory processing engine improves balance and agility for football athletes.

Objectives: To investigate the influence of the sensorimotor treatment in balance, agility and functionality soccer players assessed using force platform, functional tests and questionnaires.

Methods: This study was characterized as a randomized clinical trial. 20 male soccer players was assessed by means of questionnaires, force platform in one foot, and functional tests of balance and agility (Side Hop Test, Figure of Eight Hop Star Excursion Balance Test and Test). To the platform, the parameters of the center pressure (COP) in the anterior- posterior and medial -lateral directions was used for analysis, to functional tests the time-second performance was analyzed. Initially all athletes respond to the questionnaires, was evaluated on the force platform and through functional testing by blind evaluators. Following, they were randomized to treatment groups (n=10) and control (n=10). The treatment group performed 6 weeks of proprioceptive exercises with shifts and one-leg jumps and bipedal support.

The control group remained in soccer training. At the end of the treatment protocol and all were reassessed following the cross-over, where the control group performed the same treatment sensory motor was developed.

Eligibility Criteria:
Inclusion Criteria:

* minimum of three years of training in the sport,
* participating in state and national competitions,
* often training at least five times a week

Exclusion Criteria:

* athletes undergoing surgical procedures or have muscle and joint injuries in the lower limbs in the last three months,
* which are in physical therapy or who require the use of stabilizers to perform the tests on the platform or during the treatment protocol
Lung Inflammation and Lung Metastases From Breast Cancer

The purpose of this study is to find out if there is a link between cigarette smoking, inflammation and the spread of breast cancer to the lung. We think that women who are current or former smokers may be at increased risk for breast cancer spreading to the lung compared to women who have never smoked. Smoking causes inflammation in the lung in some women. Researchers at Memorial Sloan-Kettering (MSKCC) think that smoking-related lung inflammation may increase the chance of breast cancer spreading to the lung. In order to find out whether inflammation plays a role in breast cancer spreading to the lung, we will measure a urinary marker of lung inflammation. This will allow us to determine if this marker is more commonly elevated in women with breast cancer that has spread to the lung compared to those without breast cancer in the lung. We will also collect DNA from blood to have the opportunity to determine if there are differences in DNA in women with or without breast cancer that has spread to the other sites including the lung. We will also collect blood to determine if we can identify risk factors for the spread of breast cancer to the lungs.


Eligibility Criteria:
Inclusion Criteria:

* Registered patient at MSKCC
* Histologically proven breast cancer. It is not necessary that pathology be reviewed at MSKCC
* Age ≥18 years Group 1 (A and B)
* Diagnosed with metastatic breast cancer on biopsy or imaging study.
* Patients will be considered to have lung metastases, and will be assigned to group 1A if any of the following criteria are met, otherwise patients will be assigned to group 1B "No known Lung Metastases," Biopsy-proven lung metastasis.
* Pleural effusion with cytologic evidence of malignancy.
* Pleural effusion, exudative in character, without alternative explanation and attributed, in the opinion of the clinician to metastatic disease.
* Symptoms attributable to lung metastases and a radiological pattern interpreted by a radiologist as suspicious for metastatic disease.
* Any pulmonary nodule on chest radiograph, CT scan, PET-CT or MRI, which is interpreted by the clinician and radiologist to be metastatic in etiology, whether or not a biopsy was performed, and regardless of symptoms.
* A radiographic pattern interpreted by a radiologist as consistent with lymphangitic carcinomatosis.

Group 2 (Controls)

* History of early breast cancer and currently no evidence of disease

Exclusion Criteria:

* Inability to provide written informed consent.
* Inability to complete smoking and NSAID questionnaire.
* Steroid use within the previous 4 weeks.
* Radiotherapy to the breast, chest wall or axilla within the previous 3 months.
* Men with breast cancer.
The Impact of Light, Electrical, and Magnetic Neuroregulation Interventions on Sleep-wake Disorders

Carry out precise and effective neuromodulation interventions, and develop new neuromodulation technologies for sleep disorders. Use phototherapy, transcranial electrical/magnetic stimulation and other therapies to conduct self-controlled intervention studies on insomnia, narcolepsy, and rapid eye movement sleep behavior disorder .


Eligibility Criteria:
Inclusion Criteria:

- Patients with insomnia, narcolepsy,and RBD that have been clearly diagnosed by specialists should sign the informed consent form.

Exclusion Criteria:

1. Patients with major neurological diseases such as multi-infarct dementia, Huntington\&#39;s disease, normal pressure hydrocephalus, brain tumors, progressive supranuclear palsy, epilepsy, subdural hematoma, multiple sclerosis, or those who have sustained neurological dysfunction or known structural brain abnormalities after significant head trauma are excluded.
2. A history of major depressive disorder or bipolar disorder within the past year, as defined in DSM-IV criteria. A history of schizophrenia (meeting DSM-IV criteria).
3. History of severe drug or alcohol abuse within the past year;
4. Any significant systemic illness or unstable medical condition that may make it difficult to comply with the protocol, such as severe autoimmune diseases or a history of cancer.
5. Have significant hearing, visual, or cognitive impairments, or are unable to participate in interviews in a meaningful way.
To Investigate the Clinical Efficacy of an Experimental Toothpaste

The objective of this study is to evaluate the effect of an experimental toothpaste on maintaining gingival health over a 24 week period measured through modified gingival index, bleeding, plaque, and plaque bacteria. Prior to commencing study treatment, subjects will undergo a dental prophylaxis followed by a 2 week period of oral hygiene instruction and weekly professional tooth cleaning to bring the subjects to their optimum gingival health prior to commencing study treatment.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects aged 18 years and older
* A minimum of 20 permanent gradable teeth
* For baseline eligibility, subjects must have a minimum Modified Gingival Index score of 1.5-2.3.
Effect of Combined Remote Ischemic Preconditioning and Postconditioning on Acute Pulmonary Injury in Patients Undergoing Valvular Heart Surgery

Pulmonary dysfunction after cardiac surgery with CPB remains to be a problem complicating the postoperative course of the patients. The investigators hypothesized that RIPCcom, combined intervention of remote ischemic preconditioning and remote ischemic postconditioning, would confer beneficial influence on inflammatory response and resultant postoperative pulmonary dysfunction after CPB in patients undergoing complex valvular heart surgery who are at increased risk of postoperative pulmonary dysfunction.The aim of this study was to evaluate the lung-protective effect of combined remote ischemic pre- and post-conditioning in patients undergoing complex valvular heart surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing valvular heart surgery.
* Age: 20\~80.

Exclusion Criteria:

* Emergency operation.
* patients with peripheral vascular disease.
* Patients with a known history or clinical evidence of chronic obstructive pulmonary disease.
* Patients with hepatic or renal dysfunction
* Patients with acute myocardial infarction within 1 week before surgery
Mobile Self Management and Support for Adolescents and Young Adults With Cancer

This study is the user testing phase of a mobile application intervention which will be designed to promote positive coping skills, illness resilience, and social support, and to serve as a complement to patient-physician interactions in adolescents and young adults (AYA) with sarcoma. User testing will be conducted with a prototype of the app. Participants will be AYA ages 13-25 with sarcoma (N=16). Study participation involves the AYAs downloading and using the app for 30 days. During the 30 days, participants will interact with the app by inputting their current mood, receiving supportive feedback from the app, reading messages, and doing brief activities (such as relaxation activities, etc.). Participants will also participate in an online focus group focused around the user experience. Before and after the 30 days of user testing, participants will complete a few brief questionnaires about their behavior, how their symptoms affect their life, and how they receive support from others. These questions will take around 20 minutes to complete at each administration.


Eligibility Criteria:
Inclusion Criteria:

1. Parent or self-reported (for participants 18+ years old) physician diagnosis of sarcoma
2. Daily use of a smartphone (iOS, Android, or Windows) or tablet
3. Current Facebook account that participant can use to participate in the focus group (or, be willing to create a Facebook account for this purpose).
4. Able and willing to give informed assent and comply with study requirements
5. For patients aged 13-17 years, have one caregiver willing and able to participate in the study
6. Able to read and speak English

Exclusion Criteria:

1. Patients that are not able to participate in the study due to their medical condition and/or treatment regimen, as determined by the patients' treating oncologist in conjunction with patients' family members
2. Inability to provide informed assent/permission/consent
3. Inability to read, speak, and understand English
A Study to Assess Safety, Tolerability, and PK of EDG-5506 in Healthy Volunteers and Becker Muscular Dystrophy Adults

EDG-5506 is an investigational product intended to protect and improve function of dystrophic muscle fibers. This Phase 1 study of EDG-5506 will assess the safety, tolerability, and pharmacokinetics (PK) and of EDG-5506 in adult healthy volunteers and in adults with Becker muscular dystrophy (BMD).

Enrolled participants in this study will receive a single oral dose or multiple oral doses of EDG-5506 or a placebo. Blood and urine samples will be collected to measure how EDG-5506 is processed by the body and how the body responds when exposed to EDG-5506. Participants in the single ascending dose part of the study will remain in the clinic for 7 days with a 42-day follow-up period. Participants in the multiple ascending dose part of the study will remain in the clinic for 16 days with a 13-day follow-up period. Safety, tolerability, and pharmacokinetics of EDG-5506 will be assessed in healthy volunteers prior to enrolling participants with Becker muscular dystrophy.

Eligibility Criteria:
Inclusion Criteria:

* For all potential participants (Healthy volunteers and BMD): Male or for HV: female. For all: adults aged 18 to 55 years at time of consent.
* For HVs: Good general health, with no significant medical history, no clinically significant abnormalities on physical exam
* For BMD: Diagnosis of BMD based on documentation of mutation(s) in the dystrophin gene and BMD phenotype
* For BMD: Ability to ambulate
* For all: Weight greater than or equal to 50 kg and BMI less than 33 kg/m2
* For HV: Females must be of non-childbearing potential.
* For all: Males with female partners must use a medically accepted contraceptive regimen from first dose through 90 days after the last dose
* For all: Non-smoker and must not have used any tobacco products within 3 months prior to the Screening visit.
* For all: Able and willing to attend the necessary visits at the study center.

Exclusion Criteria:

* For all: History of, or physical exam findings indicating clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases that, in the opinion of the Investigator, would render the subject being unsuitable for the study.
* For all: Unable to refrain from strenuous exercise for 3 days prior to check-in and during study.
* For all: Participation in any other investigational drug study within 30 days or 5 half-lives (whichever is longer) of dosing in the present study.
Impact of Behavioral Feeding Intervention on Parent-Child Attachment in Young Children

The primary objective of the proposed study is to determine whether behavioral feeding intervention impacts mother-child attachment in infants and toddlers with feeding problems. The investigators propose the following hypotheses:

* Behavioral feeding intervention will not significantly impact parent-child attachment.
* Behavioral feeding intervention will not significantly impact parent-child unstructured play interactions.
* Severity of feeding problems will decrease after behavioral feeding intervention is implemented.
* Behavioral feeding intervention will have either no significant effect or a significant positive effect on general child behavior.


Eligibility Criteria:
Inclusion Criteria:

Caregiver Based

* Mothers
* Conducts feeding intervention ≥75% of the time at home
* Understands and speaks English

Child Based

* 12-14 or 30-48 months old at initial assessment
* Clinically significant feeding problem
* Self-initiates movement
* Can be left alone in a room for 3 minutes
* Capable of initiating eye contact
Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial

This clinical trial studies side effects and best treatment time of cryodevitalization in treating patients with early stage (stage I or stage II) lung cancer. Cryodevitalization is a type of cryosurgery that uses a flexible probe (cryoprobe) to kill tumor cells by freezing them. It is delivered at the time of standard diagnostic robotic bronchoscopy. Using cryodevitalization may be safe, tolerable and/or effective in treating patients with early stage lung cancer.

PRIMARY OBJECTIVE:

I. To identify the maximum tolerated dose (MTD) for cryodevitalization cycle duration.

OUTLINE: This is a dose-escalation study.

Patients undergo 3 freeze-thaw cycles of cryodevitalization over 30 seconds or 3, 5, or 7 minutes each during standard of care robotic bronchoscopy with biopsy on study. Patients then undergo standard of care surgical resection on study. Patients also undergo a chest radiography (x-ray) on study as well as computed tomography (CT) and tissue sample collection throughout the study.

After completion of study treatment, patients are followed up at 3 and 7 days and are then followed as clinically required per standard of care for 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a single pulmonary nodule with a size less than or equal to three centimeters (average long and short axis) confirmed as malignant intraprocedurally (rapid on-site evaluation with pathology assessment showing lung cancer or oligometastatic disease) without evidence of mediastinal involvement who require nodule biopsy prior to proceeding with surgical resection
* Nodules must be located in the outer 2/3 of the periphery of the lung, greater than 10 mm from the pleura and from large blood vessels or mediastinal structures to avoid injury to other visceral organs
* Patients deemed to have a surgical resection treatment option based on preoperative staging computed tomographic (CT), postoperative predicted forced expiratory volume in 1 second (FEV1) \> 40% and evaluation of medical comorbidities after discussion at multidisciplinary tumor board
* Age \> 18 years old

Exclusion Criteria:

* Target nodule is within the International Association for the Study of Lung Cancer (IASLC) "central zone" (including bronchial tree, major vessels, heart, esophagus, spinal cord and phrenic \& laryngeal nerves), or are \< 10 mm from the pleura
* Patients with an expected survival less than 6 months
* Patients with endobronchial lesions, concerning for malignancy, visualized during the initial bronchoscopic evaluation of the airways
* Patients with medically uncorrectable coagulopathy: abnormal platelet count \< 100 × 10\^9/L or an international normalized ratio \> 1.5
* Patients with known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] \> 50mmHg)
* Patients who are currently prescribed anticoagulants, clopidogrel, or other platelet aggregation inhibitors
* Patients with medical comorbidities deemed high-risk for surgical resection
* Pregnant women
* Inability to provide informed consent
A Study to Explore the Effect of Acid-reducing Agents

A Phase 1 Study of the Effect of Acid-reducing Agents on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects. The study is a single-center, open-label, 2-period, 2-treatment, fixed-sequence crossover, parallel-group study.


Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index between 18.0 and 32.0 kg/m2, inclusive.
* In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations at screening and/or check-in, as assessed by the investigator (or qualified designee).
* Females of childbearing potential will not be pregnant or lactating and must have a negative result on an approved pregnancy test at screening and check-in. Females of childbearing potential must agree to use contraception.
* Male subjects must agree to use contraception.
* Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Key Exclusion Criteria:

* Significant history of clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator.
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, any components of the IMP, or other substance (not including seasonal allergies), unless approved by the investigator.
* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications. (Uncomplicated appendectomy and hernia repair are allowed. Cholecystectomy is not allowed.)
* History of Gilbert's syndrome or suspicion of Gilbert's syndrome based on elevated total and indirect bilirubin (may be confirmed by repeat).
* Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to study drug administration on Day 1 of Period 1.