cyrilzakka/clinical-trials huggingface dataset:
A Six-month Study to Compare Outcome Differences and Visceral Response ... Irritable Bowel Syndrome

The purpose of this study is to assess the effect of participation in one of the following interventions: (1) IBS Stress Management; (2) IBS Symptom Management; or (3) IBS Educational Training on improving IBS associated symptoms. It is anticipated that this research will provide information on the usefulness of psychological approaches in treating IBS and will help scientists better understand the disorder.


Eligibility Criteria:
Inclusion Criteria:

* Irritable Bowel Syndrome

Exclusion Criteria:

* GI pathology (organic disease) that affects bowel transit
* Co-morbid pain disorders
* Current or recent history (within 24 months) of drug or alcohol abuse
* Clinical evidence (including physical exam, laboratory tests) of significant medical disease that may interfere with the patient successfully completing the trial
* Planned use of drugs or agents that affect GI motility and/or perception
Visual Mode Switching in Color Perception

Participants will be given experience wearing colored lenses that add a tint to the environment. Changes in visual perception and neural processing that arise as a result of this experience will be measured. These are expected as participants learn to switch to "colored lenses mode" where the effects of the lenses are discounted and colors appear more normal as soon as the lenses are put on.

All participants will wear tinted lenses for 1 hour at a time, 5 times per day. Perception (behavior) and neural function (with functional MRI and EEG) before and after this experience will be measured. In the neural measurements, activity will be recorded while participants view stripes of many different colors both with the lenses on and off. In the perceptual measurements, participants will adjust the color of a small patch to appear neutral, neither red nor green. Behavior will be measured in a variety of conditions to test different hypotheses about the origins of the mode-switching effects. These include: 1) surrounding the patch with different colors, 2) preceding the presentation of the patch with presentation of different colors, 3) presenting the tests in a red-illuminated room, 4) presenting the tests in a completely darkened room, and 5) using a head-mount-display (virtual reality goggles) to present simulated lenses that gradually change in strength.

Eligibility Criteria:
Inclusion Criteria:

* Normal or corrected to normal vision by contact lenses
* No known visual disorders
* Little to no experience in tinted environments (e.g. dark rooms, swimming goggles)

Exclusion Criteria:

* Abnormal color vision
Single and Multiple Ascending Dose Study Assessing the Safety, Tolerability, PK and PD of AG10

This is a single center, prospective, randomized, placebo-controlled study of AG10 in healthy adult subjects

Up to 48 healthy volunteers will be given a single dose of AG10 or placebo and be monitored for safety and tolerability over a 5-day period. Up to 48 healthy volunteers will be given multiple doses of AG10 or placebo and be monitored for safety and tolerability over a 15-day period.

Eligibility Criteria:
Inclusion Criteria:

* Weight between \>50 kg and ≤110 kg;
* BMI of 18 to 32 kg/m2;
* Subjects who are healthy as determined by medical history, physical examination, 12 lead ECG and standard laboratory tests;
* Subjects who are negative for drugs of abuse and alcohol tests;
* Subjects who are non-smokers;

Exclusion Criteria:

* Subjects who have used prescription drugs within 4 weeks of first dosing;
* Subjects who have a prior cholecystectomy;
* Subjects who have used any over-the-counter medications within 7 days prior to Day -1;
* Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue diseases or disorders;
* Subjects who have an abnormal screening ECG;
A Model for Implementation of Cervical Cancer Screening and HPV Vaccination the Emergency Department: a Pilot Study

In this pilot study, we intend to demonstrate that a great portion of women at high risk (inadequate screening, HPV 16/18 and/or cytology) are presenting to the ED, cytology/ HPV testing via ThinPrep®Pap testTM and surveillance. We intend to provide improved access to healthcare and monitoring through administration of vaccine to eligible patients and 1 year follow up for patients involved in this study.

Females meeting inclusion/exclusion criteria participating in the study (n=100) that have not had a cytology test in 2 or more years will be offered the Thin Prep® cytology test. This study will allow surveillance of disease through cytology and HPV DNA testing via collection of data using Thin Prep® cytology with reflex HPV DNA testing according to established guidelines as described below.

Provide improved access to healthcare and monitoring through administration of vaccine for eligible females as established by guidelines. Patients will receive first vaccine in the ED and will have arranged follow up for administration of the 2 month and 6 month series of the HPV vaccination. Through data collection, we intend to determine if there is a need for vaccination and determine if patients are likely to follow up..


Eligibility Criteria:
Inclusion Criteria:

* 3 years of beginning sexual activity or by age 21 years whichever occur first.
* resident of the City of Norfolk, Virginia
* uninsured

Exclusion Criteria:

* Pregnant women
* Women with Hysterectomy with cervical excision
* Women who received full HPV vaccine series
* Known history of cervical cancer
* Male sex
* Loop electrocautery excision procedure(LEEP)
* Cold-Knife conization
Novel Cavity Marking Technique in Breast Cancer Patients Undergoing Breast Conservation Surgery With Oncoplastic Reconstruction for the Delivery of Adjuvant Radiotherapy and Accuracy of Recommended Re-excisions

This study will investigate a novel approach to marking surgical cavity margins following tumor resection, to allow for more accurate radiotherapy following oncoplastic surgery. Our proposed cavity marking schema will allow radiation oncology to identify the cavity margins more accurately on CT simulation for radiation planning and delivery. This cavity marking schema also provides more accurate margin identification in patients recommended for re-excision of close or positive margins.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years of age.
* A pathological diagnosis consistent with non-invasive ductal carcinoma in-situ (DCIS) and invasive breast cancer, Tis-T3N0-3M0
* Subject is planning to undergo breast conservation surgery and oncoplastic reconstruction
* ECOG Performance status of 0-1
* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.
* Subjects must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \[as determined by the treating physician or approved by the PI\] may be included).
* Subjects of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy during surgery and radiation therapy. Prior to study enrollment, subjects of childbearing potential must be advised of the importance of avoiding pregnancy during the surgery and radiation portions of the trial and the potential risk factors for an unintentional pregnancy. SOCBP includes any subject who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopause is defined as amenorrhea that has lasted for ≥ 12 consecutive months without another cause.

Exclusion Criteria:

* Patient not recommended for, or have declined, adjuvant radiotherapy
* Subjects with prior ipsilateral breast surgery and identifiable surgical clips.
* Subjects who are confirmed to be pregnant or breastfeeding.
* History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detailed for treatment of either a psychiatric or physical illness.
Food as Medicine: An RCT to Study the Effect of Home Delivered, Medically Tailored Meals on Patients With Metastatic Cancer

The purpose of this study is to determine whether medically tailored meals (HDTM) can improve quality of life for patients with metastatic cancer.

The current standard of care at the cancer center is for all patients receiving cytotoxic therapy to undergo a nutritional consultation and evaluation with a registered oncology dietitian. The goal of this consultation is to prevent nutritional deficiencies, promote optimal nutritional intake, hydration, and weight maintenance, as well as maintain lean body mass.

All patients on this study will receive standard of care nutritional services including nutrition consult, evaluation, and as needed follow-ups. However, patients randomized to arm 2 will receive home delivered, medically tailored meals in addition to the standard nutritional care.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pathologically confirmed metastatic pancreatic, hepatobiliary, esophageal, or lung cancer, either newly metastatic or metastatic at presentation (M1+) and enrollment within 6 weeks of diagnosis; measurable disease need not be present.
* Pain Score (PS) 0-3
* Age\>18
* Both male and female subjects eligible
* All ethnicities eligible
* Access to refrigerator or freezer

Exclusion Criteria:

* Diagnosis of metastatic cancer no greater than 6 weeks prior to expected study enrollment
* Currently receiving home delivered meals from other sources
* Evidence of any alimentary tract obstruction or other condition preventing oral alimentation
* Requirement for enteral or parenteral nutrition at time of diagnosis
* Incarcerated individuals
Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit

To compare the results obtained by analysis of a self-collected anterior nasal (AN) swab as part of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit to a healthcare provider (HCP)-collected AN swab in patients with symptoms of viral respiratory infection consistent with influenza A (Flu A), influenza B (Flu B), respiratory syncytial virus (RSV) and/or SARS-CoV-2 (C-19).


Eligibility Criteria:
Inclusion Criteria:

* presents with symptoms of viral respiratory infection consistent with Flu A, Flu B, RSV and/or C-19;
* Subject can read and understand written instructions in English; and
* Subject is able, in the professional opinion of the investigator, to provide up to 18.5mL of whole blood at the clinic visit. NOTE - the blood draw will be optional for subjects \<12 years of age.

Exclusion Criteria:

* no personal access to the internet and no email address
* Subject is 14-17 years of age and their parent or legal guardian is unable to supervise the collection of the AN swab sample from the subject;
* Subject is \<14 years of age and their parent or legal guardian refuses to collect the AN swab sample from the subject; or
* Previous participation in this protocol.
Sing for Your Saunter Part 2 R33

The goal of this clinical trial is to compare to rhythm-based walking interventions to enhance gait in people with Parkinson's disease. The main questions it aims to answer are:

* How does rhythm-based training influence walking performance?
* How does brain activity change following rhythm-based training? Participants will perform walking to music and walking while singing, and will train on the use of these rhythms for 12 weeks. The investigators will compare the effects of training with music to training with singing.


Eligibility Criteria:
Inclusion Criteria:

1. at least 30 years of age
2. diagnosis of idiopathic, typical Parkinson disease according to the UK Brain Bank Criteria
3. Hoehn \& Yahr stages 2-3 (mild to moderate disease severity)
4. evidence of walking impairment (score at least 1 on gait item of MDS_UPDRS)

4) stable on all Parkinson disease medications for at least 2 months prior to study entry 5) willing and able to provide informed consent 6) right-handed

Exclusion Criteria:

1. diagnosis of any other neurological condition
2. a score of 2 or greater on item # 3 on the freezing of gait questionnaire
3. significant cognitive impairment
4. unstable medical or concomitant illnesses or psychiatric conditions which, in the opinion of the investigators, would preclude successful participation
5. cardiac problems that interfere with ability to safely participate
6. orthopedic problems in the lower extremities or spine that may limit walking
7. contraindications for magnetic resonance imaging
8. unable to walk for 10 continuous minutes independently
9. left-handed
10. uncontrolled tremor or dyskinesia
The Effect Site Concentration of Remifentanil for Conscious Sedation During Awake Nasotracheal Fiberoptic Intubation

Remifentanil provides analgesia, suppresses airway reflex, has little effect on cognitive function. It can be used for conscious sedation during awake nasotracheal fiberoptic intubation. Target-controlled infusion is more reliable technique for maintaining optimal infusion rate than manual controlled infusion. The aim of this study is to determine the effect site concentration of remifentanil for successful conscious sedation during awake nasotracheal fiberoptic intubation.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cervical spine surgery
* Age 20-65
* American Society of Anesthesiologists physical status classification I or II

Exclusion Criteria:

* Patients' refusal
* allergy to any drug used
* unable to cooperate
* Severe hepatic or renal disease
* coagulation disorder
* chronic use of opioids or sedatives
* increase risk of pulmonary aspiration.
Vitamin D Zinc Fever

Zinc and vitamin d deficiency are associated with a state of inflammation/atherosclerosis.

There are studies demonstrating an association between vitamin d deficiency and respiratory illnesses.

Both zinc and vitamin d are associated with oxidative stress and inflammation.

Both vit. d and zinc share anti inflammatory and anti oxidative actions. vit. d deficiency is associated with an increase in serum levels of proinflammatory cytokines and decreased levels of anti inflammatory cytokines.

there are reports concerning the association of vit. d deficiency with infections.

Eligibility Criteria:
Inclusion Criteria:

* age\>18 years

Exclusion Criteria:

* CCT\<90
* taking calcium
* hyper/hypoparathyroidism
* active malignancy.
Reducing Loneliness of Older Adults in Long Term Care Facilities Through Collaborative Augmented Realities

The goal of this clinical trial is to test the use of head-mounted display (HMD) augmented reality (AR) in older adults residing in long term care communities. The main questions it aims to answer are: what is the feasibility, acceptability, and satisfaction of HMD AR vs two-dimensional audio-video communication? Older adults and their designated family member will complete HMD AR activities in 8 session visits over 4 weeks. Researchers will compare HMD AR to 2-D audio-visual (AV) comparison group on feasibility, acceptability, and satisfaction with the interactive communication technology.

For both interventions, the bandwidth within the family members' homes will be measured and a hotspot created if necessary to facilitate data streaming. For each session, a trained research assistant (RA) will be physically present at the Long-term Care (LTC) to troubleshoot for technological issues. The RA will observe the staff member establish the Interactive Communication technology (ICT) connection between the older adult and family member, assisting as needed. The RA and staff member will remain within the room; the RA will monitor for technological issues. The staff member will monitor the older adults' reactions.

HMD-AR Intervention Experimental Setup. For the older adults, equipment set-up will be in a dedicated room at the LTC that allows for environmental overlays. Equipment includes two Kinect cameras, one HMD and one E4 wrist sensor that the older adult will wear to measure stress through physiological sensing. The family member will be consulted for placement of the 2 Kinect cameras in their home.

AR Activities. At least one meal session and one activity session will be conducted. The remaining sessions will consist of activities based on the preference of the older adult-family member. Staff will be trained to turn on the headset, computers, and ensure communication connection between the older adult and family member.

2D Audio-visual Intervention The 2D audio-visual sessions will take place in a dedicated room at the LTC. Staff will initiate the connection between the older adult and family member. In the unlikely event a family member does not have a device for the 2D audio-visual visits, a computer tablet will be supplied for use during the study.

Eligibility Criteria:
Inclusion Criteria:

* age 60 and older
* residing at LTC greater than 3 months

Exclusion Criteria:

* unable to provide assent or consent
* unable to understand or speak English
* physical impairment that impedes participation
* terminally ill
Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia

This is an open-label study to evaluate safety, tolerability, efficacy and PK profile of ofatumumab monotherapy in Japanese follicular lymphoma (FL) or chronic lymphocytic leukemia (CLL) patients. subject will receive ofatumumab 8 weekly infusions.


Eligibility Criteria:
INCLUSION CRITERIA:

* Signed Informed Consent.
* Histologically confirmed relapsed or refractory CD20 positive FL grade 1-3a and 1 or more clearly demarcated lesions with a largest diameter = 1.5 cm, or CD5, CD19, CD20 and CD23 positive relapse or refractory CLL.
* Subjects must have adequate blood, liver, and kidney function.
* Subjects who passed the provided periods from the last anti-cancer treatments at screening
* ECOG Performance Status of 0-2
* Life expectancy more than 24 weeks at screening

EXCLUSION CRITERIA:

* Current and past malignancy other than FL and CLL within 5 years prior to screening.
* Known Richter's transformation
* Previous autologous stem cell transplantation within 24 weeks prior to screening
* Previous allogeneic stem cell transplantation
* Known CNS involvement
* History of significant cerebrovascular disease
* Current cardiac disease requiring medical treatment
* Chronic or ongoing active infectious disease requiring systemic treatment
* Patients with pleural effusion or ascites detectable by physical examination
* Positive serology test for any of HBsAg, anti-HBc or anti-HCV
* Known HIV positive
* Pregnant or lactating women
* Women of childbearing potential and male patients not willing to use adequate contraception
Drug Abuse Among Elective Surgeries: an Observational Study.

Drug abusers and addicts form a challenge to the anesthetist because of the added potential risks involved in the administration of anesthesia to this subset of patients, including potential unforeseen drug-drug interactions. In this study, we aimed at screening all patients scheduled for elective orthopedic or general surgeries at the Cairo University Teaching Hospital during a set period of time for the most commonly abused drugs in Egypt.

All patients included in the study consented to take part in this study. Each patient was asked to answer a questionnaire and submit a urine sample in order to be screened for the most commonly abused drugs in Egypt (hashish, tramadol, benzodiazepine, and morphine). Patients were then followed up both intra and post-operatively. Values of patient vital signs, Richmond Agitation-Sedation Scale (RASS) scores as well as clinical recovery scores (CRS) were all diligently recorded and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* male or female patients classified as American Society of Anaesthesiology (ASA) I or II patients
* patients between 15 and 60 years of age
* patients scheduled for elective surgery.

Exclusion Criteria:

* emergency surgery
* those with disturbed conscious levels
* history of psychological illness
* who refused to give consent
Genetic and Neural Predictors of Adolescent Depression

This study aims to examine the relationship between mood and brain activity in adolescent girls in order to better understand the genetic and neural predictors of adolescent depression. The participants in this study will be healthy female adolescents aged 12-14 and their mothers. They will participate for a total of six months. Adolescent participants will have three study sessions at McLean Hospital, and during two of them, their mothers will also have assessments. Adolescent assessments will include interviews, questionnaires, computer tasks, and collection of a saliva sample for genetic analyses. Their second study visit will include an fMRI scan. Parent assessments will include an interview, questionnaires, and a computer task.


Eligibility Criteria:
Adult Cohort

A. MDD Mothers Cohort Inclusion Criteria:

* Current or past Major Depressive Disorder
* English as first language or English fluency
* Biological daughter who meets inclusion/exclusion criteria for High Risk Female Adolescent

B. Healthy Control Mothers Cohort Inclusion Criteria:

* No history of psychopathology
* English as first language or English fluency
* Biological daughter who meets inclusion/exclusion criteria for Healthy Female Adolescent

Adolescent Cohort

General Inclusion Criteria for Adolescent Cohorts:

* Female
* Ages 12-14
* English as first language or English fluency
* Right handed

General Exclusion Criteria for Adolescent Cohorts:

* Past or present diagnosis of Major Depressive Disorder
* Past or present diagnosis of any anxiety disorder
* Past or present diagnosis of Bipolar Disorder
* Past or present diagnosis of ADHD
* Presence of medical or neurological illness (head injury, loss of consciousness greater than 5 minutes, seizure)
* Current use of psychotropic medication
* Presence of any contraindication for MRI:

  * Cardiac pacemakers
  * Metal clips on blood vessels (also called stents)
  * Artificial heart valve, artificial arms, hands, legs, etc.
  * Brain stimulator devices
  * Implanted drug pumps
  * Ear or eye implants
  * Known metal fragments in eyes
  * Exposure to metal filings or shrapnel (sheet metal workers, welders, and others)
  * Other metallic surgical hardware in vital area
  * Certain tattoos with metallic ink
  * Certain IUDs containing metal
  * Certain transdermal (skin) patches such as:
* NicoDerm (nicotine for tobacco dependence)
* Transderm Scop (scopolamine for motion sickness)
* Ortho Evra (birth control)

  * Positive urine pregnancy test

C. High Risk Female Adolescent Additional Inclusion Criterion:

• Biological daughter of participant in the MDD Mothers cohort

D. Healthy Female Adolescent Additional Inclusion Criterion:

• Biological daughter of participant in the Healthy Control Mothers cohort