cyrilzakka/clinical-trials huggingface dataset:
COVID-19 Vaccine For Indirect Protection

The primary objective of this study is to test whether vaccinating adults ≥18 years in Hutterite colonies with mRNA-1273 (Moderna COVID-19) vaccine as compared to control (usual care) can prevent RT-PCR confirmed COVID-19 in non-vaccinated Hutterite members.

Despite the efficacy that has been demonstrated in Phase III randomized controls trials of mRNA COVID-19 vaccines, a critical question that remains unanswered is whether mRNA vaccines lead to herd immunity. The rationale for conducting this study is to learn whether vaccinating adults with a COVID-19 vaccine will prevent COVID-19 infections in non-vaccinated community members. Hutterite communities are unique since they are isolated from towns and cities and also share a number of communal activities, such as eating meals and attending church. Because of their location and practices, the Hutterite colonies give an opportunity to see whether vaccinating some Hutterite members with the COVID vaccine provides protection to the whole group. If the study shows that immunizing some of the population reduces the level of COVID-19 infection for other members of the population, this may be very important in stopping the COVID-19 pandemic and future pandemics.

Eligibility Criteria:
Group A: Anyone other than the adults aged ≥18 years who are vaccinated

Inclusion Criteria:

* Individuals under the age of 18
* Individuals with a contraindication to study vaccines
* Those not willing to be vaccinated but consent to follow up

Exclusion Criteria:

- There are no exclusion criteria for this category of participants:

Group B: Adults aged 18 years or older, who will be vaccinated as part of the intervention.

Exclusion Criteria:

* Anaphylactic reaction to any component of the study vaccine or to a previous dose of the study vaccines
* Pregnancy
Ayurveda as Prophylaxis for Suspected COVID-19 Patients

Despite worldwide efforts to contain, manage and treat Covid-19, the pandemic is continuing to spread. This calls for an urgent clinically-proven prophylaxis and therapeutic strategy. Recent developments on the use of traditional medicines in Covid-19 management has drawn enough attention to start several research studies. Based on the Indian Traditional Medicine, Ayurveda's community initiatives, preliminary studies, and our experiential knowledge on Covid-19 settings, we propose present study to prevent the development of COVID-19 symptoms in people who live or have come contact with an individual diagnosed with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Person who has come into contact with confirmed COVID-19,
* Willing to take study drug as directed

Exclusion Criteria:

* Confirmed current COVID-19
* Inability to take medications orally
* Inability to provide written consent
Combined Technique for Difficult Intubation

A difficult tracheal intubation can be a problem, even if one has taken all precautions. A possible solution can be using a videolaryngoscope in conjunct with the Bonfils® intubation scope. As such, the videolaryngoscope can be used to achieve the best possible view and space of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® intubation scope.

In this blinded, unrandomised trial the investigators would like to investigate the change in Cormack and Lehane grade when using both videolaryngoscope (Macintosh videolaryngoscope, Karl Storz, Tuttlingen, Germany) and Bonfils® (Karl Storz, Tuttlingen, Germany). They also want to record the success of intubation and the time needed until successful endotracheal intubation when using this technique as well as complications (trauma to the oral cavity, dental trauma, and regurgitation seen by the anaesthesiologist) that may occur. Also saturation (SpO2) at the end of the procedure will be noted and adjuncts that are used.

Eligibility Criteria:
Inclusion Criteria:

* Informed patient consent Age \> 18 years History of difficult intubation (Cormack and Lehane III-IV)

One or more predictors of a difficult intubation:

* restricted neck movement
* thyromental distance \< 60 mm
* interincisor/interdental distance \< 30mm
* BMI \> 35 kg.m-2 Elective surgery making endotracheal intubation necessary (other than head and/or neck surgery) Fasted (≥ 6 hours)

Exclusion Criteria:

* No informed patient consent Age \< 18 years Emergency surgery, head and/or neck surgery Fasted \< 6 hours
Knee-Hip-Spine Harmony: The Relationship Between Sagittal Spinal Alignment in Total Hip/Knee Arthroplasty

Concomitant osteoarthritis of hip/knee joint and lumbar spinal degeneration is commonly seen in elderly population. These degeneration changes of spine would change sagittal or coronal alignment and spinal flexibility in varies degrees. Total hip and knee arthroplasty (THA/TKA) are among the most successful orthopedic operations performed, aiming at the alleviation of osteoarthritic pain. Normal alignment of the spine and pelvis in the sagittal plane is critical to maintain an upright standing position with minimal energy consumption. However, there is a scarcity of studies on how THA or TKA influences the parameters of the spine and the pelvis.

Compared with the balance of coronal plane, more attention is paid to the balance of sagittal plane. The objectives of this study are to investigate changes in the truncal parameters after THA or TKA and assess whether these parameters are improved or deteriorated after these operations.


Eligibility Criteria:
Inclusion Criteria:

1. Primary degenerative arthritis of the knee or hip
2. Those who have undergone artificial knee or hip replacement surgery
3. Follow up surgery for at least 1 year
4. Track the whole trunk lower limb sagittal plane coronal aligament before and after surgery

Exclusion Criteria:

1. Previous hip surgery
2. Previous spine surgery
3. Contracture after hip fusion surgery
4. Scoliosis over 10 degrees combined with neuropathy
5. Patients with flexion contracture after knee joint surgery
6. Rheumatoid arthritis lesions
Evaluation of Depression and Anxiety in Chemotherapy Patients

This study will examine the existence and severity of depression and anxiety in patients undergoing chemotherapy at RUMC. Patients currently undergoing initial chemotherapy cycle will be compared to patients undergoing a subsequent chemotherapy cycle. Data will then be collected using standardized depression and anxiety scales to assess if these comorbidities exist and to what severity level. Data already collected for depression and anxiety in patients with chronic, but not cancer, illness will be used as a control.

The participants will be screened for signs of psychological distress using three self administered questionnaires: the Generalized Anxiety Disorder 7 item Scale (GAD7) and Patient Health Questionnaire (PHQ9). Demographic information about the participants, including medical and psychiatric history, will also be gathered from their medical records.

The purpose of the study is to see how common Anxiety, Depression and distress are in people who are undergoing treatment for cancer. We want to understand how common these issues are in order to better screen for, and treat people suffering from them. Past studies have shown that people with anxiety or depression and cancer have worse outcomes, and a study evaluating how common these issues are has not been done. Patients presenting for chemotherapy will be identified and approached for participation by members of the research team. The purpose and design of the study will be explained. After informed consent is obtained, the surveys will be administered by the study team. Completing surveys will take 20 minuets. Relevant demographic information will be collected from the patients EMR. Recruitment will extend over one year period. Those determined to be suffering from anxiety or depression will be given the option of psychiatric follow up or intervention.

Eligibility Criteria:
Inclusion Criteria:1)Patients (greater than equal to) 18 years of age 2)Patients with a confirmed diagnosis of a solid tumor or hematologic cancer 3)Patients who are able to understand the informed consent and read the selfadministered metrics. 4)Patients undergoing chemotherapy.

-

Exclusion Criteria:

* Patients unable to give informed consent.
* Patients with a previous diagnosis of anxiety or depression prior to chemotherapy
Effects of Compelled Body Weight Shift Technique for Rehabilitation of Individuals With Chronic Stroke

Stroke is one of the major cause of lifelong disability if not treated on time, the investigator's technique knows as Compelled Body Weight Shift Technique (CBWS) was utilized and administered to chronic stroke population and results were figured out using gait parameters and Tinetti POMA scale.

Total 28 sample size out of which 27 were divided into control and experimental group. Inclusion criteria was Unilateral chronic stroke with asymmetrical stance, Patients with score of 3,4 and 5 will be included according to FAS (Functional Ambulation Scale), Ability to understand and follow instructions, Both male and female, Any type of stroke, and Age 40-60. Written and informed consent was obtained from participants of study. Six weeks of exercise training was combined with compelled body weight shift technique via shoe lift of 0.6 cm thickness for experimental group and for control group training was performed without shoe lift.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral chronic stroke with asymmetrical stance
* Patients with score of 3,4 and 5 were included according to functional ambulation scale(59)
* Ability to understand and follow instruction
* Both male and female.
* Any type of stroke.
* Age 40-60.

Exclusion Criteria:

* • Serious or unstable medical, condition of patient.

  * History of other neurological diseases (i.e. Parkinson's disease, multiple sclerosis),
  * Contractures or any deformity.
  * Leg Length Discrepancy
Validation of the Korean Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)

The purpose of this study is to translate and validate the CAM-ICU for use in the Korean ICU setting.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* admitted to medical ICU at Seoul National University Hospital longer than 24 hours

Exclusion Criteria:

* comatose or moribund state throughout the study period
* preexisting neurologic problem
Contrast-medium Induced Nephrotoxicity in Patients Undergoing Coronary Angiography - Iodixanol Versus Iopromide

In the treatment of coronary heart disease which is the major cause of heart attack, direct mechanical treatment with catheters such as the coronary angiography, coronary balloon intervention and stenting intervention are the mainstay of therapy in recent years. In that procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with underlying kidney disease and decreased kidney function. The investigators intended to find out which contrast agent has less kidney toxicity in the catheter based treatment of coronary arterial diseases in patients with underlying decreased kidney function

Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium (IOCM), may be less nephrotoxic than nonionic, monomeric, low-osmolar contrast media (LOCMs) in high-risk patients. We compared the nephrotoxicity of iodixanol with that of iopromide, an nonionic, monomeric LOCM, in patients with renal impairment.

Eligibility Criteria:
Inclusion Criteria:

* patients who undergo coronary catheterization
* creatinine clearance rates ≤ 60 mL/min using the Cockcroft-Gault formula

Exclusion Criteria:

* pregnancy or lactation
* having received contrast media within 7 days of study entry
* emergent coronary angiography
* acute renal failure or end-stage renal disease requiring dialysis
* history of hypersensitivity reaction to contrast media
* unstable hemodynamic states such as cardiogenic shock, pulmonary edema or needing mechanical ventilation
* multiple myeloma
* parenteral use of diuretics
* use of N-acetylcysteine
* use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure
A Safety Assessment of the iZephyr Hood for NIV in COVID-19 Patients

This study is a safety assessment of the iZephyr hood a novel aerosol removal device in patients receiving non invasive ventilation for COVID-19.

Demonstrate that safety and suitability of the iZephyr Hood in patients receiving non-invasive ventilation (NIV) or high flow oxygen therapy (HFOT).

Determine the user acceptability of the iZephyr Hood in patients receiving NIV and HFOT.

Determine the reduction in aerosol spread of COVID-19 viral particles when using the Zephyr hood in patients using non-invasive ventilation or high flow oxygen.

Eligibility Criteria:
Inclusion Criteria:

Adult COVID-19 negative patients who are requiring non-invasive ventilation (phase II)

Adult COVID-19 positive patients who are requiring non-invasive ventilation (Phase III)

Exclusion Criteria:

Patients under the age of 18 years or those lacking capacity
CBT-I Chatbot for Youth

Insomnia is prevalent in youth, and it associates with depression and other psychiatric disorders, leading to increased mental health burden. Cognitive Behavioral Therapy for Insomnia (CBT-I) is recommended as first-line treatment for insomnia. Digital tools have been employed to automate mental health interventions, in order to address deterrents such as clinician shortage, limited appointment availability, high cost, and stigma of seeking help. Digital CBT-I is shown to be effective in treating insomnia. Future digital intervention will incorporate patient-centered design, input from key stakeholders, and new understandings of behavior change. Artificial Intelligence (AI)-powered chatbots are utilized in different industries for better customer experience. AI chatbot is also utilized in the mental health industry to extend the boundary of digital interventions from accommodating didactic and informational content to providing interactive, intelligent, and most importantly, patient-centered conversational agents. Some famous AI mental health chatbots in Western societies were developed to give tailored feedback, respond to emotions that a user expresses, and encourage users to complete an intervention. This study will investigate the effect of a CBT-I chatbot on insomnia to provide further evidence on mental health chatbot.


Eligibility Criteria:
Inclusion Criteria:

* score 8 or higher on the Insomnia Severity Index (ISI)
* between 18 and 35 years old
* read and type Chinese
* own a smartphone
* have consistent internet access to their smartphone

Exclusion Criteria:

* have a self-reported diagnosis of any psychiatric disorder(s)
* have been on regular medication(s) in the past month
* do not have instant messaging app(s) will be excluded.
Clinical Evaluation for General Electric (GE) CT System

An external evaluation to obtain clinical data to create sample clinical images.

The data will also be used for product and technology development, marketing materials, and inclusion in publications.

The image data were assessed using a Likert scale for image quality sufficient for diagnostic assessment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who voluntarily signed the Informed Consent Form (ICF).
* Male subjects 18 years of age or older.
* Female subjects 18 years of age or older. Females between 18 and 60 years of age must be non-lactating and non-pregnant as confirmed by negative urine pregnancy test., unless they had surgery resulting in sterilization or are post-menopausal according to the medical history.

Exclusion Criteria:

* • Subjects previously enrolled in this Evaluation.

  * Subjects who are not able or not willing to give written Informed Consent.
  * For IV contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents or a history of multiple allergies or asthma.
  * For IV contrast-enhanced CT exams, per the institution's guidelines on risk stratification and prophylaxis for Contrast Induced Neuropathy, subjects will be pre-screened via medical history review by qualified medical personnel for suspected renal function impairment and high risk subjects will undergo a serum creatinine lab test. Any subject with proven renal insufficiency will be excluded.
  * Known pregnancy and nursing (lactating) females.
  * Any subject with urgent medical condition requiring acute care.
  * Any conditions that, in the opinion of the Investigator, would interfere with the evaluation of the results or constitute a health hazard for the subject.
  * Subjects who do not agree to allow GEHC personnel to be present during the scan.
Evaluation of the Thyroid Volume After Radiofrequency Ablation of Thyroid Nodules and Recurrent Thyroid

Thyroid nodules are among the common alterations of the thyroid. Depending on the detection method the prevalence is between 20% and 50%, whereas the incidence increases with improvement of ultrasonic technology. The CelonPro Surge bipolar coagulation electrode operated with the compatible power control unit and compatible tube pump is indicated for ablation and coagulation of soft tissue, including thermal inactivation and/or volume reduction of locally defined tissue areas, such as tumors and metastases.

The primary objective of the study is to assess the influence of radiofrequency ablation due to thyroid volume after 24 hours, 3 months, 6 months and 1 year.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given written (personally signed and dated) informed consent before completing any study-related procedures (i.e. any assessment or evaluation that would not have formed part of their normal medical care).
* The patient must be aged 18yrs or older.
* The patient must be able to understand, and be willing to comply with the requirements of the protocol
* The patient is not pregnant
* The patient has the diagnosis of benign thyroid nodules, struma diffusa, struma uninodosa, struma multinodosa, struma per magna, Thyroidea nodosa or Thyroidea multinodosa
* The patient rejected surgery The patient rejected sole radioiodine therapy

Exclusion Criteria:

* Malign nodules
* Pregnancy
* Pacemaker near the target issue (\<4cm)
* Nerve stimulating device
* High fever
* Prosthesis for the inner ear
An Open Label Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of Deferasirox Administered to Chinese Patients With β-thalassemia Major Aged From 2 to Less Than 6 Years Old

To characterize the PK of deferasirox in pediatric β-thalassemia major patients aged from 2 to less than 6 years old, when administrated with a fixed starting dose of 20 mg/kg/day.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients aged from 2 to less than 6 years old.
* Patients with transfusion dependent β-thalassemia major.
* Serum ferritin values ≥ 1000 ng/ml at screening.
* Written informed consent must be obtained from the patient's legal guardian in accordance with local law and regulation prior to any screening procedures.

Exclusion Criteria:

* Non-transfusion-dependent thalassemia.
* Systemic diseases which would prevent study treatment (e.g. uncontrolled hypertension, cardiovascular, renal, hepatic, metabolic, etc.)
* Serum creatinine \> age adjusted ULN.
* Significant proteinuria as indicated by a urinary protein/creatinine ratio (UPCR) ≥ 0.5mg/mg in a non-first void urine sample at screening. If UPCR is found to be ≥ 0.5 mg/mg the test can be repeated after 1 month.
* ALT/AST \> 2.5xULN and total bilirubin \> 1×ULN.
* Left ventricular ejection fraction \< 56% by echocardiography.
* Patient has a known history of HIV seropositivity or history of active/treated hepatitis B or C (a test for screening is not required).
* A history of clinically relevant ocular and/or auditory toxicity related to iron chelation therapy
* Any surgical or medical conditions which will significantly alter the absorption, distribution, metabolism or excretion of the drug(e.g. ulcerative disease, uncontrolled nausea, vomiting, malabsorption syndrome, obstruction, or stomach and/or small bowel resection).
* Other conditions which investigator deems potential harm to patients if participate the study.
Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure.

The primary objective of this study is to determine whether transendocardial delivery of allogeneic human bone marrow-derived mesenchymal precursor cells (MPCs \[rexlemestrocel-L\]) is effective in the treatment of chronic heart failure (HF) due to left ventricular (LV) systolic dysfunction.

The purpose of this study is to evaluate the efficacy and safety of a single transendocardial delivery in the cardiac catheterization laboratory of human bone marrow-derived allogeneic MPCs (rexlemestrocel-L) for improvement in clinical outcomes (heart failure major adverse cardiac events \[HF-MACE\]), preventing further adverse cardiac remodeling (left ventricular end systolic volume \[LVESV\] and left ventricular end-diastolic volume \[LVEDV\]), and increasing exercise capacity (six-minute walking test \[6MWT\]) in patients with chronic HF due to LV systolic dysfunction of either ischemic or nonischemic etiology who have received optimal medical/revascularization therapy.

Eligibility Criteria:
Inclusion Criteria:

* The patient is 18 to 80 years of age, inclusive; both men and women will be enrolled.
* The patient has a diagnosis of chronic HF of ischemic or nonischemic etiology for at least 6 months
* The patient is on stable, optimally tolerated dosages of HF therapies including beta-blockers (approved for country-specific usage), angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), and/or aldosterone antagonists, without change in dose for at least 1 month before study intervention
* The patient is on a stable, outpatient, oral diuretic dosing regimen in which the patient remains clinically stable during screening.
* Other Criteria apply, please contact the investigator

Exclusion Criteria:

* The patient has NYHA Functional Class I or Functional Class IV symptoms.
* Other Criteria apply, please contact the investigator