cyrilzakka/clinical-trials huggingface dataset:
Profiling Spike Protein Antibody Response Post COVID-19 Booster

A descriptive study that will quantify the mean IgG antibodies remaining in vaccinated healthy participants after their COVID booster.

This is primarily a descriptive study that will quantify with 95% confidence intervals the mean IgG antibodies remaining in vaccinated healthy participants three to nine months after their COVID booster. At specified intervals during this period, a titer will be performed on blood drawn from participants to quantify the IgG antibodies to the SARS-CoV-2 spike protein.

This evaluation will not be performed in a lab with CLIA certification and this study will not be used to seek an EUA from the FDA. The FDA and CLIA regulate diagnostic laboratory testing but do not regulate surveillance testing.

Eligibility Criteria:
Inclusion Criteria:

* Adults at Travis Air Force Base who are Active Duty, DoD beneficiaries, and civilian employees who present with a vaccination card verifying they have received a full course of mRNA spike protein COVID vaccine (Moderna, Pfizer, or Johnson \& Johnson) and booster.

Exclusion Criteria:

* Unvaccinated, partially vaccinated, or unable to provide proof of COVID vaccination
* Unwilling or medically unable to have an initial or follow up blood sample drawn
* Positive COVID test after receiving COVID booster
* Current history of a bleeding disorder, cancer, or are immunocompromised
* Received a COVID vaccine booster seven or more months ago
Does Outpatient Palliative Care Improve Patient-centered Outcomes in Parkinson's Disease?

The purpose of this study is to improve outcomes for persons living with Parkinson's Disease (PD) and their family caregivers. The investigators hypothesize that outpatient interdisciplinary palliative care will improve patient-centered outcomes for PD patients at high-risk for poor outcomes.

Palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease. To date there have been minimal attempts to apply these principles to PD although preliminary evidence suggests that PD patients have significant unmet needs under current models of care which may be amenable through a palliative care model. This study will provide critical information to forward this field including data on the comparative effectiveness of outpatient palliative care for PD versus current standards of care; effects of this intervention on cost and service utilization; and the characteristics of patients most likely to benefit from such an approach and the specific services most needed by PD patients and their caregivers.

Eligibility Criteria:
Inclusion Criteria:

* Fluent in English
* UK Brain Bank criteria for diagnosis of probable PD or Multiple Systems Atrophy (MSA) or Corticobasal Degeneration (CBD) or Progressive Supranuclear Palsy (PSP) or Lewy Body Dementia (LBD)
* At high risk for poor outcomes as identified by the Palliative Care Needs Assessment Tool (PC-NAT)

Exclusion Criteria:

* Immediate and urgent palliative care needs
* Unable or unwilling to commit to study procedures including;

  1. randomization,
  2. study visits or
  3. the addition of a neurologist to their care team
* Presence of additional chronic medical illnesses which may require palliative services
* Already receiving palliative care and/or hospice services.
Patient and Parent Preferences for an On-Body Automated Insulin Delivery System

The goal of this study is to learn more about patient and family preferences regarding use of advanced diabetes technologies. Young persons with type 1 diabetes (ages 8-25) and parents of young persons with type 1 diabetes will complete one study visit involving a semi-structured interview and surveys. The results of the study will be used to assist in the design of a new automated insulin delivery system.

Type 1 diabetes remains the most common chronic disease of childhood and affects millions of children and adults globally. The minority of persons with type 1 diabetes achieve the recommended glycemic targets. Currently approved and unapproved automated insulin delivery systems require patients to carry and wear multiple devices (pumps, tubing, blood glucose meters, mobile devices, etc.). There is a need to design automated insulin delivery systems that reduce the burden of diabetes management for young persons and their families in an effort to improve glycemic control as well as other biomedical and psychosocial outcomes.

The purpose of this study is to conduct separate semi-structured interviews with young persons with type 1 diabetes and parents of youth with type 1 diabetes (not necessarily the parents of the youth participants) regarding their preferences for an automated, on-body insulin delivery system. Youth and parents will also complete short surveys related to perceived burden of diabetes self-care, quality of life, acceptance of diabetes, and worries about hypoglycemia. The feedback received from the interviews and surveys will help inform the design of a new on-body automated insulin delivery system.

Eligibility Criteria:
Inclusion Criteria:

* Young persons (ages 8-25 years) with type 1 diabetes for 1 year or longer
* Parents of young persons with type 1 diabetes

Exclusion Criteria:

* None
Prevention With the Health and Lifestyle Tool

In this study participants will be randomized to use a digital lifestyle tool over three years or to a control group without access to the tool. The investigators will prospectively via clinical registries follow the incidence and development of type 2 diabetes over three years in those using the tool regularly and those in the control group.

Considerable evidence suggest that lifestyle changes can prevent or delay the onset of type 2 diabetes, and self-care behaviors largely determine HbA1c. Modifiable lifestyle factors have been established as key drivers of disease onset, progression, and prognosis, motivating the use of "lifestyle as medicine".

Digital health tools are increasingly incorporated into diabetes care, and have the potential to improve both behavioral and clinical outcomes on a broad basis. However, low levels of uptake, reduced user engagement over time, and low acceptance among patients, raise concerns about their effectiveness.

The objective or this study is to evaluate a new web-based tool, developed at the University Gothenburg, Sweden, that aims to support patient autonomy and motivation to make sustainable lifestyle changes.

The investigators will test the hypothesis that individuals who have access to the tool get lower incidence of type 2 diabetes or in case they already have diabetes develop improved glucose control compared with control individuals. The participants will complete the Findrisc questionnaire to assess the risk for type 2 diabetes to enable analysis of high-risk individuals.

The study is an investigator-initiated single-center study conducted over three years.

The tool is web-based and used via a computer or mobile phone. It is used at each individual's preferred pace but participants are recommended to login at least every other week. Every round the participants choose a themes (out of appr. 80 possible covering e.g. food, exercise, stress, self-reflection aspects), which takes appr. 15-30 minutes to complete. Participants then reflect on the content and how it could be implemented in daily life. When returning for next round participants are asked to reflect on any changes done since last time. There is no interaction between individual participants.

There will be two primary endpoints:

1. Incidence of type 2 diabetes as measured in non-diabetic participants with increased risk for type 2 diabetes (controls vs. those using the tool regularly)
2. Change of HbA1c, reflecting long-term blood glucose control, from baseline to end of follow-up in participants who have type 2 diabetes (controls vs. those using the tool regularly).

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* Age above 35 years

Exclusion Criteria:

* type 1 diabetes, MODY or secondary diabetes
* conditions or treatments that in the judgement of the Investigator could affect the study evaluation
* connection with the study team, funders, authorities, universities or other public or private bodies in such a way that specific interests in the study outcomes could be suspected.
Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA with High Risk T-Cell ALL & Lymphoma

A Phase I trial to determine the safety of targeted immunotherapy with daratumumab (DARA) IV after total body irradiation (TBI)-based myeloablative conditioning and allogeneic hematopoietic cell transplantation (HCT) for children, adolescents, and young adults (CAYA) with high risk T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy).

Pre- and post-HCT NGS-MRD studies will be correlated with outcomes in children, adolescents, and young adults with T-ALL undergoing allogeneic HCT and post-HCT DARA treatment. The study will also evaluate T-cell repertoire and immune reconstitution prior to and following DARA post-HCT treatment and correlate with patient outcomes.

Total body irradiation (TBI)-based myeloablative allogeneic hematopoietic stem cell transplantation (HCT) using best available donor.

Daratumumab (DARA) treatment post-HCT:

Phase 1: 3 dose levels to determine safety (15 patients)

Dose expansion cohort (DEC): Further evaluation of PK and PD (correlative studies/exploratory endpoints) to guide future selection of RP2D (15 patients)

Treatment Schedule:

1. Induction: DARA IV weekly x 8 doses (Weeks 1-8)
2. Consolidation: DARA IV every 2 weeks x 8 doses (Weeks 9-24)
3. Maintenance: DARA IV every 4 weeks (Stop at Day +270)

Eligibility Criteria:
Inclusion Criteria:

* 0-39yrs
* T-cell ALL in second or subsequent remission (≤ 5% blasts) or relapsed T-cell LLy with complete response after re-induction therapy (including secondary malignancy)
* Planned allogeneic stem cell transplantation with donor identified
* Performance status ≥ 60%
* Fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
* Meet organ function requirements
* Signed IRB approved informed consent

Exclusion Criteria:

* May not have had a prior autologous or allogenic stem cell transplant
* May not have uncontrolled, systemic infection at the time of enrollment
* Known allergies, hypersensitivity, or intolerance to mannitol, sorbitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients
* Must not be pregnant or actively breast feeding
* Seropositive for HIV, hepatitis B or hepatitis C
* COPD
* Asthma
* Clinically significant cardiac disease
Arterial Cannulation With Ultrasound

A drop in blood pressure during anaesthesia for a surgical procedure has been associated with worse patient outcomes, including complications such as damage to the heart, brain and kidneys. Continuous blood pressure monitoring prior to the start of anaesthesia alerts the anaesthetist to drops in blood pressure and allows this to be treated promptly. This may help to avoid the complications described above.

Continuous blood pressure monitoring is carried out by inserting a small plastic tube (cannula) into an artery. In this study, the investigators propose inserting a cannula into the radial artery in the wrist before a patient is anaesthetised for surgery. The usual technique for insertion of this cannula is for the anaesthetist to identify the site of the radial artery by feeling for an arterial pulse with the fingertips (palpation). An alternative technique for identification is to use ultrasound. Ultrasound creates a two-dimensional image of the area under the skin on a screen, enabling the operator to visualise the artery being targeted. This may reduce the number of cannulation attempts required, reducing patient discomfort.

The investigators will test whether ultrasound guidance improves the success rate of radial artery cannulation, compared to palpation alone, in a randomised controlled trial in an NHS hospital. Patients will be over 45 years old, undergoing general or neuraxial anaesthesia for non-cardiac surgery lasting 120 minutes or more. Patients will be randomly assigned to a palpation or ultrasound-guided technique for arterial cannulation. Patients will receive numbing local anaesthetic cream to the area beforehand. A needle is used to introduce the cannula into the artery. There will be a maximum of one attempt allowed. In addition to measuring success rate, we will also compare whether the successfully sited cannula provides an adequate arterial waveform, requires resiting at any point during the surgery and any complications which arise directly related to arterial catheterisation. Patients will receive standard anaesthetic and surgical care in all other respects.

Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled to undergo major elective or urgent (not requiring intervention in \<24 hours) non-cardiac surgery under general anaesthesia and/or neuraxial anaesthesia, expected to take \>120 minutes from induction of anaesthesia
2. Requiring overnight hospital stay.

Exclusion Criteria:

1. Anatomical deformity
2. Unable to consent
3. Cannulation attempt within 24 hours
4. Overlying infection
Community-based Hepatitis B Interventions for Hmong Adults

The purpose of this study is to design an intervention to increase hepatitis B (HBV) screening among Hmong Americans.

The investigators will design an intervention to measure the baseline proportion of Hmong adults (ages 18-64) that have been serologically tested for Hepatitis B. Investigators will work with lay health workers to promote serologically testing for Hepatitis B and increase knowledge of Hepatitis B among Hmong adults. The effectiveness of the lay health worker intervention will be evaluated by conducting a randomized, controlled trial among Hmong adults aged 18-64 not previously tested for hepatitis B.

The primary hypothesis is that the proportion of Hmong adults, ages 18-64 reporting serologically testing for Hepatitis B at post-test will be significantly greater in the intervention group than in the control group.

Secondary hypotheses are:

There will be greater increases in knowledge of Hepatitis B and liver cancer in the intervention group than in the control group.

Participants with greater knowledge of hepatitis B and liver cancer at post-test will be more likely to be serologically tested for hepatitis B.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-64 years
* Hmong ancestry
* Never have been tested for Hepatitis B

Exclusion Criteria:

* Children under the age of 18 years
* Adults over the age of 64 years
* Non-Hmong ancestry
* Previous testing of Hepatitis B
Symptom Clusters and Immune Markers in Patients With Chronic Obstructive Pulmonary Disease (COPD) - a Longitudinal Study

COPD patients often have a wide range of physical (e.g., dyspnea, fatigue, pain) and psychological (e.g., depression, anxiety) symptoms and various other debilitating conditions that cause considerable suffering for the individual. Unfortunately, many of the symptoms and health problems in patients with COPD are unrecognized and untreated. Due to the irreversible nature of COPD, the aim is not to cure the disease, but to reduce symptoms and improve quality of life.

Therefore, the purpose of this project is to investigate the existence and nature of symptom clusters over time in patients with COPD and their effects on patient outcomes. Since this study aims to identify possible new subgroups of patients with COPD defined by the clustering of certain symptoms, the study also aims to investigate the relationship between the clinical presentation and certain immunologic and genetic factors.

The specific aims of this translational, interdisciplinary, multi-center, international research study will follow 308 COPD patients with repeated measures over 12 months, are to:

1. Explore COPD patients' symptoms, symptom clusters, and changes in symptoms and symptom clusters over time; as well as the genetic markers for subgroups of patients with different symptom clusters.
2. Identify the occurrence of HGG and assess immune function in COPD patients.
3. Explore relationships between HGG and immune function, genetic markers, symptoms, symptom clusters, health and respiratory status, frequency of exacerbations and health-related QOL.

Eligibility Criteria:
Inclusion Criteria:

* degree 2-4
* above 18 years of age
* able to read/ write/ speak Norwegian

Exclusion Criteria:

* patients who are receiving treatment for cancer
* acute exacerbations of COPD
Evaluation of the Proximal Contact Quality in Posterior Complex Carious Cavities Restored With Bulk Fill Ormocer and Resin Composite Using a Precontoured Circumferential Matrix System Versus Pre Contoured Sectional Matrix System

The use of ormocers with precontoured circumferential matrix system allow predictable restoration of complex proximal posterior cavities with less time and fewer tools required to produce optimum proximal contact size, location and magnitude and restoration durability with higher wear resistance.

After profound local anesthesia, conservative cavity preparations will be performed with high-speed burs (no.:330, Meisinger, Germany) under constant refrigeration. Intermittent rotary instrument contact with tooth limited to the removal of compromised enamel. The cavity outline is restricted to the removal of carious tissue with spherical carbide burs at low speed. In the removal of defective restorations, the friable enamel and remnant carious tissue will be removed in the same way. All teeth will be restored using a rubber dam. The universal bonding agent (Voco, Cuxhaven, Germany) will be applied with previous selective enamel etching with 37% phosphoric acid for 30 seconds. These materials will be inserted following the manufacturer's instructions.

After cavity preparation, each participant will choose a random number from an opaque sealed envelope, then patient will select from random numbers prepared by Y.H. to randomly assign interventions to the participant oral cavity.

All restorations will be prepared, restored, finished and polished by one operator.

Eligibility Criteria:
Inclusion Criteria:

- Posterior complex proximal carious lesions Vital upper or lower posterior teeth with no signs of irreversible pulpitis. Presence of adjacent and opposing teeth with normal occlusion

Exclusion Criteria:

* Proximal carious cavities in the mesial surface of first premolars. Periapical pathology or signs of pulpal pathology. Possible prosthodontic restoration of teeth. Heavy occlusion and occlusal contacts or history of bruxism. Pulpitis, non-vital or endodontically treated teeth. Sever periodontal affection
Stroke and Tocotrienol: Unique Role in Neuroprotection

Phase III, single-centre, double-blind, randomised, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of oral Vitamin E (Mixed Tocotrienol) for 6 months in patients with moderate ischemic stroke.

150 patients will be recruited and randomized to receive either placebo or mixed tocotrienol 200mg twice a day for 6 months. Patients will be followed up and assessed on their functional recovery.


Eligibility Criteria:
Adult patients within 1-10 days ischaemic stroke of moderate severity (NIHSS 6-20)

Inclusion Criteria:

1. Age 35 years old and above.
2. Subject will be included within the time frame of 1-10 days after the first onset of acute cerebral ischaemic stroke with NIHSS between 6 - 20.
3. Subject is neurologically stable after stroke onset, i.e. no fluctuation in clinical conditions.
4. Subject has a modified Rankin Scale from 2-4.
5. Subject has a clinical stroke diagnosis according to WHO stroke diagnosis.
6. Subject is willing to attend at least four sessions of physiotherapy during the study or as deemed needed by the physiotherapist
7. Subjects or his/her legally acceptable representative is willing to provide written informed consent.

Exclusion Criteria:

1. Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI
2. Recurrent stroke or previous hospitalisation due to suspected cerebrovascular event.
3. Severe stroke as assessed clinically and/or by appropriate imaging techniques
4. Subject has other significant non-ischemic brain lesion(s) which could affect function or disability.
5. Time of ischemic stroke onset not exactly known
6. Subject has documented underlying medical conditions which may affect assessment or follow-up such as (but not limited to) terminal cancer, liver cirrhosis, severe dementia or psychosis, connective tissue disease, rheumatoid arthritis, severe heart disease, severe liver disease or renal failure (based on recent medical history)
7. Subject has active systemic infection such as (but not limited to) hepatitis and pneumonia
8. Subject has definite indication for full dose or long term anti-coagulation therapy (such as warfarin)
9. Any condition that in the judgment of the investigator would place the patient under undue risk
10. Traumatic brain injury within the previous 30 days.
11. Symptoms which are rapidly improving (as in transient ischemic stroke)
12. The patient is pregnant, breast feeding or female of childbearing potential (unless the subject is willing to practice on double contraception measures for the study duration) until up to 1 month (30 days) after last treatment dose.
13. Patients who have been included in any other clinical trial within the previous three months.
Incidence of Occluded Culprit Arteries and Impact of Coronary Collaterals on Outcome in Patients With NSTEMI

It is assumed that patients with non-ST-elevation myocardial infarctions (NSTEMI) showing an infero- or posterolateral occluded culprit artery (OCA) during diagnostic angiography frequently elude standard 12-lead electrocardiogram diagnosis. In addition, coronary collaterals may have beneficial effects in patients with OCA.

We examined consecutive NSTEMI patients within 48 h of symptom onset. All patients underwent early invasive angiography plus optimal medical therapy. We compared baseline characteristics, procedural findings including analysis of TIMI-flow and collaterals using the Rentrop-classification, 30-day and 6-months major adverse cardiovascular events (MACE) in patients with and without totally OCA.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 90 years,
* onset of angina pectoris at rest \<24 h or crescendo angina in recent weeks with symptoms under minimal exertion or at rest lasting \<24 h,
* elevated troponin T ≥0.03 µg/L and
* written informed consent.

Exclusion Criteria:

* persistent angina,
* ST-segment elevation myocardial infarction (STEMI),
* hemodynamic instability including cardiogenic shock,
* oral anticoagulation therapy,
* contraindications for glycoprotein IIb/IIIa inhibitors,
* other disease with life expectancy \<6 months,
* known coagulopathy,
* pregnancy,
* other suspected causes of troponin elevation as myocarditis, secondary to hypertensive crisis, or after cardiac decompensation,
* no ability to consent, and
* participation in another study.