cyrilzakka/clinical-trials huggingface dataset:
COVID-19 Trial of the Candidate Vaccine MVA-SARS-2-S in Adults

In this multi-center phase II clinical trial, adults in stable health conditions will be vaccinated twice with either a low dose or high dose of the candidate vaccine MVA-SARS-2-S, or placebo.

The aim of the study is to assess the safety and immunogenicity of the candidate vaccine.

The vaccine contains a Modified Vaccinia Virus Ankara (MVA) vector expressing the SARS-CoV-2 spike protein (S).

This will be a combined Phase II, multi-center trial in a total of 580 participants.

The dose finding study will be conducted randomized-controlled, in adults in stable health conditions, including health care workers, COVID-19 risk populations, individuals with advanced age and seropositive individuals.

Male and female individuals in stable health conditions will be stratified for age (18-64 years and 65 and older).

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent.
2. Male and female adults in stable health conditions aged 18 - 64 at time of informed consent (participation of health care workers and risk groups will be prioritized) and male or female in stable health conditions aged ≥ 65 at time of informed consent.
3. Either in good or stable health in the opinion of the investigator. Participants may have underlying illness as long as their symptoms are medically controlled, and they are on a stable medication for the respective underlying illness for at least 8 weeks before screening and no changes are expected during the study.
4. Body mass index 18.5 - 32.0 kg/m2 and weight \> 50 kg at screening.
5. Non-pregnant, non-lactating female with negative pregnancy test.
6. Females who agree to comply with the applicable contraceptive requirements of the protocol.

Exclusion Criteria:

1. Receipt of any vaccine from 4 weeks prior to each trial vaccination (8 weeks for live vaccines) to 6 weeks after each trial vaccination.
2. Previous rMVA immunization.
3. Evidence of an active SARS-CoV-2 infection.
4. Known allergy to the components of the MVA-SARS-2-S vaccine product such as chicken proteins, or history of life-threatening reactions to vaccine containing the same substances.
5. Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine.
6. Evidence in the participant's medical history or in the medical examination that might influence either the safety of the participant or the absorption, distribution, metabolism or excretion of the investigational product under investigation.
7. Clinically relevant findings in ECG or significant thromboembolic events in medical history.
8. Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or uncontrolled diabetes (HbA1c \> 7.0).
9. Any known chronic or active neurologic disorder, including seizures, and epilepsy, excluding a single febrile seizure as a child.
A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity

To learn about the relationship between changes in pupil size and reactivity and the start of neurological side effects in patients after receiving CAR-T cell therapy.

Primary Objective:

To assess the association between the status of NPi drop from baseline (prior to CAR T-cell infusion) to the lowest NPi post Axi-cel (CD19 CAR-T cell) infusion and the status of immune effector cell-associated neurotoxicity onset within 10 days post CD19 CAR-T cell infusion.

Secondary Objective:

To evaluate the largest absolute difference in NPi between two eyes (∆ NPi) and assess its association with severity of clinical symptoms as measured by Immune Effector Cell Encephalopathy (ICE) and or radiographic / EEG findings

Exploratory Objective:

To assess the feasibility and safety of a pupillometer use in patient treated with Axi-cel therapy.

Eligibility Criteria:
Inclusion Criteria:

To be considered eligible for study participation, patient will satisfy all relevant inclusion criteria and none of the exclusion criteria.

Inclusion Criteria:

1. Ages Eligible for Study: 18 Years and above (Adult, Older Adult)
2. Sexes Eligible for Study: All
3. Patient with histologically proven DLBCL, PMBCL or tFL, or follicular Lymphoma receiving axi-cel CAR-T cell therapy in the inpatient setting at MD Anderson Cancer Center
4. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients who have already been administered CAR-T cell therapy.
2. The patient who is unwilling or unable to comply with the requirements of the study including being able to be assessed with pupillometer
3. Patient has a condition which places him at an unacceptable risk as determined by the investigator
A Study of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf®) to the Once Per Day Form (Advagraf®)

Assessment in a real situation of the conversion conditions, the efficacy and the safety of the treatment with tacrolimus in renal transplant patients converted from the tacrolimus twice per day form (Prograf®) to the tacrolimus once per day form (Advagraf®) with follow-up at one year.

Analysis of two groups of patients: patients converted from Prograf® to Advagraf® early (during the first 6 months post-transplantation) or late (between 6 and 12 months post-transplantation).


Eligibility Criteria:
Inclusion Criteria:

* Renal transplant patient for less than one year
* Patient where the conversion from Prograf® to Advagraf® has been decided by the doctor

Exclusion Criteria:

* Patient participating in an interventional clinical trial at the time of inclusion
ObservationaL Study on the Qol of RAS Wild-type mCRC Patients Receiving Anti-EGFR MAbs + FOLFOX or FOLFIRI as 1st Line

This is a national, multicentric, prospective, observational trial. The decision to prescribe FOLFOX or FOLFIRI plus panitumumab or FOLFOX or FOLFIRI plus cetuximab must have been freely taken by the clinician prior to the study entry for each patient included. Each physician will see his/her patients within the context of routine visits, without any special visit being organised for the purposes of the study. Therefore, the doctor-patient relationship and patient follow-up are not modified. Physicians are totally free to decide on their patients' therapeutic management.

EORTC QLQ-C30 and DLQI questionnaires will be completed by the patients at baseline (Day 1 of Cycle 1), at the first day of every other cycle (every 2 weeks) thereafter, and at ""End of Study Visit" (within 28 days from the end of treatment with anti-EGFR or withdrawal from study for any reason).

Before every cycle, adverse events will be recorded and graded according to NCI CTCAE v4.0. Treatment's modifications in terms of cycles' delay, dose reductions or drugs' interruptions will be recorded.

Concomitant approaches to prevent or treat dermatological toxicities during the treatment will be registered.


Eligibility Criteria:
Inclusion Criteria:- Adult (\>= 18 years old) RAS wild-type metastatic colorectal cancer patients candidate to receive FOLFOX or FOLFIRI plus panitumumab or FOLFOX or FOLFIRI plus cetuximab as upfront treatment as per clinical practice

* Willingness and ability to comply with the protocol
* Written informed consent to study procedures
* Exclusion Criteria: - Patients receiving a treatment under clinical investigation may not be included in the study
* Previous treatment with an anti-EGFR monoclonal antibody
Spectroscopic Analysis of Tongue Tumor Samples.

In squamous cell carcinoma of the tongue, complete surgical resection of the tumor generally represents the primary treatment strategy. Among factors determining the disease prognostic, the surgical margins status is essential for the continued management of the patient, with or without complementary therapies. Generally, surgical margins are defined using visual and tactile elements. Unfortunately, in 15 to 30 percent of cases, they are defined as positive after histopathological examination, on average 5 to 7 days post-surgery.

Techniques have recently been developed to analyze the cancerous and non-cancerous nature of tissues, using the spectral properties of tumor cells. SpiderMass™ is an instrument equipped with a probe for tissue micro-sampling and real-time molecular profile analysis. It is thus ultimately a tool for anatomopathological decision support, for diagnosis and prognosis of the disease. Used in the operating room, SpiderMass™ could also become an innovative surgical tool to precisely define cancerous areas in situ and the margins status in intraoperative conditions.

Based on the principle of artificial intelligence, the SpiderMass™ machine must initially learn to recognize pathological tissues versus healthy. This project aims to accomplish this first phase of machine learning for squamous cell carcinoma of the tongue.


Eligibility Criteria:
Inclusion Criteria:

* age : 18 years and older
* squamous cell carcinoma of the tongue
* surgical resection as first-line treatment
* tumor classification T1 to T4.

Exclusion Criteria:

* metastatic disease
* neoadjuvant therapies
Cosmetic Study to Improve the Appearance of Skin Afflicted With Mild to Moderate Atopic Dermatitis.

The purpose of this study is to observe the performance of a cosmetic product, AO+Mist, on the appearance of arm skin in subjects with atopic dermatitis

This is a single center, double-blind, bilateral, placebo-controlled study in subjects with Atopic Dermatitis affecting both sides of the body. Up to 20 subjects will be enrolled to participate.

Subjects will undergo a 2 week washout period prior to the Baseline procedure. Follwoing the Baseline visit assessments, subjects will be asked to apply "AO+ Mist" or placebo to the affected area of the arm twice a day (morning and night) for 30 days.

After the 30 day initial study period, subjects will automatically be rolled over to participate in the extension of the trial for another 30 days using only AO+Mist on the body parts affected by Atopic Dermatitis.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects ≥18
2. In good general health as determined by a thorough medical history i. Visible flexural dermatitis ii. Personal history of flexural dermatitis iii. Personal history of dry skin in the past 12 months
3. Subjects should have similar presentation and severity of AD on both arms
4. Ability to comprehend and comply with study procedures
5. Agree to commit to participate in the current protocol
6. Provide written informed consent prior to any study procedure being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read)

Exclusion Criteria:

1. Female subjects who are pregnant or lactating or who are trying to conceive
2. Any clinically relevant abnormality identified on the screening history or any other medical condition or circumstance making the volunteer unsuitable for participation in the study
3. Any skin condition which in the investigator's opinion may interfere with the evaluation of Atopic Dermatitis
4. Severe cases of AD that present with pustules and weeping and those cases that require urgent medical attention
5. Treatment with any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the beginning of the screening period (this includes investigational formulations of marketed products, inhaled and topical drugs)
6. Hypersensitivity to AO+Mist or its components
7. Seropositive for human immunodeficiency virus (HIV) by medical history review at screening
8. Positive for Hepatitis B virus surface antigen (HBsAg) or positive Hepatitis C virus antibody (HCV Ab) by medical history review at screening
9. Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (e.g., due to expected test product non-compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures)
The Rett Syndrome Global Registry

The Rett Global Registry is a fully remote, global, caregiver-reported registry to collect information about caring for a loved one with Rett syndrome. In addition, caregivers have the ability to track and graph their loved one's symptoms and care strategies over time, store information for central access, and opt-in to complete medical record consolidation and summary. Qualified researchers and therapeutic developers may request access to de-identified aggregate information to further Rett research, or assist with clinical development planning to facilitate and expedite more effective clinical trials.

The Rett Syndrome Global Registry is a fully remote, global, caregiver-reported registry intended to meet the needs of caregivers, clinicians and researchers, and therapeutic developers with the goal to increase our understanding of this rare disorder, support better outcomes for those with Rett syndrome, and facilitate improved therapeutic development. The Rett Global Registry allows families to provide data about their experience with Rett syndrome to improve their loved one's care while contributing to research. Participants may opt in to track and graph symptoms and care strategies over time to support day-to-day care. Participants may also access aggregate data to see similarities and differences in care strategies and consolidate their personal information in a central location. Participants may opt-in to complete medical record consolidation and summary that is centrally accessible, able to be shared with care providers, and utilized for research.

The registry database is designed and maintained to clinical trial standards and supports research and therapeutic development while meeting or exceeding federal privacy and confidentiality requirements. These datasets including caregiver-reported Rett syndrome progression, quality of life, at home day-to-day data, and consolidated medical records from office visits or hospital stays, provides unique and previously unused sources of information important for improving our understanding of Rett syndrome, allow additional avenues of research, and support therapeutic development. Specifically, the registry is intended to assist with clinical development planning, trial design, trial endpoints, and regulatory filings.

Eligibility Criteria:
Inclusion Criteria:

1. Parent/caregiver must be willing and able to provide written informed consent electronically prior to entering data into the registry.
2. Rett individuals of any age, living or deceased, must have a diagnosis of Rett syndrome and/or have a mutation in MECP2.

Exclusion Criteria:

1. Individuals who have a genetic mutation that is inconsistent with Rett syndrome or who have a different disorder.
2. Individuals with MECP2 Duplication Syndrome
Risk Evaluation and Management in Heart Failure

This is an prospective study conducted in a Chinese heart failure population. The study investigates the effects of cardiovascular disease risk factors such as lifestyle behaviors,biomarkers and intermediate diseases on heart failure prognosis.

Heart failure is the main cause of cardiovascular death. The primary goal of this study is to estimate the association of lifestyle behavior (e.g., alcohol, tea and coffee consumption, sedentary behavior, smoking habit, sleep disorder and physical activity), intermediate conditions (e.g., hypertension, diabetes and dyslipidemia), genetic risk factors and circulating biomarkers with heart failure prognosis. Another goal is to improve the health status and reduce cardiovascular events and death for heart failure patients via patient education, disease monitoring and medication titration. This study planned to consecutively enroll 1,000 heart failure patients fulfilling the inclusion criteria. Each participants will be followed up for at least 5 years. The study endpoints, all-cause mortality and cardiovascular events, will be identified by directly contacting participants during the follow-up surveys, checking pertinent medical records and discharge lists from the hospitals, or checking death certificates from local vital statistics offices. The Cox proportional hazard model will be used to estimate the risk factors for health outcomes in heart failure patients.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 and above
* inpatient with one of the following clinical situations:

  * congestive heart failure (pulmonary edema,pulmonary congestion or peripheral edema)
  * cardiogenic shock
  * Insufficient high output cardiac
* with impaired cardiac function diagnosed by echocardiography
* able to provide informed consent

Exclusion Criteria:

* expressed refusal to participate in the baseline investigation or follow-up visits Severe co-morbidity associated with a reduction in life expectancy of less than 12 months
Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy

18F-Flutemetamol (Vizamyl) is a radioactive diagnostic agent indicated and FDA-approved for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) or other causes of cognitive decline. This study is designed to evaluate a novel use for 18F-Flutemetamol in cardiac amyloidosis.

The goal of this project is to perform a proof-of-concept study to compare the ability of quantitative parametric cardiac 18F-flutemetamol positron emission tomography (PET) to assess baseline and change in disease burden after six months of therapy with tafamidis treatment in 12 patients diagnosed with transthyretin cardiac amyloidosis (ATTR-CA) at Yale-New Haven Hospital. The primary outcome of the study will be comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET metrics between the baseline and six-month 18F-flutemetamol PET scans versus clinical stage and echocardiographic features (wall thickness, strain, LVEF).

Eligibility Criteria:
Inclusion Criteria:

* 1. Age \> 18 years
* 2. Diagnosis of ATTR cardiac amyloidosis (wild-type or V142I ATTR mutation)

  a. Diagnosis of ATTR cardiac amyloidosis by established consensus diagnostic criteria of Gillmore et al. (either invasive or non-invasive diagnostic pathways)
* 3. Plan for initiation of tafamidis therapy for clinical indications and agree to continue tafamidis during the duration of the study.
* 4. Stated willingness to comply with all study procedures and availability for the duration of the study
* 5. Able to understand and sign the informed consent document after the nature of the study has been fully explained.
* 6. Women of childbearing potential who are sexually active with a non-sterilized male partner and males who are sexually active with a partner of childbearing potential must agree to use adequate contraception from screening until 30 days after the Flutemetamol.

Exclusion Criteria:

* 1. Primary amyloidosis (AL) or secondary amyloidosis (AA).
* 2. Prior liver or heart transplantation.
* 3. Active malignancy or non-amyloid disease with an expected survival of less than 1 year
* 4. Inability to lie flat for 60 minutes in the PET scanner
* 5. History of prior treatment for ATTR cardiomyopathy and/or amyloid neuropathy, or decline clinical tafamidis treatment.
* 6. Pregnancy or lactation
* 7. Known allergic reactions to components of the 18F-flutemetamol and/or polysorbate 80
* 8. High risk for non-adherence as determined by screening evaluation.
A Study of First-line JS001 and Nab-paclitaxel Versus Palcelbo and Nab-Paclitaxel in Participants With Advanced Recurrent or Metastatic TNBC

This multicenter, randomized, double-blind study will evaluate the efficacy, safety of JS001 administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel as first-line therapy in participants with primarily diagnosed stage IV and recurrent or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).


Eligibility Criteria:
Inclusion Criteria:

1. Primarily diagnosed stage IV or recurrent and metastatic, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression;
2. No prior chemotherapy or targeted systemic therapy for inoperable stage IV or metastatic TNBC；
3. Eligible for taxane monotherapy；
4. Eastern Cooperative Oncology Group performance status of 0 or 1；
5. Measurable disease as defined by RECIST v1.1；
6. Adequate hematologic and end-organ function。

Exclusion Criteria:

1. Known central nervous system (CNS) disease with active syndrome or untreated disease, except for treated asymptomatic CNS metastases；
2. History of autoimmune disease；
3. History of Anaphylaxis to PD-(L)1 antibody or CTLA-4 antibody or paclitaxel;
4. Prior allogeneic stem cell or solid organ transplantation;
5. Active hepatitis B or hepatitis C;
6. Positive of HIV antibody.
"Effect of Scaling and Root Planing on Liver Function Test (Alanine Aminotransferase and Aspartate Aminotransferase) in Systemically Healthy - Chronic Periodontitis Subjects: a Clinical Trial."

Aim:

To evaluate effect of non- surgical periodontal therapy on liver function in systemically healthy chronic periodontitis (CP) subjects.

Materials and methods:

The study is non surgical interventional trial, includes 50 CP subjects in the age group of 35- 60 years selected from the OPD (Out Patient Department) of department of periodontology Tatyasaheb Kore Dental College and Research center (TKDC and RC), Kolhapur. CP subjects were equally divided into test group and control group. Liver function test- aspartate aminotransferase (AST), alanine aminotransferase (ALT) were checked at baseline and at 1 month after treatment. Clinical examination includes plaque index, gingival index, sulcus bleeding index, probing depth, clinical attachment loss.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with CP (moderate and severe) as per Centers for disease control and prevention (CDC) criteria 2007.
2. Patients without any known systemic diseases

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Exclusion Criteria:

1. Patients who have taken anti-inflammatory/antibiotic/antioxidant within 3 months of beginning of study.
2. Subjects who have undergone periodontal treatment within six months of inception of study.
3. Smokers, tobacco habits in any form and alcoholics.
4. Pregnant and lactating women.

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