cyrilzakka/clinical-trials huggingface dataset:
Feasibility Pilot Exploring Variability in Biomarkers and PROs in AML

This research study is being conducted to help understand how the symptoms during treatment for acute myeloid leukemia (AML) may be affected by metabolism and how best to study this association. Symptoms include experiences like fatigue, sleep disturbance, pain, and depression.

This is a prospective, longitudinal, observational exploratory study. Ten participants will be enrolled and will complete baseline and week 4 blood sample collections. Symptom questionnaires will be completed at baseline, 1-, 2-, 3- and 4-weeks.

This research study is a Pilot Study, which means it is the first time that researchers are studying the associations between symptoms and metabolism in this way.

The National Institute of Nursing Research is supporting this research study by providing funding for the research study.

Eligibility Criteria:
Inclusion Criteria:

* The Cantor Center CRC will attend weekly protocol meetings in the DFCI adult leukemia center to identify eligible patients and will confirm eligibility by reviewing the electronic health record and, if needed, contacting the treating physician. Subjects enrolled in clinical trials or other studies requiring extra blood samples and/or completion of questionnaires will be discussed with their oncology care team and/or investigators of the other study teams to ensure avoidance of excess subject burden. Only subjects deemed appropriate for enrollment without adding excess burden will be approached about this study.
* Inclusion Criteria:

  * Adult (18+ years old)
  * New diagnosis of acute myeloid leukemia (AML)
  * Admitted to the DFCI Inpatient Hospital in the BWH for intensive induction chemotherapy (e.g., 7+3 regimen)
  * Eastern Cooperative Oncology Group Scale of Performance Status (ECOG PS) ≤ 3 OR Karnofsky Performance Status (KPS) ≥ 50
  * Ability to comprehend and speak English
  * Ability to provide informed consent

Exclusion Criteria:

* Cognitive or psychiatric conditions prohibiting study consent or participation
* Multiple primary cancers
* A treating clinician reports that the subject is inappropriate for the study or that the study presents excess subject burden
Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens

The purpose of this clinical trial is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in an extended wear modality.

Subjects will be expected to attend 9 office visits. The total expected duration of participation for each subject is approximately 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and sign an Informed Consent Form.
* Willing to attend all scheduled study visits as required per protocol.
* Willing and able to wear assigned study lenses as required per protocol.
* Successful wear of spherical daily wear or extended wear frequent replacement soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week.
* Manifest cylinder ≤ 0.75 diopter (D) in each eye.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
* History of eye surgery, including refractive surgery.
* Currently pregnant or breast-feeding.
* Monovision contact lens wearers.
* Daily disposable contact lens wearers.
* Other protocol-specified exclusion criteria may apply.
Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With Chronic Hepatitis B Infection.

The purpose of this study is to determine the safety and antiviral HBV activity of ACH-126,443 (beta-L-Fd4C) in the treatment of Subjects of Previous Achillion-Sponsored Phase 1 and 2 Studies in Chronic Hepatitis B Infection.

Evaluation of safety and antiviral activity of the 5mg dose of ACH-126,443 for up to three months of treatment in the population described.

Eligibility Criteria:
Inclusion Criteria:

* Participants in previous Phase 1 or 2 trials of ACH-126,443 who met entry criteria for previous studies.
* Adults ? 18 years of age
* Chronic HBV infection, known to be HbsAg positive ? 6 months
* Plasma HBV DNA level ? 100,000 copies/mL prior to initiation of ACH-126,443 in an earlier study
* Plasma HBV DNA level that in the medical judgment of the investigator, warrant's antiviral treatment
* HIV negative
* Basic hematologic and chemistry parameters within acceptable limits (defined in protocol)
* No need for excluded medications
* Subjects of reproductive capability must either practice abstinence or utilize two approved forms of birth control, one of which must be barrier protection (condom with spermicidal, diaphragm with spermicidal)

Exclusion Criteria

* HIV infection
* Active Hepatitis C co-infection
* Concurrent systemic antiviral treatment
* Treatment for HBV infection with lamivudine (3TC) for longer than three (3) months since participation in previous trial of ACH-126,443
* Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start
* Alcohol abuse
* Pregnancy or breast-feeding
* Inability to tolerate oral medication
* AST\>10.0 times the upper limit of normal
* ALT\>10.0 times the upper limit of normal
* Any clinical condition or prior therapy that, in the Investigators opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements
* Use of investigational drug not approved by Medical Monitor
Optimization of Hearing Performance in the Subject Implanted

In the past two decades, the selection criteria for cochlear implantation have been greatly relaxed so that about 60-70% of present cochlear implant (CI) candidates have significant residual hearing in their contralateral ear. However, contralateral hearing is often not considered in rehabilitation programs, mainly due to the lack of scientific evidence on the role it may play. The present project aims to better understand the mechanisms of perceptual learning of CI-processed speech after implantation and to develop and test rehabilitation strategies for CI users.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18
* Unilaterally postlingually-deafened adult cochlear implanted candidates (IC-Uni)
* Person with almost normal or moderate contralateral hearing ( under 60dB)
* Cochlear implanted person whose activation has not yet been performed
* Cochlear implanted subjects with bilateral post-lingual profound deafness, who already benefit from a unilateral cochlear implant and candidates to a bilateral cochlear implant
* Affiliated to social security

Exclusion Criteria:

* - Subjects under juridical protections or tutelage measure
* Subjects with associated neurological or neurodegenerative conditions
* Significant anatomical changes on CT scan of the temporal bone that may interfere with the insertion of the cochlear implant
Captopril Use on the Degree of Marrow Fibrosis in Bone Marrow Fibrosis/Myeloproliferative Neoplasms

The purpose of this study is to evaluate the safety and tolerability of captopril and evaluate the effectiveness captopril as measured by changes in the grade of bone marrow scar tissue. The change in spleen size by ultrasound will also be measured.

Captopril is an investigational (experimental) drug that works by inhibiting the production of angiotensin II by blocking angiotensin converting enzyme. Reducing angiotensin II may reduce the bone marrow scar tissue in myelofibrosis. It is not approved by the Food and Drug Administration (FDA) for this indication. Participants in this study will be asked to have 2 bone marrow biopsies, a total of 3 blood samples, and fill out questionnaires asking about how you feel.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have histologically confirmed diagnosis of primary myelofibrosis (PMF), or post-polycythemia vera/essential thrombocythemia-MF (i.e. secondary MF) by 2016 WHO criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 -2
* Creatinine clearance \>30 ml/minute
* Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment. All men and women of childbearing potential must use acceptable methods of birth control throughout the study.
* Participants should be able to give voluntary informed written consent to participate in the study. Informed consent will be obtained prior to enrollment and before any study-related procedure is done that is not part of standard medical care, with the understanding that consent may be withdrawn by the participants any time without prejudice to future medical care.

Exclusion Criteria:

* Completed hematopoietic cell transplant (HCT)
* Presence of \>10% blasts in peripheral blood or on bone marrow examination
* Screening blood pressure(BP)parameters of systolic BP \< 100 and diastolic BP \< 60
* Splenic irradiation within 3 months prior to the first dose of captopril
* Prior ACE inhibitor, angiotensin II receptor antagonist, or aliskiren use within 12 months prior to trial enrolment
* Known allergy/hypersensitivity to ACE inhibitors
* Participants receiving any other investigational agents
* Pregnant or nursing participants - captopril is a risk category D and is excreted in breast milk
* Participants with creatinine clearance \<30 ml/minute or on dialysis
* Any serious medical condition, laboratory abnormality, or psychiatric illness that, in the view of the treating physician, would place the participant at an unacceptable risk if he or she were to participate in the study or would prevent that person from giving informed consent
Cost Efficacy Evaluation of Robot Assisted Radical Prostatectomy

In this observational cost efficacy study, the investigator compare the Laparoscopic Radical Prostatectomy (LRP) versus Robotic-Assisted Laparoscopic Prostatectomy (RALP). Every cost of care that include hospitalization related or post operative medical consumption are obtained and recorded up to 5 years follow up. Functional results (continence, potency, quality of life) are obtained through standardised questionnaires. Carcinologic results are estimated by Prostate Specific Antigen (PSA) relapse and salvage treatments. Economic evaluation will be made to estimate direct costs of the four postoperative year along with the incremental cost-effectiveness ratio (ICER) per successful surgical treatment (preserved urinary continence and erectile function and PSA \< 0.2).


Eligibility Criteria:
Inclusion Criteria:

* Localized prostate cancer
* Gleason grade ≤ 3 + 4
* PSA \< 15 ng / mL
* Stage ≤ T2b
* Eligible to receive laparoscopic radical prostatectomy
* Candidate bilateral or unilateral erectile preservation

Exclusion Criteria:

* Patient at high risk of postoperative progression (PSA\> 15 ng / mL; grade 5 predominant, clinical or radiological stage T3
* Presenting erectile dysfunction (IIEF \< 22)
* Past history of urinary incontinence (\> grade 1 WHO)
* Body mass index \> 30
Tolerability of Pharmaton PHL 00747 in Healthy, Young Female Subjects of Child-bearing Potential

To determine the tolerability and safety of Pharmaton PHL 00747 soft gelatine capsules and film-coated tablets


Eligibility Criteria:
Inclusion Criteria:

* Healthy female out-patients of child-bearing potential
* Ages ranging between 18 and 40 years
* Willing and able to give written informed consent in accordance to Good Clinical Practice (GCP) and local legislation prior to participation in the study

Exclusion Criteria:

* Contraindications to the use of any of the trial ingredients
* Known hypersensitivity to any of the ingredients
* Alcohol- or drug-addiction
* Currently participation in another trial, or has participated in a trial within the previous 30 days
* Known abnormal values of the laboratory tests (if detected after enrolment, subjects will continue the treatment provided there are no medical objections)
* Already taking other mult-vitamin products during the last 2 weeks
Comparison Arterial Blood Pressure and Cardiac Index-based Hemodynamic Management on Postoperative Myocardial Injury

The primary aim of this study is to compare mean arterial pressure (MAP) and cardiac index (CI) based intraoperative hemodynamic management in terms of postoperative high sensitive troponin elevation.

The hypothesis of the study is that there will be at least 5ng/L difference between the two groups in terms of troponin elevation occurring in the postoperative period. When power analysis was performed with this primary output, it was calculated that while alpha was 0.05 beta 0.2, 42 patients in each group, a total of 84 patients were required.

Fluid therapy will be started as 2-4 ml/kg/h, according to the clinician's decision for the patient. Afterwards, patients will be managed hemodynamically with one of the MAP and CI algorithms.

Targeted fluid therapy will be administered in accordance with the following definitions of normal and algorithms for both groups.

Normal definitions:

MAP: Baseline MAP +/- 20% and MAP\>65mmHg Baseline MAP: MAP average in the ward at rest the day before surgery

CI: Baseline CI +/- 20% and CI \> 2.2 L/m2/min Baseline CI: CI calculated by MostCare monitor before the anesthesia induction starts

Low MAP intervention If PPV\>14, apply 500ml crystalloid If PPV\>9 and any additional finding regarding hypovolemia, apply 500ml crystalloid If PPV\<10, start/titrate noradrenaline infusion

Low CI intervention If PPV\>9, apply mini fluid challenge (MFC). If MFC is positive, apply 500ml crystalloid.

If MFC is negative, evaluate MAP. If MAP is elevated start/titrate remifentanil. If MAP is not elevated start/titrate dopamine/dobutamine in accordance with SVRI

Eligibility Criteria:
Inclusion Criteria:

1. Patients who will undergo pancreatic-hepatic surgery
2. Patients over 65 years of age or patients over 45 years of age and with at least one of the following comorbidities:

coronary artery disease, Congestive heart failure, moderate to severe heart valve disease, peripheral artery disease Moderate to Severe Pulmonary hypertension, cerebrovascular accident older than 1 month, History of pulmonary embolism more than 1 month old, Diabetes Mellitus, Hypertension

Exclusion Criteria:

1. Presence of atrial fibrillation, sepsis, pulmonary embolism
2. Presence of pulmonary embolism, acute coronary syndrome and cerebrovascular accident in the last month
3. Static respiratory system compliance \< 35ml/cmH2O
4. Patients with preoperative high sensitive Troponin T value \>65ng/liter
5. glomerular filtration rate \< 60 ml/min

Exclusion criteria during the protocol:

1. Newly developed arrhythmia, embolism, sepsis,
2. Cancellation of planned surgery
3. Postoperative hepatic failure defined as INR\>2
Integrative Approach to Identify Environmental Risk Factors for CC-17 Group B Streptococcal Neonatal Infection

Streptococcus agalactiae (GBS) is the leading cause of neonatal septicaemia, meningitis, and pneumonia in the industrialized world. Early onset (EOD) and late onset (LOD) diseases are defined in neonates by their occurring within or after the first week of life, respectively. Molecular epidemiological studies have identified a capsular serotype III clone, referred to as CC-17 by Multi Locus Sequence Typing, as accounting for the vast majority of neonatal invasive diseases and for almost all cases of meningitis in LOD.

The investigators working hypothesis is that host-environmental interactions may contribute to the colonization and persistence of the hypervirulent CC-17 GBS in the neonate. In this project the investigators will determine if reciprocal interactions between the intestinal microbiota and the innate and adaptive immune system may specifically facilitate the colonization of the neonate by the hypervirulent GBS CC-17 clone.

Four specific tasks will be addressed to:

(i) Understand whether and how the gut microbiota may influence growth and colonization of GBS CC-17 within the intestine of neonates.

(ii) Study the contribution of different diets and immune system constituents enabling the persistence of GBS CC-17 in the gut of neonates.

(iii) Determine whether the adaptive immune response elicited by maternal GBS colonization and transmitted to the infant is different for GBS CC-17 versus non-CC-17 GBS.

(iv) Determine whether or not GBS strains isolated from the mothers and from their babies are identical and whether the environment (ie. the vagina or the milk for the mother, the intestine or the oral cavity for the baby) influence the expression of specific virulence factors of CC-17.

Eligibility Criteria:
Inclusion criteria:

* Patient having a negative vaginal swab for GBS at 35-37 weeks
* Patient aged over 18 years
* Patient who received information and agreeing to sign informed consent
* Patient affiliated or beneficiary of an insurance

Exclusion criteria:

* Patient does not speak and does not understand French
MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery

The purpose of this study is to show that addition of device use to a routine breast cancer tumor excision procedure is beneficial and assists the surgeon in correctly determining the extent of excision.

The study is a prospective, multi-center, randomized, double arm study demonstrating the effectiveness of the device in adjunctive use for locating the tissue for additional excision following primary specimen excision. One arm is a "Standard of Care" (SOC) Control group and the other arm a "Device+SOC" group.In the "Device +SOC" group the surgeon will use the MarginProbe device on the tissue specimen removed during the surgical procedure.The surgeon will use the results derived from the device and other routine assessments to decide if it is necessary to remove some additional breast tissue.

Eligibility Criteria:
Inclusion Criteria:

1. Women histologically diagnosed with carcinoma of the breast
2. Women with non-palpable malignant lesions, requiring image guided localization.
3. Undergoing lumpectomy (partial mastectomy) procedure.
4. Age 18 years or more
5. Signed ICF

Exclusion Criteria:

1. Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
2. Bilateral disease (diagnosed cancer in both breasts)
3. Neoadjuvant systemic therapy
4. Previous radiation in the operated breast
5. Prior surgical procedure in the same breast
6. Implants in the operated breast
7. Pregnancy
8. Lactation
9. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
Combination of NHF and Nebulizer on Lung Function in COPD

This study will prove to concept of effectiveness of NHF in combination with a nebulizer on reversibility of lung function in COPD patients.

Patients will inhale on day 1 with a nebulizer and on another day with combination of nebulizer an NHF in a randomised order.

Eligibility Criteria:
Inclusion Criteria:

* stable disease
* COPD

Exclusion Criteria:

* exacerbation
* right heart decompensation
* acute respiratory insufficiency
* acute disease
Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma

This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab + either cisplatin or carboplatin + gemcitabine versus placebo+ either cisplatin or carboplatin + gemcitabine in approximately 420 participants with locally advanced or metastatic urothelial carcinoma who have not received prior systemic therapy.


Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female aged 18 to 75 years on the day of signing the Informed Consent Form (ICF)
2. Histologically confirmed, inoperable, locally advanced, or metastatic urothelial cancer (UC)
3. Must be eligible to receive cisplatin or carboplatin in the investigator's judgment
4. Have had no prior systemic chemotherapy for locally advanced or metastatic UC
5. Must be able to provide fresh or archival tumor tissues with an associated pathological report.
6. Must have evaluable disease (either measurable or non-measurable) as defined per RECIST v1.1.
7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
8. Adequate organ function before randomization:

Key Exclusion Criteria:

1. Received prior therapies targeting PD-1, PD-L1, PD-L2, CTLA4, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
2. Any approved anticancer therapy within 28 days before randomization.
3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis
4. Participants with uncontrolled hypercalcemia
5. Participants with active autoimmune diseases or history of autoimmune diseases that may relapse
6. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled diseases
7. A known history of HIV infection.
8. Prior allogeneic stem cell transplantation or organ transplantation.
9. History of severe hypersensitivity reactions to other monoclonal antibodies. 10．History of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
How Phenotypical Characteristics of Woebot Users Are Related to Clinical Outcomes

The goal of this observational study is to understand the characteristics of Woebot users as they relate to clinical outcomes.

The objectives it aims to address are:

1. To assess Woebot usage patterns, satisfaction ratings, self-efficacy, stress, resilience, work productivity and activity impairment, alexthymia, and bond over time based on demographic, clinical baseline levels, and attitudinal characteristics
2. Among users who present with clinical levels of anxiety or depression, to assess the contribution of demographic characteristics, attitudinal characteristics, and patterns of engagement on clinical outcomes of interest over time
3. To collect and explore attitudinal characteristics of Woebot users regarding their experiences with mental health care and perceived value of digital tools for emotional support
4. Explore meaningful subgroups of Woebot users based on demographic and attitudinal characteristics, clinical outcomes, and patterns of engagement

Participants who meet study eligibility requirements will be:

* invited to engage with the Woebot Life program for 8 weeks
* complete survey assessments at day 3, week 4 (mid-intervention), and week 8 (end of intervention)


Eligibility Criteria:
Inclusion Criteria:

* 18+ years old
* US resident
* English literacy
* Availability to complete survey assessments
* Ownership or regular access to a smartphone with WiFi and sufficient data access for the duration of the study.

Exclusion Criteria:

* Current suicidal ideation with a plan or intent or a suicide attempt within the past 12 months
* A reported lifetime diagnosis of a psychotic disorder (including schizophrenia or schizoaffective disorder) or bipolar disorder
* Previous use of the Woebot application