cyrilzakka/clinical-trials huggingface dataset:
Retention in HIV Care for Hispanic Immigrants

A randomized trial to test the feasibility and acceptability of an intervention to improve retention in HIV primary care in HIV-infected Hispanic immigrants compared to a "treatment as usual" condition. We will measure feasibility, acceptability, study retention, and effect sizes of outcomes in order to inform a larger trial. The intervention design is based on qualitative research with HIV-infected Hispanic immigrants and their HIV providers. The intervention will be led by a Spanish-speaking community health worker trained in HIV health promotion.

Overview:

Participants will be HIV-infected Hispanic immigrants age ≥18 years. Participants will be recruited from Partners-affiliated infectious disease and primary care clinics as well as clinics and community-based organizations in the Greater Boston area with high contact with HIV-infected Hispanics. In the intervention, a bilingual (English-Spanish speaking) community health worker (CHW) will deliver personalized sessions framed around a Spanish-language multi-media health communication tool. The CHW will deliver the intervention over a 16 to 24 week period.

Study procedures:

Participants will be HIV-infected Hispanic immigrants age ≥18 years at risk for inconsistent attendance (as measured during study screening). Participants will be recruited via provider referral, peer referral, flyers, and social media. Once an individual expresses interest in the study, a study staff member will screen that individual to assess eligibility. Individuals who are eligible will be invited to enroll through an informed consent process and complete a baseline survey. After completion of the baseline survey, study staff will randomize participants into a treatment as usual (TAU) group or intervention group. At trial exit, all participants, including the TAU group, will complete an in-depth assessment to measure their barriers to HIV care and provide feedback about their experience in the study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older and able to communicate in Spanish or English
* Born in Puerto Rico or Spanish-speaking Latin American country
* HIV-infected or HIV-positive
* New HIV diagnosis or unable to regularly attend HIV primary care appointments

Exclusion Criteria:

* Unable to provide verbal consent due to unstable medical or psychiatric condition
Exploratory Analysis of Pulmonary Microbiome in Intubated Patients

This prospective, multicentric study investigates the modifications of pulmonary microbiome that occur in patients who need mechanical ventilation for non-pulmonary conditions. Genomic analysis will be performed by 16S RNA amplification on biological samples (bronchial aspirate) collected from patients.

The microbiome is defined as a community of microorganisms (such as bacteria, fungi, and viruses) that inhabit a particular organ. This prospective, multicentric, observational study investigates the bacterial changes that occur in the pulmonary microbiome during the first 72 hours of mechanical ventilation in patients who have been intubated for non-pulmonary conditions in intensive care units (ICU).

To this aim, genetic analyses will be performed on bronchial aspirate samples that will be collected from patients during their staying in ICU. Demographic and clinical information will be retrieved from patients' clinical reports and recorded in an apposite clinical report forms (CRF) in anonymized way. In particular, the reason for the admission to ICU, absence fo concomitant pulmonary diseases, comorbidities, body mass index, hematological examination results, concomitant therapies, antibiotic therapy performed in the 30 days prior to the admission, ventilation associated pneumonia (VAP)-preventing procedures, complications during mechanical ventilation, length of mechanical ventilation will be recorded in the CRF.

The study will last 24 months.

Eligibility Criteria:
Inclusion Criteria:

* patients undergo mechanical ventilation for non-pulmonary conditions (i.e. neurological condition)
* patients who are expected to need mechanical ventilation for \>48 hours

Exclusion Criteria:

* diagnosis at the ICU admission of pneumonia
* need of mechanical ventilation for pulmonary conditions.
Epidemiology of Resistant Microbial Strains Among Different Groups of People (Healthy, Infected and Exposed to Animals)

This study investigates carriage rate and risk factors for acquiring multiresistant bacteria (ESBL producing E.coli and K.pneumoniae, carbapenem-resistant and multidrug resistant P.aeruginosa, MRSA and VRE) in hospitalised patients and healthy volunteers.


Eligibility Criteria:
I group Hospitalised patients Inclusion Criteria

* MDR bacteria (listed above) isolated from clinical specimen
* hospitalisation to the Tartu University Hospital or North Estonia Medical Centre or West Tallinn Central Hospital or East-Tallinn Central Hospital or The Hospital of Reconstructive Surgery

II group Healthy volunteers Inclusion Criteria

* age \>6 months
* have not received any antibacterial treatment in previous 3 months
* have not been hospitalised in previous 3 months

III group Dog owners Inclusion Criteria

* age \>6 months
* have not received any antibacterial treatment in previous 3 months
* have not been hospitalised in previous 3 months
* owning a dog

IV group veterinarians Inclusion Criteria

* have not received any antibacterial treatment in previous 3 months
* have not been hospitaliZed in previous 3 months
* working as a veterinarian

V group pig farmers Inclusion Criteria

* have not received any antibacterial treatment in previous 3 months
* have not been hospitalized in previous 3 months
* occupation as a pig farmer
Resistance to Oral Therapy in Lung Cancer

In the management of non-small cell lung cancer of the adenocarcinoma type, different therapeutic strategies can be proposed. These strategies are defined according to the results of a biological analysis of blood and/or tissue samples from the lung tumor. Mutations in the tumor DNA are sought. Thus, patients with sensitizing mutations can benefit from a treatment with a 3rd generation tyroine kinase inhibitor (TKI) whose efficacy has been widely demonstrated. Patients without tumor mutations will not benefit. However, resistance to TKIs appears after a certain time, often linked to the appearance of new mutations in the tumor. For this reason, blood biologic analyses are regularly performed to search for the emergence of resistance mutations and to propose a therapeutic alternative as soon as possible.

These analyses are performed routinely in the laboratory. In the course of these analyses, the investigators have identified conventional mutations but also new mutations not previously described in the literature.

Our objective is to list all the molecular abnormalities revealed during blood biological analyses, to determine their frequency and to study whether certain abnormalities can be linked to resistance to TKI.


Eligibility Criteria:
Inclusion Criteria:

* advanced non-small cell lung cancer stage IIIB/IV
* Documentation of activating EGFR mutations (exon 19 deletions or exon 21 L858R substitution mutations) at the time of initial diagnosis
* Patient may receive up to one line of third EGFR TKI
* Plasma sample testing performed to detect EGFR TKI resistance

Exclusion Criteria:

* Patients have other concurrent cancers
* Patients who are not eligible receive TKI
A Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

This research study is evaluating the impact a collaborative palliative care and oncology team will have on the quality of life, symptoms, mood, and end of life outcomes of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.

The main purpose of this study is to compare two types of care - standard leukemia oncology care and standard leukemia oncology care with collaborative involvement of palliative care clinicians to see which is better for improving the experience of patients and families with AML and MDS undergoing treatment.

The investigators aim to find out whether introducing patients and families undergoing AML and MDS treatment to the palliative care team that specializes in symptom management can improve the physical and psychological symptoms that patients and families experience during their hospitalizations for their leukemia care as well as enhance the quality of patients' end of life care.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with high-risk AML, defined as:
* Newly diagnosed patients with AML ≥ 60 years of age
* Newly diagnosed AML with antecedent hematologic disorder
* Newly diagnosed therapy-related AML
* Relapsed AML
* Primary refractory AML

Exclusion Criteria:

* Patients already receiving palliative care
* Major psychiatric illness or comorbid conditions prohibiting compliance with study procedures.
* A diagnosis of acute promyelocytic leukemia (APML)
Intermittent Hypoxia Intervention in MS Patients

This observational cohort study investigates the safety and feasibility of an intermittent hypoxia intervention in multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* 18-60 years
* confirmed MS (all types of MS)
* ability to come to the outpatient clinic 2-3x/week for 3 months
* EDSS ≤ 6.5
* inconspicuous medical examination
* inconspicuous ECG

Exclusion Criteria:

* relapse in the last 3 months
* EDSS progression in the last 6 months
* pregnancy
* contraindication for MRI
* severe heart disease
* severe asthma, COPD
* cancer
* severe cognitive deficits
* chronic headache
* renal insufficiency
* anaemia (Hb \< 10 g/dl)
* insulin-dependent diabetes mellitus
* severe vascular stenosis
* former episodes of severe high mountain sickness
* cancer
EFFECT OF DASH DIET AND AEROBIC EXERCISES ON PREMENSTRUAL SYNDROME

Hypothesis:

There will be no effect of the DASH diet and aerobic exercise on premenstrual syndrome.

Statement of the problem:

Do the DASH diet and aerobic exercise have an effect on premenstrual syndrome?

For some women, symptoms of PMS may be so severe that they miss work or school. Physical activity is a suitable method for the treatment of PMS and is the best method for all women to reduce pressure and balance the brain's chemical secretion. It seems that physical activity by increasing endorphins and reducing adrenal cortisol leads to the improvement of symptoms of PMS.

DASH diet has been suggested to play an important role in the development, and treatment of some psychological disorders. For instance, it has been reported that a diet rich in fish, folate, and B-vitamins can alleviate the manifestations of depression. An established association was also shown between the dietary glycemic index (GI) and psychological diseases, depressive disorder, and mental functioning.

Diets containing of "junk foods" (high energy and low nutritional) have been shown to increase the risk of mental illness, but a healthy diet is associated with less depressive symptoms and can improve mood .

Eligibility Criteria:
Inclusion Criteria:

* Fifty adolescent females were diagnosed with premenstrual syndrome.
* Their age will be ranged from 15-to 25 years (3 years post-puberty).
* Their body mass index (BMI) will range from 18-25.9 kg/m2.
* All are of regular menstrual cycles.
* All of them suffer from moderate and severe PMS.

Exclusion Criteria:

* Any pathologic findings in the pelvic cavity as a polycystic ovarian syndrome, endometriosis, and pelvic inflammatory diseases.
* Having irregular menstruation.
* Any metabolic diseases.
* Any history of gynecological intervention.
Efficacy and Safety of rhTPO in Combination With Cyclosporine Versus Cyclosporine Alone in the Treatment of TD-NSAA

Investigating the efficacy and safety of rhTPO in combination with cyclosporine versus cyclosporine alone for the treatment of TD-NSAA

Investigating the efficacy and safety of rhTPO in combination with cyclosporine versus cyclosporine alone for the treatment of transfusion-dependent aplastic anaemia of the non-severe type

Eligibility Criteria:
Inclusion Criteria:

1. aged ≥ 18 years, male and female; 2. patients with a clear diagnosis of NSAA who are dependent on transfusion therapy:

1. Meet the Camitta NSAA criteria;
2. accompanied by at least one of the following abnormalities: (1) dependence on component blood transfusion therapy, at least one component blood transfusion every 8 weeks on average, and the duration of transfusion dependence ≥ 4 months, the indication of component blood transfusion: HGB ≤ 60g / L; (2) PLT ≤ 10 × 10 \^ 9 / L, or PLT ≤ 30 × 10 \^ 9 / L with a significant tendency to bleed; (3) neutrophils ≤ 0.5 × 10 \^ 9 / L.
3. Excluding other haematological and non-haematological diseases that cause pancytopenia; 3. ECOG PS score 0-2, expected survival ≥ 3 months with follow-up; 4. functional levels of major organs must meet the following requirements: 1) Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); 2) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN; 3) blood creatinine (Cr) ≤ 1.5 x ULN; 5. has not been treated with platelet receptor agonist (TPO-RA) analogues and other immunosuppressant analogues; 6. the subject is not suitable or willing to receive haematopoietic stem cell transplantation therapy; 7. no history of serious heart, lung, liver, kidney and other important organs and endocrine system diseases; 8. Voluntarily enroll in the study, sign the informed consent, have good compliance and willing to cooperate with the follow-up.

Exclusion Criteria:

1. have used other clinical investigational drugs within 4 weeks;
2. a history of primary myelodysplastic syndromes (MDS), primary paroxysmal sleep haemoglobinuria (PNH) and leukaemia, as well as congenital bone marrow failure syndromes (IBMFS), such as Fanconi's anaemia (FA) and congenital dyskeratosis (DC)
3. history of cirrhosis or history of portal hypertension;
4. congestive heart failure, arrhythmia, peripheral arteriovenous thrombosis requiring medication within 1 year prior to enrolment, or myocardial infarction or cerebral infarction within 3 months prior to enrolment;
5. HIV infection;
6. severe autoimmune disease or immunodeficiency disease;
7. suffering from malignant tumour
8. severe mental disorders;
9. a known history of allergy to the drug components of this regimen;
10. in the opinion of the investigator, it is not appropriate to participate in this trial, e.g., any other medical, social or psychological factors that may affect safety or compliance with the study procedures.

Compliance with study procedures.
Withdrawal of Immunosuppression in Recipients of Face and Extremity Transplants

Many patients suffer from devastating injuries to vascularized composite tissues. Vascularized composite tissues are blocs of functional tissue that can contain multiple tissue types such as bone, muscle, nerves, blood vessels, tendons, ligaments, and others. Examples of patients with severe vascularized composite tissue defects include limb amputees, patients with third-degree burns to the face or extremities, soldiers with improvised-explosive-device blast injuries to the face, and others. These patients cannot be helped satisfactorily with conventional reconstructive surgery; however, recently vascularized composite allotransplantation (VCA) such as transplantation of faces and limbs became available to this patients. Unfortunately, at this juncture, patients who receive VCA must submit to life-long regime of immunosuppressant drugs with serious side effects such as infection, renal toxicity and cancer. Immune tolerance is the absence of a destructive immune response from the recipient's body to the transplant, while otherwise maintaining sufficient immune function to fight infections and other threats. Transplant recipients with immune tolerance do not need to take immunosuppression drugs. The investigators believe that they can achieve immune tolerance in recipients of face and limb transplants.


Eligibility Criteria:
Inclusion Criteria:

* adults who have received VCA transplants at Brigham and Women's Hospital
* no less than 3 months elapsed since VCA transplant,
* on steroid-free immune dual immunosuppression with tacrolimus (6-8 ng/ml trough levels) and mycophenolate mofetil,
* no current concerns of rejection

Exclusion Criteria:

* recent (\<3 months) episodes of rejection,
* active bacterial or viral infection,
* malignancy,
* non-healing wounds
* pregnancy
Gene Therapy for ACM Due to a PKP2 Pathogenic Variant

This is a Phase 1/2, first-in-human, open-label, intravenous, dose-escalating, multicenter trial that is designed to assess the safety and tolerability of LX2020 in adult patients with PKP2-ACM


Eligibility Criteria:
Selected Inclusion Criteria:

* Adults with a clinical diagnosis of ACM meeting the 2010 revised Task Force Criteria (TFC)
* Genetic testing documenting a pathogenic or likely pathogenic variant in PKP2
* Frequent premature ventricular complexes (PVCs)
* Implantable cardioverter-defibrillator (ICD) implantation ≥ 12 weeks prior to the pre-screening MRI
* Left ventricular ejection fraction ≥ 40%

Selected Exclusion Criteria:

* Evidence of variant(s) in addition to PKP2 that meets the standard criteria to be considered pathogenic or likely pathogenic for ACM
* Other cardiac abnormalities as specified in the protocol
* New York Heart Association Functional Class IV at the time of consent
* History of prior gene transfer therapy
Predictive Value of 99mTc- Albumin Spheres Before 90Y- SIR Therapy

The purpose of this study is to assess the predictive value of 99mTechnetium (Tc)- labeled albumin in macroaggregates (MAA) and in microspheres (B20) injected into the common hepatic artery for the distribution of 90Yttrium- Selective Internal Radiotherapy (SIRT)-spheres (SIR- spheres).

Patients with metastases of colorectal tumors will be included into this study provided that they are scheduled for 90Y SIR spheres therapy for clinical reasons. Before 90Y SIR spheres therapy, patients will receive a diagnostic examination with injection of MAA (group A) or B20 (group B) into the common hepatic artery to rule out a relevant shunt volume to the lung or other extra-hepatic locations (e.g., stomach) as recommended by the manufacturer. After the diagnostic scan, therapy with SIR- spheres will be conducted in 2 separate sessions with selective injection of 90Y labeled SIR spheres into the right and left hepatic artery at two separate occasions (routine procedure at the University of Magdeburg, Germany). In addition, therapeutic sessions will include the selective injection of MAA or B20 into the right / left hepatic artery according to a predefined plan (either alone or as a mixture with the SIR spheres).The intra-hepatic distribution of 90Y labeled SIR spheres will be assessed using "Bremsstrahlen"- Single- Photon- Emission- Computed- Tomography (SPECT)- imaging, the distribution of MAA and B20 will be assessed using SPECT imaging.

Eligibility Criteria:
Inclusion Criteria:

* age: between 18 and 85 years
* if female, postmenopausal or surgically sterilized
* liver metastases of a colorectal tumor in both liver lobes
* scheduled for therapy with 90Y SIR spheres for clinical reasons
* life expectancy longer than 6 months
* willing and able to undergo all study procedures
* having voluntarily provided written and fully informed consent

Exclusion Criteria:

* presenting with a contraindication to 90Y SIR spheres therapy
* variants of the arterial hepatic blood supply which interfere with the objectives of this study (e.g., variants of Michel)
* women who are pregnant, lactating or who are of childbearing potential
* patients being clinically unstable
* uncooperative, in the investigator's opinion
* any contraindication to SIRT treatment
* any concomitant chemotherapy
* shunt to the lung \>10%
* shunt to any extrahepatic organ (except the lung)
* having been previously enrolled in this study
* participating in another prospective clinical trial
Ultrasound Optimization of Initial Fluid Challenge in Sepsis

Initial sepsis treatment requires fluid challenge. While the Surviving Sepsis Campaign indicates a 30 ml/kg volume, there is concerns on the efficacy and safety of this fixed volume. The aim of this study is to assess the difference between fluid volume determined par cardiac and lung Ultrasound versus the fixed 30 ml/kg.

Initial sepsis treatment requires fluid challenge (FC). While the Surviving Sepsis Campaign (SSC) indicates a fixed 30 ml/kg volume, there is concerns on the efficacy and safety of this volume.

Actually, the required volume is highly dependent of cardiac and pulmonary comorbidities, infection focus localization and intensity. The importance of the initial volume is crucial: if too low, it could not restore the hemodynamic status, if too high, it could induce a lung edema responsible for an increased morbidity and mortality.

Cardiac Ultrasound (US) has demonstrated its efficacy to approach cardiac output by measuring the velocity-time integral (VTI) in the aortic chamber and its variations induced by the FC. While the VTI induced variation by a 500-ml FC in 20 min is above 10%, the patient is still fluid responsiveness and FC has to be continued. Conversely, when the variation is below 10%, FC has to be stopped.

Lung Ultrasound can detect a sub-clinical pulmonary edema before oxygenation degradation by visualization of diffuses B lines. The combination of both techniques is thus able to individualize the actual needed FC volume.

In patients with sepsis as defined by SEPSIS-3 and with hypotension (MAP \< 65 mm Hg or lactate \> 2 mmol/l), the FC of saline serum is individualized by the US technique. The volume is compared with the fixed 30 ml/kg.

Eligibility Criteria:
Inclusion Criteria:

* patients \>18 years old with sepsis as defined by SEPSIS-3 and with hypotension (MAP \< 65 mm Hg or lactate \> 2 mmol/l)

Exclusion Criteria:

* documented end-of-life
* pregnancy
* B/B initial profile to the first Lung US