cyrilzakka/clinical-trials huggingface dataset:
Identification of Genomic Predictors of Adverse Events After Cardiac Surgery

This study aims to identify genetic causes of adverse events after cardiac surgery, such as atrial fibrillation, myocardial infarction, renal dysfunction and heart failure.

Patients undergoing heart surgery at Brigham and Women's Hospital and Texas Heart Institute are eligible to participate.

This study aims to identify genetic causes of adverse events after cardiac surgery, such as atrial fibrillation, myocardial infarction, renal dysfunction and heart failure. In addition, we also examine blood and urine biomarkers (proteins).

Eligibility Criteria:
Inclusion Criteria:

* Undergoing heart surgery
* Willing to provide consent

Exclusion Criteria:

* Enrolled in a concurrent drug or device trial that precludes concurrent enrollment
The Effect of Laughter Therapy on the Mental Health of Elderly Living in a Nursing Home

This study was designed and conducted as a randomized controlled experimental research with a pre-test and post-test control group to evaluate the effect of laughter therapy on psychological well-being, life satisfaction, and mental health of elderly individuals living in a nursing home.

Among the most important indicators of successful aging are individuals' ability to derive satisfaction from life, maintain cognitive and social competence, sustain mental and physical health, possess a sense of personal control, and experience increased longevity. Supporting elderly individuals to live independently, maintaining their social relationships, and encouraging healthy lifestyle behaviors are key to achieving an active and successful aging process.

Life satisfaction is considered one of the most significant factors influencing mental health and determining adaptation during all stages of life, particularly in old age. As an indicator of well-being, life satisfaction has a positive correlation with psychological resilience and mental health. Thus, psychological well-being, life satisfaction, and mental health of elderly individuals are interconnected, and interventions aimed at enhancing well-being and life satisfaction are known to positively affect the mental health of older adults.

In this context, laughter therapy has recently gained attention as an approach with observed positive effects on the physical and mental health of elderly individuals. Laughter therapy, developed by Dr. Madan Kataria in 1995, aims to support physical and mental health through laughter and breathing exercises.

Meta-analyses and systematic reviews indicate that laughter therapy has positive psychosocial effects on older adults, including reducing depression, perceived stress, and anxiety, enhancing psychological well-being, regulating blood pressure and cortisol levels, improving sleep and quality of life, reducing death anxiety, loneliness, and depressive tendencies, and increasing happiness, life satisfaction, and mood. Laughter therapy is considered a non-invasive, non-pharmacological, cost-effective, accessible, and easy-to-apply complementary/alternative therapy, with calls for further evidence-based studies to promote its use.

Within this framework, the aim of this research is to determine the effect of laughter therapy on the psychological well-being, life satisfaction, and mental health of elderly individuals.

Eligibility Criteria:
Inclusion Criteria:

* Being over the age of 65
* Scoring ≥ 18 points on the Mini-Mental Examination
* Having the ability to communicate
* Not having participated in a laughter therapy session before

Exclusion Criteria:

* Having severe hearing or perception impairment that hinders communication
* Having a physical or psychological condition that prevents participation in therapy
* Having moderate-to-severe Alzheimer's disease, uncontrolled hypertension, epilepsy, abdominal surgery within the past 3 months, or a surgical procedure with a risk of bleeding
* Choosing not to continue participating in the study
Immune Function of Infants With HIV

This observational study will evaluate data from infants born to HIV infected mothers in order to better characterize disease progression in early HIV infection.

The role of HIV-specific cytotoxic T-lymphocytes (CTL) in controlling viremia and protecting against disease progression following vertical infection may be dependent upon CTL functional responses as well as on the timing of detection, magnitude, and breadth of the responses. Novel and sensitive assay systems (MHC-peptide tetramers, ELISPOT assays, intracellular cytokine assays) have enhanced the detection and characterization of virus-specific CTL responses in the peripheral blood. This study will use these novel methods to examine the timing of detection, magnitude, specificity, and in vitro functional properties of HIV-specific CTL in infants; to evaluate the effects of potent combination antiretroviral therapy on HIV-specific CTL in infants; and to evaluate the immunogenicity of recombinant pox-based vaccines in HIV infected infants with prolonged viral suppression following early potent combination antiretroviral therapy.

Blood samples from infants born to HIV infected women will be obtained from infants enrolled in other HIV trials. Generally, samples will be obtained at birth, Week 1, and Months 1, 2, 4, 6, 9, and 12.

Eligibility Criteria:
Inclusion Criteria:

* Infants and children born to HIV infected women
Clinical Evaluation of Opto-Acoustic Image Quality With the Gen 2 Imagio System

This study performs the first clinical evaluation of the Gen 2 Imagio System in a clinical setting to assess image quality with both the IUS ultrasound only probe and the OA/US (duplex probe).

1. Obtain ultrasound only probe images and duplex probe OA/US (both gray scale and OA) probe images. This includes doppler and elastography imaging with the gray scale only ultrasound probe and ultrasound mode of the duplex OA/US probe.
2. Provide breast and lymph node pathology results (except BI-RADS 1, 2 and 3 (as applicable))

Eligibility Criteria:
Inclusion Criteria:

1. Has a signed and dated informed consent, prior to initiation of any study-related activities.
2. Is at least 18 years of age.
3. Have been referred for a breast US because of a breast lesion/mass finding via a palpable lump or per standard of care imaging.
4. Is willing and able to comply with protocol-required scans

Exclusion Criteria:

1. Is pregnant or lactating.
2. Has a condition or breast impediment (i.e. insect bites, poison ivy, rash, open wounds, chafing of the skin, scar, tattoos, moles, hematoma, nipple rings, etc.) which could interfere with the intended field of view.
3. Is experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as some sulfur containing drugs, ampicillin, tetracycline.
4. Is currently undergoing phototherapy.
5. Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus) or undergoing treatment for a photosensitive disease and is experiencing photosensitivity.
6. Has had an adverse reaction in the past to medical laser procedures, such as laser hair removal or laser tattoo removal.
7. Has had prior benign excisional breast biopsy on breast of interest within the past 18 months.
8. Currently has mastitis.
9. Prisoners
Safety and Efficacy Evaluation of IM19 CAR-T Cells (IM19CAR-T)

Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia.

Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia and determine the best dosage.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with CD19+ Refractory or Relapsed B-ALL（At least 2 prior combination chemotherapy regimens）
2. To be aged 3 to 75 years
3. Blast in blood ≤ 30%
4. ECOG score ≤2
5. Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time.
6. Voluntary participation in the clinical trials and sign the informed consent.

Exclusion Criteria:

1. Intracranial hypertension or unconsciousness
2. Respiratory failure
3. CD19 negative
4. Disseminated intravascular coagulation
5. ALT /AST\>3 x normal value; Creatinine\> 1.5 x normal value; Bilirubin \>2.0 x normal value
6. Hematosepsis or Uncontrolled active infection
7. Uncontrolled diabetes
8. Abalienation;
9. WHO Sscore \>3
10. Patients in pregnancy or breast-feeding period
11. Previously treatment with any gene therapy products
12. Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial
13. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
Studying Biological Markers of Fatigue in Women With Residual Invasive Breast Cancer Enrolled on Clinical Trial NSABP-B-45

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to fatigue.

PURPOSE: This research study is looking at biological markers of fatigue in women with residual invasive breast cancer enrolled on clinical trial NSABP-B-45.

OBJECTIVES:

* To collect serial blood specimens at each time point that quality of life and patient-reported outcome assessments are performed in women with residual invasive breast cancer concurrently enrolled on and participating in the Behavioral and Health Outcomes component of clinical trial NSABP-B-45.
* To prepare, separate, and store the blood specimens at the NSABP Serum Bank at Baylor College of Medicine Breast Center into components for future DNA, RNA, and plasma analysis.
* To analyze specific proinflammatory cytokines, genetic polymorphisms, and RNA expression arrays in collaborating laboratories at University of California, Los Angeles (UCLA).
* To examine the association between markers of inflammation and symptoms of fatigue among patients treated with sunitinib malate or placebo on clinical trial NSABP-B-45.
* To examine the relationship between single-nucleotide polymorphisms in the promoter regions of IL-1 and IL-6 and symptoms of fatigue in these patients.
* To examine the relationship between RNA expression profiles and fatigue and compare the pattern of expression in these patients.

OUTLINE: This is a multicenter study.

Patients undergo blood sample collection\* at baseline and then at 3, 6, 12, 18, and 24 months for analysis of plasma concentrations of inflammatory biomarkers (IL-1ra, sTNFRII, sIL-6R, and C-reactive protein) by ELISA; DNA polymorphisms in the promoter regions of IL-6 and IL-1 by TaqMan PCR; and RNA gene expression signaling pathways by RT-PCR assays and microarray.

NOTE: \*Blood samples are collected at the same time points that the Behavioral and Health Outcomes quality of life and patient-reported outcomes questionnaires are completed on clinical trial NSABP-B-45.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of residual invasive breast cancer

  * Stage II, IIIA, or IIIB disease
  * HER2/neu-negative disease
* Randomized to receive either sunitinib malate or placebo on clinical trial NSABP-B-45

  * Has not started therapy on clinical trial NSABP-B-45
* Has completed baseline Behavioral and Health Outcome questionnaires on clinical trial NSABP-B-45
* Hormone-receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Muscle Evaluation of Patients Infected by the Coronavirus

Patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) presents risk to develop muscle weakness associated with prolonged period of mechanical ventilation support and hospital stay.

Intensive care unit (ICU) acquired muscle weakness affects both respiratory and peripheral muscles and can contribute to worsen clinical and functional outcomes. In this way, ultrasonography muscle evaluation could help to identify early alterations guiding the therapeutic planning and allowing to monitor the interventions performed. Therefore, the investigators intend to follow up mechanically ventilated patients with confirmed diagnosis of COVID-19 during ICU stay to quantify the diaphragm, parasternal intercostal, abdominals and femoral quadriceps muscles thickness assessed by ultrasonography. Additionally, functional capacity, frailty and level of physical activity will be evaluated and followed for pre-admission condition and 30, 90 and 180 days after hospital discharge .

Eligibility Criteria:
Inclusion Criteria:

* patients admitted to ICU
* having a confirmed diagnosis of COVID-19
* requiring invasive mechanical ventilation.

Exclusion Criteria:

* exclusive palliative care;
* neuromuscular diseases;
* patients who evolve with the need for lower limb amputation;
* previous known diaphragm malformations and dysfunctions;
* patients transferred from other institutions under invasive mechanical ventilation;
* clinical conditions that make the respiratory and peripheral muscle assessment through ultrasound unfeasible.
Optimization of Onpulse Technology for Patients With Post Surgical or Vascular Oedema

This study aims to facilitate further optimization of a neuromuscular electrical stimulation device for use in patients whom are suffering from oedema and neuropathy


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years and over
2. Be a non-responder to the geko MK1\&2 device
3. Able to understand the Subject Information Sheet and willing to sign the written Informed Consent Form.
4. Able and willing to follow the protocol requirements.

Exclusion Criteria:

1. Has a pacemaker
2. Pregnancy.
3. Is contraindicated for the MK1\&2 device and/or the Digitimer DS7A
4. Recently diagnosed or suspected DVT
Bevacizumab in Combination With Verteporfin Reduced and Standard Fluence in the Treatment of Hemorrhaged Lesions in Neovascular AMD

The purpose of this study is to explore the combination of PDT with verteporfin at reduced and standard fluence rates, in conjunction with bevacizumab, in the treatment of subfoveal CNV of all subtypes with a high percentage of subretinal hemorrhage (hemorrhage \>50% of total lesion area).

To assess the safety of bevacizumab in combination with verteporfin PDT (reduced fluence: 300 mW/cm2) as compared to bevacizumab in combination with verteporfin PDT (standard fluence: 600 mW/cm2) in patients whose neovascular CNV lesions containing \>50% blood.

This is a phase one study in patients with all CNV lesion subtypes who are naïve to previous treatment. Lesions must have blood as a primary component (i.e., contain more than 50% blood). Patients will receive one of two combination treatments:

* Verteporfin PDT reduced fluence (300 mW/cm2) immediately followed by bevacizumab (1.25 mg) intravitreal injection
* Verteporfin PDT standard fluence (600 mW/cm2) immediately followed by bevacizumab (1.25 mg) intravitreal injection A total of 10 patients will be enrolled, 5 per treatment arm.

Eligibility Criteria:
Inclusion Criteria:

* Patients are men or women of age 50 or older.
* Patients diagnosed with subfoveal CNV due to AMD with lesion size ≤6 DA.
* Patients have not received previous treatment for subfoveal CNV, in the study eye.
* Patients with visual acuities at baseline between 20/40 and 20/320, as evaluated on ETDRS scale.
* Fluorescein Angiography showing any type of subfoveal CNV at baseline with \>50% blood component of total lesion area.

Exclusion Criteria:

* Patients with a known hypersensitivity/allergy to verteporfin, porfimer sodium, or other porphyrins, porphyria or other porphyrin sensitivity, or hypersensitivity to sunlight or bright artificial light.
* Patients with history of glaucoma requiring treatment, or are currently on antihypertensive treatment for elevated intraocular pressure.
* Women of childbearing potential must not be pregnant of lactating, must have a negative pregnancy test at screening and must be practicing an adequate method of birth control.
* Patients who have had treatment for CNV in the study eye with photodynamic therapy (PDT), transpupillary thermotherapy (TTT), or other local treatment (e.g. submacular surgery, intravitreal triamcinolone, intra-ocular antiangiogenic agents). Previous laser photocoagulation therapy is acceptable, provided it was not subfoveal.
* Subject's currently who have been involved in any experimental procedure within the last 12 weeks.
A Phase I Study of gp100 Human Melanoma Peptide Vaccine With Incomplete Freund's Adjuvant

This is a phase I study of melanoma tumor antigen peptide vaccines. The nine amino acid peptides representing HLA-A2 restricted T cell epitope of the melanoma antigen, gp100 will be administered to patients emulsified in Incomplete Freund's Adjuvant, (IFA). The study is designed to evaluate the toxicity, immunologic effects and potential therapeutic role of repeated doses of gp100 peptide vaccines administered subcutaneously.

Immune reactivity to the gp100 epitope peptides will be monitored in all patients by analysis of melanoma-specific T cell precursor frequency prior to and after immunization.

This is a phase I study of melanoma tumor antigen peptide vaccines. The nine amino acid peptides representing HLA-A2 restricted T cell epitope of the melanoma antigen, gp100 will be administered to patients emulsified in Incomplete Freund's Adjuvant, (IFA). The study is designed to evaluate the toxicity, immunologic effects and potential therapeutic role of repeated doses of gp100 peptide vaccines administered subcutaneously.

Immune reactivity to the gp100 epitope peptides will be monitored in all patients by analysis of melanoma-specific T cell precursor frequency prior to and after immunization.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Metastatic melanoma that is HLA-A2 positive.

No primary melanoma of ocular or mucosal origin.

Measurable or resected metastatic disease required.

PRIOR/CONCURRENT THERAPY:

BIOLOGIC THERAPY: No prior (greater than 30 days) or concurrent Biologic Therapy.

CHEMOTHERAPY: No prior (greater than 30 days) or concurrent chemotherapy.

ENDOCRINE THERAPY: No prior (greater than 30 days) or concurrent hormone therapy.

No requirement for steroids.

RADIOTHERAPY: No prior (greater than 30 days) or concurrent radiotherapy.

SURGERY: Not specified.

PATIENT CHARACTERISTICS:

Age: 18 and over.

Performance Status: ECOG 0 or 1.

Life Expectancy: More than 3 months.

HEMATOPOIETIC: No coagulation disorder.

HEPATIC:

Bilirubin no greater than 2.0 mg/dL.

No Hepatitis BsAg antibody.

RENAL: Creatinine no greater than 2.0 mg/dL.

CARDIOVASCULAR: No major cardiovascular illness.

PULMONARY: No major respiratory illness.

OTHER:

No previous allergic reaction to incomplete Freund's adjuvant.

HIV negative.

No active systemic infection.

Not pregnant or lactating.
A Multi-Center Study of the Safety and Efficacy of Bevacizumab in High-Risk Corneal Transplant Survival

The goal of this study is to investigate whether using bevacizumab (Avastin®) is both safe and effective at decreasing the likelihood of a high-risk corneal graft rejection. Patients who are "high-risk" for rejection have blood vessels growing from the white of the eye into the cornea (clear, front region of the eye). The medication is used at the time of surgery and in the weeks following surgery. Participants have a 50/50 chance at receiving the active study medication or a placebo medication.

The purpose of this study is to test the effectiveness of a drug, bevacizumab (Avastin), in preventing blood vessels that often occur after a corneal transplantation which are considered at "high-risk" for rejection. In many cases these blood vessels lead to the graft rejection and eventual failure of the corneal transplant. It is hoped that this treatment will increase the chances of corneal graft survival.

The medication used in this study is called bevacizumab or Avastin (Genentech, Inc). It works by inhibiting the action of a molecule called vascular endothelial growth factor (VEGF). VEGF is a substance molecule that binds to certain cells to stimulate new blood vessel formation. When VEGF is bound to the drug, it cannot stimulate the formation and growth of new blood vessels. Growth of blood vessels into the cornea is a complication which can worsen the prognosis of your corneal transplant and put the transplant at a higher risk for rejection.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Participant willing and able to provide written informed consent
* Willing and able to comply with study assessments for the full duration of the study
* High-risk characteristics for penetrating keratoplasty:

  1. Presence of corneal NV in one or more quadrants (≥ 3 clock hours NV ≥ 2mm from the limbus) OR
  2. Extension of corneal NV to graft-host junction in a previous failed graft
* In generally good stable overall health

Exclusion Criteria:

* History of Stevens-Johnson syndrome or ocular pemphigoid
* Ocular or periocular malignancy
* Non-healing epithelial defect of at least 0.5x0.5 mm in host corneal bed lasting ≥6 weeks preoperatively
* Uncontrolled glaucoma
* Currently on dialysis
* Has received treatment with anti-VEGF agents (intraocular or systemic) within 45 days of study entry
* Concurrent use of systemic anti-VEGF agents
* Change in topical corticosteroid regimen within 14 days of transplantation
* Use of systemic immunosuppressive for indication other than corneal graft rejection
* Pregnancy (positive pregnancy test) or lactating
* Pre-menopausal women not using adequate contraception (Reliable intrauterine devices, hormonal contraception or a spermicide in combination with a barrier method)
* Uncontrolled hypertension defined as systolic blood pressure (BP) ≥150 or diastolic BP ≥90 mmHg
* History of thromboembolic event within 12 months prior to study entry
* Participation in another simultaneous medical investigation or trial