cyrilzakka/clinical-trials huggingface dataset:
PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC

This multicenter, randomized, double-blind study will evaluate the safety and efficacy of PM8002 in combination with Nab-Paclitaxel compared with placebo combined with Nab-Paclitaxel as first-line treatment in inoperable locally advanced/metastatic triple-negative breast cancer(TNBC)


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and willing to provide written informed consent and to comply with scheduled visits and study procedures;
* Female, aged 18 to 70 years (inclusive);
* Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for ER, PR, and HER-2. Testing results for all three markers conducted within 24 months prior to the initiation of the study by a local facility accredited by clinical research center are acceptable. If deemed necessary by the investigator during screening, subjects may provide additional biopsy to confirm the latest pathological;
* Subjects who have not received prior systemic treatment（except endocrine therapy） for advanced breast cancer are eligible for the study. Subjects who have received Taxane-based chemotherapy during the neoadjuvant and/or adjuvant treatment phase are eligible, as long as the occurrence of relapse or metastasis is at least 12 months after the end of treatment;
* Performance status as assessed by the Eastern Cooperative Oncology Group (ECOG) is 0-1;
* Life expectancy of 12 weeks or more;
* According to RECIST 1.1, the subject has at least 1 measurable lesion as the targeted lesion (the only bone metastasis or the only central nervous system metastasis should not be considered as a measurable lesion. A measurable lesion located at the previously irradiated radiation field or other local treatment area should not be selected as targeted lesion, unless the lesion shows unequivocal radiographic progression).

Exclusion Criteria:

* Previous treatment with immune checkpoint agonists (such as CD137 agonists) or immune checkpoint inhibitors (such as CTLA-4, PD-1, PD-L1, LAG3 monoclonal antibody, etc.) or anti-vascular endothelial growth factor (VEGF) target drugs;
* Has uncontrolled or symptomatic brain or spine cord metastases;
* Those who have had other active malignant tumors within 5 years prior to the study treatment, except for those that can be treated locally and have been cured ;
* Poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg);
* With a history of hypertensive crisis or hypertensive encephalopathy;
* With a history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within the last 6 months prior to the start of the study treatment;
* Adverse events resulting from prior anti-tumor therapies should be assessed and graded according to the CTCAE 5.0 criteria, subjects whose AEs have not returned to Grade 1 or below;
* Has uncontrollable pleural, pericardial, or abdominal effusions;
* Has received allogeneic hematopoietic stem cell transplantation or organ transplantation.
NEO Rehab for Infants at Risk of Cerebral Palsy

Premature infants are at increased risk of developing cerebral palsy (CP). Early interventions for at risk infants have the potential to decrease disease severity and improve quality of life. All infants demonstrate general movements (GMs), which are reliable indicators of brain function and can be reproducibly evaluated using the General Movement Assessment (GMA) tool.

Prior studies have demonstrated the impact of early maternal-driven intervention strategies on neurodevelopmental outcomes in preterm infants. Investigators have shown that interventions promoting the establishment of emotional connection between the infant and his or her mother, including mother/infant calming sessions with scent cloth exchange, vocal soothing, eye contact, and kangaroo care, can impact neurodevelopmental outcomes at 18 months. Investigators have also shown that 60 minutes of kangaroo care leads to decreasing levels of the stress hormone cortisol in both mothers and infants.

This pilot study aims to determine the feasibility of a maternal-driven early intervention bundle in preterm infants with abnormal GMA.

The study objective are 3-fold:

1. To determine the proportion of infants (\<32 weeks gestation and/or \<1500g) who have abnormal GMs findings using the GMA tool.
2. To determine the feasibility of NICU based rehabilitation program in 20 infants determined to be at high risk for CP using the GMA tool. The intervention bundle will consist of a maternal-driven gestational age (GA)-appropriate intervention bundle that will include evidence-based interventions including vocal soothing, comforting touch, scent exchange, kangaroo care, and infant massage. Patients will be compared to contemporary and GA-matched controls receiving standard of care with a 1:2 assignment.
3. To evaluate the short-term impact of a maternal-driven intervention bundle on the mother-infant dyad. Maternal stress will be measured using the Parental Stress Scale for NICU patients (PSS: NICU) prior to the intervention and prior to the infant's NICU discharge. Further, stress will be assessed by measuring maternal and infant salivary cortisol pre-and post-kangaroo care on 3 separate occasions (post enrollment in the study, mid-hospital stay, and prior to discharge). Measures of maternal anxiety and depression will be evaluated prior to the intervention and prior to NICU discharge using the Patient Reported Outcomes Measurement Information System (PROMIS) instrument.

The investigators hypothesize that the intervention will lead to positive and measurable outcomes for the mother-infant dyad.

Eligibility Criteria:
Inclusion Criteria:

* Infant Gestational age \<32 weeks AND/OR birth weight \<1500g

Exclusion Criteria:

* Any clinical condition / diagnosis that would restrict the ability of the mother to do Kangaroo Care per the current UVA Kangaroo Care guideline
* Non-English-speaking mother
* Mother is a prisoner
* Confirmed inability to return for follow-up appointment
Advantages and Disadvantages of Long Term Sedation in Intensive Care Unit Patients

The purpose of the study is to determine whether sedation of the critical ill patient prolongs the time receiving mechanical ventilation.

The golden standard is to sedate critical ill patients receiving mechanical ventilation with daily wake up trials. This is shown to reduce the time receiving mechanical ventilation compared to no wake up trials.

We would like to study whether no sedation but only analgesics administered as bolus doses, reduce the time receiving mechanical ventilation. The study is planned as a randomised prospective study, not blinded. The control group is patients receiving sedation with daily wake up trials. The intervention group is not sedated, but receives bolus doses of analgesics (morphine). The endpoint is the time spend receiving mechanical ventilation, lengths of stay on the intensive care unit, and total lengths of stay on the hospital.

We also examine the frequency of ventilator associated pneumonia and CT scans of cerebrum. Also we would like to examine the long term psychological effects of sedation, we plan to send some of the patients to a post traumatic stress screening. The effect on the next of kin we plan to study with a questionnaire. As a last thing we would like to study the workload on the nurses.

Eligibility Criteria:
Inclusion Criteria:

* Intubated receiving mechanical ventilation
* Expected to remain intubated more than 24 hours
* Over 18 years

Exclusion Criteria:

* Raised intracranial pressure
* Pregnant
* Treatment with muscle relaxants
Investigating the Effects of the "GameDay Ready" Behavioral Weight Management Program for Black Men Living in the Rural South

This pilot study investigates the effects of a newly developed 12-week weight management program called "GameDay Ready" (compared to a walking and general health education program) for decreasing body weight among Black men who live in the rural South. The researchers expect to see evidence of greater weight loss among participants randomized to receive the "GameDay Ready" program.


Eligibility Criteria:
Inclusion Criteria:

* Self-identified African American or Black American male
* 25-65 years of age
* BMI 27kg/m2 to ≤50kg/m2 (those with a BMI \>45 will need documented approval by a healthcare provider to participate in the study)
* Live in a rural area of South Carolina and have lived in a rural area for at least 1 year
* Able to speak and understand English
* Willing to be randomized to the intervention or comparison program

Exclusion Criteria:

* Positive response to any question on the Physical Activity Readiness Questionnaire (PAR-Q) (Participant may be included if approval is provided and documented by a healthcare provider)
* Currently participating in another weight loss trial or program or have participated in a trial or program within 6 months prior to starting the intervention
* Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg), diabetes, or asthma (Participant may be included if approval is provided and documented by a healthcare provider)
* Pulmonary disease requiring supplemental oxygen or daily use of short-acting bronchodilators
* Any musculoskeletal condition that would preclude meeting recommended levels of moderate-to- vigorous physical activity
* Within 30 days prior to participating in the study, have taken prescription or nonprescription medications, herbals, or supplements for weight loss
* On special diet for a serious health condition (does not include general dietary advice from a healthcare provider for common risk factors such as hypertension, diabetes, or hyperlipidemia).
* Major surgery in the past 6 months
* Have undergone weight loss surgery or considering weight loss surgery within the next 6 months
* Have been treated for cancer in the past 12 months (other than non-melanoma skin cancer)
* Weight loss ≥5% during the past 6 months
* Plans to move to another county in the next 6 months
* Any other perceived physical or mental health-related condition that would preclude participating in a behavioral program designed to promote weight loss
OKKO Space Academy to Check Children's Vision at Home

The purpose of this study is to determine the feasibility of the OKKO Space Academy app as a vision measuring and home-monitoring tool for children aged 3-8 years undergoing amblyopia treatment.

There are three objectives to this work:

1. Determine the feasibility of the OKKO Space Academy app for use between clinic visits from the child's and family perspective (i.e., acceptability, usability and engagement).
2. Assess the variability in day-to-day OKKO Health measurements between clinic visits (e.g., do the interim OKKO home vision measurements predict improvements in visual acuity?)
3. Explore agreement between the OKKO Space Academy measures of visual acuity against in-clinic measurements (usual standard of care), including an exploration of intra- and inter-session repeatability.


Eligibility Criteria:
Inclusion Criteria:

* Age 3.01 - 8.99 years with amblyopia
* Currently undergoing or at first visit to start amblyopia patching treatment
* Vision is fully corrected in glasses
* Visual acuity between -0.02 and 0.98 logMAR
* Have daily access to an approved smartphone or tablet
* Parent/child able to read and understand English
* Patient (child) able to understand spoken English

Exclusion Criteria:

* Parent not able to read and understand English
* Patient (child) not able to understand spoken English
* Parent/child not willing to participate
* Parent unable to give consent
* Any other ocular comorbidities
* Child has cognitive impairment or intellectual disability
Non-invasive Diagnosis of Coronary Artery Stenoses by Doppler Echocardiography

Non-invasive evaluation of patients with stable angina and unstable coronary syndromes with transthoracic Doppler echocardiography to evaluate presence of significant coronary stenoses. Blinded evaluation and comparison with coronary angiography: presence and location of stenoses, and head to head comparison of clinical value and patient classification.

Transthoracic Doppler echocardiographic evaluation with extensive evaluation of coronary stenoses in all 3 main branches using colour flow, pulsed Doppler and Coronary flow velocity reserve (CFVR)after pharmacologic stress with adenosin in the area of LAD and RDP. Blinded evaluation of Doppler results and coronary angiography regarding the other examination modality. Coronary angiography diagnostic "gold standard". Only stable and unstable patients otherwise scheduled for angiography on clinical reasons will be examined and included in the study.

Added January 2007 after ethics committee approval: comparison of CFVR with invasive fractional flow reserve (FFR) in selected subset of patients.

Eligibility Criteria:
Inclusion Criteria:

* unstable angina or acute myocardial infarction, or stable angina pectoris and
* scheduled for coronary angiography on accepted clinical reasons

Exclusion Criteria:

* past coronary artery grafting
Study of Endoscopic Barrett's Esophagus Diagnosis

Barrett's esophagus (BE) is a condition that often occurs in patients who have had GERD for a long time. The researchers are interested in BE because it can sometimes become a cancer in the esophagus. The way that we currently diagnose BE is by performing an upper endoscopy and looking for a change in the color of the esophagus. This color change may represent BE. If the doctor sees this, he/she may take biopsies of this area.

Studies have shown that making the diagnosis of BE can be hard to make. One of the reasons why this may be is because doctors may interpret what they see differently during the procedure. In other words, they may see an esophagus that appears normal in color or abnormal in color.

The purpose of this study is to compare two doctors' impressions of the appearance of the esophagus during a single endoscopy procedure.


Eligibility Criteria:
Inclusion Criteria:

* History of (h/o) GERD
* Upper GI symptoms such as acid taste in mouth, dysphagia, dyspepsia
* Screening or surveillance exam for BE

Exclusion Criteria:

* Unable to consent
* History of esophageal varices
CD19/20 Bispecific Nanobody-derived CAR-T Cells in B Cell Lymphoma

Evaluation the safety and efficacy of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma

CART cell therapy has become the treatment of choice for patients with relapsed/ refractory B cell lymphoma. Currently, CAR-T cells approved for relapsed/refractory B-cell lymphoma are mainly CAR19-T cells. Nearly half of patients who relapse after treatment with CAR19-T cells are caused by tumor cell antigen escape. Dual-target CAR-T cells targeting CD19 and CD20 may reduce the recurrence rate after treatment. This study was to evaluate the efficacy and safety of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* expected lifetime\>3 months
* CD19/CD20 positive relapsed/refractory B cell lymphoma
* KPS\>70
* at least one measurable lesion according to RECIST 1.1
* enough function of hear, liver, kidney and bone marrow
* no history of severe allergies
* no other history of malignancy
* no other diseases that conflict with this regimen
* no serious mental illness
* patient or family member sign informed consent

Exclusion Criteria:

* Pregnant or lactating women
* Severe infectious or viral disease
* Active B or C viral hepatitis
* Patients who have used large amounts of glucocorticoids or other immunosuppressive agents during the last 4 weeks
* participated in other clinical studies in the last 3 months, or have been treated with other gene products
* Others not appropriate to participate in this study examined by the investigators
A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

The overall purpose of the study is to determine if MEDI-551, when used in combination with salvage chemotherapy, Ifosfamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine (DHAP) in patients with relapsed or refractory DLBCL who are eligible for Autologous Stem Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed aggressive B-cell DLBCL, including FL transforming to DLBCL \& Grade III FL
* Relapsed from or refractory to at least one treatment containing rituximab or another anti-CD20 based immunotherapy combined with anthracycline- or anthracenedione-based chemotherapy
* Eligible for ASCT
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Life expectancy of ≥ 12 weeks
* Adequate hematological function

Exclusion Criteria:

* Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 28 days prior to treatment
* Previous cancer therapy for DLBCL other than anthracycline- or anthracenedione based chemoimmunotherapy, monotherapy rituximab prior to first line therapy and/or as a maintenance therapy, or limited field radiotherapy
* Prior autologous or allogeneic SCT
* New York Heart Association ≥ Class II congestive heart failure; Clinically significant abnormality on ECG
* History of other invasive malignancy within 5 years except for localized/in situ, carcinomas such as cervical carcinoma in situ.
* Evidence of active infection
* Documented current central nervous system involvement by leukemia or lymphoma
Definitive Concurrent Chemoradiotherapy With Docetaxel Plus Cisplatin Versus 5-fluorouracil Plus Cisplatin in Patients With Esophageal Squamous Cell Carcinoma

In this phase II study, the investigators aim to evaluated the efficacy and toxicity of definitive concurrent chemoradiotherapy (CCRT) with docetaxel plus cisplatin (DP regimen) versus 5-fluorouracil plus cisplatin (PF regimen) in patients with esophageal squamous cell carcinoma (ESCC).

Esophageal cancer is one of the most fatal malignancies worldwide. Radical surgery has been the primary treatment for patients with resectable esophageal cancer. For medically unfit patients or medically fit patients who decline surgery, definitive radiotherapy plus concurrent chemotherapy has been established as a standard treatment. Since the 1980' s, the most widely used chemotherapeutic regimen in combination with radiotherapy for esophageal cancer was cisplatin (CDDP) plus 5-fluorouracil (5-FU) (the PF regimen). However, locoregionally persistent or recurrent diseases were still quite common and survival remained poor. Several previous studies conducted by the radiation therapy oncology group (RTOG) explored the efficacy of radiation dose escalation, but all results turned out disappointing. And studies incorporating intensified PF regimen or new-generation cytotoxic agents such as paclitaxel and oxaliplatin did not show any advantage over the standard-dosage PF regimen either. In this phase II study, the investigators aim to evaluated the efficacy and toxicity of definitive concurrent chemoradiotherapy (CCRT) with docetaxel plus cisplatin (DP regimen) versus 5-fluorouracil plus cisplatin (PF regimen) in patients with esophageal squamous cell carcinoma (ESCC).

Eligibility Criteria:
Inclusion Criteria:

* patients with histologically proven squamous cell carcinoma of the esophagus
* stage II-IVA disease, including metastatic celiac or cervical nodes, according to the sixth edition of American Joint Committee on Cancer (AJCC) staging system for esophageal cancer
* aged between 18 and 70 years
* Karnofsky Performance Status (KPS) score ≥ 70
* adequate bone marrow function (leukocyte count ≥ 4000/uL, platelet count ≥ 100,000/uL), adequate liver function (serum alanine aminotransferase (ALT) level and serum aspartate aminotransferase (AST) level \< twice the upper limit of normal, and serum bilirubin level of \<1.5 mg/dL), and adequate renal function (creatinine clearance ≥ 50 mL/min)
* no other serious medical conditions
* life expectancy ≥ 3 months
* written informed consent

Exclusion Criteria:

* detection of distant metastasis (excluding metastatic celiac or cervical nodes) before treatment before treatment
* known allergy to CDDP, 5-FU, or docetaxel
* pregnancy or breast feeding
Study Comparing Sirolimus/Prograf vs Sirolimus/CsA in High-Risk Renal Transplant Recipients

The purpose of this study is to assess whether in high-risk kidney transplant patients (patients whose previous kidney transplant failed, have a high PRA lab test result or are of African-American descent) that a combination of Rapamune with Prograf and steroids will prevent acute rejection as well as Rapamune and cyclosporine and steroids.


Eligibility Criteria:
Inclusion criteria:

* Patients of African-American descent or patient with a history of multiple transplants and/or patients with a high panel reactive antibody lab test with a renal transplant from a cadaveric donor, a living unrelated donor or a living-related mismatched donor.
* Age \>= 13 years, weight \>= 40 kg
* Women must have a negative pregnancy test at study entry

Exclusion criteria

* Multiple organ transplants or double kidney transplants (pediatric en-bloc or double adult)
* Active systemic infection, or localized major infection or known HIV
* Patients with residual kidney function \>20 mL/min
Comparison of Prosthetic Feet for People With Syme's Amputation (XF Symes Study)

The purpose of this study is to compare the functional differences between two types of foot prostheses for people with ankle disarticulation (Syme's) amputations. The two feet being tested are low- and high-profile feet, with the difference being the latter has an extended keel and attaches to the posterior of the prosthetic socket, rather than the distal end. The hypothesis is that the high-profile foot (i.e., the crossover foot) will lead to functional and biomechanical improvements compared to low-profile feet.

Syme's prostheses are typically limited to low-profile prosthetic feet due to clearance restrictions below the prosthetic socket. As a result, the functional benefits provided by the long residual limb are mitigated by prosthetic design limitations. Recently, high-profile, posteriorly-attaching crossover feet have been modified for use with people who have Syme's amputation. Crossover feet theoretically improve motion and energy storage-and-return compared to traditional foot options for the Syme's level. Crossover feet also have the potential to broaden the range of high-impact activities that can be performed with a single prosthesis. However, to date there is no empirical evidence that compares functional differences when walking with high-profile crossover feet compared to low-profile feet for people with Syme's amputation. This mixed-method pilot research will use a randomized, controlled within-participants design. Investigators will assess gait biomechanics, self-reported health outcomes, and qualitative interviews to compare relative advantages and disadvantages of traditional low-profile Syme's feet and high-profile crossover feet. This proposed work will create a foundation for future research that examines the potential benefits of crossover feet in people with Syme's amputation. In addition, results from this research will be used clinically to inform prosthetic options for people with limited clearance for distally-attached prosthetic feet.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Have a unilateral Syme's amputation that occurred \>1 year prior
* Owns a crossover foot modified for Syme's use
* Able to walk in the community without assistance
* Able to read and write in English

Exclusion Criteria:

* Have other amputations
* Have a health condition that would limit completion of the study protocol (e.g., skin breakdown, heart disease)