cyrilzakka/clinical-trials huggingface dataset:
Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer

Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) as monotherapy or in combination in patients with solid tumors and aggressive non-hodgkin's lymphoma (NHL).

Part 2 VIP152 Monotherapy (Global). Part 3 dose escalation with VIP152 in combination with pembrolizumab (US only). Part 4 dose expansion with VIP152 in combination with pembrolizumab (US only).

Eligibility Criteria:
Part 2 (Global), Part 3 (US Only), and Part 4 (US Only)

Inclusion Criteria:

* Male or female patients aged \>/=18 years
* Patients with a histologically or cytologically confirmed solid tumor or aggressive NHL who are refractory to or have exhausted all available therapies with MYC expression or known C-MYC amplification/alterations
* Adequate bone marrow, liver, and renal functions
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

In the addition to the above Part 3 (US Only) and Part 4 (US Only)

* Must be eligible to use pembrolizumab per USPI

Exclusion Criteria:

* Active clinically serious infections of events \> Grade 2
* Subjects who have new or progressive brain or meningeal or spinal metastases.
* Anticancer chemotherapy or immunotherapy during the study or within 1 weeks prior to the first dose of study drug
* Major surgery or significant trauma within 4 weeks before the first dose of study drug
* Allogeneic bone marrow transplant or stem cell rescue within 4 months before first dose of study drug; patients must have completed immunosuppressive therapy before enrollment.
Developmental Intervention for Infants of Adolescent Mothers

This is a randomized control trial to evaluate a simple language intervention curriculum that utilizes LENA recordings, linguistic feedback and text-message review of content to improve language environments and outcomes for infants with adolescent mothers.

Mother-infant pairs are enrolled while in the hospital after birth. Enrolled participants are randomized into a language (intervention) or motor (control) group. All participants have a baseline LENA (device that captures 16 hour recording and associated computer analysis generates a report of numbers of adult words spoken, infant vocalization and conversational turns). Interventions after the baseline recording by group are as follows:

Intervention:

1. Review language curriculum and motor curriculum with study personnel
2. Direct linguistic feedback of baseline LENA recording
3. 2nd LENA recording completed and analyzed
4. Direct or mailed linguistic feedback of 2nd LENA recording
5. 16- Weekly text messages
6. 4 month LENA recording with mailed linguistic feedback
7. 12 month LENA recording with mailed linguistic feedback

Control:

1. Review motor curriculum with study personnel
2. 2nd LENA recording completed and analyzed
3. 4- monthly text messages
4. 4 month LENA recording
5. 12 month LENA recording with mailed linguistic feedback of all recordings

Both groups undergo the following assessments:

1. Ages and Stages Questionnaire at 4 and 12 months
2. Maternal Peabody Picture Vocabulary test at 4 months
3. Edinburgh Post-partum Depression Scale at 4 months
4. MacArthur Bates Communicative Developmental Inventory: Words and Gestures at 12

Eligibility Criteria:
Inclusion Criteria:

* Infants ≥30 weeks born to 15-20 year old mothers

Exclusion Criteria:

* Congenital anomalies associated with adverse developmental outcomes
* Non-English speaking mothers
* No cell phone
* Mother not available for follow-up
* State custody of mother or infant.
CPR Training: Video Self-Instruction Kit or Video-Only

Prompt delivery of cardiopulmonary resuscitation (CPR) is a crucial determinant of survival for many victims of sudden cardiac arrest (SCA), yet bystander CPR is provided in less than one third of witnessed SCA events. A number of barriers to bystander CPR training have been identified including time and cost of the training course. Since the large majority of arrest events occur in the home environment, studies have suggested that providing CPR training to family members of hospitalized cardiac patients may serve as a useful approach to address an environment in which bystander CPR is frequently not provided. Utilizing an existing in-hospital program to train adult family members, the investigators will assess the skills of those who learn CPR through two different education methods (video-only and video self-instruction (VSI) kit).

The long term goal of the investigators work is to implement real world CPR training strategies that match training locales with at-risk populations, maximize resuscitation skill retention, and promote willingness to act. To accomplish this, the investigators will empower stakeholders at UPHS and local area hospitals to develop local implementation approaches, using either volunteers or nursing staff as training proctors. These stakeholders will be studied as a research subset. The training proctors will train family members or friends of patients at risk for cardiac arrest using either a video-only method or video self-instruction (VSI) kit, and empower them with the lifesaving skill of CPR. The investigators will use the American Heart Association's CPR Anytime VSI kit which comes equip with a DVD and inflatable manikin. For the group receiving the video-only method, the investigators will remove the inflatable manikin and train the subjects with the DVD. The investigators will randomize family members of high risk for CA to either the video-only or VSI kit method of training. The training proctors will be instructed to switch training methods every 6 months. The investigators will follow up with the study subjects and conduct CPR skills tests from 6 to 12 months from time of training to assess whether the subjects retained their skills or if they had an opportunity to use the skills that they learned. The investigators will also gather information on how the subjects would like to be encouraged to practice their skills. The investigators will send a reminder notification every two months following training, to encourage the subjects to refresh their training skills. At the follow-up skills test at 6 to 12 months, we will administer a survey to assess whether the prompting encouraged the subjects to practice their skills.

Eligibility Criteria:
Inclusion Criteria:

* Family Members of Patients with known coronary disease or cardiovascular risk factors, such as history of diabetes and hypertension.

Exclusion Criteria:

* If someone is physically unable to undergo CPR Training
Multidisciplinary Bladder-preservation Therapy for Bladder Cancer

A multidisciplinary approach has led to the development of bladder-preservation therapy using maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing chemotherapy for muscle-invasive bladder cancer.

Multidisciplinary management improves complex treatment decision making in cancer care, but its impact for bladder cancer has not been documented. Although radical cystectomy (RC) has long been the standard of care for the management of muscle-invasive bladder cancer (MIBC), a multidisciplinary approach has led to the development of bladder-preservation therapy using maximal transurethral resection (TURBt) followed by radiotherapy with concomitant radio-sensitizing chemotherapy for MIBC. There are no randomized-controlled data comparing radical cystectomy with multidisciplinary bladder-preservation therapy (MBPT) available for comparison. However, observational data continues to support the use of MBPT as an acceptable alternative for patients with MIBC who wish to preserve their bladder or are not candidates for cystectomy because it may result in equivalent disease outcomes in select patients and offers the benefit of maintaining a functioning urinary system with subsequent improvements in quality of life. But there are also lots of issues need to be studied, such as the patient selection, approaches for completeness of TURBt, choices of radio-sensitizing chemotherapy, accuracy of radiotherapy and so on. In this study, the investigators plan to prospectively recruit 80 MIBC patients, who don't want to receive RC or are not candidates for RC, treated with MBPT from Nov 2018 to Dec 2020 in Peking University Third Hospital. The investigators will collect, compare and analyze their clinic-pathological data before and after MBPT, in order to confirm the safety and efficacy of MBPT for MIBC in China. At the same time, the investigators want to find out the patients who are not suitable for MBPT and the approach which can improve the efficacy of MBPT, as a result, the investigators intend to make a standard MBPT approach for Chinese MIBC patients.

Eligibility Criteria:
Inclusion Criteria:

1. Bladder urothelial carcinoma
2. Clinical stage: T2-T4, non-metastasis
3. Eastern Cooperative Oncology Group score (ECOG)≤ 1, Karnofsky performance score≥ 70
4. Patients don't want to receive RC or are not candidates for RC
5. Normal bladder function

Exclusion Criteria:

1. History of abdominal and pelvic radiotherapy
2. History of other malignant tumor
3. Pregnant or lactating patients
4. Severe comorbidity: cardiac infarction, arrhythmia, heart failure, et al
TEND Study:Telemedicine Nurse DBS for Parkinson's Disease

The central hypothesis is that home health nurses can improve access and provide high quality care when guided by a sophisticated platform that integrates bioinformatics, patient-specific computational modeling, and continuous symptom measurement.


Eligibility Criteria:
Inclusion Criteria:

* Pre-operative Inclusion Criteria: A good response to levodopa is required in order to exclude patients with Parkinson's plus syndromes, and will be defined as a 30% improvement in parkinsonian motor signs based upon the Unified PD Rating Scale (UPDRS) motor examination subscore, following the administration of 1.5 times the typical dopaminergic dose during the screening neurological examination. Patients must also have PD for a minimum of 5 years duration.
* Additional inclusion criteria consist of: 1) Hoehn \& Yahr stage II or worse when off; 2) Intractable, disabling motor fluctuations and/or tremor; 3) Age between 30-75 years; 4) Unsatisfactory clinical response to maximal medical management (with trials of both higher and lower doses of antiparkinsonian drugs). 5) A stable/optimal medical regimen of antiparkinsonian drug therapy for at least one month prior to surgery; 6) access to high-speed internet in the home.

Exclusion Criteria:

* Clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g. significant cardiac or pulmonary disease, uncontrolled hypertension).
* Evidence of secondary or atypical parkinsonism.
* MRI scan with significant evidence of brain atrophy or other abnormalities.
* Dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain.
* A major untreated psychiatric disorder.
Safety and Efficacy of Combination Listeria/GVAX Immunotherapy in Pancreatic Cancer

Test the safety, immune response and efficacy of GVAX pancreas vaccine (with cyclophosphamide) and CRS-207 compared to GVAX pancreas vaccine (with cyclophosphamide) alone in adults who have failed or refused prior treatment for metastatic pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Have histologically proven malignant adenocarcinoma of the pancreas; measurable disease is not required. (Subjects with mixed histology will be included if the predominant component is adenocarcinoma. Subjects must have metastatic disease.)
* Have received or refused at least one chemotherapy regimen
* At least 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Anticipated life expectancy of \>12 weeks
* For women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormone implants) must be used throughout the study period and for 28 days after their final vaccine administration. (A barrier method of contraception must be employed by all subjects \[male and female\], regardless of other methods.)
* Be willing and able to give written informed consent, and be able to comply with all study procedures
* Have adequate organ function as defined by specified laboratory values

Exclusion Criteria:

* Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
* Known history or evidence of brain metastases
* Have any evidence of hepatic cirrhosis or clinical or radiographic ascites
* Have clinically significant and/or malignant pleural effusion
* Known or suspected hypersensitivity to any component of GVAX Pancreas vaccine or CRS-207, or known allergy to both penicillin and sulfa
* Received an investigational product within 28 days of study treatment or planned to receive within 28 days after vaccine administration
* Used any systemic steroids within 28 days of study treatment
* Use more than 3 g/d of acetaminophen
* Prosthetic joint or other artificial implant or device that cannot be easily removed (there are some exceptions)
* Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug, or planned surgery requiring general anesthesia
* Infection with HIV or hepatitis B or C at screening
* Any immunodeficiency disease or immunocompromised state or active autoimmune disease or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment
* Be pregnant or breastfeeding
* Unable to avoid close contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) during the course of CRS-207 treatment until completion of antibiotic regimen
* Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures
Trial II of Lung Protection With Azithromycin in the Preterm Infant

The hypothesis of this study is that administration of azithromycin to ventilated premature infants will decrease the incidence and severity of BPD.

The purpose of this study is to determine if Azithromycin treatment is beneficial for prevention of bronchopulmonary dysplasia in preterm infants.

The survival of preterm infants has increased dramatically and has been associated with an increase in BPD. The incidence of BPD among extremely low birthweight infants ranges from 45% to 90%. Development of BPD is associated with both antenatal (maternal chorioamnionitis often due to Ureaplasma is related to BPD) and postnatal complications (oxygen toxicity, barotrauma, late onset infections). These insults appear to lead to an inflammatory response with resultant arrest of normal alveolar and vascular development. Multiple human studies support the role of inflammation in the development of BPD.

Evaluating a medication that could decrease the inflammation in BPD, with minimal side effects, could significantly improve the morbidities of prematurity and the financial burden incurred by parents. Macrolide antibiotics (erythromycin and azithromycin) have been shown to have anti-inflammatory properties that are independent of their antimicrobial properties.

Azithromycin has the potential to decrease the severity of ventilator-induced pulmonary inflammation that is commonly seen in BPD.

Eligibility Criteria:
Inclusion Criteria:

* birthweight less than 1250 grams admitted to UK NICU
* mechanical ventilation within the first 72 hours of life

Exclusion Criteria:

* confirmed sepsis by blood culture
* multiple congenital anomalies or known syndromes
* intrauterine growth retardation with birthweight less than 10%ile for gestational age
* ROM for \>7 days
Translation of Basic Research in Cognitive Science to HIV Risk

A randomized trial was conducted at drug diversion educational programs with a sample of 343 adult drug offenders who volunteered for the study. The trial tested three different interventions on HIV testing and condom use, with a 3 month follow-up. The study translated consistent basic research showing strong effects of memory practice on memory for new material. One of the conditions involved extensive memory practice of action plans involving HIV testing and condom use. Other conditions varied two active control interventions. Results showed that the memory practice condition led to a substantially larger odds of HIV testing than did the two control conditions. Condom use was also significantly more frequent in the memory practice condition than in one of the control conditions but was not significantly different from the second control condition.

This study translated basic research from several areas of cognitive science to a new intervention procedure designed to reduce HIV risk and increase screening for HIV and other infections. A randomized trial was conducted (N = 343) to test effects on testing for infection (HIV and hepatitis B/C) and condom use frequency in a sample of drug offenders at risk for infection. Many populations of drug offenders are not currently receiving evidence-based prevention for HIV or hepatitis and are in need of effective interventions that can be used in existing drug programs. At three-month follow-up, the results revealed that the condition translating basic research on memory practice and integrative processing significantly increased the odds of infection testing as compared to two alternative conditions. This condition also significantly improved the extent of condom use, compared to a traditional health education condition. The results show promise for increased translation of basic research on memory to behavioral interventions on health and prevention science. Such procedures can be effectively applied in a complex field setting in existing drug diversion programs.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in drug diversion education program
* Minimum age 18
* Understand English

Exclusion Criteria:

* Under 18
* Do not understand English
* Obviously intoxicated
Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacokinetics, and Preliminary Efficacy of FS-8002

this is a single-arm, open phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, pharmacokinetics, and preliminary efficacy of FS-8002 in patients with advanced solid tumors


Eligibility Criteria:
Inclusion Criteria:

1. Patients with advanced solid tumors confirmed by histology or cytology who have failed or become intolerant to previous standard treatments, or who do not have a standard treatment regimen；
2. At least one measurable lesion according to the RECIST V1.1 assessment criteria ；
3. The subject has sufficient organ and bone marrow function；

Exclusion Criteria:

1. Patients who have previously received TGF-β inhibitor therapy；
2. Have received any experimental drug treatment within 4 weeks prior to the first administration of the investigational drug；
3. Have used any systemic anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter) before the first administration of the study drug, including systemic chemotherapy, radiotherapy, immunotherapy, hormone therapy, targeted therapy (small molecule targeted drugs are within 2 weeks before the first administration), systemic immunomodulators (including but not limited to IFN, IL-2 and tumor necrosis factor \[TNF\]). Received Chinese herbal or proprietary Chinese medicines with anti-tumor effects within 2 weeks before the first administration;
4. Have used or are currently using aspirin (≥ 325 mg/day) or other anti-platelet aggregation drugs such as clopidogrel, dipyridamole, ticlopidine, and cilostazole, or full-dose anticoagulants or thrombolytics within 2 weeks prior to the first administration of the study drug;
5. Those who have received major surgical treatment or significant traumatic injury within 4 weeks before the first administration of the study drug, or those who have a history of fistula, gastrointestinal perforation, or tumor invasion of large blood vessels within 6 months before the first administration; or those who have intestinal obstruction during the screening period;
Study of Physical and Psychosocial Rehabilitation Needs of Patients After Diagnosis and Treatment of Upper Gastrointestinal Cancer or Gynecological Cancer

RATIONALE: Gathering information from patients who have undergone treatment for upper gastrointestinal cancer or gynecological cancer may help doctors learn more about patients' physical and psychosocial rehabilitation needs and plan the best treatment.

PURPOSE: This clinical trial is studying the physical and psychosocial rehabilitation needs of patients after diagnosis and treatment of upper gastrointestinal cancer or gynecological cancer.

OBJECTIVES:

Primary

* To explore the patients' perspective of their physical and psychosocial rehabilitation needs following the diagnosis and treatment for an upper gastrointestinal or a gynecological cancer.
* To assess patients' experiences of the physical and social impact of cancer in the treatment and post-treatment phase.
* To explore patients' met and un-met needs.
* To explore the patients' opinion of how it might be possible to manage any of the issues that arise.

Secondary

* To generate theories and a hypothesis from the data collected for use in a future interventional study.

OUTLINE: The study consist of a series of focus groups that take place in a private room within the Royal Marsden Hospital in the United Kingdom. Patients attend only one focus group session, which is audio-tape recorded. The focus groups discuss and explore the patient's needs and experiences using a semi-structured interview question schedule over 60-90 minutes. The groups are single-sex groups to allow the patients to express themselves freely with respect to any sensitive topics they may wish to discuss. If individual patient issues arise from the group discussions, the lead researcher may refer the patient to a member of the hospital team, the patient's physician, or for appropriate psychological support.

Data from the focus group dialogue and patients' baseline demographic information are analyzed. The results from this study are used to design an interventional study in the Rehabilitation Department.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of upper gastrointestinal (GI) or gynecological cancer
* Must have completed initial treatment for upper GI or gynecological cancer

  * Received primary treatment within the Royal Marsden NHS Foundation Trust
* Will be on a treatment pathway with radical intent or be post-treatment
* Reported that they have experienced a physical or psychosocial need resulting from the disease or its treatment

PATIENT CHARACTERISTICS:

* Able to attend the specialist center for a focus group session
* Willing and able to articulate their experiences in English
* Not eligible for or receiving palliative or end-of-life care

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics