cyrilzakka/clinical-trials huggingface dataset:
A Study of APTO-253 in Patients With Relapsed or Refractory AML or MDS

This study is being done to evaluate the safety and effectiveness of APTO-253 for the treatment of patients with the condition of acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) for which either the standard treatment has failed, is no longer effective, or can no longer be administered safely or poses a risk for your general well being.

This is a multicenter, open-label, Phase Ia/b dose escalation study of safety, pharmacodynamics, and pharmacokinetics of APTO-253 in ascending cohorts (3+3 design) to determine the MTD or recommended dose in patients with relapsed or refractory acute myelogenous leukemia (AML) or high-risk MDS patients. This is to be followed by a cohort expansion phase at the MTD or recommended dose.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old
* Life expectancy of at least 2 months
* Off previous cancer therapy for at least 14 days, or 5 half-lives for noncytotoxic agents prior to first study treatment administration
* Patients must have a calculated creatinine clearance \>60 mL/min
* Acceptable hematologic, renal and liver functions and coagulation status parameters

Exclusion Criteria:

* Patients with GVHD requiring systemic immunosuppressive therapy
* Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinical significant disease related metabolic disorder
* Clinically significant intravascular coagulation
* Treatment with other investigational drugs within 14 days prior to first study treatment administration
Y-90 Versus SBRT for Inoperable HCC

This phase II trial tests whether Y-90 segmentectomy (internal radiation) versus stereotactic body radiation therapy (external radiation) is more optimal in treating inoperable liver cancer. Y-90 segmentectomy consists into very tiny radioactive glass beads that can be injected into the liver through the blood vessels supplying the liver. Stereotactic body radiation therapy uses special equipment to position a patient and deliver external radiation to tumors with high precision. This study many help doctors determine which treatment, Y-90 segmentectomy or SBRT, works better in treating liver cancer.

PRIMARY OBJECTIVE:

I. Determine feasibility of trial enrollment (enrollment date).

SECONDARY OBJECTIVE:

I. To assess differences in overall survival, local control, time to intrahepatic progression, time to next treatment, rate of liver transplant, toxicity, and patient reported complications and quality of life.

EXPLORATORY OBJECTIVE:

I. Compare cumulative cost of treatment-related medical care at 13 months.

OUTLINE: Patients will be randomized in 1 of 2 arms.

Arm I: Patients undergo SBRT every other day for a total of 5 days over 2 weeks.

Arm II: Patients receive Y-90 radioembolization via injection on day 1.

After completion of study, patients are followed up at 2, 4, and 12 weeks and then every 3 months for 13 months.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent document.
* Age \>= 18 years at time of informed consent. Both men and women and members of all races and ethnic groups will be included.
* Patient with non-metastatic hepatocellular carcinoma (HCC) including lesion(s) amenable to definitive therapy with either SBRT or Y-90 segmentectomy, limited to =\< 2 liver segments, as agreed upon by the multidisciplinary tumor board consensus.
* Patient not otherwise optimal candidates for resection or thermal ablation, as agreed upon by the multidisciplinary tumor board.
* Have a Child-Pugh criteria (CP) score B7 or better.
* Eastern Clinical Oncology Group (ECOG) performance status =\< 1, or Karnofsky performance scale \> 70.
* No other prior invasive malignancy is allowed except for the following: adequately treated basal or squamous cell skin cancer, in situ breast or cervical cancer. Stage I or II invasive cancer treated with a curative intent without evidence of disease recurrence for at least five years.

Exclusion Criteria:

* Participant is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, serious or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent.
A Study of JNJ-70218902 in Participants With Advanced Stage Solid Tumors

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) and maximum tolerated dose (MTD) of JNJ-70218902 in Part 1, and to determine the safety of JNJ-70218902 RP2D(s) in Part 2.

JNJ-70218902, the investigational drug, has been shown in pre-clinical studies to work by attaching to cancer cells and activating immune cells to kill these cancer cells. This study will be conducted in 2 parts: dose escalation (Part 1) and dose expansion (Part 2) and will enroll adult men with Metastatic Castration-Resistant Prostate Cancer (MCRPC). Study evaluations will include preliminary clinical efficacy, safety, pharmacokinetics, biomarkers and immunogenicity evaluations. This study is divided into 3 periods: screening, treatment and post-treatment. The total duration of the study will be 2.5 years approximately.

Eligibility Criteria:
Inclusion Criteria:

* Histology: Metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed
* Measurable or evaluable disease
* Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or chemotherapy
* If the participant is receiving treatment with gonadotropin-releasing hormone agonists or antagonist analogs (GnRH), this therapy must have been initiated prior to first dose of study drug and must be continued throughout the study
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
* Adequate organs functions

Exclusion Criteria:

* Known brain metastases
* Concurrent use of any other anticancer treatment or investigational agent for the treatment of advanced disease
* Toxicities related to prior anticancer treatments have not returned to Grade less than or equal to (\<=) 1 or baseline, except for alopecia and vitiligo
* Solid organ or bone marrow transplantation
* Known allergies, hypersensitivity, or intolerance to JNJ-70218902 or its excipients
* Certain comorbidities
Blood Flow Restriction in Older Adults

Introduction. From the age of 80 onwards, more than 50% of people suffer from sarcopenia. The loss of muscle strength leads to a loss of muscle power, impairing functionality and preventing the correct performance of activities of daily living.

Objective. To analyse the efficacy of blood flow restriction in older adult patients by evaluating changes in the variables muscle power and strength, physical condition and functionality of the lower limbs.

Material and method. Randomised single-blind clinical study. Thirty-six older adults will be recruited and randomised to the experimental and control groups. The intervention will have a duration of 4 weeks, with 2 weekly sessions. The intervention will consist of an intervention by performing 3 quadriceps strength exercises, with a 40% restriction. The primary variable of the study will be muscle power (Sit To Stand 5 times) and the secondary variables will be muscle strength (dynamometry), physical condition (Timed Up and Go) and functionality and autonomy (Barthel index)


Eligibility Criteria:
Inclusion Criteria:

* Older adults aged 65 to 80 years
* Independent for standing and walking with the help of assistive devices such as cane and walker
* Both genders
* Normotensive or hypertensive with controlled BP (systolic blood pressure \<140 mmHg)
* Sign the informed consent form.

Exclusion Criteria:

* People dependent for the performance of activities of daily living.
* People with cognitive impairments that limit the performance of the intervention or assessments.
* Persons undergoing total hip or knee arthroplasty
* Persons receiving physiotherapy treatment at the time of the study
* History of deep vein thrombosis (DVT) or pulmonary embolism
* History of myocardial infarction or stroke
PrEPception: Expanding Assisted Reproductive Options for Serodiscordant Couples

The purpose of this study is to observe patient response to current clinical practice utilizing TRUVADA (emtricitabine and tenofovir disoproxil fumarate) for Pre-Exposure Prophylaxis (PrEP) amongst HIV serodiscordant couples desiring to conceive across four U.S. cities that are currently offering this method as standard of care. This study is an observational cohort study, which will test the feasibility and acceptability of PrEP for conception, while examining the challenges and generalizability of this current medical practice. The CDC recently released formal clinical practice guidelines for the use of PrEP in the United States. For high-risk serodiscordant heterosexual couples using PrEP during conception, the guidelines state, "PrEP use periconception and during pregnancy by the uninfected partner may offer an additional tool to reduce the risk of sexual HIV acquisition. Both the FDA labeling information and the perinatal antiretroviral treatment guidelines permit this use" (CDC 2014).

Based on CDC's guidance on PrEP as well as results of randomized controlled trials, the U.S. Food and Drug Administration (FDA) approved this daily medication (comprised of one pill) to reduce the risk of sexually acquired HIV in adults at high risk. Other medical practices to avoid transmission within this population include assisted reproductive technologies such as sperm washing (or donated sperm) coupled with in vitro fertilization, intracytoplasmic sperm injection (an in vitro procedure where a single sperm is injected directly into an egg), and intrauterine insemination (placing the sperm directly into the uterus). However, these methods are costly and often regionally scarce. PrEP is more accessible and a less expensive option for couples. When used consistently and as prescribed, PrEP has shown to significantly reduce the risk of HIV infection among adult men and women. However, risk reduction counseling and clinical monitoring are necessary for its effective implementation. Therefore, beyond efficacy trials, it is important to conduct additional studies of pre-exposure prophylaxis to observe what factors make PrEP feasible and acceptable to couples, as well as identify other factors that impact level of adherence. The study will take place in four U.S. cities: Boston, Baltimore, Philadelphia, and San Francisco and will involve couples who have chosen to begin PrEP for conception as part of their clinical care after receiving preconception counseling and reviewing their options with their health care provider.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 to 40 years
* In relationship with HIV-positive male
* Chosen to take PrEP for conception after completing counseling with health care provider

Exclusion Criteria:

* HIV-positive
* In relationship with HIV-negative female
* Partner has chosen to take PrEP for conception after completing counseling with health care provider
Natural History of Gastroesophageal Reflux (GER) in Children < 12 Years of Age

The goal of this project is to determine the long-term health outcome of children diagnosed with gastroesophageal reflux (GER). We are inviting subjects that were previously followed in the Pediatric GI programs at Massachusetts General and Children's Hospital, Boston. We have compiled a database of more than 200 subjects that completed diagnostic testing for GER in the 1970's and 1980's. Subjects are being contacted initially by mail using a previously approved recruitment letter. Subjects that fail to respond to this recruitment letter are called by phone. In each case, contact information has been abstracted from the Children's Hospital database. Subjects are then given the opportunity to complete a questionnaire either by phone or in hard copy. Subjects receive no compensation for their participation in this study. Subjects will be compared to controls. Controls will complete the same questionnaire as the subjects. Inclusion of potential controls will be determined by a lack of medical history of gastroenterological diseases before the age of 21 and whether the potential control was born within a year of a subject in the study. Controls will receive $25 to participate in the study.


Eligibility Criteria:
Inclusion Criteria for Subjects:

* Patients who were evaluated for GERD at the age of 12-17 years, inclusive at Children's Hospital, Boston or Massachusetts General Hospital
* Positive for GERD per biopsies or pH probe results

Inclusion Criteria for Controls:

* No GI diseases prior to age 21 including, but not limited to reflux, inflammatory bowel disease,Hirschsprung's disease
* Date of birth is within 1 year of a subject's date of birth
Stressors, Coping Methods and Social Support in Diabetic Patients

The increasing prevalence of diabetes brought great burden to health status of the investigators population. It is meaningful to investigate the stressor, stress perceived, social support and coping methods in diabetic population in order to provide appropriate assistance to these patients. This study will recruit diabetes patients from out-patient-department and they are invited to complete a questionnaire. The contents of the questionnaire including stress experienced, stress perceived, social support and coping methods. The investigators purpose is to find out the impact of these factors on glycemic controlled and their life quality. The results will be useful to diabetes care team when health education is delivered to patient.

Type 2 diabetes patient aged 30-80 y/o under oral hypoglycemic agents with clear conscious enable to answer questions properly who regularly follow up at our metabolism clinic is eligible. Patients are asked to complete a questions containing basic personal information, diabetes coping method Chinese version (DCM-C)questionnaire, social support and perceived stress scale.

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes
2. Aged 30-80 year old
3. under oral hypoglycemic agents
4. clear consciousness

Exclusion Criteria:

1. Type 1 diabetes
2. Age below 30 and above 80
3. Insulin use
4. Conscious not clear
Nutrition and Physical Activity Counseling for Nontraditional College Students

The purpose of this research study is to evaluate the effectiveness of two methods of delivering information about nutrition and physical activity to non-traditional college students. Participants will receive either a printed feedback report alone, or the feedback report in addition to a series of phone calls from a peer counselor. The peer counselors will provide nutrition and physical activity counseling using motivational interviewing techniques. Nutrition and physical activity outcomes will be measured for both groups and compared.


Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled undergraduate student at UMass Boston,
* Have completed high school,
* 24yrs old or older AND/OR part time students,
* Noncompliant in at least 1 of 4 behaviors: fruit \& vegetable intake, sugar sweetened beverage intake, fast food intake, or physical activity),
* Willing to randomized into either study group,
* Be able to give informed consent.

Exclusion Criteria:

* Have any contraindications to physical activity
Effect of Violent First-Person Shooter (FPS) Video Games on Shooting Accuracy

The present research tests the effects of violent shooting games on behavior within the game (Pilot Study) and on behavior after the game is turned off (Experiment Proper). The Experiment Proper is an exact replication of a previous study conducted in our lab that was retracted (see citation), but with a larger sample to get more reliable results (N=287 rather than N=151).

Violent shooting games are used to train soldiers and police officers. This research tests whether violent shooting can train people to shoot targets in the head, both during gameplay (Pilot Study) and after the game is turned off (Experiment Proper). Participants in both studies played a violent shooting game with humanoid targets that rewarded headshots, or a nonviolent shooting game that punished shots to bull's-eye targets with faces. Afterward, participants shot at a mannequin with a realistic CO2 gun. We anticipate that participants who play the violent game which rewards headshots to hit the mannequin's head more often than those who play the non-violent game.

Eligibility Criteria:
Inclusion Criteria:

* 18 and older
* Ohio State participant pool

Exclusion Criteria:

* Under age 18
Pumping to Up Maternal Milk Production for Preterms

The goal of this clinical trial is to learn about the effect of breast-pumping frequency on breast milk supply/ volume in mothers of preterm infants. The main question it aims to answer is:

- What effect does pumping frequency have on breast milk supply.

Researchers will compare breastmilk supply of mothers who pump every 2 hours to the supply of those who pump every 3 hours to see if there is a difference in the amount of breastmilk they produce.

Participants will be assigned to either pump every 2 hours or every 3 hours and record how many milliliters of breastmilk they produce daily for the first 28 days of their baby's life.


Eligibility Criteria:
Inclusion Criteria:

* Inborn infants \<32 weeks gestation
* Out-born infants transferred to our facility \<48hours of life
* Infants \<1500 grams at birth
* Infants whose parents/ guardians have provided legal consent for study participation

Exclusion Criteria:

* Infants with birthing persons' that are severe/critically ill
* Birthing persons of infants \<18 years old
* Infants with terminal illness or decision to withhold or limit support
* infants with major congenital anomalies, chromosomal disorders, or congenital infections
CorEvitas Systemic Lupus Erythematosus (SLE) Drug Safety and Effectiveness Registry

Prospective, observational registry for subjects with SLE under the care of a rheumatology provider. Longitudinal data are collected from both subjects and their treating rheumatology provider during routine clinical encounters using a structured and standardized data collection method.

The objective of the registry is to create a cohort of Systemic lupus erythematosus (SLE) subjects to evaluate long-term real-world safety and effectiveness of standard of care treatments for SLE. Data collected through the registry may be used to address a range of research questions and use cases, including but not limited to: characterizing the natural history of the disease, evaluating the effectiveness and safety of commercially available medications for the treatment of SLE, providing information to support ongoing risk-benefit evaluation by drug manufacturers and regulators, and research related to drug utilization, disease burden, and unmet needs. Further, data collected will inform clinical decision making by patients and treating providers. This will be enabled through the standardized data collection including validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization data.

Eligibility Criteria:
Inclusion Criteria:

To be eligible to participate in this registry, an individual must meet all the following criteria:

1. Has been diagnosed with SLE by a rheumatologist or a qualified rheumatology practitioner.
2. Is at least 18 years of age or older and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted at the time of enrollment.
3. Willing and able to provide informed consent.
4. Willing and able to provide Personally Identifiable Information (full legal name, sex at birth, date of birth, and home address zip/postal code at a minimum) if required based on registry location and applicable laws and regulations.
5. In addition, subjects must meet at least one of the following criteria:

   * New diagnosis of SLE (=\<12 months) from registry enrollment, OR
   * Initiation of a biologic or immunosuppressant for the treatment of SLE at registry enrollment, OR
   * Lupus Nephritis (LN; class III-V) diagnosed within 2 years of registry enrollment

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in the registry:

1. Is participating in a double-blind clinical trial for a SLE drug
2. Subjects participating in any non-blinded trial for any indication, with the exception of non-blinded CAR-T or other cell/gene therapies for the treatment of SLE
Edaravone on the Ischemia-Reperfusion(I/R) Injury in Kidney Transplantation Patients

Ischemia-reperfusion (I/R) injury is a prominent cause of delayed graft function(DGF) after kidney transplantation. Reactive oxygen species play a crucial role in I/R injury. Edaravone is a synthetic radical scavenger that has been used in acute stroke. Some animal experiments have revealed its beneficial effects against I/R injury, our goal is therefore to investigate the effectiveness of a recipient pretreatment with Edaravone at reducing the occurrence of DGF after kidney transplantation.

Participants will be randomly assigned, in a 1:1 ratio, to receive Edaravone or control (0.9 %Sodium Chloride Solution,0.9%NaCl). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center.Edaravone and 0.9 %NaCl solution will be treated at 10 minutes before kidney reperfusion, ending in 30 minutes. The number of dialysis and the serum creatinine level within the first week after the transplantation will be recorded. The participation of each patient is scheduled for 1 month.

Eligibility Criteria:
Inclusion Criteria:

1. ASAⅡ-Ⅲ,elective operation patients with end-stage renal disease
2. Age 18yrs-55yrs for donors and the recipients
3. patients under hemodialysis
4. no other severe complications history for the donors and recipients
5. the first kidney transplant recipients
6. patients with written informed consent

Exclusion Criteria:

1. ASA Ⅳ
2. a second renal transplant,a multiorgan transplant or a dual kidney transplant
3. having severe comorbidity history,for example,severe cardiac dysfunction
4. cold ischemia time\>24h or warm ischemia time\>45min
5. variation of blood vessel ，operation time more than 2 hours
6. bleeding volume in operation\>500ml and need for blood transfusion
7. participate in the other clinical trial 3 months before the enrollment
8. no suitable to participate in this experiment