cyrilzakka/clinical-trials huggingface dataset:
Study of LY3039478 in Healthy Participants

The study involves one dose of LY3039478 given by mouth followed by an intravenous infusion (IV) (via a tube linked to a small needle in the vein) of LY3039478. The results of this study will help to answer the following research questions:

* How much LY3039478 gets into the blood stream when given by mouth as a capsule compared to when given by an IV
* How long it takes the body to remove the study drug
* The safety of LY3039478 and any side effects that might be associated with it

Participation in the study is expected to last up to 7 weeks. There will be screening, a single study period, and a follow-up.


Eligibility Criteria:
Inclusion Criteria:

- Have a body mass index (BMI) of 18.5 to 32.0 kilogram per meter square (kg/m²) inclusive

Exclusion Criteria:

- Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product

• Have known allergies to LY3039478, related compounds or any components of the formulation, or history of significant atopy in the opinion of the investigator
Evaluating Public Health Interventions to Improve COVID-19 Testing Among Underserved Populations

The COVID-19 pandemic has disproportionately affected people from underserved and vulnerable populations such as low-income/uninsured, unhoused, and immigrant communities. These populations in the US are at a higher risk of acquiring COVID-19 because of poverty, type of occupation, greater use of public transit, living in multigenerational housing, lack of access to quality healthcare, and more. Despite greater risk of being infected and dying of COVID-19, those in disadvantaged communities are less likely to get tested. The investigators are collaborating with community partners in Cumberland County, Maine to implement a public health intervention focused on making COVID-19 testing more accessible to underserved populations. The intervention includes a one-time in-person training on how to take an at-home COVID-19 test and then provision of at-home COVID-19 testing kits to make testing more accessible. Five testing kits are provided at the time of training and then provided every two months for a year, for a total of 35 testing kits.

In this study, the investigators will evaluate the impact of the at-home testing kit intervention on COVID-19 testing behavior, knowledge and attitudes. The investigators will accomplish this aim by following a community cohort, with a goal of recruiting 150 participants - 15 participants from each of our 10 population groups of interest (three groups that access different health services for low-income/uninsured, unhoused individuals, and six different immigrant groups). The investigators will administer surveys to the cohort participants every month over a 12 month period. Every month the survey will ask about testing behavior, and every other month the survey will also ask about knowledge and attitudes towards testing. In order to ensure access to COVID-19 tests, the cohort participants will be provided at-home testing kits throughout the course of the study. The primary outcome of interest is "recommended testing behavior," which is defined as taking a rapid COVID-19 test when experiencing symptoms of COVID-19 or after a close contact exposure.

The investigators hypothesize that knowledge about testing, favorable attitudes towards testing, and recommended testing behavior will increase as a result of participation in the study.


Eligibility Criteria:
Inclusion criteria:

* Individual accesses services from one of these three public health facilities - community free clinic, needle exchange program, or STD clinic
* Individual is currently unhoused or living in a Housing First development
* Individual immigrated to the US, primarily from one of these six country groups - Somalia, Angola, Iraq or Syria, Burundi or Rwanda, Democratic Republic of the Congo, or a country in Latin America

Exclusion criteria:

• Individual is \<18 years old
Autologous Adipose-derived Regenerative Cells Injection for Treatment of Radiation-induced Rectovaginal Fistula

A new strategy for treatment of late radiation damage is to develop methods aimed at stimulating the regenerative capabilities of irradiated tissues. Since the main pathogenetic mechanism of the development of late radiation damage is the death or damage of the replicative mechanism of stromal cells (SC), a justified approach can be considered as transplantation of intact SC. Currently, there is convincing evidence in the scientific literature that the injection of intact autologous SCs into the zone of fibrosis surrounding the chronic radiation ulcer leads to the healing of a wound defect.

An Initiative Clinical Trial. Introduction of autologous regenerative cells of adipose tissue for the treatment of post-irradiation vaginal-rectal fistula. It is assumed that patients will be included in the project within 12 months; the monitoring of each patient will last for 6 months; the total duration of the clinical part of the study will be 18 months; The total duration of the clinical trial including the preparatory phase and the writing of the report is about 24 months. It is assumed that at least 16 patients aged 20 to 75 years who have verified diagnosis of post-irradiation vaginal-rectal fistula will participate in this pilot project. The aims of the clinical trial are to preliminarily assess the safety, effectiveness and quality of life of patients after introducing autologous regenerative cells of adipose tissue for the treatment of post-irradiation vaginal-rectal fistula.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of radiation-induced rectovaginal fistula established at least six months after radiation therapy
* Absence of oncological disease relapse during whole observation period
* Absence of rectal and anal cancer
* Patient have read and signed informed consent

Exclusion Criteria:

* Contraindications for local/general anesthesia or a history of anesthetic medicines allergy
* Acute hemorrhoid or anal fissure
* Acute purulent paraproctitis
* Inflammatory colon diseases
* History of extensive posttraumatic or postoperative alterations which causes obstacles to follow protocol examination
* Chronic sub- or decompensated internal organs diseases
* Clinically significant laboratory tests abnormalities
* Conditions that limits patient compliance (dementia, psycho-neurological diseases, drug abuse, alcohol abuse etc.)
* Patients involved in other clinical trials or taking medications under research during last three months
* Cancer patients including postoperative chemo- or/and radiotherapy at least three months after surgery
* Patients with increased activated partial thromboplastin time level 1,8 times above normal
* Patients who take anticoagulants or took anticoagulants at least one month before including into trial
* Patients who take or took before investigation glycoprotein inhibitors IIB/IIIA
* Patients with history of taking medications that influence fatty tissue structure
A Study of MDL 28,574A in HIV-Infected Patients

To characterize the safety profile of MDL 28574A following both acute and subchronic dosing in HIV-positive patients. To determine the MTD of both acute and subchronic doses of this drug when administered as oral solution. To determine the pharmacokinetic profile of MDL 28574A and castanospermine (from which MDL 28574A is derived) following both acute and subchronic dosing.

In Part A of the study, patients receive a single oral dose of MDL 28574A on day 1 and are followed through day 7. In Part B, patients receive single daily doses of the drug on days 1 through 14 and are followed through day 21.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection.
* CD4 count \>= 500 cells/mm3.
* No evidence of AIDS.
* No antiretroviral therapy within 30 days prior to study entry.

NOTE:

* Presence of lymphadenopathy in two or more extrainguinal sites, at least 1 cm in diameter for 3 or more months, is permitted.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Clinically significant abnormalities on routine hematology (other than CD4 count and Western blot), serum chemistry, and urinalysis.
* Abnormal EKG.
* Positive stool guaiac.
* Abnormal medical history or physical exam including temperature, heart rate, and blood pressure.
* Clinically significant organ abnormality or disease.
* Positive urine drug screen for illicit drugs.
* Inability to comply with study procedures.

Concurrent Medication:

Excluded:

* Routine treatment with nonprescription medications.
* Treatment with other medications except with approval of the investigator.

Patients with the following prior conditions are excluded:

* Prior participation in this trial.
* Serious physical or mental illness within 1 year prior to study entry that would confound interpretation of data.

Prior Medication:

Excluded:

* Antiretroviral therapy within 30 days prior to study entry.
* Known medications that alter renal, hepatic, or hematologic/immunologic function (such as barbiturates, phenothiazines, cimetidine, and immunomodulators) within 14 days prior to study entry.
* Routine treatment with nonprescription medications within 3 days prior to study entry.

History of alcohol or drug abuse within the past year.
BEP Targeting Strategies in Ethiopia

The goal of this randomized effectiveness study is to evaluate the different targeting strategies for the delivery of balanced energy and protein (BEP) supplements among pregnant women in Addis Ababa, Ethiopia. The main goals of the study are to: 1) determine the effectiveness of two individual-based antenatal BEP targeting strategies for preventing adverse pregnancy outcomes; 2) compare the cost-effectiveness of the universal BEP provision with two individual-based targeting strategies for preventing adverse pregnancy outcomes; and 3) generate implementation evidence regarding the feasibility and acceptability of different antenatal BEP targeting strategies. Pregnant women will be enrolled during pregnancy, assigned to different strategies of BEP supplementation, and followed from pregnancy through six weeks postpartum to evaluate the impacts of different BEP targeting strategies on pregnancy, maternal, and child outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. pregnant women aged 18 to 49;
2. attending antenatal visits in one of the study health facilities;
3. with a gestational age of 24 weeks or less;
4. no known allergies to peanuts or soybeans;
5. having resided in the current location for at least 6 months;
6. intending to continue antenatal follow-up in the health facility;
7. intending to give birth and remain in the study area until six weeks after delivery; and
8. willing to take the BEP supplements for the entire duration of the pregnancy if eligible.

Exclusion Criteria:

* Not meeting all of the inclusion criteria above
A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine in Adults

The purpose of this study is to demonstrate the efficacy of GSK Biologicals' influenza vaccine (Fluarix™) administered intramuscularly in adults.


Eligibility Criteria:
Inclusion Criteria:

* A male or female age between 18 and 64 years at the time of the first vaccination.
* non-childbearing female

Exclusion Criteria:

* Use of non-registered products
* Pregnancy
* Hypersensitivity to a previous dose of influenza vaccine
* Acute disease at the time of enrolment/vaccination.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine
* Administration of any other influenza vaccine for the season 2006-2007
* Chronic disorders of the pulmonary or cardiovascular system, including asthma.
* Administration of immune-modifying drugs
* Administration of immunoglobulins and/or any blood products
* History of requiring regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, asthma or immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus)
Listening to Mom 2: Neural, Clinical and Language Outcomes

The purpose of this study is to examine whether playing recordings of a mother's voice to her infant while in the hospital nursery is an effective treatment for promoting healthy brain and language development in infants born preterm.

Children born preterm are at-risk for developmental language delays. Language problems in preterm children are thought to be related to neurobiological factors, including injuries to white matter structures of the brain and environmental factors, including decreased exposure to maternal speech in the hospital nursery. There is evidence to suggest that maternal speech input may be important for promoting healthy brain and language development.

Participants will be randomly assigned to one of two study groups. Each infant has a 50% chance of being assigned to the group that will listen to a recording of his/her mother's voice and a 50% chance of being assigned to the group that will not be played a voice recording. Mother's of participating infants will have her voice recorded as she reads a common children's storybook. Recordings will be played to infants each day until s/he is discharged from the hospital. To assess the long term impacts of this treatment, research participants and their families will be asked to return for follow-up visiting to perform an MRI brain scan and complete questionnaires and test that assess language development. Follow-up visit occur when infants are between 12 to 18 months of age.

Eligibility Criteria:
Inclusion Criteria:

* Infants born preterm at Stanford Children's Hospital between 24 0/7 - 31 6/7 weeks gestational age

Exclusion Criteria:

* Congenital anomalies
* Recognizable malformation syndromes
* Active seizure disorders
* History of Central Nervous System infections
* Hydrocephalus
* Major sensori-neural hearing loss
* Likelihood to be transferred from NICU to alternate care facility or home environment prior to 36 weeks PMA and/or brain MRI scan
* Intraventricular Hemorrhage Grades III-IV
* Cystic periventricular leukomalacia (PVL)
* Surgical treatment for necrotizing enterocolitis
* Small for gestational age (SGA) \<3 percentile and/or Intra-uterine growth restriction (IUGR) no head sparing
* Twin-to-twin transfusions
Drug Interaction Study of SAR302503 in Patients With Solid Tumor

Primary Objective:

* To assess the effect of 15-day repeated oral doses of 500 mg SAR302503 on the cytochrome P450 activity using a CYP probe cocktail (2C19, 2D6 and 3A4).
* To document pharmacokinetics of SAR302503 after repeated 500 mg oral daily doses.

Secondary Objectives:

* To assess the safety profile of 15-day repeated oral doses of 500 mg SAR302503 in Segment 1
* To characterize the safety and tolerability of 28-day consecutive doses of 500 mg SAR302503 in Segment 2
* To determine antitumor activity in Segment 2

The duration of the study for an individual patient will include a period to assess eligibility (screening period 21 days), followed by a treatment period of at least 15 days of study treatment, and an end-of-treatment visit at least 30 days following the last administration of study drug. However, treatment may continue if patients are receiving benefit and do not have unacceptable toxicity or meet study withdrawal criteria.

Eligibility Criteria:
Inclusion criteria :

* Histologically or cytologically confirmed advanced solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist
* Signed informed consent

Exclusion criteria:

* Less than 18 years of age.
* Limited physical functioning (as evaluated by the Eastern Cooperative Oncology Group (ECOG) scale)
* Inability to follow study requirements and schedule
* Treatment of cancer within 3 weeks of study, concurrent treatment in another clinical trial or with any other anti-cancer therapy
* Serious medical illness at same time of study and/or significantly abnormal lab reports
* Lack of pregnancy contraception (women of childbearing potential), pregnancy, or breast feeding.
* Men who partner with a woman of childbearing potential, unless they agree to use effective contraception while on study drug
* Continued toxic effects of prior chemotherapy
* Evidence of other concurrent active malignancy
* Other concurrent serious illness or medical condition
* Cardiac abnormalities include bradycardia, AV block or other conduction defect on ECG, and patients taking a beta blocker.
* Patients with Insulin-Dependent Diabetes Mellitus.
* Patients with known active (acute or chronic) hepatitis A, B, C, and hepatitis B and C carries. Prior history of chronic liver disease (e.g., chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, non-alcoholic steatohepatitis \[NASH\]).
* Inadequate organ function
* History of partial or total gastrectomy, or, if in the opinion of the investigator, have any other disorder that would inhibit absorption of oral medications.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
T790M Mutation on ctDNA in Patients With NSCLC After EGFR-TKI Failure

The purpose of this study is to compare the frequency and abundance of T790M mutation among the different Clinical modes of EGFR-TKI failure.

An observational, non-interventional, multi-central study of comparison of the frequency and abundance of T790M mutation using both amplification refractory mutation system (ARMS) and digital droplet PCR (ddPCR) methods among the different Clinical modes of non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) failure

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed stage IIIB/IV NSCLC.
* Investigator confirmed progression according RECIST 1.1 during EGFR-TKI treatment within 28 days of the enrollment
* Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting ≥ 6 months
* Patient must be able to comply with the protocol

Exclusion Criteria:

* Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 defined disease progression for more than 28 days while on previous EGFR-TKI treatment.
* Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.
* Histologically confirmed small cell lung cancer or other metastatic tumors
* Patient with no histologic or cytological diagnosis.
HER2 Positive CTC in Advanced Gastric Cancer

To identify the correlation of HER2 expression in tissue and peripheral CTC. to identify the HER2 expression in CTCs with clinical prognosis in advanced/metastatic gastric cancer.

Confirm the presence of CTCs are sensitive for monitoring response to chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Having signed informed consent
* Age≥ 18 years old
* HER2 overexpression confirmed by IHC or ISH (IHC 3+,or IHC2+/ISH+)
* Histologically confirmed gastric adenocarcinoma
* Unresectable recurrent or metastatic disease
* Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
* Measurable disease according to the RECIST criteria
* Karnofsky performance status ≥70
* Life expectancy of ≥3 month
* No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
* ALT and AST\<2.5 times ULN (≤5 times ULN in patients with liver metastases)
* Serum albumin level ≥3.0g/dL
* Serum AKP \< 2.5 times ULN
* Serum creatinine \<ULN, and CCr \< 60ml/min
* Bilirubin level \< 1.5 ULN
* WBC\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl

Exclusion Criteria:

* Previous systemic therapy for metastatic gastric cancer
* Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
* Allergic constitution or allergic history to protium biologic product or any investigating agents.
* Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
* Pregnancy or lactation period
* Other previous malignancy within 5 year, except non-melanoma skin cancer
* Legal incapacity
Cognitive Exercise Therapy Approach (BETY) in Parkinson's Disease

Considering the impact of motor and non-motor findings on movement problems in the disease management of people living with PD, biopsychosocial evaluation and treatment approaches are essential. However, there are not many studies investigating the impact of a biopsychosocial-based exercise approach on the biopsychosocial characteristics of individuals in PD management.

The Cognitive Exercise Therapy Approach (BETY), an innovative exercise approach based on the biopsychosocial model, has been developed with the participation of individuals with rheumatism in exercise sessions for many years. This study investigated the effects of the BETY, a supervised biopsychosocial model-based exercise intervention, on cognitive status, physical activity, balance, and biopsychosocial status in people living with PD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with idiopathic Parkinson's disease
* between 1-3 at home according to Modified Hoehn and Yahr Staging (MH\&Y)

Exclusion Criteria:

* Individuals who were diagnosed with dementia before Parkinson's diagnosis
* Had undergone deep brain stimulation
* Diagnosed with psychiatric or additional neurological diseases
* Had limited physical activity due to orthopedic problems or previous neurological diseases
* Had communication problems
Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in HIV-Infected Women

Data suggests that women taking drugs to treat human immunodeficiency virus (HIV) have higher amounts of drugs in their body compared with men taking the same dose of anti-HIV drugs. The reason for this higher drug exposure has not yet been determined. The primary purpose of this study is to examine whether a pharmacokinetics (factors that determine the amount of drug in the body) of anti-HIV drugs change during different phases of the menstrual cycle in women and ultimately result in higher amounts of drug in the body compared with men. In other words, we plan to examine whether changes in sex hormones throughout the menstrual cycle affect the amount of anti-HIV drugs in HIV infected women. The antiretroviral drugs atazanavir, ritonavir, tenofovir and emtricitabine will be studied.


Eligibility Criteria:
Inclusion Criteria:

* HIV positive females between 21-40 years of age.
* Subjects must be receiving anti-HIV regimen consisting of tenofovir, emtricitabine, atazanavir, and ritonavir for a minimum of 4 weeks prior to the study.
* Subjects must have regular menstrual cycle (period), define at least 10 cycles a year, occurring approximately every 28 days+/- 4 days and cycle length varying by not more than 7 days.

Exclusion Criteria:

* Subjects can not be breast feeding, pregnant, or taking oral contraceptives (birth control pills) for at least 3 months prior to the study.
* Subjects may not have the intrauterine device (IUD), Mirena, in place to prevent pregnancy.