cyrilzakka/clinical-trials huggingface dataset:
Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients

The purpose of this study is to evaluate the efficacy and safety of Nintedanib with EGFR-TKI in participants with advanced EGFR-TKI-resistant non-small cell lung cancer

The efficacy of the regimen is evaluated by participants' progression-free survival and overall survival.

Nintedanib is a medication that blocks endothelial cells in tumor microenvironments and is effective in delaying tumor progression. Nintedanib is also a drug approved for idiopathic pulmonary fibrosis in the clinic.

The participants will take 1 nintedanib tablet after a meal twice per day with a twelve-hour interval. EGFR TKI-gefitinib, erlotinib, afatinib, or osimertinib will be taken 1 tablet once per day during each treatment cycle. The treatment cycle in this study is 30 days.

In this study, the participants will have a physical exam in 6 weeks and 12 weeks after the initiation of the treatment. In the 6 weeks of the study, the participants will have blood tests and a CT scan. About 5cc of blood will be collected each time. In addition, the participant's tumor will be measured by a CT scan every 12 weeks.

If the participants develop any unacceptable symptoms or changes in liver function tests, the participants' treatment may be delayed and/or the dose decreased until the symptoms are disappeared. It may even be necessary to stop your treatment. The doctor will inform the participant of any changes in the participants' treatment schedule or in the doses of medication after he/she evaluates the participants in the clinic.

After treatment ends, the participants will have a follow-up visit at the clinic. At this visit, the participants will have a complete physical exam, including blood (about 5cc) tests and CT scan to measure the size of the tumors.

This is an investigational study. Up to 20 participants will take part in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Participants between 20 to 70 years old, are pathologically confirmed advanced (stage III and IV) non-small cell lung cancer.
2. Positive EGFR mutations are diagenesis.
3. Participants with histologically/cytologically confirmed locally advanced or metastatic adenocarcinoma subtype NSCLC after the failure of first-line EGFR tyrosine kinase inhibitors- gefitinib, erlotinib, afatinib, or osimertinib.
4. Participants must have adequate hepatic, renal, and bone marrow function

Exclusion Criteria:

1. Participants previously received first-line EGFR tyrosine kinase inhibitor with serious side effects.
2. Participants have known hypertension, and chronic liver and gastrointestinal disease.
3. Participants have known brain metastasis.
4. Female participants who are pregnant or breast-feeding
5. Participants have a known diagnosis of negative nPKCδ expression by immunohistochemistry (IHC).
A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of BI 1810631 in the Blood

The main objective of this trial is to investigate the effect of multiple oral doses of the strong CYP3A inducer carbamazepine on the pharmacokinetics of a single dose of BI 1810631 in plasma.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG, the neurological examination, or the skin inspection) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Further exclusion criteria apply
Yoga for Persons With Severe Visual Impairment

This study aims to provide novel information on the feasibility of yoga interventions for secondary symptoms related to severe vision loss, such as sleep disturbances, negative mood states, fall risk and balance. This information will be important for determining safe, cost-effective and reliable practices for the benefits of yoga as an alternative means for improved health and well-being. A yoga intervention that is integrative and evidence-based will benefit the blind population through effective treatments and prevention of secondary symptoms as well as serve to inform rehabilitation specialists, educators, and clinicians in the future.

This study aims to provide novel information on the feasibility of yoga interventions for secondary symptoms related to severe vision loss, such as sleep disturbances, negative mood states, fall risk and balance. This information will be important for determining safe, cost-effective and reliable practices for the benefits of yoga as an alternative means for improved health and well-being. A yoga intervention that is integrative and evidence-based will benefit the blind population through effective treatments and prevention of secondary symptoms as well as serve to inform rehabilitation specialists, educators, and clinicians in the future.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* Legal blindness (visual acuity worse than 20/200 but better than no/bare light perception, and/or visual field less than 20º, in the better eye)
* Any ocular disease diagnosis that is expected to remain relatively stable throughout a 3-6 month period
* Being healthy to the extent that participation yoga therapy would not exacerbate any existing disease conditions;
* Willingness to participate on a weekly basis for the 12-week intervention;
* Moderate to severe sleep disturbances, defined as ratings of 5 or greater on the PSQI

Exclusion Criteria:

* Significant changes to vision within the most recent 3-month period
* Inability to understand study procedures or communicate responses to visual stimuli in a consistent manner
* Clinically diagnosed or clinically significant sleep disorder (e.g., sleep apnea) or a medical or psychiatric condition (e.g., chronic pain) responsible for sleep complaints;
* Use of prescription sleep medication more than once a week for duration of the study;
* Use of other psychotropic medication;
* Current recipient of sleep disorder treatment;
* Consumption of more than 2-3 alcoholic beverages per day
* Smoking more than 10 cigarettes per day;
Registry of Acute Coronary Syndromes in the Lazio Region of Italy

The NET-SCA Registry has been designed to document and evaluate the clinical epidemiology and current management of Acute Coronary Syndromes in the Lazio Region of Italy.

Lazio is a region of central Italy with a resident population of about 5,600,000. The NET-SCA Registry has been designed to document and evaluate the current presentation and clinical management of Acute Coronary Syndromes (ACS) in this specific regional area of Italy. All consecutive patients with ACS admitted to CCU of 15 hospitals of the Lazio Region will be included in the registry.

Eligibility Criteria:
Inclusion Criteria:

* admission to CCU for ACS

Exclusion Criteria:

* ACS due to major extracardiac causes (i.e. traumatic)
Managing Neovascular (Known as "Wet") Age-related Macular Degeneration Over 2 Years Using Different Treatment Schedules of 2 mg Intravitreal Aflibercept Injected in the Eye

This study aims to evaluate the optimal use, efficacy, and safety of a Treat-and-Extend regimen with aflibercept in subjects with nAMD.

The T\&E dosing regimen for nAMD has emerged as a preferred regimen for many treating physicians aiming at maximizing outcomes by proactively treating the subject at each visit and by extending the treatment interval (if extension criteria are met), thus limiting visits, monitoring, and injections.

To this day, there is limited evidence available addressing the question of what are useful intervals for treating and monitoring, how do they differ among subjects, and how are retreatment criteria applied to achieve long-term desirable outcomes in real-life practice. This study is designed to evaluate the optimal use, efficacy, and safety of the T\&E regimen with intravitreal aflibercept in subjects with nAMD.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 50 years of age.
* Active primary subfoveal CNV lesions secondary to nAMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye. Patients with polypoidal choroidal vasculopathy or retinal angiomatous proliferation are eligible to participate in the study, and their condition should be captured in the eCRF.
* ETDRS BCVA of 73 to 25 letters (20/40 to 20/320 Snellen equivalent) in the study eye.
* The area of CNV must occupy at least 50% of the total lesion.

Exclusion Criteria:

* Any prior ocular (in the study eye) or systemic treatment or surgery for nAMD, except dietary supplements or vitamins.
* Any prior or concomitant therapy with another investigational agent to treat nAMD in the study eye.
* Prior treatment with anti-VEGF agents as follows:
* Prior treatment with anti-VEGF therapy in the study eye is not allowed
* Prior treatment with anti-VEGF therapy in the fellow eye with an investigational agent (not approved, e.g. bevacizumab) within the last 3 months before the first dose in the study. Such treatment will also not be allowed during the study. Prior treatment with an approved anti-VEGF therapy in the fellow eye is allowed.
* Prior systemic anti-VEGF therapy, investigational or approved, within the last 3 months before the first dose in the study, and such treatment will not be allowed during the study.
* Total lesion size \>12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by FA in the study eye.
* Subretinal hemorrhages that are either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye. (If the blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV).
* Scar or fibrosis making up \>50% of the total lesion in the study eye.
* Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
* Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
Macrophage Polarization in Response to Macronutrient Intake in Healthy Humans: A Randomized Clinical Study

Macrophages can exhibit distinct phenotypes and functions in response to stimuli and can polarize into one of three distinct phenotypes: a pro-inflammatory (M1), an anti-inflammatory pro-tissue (M2) and metabolically-activated (MMe) macrophage phenotypes. Thirty-six healthy volunteers were recruited and randomized into one of three macronutrient intake groups (glucose, lipids, proteins). This study measured the effects of macronutrient intake on the macrophage differentiation.

Thirty-six normal healthy adult volunteers of normal weight were recruited into the study. All were normotensive, had a normal lipid profile, normal renal and liver function tests, and were not on any medications. All subjects gave their written, informed consent. Institutional Review Board (IRB) of the Ministry of National Guard Health Affairs (MNGHA) approved the study protocol. The 36 participants were randomly assigned by the primary investigator (PI) following simple randomization procedure (computerized random numbers) to three different groups, each received one type of macronutrient (Glucose, whey proteins or lipids). Following an overnight fast, a baseline blood sample was taken. Subjects were then given either 300 calories of glucose (NERL Trutol 75) or lipids (90 grams whipping cream, 31.5 grams fat, 1.7 grams protein and 2.25 grams carbohydrate) or protein (Isopure unflavored Whey proteins isolate (WPI) powder containing 26 grams per serving of 100% WPI, stripped of fat, carbs, fillers, sugars and lactose) solution over 5 minutes. Cream and protein preparations were diluted with water up to 300 mL solutions. Further blood samples were obtained at 1, 2 and 3 hours after the macronutrient intake. Subjects, either one week before or after the macronutrient challenge, were given 300 mL of water to drink in the fasting state. Blood samples were obtained before and at 1, 2 and 3 h after water intake as well. Each subject served as his/her own control and was randomly given macronutrient or water intake.

Eligibility Criteria:
Inclusion Criteria:

* Normal weight (BMI 18.5-25)
* Healthy adults evident by: physical examination, normal lipid profile, normal renal and liver function tests.

Exclusion Criteria:

* Renal disease
* Hepatic disease
* Cardiovascular disease
* Using multivitamins
* Using NSAIDS
Study on Antibody Persistence and Immune Memory of Inactivated COVID-19 Vaccine

The study describe 1 year durability of humoral and cellular immune responses in 150 individuals who received COVID-19 inactivated vaccine. all participants were recruited aged between 18 and 59 years old. Every participant was familiarized with the aim of the study and asked to sign an informed consent agreement, and be required blood sampling at the day 0 of first dose vaccine and 1 month, 3 months, 6 months and 12 months after fully vaccination separately. From every sample, 10 ml, 10 ml, and 5 ml were dispensed in three vacuum blood collection tubes. Peripheral blood lymphocytes cell (PBMC) were isolated with the two 10 ml samples contained heparin to detect immune memory cells and cytokines. RBD-IgG and neutralizing antibody be detected by 5ml sample from separating gel vacuum tubes. every individual conducted a detailed analysis comparing neutralizing antibody, TEM, TCM , and report on the cellular and humoral immunity 1 year after accept COVID-19 vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Working at the CDC
* Between the ages of 18 and 59
* Healthy
* Not vaccinated with COVID-19 vaccine
* Agreed to take a blood sample

Exclusion Criteria:

* who cannot take the COVID-19 vaccine due to some personal reasons
* history of SARS-CoV, SARS-CoV-2, or Middle East respiratory syndrome infection
* high-risk epidemiology history within 14 days before enrolment (eg, travel or residence history in communities with case reports, or contact history with someone infected with SARS-CoV-2)
* axillary temperature of more than 37·0℃
* history of allergy to any vaccine component.
Individualizing tDCS Dose

Transcranial direct current stimulation (tDCS) is a noninvasive method of modulating brain activity and has therapeutic potential in many neurological and psychiatric conditions. However, unlike every current FDA-approved form of brain stimulation, there is no method of individualizing stimulation dose. In this study, a method of individualizing tDCS dose on behavioral outcomes and whether this could help to improve the consistency and magnitude of the stimulation effects will be tested.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers or chronic stroke participants (at least 6 months prior to the study)
* No history of epilepsy
* No metal in the body
* No contraindications for TMS or MRI scanning
* Right handed
* Ability to find motor hotspot and acquire motor evoked potentials

Exclusion Criteria:

* Metal in the body
* History of epilepsy or claustrophobia
* Alcohol or substance abuse or dependence
* Current treatment for any psychiatric conditions (pharmacological or otherwise)
* Pregnant or actively breastfeeding
Efficacy of Memantine add-on in the Treatment of Bipolar Disorder (Type I) Nonresponders or Partial Responders Patients

The main goal of this study is evaluate the efficacy of memantine association on the treatment with a previous combination of two drugs, including quetiapine with lithium or quetiapine with aripiprazole in young patients with bipolar disorder type 1 non-responders or partial responders to that combination of drugs and evaluate the impact of this association at the cognitive functioning of the patients.

Current evidence suggests that deregulation of brain glutamatergic neurotransmission is involved in the pathophysiology of bipolar disorder and that drugs that intervene in this transmission may be therapeutic weapons in addressing the symptoms and cognitive deficits of this pathology. Among these drugs, particularly memantine is a strong candidate in view of their efficacy in antagonizing N-methyl-D-aspartate (NMDA) receptors, and their good safety and tolerability profile. The principal aim of this study is to evaluate the efficacy of memantine association with treatment with a combination of two drugs, including quetiapine with lithium and quetiapine with aripiprazole in young patients with bipolar disorder type 1 non-responders or partial responders and evaluate the impact of this association cognitive functioning of patients. An experimental study, randomized, double-blind, bipolar patients with type 1, of both sexes, aged 18 to 40, ambulatory or hospitalized, at any stage of the disease, seeking treatment in the Mood Disorders Program (GRUDA) of Institute os Psychiatry (IPq) of Sao Paulo University (FMUSP). Patients will come from ARIQUELI Project (Missio, G. et al, 2013 submitted Trial registration - ClinicalTrials.gov Identifier:. NCT01710163).

The study will be conducted in two stages: I - initial administration of memantine or placebo for 8 weeks; II - Maintenance administration for more 4 months.

Eligibility Criteria:
* INCLUSION CRITERIA:

  1) Partial responders or non-responders (HAM-D score \> 7 points and/or YMRS \> 9 points) in the ARIQUELI Study (after quetiapine + lithium or quetiapine + aripiprazole combination).
* EXCLUSION CRITERIA:

  1. Patients with Schizophrenia, Schizoaffective Disorder or Mental Retardation (Intellectual Quotient Total less than 90);
  2. Patients with severe, unstable diseases, including kidney disease, gastroenterology, respiratory, cardiovascular, endocrine, neurological, immunological or haematological;
  3. Hypo or hyperthyroidism uncorrected;
  4. Angle-closure glaucoma;
  5. Changes in blood coagulation or use of regular anticoagulants;
  6. Patients with serious risk of suicide (according to clinical criteria and / or score\> = 4 in the HAM-D item suicide) may participate in the study only in inpatients;
Alvimopan For The Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one of 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.


Eligibility Criteria:
Inclusion criteria:

* Consented to participate in this study.
* Taking opioid therapy for persistent non-cancer pain.
* Has bowel dysfunction mainly due to opioids.
* Has bowel dysfunction since starting opioids as defined by infrequent bowel movements and additional bowel-related symptoms.
* Willing to discontinue laxative therapy (will be provided study-specific standardized laxative if needed).
* Willing to report daily bowel symptoms.

Exclusion criteria:

* Pregnant, lactating, or planning to become pregnant.
* Not ambulatory.
* Participated in another trial with an investigational drug in the past 30 days.
* Taking opioids for the management of drug addiction or cancer-related pain.
* Severe constipation whereby the subject is at immediate risk of developing serious complications of constipation.
* Gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.
* HIV-infected, has active hepatitis, or has ever been infected with hepatitis C.
Sleep Disturbances as a Non-traditional Risk Factor in CKD-Actigraphy

To test if usual at home night time sleep duration as measured with activity monitors and questionnaires will predict changes in kidney function as measured by kidney filtration rate and of cardiovascular function as measured by C-reactive protein in the blood. The study will explore the role of decreased sleep time or decreased sleep quality as a non-traditional risk factor for the progression of CKD and for the development of cardiovascular disease in CKD.


Eligibility Criteria:
Inclusion Criteria:

* Mild to Moderate CKD
* Healthy controls age and gender matched to CKD subjects
* Regular bedtimes of at least 6h/night, sedentary lifestyle

Exclusion Criteria:

* Diabetes
* Current or previous dialysis for more than 1 month
* Uncontrolled hypertension
* Heart failure
* Liver disease
* HIV
* Hemoglobin \< 10.5 g/dl
* Treatment with EProcrit, Epogen, or Aranesp
* Bone or organ transplant,
* Use of immunosuppressive drugs within past 6 months
* Current oral contraceptive use
* Current pregnancy
* Chemotherapy for malignancy within past 2 years