cyrilzakka/clinical-trials huggingface dataset:
Study of Bevacizumab and Erlotinib in Patients With Advanced Non-small Cell Lung Cancer

This study will evaluate the combination of bevacizumab and erlotinib in elderly patients with advanced non-small cell lung cancer.

There is no definite evidence of a superior therapy for advanced non-small cell lung cancer in elderly patients. With the exception of one known study, single agent erlotinib has not been studied exclusively in the elderly and the combination of erlotinib and bevacizumab has never been studied exclusively in the treatment naive elderly. This is an important population that needs less toxic therapies.

Eligibility Criteria:
Inclusion Criteria:

* Cytologically or histologic confirmed non-small cell lung cancer, stage IIIB or IV or recurrent after primary surgery or radiotherapy.
* ECOG PS 0-1
* 70 years of age or older
* Must have measurable disease
* ANC \> 1500, platelets \> 100,000
* Total bilirubin \</= 1.5, SGOT \* SGPT \< 5 x ULN
* Able and willing to swallow and absorb oral medication
* Able and willing to sign consent
* Request archival diagnostic tissue for EGFR expression but not required

Exclusion Criteria:

* Proteinuria as demonstrated by UPC ratio \>/= 1.0
* Prior treatment with an investigational or marketed inhibitor of the EGFR pathway or anti-angiogenesis agent (includes thalidomide)
* Prior treatment for advanced stage disease, with the exception of surgery or radiation (no systemic)
* History of gross hemoptysis within 1 month of enrollment unless treated with surgery or radiation
* Evidence of bleeding diathesis or coagulopathy or other serious/acute internal bleeding within 6 months of enrollment.
* Current, ongoing treatment with full dose warfarin or equivalent
* Current(within 10 days)use of aspirin (\> 325mg/day) or other NSAID with antiplatelet activity
* History of hemorrhagic or thrombotic stoke, TIA, or other CNS bleeding w/in last 6 months. Clinically significant PVD
* Known CNS disease except for treated brain mets.
* Squamous cell histology
* Blood pressure \> 150/100 that cannot be ameliorated with standard anti-hypertensives
* History of hypertensive crisis or hypertensive encephalopathy
* NYHA grade II or \> CHF
* History of MI within 6 months of enrollment
* Major surgery, open biopsy, significant trauma within 28 days of enrollment
* Pregnancy, lactation
* Abdominal or other fistula, abcess, perforation
To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis

The aim of this trial is to assess the efficacy of NYC-0462 Ointment in the Treatment of Plaque Psoriasis.Treatment medication will be administered as follows: A thin layer of study product will be applied to the affected skin, excluding the face, once daily, at approximately the same time daily.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stable, symptomatic plaque psoriasis
* Good health with the exception of psoriasis
* % BSA and plaque elevation requirements

Exclusion Criteria:

* Subjects who are pregnant, nursing or planning a pregnancy within the study participation period.
* Subjects who have any systemic or dermatological disorders with the exception of psoriasis
SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast)

The study is a nationwide, multicenter single-arm phase 2 study. The current phase 2 study investigates the efficacy of the combination of fulvestrant and alpelisib directly after progression on fulvestrant (either in first or second line, with or without previous use of CDK4/6-inhibitor) in patients with HR+ HER2- advanced breast cancer with PIK3CA mutated tumors.

All eligible patients must have progressive disease on fulvestrant as latest treatment line.

Previous treatment with a CDK4/6 inhibitor in first or second line is obligatory. After progressive disease is confirmed, it is important to continue fulvestrant (without CDK4/6 inhibition) during the screening period awaiting study enrollment.

After study enrollment all participants will be treated with alpelisib and fulvestrant beyond progression. Follow-up time will be until progression or death or until a different oncolytic treatment has started (in case no progressive disease during previous fulvestrant and alpelisib treatment has been documented).

Should participants discontinue due to reasons other than progression or death (e.g. toxicity), then they should still be evaluated for disease progression every 8 weeks as per protocol until progression, unless they do not wish to proceed with these screenings, or receive a different oncolytic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult women and men (≥ 18 years of age) with proven diagnosis of adenocarcino-ma of the breast withlocoregional recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent andfor whom chemotherapy is not clinically indicated
* Estrogen receptor (ER) expression \>10% and/or progesterone receptor (PR) expression \>10% breast cancerbased on local la-boratory results. Tumor must be HER2- as defined by ASCO-CAP guidelines
* Patients must have progressed on fulvestrant as a preceding treatment line (as first or second line therapy)
* Previous treatment with a CDK4/6 inhibitor in the advanced setting
* The presence of an activating PIK3CA mutation
* Evaluable disease\* as defined per RECIST v.1.1
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

Exclusion Criteria:

* Patients with advanced, symptomatic, visceral spread, who are at risk of life-threatening complications in theshort term
* Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningealdisease as indicated by clinical symptoms, cerebral edema, and/or progressive growth
* Prior treatment with a PI3K /AKT/mTOR inhibitor
* Type 1 diabetes or uncontrolled type 2 diabetes (Hba1C \> 68 mmol/mol)
* Clinically significant, uncontrolled heart disease and/or recent cardiac events
Residual Plasma Concentration of Sorafenib and Adverse Events in CHC

To date, Sorafenib is the only drug therapy to have demonstrated a benefit in overall survival in patients with advanced or metastatic hepatocellular carcinoma. However, this treatment causes many adverse effects that may limit its prescription.

Under these conditions, predicting and therefore potentially preventing the adverse effects of sorafenib is a major issue in the management of patients with hepatocellular carcinoma treated with this drug.

Currently, there is little data available on the correlation between the pharmacokinetics of sorafenib and the side effects of this drug in patients treated for hepatocellular carcinoma.

Investigators propose an observational cohort study evaluating the correlation between residual plasma concentration of sorafenib and the risk of severe adverse effects (grades 3-5) in treatment in patients treated for hepatocellular carcinoma on cirrhosis.

This study should include 60 patients over an expected duration of 12 months. The aim of this work is to determine whether there is a correlation between the residual plasma concentration of sorafenib and the occurrence of severe adverse effects (grades 3-5) at treatment in patients treated for hepatocellular carcinoma on cirrhosis as well as potential influence of the etiology of cirrhosis on this relationship. The ultimate ambition is to be able to anticipate and thus prevent these adverse effects in order to increase the safety of the drug and potentially its effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Major Patients.
* Patients with hepatocellular carcinoma on cirrhosis.
* Patients treated for the first time with sorafenib for hepatocellular carcinoma.
* Informed information about the study.

Exclusion Criteria:

* Patients with contraindications to sorafenib.
* Pregnant or lactating woman
Susceptibility to Chronic Post-Traumatic Extremity Pain

The association between the COMT haplotypes and the presence or absence of CPSP or CRPS will be assessed stratifying the patients based on the individual categories of trauma or elective surgery.

This will be a prospective association study in which we will recruit patients who have experienced single extremity trauma, or who have scheduled elective surgery on a single extremity. HRQoL will be determined at recruitment. We will identify their haplotypes and genotypes for 4 linked SNPs in the coding region of COMT as described by Diatchenko \[2\]. Patients will receive follow-up at 3 and 6 months following trauma or surgery. Individuals who report either neuropathic pain or a reduced HRQoL score will be more closely examined, in order to identify CPSP or CRPS. Statistical analyses will be performed to determine whether haplotypes are associated with the development of either condition, and to determine the strength of this association.

Eligibility Criteria:
Inclusion Criteria:

* Provide written Informed Consent prior to participation in the study
* Be at lease 18, but not more than 80 years of age
* Have the ability to read and understand the study procedures and the use of the pain scales and have the ability to communicate meaningfully with the Study Investigator and staff.
* Be free of other physical, mental, or medical conditions, which, in the opinion of the Investigator, makes Study participation inadvisable
* Is scheduled to undergo open or arthroscopic shoulder surgery
* If the subject is a female of childbearing potential, have a negative pregnancy test on the day of surgery.

Exclusion Criteria:

- Has significant medical disease(s), laboratory abnormalities or conditions(s) that in the Investigator's judgment could compromise the Subject's welfare, ability to communicate with the Study staff, complete Study activities, or would otherwise contraindicate Study participation
Interoceptive Nutritional Processing in Healthy Participants and Patients With Binge-Eating-Disorder

Binge-Eating-Disorder (BED) is a common eating disorder characterized by recurring episodes of uncontrollable eating. The underlying neural mechanisms are largely unknown. However, dysfunctional hormonal satiety signaling as well as dysfunctional neural processing of food cues are discussed as possible casual factors in the development and maintenance of this disorder. Additional research is needed to specify the exact contribution of these observations and how they interact with each other. Accordingly, the current study plans to investigate metabolic gut-brain signaling to better understand the underlying causes of abnormal eating behavior. To this end, 25 healthy normal weight control participants as well as 25 patients with BED will be recruited. The responsivity of the hypothalamus (i.e., the core region of homeostatic control) and its interaction with the mesocorticolimbic reward system will be assessed by applying a single-blind, randomized, crossover design of intravenous infusion of glucose or NaCl. This approach allows the study of gut-brain signaling to the hypothalamus and the reward system by controlling for sensory aspects of food intake (sight, smell, and taste). The interaction between the hypothalamus and the mesocorticolimbic reward system will be investigated using an effective connectivity analysis. FMRI with high spatial resolution and with an optimized protocol for the investigation of the hypothalamus and the mesocorticolimbic reward system will be employed. A better understanding of the underlying psychobiological mechanisms of BED is a fundamental requirement for the development of improved prevention and treatment strategies


Eligibility Criteria:
Inclusion criteria:

1. patients that meet the diagnostic criteria for BED
2. Over age of 18 years.
3. Right-handedness.
4. Normal or corrected-to-normal vision.
5. No other lifetime or current medical illness that could potentially affect appetite or body weight

Exclusion criteria (for all participants):

1. History of head injury or surgery
2. History of neurological disorder
3. Severe psychiatric comorbidity (psychosis, bipolar disorder, substance abuse)
4. Smoking
5. Borderline personality disorder
6. Current psychotropic medication
7. Inability to undergo fMRI scan (e.g. metallic implants, claustrophobia, pacemakers)
8. Pregnancy
Phase I Study of OSI-930 and Erlotinib in Cancer Tumors

This is a Phase I, dose escalation, safety study of OSI-930 and Erlotinib in cancer tumors.

Multicenter, open-label, phase 1, dose escalation study to determine the maximum tolerated dose of OSI-930 and Erlotinib.

Patients may continue to receive OSI-930 and Erlotinib until one of the following occurs: disease progression, adverse event requiring withdrawal, failure to recover from toxicity despite a 14-day dosing interruption, medical or ethical reasons, patient request, or patient death.

Eligibility Criteria:
Inclusion Criteria:

* Histology or cytologically documented malignancy that is now advanced and/or metastatic and refractory to established forms of therapy or for which no effective therapy exists
* Age greater than or equal to 18 years
* ECOG PS 0-2
* ANC greater than or equal to 1.5 x 10\^9/L
* Bilirubin less than or equal to 1.5 x upper limit of normal (ULN), AST and ALT less than or equal to 2.5 x ULN
* Creatinine less than or equal to 1.5 ULN
* Predicted life expectancy greater than or equal to 12 weeks
* Prior chemotherapy is permitted provided that a minimum of 3 weeks has elapsed
* Prior tyrosine kinase inhibitor therapy is permitted
* Patients must have recovered from any treatment-related toxicities (with some exceptions) prior to registration
* Prior hormonal therapy is permitted provided it is discontinued prior to registration (with the exception of prostate cancer patients who have been on hormone therapy for at least 3 months)
* Prior radiation therapy is permitted provided that it did not exceed 25% of bone marrow reserve and patients have recovered from the toxic effects (a minimum of 21 days must have elapsed unless the radiotherapy was palliative and nonmyelosuppressive)
* Prior surgery is permitted, provided that wound healing has occurred prior to registration
* Patients must use proactive effective contraceptive measures throughout the study
* Provide written informed consent
* Accessible for repeat dosing and follow-up
* Adequate hematopoietic, hepatic, and renal function

Exclusion Criteria:

* Significant cardiac disease unless well controlled
* Current or former smokers, unless patients stopped smoking greater than 3 months prior to registration
* Active or uncontrolled infections of serious illnesses or medical conditions that could interfere with participation
* History of unacceptable toxicity with previous EGFR inhibitor therapy
* History of any psychiatric condition that might impair the patient's ability to provide informed consent or participate
* Use of CYP3A4 inducers/inhibitors during the 14 days prior to first dose
* Pregnant or breast-feeding females
* Symptomatic brain metastases which are not stable, require steroids, are potentially life-threatening or that have required radiation within the last 28 days
* History of allergic reaction attributed to a similar compound as study drug
* GI abnormalities including inability to take oral medications, required for IV alimentation
* Clinically significant ophthalmologic abnormalities
A Study of LY3154207 on Sleep in Healthy Male Participants

This study will evaluate the effect of single doses of LY3154207 on the amount of time it takes for healthy sleep-deprived men to fall asleep. The study will also estimate how much LY3154207 gets into the blood stream and how long it takes the body to remove it. Information about any side effects that occur will be collected. Each participant will complete four study periods, which will last a total of about 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy males 18 years of age or older who have given consent and are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
* Have a regular sleep pattern with routine time spent in bed between 6.5 hours and 9 hours each night

Exclusion Criteria:

* Are shift workers who shifted work within 14 days prior to screening or plan to during the study
* Have a known sleep disorder or history of a sleep disorder
* Have traveled 2 time zones or more within 7 days prior to screening or plan to during the study
* Regularly take naps during the day
* Are hearing impaired
Human Milk Fortification in Very Low Birth Neonates

The purpose of this study to find out how safely we can add extra nutrients to human milk at different feeding volume.

Very low birth weight babies (weight less than three pounds and three ounces) are extremely fragile and lacking important nutrition due to premature birth. They need enough calories for catch-up growth. Giving adequate nutrition is very important for their growth and development. Human milk is the best food, however it is not enough to provide all the required calories and nutrients for catch up growth and maintain adequate strength of the bones (bone mineralization). For premature babies, extra nutrients (human milk fortifier) are usually added to the human milk to provide adequate nutrition. These extra nutrients will be derived from cow's milk. Currently, a practice of fortifying human milk varies. There is no clear information when to start adding extra nutrients to human milk.

Eligibility Criteria:
Inclusion Criteria:

* Very low birth weight infants who receive human milk (mother's milk or banked donor human milk).

Exclusion Criteria:

* Major congenital anomalies such as cardiac defect, neural tube defect, chromosomal abnormality and gastrointestinal defect.
* Died or extended to die within 48 hours of life
Chronic Kidney Disease - REAL Life Study in Alsace

Chronic kidney disease (CKD) is a public health problem and affects about 10% of the world's adult population with a constantly increasing incidence. The approach to CKD in France is centered on access to replacement therapy (dialysis, renal transplantation), the cost of which amounts to 4 billion euros (data from the REIN registry).

Real-life data are essential to specify the characteristics of patients with chronic kidney disease and the factors associated with the evolution of CKD and the occurrence of complications in order to improve the management of CKD before the suppletion stage.

Since October 2019, CKD at the severe stage (stage 4) and at the non-dialysis end stage (stage 5) is subject to an annual flat fee (Article L. 162-22-6-2 of the Social Security Code). The reimbursement of these lump sums by the health insurance is subject to the collection and transmission of certain medical data by the establishments.


Eligibility Criteria:
Inclusion criteria:

* Major subject (≥18 years)
* Subject included in the MRC package (GFR \<30 ml/min/1.73 m2)
* Subject who has not expressed opposition, after information, to the reuse of his or her data for the purpose of this research

Exclusion criteria:

- Subject having expressed his opposition to participate in the study
Zenith® Dissection Clinical Trial

The Zenith® Dissection Clinical Trial is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection.


Eligibility Criteria:
Exclusion Criteria:

1. Age \< 18 years;
2. Other medical condition (e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the Clinical Investigation Plan, confound the results, or is associated with limited life expectancy (i.e., less than 2 years);
3. Pregnant, breast-feeding, or planning on becoming pregnant within 60 months;
4. Unwilling or unable to comply with the follow-up schedule;
5. Inability or refusal to give informed consent;
6. Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.);
7. Additional medical restrictions as specified in the Clinical Investigation Plan; or
8. Additional anatomical restrictions as specified in the Clinical Investigation Plan.
Safety and Effectiveness of Oral Anticoagulants in Patients With Non-valvular Atrial Fibrillation

An anticoagulation therapy is a critical treatment to prevent thromboembolism in non-valvular AF (NVAF) patients. Warfarin, a vitamin K antagonist, is the first oral anticoagulant approved for the treatment for prevention of thromboembolism and it had long been the only oral anticoagulant until the first non-vitamin K antagonist oral anticoagulants (NOACs). However, its safety and effectiveness remains unknown in real-world clinical practice in Japan

An anticoagulation therapy is a critical treatment to prevent thromboembolism in non-valvular AF (NVAF) patients. Warfarin, a vitamin K antagonist, is the first oral anticoagulant approved for the treatment for prevention of thromboembolism and it had long been the only oral anticoagulant until the first non-vitamin K antagonist oral anticoagulants (NOACs). However, its safety and effectiveness remains unknown in real-world clinical practice in Japan. This study will evaluate the risk of stroke/SE as well as the risk of bleeding in the real world settings in Japan in patients with NVAF who initiated any of OACs (apixaban, dabigatran, edoxaban, rivaroxaban, or warfarin)

Eligibility Criteria:
Inclusion criteria

Patients must meet all of the following criteria to be eligible for the study:

1. Diagnosed with AF anytime in the baseline period or on the index date, also have definitive diagnosis of AF anytime in the baseline period, on the index date, or post-index period.
2. Prescribed one of the index OACs (apixaban, dabigatran, edoxaban, rivaroxaban or warfarin) on or after the day of AF diagnosis. The first observed prescription will be used to identify the patient's index date and treatment cohort
3. No use of the any OACs during the baseline period (the 180 days before the index date)
4. Age of 18 years or older on the index date.

Exclusion criteria

Patients meeting any of the following criteria will not be included in the study:

1. Having a diagnosis of valvular atrial fibrillation, post-operative atrial fibrillation, rheumatic atrial fibrillation or mechanical-valvular atrial fibrillation during the baseline and post-index period 2. Having a cardiac surgery procedure record during the baseline period 3. Having a joint replacement procedure record during the baseline period 4. Having a procedure of prosthetic heart valve during the baseline period 5. Having a diagnosis of venous thromboembolism during the baseline period 6. Female patients with pregnancy during the follow-up period 7. Patients prescribed "off-label" doses of OACs (per Japanese package insert of each OAC) or patients treated with OAC but in "off-label" or "contraindicated" manners.

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