cyrilzakka/clinical-trials huggingface dataset:
Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Non-Small Cell Lung Cancer

The study will evaluate the clinical activity of nivolumab in combination with 3 separate investigational agents, glesatinib, sitravatinib, or mocetinostat.

Glesatinib is an orally administered multi-targeted tyrosine kinase inhibitor (TKI) that primarily targets the Axl and Mesenchymal-Epithelial Transition (MET) receptors. Sitravatinib is an orally-available, potent small molecule inhibitor of a closely related spectrum of receptor tyrosine kinases (RTKs) including MET, Axl, MERTK, VEGFR family, PDGFR family, KIT, FLT3, Trk family, RET, DDR2 and selected Eph family members. Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. Nivolumab is a human IgG monoclonal antibody that binds to the programmed cell death-1(PD-1) receptor and blocks its interaction with programmed cell death ligand-1 (PD-L1) and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response including anti-tumor immune response. Combining an immunotherapeutic PD-L1 checkpoint inhibitor with an agent that has both immune modulatory and antitumor properties could enhance the antitumor efficacy observed with either agent alone.

The study will begin with a lead-in dose escalation evaluation of two dose levels of each investigational agent in combination with nivolumab. Following completion of the lead-in dose escalation, enrollment into the Phase 2 study will proceed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-small cell lung cancer.
* Prior treatment with a checkpoint inhibitor (as appropriate per cohort)
* Adequate bone marrow and organ function

Exclusion Criteria:

* Uncontrolled tumor in the brain
* Unacceptable toxicity with prior checkpoint inhibitor
* Impaired heart function
Evaluation of Physical Performance in Old Adults With Sarcopenic Obesity

The primary objectives of the present study are to estimate the sarcopenic proportion in a cohort of obese older subjects who have been hospitalized. The secondary objective is to individuate several clinical variables that differ between the sarcopenic obese patient and the not sarcopenic obese patient.

80 obese patients of both genders (BMI \> 35), with an age \> 60 years, hospitalized at the Hospital San Giuseppe, Istituto Auxologico Italiano, IRCCS, Piancavallo (VB) are selected. For each patient, the following information are collected at the time of admission:

* anthropometric parameters (height, weight, BMI, waist and hip circumference);
* body composition (free fat mass, fat mass), measured with impedance (BIA) and DEXA;
* hand strength measured with the hand grip test;
* explosive strength of lower limbs, measured with the stair climbing test;
* Senior Fitness Test (SFT), a battery of tests useful to estimate the fitness level in the elderly. SFT is a test that leads to measuring different physical parameters typical of daily activities: strength of upper and lower limbs, aerobic resistance, flexibility of lower and upper limbs, agility, and dynamic equilibrium. The measurements obtained make it possible to classify the skills as high function or low function.
* Physical performance test (PPT), which evaluates 7 physical capabilities areas of the subject to perform actions during daily life. The cut-off to determine the motor limitation condition is a score of ≤ 20 (out of 28 points).
* Questionnaire SF-12 (Short Form Health Survey), which leads to a multi-dimensional measuring of the life quality related to health. It is composed of 12 questions from which can be obtained two synthetic indices, one related to physical health and one related to mental health.
* Oswestry Disability Index questionnaire, elaborated to have information on how back problems, or leg problems, can influence physical abilities related to daily life.

The presence of sarcopenia is identified based on the European Working Group on Sarcopenia in Older People (EWGSOP2) (Cruz-Jentoft AJ et al. 2019) definition. The physical performance parameters is evaluated according to the age, sex, obesity grade, and presence of sarcopenic obesity.

Eligibility Criteria:
Inclusion Criteria:

* obese patients (BMI \> 35),
* both genders
* age \> 60 years
* hospitalization at San Giuseppe Hospital, Istituto Auxologico Italiano, IRCCS, Piancavallo (VB), Italy for a multidisciplinary 3-week body weight reduction program

Exclusion Criteria:

* obese patients with BMI \< 35
* age \< 60 years
A Study to Evaluate Plasma Gelsolin in Healthy Volunteers

Study BTI-101 is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation, parallel design study to evaluate the safety, tolerability, and pharmacokinetics of IV rhu-pGSN or saline placebo administered as 5 doses each of 6, 12, 18, or 24 mg/kg of body weight. Each of 4 dosing cohorts will include 8 subjects randomized 3:1 rhu-pGSN:placebo (6 rhu-pGSN subjects:2 placebo subjects). Subjects will be healthy adult volunteers 18-55 years of age.

Doses will be administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4). Subjects will be kept in-house until after the last blood sample is taken on Day 5. Subjects will return for follow-up 7 days after the initiation of therapy (Day 8) and on Day 28 for the End-of-Study (EOS) Visit. After each cohort has completed the Day 8 visit, review of the safety results (including labs) will be conducted (and unblinded where appropriate) before the initiation of the next higher dose cohort.

To assess safety and tolerability, subjects will undergo physical examinations (including vital sign measurements), adverse event (AE) assessments, concomitant medication assessments, and safety laboratory testing. Blood samples will be collected for analysis of pGSN levels and antibodies against pGSN.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female adults 18 to 55 years of age without chronic or active acute medical conditions
2. Informed consent obtained from subject
3. Weight ≤100 kg and body mass index (BMI) \<30 kg/m2
4. Willingness to use contraception during the course of the study, starting at screening and for at least 3 months after their final study treatment

Exclusion Criteria:

1. Pregnant or lactating women
2. Acute illness during the month prior to screening
3. Circumstances that may require any medications (including prescription medication, over-the-counter medication, vitamins, or supplements) during the during the inpatient days of the study other than acetaminophen
4. Hospitalization during the year prior to screening
5. History of cancer or treatment with systemic chemotherapy or radiation therapy at any time
6. Transplantation of hematopoietic or solid organs
7. History of diabetes mellitus; myocardial infarction, angina, or other cardiovascular disease; stroke or cerebrovascular disease; chronic obstructive pulmonary disease (COPD) or asthma; deep vein thrombosis (DVT)/pulmonary embolism (PE); liver or kidney disease; clinically significant psychiatric condition; or active or chronic infection
8. Receipt of blood products during the year prior to screening
9. Chronic mechanical ventilation or dialysis
10. Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator
11. Any clinically significant abnormalities of vital signs, EKG or physical examination findings as judged by the Investigator
12. Positive results for recreational drugs during screening
13. Any other condition deemed by the Investigator as possibly interfering with the conduct of the study
Pharmacokinetics (PK) of TKI258 in Cancer Patients With Normal and Impaired Hepatic Function

This is a multi-center, open label study to assess pharmacokinetics (PK) of TKI258 at single-dose and steady state in adult cancer patients either with mild, moderate or severe hepatic impairment or with normal hepatic function. Hepatic function in study patients will be categorized as normal, mild, moderate or severe based upon pre-dose (Day 1) total bilirubin and AST/ALT levels. Starting dose of TKI258 will depend on total bilirubin and ALT/AST levels at baseline. Patients will be treated until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically or cytologically confirmed solid tumor, excluding breast cancer, that is either refractory to the standard therapy or has no available therapies.
2. ECOG performance status (PS) 0 or 1
3. Patients must have measurable and/or non-measurable lesion(s) as assessed by Computer Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) per RECIST 1.1

Exclusion Criteria:

1. Patients with known brain metastases.
2. Patients who have undergone major surgery ≤ 4 weeks prior to starting study treatment

Other protocol-defined inclusion/exclusion criteria may apply
Lipid Biomarkers for Diabetic Heart Disease

This study will test whether lowering the delivery of excess fats to the heart in persons with type-2 diabetes mellitus improves heart muscle function. The investigators will also test whether specific lipid molecular species in plasma can serve as biomarkers for diabetic heart disease.

Screening procedures include 12-hour fasting blood draw, urine pregnancy testing for females, completion of medical history questionnaire, and stress echocardiography to rule out coronary artery disease or cardiomyopathy.

Subjects who meet screening criteria will return for visit 2, which consists of a urine collection, 12-hour fasting blood draw, dual-energy X-ray absorptiometry (DXA) for body composition, magnetic resonance spectroscopy analysis of the liver, and resting echocardiogram for analysis of heart structure and function. Subjects will then be randomized to treatment with fenofibrate (160 mg/d) or an identical-appearing placebo for 12 weeks. They will be asked to continue their usual medications, diet and physical activity. Subjects will receive a pedometer to wear daily to track their physical activity. Subjects will meet with dietitians from the Lifestyle Intervention Core to complete a 24-hour dietary recall. They will be instructed to record their daily blood glucose concentrations, distance walked and any side effects, illnesses or stresses in a study-supplied log. Subjects will be instructed to either email or fax the log to the study coordinator each week (or discuss by phone).

Subjects will return 6 weeks after starting intervention for visit 3 to ensure their medical safety. Procedures at this visit include an interim medical history, urine pregnancy test for females, blood draw to rule out untoward effects of the study drug on liver or kidney function, pill count to assess compliance, review of logs of blood glucose, distance walked, and side effects, illnesses or stresses, and meeting with a dietitian for a 24-hour dietary recall.

Subjects will continue to take their study medication/placebo and keep logs of blood glucose levels, distance walked, and side effects, illnesses and stresses for another 6 weeks. They will return for visit 4 after 12 total weeks of intervention. Visit 4 involves a urine collection, 12-hour fasting blood draw, review of subject logs, pill count, and 24-hour dietary recall. In addition, magnetic resonance spectroscopy analysis of the liver and resting echocardiogram analysis of the heart will be performed to determine if there have been any changes in liver fat or heart function during the 12-week intervention.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus

Exclusion Criteria:

* body weight \> 300 lb.
* HIV
* hypothyroid
* steroid medication, fenofibrate
* smoking
* BP \> 140/90
* heart disease
* pregnant or lactating
* consumption of \> 5 alcoholic drinks/wk
* creatinine \> 1.5 mg/dL
* hematocrit \< 28
EmPOWERing Active Seniors With Energy

A pilot study comparing the emPOWER Ankle System to standard carbon fiber prosthetic feet, in active seniors.

The primary objective of this study is to characterize the increase in the distance subjects can walk during a six (6) minute period while wearing the emPOWER Ankle compared to a passive lower-extremity prosthesis.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* 55 years or older
* Subjects with transtibial amputations of either leg at least 1 year prior
* Suction or elevated vacuum suspension and Socket Comfort Score of at least 6
* Sock fluctuation of ≤ 8 ply per day
* K-level rating of 3 or 4 based on the Amputee Mobility Predictor Assessment Tool
* Ability to walk at a walking speed of \> 0.75 meters per second
* Unilateral amputees (up to 7 bilateral amputees can be included, 1 per site in addition to the unilateral amputees who will be analyzed as a separate sub group)
* Foot size: 25-30 cm
* Ability to complete a continuous 6-Minute Walk Test
* Ability to provide written, informed consent
* Ability to complete study visits and study documents
* Ability to manage the complexity of a powered device including charging and changing batteries as needed
* Ability to read and understand English

Exclusion Criteria:

* Subjects who have never used a prosthetic device
* Less than 55 years of age
* Weight \<150 lbs. or \> 287 lbs.
* Transfemoral amputees
* Active sores or ulceration on subject's residual limb
* Sore on contralateral foot.
* Cuff-link socket suspension
* Socket Comfort Score less than 6
* Sock fluctuation of \> 8 per day
* K level of 1 or 2
* Amputation clearance \< 8.625"
* History of stroke or TIA that impairs current walking
* Recent history of excessive falling defined as more than 2 falls requiring medical assistance in the prior year
* Medications potentially affecting balance
* Recent hospitalization (within past 3 months)
* Cognitive deficiency that would impact ability to charge and change batteries as needed
Effect of Orofacial Myofunctional Therapy on Mouth Air Leak in Patients With Sleep Apnea Treated With CPAP

To verify the effect of orofacial myofunctional therapy in patients with OSA during the use of CPAP with a nasal mask, on the frequency and leak flow. In addition, the impact on mouth opening frequency, sleep quality, perception of excessive daytime sleepiness, and CPAP adherence will be evaluated.

The use of continuous positive airway pressure (CPAP) with a nasal mask during sleep is the gold standard treatment for moderate to severe obstructive sleep apnea (OSA). However, low adherence to CPAP is the main limiting factor in clinical practice. Recent studies suggest that unintentional air leak through the mouth contributes significantly to poor adherence to CPAP. Orofacial myofunctional therapy (OMT) is effective for treating mild to moderate OSA and has not been tested in patients with mouth air leaks. OSA patients using nasal CPAP and mouth air leaks will be recruited and will use the standard CPAP model and nasal mask during the first and last week of the study to record adherence and home leak. Patients will be treated by performing daily (3 times a day) orofacial myofunctional exercises aimed at strengthening the muscles of the oral cavity. Exercises will be supervised weekly for 3 months. All patients will undergo at the beginning and end of treatment: polysomnography with CPAP and nasal mask, speech-language pathology assessment adequated for OSA (scores ranging from 0 to 241, with higher values indicating greater dysfunction), quality of life questionnaire, and nasosinusal symptoms (SNOT -22), sleep quality (Pittsburgh) and sleepiness (Epworth). Polysomnography will include a pneumotachograph (Hans Rudolph) in the CPAP circuit to record flow and a magnetic jaw movement sensor (Brizzy) to record the episodes of mouth opening. The mouth air leak episodes were considered when they exceeded 20% above baseline (intentional leak with the mask fitted and mouth closed at the beginning of the PSG examination with CPAP) for a minimum of 10 seconds. Leaks ending with arousal or full awakening were considered arousal or full awakening associated with mouth air leak. Mouth opening during the leak episodes was determined by the difference between the amplitude at the end of the leak and the amplitude during the leak. Our hypothesis is that the orofacial myofunctional therapy will reduce mouth leakage in OSA patients treated with CPAP and nasal mask.

Eligibility Criteria:
Inclusion Criteria:

• Diagnosis of OSA (AHI\>15 events/h) on use of CPAP (\>3 months) with suspect mouth leak as observed by the complaint of morning dry mouth and or CPAP report indicating an excessive air leak

Exclusion Criteria:

* Central Sleep Apnea, oxygen dependent, COPD.
Comparative Bioavailability Study of UDCA

The purpose of this study is to evaluate bioavailability of two formulations of ursodiol.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 19.0 and ≤ 30.0 kg/m2.
* No clinically significant findings in a 12-lead electrocardiogram (ECG)
* Be informed of the nature of the study and give written consent prior to any study procedure

Exclusion Criteria:

* Known history or presence of any clinically significant medical condition
* Participated in a clinical trial which involved administration of an investigational medicinal product within 30 days prior to drug administration, or recently participated in a clinical investigation that, in the opinion of the investigator, would jeopardize subject safety or the integrity of the study results
A Follow-Up Study of Patients With HBeAg Positive Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML22265

This multicenter, prospective, observational study will evaluate the one-year outcomes in HBeAg positive chronic hepatitis B patients who had received Pegasys (peginterferon alfa-2a) in Arm A of study ML22265. Data will be collected from each patient for up to one year post-therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were randomized to study Arm A of ML22265 and were treated and completed follow-up in the study, regardless of treatment response at any time point

Exclusion Criteria:

* Patients unwilling to provide informed consent or abide by the requirements of the study
Health Status of < 50 Year Old Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2020)

The overall project aim is to study outcomes following aortic valve replacement with either mechanical valves or bioprostheses by retrieving data from the main social security carriers in Austria for the years 2010-2020 in under 50 year old patients.

The purpose of this research project is to evaluate mortality (primary outcome) and incidence of heart attack, stroke, reoperation and first diagnosis of heart insufficiency, MACE (secondary outcomes) after aortic valve replacement in under 50 year olds. We aim to compare those outcomes between mechanical valves and bioprostheses.

Data will be retrieved from the main social security carriers in Austria (covering 98% of its population) from 2010-2020.

Eligibility Criteria:
Inclusion Criteria:

* isolated surgical aortic valve replacement in Austria

Exclusion Criteria:

* below 18 years of age
* above 50 years of age
* concomitant heart surgery
Efficacy and Safety of Insulin Glulisine in Type 2 Diabetes Mellitus

* To evaluate the superiority in the efficacy of HMR1964 and OHA combination therapy as compared with OHA therapy.
* To evaluate the superiority in the efficacy of HMR1964 mono-therapy as compared with OHA therapy.
* To evaluate the safety of HMR1964.


Eligibility Criteria:
Inclusion Criteria:

* Men or women with type 2 diabetes mellitus diagnosed at least one year prior to the study with a BMI \< 30 kg/m2 , a HbA1C of \> 8.0 - \< 11.0% at screening
* Fasting serum C-peptide at screening \> 0.7 ng/mL
* Subjects who have been on a stable regimen and at the following doses of SU for at least 8 weeks prior to signing informed consent
* Glibenclamide \> 5 mg/day
* Glimepiride \> 3 mg/day
* Gliclazide \> 80 mg/day In addition to receiving the above mentioned SU agents, subjects may have been treated with a biguanide at a stable dose for at least 8 weeks prior to signing informed consent.
* Subjects willing to administer three HMR1964 injections per day immediately prior to meals for a 16 week

Exclusion Criteria:

* Subjects unwilling or incapable of receiving a starting dose of ≥ 0.2 IU/kg/day of HMR1964
* Subjects with the likelihood of requiring concomitant treatment during the study period with the following classes of drugs: additional OHA (including thiazolidinediones, α-glucosidase inhibitors, D-phenylalanine derivative) other than those specified in the study protocol, insulin preparations other than HMR1964, systemic corticosteroids, other investigational products
* Subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine diseases; and active cancer; or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
* Subjects who are pregnant, breast feeding or wish to become pregnant during the study period
* Subjects with diabetic retinopathy who received surgical treatments (laser photocoagulation or vitrectomy) within 12 weeks prior to informed consent, who are expected to have these surgical treatments during the study period, or who were diagnosed newly proliferative diabetic retinopathy within 12 weeks prior to informed consent
The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia

The investigators propose to conduct a head-to-head, randomized clinical trial to compare the effectiveness of Minoxidil with Spironolactone and Finasteride in treating postmenopausal females with Androgenetic Alopecia (AGA).

Participants diagnosed with AGA will be randomized into one of the two treatment arms outlined below, and will take the assigned treatment for a total duration of 12 months. Medications will be dispensed by a nurse who is blinded to the participants within each treatment group. Global photograph assessment and participant questionnaires at 0, 4, 8 and 12 months will be the primary means to determine improvement in hair loss.

Compare the following interventions in treating postmenopausal female AGA:

A) Combination 5% Minoxidil and 200mg Spironolactone (Combination Group) B) 5mg Finasteride with placebo topical preparation (Single Group)

Eligibility Criteria:
Inclusion Criteria:

* female
* postmenopausal (\>60 years old or with total hysterectomy)
* diagnosed with androgenetic alopecia
* no chemical processing or changes in hair products throughout the study

Exclusion Criteria:

* men
* premenopausal women (\<60 or without hysterectomy)
* participants allergic to any of the study medications (minoxidil, finasteride, spironolactone)
* participants with other co-existing forms of alopecia (traction, alopecia areata, or scarring alopecias)
* participants with obstructive uropathy or advanced liver disease
* prior hair loss treatment within the last 6 months
* hair loss from the chemotherapy or other medication-induced alopecia
* Hair loss for greater than 5 years, as medical therapy is unlikely to have much effect at restoring hair follicles inactive for that long of a period.