cyrilzakka/clinical-trials huggingface dataset:
An Investigation of TAS-119 Monotherapy

A Phase 1, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of TAS-119 in Patients with Advanced Solid Tumors.

This is a Phase 1, open-label, non-randomized, dose escalation study of TAS-119 evaluating the safety, tolerability, PK, pharmacogenomics, pharmacodynamics, and preliminary antitumour activity in patients with advanced and unresectable solid tumours. The study will evaluate TAS-119 monotherapy, employing two sequential phases.

* A Dose Escalation Phase
* An Expansion Phase

Eligibility Criteria:
Inclusion criteria include the following:

1. Is a male or female, ≥ 18 years of age, who has provided written informed consent.
2. Has histologically or cytologically confirmed advanced, unresectable, metastatic solid tumor(s) for which the patients have no available therapy likely to provide clinical benefit.
3. Must have an archival FFPE tumor sample available, to be provided to the Sponsor upon request.
4. In the Expansion Phase: patients should be willing to undergo tumor core biopsy procedure at pre-treatment and on Day 4, Cycle 1 if, in the judgment of the investigator, it is considered clinically safe and appropriate to do so. This requirement is optional but preferred for patients in Dose Escalation.
5. Has adequate organ function.

Women of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to starting the study drug. Both males and females and must agree to use effective birth control during the study if conception is possible during this interval.

Exclusion:

1. Has received prior treatment with TAS-119.
2. Has received treatment with any proscribed treatments within specified time frames prior to study drug administration.
3. Has a serious illness or medical condition(s).
Impact of Early Mobilization on Mechanical Ventilation Duration in Intubated Critically Ill Patients

The purpose of the present study is to compare usual care in terms of mobilization performed to intubated ICU patients to a standardized program designed to deliver early mobilization at least 5 days a week.

This study has a before / after design with a control group during the experimental phase. The first phase of the study corresponds to an observational phase during which every act of mobilization performed to the included patients is going to be documented. During this first study period, total duration of mechanical ventilation is going to be recorded for all the patients included.

At the end of this first study period, the participating ICU are going to be randomized (Cluster randomization) in two groups either observational or experimental. The corresponding strategy is going to be applied to all the patients included during the second study period. During this second period, total duration of mechanical ventilation is also going to be recorded for all the patients included.

The study hypothesis is that applying a protocolized early mobilization strategy increases the number of ventilator free-days during the 28 days after intubation in ICU patients.


Eligibility Criteria:
Inclusion Criteria:

* Admission in intensive care unit
* Invasive ventilation for more than 24 hours
* Invasive ventilation for less than 48 hours
* Expected duration of invasive ventilation of more than 24 hours at the time of inclusion.

Exclusion Criteria:

* Pregnancy
* Failure to obtain a consent from someone authorized
* Patient under law protection.
* Patient non-affiliated to a health care system.
* Active therapeutic limitation
* Hospitalisation for more than 7 days before intubation
* Admission in intensive care unit after a surgical procedure, burn or trauma
* Admission in intensive care unit because of neurological disease
* Previously known neuromuscular disease
* Bilateral lower limbs amputation
* BMI above 40 kg/m²
* Limitation in daily activities before ICU admission
* Chronic ventilation (more than 12h /24 hours) on tracheotomy before ICU admission
* Participation in another interventional clinical study related to mobilization or in an interventional clinical study which has mechanical ventilation duration as primary outcome
* Previous enrolment in the same phase of the EarlyMob study
Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons

BIOD-961 is a dry powder formulation of glucagon intended for use in a device that mixes (reconstitutes) the powder with liquid to make it easier for users to treat patients with severe hypoglycemia. The purpose of this study is to evaluate how much BIOD-961 absorbs into the bloodstream, how much it raises glucose concentrations (the intended effect) and compare to two glucagon products already on the market.

Subjects receive on separate days, in random order one of the following: 1 mg BIOD-961 intramuscularly (IM), 1 mg Lilly (IM), 1 mg Novo (IM), 1 mg BIOD-961 subcutaneously (SC), 1 mg Lilly (SC), and 1 mg Novo (SC).

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index: 18.5-25.0 kg/m2 inclusive.
* Subject has provided informed consent and has signed and dated an informed consent form before any trial-related activities.

Exclusion Criteria:

* Type 1 or type 2 diabetes mellitus.
* History of pheochromocytoma, insulinoma, glucagonoma, or glycogen storage disease.
* History of regular alcohol consumption as defined by alcohol intake exceeding 7 drinks per week for females or 14 drinks per week for males, where 1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor.
* Significant cardiovascular (to include New York Heart Association (NYHA) Class III or- IV functional capacity or uncontrolled hypertension), respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease.
* Any significant cardiovascular event history, including angina, myocardial infarction, therapeutic coronary procedure (e.g, percutaneous transluminal coronary angioplasty, coronary bypass surgery), stroke, or transient ischemic attack.
* Females who are breast feeding, pregnant, or intending to become pregnant during the study.
Koebner's Phenomenon in Psoriasis and Lichen Planus

Psoriasis and lichen planus often occur at mechanically irritated skin sites (e.g. tight clothing). The investigators would like to investigate this phenomenon in more detail in this study. For this purpose, the skin is specifically irritated at a small and cosmetically favorable site by tearing off scotch tape or rubbing with a wooden spatula. In order to be able to examine the inflammatory processes caused by the irritation more closely, a small skin sample and a skin swab are taken from the irritated area. This skin sample and the swab are repeated after three and fourteen days.


Eligibility Criteria:
Inclusion Criteria:

* Dermatologist diagnosed psoriasis (group psoriasis), lichen planus (group lichen planus) or no skin disease (group healthy controls)
* Subject is capable of giving informed consent
* Signed informed consent

Exclusion Criteria:

* Use of systemic immunosuppressive/immunmodulating agents in the last three months
* Use of topical anti-inflammatory treatment in the last 7 days in the area of sampling.
* Phototherapy in the last 4 weeks
* Active or recurrent serious bacterial, fungal or viral infection at the time of enrollment by patient history, including patients with Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection, active or untreated latent tuberculosis.
* Female patients of childbearing potential who are pregnant or breast feeding or planning a pregnancy during the duration of the trial and/or not practicing acceptable birth control for the duration of the trial
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons.
Comparison of Real-time and Shear Wave Elastography

Tissue elasticity is being increasingly used as diagnostic parameter, since at the macroscopic level benign breast lesions tend to be stiffer than normal breast tissue but softer than breast cancers. Ultrasound elastography allows to probe the elasticity of breast lesions in clinics. Real time elastography (RTE) and shear wave elastography (SWE) are the two most widely used elastography modalities.

Assessment of breast lesions by either RTE or SWE improve the diagnostic performance of standard B-mode ultrasound (US) and have the potential to assist the decision about whether to perform a breast biopsy or not.

Tissue elasticity is being increasingly used as diagnostic parameter, since at the macroscopic level benign breast lesions tend to be stiffer than normal breast tissue but softer than breast cancers. Ultrasound elastography allows to probe the elasticity of breast lesions in clinics. Real time elastography (RTE) and shear wave elastography (SWE) are the two most widely used elastography modalities.

Assessment of breast lesions by either RTE or SWE improve the diagnostic performance of standard B-mode ultrasound (US) and have the potential to assist the decision about whether to perform a breast biopsy or not. However, employing RTE and SWE using the same equipment to directly compare elasticity measurements of a breast lesion has not been done. Investigators propose to prospectively investigate inter-observer agreement of each modality.

The study will investigate and compare the accuracy and reproducibility of SWE and RTE in the characterization of breast lesions. Furthermore, we plan to establish learning curves for RTE and SWE.

In this project, investigators will compare RTE and SWE concerning their potential to discriminate benign breast lesions from breast cancer. Investigators aim is to identify which modality will allow clinicians the best possible patient care.

Eligibility Criteria:
Inclusion Criteria:

* Female patients at least 18 years of age with a known breast lesion
* Signed informed consent

Exclusion Criteria:

* Male
* Younger than 18 years of age
* Pregnant or lactating women
Evaluation of Clinical Decision Support System for Scoring of ASPECT Score Using Brain CT Images

cASPECTS is a software that has been pre-learned based on ASPECTS Score of ischemic stroke patients using brain CT images, and clinical decision support system for scoring ASPECTS score by automatically analyzing brain CT images by assisting the medical team.

The specific aims of this study are to evaluate efficacy of cASPECTS for scoring ASPECTS Score compared to the sensitivity and specificity levels of human expert.


Eligibility Criteria:
Inclusion Criteria:

* Adults over 19 years old
* Brain CT acquired

Exclusion Criteria:

* Patients with ischemic stroke in posterior circulation
* Poor or incomplete brain CT image quality
Evaluation of Clinical Parameters on Admission and Medications in Covid-19 Pneumonia (Corona Virus Disease 2019)

Investigators will recruit patients diagnosed with COVID-19 pneumonia between March 11th, 2020 and April 15th, 2020 in emergency, internal medicine and cardiology outpatient clinics, retrospectively and analyze their clinical and demographic features on admission in regard to their medications used for chronic diseases regularly.

Covid-19 infections demonstrated a pandemic spread after January 2020 and their associations with patient characteristics and comorbidities are intensely studied. Investigators also want to find out potential relations between major medications taken for chronic diseases and clinical parameters of patients with Covid-19 pneumonia.

For the study, investigators will recruit patients diagnosed with COVID-19 pneumonia between March 11th, 2020 (the date at which the first case of Covid-19 in Turkey officially declared) and April 15th, 2020 in emergency, internal medicine and cardiology outpatient clinics, retrospectively. All of the demographic features, complaints on admission, reports of computed tomography (CT) scans of the chest without intravenous contrast issued by the staff radiologist, c-reactive protein (CRP) and complete blood count (CBC) values on admission will be recorded retrospectively. Their polymerase chain reaction (PCR) test results will be derived from the hospital records based on public health covid-19 database notifications and list of medications taken regularly for more than 8 weeks before the diagnosis of COVID-19 pneumonia from the national pharmacy database. Information about other systemic diseases and major medical conditions of patients will be procured from the medical histories gained by relevant physicians. Patient taking each drug group will be compared to those not taking that drugs in terms of clinical and demographical features mentioned above. Statistical analysis will be performed by using SPSS software.

Eligibility Criteria:
Inclusion Criteria:

* Covid-19 pneumonia at least with typical infiltration on CT +/- positive PCR.

Exclusion Criteria:

* no typical infiltration and negative PCR results.
* not newly diagnosed.
Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment.

The aim of the study is to determine the safety and efficacy on an autologous CD34+ subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute middle cerebral artery stroke.

The proposed trial will involve the recruitment of a total of 20 patients.

The cells will be collected from ten subject recruited as cases, via bone marrow sampling. The aspirate will be centrifuged on a Ficoll density gradient to isolate mononuclear cells, which will be resuspended in heparinized isotonic saline for infusion into the area of the stroke intra-arterially using the middle cerebral artery.

The investigators will monitor each case and control for a period of 6 months post-stem cell infusion. Initially, they will be subjected to a review after one month,three months and finally 6 months.

Assessment of adverse events will be by physical examination and measurement of laboratory parameters. Assessment of efficacy will be by physical examination and the measurement of laboratory, CT and MRI parameters.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms and signs of clinically definite middle cerebral artery acute stroke.
* Time of stroke onset is known and treatment can be started between day 5 and 9 of onset.
* DWI-MRI has reliably shown relevant acute ischemic lesions
* Extracranial duplex/transcranial Doppler must confirm intra/extracranial arteries permeability.
* The stroke is severe (NIH Stroke Scale \>= 8 before procedure).
* An age range of 18-80 years old.

Exclusion Criteria:

* Patients out of inclusion age range.
* Lacunar infarction.
* Patients with cancer.
* Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma.
* Hematological causes of stroke.
* Severe co-morbidity.
* Hepatic or renal dysfunction.
* The patient is female and of childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding.
* Patient is likely to be unavailable for follow-up.
* Patient with evidence of life threatening infection of life threatening illness.
* Patient was already dependent in activities of daily living before the present acute stroke.
Daily Aspirin Treatment After Preeclampsia

Women who develop preeclampsia during pregnancy are four times more likely to develop cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs may be related to lasting blood vessel damage after the pregnancy but there are currently no specific treatment strategies to prevent this disease progression. This study addresses this public health issue by examining whether starting low dose aspirin therapy after pregnancy is an effective treatment for lasting blood vessel damage in order to inform better clinical management of cardiovascular disease risk in women who have had preeclampsia.


Eligibility Criteria:
Inclusion Criteria:

* had preeclampsia in the past 5 years,
* 18 years or older

Exclusion criteria:

* current daily aspirin use,
* skin diseases,
* current tobacco or nicotine use (including vaping),
* diagnosed or suspected hepatic or metabolic disease including chronic kidney disease (CKD) defined as reduced eGFR \< 60 mL/min/1.73m2,
* statin or other cholesterol-lowering medication,
* current antihypertensive medication,
* history of hypertension prior to pregnancy,
* history of gestational diabetes,
* currently pregnancy,
* body mass index \<18.5 kg/m2,
* allergy to materials used during the experiment.(e.g. latex),
* known allergies to study drugs,
* bleeding disorders, peptic ulcer disease, gastritis, GI bleeding and gastroesophageal reflux disease (GERD).
Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades

Guidelines for patients having first-time implants advocate that even when heart function is only mildly impaired, modern pacing approaches should be utilised to avoid the potentially damaging effects of RV pacing to preventing symptoms from pacing induced or worsened cardiomyopathy.

However, once a traditional (RV) pacemaker is implanted, development of impaired heart function does not prompt a device upgrade. Even at the end of battery life, physicians simply replace it like-for-like.

This trial tests whether such patients have better symptoms and quality of life if changed to a modern physiological pacing strategy from the traditional RV pacing approach.

In this crossover trial, participants will be upgraded to a physiological pacing strategy.

After their procedure, they will have a one-month run-in period to recover from the procedure (their pacemaker will be programmed to continued RV pacing).

They will be have 2 one-month blinded time periods, randomised to physiological pacing or right ventricular pacing alternately. They will subsequently undergo two six-month blinded randomised time periods.

Patients will document symptoms monthly on a mobile phone application or computer. At the end of each time period, they will have measurements of heart function, a walking test and quality-of-life questionnaires including the SF-36 questionnaire.

The investigators hypothesise that upgrading to physiological pacing strategies will improve patients' quality of life.


Eligibility Criteria:
Patients with an RV pacemaker and LVEF 35-50% and a high burden of right ventricular pacing (\>40%) who are clinically indicated for a cardiac resynchronisation therapy upgrade procedure and:

1. EF reduced by \>5% of increase in LVESV by 10ml since implant
2. NT-proBNP \>250ng/L in sinus rhythm
3. NT-proBNP \> 750 Ng/L if AF
4. Left atrial volume index \> 30ml/m2
5. Regular loop diuretics prescribed
6. Decline in daily patient activity by \>1 hour per day since implant
7. Decrease in device measured thoracic impedance
8. Patient reported decline in functional class or exercise tolerance

Exclusion Criteria:

* Those unable to provide informed consent
* Patients under age 18
* Pregnant women
Oral Tonapofylline (BG9928) in Patients With Heart Failure and Renal Insufficiency

The main purpose of this study is to determine the safety and tolerability of tonapofylline (BG9928) when given at different doses to patients with heart failure and renal insufficiency.

This study will also explore:

* Disease related quality-of-life
* Exercise capacity
* Renal function
* Concomitant medications


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosis of heart failure requiring hospitalization \>1 and ≤12 months prior to screening
* NYHA Class III or IV at the time of screening
* Renal insufficiency as defined by eGFR ≥20 and ≤70 mL/min/1.73 m2
* Negative pregnancy test

Exclusion Criteria:

* History of an allergic reaction to any xanthine-containing compound.
* History of seizure
* History of stroke
* Serious systemic infection
* Sustained systolic blood pressure \>170 or \<90 mmHg
* Myocardial infarction within 30 days of Day 1
* Hemodynamically destabilizing arrhythmia within 30 days of Day 1
* Uncorrected hemodynamically significant primary valvular disease
* Known obstructive or restrictive cardiomyopathy
* Cardiac surgery within 60 days prior to Day 1
* Likely to undergo cardiac transplantation, device implantation, or other cardiac surgery within next three months
* Evidence of malignancy within 6 months prior to Day 1.
* Participation in any other investigational study of drugs or devices within 30 days prior to Day 1.
* Receiving aminophylline, theophylline, pentoxifylline, dyphylline or adenosine
* Presence of any clinically significant condition that might interfere with optimal safe participation in this study
Absorption, Distribution, Metabolism and Excretion (ADME) Study of BMS-986020

The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and extent of elimination, as well as safety and tolerability of a single oral solution dose of \[14C\] Bristol-Myers Squibb (BMS)-986020 in healthy male subjects.

Primary purpose: Other - This study will investigate the pharmacokinetic, biotransformation, routes of elimination, and mass balance of BMS-986020 in humans. The knowledge of the routes of elimination of the drug and its metabolites is useful for evaluating the likelihood of effects of renal or hepatic impairment on the disposition of BMS-986020

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Body weight of at least 50 kg (110 lbs), Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. Body mass index = weight (kg)/\[height(m)\]2
* Men, ages 18 to 50 years, inclusive
* Men who are sexually active with women of childbearing potential (WOCBP) (except those with vasectomy with documented azoospermia 90 days after procedure) must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of the investigational drug (4 days) plus 90 days (duration of sperm turnover) for a total of 94 days post-treatment completion

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study drug administration) gastrointestinal disease
* Current or recent history of constipation or irregular bowel movements (less than once per 2 days)
* Any major surgery within 4 weeks of study drug administration
* Any gastrointestinal surgery that could impact upon the absorption of study drug, including cholecystectomy
* History of Gilbert's Syndrome
* Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)
* Blood transfusion within 4 weeks of study drug administration
* Inability to tolerate oral medication
* Inability to be venipunctured and/or tolerate venous access
* Recent (within 6 months of study drug administration) history of smoking
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations beyond what is consistent with the target population
* History of allergy to LPA1 antagonists or related compounds