cyrilzakka/clinical-trials huggingface dataset:
Advanced Gravitational Physiology the Lung Under High-G Acceleration

This is a study of advanced lung physiology in altered gravitational conditions, consisting of respiratory measurements in healthy volunteers during high G acceleration on a long-arm human centrifuge.

The lung is highly gravity-dependent - it has little actual tissue mass and deforms under its own weight. This is relevant to astronauts in space, but is actually much more broadly important to life on Earth. Every time we change our posture - for example from lying to standing - the direction in which gravity acts across the lung changes. These postural effects can become clinically important in critically ill patients. Currently there is debate in the scientific world about how gravity actually influences lung function, and how it interacts with other factors such as the anatomical structure of the airways and blood vessels of the lung. New technology developed by researchers at the University of Oxford now has the potential to help answer some of these questions. This device uses a technique called laser absorption spectroscopy to make measurements of breathing gases that are much more accurate than previous techniques - it is able to count the number of oxygen, carbon dioxide and water vapour molecules in and out while a person breathes. A non-invasive 15-minute breathing test with this technology provides information on the distributions of airflow and blood flow in the lungs, and it has been deployed successfully in the operating theatre and in intensive care units. This study aims to make comprehensive measurements of lung physiology under altered gravitational conditions and develop the technology and measurement techniques for possible future use in microgravity. This will include measurements of oxygen and carbon dioxide from the laser gas analyser (and measures of lung inhomogeneity obtained from these), lung mechanics and breathing drive.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteer who has provided informed consent

Exclusion Criteria:

* any significant medical problem, as documented extensively in the study ethics documentation.
Cognitive Remediation in Early Substance Abuse Treatment

This study is for the purpose of determining whether cognitive remediation may improve cognition and treatment response in patients entering substance abuse day treatment

Background: Patients entering substance abuse treatment display cognitive deficits that may reduce their ability to benefit from their treatment. While there is considerable variety in the severity and types of cognitive impairment found in newly recovering patients, problems with attention, memory and executive function are very common. Since treatment requires sustained attention, remembering what is learned, integrating that knowledge and applying it to recovery, impairment in underlying cognitive processes makes successful treatment less likely. Although cognitive functioning improves with sustained sobriety, it is during the early phase of recovery that most patients receive the most intensive treatment. Recent research has suggested that cognitive remediation exercises during this early phase may speed up the return of cognitive functioning and in so doing may have a direct effect on whether patients find the treatment useful and complete their treatment. By keeping patients in treatment longer, cognitive remediation may have an indirect effect on substance abuse outcomes.

Objectives: To pilot test the introduction of cognitive remediation at the Substance Abuse Day Treatment Program (SADP) at the Errara Community Care Center. Aims are 1) to assess the receptivity of patients to the intervention by determining rates of agreement to participate, 2) to determine the number of cognitive remediation sessions that patients are willing to engage in, 3) to assess a variety of cognitive remediation tasks for their acceptability, 4) to evaluate neuropsychological improvements using pre-post assessment, 5) to evaluate its effects on substance abuse treatment participation, and 6) to evaluate its effects on substance abuse outcomes at 6 months follow-up.

Design: Randomized clinical trial of cognitive remediation with an active control condition with observations at baseline, end of treatment and 6-months from intake

Eligibility Criteria:
Inclusion Criteria:

* Veterans participating in a substance abuse day treatment program at the Errara Community Center

Exclusion Criteria:
A Study of Fostamatinib in Subjects With Impaired Kidney Function

A 2 stage study to evaluate the amount of fostamatinib in the blood and urine in subjects with impaired kidney (renal) function compared with healthy volunteers with normal renal function. Stage 1 will include healthy subjects and subjects with end stage renal disease, while Stage, 2 may include subjects with mild, moderate and/or severe renal impairment dependent on the outcome of Stage 1. The study will also evaluate safety and tolerability in subjects with renal impairment.


Eligibility Criteria:
Inclusion Criteria:

* Males or females (non child bearing potential) greater than or equal to 18 years of age with suitable veins for cannulation or repeated venipuncture and with a weight of at least 50 kg (110 lbs) and body mass index (BMI) between 18 and 40 kg/m2, inclusive
* Stable renal impairment with following creatinine clearance (CLCR): Stage 1 - End Stage Renal Disease (ESRD) \< 15 mL/min (requiring dialysis); Stage 2 - Mild renal impairment ≥ 50 to \< 80 mL/min; Moderate renal impairment ≥ 30 to \<50 mL/min; and severe renal impairment 15 to \< 30 mL/min
* Healthy subjects with normal renal function must have good health based on medical history, physical examination , echocardiogram and clinical laboratory evaluations including creatinine clearance \>80 ml/min"
* Negative screen for Human Immunodeficiency Virus and negative results for serum hepatitis B surface antigen and hepatitis C antibody

Exclusion Criteria:

* Subjects who have received any medications known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration
* Absolute neutrophil count less than 1600/mm3 or 1.6 x 109 L.
* Healthy subjects only: Subjects who have received any prescribed systemic or topical medication within 14 days of the first dose administration
* Subjects with a history of multiple drug allergies or with a known allergy to the drug class of fostamatinib
* In the opinion of the Investigator, any evidence of additional severe or uncontrolled systemic disease (eg, currently unstable or uncompensated hepatic, cardiovascular, or respiratory disease) or laboratory finding
Predictive Ability of Intra-Abdominal Pressure for Mortality in Patients With Severe Acute Pancreatitis

Severe Acute Pancreatitis (SAP) is an acute inflammatory condition of the pancreas characterized by organ dysfunction and increased mortality. Increased Intra-abdominal Pressure(IAP) in SAP is a result of inflammation of pancreatic and peripancreatic tissue, aggressive fluid resuscitation and increased capillary permeability, which is associated with organ dysfunction, by limiting the vascular supply to the tissue. Abdominal Compartment Syndrome (ACS) is defined as IAP greater than 20 mm of Hg and is considered an abdominal catastrophe. Intra-abdominal Hypertension (IAH, Intra-abdominal pressure \> 12mm of Hg), may contribute to early organ dysfunction, ACS and eventually hemodynamic collapse if left untreated. This signifies the need for determining the burden of the condition and identifying the high risk patient group who are prone to develop IAH /ACS and predicting mortality associated with the condition. Measurement of IAP will be done indirectly by measuring intravesicular pressure using modified kron's method. IAP will be measured at the time of admission into Intensive Care Unit (ICU) and every day thereafter during the initial five days of ICU admission. Any reading of IAP ≥12 mm of Hg shall be considered as IAH. SOFA and APACHE II score will be noted on the day of admission in the ICU. Any interventions, surgical or non surgical as per clinician's decision will be recorded. The patients will be followed up until discharge or mortality until 30 days. The proposed study aims to assess the predictive ability of IAP during the first 5 days of ICU admission for predicting mortality in patients with SAP. Prediction accuracy will also be compared with SOFA and APACHE II scores.


Eligibility Criteria:
Inclusion Criteria:

\>Patients with severe acute pancreatitis in the age group of 18-65 years admitted to ICU within 72 hours of onset of symptoms

Exclusion Criteria:

* Previous history of any abdominal or pelvic surgery
* Known case of bladder tumor or bladder abnormality.
* Difficulty in urinary catheterization
* Use of neuromuscular blockade
* Pregnant patients
Appetite Regulation by Human Chemosignals From Tears and Plasma

Obesity is closely related to metabolic diseases and its prevalence is sharply increasing. However, there is no safe and effective treatment for obesity so far, the investigators need a breakthrough idea to curtail the constant threat of obesity. It has been recently demonstrated that emotional tears of women can modify sexual responses, one of basic instincts, in men. As appetite and food intake is another basic instinct, chemosignals from tears and plasma may modify appetite and eating behavior in humans.


Eligibility Criteria:
Inclusion Criteria:

* Woman: Negative for HIV, Syphilis (VDRL), and Hepatitis B and C
* Man: Has a body mass index (BMI) of 18.5 kg/m2 to 27 kg/m2, inclusive.

Exclusion Criteria:

* Woman: Has eyelids inflammation, conjunctivitis, keratitis, lacrimal duct obstruction. Has skin diseases around eyes.
* Man: Has diabetes mellitus or dyslipidemia on medication. Received gastrointestinal surgery except appendectomy and hemorrhoidectomy.
Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes

This trial is conducted in Asia, Europe and North America. The purpose is to confirm efficacy in terms of glycaemic control of treatment with mealtime faster-acting insulin aspart in combination with insulin degludec in adults with Type 1 Diabetes Mellitus.


Eligibility Criteria:
Inclusion Criteria: - Male or female, age greater than or equal to 18 years ( for Japan and Taiwan: age greater than or equal to 20 years) at the time of signing informed consent - Type 1 Diabetes Mellitus (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) 12 months or more prior to screening - Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) - Currently treated with a basal insulin analogue for at least 4 months prior to screening (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory - Body Mass Index less than or equal to 35.0 kg/m\^2 Exclusion Criteria: - Within the past 180 days any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack - Subjects presently classified as being in New York Heart Association (NYHA) Class IV Currently planned coronary, carotid or peripheral artery revascularisation - Diabetic ketoacidosis requiring hospitalisation within the last 180 days prior to screening (Visit 1) - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of three months before screening (Visit 1)
De-escalation of Empirical Antimicrobial Therapy Study in Severe Sepsis

Rational: Severe sepsis is one of the leading cause of mortality in intensive care unit patients. Early initiation of an appropriate empirical antimicrobial therapy is associated with improved outcomes. In order to avoid an increase of selection pressure and the emergence of multidrug resistant pathogens, guidelines recommend to streamline the antimicrobial therapy after the identification of the pathogen responsible for infection. This strategy has been evaluated in several observational studies. However, at the bedside, few randomized clinical trials tested this strategy prospectively.

Method: the investigators conduct a randomized clinical trial comparing a strategy based on de-escalation (streamlining of the empirical antimicrobial therapy) and a conservative strategy (continuation of the empirical antimicrobial therapy). The investigators first aim was to show that a strategy based on de-escalation is not inferior to a conservative strategy in terms of intensive care unit length of stay. Secondary aims are to compare the rate of mortality rate, the emergence of multidrug resistant pathogens, and the feasibility of de-escalation. The study is performed in nine intensive care units from four institutions, and 120 patients are required to validate the investigators hypothesis. New technologies for the rapid diagnosis of severe infections are investigated in an ancillary study.


Eligibility Criteria:
Inclusion Criteria:

* Major Subject;
* Subject having a sepsis engraves(burns) defined according to the following criteria during the initiation of the probability antibiotic treatment:
* Criteria of SIRS \[ 14 \],
* And a suspected infection,
* And a failure of organ: low blood pressure, respiratory failure, coma, hepatic insufficiency, renal insufficiency, thrombopénia, spontaneous extension of the TCA,
* Subject for which an antibiotic treatment was begun within 6 hours following the diagnosis of sepsis engraves(burns);
* Subject for which a taking with microbiological aim was made within 48 hours following the diagnosis of sepsis

Exclusion Criteria:

* Minor Subject, pregnant or breast-feeding woman;
* Neutropénia (PN \< 1000 / mm3);
* Absence of identification of a microorganism in the microbiological examinations;
* Absence of Social Security;
* Subject deprived of freedom or under guardianship;
* Subject for which the lit(enlightened) consent is not collected(taken in) (itself and/or reliable person).
Modified TOMOX-HAIC in Combination With Sintilimab and Bevacizumab Biosimilar for First-line Treatment of Advanced Hepatocellular Carcinoma

This is a single-center, single-arm, phase II clinical study, to explore the efficacy and safety of modified TOMOX-HAIC combined with sintilimab and bevacizumab biosimilar as first line treatment in patients with advanced hepatocellular carcinoma.

Hepatocellular carcinoma (HCC) is one of the most common malignant tumors worldwide.The IMbrave150 study and the Orient-32 study demonstrated that PD-1 in combination with bevacizumab confers better survival outcomes in advanced hepatocellular carcinoma. In addition, HAIC combined with targeted therapy and immunotherapy has shown good safety and encouraging efficacy. Oxaliplatin-based FOLFOX regimen is currently the mainstream HAIC chemotherapy regimen (FOLFOX HAIC) in China.

The results of the previous study confirmed that raltitrexed shows promising antitumor activity and safety in hepatocellular carcinoma. Also, TOMOX-HAIC regimen can significantly shorten the infusion duration and is expected to improve the patient experience, quality of life, and adherence while ensuring the efficacy.

In this clinical trial, patients will receive TOMOX-HAIC combined with Sintilimab and bevacizumab biosimilar. The primary endpoint is overall response rate. The secondary endpoint are disease control rate, time to progression, duration of response, overall survival, and safety

Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to provide written informed consent/assent for the trial.
* Males or unpregnant females who age ≥ 18 years, ≤75 years.
* The investigator believes the patient is capable of complying with the study protocol.
* Histologically, cytologically or clinically confirmed advanced hepatocellular carcinoma.
* is not a candidate for radical surgery
* not received previous systemic treatment
* patients must have at least one measurable lesion (RECIST 1.1)
* ECOG PS：0-1, 14 days before enrollment
* Child-Pugh A or Child-Pugh B ≤ 7, 14 days before enrollment

Exclusion Criteria:

* Prior history of other malignant tumors
* Current or prior immunodeficiency disorders or autoimmune diseases
* Subjects have untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk of bleeding
* Subjects who are not available for follow-up or are participating in other clinical trials that have the potential to interfere with this study
* Conditions considered unsuitable for inclusion by researchers
Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR)

Study to evaluate the efficacy, safety and tolerability of GSP 301 NS compared with placebo NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis (subjects 12 years of age and older)


Eligibility Criteria:
Inclusion Criteria:

* Males and non-pregnant females who are 12 years of age and older.
* Documented clinical history of SAR (for at least 2 years preceding the Screening Visit \[Visit 1\]) with exacerbations (clinical evidence of active symptoms) for the relevant seasonal allergen during the Fall or mountain cedar allergy seasons (e.g., ragweed or mountain cedar pollen)
* A 12-hour rTNSS ≥8 out of a possible 12 and a congestion score ≥2 for the AM assessment at the Screening Visit (Visit 1).

Exclusion Criteria:

* Pregnant or lactating women.
* History of anaphylaxis and/or other severe local reaction(s) to skin testing.
* History of positive test for HIV, Hepatitis B or Hepatitis C infection.
* Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
* Subjects with an active pulmonary disorder or infection.
* Subjects with posterior subcapsular cataracts or glaucoma
* Plans to travel outside the known pollen area for the investigational site for 24 hours or longer during the last 7 days of the run-in period.
Romiplostim Treatment for Thrombocytopenia in Patients With Wiskott-Aldrich Syndrome.

The rationale for this retrospective study is to evaluate the efficacy and safety of thrombopoietin-receptor agonist (TPO-RA) romiplostim for reducing thrombocytopenia and bleeding tendency in pediatric participants with genetically confirmed Wiskott-Aldrich syndrome (WAS).

Thrombocytopenia is a life-threatening symptom in WAS patients. Subjects with WAS are at increased risk of debilitating and\\ or life-threatening bleedings due to low platelet numbers. Hematopoietic stem cell transplantation is an effective treatment of WAS and all its symptoms yet requires time for donor search and is not widely utilized in cases with mild WAS with isolated thrombocytopenia. TPO-RAs have been used in individual WAS patients, wherein publications describing large WAS cohorts treated with TPO-RAs are lacking.

Based on the previous reports, WAS patients in our Center have been receiving treatment with TPO-RA romiplostim since 2012.

The aim of the study is to retrospective analyze patients' data in order to asses treatment efficacy and safety of romiplostim in WAS thrombocytopenia.

The study will collect and analyze information that is already in the patients' medical records. Information about clinical data (assessment of bleeding tendency with a modified World Health Organization (WHO) Bleeding Scale), laboratory values (such as clinical and biochemical analysis of blood) will be included.

Evaluation of the efficacy therapy was based on the results of physical examination, including bleeding events at the time of diagnosis and after 6-month TPO-RA was initiated and platelet response. A complete response was defined as a platelet count \>100 x 109/L in the absence of bleeding symptoms, partial - 30 x 109/L higher than the patient's pretreatment baseline count to 100 x 109/L. Non-response was defined as not achieving a platelet count of \> 30 x 109/L from the baseline count.

Eligibility Criteria:
Inclusion Criteria:

* Age under \< 18 years
* Subject/legal representative has signed written informed consent. ?
* Subjects diagnosed with WAS based on genetic findings.
* Subjects with thrombocytopenia (platelet count of less than 70 x 109/L).
* Subjects with a history of bleeding.
* Subjects received treatment with romiplostim 8-9 µg /kg for at least 30 days
* Available records of the points of analysis

Exclusion Criteria:

• Patients, who do not meet the inclusion criteria.
Permanent Observatory of Heart Failure

The observatory consists of a row of data collection on a population composed of all patients with heart failure cared for in centers participating in the national education program for patients (named I-CARE) in the form of two groups. Patients who are undergoing a program of therapeutic education track are listed and included in the group of patients educated. Patients who receive no education or only a minimal element for any reason whatsoever are also listed and included in the group of patients who are not educated.

The following of patients will be periodic after their entry in the observatory, up to 2 years of follow up.

The Center for patients with heart failure cared for in a center practicing therapeutic education dedicated to heart failure.

The definition of heart failure selected for inclusion is that recommended by the European Society of Cardiology : presence of at least two signs or symptoms of heart failure (dyspnea, edema of the ankles crackles) at rest or during exercise associated with objective evidence (preferably by echocardiography) of cardiac dysfunction ( systolic and / or diastolic) (resting) and in case of doubt, a response to specific treatment of heart failure.

All patients who are undergoing a program of therapeutic education track are listed and included in the group of patients educated.

All patients who receive no education or only a minimal element for any reason whatsoever are also listed and included in the group of patients who are not educated.

Follow up is done by CRAs at the French Society of Cardiology, by mailing and phone contacts.

Eligibility Criteria:
Inclusion Criteria:

* Patient with heart failure
* Patient supported by a center participating in the I-CARE french program

Exclusion Criteria:

* Refusal by the patient to be listed in an observatory