cyrilzakka/clinical-trials huggingface dataset:
A Dose-Escalation Study of ENMD-2076 Administered Orally to Patients With Advanced Cancer

A dose-escalation trial designed to assess the safety and tolerability of treatment with ENMD-2076 administered orally over a range of doses in patients with advanced cancer that is refractory to current treatment or for which no curative therapy exists.


Eligibility Criteria:
Inclusion Criteria:

* Have histologic proof of advanced cancer that has progressed after treatment and has no standard therapy that is curative or provides clinical benefit.
* Meet the modified RECIST Criteria or have disease that can be followed for clinical benefit.
* Are greater than or equal to 18 years of age.
* AST and ALT ≤ 2.5 times upper limit of normal (ULN)
* Total bilirubin ≤ ULN
* Creatinine ≤ 1.5 x ULN
* Absolute neutrophil count ≥ 1500 cells/mm3
* Platelets ≥ 100,000/mm3
* Hemoglobin ≥ 9.0 g/dL
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Agree to use effective contraceptive methods prior to study entry, during study participation, and for at least 30 days after the last administration of study medication.
* Have the ability to understand the requirements of the study, provide written informed consent which includes authorization for release of protected health information, abide by the study restrictions, and agree to return for the required assessments.

Exclusion Criteria:

* Women who are pregnant or nursing.
* Have received radiotherapy or chemotherapy less than two weeks prior to first dose of study medication and have not recovered from all acute toxicities from prior treatments.
* Have participated in any clinical trial involving conventional or investigational drugs within 28 days prior to initiation of ENMD-2076 dosing.
* Have active, acute, or chronic clinically significant infections.
* Have uncontrolled severe hypertension or congestive heart failure.
* Have active angina pectoris or recent myocardial infarction (within 6 months).
* Have chronic atrial fibrillation or QTc of greater than 470 msec.
* Have had major surgery within 21 days of starting therapy.
* Have planned surgical treatment of tumor(s)
* Have additional uncontrolled serious medical or psychiatric illness.
* Have any medical condition that would impair the administration of oral agents including significant bowel resection, inflammatory bowel disease or uncontrolled nausea or vomiting.
* Have a 2+ protein by urinalysis or a history of nephrotic syndrome.
* Known central nervous system metastasis.
* Have history of deep vein thrombosis or pulmonary embolus, unless they are receiving therapeutic anticoagulation with warfarin or low-molecular-weight heparin.
Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children and Adolescents Aged From 7 to Less Than 18 Years Old With Autism Spectrum Disorder

The purpose of this study was to evaluate the efficacy and the safety of bumetanide/S95008 in the improvement of Autism Spectrum Disorder core symptoms.

The present study (CL3-95008-001) was performed in children and adolescents from 7 to less than 18 years old presenting with ASD. A 6-month double-blind treatment period was performed in which efficacy and safety of bumetanide 0.5mg BID were assessed versus placebo. This double-blind period was followed by a 6-month open label treatment period of bumetanide 0.5mg BID in which long term safety was evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients from 7 to less than 18 years
* Out patients
* Primary diagnosis of ASD as per Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria
* Criteria met for ASD on Autism Diagnostic Observation Schedule (ADOS-2) and Autism Diagnosis Interview Revised (ADI-R)
* CGI (Clinical Global Impression) - Severity rating Score ≥ 4
* Childhood Autism Rating Scale second edition (CARS2-ST or HF) total raw score ≥ 34
* Social responsiveness Scale second edition total score (SRS-2 T-Score) ≥ 66
* Absence of known monogenic syndrome (Fragile X, Rett syndrome ...)
* Absence of any clinically significant abnormality likely to interfere with the conduct of the study according to the judgment of the investigator

Exclusion Criteria:

* Patients not able to follow the study assessments defined by the protocol, with the exception of self-rating questionnaires which will be assessed by parent/legal representative/caregiver for those patients unable to complete them
* Patients having a high suicidal risk according to the investigator judgement
* Chronic renal dysfunction
* Chronic cardiac dysfunction
* Patient with unstable psychotherapy, behavioural, cognitive or cognitive-behavioural therapy
* Severe electrolyte imbalance that is likely to interfere with the study conduct or evaluation
Ghrelin Levels in Patients With Protein C Deficiency

In rodents with protein C deficiency elevated levels of ghrelin has been observed. The purpose of this study is to investigate if patients with protein C deficiency also have elevated levels of ghrelin, and if so, how this affects the patients.

30 patients with protein C deficiency and 30 healthy BMI and gender matched controls are recruited. Bloodsamples are taken in order to measure ghrelin and GH levels and other metabolic parameters. The patients and controls are also asked to answer a questionaire regarding appetite.

If patients with protein C deficiency have higher levels of ghrelin than the general population, this will lead to new studies that will perhaps help us understand the importance of ghrelin in humans.


Eligibility Criteria:
Inclusion Criteria:

* protein C deficiency or healthy subjects
* age 18-70
* BMI 18-35
* written statement to join the study

Exclusion Criteria:

* chronic illness, apart from protein C deficiency and lifestyle diseases
* everyday medication apart from statins, oral diabetes medication and antihypertensive drugs.
* blood donation within three months prior to the investigation.
* Alcohol abuse
Evaluating the Use of a Concentrated Surfactant Gel in Burn Patients

This will be an observational study evaluating subject's perception of pain to dressing changes during removal and application of a surfactant gel. Wound healing will also be monitored. Anxiety before dressing change will be measured using a burn specific pain anxiety scale. Study intervention will include cleansing the wound per the facility's standard of care, followed by applying the investigational product on the wound. This will be followed by placing an appropriate secondary dressing.


Eligibility Criteria:
Inclusion Criteria:

* Subject should be an inpatient, per the Two-Midnight rule at the time of study initiation.
* At the time of subject's admission in the hospital, duration of his or her burn wound should be \< or equal to 24 hours.
* Subject who has a partial thickness burn wound, or an indeterminate burn wound, or who has both these characteristics in the same wound, as determined by the site Principal Investigator.
* Subject's wound included in this study, does not require any surgical intervention.
* Subject is able and willing to comply with requirements of this trial protocol.
* Voluntarily signed informed consent obtained before any trial-related procedures are performed.
* Subject must be able to communicate effectively with study personnel.
* Subject has burn total body surface area (TBSA) between 1-20%.

Exclusion Criteria:

* Subjects with electrical or radiation burns.
* Subjects who are pregnant, nursing or planning to become pregnant during the course of the study.
* Subjects who have known allergies to any ingredients in the dressings used in the study.
* Subjects taking opiates during the study duration.
* Subjects with an active diagnosis of substance use disorder within the past six months.
* Subjects with previously diagnosed issues with pain perception, including conditions such as peripheral neuropathy, if they will preclude accurate assessment of primary and secondary endpoints.
* Subjects with an active infection prior to enrollment.
* Subject has previous or current systemic disease(s) which, in the judgement of the investigator, is likely to interfere with treatment. Subjects with well-controlled diabetes mellitus (HbA1C\<8.5) shall be permitted.
Retrospective Clinical Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine

A retrospective cohort study was performed in patients with angina pectoris who were treated with oral Chinese patent medicine and Western medicine.The hospital's medical record management system was used to collect symptoms of angina pectoris, dose and frequency of nitroglycerin use, clinical biochemical test and imaging examination.To explore the clinical efficacy of Chinese patent medicine in the treatment of coronary heart disease with angina pectoris, and provide reliable data support for its clinical application.


Eligibility Criteria:
Inclusion Criteria:

1. Age 35-75 years old, gender is not limited;
2. Admission time is September 1, 2014 - September 1, 1919;
3. Patients with coronary heart disease and angina pectoris in the Department of Cardiology or Outpatient Department, the diagnosis of angina pectoris meets the diagnostic criteria of Western medicine and the standard of TCM syndrome differentiation;
4. Patients who met the criteria for drug treatment, the exposed group was treated with traditional Chinese medicine combined with Western medicine, and the non-exposed group was treated with Western medicine alone.

Exclusion Criteria:

1. Combined with other heart diseases, neurosis, menopausal syndrome, hyperthyroidism, cervical or vertebral artery type cervical spondylosis, gastro-oesophageal reflux disease or esophageal hiatus hernia may cause chest pain;
2. patients with acute myocardial infarction, heart failure, myocarditis, cardiomyopathy, severe heart valve disease, liver failure or renal failure, malignant tumors and severe metabolic diseases, as well as patients with severe symptoms and uncontrollable angina;
3. Pregnant women, lactating women or women of childbearing age who have birth requirements;
4. Mental patients, or cognitive dysfunction;
5. The investigator believes that there are other situations that are not suitable for the trial.
Performance Indicators of the SARC-F Questionnaire in Acute Care

The study applies the Sluggishness, Assistance in walking, Rising from a chair, Climb stairs, Falls (SARC-F) questionnaire in older patients hospitalized in an acute care geriatric unit and aims to determine its performance indicators to screen for sarcopenia according to the revised European Consensus on definition and diagnosis (EWGSOP2) within this population

Sarcopenia is an age-related disease associated with health adverse outcomes, i.e. higher risk of mobility limitation, falls, fractures, mortality, and lower quality of life. The European Working Group on Sarcopenia has recently revisited one of the widely used most acknowledged definitions and launched the revised European consensus on definition and diagnosis (EWGSOP2) (4). Applying the EWGSOP2 is a three-tier process: first, screening by the Sluggishness, Assistance in walking, Rising from a chair, Climb stairs, Falls (SARC-F) questionnaire; second, diagnosis by low muscle strength, and low muscle mass; third, severity grading by low muscle function. The EWGSOP2 recommends the assessment of sarcopenia in every population, both in community-dwelling and acute care older patients. However, the evidence about the performance indicators of the SARC-F questionnaire to screen for sarcopenia in acute patients admitted to an acute care unit is really limited.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 65 and over
* Hospitalized in an acute care geriatric unit due to acute health issues or acute medical conditions
* With SARC-F, hand-grip strength and dual-energy X-ray absorptiometry administered during hospital admission

Exclusion Criteria:

* SARC-F unavailable
* Unwilling to collaborate in the sarcopenia assessment
* Unwilling to sign the informed consent
Inferior Vena Cava Collapsibility and Distensibility Assessment in Critical Care.

This study will help in determining the impact of assessment of Inferior Vena Cava Collapsibility and Distensibility Index (IVC CI and DI) through Point Of Care Ultra Sound (POCUS), for the fluid management of critically ill patients. This would help in better management of such patients in resource limited countries, where costly equipment for cardiac output monitoring and fluid management are frequently not available.

Moreover this study will help in development of future guidelines for fluid resuscitation in critically ill patients.

The current study is a randomized clinical trial with the aim to explore comparative outcome between IVC CI and DI versus clinical parameters guided fluid management groups in patients of sepsis, Acute renal failure, Acute gastroenteritis and Diabetic ketoacidosis in terms of,

1. Within 24 hours 7 day and 28 day mortality
2. Change in Sequential Organ failure Assessment (ΔSOFA) score from baseline to 24 hours after fluid management.
3. Cumulative fluid balance at 6 hours of fluid management
4. Days on mechanical ventilation
5. Days in Intensive Care Unit (ICU)
6. Change in lactic acid levels in sepsis sub group
7. Change in Blood sugar Random (BSR) in Diabetic ketoacidosis (DKA) sub group
8. Change in Power of Hydrogen (PH) in septic and diabetic ketoacidosis sub group of participant

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted in critical care with systolic Blood Pressure \< 90 mmHg with any of the diagnosis as per operational definition:
* Sepsis
* Diabetic ketoacidosis
* Acute kidney injury
* Acute gastroenteritis

Exclusion Criteria:

* Known case of right heart disease
* Known case of congestive cardiac failure
* Presence of marked ascites
* IVC could not be identified or diameter could not be measured
* Pregnant females
* Body Mass Index (BMI) \>30 Kg/meter2
Lidocaine Infusion in Radical Cystectomy

Radical cystectomy (RC) remains the gold standard for treatment of patients with muscle invasive bladder cancer, or recurrent high grade non-muscle invasive bladder cancer. Nowadays, enhanced recovery pathway is used to decrease morbidity and improve acute rehabilitation after RC. Postoperative ileus is the most frequent reason for prolonged hospital stay following cystectomy.

Radical cystectomy remains the gold standard for treatment of patients with muscle invasive bladder cancer, or recurrent high grade non-muscle invasive bladder cancer. The high rates of morbidity and mortality reflect the fact that the majority of patients undergoing this procedure are elderly patients with multiple comorbidities. Postoperative ileus is the most frequent reason for prolonged hospital stay following cystectomy. To reduce the risk of ileus, prokinetics such as metoclopramide should be used postoperatively. Local anesthetics exert their actions as local anesthesia and antiarrhythmic through Na channels blocking but still have many other important actions through other receptors (e.g., m1 muscarinic receptors) that occur at very low plasma levels compared to levels needed for Na channels blocking, one of these actions is the anti-inflammatory effect against surgical stress response. Several randomized studies found that i.v. lidocaine shortens duration of postoperative ileus and some of it reported decreased postoperative pain with i.v. lidocaine, so they recommended i.v. lidocaine as a safe, simple, and less invasive method for management of postoperative ileus and equal to postoperative epidural analgesia.

Eligibility Criteria:
Inclusion Criteria:

* 45-75 yr ASA class I,II, and III Elective radical cystectomy

Exclusion Criteria:

* Allergy to the study medication, pre-existing chronic pain at any site requiring treatment, Psychiatric disease, hepatic or renal impairment, seizure disorder requiring medication within the previous 2 years
Phase II Study of Inhaled AeroLEF for Analgesia After ACL Knee Surgery

To evaluate the safety and efficacy of self-titration to effective analgesia with inhaled AeroLEF in patients with moderate/severe acute pain in the post-surgical setting.

After elective ACL knee surgery, consented patients will receive a single dose of AeroLEF for moderate/severe acute pain. Patients stop dosing if they achieve analgesia, complete the maximum available dose, or experience dose-limiting side effects.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female between ages 18 years and 60 years.
2. A body mass index of between 18 and 30, inclusive.
3. If a female of child-bearing potential, the patient must have a negative urine pregnancy test at screening and baseline.
4. Scheduled for elective ACL arthroscopic knee repair surgery, and meet the criteria of the American Society of Anesthesiologists \[ASA\] Physical Status Criteria of Class I or Class II, and suitability for an anesthetic plan limited to general anesthesia (inhalation/IV) with post-operative PCA initiated in a PACU setting and not requiring CPM before the 12 hours post surgery observation is completed.
5. Scheduled for a morning surgery and anticipating remaining in the hospital for an overnight stay.
6. Normal laboratory values for clinical chemistry, haematology and urinalysis. If a patient has abnormal clinically significant laboratory values, inclusion will be permitted at the discretion of the investigator .
7. Physical examination with no clinically relevant findings as determined by the investigator.
8. Able to demonstrate the ability to understand the requirements of the study, willingness to provide written informed consent (prior to any study-related procedures being performed) and able to adhere to the study restrictions, and return for the required assessments.

Exclusion Criteria:

1. History of addiction to drugs or alcohol.
2. Exposure to any investigational drug within the 30 days prior to enrolment.
3. Documented hypersensitivity to fentanyl or other opioid analgesics
4. Documented hypersensitivity/allergy to the components of the liposomes used in the AeroLEF formulation
5. History of pulmonary, cardiovascular, neurologic, endocrine, hepatic, GI, or kidney disease or therapy that would jeopardize the patient's well-being by participation in this study (excluded by ASA I and II categories)
6. Currently receiving treatment, or have received treatment in the previous two weeks, with antidepressant or antipsychotic drugs (including monoamine oxidase inhibitors).
7. Clinically significant ongoing medical conditions.
8. Currently receiving treatment for chronic pain.
9. Current therapy with narcotic or CNS-depressant medications.
10. Current chronic therapy with NSAIDs, ASA or acetaminophen within the previous 7 days.
11. Patient, who in the opinion of the investigator, is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.
12. Blood donation or other blood loss within 45 days prior to enrolment in the study totalling 100 mL or greater.
Assessment of Liver Fibrosis and Prognosis in Chinese Patients With CHB Infection Using STE/STQ Elastography

This national multicenter prospective study is aimed to study the diagnositic performance of STE/STQ elastography in liver fibrosis and prognosis in patients with chronic hepatitis B infection.

Ultrasound liver elasticity measurement and imaging has not only been proposed as an alternative to evaluate the severity of chronic liver fibrosis, but also as a mean to stratify patients with advanced fibrosis according to risks of occurrence of clinical complications of end-stage liver diseases.

Sound touch elastography (STE）and sound touch quantify (STQ) developed by Mindray Resona 7 imaging system provide both two-dimensional and point shear-wave elastography of tissue elasticity with stronger penetration and easy operation.

This analysis will study the diagnositic performance of STE/STQ elastography for lver fibrosis and the prognostic value of STE/STQ elastography for the prediction of clinical complications of chronic liver diseases.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a liver ultrasound exam due to confirmed Hepatitis B infection ,
* Patients having reached the age of majority in China,
* Patients with a liver biopsy for histological evaluation of liver fibrosis, performed within 3 months after the STE/STQ measurement date, and having the recommended quality criterion:

minimal length of biopsy samples of 15 mm, stored in paraffin minimal number of portal tracts of 6 per biopsy samples

* Patients of Chinese ethnic origin.

Exclusion Criteria:

Any of the conditions below will exclude patients from the study:

* Any patient presenting with combined etiologies of chronic liver diseases:，including Non hepatitis B viral infection（Hepatitis A, C, D, E）, alcoholic chronic liver disease, hemochromatosis, autoimmune hepatitis，etc
* Any patient presenting with a co-infection of HIV
* Any patient presenting with combined liver tumor
* Any patient ever received liver transplantation
* Pregnant women
* Acute hepatitis
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABBV-1088 Oral Dose in Healthy Adult Participants.

This study will assess the single dose safety, tolerability and pharmacokinetic properties of ABBV-1088 in healthy adult participants


Eligibility Criteria:
Inclusion Criteria:

* BMI is ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at screening.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG

Exclusion Criteria:

* History of cardiac disease, including congenital structural/conduction abnormalities, cardiomyopathy, myocardial infarction, cardiac arrhythmia.
* History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption \[e.g., Crohn's disease, chronic GERD, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].
* History of suicidal ideation within one year prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the C-SSRS completed at Screening, or any history of suicide attempts within the last two years.
* History of any clinically significant neurological, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.