cyrilzakka/clinical-trials huggingface dataset:
Pneumacare SLP Validation in Infants and in Clinical Bronchiolitis

A cohort observational study to characterise baseline Structured Light Plethysmography (SLP) outputs in infants with bronchiolitis and examine response to treatment using the Thora3DiTM

Viral illness, particularly chest infection causing breathing difficulty in infants and children is the commonest reason for admission to hospital. At present, there are no objective measurements of the degree of breathing difficulty.

This is because current objective tests of breathing difficulty requires the patient to cooperate and actively perform the tests. This is not possible in babies and very challenging in young children. SLP is a noncontact, effort independent technique for measuring the rate of breathing, the amount of chest expansion and the relative contribution of chest and abdomen to the work of breathing. Measuring these parameters which are known to vary with increasing breathing difficulty will allow us to make objective assessments of breathing difficulty. This study proposes to validate this technique in babies aged 02 years who are healthy and in babies with clinical viral bronchiolitis. The Investigators intend to demonstrate that the technique is feasible in this young age group and that the investigators will be able to demonstrate clinically valid differences between normal and ill babies and also demonstrate measurable differences with the evolution of the clinical illness.

Eligibility Criteria:
Inclusion Criteria

* Aged between 0 and 1 years
* Doctor diagnosis of AVB
* Admitted to hospital within last 24hrs (AVB participants only)
* Or healthy term infant aged up to 2yrs with no current respiratory illness

Exclusion Criteria:

* Patients with significant co morbidities resulting in clinical instability (assessed by the clinician at screening only):
* An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in the study
* Parents unable to consent/comply with trial protocol
* An inpatient for over 24hrs (AVB patients only)
The Impact of Targeted Temperature Management Duration on Thrombin Function in Cardiac Arrest Patients

This study will be a single-center, prospective, randomized controlled trial with an estimated sample size of 64 patients. Eligible patients will be randomly assigned in a 1:1 ratio to receive TTM for either 24 hours or 72 hours. The primary outcome measure will be the changes in thrombin function indices at various time points during TTM treatment in both groups. The secondary endpoints of the study include additional coagulation function indicators, the incidence of bleeding-related events between the two groups, the amount of blood products used, the incidence of thrombotic events, and the CPC scores at 28 days and 6 months for both groups.


Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 80 years;
2. Glasgow Coma Scale score of less than 8 upon admission;
3. patients resuscitated after out-of-hospital cardiac arrest; and (4) patient or their legal representative has signed the informed consent form.

Exclusion Criteria:

1. cardiac arrest caused by irreversible factors such as trauma or poisoning;
2. cardiac arrest due to terminal conditions like advanced cancer;
3. uncorrected persistent cardiogenic shock, defined as a systolic blood pressure below 90 mmHg despite treatment with fluid resuscitation, vasopressors, and inotropic agents;
4. pre-existing cerebrovascular disease or CT-confirmed intracerebral hemorrhage upon admission;
5. pre-arrest Cerebral Performance Category (CPC) score between 3 and 5;
6. bradycardia or sick sinus syndrome following the return of spontaneous circulation;
7. pre-existing coagulation disorders or severe bleeding tendencies;
8. pregnant or breastfeeding women, or women of childbearing age with elevated serum hCG levels;
9. presence of treatment limitations (such as refusal by the patient or legal representative to undergo advanced life support, including mechanical ventilation, chest compressions, or targeted temperature management);
10. determination by the principal investigator that the patient is unsuitable for the trial.
Build-up Computed Assisted History Taking, Physical Examination and Diagnosis System of Emergency Patient Through Machine Learning (II)

In emergency department（ED）, physicians need to complete patient evaluation and management in a short time, which required different history taking, and physical examination skill in healthcare system.

Natural language processing（NLP） became easily accessible after the development of machine learning（ML）. Besides, electronic medical record（EMR） had been widely applied in healthcare systems. There are more and more tools try to capture certain information from the EMR help clinical workers handle increasing patient data and improving patient care.

However, to err is human. Physicians might omit some important signs or symptoms, or forget to write it down in the record especially in a busy emergency room. It will lead to an unfavorable outcome when there were medical legal issue or national health insurance review. The condition could be limited by a EMR supporting system. The quality of care will also improve.

The investigators are planning to analyze EMR of emergency room by NLP and machine learning. To establish the linkage between triage data, chief complaint, past history, present illness and physical examination. The investigators will try to predict the tentative diagnosis and patient disposition after the relationship being found. Thereafter, the investigators could try to predict the key element of history taking and physical examination of the patient and inform the physician when the miss happened. The investigators hope the system may improve the quality of medical recording and patient care.


Eligibility Criteria:
Inclusion Criteria:

* Over twenty years old
* Non-traumatic patient

Exclusion Criteria:

* Excluding the patients for administration reasons (issuing a medical certificate)
* Excluding the patients for non-emergency reasons like simply acupuncture, virus screening and prescription for medication.
* Excluding Patients who allocated to critical care station
Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes

Some patients with type 1 diabetes (T1D) can still have some remaining insulin-positive cells in the pancreas and secrete little amounts of insulin. Despite the presence of residual beta cells, the HbA1C levels remain at high levels due to functional defects of insulin secretion associated with glucotoxicity. Previous trials have indicated that treatment with a Glucagon-like peptide 1 (GLP-1 )receptor agonist in T1D with some residual beta-cell function might improve glycemic control, reduce dose of insulin and risk of hypoglycemia.

The general hypothesis of DIAMOND-GLP1 is that GLP1-R agonists will improve blood glucose

After initial screening to select insulin microsecretors and a run-in period of one month, patients will be randomized into two arms and followed in parallel for 24 weeks :

* Experimental group receiving 1.5 mg Dulaglutide s.c weekly in addition to their usual insulin regimen
* Control group receiving placebo s.c weekly in addition to their usual insulin regimen.

The primary endpoint is HbA1c value at 24 weeks


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with T1D\> 4years, with age range 20-60years
* Diabetes onset after the age of 15years
* Duration of diabetes \<15 years
* Treated with continuous sub-cutaneous insulin infusions (CSI) or multiple daily injections of insulin (MDI)
* Measuring their blood sugar at least four times daily
* Glycated hemoglobin (HbA1C) at screening \>7 and \<10%
* 16.0 kg/m2 \<BMI\<30.0kg/m2
* Patients with childbearing potential should use effective contraception, defined as methods with a failure rate ≤ 2 % per year (OMS 2011) during the study.
* Patients who gave its written informed consent to participate to the study
* Patients affiliated to a social insurance regime

Randomization criteria:

Patients with fasting ultra-sensitive (us) C-peptide above 15pmol/l

Exclusion Criteria:

* Patients are not eligible for this study if any of the following exclusion criteria apply:
* Patients with type 2 diabetes (T2D)
* Hypersensitivity to dulaglutide and/or any of its excipients
* Subjects with history of severe hypoglycemia or recent (\< 6 months) history of diabetic ketoacidosis
* History of gastrointestinal disease with prolonged (\> 3 months) nausea or vomiting, liver or kidney diseases, pancreatitis, thyroid medullary cancer or familial history of multiple endocrine neoplasia type 2
* Estimated glomerular filtration rate\<60ml/min/ 1.73m2 (CKD-EPI method)
* Congestive heart failure
* Any uncontrolled disease, cancers essentially
* Chronic use of paracetamol containing products, which may falsely raise sensor glucose readings
* Use of tricyclic antidepressant, selective serotonin reuptake inhibitor, triptans, neuroleptic drugs and glucocorticoid.
* Patient who participated in another clinical trial on experimental drug in the previous 30 days
* Patients of childbearing potential who are not using adequate contraception; Female patients who are pregnant or lactating.
* Gastric bypass surgery
* Patients under guardianship
A Study In Adults With Moderate To Severe Dermatomyositis

A Study looking at Investigational drug and Placebo administered to adult Patients with moderate to severe Dermatomyositis


Eligibility Criteria:
Inclusion Criteria for Patients with Skin Predominant Activity:

* Must have CDASI Activity score of greater than or equal to 14, and have failed at least 1 standard of care systemic treatment, (eg, corticosteroids).
* Confirmation of DM by the investigator and two of the following:

  1. Gottron's papules;
  2. Gottron's sign;
  3. Heliotrope eruption;
  4. Nailfold changes, (dilated capillary loops, capillary dropout, cuticular hypertrophy and/or rugged cuticles;
  5. Photodistributed violaceous erythema, (skin that is exposed to sunlight and appears purplish/reddish, and patchy in appearance;
  6. Positive DM serology -
* Post DM diagnosis; standard of care workup for DM must have been completed prior to entry into this research study.
* Willing to provide 8 biopsies during the course of the research study

Inclusion Criteria for Patients with Muscle Predominant Activity:

* MMT-8 ≤136/150 and PhGA, VAS ≥3 cm (0-10 cm) by visual analog scale (VAS)
* Sum of PhGA, VAS, PtGA, and extramuscular global assessment VAS scores is ≥10 cm (0-10 cm) VAS for each.

  * Participant has failed at least two or more adequate courses of an immunosuppressive agent or immunomodulatory agent, including IVIG, at a dose known to be effective for rheumatologic diseases.

Exclusion Criteria for Patients with Skin Predominant Activity:

* Investigator site staff or members of their family.
* Acute and Chronic present medical conditions
* Intake of greater than 15 mg of prednisone or equivalent per day
* Pregnant or breastfeeding females. Fertile men and women who will not comply with the use of 2 effective birth control methods as per the research protocol
* Have required management of acute or chronic infections
* Have pre existing demyelinating disorder such as multiple sclerosis, or other severe neurological deficits.
* Clinically significant lab abnormalities
* Any health condition that may be worsened by immunosuppression

Exclusion Criteria for Patients with Muscle Predominant Activity:

Similar to patients with skin predominant activity; Intake of \>20 mg oral prednisone/day, or equivalent
Methadone/Buprenorphine Cross-Over Study - 4

The purpose of this study is to explore ways to cross patients over from methadone to buprenorphine.


Eligibility Criteria:
Inclusion Criteria:

M/F ages 21-50. Opiate dependence according to DSM-IV critera. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hynotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.
Study to Evaluate the Effect of ISIS GCGRRx on Hepatic Lipid and Glycogen Content in Type 2 Diabetes

The purpose of this study is to evaluate the effect of ISIS 449884 (ISIS-GCGRRX) on Hepatic Lipid and Glycogen Content in patients with Type 2 Diabetes being treated with Metformin.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 to 75
* BMI ≥ 25.0 kg/m2 \< 36.0 kg/m2
* HbA1c ≥ 7.5% and ≤ 10.5%
* Type 2 Diabetes Mellitus and on stable dose of Metformin. Patients must have been on a stable dose of oral metformin (at least 1000 mg/day) for a minimum of 3 months prior to screening evaluation and will be required to continue their stable dose of metformin throughout the study. Patients on a stable dose of metformin plus a sulfonylurea (SU) or metformin plus a dipeptidyl peptidase-IV (DPPIV) inhibitor for a minimum of 3 months prior to Screening evaluation may be allowed
* Agree to conduct home-based (fasted) blood glucose testing as directed

Exclusion Criteria:

* Clinically significant abnormalities in medical history or physical exam
* Show evidence of uncorrected hypothyroidism or hyperthyroidism
* History of liver transplantation or renal dialysis
* History of liver disease
* History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
* Treatment with any other antidiabetic drug(s) other than metformin, SU or DPPIV within 3 months of screening
* History of diabetic ketoacidosis
* Any other significant illness or condition that may interfere with the patient participating or completing the study
* Inability or unwillingness to comply with protocol or study procedures -
EUS-guided Celiac Plexus Neurolysis for the Treatment of Abdominal Pain in Pancreatic Cancer

Studies have shown that injecting local anesthetics in areas rich in blood vessels increases the risk of drug injection into blood vessels by mistake and increases the systemic absorption of drugs, which may increase the incidence of central nervous system and cardiovascular system toxic events caused by local anesthetics.EUS-CPN-related complications have not been clearly associated with local anesthetic adverse events.However, EUS-CPN local anesthetic injection area is located around the beginning of the abdominal trunk with abundant large and small blood vessels. The choice of local anesthetics with higher safety than bupivacaine, such as ropivacaine, is of great significance to ensure the safety of eus-cpn, especially for eus-cpn beginners.At present, there are no reports on the application of ropivacaine in eus-cpn.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18-75;
2. Athologically confirmed as pancreatic cancer and clinically evaluated as advanced and unresectable;
3. The visual analogue scale (VAS) for pain ≥ 4；
4. Never received treatment for peritoneal plexus lesion or block；
5. Voluntary signing of written informed consent

Exclusion Criteria:

1. Women during pregnancy；
2. Cannot or refuses to sign the informed consent；
3. Blood clotting disorder（PLT \<50 × 103/μL, INR \> 1.5）；
4. Celiac infection；
5. Severe esophageal or gastric varices and ulcers which may affect operation;
6. The anatomical variation of the abdominal trunk abdominal aorta and could not be accurately located;
7. Alcohol allergy
8. Severe cardiopulmonary dysfunction and inability to tolerate the risk of intravenous anesthesia;
9. History of mental illness;
10. Patients with other chronic and acute diseases with unstable conditions that are expected to affect the efficacy evaluation and completion of the study.
Muscle Wasting in Children and Adolescents With Cancer

The series of the 3-year study aims to explore parents' experience of caring for a child's weight change among parents of children and adolescents with cancer, examine the associations and trends among muscle wasting and health-related variables, and then implement and assess effectiveness of a multidisciplinary approach with a personalized physical activity (walking) training intervention on improving muscle mass and other health-related variables.

Specific aims, year by year

1. The aim for Year 1 is as follows:

   Aim 1: To explore parents' experience of caring for promoting a child's exercise among parents of children and adolescents with cancer.
2. The aims for Year 2 are as follows:

   Aim 2-1: To examine the associations between the degree of muscle wasting and health-related variables (fatigue level, symptom distress level, physical activity involvement, dietary intake, and QoL) among children and adolescents with cancer.

   Aim 2-2: To examine the trends of changes in muscle wasting and health-related variables (fatigue level, symptom distress level, physical activity involvement, dietary intake, and QoL) during the first 6 months of cancer treatment among children and adolescents with cancer.
3. The aim for Year 3 is as follows:

Aim 3: To examine the effectiveness of a multidisciplinary approach with a personalized walking exercise program on changes in body composition and health-related variables (fatigue level, symptom distress level, subjective physical activity involvement, objective physical activity measurement, dietary intake, and QoL) among children and adolescents with cancer.

Eligibility Criteria:
Inclusion Criteria:

* Aim 1:(1) parents of children diagnosed with malignancies at 3-18 years old, (2) whose children have received cancer treatment for at least 6 months, (3) who are the main caregivers, and (4) who are willing to participate in the study.
* Aim 2-1:(1) children and adolescents diagnosed with malignancies at 3-18 years old, (2) who are previously or currently treated for cancer, and (3) who are willing to participate in the study. Two hundred patients will be recruited.
* Aim 2-2:(1) children and adolescents diagnosed with malignancies at 3-18 years old, (2) newly diagnosed with cancer within the past 1 month, and (3) willing to participate in the study. One hundred participants will be recruited.
* Aim 3:(1) children and adolescents aged 3-18 years old and are undergoing treatment, and (2) who are willing to participate in the study.

Exclusion Criteria:

-Aim 1-3: Children and adolescents are under poor physical or cognitive conditions.
Using Smokeless Tobacco Products With Lower Nicotine Levels to Reduce Negative Effects of Smokeless Tobacco Use

Though spit tobacco is smokeless, it still affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. This study will assess the effectiveness of limiting smokeless tobacco (ST) nicotine intake in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake.

Spit tobacco presents as many health risks to its users as smoking tobacco. It affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. Long-term effects of spit tobacco use include tooth abrasion, gum recession, mouth disease, bone loss in the jaw, yellowing of the teeth, and chronic bad breath. Although a significant number of ST users recognize the importance of quitting, many either do not want to quit or feel it is impossible. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting, or as a treatment endpoint; however, approaches to help ST users reach this goal have not been studied. This study will assess the effectiveness of limiting ST nicotine intake in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake.

Participants in this open-label study will be randomly assigned to one of three treatment conditions: switching to an ST brand with less concentrated nicotine and controlling for ST use; switching to an ST brand with less concentrated nicotine, combined with no limit on ST intake; or continued use of usual ST brand with no limit on intake (control group). Participants in both brand-switching conditions will use ST brands that have 50% less nicotine than their usual ST brands for the first 4 weeks. For the next 4 weeks, participants in the brand-switching conditions will use ST brands that have 75% less nicotine that their usual ST brands. Study visits will ocur once weekly during the 8-week treatment period. The number of participants who do not complete treatment, reduce nicotine intake, or quit completely will be assessed at Week 8 and at follow-up visits, which will be held 12 and 26 weeks following the completion of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Not interested in quitting ST use within 90 days of study entry
* Has been using ST at least six times a day for 6 months prior to study entry
* Agrees to use an effective form of contraception throughout the study

Exclusion Criteria:

* Current use of other tobacco or nicotine products
* Pregnant or breastfeeding
* Any unstable medical condition
* Use of any medication that may affect tobacco use or be affected by reduction of tobacco use
* DSM-IV diagnosis of any psychiatric disorders or substance abuse disorders within 6 months prior to study entry
* Use of any psychotropic medications within 6 months prior to study entry
Individual Nurse-led Counselling Programme for Patients Early Discharged After Myocardial Infarction.

The European guidelines of cardiovascular disease prevention recommend treatment modalities, such as lifestyle changes in order to minimize the risk of further cardiac event after a myocardial infarction (MI). However, a considerable gap exists between guidelines and their implementation in clinical practise. Further, less is known about the impact of different interventions on patient's knowledge, skills and confidence necessary for self-management after MI.

Aim: To evaluate and compare the short- and long-term effects of an individual nurse-led counselling programme together with usual care for patients early discharged after MI on self-management behaviour.


Eligibility Criteria:
Inclusion Criteria:Patients with documented evidence of myocardial infarction during hospitalisation will be considered for inclusion.

* patients over 18 years old
* living at home in the local hospital area after hospital discharge
* able to receive telephone calls, fill in questionnaire and communicate in Norwegian.

Exclusion Criteria:

* cognitive impaired/dementia
* planning for coronary artery bypass graft surgery