cyrilzakka/clinical-trials huggingface dataset:
The Effects of Physical Training and GLP-1 Receptor Agonist Liraglutide Treatment in Patients With Type 2 Diabetes

The objective of this study is to investigate the effects of physical training in patients with type 2 diabetes during treatment with the GLP-1 receptor agonist liraglutide (Victoza®) in a 16-weeks double-blinded, randomized placebo-controlled clinical trial.

Hypothesis: Physical training leads to better metabolic control in type 2 diabetic patients when training is combined with liraglutide (Victoza®) treatment.


Eligibility Criteria:
Inclusion Criteria:

* Informed oral and written consent
* Diagnosed with type 2 diabetes according to the criteria of the WHO
* HbA1C: 7-11% (doing treatment with diet and/or metformin)
* Age \>18 years
* BMI \>25 kg/m2 \<40 kg/m2
* Negative islet cell antibodies (ICA) and glutamate decarboxylase 65 (GAD- 65) autoantibodies

Exclusion Criteria:

* Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures.
* Subjects treated with sulfonylureas, dipeptidyl peptidase 4 (DPP-4) inhibitors, insulin or glitazones
* Ongoing abuse of alcohol or narcotics
* Impaired hepatic function (liver transaminases \>2 times upper normal limit)
* Impaired renal function (se-creatinine \>150μM and/or albuminuria)
* Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months
* Uncontrolled hypertension (systolic blood pressure \>180 mmHg, diastolic blood pressure \>100 mmHg)
* Anaemia
* Any condition that the investigators feels would interfere with trial participation
* Receiving any investigational drug within the last 3 months
Intermittent Fasting in Adults With Type 1 Diabetes

The majority of adults with type 1 diabetes (T1DM) have either overweight or obesity. As such, dietary management has been recommended as an adjunct to insulin treatment to improve glycemic control and facilitate weight loss in patients with T1DM. Daily calorie restriction (CR) is the main diet prescribed to patients with T1DM for weight loss. However, many patients find it difficult to adhere to CR because calorie intake must be vigilantly monitored every day. In light of these problems with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This diet is called "time restricted eating" (TRE) and involves confining the period of food intake to 6-8 h per day. TRE allows individuals to self-select foods and eat ad libitum during a large part of the day, which greatly increases compliance to these protocols. The simplicity of TRE, its accommodation of dietary preferences, and associated weight loss may translate to improved glycemic measures in patients with T1DM. The present study will be the first randomized controlled trial to compare the effect of TRE versus CR for weight management and improved glycemic control in adults with obesity and T1DM.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 75 years old
* BMI between 25 and 50 kg/m2
* Previously diagnosed with T1DM and currently using insulin
* HbA1c: 6.5-9.5% (regardless of medication use)
* On either multiple daily doses of insulin (MDI) program or using an insulin pump (with or without closed loop feature) 11
* Active prescription for glucagon

Exclusion Criteria:

* Previously diagnosed with T2DM
* Have a history of eating disorders (anorexia, bulimia, or binge eating disorder)
* Are not weight stable for 3 months prior to the beginning of study (weight gain or loss \> 4 kg)
* Are not able to keep a food diary for 7 consecutive days during screening
* Are eating less than a 10-hour window at baseline
* Are pregnant, or trying to become pregnant
* Are night shift workers
* History of severe hypoglycemia defined as requiring help from others, needed to use emergency glucagon administration in the past 6 months.
* Other significant medical history including heart failure, unstable coronary artery disease, chronic obstructive pulmonary disease requiring oxygen, cirrhosis, active cancer, history of stroke, end stage renal disease
Effects of Educational Training on Children With Developmental Delay

Using a single-blind, randomized controlled design to investigate the additional therapeutic effects of individualized educational training on traditional rehabilitation programs for preschool children with developmental delays.

A total of 20 preschool children with developmental delay who are receiving traditional rehabilitation programs will be enrolled.

The participants will be randomized into two groups, including the intervention group (traditional rehabilitation program with individualized educational training: one time per week, 50 min per session, with a total of 4 sessions in one month) and the control group (traditional rehabilitation program without individualized educational training).

Therapeutic effects, including pediatric daily activity, attention, cognitive function, functional performance, quality of life, and physical functional performance at baseline, after one month of treatment, and 3 months after the treatment, will be evaluated.

The evaluators will be blinded to the group's allocation during the whole course of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* preschool children with a diagnosis of developmental delay, under regular traditional rehabilitation programs, intelligence quotient 70 or greater

Exclusion Criteria:

* age less than 3 or greater than 6 of children diagnosed with developmental delay, under regular traditional rehabilitation programs, intelligence quotient 70 or greater
Prevention of Neural Tube Defects by Inositol in Conjunction With Folic Acid (PONTI Study)

The aim of the study is to develop a randomised, double blind clinical trial to compare (i) folic acid plus inositol, with (ii) folic acid plus placebo, for prevention of recurrent neural tube defects.

Women were eligible to join the PONTI pilot study if they had a history of previous NTD-affected pregnancy, were planning to become pregnant again, and were prepared to be randomised to one of the two study arms. Both study and control groups received 5 mg folic acid (the standard UK supplement for pregnancies at high risk of NTD); the study group additionally received 1 g inositol, whereas the control group was prescribed a placebo instead of inositol.

Eligibility Criteria:
Inclusion Criteria

1. Women with a history of one or more NTD pregnancies (spina bifida, anencephaly or encephalocele) who wished to embark upon a further pregnancy.

Exclusion criteria

1. Women who were unable to give informed consent for any reason (language difficulties, low IQ).

   Funding was not available to translate the information leaflets or to employ interpreters for the telephone interviews. It was intended to take appropriate measures to include these groups in a definitive follow-up trial.
2. Maternal age outside 18 - 40 years of age. An upper limit of forty years was stipulated because there is increased risk of a pregnancy being affected by chromosomal abnormality which may result in a NTD, but which may not be similarly susceptible to prevention by nutrient supplementation.
3. Cases where the previous affected child had abnormalities other than NTD, which might be suggestive of another underlying genetic aetiology, a chromosomal abnormality or fetal valproate syndrome. In these cases the underlying pathology would be different from spontaneous, isolated NTDs, and folic acid or inositol would not be expected to influence recurrence risk.
4. Women who were epileptic and/or taking anti-epileptic medications including valproate. It was recognised that some anti-epileptic drugs increase the predisposition to NTDs and, such NTDs might be unresponsive to inositol supplementation.
5. Women who did not have a GP or obstetrician in the UK. We needed to be able to monitor the pregnancy, confirm there were no contraindications to inositol supplementation, and seek outcome data. We did not have the facilities to seek this information for cases outside the UK.
6. Women would be required to stop participation in the trial if the following criteria were met whilst taking the prescribed drugs;

   * Diagnosed with epilepsy and were therefore required to take anti-epileptics.
   * Failed to conceive within one year of starting the trial.
   * They no longer wished to conceive .
Holter Monitoring of Critically-ill Childern in PICU at Sohag University Hospital

Holter Monitoring is a way to continuously check the electrical activity of the heart .

Continuous ECG recording show to be one of the most effective noninvasive clinical tools in the diagnosis of cardiac symptoms prognostic assessment and in the evaluation of many cardiac therapeutic intervention.

The clinical utility of ambulatory ECG lies in its ability to examine continuously a patient over an extended period of time, permitting patient ambulatory activity and facilitating the diurnal electrocardiographic examination of a patient in a changing environmental conditions (both physical and psychological) .


Eligibility Criteria:
Inclusion Criteria:

* 1- children admitted to pediatric department as in :
* Pediatric intensive care unit (PICU).
* Pediatric critical care unit (PCCU).
* Emergency room (ER). 2- Age from 1 month- 12 years. 3- Critical ill child fulfill these criteria:
* Persistent convulsions.
* Abnormal GCS
* Haemodynamic instability
* Foreign body inhalation
* Sever cardiac problem
* Irregular breathing
* DKA
* Others

Exclusion Criteria:1-Neonates 2-End-stage or those with end-organ failure . 3-Whom GCS is below 6. 4-Whom done cardiac catheterization for any purpose . 5-Previously done Holter. 6-Multiple traumatized patient.
A Study to Evaluate Efficacy and Safety of Epoetin Beta (NeoRecormon®) in Anemic Participants With Breast Cancer Undergoing Chemotherapy

This study will evaluate the efficacy and safety of subcutaneous (SC) epoetin beta in anemic participants with breast cancer undergoing chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult female participants with histological diagnosis of breast cancer
* Any type of chemotherapy planned for greater than or equal to (\>/=) 9 weeks
* Hemoglobin level less than (\<) 11 grams per deciliter (g/dL)
* Participants able to receive iron supplement, if necessary

Exclusion Criteria:

* Known or suspected contraindications to epoetin beta
* Pregnancy or lactation period
* Diagnosis of anemia only due to iron-deficiency
* Diagnosis of thalasemic syndromes
* Epilepsy and/or cerebral metastasis
* Blood transfusion or treatment with any erythropoietic factor within 4 weeks before study start
Discontinuation Order of Vasopressors in Septic Shock

The purpose of this study is to evaluate the incidence of hypotension based on the discontinuation order of norepinephrine and vasopressin in patients receiving concomitant norepinephrine and vasopressin infusions for the treatment of septic shock.

There are little data regarding the discontinuation of vasopressors in patients with septic shock. Therefore, the investigators intend to evaluate the incidence of hypotension based on the discontinuation order of norepinephrine and vasopressin in patients receiving concomitant norepinephrine and vasopressin infusions for the treatment of septic shock.

Eligibility Criteria:
Inclusion Criteria:

* patients 20 years of age or older
* patients of receiving concomitant therapy with norepinephrine and vasopressin for teh management of septic shock
* patients began to reduce the vasopressor

Exclusion Criteria:

* patients who expired or had care withdrawn while receiving norepinephrine and vasopressin
* patients being transferred into the ICU from an outside facility or the operating room
* patients who are suspected to have vasopressin deficiency (eg. HPA axis dysfunction, empty sella)
* acute myocardial infarction or Congestive heart failure (NYHA functional classification III or IV)
* acute mesenteric ischemia
* patients who were received other vasopressor except for norepinephrine or vasopressin
Safety and Therapeutic Drug Monitoring of Cefazolin in Continuous Renal Replacement Therapy

This investigation is intended to collect safety information for the technique of mixing cefazolin in the CRRT solution on the CRRT circuit, the patient, in addition to collecting information regarding the ability to obtain therapeutic cefazolin serum concentrations

This investigation is intended to collect safety information for the technique of mixing cefazolin in the CRRT solution on the CRRT circuit, the patient, in addition to collecting information regarding the ability to obtain therapeutic cefazolin serum concentrations in addition to utilizing a dosing algorithm to adjust the cefazolin concentration in the CRRT solution.

Eligibility Criteria:
Inclusion Criteria:

Patients eligible to participate in the study must have a need for continuous renal replacement therapy (CRRT) of any modality:

1. CVVH-continuous veno-venous hemofiltration
2. CVVHD-continuous veno-venous hemodialysis
3. CVVHDF-continuous veno-venous hemodiafiltration

Exclusion Criteria:

Patients will be considered ineligible if they meet any of the following criteria:

1. History of any moderate or severe hypersensitivity or allergic reaction to cefazolin (a history of mild rash followed by uneventful re-exposure and/or red man syndrome is not a contraindication)
2. Any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator)
3. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data
4. Females that are pregnant or breastfeeding
Efficacy of Two Bolus Doses of Remifentanil on the Incidence of Coughing During Emergence of Anesthesia

This study is designed to compare the effects of two bolus doses of intravenous remifentanil given prior to the emergence of anesthesia:

* on the incidence of perioperative coughing
* on the time needed for the emergence of a desflurane-based anesthesia
* on the incidence of sore throat after extubation.

The investigators hypothesis is that the use of a higher remifentanil bolus dose (0.5 mcg/kg) given prior to emergence of a desflurane-based anesthesia will reduce the incidence of perioperative coughing when compared to a lower dose of remifentanil (0.25 mcg/kg).

Emergence is an important period of general anesthesia during which several problems can occur. Coughing, hypertension, tachycardia and agitation have been observed during emergence of general anesthesia.

Most patients will cough during emergence. Different techniques and drugs have been studied to reduce coughing during emergence.

There is some evidence supporting the administration of intravenous opioids prior to emergence of general anesthesia to reduce perioperative coughing, agitation and haemodynamic stimulation. However, depending on the type of opioids given, this may delay the emergence from anesthesia. The effect of a remifentanil infusion given in combination with isoflurane as the volatile agent has been shown to reduce the incidence of perioperative coughing without delaying the emergence of anesthesia. The effect of a small bolus of remifentanil given prior to emergence to prevent perioperative coughing has yet to be studied.

Desflurane is a newer volatile agent allowing early recovery from anesthesia. This agent has led to earlier discharge and more rapid resumption of normal activities after surgery. However, an incidence of coughing around 70% has been reported after a desflurane-based anesthesia.

This study will compare the effects of two bolus doses of remifentanil (0.25 mcg/kg to 0.5 mcg/kg) when given prior to emergence to prevent perioperative coughing after a desflurane-based anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80 years
* Physical status 1-3
* Patients undergoing elective surgery under general anesthesia requiring endotracheal intubation (excluding head and neck surgery)

Exclusion Criteria:

* Current use of ACE inhibitors
* Chronic cough
* Asthma or severe pulmonary disease
* Pulmonary tract infection
* Anticipated difficult intubation
* Current use of opioids
* Current use of cough medicine
* Contraindication to remifentanil
* Pregnancy
* Symptomatic cardiac, renal or hepatic disease
Attention Bias Modification Training for Social Phobia (ABMSP)

Attentional bias has primarily been investigated as a primary cognitive etiology of social anxiety symptoms. Previous research has found that individuals with high social anxiety showed facilitated attentional engagement to threat stimuli or delayed disengagement of attention from threat. Attentional Bias Modification Training (ABMT) was developed through applying the attentional mechanism in social anxiety. During ABMT, participants are deliberately induced to shift their attention away from threat stimuli and toward neutral stimuli. Despite its proven effectiveness, a recent meta-study found that the effect size of ABMT is significant but too small. As a result, the current study focuses on improving the existing ABMT by incorporating integrative factors into attention training. The current study aims to integrate bottom-up and top-down cognitive processes in ABMT. Participants will be randomly assigned to one of two conditions (active or placebo training) and will complete the ABMT for three weeks. The ABMT's efficacy will be assessed by comparing pre- and post-training measures.

Individuals with at least mild level of social anxiety symptoms will be invited to the current study. Participants will be randomly assigned to one of the two attention training conditions: a Integrated Attentional Bias Modification (I-ABM) training or placebo training (PLT). Before and after the training, participants will complete computerized tasks (e.g., attention network task, dot-probe task) and self-report questionnaires.

The basic design of I-ABM training will follow the dot-probe task, which will ask participants to swipe or tap on the probe in the correct direction. The I-ABM training aims to shift attention away from threatening stimuli or improve the inhibitory control ability. The PLT training will have the same basic design, but this will not include therapeutic components. Participants will complete the training three times per week for three weeks (a total of 9 training sessions), and there will be post-training and a 2-week follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of social anxiety disorder (based on the DIAMOND interview - Social anxiety module)
* Moderate or severe symptoms of social anxiety as revealed by the Liebowitz Social Anxiety Scale (LSAS score of ≥ 40) or MINI-SPIN (Score of ≥ 6)
* Ages 18-60
* English as a primary language
* Possession of a mobile device for access to the app (Inquisit 6)

Exclusion Criteria:

* Self-reported visual impairment that cannot be adjusted and will prevent them from clearly recognizing words and pictures on mobile screen
* Self-reported history of a bipolar disorder or psychotic disorder
Treatment of Acute Myeloid Leukemia With Arsenic and All-trans Retinoid Acid

The clinical trial was designed to prove that Arsenic plus ATRA possibly had an effect on improving the symptoms, reducing the early mortality rate and prolonging the total survival time of patients with newly diagnosed or relapsed AML.

Acute myeloid leukemia (AML) is a genetically heterogeneous disease with a highly variable prognosis and an overall high mortality rate. The 5-year overall survival of adult AML patients is less than 50%, and only 20% of elderly patients survive over 2 years. Acute promyelocytic leukemia (APL) accounts for 10% - 15% of acute myeloid leukemia. Arsenic and ATRA are very effective treatments for APL, a distinct AML subtype characterized by the expression of the PML/RARA fusion protein. PML/RARA expression disrupts PML NBs and blunts p53 signaling, which contributes to increased self-renewal of myeloid progenitors. The application of all-trans retinoic acid (ATRA) and arsenic modifies APL from highly fatal to highly curable. Both RA and arsenic induce degradation of PML/RARA through distinct pathways. Nucleophosmin-1(NPM1) is the most frequently mutated gene in acute myeloid leukemia (AML). According to El Hajj's research, RA or arsenic trioxide synergistically induces proteasomal degradation of mutant NPM1 in AML cell lines or primary samples, leading to differentiation and apoptosis. Combined ATRA/arsenic treatment significantly reduced bone marrow blasts in 3 AML patients and restored the subnuclear localization of both NPM1 and PML. Overall, there is no consensus yet as to whether the addition of ATRA/arsenic improves the outcome of patients with NPM1 mutant AML. However, it still needs clinical research to confirm. The investigators design a clinical trial to prove that arsenic plus ATRA is possibly improving the symptoms of AML patients, reduce early mortality, and extending overall survival time.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed or relapsed AML.Diagnosis based on Chinese guidelines for diagnosis and treatment of adult acute myeloid leukemia(not APL)(2018)
* Older than 18 years old
* Patients or their families signed written informed consent

Exclusion Criteria:

* Be allergic to the drug ingredient, the supplementary material or the allergic constitution person
* Cardiac insufficiency, renal insufficiency, significant arrhythmias, EKG abnormalities or other important organ dysfunction
* Combined with other malignant tumors
* Pregnant and lactating women
* Participants in other drug trials in the last 3 months
* Suffering from mental illness or other circumstances which unable to carry out the plan
* Other patients who were not suitable for the study
Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Fentanyl

The purpose of this project is to test how fentanyl, an analgesic currently employed in the pre-hospital setting by the US Army, alters the capacity to tolerate a hemorrhagic insult in humans.

Pain management on the battlefield is critical for the wellbeing of the soldier. Given that a hemorrhagic injury on the battlefield is virtually always associated with pain, it is paramount that the selected pain medication does not disrupt appropriate physiological mechanisms that are beneficial towards the maintenance of blood pressure and vital organ blood flow during that hemorrhagic insult. Current guidelines for the selection of pain medications of a hemorrhaging soldier are based upon limited scientific evidence, with the vast majority of supporting studies being conducted on anesthetized animals. Thus, the interaction between hemorrhagic shock and pain medications commonly employed on the battlefield is yet to be determined in the conscious humans.

With this background, we will test the hypothesis that fentanyl will impair the capacity for a conscious human to tolerate a hemorrhagic insult.

The obtained data will provide the necessary scientific evidence in humans to support the Committee on Tactical Combat Casualty Care (CoTCCC) guidelines on the analgesic of choice for moderate to severe injuries where the casualty is in hemorrhagic shock. Notably, such data will identify the analgesic that least compromises a human's ability to tolerate a hemorrhagic insult, ultimately providing critical information to the combat medic on which analgesic should be employed for such an injury.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Non-obese (body mass index less than 30 kg/m2)
* Body mass greater than or equal to 65 kg

Exclusion Criteria:

* Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
* Any known history of renal or hepatic insufficiency/disease
* Pregnancy or breast feeding
* Current smokers, as well as individuals who regularly smoked within the past 3 years
* Positive urine drug screen
* Currently taking pain modifying medication(s)