cyrilzakka/clinical-trials huggingface dataset:
DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models

Currently, two ICU delirium prediction models are available: the PRE-DELIRIC model and the early prediction model (E-PRE-DELRIC). However, the use of these prediction models is not yet implemented as standard in clinical practice, as it is unknown which delirium prediction model can best be used to predict delirium in ICU patients.Therefore the main aim of this study is to compare the performance of the PRE-DELIRIC model and the E-PRE-DELRIC model.

Delirium often occurs in ICU patients and is associated with negative consequences, requiring prevention. A prediction model facilitates the identification of those patients at risk for delirium and therefore need prevention the most. At present, two ICU delirium prediction models are available. First the PRE-DELIRIC model was developed. This recently recalibrated model reliably predicts ICU patients' risk for delirium within 24 hours after ICU admission. Because a relevant number of patients develops delirium during the first 24 hours after ICU admission, and prevention ideally should be deployed as soon as possible, the investigators developed the 'early prediction model' (E-PRE-DELIRIC) which reliably predicts delirium immediately after ICU admission. To implement a delirium prediction model in clinical practice, one needs to know which model best can be used. Currently, the use of a delirium prediction model is not implemented as standard in clinical practice, as this information is unavailable. Therefore the main aim of this study is to compare the (predictive and clinical) performance of the PRE-DELIRIC model and the E-PRE-DELRIC model.

Eligibility Criteria:
Inclusion Criteria:

* ICU patients aged ≥18 years;
* Surgical, medical, neurology/neurosurgical, or trauma patients.

Exclusion Criteria:

* Delirious at ICU admission;
* Expected ICU stay shorter than 6 hours;
* Unable to reliably assess ICU delirium due to:
* sustained coma during entire ICU stay;
* unable to understand the language spoken;
* severely mentally disabled;
* serious receptive aphasia;
* serious auditory or visual disorders.
The Impact of Exergame on User Health

The purpose of this study is to examine whether exergame use can improve user health, in terms of physical fitness, self-rated mental health and physical health, and favorable attitude, strong intention, and actual behavior of future exercise. Moreover, this study also examines whether past exercise moderates the impact of exergame use on user health.

The main hypotheses are:

H1: Compared with the control group participants (who do not use exergame) the experimental group participants (who use exergame) have better change in physical fitness. The difference between these two groups in the amount of change is negatively related to past exercise.

H2: Compared with the control group participants (who do not use exergame) the experimental group participants (who use exergame) have better change in (a) mental health and (b) physical health after the intervention. The difference between these two groups in the amount of change is negatively related to past exercise.

H3: Compared with the control group participants (who do not use exergame) the experimental group participants (who use exergame) have better change in (a) attitude, (b) intention and (c) behavior of doing another exercise in the future. The difference between these two groups in the amount of change is negatively related to past exercise.

Eligibility Criteria:
Inclusion Criteria:

* junior and senior undergraduate student
* senior graduate student

Exclusion Criteria:

* asthma
* high myopia
* anemia
* vertigo
* cardiopathy
* hypertension
* unstable of intracranial pressure and blood pressure
* cardiac arrhythmia
* heart failure
* angor pectoris
* injury of vertebra
* ankylosing spondylitis
* hereditary cardiac arrhythmia
* musculoskeletal system injury
* glaucoma
* psychiatric disorders
Effect of Sildenafil Citrate Compared to Estrogen as Adjuvant Therapy for Unexplained Infertility

. This study aimed to determine and compare the effect of vaginal sildenafil citrate and estradiol valerate on endometrial thickness, blood flow and pregnancy rates in infertile women.

The study is a randomized controlled trial that was carried on 148 infertile women with unexplained infertility. Patients were divided into 3 groups. Group 1 included 48 patients who received oral estradiol valerate (Cyclo-Progynova 2mg, from day 8th till triggering of ovulation), another 50 patients in group 2 received oral Sildenafil (Respatio 20mg/12hr film coated tablets for 5 days starting from last day of menstruation till ovulation), while group 3 was the control one who included 50 patients were given ovulation induction with CC 50mg/12hr from 2nd to 7th day of cycle. Every patient underwent a transvaginal ultrasound to determine ovulation, number of follicles, and pregnancy rates. Miscarriage, ectopic pregnancy, and multiple pregnancies were tracked for 3 months, as were any adverse consequences.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 to 40 years
* unexplained infertility (primary or secondary)
* had a regular menstrual cycle;
* patent tubes;
* husbands with normal semen parameters.

Exclusion Criteria:

* hypotension;
* cardiovascular, hepatic, and renal diseases;
* uncontrolled diabetes mellitus;
* anovulatory infertility;
* ovarian cysts;
* pelvic adhesions;
* hyperprolactinemia;
* abnormal thyroid functions;
* multiple uterine fibroids;
* patients on nitrates;
* suspicion of endometriosis and adenomyosis,
* subjects have known to receive any treatment for fertility in the last six months
Feasibility Testing of a Tai Chi Program for Chemotherapy-Induced Peripheral Neuropathy Treatment (TCT)

This research is being done to determine whether a 12-week virtual Tai Chi training program, designed to improve balance and small nerve fiber function, is feasible and acceptable among cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN).

This is a prospective, randomized, waitlist-controlled pilot trial to examine the suitability of the virtual Tai Chi program in cancer survivors with CIPN. Tai Chi is a mind-body practice that involves gentle body movements, meditation, and breathing techniques. It has proven to be effective in enhancing balance control and relieving musculoskeletal pains.

This study randomly assigns cancer survivors with CIPN with self-perceived balance difficulties to one of two groups: Group A Tai Chi Group versus Group B Waitlist Group. Randomization means a participant is placed into a study group by chance.

The research study procedures including screening for eligibility, questionnaires, and sensory and functional testing.

Participation in this study is expected to last for up to 12 weeks.

It is expected that about 21 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Cancer survivors with no evidence of disease (cancer);
* Completed neurotoxic chemotherapy, i.e., platinum agents, taxanes, vinca alkaloids, and bortezomib, at least three months before enrollment;
* A CIPN diagnosis based on symptom history, loss of deep tendon reflexes, or presence of symmetrical stocking-glove pain, numbness, or paresthesia;
* Answers "yes" to the following question: "Do you feel as though your balance is affected from experiencing CIPN?" "Are you afraid of falling as a result of your CIPN?";
* On a stable regimen (no change in past three months) if taking anti- neuropathy or other pain medications; and
* ECOG Performance Status Scale score ≤ 2
* Willing to adhere to all study-related procedures, including randomization to the Tai Chi or waitlist group, two separate in- person visits to DFCI and Osher Center within 2 weeks of enrollment, and separate in-person visits to DFCI and Osher Center at week 12, and no new pain medication allowed throughout the study period.

Note: Participants receiving endocrine therapy or targeted/antibody therapy (examples including trastuzumab, perturzumab, immunotherapy) will be eligible.

Exclusion Criteria:

-Patients who have received physical therapy or Tai Chi training, specifically for CIPN, in the past three months.
Exercise for Anxiety

90 sedentary adults with a primary anxiety disorder and high anxiety sensitivity will be randomized to either 8 weeks of 1) low intensity exercise, or 2) flexible titration to high intensity exercise (HIE). Blinded, validated clinician-rated and patient-rated outcomes will be assessed over treatment and at 1- and 3-month follow-up. To better understand what mechanisms influence decisions to exercise in the real-world, we will use of heart rate (HR) as an objective mechanistic target for exercise intensity, examine changes in valuation of exercise through a neuroeconomics task, examine changes in interoceptive sensitivity with a heartbeat detection task, and integrate of ecological momentary assessment (EMA) to measure effects of immediate changes in mood with exercise on anxiety outcomes and adherence.


Eligibility Criteria:
Inclusion Criteria

* Males and females ages 18-65
* Primary psychiatric diagnosis of generalized anxiety disorder (GAD), social anxiety disorder, or panic disorder
* Anxiety Sensitivity Index-3 score of ≥23 (i.e., high anxiety sensitivity)
* Currently sedentary (≤60 minutes of moderate intensity exercise per week for the past 3 months)
* Body mass index \<40
* Able and willing to provide informed consent

Exclusion Criteria

* Lifetime history of Bipolar I or II or any psychotic disorder
* Bulimia or anorexia in the past 6 months
* Substance use disorder in the past 3 months
* Current PTSD (past PTSD is allowed)
* High current suicide risk (active suicidal ideation with plan and intent) as indicated by a score of ≥4 on the Columbia Suicide Severity Rating Scale (C-SSRS) consistent with a need for referral to higher level of care
The Combination of ATRA and Eltrombopag as the Treatment of Steroid-resistant/Relapse ITP Based on MSC-C5b-9

A Prospective, Randomized, Open-Label, Multicenter Clinical Trial study to compare the efficacy and safety of ATRA plus eltrombopag compared to eltrombopag monotherapy in the treatment of steroid-resistant/relapsed immune thrombocytopenia (ITP).

The investigators are undertaking a parallel group, multicenter, randomized controlled trial of patients with ITP in China. Patients were tested for MSCs, and they were divided into MSC-C5b-9+ group and MSC-C5b-9- group according to the test results, and the two groups were randomized to ATRA + eltrombopag and eltrombopag monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* 1. Isolated thrombocytopenia (platelet count \<30 × 109/L); 2. age \> 18 years; 3. normal white blood cells and red blood cells on bone marrow examination; 4. increased number of megakaryocytes (bone marrow examination was performed in all patients except for myelofibrosis or other conditions that can cause thrombocytopenia disease); 5. the spleen was normal in size; 6. Eastern Cooperative Oncology Group status score (ECOG score) ≤ 2; 7. ineffective or relapsed after at least 1 course of full-dose full-course hormone therapy; 8. Failure of prior ITP therapy (eg, hormones, splenectomy, and cyclosporine) and at least 4 weeks from enrollment.

Exclusion Criteria:

* 1. Secondary ITP such as drug-related thrombocytopenia; 2. thrombocytopenia due to viral infection (HIV, hepatitis B virus, or hepatitis C virus); 3. severe cardiac, renal, hepatic, or respiratory insufficiency; 4. severe immunodeficiency; 5. pregnancy or lactation; 6. myelodysplasia or Myelofibrosis; 7. history of malignancy; 8. ongoing immunosuppressive therapy for other diseases; 9. patients previously treated with eltrombopag were excluded from this study.
sST2 Biomarker Level in Acute/Chronic Coronary Syndrome After Revascularization

The role of soluble circulating suppression of tumorigenicity 2 biomarker (sST2) in the ischemic heart disease patient is a debatable point. Therefore the aims of this study are to assess the plasma level of sST2 in ischemic heart disease patients versus non-ischemic ones, the acute changes in its level after percutaneous coronary intervention (PCI) and its relation to the severity of ischemia.

A comparison of ischemic patients and non-ischemic controls will be done. The plasma level of sST2 will be withdrawn at baseline and 24-48 hours after the intervention in ischemic group. Then a study ischemic group will be divided into three subgroups; subgroup-1: single vessel disease, subgroup-2: two vessels disease and subgroup-3: multivessels disease. On admission, there will be a significant difference between the group of acute/chronic coronary syndrome cases and controls as regard sST2 plasma level or not. Moreover, the differences between the three ischemic subgroups at the baseline ST2 level will be assessed. The plasma sST2 level after PCI and the correlation between the acute change in pot-PCI sST2 level and the severity of ischemia by Modified Gensini Score (MGS) will be evaluated. The final question that will be answered by this study does the rapid impact of PCI on sST2 level will be mainly related to the severity of ischemia rather than left ventricular function or not.

Eligibility Criteria:
Inclusion Criteria:

* Any patients aged 40 years or more and have the risk factors of ischemic heart disease (IHD) with coronary artery disease symptoms will be included.
* For control subjects should be aged ≥ 40 years old with IHD risk factors including DM and HTN and without any symptoms or signs of cardiac ischemia.

Exclusion Criteria:

* Any patient with heart failure (EF \<50%), any patients with rhythm abnormalities including atrial fibrillation, obese patients, structural heart diseases, uncontrolled chronic diseases such as hypertension or diabetes mellitus, any pulmonary artery or parenchymal diseases up to respiratory failure, acute systemic infection or inflammation, and chronic/acute renal diseases.
Validation of a Multitask Deep Learning System at Spine Metastasis CT

15 resident oncologists were conducted to evaluate the clinical efficacy of DLS in multicenter. They were 1:1 randomly asked to independently read the test images without the assistance of DLS software or with the assistance. Area under the receiver operating characteristic curve (AUC), sensitivity, and specificity of the DLS were calculated with professional graders as the reference standard.


Eligibility Criteria:
Inclusion Criteria:

1. pathology-proven diagnosis of solid tumor;
2. spinal CT scan indicating spinal metastasis with at least one lesion;
3. no previous surgery for spinal metastasis

Exclusion Criteria:

1. spinal CT scans with no sagittal reconstruction;
2. the radiologist considered that the quality of CT image was unqualified.
Effects of Exercise and GLP-1 Agonism on Muscle Microvascular Perfusion and Insulin Action in Adults With Metabolic Syndrome

The primary objective of this study is to examine whether exercise training alone, liraglutide treatment alone or exercise training plus liraglutide treatment increases cardiac and skeletal muscle microvascular blood volume, improves vascular function of the conduit vessels, and enhances insulin's metabolic action in humans with Metabolic Syndrome. Subjects will be randomized to one of the 4 groups: control, exercise training, liraglutide treatment, and exercise + liraglutide. They will be studied at the baseline and then after 24 weeks of intervention.

Our hypothesis is that sustained activation of the GLP-1 receptor with Liraglutide and exercise training each will enhance microvascular insulin responses and angiogenesis in both cardiac and skeletal muscle to increase muscle insulin delivery and action and the combination of both is more effective than either alone in adults with metabolic syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥21 and ≤60 years old.
* Body mass index \>25 and ≤35 kg/m2 and is weight stable (\<5 kg weight change in the past 6 months). BMI is limited to ≤35 kg/m2 for easier vascular access and cardiac imaging.
* Meet 3 of 5 National Cholesterol Education Program Adult Treatment Panel III Metabolic Syndrome criteria:

  * Increased waist circumference (≥102 cm in men; ≥88 cm in women)
  * Elevated triglycerides (≥150 mg/dl)
  * Reduced HDL-cholesterol (\<40mg/dl in men, \<50 mg/dl in women)
  * High blood pressure (≥130 mmHg systolic or ≥85mmHg diastolic)
  * Elevated fasting glucose (≥100 mg/dl)
  * Subject may participate if on the following drugs, provided the drug doses have been stable for at least 3 months.
  * Ace inhibitor
  * ARB
  * HMG CoA reductase inhibitor
  * Beta blocker
  * Calcium channel blockers
  * Alpha-adrenergic antagonist
  * Statin

Exclusion Criteria:

* A diagnosis of any type of diabetes or history of diabetes medication use
* Recently active (\>20 min of moderate/high intensity exercise, 2 times/week)
* Subjects who are smokers or who have quit smoking \<5 years
* Subjects with hypertriglyceridemia (\>400 mg/dl) or hypercholesterolemia (\>260 mg/dl)
* Subjects with BP\>160/90
* Subjects with a history of significant metabolic, cardiac, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or malignancy
* Pregnant (as evidenced by positive pregnancy test) or nursing women
* Subjects with contraindications to participation in an exercise training program
* Allergic to perflutren
* A prior use of Liraglutide
9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED)

Bipolar disorder is characterized by mood swings that range from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. Patients who completed the 3 week trial (A7601004 or A7501005) continued on the same treatment that they received in the short term study: asenapine or olanzapine (a medication already approved for the treatment of bipolar mania) for 9 additional weeks. The short term studies (A7501004 and A7501005) were not unblinded until the 9 week extension study was unblinded. Patients treated with placebo in the 3 week short term study were crossed over and treated with Asenapine in the 9 week extension study. Patients who complete the 9 week extension study were eligible to continue in another extension (A7501007) study for an additional 40 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have completed an asenapine 3-week study for the treatment of an acute manic or mixed episode and not had a major protocol violation.in the short term study (A7501004 or A7501005) that they completed.

Exclusion Criteria:

* Patients with unstable medical conditions or clinically significant laboratory abnormalities.
Safety and Effectiveness of MPCD Therapy on the Treatment of Malignant Pleural Effusion

This is a prospective, open-label , multicenter randomized controlled trial, with 248 cases in 50 centers planned for a period of 2 years. The aim of the study is to evaluate the safety and effectiveness of microparticles packaging chemotherapeutic drugs (MPCD) therapy on the treatment of malignant pleural effusion (MPE) in patients with advanced lung cancer or breast cancer.

After obtaining informed consent, patients who meet the eligibility criteria will be randomly assigned 1:1 to treatment either with MPCD or recombinant human interleukin-2(rhIL-2) for injection. Randomization is stratified by tumor type and previous treatment. Patients in the MPCD group are first treated with microparticles packaging methotrexate (MPs-MTX) via intrapleural infusion four times on day5,6,7,8 and then undergo chemotherapy 1 cycle from day12. Patients in the control group are first treated with rhIL-2 via intrapleural infusion three times on day5,8,11 and then undergo chemotherapy 1 cycle from day12. After 4 weeks from the beginning of the treatment (day1 of treatment), the efficacy is assessed according to the WHO (1997) Response Evaluation Criteria In MPE and the evaluation methods mainly include physical examination, ultrasound and computed tomography (CT). The patients will be monitored by telephone every three months.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed as lung cancer or breast cancer;
2. Cytologically or histologically confirmed MPE needing thoracocentesis treatment;
3. Without thoracocentesis treatment within 4 weeks;
4. ECOG PS score: 0-2 points;
5. Predicted life expectancy greater than 3 months;
6. 18 years ≤Age ≤80 years；
7. Bone marrow function: hemoglobin(HGB) ≥90g/L，white blood cells(WBC) ≥3.0×10\^9/L，absolute neutrophil count(ANC) ≥1.5×10\^9/L，platelets (PLT) ≥80×10\^9/L，international standardized ratio (INR) \<1.5;
8. Hepatic function：alanine aminotransferase(ALT) and aspartate aminotransferase(AST) ≤2.5×ULN，serum total bilirubin≤1.5× ULN;
9. Renal function：blood urea nitrogen(BUN) and serum creatinine(Cr) ≤1.5×ULN, or endogenous creatinine clearance rate(Ccr) ≥60mL/min;
10. Without other severe cardiac disease or respiratory disease;
11. The volunteers voluntarily join the study, sign informed consent, and have good compliance and follow-up.

Exclusion Criteria:

1. Inappropriate to receive chemotherapy;
2. Women who are pregnant, preparing to be pregnant, breastfeeding;
3. Known or suspected hypersusceptibility to any agents used in the treatment protocol;
4. With severe cardiac disease, respiratory disease, liver disease, kidney disease, or diabetes;
5. With severe infection;
6. With severe encapsulated pleural effusion or intrathoracic tissue adhesion which is inappropriate to receive thoracocentesis;
7. With cognitive impairment or low compliance;
8. Participating in other clinical trials within 4 weeks;
9. Undergoing immunotherapy within 3 months;
10. Other conditions considered to be inappropriate to be enrolled by the investigator.