cyrilzakka/clinical-trials huggingface dataset:
Intracoronary Autologous Stem Cell Transplantation in ST Elevation Myocardial Infarction: TRACIA STUDY.

The purpose of this study is to evaluate the ejection fraction (EF) increase at 6 months follow up and major adverse cardiovascular events (MACE) after intracoronary autologous stem cell transplantation in ST elevation myocardial infarction patients versus a control group.

Experimental trials with bone marrow cell have suggested that adult stem cell can contribute to regeneration of infarcted myocardial muscle and increase the neovascularization of the ischemic tissue.

Post-myocardial infarction heart failure secondary to ventricular remodelation it's an increasing problem. A novel therapeutic approach for decrease this consequence is to induce the angiogeneses and regeneration of myocardial cells.

Many trials have shown benefits through the intracoronary injection of stem cell, however the clinical benefit is still controversial. The present trial is a randomized single blinded controlled trial designed to evaluate the improvement on EF and survival in post ST elevation myocardial infarction patients undergoing to intracoronary autologous stem cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Both gender patients between 20 and 75 years old with an acute myocardial infarction (less 24 hrs of symptoms) undergoing to primary angioplasty.
* LVEF \< o = 45% by MRI, radioisotopic ventriculography or echocardiogram.
* Informed written consent.

Exclusion Criteria:

* Cardiogenic Shock.
* Post-myocardial infarction mechanical complication
* Malignant ventricular arrythmias
* History of malignant disease during the last five years.
* Pregnancy
* Renal chronic disease with a creatinine level \> 2.6 mg/dl.
* Any kind of stroke during the last year.
* Any chronic disease that can affect the patient survival during the trial.
Evaluation of DEX-IN During Outpatient Procedures

The primary objective of this study is to evaluate the analgesic efficacy of DEX-IN compared with placebo and active control (fentanyl), in subjects undergoing painful outpatient and office based procedures.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily provide written informed consent
* Be planned to undergo a selected office-based or outpatient procedure
* Be naïve to the planned procedure, i.e. no repeated or revision procedures
* Not pregnant or planning to become pregnant, or using appropriate contraceptive measures.

Exclusion Criteria:

* Known allergy to any study treatment or excipient
* Have another painful physical condition or anxiety related diagnosis that may confound study assessments
* Evidence of a clinically significant finding on physical examination, laboratory assessment, or ECG
* Have signs or a history of significant nasal condition that may interfere with intranasal drug delivery
Mindfulness to Reduce Ambulatory Hypertension in Atrial Fibrillation

The aim of this study is to evaluate the effectiveness of a 16 week mindfulness-based coaching program compared to a cardiovascular risk reduction education program.

Both groups will undergo 24-hour ambulatory blood pressure monitoring, along with assessments of psychological measures (see bellow) at study baseline, midpoint (8 weeks), and conclusion (16 weeks).

In addition, both groups will also undergo 24-hour Holter monitoring assessments at study beginning and conclusion to assess possible episodes of atrial tachyarrhythmia during the assessed interval.


Eligibility Criteria:
Inclusion Criteria:

* Age 50-80
* Diagnosed Atrial Fibrillation
* Night time (Sleep Time) Systolic Blood Pressure≥120 OR Daytime (awake) Systolic Blood Pressure ≥ 135
* Able and Willing to sign Informed Consent Form

Exclusion Criteria:

* Scheduled for Surgery
Mobile Observation Of Depression

The primary aim of this project is to test if OCOsense glasses can function as a digital phenotyping tool derived from behavioural and physiological signals related to facial expression and motion recorded using the glasses.

Assessment of participants living with a DSM5 research diagnosis of Bipolar disorder or Major depressive disorder as well as healthy controls who will be recruited and characterised through precision phenotyping involving cross-sectional assessment of biobehavioural and physiological markers of the symptoms of depression. Correlations between objective (i.e., OCOsense glasses captured) and subjective (i.e., self-reported) symptoms of depression will be measured within as well as across diagnoses. The resulting biobehavioral clusters will form the building block of a digital phenotyping tool based upon the wider spectrum of non-verbal behaviours and physiology defined and affected by the phenotype of depression.

Eligibility Criteria:
Inclusion Criteria:

All participants:

* Ability to read \& understand English. This is because the majority of our questionnaires are validated in the English language only.
* Able to walk, sit, lay and stand unaided

Clinical cases:

● ≥ 15 on the Patient health Questionnaire-9 (PhQ9) (moderate to severe depression)

Exclusion Criteria:

Healthy control participants:

* Self-reported current or past history (suspected or diagnosed) of any psychiatric condition
* \<5 on the Generalised Anxiety Disorder-7 questionnaire (GAD-7)
* \<5 on the PhQ-9 (no depression)
* Receiving medication for any psychiatric disorder (excluding fibromyalgia)

All participants:

* \< 18 years of age or \>40 years of age
* Anatomical constraints that affect fit (e.g. facial disfigurement)
* Facial nerve damage which limits the ability to make facial expressions
* Body Mass Index (BMI) \>29.9 which we deem may affect physical mobility
Tbit System Precision and Correlation of Different Blood Samples

The Tbit™ System will detect S100B and GFAP concentrations with the blood specimen to produce and compare repeated measures from 3 blood samples from 3 fingersticks from one subject and one 1 venous whole blood sample will be collected from the same subject, on 3 different Tbit™ System by 3 different operators.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Presents to the Emergency Department with suspected traumatic brain injury
* Blood sample collected for Tbit™ System within 12 hours of injury
* Willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)

Exclusion Criteria:

* Suspect of ischemic or hemorrhagic stroke with subsequent incidental trauma based on ED examination
* Subject suspect of need of craniotomy for the acute trauma for this event
* External signs compatible with a depressed skull fracture based on ED exam
* Subject requiring administration of blood transfusion after injury and prior to study blood draw
* Subject for whom timing of injury is unable to be estimated within 1 hour of certainty
* Subject who had neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizures, brain tumors, stroke or TIA within the last 30 days, or history of neurosurgery
* Known or suspected to be pregnant
* Prisoner or under incarceration
* Participating in another clinical research study prior to this study completion
Multicenter Prospective Cohort Study of Risk Factors for Gallbladder Cancer

This trial is a prospective study, the main purpose of the study is to investigate the association between benign gallbladder disease and gallbladder carcinoma; to explain the timing of intervention, intervention and early prevention of benign gallbladder disease; according to the national epidemiology of gallbladder cancer Center Clinical Research (unpublished), 2000 National Cholecystoma Clinical Epidemiology Report, and 2005 Clinical Analysis of 2379 Cases of Gallbladder Carcinoma in 17 Hospitals in Five Northwest Provinces, Pre-experimental data, using samples The volume estimation formula, α = 0.05, β = 0.1, plans to enroll 100,000 people.Half of participants is someone with Biliary benign disease，while the other half is healthy.

Gallbladder cancer is the most common malignant biliary tract tumor. The main risk factors for gallbladder cancer include gallstones, gallbladder polyps, gallbladder adenomas, chronic inflammation of the gallbladder, etc. However, recently, there is still a lack of evaluation data on relevant risk factors. Therefore, on the basis of large-scale epidemiological investigations, large-scale prospective studies are needed to further clarify the level of risk factors associated with gallbladder cancer. With the development of modern imaging technology and deep understanding of gallbladder diseases, the detection rate of benign gallbladder lesions (cacerous polyps, gallbladder adenomyosis, gallbladder adenoma, gallstones, etc.) has increased year by year, and some benign gallbladder lesions can pass A series of pathophysiological processes have gradually evolved into gallbladder cancer. This study aimed to establish a prospective cohort of benign gallbladder disease, to explore the correlation, intervention time and socioeconomic benefits of benign gallbladder disease and gallbladder cancer. In order to further understand the current trend and diagnosis and treatment of benign gallbladder disease in China, the Chinese Society of Surgery Branch of the Chinese Society of Surgery will launch a national epidemiological survey of gallbladder cancer (2018). This study will provide a more detailed basis for the diagnosis and treatment of benign gallbladder disease in China.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who met the following four criteria entered the study.

  1. A benign gallbladder disease is detected during a medical examination or visit (according to any imaging test);
  2. healthy people without gallbladder disease;
  3. Age greater than 18 years and less than 80 years old;
  4. Sign the informed consent form. PS: If someone meets the condition (1) or (2), then he can be enrolled.

Exclusion Criteria:

* Subjects can not enter the study by combining any of the following

  1. Concomitant diseases such as severe mental illness, severe heart, lung and kidney;
  2. Refusal of follow-up requirements.
Safety, Tolerability, Immunogenicity And CPG Dosage Finding Study of Novartis CpG Adjuvanted Flu Vaccine

To evaluate the safety and tolerability of the an adjuvanted influenza vaccine combined with CpG7909 at three different doses of CpG 7909 as a single intramuscular (IM) administration in healthy adults. Safety will be assessed by observation of symptoms, physical examination findings and laboratory safety testing.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects aged 18 to ≤40 years

Exclusion Criteria:

* Any serious disease, hypersensitivity to egg or vaccine components, neurological symptoms or positive antibody test against dsDNA, RF, ANA or thyroid.
* Abnormal TSH from blood samples collected during the screening visit;
Elective Induction of Labour at Thirty Nine Weeks: a Prospective Observational Study

Adverse events are considered to increase in pregnancies extending beyond 39 weeks.

For multiparous patients, especially those with a favourable cervix, it is perhaps easy to justify an elective induction at 39 weeks given the low risk of caesarean section.

However, for nulliparous patients the current evidence, derived mainly from retrospective observational studies, does not allow a clear recommendation with the exception perhaps of the recent A Randomized Trial of Induction Versus Expectant Management (ARRIVE) trial. Given the reported increased risks of adverse events in pregnancies extending beyond 39 weeks it has been hypothesized that a policy of planned elective induction at 39 weeks could improve outcomes for the infant and the mother. There is a trend towards an increased rate of elective labour induction in pregnancies at 39 weeks, indicating that practitioners are more commonly using elective induction at this gestational age. The practice in India varies slightly from institute to institute.

The investigator intend to study the maternal and perinatal outcome, after elective induction of labour, at thirty nine weeks and zero days upto thirty nine and six days, amongst nulliparous singleton pregnancies followed up for the duration of their hospital stay, in Jubilee Mission Medical College and Research Institute (JMMC and RI).


Eligibility Criteria:
Inclusion Criteria:

1. Nulliparous - no previous pregnancy beyond 20 weeks
2. Singleton gestation.
3. Undergoing elective induction between 39weeks and 0days -39weeks and 6 days based on clinical information and evaluation of the earliest ultrasound as described in Gestational Age
4. Consenting to be part of the study

Exclusion Criteria:

1. Plan for caesarean delivery or any contraindication to vaginal delivery
2. Foetal demise or known major foetal anomaly
Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation - Part 2

In previous studies, investigators have studied if a pre-meal insulin bolus based on estimated carbohydrate meal size would alleviate the burden of carbohydrate counting without a significant degradation in postprandial glucose control. With this strategy, the patient would only have to evaluate the size of the meal in terms of carbohydrate (snack, regular, large or very large). It is however important to establish the safety of this simplified meal bolus approach. The safety of overestimating a meal insulin bolus in the context of closed-loop strategy needs to be assessed. For ethical reasons, only dual-hormone closed-loop will be tested.

Investigators hypothesize that dual-hormone closed-loop with overestimated meal size bolus will not increase time below 4.0 mmol/L compared to dual-hormone closed-loop with an adequately estimated meal size bolus.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥ 18 years old.
2. Clinical diagnosis of type 1 diabetes for at least one year.
3. The subject will have been on insulin pump therapy for at least 3 months and currently using a fast acting insulin analog (Lispro, Aspart or Glulisine).
4. Last (less than 3 months) HbA1c ≤ 10%.
5. Currently using carbohydrate counting as the meal insulin dose strategy.

Exclusion Criteria:

1. Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
2. Recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
3. Pregnancy.
4. Severe hypoglycemic episode within 1 month of screening.
5. Agents affecting gastric emptying (Motilium®, Prandase®, Victoza®, Byetta® and Symlin®) as well as oral anti-diabetic agents (Metformin, SGLT-2 inhibitors and DPP-4 inhibitors) if not at a stable dose for 3 months. Otherwise, these medications are acceptable and will be kept stable during the entire protocol.
6. Oral steroids unless patients present a low stable dose (e.g. 10 mg or less of prednisone per day or physiological doses, less than 35 mg/day, of hydrocortisone Cortef®). Inhale steroids at stable dose in the last month are acceptable.
7. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator (e.g. unstable psychiatric condition).
8. Failure to comply with team's recommendations (e.g. not willing to change pump parameters, follow algorithm's suggestions, etc).
Antidepressant Controlled Trial for Negative Symptoms in Schizophrenia

The aim of this double-blind, placebo-controlled trial is to establish the clinical and cost effectiveness of an SSRI antidepressant, citalopram, in the management of persistent negative symptoms of schizophrenia over a year.

The negative symptoms of schizophrenia represent an important dimension of psychopathology, and reflect the absence or diminution of normal behaviours and functions. They include deficiencies in emotional responsiveness, drive, and emotional and social engagement. Persistent negative symptoms are held to account for much of the long-term morbidity and poor functional outcome in patients with established schizophrenia, but if they prove resistant to antipsychotic medication there is a very limited evidence base regarding specific treatments. The aim of this double-blind, placebo-controlled trial is to establish the clinical and cost effectiveness of an SSRI antidepressant, citalopram, in the management of negative symptoms of schizophrenia over a year. The study sample will be adults with a diagnosis of schizophrenia, clinically stable for 3 months with a consistent antipsychotic regimen, and characterised by persistent negative symptoms to a criterion level of severity.

Eligibility Criteria:
Inclusion Criteria:

* An OPCRIT (Operational Criteria Checklist for Psychosis: 57) diagnosis of schizophrenia, schizophreniform, schizoaffective disorder or psychosis NOS as defined by DSM-IV.
* A negative subscale score of 20 or more on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS). At least three of the seven items on the negative symptom subscale should be rated 3 or more.
* Age 18-75 years, inclusive
* Clinically stable for the last 3 months with a consistent antipsychotic regimen.
* Competent and willing to provide written, informed consent.

Exclusion criteria:

* Any medical contraindications to an SSRI antidepressant.
* Currently receiving antidepressant or clinician wants to treat with an antidepressant;
* Taking any medications that risk interacting with citalopram
* Known congenital long QT syndrome, congestive heart failure, bradyarrhythmias
* QT limit above the upper limit of normal as determined by an electrocardiogram (ECG)
* Serum potassium and/or magnesium levels below the lower limits of normal
* Currently fulfil criteria for major depressive disorder; alcohol/substance hazardous use or dependence in past 3 months
* Treated with ECT in the last 8 weeks.
* Pregnant or planning to become pregnant
* Cognitive or language difficulties that would preclude subjects providing informed consent or compromise participation in study procedures.
* Lack of consent, as judged by the patient's psychiatrist
Dependence of LV Hemodynamics on Pacing Site

The purpose of this study is to evaluate the effects of epicardial and endocardial pacing at each side of the left ventricular (LV) segments on cardiac hemodynamics in patients with impaired LV function undergoing epicardial ablation and mapping procedure. Hemodynamic function will be assessed during a pacing protocol with a pressure catheter inserted in the LV.


Eligibility Criteria:
Inclusion Criteria:

* Patient is already indicated for epicardial mapping and ablation of arrhythmia(s) utilizing a transcutaneous subxiphoid approach
* Be in sinus rhythm
* Have LVEF \< 40%
* Have the ability to provide informed consent for study participation and be willing and able to comply with the CIP (Clinical Investigational Plan) described evaluations

Exclusion Criteria:

* Have permanent AF
* Have pericardial disease
* Have a recent myocardial infarction within 40 days prior to enrollment
* Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
* Have had a recent CVA or TIA within 3 months prior to enrollment
* Be less than 18 years of age
* Be pregnant
Exploring the Effect of Visual Feedback on Motion Trajectory in a Virtual Reality Environment.

The rehabilitation intensity and frequency of upper extremities of stroke patients is insufficient. Virtual reality technique may solved this problem. The investigators want to build up the motion trajectory system by head-mounted display virtual reality technique, and to explore the effect of visual feedback on motion trajectory in a virtual reality environment.

How to increase the rehabilitation intensity in the critical rehabilitation window for stroke patients (half year since onset) was very important. The training intensity and frequency of upper extremities is insufficient. The proprioceptive neuromuscular facilitation (PNF) movements of upper extremities are applied to all daily upper extremities movement. The goals of this study are that the investigators want to build up the motion trajectory system by head-mounted display virtual reality technique, and the investigators want to explore the effect of visual feedback on motion trajectory in a virtual reality environment. The investigators will record the motion patterns, motion trajectory and the deviation of position and angle comparing to the normal PNF movement pattern to analyze the motion accuracy.

Eligibility Criteria:
Stroke patients Inclusion criteria

1. Age:20\~100y/o.
2. Stroke onset time \> 1 week, and neurological status and medical condition are stable.
3. Brunnstrom stage III to V.
4. Can follow order.

Exclusion criteria

1. Crucial organ failure, including heart, lung, liver, and kidney.
2. Brain operation and epilepsy.
3. Severe metal illness and aphasia, so cannot follow order
4. Feel uncomfortable while using virtual reality.
5. Crucial eye problems, including color-blind, weak color, cataract, glaucoma, etc.
6. Mental illness, neuro-musculoskeletal system lesions, vertigo, claustrophobic.
7. Illness and pain to affect upper extremities movement.

Healthy people Inclusion criteria

1. Age:20\~100y/o.
2. No pain to affect upper extremities movement.

Exclusion criteria

1. Feel uncomfortable while using virtual reality.
2. Crucial eye problems, including color-blind, weak color, cataract, glaucoma, etc.
3. Cognition impairment, history of mental illness, neuro-musculoskeletal system lesions, vertigo, claustrophobic.
4. Epilepsy.
Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

This is a 3-arm, prospective, randomized, double-blind, and controlled clinical study, with 3 months of treatment to evaluate efficacy of DLBS1033 in bleeding profile and clinical outcome in patients with acute ischemic stroke compared with aspirin and clopidogrel, as active controls.

There will be 3 groups of treatment; each group will consist of 43 subjects with the treatment regimens :

* Treatment I : 1 tablet of DLBS1033 490 mg thrice daily, after meal
* Treatment II : 1 tablet of aspirin 80 mg once daily, after meal
* Treatment III : 1 tablet of clopidogrel 75 mg once daily, after meal

Bleeding profile (by measuring INR value, PT, and aPTT) and clinical outcome (by measuring Gadjah Mada Stroke Scale and Barthel Index) to evaluate the efficacy of the investigational drug will be performed at baseline and end of study (Month 3rd). General condition of the subjects will be followed-up every month over three months of study medication.

Physiotherapy will be provided to the subjects by the assigned Physiotherapist.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 20-80 years old
* Having non-bleeding stroke in CT scan examination
* Having stroke attack onset ≤ 96 hours
* Living in 100 km from RSUP Dr Sardjito Jogjakarta

Exclusion Criteria:

* Having recurrence stroke
* Having Transient Ischemic Attack (TIA)
* Have been regularly taking anti-aggregation agent
* Having intracerebral and subarachnoid bleeding stroke
* Subjects and their family do not know when the stroke symptoms appeared
* History of haemostasis disorder
* History of or will have surgery within 6 months prior to screening