cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury

This is a multicenter, randomized, placebo-controlled study to evaluate AVP-786 for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in participants with traumatic brain injury (TBI).

Eligible participants for this study must have a diagnosis of neurobehavioral disinhibition including aggression, agitation, and irritability that persists after brain injury.

This is a multicenter, randomized, placebo-controlled study, consisting of up to 12 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Participants with TBI
* Participants with neurobehavioral disinhibition symptoms that are present after trauma or after recovery of consciousness
* Score of ≥4 on the mCGI-S scale and the Agitation/Aggression or Irritability/Lability subscales of the Neuropsychiatric Inventory (NPI) scale at screening and baseline
* Participants with a reliable caregiver

Exclusion Criteria:

* Participants with significant symptoms of a major depressive disorder
* Participants with a history of or current clinical symptoms of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, or borderline personality disorder
Prevalence of Hospital Malnutrition in Afghanistan

This study aims to determine the prevalence of malnutrition among adult patients in hospitals across Afghanistan.

Malnutrition is associated with negative patient outcomes and increased healthcare costs. The purpose of this cross-sectional study is to determine the prevalence of malnutrition at admission or discharge in adult patients in hospitals across Afghanistan. The secondary outcome is to assess risk factors for malnutrition.

Eligibility Criteria:
Inclusion Criteria:

* All admitted or discharged patients age 18-65
* Males and females
* Conscious
* Informed consent provided

Exclusion Criteria:

* Patients undergoing surgery on the data collection day
* Outpatients
* Pregnant females
* Pediatric patients Patients with psychiatric or eating disorders Patients on dialysis
Safety and Immunological Response Rate Study of THERATOPE® Vaccine in Metastatic Breast Cancer Patients

The purpose of this study is to examine the immunological response rate to administration of the THERATOPE® vaccine in women with stable metastatic breast cancer who are being treated with aromatase inhibitors or Faslodex® and who do not require chemotherapy.

Post-menopausal women on aromatase inhibitors or Faslodex® alone and pre-menopausal women on aromatase inhibitors plus luteinising hormone-releasing hormone (LH/RH)-agonist may be eligible to be enrolled.

Patients must not have had radiotherapy or major surgery within four (4) weeks prior to entering the study.

Information about the safety and tolerability of administration of the THERATOPE® vaccine will also be gathered during the course of the study.


Eligibility Criteria:
Inclusion Criteria

* Histopathologically confirmed breast cancer
* Documented Stage IV disease
* Estrogen and/or progesterone-receptor positive
* Stable disease on aromatase inhibitor or Faslodex® treatment begun at least 12 weeks prior to enrolment
* Performance status, ECOG = 0 or 1
* Life expectancy \> 12 weeks
* History of freedom from progression for at least 6 months following surgery with a curative intent or for at least 6 months during adjuvant chemotherapy, adjuvant radiotherapy or adjuvant hormonal therapy such as tamoxifen/toremifene treatment
* No radiotherapy or major surgery within 4 weeks prior to enrolment

Exclusion Criteria

* Pregnant or lactating
* Known brain metastasis
* Bone marrow involvement as the only site of metastasis
* First line chemotherapy for Stage IV disease
* Past or current cancer other than breast cancer, except for curatively treated basal cell cancer or in situ cancer of the cervix with no evidence of disease
* Autoimmune disease, e. g., type I juvenile onset diabetes mellitus, antibody positive rheumatoid arthritis, Grave's disease, lupus, Crohn's disease, IBD, Hashimoto's thyroiditis
* Known intercurrent infections (including HBV or HCV) or immunosuppression \[human immunodeficiency virus (HIV) or other conditions\] or clinical evidence of these conditions
* Other significant active infection
* Pleural effusions and/or ascites requiring paracentesis every 2 weeks or more frequently
* Splenectomy
* Concurrent treatment with chemotherapeutic agents other than low-dose cyclophosphamide used in this study
* Treatment with interferons (IFNs), cytokines, systemic steroids or other biologicals within 4 weeks prior to enrolment
* Receipt of another investigational drug within 30 days of enrolment
* Known allergy to shellfish
* Known allergy to soy beans or soy products
* Known hypersensitivity to polysorbate 80
* Known hypersensitivity to the study drugs
* Legal incapacity or limited legal capacity
Intensive Statin Treatment for STEMI Patients Undergoing Primary PCI

This is a retrospective, randomized, parallel, open-labeled, controlled study to find out whether STEMI patients undergoing emergency PCI can benefit from intensive atorvastatin treatment compared with routine treatment.

ARMYDA-ACS, ARMYDA-RECAPTURE and NAPLES II demonstrated that in patients with ASP and NSTE ACS undergoing early PCI, loading dose of atorvastatin before early PCI led to a reduction of prei-PCI MI, recurrent CV events and mortality. While, theses studies included patients with non-ST-segment elevation ACS, requiring PCI; these results cannot be extrapolated directly to patients with ST-segment elevation MI, and these trials included patients sent to an early and selective PCI, but not those undergoing emergency revascularization;

This study is designed to find out whether STEMI patients undergoing emergency PCI can benefit from intensive atorvastatin treatment compared with routine treatment.

Eligibility Criteria:
Inclusion Criteria:

* 20-75 years old
* myocardiac ischemia symptom of index event appeared less than 12 hours before enrollment.
* ECG showed elevated ST segment in 3 or more contiguous leads
* diagnosed with acute STEMI
* eligible for primary PCI, and primary PCI is scheduled within 2 hours after enrollment

Exclusion Criteria:

* allergic or experienced serious adverse reaction to HMG-CoA reductase
* pregnancy, lactation, or child bearing potential women without any effective contraception
* accompanied with malignant disease
* active hepatic disease or hepatic dysfunction
rTMS of Limbic Circuitry in Stress Modulation in Healthy Volunteers

This study will be conducted with healthy male and female participants. Aim 1 will determine during sham repetitive transcranial magnetic stimulation (rTMS) how a drug stressor combination (yohimbine + hydrocortisone) relative to placebo alters : (1a) impulsivity; (1b) mood; and (1c) physiology. Aim 2 will determine whether active rTMS over the medial prefrontal cortex alters the effects of stress-exposure on (2a) decision-making, (2b) mood, and (2c) biomarkers of stress.

This study will use a double-blind, within-subjects randomized crossover design. Each participant will complete 4 sessions in this two-factor (2x2) combinatorial design: 1Hz medial prefrontal cortex (mPFC) vs. sham repetitive transcranial magnetic stimulation (rTMS) X pharmacological stressor (yohimbine 54mg + hydrocortisone 20mg) vs. placebo, with each session separated by at least 1 week. Participants will be asked not to use alcohol or drugs for 24-hr before arriving at the lab. We expect to complete screen at least 20 individuals to complete 12 individuals in this study. Candidates will first undergo psychiatric and medical screening to rule out contraindications to participation. Once enrolled, each participant will complete, in randomized order, the 4 conditions above. Periodic measures will be collected before and after the rTMS/sham and stress/placebo interventions. These measures will include subjective, behavioral and physiological assessments, as well as saliva and blood samples.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-60 yr
* Right-handed
* Males and non-pregnant/non-lactating females
* Cognitively intact (total IQ score \>80 on Shipley Institute of Living Scale)
* Screening cardiovascular indices must be within ranges that allow for safe use of stressor: resting HR 50-90 bpm, systolic BP 90-140 mmHg, and diastolic BP 50-90 mmHg
* Use alcohol and/or marijuana \<3 times/week; each "time" should consist of \<1 marijuana "joint" equivalent and \<3 alcoholic drinks

Exclusion Criteria:

* Under influence of any substance during session
* Past 7-day use of illicit drugs (excluding marijuana) based on Timeline Followback interview
* Urine positive for opioids, cocaine metabolites, benzodiazepines, barbiturates, amphetamines or pregnancy
* Medical conditions prohibiting use of rTMS (e.g. seizure history; using validated rTMS screening instrument)
* Lifetime diagnosis of: psychotic disorder, bipolar disorder, generalized anxiety disorder, obsessive compulsive disorder, or major depression that is not substance-induced
* Past-year substance use disorder
* Medical conditions making it unsafe for participation (e.g. neurological, cardiovascular, pulmonary, or systemic diseases)
* Lactose intolerance (placebo dose)
* Any prohibited medications: medications that lower seizure threshold, psychiatric medications, prescription pain medications, or blood pressure medications
* Chronic head or neck pain
* Taken part in any research studies in the past month
Phase III Study to Evaluate the Efficacy and Safety of HOB-048 CR Tab. in Comparison With HOB-048 Syrup in Patients With Cough Due to Acute or Chronic Bronchitis

A randomized, double-blind, multicenter, active-controlled phase III study to evaluate the efficacy and safety of Levotuss CR tab. in comparison with Levotuss syrup in patients with cough due to acute or chronic bronchitis


Eligibility Criteria:
Inclusion Criteria:

* moderate, severe, very severe non-productive cough patients

Exclusion Criteria:

* Patients receiving a concomitant therapy
Effect of N-acetylcysteine on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass Graft

N-acetylcysteine may prevent acute kidney injury in high risk patients undergoing off-pump coronary artery bypass graft.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing off-pump coronary artery bypass surgery and meets more than one of the following criteria;

  * preoperative serum creatinine \> 1.4 mg/dl
  * Age \> 70 years
  * Diabetes mellitus
  * left ventricular ejection fraction \< 35 % or congestive heart failure (NYHA III or IV)
  * emergency surgery or re-operation

Exclusion Criteria:

* preoperative acute renal failure, patients on dialysis, use of N-acetylcystein within 5 days of surgery, history of hypersensitivity to N-acetylcystein
Caretaker in the Cardiovascular Intensive Care Unit (CVICU)

To monitor the cardiac post-op patient population with both the pulmonary artery catheter (PAC) and the Caretaker monitor, which will seek to validate the Caretaker monitor against continuous CO via the PAC. Up to a third of post-operative cardiac surgery patients develop cardiac arrhythmias such as atrial flutter and atrial fibrillation. Secondary analysis will be performed on the collected data to assess the Caretaker monitor's agreement with the PAC during periods of arrhythmia. Successful completion this study will provide clinical validation of the Caretaker monitor in one of the most hemodynamically challenging patient populations (post-cardiac surgery patients in the ICU), including during arrhythmias. The Caretaker monitor is most beneficial as it is non-invasive, is a minimal risk device, and for this protocol will not be utilized to make treatment decisions for the study subject. This device also does not project energy into the subject.

Up to a third of post-operative cardiac surgery patients develop cardiac arrhythmias such as atrial flutter and atrial fibrillation. Secondary analysis will be performed on the collected data to assess the Caretaker monitor's agreement with the PAC during periods of arrhythmia. Successful completion this study will provide clinical validation of the Caretaker monitor in one of the most hemodynamically challenging patient populations (post-cardiac surgery patients in the ICU), including during arrhythmias. The Caretaker monitor is most beneficial as it is non-invasive, is a minimal risk device, and for this protocol will not be utilized to make treatment decisions for the study subject. This device also does not project energy into the subject.

Eligibility Criteria:
Inclusion:

* Adult post-cardiac surgery needing cardiopulmonary bypass and use of the PAC as standard of care, (s/p Coronary artery bypass graft surgery (CABG), valve, heart transplant, major aortic \& other vascular surgery, and a combination of CABG and valve procedures)
* patients (age \> 18) admitted to the Intensive Care Unit (ICU)
* Pulmonary artery catheter (continuous or intermittent thermodilution cardiac output) and an arterial catheter for Blood Pressure monitoring (standard of care)

Exclusion:

* Patients without an appropriately positioned or functioning PA catheter admitted to the cardiac surgery ICU after surgery
* Patients on left ventricular assist device (LVAD) support
VF Mapping in Brugada and Early Repolarization Syndromes

To determine the values and limitations of ECGI in guiding ablation and risk stratification in patients with BrS and Early Repolarization.

The investigators will study symptomatic BrS and ERs syndrome (N=25) and asymptomatic patients (N=25) age between 16-70 years old to determine values and limitations of non-invasive mapping using electrocardiographic imaging (ECGI) in identifying VF substrates as target sites for catheter ablations in patients with Brugada (BrS) and Early repolarization syndromes (ERS) and also determine the mechanisms of VF in BrS and ERs syndromes.

Eligibility Criteria:
Inclusion Criteria:

Patients presenting with the type1 BrS ECG or ER ECG signature pattern, with/without a sodium channel blocker. Patients with the following one of these symptoms or arrhythmias will be considered as symptomatic patients: 1) aborted cardiac arrest cases, 2) documented VF episodes, 3) agonal respiration during sleep with difficulty to arouse, 4) syncope of unknown origin, or 5) seizure suspected of arrhythmic origin.•

Exclusion Criteria:

Patients who refuse informed consent and to participate to the best ability in the study.

Patients who have structural heart disease or concomitant medical illness.
Relationship Between Hemodynamic Change and Fluid Removed During Hemodialysis

Relationship between hemodynamic change and fluid removed during hemodialysis measured by non-invasive monitor

By applying non-invasive hemodynamic monitors (ex. ClearSight, I-COM), the trends of mean arterial pressure (MAP), stroke volume (SV), cardiac index (CI) and calculated systemic vascular resistance (SVR) were collected along with volume removal by hemodialysis on ESRD patients. All data were compared and analyzed to detect the sequential body volume status as well as the autonomic responses during hemodialysis.

Eligibility Criteria:
Inclusion criteria:

1. Patients who were schedured with regular hemodialysis for end-stage renal disease.

Exclusion criteria:

1. Emergent hemodialysis
2. Medical conditions with poor peripheral circulation such as Raynaud's disease or PAOD
3. Skin defects or wounds over area to be applied for measurement (Wrist and fingers)
Cellular Stress Reactions During Graft-versus-host Disease

This study has the aim to analyze intestinal expression of cellular stress molecules in patients with intestinal GVHD. Patients with colitis and patients without intestinal inflammation will serve as controls.

Acute graft-versus-host disease (GVHD) is a major cause of morbidity and mortality in patients undergoing allogeneic hematopoietic cell transplantation (allo-HCT). Acute GVHD results from a complex multi-step crosstalk between extensive epithelial tissue damage in the patient and activation of the allo-reactive immune system transferred with the donor graft. The conditioning treatment prior to allo-HCT creates an inflamed microenvironment with high concentrations of pathogen-associated and danger-associated molecular patterns (PAMPs and DAMPs) as well as pro-inflammatory cytokines. This inflammation is perpetuated by activation of myeloid immune cells and recruitment of allo-reactive T cells to the intestine. Enterocytes are subjected to cellular stress and undergo apoptosis. As a result, patients can develop high-voluminous diarrhea, dehydration, intestinal bleeding, hypalbuminemia, and generalized infections.

In this study, the investigators aim to analyze the expression of molecules related to different types of cellular stress in the intestine of patients with acute GVHD. The hypothesis is that some stress-related markers would be upregulated during GVHD. The results will be valuable to study the role of cellular stress reactions during acute GVHD pathogenesis or as potential biomarkers for disease activity.

Eligibility Criteria:
Inclusion Criteria:

Age \>18 years intestinal biopsy depending on cohort: healthy intestinal tissue, colitis or GVHD
The Effect of Smartphone Push Notifications on Brain Power Score

This study will examine how Brain Power Score, an objective measure of brain function, is affected by the presence of smartphone push notifications.

Smartphones are a common device integrated into the lives of many individuals around the world. Researchers have previously found a relationship between mobile phone use and changes in brain activity, reaction times and sleep patterns.

Brain Power is a consumer-grade application using a proprietary combination of neurological (EEG) and behavioral (reaction time and accuracy) data to create a comprehensive score out of 1000 which allows users to have an objective evaluation of their brain performance.

This study will examine how Brain Power Score is affected by the presence of smartphone push notifications.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* ≥19 years old
* Must be proficient in English
* Must be able to understand the study procedure and give informed consent

Exclusion Criteria:

* Unable to provide informed consent
Role of CCL2 in Alcoholic Liver Diseases

Immune dysregulations, including cytokines and chemokines secretions occurs in alcoholic liver disease. Serum levels and liver expression of CCL2 are increased in patients with alcoholic hepatitis but the role of this chemokine in the pathogenesis of alcoholic liver disease is nevertheless unknown. The aim of the study is to analyze plasma level and liver expression of CCL2 and their relation with liver disease severity and inflammatory infiltrate in our cohort of alcoholic patients. We studied also the association between -2518 CCL2 polymorphism and the severity of alcoholic liver disease.


Eligibility Criteria:
ALD patients

Inclusion Criteria:

* Excess alcohol intake
* Abnormality of liver biopsy compatible with alcoholic aetiology
* Caucasian ethnicity

Exclusion Criteria:

* Presence of any other chronic liver disease
* co-infection with HIV Controls Inclusion criteria
* Caucasian ethnicity
* presence of a disease
Comparison Study of Biofoam Porous Metal Versus Allograft to Treat Adult Acquired Flatfoot

The purpose of this study is to compare the clinical and radiographic outcomes of a randomized, consecutive series of adult patients, with an acquired flatfoot, treated with a lateral column lengthening using an allograft bone wedge versus a titanium porous metal implant (Biofoam, Wright Medical).

Null hypothesis: At six months postoperatively, there is no difference in the degree of correction as measured by the talonavicular coverage angle between patients randomized to allograft and Biofoam.

Alternative hypothesis: At six months postoperatively, the degree of correction as measured by the talonavicular coverage angle will be less in patients randomized to allograft than the degree of correction in patients randomized to Biofoam.


Eligibility Criteria:
Inclusion Criteria:

* Ages 25-75
* Unresponsive to conservative treatment
* Patient with acquired flatfoot deformity, who is a candidate for lateral column lengthening (Stage IIB) = (greater than \> 40% uncoverage of talar head by navicular on standing AP radiograph)

Exclusion Criteria:

* Less than 25 years of age and greater than 75 years
* Pre-existing infection
* Peripheral neuropathy
* Charcot arthropathy
* Peripheral vascular disease
* Rhematoid Arthritis (RA) or inflammatory arthropathy
* Metal allergy or sensitivity to metal
The Effect of Individualized Precision Therapy Programs in Patients With BTC

This is a prospective cohort study. Patients who meet the inclusion criteria will be enrolled in this study. The samples of biliary tract tumors will be collected. Genome sequencing, mini-PDX and PDX will be performed according to the requirement of individualized precision therapy programs. Suitable drugs will be chose according to drug screening results. OS and PFS will be compared with traditional chemotherapy to evaluate the effect of individualized precision therapy programs.

In this prospective cohort study, patients who are eligible for inclusion criteria will enroll in the study. After bile duct tumor samples were collected, whole genome sequencing, drug screening ( including Mini-PDX and PDX) will conduct. Suitable drugs will be decided according to the different genomics classification, and then to develop individualized precise treatment programs.

The investigators hope to achieve the following objectives:

① Through the establishment of Individualized Precision Therapy Programs to improve the overall survival of bile duct malignancy (BTC)；

② To study the molecular typing of the prognosis of biliary malignancy;

③ To construct a database of BTC gene bank, as well as for drug screening information.

Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of biliary malignancies
* The expected survival time is longer than 3 months
* PKS score\> 60 points
* Willing to take part in the study

Exclusion Criteria:

* Can not or refuse to collect tumor samples
* Refused to accept the relevant treatment method
Evaluation of Prealbumin Levels in Men With Low-T

This is a single-center study intended to evaluate prealbumin (transthyretin), a marker of anabolic metabolism, in men with androgen deficiency (Low-T). There is emerging evidence that prealbumin is an indicator of anabolic, versus catabolic, metabolism, and that lower levels may be associated with hypogonadism.


Eligibility Criteria:
Inclusion Criteria:

* Provide responses to standard questionnaires administered to subjects
* Written Informed Consent obtained
* Male sex at birth
* ≥ 40 and ≤ 75 years of age
* Presentation to the clinic with symptoms suggestive of low testosterone such as loss of libido, erectile dysfunction, cognitive or mood disturbances, etc.
* Able and willing to provide blood specimens and follow study schedule
* A final diagnosis can be established (androgen deficient versus not androgen deficient)

Exclusion Criteria:

* Previous exposure to exogenous T, DHEA, clomiphen citrate, or other Selective Estrogen Receptor Modulators, or OTC or herbals (Treatment Naïve)
* Use of opioid medication within 3 months prior to enrollment
* Serious psychiatric disease or uncontrolled medical illness, as suspected from medical history or clinical examination
* Use of any sex hormones or steroidal anabolic drug supplements (OTC or prescribed)(Treatment Naïve)
* Incapable of giving informed consent or complying with protocol or unwilling to comply with protocol requirements
* Diagnosis of prolactinoma