cyrilzakka/clinical-trials huggingface dataset:
Mortality in Brain Injury at the Intensive Care Unit (TraVi II)

Introduction: traumatic brain injuries are a leading cause of disability and mortality in the young population, associated mainly with traffic road accidents and violent wounds. The study aimed to analyze factors related to the mortality in patients with brain injury admitted to the intensive care unit.

Methodology: Between 2019 and 2024, an analytical cross-sectional trial at Hospital Departamental de Villavicencio, Colombia was performed. Information was selected from the intensive care unit (ICU) database. Variables of interest and outcomes, such as mortality and ICU length of stay, were identified. The comparison was performed with the software Prism® for Mac iOS and Wizard® for the predictive model.

Results: The study will show the factors associated with mortality of brain injury patients admitted to the intensive care unit.

Objective: The study aimed to analyze factors related to the mortality in patients with brain injury admitted to the intensive care unit.

Methodology: Between 2019 and 2024, an analytical cross-sectional trial at Hospital Departamental de Villavicencio, Colombia, a reference center for the Colombian Orinoco region with 400 hospital beds and 53 polyvalent ICU beds was performed. Information was selected from 2,154 admission registers in the intensive care unit (ICU) database. Data of admissions considered for review were from patients with diagnostic codes of brain injury, brain edema, polytrauma, ventilatory failure, neurogenic shock, and traumatic subarachnoid hemorrhage. All the registries with codes S00-S09 from the 10th revision of the International Diseases Classification from the World Health Organization were reviewed. Variables of interest and outcomes, such as mortality and ICU length of stay, were identified. The comparison was performed with the software Prism® for Mac iOS and Wizard® for the predictive model.

Results: The study will show the factors associated with mortality of brain injury patients admitted to the intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic brain injury.
* Admitted to the intensive care unit.

Exclusion Criteria:

* Remission from another hospital.
* Decease for causes other than the brain injury.
Neuropsychological Norms for Ethnically Diverse Florida Elders

The goal of this proposal is to collect normative data from a sample of ethnically diverse Florida elders on a brief, standardized neuropsychological test battery . The norms collected in this multi-cultural dataset will provide appropriate corrections for demographic and sociocultural variables that contribute to performance variance on neuropsychological tests. By accounting for these variables, the normative corrections will improve specificity and eliminate disparities in diagnostic validity and clinical utility of neuropsychological tests when administered to Florida's ethnic minority elders.


Eligibility Criteria:
Inclusion Criteria:

* Age 60 or above.
* Any gender.
* Primary language of English or Spanish.
* Self-identifies as Hispanic, non-Hispanic Black/African American, or non-Hispanic Caucasian.
* Global Clinical Dementia Rating (CDR) score = 0.

Exclusion Criteria:

* Memory decline reported by participant, informant (if available), or study clinician.
* Currently uncontrolled health condition that could affect cognition.
* Abnormal findings on current neurologic examination.
* History of chronic neurological diseases (stroke, active seizure disorder, parkisonism, TBI with subsequent cognitive change.
* Current substance abuse or history of substance dependence.
* History of chronic psychiatric disease (Bipolar disorder, schizophrenia).
* Currently active mood disorder. History of depression or anxiety is acceptable if symptoms are controlled (Score \<6 on the Geriatric Depression Scale). If taking psychoactive mood medication dosage must be stable for at least one month prior to testing.
* Use of cognitive enhancing medications (i.e. cholinesterase inhibitors, memantine).
* Need for assistance in activities of daily living due to cognitive reasons.
* Sensorimotor deficits that would interfere with ability to perform neuropsychological tests.
Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium Before Office Hysteroscopy

The study aims to determine the efficacy of oral hyoscine butyl bromide versus diclofenac potassium on the pain scores during office hysteroscopy


Eligibility Criteria:
Inclusion Criteria:

1. Patients that must perform a diagnostic hysteroscopy.
2. Acceptance to participate in the study.
3. Signed informed consent.
4. Not taking analgesics (acetaminophen, ibuprofen, mefenamic acid) before admission.
5. Absence of sedative use before admission

Exclusion Criteria:

1. Hypersensitivity to drugs
2. refusal of the patient
3. Patients are pregnant.
A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia

The objective of the study is to assess the continued safety of the daily coadministration of ABT-335 in combination with rosuvastatin calcium, simvastatin or atorvastatin calcium.


Eligibility Criteria:
Inclusion Criteria:

* Adult male and female subjects who voluntarily sign the informed consent.
* Subject has successfully completed the treatment phase of the preceding open-label year 1 study.

Exclusion Criteria:

* Subject is using or will use investigational medications, except as approved by Abbott.
* Subject has prematurely discontinued his/her combination therapy administered in the preceding open-label year 1 study.
Amlodipine for Myocardial Iron in Thalassemia

Children with thalassemia may have high iron levels after receiving blood transfusions. These high iron levels can have damaging effects on the body, especially the heart. Conventionally only chelation therapy was given for prevention of iron buildup in the heart. However, current research has shown that another drug, amlodipine, also helps to slow down the deposition of iron in the heart. This study is designed to see if patients receiving amlodipine along with their regular chelation therapy have a slower rate of iron buildup in the heart when compared with patients who are receiving chelation only.

Null Hypothesis There is no difference between the efficacy of chelation plus amlodipine therapy and chelation therapy alone in retarding the rate of myocardial iron deposition in thalassemia patients with iron overload and a constant transfusion need.

Alternate Hypothesis Chelation plus amlodipine therapy is more efficacious than chelation therapy alone in retarding the rate of myocardial iron deposition in thalassemia patients with iron overload and a constant transfusion need.

The aim of the investigators study is to determine if amlodipine, an L-type specific calcium channel blocker, in addition to the standard aggressive chelation therapy, can retard the deposition of iron in the myocardium of thalassemia patients with significant myocardial iron load with or without cardiomyopathy.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients aged ≥ 6 and ≤ 20 years managed at AKUH for at least 1 year
* ≥ 10 blood transfusion in life time
* Transfusion need ≥ 180 ml/kg/year
* Serum ferritin ≥ 1000 ug/dl
* Patient deemed capable of receiving chelation therapy (by treating hematologist) either subcutaneous infusion of Deferoxamine (Desferal) (3-5 days a week) or oral deferasirox (daily) or Defeperione (oral) or a combination of Desferal and Defeperione.
* Patients who have been on a stable chelation regimen ≥ 6 months
* Completed and signed Informed consent/assent.

Exclusion Criteria:

* Patients with known hypersensitivity to amlodipine.
* Patients with known sinoatrial nodal disease or aortic stenosis.
* Patients with known severe myocardial dysfunction, defined as A LV ejection fraction of ≤ 4 SD for age even without symptoms.
* Patients with known signs and symptoms of heart failure.
* Patients with a T2\* value of \< 4 ms on cardiac MRI.
* Patients with systolic blood pressures ≤ 2 SD for age (systemic hypotension) at the time of enrolment.
* Patients with previously diagnosed significant congenital heart diseases or acquired heart diseases other than thalassemia (as defined earlier).
* Patients with known contraindications to MRI (pacemakers, cerebral aneurysm metal clips, etc.)
* Patient with a known history of developing tetany after use of a calcium channel blocker
* Known pregnancy.
Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period

This clinical trial is studying the use of different levels of oxygen exposure during and after cardiopulmonary bypass in eligible infants to learn about its safety during heart surgery.

In addition to having the various doses of oxygen, participants will also have blood samples, ultrasounds of the head, and brain wave patterns monitored.

The hypotheses of this trial are:

* that there will be no difference with regards to adverse events between the infants in the normoxia group compared to the infants in the standard of care group
* there will be a significant difference in the measured partial pressure of oxygen (PaO2) values between the two treatment groups.
* the use of normoxia during cardiopulmonary bypass and in the immediate post-operative period will result in clinically significant decrease in oxidative stress as measured by thiobarbituric acid reactive substances (TBARS) after cardiac surgery


Eligibility Criteria:
Inclusion Criteria:

* Age less than 30 days of age at time of surgery with need for cardiopulmonary bypass with cardioplegic arrest (with or without deep hypothermic circulatory arrest)
* Diagnosis with cyanosis at baseline (pre-operative PaO2 of less than 50mmHG) due to:

  * Complete admixture lesion (example: hypoplastic left heart syndrome, total anomalous pulmonary venous return, truncus arteriosus, pulmonary atresia with VSD)
  * Transposition physiology (example: D-Transposition of the great arteries or Double outlet right ventricle with subpulmonary VSD)
  * Right-to-left shunt (example: Tetralogy of Fallot, double outlet right ventricle with subaortic VSD and pulmonary stenosis)

Exclusion Criteria:

* Corrected gestation at time of surgery less than 37 weeks
* Prior cardiac arrest
* Current or prior history of extracorporeal membrane oxygenation (ECMO) support
* Current or prior history of needing renal replacement therapy with dialysis
* Prior cardiac surgery requiring cardiopulmonary bypass
* Diagnosis of Ebstein's Anomaly
* Known genetic syndrome other than Trisomy 21 or DiGeorge Syndrome
Management of Thirst, Nursing Care, Postoperative Care

The study was conducted to determine the effect of oral water and ice popsicle on management of thirst in the immediate postoperative period as experimental.

Also, it is aimed to evaluate validity and reliability of "Safety Protocol for Management Thirst in the Immediate Postoperative Period Protocol" which is used to take oral water and ice of patients in the immediate postoperative period, as administrative. The study was conducted with 150 patients who are transferred to the postanesthesia care unit (PACU) after their operation and met study criteria. Patients divided into three groups as the study (water group=50, ice group=50) and control (n=50). Patients in the study group were performed oral water/ice popsicle after their accession to PACU. However, the control group patients have performed rutin treatment and care without any other intervention. Physiologic variables and symptoms with thirst were followed in every three group patients at certain times. Data were evaluated by using NCSS (Number Cruncher Statistical System) 2007 program.

Eligibility Criteria:
Inclusion Criteria:

1. have a surgical operation other than gastrointestinal system surgery,
2. Surgical fasting duration is at least 8 hours,
3. According to the American Society of Anesthesiologists (ASA) classification; Class I, II and III;
4. Having the ability to express the thirst status verbally and experiencing moderate or severe thirst when the thirst status is evaluated by VAS,
5. The duration of anesthesia is longer than 1 hour and accepted into the PACU after surgery.

Exclusion Criteria:

1. have a second surgical intervention during hospitalization,
2. The need of intensive care after surgery,
3. Having problems in the process of separation from respiratory support after surgical intervention,
4. A change in the state of consciousness after surgical intervention / acute confusion,
5. Liquid electrolyte imbalance,
6. Patients with difficulty in swallowing or restriction of oral fluid intake,
Ambrosia: Evaluating the Effects of a Food-As-Medicine Platform on Gut Microbiome Composition and Metabolism

The objective of this study is to test whether dietary behavior modification impacts diet quality and stool microbiome composition and metabolism using microbial whole genome sequencing, targeted metabolomics, and immune profiling.

400 adults 18-64 years old at high risk for CRC (based on past colonoscopy findings or lifestyle risk factors) will be assigned to one of two cohorts, with approximately 200 participants in each.

* Cohort 1 will serve as the control group without any directed dietary modifications.
* Cohort 2 participants will receive medical nutrition therapy (MNT) via 5 Telenutrition (TN) visits with a registered dietitian (RD), utilizing the Academy of Nutrition and Dietetics' Nutrition Care Process.

Stool samples will be obtained for each subject at baseline and end of study. Whole genome sequencing, metabolite analysis, and immune profiling will be performed on the samples. Demographic data, general health information, diet and lifestyle information will be collected from the subjects (all self-reported). When applicable, notes from telenutrition appointments will also be collected. Diet information will be collected using the Picture Your Plate(TM) validated food questionnaire.


Eligibility Criteria:
Inclusion Criteria:

1. Adults 18 to 64 years old at the time of enrollment at high risk for colorectal cancer, defined as follows:

   1. EITHER a personal history of colorectal cancer, advanced adenoma, or 3 or more non-advanced adenomas in a single screening
   2. OR TWO of the following criteria:

      * One or more first-degree relatives with a history of colorectal cancer
      * Body mass index above 30 (Persephone will calculate given height and weight
      * Have smoked an average of 5 or more cigarettes (1/4 pack) per day for a continuous period of 10 years or more.
2. Able to provide stool samples at study start and after approximately 5 months
3. Willing and able to undergo virtual Medical Nutrition Therapy based on cohort assignment
4. Willing to complete online questionnaires concerning diet and lifestyle, in English
5. Competency in spoken and written English
6. Can provide written informed consent

Exclusion Criteria:

1. Subjects with known HIV, Hepatitis A, Hepatitis B, Hepatitis C
2. Known Familial Adenomatous Polyposis or Lynch Syndrome (aka Hereditary Non-Polyposis Colorectal Cancer or HNPCC) diagnosis
3. A history of Crohn's Disease, Inflammatory Bowel Disease, or chronic colitis.
4. Active cancer in the past 2 years, or currently undergoing any form of cancer therapy.
5. Confirmed case of COVID-19 or influenza within one month prior to enrollment
6. Oral or systemic antibiotic or probiotic use, or a known GI infection, within 3 months prior to enrollment
7. Engaged in a nutritional or dietary intervention in the past 3 months.
8. Women who are pregnant or plan to become pregnant in the next 6 months, or currently nursing.
Radiotherapy 3 vs 6 Gy in Gonarthrosis and Coxarthrosis

This is a non-inferiority study in which the investigators compare two low-dose radiotherapy schemes, which are recommended from DEGRO Clinical Practice Guidelines (3 Gy vs 6 Gy) for the treatment of osteoarthritis and other osteodegenerative disorders.

A first randomization will be carried out among the patients included in the study:

* Patients in arm A will be treated at 3 Gy (0.5 Gy/fraction, 3 fractions/week), and patients in arm B will be treated at 6 Gy (1 Gy/fraction, 3 fractions/week).
* Patients should not know the arm to which they have been randomized.
* Once the treatment is finished, patients will be assessed at 8 weeks. If pain does not improve, a re-irradiation will be performed. If the patients were treated with 3 Gy a new randomization will be performed (3 vs 6 Gy again). If the patiens were treated with 6 Gy they will be re-irradiated with 6 Gy again.

The investigators will analyze the results obtained depending on the dose received and depending on the location of the treatment.

Painfull skeletal disorders are susceptible to be treated with low-dose radiotherapy. DEGRO guidelines recommend a dose between 3 and 6 Gy at 0'5 Gy/fraction or 1 Gy/fraction respectively. The investigators want to verify that both treatments (3 and 6 Gy) are similar to improve the pain and function in patiens with gonarthrosis and coxarthrosis, and there are no differences between both treatments, therefore, 3 Gy is not less than 6 Gy.

In this context, a prospective multicenter study is proposed. The study will include 338 patients to assess the efficacy of low dose irradiation (3 vs 6 Gy) in gonarthrosis and coxarthrosis.

Eligibility Criteria:
Inclusion Criteria:

* Age \>50 years
* Gonarthrosis or/and Coxarthrosis diagnose
* At least 1 year of evolution
* Non response to drug or surgery treatments
* Risk of colateral side effects due to the comorbidity of the patient with conventional treatments.

Exclusion Criteria:

* Previous high dose radiotherapy in the same location
* Conective tissue disease (LUPUS, reumathoid artritis, esclerodermia, Sd. Raynaud, Sd. Sjögren, polymiositis)
* Inherited Hipersesitivity Sindromes (ataxia-telangiectasia, Fanconi's anaemya, Sd. Nijmegen, Sd. Gorlyn, Sd. Cockayne, Sd. Down, Sd. Gardner, Sd. Usher)
* No follow up possibility
* Other study inclusion
Towards Improved Diagnostics for Suspected Platelet Function Disorders

This study aims to improve platelet function testing during bleeding investigations. To this end, the study will evaluate the diagnostic accuracy of novel platelet function tests in patients with confirmed or suspected platelet function disorders. Study participants will be recruited from patients that are referred to or treated at the Coagulation Unit, Karolinska University Hospital, and Pediatric Coagulation Unit, Astrid Lingren Children's Hospital.


Eligibility Criteria:
Inclusion Criteria, known defects:

* Known platelet function disorder under follow-up at Karolinska University Hospital (genetic or functional assay)
* High likelihood of platelet function disorder (aberrant screening test with inheritance)
* Family investigation for platelet disorder

Exclusion Criteria, known defects::

* Antiplatelet or anticoagulant drugs
* vWF:GPIb below 0.40 IU/mL
* Hematocrit below 0.35 or above 0.50
* Other coagulation disorder

Inclusion Criteria, suspected platelet function disorder:

* Bleeding investigation at Karolinska University Hospital

Exclusion Criteria, suspected platelet function disorder::

* Antiplatelet or anticoagulant drugs
* vWF:GPIb below 0.40 IU/mL
* Hematocrit below 0.35 or above 0.50
* Other coagulation disorder
A Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumors

This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with select advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects
* 18 years and older
* Histologic confirmation of advanced solid tumors
* Subjects must have recurrent/metastatic disease and may have been previously treated in the recurrent/metastatic setting.

Exclusion Criteria:

* Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment
* Active or prior documented autoimmune disease within the past 2 years
* Current or prior use of immunosuppressive medication within 14 days with some exceptions.
Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study

This is a single-site, sham-controlled, randomized trial in a total of 60 subjects between ages 18 and 40 years with schizophrenia. This study will investigate the effects of 4-week rTMS treatment on brain and cognitive functions in patients. Subjects will be randomized to one of the following arms:

Arm 1: Standard of Care (SOC) and active rTMS Arm 2: Standard of Care (SOC) and sham rTMS

Each participant will receive rTMS five days per week, for four consecutive weeks. Functional magnetic resonance imaging (fMRI) scans, clinical assessments, and cognitive tests will be performed at baseline, end of the 2nd week, and end of the 4th week.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects 18 to 40 years of age
2. DSM-V diagnosis of schizophrenia spectrum disorders
3. Competent to provide informed consent

Exclusion Criteria:

1. Lifetime DSM-V diagnosis of an Axis-I disorder other than schizophrenia spectrum disorders
2. Lifetime diagnosis of ataxia or other cerebellar disorders
3. Lifetime diagnosis of mental retardation, dementia, Alzheimer's disease, Parkinson's disease, Huntington's disease, or other neurodegenerative disorders
4. Any active general medical condition or CNS disease which can affect cognition or response to treatment
5. Substance dependence or abuse in the past six months
6. Seizure history
7. TMS within three months or ECT within six months
8. Pregnancy as indicated by self-report
9. MRI contraindications
Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam

The main purpose of this study is to evaluate the effect of desvenlafaxine administered as DVS SR on the pharmacokinetics of midazolam in healthy male and female subjects. The amount of drug in the body and the effect of the drug will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Men or non-pregnant, non-lactating women, 18 to 55 years of age inclusive at screening.
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
* Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 Ilbs).

Exclusion Criteria:

* Presence or history of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Presence or history of glaucoma or intraocular pressure.
* Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational product.
* Allergy to midazolam, other benzodiazepine, desvenlafaxine, or venlafaxine.
* Acute disease state (eg, nausea, vomiting, fever, or diarrhea) with 7 days before study day 1.
* Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements. History of drug abuse within 1 year before study day 1.