cyrilzakka/clinical-trials huggingface dataset:
Impact of Predictive Modeling on Time to Palliative Care in an Outpatient Primary Care Population

A machine learning algorithm will be used to accurately identify patients in certain primary care units who may benefit from palliative care consults.

A machine learning algorithm will be used to accurately identify patients in certain primary care units who may benefit from palliative care consults. These patients will be presented weekly to a palliative care specialist in a custom user interface. The palliative care specialist will reach out to primary care teams if she determines that the patient would benefit from palliative care. If the primary care provider agrees, he/she would write a palliative care consult order for the patient. The goal is to reduce the time to palliative care for these patients, who may not have been identified as quickly without the algorithm.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient assigned to a primary care unit from July 2020 to June 2021.
* Weekly the palliative care specialists will select patients by looking at patients in sorted order starting with the highest score and proceeding down the list and evaluating each patient for exclusion criteria.

Exclusion Criteria:

* Patients that have been seen by Palliative care will be excluded for 75 days
* Patients under the age of 18 years.
* Patients currently enrolled with hospice
Effect of Different Working Conditions on Risk Factors in Dentists Versus Trainers

The aim of the study is to validate the sanitary consequences of dental studies respectively the longtime executed profession. In comparison to this cohort we will also check a collective of subjects with an optimum of physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Age 19-30 years(longitudinal)
* 55-60 years (crosssectional)
* Dentists
* Trainers

Exclusion Criteria:

* Pregnant
* CVD
* Medication; and
* Diseases affecting body composition
Perioperative Music Listening on Anxiety, Pain, Analgesia Use and Patient Satisfaction

The use of music to relieve pain has been studied in many forms of medicines and has been proven to reduce anxiety, pain and analgesic use in the perioperative setting. However, music listening as an inexpensive and duplicable method has not been investigated and implemented in the local context. The investigators hereby propose a prospective study to recruit patients undergoing surgery to evaluate the effectiveness of music in pain relief and post-operative recovery; as well as the implementation and operational readiness of music listening.

Some tissue injury is often unavoidable during surgery, which leads to unavoidable pain and anxiety during the perioperative and post-operative period. Acute post-operative pain and anxiety have been managed via pharmacological interventions. However, non-pharmacological interventions have also been shown to be safe and cost-effective, improve the overall patient experience, and improve outcomes across a variety of surgical settings.

Music has been shown to decrease perioperative pain and modulate the inflammatory response. Additionally, anxiety scores and pain scores have shown statistically significant reductions in the perioperative period, when music therapy was available. Currently only few studies investigate its effects during perioperative period especially in local setting. Thus, the investigators will investigate the feasibility and practicability of deploying music listening in KKH pain management and further determine the nature of the music (duration, genre) by fitting the local context in order to improve the patient outcome in perioperative settings.

Phase 1: A total of 300 patients will be offered to select from pre-determined lists of music of different genres or patient choice, before and after surgery. Hospital Anxiety and Depression Scale (HADS) score, pain scores, analgesia usage, patient satisfaction, and quality of life measurement will be collected. Analysis of the type of music, duration of music listening, and the genre chosen will be analysed.

Phase 2: A hundred and ten women undergoing Caesarean delivery at KK Women's and Children's Hospital (KKH) in 1:1 allocation ratio of experimental (music listening) and control (no music listening) groups. Pain and psychological assessments and demographic data collection will be conducted before surgery, and those allocated to experimental group will be asked to use music listening before, during and after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants who are American Society of Anesthesiologists (ASA) 1 and 2 (with well-controlled medical problems);
* Undergo day surgery, same-day-admission gynecologic surgery or cesarean section;
* No hearing impairment.

Exclusion Criteria:

* Patients with significant respiratory disease and obstructive sleep apnea;
* Patients who are unable to read and understand the hospital anxiety questionnaire.
The Serum Angiotensin Converting Enzyme and Lysozyme Levels in Patients Non-infectious and Infectious Uveitis

This study evaluates the significance of differences in serum angiotensin converting enzyme and lysozyme levels of patients with ocular involvement of other autoimmune inflammatory and infectious diseases.

Increased serum levels of angiotensin converting enzyme and lysozyme are considered as inflammatory markers for diagnosis of sarcoidosis which is an autoimmune inflammatory disease. Sarcoidosis, ankylosing spondylitis and Behcet's disease are the most common autoimmune inflammatory diseases involving the eye.

Elevated serum angiotensin converting enzyme levels have also been reported in tuberculosis. Syphilis and tuberculosis are the most common infectious diseases involving the eye.

Eligibility Criteria:
Inclusion Criteria:

* Subjects have ocular inflammation diagnosed as sarcoidosis, ankylosing spondylitis, behcet's disease
* Subjects have ocular infection diagnosed as tuberculosis and syphilis
* Subjects have refractive errors only

Exclusion Criteria:

* Subjects using ACE inhibitors, systemic steroids, immunosuppressive or immunomodulatory therapies
HR+/ HER2- Advanced/ Metastatic Breast Cancer Real World Treatment Patterns and Outcomes

This is a retrospective, observational study that will document the treatment patterns and clinical outcomes of patients diagnosed with HR+/HER2- A/MBC who received CDK4/6i combination therapy with aromatase inhibitors (AI) as the initial endocrine-based therapy in the A/MBC setting.


Eligibility Criteria:
Inclusion Criteria:

1. Female or male sex.
2. Diagnosis (confirmed by clinical review) of A/MBC, defined as breast cancer at stage IIIB, stage IIIC, stage IV or identified as having distant metastasis.
3. Age ≥18 years at A/MBC diagnosis.
4. Initiated a CDK4/6i in combination with an AI as initial endocrine-based therapy after A/MBC diagnosis on or after 2/3/2015 and before 4/1/2019.

   •Note that the date of the start of the inclusion period reflects the month that the first CDK4/6i (ie, Palbociclib) received U.S. FDA approval.
5. Evidence of ER or PR positive disease, or absence of any indication of ER and PR negative disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of ER/PR+ status as long as ER/PR- indication is not present).
6. Evidence of HER2 negative disease, or absence of any indication of HER2 positive disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of HER2- status as long as HER2+ indication is not present).

Exclusion Criteria:

1. Enrollment in an interventional clinical trial for A/MBC during the study observation period.
Biomarkers Serum Collection Methodology Pilot Study

The purpose of this study is to compare the standard collection of whole blood in tiger top tubes for serum collection versus a collection method of added FVIII to whole blood samples in the hemophilia population for routine biomarker assays to ensure reliable assay results.

20 adults with severe Hemophilia A seen in one HTC site for routine blood drawing will be consented for discard blood sampling.

Half of the whole blood discard will be placed in a tiger top test tube, and half of the whole blood discard sample will be placed in a red top test tube containing exogenously added recombinant human FVIII concentrate \[Advate, Baxter immuno\] to assure an end concentration of once IU per CC of whole blood.

Both whole blood specimens will be allowed to coagulate at room temperature and then will be centrifuged to prepare serum. The separated serum from each type of collection test tubes will be aliquoted into eppendorf tubes (a minimum of two aliquots per sample) at a volume of 150 microliters. Aliquoted serum samples will be stored at -70 degrees centigrade and shipped on dry ice to Synarc Labs.

A panel of standard CTX bone resorption assays will be preformed in duplicate on the two differently processed serum specimens obtained from each subject.

Results will be analyzed for inter-subject variability using stored age-matched samples provided by Synarc and intra-subject variability will also be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Severe Hemophilia A

Exclusion Criteria:

* If they are not diagnosed with severe hemophilia A.
Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Zilbrix™ Hib and Polio Sabin™

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of African Sub-Saharan infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and oral polio vaccine in children during the first 4 months of life.

Vaccination course at 6, 10, 14 weeks of age.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
* Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
* Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
* Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* A family history of congenital or hereditary immunodeficiency.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (Hepatitis B immunoglobulins at birth are allowed).
* Previous vaccination against, diphtheria, tetanus, pertussis, Haemophilus influenzae type b and/or Streptococcus pneumoniae.
* History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* History of any neurological disorders or seizures.
* Major congenital defects or serious chronic illness.
* Acute disease at the time of enrolment. Study entry should be delayed until the illness has improved.
* Babies for which birth weight is \< 2 kilogram (if known) at Visit 1
Cubicin(R) for Complicated Post-surgical Wound Infections

The purpose of the study is to describe the clinical efficacy of CUBICIN therapy in patients with superficial and deep post-surgical Gram-positive wound infections

A multi-center, single-arm, open-label, non-comparative study to describe the clinical efficacy of CUBICIN therapy in patients with superficial and deep post-surgical Gram-positive wound infections. Adjunctive treatment with aztreonam and/or metronidazole could be given for Gram-negative and/or anaerobic organisms. Patients are to be treated for a period of 7-14 days as specified in the package insert. An evaluation is to be performed on the day CUBICIN treatment is completed (assessment for outcome of cure, improved, failure or unable to evaluate). A follow-up is required for patients with an Investigator response of 'Improved' at the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Read and signed informed consent form
* female of childbearing potential, negative pregnancy test result
* Confirmed diagnosis of post-surgical wound infections known or suspected (based on Gram stain) to be due to Gram-positive organisms obtained within 3 calendar days prior to first dose of study medication
* Onset of surgical wound infection within 30 days after surgery
* At least three clinical signs and symptoms of skin infection

Exclusion Criteria:

* previous systemic antimicrobial therapy exceeding 24 hours duration administered anytime during 72 hours prior to the first dose of study drug
* Uncomplicated surgical infections (eg, stitch abscesses)
* osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary tract infection
* Any type of space infection
* Conditions requiring surgical removal of wound infection
* necrotizing fasciitis, synergistic gangrene, Clostridial myonecrosis (gas gangrene), or Fournier's gangrene;
* Foreign material involved in the post-surgical wound infection
* Known to be allergic or intolerant to study medication
* Creatinine Clearance (CLCR) \<30 mL/min
* history of neurological disease (eg, Guillain-Barré, multiple sclerosis)
Epidemiology of Acute Mesenteric Ischemia

Retrospective population-based study on epidemiology of acute mesenteric ischemia in Estonia Study objective is to describe epidemiologic features in adult patients with acute mesenteric ischemia during years 2016-2020. Patients from all hospitals in Estonia are included.


Eligibility Criteria:
Inclusion Criteria:

All at least 18-year-old patients with acute mesenteric ischemia during years 2016-2020.

Exclusion Criteria:

-
A Trial to Study the Influence of Growth Factors on Bone Marrow and Hepatic Regeneration in Patients With Decompensated Cirrhosis.

This will be a randomized double blind study which will be conducted on patients admitted to Department of Hepatology from June 2013 to may 2014 at ILBS, New Delhi. Patients not having any exclusion criteria will undergo bone marrow examination and liver biopsy at the baseline.

60 patients of decompensated cirrhosis will be randomised into two limbs- limb A (30 patients) will receive G-CSF and erythropoietin while those on limb B (30 patients) will receive G-CSF alone. The drugs will be given for 2 months and patient will be followed for 1 year. G-CSF will be given at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 60 (total 22 doses). Erythropoietin will be given s/c at dose of 500 IU/Kg twice a week for 2 months.

Follow up will be done on days 0,3,7,14,28, day 42 (6 weeks), day 60 (2 months), day 90 (3 months), day 180 (6 months), day 270 (9 months); and day 360 (1 year).


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18-65 years
* All patients who are known to have cirrhosis of liver with portal hypertension and are compensated on presentation with no features of ascites/ jaundice/ bleed/ HE/ HRS.
* Only patients with alcoholic cirrhosis and cryptogenic cirrhosis (etiology work up negative) will be enrolled in the study.

Exclusion Criteria:

* Sepsis ( Any culture positive: blood, urine, any other obvious source of infection: UTI, LRTI)
* Variceal bleed in the past 3 months
* Autoimmune disorders
* HCC (Hepatocellular Carcinoma)
* Multi organ failure
* Any features of decompensation in form of ascites/Jaundice/ HE (grade 3 or 4) / HRS
* HIV seropositivity
* Essential hypertension
* Pregnancy
* Refusal to participate in the study
Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)

Overall improvement, severities and changes of specific clinical symptoms were surveyed in outpatients with depression or in a depressed state to evaluate the efficacy and safety of PAXIL tablets in patients in whom the PAXIL dose was increased and those treated with a constant dose.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who is 18 years or more
* Subjects diagnosed with depression or in a depressed state

Exclusion Criteria:

* Subjects who have been treated with paroxetine prior to this investigation
* Subjects with hypersensitivity to paroxetine
* Subjects taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
* Concomitant use in subjects taking pimozide
Newborn Infant Parasympathetic Evaluation (NIPE) Index After Standardized Tetanic Stimulations Under General Anesthesia

NIPE monitor is the recently developed pediatric version of the ANI monitor, which is used in adults to monitor analgesia during general anesthesia. In adults, under general anesthesia, ANI decreases after a nociceptive stimulation. The amplitude of this decrease is related to the intensity of the stim. This study aims to investigate if NIPE index decreases in the same manner after stimulations in anesthetized children.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgery under general anesthesia requiring tracheal intubation and muscle relaxation
* Written informed consent obtained from parents (and from child if appropriate)

Exclusion Criteria:

* Thoracic or cardiac surgery
* Cardiac arrhythmia, Pace maker
* Analgesic medication less than 24 hours before surgery
* Chronic anticholinergic medication
* Contraindication to muscle relaxants or general anesthetics
Postpartum Weight Loss for Women at Elevated Cardiovascular Risk

The aim of this study is to test the feasibility and effectiveness of a 16-week online behavioral weight loss program compared to usual care to promote weight loss in the postpartum period among women with cardiovascular risk factors. The investigators will also be testing different behavioral strategies to recruit postpartum women to the study, including 2 email recruitment strategies and 2 mailer recruitment strategies, informed by behavioral design.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years;
2. Delivered a baby at HUP or PAH within 3-12 months prior to study start;
3. BMI ≥ 27 kg/m2
4. Diagnosis of one of the following medical conditions: chronic hypertension, gestational hypertension, preeclampsia, eclampsia, gestational diabetes, or diabetes mellitus (type 1 or 2) based on diagnosis codes in the EMR
5. Has online access through smartphone or computer and has email address
6. Ability to read and provide informed consent to participate in the study

Exclusion Criteria:

1. Delivered prior to 32 weeks gestation in the EMR
2. Documentation of fetal demise or neonatal demise in the EMR
3. Currently pregnant or planning to get pregnant within the next 5 months
4. Does not speak English
5. Answers yes to any of the following questions:

   * Are you currently participating in any other weight loss or physical activity studies?
   * Do you have any medical conditions or other reasons why you could not participate in a 16-week weight loss or physical activity program?
6. Participants will be excluded after completing the run-in period if they do not complete the daily food log or their baseline BMI is \< 27 kg/m2
A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid Arthritis

This open-label study will evaluate the long-term safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with disease modifying anti-rheumatic drugs (DMARDs) in patients with moderate to severe rheumatoid arthritis. Patients who successfully completed studies WA17823 and WA18696 in South Africa are eligible to participate in this study. Patients will be allowed DMARDs according to the treatment they received in the previous studies. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 104 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Moderate to severe rheumatoid arthritis of more than 6 months duration upon entering the study
* Patients successfully completed studies WA17823 and WA18696 in South Africa
* Body weight \<150 kg

Exclusion Criteria:

* Patients who have withdrawn from studies WA17823 and WA18696 are not eligible to participate in this study Treatment with any investigational agent since last administration of study drug in studies WA17823 and WA18696
* Previous treatment with any cell depleting therapies
* Treatment with intravenous gamma globulin, plasmapheresis or Prosorba(TM) column since the last administration of study drug in studies WA17823 and WA18696
Study Evaluating Approach to Treatment of Haemophilia A and B in Spain

Analyze the clinical and therapeutic approach to treatment of haemophilia A and B in habitual clinical practice conditions in Spain.

Analyze the clinical and therapeutic approach to treatment of haemophilia A and B in habitual clinical practice conditions in Spain during the first 3 years since diagnosis.

Assess haemophilia A or B patient profile, study different kinds of hanitual clinical treatment of haemophilia A and B patients, and estimate the kind of treatment and dosage units used per year in patients under habitual clinical practice conditions.

Eligibility Criteria:
Inclusion Criteria:

* Haemophilia A or B patients of any age
* Written informed consent
Safety, Tolerability and Abeta-specific Antibody Response of Repeated i.m. Injections of Adjuvanted CAD106 in Mild Alzheimer Patients

This study will assess the safety, tolerability and Abeta-specific antibody response of repeated intra-muscular injections of adjuvanted CAD106 in patients with mild Alzheimer's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female patients below 85 years of age (inclusive)
* Diagnosis of mild Alzheimer's Disease
* Mini-Mental State Examination (MMSE) 20 to 26 (inclusive) at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 4 weeks prior to clinical assessments

Exclusion Criteria:

* Previously participated in an AD vaccine study and received active treatment
* History or presence of an active autoimmune disease
* History or presence of seizure disorder
* Presence of significant coronary heart disease and/or cerebrovascular disease
* Presence of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
* Advanced, severe, progressive or unstable disease that might interfere with the safety, tolerability and pharmacodynamic assessments of the patient

Other protocol-defined inclusion/exclusion criteria may apply