cyrilzakka/clinical-trials huggingface dataset:
Outcome of Very Old Patients Admitted for Elective Major Surgery, the Effect of Frailty

The aim of the study is to investigate the effect of frailty in patients ≥ 80 years admitted for elective major abdominal surgery.

Patients ≥ 80 years admitted for elective major abdominal surgery will be asked to participate in this study where frailty will be scored using the Clinical Frailty Scale and by measuring hand-grip-strength.

Primary outcome is mortality at 30 days, 90 days and 1 year.

Eligibility Criteria:
Inclusion Criteria:

* age 80 years or above
* elective abdominal surgery
* informed consent

Exclusion Criteria:

* age less than 80 years
* emergency surgery
* palliative surgery ( e.g performing entero-enteroanastomosis to relieve obstruction)
Evaluation of the Uses of a Digital-assisted Self-rehabilitation Device (TELE-PARK)

Evaluate the use by the patient and his family and professional environment of a self-rehabilitation device with follow-up in tele-rehabilitation in people with Parkinson's disease taking into account the different actors within a health area (health professionals and paramedics in structure and in liberal).


Eligibility Criteria:
Inclusion Criteria:

Patients:

* Men and women over the age of 18
* With Parkinson's syndrome due to idiopathic Parkinson's disease or related syndromes
* Presenting a complaint about balance and/or walking
* With possible walking over a perimeter of at least 100 meters with or without technical aid
* Hoehn and Yahr scale \< or = to 4
* Formulating their free and informed consent in writing.

Health professionals:

- physiotherapists and physiatrists hospital or voluntary volunteers practicing in the territory of health 5 in Brittany agreeing to participate in the study

Exclusion Criteria:

* Orthopedic and rheumatologic pathologies that may prevent the achievement of measures
* Comprehension disorders preventing the implementation of the protocol
Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 1

The Purpose of this study is to:

1. Refine and validate a computerized bedside decision support tool blood glucose management in critically ill adult and pediatric ICU patients.
2. Monitor how often low blood sugar levels occur during use of the bedside tool.
3. Determine how the computerized tool effects the workload of the ICU nurses.

This first phase will be a prospective cohort study. We will validate the bedside tool in at least 4 adult and at least 4 pediatric ICUs and if necessary we will modify the bedside tool. The computerized bedside tool will be considered refined if \>90% of the generated instructions are accepted and if the percent of glucose values in the 70-110 mg/dl range are equivalent to our pilot experience rate of 55%, and if the rate of glucose values less than or equal to 40 mg/dl is less than 0.5% of glucose measurements.

Eligibility Criteria:
Inclusion Criteria:

1. Pediatric ICU: Proposed indications by pediatric clinicians at participating ICUs for glucose control in their ICUs would include patients who require mechanical ventilation for greater than 24 hours and/or require a vasoactive infusion (e.g. dopamine \>3 mg/kg/min, dobutamine, epinephrine, or vasopressin).
2. Adult ICUs: Proposed indications by clinicians in participating ICUs for glucose control in participating adult ICUs include critically ill patients with an anticipated ICU length of stay of 3 or more days.

Exclusion Criteria:

1. Pregnancy (negative pregnancy test required for females of child-bearing age)
2. Age less than one month
3. Inborn errors of metabolism that the clinician suspects will affect glucose homeostasis
4. Acute or chronic liver disease with any documented episode of blood or plasma glucose \<60 mg/dl within the 24 hours prior to study entry
5. Diabetic Ketoacidosis (critically ill patients with insulin dependent diabetes not in ketoacidosis will be eligible if attending physicians intend to use intravenous insulin as part of ordinary care)
6. Severe chronic liver disease (Child-Pugh score \>10)
A Study to Determine the Antiviral Activity of TMC310911 When Administered With Ritonavir in Treatment-Naive Human Immunodeficiency Virus - Type 1 (HIV-1) Infected Patients

The purpose of this study is to evaluate the antiviral activity as measured by the change in viral load from baseline in the 14 days following initiation of treatment with 4 different dose regimens of TMC310911 co-administered with ritonavir.

This is an open-label (all people know the identity of the intervention) and randomized (study medication assigned by chance) study in treatment-naive human immunodeficiency virus type 1 (HIV-1)-infected participants (participants who had not been treated with a therapeutic HIV vaccine within 1 year prior to enrollment and who had never been treated with an antiretroviral \[ARV\] medication indicated for the treatment of HIV-infection or ARVs for treatment of hepatitis B infection with anti-HIV activity prior to screening). In this study approximately 32 participants will be enrolled and randomly assigned to receive 4 different dose regimens co-administered with ritonavir (8 participants in each dosing regimen). The trial will consist of a screening period (maximum 6 weeks), a treatment period with TMC310911 (2 weeks), and a follow-up period (4 weeks). Safety evaluation will include assessment of adverse events, clinical laboratory tests, vital sign measurements, physical examinations and electrocardiograms.

Eligibility Criteria:
Inclusion Criteria:

* Documented human immunodeficiency virus type 1 (HIV-1) infection for at least 6 months prior to the screening date
* Participant who has not been treated with a therapeutic HIV vaccine within 1 year prior to enrolment and has never been treated with an antiretroviral (ARV) medication indicated for the treatment of HIV infection or ARVs for treatment of hepatitis B-infection with anti-HIV activity
* Participant agrees not to start antiretroviral therapy (ART) before the baseline visit
* Able to comply with the protocol requirements and have good accessible veins
* HIV-1 plasma viral load at screening visit of above 5,000 HIV-1 Ribonucleic acid copies/mL
* CD4+ cell count above 200 cells/mm3 at screening

Exclusion Criteria:

* HIV-2 infected participants and/or participants with any active or chronic hepato-renal disease
* Life expectancy of less than 6 months
* Documented acute (primary) HIV-1 infection
* Pre-existing protease inhibitor (PI) medication resistance
* Any currently active Acquired Immunodeficiency Syndrome (AIDS) - defining illness
* Any active clinically significant disease or findings during screening or medical history or physical examination that in the investigator's opinion, would compromise the outcome of the study
* Any confirmed grade 3 or 4 toxicity according to the Division of AIDS (DAIDS) grading scale at screening
Predictive Markers of Glitazone Efficacy in Diabetic Patients - Pilot Study

Hypothesis:

A cluster of biochemical measurements (biomarkers) predict which diabetic patients will respond to treatment with a therapeutic dose of rosiglitazone over a 12 week treatment period.

Brief Summary:

The purpose of this study is to assess the predictive value of the biomarkers in diabetic patients treated with a full dose of a thiazolidinedione (eg 4mg bid rosiglitazone) for 12 weeks.

Specifically - the questions asked are:

1. Do baseline measurements of a selected panel of biomarkers predict the patients' response to rosiglitazone over 12 weeks?
2. How does the panel of biomarkers change over that 12 week treatment period?

Rosiglitazone (Avandia) is a medicine used to treat type 2 diabetes. It works by increasing the sensitivity of body tissues to insulin.

This pilot study will examine the possibility that baseline biochemistry might predict the response to rosiglitazone. The study will be conducted in males and the biomarkers of interest measured by specific assays. In addition, since the biomarkers to be measured come from body fat, interpretation of the data would be facilitated by accurate measurements of changes in body fat mass during treatment and these data can be obtained from Echo-MRI scans.

Eligibility Criteria:
Inclusion Criteria:

1. Male subjects aged 18 to 65 years.
2. Eligible subjects must be free from clinically significant illness or disease (other than type 2 diabetes)with the exception of chronic stable-treated hypertension (BP\<160/90, and \>90/50), thyroid disease (TSH in the normal reference range) and/or dyslipidaemia.
3. BMI must be \> or = 25kg/m2 to \< or = 40kg/m2,
4. HbA1c between 7and 10%, fasting blood glucose above 7mmol/L (fasting means greater or = 8 hours prior to screening).
5. On diet alone or diet plus metformin (GSK data indicate that the latter group more faithfully reflect the behaviour of 'naive' patients than those who have been washed off prior medications)for at least 1 month.
6. On stable doses of anti-hypertensive medication, thyroid hormone replacement and statin therapy as required.

Exclusion Criteria:

1. Prior treatment with thiazolidinedione, insulin or GLP-1 analogue (Byetta)
2. History of hepatic disease, impairment or abnormal liver function test i.e. AST, ALT\>2 times upper limit of normal range (ULN), bilirubin\>1.5 time ULN.

   History of renal disease or serum creatinine greater than 1.5 X ULN.
3. Contraindications to rosiglitazone treatment.
4. Serum creatinine greater than 1.5 X upper limit of normal range.
5. Any other clinically significant laboratory abnormality.
6. Claustrophobic or other contraindication to MRI scan
7. Females of child-bearing age who are unwilling to use appropriate methods of contraception.
8. Unable to give informed consent.
9. Unable to comply with study protocol.
10. Clinically significant co-morbidity. -
Genetic Etiology in Patients With Cerebral Palsy

Cerebral palsy (CP) is a permanent disorder of movement or posture due to non-progressive impairments of the developing brain. Current estimates indicate that as many as 30% of CP cases may be genetic in nature. In our study, the investigators will re-examine the data of children with CP, who are registered in the Slovenian National Registry of Cerebral Palsy. All children will be invited to the University Children's Hospital, University Medical Centre Ljubljana, where they will be re-examined by a neurologist. Blood for genetic testing will be taken. In the case of confirmed genetic ethiology of CP, the search for specific therapy will be possible.

Cerebral palsy (CP) is a permanent disorder of movement or posture due to non-progressive impairments of the developing brain. In children, CP is the most common cause of motor impairment, which is often accompanied by other disorders such as epilepsy, mental retardation, speech and language disorders, eating disorders, visual and hearing disorders, and behavioral disorders. Approximately 1 child in every 500 live births is diagnosed with cerebral palsy.

The causes of CP are usually related to inadequate blood flow and oxygen supply to the baby's central nervous system during pregnancy or birth, complications of premature birth, and other complications in the neonatal period such as respiratory distress, infections, or jaundice. It is estimated that in up to one third of children with CP the cause is unexplained. The cause of CP in these children may also be rare genetic diseases. For some of these diseases a targeted treatment is available.

In Slovenia, all children with CP, born since 1996, are included in the Slovenian National Registry of Cerebral Palsy (SRCP), which is part of the European registry - Surveillance of Cerebral Palsy in Europe (SCPE). Children are entered into the register at University Children's Hospital, University Medical Centre Ljubljana at the age of 5, after prior parental consent, otherwise anonymously.

In our study, the investigators will re-examine the data of children with CP, who are registered in the SRCP. All children will be invited to the University Children's Hospital, University Medical Centre Ljubljana, where they will be re-examined by a neurologist. With the consent of the patient or his/her parent/guardian, blood for genetic test will be taken. Utilising next gen sequencing (NGS), a gene panel of more than 100 genes associated with the CP spectrum disorders will be performed. In the case of confirmed genetic ethiology of CP, the search for specific therapy will be possible.

Eligibility Criteria:
Inclusion Criteria:

* Children with cerebral palsy who are included in the Slovenian National Register of Cerebral Palsy (SRCP)
* Patients whose parents/caregivers were informed about the aims of the study and have signed the Informed consent form.

Exclusion Criteria:

* Patients who are not diagnosed with cerebral palsy
* Patients whose caregivers have not signed the Informed consent form.
SPECTAmel: Screening Patients With Melanoma Tumors for Efficient Clinical Trial Access

SPECTAmel is a standardized, quality-assured molecular screening platform for tumor characterization and storage of human biological material (HBM) for the purpose of integrating new biomarkers into clinical trials and optimizing access of patients to therapeutic biomarker-driven clinical trials. HBM and clinical/pathological data are collected from consenting patients.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed melanoma of any stage (the steering committee will decide on which stage to include at any particular time point during this trial, this will be communicated appropriately to all participating sites)
* Mandatory availability of adequate human biological material (HBM): FFPE tissue sample from the primary tumor, recurrent tumor, metastasis, obtained at the time of primary surgery/biopsy; minimal amount requested is detailed in the HBM guidelines; if feasible, inclusion of samples taken at any recurrence diagnosed during follow-up is strongly encouraged but optional;
* Age ≥ 18 years;
* At least three months life-expectancy;
* Written informed consent according to ICH/GCP and national/local regulations;
* Absence of any active malignancy, except pT1-2 prostatic cancer Gleason score \< 6, or carcinoma in situ of the cervix, in the 5 years before study entry;
* Absence of exclusion criteria like active hepatitis B/C or HIV, second malignancies, no severe organ dysfunction or other comorbidities that may prevent inclusion into clinical trials.
* Central confirmation of human biological material (HBM) adequacy for step 2:
* Centrally performed confirmation of tumor tissue adequacy in terms of quality/ quantity for central screening.

Exclusion Criteria:

* active hepatitis B/C or HIV
* second malignancies
* severe organ dysfunction or other comorbidities
Quinine and Food Intake

Rationale: The appearance of tastants in the small intestine following food ingestion results in the onset of digestion and absorption but can also result in the activation of a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. These processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. In this study, we aim to investigate the effects of oral sham feeding and intragastric delivery of a bitter tastant (quinine) on ad libitum food intake, satiation, gastrointestinal symptoms, and heart rate variability.

Objective: To investigate the effect of oral sham feeding and intragastric delivery of a bitter tastant on food intake.

Secondary Objective(s):

1. To compare the effect of oral sham feeding and intragastric delivery of a bitter tastant on satiation.
2. To assess the effect of oral sham feeding and intragastric delivery of a bitter tastant on gastrointestinal symptoms/complaints.
3. To assess the effect of oral sham feeding and intragastric delivery of a bitter tastant on heart rate variability.


Eligibility Criteria:
Inclusion Criteria:

* Based on medical history and previous examination, no gastrointestinal complaints and/or gastrointestinal disorders can be defined.
* Age ≥18 and ≤65 years. This study will include healthy adult subjects (male and female).
* BMI ≥18 and ≤25 kg/m2
* Body weight stable over at least the last 6 months (≤ 5% weight change allowed)

Exclusion Criteria:

* History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
* Use of medication that can influence study end-points (to be discussed by medical doctor and principal investigator), including vitamin supplementation, within 14 days prior to testing
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
* Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy and hysterectomy allowed, and other surgery upon judgement of medical doctor and principle investigator)
* Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic)
* Unwillingness to eat lasagna Bolognese meal
* Pregnancy, lactation
* Excessive alcohol consumption (\>20 alcoholic consumptions per week)
* Smoking
* Non-tasters of bitter
Spray Skin Treats for Pediatric Burns

The treatment of burns in children remains a global challenge. At present, the clinical treatment plan is still waiting for further improvement. This study intends to retrospectively analyze the experience of treating children burn in recent years and promote sharing and application.

The treatment of burns in children remains a global challenge. Children's burn wounds have many characteristics that are different from those of adults, such as easy deepening of the wound, uncooperation in dressing change, poor resistance and so on. At present, there are new dressing applications a nd surgery in clinical treatment, etc., but how to treat children to achieve better therapeutic effects still needs to be explored. This study intends to retrospectively analyze the experience of treating children burn in recent years and promote sharing and application.

Eligibility Criteria:
Inclusion Criteria:

* burn for any reasons
* Children

Exclusion Criteria:

* Combined with mental illness
* Congenital immune disease
* Severe cardiopulmonary failure，etc
A Comparative Study of CCI, EmSFI, and fTRST Scoring Systems

Frailty assessment tools and comorbidity indices play a crucial role, particularly in predicting outcomes for elderly patients undergoing emergency surgery. The Emergency Surgery Frailty Index (EmSFI), Charlson Comorbidity Index (CCI), and the Flemish version of the Triage Risk Screening Tool (fTRST) are considered valuable tools that help understand patients perioperative risk profiles. This study aims to investigate the accuracy and clinical utility of these scoring systems in predicting mortality in individuals aged 65 and older undergoing emergency surgery


Eligibility Criteria:
Inclusion Criteria Patients aged 65 years and older who underwent emergency abdominal surgery

Exclusion Criteria:

* Multiple hospitalizations for the same pathology,
* Initial admission at another facility,
* History of emergency abdominal surgery before the study period,
* Terminal-stage cancer
* Emergency reoperations following elective surgery,
* Surgery while in the intensive care unit.
Investigating KardioPAC Mobile App to Improve Physical Fitness Among Cardiac Rehabilitation Patients

The purpose of this study is to sustain regular physical activity, improve health-related quality of life, improve resting blood pressure, improve anthropometrics, and improve adherence to prescribed cardiac rehabilitation sessions among individuals referred for cardiac rehabilitation (CR). Numerous studies show that CR improves clinical outcomes in cardiovascular disease (CVD). Exercise as a reliable adjunctive intervention, however, remains limited due to poor short- and long-term adherence. This proposed study will examine the effectiveness of the Kura Care KardioPac digital application plus CR to significantly sustain exercise adherence among CR patients, as compared to standard of care alone.


Eligibility Criteria:
Inclusion Criteria:

1. Referred to the University of California San Diego Health Cardiac Rehabilitation Center for 36-72 sessions of intensive cardiac rehabilitation for one of the following medical conditions: myocardial infarction, coronary artery bypass surgery, stable angina, heart valve repair or replacement, coronary angioplasty or stenting, congestive heart failure, heart transplant, or peripheral arterial disease
2. Able to give informed consent in English
3. Able to perform study assessments as described
4. Resting BP\<180/110 mmHg
5. Able to perform light to moderate exercise
6. Have not had a fall during the previous 6 months resulting in an injury
7. Clinical staff's permission to participate, including their assessment that participant is a good candidate for this research study
8. Ability to complete written or app-based surveys
9. Owns an Apple or Android mobile telephone capable of downloading and running the app

Exclusion Criteria:

1. Referred to CR following Ventricular Assist Device procedure
2. Angina not adequately managed with nitrates
3. Oxygen-dependent Chronic Obstructive Pulmonary Disease
4. Recent stroke or significant cerebral neurologic impairment that would interfere with participation.
5. Unable to operate a BP device
Risk Factors for Stroke or Systemic Embolism in Chinese Patients with Non-Valvular Atrial Fibrillation Registry

This study is aimed to validate the existing stroke risk stratification model for patients with atrial fibrillation (AF) (CHA2DS2-VASc Score, CHADS2 Score, ATRIA score, ABC score, etc.) and establish a new stroke risk assessment model using a nationwide AF -specific registry in China.

This study is a multicenter prospective disease-specific registry of patients with atrial fibrillation (AF) that will analyze factors that are associated with stroke or systemic embolic events in patients with AF in China. Approximately 5,000 prospective cohort of patients and 22,000 retrospective cohort of patients will be enrolled. Consecutive patients who meet the eligibility criteria and provide informed consent. Patients enrolled in the registry will be followed for approximately 3 years. Patient follow-up by National Center for Cardiovascular Diseases will continue as scheduled. Atrial Fibrillation Data capture will include demographics, cardiovascular risk factors, diagnosis, type of AF (paroxysmal, persistent, permanent AF), treatment strategy (rate vs. rhythm), antithrombotic therapy, concomitant medications and doses, laboratory tests, echo and computed tomography results, blood sample, insurance and provider information, comorbidities, and outcomes. The primary outcome will be stroke or non-CNS embolism. Other pre-defined outcomes of interest will include major adverse cardiac events, all-cause mortality, cause-specific death (sudden, non-sudden, heart failure-related), major bleeding, and hospitalization for heart failure.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older; male or female.
* History of documented atrial fibrillation.
* Able to provide written informed consent.

Exclusion Criteria:

* Subjects with moderate or severe mitral stenosis or a mechanical heart valve
* Subjects with previous or planned AF ablation.
* Subjects with previous or planned left atrial appendage closure.
* Subjects unable to cooperate with follow-up after assessment.