cyrilzakka/clinical-trials huggingface dataset:
Phase 2 Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Chylomicronemia Syndrome (FCS)

This is a single center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3-LRx for reduction of triglyceride (TG) levels in participants with FCS.


Eligibility Criteria:
Key Inclusion Criteria:

* Genetically confirmed chylomicronemia syndrome.
* Fasting triglycerides greater than or equal to (\>=) 750 milligrams per deciliter (mg/dL) \[8.4 millimoles per liter (mmol/L)\] at Screening.

Key Exclusion Criteria:

* Diabetes mellitus if newly diagnosed or if glycated hemoglobin (HbA1c) \>= 9.0%.
* Active pancreatitis within 2 weeks of screening.
* Acute coronary syndrome within 6 months of screening.
* Major surgery within 3 months of screening.
* Treatment with Glybera therapy within 2 years of screening.
* Previous treatment with AKCEA-ANGPTL3-LRx.
* Have any other conditions in the opinion of the investigator which could interfere with the patient participating in or completing the study.
Robot-assisted Laparoscopic Hysterectomy-RALH- Postoperative Complications, Quality of Life and Health Economics

The propose of this study is to describe recovery and experience of pain and health related quality of life after robot-assisted laparoscopic hysterectomy for women with Endometrial Cancer or Atypical Complex Hyperplasia.


Eligibility Criteria:
Inclusion Criteria:

Women suspected of having Endometrial Cancer or having Atypical Complex hyperplasia

* Ability to understand and speak Danish
* Ability to cooperate
* Provision of written informed consent

Exclusion Criteria:

* Having a benign condition after histopathology postoperatively
* Bing assigned to radiation or chemotherapy postoperatively
Palbociclib Induced Neutropenia; Risk Factors and Treatment Outcome in Metastatic Breast Cancer Patients

Aim of the study to assess the neutropenia induced by Palbociclib in patient receiving Palbociclib in combination with hormonal treatment as first-line therapy in metastatic hormone receptor- positive HER2 negative breast cancer. To evaluate the risk factors for occurrence of neutropenia and treatment outcome as 2 years PFS and OS.

Palbociclib is an orally active cyclin-dependent kinase (CDK) and is considered the standard treatment for hormone receptor (HR)-positive, (HER) negative metastatic breast cancer.

The PALOMA studies' showed improvement in progression-free survival (PFS) compared to endocrine therapy alone but a non-significant trend towards improved overall survival (OS).

MONALEESA and MONARCH suggest significantly improved OS with the addition of CDK inhibition.

Neutropenia is considered the dose-limiting and most frequent adverse effect of CDK inhibitors resulting in frequent dose reductions and treatment interruptions that are potentially associated with a lack of efficiency. Grade III/IV neutropenia rates were 62-66% in the PALOMA studies.

Some studies investigated the risk factors for the development of palbociclib-induced neutropenia. One concluded that no concomitant use of statins and high BMI were identified as significant predictors for the development of palbociclib-induced neutropenia. and another study also concluded that low baseline ANC, WBC, PLT, and BSA were associated with early grade III/IV neutropenia.

Regarding treatment outcome, two Phase Two clinical trials concluded that the treatment-related neutropenia in the first two cycles was significantly and independently associated with prolonged PFS, suggesting that neutropenia may be a useful pharmacodynamic marker to guide individualised palbociclib dosing.

However, another study concluded that limited dose modification may lead to longer PFS, without increasing toxicity, than the conventional dose scheme.

A study of variable risk factors and treatment outcomes for palbociclib-induced neutropenia will be useful for careful monitoring leading to adapted therapy.

Eligibility Criteria:
Inclusion Criteria:

* Histological pathological confirmation of primary breast cancer or metastatic disease.
* Hormonal receptor-positive, HER2 negative.
* Metastatic breast cancer at presentation (Den novo) or recurrent.
* Patients did not receive any previous systemic therapy for metastatic disease.
* Performance status (ECOG) 0-2.

Exclusion Criteria:

* Patient with co-morbidity
* Pregnant and breast lactating women
Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance

This is a randomized phase II study of secondary cytoreductive surgery (CRS) in patients with relapsed ovarian cancer who have progressed on PARP inhibitor maintenance.

The primary objective is to find out whether the CRS is beneficial in patients who have progressed on PARPi maintenance.

Eligibility Criteria:
Inclusion Criteria:

* Patients with first recurrence of platinum sensitive, invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage.
* Progression-free interval of at least 6 months after end of last platinum- containing therapy,
* Progressed during PARP inhibitor maintenance
* Women aged ≥ 18 years
* Complete resection of the tumor seems possible (estimated by an experienced surgeon). Intra-abdominal disease has to be excluded by MRI/CT, if other surgical approaches for isolated extra-abdominal recurrences are planned

  1. A positive AGO-score or iMODEL+PET/CT
  2. Patients who are likely to be completely resected according to the investigator's judgment will be allowed by consensus between PI(surgeon) and designated radiologist even if AGO or iMODEL+PET/CT negative.
* Patients who have given their signed and written informed consent and their consent to data transmission and -processing.

Exclusion Criteria:

* Patients with non-epithelial tumors as well as borderline tumors.
* Patients without recurrence who are scheduled for diagnostic/second-look surgery or debulking surgery after completion of chemotherapy
* More than one prior chemotherapy
* Patients with second, third, or later recurrence
* Patients with second malignancies who have been treated by laparotomy, as well as other neoplasms, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected.
* Patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months after end of former first platinum- containing therapy
* Only palliative surgery planned
* Radiological signs suggesting metastases not accessible to surgical removal (i.e. complete resection is deemed impossible)
* Any concomitant disease not allowing surgery and/or chemotherapy
* Any medical history indicating excessive peri-operative risk
* Any current medication inducing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents, bevacizumab)
* No assessable archival tumor tissue
Influence of Preconceptional Obesity on the Myometrial Cells Differentiation Toward a Contractyl Phenotype

The purpose of this study is to improve the understanding of cellular mecanism involved in delivery disorders in obese women, first by characterizing the hyperplasia phenomenon of myometrail cells induced by inflammatory stimulation (Il-1B), then by studying the role of blood mononuclear cells, of leptine and of obese women sera to interfere with the transition of myometrial cells toward hyperplasia phenotype.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed
* Patient affiliated with a social security scheme
* In front of for obstetrical reasons to give birth by caesarean section (scheduled caesarean section)
* Or a woman who is not obese in labour and needs to undergo a cesarean section
* No obvious infectious context
* Age \> 18 years old

Exclusion Criteria:

* Obvious inflammatory or autoimmune diseases
* Suspected or confirmed infectious context, including virale infection VIH, VHC, VHB
* Coagulation disorders
Evaluation of Tethered Capsule Endomicroscopy as a Screening Tool for Barrett's Esophagus in the Primary Care Setting

The investigators will conduct a large study in the primary care clinic to determine the feasibility of using tethered capsule endomicroscopy as a screening method for Barrett's esophagus (BE) in the primary care practice environment. The investigators are also determining the prevalence of Barrett's esophagus in a primary care practice cohort at MGH.

The investigators have developed a tethered capsule OCT device intended as an inexpensive screening tool for BE. The capsule, which is attached to a thin, flexible tether, is reusable after being processed by a standard disinfection technique. Used without sedation, the capsule is swallowed by the participant and travels in the esophagus to the gastroesophageal junction (GEJ) via peristalsis. Cross-sectional microscopic OCT images of the entire esophagus are collected during transit. The total time needed for swallowing, imaging and retrieval does not exceed 10 minutes, with a total of 30 minutes for the procedure. The investigators have tested the feasibility and the tolerability of this new OCT screening technology in 250 procedures in healthy volunteers and patients with various esophageal diseases including BE. The procedure has been safe and well tolerated. High quality microscopic images of the esophagus have been obtained in 90% of the enrolled subjects.

Eligibility Criteria:
Inclusion Criteria:

* Subjects registered as patients at the Assembly Row primary care practice.
* 18 years or older
* Able to give informed consent
* Subject must have no food for 1 hour before the procedure

Exclusion Criteria:

* Subjects older than 75 years.
* Subjects with current symptoms of dysphagia
* Subjects with gastro-intestinal strictures with a diameter less than 8mm, prior GI surgery (Esophageal and/or stomach surgeries), or history of intestinal Crohn's disease
* Pregnancy
* Patients scheduled for an urgent care visit for the following symptoms: fever, sore throat, upper respiratory infection symptoms, nausea, vomiting, diarrhea, abdominal pain, or other symptoms as per clinical staff discretion.
Validation and Clinical Application of Dysphagia Screening Questionnaire

The aim of this research was to develop a dysphagia screening measure and evaluate the prevalence of dysphagia and its clinical manifestation in different in age population groups.

The dysphagia screening questionnaire had the stages of validation - translation and back translation, a review of the translation and back translation committee, pre-test study (36 persons) with monolingual individuals and the test re-test study (67 subjects included).

The case - control study groups were tested using dysphagia screening questionnaire and clinical screening - water drinking test. Barthel index and nutrition questionnaire were used to identify the nutritional and functional state. M. D. Anderson dysphagia inventory questionnaire, sf-12 questionnaire were used to assess dysphagia effects on the quality of life.

The research group consisted of two subgroups - 171 nursing home residents from 3 different nursing homes and 82 outpatients of the Hospital of Lithuanian University of Health Sciences. The control group consisted of randomly selected 40 community-dwelling elderly healthy individuals.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Consent for participating in the research
* No cognitive disorders or mental illnesses

Exclusion Criteria:

* Refusal to participate in the research
* Serious mental or cognitive conditions
Evaluating the Shared Decision Making Process Scale in Cancer Screening Decisions

The purpose of this retrospective observational study is to evaluate the performance of the Shared Decision Making Process scale in a sample of patients who have received a decision aid about the decision to screen or not screen for breast cancer, colon cancer, prostate cancer, or lung cancer.

This is a retrospective observational study that will examine the performance of the Shared Decision Making Process in a sample of patients who made a decision about cancer screening in the last 2 years. Patients from 4 hospitals who have received a patient decision aid for breast, colon, prostate, or lung cancer screening will be screened for eligibility. A random sample of eligible patients will be sent a one-time survey. The survey asks patients about their experiences talking with healthcare providers about the specific cancer screening decision. The survey includes the Shared Decision Making Process scale, knowledge, preferences, decisional conflict and decision regret. The study will obtain 400 completed surveys, or 100 for each cancer topic.

The sample consists of patients who received a decision aid for cancer screening within the last two years and meet specific qualifications.

All analyses will be conducted separately for each group, and results may be pooled. First, study staff examine the descriptives for the Shared Decision Making Process items. Study staff will also test several hypotheses to examine performance of the scores such as whether higher shared decision making process scores are associated with less decisional conflict and less regret.

Eligibility Criteria:
Inclusion Criteria:

Breast Cancer group

* Female sex
* Between ages of 35-55
* No previous diagnosis of breast cancer

Colon Cancer Group

* Between ages of 45-75
* No previous diagnosis of colon cancer

Prostate Cancer Group

* Male sex
* Between ages of 45-74
* No previous diagnosis of prostate cancer

Lung Cancer Group

* Between ages of 50-80
* No previous diagnosis of lung cancer

Exclusion Criteria:

Breast Cancer group

* Unable to confirm primary language is English
* History of breast cancer
* Severe cognitive impairment who cannot consent for themselves

Colon Cancer Group

* Unable to confirm primary language is English
* History of colon cancer
* Severe cognitive impairment who cannot consent for themselves

Prostate Cancer Group

* Unable to confirm primary language is English
* History of prostate cancer
* Severe cognitive impairment who cannot consent for themselves

Lung Cancer Group

* Unable to confirm primary language is English
* History of lung cancer
* Severe cognitive impairment who cannot consent for themselves
Patterns of Fatty Acids in Framingham Offspring

To study the absolute concentrations and percent of fatty acids in 480 plasma samples from an age and sex stratified random sample of subjects in the Framingham Offspring Study in order to calculate the distribution of fatty acids in this general population and to determine the inter-relationships among levels of fatty acids, in particular w3 and w6 fatty acids, with lipoproteins and apolipoproteins.

BACKGROUND:

In 1988, research suggested that high intake of saturated fat increased the risk of cardiovascular disease and cancer, and feeding polyunsaturated fatty acids decreased plasma lipid values. However, understanding of the roles of specific types of fatty acids in nutrition and health remained limited. This was primarily because the technology for analysis of fatty acid compositions in human tissue had only recently achieved the required specificities and secondarily because application of the technology on the large scale of an epidemiologic study had to await recent advances in automation of the chromatography. Also intervention studies, aimed at reducing dietary intake of polyunsaturated fatty acids for long periods of time, were either impractical or unethical. The study was conducted to confirm preliminary results suggesting greater prevalence of low levels of essential fatty acids, particularly w3 fatty acids, among people with cardiovascular disease and hypertension, and to provide further confirmatory evidence to results that hyperlipidemia was inversely associated with essential fatty acid levels.

DESIGN NARRATIVE:

Subjects were randomly selected from existing lists so that six men and six women were selected from each age-year group from 30 to 69 broken down as follows: ages 30-34; 35-39; 40-44; 45-49; 50-54; 55-59; 60-64; 65-69. Plasma samples for these subjects were retrieved from storage in batches and analyzed. The prevailing distribution of fatty acids in the general population was calculated. The interrelationships were studied among levels of fatty acids, particularly w3 and w6 fatty acids, with lipoproteins and apolipoproteins. Relationships among fatty acid compositions of different lipid fractions were explored and their relationship with various cardiovascular risk factors were evaluated. Over 60 fatty acids were quantitated using capillary gas-liquid chromatography. Tables of reference values were produced for the general population and for selected subpopulations. Multivariate analysis was used to correlate fatty acids and other biochemical markers.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Benefits of Drinking Clear Fluids Until Called to the Operating Room in Adult Surgical Patients

The purpose of this study is to show if - compared to standard practice - allowing adults undergoing surgical procedures under anaesthesia care to drink clear fluids up to a volume of 200 ml between 2 h prior to the operation and the call to operation room (approximately 30 min prior to anaesthesia induction) will decrease patient thirst and increase patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (≥ 18 years)
2. American Society of Anesthesiologists (ASA) physical status classification I-III
3. Undergoing surgical procedure under anaesthesia care: general anaesthesia, regional anaesthesia, combined anaesthesia or monitored anaesthesia care.

The proportion of Patients undergoing general or combined anaesthesia is aimed to exceed 75%

Exclusion Criteria:

1. Absolute indication for rapid sequence induction including but not limited to:

   1. Bowel obstruction including ileus
   2. Stricture and oesophageal disorders including achalasia
   3. Recent polytrauma or trauma of the upper gastrointestinal tract
   4. Acute abdomen/peritonitis including active gastrointestinal bleeding
2. Relative indication for (modified) rapid sequence induction includes, but is not limited to:

   1. Symptomatic gastroesophageal reflux disease, independent of food intake and persistent under medical treatment (PPI)
   2. Hiatus hernia or upside down stomach
   3. Upper gastrointestinal tumour
   4. History of upper gastrointestinal surgery (oesophageal, gastric, duodenum, pancreatic)
   5. Medically confirmed gastroparesis
   6. Severe obesity, defined as body mass index ≥ 40 kg/m2
3. Dysphagia
4. Renal replacement therapy
5. Fluid restriction therapy
6. Pregnancy
7. Expected need for postoperative mechanical ventilation
Evaluation of the TICCS Capacity to Identify Trauma Patients With Acute Coagulopathy and Massive Bleeding

A prospective single-centre non-comparative non-interventional open study has been designed to validate, in a target number of 100 trauma patients, the correlation between TICCS evaluated on the site of injury and thromboelastography made on a whole blood sample taken at the latest 30 min after patient's arrival in the resuscitation room.

The aim of this study was to evaluate the capacity to discriminate trauma patients suffering from active bleeding and arly acute coagulopathy of trauma and needing Damage control resuscitation from those without this aggravating combination with a new purely clinical easy-to-measure pre-hospital score: the Trauma Induced Coagulopathy Clinical Score (TICCS).

It started in January 2012 and was completed in June 2013. The TICCS was to be calculated for each patient. The presence of coagulopathy was to be assessed by thromboelastography measured at the latest 30 minutes after patient's hospital entry or, if not available, by standard coagulation tests (International Normalized Ratio or Prothrombin Time, activated partial thromboplastin time, fibrinogen, platelets).

Haemorrhagic shock was to be assessed by the treating physician at hospital entry on the basis of persistent hypotension due to a demonstrated active bleeding.

Surgical procedures and transfusion needs (up to 24 hours) were to be recorded all along patients' hospitalization. The transfusion of more than 4 Red Blood Cells units and more than 3 Fresh Frozen Plasma units within the first hour of care was defined as a massive transfusion.

We defined two populations of patients. "Severe" patients were defined by associating all the following conditions: active bleeding + early acute coagulopathy of trauma + need for massive transfusion + need for emergent surgical or endovascular hemostasis; "non-severe" patients were defined as patients without this 4-conditions association. Patients meeting only three of the four criteria or less were thus recorded as "non-severe".

Quantitative variables were summarized as mean, standard deviation (SD) and range, while frequency tables were used for categorical findings. The cut-off value for TICCS was obtained by Receiver Operating Characteristic curve analysis based on the severity of the patients. Group comparisons were done by Student t-test for continuous variables and by the chi-square test (or Fisher exact test) for categorical variables. Each trauma score was characterized by its sensitivity, specificity, positive and negative predicted values and area under the curve (AUC). Results were considered significant at the 5% critical level (P\<0.05). Calculations were performed with the Statistical Analyses System statistical package for Windows (version 9.3).

Eligibility Criteria:
Inclusion Criteria:

* Every trauma patients admitted in our resuscitation

Exclusion Criteria:

* age under 12
Using Surveys to Examine the Association of Exposure to ML Mortality Risk Predictions With Medical Oncologists' Prognostic Accuracy and Decision-making

Nearly half of cancer patients in the US will receive care that is inconsistent with their wishes prior to death. Early advanced care planning (ACP) and palliative care improve goal-concordant care and symptoms and reduce unnecessary utilization. A promising strategy to increase ACP and palliative care is to identify patients at risk of mortality earlier in the disease course in order to target these services. Machine learning (ML) algorithms have been used in various industries, including medicine, to accurately predict risk of adverse outcomes and direct earlier resources. "Human-machine collaborations" - systems that leverage both ML and human intuition - have been shown to improve predictions and decision-making in various situations, but it is not known whether human-machine collaborations can improve prognostic accuracy and lead to greater and earlier ACP and palliative care. In this study, we contacted a national sample of medical oncologists and invited them complete a vignette-based survey. Our goal was to examine the association of exposure to ML mortality risk predictions with clinicians' prognostic accuracy and decision-making. We presented a series of six vignettes describing three clinical scenarios specific to a patient with advanced non-small cell lung cancer (aNSCLC) that differ by age, gender, performance status, smoking history, extent of disease, symptoms and molecular status. We will use these vignette-based surveys to examine the association of exposure to ML mortality risk predictions with medical oncologists' prognostic accuracy and decision-making.


Eligibility Criteria:
Inclusion Criteria:

* Medical oncologists who treat lung cancer

Exclusion Criteria:

* Medical oncologists who do not see lung cancer patients