cyrilzakka/clinical-trials huggingface dataset:
Is the Artificial Pancreas, Without Carbohydrate Counting, Efficient and Safe in an Outpatient Setting

This is a pilot, interventional clinical trial to assess the effectiveness and safety of artificial pancreas (AP) using the ARG algorithm closed-loop system in a monitored 3-day period outpatient study. Once the safety of the device has been validated in the open-loop first 3-day period (continuous subcutaneous insulin infusion (CSII) plus continuous glucose monitoring (CGM)) the investigators will move the study to the second 3-day closed-loop period, without carbohydrate (CHO) counting.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with T1DM at least two years ago and has been using an insulin pump and a CGM for at least 6 months prior to the trial first visit
* Patient is \>18 and \<65 years
* Patient has HbA1c \< 10%
* Woman in premenopausal age agrees to use contraceptive methods
* Woman in premenopausal age has negative B-HCG in the tests performed in the trial
* Patient is trained in CHO counting
* Patient has signed informed consent and has the ability to understand the nature and intent of the study including the ability to comply with study procedures and is willing to keep scheduled visits

Exclusion Criteria:

* Patient has been hospitalized for diabetic ketoacidosis in the last 12 months
* Patient has experienced severe hypoglycemia with loss of consciousness in the last 12 months
* Patient has a history of coronary disease or cardiac failure
* Patient with uncontrolled arterial hypertension
* Patient with a condition that makes the researcher believe that it might increase the chance of hypoglycemia
* Patient has symptoms compatible with active infectious disease
* Patient has Cystic Fibrosis
* Pregnant women, or women with the intention of getting pregnant; women breastfeeding
* Patient has been hospitalized for psychiatric treatment in the last 6 months.
* Patient with a diagnosis of adrenal disease
* Patient has abnormal laboratory values for liver function: transaminase \> 2x upper limit normal
* Patient has abnormal laboratory values for renal function: GFR \< 60 ml/min/1.73m2
* Patient has active gastroparesis
* Patient is under oncological treatment
* Patient has taken acetaminophen 72 hours previous to the study
Comparison of Three Laryngoscope Blades for Orotracheal Intubation in the Operating Room

The purpose of this study is to determinate if there is a difference in performance provided by three laryngoscope blades: plastic single use, metallic single use and metallic reusable blades.

Primary outcome: success of intubation at the first attempt

Secondary outcomes: quality of laryngeal exposition (Cormack and Lehanne modify grade), duration to success intubation, Intubation difficult Scale and result of intubation procedure

Eligibility Criteria:
Inclusion Criteria:

* patient age over 18 who need general anesthesia with orothracheal intubation

Exclusion Criteria:

* patient age under 18 or major assist
* presence of upper airway malformation or abnormality
* cervical or facial trauma
* previous difficult intubation known
* no use of curare
* Body Mass Index over 30kg/m2 if crush induction use
Motorized Mechanical Massage Associated With Cosmetics in Improving Body Contour and Appearance of Gynoid Lipodystrophy

PURPOSE: To evaluate the efficacy of motorized mechanical massage associated with cosmetics in improving body contour and appearance of gynoid lipodystrophy.

SUBJECTS AND METHODS: A prospective and comparative longitudinal clinical study will be performed in 30 women with localized fat and gynoid lipodystrophy. Patients will be submitted data collection and assessments and before and after treatment.

HYPOTHESES: It is expected that the patients will present improvement in the body contour and in the picture of the gynoid lipodystrophy after the association of the therapies.

STATISTICAL ANALYSIS: A descriptive analysis will be done before and after vibration-oscillatory therapy, with frequency tables for categorical and descriptive variables (mean, standard deviation, median, minimum and maximum values) for continuous or numerical variables. In order to compare the main variables between the groups and the collection times, the analysis of variance (ANOVA) for repeated measurements will be used. Tukey's test will be used to compare groups. The level of significance adopted for the statistical tests will be 5% or p \<0.05.

After signing the informed consent, the participants will be evaluated by two physiotherapists where the data collected will be from personal data, anthropometric and complementary diagnostic tests such as: ultrasound diagnosis in order to evaluate the thickness of the adipose tissue and Cutomiter analysis of the Viscoelasticity of the skin. Afterwards they will be divided and started the treatment with another physiotherapist who will perform the following protocol of the study: exfoliation of the skin, application of the motorized mechanical massage with the device Dermotonus Slim with 550mg of vacuum, continuous mode, for 20 minutes subdivided into region Abdominal and posterior thigh, after the end will be applied the creams for lipolytic purposes. The protocol will be performed twice a week for 1 hour each, totaling 10 sessions.

Eligibility Criteria:
Inclusion Criteria:

* Female gender, over 18 years of age;
* With a body mass index up to 29.9 considered overweight;
* Carriers of GI lipodystrophy;
* Non smokers;
* That they agree to participate and sign the term of free and informed commitment - TCLE

Exclusion Criteria:

* Male gender;
* Performed esthetic treatment in the gluteal region and thighs in the last month;
* Patients with skin lesions, such as dermatitis and dermatoses;
* Patients with capillary fragility;
* Patients with acute deep vein thrombosis (DVT);
* On or near cancerous lesions;
* Patients with cardiac pacemaker or other implanted electronic device.
Using the Hunt Motivational Scale to Aid in Weight Loss and Weight Maintenance

In this study, we plan to determine the efficacy of the Hunt Motivational Scale as a tool for weight loss compared to standard of care in the Penn Medicine Princeton Health weight management program.

Obesity is rising at alarming rates, currently at nearly 40%. There are very few tools, specifically questionnaires, for healthcare providers to help their patients lose weight or maintain their weight loss. The Hunt Motivational Scale is one such tool to help patients identify areas that need improvement in order to aid in weight loss and weight maintenance. The HMS is designed to motivate patients to track, plan, and practice other healthy weight loss and weight maintenance practices so that they will have success.

In this study, approximately 75 subjects in the Penn Medicine Princeton Health weight management program will be randomly assigned to either receive the HMS or not (standard of care). They will be followed for a period of six months at the end of which it will be determined whether the group that received the HMS lost more weight than the control group.

Eligibility Criteria:
Inclusion Criteria:

* patient in weight management program at Penn Medicine Princeton Health

Exclusion Criteria:

* does not have a visit every three to four weeks
* not in active weight loss phase of the program
* diminished intellectual capacity to complete questionnaire i.e. Down's syndrome
Sedation During Noninvasive Ventilation (NIV)

In patients undergoing NIV for acute respiratory, lack of tolerance is one of the main reason of failure.

This may result in a poor synchrony between the patient and the machine, leading to gross mismatching and potentially to an increased work of breathing.

The investigators aim to investigate whether in these patients poorly responding to NIV the use of a sedation protocol using remifentanil will lead to an improve patient-ventilator interaction and better compliance to NIV.

In patients undergoing NIV for acute respiratory, lack of tolerance is one of the main reason of failure.

This may result in a poor synchrony between the patient and the machine, leading to gross mismatching and potentially to an increased work of breathing.

The investigators aim to investigate whether in these patients poorly responding to NIV the use of a sedation protocol using remifentanil will lead to an improve patient-ventilator interaction and better compliance to NIV.

In this physiological study the investigators will study 15 patients at risk of failing NIV because of scarce tolerance and showing clinical signs of poor interaction with the ventilator.

Once the patient will be enrolled the investigators will record using the balloon-catheter technique the online measurement of respiratory mechanics, to assess the inspiratory muscle effort and the matching between the patient breathing pattern and that of the ventilator The investigators will also record the clinical success of sedation (i.e. need or not for endotracheal intubation)

Eligibility Criteria:
Inclusion Criteria:

* Ph\<7,35 and PaCO2\>50 mmHg with acute respiratory failure
* Signs of respiratory distress and poor synchrony with the ventilator as assessed on the ventilator screen and by looking patient own rate and ventilator recorded rate

Exclusion Criteria:

* Patients responding well to NIV and not showing signs of poor synchrony
Thoracotomy Closure Technique and Postoperative Pain Study: A Randomized Controlled Trial

The purpose of this study is to examine pain associated with thoracotomy (incision made during surgery to obtain access to your thoracic cavity) and how the closure technique may influence postoperative pain. Two types of routinely selected thoracotomy closure techniques will be examined; pericostal and intracostal sutures. The investigators hypothesize that intracostal sutures will result in less postoperative and chronic pain as a result of less compression of the intercostal nerve.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing an elective procedure that will include a thoracotomy.
* All patients will undergo epidural catheter placement.

Exclusion Criteria:

* Previous thoracotomy on the operative side.
* Previous history of chronic chest pain.
* Previous history of thoracic trauma on the operative side.
* Less than 18 years of age
* Inability to provide informed consent or to complete testing or data collection
* Need for a chest wall resection
* Patients requiring other incisions in addition to a thoracotomy (i.e., Laparotomy, sternotomy
Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing

In this pilot study the investigators attempt to answer the question, does mindfulness exercises before urodynamic testing reduce patient's perception of anxiety or pain?

The subjects are being asked to consider participation in this research study. The purpose of this study is to see if incorporating mindfulness exercises prior to urodynamic studies (UDS) results in less pain, anxiety and discomfort.

The participants will be guided through a mindfulness meditation exercise by a licensed professional. During this exercise participants will be asked to focus attention on breathing, physical sensations, and thoughts. This exercise will last for approximately 10 minutes in which participants will not be asked to engage in any physical activity other than sitting and breathing. The participants will be randomly assigned to one of 2 treatment plans. Randomization is a process like flipping a coin and means the chance of being assigned to either of the plans. One treatment plan includes undergoing mindfulness exercises prior to your UDS evaluation. The other treatment plan includes simply undergoing the UDS evaluation.

After the participants UDS evaluation, questions will be asked about the urodynamic procedure. The participants will be asked to answer questions on a UDS and anxiety questionnaire which pertain to emotional and physical experiences during the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of urinary symptoms requiring urodynamic testing

  * Stress incontinence
  * Mixed incontinence
  * Urge incontinence
  * Overactive bladder
  * Urinary retention
  * Lower urinary tract symptoms
* Are Department of Defense (DoD) beneficiaries

Exclusion Criteria:

* Neurogenic bladder
* Interstitial cystitis
* Chronic bladder pain
* Inability to have urodynamics performed
* Are Not DoD beneficiaries
* Pregnant
* Lack capacity to consent
R-MegaCHOP-ESHAP-BEAM in Patients With High-Risk Aggressive B-Cell Lymphomas

The purpose of this study is to show if addition of Rituximab to intensive induction (MegaCHOP/ESHAP) and high-dose consolidation (BEAM) improves progression-free and overall survival in patients younger than 65 years with aggressive B-cell lymphoma and aaIPI 2 or 3.

Previous study of Czech Lymphoma Study Group (4_2002)have shown that intensive induction (MegaCHOP - Cyclophosphamide 3 g/m2, Vincristine 2 mg, Adriamycin 75 mg/m2, Prednisone 300 mg/m2 every three weeks with G-CSF for three cycles, followed by ESHAP - Etoposide 240 mg/m2, Cisplatin 100 mg/m2, Solumedrol 2000 mg and cytarabine 2000 mg/m2 for three cycles every three weeks with G-CSF) followed by intensive consolidation (BEAM) and stem cell support improves progression-free survival in adult patients (18-65 years old) with aggressive B-cell lymphoma (namely, diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and follicular lymphoma grade II) with aaIPI 2 and namely, with aaIPI 3. This study was aimed to find out if addition of four to six doses of Rituximab 375 mg/m2 on first day of every cycle of intensive induction further improves prognosis of these patients.

Inclusion criteria for this trial were:

* newly diagnosed aggressive B-cell lymphoma, namely diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and follicular lymphoma grade III
* age 18-65 years
* age adjusted IPI (International Prognostic Index) score 2 or 3
* ECOG performance status 0-3
* signed informed consent

Exclusion criteria were:

* relapsed lymphoma
* previous treatment (up to one cycle of standard pretreatment - COP, CHOP or steroids was permitted and later became mandatory to decrease disease burden and/or improve the performance status of the patient)
* Burkitt lymphoma
* posttransplant lymphoproliferation
* CNS involvement
* other malignant tumor in previous history, except basalioma, skin squamocellular carcinoma or cervical carcinoma in situ
* other serious comorbidity

Primary endpoints was progression-free survival

Secondary endpoints were:

* rate of complete remission and overall response rate
* overall survival
* toxicity of the protocol, measured as grade III-IV toxicity and/or inability to finish the protocol as planned

Planned number of accrued patients was 100.

Eligibility Criteria:
Inclusion Criteria:

* Aggressive B-cell lymphoma, namely diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, follicular lymphoma grade III
* Age 18-65 years
* Age-adjusted IPI score 2-3
* ECOG performance status 0-3
* Signed informed consent

Exclusion Criteria:

* Burkitt lymphoma
* Posttransplant lymphoproliferation
* Previous treatment (up to one cycle of standard pretreatment with COP, CHOP or steroids permitted and latter mandatory to decrease tumor burden and/or improve performance status)
* Other tumor in previous history with the exception of basalioma, squamous cell carcinoma of the skin or cervical carcinoma in situ
* Pregnancy/lactation
* CNS involvement
* Other serious comorbidities
Intensified Treatment With Carfilzomib in Myeloma Patients Still PET-positive After First Line Treatment.

A PET-CT will be performed on patients with myeloma after a standard first-line treatment. The PET-positive patients will receive 4 cycles of Carfilzomb-Revlimid-Dexamethason (KRd), before a new PET-CT will be performed.

Patients will be evaluated for inclusion after finishing first-line therapy, or after a sufficient amount of treatment in first-line, and a sufficient respons (VGPR). Eligible performed regimens are defined in the protocol. All patients will perform a PET-CT, and PET-negative patients will be excluded from protocol treatment. The PET-positive patients will do a minimal residual disease (MRD-)evaluation in the bone marrow before entering treatment. After 4 28day cycles of Carfilzomib-Revlimid-Dexamethason, a new MRD and a new PET-CT will be performed, as measures of outcome. Patients will continue treatment as written in the protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Prior confirmed diagnosis of multiple myeloma (2014).
2. Received standard first line treatment with at least partial response. Standard first line treatment is defined as

   * VRD, VTD or VCD followed by ASCT, or
   * MPV at least 6 cycles, or no further reduction in monoclonal component the last 2 cycles, or
   * Rd at least 9 cycles or no further reduction in monoclonal component the last 2 cycles.
3. Carfilzomib naïve.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
5. Absolute neutrophil count (ANC) ≥ 0,5 x 109/L) and platelet count \>35 x 109/L.
6. At least very good partial remission (VGPR) from first line treatment

Exclusion Criteria:

1. Change of first line treatment because of stabile or progressive disease.
2. Major surgery within 28 days before enrollment.
3. Radiotherapy within 14 days before enrollment, but if the involved field is small, 7 days will be considered a sufficient interval before onset of the treatment.
4. Glucocorticoid therapy within the 14 days prior to inclusion that exceeds a cumulative dose of 160 mg dexamethasone or 1000 mg prednisone.
5. Central nervous system involvement.
6. Uncontrolled heart disease, including congestive heart failure (NYHA III-IV), uncontrolled angina pectoris, uncontrolled conduction abnormalities, acute diffuse infiltrative pulmonary disease, pericardial disease or myocardial infarction within 6 months prior to enrollment
7. Uncontrolled hypertension or uncontrolled diabetes despite medication
8. Active hepatitis B or C infection or known human immunodeficiency virus (HIV) positivity.
9. Another active malignancy. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
10. Primary plasma cell leukemia, systemic AL amyloidosis, Waldenströms macroglobulinemia, POEMS syndrome
Non-invasive Method for Predicting the Presence of Gastroesophageal Varices in Patients With Cirrhosis-a Prospective, Multicenter Trial

Gastroesophageal varices are a complication of portal hypertension in cirrhosis.Endoscopy is an unsatisfactory screening test.In this prospective clinical study,we will enroll patients with cirrhosis of various causes, all of whom undergo laboratory tests, elastography, and serum proteomic differential protein testing, including liver elastography (LSM) and spleen elastography (SSM). Baveno VI or expanded BavenoVI criteria are validated by comparing patients' LSM and PLT. LSM, SSM, serum differential protein, platelet count, and EGD data to evaluate the clinical value of SSM and differential proteins in excluding cirrhosis with varices. At the same time, a new predictive model of variceal varices will be established to evaluate the diagnostic value of SSM and differential protein for esophagogastric varices, and a non-invasive method for reliably predicting and evaluating cirrhosis with esophageal varices will be found. And each patient will be followed up every 6 months to 1 year, and the outcome event will be recorded.

Gastroesophageal varices are a complication of portal hypertension in cirrhosis.Endoscopy is invasive method as an unsatisfactory screening test.In this prospective clinical study, we will enroll patients with cirrhosis of various causes, all of patients whom undergo laboratory tests, elastography, and serum proteomic differential protein testing, including LSM and SSM. Baveno VI or expanded BavenoVI criteria are validated by comparing patients' LSM and PLT. LSM,SSM, serum differential protein, platelet count, and EGD data to evaluate the clinical value of SSM and differential proteins in excluding cirrhosis with varices. At the same time, based on SSM and serum differential protein, a new predictive model of variceal varices will be established to evaluate the diagnostic value of SSM and differential protein for esophagogastric varices, and a non-invasive method for reliably predicting and evaluating cirrhosis with esophageal varices will be found. And each patient will be followed up every 6 months to 1 year, and the outcome event will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* 1. The age ranged from 18 to 80 years. 2. Clinical or pathological diagnosis of cirrhosis; 3. Electronic gastroscopy is planned; 4. To agree and sign the informed consent;

Exclusion Criteria:

* 1.Orthotopic liver transplantation patients; 2. Patients who have undergone transjugular intrahepatic portosystemic shunt (TIPS),or previous surgical shunt; 3. Pregnant women; 4. Neurological or psychiatric disorders;
Management of Eyelid Disorders by Ophthalmologists in Usual Medical Practice

The purpose of this study is to determine the incidence and characteristics of eyelid inflammatory disorders during general ophthalmological consultations and to demonstrate association between palpebral pathologies and ocular surface pathologies.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients of either sex, aged at least 18 years, seen in general ophthalmological consultation
* Patients informed of the objectives of the survey and agreeing to participate.
* Patient attending to the ophthalmological consultation for any reasons: regular check-up of chronic disease, acute symptoms, or for surgery preparation or follow up.