cyrilzakka/clinical-trials huggingface dataset:
Remote Management of Diabetic Patients Via Data Transmission by Accu-Chek 360 Software

The purpose of this study is to determine if providing some care to diabetic patients remotely, using Accuchek 360 yields at least the same clinical results for their diabetes care, according to existing guidelines, as providing all care to patients in person.

This will be a non-inferiority study between two groups: a control group, which will receive 5 routine office visits in one year; and a study group which will receive 3 routine office visits in the same time, and have two visits conducted by computer interaction, using the Accuchek 360 software. All will be capable of independent care of their diabetes. All patients will be 19-65 years of age. The end-points will include similar changes in hemoglobin A1c, systolic and diastolic blood pressure, body mass index, lipid fractions, and similar levels of patient satisfaction with care.

There will be 50 patients in each group, matched for age and sex distribution, educational level, computer literacy, and type of diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female
* 19-65 years of age
* Type 1 and 2 diabetes
* Computer literate
* Independent care of diabetes
* Insulin pump allowed (Spirit pump only)
* Females on birth control
* Can demonstrate competency in the use of the Accuchek Aviva meter, reliability in doing regular home blood sugar determinations

Exclusion Criteria:

* Creatinine clearance \< 30 cc/min
* Severe loss of vision (diabetic retinopathy)
* Severe diabetic neuropathy
* Known or suspected diabetic gastroparesis
* Patients with heart disease
* Patients with liver disease
* Drug or substantial alcohol use
* Use of pharmacological doses of glucocorticoids or other medications that affect blood sugar and blood pressure
* Females that are pregnant or are capable of becoming pregnant
* Insulin pump use other than Accucheck Spirit pump
Ongoing Registry of Treatment of Venous Thromboembolism

Ongoing registration of patients with venous thromboembolism treated by means of antithrombotic therapy, thrombolisys, open surgery, endovenous desobstruction and stenting.

Data of patients with VTE treated in different Russian medical centers are entered in a prospective digital database, and continuously updated.

There is planned to conduct prospective randomized, cohort and observational studies on the site of register

Eligibility Criteria:
Inclusion Criteria:

* case of venous thrombosis of a limb or pulmonary embolus

Exclusion Criteria:

* no exclusion criteria
Severe Obesity: Bariatric Surgery vs. Life-Style-Intervention

The purpose of this study is to investigate the effects of weight loss induced by gastric bypass surgery in comparison to a psychotherapy-enhanced lifestyle intervention on cardiopulmonary performance and quality of life in patients with morbid obesity.

Obesity is a rapidly emerging health problem and an established risk factor for cardiovascular diseases. Bariatric surgery profoundly reduces body weight and mitigates sequelae of obesity. Especially randomized trials comparing the effects of bariatric surgery to conservative treatment in concerns of cardiac function are still lacking.

The randomized WAS trial compares the effects of Roux-en-Y gastric bypass (RYGB) versus psychotherapy-supported lifestyle modification in morbidly obese patients. The co-primary endpoint addresses 1-year changes in cardiovascular function (peak VO2 during cardiopulmonary exercise testing) and quality of life (Short-Form-36 physical functioning scale). Prior to randomization, all included patients underwent a multimodal anti-obesity treatment for 6-12 months. Thereafter, patients were randomized and followed through month 12 to collect primary endpoints. Afterwards, patients in the lifestyle group could opt for surgery, and final visit was scheduled for all patients 24 months after randomization.

The study was initially designed in 2008 as part of several interdisciplinary studies for a targeted grant and received a positive vote from the responsible ethics committee.

Prior the actual start of the study in July 2011, the initial study protocol and the patient informed consent were updated and further specified. This amendment was submitted to the Ethics Committee on June 9, 2011, with a positive vote on June 30, 2011 (Amendment 1).

An Amendment 2 was submitted to Ethics Committee on 08.10.2014 (positive vote 16.12.2014) to adjust randomization (previously 1:1 to the two study arms) for an unequal drop-out rate in the two study arms with higher rate in the intensified lifestyle modification. In addition, few secondary endpoints were adapted and the role of the principal investigator changed from Prof. Stefan Frantz to Prof. Martin Fassnacht.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* BMI \>40 kg/m2 or BMI \>35 kg/m2 with severe comorbidities
* Indication for Roux-en-Y gastric bypass surgery
* Ability to perform cardiopulmonary exercise testing (CPET)
* Written informed consent

Exclusion Criteria:

* Pregnancy or breast feeding
* Unstable angina pectoris
* Life expectancy \<12 months
* Endocrine or psychiatric disorder as cause of obesity
* Systemic glucocorticoid treatment (with exception of glucocorticoid replacement therapy)
* Abuse of drugs or alcohol within the last 5 years
* Inability to attend regular study visits for logistic reasons
* Participation in competing trials
Onset and Duration of Mometasone by Oscillometry and Spirometry

Inhaled corticosteroids (ICS) are appreciated for their long term anti-inflammatory effects in chronic asthma. However, they also have largely unappreciated early effects when initiated as a controller therapy in a steroid-naïve population. Impulse oscillometry might reveal such an early effect better than spirometry. The investigators sought to examine the onset of action and sustained effects over 4 weeks treatment of mometasone furoate as measured by Impulse Oscillometry System (IOS) versus spirometry.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-65 years inclusive.
* Written informed consent (conducted according to the GCP and ICH guidelines) to participate in the study. Ability to comply with all study requirements.
* Mild to moderate persistent asthma with symptoms at least 2 times per week, managed by as-needed SABA only.
* A 35% or greater improvement in small airway dysfunction defined by IOS AX after inhaled SABA.
* Allergic response to one or more common allergens at screening via skin test.
* Male, or female of childbearing potential using a medically approved birth control method.
* Evidence of SAD manifested by an index of peripheral airway reactance of \> 10.5 cm H2O/L (3 times the upper limit of adult normal).
* Symptoms of airflow obstruction (i.e. dyspnea on exertion greater than peers at similar exercise levels, wheeze, or cough \> 3 weeks without respiratory infection, or nocturnal dyspnea, and use of SABA \> 2 times per week)

Exclusion Criteria:

* Subjects with severe persistent asthma and/or subjects taking inhaled or systemic corticosteroids or long acting beta agonists (LABA).
* Subjects \< 18 years of age or \> 65 years.
* Pregnant or lactating females.
* History of diabetes.
* Acute infections within 4 weeks prior to Screening.
* Concurrent medical condition that might interfere with the interpretation of efficacy and safety data during the study.
* Contraindications and warnings according to the specific label for Asmanex.
* Chronic inhaled or systemic corticosteroid treatment (\> 7 consecutive days of treatment) within 30 days prior to Screening.
* Investigational drug treatment within 30 days prior to Screening. Treatment with any drug with a known and frequent toxicity to a major organ system within the past 60 days.
Comparison of Different Analgesic Nerve Blocks in Total Knee Replacement Surgery

The goal of this observational study is to compare the equivalent analgesic efficacy of three regional anesthesia techniques in total knee replacement surgery. The main question it aims to answer is:

• Non inferiority of each technique in relation to the others Participants will receive selective spinal anesthesia and the antalgic nerve block depending on the group they happen to be in.

Researchers will compare the Femoral Nerve Group+IPACK block, the Saphenous Nerve block+IPACK and the Subsartorial Block groups to see if there is any difference in the pain control in the 24 hours after the surgery.

After adequate venous access is obtained, a light sedation with Midazolam 1-2 mg is administered. The patient will be monitored and a selective spinal anesthesia will be performed. After the neuraxial procedure the antalgic block of choice is performed with about 40 mL of long acting local anesthetic.

Magnesium Solfate 1g and Dexametasone 4mg are administered after the block. If the patient wishes, a propofol continuos infusion may be administered for sedation during the surgery. Before the patient leaves the OR, Ketorolac 30mg will be administered.

Pain control after surgery will be achieved with acetaminophen 1g t.i.d., Ketorolac 30mg on demand, and Morphine solfate if NRS \>5 after Ketorolac.

Every 6 hours the patient will be monitored by the anesthesia team. After 24 hours the antalgic effect of the nerve block is reasonably thought to be over, so the follow up is interrupted.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 y/o
* Total knee replacement elective surgery
* Informed consent

Exclusion Criteria:

* Age \< 18 y/o
* Surgery with general anesthesia
* Patients with coagulopaties
* Patients in chronic opioid therapy
* Refuse to sign informed consent form
* Unable to sign informed consent form
* Know allergies to medication used for analgesia
Study Assessing an Insulin Pump-controlling Algorithm to Minimize Hypo and Hyper in Type 1 During CRC Setting

Feasibility study assessing the ability of an insulin pump-controlling algorithm to minimize hypoglycemia and hyperglycemia in patients with type 1 diabetes in a clinical research setting.

This study is a non-randomized, uncontrolled feasibility study that looks to enroll people with type 1 diabetes who are currently using an insulin pump. During the subject's participation, the study staff will closely monitor the study subject in a clinical research center environment for approximately 30 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-65 years
* type 1 diabetes mellitus for at least one year
* Currently using an insulin infusion pump for at least the past 6 months

Exclusion Criteria:

* Pregnancy
* History of Diabetic Ketoacidosis (DKA) in the past six months
* Histoey of severe hypoglycemia (Seizure, unconsciousnesss) in the past 6 months
Does Diabetes Related Distress Impact on Balance Glycemic ?

The main objective is to assess the overall diabetes distress score in adult patients with diabetes during their hospitalization in a diabetes ward, using the Diabetes Distress Scale (DDS-17).

The correlation between the overall diabetes distress score and the patient's glycosylated haemoglobin will then be assessed.

The health consequences of emotional problems are associated with poor self-care behaviour, poor metabolic outcomes (HbA1c) and reduced quality of life. If quarterly glycated haemoglobin (HbA1c) testing is the gold standard for monitoring the risk of diabetes complications, should it not be systematically combined with the assessment of distress related to living with diabetes? To our knowledge, there are few studies in France that have correlated glycaemic control with a scale assessing the emotional stress factors associated with diabetes.

The main objective is to evaluate diabetes-related distress in adult patients with diabetes during their hospitalization in a diabetes ward, using a self-assessment instrument: the Diabetes Distress Scale (DDS-17).

The secondary objective is to assess the correlation between the overall diabetes distress score and the patient's glycosylated haemoglobin.

Eligibility Criteria:
Inclusion Criteria:

* Patients living with type 1 or type 2 diabetes.
* Patients hospitalised in the diabetes department of the IE3M.
* Patients aged ⩾ 18 years.
* Patients agreeing to participate in this study after information.
* Beneficiary of the health insurance.

Exclusion Criteria:

* Refusal to participate.
* Inability to communicate in French.
* Inability to read or write French.
* Communication disorders.
* History of psychiatric disorders, dementia.
* Patient under guardianship or curatorship.
* Patient not affiliated to social security.
* Patient affiliated to the Aide Médicale d'Etat (AME).
Evaluation of Outcome Metrics in Alexander Disease

The purpose of this study is to define the natural history of Alexander Disease, a leukodystrophy that causes neurological dysfunction. Investigators will obtain clinical outcome assessments to measure how the disease affects a patient's gross motor, fine motor, speech and language function, swallowing, and quality of life. Specimens are collected to measure glial fibrillary acidic protein (GFAP) levels in cerebrospinal fluid (CSF) and blood. The data obtained from this study will be used for the design of future treatment trials.

Participants will be asked to complete physical examinations including physical therapy, occupational therapy, speech and language therapy, neurocognitive and swallowing assessments. Patients (or caretakers) may be asked to complete questionnaires as well. Specimen collection is an optional procedure. The study asks for participants to return at least once yearly to repeat assessments.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Alexander Disease

Exclusion Criteria:

* Other Leukodystrophies will not be enrolled
Training in Shared Decision-making of Cystic Fibrosis Centers Competences in the Treatment of CF Related Diabetes in Adult Patients

Diabetes affects half of cystic fibrosis patients aged 30 years and older. It develops asymptomatically for a long time. Also, two options are possible: start insulin treatment now with the additional constraints associated with cystic fibrosis or wait while monitoring the patient's clinical status and initiate insulin treatment when he has developed symptoms and therefore later. In practice, the choice between these two options takes place over two medical consultations without a formalized shared decision-making process between the doctor and the patient.

Shared decision-making is a decision-making process in which the healthcare provider and the patient learn about patients care options and then deliberate to reach a common agreement on the decision taken.

Shared decision-making seemed particularly relevant to us in cystic fibrosis where there are complex treatment options with variable short-, medium- and long-term side effects and where the disease and its treatments have a high impact on the patient's quality of life.


Eligibility Criteria:
Inclusion Criteria:

Concerning the patient :

* Patient major
* Patient affected by cystic fibrosis
* Patient able to understand french
* Patient sable on Respiratory and nutritional status
* Patient with disorders of carbohydrate metabolism in the glucose tolerance test (OGTT)
* Patient with normal fasting blood sugar

Concerning the health professionals :

Medical and paramedical professionals practising in the adult Cystic Fibrosis Centers Competences (doctors, nurses, dieticians, psychologists, physiotherapists, etc...)

Exclusion Criteria:

* Patient with transplant
* Patient who have received insulin therapy
A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer

BZL 101 is an aqueous extract from herba Scutellaria Barbata D. Don of the Lamiaceae family. Preclinical studies suggest that this herb has antitumor activity for breast cancer and preliminary clinical data suggest that it is tolerable in patients with metastatic breast cancer. The overall goals of this Phase I/II trial are to assess the toxicity, maximum tolerated dose, safety and preliminary efficacy of BZL101 for the treatment of advanced metastatic breast cancer.


Eligibility Criteria:
Key Inclusion Criteria:

* Women 18 years or older
* Histologically confirmed breast cancer
* Clinical evidence of metastatic (stage IV) metastasis (other than bone metastasis)
* Availability of estrogen and progesterone receptor status
* At least one measurable disease site defined by RECIST criteria, 30 days prior to study therapy
* For the phase 1, no more that 3 prior cytotoxic regimens for metastatic breast cancer. For the phase 2, no more than 2 prior cytotoxic regimens for metastatic breast cancer
* Life expectancy ≥ 12 weeks
* Eastern Cooperative Oncology Group performance status ≤2
* Women of child bearing potential must agree to 2 forms of contraception during the course of the trial.

Key Exclusion Criteria:

* Inability to understand/unwillingness to sign a written informed consent
* Any significant side effects related to prior chemo, radiation, biology or hormonal therapy that did not resolve in the judgment of the investigator
* Currently using an investigational agent
* Clinically significant gastrointestinal abnormalities
* Currently using coumadin at therapeutic doses or within 2 weeks of taking study medication
* Concurrent palliative radiation or anti-cancer treatment
* Women who report pregnancy, are breast-feeding or have a positive pregnancy test
Establishment of Optimal Transfusion Threshold During Spine Surgery

The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the tissue oxygenation.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Patients undergoing spine surgery
* Be legally competent
* Read and understand Danish

Exclusion Criteria:

* Present malignant disease
* Previously apoplexia cerebri
* Known heart disease with functionality equivalent to NYHA II or CCS II or worse
Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women

This is a Phase IV prospective, randomized, open label, comparative, multicenter study in generally healthy postmenopausal women receiving Totelle (17B Estradiol/TMG CC (1mg)) and Livial (Tibolone).


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy postmenopausal women
* Last natural (without exogenous hormone therapy) menstrual cycle completed at least 12 consecutive months prior to screening and without any other kind of gynecological bleeding during this same period
* At least 1 year of natural occurring amenorrhea

Exclusion Criteria:

* Known or suspected estrogen-dependent neoplasia
* Endometrial hyperplasia
* Any malignancy with the exception of a history of basal cell carcinoma of the skin
FES-PET to Determine ER-expression in Epithelial Ovarian Cancer

Estrogens are implicated in the development of ovarian cancer and estrogen receptors (ER) alpha and beta are present in 20-100% of ovarian cancer patients. For this reason, antihormonal therapy with anti-estrogens or ER-antagonists is potentially an attractive treatment option. However, only a small proportion of patients (5-19%) will respond to antihormonal therapy. ER-expression in ER-positive breast cancer can be assessed by positron emission tomography (PET) with \[18F\]fluoroestradiol (FES). In this study the investigators will evaluate whether FES-PET can be used to visualize and quantify ER-expression in ovarian cancer. If these results are positive, this would warrant further exploration of FES-PET imaging in ovarian cancer.

Investigators will evaluate whether FES-PET can be used to visualize and quantify ER-expression in ovarian cancer. If these results are positive, this would warrant further exploration of FES-PET imaging in ovarian cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Histological evidence or high clinical suspicion of epithelial ovarian cancer
2. The presence of at least one measurable lesion (RECIST version 1.1).
3. Histology or cytology can be obtained (may be ascites)
4. Eastern Cooperative Oncology Group performance status 0-2.
5. Postmenopausal status (defined as either \>45 years with amenorrhea \>12 months, or prior bilateral ovariectomy)
6. No history of other ER-positive malignancies
7. Signed written informed consent
8. Able to comply with the protocol

Exclusion Criteria:

1. Use of estrogen receptor ligands, including tamoxifen, fulvestrant or estrogens, during the 5 weeks before entry into the study
2. Life-expectancy ≤ 3 months
Predictive Remote Photoplethysmography Algorithm for Blood Pressure Pressure Assessment and Monitoring

Significant advancements in the field of medical technologies have resulted in the rise of contact-free methods of haemodynamic monitoring. Remote photoplethysmography (rPPG) is a videobased, contactless form of monitoring that operates through a camera-enabled device. This innovation interprets minute variations in skin colour due to blood flow which, when analysed with complex signal processing algorithms, generates vital sign readings. Currently, Nervotec's rPPG technology allows for the collection of rPPG waveforms, which enables the measurement of heart rate, heart rate variability, respiration rate and blood oxygen saturation (SpO2) level through signal processing techniques. The plethysmography signals can be used to estimate blood pressure through the creation and training of a predictive model. By examining and extracting key features of a continuous PPG waveform by training an artificial neural network, correlations between these features and BP can be studied.

This is a prospective, feasibility study.Background literature has shown that plethysmography (PPG) signals can be used to estimate blood pressure through the creation and training of a predictive model. By examining and extracting key features of a continuous PPG waveform by training an artificial neural network, correlations between these features and blood pressure can be studied.

Nervotec, a digital health and AI company , has successfully used rPPG technology to allow for collection of rPPG waveforms, which enables the measurement of heart rate (HR), heart rate variability (HRV), respiration rate (RR) and blood oxygen saturation (SpO2) level through signal processing techniques. They have incorporated rPPG technology into a mobile application using smartphone cameras for scanning an individual's face. However, this is yet to be established for blood pressure. We aim to perform a prospective study to evaluate the feasibility and accuracy of obtaining blood pressure measurements through rPPG.

Hypothesis: Remote photoplethysmography can be used to determine blood pressure and this algorithm can develop into a customised smartphone based application.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 21 years old
* Ability to provide informed consent
* Any surgery except head and neck surgeries

Exclusion Criteria:

* Age ≤ 21 years old
* Inability to provide informed consent
* Patients going for head and neck surgery