cyrilzakka/clinical-trials huggingface dataset:
Self Operating of the ADI Insulin Pump By Intended Users - A Usability Study

Diabetes mellitus (DM) is a multisystem disease with both biochemical and anatomical consequences. Insulin pump therapy (continuous subcutaneous insulin infusion \[CSII\]) is an attractive way of treating patients with diabetes. The NiliMedix ADI Insulin Pump is an ambulatory, battery operated, rate programmable micro infusion pump, designed for continuous delivery of insulin.

Insulin pumps require extensive user interaction because it is critical for treatment. Avoidance of use-related risks that could harm the patient or impact the quality of the treatment is important. Testing for ease and accuracy of use is the only way to ensure that users can safely and effectively operate, install, and program and maintain the insulin pump device.

This usability study was designed in order to test independent home use and device interface effectiveness of the NiliMedix Adi Insulin Pump, in order to validate safe and effective use by intended users. The study objectives are as following:

* Validate the safe and effective use while using the ADI Insulin Pump by intended users. This objective will be assessed by carrying out list of tasks (operating the device, programming the appropriate flow rate and volume-to-be-infused parameters, and reacting to hazard massages) independently and successfully.
* Evaluate user's satisfaction. Study Design Orientation, consent, and pre-test questionnaire Participants will receive a short, scripted verbal orientation explaining the purpose of the usability test.

Prior to any study related procedures participant will provide written informed consent.

Performance evaluation The performance evaluation will consist of a list of tasks that participants will attempt to complete. The tasks were designed to explore the usability concerns. Participants will be provided with the Adi Insulin Pump and the user manual.

All participants will be guided by the investigator how to use the ADI Insulin Pump independently, how to read and interpret the display readings, how to program the device including insulin Basal and Bolus settings as well as how to maintain the device. In addition, participants will be given sufficient time to read carefully the user manual.

After ensuring that the participant has perceived the directions for use he will be asked to operate the Adi Insulin Pump by performing list of tasks.

All tasks will be conducted by the participants independently. The investigator will not guide the subject during this phase- unless the subject asked him to.

Eligibility Criteria:
Inclusion Criteria:

* Male/female age 18 years and up.
* Subject is diagnosed as a diabetic, or subject is parent/guardian of a diabetic child age under 18 years.
* Subject understands the study procedure.
* Subject is able to read the User Manual.
* Signed Informed Consent form
* Compliance with study requirements.

Exclusion Criteria:

* Major physical, motor, mental, behavioral, or psychiatric limitations.
* Concurrent additional major illness.
* Subject objects to the study protocol.
Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder

The purpose of this study is to assess the effect of escitalopram on sleep architecture utilizing a prospective design.

Hypothesis: Escitalopram will improve REM latency in patients with MDD that have responded clinically to treatment.

Disturbance of sleep is a prominent symptom in depressive disorders. Alterations of sleep patterns in depressed patients include insomnia, frequent awakenings, early wake-up and non-refreshing sleep. Polysomnographic recordings have confirmed these reports, reporting reduced latency of the first REM episode of the night, with decreased density of rapid eye movements, and enhancement of total percentage of REM sleep, a reduction of deep slow wave sleep (SWS) and increase in night awakenings (Benca et al., Classification of sleep disorders).

The effects of antidepressant drugs on depression and sleep disorders, specifically SSRIs, have been thoroughly researched. The effects of escitalopram on sleep in depressed patients have been reported using a retrospective design, and in this proposed protocol, we suggest to assess the effect of escitalopram on sleep architecture utilizing a prospective design.

Hypothesis:

Escitalopram will improve REM latency in patients with MDD that have responded clinically to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from MDD, excluding a depressive episode of Bipolar Disorder.
* The depressive episode is not secondary to a general medical condition or substance abuse.
* Ages between 18-65 years old.
* Patients receiving other medications must be on a stable dosage for one month before entering the trial, including hypnotics.
* Able to understand and sign an informed consent form.

Exclusion Criteria:

* Patients suffering from sleep disturbances due to a physical condition (COPD, sleep apnea or essential insomnia preceding the diagnosis of depression).
* Patients suffering from an unstable clinically significant medical condition (cardiovascular, endocrine, nutritional, hepatic, urinary).
* Patients suffering from a malignancy or neuro-degenerative such as Parkinsons' disease
* Patients suffering from a clinically significant psychiatric psychotic disease, as judged by DSM-IV criteria, such as schizophrenia or acute psychosis.
* Patients experiencing severe withdrawal symptoms following a discontinuation of hypnotic drugs, upon entry into the baseline phase.
* History of drug or alcohol dependence within the last year.
A Retrospective Observational Study on the Effects of Probiotics on HBsAg Clearance

The goal of this retrospective observational study is to find out the effects of probiotics on HBV clearance. The main question it aims to answer is:

Are the probiotics have an effect in promoting HBV clearance? The participants will observe the HBV clearance rate in chronic hepatitis B patients receive probiotics in addition to the routine antiviral therapy.

Researchers will compare the HBV clearance rate in chronic hepatitis B patients receive probiotics and antiviral therapy with those receiving solely antiviral therapy.


Eligibility Criteria:
Inclusion Criteria:

* chronic hepatitis B patients

Exclusion Criteria:

* patients with malignancies
* patients with other liver diseases
* pregnancy patients
Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair

Hypothesis / aims of study The aim of this multicentre study is to evaluate anatomical and functional results of an innovative posterior tape in vaginal prolapse repair by vaginal route, in comparison to the sacrospinous suspension.

Study design, materials and methods This study involves 5 centres in French Public Hospital. Patients will be randomly allocated to be operated by a sacrospinous suspension or by an posterior IVSTM (Tyco Healthcare, France). Prolapse severity will be evaluated using the POP-Q system. In order to evaluate the patient's quality of life, the validated PFDI and the PFIQ questionnaires will be used preoperatively and during follow-up, as well as a validated questionnaire on sexual problems. The difference on early post-operative pain should be 30% (40% for the sacrospinous suspension and 10% for the posterior IVS). Then the estimated number of patient is 40 in each arm.


Eligibility Criteria:
Inclusion Criteria:

* Age more than 18
* Vaginal vault prolapse of grade 2 or more (POP-Q system)
* Symptomatic prolapse

Exclusion Criteria:

* Patient unable to read French language
* Cystocele without vaginal vault prolapse
* Vaginal vault prolapse of grade 1
* Associated rectal prolapse
* Rectal inflammatory disease (Crohn, RCH).
Manual Lymphatic Drainage in the Superior Member in Women in Post-surgery for Breast Cancer

Evaluate the effect of Manual Lymphatic Drainage (MLD) massage in arterial and venous circulation of the upper limb ipsilateral of women submitted after axillary lymphadenectomy breast cancer.

The aim of the study is to evaluate the effect of Manual Lymphatic Drainage (MLD) massage in arterial and venous circulation of the upper limb ipsilateral of women submitted after axillary lymphadenectomy breast cancer. Will be evaluated 30 volunteers aged between 40 and 60 years, divided into 2 equal groups, submitted at MLD: Group 1 - volunteers who underwent surgery for breast cancer that have lymphedema, subject to manual lymphatic drainage without upper limb elevation; Group 2 - volunteers who underwent surgery for breast cancer that have lymphedema, subject to manual lymphatic drainage with the upper limb elevation to 30º. Data will be collected by ultrasound Doppler in vein and brachial artery before, after MLD, immediately after, and 30 minutes after therapeutic treatment, with and without elevation of 30°, cross over delimitation, being made a therapy session for therapeutic use with and without elevation, with interval period (washout) for seven days. The order of treatment protocols will be randomized by simple raffle for each volunteer. The data within and between groups will be evaluated by a statistical test t student or ANOVA. Otherwise it will be used Kruskal-Wallis followed test by Dunn. Data processing will be performed by software and fixed the critical level of 5% (p\<0,05).

Eligibility Criteria:
Inclusion Criteria:

* Women with axillary lymphadenectomy surgery
* Lymphedema
* Aged 40-60 years.

Exclusion Criteria:

* Women with muscle-tendon injury and / or joint injuries member
* Skin disorders
* circulatory diseases.
ITA - Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ in Women With Breast Cancer Treated With NOLVADEX for at Least 2 Years

The purpose of this study was to assess the difference in disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued on tamoxifen.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal status; age ≤75 years;
* histologically confirmed invasive breast cancer with metastases in the axillary lymph nodes;
* oestrogen receptor status positive or unknown;
* primary treatment (surgery +/- radiotherapy, +/- chemotherapy) completed

Exclusion Criteria:

* Clinical evidence of metastatic disease (including local or remote recurrence, even if the patient appeared to be in complete remission at the time of randomisation).
Loss to Follow-up in PDR Patients

This study determined the clinical impact and causes of loss to follow-up (LTFU) from the patients' perspective in individuals with proliferative diabetic retinopathy (PDR) who received panretinal photocoagulation (PRP) and/or intravitreal injections (IVIs) of anti-vascular endothelial growth factor (VEGF).

This prospective cohort study included 467 patients with PDR who received PRP and/or IVIs of anti-VEGF between May 2013 and June 2018. LTFU was defined as missing any follow-up visit for any interval exceeding 6 months, provided that patients eventually resumed care. Main outcome measures include rates and causes of LTFU.


Eligibility Criteria:
Inclusion Criteria:

* included treatment-naïve patients who had developed PDR in one eye with a best corrected visual acuity (BCVA) ranging from 20/22 to 20/69, as determined by the Snellen equivalent. Patients were allocated to receive PRP, IVIs of anti-VEGF, or a combination of both procedures.

Exclusion Criteria:

1. patients receiving follow-up ophthalmic care for their PDR with or without interventions at any other medical care provider during the observation period, as declared by the patients at any follow up visit.
2. patients LTFU who did not resume follow-up until the end of the observation period.
3. patients needing PPV at first presentation or having additional retinal pathology. 4) patients receiving their treatment procedure during December 2017 or having vitreous hemorrhage that failed to clear up by June 2018 but still ineligible candidates for PPV.
Xcellerated T CellsTM in Patients With Multiple Myeloma

This trial is a phase II, randomized study of patients with multiple myeloma. All patients will receive Xcellerated T Cells, with or without prior fludarabine therapy.

15 patients in each study arm will be followed for 6 months.

This randomized Phase II clinical study is designed to examine the safety and efficacy of Xcellerated T CellsTM, an activated, autologous T cell product, in subjects with multiple myeloma. Subjects must have failed at least one, but no more than three, prior cytotoxic therapies prior to study registration and may not have relapsed or progressed within one year following hematopoietic stem cell transplantation. Patients will be randomized to treatment with either Xcellerated T Cells alone, or lymphoablative therapy with fludarabine followed by Xcellerated T Cells. Thirty subjects will be treated, with 15 patients in each arm. Patients will be followed for six months following treatment.

Eligibility Criteria:
* Previous diagnosis of multiple myeloma (MM) based on standard criteria. Tests need not be performed within 30 days of registration.
* Failure of at least one, but no more than four, prior systemic therapies for MM prior to registration and may not have relapsed or progressed within 1 year following autologous hematopoietic stem cell transplantation. Repeat courses of the same therapeutic regimen separated in time by 6 or more months are considered separate therapies. Induction therapy followed by high dose chemotherapy and autologous hematopoietic stem cell transplantation counts as one therapy.
* Measurable serum and/or urine M-protein
* Disease progression or relapse, since most recent therapy for multiple myeloma
* Age \> 18 years old and \< 75 years old
* ECOG performance status of 0 or 1
* Females of child-bearing potential must have a negative serum bHCG test and be willing to use effective contraception (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the trial
* Negative test results for current/active infection with HIV-1, HIV-2, HTLV-1, HTLV-2, hepatitis B, and hepatitis C within 30 days of registration (Antibody, antigen, and nucleic acid tests acceptable, depending on institutional standards)
* Hemoglobin \>= 10.0 g/dL. Transfusion with red blood cells or use of erythropoietin is permissible.
* White blood count (WBC) \>= 3,000/mm3 and absolute neutrophil count (ANC) \> 1000/mm3
* Platelet count \> 75,000/mm3
* Corrected serum calcium \< 11 mg/dL, and no evidence of symptomatic hypercalcemia. (Corrected serum calcium is calculated by adding 0.8 mg/dL to the measured serum calcium for every 1 g/dL that the serum albumin falls below 4.0 g/dL)
* Serum total bilirubin and alanine aminotransferase (ALT) \< 2.0 times the upper limit of normal
* Serum creatinine \< 2.5 mg/dL
* Serum human anti-mouse antibody (HAMA) titer undetectable or within the normal range, and no history of allergies to mice or murine (mouse) proteins
* The patient must be able to comprehend and have signed the informed consent
Fentanyl Matrix Application for Cancer Pain: Multicenter, Prospective, Observational Study

The purpose of this study is to show the clinical usefulness of fentanyl matrix by measuring satisfaction with pain treatment after administering fentanyl matrix in patients whose pain was not controlled sufficiently with the previous analgesic use in real practice at the investigator's discretion.

This is a multi-center, open-label (all people know the identity of the intervention), prospective (the patients are identified and then followed forward in time for the outcome of the study) observational study. The study population comprises patients who are admitted to a study center during the study period and are receiving a strong oral long-acting opioid analgesic but deemed to control pain insufficiently. Since this study is an observational study conducted in real practice, a dose of fentanyl matrix should be adjusted depending on an individual patient's response at the investigator's discretion. However, for the patients whose pain is not sufficiently controlled despite administration of strong long-acting opioid analgesics, the minimum initial dose will be fentanyl matrix 75 micrograms/h and the investigator can adjust dosage according to the degree of the patients' pain control during the 9 days of the study period.

Eligibility Criteria:
Inclusion Criteria:

* Patients complaining of cancer pain which requires administration of long-acting opioid analgesics
* Patients whose pain is not sufficiently controlled despite administration of strong long-acting opioid analgesics
* Patients who are deemed to need an initial minimum dose of fentanyl matrix 75 micrograms/h
* Patients who signed the informed consent form

Exclusion Criteria:

* Patients with a history of or current drug or alcohol abuse
* Childbearing women who are pregnant or likely to be pregnant during the study period and men who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception
* Patients who are unable to use a transdermal system due to skin disease
* Patients with history of hypersensitivity to opioid analgesics
* Patients who are not eligible for the study participation based on warnings, precautions and contraindications in the package insert of the study drug at the investigator's discretion
Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg Under Fasting Condition

This study were to compare the relative bioavailability of Duloxetine HCl delayed release capsule 60 mg with that of 'CYMBALTA®' delayed release capsule 60 mg (Duloxetine HCl delayed release capsule 60 mg) in healthy, adult, human subjects under fasting conditions and to monitor safety of subjects

Open label, randomized, two period, two treatment, two sequence, crossover, balanced, single dose comparative oral bioavailability study in healthy, adult, human subjects under fasting conditions

Eligibility Criteria:
Inclusion Criteria:

1. Be healthy human between 18 and 45 years
2. Screened within 21 days prior to administration of first dose of study drug
3. Having a BMI between 18.5 and 24.9 weight in kg/ height2 in meter
4. Be able to communicate effectively with study personnel
5. Be able to give Written informed consent to participate in the study If subject is a female volunteer and
6. is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
7. is postmenopausal for at least 1 year.
8. is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).

Exclusion Criteria:

1. History of allergic responses to Duloxetine or other related drugs.
2. Have significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG \& X-ray recordings.
3. Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
4. History or presence of bronchial asthma.
5. Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
6. History of drug dependence, recent history of alcoholism or of moderate alcohol use.
7. Smokers, who smoke more than or equal to 10 cigarettes per day or more than or equal to 20 biddies per day or those who can not refrain from smoking during study period.
8. History of difficulty with donating blood or difficulty in accessibility of veins. Donation of blood (I unit: 350 mL/450 mL) within 90 days prior to receiving the first dose of study medication.
9. A positive hepatitis screen (includes subtypes A, B, C \& E)
10. A positive test result for HIV antibody and/or syphilis (RPR/VDRL).
11. The receipt of an investigational product, or participation in a drug research study within a period of 90 days prior to the frst dose of study medication administration.
12. Female volunteers demonstrating a positive pregnancy screen
13. Female volunteers who are currently breast-feeding
14. Female volunteers not willing to use contraception during the study
A Multicentre Study to Evaluate the Safety and Efficacy of AD 923 in Comparison to MSIR for the Treatment of CBP in Subjects

Purpose:

The purpose of this study is to compare the efficacy and safety of AD 923 to the most widely used current treatment (MSIR) in the management of target BTP in subjects with malignancies who are taking a stable dose of background opioids. The efficacy evaluation criteria have been designed to determine whether AD 923 provides superior analgesia compared with MSIR as measured by the primary endpoint.


Eligibility Criteria:
Main Inclusion Criteria:

* The subject is a male or female, at least 18 years of age.
* The subject has a malignancy, is receiving opioid therapy for his or her underlying persistent cancer pain, and is tolerant to the opioid therapy.
* The subject typically has 2 to 6 episodes of target BTP per day that require treatment.
* The subject has a life expectancy of \>3 months.
* The subject or his or her caregiver has easy, reliable access to a telephone.

Main Exclusion Criteria:

* The subject is a female who is pregnant or lactating.
* The subject has any respiratory or cardiac condition that, in the opinion of the investigator, may be clinically worsened by opioids.
* The subject has any allergy to the AD 923 product or excipients, namely: fentanyl, dehydrated alcohol, menthol, saccharin, and citrate buffer; or to the MSIR product excipients, namely: morphine sulphate, lactose (anhydrous), pregelatinized maize starch, povidone, purified water, magnesium stearate, talc, and tablet coatings.
* The subject has any neurological or psychiatric disease that, in the opinion of the investigator, would compromise data collection.
* The subject has uncontrolled or rapidly escalating pain.
* The subject has any significant laboratory test results that, in the opinion of the investigator, will compromise subject safety or the conduct of the study.
* The subject has plans to undergo chemotherapy, radiotherapy, or surgery during the treatment period. The exception is that subjects may continue chemotherapy over the study period, provided it is not expected to alter the pain state or response to pain medication.