cyrilzakka/clinical-trials huggingface dataset:
To Compare the Similarity of a Combination Dapagliflozin/Metformin Tablet With the Two Drugs Administered Separately

This is an open-label, randomised study to compare the similarity of a combination Dapagliflozin/Metformin tablet with the two drugs administered separately under fasting and fed conditions in healthy volunteers.

A Bioequivalence Study of the Fixed Dose Combination Dapagliflozin/Metformin Tablet (5.0 mg/850 mg) Relative to a 5.0 mg Dapagliflozin Tablet and an 850 mg Metformin (Glucophage® Marketed in Canada by Sanofi-Aventis) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged 18 to 55 years inclusive with suitable veins for cannulation or repeated vein puncture
* Male subjects should be willing to use barrier contraception ie, condoms and spermicide, from the day of dosing until at least 3 months after dosing with the investigational product
* Non-pregnant, non-lactating female subjects who if pre-menopausal are using adequate birth control eg, oral, injectable, transdermal or implanted hormonal contraceptives, vaginal contraceptive ring, intrauterine device (IUD)/intrauterine systems
* Have a body mass index (BMI) between 18.5 and 30.0 kg/m2 inclusive (ie, within 15% of normal range) and weigh at least 50 kg and no more than 100 kg.

Exclusion Criteria:

* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with individual safety evaluation Current smokers who smoke more than 5 cigarettes per day (or equivalent use of tobacco products) or cannot give up smoking during the study
* Excessive intake of caffeine containing drinks eg, coffee, tea, caffeine containing energy drinks and cola (more than 5 cups of coffee or equivalent per day)
* Plasma donation within one month of screening or any blood donation/blood loss \>500 mL during the 3 months prior to screening
Community-Acquired Pneumonia Diagnosis Using Lung Ultrasound in Emergency Room Adults

Community-Acquired Pneumonia (CAP) is a major problem in Emergency Department (ED). Diagnosis relies on combination of clinical symptoms and results of chest radiography (CR). Patients' management (treatment, support) depends on delay and quality of the diagnosis. However, signs and symptoms are highly aspecific and interpretation of CR is subject to frequent discrepancies. Then diagnosis of CAP may be uncertain; therefore, overdiagnosis is frequent and leads to over-use of antimicrobial therapy; missing diagnosis is also deleterious and delays adequate treatment including antibiotics. CT scan completes CR and helps clinician making properly diagnosis of CAP; obtaining CT in a 4-hour time-lapse allows better diagnosis and management as accurate as an independent expert adjudication committee does. However availability of CT as well as radiation interrogates on the benefit that Lung Ultrasounds (LUS) may have in diagnosis strategy of suspected CAP. LUS is a noninvasive easy-to-use device whose practice is widely endorsed worldwide by emergency medicine associations and societies. Additionally, previous studies advocate for the use of LUS for diagnosis of CAP in the ED. Therefore the Promotor developed a study to compare LUS and CR as a primary imaging for diagnosis of CAP at the ED.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18+)
* Suspected CAP by attending emergency physician
* And new onset of systemic infection (at least one among sweat, chills, aches and pain, temperature ≥38°C or \<36°C)
* And symptoms of an acute lower respiratory tract infection (at least one among cough, sputum production, dyspnea, chest pain, altered breathing sounds at auscultation
* No previous imaging for the current medical problem
* Inform consent (signed)
* Affiliation to insurance (France, Monaco)

Exclusion Criteria:

* Age below 18-year of age
* Patients in palliative care
* Pregnant women
* anticipated barriers to completing follow-up data collection,
* patients classified three or higher according to the CRB65 score,
* patients requiring intensive care for any purpose because of specific management of critically ill
* refusal to participate to the study
Perioperative Lignocaine and Sleep Disturbance

The aim of this clinical trial is to study the effect of an intravenous infusion of lidocaïne in a multimodal analgesic protocol on the architecture sleep during the first postoperative night.

To study the effect of lidocaïne, we plan to include 40 patients, randomized in 2 groups, undergoing open prostate surgery in this randomized placebo-controlled trial.

Before anesthesia induction, these patients receive an intravenous lidocaine infusion (bolus 1,5 mg.kg-1 followed by a continuous infusion of 2mg.kg-1.h during 24 hours) or an equal volume of placebo. Then the anesthesia is induced with propofol, sufentanil et rocuronium. The postoperative analgesia is provided by paracetamol, tramadol and patient-controlled analgesia (PCA) with morphine or oral oxycodone. A polysomnography is registred on the preoperative night and on the first postoperative night.

Eligibility Criteria:
Inclusion Criteria:

* Radical prostatectomy

Exclusion Criteria:

* BMI \> 30
* Neurologic/psychiatric diseases or therapeutics, seizyres
* Cardiac disease, second or third degree atrioventricular block
* Obstructive sleep apnea syndrome
* History of liver or renal insufficiency
* and any contraindication to the anesthetic protocol of the study.
Role of FXR in Hepatitis C Virus Replication

In vitro in the hepatitis C virus (HCV) replicon system, modulation of the biliary salts nuclear receptor FXR by either agonists or antagonists respectively increases or decreases the replication of HCV (J Hepatol, 2008, 48: 192-9). One antagonist of FXR is a vegetal sterol, guggulsterone, that is extracted from the Commiphora mukul tree and that has already been given safely to hyper cholesterolemic patients in a clinical trial (JAMA 2003, 290: 765-72). The aim of this trial is to test the effect of the FXR antagonist guggulsterone given orally, three times a day, on the viral load in 15 HCV genotype 1 chronically infected patients.


Eligibility Criteria:
Inclusion Criteria:

* Male patients infected by HCV genotype 1, with anti-HCV antibodies, non responders to at least one first line of therapy
* Viral load \> 1 x 105 UI/mL for more than 6 months and not treated for at least the last two months.
* METAVIR score \< F4

Exclusion Criteria:

* Alcohol intake \> 20 g/day
* Immuno - suppressive therapy
* Obesity BMI \> 30, diabetes
* Dyslipidemia requiring specific therapy
* Liver cirrhosis or carcinoma
* HIV or HBV co-infections
* Other liver diseases
* Major organ failures
* Therapy with cytochrome P450 metabolized drugs
Dementia Patient's Behavior Evaluation Using Noninvasive Ambient Sensor

This study is an observational study that uses daily activity and environmental sensing techniques to establish behavioral models of early dementia patients and cognitive healthy function to assess their daily behavior and determine their activities. Specifically, the team will collect information on a number of wireless sensors for dementia, mild cognitive impairment and healthy elderly residents, and use special mathematical models to establish the behavior of the two groups of subjects Model. The model will be developed a reliable algorithm to assess health risk of the subjects.

With the help of intelligent home environment and Pervasive Computing, it is possible to bring information about the behavior of the patients to the caregivers and their relatives. In this study, non-invasive wireless sensors such as infrared motion sensor the switch sensor will be built in the home of the subjects. The wireless sensor data collected by the input to the team's "activity identification system" in order to assess the mathematical model of the subjects "capacity" and immediate judgment of their activities. In the identification of activities can be divided into two categories of behavior, risk behavior (harmful to the subjects) and protective behavior (beneficial to the subjects), real-time activity detection, can avoid dangerous behavior, such as water and gas off, roaming , Repetitive behavior (over-eating), forgetting to eat and day-night reversal (sleep disturbance), etc., the protection of behavior can be observed through a long time to help patients conduct beneficial behavior, such as regular quantitative diet.

Eligibility Criteria:
Inclusion criteria:

* Can communicate in Mandarin or Taiwanese.
* Consciousness is clear.
* Can do the daily activity by their own.

Exclusion criteria:

* Have a serious cardiopulmonary disease or physical activity is limited to those unable to carry out daily activities.
* Consciousness is not clear.
* Difficult communication, such as: aphasia patients, the use of respirator patients.
* Suffering from serious mental illness that can not match.
* Adopt absolute isolation, such as: open tuberculosis patients.
* Hearing or severe visual impairment that can not match.
* Can not exercise their consent.
The Effect of Food Hedonics on Appetite Hormones Levels

30-40 healthy male subjects with a BMI between 18.5 and 24.9 kg/m2 will be tested for food preferences using a questionnaire with 141 different foods. Accordingly, a high acceptability/palatability food will be selected (average score of ≥ 7 on the 9-point hedonic scale). Two versions of the selected high palatability food will be devised by modifying it to yield the original high and the modified low acceptability versions. The two versions will differ only in palatability and will be equicaloric. Subjects who agree on the acceptability of the two versions of the food (11 subjects) will consume, at fasting, the two versions of the food in a cross over design over two sessions. Each session will include an acceptability test, using the 9-point hedonic scale, on three instances: after sampling a spoonful, eating the whole portion and after 240 min. The quantity consumed on each session will constitute 30% of the subject's resting energy expenditure. Moreover, fasting and postprandial hunger ratings and blood samples will be collected at time 0 and after 15, 30, 60, 120, 180 and 240 min of the food/meal's ingestion. The visual analogue scale will be used for huger ratings.


Eligibility Criteria:
Inclusion Criteria:

* Gender: Male
* Age: 18-50 years
* Body Mass Index (BMI): 18.5-24.9 kg/m2
* Stable body weight for at least three months before the study with absence of any form of dieting, food restriction or other abnormal eating behaviors (to minimize effect of weight change on ghrelin status)

Exclusion Criteria:

* Smoking
* Substance abuse such as alcohol or drugs
* Medical or psychological illness
* Use of medications
* Previous gastrointestinal surgery
* History of weight fluctuation (weight loss of greater than 5% within the past 3 months)
Pain Neuroscience Education for Middle School Students

This project was designed as a single-blind, randomised controlled, prospective intervention study. The research question of the project is 'Is pain neuroscience education an effective method to improve various aspects of child health, conceptualise pain and change pain-related behaviours in middle school children?'. In other words, the aim of this project is to investigate whether pain neuroscience education (PNE4Kids) is an effective method for improving various aspects of child health, conceptualising pain and changing pain-related behaviours in middle school children. For this purpose, it is planned to implement PNE4Kids based power point presentation and interactive game training. It is aimed to evaluate children in terms of physical activity level, sleep quality/habits, pain conceptualisation level and participation in leisure time activities. Physical activity levels will be assessed with Actigraph GT3X+ accelerometer device and 'Physical Activity Scale for Older Children'. Sleep quality/ habits will be assessed with Actigraph GT3X+ accelerometer and 'Children's Sleep Habits Scale-short form'. Knowledge of pain conceptualisation will be assessed with the 'Conceptualisation of Pain' scale. Children's level of participation in leisure time activities will be assessed through the participation section/domain of the Participation Environment Measure for Children and Youth (PEM-CY). After the baseline measurements of the individuals included in the study and who volunteered will be completed, they will be randomly assigned to the control or intervention group. Participants in the intervention group will receive 'Turkish PNE4Kids Programme'. Individuals in the control group will not receive any intervention. All evaluations will be repeated before the training, immediately after the training and at the end of the 3rd month after the training.


Eligibility Criteria:
Inclusion Criteria:

* Being actively educated at midschool level,
* Having sufficient reading and understanding skills in Turkish.

Exclusion Criteria:

* Chronic pain (pain in ≥1 anatomic region that persists or recurs for longer than 3 months,
* Chronic illness (e.g. cancer, diabetes, asthma, juvenile rheumatic arthritis),
* Being diagnosed with a specific learning disability,
* Being diagnosed with attention deficit hyperactivity disorder,
* Being diagnosed with autism spectrum disorder,
* Not being willing to participate in the study by oneself or one's parents.
Improving Quality of Life in Early Parkinson's Disease

The study will examine 30 patients between ages 50-80, newly diagnosed with early-stage Parkinson's Disease. Patients will be randomized to receive either Citalopram or Carbidopa-levodopa. The investigators' primary outcome measure will be change in quality of life over a prospective period of 6 months. Secondary outcome measures will include change in mood state and motor symptoms, as well as comparison of improvement between two treatments.

Primary investigators would also like to collect quantitative electroencephalogram (qEEG) recordings, which is a reading of brain activity as an additional interest of this study. Primary investigators will assess the qEEG recordings for electrophysiological findings before and after interventions.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 50-80 years of age presenting with diagnoses of early stage Parkinson's Disease (UPDRS part III score \<20) without a previous treatment trial of either antidepressants or levodopa and able to provide consent.
* Screened positive with depressive symptoms suggestive of an underlying mild to moderate major depressive episode on the PHQ-9 (scores 10-20).

Exclusion Criteria:

* Currently taking an antidepressant (SSRI, SNRI, TCA, MAOi), antipsychotic, or dopaminergic Parkinson medication, or in the last 8 months.
* Tremor with a UPDRS-part III score of 3 or more.
* Currently participating in another clinical trial, which might directly influence findings of this study.
* Inability to provide informed consent.
* Dementia as defined by Montreal Cognitive Assessment (MoCA) score of \<24 and/or clinical evidence of dementia.
* A lifetime diagnosis of another mental disorder including bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, moderate and severe alcohol use disorder as per chart review or patient self-report.
* High risk of suicide (e.g. active suicidal ideation and/or current/recent intent or plan) as per self-report or relevant item on the PHQ-9.
* Non-correctable clinically significant sensory impairment.
* Unstable medical illnesses including delirium, uncontrolled diabetes mellitus, hypertension, and hyperlipidemia or cerebrovascular or cardiovascular risk factors that are not under medical management, including QTc\>480 on Electrocardiogram.
Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia

The purpose of the study is to demonstrate the effect of Lyrica on Wake after sleep onset in subjects with fibromyalgia with sleep maintenance disturbance (on polysomnogram)


Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet diagnostic criteria for fibromyalgia;
* Subjects must report difficulty in maintaining sleep at least 3 times per week and meet Research Diagnostic Criteria (RDC) for insomnia disorder, corroborated by subject diary, and meet PSG inclusion criteria at visit 3.

Exclusion Criteria:

* History of active sleep disorder other than Research Diagnostic Criteria(RDC) insomnia criteria or any sleep or circadian rhythm disturbance;
* Use of medications known to affect sleep wake function by Visit 2;
* Involved in night or rotating shift work, or travel across \>4 time zones 14 days prior to screening and during study; regular daytime napping
* PSG finding of apnea/hypopnea or periodic limb movement with arousal index \>10/hr on either night of PSG.
Platelet Rich Plasma Study With Meniscal Repair

This study will compare meniscal healing with or without platelet rich plasma. The assessments will include validated, disease specific, patient oriented outcome measures, MRI arthrogram (MRA). Results of this study will help ascertain whether PRP improves meniscal healing rates.

Null Hypothesis: There is no difference in meniscal healing with or without the use of PRP.

The integrity of the meniscus is pivotal to the distribution of joint reaction forces and shock absorption across the knee and meniscal damage can lead to secondary degenerative joint disease. This has lead to treatments directed towards repairing and preserving the meniscus to alter the progression of joint degeneration. Although success rates of meniscal repair are greater when performed in association with anterior cruciate reconstruction, healing rates remain in the 70-80% range for isolated repairs.

Therefore, techniques such as the use of fibrin clots, trephining and rasping of the tissues, have been incorporated to improve healing results of meniscal repair. There has been a surge of enthusiasm for the use of Platelet Rich Plasma (PRP) to improve healing rates of soft tissue injuries. Therefore, it may be reasonable to surmise that applying blood products, such as thrombin and platelet rich plasma, to the meniscal repair bed may induce more complete and possibly faster healing.

Eligibility Criteria:
Inclusion Criteria:

* complete vertical longitudinal tear \> 10 mm in length
* tear located in the vascular portion of the meniscus, classified as either red-red or red-white zones
* a stable knee, or a knee that is stabilized with a concurrent ACL reconstruction
* unstable peripheral tear that can be displaced toward center of joint
* single tear of the medial and/or lateral meniscus
* skeletally mature patients 18-60 years of age

Exclusion Criteria:

* associated significant ligament instability: Grade III MCL, Grade III PCL
* discoid meniscus
* ACL deficient knee
* Outerbridge Grade III or IV cartilage changes on arthroscopy in the involved compartment
* Significant degenerative changes on radiographs (Kellgren Lawrence \>/= Grade III)
* Associated osteochondral defect that requires treatment
* Inflammatory arthropathy (e.g. rheumatoid arthritis)
* Non repairable meniscus (ie white zone, irreducible meniscus)
* Degenerative meniscus or presence of CPP crystals in meniscus
* Underlying bleeding disorder or coagulopathy
Investigation Into the RAtio of LDL-CHolestEroL to HDL-Cholesterol Improvement After Statin Treatment in Korean Patients

An observational, non-interventional, multi-centre study to provide further information on the ratio of LDL-C to HDL-C improvement after statin treatment in Korean patients group.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are taking lipid-lowering medication after diagnosed as dyslipidaemia
* Subjects who have at least made 1 visit to the outpatient clinic within previous 6 months
* Subjects who have records of both LDL-C and HDL-C before \& after statin treatment (at least four weeks after statin taking)

Exclusion Criteria:

* Subjects who are unwilling or unable to provide their examination and lab result of medical chart.
Prospective Study of the Prognostic Value of New Markers in Adults With ALK-positive Large Anaplastic Lymphoma

The study aims to evaluate the prognostic value on the complete metabolic response rate (MCR), the incidence of relapse / progression, the Progression Free Survival (PFS) and the Overall Survival (OS).

* at diagnosis
* after the first cycle of CHOEP (early evaluation)
* at the end of treatment

ALK-positive anaplastic large cell (anaplastic large-cell lymphoma, ALCL) is a rare adult disease for which almost all published studies are retrospective. The overall survival (OS) at 5 years varies from 70 to 87%. A recent international pooled analysis showed that the International Prognostic Index (IPI) had good predictive value for the PFS and the OS.

In children, new prognostic factors have been identified: the titre of circulating anti-ALK antibodies (inverse correlation between the antibody titre and the prognosis), the detection of a NPM-ALK transcript in the blood at diagnosis (minimal disseminated disease, MDD); correlation between MDD positivity and pejorative prognosis) and its minimal residual disease (MRD), and the histological subtype (common versus small cells / lymphohistiocytic).

The predictive value of the oncogenic profile of ALK-positive ALCL and circulating tumor DNA will be studied in this study.

* At diagnosis (before starting treatment):
* Cycle 2 Day 1 (before starting cycle 2 treatment):
* At the end of treatment evaluation:

  40 patients treated with 6 cycles of CHOEP every 3 weeks and 1 lumbar puncture at diagnosis with intrathecal prophylaxis with methotrexate will be included prospectively.

During a 2-year period, relapses / progressions and patient deaths will be monitored for the calculation of the incidence of relapse / progression, progression free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

Over 18 years old Diagnosed with Anaplastic large-cell lymphoma ALK+

Planned treatment : 6 cycles of CHOEP 21

Planned lumbar puncture at diagnosis or at the first cycle with intrathecal prophylaxis with methotrexate (15 mg) at the first cycle

Planned interim positron emission tomograph (PET)-scan after 3 cycles of treatment and at the end of treatment according to the center standard of care

Exclusion Criteria:

Involvement of the central nervous system

Intent of Autologous stem-cell transplant in first line