cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Insuman Basal/Comb/Rapid in Patients With Type 2 Diabetes

Primary Objective:

- To evaluate the decrease of Hb A1c ≥ 1% after 6 month treatment in patients with Type 2 Diabetes Mellitus (T2DM) uncontrolled on Oral Antidiabetics (OADs)

Secondary Objectives:

* To evaluate the percentage of patients with Hb A1c \< 7.5%,
* To evaluate the rate of hypoglycaemia (symptomatic, severe)
* To evaluate the middle dose of insulin per product - Insuman Basal, Insuman Comb, Insuman Rapid after 6 month treatment
* To evaluate the change in Fasting Plasma Glucose (FPG) after 6 month treatment
* To assess the overall safety
* To evaluate the efficacy of education courses in Diabetes Schools (% of correct answers after second test compare to the testing of the initial level)

6 months

Eligibility Criteria:
Inclusion criteria :

* T2DM patients uncontrolled by maximum tolerated dose of 1-2 OADs
* Males and Female \> 18 years
* HbA1c \> 7.5%
* Patients with abilities of self-monitoring of Diabetes, managing of patient's diary, ability to obtain education in Diabetes School, completion of Questionnaire
* It is expected that the patient will remain on a stable dose of OADs within 6 months of treatment

Exclusion criteria :

* Type 1 diabetes
* Current temporary insulin therapy (gestational diabetes, pancreas cancer, surgery, clinical trial)
* Any clinically significant acute major organ or systemic diseases making interpretation of the evaluation results difficult
* Patient planning a pregnancy now or in the next 6 months
* The patient is participating in another clinical study now or in the last 28 days prior to Visit 1
* The patient is a drug user (currently or in the past)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Efficacy of Spinal Oxytocin in Healthy Volunteers

The purpose of this study is to determine the effect of intrathecal oxytocin on areas and intensity of hyperalgesia and allodynia induced by topical capsaicin.

Purpose: There is a strong experimental basis to support the study of oxytocin by the spinal route for analgesia in humans. Oxytocin containing cells in the dorsal parvocellular division of the paraventricular nucleus (PVN) project to the spinal cord (1). Noxious stimulation activates these cells via the A1 noradrenergic relay in the pons (2) and produces analgesia by spinal release of oxytocin, since intrathecal injection of an oxytocin receptor antagonist worsens pain behaviors from peripheral inflammation (3). Direct electrical stimulation of the PVN reduces dorsal horn neuronal responses to noxious stimulation, and this is blocked by administration of sequestering antibody for oxytocin (4). Similarly, direct electrical stimulation of the PVN reduces behavioral sensitivity in a model of chronic neuropathic pain, and this effect is blocked by an oxytocin receptor antagonist (5). Intrathecal injection of oxytocin in normal rats reduces dorsal horn neuronal responses to noxious stimuli (6) as well as behavioral responses to noxious thermal (3), mechanical (3), and chemical (7) stimuli. Finally, intrathecal injection of oxytocin in rat models of chronic pain also reduces dorsal horn neuronal responses to sensory stimulation (6) as well as behavioral responses to thermal (5) and mechanical (7) stimuli.

Rationale: We anticipate that oxytocin will be effective after spinal injection in humans against chemical induced hypersensitivity states.

Objectives: Determine the effect of intrathecal oxytocin on areas and intensity of hyperalgesia and allodynia induced by topical capsaicin.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* weight \< 240 pounds
* American Society of Anesthesiology Category 1 or 2

Exclusion Criteria:

* allergy to oxytocin or lidocaine
* allergy to chilli peppers
* Females: active gynecological disease such as uterine fibroids or ongoing bleeding
* Pregnancy or currently breastfeeding
* Females that have delivered a baby within 2 years of study
* Taking prescription medications (exception: oral birth control medication)
TMD-specific Physiotherapy in hEDS Patients Individuals With Hypermobile Ehlers-Danlos Syndrome

The aim of this study is to analyze the effects of strictly defined physiotherapy in patients temporomandibular dysfunction (TMD) and hypermobile Ehlers-Danlos Syndrome (hEDS). Patients will be clinically examined before starting physiotherapy and fill in the questionnaires. Subsequently, it will be followed up whether changes occur as a result of physiotherapy.

This study is a pilot study and is intended to be hypothesis generating in nature. Based on the resulting hypothesis, it will be verified by a study with a control group.


Eligibility Criteria:
Inclusion Criteria:

1. written consent to participate in the study
2. confirmed diagnosis of hEDS (based on the diagnostic criteria of the current classification of 2017).
3. pain in the area of the masticatory muscles and/or the temporomandibular joints
4. command of the German language, both spoken and written

Exclusion Criteria:

1. currently undergoing TMD-specific treatment (physiotherapy, pain therapy masticatory muscles and/or temporomandibular joint, orthopedic treatment, osteopathic treatment).
2. persons diagnosed with depression, anxiety or stress disorder
3. taking opiates
4. pregnant women
5. minors
6. persons with mental disability
7. persons who are not able to speak and write the German language
8. persons with legal representatives
Improvement of Self Management for Oncologic Patients With Pain

This study will test the SCION (Self care improvement through oncology nursing)-PAIN program, a multi-modular structured intervention to improve self management in oncologic patients with pain compared to care as usual (standard pain treatment and standard care). The study will determine if the self management skills of the patients continue to be used when the intervention stops, e.g. after discharge from hospital.

It is hypothesized that patients who receive the multi-modular structured intervention will have less patient-related barriers to the management of cancer pain.

According to modified "Precede Model of health behavior" from Green, patients self management skills are affected by the patients' knowledge, activities and attitude to pain management.

Therefore, we conduct a cluster randomized clinical trial (C-RCT) that will test the effectiveness of SCION-PAIN program against care as usual on self pain management of the patient and average pain level.

As allocation to intervention or control is performed on the level of wards, randomization is stratified by ward profile (e.g. gynaecological, haematological, urological).

Wards were included if they agreed to participate and had more than 10% patients with a diagnosis of cancer in 2006. Wards with a pediatric profile were excluded.

Adult oncology patients with persistent pain will be recruited by the nurses of the participating wards under the guidance of a research nurse. Patients are included in the trial if they meet the inclusion criteria and sign informed consent. They will receive the intervention that the respective ward was allocated to.

The SCION-PAIN program as a multi modular structured nursing intervention (see Arm Description) will be conducted by specially trained ward nurses in cooperation with the research nurse. The intervention will include components of knowledge, skills training, and coaching (particularly against patient-related barriers to pain medication) to improve cancer pain management. Patients in intervention group will receive follow-up telephone counseling within 2 to 3 days after discharge. The self management skills of the patients will be observed up to 28 days post discharge. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* adult oncology patients
* able to read, write, and understand German
* agree to participate and give informed consent
* have an average pain intensity score of \> 3.0 on a 0 to 10 NRS
* pain persists for more than 3 days
* scheduled for another visit to the clinic

Exclusion Criteria:

* documented actual alcohol or drug abuse
* surgery within the last 3 days
* disorientated to date, place and situation
* have a ECOG Performance Score of 4
A Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and evaluate the safety and pharmacokinetics of KPS-0373 in SCD patients.


Eligibility Criteria:
Inclusion Criteria:

* Japanese SCD patients with mild to moderate ataxia

Exclusion Criteria:

* Patients with secondary ataxia
* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Premature Rupture of Membranes With a Bishop Score<6: Comparison of Medical Induction/Expectant Management

The study is intended to compare expectant management and on presentation labor induction in women with premature rupture of membranes.

The means of labor induction and cervical ripening are either oxytocin or dinoprostone.

Expectant management in this obstetrical state means waiting 24 hours from the onset of rupture of membranes and then commencing labor induction with either oxytocin or dinoprostone depending on the patient's obstetrical history and cervical condition.

The investigators' hypothesis is that active management will lead to a higher rate of vaginal deliveries, a shorter interval between the time of rupture of membranes and the time of delivery, a lower rate of cesarean sections and a better obstetric result for the mother and the fetus/newborn.

In the setting of premature rupture of membranes in term pregnancies, it is customary in women who are not in active labor to wait for 24 hours before attempting to induce labor. The means of labor induction used at our medical center are either intravenous oxytocin or per-vaginal dinoprostone, depending on patient's obstetric history and cervical conditions.

The investigators hypothesize that commencing induction of labor at presentation in these women by either means of induction will lead to higher rates of vaginal delivery, shorter intervals between the time of onset of rupture of membranes and the time of delivery and lower rates of cesarean sections.

The participants in the study, upon signing informed consents, will be randomized to 4 groups-2 groups of expectant management in which labor induction will be commenced after 24 hours with either oxytocin or dinoprostone and 2 groups of active management in which labor induction will be commenced at presentation with either oxytocin or dinoprostone.

The participants will be followed from the time of presentation with rupture of membranes at the delivery room and until the time of delivery.

Further obstetric, clinical and demographic information will be acquired from the patient's electronic medical file for analysis accuracy and sub-analysis.

Eligibility Criteria:
Inclusion Criteria:

* Term pregnancies \>37 weeks of gestation.
* Certain rupture of membranes.
* Bishop score \< 6.
* Singleton pregnancies.
* Vertex presentation.
* No obstetric or clinical contraindications for labor induction.
* Reactive non stress test on presentation.

Exclusion Criteria:

* Previous cesarean section.
* Previous uterine surgeries (Myomectomy etc.).
* Placenta Previa.
* Multiple gestation pregnancies.
* Pregnancies with history of fetal reduction or Intrapartum uterine fetal demise.
* Known fetal defects/Chromosomal abnormalities.
* Active genital Herpes.
* HIV carrier.
* Contractions that are less than 10 minutes apart.
Cohort Study to Identify Predictor Factors of Onset and Progression of Parkinson's Disease

Observational, prospective, monocentric study to assess clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients and rate of progression compared to healthy controls (HC) and subjects at risk to develop PD.

The primary objective of this study is to identify clinical, imaging and biologic markers of PD onset and progression for use in clinical trials of disease-modifying therapies.

ICEBERG will be a four-year natural history study of de novo idiopathic PD patients, healthy controls, and subjects at risk to develop PD (idiopathic Rem Behavior Disorder -iRBD, and probants of patients with PD genetically confirmed).

All subjects will be comprehensively assessed at baseline and every year thereafter. Subjects will undergo clinical (motor, neuropsychiatric, sleep, ocular and cognitive evaluations) and imaging assessments. Blood (including a DNA sample), stools, skin biopsy and cerebral spinal fluid (CSF) samples will be collected.

Eligibility Criteria:
Inclusion Criteria:

* All subjects: Male or female age 18 years and older, MMSE score \> 26, negative pregnancy test in potentially child-bearing women (contraindication to SPECT with DatScan).
* Idiopathic Parkinson disease subjects: diagnosis confirmed according to UK Parkinson's Disease Society Brain Bank criteria (UKPDSBB); disease duration less than 3 years.
* Genetic Parkinson disease subjects: parkinson diagnosis confirmed and mutation in parkin, LRRK2, SNCA or GBA genes.
* Prodromal subjects: subjects with identified relative with PD genetically confirmed or subjects with diagnosis of idiopathic Rem sleep Behavior Disorder (iRBD); neurological examination normal (no signs of parkinsonism).
* Healthy subjects: neurological examination normal

Exclusion Criteria:

* All subjects: Psychiatric disorder or any progressive life-threatening disease, impairment precluding appropriate information and instructions given concerning participation to the study; contra-indication to MRI or SPECT scan.
* Parkinson disease subjects: no dopamine transporter deficit at SPECT scan; parkinsonism induced by neuroleptics; neuroleptics intake within 6 months; atypical parkinson syndrom (MSA, PSP, CBD...)
* Parkinson disease subjects with mutation in Parkin, LRRK2, SNCA or GBA gene: atypical parkinson disease syndromes due to either drugs (e.g., metoclopramide, flunarizine, neuroleptics) or metabolic disorders (e.g., Wilson's disease), encephalitis or degenerative diseases (e.g., progressive supranuclear palsy) or currently taking neuroleptics or has taken neuroleptics within 6 months of baseline or any biological anomaly.
Ultra-long Acting Bronchodilator Therapy in Smoking Asthmatics

Single centre, open-label, random order, cross-over trial, recruited over a period of approximately 2 years. Sufficient participants enrolled to complete 16 adults. Withdrawn subjects may be replaced.

This clinical trial will assess the effects of ultra-long acting bronchodilator therapy in smoking asthmatics taking inhaled corticosteroids. This will be via a pulmonary function test called impulse oscillometry.

Cigarette smoking in asthma is associated with poorer asthma control and a higher frequency of asthma attacks. Despite this, smoking cessation rates are very low due to the highly addictive nature of tobacco smoking. Asthma in smokers is particularly challenging to manage because it is resistant to the beneficial effects of inhaled corticosteroids, the main treatment for asthma.

Unfortunately, there is no guideline consensus regarding how to best manage asthmatics who smoke. Research studies in asthma tend to exclude smokers because of concerns about recruiting patients with chronic obstructive pulmonary disease (COPD). Hence, there is an unmet need for research studies in asthmatics who are unable to stop smoking.

In view of the above, we propose to assess the effects of two different types of bronchodilators (inhalers which help open up the airways), in asthmatics who continue to smoke.

Participants will receive both of the following drugs for 2-4 weeks in random order, with a 2-3 week washout period in between:

Olodaterol which is a new long-acting bronchodilator. Olodaterol combined with tiotropium (dual bronchodilators). We wish to compare these inhalers using a sensitive pulmonary function test called impulse oscillometry.

Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers aged 18-65 years with persistent asthma and on inhaled corticosteroids (at least 400 micrograms beclomethasone dipropionate equivalent dose daily)
* Current smoker
* Forced Expiratory Volume in 1 second (FEV1) ≥ 60 % predicted
* Ability to give informed consent
* Agreement for their General Practitioner to be made aware of study participation and to receive feedback as relevant to the participant's well being

Exclusion Criteria:

* Other significant respiratory diseases, in the opinion of the investigator, such as COPD or bronchiectasis.
* An asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement or 3 months if hospital admission was required
* Any clinically significant medical condition that may endanger the health or safety of the participant
* Participation in another drug trial within 30 days before the commencement of the study
* Pregnancy or lactation
* Unable to comply with the procedures of the protocol
* Unable or unwilling to consent
Accuracy Assessment of an Automatic Blood Pressure Measurement Device in Adult Volunteers

The research team has developed an automatic blood pressure monitor (Sphygmo) to be used for the monitoring and diagnosis of pre-eclampsia in pregnant women, particularly in low-resource settings where current monitoring is limited.

90 adult volunteers will be enrolled by researchers at Rice University. The participant will be seated in a comfortable chair with arm at heart level. Arm circumference will be measured and a blood pressure cuff will be placed on the arm. The cuff will be inflated and blood pressure measurements will be taken by a commercially available device and by the Sphygmo device. Blood pressure measurements from both devices will be recorded. The participant's blood pressure will be measured up to 9 times with a waiting period of 45-60 seconds between each measurement.

The results of this study will be used to optimize the blood pressure detection algorithm and thus further develop the device.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Willing and able to provide informed consent

Exclusion Criteria:

* Unable to provide informed consent
The Effect of a Ketogenic Diet on the Exercise Induced Immune Response

comparing the exercise induced immune response after two weeks on a low carbohydrate (ketogenic) diet with the response after two weeks on a high carbohydrate diet.

A cross-over intervention study, with a total duration of 6 weeks. An athlete follows a high, or low carbohydrate (ketogenic) diet. After 2 days a test day takes place where the athlete performs an exercise test and blood samples are taken at different time points. After that, the athlete continues following the diet for another 12 days, after which he comes back again for another identical test day. Then a 2 weeks wash-out period. After that, the athlete follows the same protocol but then with either the low (ketogenic), or high carbohydrate diet.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age: 18 - 45 y
* BMI: 18.5 - 25 kg/m2
* Hb ≥ 8.5 mmol/L, determined with blood sample from finger tip
* Minimal of 3 hours of training per week, and a maximum of 10 hours
* DKTP (diphtheria, pertussis, tetanus and polio) vaccinated (for stimulation of isolated cells (PBMC's) with tetanus toxoid)
* No asthma medication and/or anti-inflammatory medication
* No use of immunosuppressive medication
* No flu and/or travel vaccinations in the 4 months before and during the study
* Able to be present and participate at all test days
* Willing and able to follow prescribed 2 times a diet for 2 weeks in a row

Exclusion Criteria:

* Chronic illness
* Food allergies (e.g. nuts, gluten, avocado)
* Vegetarian diet
* Blood donations during study or in the 2 months prior to the study
* Use of immunosuppressive medication
* Flu and/or travel vaccination 4 months before and during the study
* Hb \< 8.5 mmol/L
* Working at "Human Nutrition" - Wageningen University
Validation of a New Algorithm for Screening Sleep Apnea Syndrome From Electrocardiogram

Sleep apnea syndrome is a prevalent disease, recognized as an independant risk factor for cardiovascular diseases The gold standard for the diagnosis of sleep apnea is the polysomnography. But polysomnography is time-consuming and very expensive. We developed an algorithm for screening sleep apnea from electrocardiographic signal. This would lead to the simplification of screening sleep apnea by using a two-channels recording device and computerizing the scoring of respiratory events. The validation of the algorithm will consist in comparing the number of apnea and hypopnea per hour of sleep (AHI) detected by the algorithm from the electrocardiographic signal recorded during a standard polysomnography in the Center for Sleep Medicine and Research in Nancy, with the AHI resulted from the standard interpretation of the same polysomnography by experts in sleep scoring (gold standard).


Eligibility Criteria:
Inclusion Criteria:

* all patients with a polysomnography recorded in the Center for Sleep Medecine and Research (CSMR) in Nancy from january 2019 and june 2020
* results of standard interpretation of polysomnography giving a number of hypopnea and apnea per hour of sleep (AHI) superior to 5

Exclusion Criteria:

* refusal to participate
Comparison of the Efficacy of a Protocol for the Withdrawal of Neurosedation From the Usual Strategy in Cerebroses

The withdrawal syndrome in benzodiazepines and morphine is common in intensive care, the incidence is estimated at 32.1%.

Cerebrospatized patients are probably more prone to withdrawal because they require high doses of sedation.

Moreover, this syndrome is probably deleterious on the cerebral hemodynamics (high point of the therapeutic management).


Eligibility Criteria:
Inclusion Criteria:

* Major Patient
* Admitted in Neuroreanimation
* Cerebroséé (TC-HSA-AVC)
* Mono or multi failing
* After a neurosedation ≥ 3 days by hypnotic type benzodiazepine (Midazolam®) and morphinomimetic (Sufentanyl®) in IVSE
* Affiliation to Social Security
* Agreement of the person of confidence

Exclusion Criteria:

* Addiction to opiates, cocaine or cannabis
* Neurological Pathology Before Hospitalization
* Patient suffering from cardiac arrest
* Pregnant woman
* Sedation window
* Patient under tutelage or curatorship or deprived of public law
KL-6 Protein as a Biomarker of Lung Injury in Viral Bronchiolitis

Serum KL-6 protein has been described as a biomarker of epithelial lung injury in Respiratory Syncytial Virus bronchiolitis. The investigators can imagine that epithelial injury intensity has consequences on immediate and later respiratory prognosis. Furthermore, this prognosis seems to be different according to the respiratory causative virus. The investigators propose to study, during an epidemic season, the correlation between KL-6 levels and clinical severity, and the type of viral infection.

Prospective, monocentric, case-control and transversal study Primary end-point: correlation between serum KL-6 level and severity of the bronchiolitis, evaluated by a clinical scoring system established at the time of the admission in Paediatric Emergency Unit Secondary end-points: respiratory virus detected by EIA and RT-PCR, phylogenetic study of rhinovirus, length of hospitalisation, immediate morbidity and mortality, risk of asthma at the age of three years old.

Eligibility Criteria:
Inclusion Criteria:

* Cases: Inaugural acute bronchiolitis in infant aged under 1 year; bronchiolitis is defined by rhinorrhea and/or cough, dyspnea, associated with clinical or radiological distension, wheezing or crackling or brake expiratory.
* Controls: Infant aged under 1 year with blood sample test performed for a non-infectious disease (preoperative assessment)

Exclusion Criteria:

* Cases: bronchopulmonary dysplasia, prematurity, cystic fibrosis, immunodeficiency, primary ciliary dyskinesia, congenital cardiopathy, use of corticotherapy the week between inclusion
* Controls: infectious documented disease, respiratory symptoms