cyrilzakka/clinical-trials huggingface dataset:
Objective Confirmation of thе Anti-ischemic Effectiveness of Trimetazidine 80mg Once Daily in Patients With Stable Angina Who Had a History of Myocardial Infarction (METHOD)

METHOD is a prospective observational program that will be conducted in 1centre of the Russian Federation. Prospective follow-up will be for about 6 months. The METHOD study is a 2 visit study with first visit of inclusion and second visit of completion of the study. Patients with stable angina pectoris eligible to the study inclusion criteria will be invited to participate in this observational program. The parameters for analysis will be collected by doctors and entered into CRF. The final analysis will include data from patients who were taking TMZ 80 mg OD during the observational period. The decision to stop the study will be made once 36 patients receiving treatment with trimetazidine 80 mg OD will have been evaluated at V1.

It is expected that 5 cardiologists will participate in the program. The planned number of patients is 36.

To describe antiischemic and antianginal effectiveness of trimetazidine OD 80 mg as well as adherence to the treatment with TMZ 80 mg OD in patients with stable angina pectoris and prior MI in real clinical practice in Russia

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 yearsAge older than 18 years
* Signed informed consent form
* Stable angina pectoris (CCS I-III FC) with signs of myocardial ischemia despite treatment with antianginal drug(s) present either clinically and/ or at stress ECHO test with dobutamine
* History of myocardial infraction occurred 6 months and more from the inclusion date
* Trimetazidine (TMZ) is recommended as add on to the current antianginal treatment and this recommendation precedes inclusion of a patient in the study
* Intention to perform a stress echo with spackle tracking precedes the start of TMZ
* Physician's intention to perform a stress ECHO test within a 6-month period after the date of inclusion in the study

Exclusion Criteria:

* Age over 75 years or under 18 years old
* Hypersensitivity to the active substance or any excipient specified in SmPc of TMZ 80 mg OD
* Parkinson's disease, parkinsonism symptoms, tremors, restless legs syndrome and other accompanying movement disorders
* Known severe or moderate renal impairment (creatinine clearance \<60 ml / min).
* Angina pectoris of IV functional CCS class
* Heart failure IV functional class by NYHA
* Cardiac valves insufficiency with regurgitation of stage III and higher
* Myocardial infarction less than 6 months from the inclusion date
* Acute cerebrovascular event (stroke of various origins, transient ischemic attack) within 6 months before screening date
* Uncontrolled arterial hypertension of stage 3 (blood pressure above 180/100 mm Hg) despite ongoing antihypertensive therapy
* Fructose / sucrose intolerance, presence of glucose-galactose malabsorption syndrome, sucrose-somaltase deficiency and other enzymopathies associated with intolerance to sucrose, which is part of the drug
* Pregnancy, breastfeeding
* Any contraindications to stress echocardiography with dobutamine
D-dimer to Improve Anticoagulation Outcome During ECMO loNg-term supporteD

This was a prospective, cohort study.

Adult Patients receiving ECMO surpport in Wuhan Asia Heart Hospital were enrolled by cohort. Unfractionated heparin was used for Anticoagulation therapy, APTT or Anti-Xa activity is monitored for dose adjustment. Meanwhile, D-dimer is mornitored. If D-dimer levels continue to rise (\>1.5 times previous result ), increase the dose of heparin to reach the upper limit of the treatment target; If the D-dimer levels is stable (\<1.5 times previous result ) or is decreasing, the anticoagulation dose is maintained at current level (no active bleeding) or decreased (active bleeding). All patients were followed up The occurrence of endpoints during in-hospital and 30 days after discharge, including bleeding events, thrombotic events and all-cause deaths were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients
* Receiving ECMO surpport for any reason

Exclusion Criteria:

* The duration of ECMO surpport was less than 24 hours .
* Those who had difficulty in compliance or were unavailable for follow-up.
Effect of U-Health Service in Stroke Patients

Provides mobile programs for occupational and speech therapy to patients with stroke.


Eligibility Criteria:
Inclusion Criteria:

* stroke confirmed by brain imaging study
* Impairment in upper extremity function or speech
* native speaker of Korean

Exclusion Criteria:

* previous history of aphasia
* psychiatric or psychotic problem
* severe cognitive dysfunction
* severe hearing or visual loss
* cannot sit with devices
Fucoidan Improves the Metabolic Profiles of Patients With Non-alcoholic Fatty Liver Disease (NAFLD)

Studies reveal special function of fucoidan so far include anti-virus, anti-tumor, immunomodulatory, anti-inflammatory, blood fat, anti-oxidation and liver and kidney dysfunction and improve fibrosis. The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.

Fucoidan is a water-soluble dietary fiber which is extracted from brown seaweed. Slimy surface of brown seaweed has unique ingredients and different kind of brown seaweed has slightly different effectiveness. The strongest fucoidan among all seaweed for inhibiting cancer cells is in Okinawa Japanese waters. For chemically speaking, the major components for fucoidan consisted of mainly fucose which is a kind of polysaccharide with strong biological activity. However, patients need to take actual fucoidan in order to reach the best effectiveness for inhibiting cancer cell.

Studies reveal special function of fucoidan so far include anti-virus, anti-tumor, immunomodulatory, anti-inflammatory, blood fat, anti-oxidation and liver and kidney dysfunction and improve fibrosis. The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are aged between 20-75 with non alcoholic fatty liver disease (NAFLD).

Exclusion Criteria:

1. Patients were allergic to seafood.
2. Patients who take Vitamin E or Pioglitazone.
Long-Term Effect of LIAM on Respiratory Performance in NIV Patients Suffering From Neuromuscular Disease

The long-term effect of LIAM (Lung Insufflation Assist Maneuver) on respiratory performance in home non-invasively ventilated (NIV) patients suffering from neuromuscular disease will be assessed in a prospective, randomized, cross over, open label study

In advanced neuromuscular disorders, respiratory complications represent the main cause of morbidity and mortality. Beside chronic respiratory insufficiency, necessitating a ventilatory support, mostly performed by non-invasive ventilation (NIV), cough is impaired due to the muscle weakness, and respiratory physiotherapy becomes an essential part of the management.

Various techniques have been proposed to improve lung recruitment and cough in neuromuscular patients. The assisted techniques based on a positive pressure insufflation maneuver have shown an improvement in physiological variables on the short term, but there is to date no good-quality prospective study allowing to evaluate the long term efficacy of mechanical cough assistance devices in neuromuscular patients.

We designed a randomized, cross over, open label study to assess the long-term effect of LIAM (Lung Insufflation Assist Maneuver) on respiratory performance in NIV patients suffering from neuromuscular disease.

Eligibility Criteria:
Inclusion Criteria:

* o neuromuscular disease ( progressive muscular dystrophy, for example; Duchenne muscular dystrophy, spinal muscular atrophy)

  * age ≥ 18 years
  * indication to NIV (ongoing ventilation or new patients)
  * vital capacity ≤ 50% pred
  * peak cough flow \< 270 l/min
  * "LIAM Responder" = increased insufflation capacity (≥ + 50%) and Peak Cough Flow (PCF ≥+ 50%) with LIAM

Exclusion Criteria:

* o acute respiratory failure (respiratory acidosis)

  * home treatment by instrumental cough assistance in the preceding 12 months
  * ongoing medical treatment of the neuromuscular disease (for ex: corticosteroids in Duchenne disease, enzyme therapy in Pompe disease)
  * previous pneumothorax
  * plan of legal protection
  * pregnant or breastfeeding women
  * failure to cooperate
  * no affiliation to a social security scheme
Reduce Emotional Symptoms of Insomnia With SleepTreatment

The purpose of this research is to test whether Mindfulness-Based Therapy for Insomnia (MBTI) significantly reduces symptoms of insomnia and cognitive arousal in patients with treatment-resistant insomnia.

Cognitive-behavioral therapy and pharmacotherapy are effective interventions for insomnia. Even so, about half of patients do not adequately respond to these treatments. Non-remission has been linked to high cognitive arousal that does not improve with traditional therapies. This study will examine the effects of mindfulness-based therapy for insomnia (MBTI) in a sample of patients who previously failed cognitive behavioral therapy and/or pharmacotherapy for insomnia.

This trial utilizes a single-arm, open label trial of MBTI. MBTI is delivered via telemedicine video in an individual therapy format.

Male and female participants who have insomnia, are age 18 and older, and who are recruited into the study will complete an initial assessment of their qualifications that are based on the severity of their insomnia symptoms, depression symptoms, and physical and mental health status. Eligible participants will undergo a clinical sleep interview and then complete 8 sessions of MBTI. Study outcomes are assessed via online survey before treatment, after treatment, and then a 6-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Determination of insomnia (ISI\>10)
* Inadequate response to prior insomnia psychotherapy (e.g., CBTI) and/or pharmacotherapy per patient report.

Exclusion Criteria:

* Age \< 18
* Current use of antidepressants for depression
* Bipolar or Seizure disorders
* Known sleep disorders other than insomnia (e.g. obstructive sleep apnea, narcolepsy, restless leg syndrome).
Evaluation of the Glycaemic Control With Insulin Detemir as an add-on to Current Oral Anti-diabetic Drug Treatment in Subjects With Type 2 Diabetes in Korea

This trial is conducted in Asia. This trial aims for evaluating the glycaemic control, measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to oral antidiabetic drug (OAD) in subjects with type 2 diabetes mellitus in Korea.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes (diagnosed more than 12 months ago)
* HbA1c greater than 7.0 and less than 12.0% at screening
* Currently on any OAD in more than 3 months ago
* BMI (Body Mass Index) less than 35kg/m2

Exclusion Criteria:

* Previous treatment with insulin in more than 7 days within the last 3 months
* Uncontrolled treated/untreated hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure less than 110mmHg)
Combined Plexus Block for Hip Fracture Surgery.

Hip fracture surgery requires high risk anesthetic procedure for elderly patients (1). General anesthesia, continuous spinal anesthesia and peripheral nerve blocks are three anesthetic techniques possible. Continuous spinal anesthesia has proven its efficacity to provide an intraoperative haemodynamic stability wich guarantees good patients outcomes (2), in comparison with general anesthesia but there is poor evidence in the literature concerning the use of peripheral nerve blocks.

The primary objective of this study was to compare intraoperative haemodynamic stability provides by peripheral nerve block versus general anesthesia and continuous spinal anesthesia.

Secondary outcomes included : use of vasoactive drugs, opioids consumption, lengh of stay and inhospital mortality.

After receiving the ethic approval from the "CERAR", the investigators retrospectively identified all patients who underwent hip fracture surgery from January 1 2015, to December 31, 2016 in the CHU of Montpellier. The exclusion criteria were: multiple trauma victims, two hip fractures in the same patient and single shot spinal anesthesia. In our institution the investigators used to perform three types of anesthesia: general anesthesia (GA), continuous spinal anesthesia (CSA) and combined plexus blocks (CPB). The investigators therefore made three groups GA, CSA and CPB and used a propensity score to make these groups comparable. The matching criteria were age, arterial hypertension, ASA status, Frailty score, chronic cardiac failure and type of surgery.

Eligibility Criteria:
Inclusion criteria:

* Adult
* Hip fracture surgery

Exclusion criteria:

* Multiple trauma victims
* Second hip fracture in same patient
* Single shot spinal anesthesia
Can Novel Telemedicine Tools Reduce Disparities Related to Early Identification of Autism

In this study, the investigators are trying to find new ways to screen for autism spectrum disorder (ASD) in young children. The investigators want to see if people like pediatricians can screen children for ASD while a psychologist watches on a monitor. The investigators are testing two screening tools. The investigators want to see if they are good at identifying children with ASD and children without ASD. The investigators hope this research will make it easier for families to get answers when there are concerns for ASD.

The investigators will evaluate and compare two telemedicine assessment tools (TELE-STAT and TELE-ASD-PEDS) that could allow parents or naive providers in remote locations to complete an Autism Spectrum Disorder (ASD) risk assessment via telemedicine consultation via an expert psychologist. These tools will be low cost, compliant with privacy rules, easily deployed in community practice settings, and explicitly designed to work within paradigms that may be pragmatically and financially viable for systems of care housing remote clinicians. These telemedicine tools could provide methodologies wherein children could be rapidly linked to and appropriately assessed by ASD experts within practice locations where the children are currently receiving care. In turn, these children, who without such assessment may wait months or over a year in many circumstances to access assessments and interventions, may be able to receive appropriate ASD assessments within days or weeks of screening/surveillance concerns within practice settings where the children are already accessing and familiar with (i.e., minimizing loss to referral and follow-up)

Eligibility Criteria:
Inclusion Criteria:

* Children who have been diagnosed with autism or developmental delay

Exclusion Criteria:

* Children with genetic disorders
* Children with medical complexities, such as blindness or deafness
* Children whose families do not speak English
Efficacy and Tolerability Study of Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis in Adults

The purpose of this study is to find out if investigational device, RD047-26, is safe and useful for the treatment of mild to moderate atopic dermatitis.

RD047-26, a device, may be tolerable and effective for the treatment of mild to moderate atopic dermatitis with associated pruritus in adults. The treatment effect will be evaluated by the subject and investigator.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Female or male, 18 to 65 years of age and in good general health
* Clinical diagnosis of stable mild to moderate atopic dermatitis
* Willing and able to follow study instructions and likely to complete all study requirements

Exclusion Criteria:

* Severe or uncontrolled asthma
* Pregnant, nursing, or planning a pregnancy during the study; or is a WOCBP but is not willing to use an effective method of birth control
* Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to Baseline (Day 0)
Acute Effects of Neonatal Hydrokinesiotherapy in Newborn Preterm Hospitalized

This study aims to evaluate the acute effects of neonatal hydrokinesiotherapy in reducing stress in newborn preterm infants in the neonatal intensive care unit. Salivary cortisol samples were collected, pain applying the Neonatal Infant Pain Scale Scale (NIPS), heart rate, respiratory rate and oxygen saturation before and after hydrotherapy.

Newborns have the neurological maturity to perceive pain, including preterm. In the environment of the neonatal intensive care unit newborns are subject to environmental stress and numerous painful interventions. Based on the physiological properties of water, it is known that the hydrotherapy promotes comfort, reduces stress, and as a resource for treatment of various diseases. This study aims to evaluate the acute effects of neonatal hydrokinesiotherapy in reducing stress in newborn preterm infants in the neonatal intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

* gestational age above 37 weeks
* clinically stable
* without ventilatory support

Exclusion Criteria:

* access deep below the shoulders
* umbilical catheterization
* neurological and cardiac disorders
* clinically unstable
Tenaculum Pain Control Study

The purpose of this clinical trial is to evaluate the effect of an intracervical lidocaine injection versus topical lidocaine gel on the pain experienced by patients undergoing tenaculum application to the cervix during office gynecologic procedures. This study will also evaluate how satisfied women are with the method of pain control used.

The researchers hypothesize that:

1. There is less pain perceived by patients undergoing placement of a tenaculum on the cervix when a lidocaine injection is used compared to a topical lidocaine gel.
2. Patients are more satisfied with pain control during the overall experience of undergoing tenaculum placement on the cervix when a lidocaine injection is used compared to a topical lidocaine gel.

Subjects who have already scheduled an IUD insertion or endometrial biopsy will be asked to join this study assessing two pain control interventions at the time of tenaculum application to the cervix during office gynecologic procedures. Only healthy women ages 18 and over with an indication for endometrial biopsy or IUD placement will be recruited. The participants will be randomized to one of two arms: an intracervical lidocaine injection versus topical lidocaine gel. They will be asked to indicate their level of pain and level of satisfaction using a Visual Analog Scale. The primary outcome, pain with tenaculum placement, and the secondary outcome, satisfaction with the experience of tenaculum placement, will be compared between the study groups.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy women
* Age 18 and over
* Indication for endometrial biopsy or IUD placement

Exclusion Criteria:

* Allergy to lidocaine or other local anesthetic
* Pregnancy, known or suspected
* Patients who are premedicated with misoprostol
* Patients with a chronic pain condition for which the patient takes daily pain medication
Changes in Serum antimüllerian Hormone Levels in Patients 3 and 12 Months After Endometrioma Sclerotherapy

Endometriosis affects 6-10% of women in childbearing age. It is a heterogeneous disease with three different forms: superficial endometriosis (peritoneal), ovarian endometrioma and deep pelvic endometriosis (subperitoneal).

Surgical management of endometriomas is justified in cases of significant clinical symptoms (like pain), especially in cases of resistance to medical treatment. Currently, laparoscopic cystectomy surgery is the recommended technique to treat ovarian endometrioma. However, it is now well demonstrated that this surgery significantly reduces the ovarian reserve.

Ethanol sclerotherapy is an alternative technique used to treat ovarian endometriomas. Several studies demonstrated the effectiveness and safety of this treatment, particularly in terms of preserving fertility. Regarding these reassuring data, many clinicians changed their practices and propose this technique as a first-line surgery.

Ovarian reserve comprises two elements: size of the primordial follicle stock and quality of the ovocytes. Antimüllerian hormone (AMH) has been shown to be the best marker of fertility.

The aim of this study is to observe changes in AMH levels after endometrioma sclerotherapy. This study is conducted in the Hospices Civils de Lyon, in 3 different sites.


Eligibility Criteria:
Inclusion Criteria:

* Patient in childbearing age from 18 to 42 years.
* Patient with uni- or bilateral endometrioma(s) without clinical and ultrasound criteria for ovarian carcinoma.
* A sclerotherapy is programmed.
* Patient affiliated to a social security scheme.
* Patient who gave consent for this research.

Exclusion Criteria:

* doubt about the endometriotic origin of the cyst
* suspect malignant ovarian disease.
* Pregnant or breastfeeding patient.
* Patient participating in other research with an exclusion period still in progress at the time of inclusion or those included in interventional research that interferes with the study protocol.
* Patient deprived of liberty by judicial or administrative decision.
* Patient (≥ 18 years old) under legal protection or unable to give consent.
* Patient does not speak French.
Randomized Trial of Primary Surgery Followed Selective Radiochemotherapy for Rectal Cancer With MRI Negative CRM

The purpose of this study is to determine whether primary radiotherapy can be omitted for the locally advanced rectal cancer with Magnetic Resonance Imaging (MRI) negative circumferential margin.

The preoperative radiochemotherapy with fluorouracil followed surgery is the standard therapy for patients with locally advanced rectal cancer. However, the necessity of radiotherapy has been questioned for a long time especially for patients with enough circumferential margins. Moreover, indiscriminate radiotherapy will result Irreversible ovarian dysfunction for female. In the past decade, there were two major progresses for colorectal cancer. Firstly, oxaliplatin with fluorouracil has become the standard adjuvant chemotherapy for advanced colon cancer. Oxaliplatin improved the survival of colon cancer patients than single fluorouracil. Our experience showed that oxaliplatin with fluorouracil could improve the prognosis of rectal cancer without radiotherapy. It has been proven that oxaliplatin should not add to radiotherapy for rectal cancer. However, whether oxaliplatin can replace radiotherapy for certain rectal cancer patients is still unknown. Secondly, Magnetic Resonance Imaging (MRI) has been proven that can predict the circumferential margin status for rectal cancer. Now, preoperative MRI scan can recognize the rectal cancer patients with low recurrence risk. The radiotherapy may be omitted to the patients with low recurrence risk. This study is a randomized controlled trial to compare the 3-year disease-free survival (DFS) differences of group of experiment (the patients receive primary surgery followed selective radiochemotherapy) and group of control (the patients receive indiscriminate preoperative radiochemotherapy followed surgery) for locally advanced rectal cancer with negative MRI circumferential margin.

Eligibility Criteria:
Inclusion Criteria:

* Rectal adenocarcinoma or mucinous adenocarcinoma that is 6-12 cm from the anal verge.
* MRI scan confirmed cT3N0 or cT4aN0 or cT1-4aN+ mid rectal cancer (6-12cm from the anal verge).
* MRI scan confirmed more than 1 mm circumferential margin.
* Age 18-75 years old.
* Without distant metastasis.

Exclusion Criteria:

* Malignant history.
* Contraindications of MRI scan.
* Contraindications of radiotherapy.
* Contraindications of chemotherapy.
* Pregnancy.
* Multidisciplinary team thinks that the patient is unsuitable to take part in research (For example, there are obvious regional lymph nodes involved in low rectal cancer patients who are thought with high risk of recurrence).
* Refuse to take part in research.