cyrilzakka/clinical-trials huggingface dataset:
GOAL: A Research Study Looking at Long Term Blood Sugar Control in People With Type 2 Diabetes Treated With Xultophy® in Local Clinical Practice in Japan.

The purpose of this study is to collect information on how Xultophy® works with other oral anti diabetic medication in patients with type 2 diabetes.

Participants will get Xultophy® as prescribed by the study doctor. The study will last for about 26 weeks. Participants will be asked questions about health and diabetes treatment and lab tests as part of normal doctor's appointment.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* The decision to initiate treatment with commercially available Xultophy® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
* Male or female, age above or equal to 20 years at the time of signing informed consent
* Diagnosed with T2DM (Type 2 diabetes mellitus ) above or equal to 180 days prior to initiation of Xultophy® treatment.
* Treated with any oral anti-hyperglycaemic medication(s), except for oral GLP-1 RAs, for at least 60 days prior to initiation of Xultophy® treatment.
* Available and documented HbA1c value less or equal to 12 weeks prior to initiation of Xultophy® treatment.

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before prior to initiation of Xultophy® (Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days before screening.).
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 60 days prior to initiation of Xultophy® treatment. However, short term insulin treatment for a maximum of 14 days prior to initiation of Xultophy® treatment is allowed, as is prior insulin treatment for gestational diabetes.
* Previous treatment with Xultophy®.
* Female who is known pregnant, breast-feeding or intends to become pregnant.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
* Known or suspected hypersensitivity to the active substance or to any of the excipients as specified in the approved Xultophy® label in Japan.
Study of (Telintra®) in Non-Del(5q) Myelodysplastic Syndrome

This is a multicenter, single arm open label Phase 2b Study of oral ezatiostat (Telintra®) in Patients who are RBC tranfusion dependent, Low to INT-1 IPSS risk, non-del (5q) Myelodysplastic Syndrome (MDS).


Eligibility Criteria:
Inclusion Criteria:

* Primary or de Novo MDS
* Low to Intermediate-1 IPSS risk of MDS
* ECOG performance score of 0 or 1
* Documentation of significant anemia with or without additional cytopenia
* Adequate kidney and liver function
* Patients must have discontinued hematopoietic growth factors at least 3 weeks prior to study entry

Exclusion Criteria:

* Deletion of the 5q chromosome \[del(5q) MDS\]
* Prior allogenic bone marrow transplant for MDS
* Known sensitivity to ezatiostat (injection or oral tablets)
* Prior treatment with hypomethylating agent (HMA) (e.g., azacitadine, decitabine)
* History of MDS IPSS risk score of greater than 1.0
* Pregnant or lactating women
* Any severe concurrent disease, infection or comorbidity that, in the judgement of the investigator, would make the patient inappropriate for study entry
* Oral steroids greater than 10 mg per day. Exceptions: those prescribed for other conditions (such as new adrenal failure, asthma, arthritis) or brief sterioid use (such as tapered dosing for an acute non-MDS condition)
* History of hepatitis B or C, or HIV
Cohort Trial on Perioperative Localization Techniques of Parathyroid Adenomas

A prospective database of consecutive patients with hyperparathyroidism subject to surgery is created. Preoperative workup and operative findings are recorded in this registry to allow comprehensive analysis.

This is a non-interventional, prospective, monocentric, non-randomized trial. All patients with biochemically confirmed Primary Hyperparathyroidism (PHPT) who are scheduled for elective parathyroidectomy in the Endocrine and Digestive Surgery Unit of the University Hospital of Strasbourg are considered. Data concerning the age, the operative date, the results of the pre-operative biological work-up (plasma calcium, phosphor, parathyroid hormone (PTH) level, vitamin D), the results of pre-operative imaging (CT (computerized tomography) scan, 99mTc SestaMIBI Scan, 3D-Vitual Neck Exploration (VNE)), the operative data (the surgical approach, the localization and the dimensions of the adenoma (s), the necessity to convert to classical approach and its reason, the values of the intra operative PTH), the pathology results, the biological work-up at follow-up (plasma calcium, phosphor, PTH, vitamin D) are prospectively recorded in the database.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with biochemically confirmed PHPT who are scheduled for elective parathyroidectomy
2. Patient able to receive and understand trial information
3. Patient affiliated with the French social security system

Exclusion Criteria:

1. Patient expressing opposition to the use, after anonymization, of medical data for scientific research
2. Pregnant or breast-feeding woman
3. Patient under guardianship or curatorship
4. Patient under the protection of justice
Effects of Pulmonary Rehabilitation on Skeletal Muscle in COPD Patients

In a former study, the investigator observed significant differences in the response to pulmonary rehabilitation between COPD patients with the "normal" genetic variant of alpha-1 antitrypsin (PiMM) and those with a homozygous deficient variant (PiZZ) (Jarosch et al., 2016, DOI: 10.1159/000449509). PiZZ COPD patients showed less improvement in exercise capacity compared to PiMM patients. This latter finding was mirrored by an increase of oxidative myofiber type I proportion - that is important for aerobic exercises in daily life - in PiMM but not PiZZ patients.

Based on this finding of impaired skeletal muscle adaptation, the aim of this study is to compare the effects of pulmonary rehabilitation including exercise training on a) specific enzymes of energy metabolism reflecting the oxidative capacity of the skeletal muscle and b) the analogue gene expression of these oxidative enzymes in a cohort of PiMM and PiZZ COPD patients.


Eligibility Criteria:
Inclusion Criteria:

* Chronic obstructive pulmonary disease
* phenotype PiMM or PiZZ
* written informed consent

Exclusion Criteria:

* any comorbidities that prevent patients from participating in an exercise Training program
* necessity of anticoagulant therapy
* other genetic variants of alpha-1 antitrypsin than PiMM or PiZZ
Time Up and go in Hemiplegic Patients

Investing the Timed Up and Go (TUG) Test in Hemiplegic Patients Using 3D Motion Analysis

The timed up and go is a routine quick test assessing motor functional tasks including stand up ,walk 3 m,turn around and sitting down.We will included hemiplegic patients to quantify biomechanic parameters

Eligibility Criteria:
Inclusion Criteria:

* Patients performing 3D gait analysis
* Male or female adults aged ≥ 18 years,
* Hemiplegia following unique stroke- Patients with hemiplegia able to stand up alone,walk and turn around alone without assistance.

Exclusion Criteria:

* Patient with a protective measure,
* Pregnant women, breastfeeding
* Brain damage bilateral cerebellar syndrome, apraxia and / or severe aphasia,
* Patient who received botulinum toxin injection in the 3 months prior to inclusion, patients who underwent surgery of the locomotor system in the 6 months prior to inclusion,
* No affiliation to a social security
* other pathology, complications with significant impact on the activities of walking.
Changes in Tissue and Cerebral Oxygenation Following Spinal Anesthesia in Neonates, Infants, and Children

Investigators have started an awake spinal anesthesia program in conjunction with pediatric surgical colleagues. Patients are offered the option of awake spinal anesthesia instead of general anesthesia for appropriate surgical procedures. Previous studies have demonstrated a lack of significant hemodynamic changes in neonates and infants following spinal anesthesia; however, there are limited data regarding its impact on tissue oxygenation. The goal of the current study is to assess changes in tissue and cerebral oxygenation using non-invasive near infrared spectroscopy following spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* All patients that are candidates for and have agreed to spinal anesthesia.

Exclusion Criteria:

* none
Cohort Study of the Clinical Course of Macular Diseases in Kagawa

Macular diseases often cases severe visual impairment. Recent clinical introduction of anti-vascular endothelial growth factor agents may change the clinical course of various macular diseases, including age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), central serous chorioretinopathy (CSC), myopic choroidal neovascularization (CNV), retinal vein occlusion (RVO), diabetic macular edema (DME), and so forth. The advance in vitrectomy improve visual outcomes in some maculae diseases, including epiretinal membrane (ERM), macular hole (MH), vitreomacular traction syndrome (VMTS).

Patients with such macular diseases are registered and are followed up for 5 years with appropriate treatment for each patient. By the analysis of the correlation between initial examinations and final visual acuity, factors associated with good visual prognosis will be elucidated.


Eligibility Criteria:
Inclusion Criteria:

* Patients who visit Department of Ophthalmology, Kagawa University Hospital with macular diseases, such as AMD, PCV, RAP, RVO, DME, ERM, MH, VMTS.
* Patients who are agreed with the participation of this study.

Exclusion Criteria:

* None
Effects of Deep Neuromuscular Blockade on Intraoperative Respiratory Mechanics

The primary objective of the current study is to compare intraoperative respiratory mechanics in patients receiving laparoscopic renal surgery under deep neuromuscular blockade (dNMB) and under moderate neuromuscular blockade (mNMB). In addition, we will compare intraoperative hemodynamics and postoperative pulmonary function between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* ASA I or II patients scheduled to undergo laparoscopic renal surgery

Exclusion Criteria:

* BMI ≥35 kg/m2
* Known neuromuscular disease
* History of chronic obstructive pulmonary disease
* Asthma
* Pneumothorax
* Bronchopleural fistula
* Previous lung surgery
* Previous retroperitoneal surgery
* Hemodynamic instability
* History of cardiopulmonary disease
* Renal insufficiency
Discontinuation of Postmenopausal Hormone Therapy: Impact on the Cardiovascular System and Quality of Life

Although the impact of postmenopausal hormone therapy (HT) on cardiovascular disease risk has been studied in several large randomized trials, little is known about the acute cardiovascular consequences of HT discontinuation. In this randomized, double-blind, placebo-controlled trial, the investigators will compare the cardiovascular consequences of abrupt and tapered modes of HT discontinuation in 150 Finnish healthy postmenopausal women under age 60 years. The primary outcome is brachial artery flow-mediated dilatation. In addition, biochemical markers will be measured during the study period of 20 weeks. Health-related quality of life, frequency of hot flush recurrence and other menopausal symptoms will be also assessed in these groups. The trial will provide new high-quality information about the cardiovascular safety as well as the correct timing and method of HT discontinuation.


Eligibility Criteria:
Inclusion Criteria:

* healthy postmenopausal women
* age ≤ 60 years
* has used postmenopausal hormone therapy for at least 3 years

Exclusion Criteria:

* any clinically significant disease
* use of regular medication
* history of cardiovascular events
* history of smoking
* body mass index over 30 kg/m2
* thickness of endometrium over 6 millimeters
Family Connections

This study seeks to evaluate a Structured Family Deliberation that will serve as the primary intervention in a multicenter controlled trial involving families considering tracheostomy and home ventilation for the child. In this study, the investigators will evaluate the feasibility, usefulness, face validity, and preliminary impact of this approach on preparedness for decision making among participants.

The investigators will recruit 10 intervention families and 5 control families who are currently admitted to the neonatal or pediatric intensive unit and whose physician anticipates a decision about home ventilation within the next 30 days. Intervention families will receive the Structured Family Deliberation, which includes a guided review of a web-based decisional aid. Control families will receive a link to the website for independent review. All families will be assessed at 1 month with a survey assessing preparedness for decision-making, parental stress and coping, and a qualitative interview.

Eligibility Criteria:
Inclusion Criteria:

* Parents/legal guardians of children admitted to the neonatal or pediatric intensive care unit and whose physician anticipates a decision about home ventilation within the next month.

Exclusion Criteria:

* Parents will be excluded if:
* their child is in foster care or state guardianship
* they are unable to understand the purpose of the study
* they cannot reasonably participate in study demands
* are not fluent in English (the web-based decisional aid is not yet available in other languages).
Helmet Ventilation in Acute Hypercapnic Respiratory Failure

Lack of tolerance to the treatment, makes the interface choice for non-invasive ventilation (NIV) one of the key factor. To date the helmet is rarely used in Acute Hypercapnic Respiratory Failure (AHRF), because of its large dead space, despite in hypoxic respiratory failure, it is largely employed as a "rotating" strategy when the facial mask is poorly tolerated.

In a multicenter randomized controlled trial, the investigators will compare the clinical efficacy of a new helmet designed to specifically improve the performance in chronic obstructive pulmonary disease (COPD) versus a full face mask during an episode of AHRF.


Eligibility Criteria:
Inclusion Criteria:

* pH \< 7,35 and PaCO2 \> 45 mmHg
* respiratory rate \> 20 b/min

Exclusion Criteria:

* hypoxic respiratory failure
* coma
* inability to stand NIV
* lack of informed consent
Project VOICES: Vocal Optimization in Children Elevating the Spectrum

Thirty percent of children with autism barely talk or do not talk at all despite years of intervention. This study aims to address this important and long-standing challenge by developing a novel intervention to increase the quantity and quality of vocalizations (i.e., sounds children make before words) and expressive language in young children with autism (aged 2 to 5 years) with minimal verbal skills. The intervention includes contingent responses to the child's vocalizations and vocal elicitation strategies. We also collect social validity information from parents about how they perceive the novel intervention.


Eligibility Criteria:
Child participants

* Inclusion criteria

  * Diagnosed with autism spectrum disorder
  * Aged 2 to 5 years old
  * Use no more than 20 words (spoken, signed, or via augmentative and alternative communication) per parent report
  * Use of \< 5 different words during a 15-min communication sample
  * Use of at least one consonant (observed or reported)
  * Primary language of English
* Exclusion criteria

  * Uncorrected visual or hearing impairment
  * Evidence of severe motor impairment

Caregiver participants

• Inclusion criteria

* Have a child enrolled in the study (One caregiver per child participant is enrolled.)
* Sufficient English skills to complete surveys
Scan-Rescan Sub-Study of MS PATHS

The primary objective of this sub-study is to calculate the reproducibility and other technical performance measures of various magnetic resonance imaging (MRI) image analysis algorithms in order to assess their suitability for detecting changes due to multiple sclerosis (MS) in a real-world setting in participants with MS. The secondary objective of this sub-study is to use the primary endpoint results to calibrate measurements across scanners within each MS PATHS center.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants (or participant's legal representative) has the ability to understand the purpose and risks of the sub-study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and l local participant privacy regulations.
* Diagnosis of relapse-onset MS (relapsing-remitting or secondary progressive).
* First MS symptom within the past 1 to 30 years.

Key Exclusion Criteria:

* Initiation of any MS disease-modifying treatment within 4 weeks prior to Visit 1.
* Steroid treatment or suspected MS relapse within 6 weeks prior to Visit 1.

Note: Other protocol specified inclusion and exclusion criteria may apply.
Multi-Center, Pediatric, Open-Label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec ® 5.0 mg Chewable Tablet Medications (Study P04573) (Completed)

The primary objective of this study was to determine whether children ages 6-11 years prefer desloratadine RediTabs (2.5 mg) or a marketed competitor (Zyrtec® 5 mg Chewable Tablets). The secondary objectives of this study were to compare acceptance of the two attributes, taste and feeling in the mouth, of desloratadine 2.5 mg RediTabs and Zyrtec® 5 mg Chewable Tablets


Eligibility Criteria:
Inclusion Criteria:

* Subject and the parent/guardian of the subject, was to have demonstrated their willingness to participate in the study and comply with its procedures by signing a written Informed Consent
* 6-11 years old, either sex, either race
* If female, subject to be premenarcheal
* Willing to avoid eating, drinking, gum chewing, and teeth brushing for one hour prior to enrollment.
* Free of any clinically significant disease that would interfere with study evaluations, including allergic rhinitis and respiratory infections.
* Able to adhere to the dosing and visit schedules

Exclusion Criteria:

* If female, subject who was pregnant, intended to become pregnant during the study or nursing.
* Subject had used any investigational product within 30 days prior to enrollment.
* Subject had any of the following clinical conditions: history of any significant medical conditions (based on reporting by parent or guardian): e.g., diabetes, heart disease, liver disease, kidney disease, breathing problems, cough with excessive phlegm, or persistent or chronic cough.
* Subject had a current medical condition that, in the opinion of the Investigator or designee, may interfere with the ability to discriminate taste (e.g., common cold, sinus infection, bronchial infection, allergic rhinitis, etc.).
* Subject was participating in any other clinical study(ies).
* Subject was part of the staff or a family member of the staff personnel directly involved with this study.
* Subject was allergic to or has sensitivity to the study drug or its excipients.
* Subject had a history of allergic reaction to prescription and/or over the counter (OTC) medications and/or food products.
* Subject had used any antihistamines within 24 hours prior to tasting as outlined in Section 9.4.7.
* Subject used sedatives, tranquilizers, or monoamine oxidase inhibitor drugs.
Respiratory Measurement Using Infrared Camera and Electrical Impedance Tomography for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia

Tidal volume may be the most important technical indicator for ventilation. Measuring tidal volume can be used as an indicator of how effective a patient's gas exchange is, and can also be used as a predictive indicator to indirectly predict the severity of respiratory disease. This tidal volume can be measured using spirometry and pneumotachograph, and the lung function of the patient can be assessed directly or indirectly through the respiratory volume and air flow velocity. In addition, the measurement itself can change the patient's breathing pattern, and for accurate measurement, it has to be carried out in a certain space, so there is a limitation in that it is difficult to measure in a hospital bed or in a laboratory. To overcome this limitation, various methods have been introduced. The basic principle is that the tidal volume is directly proportional to the movement of the chest and proportional to the change in the length of the circumference of the chest. Over the past decade, several studies have been conducted to measure respiratory mechanics in a non-invasive way. Methods using thoracic impedance, acoustic monitoring, strain gauges, and magnetometers have been developed. Non-invasive, non-contact imaging methods have also been developed, such as thermal image, structured light plethysmography (SLP), and optoelectronic plethysmography (OEP). Therefore, in this study, the thoracic movement due to respiration was measured with a non-invasive method (IR camera), and the accuracy was compared through the impedance change obtained through impedance tomography to evaluate the effectiveness of the non-invasive equipment.


Eligibility Criteria:
Inclusion Criteria:

* A male aged 19 years or older
* normal BMI
* patients undergoing transurethral prostate or cystectomy under spinal anesthesia

Exclusion Criteria:

* Presenting alteration in respiratory function detected by functional analysis of lung volume and capacity- pneumonectomy patient, severe ipsilateral destroyed lung patient
* Inability to understand or perform the procedure.
* ASA class 4, 5
Predicting If the Blood Pressure Will Drop After Spinal Anesthesia Using Ultrasound of the Neck

After a spinal injection, blood pressure might drop for a short time, similar to what happens with general anesthesia. This drop can be different for each person. An anesthesiologist will use medicine to bring the blood pressure back to normal. If this drop could be predicted in advance, it would help the anesthesiologist treat it faster, making the procedure even safer and preventing side effects like dizziness or nausea.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of either sex who are scheduled for elective surgery under spinal anesthesia,
* Who fasted for 6 hours or more

Exclusion Criteria:

* Age \<18 years old
* No informed consent for study participation
* Contra-indication for spinal anesthesia
* Emergency surgery
* Known poor left or right ventricular function / heart failure
* Moderate to severe valvular disease
* Atrial fibrillation
* Pacemaker rhythm
* Carotid artery stenosis \> 50%
* History of cerebrovascular accident (CVA) or transient ischemic attack (TIA)
* History of cerebral trauma
* Pregnancy
* Neck complaints
* Morbid obesity (BMI \> 40 kg/m2)