cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Tubular Coaxial Nickel-titanium and Copper Nickel-titanium Orthodontic Aligning Archwires

This study will be done to compare the effectiveness of using coaxial tubular superelastic nickel-titanium and copper-nickel-titanium archwires during the initial phase of orthodontic treatment regarding alignment efficiency, pain perception, and root resorption.

This will be a prospective blinded non-stratified randomized clinical trial , parallel group trial with equal randomization (1:1 allocation ratio), different private clinics and general hospitals will allocate patients for this trial. The patients will be initially assessed for eligibility to be included in the study by the investigator. Those who will meet the inclusion criteria will be informed about the nature of the study verbally to take the initial approval for participation. The patients were asked to read the patient information sheet carefully at home and inform the investigator about their decision of participation at the subsequent appointment and to sign consent form sheet in case of agreement.

The patients will be treated using MBT prescription brackets with 0.022-inch slot (Pinnacle®, Ortho Technology, USA). Initially, teeth polishing will be performed with pumice and rubber cup, followed by water rinsing and air drying

All the participants will receive the same treatment. At the day of bonding, the first archwire will be placed for each group. Eight weeks later it will be replaced by the next size archwire for another eight weeks. Archwires will be tied to the bracket using elastomeric ligatures. Any debonding during treatment should be considered an emergency and re-bonded within 24 hours, otherwise the case will be dropout. A good alginate impression for the lower arch should be taken pre-treatment and after 4, 8, 12 and 16 weeks and a stone study model is obtained. Periapical X-ray for the mandibular central incisors will be taken pre-treatment and after 16 weeks. The participants will be given visual analog scale to record their pain p during the first week after each archwire placement.

Eligibility Criteria:
Inclusion Criteria:

1. Patients indicated for fixed appliance orthodontic treatment with 5-9 mm crowding of mandibular anterior teeth according to Little's irregularity index (LII).
2. Presence of all the mandibular permanent teeth, except the third molars.
3. Overbite and overjet that do not interfere with bracket placement on mandibular anterior teeth.
4. No history of trauma or root resorption in the mandibular incisors.

Exclusion Criteria:

1. Previous orthodontic treatment.
2. Less than 5 mm of mandibular incisors crowding (LII).
3. Severe crowding which requires treatment by extraction of premolars in the mandibular arch.
4. Blocked-out teeth that cannot be engaged with the aligning archwire.
5. Prior experience of periodontal disease and loss of attachment.
Cohort of STEMI Patients 2

ST-segment elevation myocardial infarction (STEMI) is an acute condition that accounts for 75% of sudden deaths in adults over 35 years of age and more than half of all cases of chronic heart failure. However, the mechanism of myocardial infarction remains poorly understood. At present, there is no national information system for myocardial infarction, as there is for other diseases such as multiple sclerosis (OFSEP cohort).

The purpose of this cohort is to enable studies and research projects to be carried out on the descriptive epidemiology of myocardial infarction, monitoring of patients undergoing treatment (safety, efficacy), quality of life and functional consequences of infarction, and research into new biological and imaging prognostic biomarkers. Its general objective is to provide researchers, hospital practitioners, medical interns, academics or industrialists with a quality epidemiological tool for research.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of STEMI defined by ST segment elevation ≥ 0.2 mV in 2 contiguous leads on a 12-lead ECG.
* Management in primary ACT
* Prior oral informed consent followed by signed informed consent as soon as possible.

Exclusion Criteria:

* Diagnosis of STEMI not confirmed on angiography
* Inability to give the subject informed information
* Lack of coverage by a social security scheme
* Obvious contraindication to injected magnetic resonance imaging (claustrophobia, pacemaker, defibrillator, or a metallic body (ferromagnetic), severe renal insufficiency (GFR\<30 ml/min), known allergy to the contrast medium ....)
* Pregnant woman or woman of childbearing age without effective contraception, breastfeeding woman.
* Deprivation of civil rights (curators, guardianship, safeguard of justice)
Perineal Massage and Warm Application in Labor

The aim of this study is to determine the effect of perineal massage and warm compress application at first and second stage of labor on perineal trauma, pain and delivery comfort.

Perineal trauma is the damage caused by rupture, laceration or episiotomy during birth. Birth-related perineal trauma can lead to many short and long-term physical and psychological morbidities that affect the woman's life. Problems such as pain, bleeding and delay in the attachment of mother and newborn appear in the early postpartum period. In the following period problems such as prolapse, incontinence, sexual dysfunction and anxiety may be experienced.

This randomised controlled study was executed at a research hospital between May 2018 - September 2019. The sample of study is made consisted of three intervention groups and a control group of total 120 pregnant women by randomisation method. Perineal massage, perineal warm compress application, perineal massage and warm compress was done to the intervention groups respectively. Nothing was done to the control group. Perineal massage was given for 10 minutes, warm compress application was done 30 minutes three times when cervical dilatation 3-4 cm, 5-7 cm and 8-10 cm respectively. The data was collected by using Socio-Demographic and Obstetric Data Collection Form, First and Second Stage of Labor Stage Data Collection Form, Childbirth Comfort Scale, Newborn Data Collection Form, Perineal Trauma and Bleeding Monitorisation/ Measurement Form, Visual Analogue Scale, Birth Satisfaction Scale and Perineal Massage and Perineal Warm Compress Application Satisfaction Evaluation Form. When evaluating the data; number, percentage, mean, standard deviation, median, ANOVA Test, Tukey Test, Kruskal Wallis Test, Paired Sample T Test, Friedman Test, Ki-Square Test and Fisher's Exact was used.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous
* 38"week of pregnancy
* Singleton pregnancy
* Cervical dilatation 3"cm
* Cephalic presentation

Exclusion Criteria:

* Chronic disease
* Presence of fetal macrosomia
* Presence of uterin surgery
* Presence of fetal anomaly
DYsphagiA in interMedIate Care UnitS

Retrospective study in intermediate care unit patients on the incidence, Risk factors, and effects on mortality of dysphagia. During a 6-month observational period, routine data will be collected and analysed.


Eligibility Criteria:
Inclusion Criteria:

* Intermediate care unit patients admitted within the observational period

Exclusion Criteria:

* documented refusal to General Consent
A Study to Assess Thymic Function Using PET/CT and MRI

The purpose of this study is to see if a positron emission tomography/computed tomography (PET/CT) scan and a magnetic resonance imaging (MRI) of the chest can assess changes in the thymus size and function. The researchers would like to monitor the thymus with a PET/CT scan and a MRI before and after the participants transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Patient's age is ≥18 or ≤65 years old.
* Patients must have a plan to receive a CD34-selected peripheral blood stem cell graft.

Exclusion Criteria:

* Patient is not able to undergo MR imaging due to any contraindication to MRI based on departmental MR questionnaire (e.g. past gadolinium allergies, failure of metallic screening, claustrophobia, inability to lay flat for duration of the study, inability to hold breath, etc.)
* Pregnant or breastfeeding.
MGuard Stent and Microcirculation

NSTE-ACS represents the most frequent indication for coronary angiography and percutaneous coronary intervention (PCI) worldwide. PCI permit to reestablished coronary flow but effectiveness of PCI within thrombus containing lesions is limited by the risk of occurrence of distal embolization and no-reflow phenomenon. Distal embolization lead to coronary microcirculation lesions. This complication is related to poor prognosis.

MGuard stent is a stainless-steel closed cell stent covered with an ultra-thin polymer mesh sleeve, which allows to prevent distal embolization during percutaneous coronary intervention in ST-segment-elevation myocardial infarction.

Index of microcirculatory resistance (IMR) is a validated method to assess coronary microcirculation.

Accordingly, the purpose of this study is to demonstrate that MGuard micronet mesh-covered stent prevent distal embolization and microvascular reperfusion impairment during primary PCI, compared with a bare metal stent (BMS) and drug eluting stent (DES) in patients with NSTE-ACS, assessed by Index of microcirculatory resistance.

GUARDIANCORY study is a multicentre, prospective, randomized, non inferiority, open-label trial with a planned inclusion of 52 patients with STE and NSTE ACS and prescribed PCI. Patients will be randomized to benefiting either DES /BMS implantation (n=26) or MGuard stent (n=26) on the culprit lesion. Assessment of coronary microcirculation will be done by IMR immediately after PCI by using a pressure-temperature sensor-tipped coronary wire, thermodilution-derived.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients affiliated to social security
* Patients with an NSTEMI or STEMI (1)
* Thrombus containing coronary lesions on angiography (TIMI thrombus grade ≥ 3)
* Eligible patients for revascularization with angioplasty
* Patients consenting to participate in the study.

Exclusion Criteria:

* Age \< 18 years
* Prior myocardial infarction
* Prior CABG
* Inability to comply with the protocol
* Major patient protected by law (article L1121-8),
* Person deprived of liberty (article L1121-8),
* Pregnant woman
* Breastfeeding women
* Patient with terminal illness,
* Terminal Renal failure
* Allergy to iodine
* Adenosine's contraindications: Asthmatic patients, Second- or third-degree AV block without a pacemaker or sick sinus syndrome. Systolic blood pressure less than 90mmHg. Recent use of dipyridamole or dipyridamole-containing medications, Methyl xanthenes such as aminophylline caffeine or theobromine block the effect of adenosine and should be held for at least 12 hours prior to the test. Known hypersensitivity to adenosine. Unstable acute myocardial infarction or acute coronary syndrome.
Vaginal Isonicotinic Acid Hydrazide Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System

To investigate whether vaginal isonicotinic acid hydrazide (INH) administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions, insertion-related complications, and pain in Women With no Previous Vaginal Delivery.

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant women
* Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to insertion
* Women who delivered only by cesarean section

Exclusion Criteria:

* Women with any uterine abnormalities such as congenital anomalies, endometrial lesions, adenomyosis, or fibroids.
* Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
* Allergy to isonicotinic acid hydrazide
* known psychiatric disorders ( anxiety and depression) and chronic use of medications that could interfere with pain perception (antidepressants and anticonvulsants)
* Women refuse to participate in the study
Development of a mHealth Intervention for Ambivalent Smokers

The current pilot study will assess the feasibility and acceptability of a novel mHealth app designed for people who are ambivalent about quitting smoking. Results will be used to refine the intervention and plan for a future randomized effectiveness trial.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older;
* Can speak/read English;
* Current smoker;
* Own and regularly use an eligible smartphone;
* No vision impairments;
* Willing to install and use the study program;
* Willing to use birth control if elect to use nicotine replacement during the study (females);
* Meet definition for ambivalence
* Not actively using treatment

Exclusion Criteria:

* Smoke less than 10 cigarettes per day
* Self-report a lifetime history of dementia, manic depression, bipolar disorder, or schizophrenia;
* Have medical contraindications for nicotine replacement therapy;
* Another household member is enrolled in the study
* Unable to verify contact information
* Fail to install app
Human Urine Sample Collection for Alport Nephropathy Biomarker Studies

This is a prospective cross-sectional, observational, single-center study of Alport patients, in which a single, first morning voided urine collection will be acquired and used to validate assays of urine biomarkers that reflect changes in glomerular protein filtration barrier function.

The purpose of this study is to identify biomarkers indicative of changes in glomerular filtration function that occur during the course of proteinuric renal diseases such as Alport nephropathy.


Eligibility Criteria:
Inclusion criteria:

* Alport syndrome diagnosis (clinical and/or histopathologic and/or genetic diagnosis, per subject's physician and/or genotyping)
* Physically able to provide a single first-morning urine sample of at least 30 mL

Exclusion criteria:

* Diagnosis of chronic kidney disease
* Receiving chronic phosphate-lowering therapy or erythropoietin therapy
* Ongoing chronic hemodialysis therapy and/or renal transplant recipient
* Nephrotic-range proteinuria: spot urine protein-to-creatinine ratio ≥ 3 on at least 2 of the last 3 clinical assessments Other protocol-defined inclusion/exclusion criteria may apply
A Study of the Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Dose Basimglurant in Healthy Subjects and in Patients With Major Depressive Disorder (MDD)

The study will assess the safety, tolerability, and pharmacokinetics of basimglurant compared to placebo after multiple ascending oral doses for up to 22 days in healthy subjects and in patients with MDD on stable selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) background therapy.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age, inclusive
* Body weight at least 50 kg
* Healthy male or female subjects (Healthy Cohorts)
* Body mass index (BMI) 18 to 30 kg/m\^2, inclusive (Healthy Cohorts)
* Nonsmoker for at least 90 days prior to dosing (Healthy Cohorts)
* Primary diagnosis of MDD without psychotic features (MDD Cohort)
* BMI 18 to 35 kg/m\^2, inclusive (MDD Cohort)
* Current partial response to ongoing SSRI or SNRI antidepressant treatment at an adequate dose and for at least 4 weeks (MDD Cohort)
* Clinical Global Impression of Severity (CGI-S) score 3 or greater (MDD Cohort)
* Other regimens stable for at least 8 weeks prior to screening (MDD Cohort)

Exclusion Criteria:

* Pregnant or lactating women
* History of alcohol or substance abuse in the past 6 months
* Hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
* Clinically relevant electrocardiogram (ECG) abnormalities or a personal or family history of congenital long QT syndrome
* Participation in an investigational study within 90 days of screening
* Blood donation over 500 mL within 3 months of screening
* Hypersensitivity to any study medication or excipients
* Psychotic symptoms or comorbid mood disorder
* Significant suicide risk
* Major illness within 1 month before screening, or febrile illness within 1 week (Healthy Cohorts)
* Average alcohol consumption of more than 2 units per day (Healthy Cohorts)
* Multi-drug therapy for depression including antidepressants or adjunctive medications (MDD Cohort)
* Prior use of basimglurant (MDD Cohort)
* Cigarette use of greater than 1 pack per day (MDD Cohort)
Effect of Acute Normovolemic Haemodilution on Allogenic Transfusion Needs In Laparotomy

This study is aimed to determine if acute normovolemic hemodilution (ANH), an established blood conservation technique, reduces the requirement for allogeneic blood transfusion in operations with prediction of surgical bleeding over 20% of estimated blood volume (EBV)

Allogeneic blood transfusion is often done during surgery to save life- threatening conditions. Blood conservation is a method that can reduce peri-operative allogeneic blood transfusion. This study has been conducted on 34 patients underwent laparotomy surgery with bleeding more than 20% of EBV. After being informed concent, research subjects were randomized into two groups: ANH (conducted ANH) and control group (without ANH). After starting general anesthesia, the ANH group was withdrawing blood based on Gross formula. Restoration of circulated volume was instituted by infusion of colloids. In control group, the operation was started right after the induction of anesthesia. The monitoring of blood pressure, heart rate, the amount of bleeding, total fluid, urine production, hemoglobin concentration and number of allogenic transfusion were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for laparotomy under general anesthesia with potentially surgical bleeding \> 20% of EBV
* ASA physical status I - II
* hemoglobin level before surgery \> 11 g / dl for men and \> 10 g / dl for women

Exclusion Criteria:

* impaired coagulation (INR\> 1.5 and / or platelet count \<100,000)
* active infection
* disruption of metabolic liver
* received anti fibrinolytic drugs
Perioperative Outcomes of Simultaneous Colorectal and Liver Resections

The use of a simultaneous resection in patients with synchronous colorectal liver metastases has increased over the past decades. However, it remains unclear when a simultaneous resection is beneficial and when it should be avoided. The objective of this retrospective study is therefore to compare the outcomes of a simultaneous resection for synchronous colorectal liver metastases in different settings, and to assess which factors are independently associated with unfavorable outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Elective minimally invasive or open simultaneous resection of colorectal cancer and synchronous colorectal liver metastases

Exclusion Criteria:

* (Partially) robotic-assisted or thoracoscopic procedures
* First stage of associating liver partition and portal vein ligation for staged hepatectomy (ALPPS)
* Patients that underwent major concurrent procedures
Intervention for Caregivers of Patients Who Have Recently Undergone HSCT

The purpose of this study is to find out if providing support to caregivers of patients who have recently had a HSCT is possible and helpful.

This study will test the feasibility, acceptability, usability, satisfaction and preliminary efficacy of a behavioral (psychoeducation) intervention. All participants will receive the standard post-hospital HSCT information for patient follow-up care as provided by the patient's oncologist. In addition, the all participants will receive 4 individual sessions with an interventionist.

Eligibility Criteria:
Inclusion Criteria:

* An adult family or friend of a patient who has been discharged from the hospital in the past 1-2 weeks after receiving HSCT
* Identifies himself/herself as the caregiver who will be responsible for the patient's care post-HSCT
* Has English as their primary language

Exclusion Criteria:

-Not meeting inclusion criteria
Effects of HIIT Integrated in PE Classes, on Physical Condition, Physical Activity and Motivation for Exercise

Levels of activity and physical condition among adolescents are low, increasing the risk of chronic diseases. The most recent literature suggests that physical activity and physical condition are correlated with improved biopsychosocial variables of the young. The School and, concretely, the Physical Education classes are privileged spaces, promoters of positive changes for the rest of the life. HIIT is an efficient alternative to the invested time compared to aerobic training, being a powerful stimulus in improving cardiorespiratory performance, muscles oxidative capacity and sensitivity to insulin. This study intends to verify the effectiveness and feasibility in the implementation of HIIT in High-School Physical Education classes. The activity levels and physical condition of the adolescents will be evaluated and identified, before and after 16 weeks of implementation of the training program, as well as their effects on the motivation for the practice.


Eligibility Criteria:
Inclusion Criteria:

* Students enrolled in years 10-12

Exclusion Criteria:

* Students will be ineligible if they do not provide parental consent to participate