cyrilzakka/clinical-trials huggingface dataset:
Microanalysis of Changes in 3D Geometry of Orthodontic Mini-implants

The orthodontic mini-implants used in the study are temporary screws inserted into the bone to provide anchorage for challenging tooth movements that could not be carried out using the patient's own teeth. They are made of a medical grade titanium alloy (Ti6Al4Va), with a length of 8 mm and a diameter of 1.3 mm. After the completion of the treatment phase requiring specific anchorage, they are removed and disposed of as a medical waste.

The insertion of the mini-screw is conditioned by the individual treatment plan and the treatment protocol would not differ from the standard treatment.

The aim of the project is to analyze changes in the macrogeometry and wear of the surfaces of retrieved orthodontic micro-implants after their clinical use. Upon completion of clinical tasks, the mini-screws will be removed and retrieved for laboratory phase of the study. The laboratory phase will consist of: microscopic and profilometric examinations, as well as scanning before insertion and after removal of the mini-implants, and a clinical phase: the use of previously scanned and sterilized mini-implants in patients participating in the study.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient in the active phase of orthodontic treatment with a fixed orthodontic appliance.
* The individual treatment plan involving tooth movements that require anchorage reinforcement: asymmetric intrusion, space closure through mesialization or distalization.
* Clinical indications and the possibility of placing a mini-implant in the interradicular space of the maxillary/mandibular alveolar bone (possibility of using the AbsoAnchor SH1312-08 mini-implant).
* Informed consent of the patient.

Exclusion Criteria:

* Individualized treatment plan involving the use of a mini-implant different from the one used in the study.
* Lack of consent for participation in the study.
Dynamics of T Cell Expression of Immune Checkpoint Molecules in Progressive Multifocal Leukoencephalopathy

Progressive multifocal leukoencephalopathy (PML) is a rare viral infection of the central nervous system (CNS) occurring in immunocompromised patients. Recovery of JC virus (JCV) specific T cell immune responses is the only available therapeutic option. JCV may use immune checkpoint inhibitory pathways to evade immune responses. The aim of this project is to determine whether T cell expression of immune checkpoint molecules is correlated to antiviral T cell responses, control of JCV replication and PML outcome. Immune checkpoint blockade by reversing T cell exhaustion may represent a therapeutic perspective for PML.

PML is a devastating orphan disease of the CNS due to the reactivation of JCV in immunocompromised patients. Given the lack of drugs controlling JCV replication, initiation of antiretroviral therapy in HIV-infected patients or cessation of immunosuppressive therapies in others, and subsequent recovery of JCV-specific T cell immune responses remains to date the only available therapeutic option. Promoting antiviral immune responses may improve the control of viral replication and the outcome of this severe disease. Immune checkpoint molecules such as PD-1 are inhibitory receptors expressed on T cells that trigger inhibitory signaling pathways, limiting effector immune responses in cancer and chronic infections. Immune checkpoint inhibitory pathways implicated in evading immune responses may be at play in PML. Immune checkpoint blockade using monoclonal antibodies targeting PD-1, by reversing T cell exhaustion, has been suggested as a therapeutic perspective for PML. More insights in the dynamics of immune checkpoint molecules expressed by T cells in PML patients are needed to pave the way for a therapeutic study.

The aim here is to determine whether T cell expression of a broad range of immune checkpoint molecules, and its dynamics, correlates with the generation of antiviral of immune responses, the control of JCV replication and PML outcome.

To this end the investigators will recruit 15 PML patients from 4 teaching hospitals in the South West of France and assess at PML diagnosis and 1, 3 and 6 months after, the expression of immune checkpoint molecules on circulating T cells, ex vivo specific immune responses against a JCV peptide library, JC viral load in cerebrospinal fluid, blood and urine, and clinical and neuroradiological outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years old
* Informed consent
* Active virological PML : Recent neurological symptoms (\< 3 months) with brain MRI lesions suggestive of PML and positive PCR in cerebrospinal fluid for JCV
* Affiliated or benefiting from public health insurance.

Exclusion Criteria:

* Non active PML
* Possible PML with negative JCV PCR
* Adults under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision
* Pregnant and/or breastfeeding women
Instrument Assisted Soft Tissue Mobilization vs Therapeutic Cupping on Hamstring Tightness Among Football Players

The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through sealed envelope method by Non-probability Convenient random sampling technique. Subjects in Group A will receive Instrument Assisted Soft Tissue Mobilization. Group B will receive Therapeutic Cupping.

The objective of the study is to determine the effects of Instrument Assisted Soft Tissue Mobilization and Therapeutic Cupping on Hamstring tightness among football players. The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through sealed envelope method by Non-probability Convenient random sampling technique. Subjects in Group A will receive Instrument Assisted Soft Tissue Mobilization. Group B will receive Therapeutic Cupping. Players will be assessed by Numeric pain rating scale, Universal Goniometer and Sit \& Reach Test after the completion of treatment at 6 weeks.

The data will be analyzed by SPSS, version 25. Statistical significance is P=0.05.

Eligibility Criteria:
Inclusion Criteria:

* Age (18-25),Male Gender Only,
* Football Players, Bilateral Hamstring Tightness,
* Previous hamstring injury in the last 6 months,
* Positive SLR test,
* Positive Passive/Active Knee Extension test

Exclusion Criteria:

* Malignancy of lower limb,
* History of Lower Limb fracture in the last 6 months,
* Post-surgical condition from past 6 months,
* Neurological Conditions such as SLE, Herpes zoster, parkinsonism, Shingles disease, Musculoskeletal disorders like adductor tendinopathy, low back pain, knee injuries, hip injuries,
* Skin Allergies.
Improving Quality of Life and Daily Life Activities With Bioarginine in Patients With COPD

Different studies have suggested that COPD is associated with elevated alveolar NO and increased expression of NOS2 in alveolar walls, small airway epithelium and vascular smooth muscle. Furthermore, arginase activity in COPD is shown to correlate inversely with total NO metabolite in sputum and with pre- and post- bronchodilator FEV1; at the same time ADMA levels in serum is shown to be correlated with airway resistance and ADMA in COPD airways was documented to be able to shift the L-arginine metabolism towards the arginase pathway. As demonstrated in a guinea pig model, the arginase inhibition can shift the L-ornitine: L-citrulline ratio towards L-citrulline, preventing neutrophilia, mucus hypersecretion and collagen synthesis. Thus, increasing substrate availability for NOS by arginase inhibition or supplementation of L-arginine or L-citrulline or a combination thereof, may represent a window of opportunity in patients with COPD.

The present study was constructed in order to investigate as a primary objective whether in symptomatic patients with COPD, daily bioarginine on top of chronic inhaled therapy can improve patients' respiratory symptoms and dyspnea during daily life activities. The secondary objective of the study is to determine whether there is any correlation between improvement in respiratory symptoms and distance walked at the 6MWT and lung function parameters. In order to do so, the investigators designed a multi center, interventional, prospective, randomized, controlled vs placebo, proof of concept study: COPD patients will be randomized to receive BioArginine twice daily on top of chronic inhaled therapy or to continue their chronic Inhaled therapy plus placebo for 6 weeks. In order to evaluate the impact on respiratory symptoms and dyspnea the CRQ (Chronic Respiratory disease Questionnaire) and the LCADL (London Chest Activities of daily Living) Scale, as well as the 6MWT, will be used.


Eligibility Criteria:
Inclusion Criteria:

* \> 40 years old
* Smoke history \>10 pack years (PYs)
* Forced expiratory volume (FEV1 70-40% predicted)
* COPD Assessment Test score \>= 10
* Stable Inhaled therapy in the three months prior to study enrollment

Exclusion Criteria:

* Exacerbations in the three months prior to study enrolment
* Dementia and inability to perform study test bundles
* Interstitial lung disease
* History of asthma
* Patients unable to perform a 6MWT or necessitating a walker to ambulate
* Long term oxygen therapy (excluding patients on nocturnal O2 therapy)
* Patients enrolled In pulmonary rehabilitation programs during the study or that have completed a pulmonary rehabilitation program in the 6 months before study enrollment
Sonodynamic Therapy Manipulates Atherosclerosis Regression Trial on Patients With Carotid Atherosclerotic Plaques

Sonodynamic therapy (SDT) is a new treatment for carotid atherosclerotic plaque. The aim of this study is to assess the safety and efficacy of this technique.

Carotid atherosclerotic plaque is an important cause of ischemic stroke, causes about 30% stroke/TIA attacks. Patients with carotid stenosis face an escalated risk of MI, PAD, and death. Treatments for patients with carotid plaque include lifestyle changes, medical management(such as control of hyperlipidemia, hypertension, and diabetes) and carotid revascularization(carotid endarterectomy or carotid artery stenting). Studies have suggested that plaque morphology and composition are important determinants of plaque stability, using serial MR imaging of the carotid artery allowed observation of changes in plaque composition. Contrast enhanced ultrasound (CEUS) is a well accepted technique for detection of intraplaque neovascularization(IPN) in carotid atherosclerotic disease.

The aim of this trial is to assess the safety and efficacy of SDT. The SDT can induce macrophage elimination and inhibiting matrix degradation, which will promote plaque lipid depletion, inflammation level decrease and changes in other plaque tissue components, leading to plaque stabilization and reduction.

An estimated 80 eligible patients will be randomly divided into two groups: optimal medical care (OMC) combined with pseudo-SDT and OMC combined with SDT. Recruitment will be performed over 1 year and patients will be followed for 3 months; the anticipated total study duration will be 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Age 18- 80 years
* Carotid artery with 30%\~70% stenosis by ultrasound and plaque thickness\>2.5mm
* Patients without transient ischemic attack, minor stroke or amaurosis fugax within 6 months
* Patients' LDL-c level below 100 mg/dL(2.6mmol/L), well-controlled blood pressure(systolic BP\<140 and diastolic BP\<90 under resting conditions) and diabetes(HbA1c\<7%)
* Written informed consent

Exclusion Criteria:

* Non-atherosclerotic carotid artery stenosis
* Contraindication to MRI( uses pacemaker, has metallic implants, claustrophobia)
* Acute MI, acute coronary syndrome or stroke within 4 weeks prior to visit or during run-in
* Severe cerebral artery stenosis, atrial fibrillation or MRI detected thrombosis that would cause stroke
* Previous significant adverse reaction to a statin
* Systemic disorders such as hepatic, renal, hematologic, and malignant disease
* Medical history that might limit the individual's ability to take trial treatments for the duration of the study
* Allergic to DVDMS or sonovue
* Diagnosis of porphyria
* Pregnant women and nursing mothers
* History of bilateral carotid endarterectomy or has immediate plans for carotid endarterectomy
* Not willing to be randomized into the 3 months trial
* Patient who is attending other clinical trial
Study Evaluating the Safety of FXR-450 in Healthy Subjects

The primary purpose of the study is to evaluate the safety of FXR-450 in healthy subjects. This study will also evaluate pharmacokinetics (PK) of FXR-450 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive at screening.
* Healthy as determined by the investigator on the basis of screening evaluations.
* Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Exclusion Criteria:

* Any significant medical disease.
* History of cholecystectomy (removal of gallbladder).
* Any clinically important finding in physical examination, vital signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results.
Secondary Prevention of Dug-related Problems Through Digital Health

The purpose of this study is to evaluate the clinical impact of a program for the secondary prevention of drug-realted problems (DRP) focused on the patient empowerment through Digital Health in patients who visit the Emergency Department (ED) of the Hospital de la Santa Creu i Sant Pau (HSCiSP) for a health problem related to medication in terms of readmissions, revisits and quality of life.

After being infomed about the estudy and potential risks, all patients who meet the eligibility requirements and giving written informed consent, will be randomized.

The project is structured in two consecutive phases.

1. st Phase: 3-month randomized pilot study. Patients will be randomized with a 1:1 distribution to be included in the Drug Code Active Patient or DCAP (intervention group) or to receive usual care (control group). The pilot study will confirm whether the proposed methodology is feasible to implement it on a large scale, as well as providing the information necessary to calculate the sample of patients according to the main objective of the study.
2. nd Phase: Randomized clinical trial lasting 18 months (6 of which will be recruitment and 12 months follow-up) following the methodology described for the pilot in a larger sample of patients until the calculated sample size is achieved.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years.
* Visit ED for a DRP caused bu a drug of the ATC groups A, B, C or N.
* Be independent for activities of daily living (equivalent to Barthel 100).
* Have a Chalson Comorbidity Index 2 \<= 3.
* Not present cognitive impairment.
* Be directly responsible for pharmacotherapy.
* Have a mobile device compatible with the MyPlan mobile application and access to Wi-Fi or mobile data, enabling the use of the technology platform from home.

Exclusion Criteria:

* Important language barrier.
* Impossibility of carrying out the necessary questionnaires or interviews defined in the methods of this study.
* Mental pathology that makes the autonomous use of technology impossible or that represents a safety problem for the patient according to clinical criteria.
* Patients not residing in the territory who cannot be followed-up later.
The Use of the Hem-o-lok Clip in Appendectomy: Single or Double?

Stump safety is provided by different methods in laparoscopic appendectomy. Stapler use, binding with endoloop and nonabsorbable clip are the most common methods. Although the stapler is safe, it creates a significant cost increase. In connecting with the endoloop, the learning curve and surgical time are longer. Nonabsorbable clip application which has been used recently; Urethra was also used in appendectomy after its safety has been proven by large studies to close cystic ducts and vascular structures. Its advantages such as low cost, no need for a learning curve and shortening the surgical time have increased the frequency of use.In this prospective observational study; It will be aimed to investigate the effects of stump closure methods applied in laparoscopic appendectomy on short-term clinical results. In addition, the factors that determine the surgeon's stump closure method and cost results will be tried to be determined.

Detailed explanation will be made later if necessary.

Eligibility Criteria:
Inclusion Criteria

* diagnosis of acute appendicitis
* Performing laparoscopic surgery
* Patients with an ASA score of I-II-III

Exclusion Criteria:

* Appendectomies with the patient's refusal to participate in the study
* Open surgery
* Primary pathology without appendicitis
Safety and Performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in Shoulder and Hip Arthroscopic Repair

The scientific justification is to fulfill post-market clinical requirements in order to support re-certification of the CE-Mark for this marketed product and to look into safety and efficacy.

Shoulder: The superior labrum (fibrous cartilage) and biceps anchor improve joint stability by acting like a secondary stabilizer to the shoulder. Labral injuries are usually associated with anterior shoulder dislocation. When conservative treatment fails, such as physical therapy, strengthening programs, anti-inflammatories and activity modification to improve symptoms, surgical intervention may be required. Surgical treatments can include simple debridement, stabilization of the biceps-labrum complex through repair, or biceps tenodesis where the end of a tendon is joined surgically to the bone. Outcomes of SLAP (superior labral tear from anterior to posterior) repairs have been reported good throughout the literature, with reported success rates ranging from 71-97%.

Hip: The labrum of the hip is a fibrocartilaginous tissue that connects to the bone edge of the acetabulum (the socket of the hip bone), and deepens the acetabular socket while extending coverage of the femoral head; it also aids in hip stabilization. The goal of surgical intervention is to restore normal hip mechanics and treat existing damage.

Eligibility Criteria:
Inclusion Criteria:

* Subject has consented to participate in the study by signing the EC-approved informed consent form
* Subject condition meets proposed indication to SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchor
* Subject requiring shoulder or hip arthroscopic labral repair surgery from physical findings, subject symptoms and radiographic finding
* Hip subjects only:

  * FAI (Femoroacetabular Impingement)
* Shoulder subjects only:

  * Subject with a history of recurrent dislocation/subluxation of the shoulder

Exclusion Criteria:

* Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1 (pre-operative)
* Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures
* Contraindications or hypersensitivity to the use of the SUTUREFIX ULTRA and/or SUTUREFIX CURVED Suture Anchor, or their components (e.g. silicone, polyester). Where material sensitivity is suspected, appropriate tests should be performed and sensitivity ruled out prior to implantation
* Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation
* Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture
* Comminuted bone surface, which would compromise secure anchor fixation
* Hip subjects only:

  * Dysplasia latera/central less than 20°
* Shoulder subjects only:

  * Glenoid and/or humeral bone loss considered excessive by the treating orthopaedic surgeon
Intervention of Diet Registration Method for Rehabilitation Patients

Study aims to investigate whether dietary registration can be performed with greater precision using digital registration units (mobile devices), rather than conventional paper based dietary registers.

Study intervention is based in the M3 rehabilitation unit, as part of Hobro hospital. The intervention will proceed until 6 full-day dietary registrations have been collected per patient (40 patients total), 3 for each registration method. The estimated time requirement is 30 days.

Study aims to investigate whether dietary registration can be performed with greater precision using digital registration units (mobile devices), rather than conventional paper based dietary registers.

These mobile devices have been equipped with a dietary registration app, developed by the company Movesca ApS, specializing in digital healthcare solutions.

Nurses, and other relevant staff members at the M3 rehabilitation unit at Hobro hospital, will be testing this alternative registration method, as they engage in their day-to-day dietary registration for in-house patients. The data collection requires 6 full-day dietary registrations from each individual patient (40 patients in total). Of these 6 registrations, 3 will be gathered using mobile devices and 3 using conventional paper based registers.

The study primary endpoint is precision. The golden standard is dietary recall. The two methods will be assessed in accordance with their uniformity to the dietary recalls, which will be performed by the investigators following the meals.

As a preemptive measure, an internal retrospective audit was performed, with dietary registration as the objective. This audit was completed to retrieve baseline data on dietary registration, and determine whether the rehabilitation unit conforms to the regulations set by the region.

Eligibility Criteria:
Inclusion Criteria:

* The patient needs to be admitted to the rehabilitation unit at Hobro Hospital
* The patient need to give consent to be included.
* The patient needs to be admitted to the unit for at least 6 days
* The patient has to have 3 days of diet registration with both methods to be included in the data
* The patient need to be of legal age to give consent

Exclusion Criteria:

* The patient mustn be afflicted by any psychological illness, and must be of sound mind, so a normal conversation doesn't pose any problems.
* The patient mustn be sick with Covid-19, or other infectious diseases
* The patient mustn be terminal
Evaluation and Validation of New Biomarkers by Mass Spectrometry

The investigators will perform biochemical and metabolic evaluations on cord blood, venous blood of the mother and urine of the foetus and mother using time-of-flight and tandem mass spectrometry. The investigators could evaluate, dose and validate gestational diabetes mellitus biomarkers of the fetus and mother.


Eligibility Criteria:
Inclusion Criteria:

For women:

* Aged 18 or more
* 24 weeks of gestation or more
* Type 1, type 2 or gestational diabetes mellitus for group 1
* Without diabetes for group 2.

For newborn:

* 37 weeks of gestation or more
* Birth weight 2500 g or more

Exclusion Criteria:

* Multiple birth