cyrilzakka/clinical-trials huggingface dataset:
Maxillary and Mandibular Arch Response to RME: a Multicentric Randomized Controlled Trial

Posterior crossbite is a common clinical condition often associated with transverse maxillary deficiency and functional mandibular shift. This frequent malocclusion is not self-correcting and can lead to the development of craniofacial asymmetries and mandibular dysfunction.

The aim of the current study was to evaluate maxillary and mandibular arch widths' response to RME when it is anchored to the upper second deciduous molars or to the upper first permanent molars and to create a decision-making protocol for RME therapy in mixed-dentition patients.

The effects of rapid maxillary expansion (RME) on the maxillary complex have been highly investigated,4 reporting a maximum maxillary intermolar and intercanine width increase of 6.7 mm and 5.3 mm,5 respectively, when RME is banded on upper first permanent molars.

Literature also reported cases of periodontal and endodontic damage on RME anchoring teeth; therefore, some authors have suggested banding RME on primary teeth and reporting also different mean intermolar (3.6-4.1 mm) and intercanine width increases (5-5.9 mm).

Few studies have investigated the changes in molar dental tipping and inclinations (on average from 3° up to 16.7°) following RME but comprised difficult (ie, barium sulfate solution) and more invasive examinations such as computed tomography and cone beam computed tomography (CBCT) Few articles concerning the indirect effects on mandibular arch following RME reported a low but statistically significant increase of lower intermolar (0.66-0.97 mm) and intercanine width (0.9 mm). Since no studies in the literature have analyzed the differences in permanent vs primary molars as anchoring teeth for RME, the decision to band the permanent deciduous molars did not follow a clinical protocol, but an individual decision was made for each patient based on clinician experience.

Eligibility Criteria:
Inclusion Criteria:

* Patients in mixed dentition
* Unilateral posterior crossbite at least of the first permanent molar
* Upper deciduous second molars available as RME anchoring teeth

Exclusion Criteria:

Primary exclusion criteria

* Previous orthodontic treatment
* Hypodontia in any quadrant excluding third molars
* Inadequate oral hygiene
* Temporomandibular joint disorders
* Craniofacial abnormalities
* Secondary exclusion criteria
* Lack of records
* Need for lingual arch
* Lack of consensus
* Need for other orthodontic treatment during rapid maxillary expansion
Experimental Study of the Impact of a Group Therapy Psychological Intervention for Caregivers of Alzheimer's Disease Patients

A randomized controlled trial designed to test the effectiveness of a psychological intervention based on group therapy for the caregivers of Alzheimer's disease patients. The intervention consists of 14 sessions of a cognitive-behavioral psychological group therapy. This study aims to demonstrate that Alzheimer's patients' caregivers can benefit from group counseling, with an improvement in mood state, quality of life, perceived burden and a decrease in anxiety and depression. Two evaluations will be done: before the therapy sessions (basal) and when intervention is finished (final).

The aim of this study is to conduct group therapy with Alzheimer's caregivers at three centers in the province of Barcelona: Hospital El Carme Badalona, Sanitary Center of Les Corts and Sarrià.

The therapy sessions are conducted by an expert in group therapy (from the sponsor Pasqual Maragall Foundation) and the social worker of each of the centers. The study takes place for four months and consists of weekly therapy sessions of an hour and a half each (14 sessions in total), based on cognitive and behavioral theory. The participants and the control group are evaluated at the beginning and at the end of the study in terms of mood, quality of life, anxiety and depression.

This study aims to demonstrate that Alzheimer's patient's caregivers can benefit from group counseling, resulting in an improvement in their emotional state, perceived burden, quality of life and a more positive attitude coping with the new situation.

Eligibility Criteria:
Inclusion Criteria:

* To be the principal caregiver of a person with Alzheimer's disease
* The patient has a possible or probable diagnosis of Alzheimer's disease made for an Accredited Dementia Unit.
* The patient score in the Global Deterioration Scale must be: 4, 5 or 6A.
* The caregiver must dedicate at least 5 hours a day or spend a significant part of his time to care-related tasks
* The caregiver must sign the Informed Consent

Exclusion Criteria:

* To receive a financial compensation for the care of the patient
* The caregiver or the patient has a psychiatric illness according to the DSM-IV TR, such that the investigator considers it might hinder the dynamics of the group and affect the objectives of the study
* Be receiving some type of formal counseling (conducted by a therapist
The Possible Correlations Between the Genes Related to Pain Sensation and the Pain Sensitivity in the General Population

Objective: This study was conducted to explore the possible correlation between some gene related to pain sensation and individual basal pain perception and postoperative pain intensity in the general population. Methods: Patients receiving elective surgery under general anesthesia were recruited into this study. The investigators measured their preoperative pressure pain threshold (PPT) and pressure pain tolerance (PTO). Pain intensity at rest and movement after the operation was evaluated . And the PCA drug consumption were recorded. Also there were healthy college students volunteer be recruited into this study. The investigators measured their experimental pain sensitivity including pressure pain threshold (PPT) and pressure pain tolerance (PTO), etc. Then genotyping was carried out.

Subjects with the following diseases were excluded: known history of chronic disease, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy smoker, Pregnancy or at lactation period .

Eligibility Criteria:
Inclusion Criteria:

* •Aged 18-65 years

  * Receiving elective gynecological laparoscopic surgery
  * Anesthesiologists (ASA) physical status I or II
  * Agreed to participate the research

Exclusion Criteria:

* •History of chronic pain

  * Psychiatric diseases
  * Diabetes mellitus
  * Severe cardiovascular diseases
  * Kidney or liver diseases
  * Alcohol or drug abuse
  * Heavy smoker
  * Pregnancy or at lactation period
  * Disagree to participate to the research
Comparison of Frozen-thawed Embryo Transfers and Fresh Embryo Transfers With Whole Chromosome Analysis Using Next Generation Sequencing

The investigators propose to perform a clinical randomized trial to evaluate the effect of a frozen-thawed embryo transfer and a fresh embryo transfer on pregnancy and implantation rates; with the added benefit of a blastocyst biopsy and whole chromosome analysis by Next Generation Sequencing (NGS).

1. Fresh group: All embryos will be hatched on day 3. Patients will have hatching blastocysts (\*) biopsied on day 5, analyzed by NGS, and will have one or two euploid embryo transferred on day 6, in the am. If more than two euploid blastocysts are available the one(s) to be transferred will be selected based on morphology (\*). Any morulas developing to hatching blastocyst on day-6 will be also analyzed but vitrified for use in a future cycle.
2. Frozen group: All embryos will be hatched on day 3. Patients will have hatching blastocysts (\*) biopsied on day 5 or day 6, embryos will then be vitrified, analyzed by NGS, and will have one or two euploid embryo(s) thawed and transferred on a FET cycle, before noon. If more than two euploid blastocysts are available the one(s) to be transferred will be selected based on morphology (\*).

(\*) Hatching blastocysts as described by Gardner and Schoolcraft (1999):

Eligibility Criteria:
Inclusion Criteria (pre-stimulation):

* Age up to 42 years

Exclusion Criteria (pre-stimulation):

* MESA and TESE patients
* At least one partner carrier of a chromosomal abnormality
* Egg donor cycle (sperm donor is acceptable)
* Gender selection cycles
* Thaw cycles
* Any patient who cannot have a fresh embryo transfer
* FSH above 12 or AMH less than 1
SMART Protocol vs Antagonist Protocol in IVF

This retrospective study aims to assess the effect of adding letrozole in patients who have previously undergone an IVF cycle with either an antagonist or short protocol, with patients who have undergone a second cycle of IVF with an antagonist or short protocol without the addition of letrozole.

A limited number of studies suggest that the addition of letrozole to gonadotropins for IVF is associated with an increase in oocyte count, blastocyst count and implantation rate. These differences are presumed to be caused by an increase in intra-ovarian androgens associated with the addition of letrozole.

In patients with reduced ovarian reserve or reduced oocyte quality in the previous cycle, supplementation with of letrozole has the potential to increase oocyte count or oocyte quality, thereby resulting in more transferable blastocysts. The antagonist stimulation protocol with the addition of letrozole is commonly referred to as the SMART protocol (Stimulation with Minimal Adverse effects, Retrieval and Transfer

Eligibility Criteria:
Inclusion Criteria for the SMART IVF protocol:

* Women between the ages of 20 and 42 inclusively
* Women proceeding with a SMART IVF protocol following an antagonist IVF protocol between 2010 and 2020 (study group) or women proceeding with an antagonist protocol following an antagonist IVF protocol between 2010 and 2020 (control group)
* Delay of 1 year between both IVF cycle

Exclusion Criteria:

* Women undergoing fertility preservation
* Oocyte donation IVF cycles
* Diagnosed severe male factor requiring surgical sperm extraction (micro-tese or TESA)
Error Augmentation Training Post Stroke

Post-stroke individuals continue to suffer from significant motor impairments years after the stroke. Motor recovery is usually limited to the first 6 month after the stroke, in which the majority of improvements occur at the first three months. Error augmentation (EA) training using a robotic apparatus was suggested to enhance motor recovery by exploiting the adaptation mechanisms within the intact cerebellum in individuals who sustained cortical stroke.

The aim of this study is to investigate whether error augmentation training for the upper extremity may enhance motor recovery in individuals that sustained cortical stroke.

Fifty post-stroke individuals will be randomaly assigned into either EA training (study group- SG) or robotic training in null field environment (control group- CG). Both groups will carry out the same treatment protocol on the robotic device in addition to the standard rehabilitation protocol of the rehabilitation center. Treatment protocol will be consisted of about six training sessions on the robotic device, taken twice or three times a week for two to three weeks. Each training session will be composed of 20-30 minutes upper extremity training with or without EA force field.

Motor performance will be evaluated before and after the treatment protocol by the Fugl-Meyer Assessment scale.

Post-stroke individuals continue to suffer from significant motor impairments years after the stroke. Motor recovery is usually limited to the first 6 month after the stroke, in which the majority of improvements occur at the first three months. Error augmentation (EA) training using a robotic apparatus was suggested to enhance motor recovery by exploiting the adaptation mechanisms within the intact cerebellum in individuals who sustained cortical stroke.

The aim of this study is to investigate whether error augmentation training for the upper extremity may enhance motor recovery in individuals that sustained cortical stroke.

Fifty post-stroke individuals will be randomaly assigned into either EA training (study group- SG) or robotic training in null field environment (control group- CG). Both groups will carry out the same treatment protocol on the robotic device in addition to the standard rehabilitation protocol of the rehabilitation center. Treatment protocol will be consisted of about six training sessions on the robotic device, taken twice or three times a week for two to three weeks. Each training session will be composed of 20-30 minutes upper extremity training with or without EA force field.

Motor performance will be evaluated before and after the treatment protocol by the Fugl-Meyer Assessment scale.

Eligibility Criteria:
Inclusion Criteria:

* Cortical stroke, unilateral hemiparesis

Exclusion Criteria:

* other neurological disorders (Alzheimer's disease, PD), complete plegia,unilateral neglect,sensory aphasia, Mini Mental State Examination\<20
Stem Cell Therapy in Chronic Ischemic Heart Failure

The purpose of this study is to determine whether intracoronary bone marrow transplantation can improve left ventricular ejection fraction in patients with severe ischemic heart failure and no other option for standard therapies (revascularization and drugs).

Despite standard therapies (revascularization and drugs), patients with severe ischemic heart failure have a high morbidity and mortality.

The purpose of this study is to determine whether intracoronary transfer of autologous bone marrow cells can induce angiogenesis, subsequently improving regional myocardial perfusion, and finally resulting in improved systolic and diastolic left ventricular function in patients with severe ischemic heart failure.

35 patients with stable left ventricle function will - with four months interval - receive two treatments with bone marrow transplantation intracoronary in vessels supplying dysfunctional myocardial territories. Echocardiography is performed three times prior (four and two months and just before) and two times after (four and eight months after) therapy. It is a non-randomised trial, patients will enter as their own control.

Eligibility Criteria:
Inclusion Criteria:

1. Severe ischemic heart failure and no other other option for standard therapies (revascularization and drugs),
2. Stable left ventricular ejection fraction \< 40%,
3. CCS class 2-3 and/or NYHA class 2-3, and
4. Signed informed consent.

Exclusion Criteria:

1. Implantation of pacemaker (including implantable cardioverter defibrillator \[ICD\] and biventricular pacing),
2. Acute myocardial infarction within 3 months,
3. Atrial fibrillation, or
4. Severe comorbidity that could impact the patient's short-term survival (including primary hematologic disorders)
Project Frazier 3 Regulatory Clinical Evaluation

Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)

User performance, system use, system accuracy, user instruction for use and marketing claims evaluation of Blood Glucose Monitoring Systems.

Eligibility Criteria:
Summary of Inclusion Criteria

* Age - Subject is at least 12 years old.
* Informed Consent - Subject reads the appropriate Participant Information Sheet and signs the Informed Consent Form (section 12.0).
* Diabetes Diagnosis when applicable - type 1 or type 2 diabetes mellitus.
* Language - Subject reads and understands local language
* SMBG status confirmed
* Subject agrees to complete all aspects of the study

Summary of exclusion criteria

* Conflict of Interest
* Pregnancy - Subject is pregnant (as confirmed by Subject)
* User Performance Accuracy Testing - Technical Expertise
IN-HOspital Program to systematizE Chest Pain Protocol (IN-HOPE)

Multicenter Nationwide Study for Analysis of the Potential Impact in Clinical Practice of Early Exclusion Protocols for Acute Myocardial Infarction with High Sensitivity Troponin T

Chest pain is the main clinical complaint in emergency room visits and represents the most common symptom of Acute Myocardial Infarction, which is the main cause of death in Brazil and worldwide. Although most patients with chest pain do not have a final diagnosis of AMI, they remain under observation until the diagnosis of AMI is excluded. The most current strategy recommended for rapid AMI exclusion uses high-sensitivity cardiac troponin T at time zero and one hour later. However, some points that have not yet been properly evaluated in previous studies can be evaluated in the current study:

* Evaluation of the early exclusion protocol (0 -1 hour) in a Brazilian population
* Evaluation of the early exclusion protocol (0 -1 hour) in isolation and associated with traditional risk scores (TIMI, GRACE, HEART and EDACS)
* Systematic evaluation of the early exclusion protocol (0 -1 hour) in patients without chest pain but with a pre-defined condition of suspected AMI
* Evaluation of the prognostic value of an isolated high-sensitivity cardiac troponin T \< 5 ng/L in a diverse population.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age
* The patient agrees and signs an informed consent form
* One of the following 2 criteria:

  1. Acute chest pain (last episode of pain beginning \<6 hours after inclusion) or
  2. Syncope, dyspnea or epigastric pain without an obvious cause at the initial assessment (last episode of one of these symptoms beginning \<6 hours after inclusion) associated with at least one of the following factors: Age ≥ 65 years, history of arterial disease, history of diabetes mellitus.

Exclusion Criteria:

* Cardiac arrest or hypoxemia or hemodynamic instability or cardioversion during the first hour of assessment
* Thrombolytic therapy, primary angioplasty or other medical condition that requires hospitalization identified within one hour after the evaluation
* Dialysis patients
* Patients with trauma
* Myocardial revascularization or acute myocardial infarction in the last month
* Pregnant and breastfeeding women
* Patient unable to be followed for 30 days
Trial Study of an Exercise Program for Youth With Persistent Symptoms After Concussion

The purpose of this randomized control trial study is to determine if an active rehabilitation (low intensity exercise program) in combination with a comprehensive education intervention (standard care) is more effective than the comprehensive education intervention alone in reducing post-concussion symptoms and improving participation in daily activities in youth who have persistent post-concussion symptoms.

There is a portion of youth who continue to experience persistent post-concussion symptoms beyond the first few weeks of injury. There is limited evidence with respect to the best ways to treat persistent post-concussion symptoms in youth following concussion. There is a small amount of literature that suggests active rehabilitation as a positive intervention for promotion of recovery of persistent post-concussion symptoms. However, this approach to rehabilitation has yet to be explored using a randomized control trial protocol.

Therefore, this study aims to answer the following question: Is a 6 week active rehabilitation program in combination with a comprehensive education intervention (standard care) effective in reducing post-concussive symptoms and improving functional recovery compared to receiving comprehensive education intervention alone among youth experiencing persistent post-concussion symptoms?

We hypothesize:

1. youth ages 10 to 18 years who present with persistent self-reported post-concussion symptoms 4 weeks after the initial injury and receive the active rehabilitation intervention, will present with decreased post-concussion symptoms at the completion of the intervention.
2. youth ages 10 to 18 years who receive the active rehabilitation intervention, will present with more complete functional recovery and increased participation in unrestricted physical activity at the completion of the active rehabilitation intervention compared to children receiving the comprehensive education intervention only

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of concussion
* have at least one post-concussion symptom (as measured by the Post Concussion Symptom Inventory)
* are at least 4 weeks post injury
* between the ages of 10 and 18 years
* ability to speak English
* ability to demonstrate capacity to consent to study

Exclusion Criteria:

* prior moderate or severe brain injury
* neck pain/dysfunction or oculormotor/vestibular dysfunction, developmental delays, mental health disorders or chronic pain conditions that prevent participation in active rehabilitation, assessment of gait and balance, or participation in cognitive testing
* participating in any other physical rehabilitation interventions for post-concussion symptoms (e.g., physiotherapy, massage therapy, chiropractic) at time of enrollment and throughout the duration of the study
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0143-0406 A 0.6 mmol/L in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of the trial is to investigate the Safety, Tolerability,Pharmacokinetics (the exposure of the trial drug in the body) and Pharmacodynamics (the effect of the investigated drug on the body) of subcutaneous NNC0143-0406 A 0.6 mmol/L in Subjects with Type 1 Diabetes


Eligibility Criteria:
Inclusion Criteria:

* Male, aged 18-55 years (both inclusive) at the time of signing informed consent
* Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening
* Body mass index between 18.5 and 28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products.
* Males who are sexually active and not surgically sterilised (vasectomy or otherwise) and their partners that are not using a highly effective contraception method, from randomisation until 90 days after dosing, such as double barrier contraception (e.g. condom and spermicide) or combination of either an oral contraceptive, a contraceptive patch, a diaphragm or intrauterine device, together with a physical barrier such as condom. Malesubjects must also agree to refrain from sperm donation from randomisation until 90 days after dosing
* History or presence of any clinically relevant respiratory, metabolic (including dyslipidaemia), renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus)
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 90 days prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the in-patient period
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the last 180 days