cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Mini-implant Assisted Maxillary Expansion in Adolescents and Adults

Transverse maxillary deficiency is a common orthodontic issue, affecting around 10% of adults. Late adolescents and adults often require more force to expand the midpalatal suture due to its increased interdigitation. This study aims to assess the effectiveness of MARPE in this demographic and determine the best activation protocol for non-surgical maxillary expansion using mini-screw-supported appliances. Additionally, the study will evaluate the effectiveness of MARPE on nasal permeability and airway volume.

The study design comprised a three-arm, parallel-group randomized controlled trial (RCT) conducted at the Orthodontics clinic of Brussels University Hospital. Patients were randomly allocated into one of three groups:

1. Continuous rapid activation protocol: Patients received one activation of 0.17 mm per day until reaching the clinical goal.
2. Continuous slow activation protocol: Patients underwent two activations (0.33 mm) per day for the first 7 days, followed by one turn forward every third day (0.17 mm / 3 days).
3. Force-controlled polycyclic protocol: Patients underwent two activations (0.33 mm) per day for the first 7 days. Then, the hex nut was turned 6 sides backward, followed by 6 sides forward after 15 minutes. Additionally, the device was activated by 0.17 mm every third day.

Intervention:

All patients underwent maxillary expansion with MARPE. Four orthodontic mini-screws were inserted under local anesthesia using a surgical guide and motor. Surgical incision was not required, and predrilling was performed if necessary. The MARPE remained in place for 12 months after expansion to allow bone remodeling in the midpalatal suture. Fixed straight-wire treatment commenced 2 months after expansion termination. Patients underwent retention check-ups at 6 and 12 months post-expansion, and expansion screws and mini-screws were removed after 12 months or before orthognathic surgery, if applicable.

The specific aims of the study were to evaluate the success rate of nonsurgical maxillary expansion, compare the efficacy of the three activation protocols, assess and compare complications, analyze the correlation between success rate and Midpalatal Suture Maturation Stage (MPS), age, and sex, and measure nasal permeability variation using anterior rhinomanometry.

Eligibility Criteria:
Inclusion Criteria:

* from the age of 16 onwards
* who presented with transverse maxillary discrepancy (unilateral, bilateral, anticipated, or constriction without crossbite).

Exclusion Criteria:

* history or presence of maxillofacial surgery, cleft lip and palate, craniofacial anomalies or syndromes, congenital tooth anomalies, and periodontal disease.
* Patients who had previously palatal expansion were excluded also.
* Presence of anatomic or pathological obstacle of the palatal mini-screw insertion (impacted tooth, tumor.)
* refusal of study participation
Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD

Randomized,double-blind,multicenter,multinational,parallel-group,Phase III study to demonstrate the superiority of the triple fixed combination of Beclometasone+Formoterol+Glycopyrrolate (BDP/FF/GB) administered via pMDI over the equivalent dose of Foster® in COPD (Chronic Obstructive Pulmonary Disease) patients after 52 weeks of treatment

This 52-week randomised 2 parallel groups study aimed at evaluating the superiority of fixed triple therapy with ICS/LABA/LAMA compared to ICS/LABA in severe to very severe COPD patients.

Patients' eligibility was checked during the screening visit including the review of medical history, spirometry assessments, routine labs, physical examination, 12-lead ECG, vital signs measurement. This visit was followed by a 2-week open-label run-in period under Foster® (BDP/FF 400/24 µg total daily dose). Eligible patients were then randomised to either fixed triple therapy BDP/FF/GB or BDP/FF. During the 52-week treatment period, completing patients did have 5 subsequent visits post randomisation scheduled respectively after 4 (Visit 3), 12 (Visit 4), 26 (Visit 5), 40 (Visit 6) and 52 (Visit 7) weeks of treatment.

During these, pre-dose and post-dose spirometry, 12-lead ECG, vital signs, dyspnea assessments were performed. Rescue medication use, compliance with the treatment and EXACT-PRO questionnaire were recorded daily (via an electronic diary) during the run-in and randomised treatment periods.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults aged ≥ 40 years with a diagnosis of COPD
* Current smokers or ex-smokers
* A post-bronchodilator FEV1 \< 50% of the predicted normal value and a post- bronchodilator FEV1/FVC \< 0.7
* At least one exacerbation in the 12 months preceding the screening visit

Exclusion Criteria:

* Pregnant or lactating women
* Diagnosis of asthma or history of allergic rhinitis or atopy
* Patients treated with non-cardioselective β-blockers in the month preceding the screening visit
* Patients treated for exacerbations in the 4 weeks prior to screening visit
* Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as PRN
* Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia
* Known respiratory disorders other than COPD
* Patients who have clinically significant cardiovascular condition
Treatment of Self Harm Scars With Fraxel Laser

Treatment of self harm scars with fractionated laser.

Fractionated resurfacing lasers have been shown to be useful for scars including acne scars, burns scars and striae. We will treat self harm scars with 3 to 4 treatments using a "Fraxel" fractionated laser. Patients will be screened to ensure they are not actively engaged in self harm behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Self harm scars

Exclusion Criteria:

* Active self harm behaviors
Healthy Weight Poster, Multi-site Study

This is a multi-site, cross-sectional study of 3-8 year old children and their parents presenting for a well-child check. The investigators are assessing whether a novel, educational, exam room poster can effectively prompt parents to ask their pediatricians about their children's weight status and improve parents' perceptions of their children's weight status.

The purpose of this study is to evaluate whether a novel, educational, exam room poster can effectively prompt parents to ask their pediatricians about their children's weight status. Exam rooms within clinics will be randomized to either have the poster or not and parents will complete questionnaires assessing weight perception, whether they discussed their child's weight with their physician, and basic demographics. Participants who are in exam rooms with a poster will also answer questions specifically about the poster.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 3-8 years old presenting to pediatric clinic for a well-child visit.
* Parents of include children who speak English or Spanish and are able to complete a written survey.

Exclusion Criteria:

* Parents that are \<18 years old
* Children with no documented weight or height for their visit
* Any medical condition that would affect weight gain or growth such as failure to thrive, congenital heart defect, etc.
Web-Based Newborn Care Education for Primiparous Pregnant Women

For pregnant women expecting their first baby, readiness during pregnancy is an important factor in successfully performing hygienic care for their babies. This study was planned to determine the effect of web-based education on the readiness levels of primiparous pregnant women for newborn hygienic care practices. In this study, the aim was to support pregnant women and mothers after birth in newborn care and to develop their application skills with the web-based education program given to primiparous pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 15 and 19 years
* Being 19 years old and above
* Being literate
* Being primigravida
* Having a single baby (not twins or more)
* Being a volunteer to participate in the study
* Having no health problems for the mother and the baby
* Having a computer, tablet or smart phone and the ability to use it
* Having regular internet access

Exclusion Criteria:

* The mother being 18 years of age or younger
* Being multigravida and/or multiparous
* Having a health problem related to the mother or the baby
* Not having a smart phone or wireless internet during the study period
* Not filling out the survey forms incompletely and not watching videos about hygienic care of the newborn
Pretreatment Assessment of Oropharynx Ans Soft Palate Radiofrequency Surgery - a Multi-center Study

Interstitial radiofrequency (RF) surgery of the soft palate (SP) is an established option in the treatment of habitual snoring. The decision making process in the management of habitual snoring would benefit from diagnostic guidelines for oropharyngeal findings. The aim was to investigate the correlation of systematic clinical pretreatment oropharyngeal examination scores with the efficacy of interstitial RF surgery of SP in a multi-center study

TABLE 1. The inclusion and exclusion criterion used for the multicenter study.

Criteria Inclusion Exclusion _____________

Age (years) 18-65 \< 18, \> 65

Habitual snoring yes no Excessive daytime sleepiness no yes

BMI (kg/m2) \< 28 \> 28

AHI (events/hour) \< 15 \> 15

Overjet (mm) \< 5 \> 5 Clinical suspicion of obstruction no yes at base of tongue

Size of palatine tonsils (grade) 0-II III-IV

Nose breathing problems no yes

Pharyngeal tonsil hypertrophy no yes

A bed partner to assess snoring yes no

_____________

Abbreviations: BMI = body mass index, AHI = apnea-hypopnea index.

Eligibility Criteria:
TABLE 1. The inclusion and exclusion criterion used for the multicenter study.

Criteria Inclusion Exclusion _____________

Age (years) 18-65 \< 18, \> 65

Habitual snoring yes no Excessive daytime sleepiness no yes

BMI (kg/m2) \< 28 \> 28

AHI (events/hour) \< 15 \> 15

Overjet (mm) \< 5 \> 5 Clinical suspicion of obstruction no yes at base of tongue

Size of palatine tonsils (grade) 0-II III-IV

Nose breathing problems no yes

Pharyngeal tonsil hypertrophy no yes

A bed partner to assess snoring yes no

_____________

Abbreviations: BMI = body mass index, AHI = apnea-hypopnea index.
On Open-Label Study in Participants With Systemic Lupus Erythematosus

The purpose of this SLE study is to evaluate the long-term safety and efficacy of LY2127399 in eligible SLE participants who have completed the core studies (NCT01196091) (NCT01205438).


Eligibility Criteria:
Inclusion Criteria:

* Have completed 52 weeks of treatment in core studies (NCT01196091) (NCT01205438)
* Given written informed consent
* Test negative for pregnancy at the time of enrollment
* Agree to use a reliable method of birth control

Exclusion Criteria:

* Unwilling to comply with study procedures
* Any condition that renders the participants unable to understand the nature and scope and possible consequences of the study
* Any condition that in the opinion of the investigator poses an unacceptable risk to the participants if study drug would be administered
Egg Freezing Pilot Study

University Reproductive Associates is conducting a pilot study to study the technique of egg freezing. Your participation in this study will provide us with important information to allow us to offer this technology for women wishing to freeze their eggs before cancer treatments. Your participation will include a standard IVF cycle with your eggs being frozen for a brief period of time and then transferred back to you as usual. You will receive a significant reduction in your IVF cycle cost.


Eligibility Criteria:
Inclusion Criteria:

1. 10 women between the ages of 18-35 inclusive at time of signing Informed Consent Form.
2. In good general health off of current medications which may confound response to study medications.
3. Desire to seek pregnancy actively during the study period by IVF-ICSI.
4. A normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study.
5. Ability to use the required medications.
6. Day 3 FSH level \< 12 IU/ml

Exclusion Criteria:

1. Current pregnancy
2. Patients with significant anemia (Hemoglobin \< 10 mg/dL).
3. Patients enrolled simultaneously into other investigative studies that would interfere with this research study.
Role of Positron Emission Tomography in Detecting Primary Tumor in Cases of Metastases of Unknown Origin

In most cases of malignancies, the site of origin of the cancer is clear at presentation or identified soon after. However, Metastatic cancer of unknown primary site (MUO) accounts for 3-5% of all malignant neoplasms, and it is defined as metastatic cancer from an unknown primary site, for which no original site can be detected even after performing all possible tests. Most common metastatic sites include the liver, lymph nodes, lungs, and bones.

18F-fluoro-2-deoxyglucose positron emission tomography (FDG-PET) allows whole-body tumor detection and has proven to be useful in patients with metastasis of unknown primary tumor.


Eligibility Criteria:
Inclusion Criteria:

Age \> 18 years Patients with metastatic tumor. Primary site was not detected with other radiological examinations Both male and female.

Exclusion Criteria:

Patients with known primary tumor Pregnancy. Age \< 18 years.
Autonomic Dysfunction and Hemodynamic Instability During Per-oral Endoscopic Myotomy

This prospective observational study aims to investigate the association between the autonomic dysfunction and hemodynamic instability during per-oral endoscopic myotomy under general anesthesia in achalasia patients. Per-oral endoscopic myotomy is known as the effective treatment for achalasia patients. During per-oral endoscopic myotomy, capnoperitoneum, capnomediastinum, and systemic CO2 accumulation can potentially impair hemodynamics. Moreover, it has been suggested that achalasia is associated with autonomic dysfunction. We hypothesized that patients with autonomic dysfunstion would esperience more hemodynamic instability during per-oral endoscopic myotomy compared with patients without autonomic dysfunction. In this prospective observational study, the autonomic function test will be performed before surgery, and advanced hemodynamic parameters will be recorded using EV1000 clinical platform (Edwards Lifesciences, USA) during surgery. The association between the autonomic dysfunction and hemodynamic instability during per-oral endoscopic myotomy will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are scheduled to undergo per-oral endoscopic myotomy in Gangnam Severance Hospital
2. Patients aged ≥ 19 years

Exclusion Criteria:

1. Patients who are hemodynamically unstable before surgery
2. Patients in whom preoperative heart rate variability (HRV) test cannot be conducted
3. Pregnant women of breastfeeding women
4. Patients unable to read the informed consent form
Study of Clofarabine and Fludarabine Drug Exposure in Pediatric Bone Marrow Transplantation (HCT)

Fludarabine and clofarabine are chemotherapy drugs used extensively in bone marrow transplantation. The goal of this study is to determine what causes some children to have different drug concentrations of clofarabine and fludarabine in their bodies and if drug levels are related to whether or not a child experiences severe side-effects during their bone marrow transplant. The hypothesis is that clinical and individual factors cause changes in clofarabine and fludarabine drug levels in pediatric bone marrow transplant patients and that high levels may cause severe side-effects.

Fludarabine and clofarabine are nucleoside analogs with potent antitumor and immunosuppressive properties used in conditioning regimens of pediatric allogeneic hematopoietic cell transplantation (alloHCT) to promote stem cell engraftment.

This is a single-center, prospective, non-interventional pharmacokinetic (PK) study investigating the clinical pharmacology of combination nucleoside analogue therapy in 24 children undergoing alloHCT at University of California, San Francisco Benioff Children's Hospital.

Patients would receive clofarabine and fludarabine regardless of whether or not they decide to consent to PK sampling.

Clofarabine and fludarabine doses will not be adjusted based on PK data.

The investigators will apply the combination of a limited sampling strategy and population PK methodologies to determine specific factors influencing clofarabine and fludarabine exposure in pediatric alloHCT recipients and identify exposure-response relationships.

Subjects will undergo PK sampling of clofarabine and fludarabine drug concentrations over the duration of combination therapy (3 to 5 days).

To evaluate sources of variability impacting clofarabine and fludarabine exposure clinical data will be obtained from the patient's medical chart on each day of PK sampling.

To assess exposure-response relationships neutrophil engraftment, treatment-related toxicity, and survival data will be collected through day 100 post-transplant.

Eligibility Criteria:
Inclusion Criteria:

* Children 0-17 years of age
* Undergoing alloHCT for the treatment of malignant or nonmalignant disorder
* Receiving clofarabine and fludarabine-based preparative regimen

Exclusion Criteria:

* Any child 7-17 years of age unwilling to provide assent
Turkish Version of Telehealth Usability Questionnaire (TUQ)

The Telehealth Usability Questionnaire (TUQ) was developed to evaluate the usability of telehealth applications and services. The Turkish validity and reliability study of the scale, originally in English, has not been conducted before.

The aim of this study is to develop the Turkish version of the Telehealth Usability Questionnaire (TUQ), which is a new stability tool, and to report its reliability assessment.

The Telehealth Usability Questionnaire (TUQ) turkish version will be asked by using google forms to participants whom use telehealth.

Eligibility Criteria:
Inclusion Criteria:

Participants will undergo screening to confirm eligibility, completion of initial screening form, and MMSE evaluation. Study subjects were enrolled with MMSE scores between 29-30, inclusive (healthy/control), 25-28, inclusive (mild cognitive impairment), and 10-24 (dementia).

-

Exclusion Criteria:

* Unable to complete computerized and standard pencil-and-paper based assessments
Effect of Hypnotherapy in Irritable Bowel Syndrome (IBS)

In this trial, the effects of two psychological interventions - i.e. hypnotherapy and relaxation training - are compared with care as usual in IBS treatment. The investigators hypothesized that hypnotherapy is most effective in reducing complaints in IBS.


Eligibility Criteria:
Inclusion Criteria:

* Irritable bowel syndrome (Rome II)
* Presence of complaints \< 12 months

Exclusion Criteria:

* Gastrointestinal disorders, other than IBS
* Previous psychotherapeutic treatment for IBS
* Severe psychological comorbidity
Restrictive Eating Disorders: From Childhood Orality Disorder to Adolescent Dysensoriality

This study offers to determine whether adolescent patients with a restrictive eating disorder have variations in their sensoriality compared to a control group.

Eating disorders are a frequent reason for consultation in pediatrics at all ages.

When they are small, children may have an orality disorder. There are multiple potential causes for this disorder: psychogenic, oropraxic but also sensory. The treatment is then adapted to the patient, with, among other things, an orientation towards professionals trained in sensory disorders.

As they grow up, adolescents are particularly at risk of developing eating disorders, which are pathologies that correspond to a biopsychosocial model of understanding that includes psychogenetic, neuroendocrine and immune factors.

Despite major advances in the understanding of this disease, the sensory dimension for these patients is still little studied and is not taken into account in the treatment proposed to adolescents suffering from eating disorders.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent between 12 to 18 years old.
* Non-opposition of the adolescent and his or her legal guardians collected before the start of the study.
* Patient group: Diagnosis of restrictive eating disorders (Anorexia Nervosa typical or atypical, ARFID) meeting DSM-5 criteria.
* Control group: absence of eating disorders.

Exclusion Criteria:

* Eating disorders secondary to another psychiatric pathology.
* Precarious health status with somatic and/or psychiatric instability that does not allow to answer the questionnaire.
* Language barrier.
* Opposition of the adolescent and/or his/her legal representatives obtained before the start of the study
* Patient under " AME " (medical state help)
Effects of Neuromodulation and Cognitive Training for Suicide in Veterans (ENACTS)

Impaired executive function, such as impaired decision making and impulsivity, has been identified as an important contributor to the transition from suicidal ideation to suicide attempt. To address the epidemic of Veteran suicide in the United States, this study tests the feasibility, acceptability, and preliminary effectiveness of a five day transcranial direct current stimulation (tDCS) augmented executive functioning training intervention. This intervention is delivered to high suicide risk inpatients. The ultimate goal is to reduce future suicide events (ideation, attempts, deaths) and improve quality of life (e.g. social relationships, health resource utilization).


Eligibility Criteria:
Inclusion Criteria:

* currently admitted into the MVAHCS Inpatient Psychiatric Unit
* at a heightened risk for suicide (defined as a positive screen on the VA Comprehensive Suicide Risk Evaluation (CSRE) at intake and/or a suicide attempt within the previous 12 months)
* able to complete procedures and tasks

Exclusion Criteria:

* are unable to provide informed consent as determined by the Modified Dysken Tool
* have moderate/severe cognitive impairment as determined by the Mini-Mental State Examination (score 27)
* have contraindications for tDCS (history of seizures, metallic cranial plates/screws or implanted device, history of eczema on scalp)
* do not have a smartphone or device running Android or Apple iOS with which to download the mPRO EMA app
* have been involuntarily committed
A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains

The examination of the ability of the OrthoPAT® blood collection device to decrease the transfusion rate and volume of adults undergoing posterior spine surgery for deformity correction of 6 levels or more.

The purpose of this study is to investigate the use of postoperative drains with blood salvage capabilities to determine if they decrease both the volume and rate of allogenic blood transfusion in adult patients undergoing multilevel spine surgery for deformity. In addition, the ability of these drains to decrease the complications that are associated with allogenic blood exposure (postoperative infection, volume overload and transfusion reactions) will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

The patient is at least 18 years of age The patient is to undergo posterior spine surgery in the thoracic or lumbar region for deformity correction of greater than 6 levels The patient has signed a patient Informed Consent

Exclusion Criteria:

The patient is less than 18 years of age The patient has a hematologic disorder of any etiology The patient has received active anticoagulant therapy, including aspirin, Plavix, Heparin, Lovenox or Coumadin within one week of admission The patient has a known active infection or malignancy. The patient has a terminal illness with a life expectancy of less than one year.

The patient requires immuno-suppressive therapy. The patient is undergoing a combined anterior/posterior fusion. The patient has a history of drug or alcohol abuse that may interfere with his/her ability to provide written informed consent.