cyrilzakka/clinical-trials huggingface dataset:
Effect of Carriere® Motion™ Appliance on Airway Dimensions

Objectives: to evaluate the effect of treatment with Carriere® Motion™ Appliance on pharyngeal airway, skeletal and dental dimensions using lateral cephalometric radiographs and to compare these changes with a control group.

Materials and Methods: a prospective controlled clinical study on 17 patients treated at King Abdulaziz university dental hospital, Jeddah, Saudi Arabia with a mean age of 15.25 ± 2.49 years with class II molar relationship (treatment group). They were treated with Carriere® Motion™ Appliance and initial and post treatment lateral cephalograms were taken to assess the effect of the appliance on the pharyngeal airway dimensions, skeletal and dental measurements. A matched sample of 18 untreated patients (with a mean age of 14.44 ± 2.25 years) acted as a control group. Independent sample T-test and paired T-tests were conducted. The significance level was set at P\< 0.05.

Results: when the cephalometric changes associated with the treatment by Carriere® Motion™ Appliance were compared to the changes in the untreated control group, no significant differences were found between the groups in regard to the pharyngeal airway and the skeletal dimensions. The only significant difference between the two groups was in the proclination and the protrusion of the lower incisors. The treatment group showed significantly increased lower incisors proclination and protrusion (L1 to mand plane°= 3.38±2.6, L1-Apo= 0.99±1.45) compared to the control group (L1 to mand plane°=0.49±2.81, L1-Apo=0.39±1.86) (P\<0.05).

Conclusion: treatment with Carriere® Motion™ Appliance does not have a significant effect on pharyngeal airway and skeletal dimensions. However, it significantly increases the lower incisors proclination and protrusion.


Eligibility Criteria:
Inclusion Criteria:

* Class II molar relationship.
* Full set of teeth from 1st molar to 1st molar.
* Age: between 12 and 20 years.

Exclusion Criteria:

* Craniofacial deformities.
* Previous orthodontic treatment.
* History of respiratory illness.
Effect of Oral Combination Therapy in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus

The aim of the study is to determinate the effect of combined oral therapy of long acting metformin/glimepiride in a single dose in patients with type 2 diabetes mellitus and monotherapy failure.

A randomized double-blind clinical trial, to determine the effect of combined therapy of oral prolonged-release metformin/glimepiride in a single dosage form on fasting glucose and HbA1c. Patients will be included in this study are patients with diabetes mellitus and secondary failure to monotherapy. Will also assess the effect of combined therapy on the oral lipid profile (total cholesterol, LDL, HDL, VLDL, Triglycerides) and on the sensitivity and insulin secretion. We evaluate the clinical measurements, laboratory and safety during 3 months, through the allocation of subjects to three study groups (metformin, glimepiride and metformin extended release / glimepiride)

Eligibility Criteria:
Inclusion Criteria:

* 40 to 65 years old
* Ability to communicate and to meet the requirements of the study
* Signed Written Informed Consent before to conducting any study
* Body Mass Index (BMI) = 25-40kg/m2
* Stable weight in the past three months (variability \<5%)
* Meal plan and monotherapy with oral hypoglycaemic fails
* Fasting glucose = 130-270 mg/dL
* HbA1c \> 7%
* isocaloric diet with a minimum of 250 grams of carbohydrates per day in the three days prior to making the laboratory tests

Exclusion Criteria:

* Suspected or confirmed pregnancy
* Nursing
* Inability to secure the non-pregnant during the study duration
* Hypersensitivity to any of the drugs under study
* Treatment with oral hypoglycemic or insulin
* Consumption of substance with toxic effects on any organ system
* Liver failure, heart failure, kidney failure or thyroid disease
* Chronic intake of alcohol
* Periods of acute or chronic diarrhea or vomiting
* Consumption of antifungal azoles, MAO inhibitors, nifedipine,furosemide, amiloride, digoxin, procainamide, quinidine, quinine, triamterene and vancomycin
Impact of the Safe Childbirth Checklist in Luapula Province of Zambia Province of Zambia

This study would like to determine if the introduction of the Safe Childbirth Checklist and associated mentorship can improve the adherence of skilled birth attendants (SBAs) to the essential practices of childbirth delivery.

This study will use a pre-post study design to measure health worker adherence to the essential practices for delivery care outlined in the Safe Childbirth Checklist (SCC). The intervention, including the introduction of the SCC and mentorship visits to support uptake, will be tested in four purposively selected health facilities in Nchelenge District, Luapula Province of Zambia. Since the essential delivery care practices outlined in the SCC are evidence-based practices broadly accepted to support positive clinical outcomes for mothers and infants, this evaluation will focus on adherence to the checklist rather than on patient outcomes. Data will be collected through observations of skilled birth attendants assisting with childbirth delivery before the start of the intervention and again at 3 months and 6 months post-intervention. A health worker questionnaire will be administered at the time that the SCC is introduced and six months later to gather their perspectives on incorporating the SCC into clinical practice in Zambia.

Eligibility Criteria:
Inclusion Criteria:

* For facility observations, all consecutive deliveries will be observed. If a pregnant woman or health worker declines to participate in the consent process, no observations will be recorded.

Exclusion Criteria:

-
Early Versus Late Application of STN DBS to PD Patients With Motor Complications

Although deep brain stimulation of the subthalamic nucleus(STN DBS) has become the surgical treatment of choice for Parkinson's disease(PD), a consensus on the timing of surgery is lacking. This study is intended to demonstrate that early, compared with delayed, introduction of STN DBS is more beneficial for PD patients who have developed motor complications.

In this prospective study, 200 PD patients will be recruited for STN DBS over three years, including 133 with motor complications existing for more than three years (late complication group) and 67 less than three years (early complication group). To make a comparison of therapeutic efficacy between the two groups, motor and non-motor symptoms will be assessed using specific rating scales and questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's Disease with good response to levodopa(i.e. more than 30% improvement in the MDS-UPDRS Part III score after an acute levodopa challenge)
* Presence of fluctuations and/or dyskinesias
* Age ranging from 18 to 75 years old
* Normal brain MRI
* Absence of dementia (Mini Mental State Examination ≥ 26)
* Absence of severe psychiatric diseases
* Written informed consent

Exclusion Criteria:

* Presence of severe metabolic diseases
* Severe cardiac/respiratory/renal/hepatic diseases
* Secondary parkinsonism or multiple system atrophy
* Illiteracy or insufficient language skills to complete the questionnaires
* Poor compliance and unreasonable expectation
* Women who are pregnant or breast feeding
* Simultaneous participation in another clinical trial
Epidemiological, Clinical and Biological Caracteristics of Patients Presenting With Invasive Meningococcal Disease

An unusual increase in cases of invasive meningococcal infection between late 2022 and early 2023. These cases sometimes had atypical presentations (large numbers of bacteremias without meningitis). The distribution of serogroups was also unusual in our center (large number of serotype Y meningococcal IMD).

This development comes after three years marked by the Corona-Virus-Disease-19 pandemic, which led to a profound change in the behaviors involved in the transmission of infectious diseases. Barrier measures have considerably reduced the population's exposure to meningococcus, and may have encouraged a reduction in mucosal immunity to this pathogen. The end of 2022 was also marked by intense viral circulation (syncitial respiratory virus-influenza-COVID), which may have favored invasive forms.

Invasive meningococcal disease (IMD) accounts for a small number of cases (500-600 cases/year) in mainland France. Despite advances in its management, the disease is still associated with a 10-20% mortality rate and impaired quality of life in 50% of surviving patients.

An unusual increase in cases of invasive meningococcal infection during the winter of 2022. These cases often had atypical presentations (large number of bacteremias without meningitis, digestive picture in the foreground). The distribution of serogroups was also unusual at our center (large number of serotype Y meningococcal IMD). These data appear to be confirmed by Santé Publique France's national data for 2022, with no warning of the spread of a hyper-virulent clone.

This development comes after three years marked by the SARS-CoV2 pandemic, which led to a profound change in the behaviors involved in the transmission of infectious diseases .

Barrier measures have considerably reduced the population's exposure to meningococcus, and may have led to a reduction in mucosal immunity to this pathogen. This is particularly true of teenagers and young adults, for whom contact has fallen sharply due to the closure of schools and universities. It would be interesting to see whether this population is more affected this year than in previous years.

The end of 2022 was also marked by intense viral circulation (SRV-Flu-Covid), which could have favored invasive forms. Evidence of a significant number of viral co-infections could support this hypothesis.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Invasive Meningococcal infection (defined by the isolation of Neisseria meningitis in a normaly steril site (CSL, blood, articulation, ..) by PCR or culture.

No exclusion Criteria
Evaluation of an Intervention Based on Cell Phones

The aim of the study was to assess the effect of an individualized intervention based on cell phones to improve glycemic control in patients with type 2 diabetes attending Epidemiology Research Unit in Cuernavaca, Morelos. Mexico

In this study before randomization, the participants received workshops on diet, physical activity, glycemic index of foods.

Bandura´s theoretical model was used in the voice messages sent to the intervention group.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus \> 10 years
* Glycated hemoglobin \>7%

Exclusion Criteria:

* Take insulin regularly
* Pregnant woman
* Woman who expected to be pregnant the next 6 months
* 24 hrs creatinine \< 30 ml/minute
FOCAL HIGH-INTENSITY FOCUSED ULTRASOUND FOR PRIMARY LOCALIZED PROSTATE CANCER: MIDTERM ONCOLOGICAL OUTCOMES

Single-center evaluation of all patients treated for primary localized prostate cancer with focal HIFU from November 2009 to December 2016. To evaluate midterm oncological outcomes of focal HIFU therapy in low an intermediate risk prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* • The patients with low or intermediate risk PCa (PSA \<20 ng/ml, Gleason score 7 or less and clinical stage T2b or less) who received PGA/FT using HIFU were included.

Exclusion Criteria:

* Patients who were previously treated with radiotherapy, androgen deprivation therapy (ADT) or other treatment for their prostate cancer were excluded.
Effect of COVID-19 Pandemic on Perceived Stress, Anxiety, Mood, and Training Quality in Elite Athletes.

In this study, the investigator aims to measure stress, anxiety, mood, life satisfaction measures among elite athletes during COVID-19 and measure the relationship between these measures and the changes in training characteristics in elite athletes during the COVID-19 pandemic.

On 11 March 2020, the World Health Organization declared the COVID-19 outbreak as a pandemic. On the same day, the first COVID-19 case reported in Turkey and nationwide quarantine regulations started after a spike in case numbers. In the world of sports, the effects of the COVID-19 pandemic started with staging games without spectators, gradually all sports events and team practices were postponed. Soon later, athletes advised to quarantine at home and continue training individually. Similar to previous study results, the COVID-19 outbreak expected to cause a profound and wide range of psychosocial impacts on people during outbreaks of infection. In fact, preliminary results from a study in China showed a moderate to severe degree psychological impact on more than half of the respondents. However, the effect of COVID-19 on mental health symptoms in elite athletes has not been investigated.

In this study, the investigator aims to investigate stress, anxiety, mood, life satisfaction measures among elite athletes during COVID-19 and explore the potential relationship between these measures and the changes in training characteristics during the COVID-19 pandemic.

Eligibility Criteria:
Inclusion Criteria:

* Elite Athletes between age of 18-35

Exclusion Criteria:

* Athletes with history of COVID-19 disease
* Athetes with first-degree family members who have/had the COVID-19 disease
* Athletes with non-covid related injuries restraining from physical activity
* History of psychiatric disease
Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients

The purpose of this study is to evaluate the efficacy and Safety after conversion to RaparoBell® or Myrept® in patients who in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.

This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety after conversion to RaparoBell® or Myrept® administration for 24 weeks in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who at least 1 year and less than 10 years after kidney transplantation
2. Over 20 years old
3. Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolic acid after kidney transplantation

Exclusion Criteria:

1. Patients who have transplanted organs other than kidney
2. At the time of Screening

   * Treatment with active liver disease or Liver function test(T-bilirubin, AST, ALT)is over 3 times than upper normal limit
   * WBC\< 2,500/mm\^3, or platelet \< 75,000/mm\^3, or ANC \< 1,300/ mm\^3
   * Protein/Creatinine ratio≥1.0(mg/mg)
3. Patents who had a record of taking mTOR inhibitor before 3 months
4. In investigator's judgement
Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair

The aim of the study will be to compare the laparoscopic pectopexy (LP) and laparoscopic lateral suspension (LLS) techniques in the management of uterine sparing apical prolapse (POP-Q \>2) at 1 year and yearly up to 2 years.

Primary and secondary endpoints:

Primary outcome measures will be the subjective cure of prolapse ("absence or presence of a bulge in the vagina"), objective success with anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total.

Secondary outcome measures include all other parameters such as perioperative outcomes, patient satisfaction, quality of life outcomes, complications, scores on questionnaires, and reoperations.

The study protocol will be submitted to the institutional review boards of every participating study site and written informed consent will be obtained from all participants on enrolment.

Project design: The investigators will perform an international multicentre single-blind randomized controlled trial with participating our tertiary referral hospital.

Eligibility Criteria:
Inclusion Criteria:

* Women with symptomatic stage 2 or greater (point C -1 or more pelvic organ prolapse quantification POP-Q) apical prolapse

Exclusion Criteria:

* Women not eligible for surgery for medical or anesthesiological reasons
* Inability to comprehend questionnaires
* Inability to give informed consent
* Inability to return for a review
* Prior laparoscopic prolapse repair
* Prior vaginal mesh prolapse procedure
* Severe cardiovascular or respiratory disease
* Women who don't want uterine preserving surgery
* Pregnancy
* Age \<18 years, Age \>45 years
Online or Face-to-face Treatment for Insomnia?

The object of this study is to compare internet-delivered treatment for insomnia to face-to-face treatment and a waiting-list. In this study participants are randomized to: 1) online cognitive-behavioral intervention; 2) face-to-face cognitive behavioral intervention; 3) waiting-list. Both the online and face-to-face interventions consist of: diary; psycho-education; relaxation exercises; stimulus control/sleep hygiene; sleep restriction; challenging the misconceptions about sleep; and paradoxical exercise. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants fill out questionnaires and a dairy at baseline post-test, 3-month follow-up, and 6-month follow-up. Participants on the waiting-list receive online treatment after the first post-test. The investigators expect that the online-delivered treatment and the face-to-face treatment are equally effective.


Eligibility Criteria:
Inclusion Criteria:

* Insomnia disorder according to DSM-5
* Sleep onset latency/wake after sleep onset \> 30 minutes , three times or more a week
* Insomnia three months or longer
* Access to internet
* Possibility to travel to one of the treatment sites

Exclusion Criteria:

* Earlier cognitive behavioral treatment for insomnia
* Start other psychological treatment in the last 6 months
* Doing shift work
* Major depression disorder
* Pregnancy or breast feeding
* Schizophrenia or psychosis
* Suicidal plans
* Sleep apnea
* drugs or alcohol abuse
Effect of Educational Program of Virtual Reality on Critical Thinking Disposition Among Nursing Students at Damietta University

The present study aims to evaluate the effect of an educational program of virtual reality on critical thinking disposition among nursing students at Damietta University.

Education is the basis for a thriving society, and the transfer of knowledge has been a top priority for civilization since the very beginning, in all the world people are constantly looking for more easily, more quickly, and more effective in a world where technology is a dominant feature in our daily life.

Virtual reality in the field of medical and nursing education is defined as a type of computer-based 3D simulation that makes users feel like they are in clinical settings where they can practice skills without putting patients at risk. Therefore, such simulations with active engagement improve learning retention and enable participants to learn interactively and analyze problems.

Critical thinking disposition is one of the skills that need to be developed in the current era. Critical thinking skills can be defined as a student's ability to test their idea in dealing with problems the art of analyzing and evaluating thinking, deducting and inferring conclusions from problems and facts.

Eligibility Criteria:
Inclusion Criteria:

* Age from 21 to 22 years.
* Both sexes.
* Nursing students.

Exclusion Criteria:

- Mental retardation
Bone Effects of Teriparatide Following Alendronate

The purpose of this study is to assess the effect of 24 months of treatment with once daily teriparatide injection (recombinant human PTH \[1-34\]) 20 micrograms on bone histomorphometry and architecture. Patients will include postmenopausal, osteoporotic women who have been treated long term (at least 36 months) with alendronate, as well as postmenopausal, osteoporotic women who have never been treated for osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Osteoporosis: Pretreated patients currently osteoporotic or osteopenic. Treatment-naive patients currently osteoporotic
* Pretreated patients will have had at least 36 months of treatment with alendronate Na 10 mg/day or 70 mg/week. Treatment-naive patients will have no significant osteoporosis treatment in the prior 36 months, as assessed by the investigator

Exclusion Criteria:

* History of bone metabolic diseases, Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hyperparathyroidism (uncorrected), and intestinal malabsorption.
* History of malignant neoplasms in the prior 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. If malignant neoplasm was ever diagnosed, patient must presently be free of disease.
Pomegranate Juice in Treating Patients With Recurrent Prostate Cancer

RATIONALE: Pomegranate juice may contain substances that decrease or slow the rise of prostate-specific antigen (PSA) levels and may be effective in delaying or preventing recurrent prostate cancer.

PURPOSE: This phase II trial is studying how well pomegranate juice works in decreasing or slowing the rise of PSA levels in patients who have undergone radiation therapy or surgery for prostate cancer.

OBJECTIVES:

* Determine whether pomegranate juice can decrease or slow rising prostate-specific antigen (PSA) levels in patients who have undergone radical prostatectomy or radiotherapy for adenocarcinoma of the prostate.

OUTLINE: Patients receive oral pomegranate juice once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 29-40 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Must have undergone prior surgery or radiotherapy for the primary tumor
* Documented rising prostate-specific antigen (PSA) level, defined by the following criteria:
* Absolute level of PSA at least 0.2 ng/mL but less than 5.0 ng/mL
* Rising PSA level must be confirmed at least 1 week later
* Adequate PSA time points to calculate a PSA doubling time
* Gleason score no greater than 7
* Age 18 and over
* Performance status ECOG 0-1
* Life expectancy at least 6 months
* No other malignancy within the past 5 years except nonmelanoma skin cancer
* No other serious concurrent systemic medical disorders that would preclude study compliance
* No known allergy to pomegranate juice
* More than 4 weeks since prior participation in another experimental study

Exclusion Criteria:

* nodal involvement
* evidence of metastatic disease
* prior hormonal therapy
* concurrent hormonal therapy for rising PSA levels after initial therapy for prostate cancer
* concurrent participation in another experimental study
* other concurrent systemic or local therapy for prostate cancer
* initiation or discontinuation of any new nutritional or dietary supplements during study participation