cyrilzakka/clinical-trials huggingface dataset:
Tooth-Borne Versus Tooth-Bone-Borne Rapid Maxillary Expanders: A Stereophotogrammetric Evaluation of Soft Tissues

The force exerted by the rapid maxillary expansion (RME) appliances provides expansion of the transverse dimension by splitting of the midpalatal suture. This expansion results in three-dimensional (3D) changes in maxillary position which also effects circummaxillary surrounding structures. The aim of this randomized clinical trial (RCT) was to evaluate the effects of tooth-borne and tooth-bone-borne rapid maxillary expansion (RME) on soft tissue with stereophotogrammetry.

Introduction: To evaluate the effects of tooth-borne and tooth-bone-borne rapid maxillary expansion (RME) on soft tissue with stereophotogrammetry. Methods: 32 patients (15 males, 17 females) who met inclusion criteria were divided into two groups. In the first group, tooth-borne RME appliance (Hyrax) was applied to 16 patients (9 males, 7 females mean age 13.4 ± 1.3 years) and in the second group, tooth-bone-borne RME appliance (Hybrid Hyrax) was applied to 16 patients (6 males, 10 females mean age 13.05 ±1.24 years). A simple electronically generated randomization was performed before trial commencement using the Random Allocation Software program. Allocation concealment involved numbered, sealed, and opaque envelopes prepared before trial commencement. One envelope was sequentially opened for each participant during recruitment. Each envelope contained a card with the name of 1 expander. The initials of the name of the participant, the type of expander, and the date of allocation were identified in the external surface of the envelope. One operator was responsible for the randomization process, allocation concealment, and implementation. The primary outcomes of this study was assessment of changes in soft tissues before RME (T0) and post-retention (T1) period by stereophotogrammetry. Independent and dependent sample t tests were used to compare intra- and inter-group differences at P\<0.05 significance level.

Eligibility Criteria:
Inclusion Criteria:

1. No previous tonsillar, nasal or adenoid surgery and orthodontic treatment,
2. Bilateral crossbite and need for RME,
3. Maxillary and mandibular permanent teeth fully erupted,
4. Willingness to participate in the study

Exclusion Criteria:

1. the presence of adenotonsillectomy due to tonsillar hypertrophy or adenoidal hypertrophy
2. Having nasal/nasopharyngeal /oropharyngeal pathologies, craniofacial syndromes, systemic disease, poor oral hygiene,
3. History of previous orthodontic treatment.
Phase III Study of Two Different Schedules (Weekly and Tri-weekly) of Combination of Gemcitabine and Two Taxanes in MBC

Multi-center, randomized Phase III study. 4 arms. 360 Patient to enroll. Purpose is evaluate time to progression disease (PD).


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of metastatic breast cancer (MBC).
* Prior neoadjuvant or adjuvant taxanes regimen is allowed if ≥12 months since completion of the regimen.
* Relapsing after receiving one adjuvant/neoadjuvant chemotherapy containing an anthracycline if not clinically contraindicated.
* Patients with measurable disease.
* Previous hormonal therapy for adjuvant setting or metastatic disease.

Exclusion Criteria:

* Previous chemotherapy for MBC
* Previous chemotherapy with gemcitabine in any setting of disease
* Patient candidable to treatment with trastuzumab.
Prediction of Intrahospital Cardiac Arrest Outcomes

Intrahospital cardiovascular arrest is one of the most common causes of death in hospitalized patients. In contrast to extramural cases of cardiovascular arrest, hospitalized patients often have severe medical conditions that can affect the outcome of resuscitation. Nevertheless, survival rates from resuscitation are better in hospitals than outside, because there is often a rapid start of resuscitation measures and predefined resuscitation standards. Regular CPR training and the availability of defibrillators in all bedside units can also positively influence outcome. Despite these many efforts, survival rates, especially of patients with good neurological outcome, remained stable at low levels even within hospitals in recent years and did not improve.

Most outcome parameters are nowadays well known. (e.g., initial rhythm, age, early defibrillation, etc.) Nevertheless, we still do not know today how relevant the corresponding factors actually are, especially in relation to each other. One approach to this might be machine learning methods such as "random forest", which might be able to create a predictive model. However, this has not been attempted to date.

The hypothesis of this work is to find out if it is possible to accurately predict the probability of surviving an in-hospital resuscitation using the machine learning method "random forest" and if particularly relevant outcome parameters can be identified.

Design: retrospective data analysis of all data sets recorded in the resuscitation register of Kepler University Hospital.

Measures and Procedure: Review of the registry for missing data as well as false alarms of the CPR team and, if necessary, exclusion of these data sets; evaluation of the data sets using the machine learning method random forest.


Eligibility Criteria:
Inclusion Criteria:

* All adults patients suffering cardiac arrest and having been resuscitated by the medical emergency team of the Kepler University Hospital, Linz, Austria in the period of 2006-01-01 to 2018-10-31.

Exclusion Criteria:

* None.
Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty

Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.

Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.

Eligibility Criteria:
Inclusion Criteria:

* Phakic study eye or study eye with a posterior chamber intraocular lens (PC-IOL)
* Primary open-angle glaucoma (including pseudoexfoliative)

Exclusion Criteria:

* Aphakic or pseudophakic with anterior chamber IOLs (AC-IOLs) (study eye)
* Prior stent implantations (study eye)
Multisite Feeding Study: Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle

This study will assess 75-100 patients for feeding issues following surgery for single ventricle.

We wish to consent 75-100 subjects at Children's Healthcare of Atlanta.

If subjects take part in this study, the following will happen:

1. Prior to discharge, the parent/guardian will be given a home feeding log and
2. Parents will bring the feeding log to regularly scheduled clinic visits. Clinic staff will also weigh the child and measure head circumference at each clinic visit.
3. The investigators will look at the child's medical record to obtain other information including diagnosis, surgery, oxygen saturation levels and medications.
4. The parent/guardian will be asked to fill out a questionnaire about their stress and uncertainty caring for their baby after heart surgery. They will be asked to fill out the same questionnaire 3 times:

   * First time will be before they leave the hospital after the baby's surgery, while still a patient on the Cardiac Step Down Unit (CSU).
   * Second time will be at the Sibley Heart Center Cardiology clinic after they have been home for approximately 4 weeks.
   * Third time will be at the Sibley Heart Center Cardiology clinic after they have been home for approximately 12 weeks or at the time of the routine cardiac cath prior to their second stage surgery.

It should take about 15 minutes to fill out the questionnaire. The questionnaire is the only research procedure.

The data from the feeding log and clinic visits will be submitted to Cincinnati Children's, the primary site for this study.

Eligibility Criteria:
Inclusion Criteria:

* Single ventricle patients who have received the Norwood Stage I operation.

Exclusion Criteria:

* Infants with chromosomal anomalies or other non-cardiac conditions (cleft palate, necrotizing enterocolitis \[NEC\] or other gastrointestinal \[GI\] anomalies)
* Prematurity less than 37 weeks
* Infants greater than 30 days of age at Stage I palliation
* Parents who cannot read or understand questionnaires administered as a part of the study.
Relative Bioavailability of 2 Fixed Dose Combinations of Linagliptin/Metformin Compared With Single Tablets

The purpose of the trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing linagliptin \& metformin and the single tablets of linagliptin and metformin when administered singularly.


Eligibility Criteria:
Inclusion criteria:

1. Healthy males or females
2. Age 18 -50 years (incl)
3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
4. Subjects must be able to understand and comply with study requirements

Exclusion criteria:

Any deviation from healthy condition
A Prospective Study on Optimizing Treatment for ABPA

This study is being done to evaluate the efficacy of treatment using oral glucocorticoid, anti-fungal agent, anti-IgE mAb for patient with ABPA.

This is a study randomly treating ABPA patients with either anti-fungal agent plus OCS or anti-IgE mAb (omalizumab) plus OCS.

OCS is the basic treatment for ABPA by suppressing allergy and inflammation. Prednisone tablets is given orally 0.5mg/kg/d for 4 weeks and gradually reduced to for a total usage of 6 months. Reduction may failed if disease exacerbate.

Anti-fungal agent (mainly itraconazole) could reduce the load of fungus but its application is still controversial. The investigators use itraconazole 200mg bid for 8 months and 100mg bid for another 8 months.

Omalizumab was given 600mg q4w for at least 6 months. The investigators use Anti-fungal agent and Omalizumab as a supplement to OCS to evaluate the better treatment plan for ABPA patients.

Eligibility Criteria:
Inclusion Criteria:

* 18\~75 years old, male or female
* associated past medical history, including asthma, bronchiectasis, COPD ect.
* elevated serum total IgE (\>100IU/mL)
* elevated aspergillus specific IgE

Exclusion Criteria:

* According to the investigator, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness).
* Pregnancy or breastfeeding
* Abnormality of liver or kidney function
Effect of Increased Pain Tolerance on Exercise Performance

Clinical prescription and use of opioids is a clear problem in large parts of the world and has the recent years received an increasing publicity in sports. This is in particular due to the World Anti-Doping Agency monitoring list, which reveal that endurance athletes utilize the opioid Tramadol frequently with the aim to enhance performance according to anecdotal evidence.

Studies investigating the effect of tramadol on exercise performance in healthy humans is limited to one study in moderate trained subjects. However, this effect may be different in highly trained subjects due to the effects of chronic exercise. Furthermore, ingestion of tramadol may impact motor-cognitive performance and it remains unknown whether tramadol can be detected in highly trained subjects following exercise.

In the present study the investigators apply a randomized double-blind placebo-controlled counterbalanced cross-over design to investigate whether tramadol treatment improves a preloaded cycling time trial performance, whether it affects motor-cognitive performance and whether it is detectable following exercise.


Eligibility Criteria:
Inclusion Criteria:

* Maximal oxygen uptake \< 55 ml O2/min/kg
* Plasma creatinine concentration between 60-105 umol/L
* Plasma alanine aminotransferase between 10-70 U/L
* Familiarized with endurance training for at least a few years

Exclusion Criteria:

* Donated blood within the last 3 months
* Exposed to an altitude greater than 1000 m above sea level within the last two months
* Smoking
The Effect of Topical Anesthetics on Patients' Pain and Operative Experience During Treatment with QSwitched Laser

This study will conduct a split-face and -body randomized control trial to compare lidocaine 2.5%/prilocaine 2.5% topical anesthetic (LPTA), lidocaine 7%/tetracaine 7% topical anesthetic (LTTA), and placebo vechicle (PV) on patients' pain perceptions with Q-switched 532nm laser for the treatment of lentigines and/or photorejuvenation.Subjects will fill out a pain score on a visual analog scale (VAS) with 0 being no pain and 10 being most pain after each treatment area is completed.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have moderate lentigines and/or photodamage and desire laser toning.
2. Females 25-65 years of age.
3. In good health.
4. Have Fitzpatrick phototype I-III.
5. Willingness and the ability to understand and provide informed consent and communicate with the investigator/study staff.

Exclusion Criteria:

1. Younger than 25 or older than 65 years of age.
2. Pregnant or lactating.
3. Is a male.
4. Has received the following treatments on the face:

   * ablative or non-ablative laser procedure in the past 3 months
   * radiofrequency device treatment in the past 3 months
   * ultrasound device treatment in the past 3 months
   * medium to deep chemical peel in the past 3 months
5. Has an active infection on the face or upper inner arms (excluding mild acne).
6. Is allergic to lidocaine, tetracaine, or prilocaine.
7. Has kidney disease and/or liver disease.
8. Has G-6-PD and/or pseudocholinesterase deficiency.
9. Is taking a class I anti-arrhythmic medication.
10. Is tanned.
11. Has a history of hyperpigmentation with laser treatment.
12. Has a mental illness.
13. Has a history of a chronic pain condition such as fibromyalgia or vulvodynia.
14. Unable to understand the protocol or to give informed consent.
15. Multiply recurrent episodes of cold sores.
16. Any significant skin disease beyond mild acne.
17. Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical clinical study, or would pose as an unacceptable risk to the subject.
First rTMS for Treatment of Drug Induced Tardive Syndromes. Double Randomized Clinical Trial

This study aims to evaluate the efficacy of rTMS on DITS. Twenty patients with DITS were recruited from the outpatient clinic of Aswan University Hospital. The patients were classified into two equal groups, 1st group received real high frequency rTMS at 100% RMT and the 2nd group received sham stimulation with the same pulse delivery but with the coil placed perpendicular to the scalp. For each patient 10 sessions were administered once per day for 5 consecutive days each week for two weeks. All patients were assessed before rTMS and immediately after the end of the 10 sessions. This study is double blinded (the doctor and the patients). Assessment with AIMS scale and different parameters of cortical excitability were performed before and after the end of sessions treatment.

The aim of this study was to evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS) on drug induced tardive syndromes.

the effect of rTMS compare. Twenty patients with drug induced tardive syndromes were recruited from the outpatient clinic of Aswan University Hospital. The patients were classified into two equal groups, 1st group received real 20 Hz-rTMS at 100% RMT (a total of 2000 pulses to each hand area consisting of 10 trains of 200 pulses with intertrain interval 30 s), and the 2nd group received sham stimulation with the same pulse delivery as the 1st group but with the coil placed perpendicular to the scalp. For each patient 10 sessions were administered once per day for 5 consecutive days each week for two weeks. All patients were assessed before rTMS and immediately after the end of the 10 sessions. The patients did not know which type of stimulation they received and to ensure that, the study was double blinded the doctor who assessed the patients didn't know which type of stimulation the patients received. None of the patients had had rTMS before and were unaware of the type of stimulation.The AIMS scale and different parameters of cortical excitability were assessed before and after the end of session treatment.

Eligibility Criteria:
Inclusion Criteria:

* All patients with the spectrum of Tardive dyskinesia (TD) according to the diagnostic and statistical manual of mental disorders, fourth edition (DSM IV)

Exclusion Criteria:

* None of the patients suffered from any other clinically relevant disorders.
* We exclude any patient with pacemaker or metallic devices
* patients with history of epilepsy or metabolic diseases.
Fabry's Disease and Pregnancy (PREFAB)

Fabry's disease is a progressive systemic disease X-linked which combines neurological (Fabry's pain crises), dermatologic (angiokeratomas), renal (renal failure), cardiovascular (hypertrophic cardiomyopathy, valvular disease, conduction disorder, coronary heart disease) and cerebral vascular (stroke) symptoms .

It is a glycosphingolipid metabolism disorder due to deficient or absent activity of the alpha-galactosidase A, causing accumulation of globotriaosylceramide in the lysosomes.

The incidence is estimated being 1/40 000. Some patients suffering from Fabry's disease today are of childbearing age and their multidisciplinary care (by neurologists, obstetricians and anesthetists) raises several questions.

About the anesthetic, the question of epidural block is debated in patients with neurological diseases and recommendations are not unequivocal.

Indeed one of the problems of the management in those conditions is the potential worsening of the disease because of the anesthetic procedure. In addition, the possibility of an antiplatelet and / or an anticoagulant treatment in these patients may also contre-indicate an epidural block.

The rate of epidural block achieved in patients with Fabry's disease is not currently known. Moreover, only sparse data on pregnancy outcomes in these patients are reported.


Eligibility Criteria:
Inclusion Criteria:

* Fabry's disease patients, aged 18 years or more, having had at least one childbirth

Exclusion Criteria:

* Patient under a legal protection procedure
* Patient denying to participate to the study
* Lack of affiliation to a social security system
Randomized Trial Comparing EmbryoScope With EmbryoScope+.

The purpose of the study is to compare the current EmbryoScope Time-Lapse System being used in IVF which has become standard of care to the new model EmbryoScope to demonstrate that the EmbryoScope+ is as safe and reliable as the EmbryoScope.

This is a randomized, controlled, single-center study in otherwise healthy infertile female subjects undergoing in vitro fertilization (IVF). The subjects recruited for this study will be among those patients who have been diagnosed with infertility and are planning to undergo IVF at the center where this study is being performed. The subjects will have undergone the usual informed consent procedure at the center.

Subjects will undergo ovarian stimulation, oocyte retrieval, IVF, and Intra Cytoplasmic Sperm Injection (ICSI) procedure following the center's usual procedures. At the time of retrieval, participant's oocytes will be randomly assigned to both groups for comparison: Standard EmbryoScope Time-Lapse system versus EmbryoScope+. The best quality embryos are selected for embryo transfer and the pregnancy outcome is evaluated.

"Best grade" embryos will be transferred regardless of EmbryoScope use. The standard EmbryoScope as well as the EmbryoScope+ monitor system as assigned during the randomization process will be used to observe the embryo development and document timing of embryo cleavages and morphology dynamics. Subjects will not be provided with the time- lapse images.

Endpoints will be Day 3 and Day 5/6 embryo development, implantation and pregnancy rate. The study is approximately 2 months, the estimated time it takes a physician to perform one IVF-ART treatment cycle. If embryos are frozen, the patient may be in the study until the time they choose to thaw the embryos or up to 1 year if they become pregnant.

Eligibility Criteria:
Inclusion Criteria:

* 40 years of age or younger (maternal)
* 65 years of age or younger (paternal)
* Fresh or frozen (including donor) sperm can be used
* Fresh oocytes only (including donor)
* Frozen embryos from this study can be included in the outcome portion of this study.
* Single or double Blastocyst transfer only

Exclusion Criteria:

* 3 or more previous failed cycles
* Sperm obtained by testicular biopsy
* Co-culture patients
Platelet-Rich and Concentrated Platelet-Poor Plasma to Reduce Air Leak Post-Lobectomy: A Randomized Controlled Trial

The purpose of this study is to determine whether the use of platelet-rich plasma (PRP) and concentrated platelet-poor plasma (PPPc) can reduce the duration of post-operative air leak after lobectomy for lung tumours.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring a lobectomy

Exclusion Criteria:

* Pneumonectomy
* Sleeve lobectomy
* Determination of unresectability (prior to the initiation of lobectomy)
* Wedge resection alone
Silybin Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin Reduces Depression and Increases Work Ability

Background: Hepatitis C virus infection and interferon treatment have shown to be risk factors for depression, distressing, psychosocial burden and poor health-related quality of life.

Aim: To determine the effect of a Sylibin-vitamin E-phoshpolipids complex on work ability and whether health related factors (anxiety and depression) were associated with work ability in subjects with chronic hepatitis C treated with Peg-IFN-α and RBV.

Patients and Methods: In this prospective, randomized, placebo controlled, double blind clinical trial, 31 subjects (Group A) with chronic hepatitis, received Pegylated-Interferon-α2b (1.5 mg/kg per week) plus Ribavirin and placebo, while 31 subjects (Group B) received the same dosage of Pegylated-Interferon-α2b plus Ribavirin plus association of Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill for 12 months. All subjects underwent laboratory exams and questionnaires to evaluate depression (Beck Depression Inventory - BDI), anxiety (State-trait anxiety inventory - STAI) and work ability (Work ability Index - WAI).


Eligibility Criteria:
Inclusion Criteria:

* HCV infection

Exclusion Criteria:

* cancer severe jaundice pulmonary and renal chronic diseases prostatic diseases autoimmune diseases diabetes mellitus decompensated cirrhosis pregnancy hemoglobinopathies hemocromatosis