cyrilzakka/clinical-trials huggingface dataset:
Plaque Removal by Triple-Headed Manual Toothbrush

This randomized controlled trial aimed to determine the effectiveness of a plaque removal by triple-headed manual toothbrush by comparing changes in Rustogi Modifiye Navy Plaque Index.

Participants will be divided into two groups and will be made to brush with different designed toothbrushes.

The researchers will compare the plaque removal efficiency of the brushes by comparing the changes in the plaque index of the intervention and control groups before and after brushing.


Eligibility Criteria:
Inclusion Criteria:

* age ranging from 18-60 years;
* a minimum of 12 teeth;
* participants were wanted to be right-handers when toothbrushing to standardization.

Exclusion Criteria:

* Patients with systemic illnesses or conditions,
* smokers and individuals taking any medication that may affect periodontal health were not included in the study.
* Individuals who had previously been treated for periodontal disease in the past 6 months were also excluded.
Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease

The objective of this open-label extension is to assess the long-term effect of the 24-hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non-motor symptoms of Parkinson's disease. The long-term safety and tolerability of the rotigotine transdermal patch will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Completion of trial SP889

Exclusion Criteria:

* Ongoing serious adverse event assessed as related to trial medication
Anxiety and Depressive Symptoms in Placenta Previa / Accreta

placenta previa is an obstetric complication which is associated with depression and anxiety.

As little is known about the emotional reaction to the diagnosis of placenta previa/accrete, a study is badly needed to estimate the magnitude of this problem and its effects on the mother

Placenta previa is an obstetric complication with a prevalence of 5.2 per 1000 pregnancies. placenta previa is associated with maternal morbidity and mortality. The delivery carries a risk of bleeding, emergency hysterectomy, organ damage and even death. During admission, counselling is done for the possible need for delivery at any time and the need for life saving hysterectomy. hysterectomy is a tough and difficult choice for patients, and the subsequent emotional process is often associated with depression, severe and prolonged feelings of sadness, diminished interest in activities and in sexual intercourse. Similarly, severe adverse psychological outcomes, including post-traumatic stress disorders, have been reported as a result of traumatic birth events. Antenatal depression and anxiety occur in approximately 13% and up to 21.7% of women, respectively. Rates of antenatal depression among women hospitalized for obstetrical risk can be as high as 19%.

Research about the responses to a diagnosis of placenta previa is scarce. A study found increased anxiety score in women diagnosed with Placenta accreta spectrum. Other studies focussed on the post-trauma stress associated with hysterectomy versus uterine conservation.

As little is known about the emotional reaction to the diagnosis of placenta previa/accrete, a study is badly needed to estimate the magnitude of this problem and its effects on the mother.

Eligibility Criteria:
Inclusion Criteria:

* patient diagnosed to have placenta previa or accrete
* plan to deliver baby in Assiut women health hospital
* willing and able to participate

Exclusion Criteria:

* pre-existing psychological disorders
* severe medical complications
* severe obstetric complications
* fetal abnormality
Effects of a Therapeutic Exercise Program for Injuries Prevention in Wheelchair Basketball (WB) Players

Shoulder pain is the most common symptom of physical dysfunction in wheelchair basketball players. About the 85% of this population had shoulder pain in some moment of their life. Some studies suggest that exercise is an important tool as an element to treat and prevent shoulder injuries. For that reason, an intervention program would be a useful tool for prevent shoulder injuries in this population.

The purpose of this study is determine the effects of therapeutic exercise program wheelchair basketball players, in order to prevent shoulder injuries.

The hypothesis of the study was that the exercise program was effective to prevent shoulder injuries in this population.

Eligibility Criteria:
Study Population 36 wheelchair basketball players belonging to the male and female preselection Spanish wheelchair basketball national team were recruiting during a campus. The inclusion and exclusion criteria were chosen to include a specific population.

Inclusion Criteria:

* Players belonging to the male and female preselection Spanish wheelchair basketball national team.
* Have the federal license at the Spanish Sport Federation for People with Physical Disabilities available at the time of the study (2015-2016 season).
* For players using wheelchair for daily activities, to use the manual wheelchair at least for 3 hours a day and 6 hours of wheelchair basketball training per week.
* For players not using wheelchair for daily activities, to use the manual wheelchair at least for 6 hours of wheelchair basketball training per week.
* Use wheelchair at least one year before the study and at least one year of experience in the sport competition.
* Acceptance of informed consent.

Exclusion Criteria:

* History of acute injuries in the post-surgical process or dislocation along the year before the study. These conditions may affect the effective of the exercise intervention.
* Differential diagnosis as acute injuries at cervical region and recent traumatic injury in shoulder one year before the study. The exercise program may not be appropriate for these conditions.
Effects of Inhaled Ciclesonide Versus Fluticasone Propionate Versus Placebo on Lower Leg Growth in Prepubertal Children With Mild Persistent Asthma (6 to 12 y) (BY9010/M1-208)

The aim of the study is to compare the effects of ciclesonide inhaled at one dose level twice daily versus fluticasone propionate inhaled at one dose level twice daily versus placebo, on short-term lower leg growth in prepubertal children with mild persistent asthma. The study duration consists of a baseline period (2 weeks), a treatment period (2 weeks for each treatment), and a wash-out period (2 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent by the patient's parent(s) or legal guardian(s) and by the patient, if capable
* Prepubertal stage
* Good health with the exception of asthma
* History of asthma for at least 6 months
* Currently using rescue medication only

Main Exclusion Criteria:

* Childbearing potential (beyond menarche)
* Concurrent diseases or conditions which may subsequently affect growth
* COPD or relevant lung diseases causing alternating impairment in lung function
* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* History of life-threatening asthma
* Current smoking
A Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis

A Phase 2a, multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic effect of ABT-981 in patients with symptomatic, radiographic, and inflammatory knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

1. Radiographic knee osteoarthritis with Kellgren-Lawrence Grade 2 or 3
2. Body Mass Index (BMI) 18-34 kg/m2
3. One or more clinical signs and symptoms of active inflammation in the index knee

Exclusion Criteria:

1. History of allergic reaction to any constituents of the study drug, or to any Immunoglobulin G (IgG)-containing product
2. History of anaphylactic reaction to any agent
3. Significant trauma or surgery to the index knee
4. Severe knee malalignment
5. Any uncontrolled medical illness or an unstable treatment or therapy
Hip POCUS for the Diagnosis of Pediatric Hip Effusion.

Limping is a common complaint among children presenting in the Pediatric ED the evaluation of a limp among infants and toddlers is challenging doe to the lack of specific history and the difficulty in locating the pain - therefore hip sonography is frequently used in the clinical evaluation of these children.

Sonographic examination for the diagnosis of hip effusion is routinely performed by the radiologist, however, since the integration of Point of care Ultrasound (POCUS) as part of the clinical evaluation of children in the ED in many application - Hip pocus is frequently performed by pediatric Emergency Medicine physicians.

The existing data on hip POCUS is scarce and comprised of small uncontrolled studies.

We aimed to examine the specificity and sensitivity of hip Pocus performed by pediatric emergency physicians by comparing it to the scan performed by the radiologist.

the primary outcome measurement is the ability of the POCUS exam to identify or rule out the existence of hip effusion as demonstrated in the formal radiological Ultrasound scan.

Children (0-18 years) presenting to the PED in Meir medical center with limp pain (not due to trauma) or a limp are recruited After consenting to participate in the study and completing the registration process the primary physician who is an approved researcher by the institutes IRB will perform hip POCUS as part of the clinical evaluation and will record his interpretation in the medical file. A formal ultrasound scan will be perfumed additionally by the radiologist. Both examination will be reviewed by POCUS lead physician and the Pediatric radiologist.

The patient's clinical and epidemiological data will be extracted from the electronic chart.

Eligibility Criteria:
Inclusion Criteria: pediatric patients presenting to the PED with the complaint of a limp or a lower limb pain

-

Exclusion Criteria:

* trauma patients
* patients with an obvious diagnosis other than pain resulting from the hip joint on their physical examination.
BIO|MASTER.Edora Family Study

This study is designed as post market clinical follow-up study with CE-marked products to evaluate the AV Opt and LV VectorOpt features in the respective Edora family pacemakers under clinical conditions. Furthermore, adverse events will be evaluated to identify residual risks associated with the use of the BIOTRONIK Edora family pacemakers. The study is further designed to address potential regulatory needs of clinical data for countries and regions not covered by the CE approval.

Study Design

* Open-label, prospective, non-randomized, multicenter, international
* about 13 study sites

Study Endpoints

The following endpoints are defined and will be assessed with descriptive analysis:

1. AV Opt feature:

   The feature's AV delay recommendation was
   1. used as basis for the device programming or is at least considered to be clinically acceptable or
   2. other AV delay values were chosen by the investigator and the recommendation was rated as not clinically acceptable.
2. LV VectorOpt usability using an overall score (categories: excellent, good, average, fair, poor).
3. (S)ADEs and calculation of the SADE free rate until the 6-month follow-up

Eligibility Criteria:
Inclusion Criteria:

* Standard indication for pacemaker therapy or cardiac resynchronization therapy
* Patient is able to understand the nature of the study;
* Patient provides written informed consent;
* Patient is able and willing to complete the planned follow-up visits at the investigational site;
* Patient accepts Home Monitoring® concept;
* Age ≥ 18 years.

Exclusion Criteria:

* Any contraindication for pacemaker or cardiac resynchronization therapy (whichever applies);
* Patient has received or is planned to receive an epicardial LV lead implant;
* Pregnant or breast-feeding;
* Life expectancy of less than 6 months;
* Participation in an interventional clinical investigation
Self-estimates and Objective Blood Alcohol Concentration in Emergency Department

Many patients presenting in Emergency Department (ED) present alcohol acute intoxication. Some previous studies in general population found that young people under- or over-estimated of blood alcohol concentration (BAC). The hypothesis of the study is that self-estimation of BAC by the patient is under-estimated. Moreover, comparing self-estimation of BAC and objective measure of BAC, which is routinely performed in ED, could increase in patients the awareness of the disorders, increase motivation to change of the patient, and increase the rates of seeking-treatment six months after the first evaluation, in particular in patients with alcohol use disorders.

To the investigators knowledge, there is no study investigating self-estimation, compared to objective measurement of blood alcohol concentration in patients with alcohol intoxication presenting to an Emergency Department (ED). The study will assess blood alcohol concentration and self-estimates of BAC, using the Subjective Effects of Alcohol Scale for Measuring Subjective Response to Alcohol in 100 patients with or without alcohol use disorders according to DSM-5 classification (using MINI scale and Alcohol Use Disorders Identification Test (AUDIT)


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted in Emergency Department while intoxicated will be included in the study, including patients with or without alcohol use disorders according to DSM-5 classification.
* aged 15-64 years old
* patients who will be orally informed and receive a written summary
* blood alcohol concentration of 60mg/dl or higher
* Patients not opposed to participating in the study, who have received an oral and written information

Exclusion Criteria:

* Drug intoxication (cannabis, opiates, amphetamines, cocaine), psychotropic medication intoxication (benzodiazepines, antipsychotics), primary neurologic conditions, mental retardation, dementia, amnestic disorders, mental disorders due to a general, medical condition and substance-induced psychotic disorders.
Cardiovascular Risk Markers and Response to Statins After Kawasaki Disease

The purpose of this study is to determine whether Chilean children with history of Kawasaki disease have endothelial dysfunction years after the acute phase of the disease, and if this condition can be modified by treatment with statins.

Kawasaki disease (KD) in its acute phase produces endothelial inflammation that can lead to dilatation and aneurysms of coronary and peripheral arteries. This initial injury leads to persistent endothelial dysfunction several years after having the disease. As a consequence, these patients may have a higher cardiovascular risk than general population. Studies with HMG-CoA reductase inhibitors (statins) have suggested that these have an anti-inflammatory effect over the endothelium, that may be independent of its lipid-lowering effects. The hypothesis of this study is that KD produces endothelial dysfunction that is persistent years after acute disease, and that this dysfunction can be modified by treatment with statins.The study consists of two phases. On the first we will perform ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery and evaluate other cardiovascular risk markers in patients and healthy controls. On the second phase patients with history of Kawasaki disease will be randomized and allocated to treatment with Pravastatin or placebo, after which a new evaluation of flow-mediated dilation of the brachial artery and cardiovascular risk markers will be performed.

Comparison(s): Children older than 8 years of age with history of Kawasaki disease more than 12 months before enrollment, compared with paired by age children without history of KD or other cardiovascular risk factors.

Eligibility Criteria:
Inclusion Criteria:

* History of Kawasaki disease more than 12 months before enrollment
* Present age of 8 years or older

Exclusion Criteria:

* Diabetes mellitus
* Not controlled hypertension
* Treatment with drugs thay modify endothelial function such as angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists, and calcium channel blockers
* Smokers of more than 5 cigarettes per day
* Total cholesterol higher than 250 mg/dl
* Triglycerides higher than 300mg/dl
* Chronic treatment with statins
* Chronic renal insufficiency (creatinine \> 1.5 mg/dl)
Comparison Between Two Strategies of Discharge Planning for the Reduction of Short Term Hospital Readmissions

The purpose of this study is to improve discharge planning effectiveness by comparing two strategies \[on-Demand Discharge Planning (DDP) vs. Routine Discharge Planning (RDP)\], in terms of reduction of hospital readmissions for inpatients classified at intermediate risk of complex discharge using the simplified Blaylock Risk Assessment Screening Score (BRASS).

The purpose of this study is to improve discharge planning effectiveness by comparing two strategies \[on-Demand Discharge Planning (DDP) vs. Routine Discharge Planning (RDP)\], in terms of reduction of hospital readmissions for inpatients classified at intermediate risk of complex discharge using the simplified Blaylock Risk Assessment Screening Score (BRASS).

Five Internal Medicine Unit and four Units of Neurology will be randomized to the two different strategies of discharge planning (RDP or DDP), based on two different alternating sequences of four periods (each period comprising three months). The randomization will be stratified by type of unit.

Patients at risk of complex discharge, according to the simplified BRASS score, are assigned to the Hospital Unit of Continuity of Care (NOCC) team, using the hospital telematics system. Afterwards, the NOCC team proposes an appropriate discharge planning, considering clinical and social needs.

Eligibility Criteria:
Inclusion Criteria:

* Adults patients (age ≥ 18 years);
* Residents in Piedmont, Italy;
* Patients admitted to General Internal Medicine or Neurology Units of Molinette Hospital (Turin)
* Patients with a score in the simplified BRASS between 4 and 6 at admission

No specific exclusion criteria were applied.
Evaluation of Performance Characteristics and Applicability in Oncology of Devices Customized Medical Devices Made by 3D Printing

Technologies 3D are demonstrating enormous potential for innovation in the field of surgery,introducing the concept of "treatment customization" (from planning surgery to implant design and manufacturing) on the patient's anatomy, simply by taking advantage of the patient's own common diagnostic images and the flexibility of 3D printing. In fact, this new construction technology allows the construction of the complex anatomical geometries with economy, simplicity and on scales of production unattainable by other traditional technologies. This new construction technology allows, in fact, the construction of complex anatomical geometries with economy, simplicity and on scales of production unattainable by other traditional technologies.


Eligibility Criteria:
Inclusion Criteria:

* Primary tumor of the pelvic bone Primary meta-diaphysial tumor of the long bones; squamous cell carcinoma of the oral cavity in the upper and/or lower jaw. over 10 years of age
* Primary sarcoma of bone and soft parts involving the scapula, the pelvis and upper and lower limbs; brain tumor aged 7-18 years
* Intracranial oncologic pathology with bone involvement and lesions of the skull theca primary or secondary aged 18-70years
* signed informed consent form

Exclusion Criteria:

* inoperability;
* presence of pathological fractures.
Trial on the Efficacy and Safety of Two Different Glucocorticoid Dose Regimens in Allergic Bronchopulmonary Aspergillosis

Allergic bronchopulmonary aspergillosis (ABPA) is a pulmonary disorder caused by a complex hypersensitivity response to antigens released by the fungus Aspergillus fumigatus. Oral corticosteroids are currently the treatment of choice for ABPA associated with bronchial asthma. They not only suppress the immune hyperfunction but are also anti-inflammatory. However, there is no data to guide the dose and duration of glucocorticoids and different regimens of glucocorticoids have been used in literature. The disorder is highly prevalent in India. The investigators have previously reported their experience with screening stable outpatients with bronchial asthma and acute severe asthma for ABPA. The investigators have also recently reported the prognostic factors associated with clinical outcomes in patients with ABPA.

The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and safety of two different glucocorticoid dose protocols in patients with ABPA.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ABPA
* Presence of all the following three criteria:

  1. immediate cutaneous hyperreactivity on aspergillus skin test
  2. elevated total IgE levels \> 1000 IU/mL
  3. A fumigatus specific IgE levels \> 0.35 kU/L, AND,
* Presence of two of the following criteria:

  1. presence of serum precipitating antibodies against A fumigatus
  2. fixed or transient radiographic pulmonary opacities
  3. absolute eosinophil count \> 1000/µL
  4. central bronchiectasis on HRCT

Exclusion Criteria:

* If they have taken glucocorticoids for more than three weeks in the preceding six months
* Failure to give informed consent
* Enrollment in another trial of ABPA