cyrilzakka/clinical-trials huggingface dataset:
Subscapularis Repair in Reverse Shoulder Arthroplasty

This study will evaluate the subscapularis repair versus non-repair during a reverse shoulder arthroplasty (RSA).

The primary objective of this study is to evaluate pain and function in patients undergoing RSA with or without subscapularis repair. This primary outcome will be measured by analysis of Constant scores at two years post-operative.

Secondary objectives are to evaluate pain, function and imaging, between the two groups at each applicable time point.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is scheduled to undergo a reverse shoulder arthroplasty procedure using the Arthrex ReversTM system.
2. Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.
3. Patient meets FDA cleared indications for reverse shoulder arthroplasty
4. Patient is between 18-100 years old
5. Patient agrees to also be enrolled in the Arthrex Total Shoulder Registry Study
6. Patient has a standard of care pre-operative CT taken within 6 months that has been submitted for Arthrex Virtual Implant Positioning TM (VIP) planning

Exclusion Criteria:

1. Patient has a history of ipsilateral shoulder arthroplasty
2. A history of shoulder septic arthritis
3. A full thickness subscapularis tear
4. An acute or malunited proximal humeral fracture
5. Chronic locked dislocation
6. Rheumatoid arthritis
7. Tumors
8. Axillary nerve damage
9. Non-functioning deltoid muscle
10. Glenoid vault deficiency precluding baseplate fixation
11. Infection and neuropathic joints
12. Known or suspected non-compliance, drug or alcohol abuse
13. Patients incapable of judgement or under tutelage
14. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for imaging etc.
15. The subject is related to investigator as family members, employees, or other dependent persons
16. Any prior open anterior shoulder surgery that included takedown of the subscapularis tendon or violation of the subscapularis tendon (i.e. Latarjet, Bristow)
Transverse Dento-skeletal Effects of Two Rapid Palatal Expansion Appliances in Cleft Lip and Palate Patients

Aim of the study: to compare the effect of Hyrax appliance and the Haas appliance improving the transverse skeletal and dental dimensions in cleft lip and palate patients during mixed dentition.

•Steps in short Full records pre-treatment. Bands selection for upper first molars then construction of expansion appliances(Haas or Hyrax) . Delivery of appliances and instructions to the patients and their parents about their activation regimen 2 quarter turns in the morning and 2 in the evening.The posterior crossbite will be measured as the distance from the palatal cusp tips of upper first molars to central fossae of lower first molars then the needed time for expansion will be calculated .When the time calculated for correction ends, we will stop activation, we will take impressions for digital models to see if real expansion occurred or not and so testing the efficiency of the two appliances.

Afterthat, if correction was not yet achieved, activation of the appliances will continue till overcorrection at the molar region with the palatal cusp tip of the maxillary posterior teeth contacting the buccal cusp tip of the mandibular posterior teeth. We will then leave the appliance insitu for retention.

After 6 months from the first CBCT we will take a second CBCT to see any bony changes .

Eligibility Criteria:
Inclusion Criteria:

* (1) Mixed dentition; (2) Both males and females; (3) Lip repair performed between 3 and 6 months of age and palate repair performed between 12 and 24 months of age; (4) Presence of maxillary constriction and posterior crossbite and need for maxillary expansion previous to the secondary bone graft; (5) Permanent first maxillary molars present; (6) Good periodontal health; (7) No previous orthodontic treatment;

Exclusion Criteria:

* (1) Presence of a syndrome in companion with the present cleft defect (2) Previous secondary alveolar bone grafting (3)Taking medications affecting growth
Intraoral Grafting of Ex Vivo Produced Oral Mucosal Composites

The purpose of this study is to see if we can develop a good graft for oral mucosal tissue that is like the top of the mouth in a "test tube" that could be used successfully in humans. We have already done this successfully mice. The next step is to take a small piece of tissue from a human volunteer and see if we can grow a larger piece of tissue from it outside the human body and graft it back into the same person successfully. We expect that this technique will work. It has already been tried in patients with burns of the skin who have had similar procedures where the skin is grafted back to them. The significance of this research is that oral tissue taken from the top of the mouth or palate is in limited supply and leaves the patient with a painful and uncomfortable post surgery experience. If we are successful with our technique the patient will experience less pain and discomfort from the site that we are using to grow our tissue outside the body than if we had taken it from the top of the mouth or palate. In addition, by waiting longer periods to grow the patient's cells we can make larger pieces of oral tissue than we could have gotten directly from the patient's mouth. Patients who will participate in this study will need to require a soft tissue graft from the mouth to an area that needs additional attached or keratinized mucosa. This will most likely be either in preparation for patients who have or will have dental implants placed. Another subset of patients are those who need scar tissue released or the vestibule of their mouth (area that turns from the gums to the lip) released.


Eligibility Criteria:
Inclusion Criteria:

* Lack sufficient attached keratinized tissue at recipient surgical site in question
Nasal Septum Autologous Chondrocytes Transplantation for Condylar Resorption After Orthognathic Surgery

This clinical study has as main objective to evaluate if the Nasal Septum Autologous Chondrocytes Transplantation for Condylar Resorption is safe and effective in the treatment of degenerative lesions of temporomandibular joint (TMJ). It is a case series, in which 10 participants with diagnosis of condylar reabsorption of TMJ will be selected, with orthognathic surgery indicated. Orthognathic surgery is conventionally indicated for patients with condylar resorption to correct dentofacial deformity and, therefore, will not be performed only in function of this clinical study. The selected participants will be submitted to nasal cartilage biopsy, for isolation and preparation of the chondrocytes. The only experimental group to be evaluated will be the group treated with autologous chondrocytes diluted in hyaluronic acid. The experimental treatment will be performed 15 days after orthognathic surgery, and will be injected through arthrocentesis. Clinical follow- up will be performed in the following periods: 7 and 15 days and 1, 3, 6 and 12 months after treatment. During the consultations, participants will also be evaluated for the intensity and severity of the pain experienced, as well as the disability related to it, through the same system used for the diagnostic classification (RDC / TMD). Imaging of the TMJ will be performed before, 6 and 12 months after the injection of the experimental treatment for bone and cartilaginous joint tissue analysis. Autologous chondrocyte implantation is expected to promote the regeneration of TMJ cartilage tissue safely and effectively.

The only experimental group to be evaluated will be the group treated with autologous chondrocytes diluted in hyaluronic acid, to be included in groups of 2, 4 and 4 participants. Only two participants will initially be included. If these two treated participants do not present adverse effects in 3 months, we will start a second stage with 4 participants. Again we will analyze the group over 3 months and if there are no problems we will include the 4 final participants, totaling the 10 participants.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of dentofacial deformities related to osteoarthritis of TMJ;
2. must have surgical indication.

Exclusion Criteria:

1. pregnant or breastfeeding;
2. infection or other comorbidities;
3. rheumatologic diseases;
4. chronic pain in another joint;
5. chronic use of corticosteroids and immunosuppressants.
Efficacy of Artesunate-amodiaquine (AS-AQ) in Children With Malaria and Severe Acute Malnutrition, Madaoua, Niger 2010

The purpose of the study is to determine whether the artesunate-amodiaquine combination is effective in treating uncomplicated Plasmodium falciparum malaria in children with severe acute malnutrition.

Infection with Plasmodium falciparum malaria remains a significant cause of morbidity and mortality in malnourished children. Malnutrition is known to have a modulating effect on the incidence of malaria infections, its severity and effectiveness of treatments. However, little data exists on antimalarial drug efficacy in malnourished children. Artesunate-amodiaquine combination is the first line treatment used in Médecins Sans Frontières programmes in Niger. The assumption of current efficacy of artesunate-amodiaquine is based on non malnourished children. The aim of this study is to measure the clinical and parasitological efficacy in severely malnourished children.

The study is consistent with the standard WHO protocol for monitoring antimalarial drug efficacy (WHO: Methods for surveillance of antimalarial drug efficacy. Geneva; 2009), except for one inclusion criterion. Severe acute malnutrition is an inclusion criteria, instead of being an exclusion criteria. The study will encompass a pharmacokinetic part that will provide important information on the absorption of the drug.


Eligibility Criteria:
Inclusion Criteria:

* Age between 6 and 59 months
* Weight ≥5kg
* P. falciparum monoinfection confirmed on a thick blood film
* Parasitic density between 1,000 and 200,000 asexual forms/uL of blood
* Measured axillary temperature ≥37.5°C or history of fever during the previous 24 hours
* Severe malnutrition (defined as a weight/height ratio less than -3 z-scores)
* High probability of compliance with follow-up visits (home is within two hours of walk from the outpatient department, no near-term travel plans, etc..)
* Consent of a parent or guardian who is at least 18 years of age.

Exclusion Criteria:

* Signs of a critical illness as defined by the WHO (WHO (2000) Severe falciparum malaria; Clinical features of severe falciparum malaria in children. Royal Society of Tropical Medicine and Hygiene, 94 (supplement 1), 5-11).
* Signs of severe or complicated malaria as defined by the WHO (WHO (2000) Severe falciparum malaria; Clinical features of severe falciparum malaria in children. Royal Society of Tropical Medicine and Hygiene, 94 (supplement 1), 5-11).
* Severe anaemia (haemoglobin \<5 g/dL)
* Known history of hypersensitivity to any of the study medications,
* Symmetric oedema in the feet,
* Concomitant febrile illness not originating from malaria, which could alter the outcome of the study (measles, acute lower respiratory tract infection, otitis media, tonsillitis, abscesses, severe diarrhea with dehydration, etc.),
* History of a full treatment course with the study drug in the past 28 days.
Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy

This study evaluates (risk)factors influencing (in)continence in children with and without a brain injury.

Children with cerebral palsy (CP) (Rosenbaum, 2007) gain bladder and bowel control at older age compared to typical developing children (Ozturk, 2006). The incidence of urinary incontinence during day and night, fecal incontinence and constipation is higher in this population.

Incontinence in children is often treated with urotherapy. This is a nonsurgical, nonpharmacological treatment for lower urinary tract dysfunctions. Standard urotherapy is noninterventional and it includes giving information, instructions, advice regarding life-style, fluid intake and bladder diaries. Additionally specific interventions can be used, such as: various forms of pelvic floor training, behavioral modification, biofeedback, electrical stimulation and catheterization (Neveus, 2006). Recent research has proven urotherapy to be successful for the treatment of children with daytime incontinence (Mulders, 2010).

Despite the high prevalence of incontinence in children with CP the possible treatment strategies in this population are poorly investigated. Far too often, urinary incontinence in children with CP is considered a normal, unavoidable and even a minor problem.

Aim: Analyze (risk) factors influencing (in)continence in children with and without CP.

Possible parameters will be registered through questioning, measurement (uroflow combined with pelvic floor EMG and postmictional residue) and retrospective analysis of the patient files. Parameters will be compared between continent and incontinent children with and without CP. This comparison evaluates whether the same therapeutic strategies can be applied in incontinent children with and without CP.

Eligibility Criteria:
Inclusion Criteria:

* Daytime urinary incontinence with or without enuresis and/or fecal incontinence (Groups with incontinence)
* No urinary or fecal incontinence (Groups without incontinence)
* Cerebral palsy (Groups with children with CP)
* Normal development (Groups with children without CP)

Exclusion Criteria:

* Isolated urinary tract infections
* Isolated enuresis
* Isolated dysfunctional voiding
* Isolated fecal incontinence
* Anatomical abnormalities
* History of genitourinary or renal surgery
* Medication for incontinence during the last 3 months
* Pelvic reeducation during the last 6 months
* Other neurologic problems influencing continence
Cognate Patient Care Insight Scale

Schizophrenia is a disease of young adults that affects 1% of the general population. According to numerous studies, it has been estimated that between 50% and 80% of patients with schizophrenia do not consider to have a mental disorder and are therefore not aware of their disorders. A poor degree of insight is associated with poor compliance, a higher number of re-hospitalizations, altered social and relational functioning, and a higher number of suicides and violent behaviors. This is why insight, which is an essential dimension of psychopathology, must be evaluated, as it depends to a large extent on the therapeutic alliance, adherence to treatment, likelihood of relapse and prognosis.

Evaluation (test, re-test) This new tool for assessing insight will allow for a discrepancy in assessment and a more refined assessment with a view to developing specific care for the patient and / or the relative with regard to the three dimensions Evaluated: disease, treatment and functional implications

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia
* Age from 18 to 50 years old
* Stabilized clinical condition (without therapeutic modification during the month prior to inclusion)
* French language read, spoken and understood (patient and family member)
* Having given his consent
* Agreement of the guardian for persons under guardianship
* Consent of the relative

Exclusion Criteria:

* Refusal of patient or legal guardian
* Refusal of the loved one
* Patient and / or neurological disorder of neurological origin of vascular, infectious or neurodegenerative origin
Behavioral and Affective Skills in Coping (BASIC) Open Trial

The overall objective of the project is to develop and assess the feasibility of a brief, practice-friendly approach to psychotherapy for children, entitled Behavioral and Affective Skills in Coping (BASIC) and designed for use as a first step toward evidence-based practice by practitioners in clinical service settings.

The investigators seek to develop a treatment protocol that integrates five core intervention principles that are common to evidence-based treatments for youth depression, anxiety, and disruptive behavior problems. The protocol will be designed for implementation in everyday community practice settings by practitioners. Because many empirically supported treatments for youth disorders address only one area of impairment, they may not be an ideal fit to community clinics, where (a) most practitioners treat an array of disorders rather than specializing in just one, (b) most referred youths present with multiple disorders, and (c) priority problems and treatment needs may shift for many youths during an episode of care. Moreover, because many evidence-based treatments have been developed in research settings, they may not be designed in ways that are ideal for front-line therapists in community settings. The investigators hope to reduce the difficulty of transporting treatments into community practice by incorporating the perspectives of community practitioners in the development and design of the protocol. By incorporating the feedback of expert treatment developers, the investigators hope to ensure that BASIC is not only appealing to users but also consistent with what has been learned through treatment research over the years. Finally, the trial will provide preliminary evidence on whether this brief "first course" in evidence-based treatment is beneficial for youths with depression, anxiety, and disruptive behavior problems-three clusters that account for a large percentage of youth referrals.

Eligibility Criteria:
Inclusion Criteria:

* 8-15 year-old youth
* The youth will meet diagnostic criteria for one or more target disorders in the broad areas of anxiety (including Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia, Obsessive Compulsive Disorder, Specific Phobia, Panic Disorder, Anxiety Disorder Not Otherwise Specified, Adjustment Disorder with Anxiety), depression (including Major Depressive Disorder, Dysthymic Disorder, Minor Depression, Depressive Disorder Not Otherwise Specified, Adjustment Disorder with Depressed Mood), and conduct (Oppositional Defiant Disorder, Conduct Disorder, Disruptive Behavior Disorder Not Otherwise Specified, Adjustment Disorder with Disturbance of Conduct).

Exclusion Criteria:

* Youth with primary ADHD
* Youth with developmental disorders
* Youth with symptoms of a thought disorder including delusions and hallucinations
Tramadol Hydrochloride and Dexketoprofen Trometamol for the Oral Treatment of Moderate to Severe Acute Pain Following Removal of Impacted Lower Third Molar

The study is aimed to evaluate the analgesic efficacy of TRAM.HCl/DKP.TRIS 75mg/25mg oral fixed drug combination in comparison with TRAM.HCl /paracetamol 75mg/650mg in the treatment of moderate to severe acute pain.

The present phase IV study is a randomised, double-blind, placebo and active-controlled, parallel group study in moderate to severe acute pain after removal of impacted lower third molar.

In this single-dose clinical trial patients are randomized to the following 3 treatment arms in a 2:2:1 ratio:

* TRAM.HCL/DKP.TRIS
* Paracetamol/TRAM.HCL
* Placebo.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged more than 18 years. Females participating in the study must be either non-childbearing potential or routinely using an effective method of birth control resulting in a low failure rate.
* Scheduled for outpatient surgical extraction -under local anaesthesia of lower third molar teeth, with at least one partially impacted in the mandible requiring bone manipulation.
* Pain of at least moderate intensity in the first 4 hours after the end of surgery (NRS score ≥ 4).

Exclusion Criteria:

* History of allergy or hypersensitivity to the study treatments, RM or to any other NSAIDs, opioids and acetyl salicylic acid.
* History of peptic ulcer, gastrointestinal disorders by NSAIDs or gastrointestinal bleeding or other active bleedings.
* History of any illness or condition that, in the opinion of the Investigator might pose a risk to the patient or confound the efficacy and safety results of the study.
* Patients using and not suitable for withdrawing the prohibited medications specified in the protocol.
Impact of Structured Physical Activity Education Delivery in Patients With Type 2 Diabetes Mellitus

The objective of this study is to assess whether a structured exercise program compared to routine recommendation for exercise has any positive impact on disease outcome in patients with type 2 diabetes.

This study aims to assess whether a structured exercise program has an impact on the following determinants of the disease in type 2 diabetes: HbA1C, blood pressure, lipids, body mass index and waist circumference. It also aims to assess the compliance and retention of patients with type 2 diabetes in a structured exercise program.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman with type 2 diabetes
* Ready to begin regular physical activity
* Age equal to or greater than 18
* Age equal to or less than 64.

Exclusion Criteria:

* Any vascular disease
* Exhibits symptoms of coronary artery disease (CAD)
* History of losing balance because of dizziness
* History of losing consciousness
* Has a bone or joint problem that could be made worse by a change in physical activity
* Pregnant
* Has been excluded by the Patient's Physician for any other health-related reason not stated under these exclusion criteria.
Everolimus-Eluting Stent for Bifurcation Coronary Lesions: Comparison of Simple Versus Complex Techniques

The purpose of this study is to evaluate the efficacy and safety of the treatment of true bifurcation lesions with the XIENCE V stent using the simple strategy (stent in main vessel and provisional T-stenting in the side branch) compared to the complex strategy (stent in main vessel and T-stenting in the side branch).


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old.
* True Bifurcation lesion (Medina classification 1-1-1), in at least one main coronary vessel. Diameter of main vessel between 2,5-4mm, and diameter of side branch 2mm or greater.

Exclusion Criteria:

* Significant left main stenosis.
* ST elevation myocardial infarction \< 48 h.
* Thrombus burden target lesion.
* Ejection Fraction \< 30%.
* Severe Renal Insufficiency (creatinine \> 3 mg/dl).