cyrilzakka/clinical-trials huggingface dataset:
The Correlation Between Femoral Component Implanting Flexion Angle and Posterior Condyle Offset in Cruciate Retaining Total Knee Arthroplasty

The main aim and scope is making measurement and comparison about the femoral component posterior offset under different femoral component implanting flexion angle in cruciate retaining total knee arthroplasty. The results may identify the influence of the flexion component implanting flexion angle on the femoral component posterior offset.


Eligibility Criteria:
Inclusion Criteria:

* The patients undertaken the primary cruciate retaining total knee arthroplasty;
* using the curiate retaining total knee arthroplasty prothesis from Biomet and Smith\&Nephew;
* Complete surgery documents and radiologic data,such as standard X-ray postoperative both at antirior-posterior position and medial-lateral position(overlap of the medial and lateral femoral condyle).

Exclusion Criteria:

* The patients without standard X-ray postoperative both at antirior-posterior position and medial-lateral position(poor overlap of the medial and lateral femoral condyle);
* Complex primary total knee arthroplasty, using extra component such as trabecular metal,stem or et al.
Management of the Fresh Extraction Socket in the Aesthetic Area

After atraumatic tooth extraction and the assessment of the feasibility of immediate implant placement, patients will be randomly assigned to one of three treatment concepts:

1. Immediate Implant Placement and Immediate Provisionalization
2. Alveolar Ridge Preservation. After 4 months of healing an implant will be placed with simultaneous GBR and/or Soft Tissue Augmentation procedures, if needed.
3. Spontaneous Healing of the socket. After 4 months of healing, an implant will be placedwith simultaneous GBR and/or Soft Tissue Augmentation procedures, if needed.

In all groups, four months after implant placement, a prosthesis will be delivered. From this experimental period onward, patients will be scheduled for maintenance. Clinical, radiographic and volumetric assessment will be performed by clinicians not involved in the surgery and blind with respect to treatment assignment at 1, 3 and 5 years post loading.

The overall objective of this study will be to compare the three treatment modalities after tooth extraction (immediate implant placement, alveolar ridge preservation, spontaneous healing) in terms of:

* patient-related (morbidity) outcomes during surgical procedure and the first 2 weeks after the surgical procedure
* cost-effectiveness ratio (treatment time, number of surgeries, number of appointments and overall appointments time, need for bone and soft tissue augmentation, overall costs) at the time of prosthesis delivery
* volumetric bone and soft tissue changes of the site before treatment (prior to tooth extraction), 4 months after tooth extraction, 1, 3 and 5 years after final prosthesis.
* clinical, radiographic, aesthetic and patient-related (satisfaction) outcomes at the time of prosthesis delivery and 1, 3 and 5 years after final prosthesis.
* Implant Success and Survival at 1, 3 and 5 years after final prosthesis.

Eligibility Criteria:
Inclusion Criteria:

* single tooth extraction in the anterior region of the dentition (including premolars) to be extracted
* smoking no more than 10 cigarettes/day,
* periodontal health (BoP \< 10%) and good plaque control (\< 20%)
* absence of symptomatic periapical radiolucencies, acute abscesses at the site of extraction,
* extraction sites with less than 30% loss of one or more walls
* adequate quantity and quality of native bone to achieve primary stability

Exclusion Criteria:

* growing patients
* patients with autoimmune disease, uncontrolled diabetes or immunocompromised
* history of head and neck radiation for cancer treatment,
* pregnancy
Efficacy and Safety Study for Subjects With Mild-to-Moderate Alzheimer's Disease

This is a efficacy and safety study evaluating new treatment for subjects with mild to moderate Alzheimer's Disease.

This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in approximately 260 adults with mild-to-moderate Alzheimer's disease (AD). Subjects will be randomized to one of the four treatment groups (ABT-126, donepezil, or placebo) for a 12-week Treatment Period. Acronyms are listed in the secondary outcome section, below, you will find a list of the acronyms defined:

* MMSE - Mini Mental Status Exam
* QoL-AD - Quality of Life - Alzheimer's Disease
* CIBIC-plus - Clinician Interview-Based Impression of Change
* NPI - Neuropsychiatric Inventory
* CSDD - The Cornell Scale for depression in Dementia
* ADCS-ADL - Alzheimer's Disease Cooperative Study - Activities of Daily Living

Eligibility Criteria:
Inclusion Criteria:

* The subject is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit 1.
* The subject meets the NINCDS/ADRDA criteria for probable AD.
* The subject has a Mini-Mental Status Examination (MMSE) total score of 10 to 24, inclusive, at Screening Visit 1.
* The subject has a Modified Hachinski Ischemic Scale (MHIS) score of less than or equal to 4 at Screening Visit 1.
* If female, subject must be postmenopausal for at least two years or surgically sterile
* The subject has an identified, reliable, caregiver.

Exclusion Criteria:

* The subject is currently taking or has taken a medication for the treatment of Alzheimer's disease or dementia within 60 days prior to Screening Visit 1
* The subject has a history of any significant neurologic disease other than AD.
* In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness.
* The subject has reported history of discontinuation of donepezil due to lack of efficacy.
* The subject has a history of intolerance or adverse reaction to donepezil that led to discontinuation.
* The subject has a known hypersensitivity to donepezil, piperidine derivatives, or any of the excipients in either donepezil hydrochloride or ABT-126 formulations.
* Patient uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence.
* Subjects with AST and ALT values at Screening Visit 1 that are greater than or equal to 1.5-fold the upper limit of normal (ULN).
The Effects of a Systematic Pain Assessment Approach on Critically Ill Patients Outcomes in ICU

The purpose of this study is to investigate the effectiveness of a systematic approach to pain assessment in the critically ill patients' outcome The investigators hypothesize that, patients who will undergo systematic pain assessment and they will have their results notified to physicians and nurses, will demonstrate favorable effects on pain intensity, more efficient use of sedatives and analgesics, duration of mechanical ventilation, length of ICU stay, mortality, adverse events and complications, in relation to patients who will receive standard care alone. Moreover it is expected that they will demonstrate altered levels of plasma neuropeptides and biochemical markers in peripheral blood.

Appropriate pain management depends on the systematic and comprehensive assessment of pain. Inaccurate pain assessment and the resulting inadequate treatment of pain in critically ill adults can have significant physiological and psychological consequences.

The investigators will examine whether a systematic pain assessment approach can improve patients outcomes.

120 ICU patients will be randomized either to control or intervention group. The control group will receive standard care plus pain assessments but nurses and physicians will be blind of these results. The intervention group will receive standard care plus systematic pain assessment and the results will be notified to nurses and physicians.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* All patients with an estimated source of pain or due to immunological process as trauma, surgery, or due to general factors such as endotracheal intubation, interventional catheters

Exclusion Criteria:

* Length of stay in the ICU \<24 hours
* The patient receives neuromuscular blockers,
* The patient has a disease or condition, such as Guillain-Barre, peripheral neuropathy, which modifies sensory transmission of painful stimuli
* The patient has a disease or condition which complicates the assessment of pain behavior, such as decerebration or vegetative state, agitation\> 3 in the Richmond Agitation sedation Scale (RASS)
Changes in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected Individuals

Randomized controlled parallel open-label study in people living with HIV and at least 6 month of treatment with dolutegravir/abacavir/lamivudine prior to inclusion.

Participants (n=95) are randomized to continue 3 drug-regimen dolutegravir/abacavir/lamivudine (control) or switch to two-drug regimen with dolutegravir/lamivudine (intervention). Follow-up is 48 weeks. Data is collected at baseline and week 48. Primary outcome is changes in weight from baseline of more than 2 kg. Secondary outcomes are changes in cardiac risk, composition and calcification of the heart tissue, and changes in body composition and metabolism, inflammation and coagulation. A MRI substudy is applied to focus on the cardiac adverse effects of abacavir.

In the MRI sub study 40 patients from the main study (20 from each group) are included. A cardiac MRI are performed at baseline and week 48 to evaluate cardiac effects of abacavir.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Diagnosed HIV
* At least 6 months of ongoing treatment with dolutegravir/ abacavir/lamivudine
* Plasma viral load (HIV-RNA) \< 50 copies/ml at inclusion

For women of childbearing potential:

* Negative pregnancy test
* Willingness to use contraceptive (consistent with local regulations) during study period

Exclusion Criteria:

* Pre-existing viral resistance mutations to lamivudine or to dolutegravir
* Presence of hepatitis B antigen (HBsAg) or Hepatitis B virus DNA (HBV DNA)
* Cancer within past 5 years
* Diabetes, cardiovascular disease or other chronic illness considered stable as assessed by the treating physician

For women of childbearing potential:

* Pregnancy
* Breastfeeding
Dietary Sodium, Oxidative Stress, and Pulsatile Hemodynamics

High sodium diets impair vascular function, which may influence the work of the heart. This investigation is designed to determine if this change in vascular function results in a greater workload in the heart and if people who regularly exercise are protected from these effects.

Excess dietary sodium is associated with cardiac hypertrophy independent of changes in blood pressure. Importantly, increased arterial pulsatile load predicts left ventricular hypertrophy, and thus presents a potential mechanism through which high dietary sodium augments cardiovascular disease risk.

While high sodium diets impair vascular function via an increase in oxidative stress, how high sodium influences central pulsatile hemodynamics is not known. This project aims to a) determine how impaired vascular function affects pulsatile hemodynamics and thus influences the work of the heart during periods of high sodium consumption and b) examine whether regular aerobic exercise and/or fitness protects against the deleterious effects of excess sodium.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals (age 21-45) who are either sedentary (1 or less days of exercise per week during past year) or habitually active (4 or more days of aerobic exercise per week for a minimum of 1 year)

Exclusion Criteria:

* Body mass index \<18 or \>35
* Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90
* Blood donation within past 8 weeks,
* Glucose 6 phosphate dehydrogenase (G6PD) deficiency
* A history of cancer, diabetes, or any other chronic disease
* A history of any heart disease
* A history of hormone therapy
* Use of nicotine products
* Pregnancy
* Nursing mothers
* Participation in regular physical activity greater than 1 day/week- but less than 4 days/week
Impact of Pharmacotherapy Management in Patients With Alzheimer's Disease

In Brazil, patients with Alzheimer's disease (AD) receiving free drugs of government. Even having access to, little is known about the effectiveness, safety and adherence of drug therapy in this group of patients. The research aims to promote adherence and develop strategies to address Drug-Related Problems (DRP's) in AD patients elderly of reference centre for the Elderly of Araraquara. The clinical parameters will be assessed at the beginning and after the educational intervention period from April 2014 to April 2015.

Dementia is characterized by memory loss associated with cognitive impairment, which directly interferes in learning process, social and professional performance, besides being the main cause of dementia or Alzheimer's disease (AD). In Brazil, patients are medicated for AD through "Programa de Medicamentos Excepcionais" (Exceptional Drug Program) that ensure the patient´s treatment by providing high cost medications. Even having access to, little is known about the effectiveness, safety and adherence of drug therapy in this group of patients. The research aims to promote adherence and develop strategies to address Drug-Related Problems (DRP's) in AD patients. For this end, we intend to conduct a descriptive, almost experimental and longitudinal uncontrolled research, from April 2014 to December 2015, at the CRIA: "Centro de Referência do Idoso de Araraquara" (Reference Centre for the Elderly of Araraquara). Patients included in the research must have a diagnosis of AD and must be using drugs supplied by the "Programa de Medicamentos Excepcionais". For data collection pharmaceutical care will be employed as a technique, carried out through pharmaceutical meetings, including the steps of initial assessment, care plan (pharmaceutical intervention) and results evaluation. The results will be monitored for pharmacotherapy adherence, cognitive assessment and other clinical parameters related to their health problems and resolution of DRP's before and after the proposed follow-up.The expected outcomes include knowledge of the medication experiences of AD patients, how they influence the adherence and other DRP's and how they can contribute by solving these problems, in addition to the impact evaluation of pharmaceutical care in cognitive improving and other clinical parameters monitored and evaluated individually.

Eligibility Criteria:
Inclusion Criteria:

* Elderly patients who are assisted in CRIA, diagnosed with Alzheimer's in use of rivastigmine or donepezil or galantamine, assisted by the "Program for special drugs".
* Be resident in the city of Araraquara / SP
* Accept part of pharmacotherapeutic follow-up;
* Sign the Statement of Informed Consent Form (ICF).

Exclusion Criteria:

* Fold over pharmacotherapy follow-up;
* Being institutionalized;
* Patients unable to respond to collection instruments MMSE and CDR data;
* Patient without phone contact.
International Severe CRSwNP Registry 2024-2028

The objective of the study is to collect real-life data worldwide, which already have been collected in national databases, to merge the data and the knowledge with the focus of better care for the individual patients, more efficient use of the hospital cost of biologics and working for "personalized medicine".

Regional or national registries have evaluated the efficacy of different biologics in severe uncontrolled CRSwNP coordinated by several academic centres in Europe. At present, these registries have not been merged nor allowed the comparison in real-life efficacy between the 3 different monoclonal antibodies (mepolizumab, dupilumab, omalizumab) with different mechanism which has been approved for the indication of CRSwNP and the effect of the nasal polyp score. Some countries have allowance for some of the different biologic drugs, other countries have other combination of the drugs. Despite the heterogeneity in availability of biologics for the indication of CRSwNP, the merge of data might lead to very interesting outcomes.

The objective of the study is to collect real-life data worldwide, which already have been collected in national databases, to merge the data and the knowledge with the focus of better care for the individual patients, more efficient use of the hospital cost of biologics and working for "personalized medicine".

Compare the outcomes of different biologics in different national registries, at screening and 6-month follow-up: Primary aims:

1. Delphi process to point at the viable of importance.
2. The speed and size of SNOT-22 reduction
3. The speed and size of NPS reduction
4. The speed and size of Nasal congestion score (NCS) reduction
5. The speed and size of smell score increase.
6. The CTscan/Lund-Mackay score response
7. The evolution of the response on VAS scale (patients)
8. The Type 2 biomarkers at entrance and during the study
9. The (non)responder percentages defined based on EUFOREA criteria
10. The use of OCS (amount and frequency)
11. The frequency and time (days) since last sinus surgery
12. The effect of biologics on comorbidities (atopic dermatitis, allergic rhinitis, asthma and NSAID intolerance) in patients with CRSwNP
13. The reduced in need of Otrivin or similar drugs
14. Differences between inclusion criteria for biologic drugs, and differences between countries.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of CRSwNP
* Indication for biologic treatment as suggested by EPOS/EUFOREA
* Have been followed for 6 months

Exclusion Criteria:

* Unilateral polyps
* Non-Type-2 inflammation
* Treatment less than 6 months
BAT Cow's Milk for the Replacement of the Food Challenge Test

The prevalence of children suspected of a cow's milk allergy is 17% in the Netherlands. Cow's milk diagnosis is based on a food challenge test However, this food challenge test is expensive, time consuming, risky, with waiting lists of several months. This waiting time results in unnecessarily long-term use of expensive hypoallergenic milk formula Therefore, there is a great need to introduce a better and faster diagnostic test for cow's milk allergy diagnosis in standard care. The in vitro Basophil Activation Test (BAT) is cheap, quick (result \< 1 day, no waiting list), safe for the child and is a reliable alternative for the food challenge test to diagnose an IgE-mediated allergy. A diagnostic work-up with the BAT is expected to achieve a relevant reduction in the number of expensive and risky food challenges and the prescription of hypoallergenic formula. The reduction in diagnostic delay will increase quality of life.

Objective: Determination of the (cost)effectiveness of the replacement of the expensive, risky and time-consuming food challenge test by the Basophil Activation Test (BAT) for the diagnosis of an IgE-mediated cow's milk allergy in children.


Eligibility Criteria:
Inclusion Criteria:

1. Age 0-12 years
2. Suspected of cow's milk allergy with one or more of the following complaints after intake of cow's milk:

   * angioedema
   * urticaria
   * sneezing and rhinitis \<2 hours after feeding
   * sensation of swelling in the throat and/or difficulty swallowing \<2 hours after feeding
   * voice change/hoarseness \<2 hours after feeding
   * cough \<2 hours after feeding
   * wheezing and/or shortness of breath \<2 hours after feeding
   * loss of consciousness \<2 hours after feeding
   * vomiting or abdominal pain or diarrhoea \<2 hours after feeding in children \<4 years only in combination with IgE-mediated complaints in other tracts
3. Placed on a waiting list for a hospital food challenge test
4. Blood draw for cow's milk sIgE and BAT \< 3 months before the food challenge test. This blood draw will be simultaneously scheduled with a blood draw for regular diagnostics.
5. Signed informed consent parents/guardians

Exclusion Criteria:

1. Age \> 12 years
2. Suspicion of Food Protein-Induced Enterocolitis Syndrome (FPIES)
3. Eosinophilic esophagitis due to a cow's milk allergy
4. Suspected cow's milk allergy \<4 years with crying and/or agitation and/or eczema and/or abdominal pain and/or failure to thrive and/or blood loss per anum and/or diarrhoea and/or reflux and/or vomiting as the only manifestation of the allergy without IgE-mediated symptoms in another organ system
5. Systemic immunosuppressant use
6. Other underlying chronic conditions (immunological, oncological, chromosomal abnormalities).
Safety and Efficacy Study of RENEWAL 4 AVT

The purpose of this study is to assess the safety and effectiveness of the CONTAK RENEWAL 4 AVT device.

This is a prospective, two-arm, non-randomized, multi-center European field following, designed to demonstrate the safety and effectiveness of the CONTAK RENEWAL 4 AVT device in humans.

Eligibility Criteria:
Inclusion Criteria:

* Indications for the device
* Availability for follow-up at an approved Field Following center, at the protocol defined intervals
* Willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
* Prescribed to stable optimal pharmacologic therapy for HF
* Age 18 or above, or of legal age to give informed consent specific to national law
* Able to provide documented evidence of one or more episodes of AF/AT within 12 months of implantation NOTE: Guidant recommends anticoagulation therapy per physician discretion.

Exclusion Criteria:

* Right bundle branch block morphology
* Life expectancy of less than six months due to other medical conditions
* Expectation of a heart transplant during the period of the study
* Patients with or who are likely to receive a mechanical tricuspid valve during the course of the study
* Have a preexisting unipolar pacemaker that will not be explanted/abandoned
* Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) within 180 days prior to enrollment
* Have a known hypersensitivity to dexamethasone acetate
* Enrolled in any other study, including drug investigation
* Women that are pregnant or planning to become pregnant
* A Cerebral Vascular Event/ Transient Ischemic Attack within 12 months of implantation
* During the four weeks prior to implantation, a patient experiences an episode of AF \>= 48 hours in duration and was not anticoagulated for at an adequate therapeutic level (INR \>= 2.0) for the 4 weeks prior to enrollment
Office Hysteroscopy in Secondary Infertility After Cesarean Section

All women with history of secondary infertility after caesarean section will be subjected to office hysteroscopy according to Royal college of obstetrics and gynecology guidelines to diagnose any subtle uterine abnormalities not detected by conventional means.

Hysteroscopic examination will be done during the proliferation phase of the menstrual cycle.

The hysteroscopic evaluation will include assessment of the cervical canal, intrauterine lesions, the endometrium and the uterotubal junction. .

If hysteroscopy reveal a lesion, its type, size, location will be recorded. Transvaginal ultrasound will be done after the procedure to detect fluid in the douglas pouch to confirm patent tubes.

Asses the uterine scar in details.


Eligibility Criteria:
Inclusion Criteria:

* Patients with secondary infertility more than 2 years after cesarean section.
* Normal semen analysis
* Normal hysterosalpingography or laparoscopy within 1year
* Evidence of ovulation by transvaginal ultrasound

Exclusion Criteria:

* • Cases with abnormal semen parameters.

  * Patients with abnormal hysterosalpingography.
  * Patients with anovulation.
  * Hormonal disturbances; high level of prolactin, thyroid hormone disturbances, very high or very low follicular stimulating hormone and luteinizing hormone
  * Patients known to be epileptic or with history of fits.
  * Cardiac patients ( valve diseases, ischemic, arrhythmic)