cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of Stability of Dental Implant Placed Simultaneously With Closed Sinus Lifting Using Hydraulic Lift Technique Versus Summer's Osteotome Technique in Posterior Edentulous Maxilla (RCT)

Clinical evaluation of stability of dental implant placed simultaneously with closed sinus lifting using hydraulic lift technique versus summer's osteotome technique in posterior edentulous maxilla (RCT)

Clinical evaluation of stability of dental implant placed simultaneously with closed sinus lifting using hydraulic lift technique versus summer's osteotome technique in posterior edentulous maxilla (Randomised clinical trial)

Eligibility Criteria:
Inclusion Criteria:

* Edentulous patients in the maxillary posterior region.
* Patients in need to fixed restorations in posterior region.
* Patients with healthy systemic conditions. (Apparently medically free)
* Patients with adequate inter-arch space for placement of the prosthetic part of the implant .
* Patients who had approximately 5-8 mm of available bone height between crest of bone and floor of sinus
* Both sexes.
* Patients with Good oral hygiene
* Patients more than 20 years old
* Cooperative and motivated patients

Exclusion Criteria:

* Patients with local pathological defects related to posterior maxilla.
* Heavy smokers.
* Abnormal habits that may alter results such as alcoholism or parafunctional habits.
* Patients with systemic diseases that may affect normal healing.
* Patients with psychiatric problem
* Patients with history of recent radiation therapy to the head and neck area.
* Patients with aggressive periodontitis.
Evaluation, Treatment and Monitoring of Patients With a Known or Suspected Parasitic Infection

The purpose of this study is to evaluate, treat and follow patients with parasitic infections.

People with a known or suspected parasitic infection who are at least 1 year old may be enrolled. This study does not involve any experimental treatments.

Participants will have a physical examination and laboratory tests on blood, stool, or urine. Blood samples may be collected at regular intervals, but no more than 450 ml (15 ounces) of blood will be drawn from adults, and no more than 7 ml (1-1/2 teaspoons) per kg (2.2 pounds) of body weight from children, in any 6-week period. Other tests may include x-rays, electrocardiogram (EKG), or tissue biopsy (surgical removal of a small tissue sample), depending on the individual s condition.

Patients may be offered treatment or may be referred to another study that is more appropriate for the problem. Any treatment provided in this study will be according to standard medical practice for the patient s specific medical problem. Patients responses to treatment will be evaluated at regularly scheduled clinic visits. The length of time between visits and the total duration of the study for a given individual will be determined by the study doctor, based on that person s medical condition.

This study is designed as a prospective study to evaluate and treat patients with parasitic infection. Patients with known or suspected parasitic infection will be enrolled and will be evaluated for the presence of a parasitic infection. Minimal studies scheduled for each visit will include a medical history, physical examination, routine laboratory tests, and specialized diagnostic procedures for possible parasitic infections. Treatment plans will be individualized for each patient's particular condition, and the number and length of additional visits and diagnostic evaluations will vary accordingly. Specific treatment regimens will be in accordance with standard medical practice.

Eligibility Criteria:
* INCLUSION CRITERIA:

Age 3 or over.

Access to a primary medical care provider outside of the NIH

Clinical evidence suggestive of a parasitic infection

EXCLUSION CRITERIA:

Less than 3 years of age

No evidence suggestive of a parasitic infection
GLOBAL Clinical Study

The GLOBAL study is an international multi-center, prospective study designed to enroll up to 10,000 consecutive eligible subjects who are clinically referred for coronary CT angiography for assessment of suspected coronary artery disease (CAD).

The purpose of the study is to perform extensive biomarker analysis of atherosclerosis in patients phenotyped using advanced imaging modalities of atherosclerosis.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 18-90
2. Caucasian and of Non-Hispanic or Non-Latino origin
3. Referral for coronary CT angiography to evaluate for presence of CAD
4. The patient has signed the appropriate Institutional Review Board approved Informed Consent Form

Exclusion Criteria:

1. Immunosuppressive or immunomodulatory therapy including any dose of systemic corticosteroids in the preceding 30 days (except if steroids are administered as pre-medication prior to contrast administration for CT scan within 24 hours).
2. Chemotherapy in the preceding year
3. Major surgery in the preceding 2 months
4. Blood or blood product transfusion in the preceding 2 months
5. Subjects for whom coronary CT angiography is contraindicated per institutional standard of care
6. Subjects with previous coronary arterial revascularization (PCI or CABG)
7. Subjects with atrial fibrillation/flutter or frequent irregular or rapid heart rhythms, which occurred within the past 3 months
8. Subjects with a pacemaker or implantable cardioverter-defibrillator implant
9. Active congestive heart failure or the presence of known non-ischemic cardiomyopathy
10. Known genetic disorders of atherosclerosis, lipid or lipoprotein metabolism
Clinical Study to Evaluate the Correction of Facial Wrinkles and Folds and Safety of YVOIRE Volume Versus Perlane in Nasolabial Fold Injection

This study was purposed to evaluate the non-inferiority of YVOIRE volume, a hyaluronic acid product, in terms of correction of wrinkles and safety in nasolabial fold deep-dermal injection, compared to Perlane, the control preparation.


Eligibility Criteria:
Inclusion Criteria:

1. Age: Women in 30\~55 years.
2. Those whose wrinkle scores in the treatment site (nasolabial fold) at the screening visit were Stage 3 or 4 in the 5-stage Wrinkle Severity Rating Scale (WSRS) symmetrically
3. Those who were informed on this study in detail, understood it completely, decided to participate in the study own their own and signed on the informed consent form.

Exclusion Criteria:

1. Those with a skin disease in the face (skin infection, eczema, psoriasis, rosacea, herpes etc.)
2. Those with a history of severe allergy
3. Those with hypertrophic scar or a history of kelloid
4. Patients with an autoimmune disease
5. Those with hepatic dysfunction or abnormality in coagulation, or those administering an anticoagulant (aspirin, warfarin etc.) concomitantly
6. Those who had used a local topical preparation (steroid, retinoid) within 4 weeks prior to the study
7. Those who had underwent a chemical peeling, laser procedure (including IPL) or insertion of other bioadaptive materials (however, those who had been treated with HA filler could participate in the study if the date of treatment was known and the investigator judged that the filler effect had disappeared).
8. Patients with a malignant tumor
9. Women in pregnancy or lactation
10. Hepatitis carriers or VDRL/HIV positive patients
11. Those with a hypersensitivity to the investigational medical device of this study
12. Other persons including those considered as difficult to perform this study by the principal investigator
Effects of Probiotic and Prebiotic Combinations on Premature Infants

The purpose of this study is to see how oral preparations containing both probiotics and prebiotics impact the growth, bacterial colonization of the intestines, and fecal short chain fatty acid content in premature infants. Our hypothesis is that short term growth will be improved, the stool will have more healthy bacteria, and the fecal short chain fatty acid content will increase in the babies who receive the probiotic/prebiotic combinations compared to control groups.

Premature infants are at risk for a devastating infection of the intestines due to the immaturity of their intestines and immune system. Probiotics are bacteria with healthful qualities that are taken by mouth to improve the number of healthy bacteria in the intestines. Probiotics have been shown in several studies outside the U.S. to decrease the risk of serious intestinal infection and in one small study to improve the rate of weight gain in premature infants. Prebiotics are food supplements that stimulate the growth of healthy bacteria and suppress the growth of unhealthy bacteria. Prebiotics have been shown to improve the numbers of healthy bacteria in the stool of premature babies. Our study is designed to compare two over the counter probiotic/prebiotic combinations to each other and to a control group. Infants less than 35 weeks with a birthweight of 750-2000 gm are eligible and must be enrolled in the study within the first week of life. The babies are randomly assigned to either a control group (no probiotic/prebiotic, just a placebo), a group which receives Culturelle (Lactobacillus rhamnosus GG plus fructo-oligosaccharide, ConAgra), or a group which receives ProBioPlus (three strains of Bifidobacteria plus Lactobacillus acidophilus plus fructo-oligosaccharide, UAS Laboratories). The babies receive the study product by mouth twice daily for 28 days or until discharge (whichever comes first). Weekly measurements (weight, length, head size) and stool cultures are performed. Clinical progress is closely monitored and any episodes of infection are recorded.

Eligibility Criteria:
Inclusion Criteria:

* less than 35 weeks gestation, birth weight 750-2000 grams
* born in or transferred to University of California Davis Medical Center within first week of life
* less than eight days of age at the time of enrollment

Exclusion Criteria:

* Severe intestinal or cardiac congenital anomalies
A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)

This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both intradermally and subcutaneously at various doses.

This is an exploratory, randomized, partially blinded, multicenter clinical study designed to compare safety and biomarkers of varicella zoster virus immunogenicity when administering ZOSTAVAX™ (V211) at various doses both intradermally and subcutaneously in healthy male and female participants 50 years of age and older.

Eligibility Criteria:
Inclusion Criteria:

* Prior history of varicella (chickenpox) or residence in a country with endemic varicella zoster virus infection for at least 30 years
* Temperature less than 100.4 °F on day of vaccination
* Female participants of reproductive potential must have a negative pregnancy test and agree to remain abstinent or use two acceptable contraceptive methods for 3 months postvaccination
* In good health

Exclusion Criteria:

* History of hypersensitivity reaction to any vaccine component, including gelatin or neomycin
* Household exposure to pregnant women who have not had chickenpox and have not been vaccinated against varicella or to immunosuppressed/immunodeficient individuals
* Household or workplace exposure to children 18 months and younger who have not been vaccinated against varicella
* Prior history of herpes zoster
* Prior receipt of any varicella or zoster vaccine
* Received or is expected to receive immune globulin and/or blood products from 5 months prior to randomization through 42 days after vaccination
* On immunosuppressive therapy
* Known or suspected immune dysfunction
* Received a live virus vaccine or is scheduled to receive a live virus vaccine from 4 weeks prior to study vaccination through the completion of all study visits
* Received any inactivated vaccine or is scheduled to receive any inactivated vaccine from 7 days prior to study vaccination through 7 days postvaccination, except for inactivated influenza vaccine
* Not ambulatory
* Pregnant or breastfeeding
* Use of nontopical antiviral therapy with activity against herpes viruses
* Active untreated tuberculosis
Dexpramipexole SAD/MAD Study

This Phase 1 study will explore the safety, tolerability, and pharmacokinetics of single doses ranging from 300 to 600 mg and multiple daily doses ranging from 225 mg to 300 mg BID dexpramipexole in healthy volunteers.

Preclinical and clinical data to date support the exploration of doses of dexpramipexole higher than 150 mg twice daily for their effectiveness in slowing the progression of ALS. Exploration of doses of dexpramipexole higher than 150 mg twice daily is justified by preclinical and clinical data that suggest that higher doses could potentially be more effective in slowing the progression of ALS than the dose of dexpramipexole currently being explored in Phase 3 studies (150 mg twice daily).

This is a Phase 1, single-center, blinded, randomized, placebo controlled, ascending-dose study consisting of 2 parts; Part A (single-ascending dose \[SAD\]) and Part B (multiple ascending dose \[MAD\]). The study will explore safety, tolerability, and pharmacokinetics of single doses ranging from 300 to 600 mg and multiple daily doses ranging from 225 mg to 300 mg BID dexpramipexole in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Must give written informed consent.
* Adult males/females aged 18 to 55 years inclusive and between 19 and 30 kg/m2 body mass index (BMI), inclusive at screening.
* Subjects who are healthy as determined by prestudy medical history, physical examination and 12-lead ECG.
* Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 1 month (females) or 3 months (males) after their last dose of study treatment.
* Normal systemic blood pressure defined as a systolic blood pressure of 90 to 140 mmHg and a diastolic blood pressure of 50 to 90 mmHg.

Exclusion Criteria:

* History of cardiovascular disease (e.g., hypertension, arrhythmia, heart failure, Long QT Syndrome, or other conditions/diseases causing prolongation of the QT/QTc interval).
* A prolongation of QT/QTc interval (e.g., repeated demonstration of a QT/QTc interval \>450 ms before study treatment administration) at screening, admission or pre-dose on Day 1.
* Any clinically important abnormalities in resting ECG that may interfere with the interpretation of QTc interval changes at screening, admission or pre-dose on Day 1.
* Prior exposure to dexpramipexole.
* Treatment with pramipexole or any dopamine agonist within 1 year.
* Treatment with another investigational drug or approved therapy for investigational use within 30 days, or 5 half-lives (whichever is longer), or in follow up for any other drug, biologic, or device study.
* Currently active infection or serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -2 as determined by the Investigator.
* Female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study.
Lingual Frenum and Articulation of Phonemes

Purpose To investigate the relationship between lingual frenum and possible alterations in the articulation of phonemes.

Methods This is a quantitative observational study, the individual operative kind with transversal time reference. The population sample consisted of 16 individuals, each one with their phonological system complete. The data were captured through an application form that contained relevant aspects as to the qualitative-classification of the lingual frenum, quantitative-relation of mouth opening, with and without the tongue in the papillae, tongue mobility and ERT - 78 phonologically balanced words.

The data were captured through an application form that contained relevant aspects as to the qualitative-classification of the lingual frenum, quantitative-relation of mouth opening, with and without the tongue in the papillae, tongue mobility and ERT - 78 phonologically balanced words.

Eligibility Criteria:
Inclusion Criteria:

* patients with the frenulum of the tongue - the presence of the central incisors and upper and lower side

Exclusion Criteria:

* patients in speech therapy aimed at enabling oral motor or speech - without integrity orofacial motor - patients using grid palate - with changes in the temporomandibular joint - anterior open bite
Effects of Chest Physiotherapy (CPT) on Lung Clearance Index (LCI) in Non Cystic Fibrosis (CF) Bronchiectasis

This study will investigate the effects of on technique of chest physiotherapy on pulmonary function. Effects of pulmonary function will be measured by the spirometry, body plethysmography and by the multiple breath nitrogen washout technique.

This is a before-after intervention study.

Spirometry, body plethysmography and then multiple breath nitrogen washout will be measured before the application of chest physiotherapy.

The chest physiotherapy technique used will be autogenic drainage during 30 minutes. A resting period of 5 minutes will be given to the participant before the following tests.

Spirometry, body plethysmography and then multiple breath nitrogen washout will be measured again, in the same order, after the application of chest physiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Non cystic fibrosis bronchiectasis in stable state

Exclusion Criteria:

* Not in stable state
* Bronchiectasis with severe respiratory morbidities likely to reduce the chest physiotherapy session efficacy (e.g. : severe chronic obstructive pulmonary disease)
Manually Versus Digitally Fabricated Removable Partial Dentures

In the clinical trial, the Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) fabricated removable partial dentures (RPD's) are evaluated on casts and clinically compared with a traditional fabricated RPD for 50 consecutive patients.

During 5 years the patients are in a follow-up program in order to judge long-term stability, loss of retention, fractures, ... of both groups of dentures.

The classic removable partial denture (RPD) is a denture fabricated in CrCo using the "lost wax" technique. This hand-made way of working makes the final result vulnerable, not always predictable and not reproducible.

Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) techniques have been introduced in dentistry, particularly to fabricate crowns and bridges (fixed partial dentures). There is little research in the field of removable partial framework fabrication. This may be in part be attributed to the lack of suitable dedicated software.

In the technical part of the study, existing software and hardware is adjusted to maximize the automation in the application of computer-aided technologies to surveying of digital casts and pattern design and the subsequent production of sacrificial patterns using removable partial (RP) technologies.

In the clinical trial the CAD/CAM fabricated RPD's are evaluated on casts and clinically and compared with a traditional fabricated RPD for 50 consecutive patients. For every patient, two RPDs are made in the same material (CrCo).The clinical parameters (fit, stability, retention, support, friction) are double blind evaluated by two dentists. At the end of the treatment, the patient can choose one of them.

Both RPDs are fabricated in the same time frame for the fabrication of the "classic" RPD. There are for the patient no extra sessions scheduled.

During 5 years the patients are in a follow-up program in order to judge long-term stability, loss of retention, fractures, ... of both groups of dentures.

Hypothesis1: CAD/CAM fabricated RPD's can meet the clinical standards for RPD's.

Hypothesis 2: Dentists do not observe a difference between the classic and CAD/CAM fabricated RPD.

Hypothesis 3: Patients do not see/feel any difference between the classic and CAD/CAM fabricated RPD.

Eligibility Criteria:
Inclusion Criteria:

* patients in need of a classic removable partial denture (RPD)
From the Gut to the Strut: Reducing Inflammation for Healthy Muscles

This research aims to evaluate the effectiveness of a dietary supplement on reducing inflammation and improving muscle health. The product is a food supplement notified to the Ministry of Health consisting of: hydroxymethylbutyrate, carnosine, lactoferrin and magnesium, which help reduce inflammation and intestinal permeability and to improve muscle health.


Eligibility Criteria:
Inclusion Criteria:

* sarcopenic patients aged 55-85. Sarcopenia will be diagnosed according to the European Working Group on Sarcopenia in Older People (EWSGOP-2) criteria by muscle strength or chair stand test.

Exclusion Criteria:

* severe kidney disease (glomerular filtration rate \<30 mL/min),
* moderate-to-severe hepatic failure (Child-Pugh Class of B or C),
* endocrine diseases associated with disorders of calcium metabolism (with the exception of osteoporosis),
* psychiatric disorders,
* cancer (in the previous 5 years),
* hypersensitivity to any investigational food component
* subjects taking protein/amino acid supplements (up to 3 months prior to the study).
* patients not capable of taking oral therapy and those receiving or having indication for artificial nutrition or included in another clinical nutrition trial
Sodium Bicarbonate Supplementation in Chronic Kidney Disease Evaluation of Dose Response, Safety and Beneficial Effects

This study will enroll 25 patients with kidney disease to evaluate the effects of different doses of sodium bicarbonate (baking soda) on levels of bicarbonate in the blood, kidney function and muscle strength. The investigators will also evaluate safety and tolerability of different doses.

This study enrolled 20 patient to evaluate the effects of different doses of sodium bicarbonate. We will test serum bicarbonate levels, potassium levels and muscle function.

Eligibility Criteria:
Inclusion Criteria:

* Estimated GFR \< 45 ml/min/1.73m2 and \>15 ml/min/1.73 m2 determined by abbreviated 4 variable modification MDRD equation
* Age \>21

Exclusion Criteria:

* Previous chronic treatment with alkali (including sodium bicarbonate, calcium carbonate or baking soda)
* Bicarbonate level \<20 or \>25 mEq/L
* Decompensated heart failure
* Systolic blood pressure \>160 mm/Hg
* Moderate or greater lower extremity edema
* Initiation of ESRD treatment planned within 6 months
* Kidney transplantation
* Treatment with immunosuppressives within the last 3 months