cyrilzakka/clinical-trials huggingface dataset:
Preventive Regimens With Herbal and Fluoride Toothpaste on Remineralization in High Caries Patients With Initial Lesions

This study will be conducted to assess the effect of different preventive regimens using herbal toothpaste versus fluoride toothpaste on the management of remineralization and caries risk in high caries risk patients.

Dental caries is a major universal health problem with multiple etiological factors, so looking for economical and accurate plans for recognizing high-risk persons, and multiple risk factors to reduce the risk, in addition to caries management, using a caries risk assessment to detect the person who will develop caries, and provide them with suitable preventive and treatment regimens to disruption the disease procedure.

The treatment should evade invasive treatments and a large emphasis on prevention (using fluoride toothpaste, solutions, patient education, and so on), to achieve the aim of new dentistry (minimal intervention). The application of such a regimen to manage initial caries lesions allows the dentist to reverse initial lesions with the minimal victim of healthy dental tissues.

Eligibility Criteria:
* Inclusion criteria of the participants:

  1. Healthy patients with free medical history.
  2. Age range 15-50 years.
  3. Patients with high caries risk assessment according to Cariogram.
  4. Patients with initial carious lesions at the facial surface of any teeth
  5. High plaque index
  6. Not under antibiotic therapy either at the time of the study or up to the last month before the start of the study
* Exclusion criteria of the participants:

  1. Patients with a compromised medical history.
  2. Patients with dentin caries
  3. Extreme plaque accumulation and periodontal problems
  4. Completely edentulous patients
  5. Participants with a history of allergy to any of the drugs or chemicals used in the study.
  6. Patients on any antibiotics during the past month
* Inclusion criteria of the teeth:

  1. The WSLs with LF measurements inside the range 14-20 were involved in this study.
  2. The lesions with scoring either 2 or 3 according to (ICDAS) scoring were included in the study
* Exclusion criteria of the teeth:

  1. The white spot lesion scoring is (\<14) or (\>20) according to diagnodent
  2. The white spot lesion scoring is other than 2, 3 according to ICDAS
  3. White spot lesions due to hypomineralization or fluorosis
To Evaluate the Long-Term Safety of Pregabalin in Refractory Partial Epilepsy.

To evaluate the long-term safety of pregabalin in refractory partial epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Must have met the inclusion criteria for preceding double-blind study.
* Have received double-blind study medication and wish to receive open-label pregabalin.

Exclusion Criteria:

* Pregnant or considering becoming pregnant.
* Receiving any concomitant medication that could alter the effectiveness of their medication response or seizure frequency.
5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) Versus Epirubicin, Cisplatin and 5-FU (ECF) in Patients With Locally Advanced, Resectable Gastric Cancer

Patients with locally advanced resectable adenocarcinoma of the stomach or the esophagogastreal junction without previous therapy will be treated with one of two chemotherapy combinations before and after surgery. One half of the patients gets 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the others Epirubicin, Cisplatin and 5-FU (ECF). Main objective of the study is median overall survival.

714 Patients with locally advanced resectable (T2-4 and/or N+, M0) adenocarcinoma of the stomach or the esophagogastreal junction without previous therapy will be included in this study. After randomization patients receive perioperatively 4 cycles FLOT or 3 cycles ECF, followed by a restaging of the tumour status and surgery. Subsequently another 4 cycles of FLOT or 3 cycles ECF are applicated. Then a central validation of the pathological remission rate is scheduled. Primary endpoint is overall survival, secondary endpoints are disease free survival, perioperative morbidity and mortality, histopathologic regression rate and R0-resection rate.

Eligibility Criteria:
Inclusion Criteria:

1. locally advanced (\>T1) and/or nodal positive (N+) histologically proven adenocarcinoma of the esophagogastreal junction (AEG I-III) or the stomach without distant metastases (M0) and without infiltration of adjacent structures and organs
2. no previous surgical resection
3. no previous cytostatic chemotherapy
4. Age \> 18 years (female and male)
5. ECOG ≤ 2
6. surgical resectability
7. Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy
8. Leucocytes \> 3.000/µl
9. Platelets \> 100.000/µl
10. Serum creatinin ≤ 1.5x of normal value, or Creatinin-Clearance \> 50 ml/min
11. written informed consent.
12. Ejection fraction \> 50% in echocardiography before start of therapy

Exclusion Criteria:

1. distant metastases or infiltration of adjacent structures or organs and all primarily not resectable stages
2. relapse
3. Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Cisplatin. Epirubicin and Docetaxel
4. Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin, Cisplatin, Epirubicin or Docetaxel
5. Active CHD, Cardiomyopathy or cardiac insufficiency stage III-IV according to NYHA
6. malignant secondary disease, dated back \< 5 years (exception: In-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma)
7. severe non-surgical accompanying disease or acute infection
8. peripheral polyneuropathy \> NCI Grad II
9. severe liver dysfunction (AST/ALT\>3,5xULN, AP\>6xULN, Bilirubin\>1,5xULN)
10. chronic inflammable gastro-intestinal disease
11. inclusion in another clinical trial
12. pregnancy or lactation
Coronary Calcification Progression Study

To investigate use of Fast Gated Helical Computed Tomography (FGHCT) measures of coronary artery calcium (CAC), FGHCT-CAC, for discrimination of coronary artery disease (CAD) and to quantify progression of coronary artery calcium over time.

BACKGROUND:

While advances have been made in control of some coronary heart disease (CHD) risk factors, especially smoking and high dietary fat intake, much of the decline in age-adjusted CHD mortality rates has been due to medical treatment and procedural interventions for overt CHD as well as hypertension and hypercholesterolemia. In this context, the availability of an inexpensive, sensitive and specific method for noninvasive detection of both early coronary atherosclerosis and asymptomatic but advanced CHD could allow beneficial treatments to be targeted at many high-risk individuals. The study was designed to determine whether fast-gated helical computed tomography (FGHCT), a more advanced and readily-available variant of a technique (EBCT) that has not achieved its full promise, could play such a role.

DESIGN NARRATIVE:

Dr. Crouse and his colleagues augmented ongoing case-control studies, HL35333, "Carotid Atherosclerosis Progression Study" and HL59503, "Vascular Disease, Structure and Function". HL35333 comprises 280 symptomatic individuals \> 45 years equally divided between men and women, half with and half without angiographically defined coronary artery disease evaluated for risk factors and extracranial carotid intimal-medial thickness (ECIMT, with B-mode ultrasound) at baseline and yearly for three years. The grant has quantified the associations of coronary artery disease and coronary artery disease risk factors for ECIMT and its progression. HL59503 quantifies flow-mediated brachial artery reactivity (FM-BAR) in this cohort. Literature review suggests that while ECIMT predicts coronary artery disease status in clinical samples it does less well in asymptomatic samples; longitudinal data (CLAS study) suggest that progression of ECIMT best predicted incident coronary artery disease, and Electron Beam Computed Tomography (EBCT) quantification of Coronary Artery Calcium (CAC) likely has even greater discriminatory power for coronary artery disease than ECIMT. However, EBCT has limited accessibility.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Study Evaluating The Coadministration of Begacestat And Donepezil

This study examines the cardiac effects (effects on the heart) of administering donepezil and begacestat together to healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Men and women of non-childbearing potential
* Non smoker or smoker of \<10 cigarettes per day and able to refrain from smoking during study
* 18-50 years old

Exclusion Criteria:

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Cardiac rhythm abnormalities
* Family history of cardiac risk factors
Synergistic Effect of Ibuprofen and Hydromorphone for Postoperative Pain

Intravenous form of ibuprofen is recently approved by FDA and reports are rare on the co-administration with opioids. The investigators searched whether intravenous ibuprofen-hydromorphone combination is synergistic, additive, or infra-additive on postoperative pain using combination index (CI), dose reduction index (DRI) and isobologram.

Ninety patients, undergoing breast surgery, were included in one of the three groups (Ibuprofen, Hydromorphone, Ibuprofen+Hydromorphone groups). Positive analgesic efficacy was defined as a numeric rating scale (NRS) ≤3 on a 0-10 NRS, 30 min after the drug administration. Drug was administered by the Dixon and Mood up-and-down method. Starting doses were ibuprofen 50 mg, hydromorphone 0.25 mg, or ibuprofen 25 mg + hydromorphone 0.125 mg. The maximum doses were ibuprofen 800 mg, hydromorphone 2 mg, or ibuprofen 400 mg + hydromorphone 1 mg. Combination index (CI) (additive: 0.9-1.1, synergism: \<0.9, antagonism: \>1.1), dose reduction index (DRI, a measure of how much the dose of each drug in a combination can be reduced), and isobologram were used to define the nature of their interaction.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status І or ІІ who were able to communicate and understand the pain scales

Exclusion Criteria:

* any contraindication to the use of ibuprofen or hydromorphone
* a history of allergy or hypersensitivity
* a calculated creatinine clearance of \<75 mL/min
* the presence or history of asthma, bleeding tendency, coronary artery bypass graft (CABG) surgery, heart failure, peptic ulcer disease, inflammatory bowel disease or any other gastrointestinal disorder, and renal or hepatic disease
* pregnancy
* age younger than 18 yr
* intraoperative use of regional anesthesia
* intraoperative administration of analgesics other than remifentanil
* postoperative pain ≤3 on a NRS in the post-anesthesia care unit (PACU)
Reminerlization Potential of Innovative Biomimetic Material in Caries White Spot Lesions

to remineralize the white spot caries lesions after orthodontic treatment , the investigator will use two different materials ( Clinpro tooth creme versus Gc tooth mousse) and will compare between their effects in remineralization of white spot caries lesions.

Dental caries is the localized destruction of tooth tissues by acids, especially lactic acid, produced by the fermentation of dietary carbohydrates by bacteria in dental plaque. Demineralization can be arrested or reversed when remineralization agents are applied to incipient carious or non-cavitated carious lesions. A large number of therapeutic agents including non-fluoridated products have been developed to promote enamel remineralization. The process of restoring lost mineral ions to the tooth structure and strengthening the lattice work is known as remineralization.

The development of decalcification around orthodontic brackets and bands, commonly called white spot lesions (WSLs), is often observed in patients with poor oral hygiene during treatment .In many instances, these WSLs continue to be visible after the removal of fixed appliances and after natural remineralization. The remineralized enamel crystallites are generally more resistant to decalcification and also have the same orientation as the original enamel crystallites. The early enamel lesions have a potential for remineralization with an increased resistance to further acid challenge, particularly with the use of enhanced remineralization treatments.

Recaldent™ is derived from the milk protein, casein. For many years it has been known that milk and its derivatives have a tooth protective effect. Research has shown that this activity is due to a part of the casein protein called Casein Phosphopeptide (or CPP), which carries calcium and phosphate ions in the form of Amorphous Calcium Phosphate (or ACP) which used in reminerlization of white spot caries lesions.

Clinpro tooth crème (3M ESPE) is a 0.21% w/w sodium fluoride (NaF) anti caries dentifrice that contains 950 ppm fluoride and a functionalized tricalcium phosphate (f-TCP) ingredient.One major advantage of this calcium phosphate system is that it is stable in aqueous environment and also does not affect the fluoride activity added in the dentifrices. Furthermore,it has been suggested that fluoride combination with f-TCP not only provides greater remineralization in terms of microhardness and fluoride uptake, but also decreases the dose of fluoride required to achieve the same degree of remineralization,

Eligibility Criteria:
Inclusion Criteria:

* Patients should have at least one white spot caries lesion
* age from 18 to 40 years
* no gender restriction

Exclusion Criteria:

* Patients with a compromised medical history.
* Severe or active periodontal disease
* Patients with developmental hypo-calcified lesions
Physiology of Vestibular Dysfunction and Clinical Implications

Vestibular dysfunction is a known contributor to imbalance and fall risk, and may be a precursor to the frailty phenotype seen in the elderly population. A recent study found that vestibular dysfunction is common in the US population, and that the prevalence of this impairment increases steeply with age. However, it is unknown whether the aging process has global effects on the vestibular end-organ or whether specific structures, e.g. the semicircular canals or the otoliths, are selectively impaired. Moreover, the clinical implications of specific deficits of the vestibular end-organ are unclear. As such, the aims of this proposed research are: 1) to evaluate whether the normative aging process is predominantly associated with dysfunction of the semicircular canals (as measured by caloric and angular vestibulo-ocular reflex testing) or of the otoliths (as measured by vestibular-evoked myogenic potential (VEMP) testing); 2) to determine if there are any characteristic clinical features associated with the subtypes of vestibular dysfunction; and 3) to assess whether dysfunction of the semicircular canals or of the otoliths is associated with a higher risk of frailty and falls. The investigators plan to pursue these aims through a cross-sectional and prospective cohort study of a group of individuals age 70 and above. Vestibular physiologic tests will be administered to all study participants, and test results will be correlated with baseline clinical symptoms and frailty status as well as prospective one-year fall risk. A greater understanding of vestibular physiologic deficits and clinical implications in older individuals can inform the development of rational vestibular rehabilitation strategies that may more effectively mitigate the frailty phenotype and reduce fall risk.


Eligibility Criteria:
Inclusion Criteria:

* Participant's age is 70 years and over?
* Participant is willing and able to give informed consent?

Exclusion Criteria:

* Participant has diabetes mellitus
* Participant has blindness, limited neck range of motion or cervical spine instability
Evaluation of Obstructive Sleep Apnea With Long Range 3D Endoscopic Fourier Domain Optical Coherence Tomography (FDOCT)

The purpose of this study is to determine whether the Optical coherence tomography (OCT) can image the structure and geometry of hollow organs of the upper airway in sleep disorder. The research can identify the obstruction sites that help the select the appropriate treatment for potential surgical candidates.

The National Commission on Sleep Disorders Research estimated that 18 million Americans suffer from obstructive sleep apnea (OSA) The majority of them are undiagnosed and untreated at this time.

The current diagnostic gold standard for OSA is in-laboratory, a full night polysomnography (PSG). However, PSG is unable to provide information on upper airway structure and anatomy, and cannot identify the obstruction sites. OSA can lead to severe health complications including hypertension, heart failure, memory impairment, motor vehicle and work accidents, decreased work productivity, and increased risk of death.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female age 18-65 years has no history of obstructive sleep apnea
2. Male or Female age 18-65 years has been diagnose of mild to moderate obstructive sleep apnea
3. Male or Female age 18-65 years has been diagnose severe obstructive sleep apnea

Exclusion Criteria:

1. Pregnant women.
2. Breastfeeding women.
3. Unable to understand or give consent to the study.
4. Currently taking drugs that are sensitive to light.
5. Currently taking routine anti-convulsion, sedative or antihistamine drugs.
6. Currently taking immuno-suppressive drug therapy.
The Use of Botox in Advanced Parkinson's Patients Experiencing Pain

Most Parkinsonism related pain can be assigned to one or more of five categories: musculoskeletal pain, neuritic or radicular pain, dystonia associated pain, primary or central pain, and akathitic discomfort. In PD pain tends to affect the side of the body that was initially, or more severe affected by the motor symptoms. Botulinum toxins are an effective treatment modality for a growing number of neurological conditions. They have been studied for a variety of conditions associated with PD including dystonia, jaw tremor, apraxia of eyelid opening, camptocormia, dyskinesias, freezing of gait, sialhorrea, overactive bladder and constipation. There are no studies for the use of Botulinum Toxin for pain in PD. The investigators will perform a double-blind, randomized cross-over study evaluating the efficacy and safety of an individual pattern of BTXA injections targeted at painful muscles vs. placebo injection.

The investigators will perform a double-blind, randomized cross-over study evaluating the efficacy and safety of an individual pattern of BTXA injections targeted at painful muscles vs. placebo injection. Primary outcome will be a measure of global pain as perceived by the participants. To assess this endpoint the investigators will use:1.

change in pain on a Numeric Rating Scale (NRS) by telephone between BTXA and placebo injections at 4 week post injection and 2.change in Visual Analogue Scale (Edmonton Symptom Assessment System: Numerical Scale) at study visits.

Secondary outcomes will be the percentage of responders, Physician rated Clinical Global Impression (CGI), Unified Parkinson Disease Rating Scale (MDS-UPDRS) on medication, quality of life by Parkinson Disease Questionnaire (PDQ-39) and adverse events as assessed at each study visit.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with advanced PD (Hoehn and Yahr 3-5) and painful limbs not responding to antiparkinsonian agents sufficiently.
* BTXA treatment naÃ-ve patients or not received any within last 12 months (including other indications).
* Stable PD and pain medications for at least 30 days
* Competence to self-report pain severity in a Visual Analogue Scale (VAS)

Exclusion Criteria:

* Subjects with a primary cause of pain unrelated with PD and associated with another medical condition e.g. severe arthritis
* Subjects that because of the severity or refractory pain are under an unfixed analgesic schedule
* Subjects unable to self- report pain severity in a VAS
* Subjects undergoing acute infections or other acute intercurrences.
* Any contraindication to receiving BTXA injections:

  1. Subjects who are hypersensitive to any BTXA or to any ingredient in the formulation or component of the container (Clostridium Botulinum toxin type A neurotoxin complex 900 kD, Human Serum Albumin and Sodium Chloride).
  2. The presence of infection at the proposed injection site(s).
Assessment of EF192A Potential Sensitization and Accumulated and Primary Irritability in Controlled/maximized Conditions

The investigational product constitutes a medical device that is freely accessible to consumers and, as such, must be safe under real or reasonably foreseeable conditions of use and its safety must be tested before being placed on the market. Therefore, this study was designed to evaluate the biocompatibility of the experimental product, as provided for in legislation.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years old.
* Fitzpatrick phototype I to IV.
* Presence of intact skin in the test region.
* Agreement to comply with the study procedures and requirements and attend the institute on the days and times determined for the assessments.
* Signature of the Informed Consent Form (ICF) before carrying out any study procedure.

Exclusion Criteria:

* Presence of skin marks in the test region that interfere with the assessment of possible skin reactions (for example, pigmentation disorders, vascular malformations, scars, increased hairiness, large quantities of ephelides and nevus, sunburn).
* Presence of active dermatosis (local or disseminated) that could interfere with the study results.

istory of atopy (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic conjunctivitis, etc.).

- History of allergic reactions, irritation or intense sensations of discomfort to topical products such as, for example, cosmetics, health products or medicines.