cyrilzakka/clinical-trials huggingface dataset:
Root Proximity During Mini-Screw Insertion Using a Digital Three-Dimensional Printed Guide

Although mini screw insertion is considered as a simple and non-invasive technique, it's a critical procedure which requires precision and accuracy. The placement of mini-screw poses a challenge to the orthodontist, particularly if the space available for mini-screws is limited.4 The proximity to the vital structures surrounding the proposed mini-screw position necessitates the precise knowledge of the anatomy of the insertion area.5 The incidence of mini-screw to tooth contact in the placement of inter-radicular region was 27%.6 Although failure of mini screw is considered a multi-factorial concern, many studies reported the proximity of a mini-screw to tooth structures is a major risk factor for failure, especially in the inter-radicular inserted mini-screws. guided insertion was believed to give more favorable results. Above all, the recent technology of the scanning and three-dimensional printing could pave the way to construct a simple accurate guide. Additionally all previous studies assessed the insertion accuracy using CBCT post-operatively, that can't be applied on human subjects for ethical reasons. Thus a non-invasive method for assessment of mini-screw insertion should be implemented.

PICOs P: Adult orthodontic patients need mini screws in maxillary arch bilaterally for anchorage I: Three dimensional printed digital guide for mini screw insertion C: Conventional free hand insertion technique

- O: Primary outcome: Root proximity

Secondary outcomes:

* Patient discomfort during insertion 17
* Insertion accuracy
* Angular deviation
* Linear deviation
* Failure 18 S: Split Mouth Randomized clinical Trial

Eligibility Criteria:
Inclusion Criteria:

* Orthodontic patients with Angle's Class I bimaxillary protrusion • Patients having average mandibular plane angle

Exclusion Criteria:

* Mixed dentition patients

  * Smoker patients
  * Patients with Increased lower facial height
  * Patients with missing posterior teeth
  * Bleeding disorders or anticoagulant therapy
  * Patients with cleft lip \& palate
  * Patients with facial asymmetry
  * Patients with transverse maxillary deficiency
E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers

The purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 10 mg in treating frequent heartburn.

This is a multicenter, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn. The study will last for up to five weeks and consists of the following three phases: a one to two week screening period that includes a one-week, single-blind, placebo run-in phase, a two week double-blind, randomized treatment phase, and a one week single-blind, placebo follow-up phase.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients \> 18 years of age.
2. If female, not of childbearing potential by reason of surgery or menopause, or of childbearing potential, but using an approved method of contraception since the last menstrual period. Females of childbearing potential must have a negative serum pregnancy test before starting the study.
3. Patients must report a history of heartburn at least two days per week over the past month.

Exclusion Criteria:

1. History of erosive esophagitis verified by endoscopy.
2. History of gastroesophageal reflux disease (GERD) diagnosed by a physician.
3. Patients who have a history of Barrett's esophagus or esophageal stricture.
4. Evidence of any medical condition that may interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study.
5. Patients who require continuous use of proton pump inhibitors, histamine receptor (H2) blockers, or prokinetics. Prior intermittent use of these agents is permitted if they are discontinued at least three days prior to the run-in phase. The H2 blocker, cimetidine (Tagamet®), must be discontinued for at least seven days before the study drug is administered.
Steroid Injection in De Quervain Tenosynovitis

This study is carried out to find out the degree of pain relief achieved with standard treatment as steroid injection as well as its time to onset. It will recruit 50 subjects over a period of 18 months.

The aim of the study is determine how effective these injections are and when will the patient start feeling relief of his/her symptoms.The aim of the study is not to change the current practice, but provide hand surgeons enough data to clarify their patients the expected outcomes and onset timing of the treatment performed.

Eligibility Criteria:
Inclusion Criteria:

* \>21 years old

Exclusion Criteria:

* Pregnancy
Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults

This study is being conducted to assess any potential differences in the absorption and excretion between two lanthanum carbonate formulations. This study is also being done to assess the safety and tolerability of the two lanthanum carbonate formulations.


Eligibility Criteria:
Inclusion Criteria

* Ability to provide informed consent to participate in the study.
* Healthy volunteers, age 18-55 inclusive.
* Subject must be willing to comply with applicable contraceptive requirements of the protocol
* Female subjects must have a negative pregnancy test
* Ability to chew and or swallow doses of the investigational products as prescribed in the protocol.
* Ability to fully comply with all study procedures and restrictions, including consumption of all food provided while a resident in the CRC.

Exclusion Criteria

* Current or relevant previous history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or study procedures.
* Clinically significant abnormal serum phosphate levels, outside of normal limits.
* Current use of any medication with the exception of hormonal replacement therapy or hormonal contraceptives within 7 days of first dose of investigational product.
* A known history of lactose intolerance or allergy to milk or other foods.
* Clinically significant or multiple allergies as determined by an Investigator.
* History of alcohol or other substance abuse within the last 6 months.
* A positive screen for alcohol or drugs of abuse.
* Male subjects who consume more than 21 units of alcohol per week or three units per day. Female subjects who consume more than 14 units of alcohol per week or two units per day.
* A positive human immunodeficiency virus (HIV) antibody screen, Hepatitis B surface antigen (HBsAg) or Hepatitis C virus (HCV) antibody screen.
* Female subjects who are pregnant (positive pregnancy test), lactating, or less than 90 days post-partum.
* Subjects that have previously been randomized in this study.
* Use of tobacco in any form or other nicotine-containing products in any form. Ex-users must report that they have stopped using tobacco for at least 60 days prior to receiving the first dose of investigational product.
* Routine consumption of more than two units of caffeine per day or subjects who experience caffeine withdrawal headaches.
* Donation of blood or blood products within 60 days prior to receiving the first dose of investigational product.
* Plasma donation within 28 days prior to the first dose of the investigational product.
* Use of another investigational product within 30 days prior to receiving the first dose of investigational product or active enrolment in another drug or vaccine clinical study.
High-resolution Ultrasound in Lower Extremity Nerves and Common Fibular Neuropathies.

This study establishes reference material of selected lower extremity nerves at pre-defined sites with high-resolution ultrasound. Furthermore in this study, high-resolution ultrasound of patients with common fibular compression neuropathy and patients with type 2 diabetic polyneuropathy involving the common fibular nerve will be examined and compared to healthy controls. High-resolution ultrasound measurements will be correlated with history, clinical information and electrophysiological data.

The usual diagnostic work-up of patients referred for lower-extremity neuropathy includes clinical examination, biochemical tests (blood and cerebrospinal fluid), electrophysiological assessment and if necessary nerve biopsy. The electrophysiological assessment usually consists of nerve conduction studies (NCS) and electromyography (EMG). While electrophysiological measurements generally give information about the function of nerves, high-resolution ultrasound may provide information about the structure of nerves.

High-resolution ultrasound examination has shown promising results as a supplementary tool in the diagnostic work-up of various peripheral neuropathies. The clinical utility of ultrasound in the diagnosis of common fibular neuropathies, however, calls for further elucidation.

This study establishes reference material of selected lower extremity nerves at pre-defined sites with high-resolution ultrasound. Furthermore in this study, high-resolution ultrasound of patients with common fibular compression neuropathy and patients with type 2 diabetic polyneuropathy involving the common fibular nerve will be examined and compared to healthy controls, as well as each other. High-resolution ultrasound measurements will be correlated with history, clinical information and electrophysiological data.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes polyneuropathy common fibular nerve affection or
* Common fibular nerve compression neuropathy

Exclusion Criteria:

* Lumbar radiculopathy
* Other competing lower extremity peripheral neuropathy
* Peripheral vascular disease
* Hypothyroidism
Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets

This study is being conducted to demonstrate the superior clinical effectiveness of Salmeterol/Fluticasone Propionate compared to montelukast in the management of persistent asthma in children aged 6-14 years, and to assess the effect of each treatment \[Salmeterol/Fluticasone Propionate (50/100 mcg) and montelukast (5 mg)\] on lung function, asthma control, Health Outcomes including the child's quality of life as measured by Paediatric Asthma Quality of Life Questionnaire (PAQLQ) and the caregiver's quality of life as measured by Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) at selected centers where a valid translation is available.

Pediatric Asthma Clinical Effectiveness study (PEACE). A Randomized, Double-Blind, Double Dummy, Parallel Group comparative clinical study of Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID) via DISKUS† with Oral montelukast (5mg QD) Chewable Tablets in Children 6-14 years of Age with Persistent Asthma

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of asthma for at least 6 months (per American Thoracic Society \[ATS\] definition).
* Best forced expiratory volume in one second (FEV1) between 55% and 80% of predicted normal.
* More than or 12% FEV1 reversibility following inhalation of salbutamol.
* Must also be symptomatic on short-acting beta-agonists.
* Must not have used inhaled corticosteroids over the previous month or LTRAs (Leukotriene antagonists)over the previous 2 weeks.

Exclusion criteria:

* Hospital admission for asthma within 3 months prior to Visit 1.
* Sinus, middle ear, oropharyngeal, upper or lower respiratory tract infections within two weeks immediately preceding Screening Visit 1.
* Oral or parenteral steroid therapy in the last 12 weeks, or more than 3 courses in the last 6 months.
Knowledge and Awareness of Pelvic Floor Health

The aim of this study is to investigate the relationship between knowledge and awareness of pelvic floor health and dyspareunia, pelvic floor dysfunctions, and quality of life in postpartum women.


Eligibility Criteria:
Inclusion Criteria:

* Being a native speaker of Turkish
* Being in the first year of postpartum
* Women who had a vaginal delivery
* Primiparous women
* Women aged 18 and over

Exclusion Criteria:

* Women who have not given birth
* Multiparous women
* Women who had a cesarean delivery
* Having difficulty to understanding evaluations
Occlusal Contact Trueness Affected by Six Chairside CAD/CAM Ceramic Materials

The aim of this clinic self-control study was to evaluate the trueness of occlusal contact affected by six ceramic materials during chairside fabricating process and offer recommendations for occlusal offset according to different ceramic materials in CEREC CAD/CAM design process.

Ten participants were selected for this study. InCoris TZl(ZIR), Celtra Duo(CD), IPS e.max(EMA), UPCERA LICI (LC), Vita enamic(ENA), UPCERA RUNCI (RC) were used to produce crowns for everyone by CEREC chairside CAD/CAM system. The milling trueness, postprocessing trueness and clinical adjustment of occlusal contact were quantitatively analyzed by the ATOS high-precision scanner and Geomagic reverse engineering software.

Eligibility Criteria:
Inclusion Criteria:

1. with one mandibular first molar requiring crown restoration that have undergone root canal treatment;
2. with complete permanent dentition;

Exclusion Criteria:

1. with carious lesions, abrasions, attrition, erosions or any kind of tooth defects;
2. with any kind of restorations in occlusal surfaces;
3. with any sign of temporomandibular dysfunction.
Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)

The primary objective of this study is to compare the effect of ipratropium bromide/salbutamol inhalation spray combination administered by the Respimat® inhaler (20 mcg/100 mcg), ipratropium bromide inhalation spray administered by the Respimat® inhaler (20 mcg), and COMBIVENT® MDI administered q.i.d on FEV1 at intervals over a treatment period of 12 weeks in patients with COPD. Specifically, non-inferiority of Combivent Respimat® to COMBIVENT® MDI in FEV1 AUC from 0 to 6 hours , superiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 0 to 4 hours, and non-inferiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 4 to 6 hours will be analyzed. In addition, steady state pharmacokinetics over one dosing interval following 4 weeks of therapy will be characterized in a subgroup of patients.


Eligibility Criteria:
Inclusion Criteria:

Outpatients of either sex, 40 years or older, with a diagnosis of COPD (FEV1 65% predicted normal and FEV1/FVC 70%).

Exclusion Criteria:

Patients with significant diseases other than COPD that may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study, with a history of asthma or allergic rhinitis, who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy or using oral corticosteroid me dication at unstable doses (i.e., less than 6 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day will be excluded.
Comparing Stainless Steel Crowns with Prefabricated Resin Crowns in Primary Molar Teeth

The main reason for this research study is to learn more about a new flexible white dental crown (BioFLX) by comparing it to an existing flexible metal crown (Stainless Steel Crown). It is of interest to see if this new white crown is clinically equivalent to the existing silver crown that is mainly used in pediatric dentistry. A potential participant for this study would have cavities that require a crown, a type of filling that covers the entire tooth, and recommended dental work be done under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* CCHMC pediatric dental patients between the ages of 2 years to 5 years and 11 months, at the time of recruitment, who present to any CCHMC dental clinic location and then are found to need full mouth dental rehabilitation.
* Patients who speak the most common languages at CCHMC will be able to be recruited for the study.

  o English, Spanish, Arabic, Uzbek, Nepali, Chinese Mandarin, Russian, French.
* These patients must qualify for treatment at the CCHMC dental in-office general anesthesia (IOGA) area or the Procedure Center (PC). IOGA and the PC will be selected as a venue of treatment to control behavioral factors. This is not specific to the study and would occur due to their treatment needs.
* Participants will have at least one pair of contralateral primary molars with the need for a full coverage restoration in the same arch.

  * For example, tooth A \& J, B \& I, S \& L, or T \& K
  * For each participant, a minimum of one SSC or one PRC will be randomly assigned via a split mouth design to be placed as part of the study.
* Need for Full coverage and high caries risk will be defined by AAPD Best Practice Guidelines 2,16

  o Teeth With
  1. Extensive caries
  2. Cervical decalcification
  3. Developmental defects (e.g., hypoplasia, hypocalcification)
  4. When failure of other available restorative materials is likely (e.g., interproximal caries extending beyond line angles, patients with bruxism)
  5. Following pulpotomy or pulpectomy
  6. For definitive restorative treatment for high caries-risk children as defined by the AAPD
  7. For patients who exhibit high caries risk and whose treatment is performed under sedation or general anesthesia. This would be normal and not specific to the study.
* Participants who consent to the study, and who can be available for follow-up recall appointments.
* All participants will be ASA I or ASA II as defined by the American Society of Anesthesiologists.15

Exclusion Criteria:

* Participants who do not meet inclusion criteria will be excluded.

  * Participants whose teeth do not meet the inclusion criteria.
  * Participants who do not wish to participate in the study.
  * Patients who do not wish to or cannot reliably return for follow-up visits.
  * Red dye allergy as patient will not be able to be plaque disclosed during follow-up visits.
  * Participants who do not speak English, Spanish, Arabic, Uzbek, Nepali, Chinese Mandarin, Russian, French.
The Effect of Tesetaxel on the QTc Interval and the Effect of Food, Itraconazole, and Rifampin on Tesetaxel Pharmacokinetics in Patients With Advanced Solid Tumors

This is a 3-cohort, multicenter, Phase 1 study of the effect of tesetaxel, an investigational, orally administered taxane, on the corrected QT (QTc) interval and the potential effect of food, a cytochrome P450 (CYP) 3A inhibitor (itraconazole), and a CYP3A inducer (rifampin) on tesetaxel pharmacokinetics (PK) in adult patients with advanced solid tumors.

Cohort 1:

Cohort 1 is a 2-period, 2-sequence, crossover study designed to assess the effect of food on the PK of tesetaxel and tesetaxel metabolites. Patients were randomized in a 1:2 ratio to receive tesetaxel on Day 1 of two 21-day cycles under fed and fasting conditions in one of two opposing sequences (Sequence 1A and Sequence 1B).

Cohort 2:

Cohort 2 is a 2-period, single-sequence, crossover study designed to assess the potential PK drug-drug interaction (DDI) of a strong CYP3A inhibitor (itraconazole) on tesetaxel and tesetaxel metabolites. Patients receive tesetaxel during Cycle 1 followed by a reduced dose of tesetaxel plus itraconazole during Cycle 2.

Cohort 3:

Cohort 3 is a 2-period, single-sequence, crossover study designed to assess the potential PK DDI of a strong CYP3A inducer (rifampin) on tesetaxel and tesetaxel metabolites. Patients receive tesetaxel during Cycle 1 followed by tesetaxel plus rifampin during Cycle 2.

Patients in all cohorts also participate in a study designed to assess the effect of tesetaxel and tesetaxel metabolites on cardiac repolarization as measured by the change from baseline in the QTc interval over the first cycle of treatment. Patients who are tolerating and benefitting from treatment with tesetaxel have the opportunity to continue onto an optional treatment extension.

Eligibility Criteria:
Inclusion Criteria:

* Female or male patients at least 18 years of age
* Histologically or cytologically confirmed solid tumor
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* Adequate cardiac conduction by ECG
* Adequate bone marrow, hepatic, and renal function

Exclusion Criteria:

* Presence of risk factors for QTc prolongation
* Presence of neuropathy Grade \> 1
* Anticancer treatment ≤ 14 days prior to randomization
* Major surgery ≤ 28 days prior to randomization
* Less than 2 weeks or 5 plasma half-lives (whichever is greater) since last use of:

  * A moderate or strong inhibitor or inducer of CYP3A
  * A CYP3A substrate with a narrow therapeutic range or that is contraindicated with either itraconazole or rifampin
Language Stimuli Screening in Children

This study will determine baseline language skills in children 4 to 8 years old. The data will be used to design studies using functional magnetic resonance imaging (fMRI) to identify what areas of the brain in children are involved in understanding language. This information is important for children who require brain surgery to control seizures.

Healthy normal volunteers between the ages of 4 and 8 years who have an IQ of 70 or more; who have no history of neurologic, psychiatric or language disorder; who are performing at or above grade level, and who are native English speakers may be eligible for this study.

Participants will be asked to do the following:

* name pictures or read words that appear on a computer screen
* listen to stories and answer questions about them
* match pictures to a spoken word

The children's responses will be recorded.

We propose to study normal children to establish baseline data to use to develop novel sets of stimuli for functional imaging paradigms. Tasks using these stimuli will include object naming, sentence comprehension, and single word reading.

Eligibility Criteria:
INCLUSION CRITERIA:

Children will be between the ages 4 and 8 are eligible.

EXCLUSION CRITERIA:

Children who meet one of the following criteria are not eligible:

IQ below 70;

History of neurologic or psychiatric disorders;

History of an language disorder;

Performing below grade-level;

Non-native English speaker.
Evaluating the Impact of a Value-based Prescription Drug Formulary

The objective of this study is to evaluate the impact of the value-based formulary on patient out-of-pocket spending and health plan spending as well as the impact of the value-based formulary on medication use, emergency department visits, hospitalizations, and outpatient office visits.


Eligibility Criteria:
Inclusion Criteria:

* Individuals:

  * aged 0-64
  * Continuously enrolled in an employer-sponsored health plan for at least 12 months (with one-month allowable gap) prior to the index date

    * For individuals in the exposed group, the index date is defined as the start date of value-based formulary implementation at the employer group level
    * For individuals in the control group, the index date is defined as the index date of the matched exposed individual
* Employer groups:

  * that transition to the value-based formulary if they transitioned all enrollees in that employer group (no individual selection)

Exclusion Criteria:

- Individuals with:

* missing gender information
* missing zip code level demographics at all member months