cyrilzakka/clinical-trials huggingface dataset:
A Commercial Available Tooth Positioner for the Treatment of Simple Orthodontic Relapse

Orthodontic relapse occurs in almost 80% of Orthodontic Treatment. The only prevention to phenomenon is the use of fixed retainers or life time active retention. Unfortunately, patients do not comply and after a year of treatment, many stop wearing their retainers and Orthodontic relapse occurs.

The aim of this project is to prospectively analyze the treatment result of consecutive treated patients who have had active orthodontic relapse. 20 patients will be recruited through advertisement to the Department of Orthodontics at the University of Alabama at Birmingham (UAB). The sample will comprise of 20 patients with Class I malocclusions. The records to be collected will comprise of clinical pictures and pre and post study casts. The 3D study casts will be evaluated using the Little's Index. The results will be analyzed with the paired t-test and ANOVA, using the Statistical Analysis System (SAS/STAT®) software.


Eligibility Criteria:
Inclusion Criteria:

1. Permanent dentition
2. Class I malocclusion with crowding or spacing of less than 6 mm for mandibular or maxillary incisors, lower number 1's through 3's
3. Predicted compliance with device use, as determined by the investigator orthodontist
4. Good oral hygiene, as determined by the investigator orthodontist
5. At least average intelligence, as determined by investigator orthodontist

Exclusion Criteria:

1. Any medical or dental condition that in the opinion of the investigator could impact study results during the expected length of the study
2. Patient is currently using any investigational drug or any other investigational device
3. Patient plans to relocate or move within six months of enrollment
4. Allergic to acetaminophen (use of aspirin or non-steroidal anti-inflammatory drugs is excluded for patients while on the study)
5. Use of bisphosphonates, such as osteoporosis drugs, during the study
6. Pregnancy
Pleotropic Effect of New Oral Anticoagulants

Atrial fibrillation (AF) has been known to have several pathophysiologic mechanisms including endothelial dysfunction of heart and vessel. This study was designed to determine the efficacy of NOAC therapy in the prevention of endothelial dysfunction and progression of atherosclerosis of AF subjects.

The properties of oral, direct inhibitors of factor Xa (e.g. rivaroxaban) and thrombin (e.g. dabigatran) have been examined the haemostasis and thromboembolism management. Preclinical studies have provided evidences for the effects of direct factor Xa or thrombin inhibition beyond anticoagulation, including anti-inflammatory and protective activities in atherosclerotic plaque development . Therefore, this study evaluates the protective effects of NAOC with the reactive hyperemia peripheral arterial tonometry (RH-PAT) measurements reflecting endothelial function by Endo-PAT2000 and intima-media thickness (IMT) of the carotid artery, which is used as a surrogate endpoint of atherosclerosis.

Eligibility Criteria:
Inclusion Criteria:

* CHA2DS2-VASc score above 2

Exclusion Criteria:

* severe peripheral arterial disease (greater than a Fontaine IIb category)
* grade 4 or higher cerebral infarction on the Modified Rankin Scale
* proven coronary artery disease by coronary angiogram
* severe hepatic or renal dysfunction
* uncontrolled congestive heart failure
* uncontrolled hypertension or diabetes mellitus
* hematologic disorders
* allergy or hypersensitivity to the investigational drugs
* pregnant or lactating women or women wishing to become pregnant
Radiographic and Clinical Outcomes of PureGen in Posterior Lumbar (PLIF) and Transforaminal Interbody Fusion (TLIF)

The purpose of this study is to assess the safety and efficacy of PureGen Osteoprogenitor Cell Allograft in patients undergoing Posterior Lumbar or Transforaminal Interbody Fusion.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with back and/or leg pain electing to receive Transforaminal Lumbar Interbody Fusion (TLIF)/ Posterior Lumbar Interbody Fusion (PLIF) procedure and posterior transpedicular stabilization with or without decompression at any level
* Unresponsive to conservative treatment for at least 6 months
* Radiographic confirmation of primary diagnosis

Exclusion Criteria:

* More than 2 levels requiring lumbar interbody fusion
* Spondylolisthesis greater than Grade I
* Prior failed fusion surgery at any lumbar level(s)
* Local or systemic infection past or present
* Active systemic disease
* Osteoporosis, osteomalacia, or other metabolic bone disease that would significantly inhibit bone healing
* BMI greater than 40
* Use of other bone graft, Bone Morphogenetic Protein (BMP) or bone graft substitutes in addition to or in place of those products specified
* Use of post operative Spinal Cord Stimulator (SCS)
* Any condition requiring postoperative medications that inhibit fusion, such as chronic use of oral or injected steroids or prolonged use of non-steroidal anti-inflammatory drugs
* Known or suspected history of alcohol and/or drug abuse
* Involved in pending litigation or worker's compensation related to the spine
* Pregnant or plans to become pregnant during the course of the study
* Insulin-dependent diabetes mellitus
* Known sensitivity to device materials
* Life expectancy less than duration of study
* Any significant psychological disturbance that could impair consent process or ability to complete self-assessment questionnaires
* Undergoing chemotherapy or radiation treatment
* Known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO)
Use of the Individual Challenge Inventory Tool (ICIT) by General Practitioners

Many patients in general practice present symptoms that do not refer to specific pathology. We refer to these patients at Medical Unexplained Physical Symptoms (MUPS). Practice and research have well documented that these patients frustrate most General Practitioners (GPs). They also produce a lot of unnecessary investigations and are overrepresented on sick-listing. The conversational tool Individual Challenge Inventory Tool (ICIT) offers an aid for the GPS to the consultation and aims to increase the patients' coping abilities with their health challenges. The aim of the study is to investigate whether patients experience such increased coping following a session of consultations with their GP based on ICIT.

The study is a Cluster Randomized Controlled Trial (cRCT) with GPs as clusters. We plan to includ 50 GPs to participate as intervention group and 50 GPs as controls. Each cluster will include 10 patients. GPs in the intervention group will be trained in the use of ICIT through a 30 hours course, partly digital and partly in presence. The participants will receive lectures on the background for the conversation tool, and the study, and will practice on each other. At the end of the study, also the 50 GPs of the control group will be invited to an identical course.

The outcome of the study is any changes of the patients coping abilities. If the symptoms cannot be healed, a goal for the patients will be to reduce the impact of the symptoms. In practice, this is to reuptake normal activities, including work, in spite of pain, fatigue or mood disturbances. Through the ICIT, the patients will be challenged to look at themselves in a broader spectrum and decide for themselves which activities are possible to reuptake and making a thorough plan for doing so.

The patients will be treated by their regular GP across several meetings and they will agree on a specific plan across weeks or months to achieve their individual goal.

The patients of the GPs in the control group will represent identical medical symptoms and will be treated and followed by their GP as usual. They will, however, be informed and asked to consign to participate in the study, and will respond to the same questionnaires as the patients in the intervention group.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a condition the GP deems as MUPS (unspecific og generalized pain, fatigue or mood disturbances without being depressed)
* Patients must be deemed satisfactory clinical examined without specific findings
* Patients must be able to speak and understand Norwegian language without interpreter
* Patients must sign on a consignment form

Exclusion Criteria:

* Patients must not have any well defined psychiatric diagnosis
* Patients must not have any alcohol or drug abuse
* Patients must not be using more than 10 mg Benzodiasepine per day
Impact of Point-of-Care EID for HIV-Exposed Infants

This mixed methods study will utilize a randomized step-wedge design to assess the impact of point-of-care (POC) versus conventional early infant diagnosis (EID) on key outcomes including timely return of results to caregivers and time to initiation on treatment for HIV-infected infants. Data will be collected through longitudinal clinical follow-up and medical chart extraction of routine records and lab forms. Feasibility and acceptability data will be collected through interviews with mothers/caregivers of HIV-exposed infants, and community focus groups.

This study seeks to evaluate the impact of point of care (POC) early infant HIV diagnosis (EID) on turn-around time from sample collection until notification of parents/caregivers of test result, linkage to care, and time to initiation of treatment, and early retention in HIV care (3-6 months) for those infected.

The study will take place in two countries, Zimbabwe and Kenya, with high HIV prevalence, and where EGPAF-supported POC EID platforms are being implemented as part of a Unitaid-funded POC EID project. As part of POC program implementation activities, in each country up to 50 EGPAF-supported sites will implement POC EID platforms. These sites may be prevention of mother-to-child transmission (PMTCT) of HIV clinics, HIV clinics or multidisciplinary health facilities. Project sites have been selected as part of the program implementation. In each country, 18 sites will be randomly selected as study sites for the impact evaluation.

Using a stepped wedge design, the intervention (the POC EID platforms) will be rolled out sequentially to the study facilities over three randomly-assigned time periods. Quantitative data will be derived from routine medical and laboratory charts and longitudinal tracking and follow-up of HIV-infected infants.

Qualitative data on feasibility and acceptability of POC will be derived from in-depth interviews with mothers/caregivers of HIV-exposed infants at the beginning and end of the study and community focus group discussions at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Any infant who receives an EID test, either conventional or POC, for the 4-6 week EID indication at one of the study sites (which were randomly selected from project sites in country)
* HEI under 12 weeks of age or their parents/caregivers
* Some methods will only include HEI who test positive (medical chart extraction and longitudinal follow up)
* Purposively selected caregivers of HEI for in-depth interviews
* Focus groups with community members will not require participants to have sought testing for EID

Exclusion Criteria:

* Participants not at selected study sites
* For some methods (medical chart extraction and longitudinal follow-up), HEI who test negative
* For qualitative component, excluded if unable to consent due to age, competence, or inability to speak any of the study languages
Efficacy Study of Travoprost APS Versus TRAVATAN

A Multi-Center Double-masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN in Patients with Open-angle Glaucoma or Ocular Hypertension


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older, either gender and any race.
* Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT).
* Not currently on any IOP-lowering medication or currently on a stable treatment (i.e, at least 30 days) with and IOP-lowering monotherapy.
* All patients: Mean IOP in same eye (at both Eligibility 1 \& 2 Visits):

  ≥ 24 and ≤ 36 mmHg at 9 AM; and ≥ 21 and ≤ 36 mmHg at 11 AM \& 4 PM.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Females of childbearing potential not meeting conditions set in the protocol.
* Severe central visual field loss.
* Angle Shaffer grade \< 2.
* Cup/disc ratio \> 0.8 (horizontal or vertical measurement).
* Best corrected visual acuity (VA) score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal).
* Intraocular surgery or trauma within last 6 months.
* Any abnormality preventing reliable applanation tonometry.
* History of or current ocular pathology (including severe dry eye) that would affect the conduct of the study.
* Allergy/hypersensitivity to study medications.
* Unable to discontinue use of all IOP-lowering medications for a minimum wash-out period of 5 to 28 days prior to the Eligibility Visit.
* Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP.
* Use of any additional topical or systemic ocular hypotensive medication during the study.
* Therapy with another investigational agent within 30 days prior to the Screening visit.
* Other protocol-defined exclusion criteria may apply.
Evaluation of Technological Innovation in Radiotherapy

Prospective cohort study of patients receiving standard-care radiotherapy is paramount to a better understanding of radiation effects and longterm outcomes.

The primary objective is to determine the feasibility of establishing infrastructure to systematically collect clinical data, patient-reported outcomes, and imaging data from daily radiotherapy practice.

Secondary objectives are to provide a control cohort for comparative effectiveness research of investigational interventions through a cmRCT design; compare imaging features with clinical outcomes; understand dose-effect relationships; quantify imaging quality metrics.

The study consists of an effort to develop infrastructure that will support systematic collection of data from daily radiotherapy practice. At the core, PERA is a large observational cohort study, serving as a multiple cohort randomized trial and image banking facility. It includes consent for the collection of imaging data, patient-reported outcomes, and broad randomization for studies according to the innovative cohort multiple randomized controlled trial design (cmRCT).

The basis of this design is a prospective cohort of participants receiving care as usual, who give informed consent for cohort participation.

Participants can furthermore be asked for informed consent to be randomized in future RCTs conducted within the cohort. Participants are informed that they will be offered an experimental intervention if they are randomly selected. They are also informed that they otherwise might serve as controls without being notified and that their data can be used in a trial context. For each participant in the cohort, PROs are captured at baseline and at regular intervals during follow-up. Within this cohort, multiple RCTs can be conducted. The design is especially attractive for clinical research areas with rapid evolution of technology, and for highly desired or expensive interventions.

In the first stage, at entry into the cohort, all potential participants are asked for their informed consent to participate in a cohort study and broad consent to be either randomly selected to be approached for experimental interventions or to serve as control without further notice during participation in the cohort. In a second stage, at the initiation of an RCT within the cohort, informed consent to receive the intervention is then only sought in those randomly selected for the intervention arm. At the third stage, after completion of each RCT, all cohort participants receive aggregate disclosure of trial results.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Receiving radiotherapy or brachytherapy

Exclusion Criteria:

-
Duration of Face Down Positioning for Full-Thickness Macular Hole Repair

A full-thickness macular hole is when there is a small gap that opens in the center part of the retina (the light-sensitive layer of tissue in the back of the eye). Following surgical repair of these holes, patients have to lie face down for a number of days and nights. The exact amount of time necessary to position is however unknown. The goal of this randomized feasibility clinical trial is to compare 3 days and nights of face-down positioning to 7 days and nights of face-down positioning following pars plana vitrectomy surgery for full-thickness macular holes on key patient outcomes. This study will be a feasibility study to better inform a future larger clinical trial. Additionally, this investigation will be examining the rates of macular hole closure, patient visual acuity following surgery, patient quality of life, patient compliance, and complication rates.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with an idiopathic full-thickness macular hole
* Symptom duration of less than 6 months
* Patient must agree to participate in this investigation

Exclusion Criteria:

* Macular hole minimum diameter \>1000 μm
* A history of high myopia (\> -6)
* Traumatic macular hole
* Amblyopia
* Retinal vein occlusion
* Inflammatory eye diseases
* Patients found to have a retinal tear during either the pre-operative assessment or intraoperatively
Effect of Ischemic Preconditioning on Atrial Fibrillation After Electrocardioversion

Remote ischemic preconditioning is one way to influence the success of therapy in cardiovascular patients. By means of remote ischemic preconditioning the incidence of atrial fibrillation after cardiac surgery was reduced by 54%. The investigators aim to investigate the effect of ischemic preconditioning in an easy-to-perform protocol with regard to the recurrence of atrial fibrillation after electrical cardioversion.


Eligibility Criteria:
Inclusion Criteria:

* Patients with paroxysmal or persistent atrial fibrillation who give written informed consent to participate in the study
* Age \> 18 years
* Consent capacity

Exclusion Criteria:

* Age under 18 years
* Pregnancy
* Lack of consent capacity
Clinical Pharmacist Intervention to Reduce Drug-related Readmissions Among Older People

This randomized controlled trial primarily investigates if a clinical pharmacist intervention can reduce drug-related readmissions among patients \>75 years. The intervention targets the transfer between hospital and primary care. In brief, the intervention includes medical chart reviews and patient interviews during a period of 180 days.

At discharge from the hospital, patients that meet the inclusion criteria are offered to participate in the study. At this point the investigators will also gather baseline data through questionnaires on self-reported adherence (MARS-5) and quality of life (EQ-5D). The participants are randomized to the different study arms according to a stratified procedure based on their cognitive function.

The intervention group will have their charts reviewed every second week and be contacted by the clinical pharmacist through phone within 7 and after 30 and 60 days respectively to discuss their medications. If possible drug-related problems are suspected during the interviews that cannot be solved immediately, the physician is contacted.

Both groups have a follow-up time of 30 and 180 days. After 30 and 180 days, the patients will once again report adherence and quality of life. All other data can be gathered from the medical charts.

Eligibility Criteria:
Inclusion Criteria:

* Living at home
* Acutely admitted
* Registered at one of ten pre-specified primary care health centers

Exclusion Criteria:

* Patients unable to communicate or who do not speak Swedish
* Patients scheduled for palliative care
* Patients admitted due to intoxication by alcohol or drug (non prescription)
Perineural Catheter Insertion Distance for Continuous Peripheral Nerve Blocks

This is a research study to determine if the effects of continuous peripheral nerve blocks are influenced by the distance of insertion past the needle tip of the perineural catheter.

Specific Aim: Research study to determine the relationships between perineural catheter insertion distance and subsequent continuous peripheral nerve block effects.

Hypothesis: during ultrasound-guided perineural catheter placement, inserting the catheter 0-1cm past the needle tip is associated with decreased postoperative pain compared with inserting the catheter 5-6cm past the needle tip.

Eligibility Criteria:
Inclusion Criteria:

* undergoing surgery with a planned popliteal perineural catheter for postoperative analgesia
* age 18 years or older

Exclusion Criteria:

* pregnancy
* inability to communicate with the investigators and hospital staff
* incarceration
* clinical neuropathy in the surgical extremity
* chronic high-dose opioid use
* history of opioid abuse
Epidemiology of Acute Otomastoiditis in Pediatric Age

It was decided to conduct this study because there are no standardized guidelines. regarding the management of acute otomastoiditis. The aim of the study is to describe the epidemiology of otomastoiditis in order to outline the scientific and rational basis necessary to standardize the diagnostic and therapeutic approach to this condition in order to reduce the diagnostic delay and improve the therapeutic outcome. It also aims to evaluate the effectiveness of different treatment modalities and identify possible risk factors associated with complications.

Acute otomastoiditis is the main suppurative complication of acute otitis media (OMA) and is secondary to the extension of the inflammatory process from the middle ear to the mastoid process of the temporal bone through a narrow canal, termed aditus ad antrum, which in the youngest child is more likely to be obstructed (due to the absence of pneumatization of the mastoid).1,2 Rarely, mastoiditis can occur even in the absence of signs and symptoms suggestive of OMA.3 Currently, risk factors leading to the evolution of OMA into otomastoiditis are not known in the literature, so the debate on the proper management of the single episode of otitis as a preventive strategy is still very much alive, also in light of the extreme frequency of OMA in pediatric age, its frequent self-resolution and the rarity of its complications. In particular, acute otomastoiditis remains a rare complication; in fact, it is estimated that the percentage of OMA that goes on to evolve into otomastoiditis is 0.24%.

The annual incidence of acute mastoiditis has been greatly reduced since the introduction of antibiotic therapy and is estimated to be between 1.2 and 4.2 cases per 100,000 children in industrialized countries.

Over the past decades, several scientific societies have updated guidelines for the management of OMA in order to reduce the overprescription of antibiotics and the consequent increase in drug resistance.In the latest Italian guidelines, the strategy of watchful waiting, i.e., clinical observation for the first 48-72 hours after symptom onset, has been confirmed only in children older than 2 years with mild monolateral, severe monolateral, and mild bilateral OMA. According to some authors, this treatment choice did not impact the incidence of complications, particularly otomastoiditis, but conflicting opinions exist in the literature.

In recent years, numerous studies have documented an increasing trend in the incidence of acute otomastoiditis, in particular, a study conducted from 2002 to 2013 at 25 hospitals in our country documented an increase in the annual number of acute otomastoiditis in patients older than 4 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≤14 years with an established diagnosis of acute otomastoiditis

Exclusion Criteria:

* NA