cyrilzakka/clinical-trials huggingface dataset:
Comparison of Patient Satisfaction and Chewing Efficiency Between Conventional and 3D Printed Complete Dentures.

Twenty completely edentulous patients were enrolled in this study. Each patient received two types of prostheses. 1) Conventional complete dentures. 2) 3D printed dimethacrylate-based resin complete dentures. Patient satisfaction was assessed using the oral health impact profile (OHIP-EDENT-N) survey questionnaire, and masticatory performance was evaluated with the two-colored chewing gum mixing ability by evaluation of the standard deviation of hue at (T0) at the time of complete denture insertion, (T3) after 3 months of denture use and (T6) after 6 months of denture use.

For each patient, conventional maxillary and mandibular complete dentures were constructed, followed by 3D printed complete dentures construction as follows: Scanning of maxillary and mandibular complete dentures and scanning of master casts were done using 3D scanner (VDSL Home Gateway model EchoLife DG8045 China) after lightly coated with anti-glare spray (Siladent Marmoscan spray basic Ref. 250022). The resultant data in STL format were transmitted to the CAD-CAM complete denture provider using a purpose-built software program (Exocad DentalIDB 2.4 plovdiv7290\[version 2.4 Enginebuld 7290\]). The anatomic landmarks were identified, and the peripheral limits were marked on a virtual model in the design software, which then were served to design the definitive complete denture.

The scanned STL image of the conventional complete denture which have been previously constructed was superimposed on the newly designed denture for comparison of polished surface, teeth alignment, size, and form of teeth. A digital preview was generated and sent for approval before fabrication.

Printing Preparation: The denture base shade was selected, and then the cassette of the 3D printer (RASDENT 3D printer) was filled with fresh DENTCA Denture Base II dimethacrylate-based resins with photo-initiator). Then the printer door closed. Printing procedures: The denture base model STL file was uploaded into the software. The denture base was oriented vertically on the build platform. Supports were generated around the perimeter of the denture base. The desired slice thickness was selected and then the printing was started. Cleaning, Bonding teeth to the denture base, Post-curing procedures, Finishing Evaluation of patient satisfaction: The OHRQoL of the patient was assessed using an instrument called OHIP-EDENT-N10.

Eligibility Criteria:
Inclusion Criteria:

* They were healthy, free from any systemic diseases affecting bone metabolism such as uncontrolled diabetics or osteoporosis. This was achieved through detailed medical history and clinical examination by physician. They had no previous denture experience. Residual alveolar ridges covered with healthy firm mucosa. Angle's class I maxilla-mandibular relationship.

Exclusion Criteria:

* Systemic disease
A Study of Oral Calcitonin Given at Night to Healthy Postmenopausal Women

This study is being conducted to assess the plasma CTx-1 concentrations when dosing is at night and to compare these results with those obtained with a placebo control and with commercially available nasal calcitonin.

Timing of the dose of recombinant salmon calcitonin (rsCT) is important in effecting reduction of osteoclast activity. It is theorized that a dose administered before bedtime will be more effective than a dose administered in the morning. See protocol summary for information.

Eligibility Criteria:
Inclusion Criteria

* Postmenopausal female, in good health (at least five years since last menses).
* Age greater than or equal to 45 years old and less than or equal to 70 years old
* Weight ± 20% of the Metropolitan Life weight table.
* Plasma CTx-1 greater than or equal to 0.25 ng/ml.
* Total calcium, phosphorus, and magnesium within normal range.
* Willing and able to comply with all study requirements.
* Willing and able to sign written informed consent.
* Negative urine pregnancy test at screening.
* Negative Screen for Hepatitis B and C, HIV and drugs of abuse.

Exclusion Criteria:

* History of parathyroid, thyroid, pituitary or adrenal diseases.
* History of musculoskeletal disease.
* History of gastro-esophageal reflux disease (GERD) or other significant gastrointestinal disorders.
* History of cancer within 5 years of enrollment other than basal cell carcinoma.
* History of regular use of a Non-Steroidal Anti-inflammatory Drug (NSAID).
* History of surgery within 60 days of enrollment.
* History of hypersensitivity or allergies (other than seasonal allergies) within -years of enrollment including known sensitivity to the active ingredients or the excipients in the study medications.
* Use of concomitant medications other than acetaminophen within 7 days of enrollment or anticipated need to use such concomitant medications during the study.
* Use of bisphosphonates within 6 months, SERMS, estrogen or estrogen-like drugs 2 months, or calcitonin 1 month.
* Presence of any clinically significant illness.
* Unwilling or unable to comply with all study requirements.
* Unwilling or unable to sign written, informed consent.
* History of drug or alcohol abuse.
* Participation in any clinical study of an investigational drug within 60 days of enrollment.
* Plasma CTx-1 less than 0.25 ng/mL.
Lateral Arm Free Flap for Reconstruction of the Oral Cavity and Head and Neck Soft Tissue Defects.

The excision of oral cancers causes extensive impairment of the oral cavity soft tissue. Complete excision of the tumors is vital, and the reconstruction of the resected area influences not only the postoperative recovery period of patients but also physiological functions such as swallowing, phonation function ,daily activities and psychosocial impact.

Oral and maxillofacial surgeons are faced with the task of reconstructing the affected area to reduce these problems as much as possible.

In 1982, Song introduced the lateral arm flap (LAF). Since this time, its used in surgical repairs of oral defects, But the specific subject of publications generally restricted to a small number of cases.

LAF is a thin and pliable flap with consistent anatomy and a high success rate. It is also claimed that there is no risk of vascular compromise to the arm

reconstruction of oral , head and neck defects with Lateral Arm Free Flap

Eligibility Criteria:
Inclusion Criteria:

1. All patients post glossectomy.
2. Patients post maxillectomy with malignant maxillary swelling with no distant metastases.
3. All patients which defect after surgery for head and neck neoplasia.

Exclusion Criteria:

* 1. Small defect post excision can be closed directly 2. medically unfit patients
Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia A

Participants will be assigned to A or B groups with a scale of 1:1 based on a prospectively randomized treatment-sequence assignment, i.e. infuse SCT800 followed by Xyntha (group A), or the alternate sequence (group B). All participants who completed the SCT800HA1 study will enter the efficacy and safety study (Protocol No.: SCT800HA3).


Eligibility Criteria:
Inclusion Criteria:

* 12 to 65 years old;
* The activity of the coagulation factor VIII (FVIII:C) ≤2%, and was previously treated with FVIII concentrate(s) for a minimum of 50 exposure days (EDs) prior to study entry
* Non-bleeding state (No clinical manifestations of active hemorrhage);
* Negative assays for FVIII inhibitors (\<0.6 BU/mL);
* The platelet count is normal；
* Normal prothrombin time or INR ≤1.5；
* Given informed consent

Exclusion Criteria:

* Hypersensitivity to recombinant coagulation factor VIII concentrate or any of the excipients ;allergic to heterologous proteins (e.g. murine, bovine or hamster origin);
* Family history or history of FVIII inhibitors (≥0.6 Bethesda Units \[BU\] mL-1);
* Received an infusion of any FVIII for on-demand therapy or prophylaxis within 4 days prior to study entry (including rFVIII, plasma-derived factor VIII \[pdFVIII\], cryoprecipitate and whole blood);
* Significant hepatic or renal impairment (ALT and AST ≥2×ULN; BUN and Cr≥2×ULN);
* HIV seropositive;
* Abnormal hemostasis from causes other than hemophilia A；
* Patients with severe heart disease, including myocardial infarction, heart failure (III or higher level);
* Patients who received any anticoagulant or antiplatelet therapy within one week (including NSAIDs) or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials;
* Alcoholism, drug abuse, mental disorders and mental retardation;
* Elective surgery planned during the process of study;
* Patients who previously participated in the other clinical trials prior to study entry;
* The patient or parent/legal guardian is unable or unwilling to sign an informed consent form or to comply with the requirements of clinical protocol;
* Other conditions confirmed by the researchers, resulting in that patients are unable to benefit from clinical observation;
Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage

Intracerebral hemorrhage (ICH) is a critical disease of public health importance. Inflammatory mechanisms play a significant role in ICH. Thus, immune targets are supposed to be effective in protecting the neurological function of ICH. Fingolimod, a sphingosine-1-phosphate receptor regulator (FTY720), is an effective immunology modulator. It has been widely used in autoimmune disease and has also been testified effective in ICH who received conservative treatment. The present study aims to evaluate the efficiency and safety of fingolimod for ICH with minimal invasive treatment.

40 ICH patients who meet the inclusion criteria will be enrolled in the present study.

All ICH patients will be screened. If meeting the including criteria, the investigators will contact the family, explain the study, and send a consent form for review.

After obtaining written consent from the family, patients randomly assigned to the fingolimod group will be given 0.5mg/day oral fingolimod over a course of 3 consecutive days. Patients assigned to the control group will not receive fingolimod. All patients will receive minimal invasive puncture and drainage of hematoma. The investigators will evaluate the neurofunctional before and 30 days, 90 days and 180 days after oral fingolimod. CT scan will be performed at before, 7 and 14 days after oral fingolimod. 5ml intravenous blood for flow cytometry is also taken before and 1day, 3days, 7days after fingolimod use.

Eligibility Criteria:
Inclusion Criteria:

* spontaneous basal ganglia ICH with volume larger than 20ml;
* age: 18-80 years;
* admission Glasgow Coma Scale score: 5-12;
* admitting to hospital with 24 hours after injury;
* no fever or signs infection on admission to hospital;
* admission heart rate≥60/min on admission.

Exclusion Criteria:

* refuse follow-up;
* received operation before admitting to hospital;
* hemorrhage by tumor, arteriovenous malformation, arterial aneurysm, hematological disease or traumatic brain injury;
* severe vomiting;
* mRS\>1 before ICH;
* prior history of bradycardia;
* prior history of Atrioventricular block;
* prior history of traumatic brain injury, craniotomy or stroke;
* expected lifetime less than 1 year;
* undergoing antitumor, antiepileptic, immunomodulatory or immunosuppressive therapy;
* admitting to other ongoing study;
* systemic disease: uremia, liver cirrhosis, malignant tumor, mental disease, drug or alcohol dependence;
* received anticoagulant or antiplatelet therapy within 7 days;
* intraventricular hemorrhage requires intraventricular catheterization.
Interactive Care Plan for the Monitoring of Symptoms and Recovery in Patients With Stage 0-III Breast Cancer

This phase I trial evaluates how well a mobile device-based breast cancer survivorship interactive care plan works in monitoring symptoms and recovery in patients with stage 0-III breast cancer. The interactive care plan provides patients with individualized, 'just in time' education materials to promote self-management for those reporting difficult to control symptoms, as well as escalations to contact their care team for signs or symptoms concerning for cancer coming back (recurrence). The interactive care plan may help alleviate the symptoms of fatigue, insomnia, hot flashes, and sexual dysfunction; increase physical activity level and improve quality of life in patients with breast cancer.

PRIMARY OBJECTIVES:

I. To evaluate the feasibility and usability of the breast cancer (BC) survivorship interactive care plan (ICP) as designed.

II. To determine the behavioral, toxicity symptom burden and quality of life (QOL) changes in patients engaged with the ICP.

III. To assess clinical workflow impact by the introduction of the ICP in the BC survivor practice.

OUTLINE:

Patients complete surveys for 4 common symptoms: fatigue, hot flashes, insomnia, and sexual dysfunction and receive educational material via mobile application (app) to help with bothersome symptoms. Patients also complete questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Recently diagnosed and treated for breast cancer -- having a biopsy-proven, stage 0-III breast cancer and are within 12 months of completion of loco-regional breast cancer treatment and (as indicated) neoadjuvant and/or adjuvant chemotherapy. Ongoing treatment with adjuvant endocrine, bisphosphonate, and single-agent, HER2-directed therapy during the study period is allowed
* Willing to install an application (APP) on personal smart device

Exclusion Criteria:

* Unwilling to return to Mayo Clinic for routine follow-up visits
* Unwilling to use the Mayo Clinic Mobile App
* Unable to provide consent
* Unable to speak or read English
* Unable to participate in mild activity
Evaluate Clinical Research From Commerical Oral Care Products

The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of commercial oral care products.

The purpose of this study is to compare efficacy of two commercially available toothpastes and one oral rinse on dental plaque control.

Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers 18-65 years of age
* Good general health
* Must sign informed consent form
* Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
* No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria:

* Subjects unable or unwilling to sign the informed consent form.
* Medical condition which requires pre-medication prior to dental visits/procedures
* Moderate or advanced periodontal disease or heavy dental tartar (calculus) requiring more than one visit of cleaning sessions
* 2 or more decayed untreated dental sites at screening.
* Other disease of the hard or soft oral tissues.
* Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
* Use of medications that can currently affect salivary flow.
* Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
* Pregnant or nursing women.
* Participation in any other clinical study within 1 week prior to enrollment into this study.
* Allergy to chlorhexidine
* Use of tobacco products
* Subjects who must receive dental treatment during the study dates.
* Current use of Antibiotics for any purpose.
* Presence of an orthodontic appliance.
* History of allergy to common dentifrice ingredients.
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
¡Yo no Estoy Loc@! Improving Treatment Engagement for Latinos Using an E-E Video

The underutilization of behavioral health services for mood and anxiety disorders by Latinos is a public health concern warranting intervention development. Perceived stigma associated with the pursuit of behavioral health services disproportionately restricts mental healthcare in Latinos. The current study empirically tests an intervention aimed at improving perceptions of behavioral health services for mood and anxiety disorders, ultimately improving Latinos' mental health through access to treatment. The experimental intervention is based on the Entertainment-Education (E-E) model, a popular media campaign that incorporates health and educational messages in an entertaining, story-telling narrative. The E-E model incorporates characters who have characteristics, beliefs, attitudes, and behaviors that are similar to those of the targeted audience to maximize social validity. Using data gathered in focus groups with Latinos a 3-minute E-E video (in Spanish) that aims to reduce stigma towards mental illness and behavioral health services was developed. Sixty adult Latinos pursuing care at a Federally Qualified Health Center, who screen positive for anxiety and/or depression will be invited to participate in the study. Participants will be administered a structured demographic interview and measures that assess stigma and attitudes towards mental health and behavioral health services and then randomized to the E-E video or control (structured discussion about depression and anxiety) condition. Participants will then complete the study measures and be invited to attend a Cognitive Behavior Therapy (CBT) group for depression or anxiety. Consumer satisfaction will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Spanish-speaking

Exclusion Criteria:

* Screen positive for suicidality or psychosis
Specific Respiratory Infections as Triggers of Acute Medical Events

This study will investigate whether there is a population-level association between circulating respiratory viruses and NHS hospital admissions for acute vascular events using data from national infection surveillance and Hospital Episode Statistics.

We will conduct a time series study correlating anonymised population level data on all samples from NHS laboratories testing positive for six common respiratory viruses with admissions to NHS hospitals in England for a range of cardiac and vascular outcomes over the time period 01/01/2004 to 31/12/2014. This will involve generating Poisson regression models controlling for factors such as seasonal and long-term trends, environmental temperature and humidity.

This study is funded by an Academy of Medical Sciences Starter Grant for Clinical Lecturers.

Eligibility Criteria:
Inclusion Criteria:

* Any individual with a record of an eligible outcome (ICD-10 coded hospitalisation for myocardial infarction or stroke) within the study period aged 45+ years
* Any individual with a record of an eligible exposure (laboratory-confirmed respiratory virus) within the study period at any age

Exclusion Criteria:

* Outcome events occurring in people aged \<45 years
Genome-Wide Association Study in Patients With Nontuberculous Mycobacterial Lung Disease

The aim of this study was to elucidate genetic susceptibility of patients with nontuberculous mycobacterial lung disease using genome-wide association study.

Nontuberculous mycobacteria (NTM) are ubiquitous environmental organisms. NTM lung disease is increasing, however, genetic susceptibility of patients with the disease have not been identified. To elucidate the genetic susceptibility of NTM lung disease, the investigators perform a genome-wide association study (GWAS) including patients with NTM lung disease and healthy controls (case : control = 1 : 3). The age-, sex-matched control group will be recruited from the Korean Healthy Twin Study.

Eligibility Criteria:
Inclusion Criteria:

* Case: Patients with NTM lung disease satisfying diagnostic criteria suggested by American Thoracic Society
* Control: Healthy subjects enrolled in the Korean Healthy Twin Study

Exclusion Criteria:

* Case: none
* Control: 1) Subjects who have respiratory symptoms including cough and sputum 2) Subjects who have abnormalities on chest radiography
Echocardiographic Assessment of Ventricular Strain During a Healthy Pregnancy in the First, Second, and Third Trimester.

Pregnancy is a physiological situation that produces transient preload and afterload changes. The heart is subjected to reversible morphological remodelings and hemodynamic and functional adaptations. The characterization and understanding of maternal cardiac function during normal pregnancy by echocardiography 2D is of clinical importance for the opportune recognition of cardiac pathology.

This study aims to investigate pregnancy-induced changes in ventricular strain in healthy pregnant women by echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years and \< 35
* Patients who coursing the first trimester of pregnancy
* No history or symptoms of cardiovascular or lung disease
* No ongoing or previous cardio or vasoactive treatment
* Normal ECG
* Normal physical examination
* Able to give informed consent

Exclusion Criteria:

* Poor acoustic window
* Obesity in the first trimester (body mass index \[BMI\], ≥30 kg/m2)
* Inability to provide consent.
* Tricuspid regurgitation more than mild
* Collagen disease
* Professional sports activity
* Twin pregnancy
* Hyperthyroidism
Ultrasound Guidance for Epidural Analgesia and Anesthesia

Most women delivering by cesarean at BC Women's receive regional anesthesia; which includes spinal, epidural, or combined spinal-epidural anesthesia. In all these techniques a needle is placed in the lower back and local anesthetic is injected to freeze the body. Normally, before the needle is placed in a patients' back, the anesthesiologist will feel between their back bones with his/her fingers to find the right spot for the needle. This study will be evaluating if the distance from the skin to the appropriate spinal space measured with a novel 3D Ultrasound will equal the actual depth of the needle insertion.

The investigators will be evaluating if the distance from the skin to the appropriate spinal space measured with a novel 3D Ultrasound will equal the actual depth of the needle insertion.

Eligibility Criteria:
Inclusion Criteria:

* term pregnancy
* elective cesarean

Exclusion Criteria:

* scoliosis
* high bmi