cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques

The purpose of this study is to compare standard fillings and silver diamine fluoride (SDF) for treatment of cavities in baby teeth. The investigators will compare the effectiveness of stopping the cavity, cost of the treatments and the opinions of the families and the dental providers.

To determine the effectiveness of the application of silver diamine fluoride (SDF) in comparison to conventional restorative treatments in International Caries Detection and Assessment System criteria (ICDAS) 5 and 6, one and two surface carious lesions in primary molars which will be assessed based on major and minor failure criteria when followed for one year. Additionally, parents'/children's and providers' perceptions will be assessed as well as the cost of both regimens, to include both chair time spent and materials' costs.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least one active (soft) cavitated carious lesions in the primary dentition, extending into dentin (ICDAS 5 or 6)
* The selected tooth must have a one or two surface lesion (more than 1/3 of the crown of the tooth must be remaining) and must allow for direct application of SDF
* Study teeth will not have any spontaneous or elicited pain due to caries, tooth mobility, or signs of pulpal infection
* Selected primary teeth must have an anticipated exfoliation date greater than 12 months away

Exclusion Criteria:

* Hereditary developmental defects such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta
* Severe medical conditions that do not allow the child to be managed in the clinic
* Known allergy /sensitivity to dental materials being used, including SDF
* Inability of the child to cooperate for treatment, recall examinations, or periapical radiographs
* Wards of the State, for consenting reasons
A Retrospective Analysis of Percutaneous Endoscopic Gastrostomy Experiences

The application of PEG in geriatric-palliative care has not been well discussed. With the development of endoscopic procedures and PEG devices, we can perform this minimally invasive method more safely, even in challenging cases. We should discuss the indications of PEG in the field of palliative care of geriatric patients.

The presented study evaluated geriatric (\> 65-year-old) palliative care patients to whom PEG applied at our institution.

Palliative care is a treatment method that focuses on the patient and patient's family, aims to minimize the complaints caused by chronic diseases that cannot be treated, and increases life quality. The National Institute for Health and Care Excellence defines palliative care as; the active, holistic care of patients with an advanced progressive illness. Management of pain and other symptoms and providing psychological, social, and spiritual support is paramount. Anorexia, weight loss, and sarcopenia are highly visible and distressing reminders of the life-limiting disease's influence on patients who require palliative care. Given this multifaceted and significant role, it is not unexpected that nutritional treatment method choices can be challenging.

Percutaneous endoscopic gastrostomy (PEG) is a minimally-invasive endoscopic procedure that creates a passage from the patient's stomach to the abdominal wall via a feeding tube and provides a means of feeding if oral intake is not adequate. This safe and effective minimally-invasive option has been utilized in medical practice for over 40 years. PEG has advantages such as being minimally invasive, causing a low rate of complications and morbidity, and providing a long-lasting and safe feeding route. It is currently the chosen procedure for medium- and long-term enteral feeding in cases who need palliative care.

The application of PEG in geriatric-palliative care has not been well discussed. With the development of endoscopic procedures and PEG devices, we can perform this minimally invasive method more safely, even in challenging cases. We should discuss the indications of PEG in the field of palliative care of geriatric patients.

The presented study evaluated geriatric (\> 65-year-old) palliative care patients to whom PEG applied at our institution.

Eligibility Criteria:
Inclusion Criteria:

- We retrospectively assessed the medical datum of PEG applied \>65-year-old patients at our institution between December 2017 and March 2021 in our clinic.

Exclusion Criteria:

* We excluded the patients who were not treated in our palliative care center.
The Effect of Histopathologic Analysis and Tissue Cultures on Inpatient Management of Cellulitis and Pseudocellulitis

The Investigators wish to study the value of dermatologic testing assessments in differentiating between cellulitis and pseudocellulitis in the inpatient setting. The Investigators propose that by utilizing cutaneous biopsies and tissue cultures in patients that have been admitted to inpatient internal medicine teams, the investigators may be able to improve multiple measures of hospital efficiency in patients presenting with cellulitis-like symptoms, by more accurately recognizing cellulitis from pseudocellulitis. The patient will undergo encrypted digital imaging for his or her condition. This image will then be sent to the study investigators, along with basic clinical information on the skin evaluation form. The study investigators will develop a differential diagnosis and then the patient will undergo a skin biopsy. The patient will then be randomized to one of two arms using a random number generator: A) Skin biopsies and tissue cultures recorded and published in patient's medical chart as they would be in a standard of care procedure B) Skin biopsies and tissue cultures consultation performed but not published in the patient's medical chart unless medically necessary. Information will be collected from medical records in IHIS. Patients will be contacted by phone 30 days after discharge.


Eligibility Criteria:
Inclusion Criteria:

* admitted inpatient to The Ohio State University Wexner Medical Center Internal Medicine ward with cellulitis-like symptoms, including but not limited to the following: tenderness, redness, swelling, expansive lesion.
* Affecting one or more extremities
* are at least 90 days post any associated operation of the extremity
* are above the age of 18
* Participants will be patients with cellulitis or pseudocellulitis.
* Patients who have recurrent cellulitis will be eligible for enrollment into the study, but only once.

Exclusion Criteria:

* Patients who are pregnant
* Prisoners
* Patients may not have trauma, ulcer, or puncture wound to the area
* May not be transferred from another hospital
* May not be admitted to the Cancer Hospital or with a known active solid organ or hematologic cancer other than nonmelanoma skin cancer
A Clinical Pharmacology Study of K-877 Controlled Release Tablet

A study to compare the efficacy, safety, and pharmacokinetics of K-877 controlled release tablets with a current normal K-877 tablet in dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with dyslipidemia had to be age 20 years or older at written informed consent(ICF)
2. Men and postmenopausal women.
3. Patients who have received dietary or exercise guidance from 12 weeks prior to Screening.
4. Patients who have clinical laboratory records with fasting serum TG ≥ 150 mg / dL (or ≥ 200 mg / dL if not fasting) within 6 months before written informed consent.
5. Patients with a fasting serum TG ≥ 150 mg / dL at Screening.

Exclusion Criteria:

1. Patients with a fasting serum TG ≥ 500 mg / dL at Screening
2. Patients who require administration of prohibited drugs during the clinical trial period after written informed consent
3. Patients who have malabsorption or those who have had the history, or who have undergone other surgical procedures that may affect absorption (excluding appendectomy or hernia treatment etc)
4. Patients with uncontrolled thyroid disease
5. Patients with uncontrolled diabetes as defined by a HbA1c(NGSP) ≥ 8.0％ at Screening
6. Persons with uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg)
7. Patients with an AST or ALT three times the upper limit at Screening
8. Patients with cirrhosis or those with biliary obstruction
9. Patients with malignant tumor or those who are judged to have a high risk of recurrence
10. Patients who have collected 400 mL or more of whole blood within 16 weeks, or 200 mL or more of whole blood within 4 weeks, or blood samples (plasma and platelet components) within 2 weeks before Screening
11. Patients with a history of serious drug allergies (anaphylactic shock, etc.)
12. Patients with a history of hypersensitivity to pemafibrate, patients who have stopped taking pemafibrate for reasons of insufficient efficacy or safety
13. Patients who participate in other clinical trials at the time of written informed consent or who have received clinical trials other than placebo for less than 16 weeks
14. Patients who have been determined inappropriate by the investigator or subinvestigator
Comparison of Hepatus and FibroScan for Evaluation of Fibrosis and Steatosis

Totals of 400 chronic hepatitis B or non-alcoholic fatty liver disease (NAFLD) patients with or without cirrhosis will be enrolled. Patients' clinical characteristics, including alanine aminotransferase, aspartic aminotransferase, total bilirubin, direct bilirubin, indirect bilirubin, triglyceride and total cholesterol, hepatitis B surface antigen, steatosis, and liver stiffness measurement will be collected. The consistence of liver fibrosis and steatosis assessment between Hepatus and FibroScan will be evaluated in this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with or without cirrhosis diagnose as chronic hepatitis B or non-alcoholic fatty liver disease;
* Age above 18 years;
* Signature of informed consent.

Exclusion Criteria:

* Patients with HCV and/or other viral hepatitis, autoimmune liver disease, alcoholic liver disease, genetic liver disease or other chronic liver diseases;
* Patients with decompensated cirrhosis;
* Patients with serum total bilirubin level higher than 51 umol/L;
* Patients with liver malignant lesion, hemangiomas, giant liver cysts and other liver lesions;
* Patients with HIV infections;
* Patients after liver transplantation or TIPS;
* Pregnant women;
* Patients with Budd-Chiari syndrome, chronic congestive heart failure, constrictive pericarditis or other liver congestion lesions.
Rituximab in Interstitial Pneumonitis

This project will address rare immune mediated inflammatory diseases (IMIDs) involving the lungs, i.e. interstitial pneumonitis (IP). The main objective of this study is to assess the effects of rituximab (RTX) as a rescue therapy for progressive IMID-IP patients. The primary study parameter is pulmonary function.

The secondary objectives are to explore the application of imaging with radiolabeled RTX as early predictor for efficacy of RTX, to study the effects of RTX treatment on quality of life, and to further elucidate the pathophysiology of IMID-IP by analyzing biochemical markers.


Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in the study, subjects must meet all of the following criteria:

* Age 18 to 70 years
* No previous therapy with rituximab
* At least 2 pulmonary function tests within past 6 months
* Diagnosis of co-existing IMID and a severe and / or progressive IP characterized by 3 out of the following items:
* Respiratory symptoms consistent with interstitial lung disease
* Diagnosis of usual interstitial pneumonia (UIP), non-specific interstitial pneumonia (NSIP), organizing pneumonia (OP) or a mixed form of UIP / NSIP / OP by either of the following:
* Open or video-assisted thoracic surgery (VATS) lung biopsy showing definite or probable UIP / NSIP / OP
* High Resolution Computer Tomography (HRCT) scan showing definite or probable UIP/NSIP/OP/mixed
* Forced Vital Capacity (FVC) \< 50% predicted and/or diffusing capacity of the lung for carbon monoxide (DLCO) \< 40% predicted or worsening of lung function as demonstrated by any one of the following within the past year:
* \> 10% decrease in FVC
* \> 15% decrease in DLCO
* Therapy resistance to 1st (corticosteroids) and 2nd line therapy(cyclophosphamide or azathioprine)

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Residual volume \>120% predicted at screening
* DLCO \<25% of predicted value at screening + resting Oxygen Saturation (SAO2) without external oxygen \<90%
* History of unstable or deteriorating cardiac or neurological disease
* Pregnancy or lactation
* Hematology lower than specified limits (leucocytes)
* Positive HIV, hepatitis B or C serology
* Pre-existing conditions which lead to a life expectancy of less than 6 months
* Receipt of any vaccine, particularly live viral vaccines, within 4 weeks before first rituximab dose
* Hypersensitivity for murine proteins

NOTE:

* Fever (\>37,9 °C) at presentation is reason to delay therapy by 1 week
* Evidence of active infection is reason to postpone rituximab treatment until no further signs of active infection
* Severe renal impairment is not a contraindication for rituximab therapy, however, if patients (might) require dialysis frequently they will be excluded from the study group
Collection of Samples and Clinical Data From Patients With Amyloid Diseases

RATIONALE: Collecting and storing samples of blood, urine, tissue and data from patients with amyloid diseases to test in the laboratory may help the study of this disease in the future.

PURPOSE: This research study is collecting samples from patients with amyloid diseases

OBJECTIVES:

* To establish and maintain a database of clinical material (i.e., blood, urine, and tissue) and information on patients with amyloid diseases.

OUTLINE: Blood, urine, tissue, and bone marrow samples are collected during standard laboratory evaluations to maintain a repository of biospecimens in the Gerry Amyloid Research Laboratory, to permit the correlation of clinical results with measured biological events, and for future research studies. Bone marrow RNA samples are examined for immunoglobulin light-chain gene sequences and amino acids by polymerase chain reaction and positional cloning. Blood serum and urine samples are evaluated for amyloid protein stability by high-resolution calorimetry, isothermal-titration calorimetry, and far- and near-UV circular dichroism and fluorescence spectroscopy. Urine samples are also examined for post-translational modifications (e.g., glycosylation, sulfation, and cross-linking) to identify common features unique to amyloid proteins. Tissue samples are analyzed for biochemical and biophysical properties and for post-translational modifications in light chains.

Quality of life is assessed by the 36-Item Short Form Survey (SF-36).

Eligibility Criteria:
Inclusion Criteria:

DISEASE CHARACTERISTICS:

* Diagnosis or suspicion of amyloidosis

PATIENT CHARACTERISTICS:

* Referred to the Amyloid Treatment and Research Center at Boston University Medical Center

PRIOR CONCURRENT THERAPY:

* Not specified

Exclusion Criteria:

None
Migration Pattern of C-stem AMT Versus Exeter in Total Hip Arthroplasty

Hypothesis: Migration of C-Stem AMT is equal to the well documented Exeter prosthesis

In Norway it is annually performed approximately 600 primary and 100 revisions THA. Osteolysis around the prosthesis is one of the major difficulties while performing revision surgery. C-stem is a triple tapered cemented prosthesis designed to increase the stress and strain of proximal femur and thereby decreasing osteolysis. We are planning til include 70 patients and randomize to C-stem AMT or Exeter prosthesis. Both prosthesis will be combined with previously non documented "Marathon" acetabular prosthesis.

The result will be followed clinically and with RSA and DXA. Soft endpoint after 2 years


Eligibility Criteria:
Inclusion Criteria:

* coxarthrosis

Exclusion Criteria:

* age over 80
* major medial condition such as renal failure, chronic obstructive lung disease heart failure etc
Improving Psoriasis Through Health and Well-Being

The purpose of the study is to examine and compare the effects of the Mindfulness-Based Stress Reduction (MBSR) program and the Living Well (LW) program on adults with psoriasis in terms of how these programs may affect their psoriasis, immune function, physical and emotional health, and well-being.

The study examines the effects of two eight-week programs (MBSR vs. LW) for disease processes in patients with psoriasis severity reporting moderate or higher perceived stress. The research will focus both on clinical measures of the disease state and overall well-being.

The Aims of our proposed intervention study are the following:

1. To examine the effects of MBSR, versus the Living Well (LW) program, on (a) disease severity, immunological markers of inflammation, and keratinocyte proliferation, (b) psoriasis-related stress and perceived stress in general, and (c) anxiety and depression.
2. To examine whether treatment effects of either program are moderated by personality traits, mindfulness, and age.
3. To examine the effects of behavioral and psychological mediators on immune outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* English speaking
* Clinical diagnosis of psoriasis (active at initial visit)

Exclusion Criteria:

* currently receiving immunosuppressive therapy for cancer or for diseases unrelated to psoriasis (or \< 6 months post-chemo or radiation)
* major, uncorrected sensory impairments
* cognitive deficits (MMSE \<25, or deficits deemed significant enough to interfere)
* severe cardiovascular disease
* current alcohol abuse or non-alcohol psychoactive substance use disorders, psychotic disorders (current and lifetime), and current mood disorder with psychotic features.
Posterior Maxillary Ridge Augmentation With Sinus Lift Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft

Using growth factors obtained from patient's venous blood mixed with particulate autogenous bone the study compares bone gain by implant with gold standards in sinus Lift procedures for future implant insertion.

To study the effectiveness of MPM in ridge augmentation with implant insertion compared with autogenous bone graft.

-PICO Population(P) : Patients with defective posterior maxillary alveolar ridge. Intervention (I) :Implant placement and ridge augmentation with MPM. Comparator (C) : Autogenous bone graft. Outcome (O) : Patient satisfaction - Implant stability.

Eligibility Criteria:
Inclusion Criteria:

1. Patients systemically free.
2. Patients with posterior maxillary defective ridges indicated for sinus lift procedure.
3. Cases with 5 mm bone height or less are included in the study.
4. Age between 18 and 50 years.
5. Both sexes.
6. Patients physically able to tolerate surgical and restorative procedures.
7. Good oral hygiene.
8. Highly motivated patients.

Exclusion Criteria:

1. Patients allergic to local anesthetic agent.
2. Medium and heavy smokers.
3. Pregnant females.
4. Presence of any pathosis in the pre-implant site.
5. Presence of any mucosal disease.
6. History of oral radiotherapy.
7. History of prolonged steroids use.
8. Psychological disorders.
Thermal Camera Detection of Ventriculoperitoneal Shunt Flow

There have been reports in the past of using thermal cameras to demonstrate flow in the tubing as a surrogate of proper shunt function. This was shown to have almost 90% accuracy at determining proper functioning but required expensive equipment that was not universally available. There is now smart phone based thermal camera technology (Flir One: http://www.flir.com/flirone/) that could make this technique widely available for health care use. The goal of the study is to determine if this device can demonstrate flow in the distal tubing of a VP shunt.


Eligibility Criteria:
Inclusion Criteria:

* Patients with known VP shunt
* Status of shunt function known.
* Patients with well healed wounds (no immediately post op patients)

Exclusion Criteria:

* Patients in urgent need of shunt revision
* Age less than 18
Simple Breath Test to Examine Phenylalanine Metabolism

Phenylketonuria(PKU)is a rare condition caused by the body's inability to properly breakdown an amino acid called phenylalanine(PHE), due to a missing enzyme, phenylalanine hydroxylase(PAH). When the enzyme is missing and/or not functioning properly, it increases the level of PHE in the body. High levels of PHE can cause severe brain damage or nerve damage unless the children are on a strict low PHE diet. A low PHE diet restricts the intake of protein rich foods and can pose a significant burden to both the patient and the family.

Investigators at the University of British Columbia and British Columbia Children's Hospital will examine the phenylalanine metabolism in children with PKU using a simple breath test.

Patients (5-18y) receiving standard clinical care at the BC Children's Hospital's Biochemical Diseases Clinic will be enrolled.The study will be conducted twice on each patient. Baseline measurements will be performed at the beginning of each study for each patient.The Physician in charge will then prescribe the standard dose of sapropterin dihydrochloride (Kuvan®) (20mg/kg/d) or otherwise as deemed appropriate by the physician-in-charge. The test will be repeated a week (minimum) after the beginning of treatment with the prescribed dose.

The investigators propose that children who are responsive to sapropterin dihydrochloride (Kuvan®) will have increased 13CO2 in breath after treatment, and those who do not respond will have no change in the 13CO2 in the breath before and after treatment.

As a comparison to the experimental group, age and gender matched healthy controls will also be studied. The test in healthy controls will be performed once without any intervention, and is only used as a comparative value.


Eligibility Criteria:
Inclusion Criteria:

Study Subjects:

1. Children (4-18y)diagnosed with PKU
2. Parent(s) or guardian(s) willing and able to provide informed signed consent.
3. Parent(s) or guardian(s) willing and able to comply with all study procedures

Healthy controls:

1. Healthy Children (4-18y) with no health condition
2. Willing to go through an initial screening for age and gender match
3. Parents or guardians willing and able to provide informed signed consent.
4. Parents or guardians willing and able to comply with study procedures

Exclusion Criteria:

Study Subjects:

1. Children \< 4y of age diagnosed with PKU, as it may be challenging to collect breath samples and perform indirect calorimeter in very young children
2. Children (4-18y)who are diagnosed with PKU, but are currently ill, with a fever, cold, vomiting or diarrhea

Healthy controls:

1. Healthy Children \< 4y of age , as it may be challenging to collect breath samples and perform indirect calorimeter in very young children.
2. Healthy Children (4-18y), but are currently ill, with a fever, cold, vomiting or diarrhea.