cyrilzakka/clinical-trials huggingface dataset:
Comparison Between Cobalt-chromium Partial Dentures and Thermoplastic Partial Dentures

The cobalt-chromium (CoCr) partial denture has been made for a long period. It respects biomechanical principles, providing harmony between mechanical and biological activities. The fundamental principles of biomechanics applied in the manufacture of steel structure are: retention, reciprocity, attachment and stability. To get the proper planning, we need to assess the dental support system, with its qualitative and quantitative values. But conventional dentures has a inherent problem which is the metallic elements apparent and in some cases the stiffness of the component support elements that generates stress.

The Thermoplastic partial dentures increase aesthetics in replacement of metal structures in oral rehabilitation. So many treatments are being done in everyday practice without a defined concept on various aspects of its construction and oral applicability.

This trial aims to assess the basic parameters of both dentures in: nutrition, speech therapy, chewing force, chewing efficiency and quality of life.

60 years old or older patients who require removable prosthesis. These will be randomly selected for the fabrication and installation of removable partial dentures (Gold Standard - control group - CoCr partial denture) and thermoplastic partial denture(experimental group).

Before beginning the work, selected patients will make some preliminary tests such as controlling the individual condition, they are:

* three questionnaires:
* instrument for assessing quality of life related to oral health, GOHAI - General Oral Health Assessment Index of Atchinson \& Dolan
* instrument for assessing the social and economic profile of ABEP (Brazilian Association of Research Companies) CCEB 2011;
* Instrument for assessing cognitive condition MINI-MENTAL;
* Speech evaluation
* Nutritional assessment;
* Evaluation of masticatory efficiency and
* Chewing strength. After preliminary assessments patients will be subjected to treatments for manufacture of partial dentures. After the installation (end of the technical construction of the dentures) and the adjustments appointment the tests will be repeated and in successive control periods of 3 months, 6 months, 12 months, 18 months and 24 months respectively, when the tests will do again now to see if there was a change in the initial condition.


Eligibility Criteria:
Inclusion Criteria:

60 years old or older patient with partial edentulous jaws with indication of removable partial denture

Exclusion Criteria:

patient younger than 60 years patient with edentulous mouth
Pain Management in Response to Exparel vs. Standard Bupivicaine

This study is looking to evaluate the efficacy of liposomal bupivicaine (Exparel) on decreasing the amount of consumed pain medications.

Patients will be randomly selected to received either Exparel or standard bupivicaine injection during surgery. Patients will be followed up to assess pain levels using a visual pain scale, and to assess how much pain medication was consumed.

Exparel is a formulation of liposomal bupivacaine that is reported to allow local anesthesia for up to 72 hours post injection.

It is the investigators' aim to follow their prior study with a randomized trial to compare local infiltration of liposomal bupivacaine at the conclusion of each procedure with injections of standard .25% bupivacaine.

Patients in group A will receive, at the end of the surgical procedure, injections of liposomal bupivacaine (Exparel) (266 mg, 20 mL, diluted at surgeon's discretion) into the thoracoscopic port incision sites and around the intercostal nerves serving that space.

Patients in group B will receive, at the end of the surgical procedure, injections of standard .25% bupivacaine into the thoracoscopic port incision sites and around the intercostal nerves serving that space.

Eligibility Criteria:
Inclusion Criteria:

* All patients over 18 years of age
* Isolated thoracoscopic procedure for therapeutic or diagnostic purposes

Exclusion Criteria:

* Previous ipsilateral thoracic surgery
* Need for operative pleurectomy or pleurodesis
* Chronic use of pain medication -narcotics or nonsteroidal antiinflammatory drugs (NSAIDs), sedatives, or hypnotics
* Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or acetaminophen
* Liver dysfunction (INR \> 1.5, albumin \< 2.8g/dl, bilirubin \> 2mg/dl)
* Renal dysfunction (eGFR \< 60ml/min/1.73m2)
* History of peptic ulcerative disease
* Severe chronic obstructive pulmonary disease (COPD) requiring continuous oxygen supplementation
* Inability to consent
* Pregnancy
* Need for conversion from a Video-Assisted Thoracic Surgery procedure to a thoracotomy
* Patient is discharged from the hospital with a chest tube in place
* Patient fails to comply with post-operative instructions
Web-based Support to Caregivers in Heart Failure

Caregivers of people with heart failure experience a lack of support from health care in their caring role. They often want to become more involved in care, receive education and have the opportunity to share experiences with other caregivers.

Objectives and hypothesis: Our hypothesis is that an internet-based support program that is developed in collaboration with caregivers of people with heart failure will increase preparedness to care (Preparedness for Caregiving Scale). We will also evaluate the effects of the support program on the experiences of caring including positive experiences and the impact of care on health and lifestyle (Caregiver Competence Scale, Rewards of Caregiving Scale, Heart Failure-Caregiver Questionnaire) and their management of heart failure (knowledge of heart failure, support for heart failure self-care and perceived control over heart disease). We will also explore if the patients' healthcare consumption is altered when caregivers receive more support.

Method: The project is a randomized controlled study where 300 caregivers from four health care regions will be randomised to either receive a support program via 1177 care guide or to a control group waiting list who receive standard support from health care and municipalities. After the termination of the study participants in the control group will also be offered access to the support program. Data will be collected with questionnaires at baseline and after 3 and 6 months. A process evaluation with semi-structured interviews to describe the relatives' experiences of using the program with be conducted.

Relevance: Caregivers have been involved in all stages of the development of the Internet-based support program. The evaluation focuses on both the effects of the intervention and factors that affect implementation and equality. Caregiver support that is delivered through 1177 care guide enables a more equal, efficient and accessible support for caregivers.


Eligibility Criteria:
Inclusion Criteria:

* A close relative identified by the patient who cares for, supports or helps this patient with a verified heart failure diagnosis ICD codes within I42 or I50 (i.e. all types of heart failure).

Exclusion Criteria:

* Relatives who are unable to carry out the data collection or participate in intervention (e.g. non-Swedish speaking, cognitive problems, severe mental illness, addiction)
* The patient or the close relative have a serious disease with expected short survival of \< 6 months.
A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

The purpose of this study is to evaluate the safety and efficacy of a 6 mg twice a day dose of an investigational product in subjects with diabetic neuropathy


Eligibility Criteria:
Inclusion Criteria:

* Males and females, age 18 to 75
* If female, must be of non-childbearing potential or practicing birth control
* Has diabetes mellitus (Type 1 or 2) and a diagnosis of painful distal symmetric diabetic polyneuropathy
* Has had pain from distal symmetric diabetic polyneuropathy for a minimum of 6 months
* Must be willing to washout of all analgesic medications prior to entry into the study

Exclusion Criteria:

* Has other conditions that may cause pain
* Currently receiving analgesic medications for conditions other than diabetic neuropathic pain
* Has a history of certain psychiatric diseases
* Has a history of certain heart or cardiovascular conditions
* Has any clinically significant recent infection, injury, or illness
* Current participation in another clinical study or participation within the past 30 days
* Is incapacitated, bedridden or confined to a wheelchair
* Is pregnant and/or breastfeeding
* Previous participation in this study or any other study with this investigational product.
Probiotic Treatment of Orthodontic Patients

The purpose of this study is to examine the effect of treatment with a lozenge containing the probiotic strain S. salivarius M18 on the formation, composition and virulence of dental plaque and in healthy orthodontic patients, compared to placebo control.


Eligibility Criteria:
Inclusion Criteria:

1. Generally healthy males and females ≥ 10 years of age.
2. Able to read and receive a copy of the signed informed consent form.
3. Have at least 20 natural teeth.
4. Have been undergoing orthodontic treatment with fixed orthodontic appliances in the upper and/or lower jaw \> 6 months.
5. An average plaque score of \> 2 according to the Modified Orthodontic Plaque Index (MOPI) at the screening appointment.

Exclusion Criteria:

1. Significant oral soft tissue pathology based on a visual examination.
2. History of allergy or significant adverse events following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients.
3. History of allergies to milk proteins.
4. History of allergies towards probiotics.
5. Self-reported as pregnant or nursing.
6. Self-reported serious medical conditions.
7. Antibiotic or anti-inflammatory medication within 30 days of screening visit.
8. Acute sinusitis or severe oral-pharyngeal infections.
9. Smoker.
Fluorine F 18 EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Cervical Cancer

RATIONALE: Diagnostic procedures, such as fluorine F 18 EF5 PET/CT imaging, may help find oxygen in tumor cells. It may also help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This trial is studying fluorine F 18 EF5 PET/CT imaging to see how well it works in finding hypoxia in tumor cells of patients with locally advanced or recurrent/metastatic cervical cancer.

OBJECTIVES:

* To determine if the presence and heterogeneity of hypoxia can be detected by fluorine F 18 EF5 binding in tumors during PET/CT imaging in patients with newly diagnosed or recurrent carcinoma of the cervix.
* To determine if fludeoxyglucose F 18 uptake correlates with fluorine F 18 EF5 uptake.
* To assess the relationship between fluorine F 18 EF5 uptake and disease-free and overall survival.

OUTLINE: Patients are stratified according to disease stage (locally advanced vs recurrent or metastatic disease).

Patients receive fluorine F 18 EF5 IV followed by PET/CT imaging from the base of skull to upper thigh at baseline and during radiotherapy or chemotherapy (i.e., at 3-4 weeks after the initiation of radiotherapy or after the 4th, 5th, or 6th course of chemotherapy). Patients also undergo fludeoxyglucose F 18 PET/CT imaging within 7 to 10 days of the second fluorine F 18 EF5 scan.

After completion of study treatment, patients are followed up at 30 days and then annually thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of carcinoma of the cervix meeting 1 of the following criteria:

  * Pathologically confirmed, newly diagnosed stage IB-IVA (locally advanced) disease
  * Imaging evidence of recurrent or metastatic disease
* Measurable disease, defined as ≥ 1 cm on anatomic imaging

PATIENT CHARACTERISTICS:

* Karnofsky performance status 70-100%
* WBC \> 2,000/mm³
* Platelet count \> 90,000/mm³
* Total bilirubin \< 2.0 mg/dL
* Creatinine \< 2.0 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of allergic reactions attributed to Flagyl (metronidazole)
* No other condition or personal circumstance that, in the judgment of the Investigator, may interfere with the collection of complete, good-quality data

PRIOR CONCURRENT THERAPY:

* Not specified
Remifentanil Versus Dexmedetomidine for Post-Cardiac Surgery Patients With Noninvasive Ventilation Intolerance

The aim of this study is to compare the sedation effects between remifentanil and dexmedetomidine in post-cardiac surgical patients who developed noninvasive ventilation (NIV) intolerance.

This study is a prospective,observational,cohort study. Data of post-cardiac surgical patients who receives noninvasive ventilation (NIV) in the investigators' cardiac surgical intensive care unit are prospectively collected into a database for further analyzation since January 2018. Tolerance of NIV is estimated by a four-point NIV intolerance score system: A score of 1 indicates a comfortable and relaxed patient tolerating NIV; a score of 2 indicates mild intolerance with some discomfort and occasional grabbing at the NIV mask; a score of 3 indicates moderate intolerance and discomfort with the NIV mask most of the time with frequent grabbing at the mask (sometimes pulling it off); and a score of 4 indicates severe NIV intolerance with agitation or/and an inability to leave the NIV mask in place. Participants who receives re-intubation will be recorded as 4 points. Application of remifentanil or dexmedetomidine will be initiated when a score of 3 or 4 was recorded, according to the intensivists' preference.Depending on the sedation regime applied, patients with NIV intolerance are divided into two groups: remifentanil group and dexmedetomidine group.The investigators will compare the two groups with the NIV intolerance score at 15min,1, 3, 6, 12, 24, 48, 60 and 72 hours after the initiation of the sedation regime. The investigators will also compare the two groups with clinical outcomes such as NIV failure, tracheotomy rate, mortality, ICU length of stay etc.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* after cardiac surgery
* receiving noninvasive ventilation
* moderate to severe NIV intolerance (NIV intolerance score of 3 or 4)

Exclusion Criteria:

* difficult expectoration
* pregnancy or breastfeeding
* intensive care delirium screening checklist score more than 4
* drug abuse history
* known allergy to opiods
* cardiogenic shock
* malignant arrhythmias
A Study to Determine the Location of the Blind Spot and the Macula-disc Centre Distance on a Fundus Photograph

The study is aimed to develop a new reaction-time based method for examining the visual field and to study the effect of refractive error on the magnification of a fundus photograph in order to evaluate the true size of a retinal feature.


Eligibility Criteria:
Inclusion Criteria:

* No disease that effect the fundus photograph or visual field

Exclusion Criteria:

* any disease that effects the fundus photograph or visual field
Mobilization With Movement Versus Joint-Specific Manipulation in De Quervain's Tenosynovitis

A comparative study on the effectiveness of mobilization with movement (MWM) versus joint-specific manipulation (JSM) in patients with De Quervain's tenosynovitis typically aims to assess how each technique impacts pain relief and functional improvement. De Quervain's tenosynovitis is an inflammation of the tendons around the thumb and wrist, often causing pain, swelling, and difficulty in performing everyday tasks. The study would likely compare the two interventions by measuring pain levels, range of motion, and overall functional outcomes before and after treatment. MWM involves applying specific, controlled movements while the patient is actively engaging in their joint motion, targeting the tissue's mobility and reducing pain. JSM, on the other hand, focuses on manipulating the joint directly to restore normal function, specifically targeting the wrist and thumb regions affected by the condition.

A comparative study on the effectiveness of Mobilization with Movement (MWM) versus Joint-Specific Manipulation (JSM) in patients with De Quervain's Tenosynovitis would delve deeper into the physiological mechanisms and clinical outcomes associated with each technique, providing valuable evidence for therapeutic decision-making. De Quervain's Tenosynovitis is a condition characterized by the inflammation of the tendons at the base of the thumb, particularly affecting the abductor pollicis longus and extensor pollicis brevis tendons. This condition is commonly caused by repetitive strain, overuse, or trauma, leading to pain, swelling, and restricted movement, which significantly impacts the patient's daily activities.

Eligibility Criteria:
Inclusion Criteria:o Patients clinically diagnosed with De Quervain's tenosynovitis

* Age between 25-45 years.
* Positive Finkelstein test.
* Pain over the first dorsal compartment.
* Limited wrist and thumb function.
* Willingness to take part and adhere to the study's guidelines.

Exclusion Criteria:Participants fall in this category would be excluded of the study.

* Previous surgery of wrist or thumb.
* Presence of neurological symptoms like numbness, weakeness.
* Rheumatological conditions like rheumatoid arthritis.
* Pregnancy.
* Presence of wrist fracture or osteoporosis.
* Carpel tunnel syndrome.
SMYLS Multi-site Trial

The purpose of this study is to find out whether a web-based intervention using a mobile app is helpful for teens and young adults with sickle cell disease (SCD) in learning how to care for and manage their symptoms.

The purpose of this study is to test the effectiveness of and identify barriers and facilitators to the implementation of SMYLS, an mHealth intervention designed to facilitate self-management behaviors in adolescents and young adults (AYA) with sickle cell disease (SCD). Specifically, the investigators propose to determine the effect of the intervention on the primary outcome of self-management behaviors and the secondary outcomes of quality of life, transition readiness, healthcare utilization, and pain interference. In addition, the investigators will explore how patient activation moderates development of self-management behaviors and systemic, structural, and social variables that moderate relationships between patient activation, the primary outcome, and secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* documentation in the electronic health record of any type of SCD
* owns mobile device compatible with the intervention
* access to the internet

Exclusion Criteria:

* Plans to relocate outside of study site area in the next 12 months
* Plans to transition to adult care in 12 months or less
* Parent/caregiver or provider report of neurocognitive impairment that precludes ability to use intervention and participate in study
* non-English speaking
Fat Metabolism in Response to Acute Diet- and Exercise-induced Changes in Energy Balance

This study is being conducted to learn more about the role of diet and exercise in regulating plasma triglyceride (fat) metabolism. The investigators will examine the effect of acute (24 hour) changes in energy intake and expenditure on fat metabolism the following day.

Excess body fat and a sedentary lifestyle are associated with increased plasma triglyceride (TG) and apolipoprotein B-100 (apoB-100) concentrations, which are important risk factors for the development of cardiovascular disease.

Weight loss and endurance exercise improve plasma lipid and lipoprotein concentrations. However, the mechanisms responsible for this effect are largely unknown, and much uncertainty remains regarding the independent roles of dietary energy intake, exercise energy expenditure, and net energy balance in controlling plasma TG concentrations.

The main goal of this project, therefore, is to investigate the mechanisms by which acute alterations in energy balance, induced by diet and/or physical activity (endurance exercise), regulate very-low density lipoprotein (VLDL) metabolism.

Subjects will be asked to perform 3 separate trials. One of these will always be an "energy balance" trial that will act as the control trial for the other 2 trials they perform. Subjects will therefore be randomized to 2 different study arms.

Eligibility Criteria:
Inclusion Criteria:

* overweight and obese men
* normal to mild hypertriglyceridemia

Exclusion Criteria:

* Smoking
* Any medical condition other than increased body weight (e.g. diabetes, heart disease, etc.).
* Use of drugs known to affect lipid metabolism (e.g. statins, etc.).
* Regular exercise training.
Ganoderma Tea on Eczema Patient

This is a single-blind, cross-over pilot study to observe the safety and efficacy of Ganoderma tea on eczema patients.

Objective This study is to conduct a preliminary observation on the effect of A Master Ganoderma Detox Tea in improving eczema symptoms. Because it is a preliminary study, there will not be a placebo control. However, in order to exclude the impact of spontaneous improvement, we will set up a cross over control group. Thus, we want to find out whether there is any difference in taking the tea and without taking the tea.

Research Design This is a randomized, cross-over-control and assessor-blinded clinical trial. Subjects will be divided into groups A and group B. Group A will receive the intervention for 8 weeks, followed by an 8-week period of no intervention. Group B will be observed without having any intervention for 8 weeks, and then receive the intervention for 8 weeks. Randomization will be carried out using a computer program.

Interventions Subjects in the treatment group (A) will take the A Master Ganoderma Detox Tea for 8 weeks. Initially, the dosage is twice a day, one pack (5g) each time, and then increased to three times a day, two packs each time within two weeks. The control group (B) will not receive any study intervention for 8 weeks, followed by similar intervention for 8 weeks.

In case of allergies or severe adverse reactions occur, the subject should stop taking the tea immediately and be excluded from the trial. During the control or intervention period, if necessary, subject may use short-term steroids or other topical medication to relieve the symptoms of eczema.

Eligibility Criteria:
Inclusion Criteria:

* eczema for 1 year, without other systemic illness.

Exclusion Criteria:

* severe systemic illness,
* oral steroid in the last month