cyrilzakka/clinical-trials huggingface dataset:
Intra Oral Scanning of Edentulous Arches

the aim of this study is to compare the influence of different palatal vault configurations on the accuracy and scan speed of IO scans in cases of completely edentulous arches. The null hypothesis is that there is no difference in scanning time, and trueness and precision of IO scans between class I, II and III palatal vault configurations.

A reference model will be created for each of the three groups with different palatal vault configurations. PVS material (DMG Silagum, Germany) will be used for impressions in a one-step process by an experienced operator, and type IV plaster (Heraeus, Germany) will be used to produce the models. These models will then bedigitized by an experienced operator using an extraoral scanner (Trios 3; 3Shape, Copenhagen, Denmark). The STL scan file of the maxillary model will be imported into CAD software (Meshmixer; Autodesk, San Rafael, CA, USA) to generate a reference file. Reference markers will then be added to the digital files to aid the superimposition process during digital subtraction operations.For intraoral scans, the entire maxilla of each patient will be digitally captured using an intraoral scanner (TRIOS POD, 3Shape, Copenhagen, Denmark).According to ISO standards, specifically ISO 5725-1, the accuracy of digital impressions obtained with intraoral scanners (IOS) will be evaluated according to two main parameters: trueness and precision.

Eligibility Criteria:
Inclusion Criteria:

* 1. Full tooth loss in the maxilla; 2. Absence of infectious diseases; 3. Systemic good health; 4. Age between 50 and 75 years; 5. Willingness to cooperate throughout the data collection process

Exclusion Criteria:

* Exclusion criteria included: 1. Presence of any remaining teeth; 2. Inability to comprehend the study's objectives and procedures; 3. Palatal defect or lesion; 4. Postoperative scarring on the palate; 5. Limitations in mouth opening.
A Trail of CDK4 / 6 Inhibitor and MEK Inhibitor in the Treatment of Metastatic Digestive System Tumors

This is a prospective, open, phase I clinical study to evaluate the safety and tolerability of a CDK4 / 6 inhibitor and a MEK inhibitor in the treatment of metastatic digestive system tumors


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-75 years;
2. ECOG score ≤ 1;
3. Patients with advanced KRAS mutation or metastatic digestive system tumor confirmed by histology or cytology and imaging diagnosis;
4. According to Recist1.1, there was at least one measurable lesion;
5. The expected survival time was more than 12 weeks;

Exclusion Criteria:

1. Patients who received any anti-tumor treatment within 4 weeks before enrollment, including radiotherapy, chemotherapy, molecular targeted therapy and immunotherapy, or participated in another intervention clinical trial;
2. Previous treatment with targeted BRAF, MEK, ERK or CDK family related inhibitors;
3. The third space effusion (such as massive pleural effusion or ascites) with clinical symptoms that cannot be controlled by drainage or other methods;
4. Allergy to any test drug and its excipients, or serious allergic history, or contraindication of the test drug;
5. Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
Adductor Canal Block With Continuous Infusion Versus Intermittent Boluses and Morphine Consumption

The investigators believe sufficient spread to all nerves within the adductor canal-and thereby sufficient analgesia-can only be obtained by bolus injections and not by continuous infusions via a catheter. The aim of the study is to investigate whether an adductor canal block performed as repeated intermittent boluses provides superior pain relief to continuous infusion. The investigators hypothesize that adductor canal block performed as intermittent boluses via a catheter will reduce morphine consumption and pain as well as enhance ambulation and muscle strength compared with continuous infusion.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for total knee arthroplasty in spinal anesthesia
* Patients who gave their written informed consent to participating in the study after having fully understood the contents of the protocol and restrictions
* American society of anesthesiologists 1-3
* Ability to perform a timed up and go test preoperatively

Exclusion Criteria:

* Patients who cannot cooperate
* Patients who cannot understand or speak Danish.
* Patients with allergy to the medicines used in the study
* Patients with a daily intake of strong opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl) during the last 4 weeks
* Patients suffering from alcohol and/or drug abuse - based on the investigator's assessment
* Rheumatoid arthritis
* BMI \> 40
* Neuromuscular pathology in the lower limbs
* Pregnancy
Information Improvement for Surgical Patients Through Portable Video Media

The aim of this study is to evaluate the comprehension of the Informed consent with the Standard Verbal Communication (SVC) versus Portable Video Media (PVM).

The informed consent (IC) is a fully ethical and legal consolidated requirement. IC is the voluntary authorization by a patient for surgical treatment (MeSH). The IC has to include: 1. What is and for what is it, 2. How is it made, 3. What effect will produce, 4. which patients will benefit, 5. Alternatives, 6. Risks and special situations.

The standard IC is based in written and verbal information, but the information provided is insufficient, leading to misunderstanding and even litigation.

Technology plays an important role in the improvement of IC: the portable video media, tablet, with the application (app) iURO assists the procedure through videos and illustrations.

To evaluate and measure the comprehension of the information that patients received, we elaborated and validated a "Questionnaire to evaluate the comprehension of IC" (the process was mounted as "Questionnaire for urology IC validation" in the poster session at the 17th International European Association of Urology Nurses (EAUN) Meeting, Munich-Germany).

The patients undergoing to bladder or prostate transurethral resection were selected. Afterwards they were randomized previous the interview, into two groups: patients informed by PVM with the app iUro (experimental group) versus patients with an SVC (control group). The questionnaire was used to compare the comprehension of the surgery immediately and 15 days after the surgery. The items regarding questionnaire were: information, utility of the intervention, side effects, complications, comorbidity, usefulness of information, anxiety and risks.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are going to receive transurethral resection of bladder or prostate
* Patients, women and men, older than 18 years without any mental disability

Exclusion Criteria:

* Patients who refuse to participate in the study
* Patients who have inability to communicate in spanish.
* Several visual problems that limit the ability to read written material
The Halland Obesity Municipal Effort for Children

A retrospective study to investigate the method called The Halland Obesity Municipal Effort for children. All children participating in the intervention since the start of this specific method will be eligible for inclusion. The aims are to describe participants and the method-specific activities they are participating in, as well as the effect on their health and school grades.

This method involves the entire municipal community in Laholm and Kungsbacka (two cities in Sweden): Pediatric care unit, Child Psychiatry, Social services, School healthcare, private companies, and local sports clubs. The model includes group activities and individual activities and offer 15 different health promoting and free activities per week.

All activities are modified and take place in a safe environment. The activities range from golf, riding, gym training, swimming, fishing, art classes, karate, dance classes, and the possibility for the child to get a grade in Physical Education through a specific collaboration with the local schools in the municipality.

The children are given a fruit at each activity and cooking classes are frequently given. The municipal activity coordinator who is responsible uses different methods such as KASAM, Health Action Model and Empowerment to help each child develop skills in self-monitoring, goal setting, problem solving, contingent reward systems, and stimulus control. Parents are given a specific support program called COPE, Community Parent Education. Some activities include the whole family.

In addition to the weekly activities, the activities are also always given on school holidays and weekends when children are known to be less active.

This study will investigate this method by focusing on BMI, metabolic control, blood pressure, level of physical activity, age, sex, the existence of comorbidities, presence of neurodevelopmental disorders, school related issues, involvement of social services, need of grades in Physical Education and help to learn how to swim, which activities the children were undertaking as well as the frequency of participation. The proportion of children achieving full 12 years of education will also be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients involved in the HOME project since the start. Children that have been offered this intense intervention.

Exclusion Criteria: Those who are not willing to participate.

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Establishing Malnutrition Diagnosis System by Using Artificial-intelligence Technology

The prevalence of malnutrition is estimated at 30-50% of hospitalized patients in China. Disease-related malnutrition increases the risk of infection, mortality, length of hospitalization as well as the economic burden. National Nutrition Plan proposed to reduce malnutrition, but a clear, effective roadmap and protocol has not existed yet. Several factors impede to resolve the above challenges. They include :1) the low efficiency of current malnutrition diagnosis methods; 2) the lack of dynamic, standard method that can evaluate nutritional status in quantitative way. To this end, the investigators aim to establish an artificial-intelligence malnutrition diagnosis system to improve the application of malnutrition Clinical Pathway. Firstly, the investigators will establish a multidimensional malnutrition large data set, based on our previously built national hospital nutrition screening data set.

It will contain deep 3D facial images, semi-structured and structured electronic medical record. Then, the investigators will use ensemble learning algorithm to establish a fully automatic, artificial-intelligence malnutrition diagnosis model that includes both etiological and phenotypic diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years old);
* Within 48 hours of admission;
* Inpatients at high risk of malnutrition, such as malignant tumors, chronic obstructive pulmonary disease, etc;
* Han nationality;
* Able to given informed consent.

Exclusion Criteria:

* Patients with artificial facial changes (such as plastic surgery , head and neck radiotherapy , head and neck trauma);
* Diseases with special facial changes (such as acromegaly);
* High dose glucocorticoid users;
* Patients with facial edema;
* Emergency admission with an expected length of stay of less than 3 days;
* Other conditions researchers thought could not be included
Evaluating the Efficacy and Quality of Life Impact of Transitioning to Advanced Hybrid Closed-Loop Insulin Pump Therapy in Romanian Children With Type 1 Diabetes Mellitus

The proposed study aims to demonstrate the potential benefits of transitioning T1DM children from predictive low glucose suspend insulin pump therapy to advanced hybrid closed-loop insulin pump therapy in Romania. Primary Outcome: Variations in HbA1c between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G).

Secondary Outcomes: changes in insulin requirements, time in range (TIR) levels, time below range (TBR), coefficient of variation (CV), frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization, and PedsQL SF15 questionnaire scores.


Eligibility Criteria:
Inclusion Criteria:

* Age 7 years or older at baseline
* Diagnosis of type 1 diabetes
* Current use of a predictive low glucose suspend insulin pump (740G)
* At least 30% of subjects must have an HbA1c \> 7,5% (58 mmol/mol)

Exclusion Criteria:

* Age \< 7 years or ≥ 18 years at baseline
* Diabetes duration \< 1 year at baseline
* HbA1c ≤ 7% (53 mmol/mol)
* Not meeting the Romanian national standards for closed-loop insulin pump therapy
* Other criteria deemed inappropriate by the principal investigator (to be documented)
A Pharmacokinetic Study of Once Daily Efavirenz 400 mg Versus 600 mg in Thai HIV-1 Infected Subjects

A Pharmacokinetic study of once daily Efavirenz 400 mg versus 600 mg in Thai HIV-1 infected subjects.

Efavirenz Pharmacokinetic evaluation supports once-daily dosing (T1/2 is 10-52 hours). The recommended dosage of efavirenz in combination with nucleoside reverse transcriptase inhibitor (NRTI) and/or protease inhibitor (PI) is 600mg orally, once daily.

In Thai populations, many ARV levels are very high. We believe that 600 mg efavirenz is too high for Thai people and would like to see the pharmacokinetic data and safety and efficacy of efavirenz at 400 mg.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years of age or older with HIV-1 infection
* Who are on stable PI-based highly active antiretroviral therapy and have HIV-1 RNA \<50 copies/ml within 6 months.
* No active opportunistic infection.
* Sexually active subjects must be willing to use an effective form of birth control.
* Able to provide written informed consent.

Exclusion Criteria:

* Pregnant or breast-feeding females are excluded.
* Inability to understand the nature and extent of the study and the procedures required.
* ALT/ AST more than 5x upper limit
* Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
* Use of concomitant medication that may interfere with the pharmacokinetics of efavienz
* History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study.
* Active drug abuse
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349

The present study is planned to assess the safety, tolerability and pharmacokinetic profile of WCK 2349 in US subjects with selected ascending multiple doses of WCK 2349 and to compare the safety, tolerability and pharmacokinetic data with the data observed in similar studies conducted in India.


Eligibility Criteria:
Inclusion Criteria:

* Must be healthy males or non-pregnant females
* Have a Body Mass Index (BMI) between 18 and 32 (both inclusive), calculated as weight in kg / height in m2
* Have no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations and ECG recordings.
* Should test negative for drugs of abuse and urine alcohol test.

Exclusion Criteria:

* Known hypersensitivity or idiosyncratic reaction to quinolones or any other related drugs.
* Any history or evidence of disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
Dynamic Light Scattering Device (DLS) Study of Age-Related Changes in the Lens and Cataracts

This study will use a newly developed instrument called dynamic light scattering device (DLS) to examine age-related changes in the human lens and to study the causes and development of cataracts. DLS uses a low intensity laser light (similar to that used in supermarket checkouts) to measures lens cloudiness. It detects changes in the human lens at the earliest stages, when anti-cataract treatment would be most effective in reversing, delaying or preventing cataract formation.

Patients 18 years of age and older with cataracts and normal volunteers between the ages of 18 and 70 years may be eligible for this study. Participants will have a standard eye examination, including a vision check, pressure measurement, lens examination using DLS and examination of the retina. Photographs of the lens or retina, or both, may be taken.

This study does not involve treatment. No anti-cataract medications will be given.

Recently, a device has been created to determine molecular interactions that occur in the nucleus of the lens, called Dynamic Light Scattering Device (DLS). Preliminary studies have shown its potential in the detection of the earliest changes occurring in cataract, at the stage where anticataract treatment would theoretically be most effective in reversing, delaying or preventing cataracts. A new miniaturized version of this device has been developed by NASA using lower energy lasers and offered for further development and testing at the NEI. We recently conducted a pilot study to evaluate the usefulness and reproducibility of this instrument for quantitating lens changes, and found good reproducibility. We also determined that the most useful parameter to use is mean particle size derived from particle size distribution. We therefore propose to conduct a study on changes on the lens due to aging (age related changes), as well as on the three representative types of cataracts (nuclear, cortical and PSC).

Eligibility Criteria:
INCLUSION:

Patients 18 years or older will be admitted to this study.

There will be no gender or sex bias in the recruitment.

Fifteen subjects (30 eyes) who are normal volunteers of either sex, 3 for each decade from 18-70, will be recruited.

These normal volunteers should have clear lenses with LOCS II clinical score for nuclear opalescence of 0.5 or less.

Three patients (18 eyes) for each major type of cataract (nuclear, cortical and PSC), will be recruited also for evaluation with the DLS device.

All 3 types of cataracts will be graded using the LOCS II system and will have a clinical score of at least one.

EXCLUSION:

Patients who have uveitis, glaucoma and who are thought to be at risk for an adverse reaction to pupil dilation, or have a history of allergic reaction to one of the dilating agents that will be used.
Endothelial Leakage and the Association to Endothelial Biomarkers After Surgery

The primary aim of this study is to investigate fluid loss from the blood stream (''endothelial leakage'') and the damage on the vessel wall (''endothelial function'') during surgery.

Cardiovascular complications during surgery are said to have different causes, e.g. lack of fluid in the blood stream (''hypovolemia'') and decreased vascular tone. Hypovolemia can have different causes, one being damage to the endothelial function. During trauma and infection, it has been previously shown, that damage to the endothelial function causes fluid loss from the blood stream. Nevertheless, this has never been demonstrated during surgery.

Secondary this study will measure the blood flow using a thermo-camera during surgery. This will together with selected blood tests provide information on various possible causes to hypovolemia.

The purpose of this study is to describe and quantify endothelial damage (assessed by selected endothelial biomarkers) and albumin escape rate as a proxy for endothelial leakage (assessed by measuring radioactive 125-I labeled HSA injected postoperatively), combined with assessment of MTS (assessed by Laser Speckle Contrast Imaging (LSCI) and digital thermography). This will allow a detailed description of the surgery's impact on the endothelial integrity and contribute to a better understanding of the physiological changes that occur postoperatively.

The study will investigate patients undergoing pancreaticoduodenectomy (Whipple) and total pancreatectomy. These patients have a vast clinical need, being one of the most extensive abdominal surgical procedures with great stress response.

The study is a prospective exploratory cohort study and methods include blood sampling pre- and post-operatively, 125-I labeled humane serum albumin postoperatively (and preoperatively if logistically possible) and thermography.

The hypothesis of this study is that the extent of endothelial damage measured by selected biomarkers is associated with the level of albumin escape rate after major abdominal surgery. Secondly, inflammation increases albumin escape rate after major abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients are scheduled for Whipple or total pancreatectomy

Exclusion Criteria:

* Patient having received immunomodulating treatments less than four weeks prior to surgery
* Patient having other major surgery performed less than four weeks prior to surgery. Thus, minor surgery allowed, for instance minor skin incisions
* Patient having endoscopic retrograde cholangiopancreatography (ERCP) or Percutaneous transhepatic cholangiography (PTC) performed less than two weeks prior to surgery
* Patients scheduled for major vascular surgery during Whipple or total pancreatectomy
* Patient is diagnosed with chronic kidney failure or is in diuretics treatment
Evaluating the Personal Computer as a Treatment Activity in Occupational Therapy

This study will evaluate the use of the personal computer (PC) in occupational therapy. The results of the study will help occupational therapists develop improved treatment activities using PCs.

Patients enrolled in various NIH clinical trials who are referred for occupational therapy may be eligible for this study. Each patient will have at least four computer sessions within 6 months. They will use the PC to achieve goals they set for themselves-for example, to build work skills, improve concentration, or simply have fun. At the end of each session, the occupational therapist will interview the patient, asking, for example, about the goal of the session and what may have occurred during the session to make it more helpful or less helpful. The interviews will be tape recorded and used to help determine how computers may be used most therapeutically.

Occupational therapy approaches rehabilitation through the concept of "occupation", the component of human behavior regarding one's engagement in self-initiated, self-directed, adaptive, purposeful, culturally relevant, organized activity. Rehabilitation through occupation is a process, stemming from interactions among the three domains: (a) performance areas; (b) performance components; and (c) performance contexts. At the core of the occupational therapy is a sub-process created by patients and therapists through their actions and reactions to treatment. It is a significant sub-process because it sets into motion the use of occupation as therapy. It is believed that the appropriate, therapeutic use of occupation affects "performance" or how one functions.

There is a need to develop ways to articulate and measure complex therapeutic interventions themselves. This is especially true of those treatment approaches which integrate human relationships, collaborative problem-solving, and the targeted doing of unique, personally relevant occupations. Occupational therapy is a health profession characterized by such interventions. The capacity to delineate key process variables may lead to credible examination of process-outcome relationships. Ultimately, results from the proposed study may provide information needed to further establish patient outcomes from occupational therapy interventions.

Eligibility Criteria:
INCLUSION CRITERIA:

Men, women and children from across the United States and from around the world who participate in clinical research at the National Institutes of Health, and who have been referred to occupational therapy as part of their routine care, are eligible to be considered for this study.

Patients whose occupational therapy treatment plan recommends the personal computer intervention will be eligible to participate.