cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of Short Dentin Etching

To evaluate and compare the two-year clinical performance of Class I resin composite restorations utilizing a universal adhesive used in different etch-and-rinse strategies (15-second and 5-second etching) and self-etch strategies for bonding.

The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. The trial will follow a split mouth design. A total of thirty adult patients, who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Operative Department clinic at the Faculty of Dentistry, University of Mansoura. The study will focus on ninety Class I restorations. No active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The study is scheduled to be conducted from December 2024 to December 2026. The form and protocol of the study will be approved by Mansoura University's ethics committee before initiation. To determine the appropriate sample size, previous studies examining the clinical success rate of posterior Class I restorations restored using different adhesive strategies were considered. Based on various parameters, including a significance level of 5%, a test power of 80%, and an equivalence limit of 15%, the sample size was calculated. Considering a potential dropout rate of 20%, a sample size of 30 subjects (Three restorations per patient) was determined to be suitable.

Eligibility Criteria:
Inclusion Criteria:

* Patients with three primary occlusal caries of upper or lower posterior teeth.
* Patients must have a good oral hygiene;
* Patients with tooth gives a positive response to testing with an electric pulp tester
* Patients with normal and full occlusion,
* Patients with opposing teeth should be natural with no restorations.

Exclusion Criteria:

* High caries risk patients with extremely poor oral hygiene

  * Patients involved in orthodontic treatment or periodontal surgery,
  * Patients with periodontally involved teeth (chronic
Immunological and Clinical Responses to Zinc in Children With Diarrhoea

Zinc deficiency has been found to be widespread among children in developing countries.Clinical and field studies have consistently observed an association between zinc deficiency and higher rates of infectious diseases, including skin infections, diarrhea, respiratory infections, malaria, and delayed wound healing. Based upon the impact of zinc deficiency on diarrheal disease alone, it is estimated correction of this deficiency could save 450,000 under-five deaths annually. What is the physiological explanation for this? Zinc has been identified to play critical roles in metallo-enzymes, poly-ribosomes, the cell membrane, and cellular function, leading to the understanding that it also plays a central role in cellular growth and in the function of the immune system. With zinc deficiency epithelial barriers are compromised and multiple components of the immune system malfunction. The obvious conclusion is that zinc deficiency results in diminished immunological competence that in turn leads to an increased risk for infectious diseases and greater severity of illnesses. Whether this is the case requires substantiation. A related, but more pragmatic question is the value added of zinc supplementation in addition to zinc treatment. The scale-up strategy being pursued in Bangladesh is to provide zinc for 10 days as a treatment at the time of a diarrhea episode. This is in accordance with recently revised WHO recommendations for the treatment of childhood diarrhea (WHO, in press). Can we conclude there is no or minimal value added to continuing zinc as a dietary supplement in zinc deficient children following an acute episode? If there is added benefit, can this be explained by improvement in zinc levels and/or immune function? The aims of this study include:1. In children six to twenty-four months of age with an acute episode of diarrhea attributable to enterotoxigenic E. coli (ETEC), to describe the innate and adaptive immune response to zinc and to relate changes in immune function or zinc status to the occurrence of repeat infectious illnesses over a 9 month period of observation. 2a. In children six to twenty-four months of age with an acute episode of diarrhea with enterotoxigenic E. coli (ETEC), and other non-ETEC diarrhea, to determine the value added of zinc supplementation following treatment in terms of the future occurrence of ACD, ARI, and impetigo and 2b. to assess the impact of zinc supplementation on health services utilization and household expenditures for ACD, ARI and impetigo.


Eligibility Criteria:
Inclusion Criteria:

* Children 6-24 months of age with acute childhood diarrheal illness.

Exclusion Criteria:

* Severe dehydration, suspected cholera or pneumonia, chronic illness, bipedal edema (seriously ill children will be referred to ICDDR,B/Shishu Hospital).
* The child is currently receiving zinc (as a treatment or supplement)
* Wt/length, z-score below -3 (these children will be referred to ICDDR,B/ Shishu Hospital)
* Already participating in another study involving nutritional or therapeutic interventions
Follistatin Levels in Metabolically Healthy and Unhealthy Obese Individuals

There is no clear boundary on which obese individuals should be considered metabolically healthy and which should be considered metabolically unhealthy. It is also not very clear whether the individuals who are considered metabolically healthy will remain healthy in the future. The objective of this study was to assess potential disparities in serum follistatin levels between these two distinct groups. Furthermore, the study sought to investigate whether this disparity could serve as a reliable indicator for distinguishing between metabolically healthy and unhealthy obese individuals.

Individuals with similar body mass indexes may have different metabolic health and cardiovascular risks. Research shows that some individuals with comparable body mass index (BMI) are metabolically healthy and have a lower risk of cardiovascular issues, while others are metabolically unhealthy and have a higher risk. Studies indicate that the lifestyles of metabolically healthy and unhealthy obese individuals, such as diet, physical activity, and sleep patterns, do not differ significantly, even though the individuals have similar levels of total or subcutaneous adiposity. However, it has been shown that metabolically healthy obese individuals tend to have lower levels of visceral adiposity compared to unhealthy ones.

Patients with BMI≥30, who applied to the internal medicine clinic, were included in the study. Among these patients, those without criteria of metabolic syndrome other than an increase in waist circumference (blood pressure ≥130/85 mmHg, fasting blood sugar ≥100 mg/dl, triglycerides ≥150 mg/dl, HDL-cholesterol \<40 mg/dl in men and \<50 mg/dl in women) and without prediabetes were defined as metabolically healthy obese individuals. Those with at least 1 metabolic syndrome criterion other than an increase in waist circumference were classified as metabolically unhealthy obese individuals. The participants' fasting blood sugar levels, HbA1c levels, insulin levels, lipid panel results, liver enzymes levels,urea levels, creatinine levels, whole blood count, and thyroid hormones were examined. Anthropometric measurements including height,weight and waist circumference were also taken for each individual.

Participants were then invited back to repeat follistatin levels.

Eligibility Criteria:
Inclusion Criteria:

* Having given consent to the study
* Being over 18 years of age
* Being under 60 years of age
* Body mass index \>=30 kg/m2

Exclusion Criteria:

* Antidiabetic medication usage
* obesity surgery
* Antihypertensive medication usage
* Those receiving lipid-lowering therapy
* Pregnant women
* Those with hypo/hyperthyroidism
* Steroid use
* Benign/malignant tumors
* Advanced liver disease
* Secondary causes of obesity
Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty

The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices. The study will evaluate the outcome of Total Hip Arthroplasty using medical devices from SYMBOL range over a period of 10 years.


Eligibility Criteria:
Inclusion Criteria:

* Patient age \> 18 years at implantation.
* Patient who will undergo, during the study's period of inclusion, a total hip arthroplasty (primary or revision) with at least one SYMBOL medical device (DEDIENNE Santé).
* Patient informed of his/her participation and willing to participate in the study.
* Patient able to read, write and understand French.

Exclusion Criteria:

* Patient deprived of freedom, under guardianship/curatorship or placed under judicial protection
* Patient unable to follow study procedures.
* Patient who has already been included in the study for a total hip arthroplasty (primary or revision) with at least one SYMBOL medical device.
A Trial of Behavioral Economic Interventions to Reduce Cardiovascular Disease (CVD) Risk

Using a 4-arm, cluster-randomized controlled trial, the investigators will test the effectiveness of different behavioral economic interventions in increasing statin use and reducing LDL cholesterol among patients with poor cholesterol control who are at very high risk for CVD. The investigators will test these approaches among primary care physicians and their patients at very high risk of CVD at Geisinger Health System and University of Pennsylvania outpatient clinics.

Cardiovascular disease (CVD) is the leading cause of death in the United States. Despite strong evidence that reducing low-density lipoproteins (LDL) with statins successfully lowers CVD risk, physicians under-prescribe statins, physicians fail to intensify treatment when indicated, and more than 50% of patients stop taking statins within one year of first prescription, though such therapy typically should be life-long. In this study, we will test the effectiveness of different behavioral economic interventions in increasing statin use and reducing LDL cholesterol among patients with poor cholesterol control who are at very high risk for CVD. The application of conceptual approaches from behavioral economics offers considerable promise in advancing health and health care. Pay for performance initiatives represent one such potential application, but one in which incorporating the underlying psychology of decision makers has not generally been done, and experimental tests have not been conducted. We will test these approaches among primary care physicians and their patients at very high risk of CVD at Geisinger Health System and University of Pennsylvania outpatient clinics. Using a 4-arm, cluster-randomized controlled trial, we aim to answer these questions: \[1\] How does the provision of provider incentives compare to the provision of patient incentives, to a combination of patient and provider incentives, or to no incentives at all? \[2\] Are results sustained after incentives and other interventions are withdrawn? \[3\] How do these approaches compare in implementation, acceptability, cost, and cost-effectiveness?

Eligibility Criteria:
Inclusion Criteria:

* Physicians: All primary care providers who have at least 5 patients who meet eligibility criteria will be eligible.
* Patients: 10-year CVD risk of between 10-20% who do not have an LDL below 140 mg/dl or 10-year CVD risk of at least 20% (including those with preexisting CHD) who do not have an LDL below 120 mg/dl will be the primary inclusion criteria. We have chosen to include all patients meeting these inclusion criteria regardless of their reported adherence to statins, as there clearly is room for improvement in the LDL through a combination of physician and patient actions.

Exclusion Criteria:

* Patients will be excluded if they have a known allergy or history of side effects to statins, will not or cannot give consent, or have a markedly shortened life expectancy (diagnosis of metastatic cancer, end-stage renal disease on dialysis, or dementia).
Detection of Airway Obstruction by Manometry in Different Sleep Stages and Comparing it to DISE

Patients with OSA receive manometry measurements with Apneagraph (AG) during one night of sleep. All patients are simultaneously evaluated with polysomnography. Patients who are not eligible for CPAP therapy are additionally studied with drug-induced sleep endoscopy (DISE). The frequency and obstructions patterns in different sleep stages are assessed. In addition obstruction patterns detected with AG are compared with DISE examination in the selected cases.


Eligibility Criteria:
Inclusion Criteria:

* Apnea-Hypopnea-Index (AHI) ≥ 5.

Exclusion Criteria:

* age \<18 years;
* body mass index (BMI) of \>35 kg/m2; active infection;
* previous oral, head, or neck surgery in the last 3 months; pregnancy; chronic use of alcohol (\> 60g ethanol per day or \> 150g ethanol per week) or sedatives; illicit drug use;
* chronic obstructive pulmonary disease.
Lighthouse Project on Dementia, Ulm, Germany

The Geriatric Center Ulm scientifically supported a three-year pilot study (ProjektDEMENZ Ulm), in which numerous findings on the system of care regarding people suffering from dementia and their relatives were determined.

One of the most important conclusions is the significant lack of information on the well-functioning network of the care system in Ulm. The full potential of the network is not being exploited.

The situation in the Alb-Donau-Kreis - the area surrounding Ulm - is very similar.

The investigators' aim is to improve the utilization of the system of care for those suffering from dementia in Ulm/Alb-Donau-Kreis by using a newly designed advisory approach (Lighthouse Project on Dementia, Ulm, ULTDEM study).

The purpose of the study is to prove the effectiveness of this procedure by using a prospective, open, randomized, controlled, interventional study.

After the randomization, the interventional group is given comprehensive, individual advice about available treatment possibilities for people suffering from dementia.

In addition, they have the opportunity to re-evaluate their present diagnostic procedure.

The participants of the control group receive the standard treatment. Inclusion criterion is the application of a care level ( level 0 or 1). Recruitment will take one year. A final assessment will be taken every six months.


Eligibility Criteria:
Inclusion Criteria:

* dementia (MMSE \< 24)
* signing up for classification of care level (0 or 1)
* community dwelling elderly (older than 60 years)
* member of certain health insurance provider (AOK, Barmer, DAK)
* residents of Ulm / Alb-Donau-Kreis

Exclusion Criteria:

* result from the inclusion criteria
* cancer
* consuming disease
Study of QLS31905 and/or QL1706 Combination With Chemotherapy in the Advanced Malignant Solid Tumors

This study aims to evaluate the efficacy and safety of QLS31905 and/or QL1706 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Subjects voluntarily participate in the study and sign the informed consent form;
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
* Expected survival time ≥ 3 months;
* Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors;
* No prior systemic anti-tumor treatment for locally advanced unresectable or metastatic disease;
* Tumor tissue samples determined to be positive for Claudin18.2 by immunohistochemistry (IHC);
* At least one measurable lesion per RECIST v1.1;
* Patients with adequate cardiac, liver, renal function, etc.

Exclusion Criteria:

* History of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product ;
* Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study;
* Known central nervous system metastases;
* Patients with hepatitis B; patients with hepatitis C; patients who test positive for syphilis, or patients with a known history of HIV or positive HIV screening test; Patients with a known history of psychoactive drug abuse, alcohol abuse, or substance abuse;
* Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator and/or sponsor.
Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System

This study will assess the helpfulness of the integrated call center in optimizing use of the Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder, or Bipolar Disorder taking oral aripiprazole.

The Digital Medicine System includes a drug-device combination of aripiprazole + an ingestible event marker (IEM), a wearable sensor (skin patch), and application software to convey the level of activity and rest, and to mark events through the act of ingestion.

Physician and self-report are the most commonly used to assess medication compliance yet studies have consistently found that healthcare providers' subjective judgments of medication compliance are often inaccurate, with a tendency for practitioners to overestimate subject adherence. The sponsor's intent is to develop a system that will benefit future subjects by providing the ability to measure their medication-taking behavior in an objective manner and being able to monitor several physiologic parameters.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Schizophrenia (SCH), Major Depressive Disorder (MDD), or Bipolar 1 Disorder (BP1), per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* Must be able to swallow tablets
* Currently taking a stable daily dose of oral aripiprazole
* Must have capacity to utilize the technology
* Skin in area of patch application must be free of any skin disorders or dermatological problems

Exclusion Criteria:

* Subjects using long acting injectable antipsychotic medications
* Subjects likely to be incapable of using the Digital Medicine System even with assistance
* Subjects who present serious risk of suicide
* History of epilepsy or seizures
* History of hypersensitivity to antipsychotic agents, adhesive tape or any component of the sensor skin patch or ingestible event marker
* Current history of substance use disorder meeting DSM-5 criteria
* Subject with unstable mood, acute psychosis or exhibiting symptoms requiring hospitalization
Video-Assisted Thoracoscopic Pulmonary Vein Isolation Versus Percutaneous Catheter Ablation in Atrial Fibrillation Trial

Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) and surgically video assisted thorascopic pulmonary vein isolation (VATS-PVI) are acceptable or even superior alternatives to antiarrhythmic drug therapy in patients with symptomatically paroxysmal atrial fibrillation (AF). However, data comparing effectiveness in both interventions are limited.

The investigators want to compare the effectiveness of PVI and VATS-PVI. Secondary objectives are to compare the duration of hospitalization, quality of Life, cost and to compare the satisfaction of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of age
* Documented, symptomatic, episodes of paroxysmal or persistent AF
* During the last 6 months patients must have at least 2 documented episodes of AF, despite the use of at least 1 anti arrhythmic drug.
* Able of providing informed consent

Exclusion Criteria:

* Pregnancy
* Unwillingness to use or contra-indications for vitamin K antagonists
* Severely enlarged left atrium (\>50 mm) on echocardiography
* Prior AF ablation or AF surgery
* Intracardiac thrombus
* Prior heart surgery or pulmonary disease hampering thoracoscopic surgery
Partnership-based Nursing Practice for Lung Patients and Their Families

This study aims to describe and measure the effectiveness of partnership-based nursing care for people with Chronic Obstructive Pulmonary Disease (COPD) and their families. Investigators hypothesize that an holistic, inclusive -taking account of the challenge of multi-morbidity and the long-term relationship that patients with COPD and their families have with the nurses along with the open structure of whatever kind of services is needed in each patient-family case, often in interdisciplinary and inter-institutional collaboration- , is beneficial as regards use of healthcare, health characteristics, HRQL, use of inhaler medications, sense of security in care and illness intrusiveness.

Growing number of people with chronic lung diseases, particularly chronic obstructive pulmonary disease (COPD), and the wide ranging burden that the disease induces to individuals, families and societies, has spurred concerted efforts to develop new healthcare for these people. Outpatient clinics are receiving increasing recognition, particularly those managed by nurses. An out-patient nursing clinic based on theoretical premises of partnership as practice has been established at Landspitali University Hospital. Initial research has shown effectiveness of the practice on the use of healthcare, health status, health related quality of life as well as increased capacity of families to live a meaningful life with the disease. There is a need to substantiate knowledge of the effectiveness of the partnership-based practice by focusing on use of healthcare resources, health and the experience of patients and families, as well as developing educational material for nurses.

Investigators hypothesize that the holistic, inclusive -taking account of the challenge of multi-morbidity and the long-term relationship that patients with COPD and their families have with the nurses along with the open structure of whatever kind of services is needed in each patient-family case, often in interdisciplinary and inter-institutional collaboration- , is beneficial as regards use of healthcare, health characteristics, HRQL, use of inhaler medications, sense of security in care and illness intrusiveness. The experience of patients with COPD and their families of living with the disease and receiving the care will substantiate the previously indicated variables. To this study a multi-dimensional approach is needed which includes both a holistic evaluation (qualitatively studying the experience of participants) and which measures variables prevalent in studies on self-management and palliative care (quantitative use of instruments and demographic variables).

Eligibility Criteria:
Inclusion Criteria:

* Clinical ICD 10 diagnosis of J40 to J44 and J96
* Currently receiving the partnership-based nursing care

Exclusion Criteria:

• Not speaking Icelandic