cyrilzakka/clinical-trials huggingface dataset:
Iowa Fluoride Study/Iowa Bone Development Study

A cohort of newborns was recruited for the Iowa Fluoride Study from 1992-95 to assess the complex relationships among fluoride intakes, fluoride exposures, dental fluorosis, and dental caries. Detailed questionnaires were sent every 1.5-6 months concerning water sources, fluoride exposures, dietary intakes, etc. Standardized dental exams were conducted at \~ages 5, 9, 13, 17, and 23. At about age 5, participants were invited to join the offshoot Iowa Bone Development Study. Bone densitometry assessments were conducted at ages 5, 8, 11, 13, 15, 17, 19, and 23. These included Dual-energy X-ray Absorptiometry (DXA) of hip, lumbar spine, and whole body from age 5; peripheral Quantitative Computed Tomography (pQCT) of the radius and tibia from age 11; and Multi-Detector Computed Tomography (MDCT) of the tibia from age 19. Physical activity and other factors also were assessed longitudinally.

A cohort of newborns was recruited for the Iowa Fluoride Study from 1992-95 to assess the complex relationships among fluoride intakes, fluoride exposures, dental fluorosis, and dental caries. Detailed questionnaires were sent every 1.5-6 months concerning water sources, fluoride exposures, dietary intakes, etc. Standardized dental exams were conducted at \~ages 5, 9, 13, 17, and 23. At about age 5, participants were invited to join the offshoot Iowa Bone Development Study. Bone densitometry assessments were conducted at ages 5, 8, 11, 13, 15, 17, 19, and 23. These included Dual-energy X-ray Absorptiometry (DXA) of hip, lumbar spine, and whole body from age 5; peripheral Quantitative Computed Tomography (pQCT) of the radius and tibia from age 11; and Multi-Detector Computed Tomography (MDCT) of the tibia from age 19. Physical activity and other factors also were assessed longitudinally.

Eligibility Criteria:
Inclusion Criteria:

* healthy newborn

Exclusion Criteria:

* not health newborn
Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy

The FANCY study will investigate whether a selective policy of histopathological examination of appendices and gallbladders based on the intraoperative findings of the surgeon is safe and cost-effective.

Traditionally, all surgically removed appendices and gallbladders are sent to the department of pathology for histopathological examination. This is most likely not necessary in appendices and gallbladders that are not suspicious for a tumour when inspected visually or by palpation. If not detected by visual inspection or palpation, the tumour is usually of early stage and already treated with the resection of the organ. A policy of selective histopathological examination based on the intraoperative findings of the surgeon can probably reduce the amount of appendices and gallbladders that have to be examined by the pathologist, without a risk of undertreatment, with less risk of overtreatment and huge savings annually. In the FANCY study, a nationwide prospective multicenter observational cohort study, all appendices and gallbladders will be evaluated for tumours by visual inspection and palpation by the operating surgeon. The operating surgeon will report his or her findings and also write down whether he or she thinks there is an indication for histopathological examination. Subsequently, all specimens are sent to the pathologist for histopathological examination. Therefore, no aberrant findings will be missed due to this study. The prospective cohort can be compared through modelling to a hypothetical situation where appendices and gallbladders are only examined by the pathologist on indication. The primary outcome is the number of patients per 1000 examined appendices/gallbladders with a neoplasm requiring additional therapy benefitting the patient that would have been unnoticed in the policy of selective histopathological examination.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo an appendectomy or cholecystectomy in the elective or non-elective setting.

Exclusion Criteria:

* Primary indication for surgery: strong suspicion or proven malignancy in the appendix or gallbladder.
* Appendix or gallbladder removed as part of more extensive surgery, so-called incidental appendectomies or cholecystectomies.
* Patients included in the ACCURE trial (effect of appendectomy on ulcerative colitis).
* The presence of a gallbladder polyp of \>10 mm on preoperative imaging.
Effect of Colchicine On Left Ventricle Function After Anterior Myocardial Infarction Assessed By Speckle Tracking

Effect of colchicine use on Left ventricles systolic function in patients with anterior S-T elevation myocardial infarction undergoing primary Percutaneous coronary intervention by using speckle tracking Echocardiography longitudinal strain pattern

The study participants are patients presented with anterior myocardial infarction.

They will be divided into 2 groups. The first group will receive colchicine loading dose of 1mg then 0.5 mg maintenance dose in addition to the standard anti ischemic treatment for 6 months.

The other group will only receive the standard anti ischmic treatment. Speckle tracking echocardiography will be done to all patients to assess left ventricular longitudinal strain pattern.

Eligibility Criteria:
Inclusion Criteria:

▪︎Anterior S-T segment elevation myocardial infarction with time of presentation less than 12 hours.

Exclusion Criteria:

* Severe renal impairment.
* Cardiac arrest.
* Cardiogenic shock.
Protein Tyrosine Kinases (PTK) in Multiple Myeloma

The purpose of this study is to determine whether or not cancer cells in the body are affected by PTK and whether it affects the growth of these cells.

Patients will take PTK orally once a day for the duration of their time on the study. Each cycle of chemotherapy will last for 4 weeks.

Measurement of vital signs will be done weekly during the first month of treatment.

Physical exam, vital signs, blood work, a quality of life assessment, and x-ray or MRI wil be performed every 4 weeks.

Patients will remain on the study until their disease fails to respond to treatment or there are intolerable side effects. Typically treatment is performed for 12 weeks and up to one year in patients that are stable and responding.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years of age.
* Confirmed diagnosis of active progressive multiple myeloma
* History of \> 2 prior cytotoxic treatment regimens. Bone marrow transplantation will be considered as one regimen.
* Current measurable disease based on serum and/or urine M protein and/or measurable plasmacytoma.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Absolute neutrophil count (ANC) \> 1,500 mm3
* Platelets \> 100,000 mm3
* Serum creatinine \< 1.5 upper limit of normal (ULN)
* Serum bilirubin \< 1.5 ULN
* AST/AGOT and ALT/SGPT \< 3.0 ULN
* Life expectancy \> 12 weeks

Exclusion Criteria:

* Chemotherapy \< 3 weeks prior to registration.
* Biologic or immunotherapy \< 2 weeks prior to registration
* Full field radiotherapy \< 4 weeks or limited field radiotherapy \< 2 weeks prior to registration.
* History or presence of central nervous system (CNS) disease
* History of leukemia
* History of another primary malignancy with the exception of inactive basal or squamous cell carcinoma of the skin
* Major surgery \< 4 weeks prior to registration
* Prior therapy with anti-vascular endothelial growth factor (VEGF) agents excluding thalidomide, Revimid, velcade and arsenic trioxide
* Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
* Pleural effusion or ascites that cause respiratory compromise
* Female patients that are pregnant or breast feeding
* Uncontrolled high blood pressure, history of labile hypertension or history of poor compliance with an antihypertensive regimen
* Unstable angina pectoris
* Symptomatic congestive heart failure
* Myocardial infarction \< 6 months prior to registration
* Serious uncontrolled cardiac arrhythmia
* Uncontrolled diabetes
* Active or uncontrolled infection
* Acute or chronic liver disease
* Impairment of gastrointestinal (GI) function or GI disease
* Confirmed HIV infection
Effectiveness of the Single Implant-retained Mandibular Overdenture Treatment

This study aims to evaluate the treatment with single implant overdenture for the edentulous mandible. The investigators hypothesize that treatment with lower overdenture retained by a single implant appears to have satisfactory effectiveness as a treatment for patients with specific conditions (such as maladaptive patients), with the advantages of simplicity and greater immediate benefits when compared to the conventional full denture, improving the retention and stability of the denture and better oral-related quality of life.

This study is a longitudinal evaluation of clinical and patient-reported outcomes related to the single-implant mandibular overdenture treatment. Sixty completely edentulous individuals will be included. First, new complete dentures will be fabricated for all of them. Panoramic radiographs and conventional tomograms of the mandibular midline region will be obtained in order to plan the implant placement surgery. After the adaptation period related to the use of the new dentures, a single implant (Titamax IT Cortical, Neodent, Curitiba, Brazil) will be installed in the mandibular midline of all participants. According to the primary stability obtained in the implant placement patients will be treated with an immediate loading protocol when achieving torque of at least 30 Ncm and implant stability quotient (ISQ) of at least 60. In cases of values below cited, conventional loading protocol will be adopted. Ball O-ring will be used as the attachment system for the mandibular overdenture. Clinical and patient-reported outcomes will be collected after 1, 3, 6 and 12 months after the installation of the overdentures.

Eligibility Criteria:
Inclusion Criteria:

* Fully edentulous patients
* Need of replacement of the mandibular denture or patient without mandibular denture
* Patients with poor adaptation to the mandibular denture
* Patients with good general health

Exclusion Criteria:

* Patients who refuse to receive a conventional dentures opposed to a mandibular overdenture retained by a single implant
* Patients with local intraoral diseases that influence denture stability, retention and adaptation of the lower denture (such as changes or anatomical deformations of the jaws, mucosal changes caused by fungi and bacteria, tumor changes and absolute xerostomia)
* Patients with systemic, psychological or neurological diseases that preclude or hinder oral movements of the patient for clinical care and/or clinical follow-up in all stages of the research
* Patients who choose other treatment modalities not covered by the study
* Patients with alcoholism or other severe behavioral disorders that compromise their participation in the study
An Indicator of Successful Peripheral Nerve Block

The aim of the study was to investigate whether a color changing nail polish would be an indicator to assess infraclavicular brachial plexus block success based on skin temperature differences before and after performed the block.

After performed the block, sensory and motor block assessments will be carried out by blinded observer every 5 min after needle removal for 30 min in the regions of the radial, median, ulnar, and musculocutaneous nerves of the forearm. Skin temperature measurements will be performed from both the anesthetized side and the contralateral arm before the procedure and every 5 min for 30 min by a blinded observer. Before the block, the color changing nail polish will be applied to all hand nails of the patient. An independent observer will photograph the reaction of the nail polish (i.e. color change) in both hands immediately after application of nail polish and at two minute intervals for 30 min after performing the block. Two blinded observers were reviewed the digital photographs. They were asked to compare the colors of nail polish in both hands and to score the difference based on a three-point scale (0: absolutely no difference, 1: I am not sure, 2: indisputable difference)

Eligibility Criteria:
Inclusion Criteria:

* patients who received infraclavicular brachial plexus block for elective elbow, forearm, wrist, or hand surgery
* American Society of Anesthesiologists class I, II or III

Exclusion Criteria:

* patients \<18 years old
* \>65 years old
* body mass index (BMI) \<20 or \>35 kg/m2
* inability to provide written informed consent
* refusal of regional anesthesia
* pregnancy
* contraindication for regional anesthesia
* peripheral neurological disease,
* Raynaud disease
Safety Analysis of Chronic Intake of a β-alanine Supplement

Single-center, double-blind, placebo-controlled clinical trial with two arms (product and placebo) to analyze the safety of beta-alanine consumption in active people.

After recruitment, subjects will be randomized and assigned to one of the two arms of the study: beta-alanine group or control group (placebo).

Subjects must be active people, and will take a dose of 15 g per day of the product for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Men between 18 and 40 years of age.
* Physically active people. They must train at least 3 sessions per week.
* Have been training continuously for at least one year.

Exclusion Criteria:

* Participant suffering from chronic illness.
* Serious or terminal illness.
* Suffering from a lasting injury that prevents him/her from training in the month prior to the intervention.
* Inability to understand the informed consent.
* Previous experience in the consumption of beta alanine.
Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery with Traditional Care

The goal of this is to evaluate performance of the Pathkeeper Surgical System. The main question\[s\]it aims to answer are: 1) evaluate pedicle screw position Participants will in compare Experimental arm: PathKeeper System (PKS) with control arm

Trial design

* Allocation: Randomized
* Interventional Model: Parallel Assignment (double armed)
* Interventional Model Description: Dual center, prospective, randomized cohort study.
* Masking: None (Open Label)
* Primary Purpose: Treatment
* Enrolment: 32 (thirty-two) patients - 16 (sixteen) patients experimental and 16 control arms (100 screws each arm, estimated 20% of patients drop out).

Study arms

1. Experimental arm: PathKeeper System (PKS) One to ten-level posterior, open, instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under PKS intraoperative navigation guidance.

   Interventions: Medical Devise - PKS. The PKS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw implantation in patients undergoing posterior fixation in single or multiple levels.
2. Control arm: free-hand technique guided by intra-operative 2D Fluoroscopy One to ten-level posterior, open, instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under free-hand technique guided by intra-operative 2D fluoroscopy.

Interventions: Pedicle screws will be placed using the free-hand technique with 2D fluoroscopy as the intraoperative imaging modality.

Primary endpoints:

Evaluate and classify the pedicle screw positions as per the Gertzbein-Robbins classification scale based on a low-dose post-operative CT scan, in each study arm and comparatively.

Number of misaligned screws as per the Gertzbein-Robbins classification scale (Gertzbein and Robbins, 1990) class E screws class D screws class C screws class B screws class A screws

Secondary endpoints:

1. Evaluate radiation exposure dose and time in the operating room during the procedure in each study arm and comparatively.
2. Evaluate time-per-screw for the experimental device arm (PKS) arm.
3. Length of stay - (non-critical)
4. Estimated blood loss (EBL) - (non-critical)
5. Number of reported complications (neurological deficits, dural tears, deep wound infections, etc.) while hospitalized

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* 16 and above years old
* Patients who are about to undergo open, instrumented spinal surgery
* Signed informed consent form

Exclusion Criteria:

* Men and women
* 16 and above years old
* Patients who are about to undergo open, instrumented spinal surgery
* Signed informed consent form
The Effect of Two Different Teaching Approaches in Nursing Skills Training

The purpose of this study is effectiveness of Peyton 4-step teaching method and Halsted method on nursing students. The research was conducted as a randomized controlled experimental study with first-year nursing students on urinary catheter within the scope of the Nursing Fundamentals course of Sakarya University Health Sciences Institute. The result of Personal Information Form, Self-Directed Learning Scale in Clinical Nursing Practice, Stress and Satisfaction Vas Scale, Urinary Catheterization Success Pre and Post-Test and Urinary Catheter Application Skill Checklist were comperisoned.

Nursing is a discipline where teaching clinical skills is extremely important. In addition to the traditional methods used in laboratory practices in nursing, the use of innovative methods contributes to learning. This research was conducted experimentally to evaluate the effectiveness of the Peyton and Halsted teaching method in nursing student's urinary catheterization skill learning.

The research was conducted as a randomized controlled experimental study with first-year nursing students within the scope of the Nursing Fundamentals course of Sakarya University Health Sciences Institute in the spring semester of the 2022-2023 academic year. The sample of the study consisted of 217 randomly selected students, 108 students in the experimental group and 109 students in the control group. In the research, Peyton's 4-step teaching method was applied to the experimental group during urinary catheterization laboratory applications. For the control group, the traditional Halsted method was used. Data were collected with the Personal Information Form, Self-Directed Learning Scale in Clinical Nursing Practice, Stress and Satisfaction Vas Scale, Urinary Catheterization Success Pre- and Post-Test, and Urinary Catheter Application Skill Checklist. The knowledge and skills learning levels of the experimental and control group students were compared. Descriptive statistics, Pearson chi-square, Mann-Whitney U and Kruskal Wallis tests were used to analyze the data.

Eligibility Criteria:
Inclusion Criteria:

* First year student at the Faculty of Nursing,
* Enrolling in the "Fundamentals of Nursing" course for the first time,
* Have watched the video recordings of the online application of Sakarya University Faculty of Health Sciences SAÜSEM (Sakarya University Continuing Education Application and Research Center),
* Students who agreed to participate in the research

Exclusion Criteria:

* Graduate of health vocational high school,
* Settled through the foreign student exam (YÖS),
* After graduating from the fields that provide associate degree education related to health, they were placed in the nursing department with the vertical transfer exam (DGS),
* Students who take the "Fundamentals of Nursing" course as a repeat
Diagnostic Value of Whole-Body MRI for Rectal Cancer Preoperative Staging

The purpose of this study is to determine whether whole-body MRI (WB-MRI) accuracy is superior to FDG-PET-CT considered as the gold-standard for the staging of distant lesions of rectal cancer.

Rectal cancer is the second cause of mortality after lung cancer in industrialized countries and represent 28% of colorectal carcinomas. Despite major improvements in diagnosis and treatment made those last years,mortality and morbidity remains high, because of high prevalence of metastasis and local recurrence. A accurate initial staging is of paramount importance for an appropriate treatment (neoadjuvant chemiotherapy and radiotherapy, surgery).

Actually, there is no international consensus concerning imaging for the staging of rectal cancer and modalities used are variable from one center to another.

WB-MRI represented a attractive and promising technique for the staging of rectal cancer, free of ionizing radiation .

Eligibility Criteria:
Inclusion Criteria:

* rectal cancer T3 N+ or T3 or T4

Exclusion Criteria:

* renal failure
* allergy to iodinated contrast medium
* contraindication to MRI
Virtual Reality in Reducing Acute Orthopedic Pain

The primary aim of this research is to show that a virtual reality (VR) service line is feasible and can sustain itself with the ability to take care of patients. Additionally, the investigators aim to learn about the limitations of a service line and provide a pathway for future improvements in building a VR service line that is optimally aligned with the user's needs. Secondary aims are to evaluate the clinical aspects of the patient's outcomes including length of stay, morphine equivalents in pain medicine required during the hospital stay, and user experiences.


Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized with an orthopedic fracture
2. Able to participate fully in all aspects of the study
3. Able to understand and sign informed consent
4. Individuals with unaided vision or those who can correct their vision using contact lenses

   Exclusion Criteria:
5. Non-English speaking
6. Self-reported history of acute and/or chronic severe motion sickness
7. The presence of a facial/head deformity that will prohibit the wearing of a VR head mounted display.
8. Legally blind or deaf
9. Have had a seizure within the past 1 year
10. Have current (within the past 30 days) clinically significant acute or chronic progressive or unstable/uncontrolled neurologic disorder
11. Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence