cyrilzakka/clinical-trials huggingface dataset:
Exploring the Impact of Fully Guided Implant Placement on Classifying Bone Quality Through Tactile Sensation

Bone quality stands as a crucial determinant impacting the success rate of dental implants, exerting influence on both implant primary stability and the efficacy of osseointegration. While radiographic images can partially reveal bone quality, experienced surgeons often rely on tactile sensation during bone drilling to assess it. Subsequently, based on the diagnosed bone quality, distinct implant designs and surgical protocols have been invented to enhance survival rates.

Technological advancements now enable the preoperative design of implant placement through a comprehensive guide, merging CBCT DICOM files with digital oral scanning data. This "fully guided" approach enhances the precision, stability, and safety of implant placement surgery. However, the use of a fully guided surgical guide introduces an additional factor-the friction between the drill and guide-potentially impacting the surgeon's tactile feedback.

This study aims to assess the difference in bone quality evaluation by tactile sensation between freehand drilling and drilling with a fully guided surgical guide, using test blocks of different bone density. The discussion will explore the pros and cons of employing a fully guided guide to optimize outcomes in implant treatment.

The pilot study involves five subjects, while the main experiment will include thirty subjects. The experiment consists of two rounds, each with seven simulated bone samples. These samples include four different densities (5pcf, 5pcf, 10pcf, 10pcf, 15pcf, 15pcf, 30pcf) tested in random order. Before each round of testing, participants drill into a 50 pcf bone sample and identifying it as the hardest scale. The experiment then commences with the first round employing conventional drilling tests, followed by the second round drilling with a fully guided surgical template. After each drilling session, participants assess the hardness by recording a VAS score on a 10cm scale. The evaluation criteria utilize VAS scores as the measurement tool. The aim of this experiment is to investigate whether there are differences in the classification of bone density judged by using a fully guided surgical template compared to judgments made without using the template, under the same bone density conditions. Additionally, the study aims to determine if the use of the template affects the accuracy of bone density assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Board-certified dentist
2. Practice within 10 years
3. Experience of Implant surgery should be less than 10 implants
4. Age: 24-40 y

Exclusion Criteria:

1. Unable to follow the entire test
Childhood Influenza Immunisation Invitation Trial in Schools

This study will investigate whether influenza vaccine uptake by school-age children (in school-based clinics) can be increased by making behavioural-insight informed changes to the invitation process which encourage parents to return consent forms.

Previous research has shown that small changes to the invitation phrasing and/or process informed by understanding and insights into behaviour can be used to increase a desired behaviour (e.g. uptake of health checks, reducing primary care antibiotic prescribing).

This trial will determine whether a behaviour-insight informed invitation letter and/or reminder Short Message Service (SMS)/email message can increase return of consent forms and thereby increase uptake of childhood flu vaccine in schools.

The trial will take place within the existing national childhood immunisation programme in participating areas in England. Randomisation will be at the school-level (stratified by local authority). All eligible children within a school will therefore be in the same arm of the trial and be subject to the same invitation process. Outcome data will be routinely collected, school-level influenza vaccine uptake data. Data will also be collected on the implementation of email/SMS reminders in all schools.

The analysis will investigate the main effects of the interventions and their interactions, take into account provider, local authority and school effects and explore the impact of other factors such as deprivation indicators.

An analysis of letters used by providers of childhood influenza immunisation in schools not involved in the trial will also be conducted. All providers will be asked to submit a copy of their invitation letter for the 2016/17 programme and these will be analysed using the Theoretical Domains Framework.

Eligibility Criteria:
Inclusion Criteria:

* Attendance at a school where national childhood influenza immunisation programme is delivered by a provider participating in the trial
* Eligible for influenza immunisation

Exclusion Criteria:

* Ineligible for influenza immunisation
Cognitive Behavioral Therapy by Humor Based Psychoeducation

This study aims to reveal the effectiveness of based cognitive behavioral therapy by humor based psychoeducation on sense of humour, self-esteem and depressıon level patient in diagnosed with deppression .

Aim: This study aims to reveal the effectiveness of based cognitive behavioral therapy by humor based psychoeducation on sense of humour, self esteem and depression level patient in diagnosed with depression .

Method: This study will be conducted as a randomized controlled experimental study by the researcher, who is a specialist psychiatric nurse, to the elderly patient in diagnosed with depression staying in the mardin traning and research hospital and kızıltepe state hospital. In the study, "power analysis" was performed and a total of 44 individuals, including 22 intervention people and 22 control group, were considered suitable for the sample size. It was decided to have 30 people in the groups, considering the high power of the test and the loses in the study. Accordingly, 30 people were determined as the intervention group and 30 people as the control group. In this study, personal ınformation form, coping humor scale, rosenberg self-esteem scale, beck depression scale, multidimensional sense of humor scale.

Findings: Aims to reveal the effectiveness of based cognitive behavioral therapy by humor based psychoeducation on sense of humour, self esteem and depression levels patient in diagnosed with depression .

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Not having any obstacle to communication
* Being between the ages of 18 and 65
* Being monitored on an outpatient basis with a diagnosis of depression according to the diagnostic and statistical manual of mental disorders criteria
* Being literate
* Not having undergone such training in the last 6 months

Exclusion Criteria:

* Serious factors that may prevent you from answering the survey
* Presence of physical and cognitive disability
* Refusing to participate in the study after being informed
* Having a comorbid psychiatric diagnosis
* A patient diagnosed with depression with psychotic features
* Having received any psychotherapy in the last 6 months
Gait Training for Individuals With Paraplegia Using the H-MEX Exoskeleton

This study evaluates the feasibility and effects of H-MEX powered exoskeleton in individuals with paraplegia as a result of spinal cord injury.

Participants with paraplegia will attend gait training using H-MEX powered exoskeleton 3 times a week for 10 weeks.

The aim of this study is to assess the impact of gait training using H-MEX powered exoskeleton on walking ability, gait analysis, medical examination, body composition, functional evaluation, laboratory findings, quality of life, and subjective experience in individuals with paraplegia.

Participants will be evaluated before, during, and after training.

Eligibility Criteria:
Inclusion Criteria:

* Neurologically stable paraplegia due to traumatic or non-traumatic spinal cord injury at least 2 months since injury
* Age more than 18 years
* Body weight less than 110kg, height between 160-180cm
* Sufficient postural stability to perform level transfer
* Sufficient upper extremity strength to use a walker or crutch

Exclusion Criteria:

* Spinal instability
* Severe joint contracture in lower extremity
* Unhealed fracture in the major weight bearing bone in the lower extremity
* Skin compromise in areas of contact with the device
* Unresolved deep vein thrombosis
* Uncontrolled hypertension or hypotension
* Severe osteoporosis or osteoporotic fracture unable to gait training
* Lower extremity spasticity exceeding 3 out of 4 (Modified Ashworth Scale) in any joint
* Upper extremity functional limitation due to weakness or contracture
* Psychological or cognitive problem that may limit the participants to understand instructions by investigator
* Any other issue that may interfere with the trial
The weWomen and ourCircle Intervention for Immigrant, Refugee and Indigenous Women

This study evaluates the impact of administering culturally-specific versions of the Danger Assessment (DA) tool followed by the tailored safety planning/referral via use of internet/smartphone-based safety decision aid (SDA) on immigrant, refugee and indigenous women's empowerment, safety and mental health. Half of survivors will receive tailored safety planning/referral based on their level of risk assessed by the DA, while the other half will receive non-DA informed usual safety planning/referral.

The DA is a tool to assess risk for homicide, near homicide, re-assault or severe re-assault by an intimate partner. In the culturally adapted DA-informed safety decision aid intervention, women answer questions on the DA, receive immediate feedback on their level of danger as well as personalized messages about safety based on their scores on the DA. The risk factors and scores on the DA are then combined with the safety priorities of women to develop a tailored safety action with links to community resources. Using a computerized randomization scheme, women are randomly assigned to either the internet and/or smartphone app accessible SDA website or control website.

This trial is being conducted in various geographical regions in the US to address the following aims:

1. Evaluate the impact of administering culturally adapted DA-informed interactive internet-based SDA intervention on abused women's safety compared to women assigned to the control website. It is hypothesized that at 3, 6, and 12 months post-baseline, the intervention group will have increased safety seeking behaviors and reduced exposure to intimate partner violence in comparison to the control group.
2. Evaluate the impact of administering culturally adapted DA-informed interactive internet-based SDA intervention on abused women's mental health compared to women assigned to the control website. It is hypothesized that at 3, 6, and 12 months post-baseline, the intervention group will have improved mental health in comparison to the control group.
3. Evaluate the impact of administering culturally adapted DA-informed interactive internet-based SDA intervention on promoting abused women's empowerment compared to women assigned to the control website. It is hypothesized that at 3, 6, and 12 months post-baseline, the intervention group will have increased empowerment in comparison to the control group.

The study will establish evidence base for a culturally-informed intervention for immigrant, refugee and indigenous women. The intervention will not only prevent future exposure to intimate partner violence, it will also promote abused women's mental health and empowerment.

Eligibility Criteria:
Inclusion Criteria:

* Experiences of intimate partner violence within the past one year
* Foreign born immigrant or refugee woman OR Native American woman
* 18-64 years of age
* Can access and use internet

Exclusion Criteria:

* No experience of intimate partner violence within the past one year
* US born and not Native American
* Younger than 18 or older than 64
* Cannot access or use internet
Rotating Frame Relaxation Imaging in Patients With Multiple Sclerosis

The aim of this study is to develop novel magnetic resonance imaging (MRI) protocols suitable for patients with multiple sclerosis using advanced MRI such as rotating frame relaxation imaging. In addition, the investigators want to study the correlation between advanced MRI parameters and clinical disease progression.


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of relapsing remitting MS made according to the Poser, McDonald's or revised McDonald's criteria (Group I) before participating in the study
* Initial MS diagnosis of relapsing remitting form of the disease according to the criteria as mentioned above, and conversion into the secondary progressive phase of the disease as evaluated by the referring neurologist according to the clinical evaluation and confirmed by the study physician (Group II).
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

* Any other autoimmune disease than MS requiring immunomodulatory or immunosuppressive medication
* High-dose corticosteroid treatment within 30 days before participating in the study
* Prior medical history: Patient must have no history of serious cardiovascular, liver or kidney disease
* Any psychiatric condition that compromises the subject's ability to participate in the study
* Infections: Patient must not have an uncontrolled serious infection
* No contraindications for MRI (cardiac pacemaker, intracranial clips etc)
MRI-Targeted Focal Ablation of the Prostate in Men With Prostate Cancer

This is a prospective single center trial to examine the rate of negative biopsy result and quality of life after focal ablation by radiofrequency energy. The primary evaluation involves assessing the rate of negative biopsy result using MR-US fusion biopsy six months after focal ablation of the prostate. Urinary and sexual quality of life will be assessed through validated measures. The hypothesis of our study is that focal ablative therapy will result in a greater likelihood of negative biopsy on followup biopsy than that observed in men who elect not to undergo therapy.


Eligibility Criteria:
Inclusion Criteria:

Subject Population:

* Men 40-80 years of age
* Diagnosis of adenocarcinoma of the prostate, confirmed by TransRectal Ultrasound (TRUS) biopsy
* No prior treatment for prostate cancer
* Prostate Cancer Clinical Stage T1c
* Prostate-specific antigen (PSA)\<10 ng/ml (this will be the PSA level prompting the initial prostate biopsy)
* Declined all standard treatment options

Pre-enrollment biopsy parameters:

* Minimum of 12 biopsy cores
* Gleason 6 (3+3) or 7 (3+4)

Final enrollment biopsy parameters after fusion biopsy:

* 12 standard biopsy cores plus targeted regions based upon MRI
* Gleason 6 (3+3) or 7 (3+4)
* No demonstrated cancer diameter \>1.2 cm

Exclusion Criteria:

* Histology other than adenocarcinoma
* Biopsy does not meet inclusion criteria
* History of transurethral resection of prostate (TURP) or other similar procedures transurethral microwave therapy (TUMT), transurethral needle ablation (TUNA)
* History of prior pelvic radiation
* Men who have received any hormonal manipulation (antiandrogens; luteinizing hormone-releasing hormone (LHRH)-agonist; 5-alpha-reductase inhibitors) within the previous 12 months
* Contraindication for Multiparametric-MRI
Glycemic Control on Coronary Inflammation Evaluated by FAI in ACS

This study aimed to clarify the relationship between blood glucose control and the FAI based pericoronary inflammation in low-risk ACS patients with or without diabetes. The results of this study are expected to provide evidence that quantitative assessment of pericoronary FAI helps monitor the local inflammatory activation in diabetic patients with poor glycemic control, therefore, pericoronary FAI evaluation, as a noninvasive imaging biomarker, plays an important role in early detecting coronary atherosclerosis risk in diabetes and allow timely providing appropriate risk reduction strategies in patients at high risk for future cardiovascular events.

Coronary inflammation has been shown to be a cause of the significantly increased risk of cardiovascular disease (CVD) in diabetic patients. This study aimed to investigate the relationship between coronary local inflammation detected by pericoronary fat attenuation index (FAI) and different blood glucose control levels in low-risk acute coronary syndrome (ACS) patients with or without diabetes.A total of 309 patients with low-risk ACS were included in the analysis. Patients were classified into three groups: non-diabetes, well-regulated diabetes and poorly regulated diabetes, depend on the presence or absence of diabetes and the glycemic control evaluated based on a target HbA1c value of 7%. Pericoronary FAI around the proximal of left anterior descending artery (LAD), left circumflex artery (LCX), and right coronary artery (RCA) were evaluated by CCTA, while systemic inflammatory variables and other biochemical indicators were detected by flow cytometry. The results of this study are expected to provide evidence that quantitative assessment of pericoronary FAI helps monitor the local inflammatory activation in diabetic patients with poor glycemic control, therefore, pericoronary FAI evaluation, as a noninvasive imaging biomarker, plays an important role in early detecting coronary atherosclerosis risk in diabetes and allow timely providing appropriate risk reduction strategies in patients at high risk for future cardiovascular events.

Eligibility Criteria:
Inclusion Criteria:

* patients exhibited chest pain but troponin negative who suspected of low-risk ACS\[17\];
* patients underwent CCTA examination before elective coronary angiography;
* patients with at least one significant stenosis (≥50%) in major epicardial vessels based on coronary angiography.

Exclusion Criteria:

* patients with missing preprocedural HbA1c values;
* patients with insufficient image quality for FAI analysis,
* patients with previous history of coronary revascularization or myocardial infarction, or chronic kidney disease requiring hemodialysis, or malignant tumor, or immune system disorders, or statin use within 3 months
Distraction Technique to Reduce Discomfort of Transnasal Fiberoptic Laryngoscopy

To compare the effectiveness of reducing discomfort during flexible nasal endoscopy using simple distraction techniques compared to topical anaesthetic spray and a control group that does not receive topical anaesthetic spray or a distraction technique.

In this randomised controlled study patients will be randomly allocated into one of four groups; the first group will receive topical (co-phenylcaine) anaesthetic spray without distraction, the second group will receive topical (co-phenylcaine) anaesthetic spray with distraction, the thirds group will receive no topical (co-phenylcaine) anaesthetic spray without distraction and the fourth group will receive no topical (co-phenylcaine) anaesthetic spray with distraction. The distraction technique that will be employed is counting backwards from 30 to 1 in even numbers only. All flexible nasal endoscopies will be performed by either of the two most senior clinicians involved in the study. The procedure will be carried out in standard outpatient clinic room setting. Post procedural discomfort assessments will be undertaken using a visual analogue scale (VAS). Power calculations shows that \>24 patients would result in an adequately powered study (\>80%). Data analysis will be undertaken by SPSS and independent T-tests will be performed to assess for statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female participants aged 18+
* Patient requires flexible fiberoptic transnasal laryngoscopy.
* Patient has no preferences in relation to which arm of the study they would like to be in.

Exclusion Criteria:

* Flexible nasal endoscopy not indicated
* Local anaesthetic required for other reasons - e.g. vasoconstrictor effects
* Patient has a clear preference to which group they are randomised to
* Significant sino-nasal disease
* Patient under the age of 18
Evaluation of Urine Samples and Their Relation to Urinary Tract Infection

The aim is to explore the human urine composition and its relation to urine tract infections


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. For the 2 patient populations: Use intermittent catheter on a daily basis due to neurogenic bladder or enlarged prostate and have used IC for at least 2 months
4. For healthy volunteers without UTIs: No diag-nosed UTIs within the last year
5. For healthy volunteers with recurrent UTIs: 3 or more UTIs within the last year or 2 UTIs within the last 6 months (treated with antibiotics)

Exclusion Criteria:

1. Be treated for urinary tract infection at time of enrolment
2. May not take prophylactic treatment for urinary tract infections (antibiotics only)
OCP vs Metformin for Improvement in Clinical Symptoms and Metabolic Markers in Indian PCOS Women

Objective: To assess effectiveness of ISD (Insulin sensitizing drugs) Vs OCP (Combined E\&P cyproterone acetate) in improving clinical, hormonal and metabolic features of PCOS( polycystic ovary syndrome)women from India.

Intervention:

Randomized to receive Metformin 1500 mg / day OR OCP (EE+CA) Life style advice to women with BMI ( body mass index) more than 28 , in both groups (PS: progesterone can be added for getting withdrawal bleeding for amenorrhoea of more than two months, or for prolonged menstrual bleeding. ) Study period: 6 months Clinical evaluation points and tests at enrollment and again after 6 month. Clinical: BMI, Waist circumference, Hip circumference, Acne score, FG (modified Ferriman Gallwey score ) (after no epilation for last 6 weeks), Menstrual History Biochemical: Thyroid function tests, Prolactin,Total Testosterone, Lipid Profile, FAsting blood sugar \& 75 gm 2 hr Glucose tolerance test (GTT), Sr Insulin, 25- hydroxy vitamin D (optional), (Only Radioimmunoassay / Chemiluminescence assays)

Acronyms: OCP(oral contraceptive pills); PCOS (polycystic ovary syndrome); FBS(fasting blood sugar); GTT(glucose tolerance test)


Eligibility Criteria:
Inclusion Criteria:

* PCOS Women diagnosed by Rotterdam criteria
* Age \> 16 or menarche of at least 2 yr upto age 40.
* Diagnosed by Rotterdam Anovulation F.G. Score ≥ 8 or Total testosterone ≥ 40 ngms/dl ovarian volume ≥ 10 cc BMI\>23
* Women not attempting pregnancy at present.

Exclusion Criteria:

* PCOS Women with BMI ≤ 23
* Undergoing any treatment for acne hirsutism. Including Homeopathic, Ayurvedic
* Known diabetic or hypertension .