cyrilzakka/clinical-trials huggingface dataset:
Artificial Intelligence in Smile Designing

The study aims to assess the accuracy and patient satisfaction of smile designs based on artificial intelligence versus conventional DSD.

Advances in digital technology are transforming dental esthetic treatments, particularly through the use of Digital Smile Design (DSD) software. These programs enable dentists to create personalized, natural-looking smile designs, improving both treatment planning and patient satisfaction. Initially, tools like PowerPoint and Photoshop were used for smile design, but modern DSD programs allow dentists to work with high-resolution 3D models to design smiles that align with facial features.

Digital smile design (DSD) technology allows dentists to create and preview new smile designs before treatment, aiding in detailed planning and clear communication with patients. This process consists of three main steps: (1) capturing digital images or videos to assess the patient's current smile, (2) analyzing these images to identify aesthetic needs, and (3) using digital tools to simulate the planned changes. Although these digital tools have greatly improved patient experience, they can be challenging to adopt in routine practice due to the required time, skill, and cost. However, this procedure could be time consuming and subjective to the dentist's skills and expertise.

To address this, artificial intelligence (AI) has been integrated into smile design software, automating tasks like facial analysis, image alignment, and smile design simulation. Accessible through apps or cloud-based platforms, AI software supports a variety of tasks, including identifying anatomical landmarks, adjusting images, and conducting live treatment simulations. DSD's integration with artificial intelligence (AI) offers further advancements, promising rapid, automated esthetic evaluations and smile designs Although AI-powered smile design tools are becoming popular in dental practices, some concerns exist that these tools may be used more for marketing purposes than for identifying genuine patient needs.

Eligibility Criteria:
Inclusion Criteria:

* Patients with esthetic problems that require digital smile design.
* Patient's age ranging from 19-30
* Good oral hygiene.
* Patients who have stable occlusion.

Exclusion Criteria:

* Poor oral hygiene.
* Patients with high caries or high plaque index.
* Patients with periodontal problems.
* Heavy bruxism habit or presence of any parafunctional habits.
* Pregnant or lactating women.
* Participating in another trial.
Telemedical vs. Conventional Prehospital Care in Acute Coronary Syndromes

Telemedically supported paramedic care of acute coronary syndromes was compared to a historical control period of solely conventional on-scene physician care. Quality outcomes based on current guidelines were researched als well as time requirements in both groups.

Telemedically supported paramedic care of acute coronary syndromes was compared to a historical control period of solely conventional on-scene physician care. Quality outcomes based on current guidelines were researched als well as time requirements in both groups. All data was collected prospectively for quality management purposes and analyzed retrospectively after ethical approval by the local ethics committee.

Eligibility Criteria:
Inclusion Criteria: symptoms of acute coronary syndrome -

Exclusion Criteria: secondary transfers from hospital to hospital, traumatic chest pain

-
A Comparison of Hyaluronic Acid and Estradiol Treatment in Vulvovaginal Atrophy.

The goal of this observational study isto compare the effect hyaluronic acid and estradiol in vulvo-vaginal atrophy.Hyaluronic acid and Estrogen were equally effective in vaginal treatment. Hyaluronic acid may be preferred for patients in whom hormonal therapy is contraindicated or who wish to receive non-hormonal therapy.

This randomized, controlled, monocentric, prospective, comparative (before/after) study was conducted at Koru Ankara Hospital between April 2023 and September 2023. Patients were randomized into 2 groups. A total of 300 patients, 150 in each group, were included in the study. Informed written consent was obtained from the volunteers who willingly participated in the study. Group I received 25 µg vaginal estrodiol (Vagifem®). 1 tablet a day for two weeks, then 2 times a week for the next 2 weeks. Group II received 5 mg of vaginal hyaluronic acid every day for 14 days, then 2 days a week for the next 2 weeks. Hyaluronic acid gel for vaginal use was supplied by ORTHOGEN®. The treatment period lasted 1 month in both groups.

Before receiving treatment, patients who consented to participate in the study were examined by a Gynecologist, and Vaginal Health Index (VHI)12 score was determined. After the end of the treatment period, the patients were re-evaluated by the same physician, and the VHI score was obtained again. The VHI is the most common score based on vaginal elasticity, secretions, pH, presence of petechiae on the epithelial mucosa, and hydration assessment. The score can range from 5 to 25, and \<15 is considered an atrophic vagina index.

Vaginal pH was measured by placing pH paper on the anterior wall of the vagina. A value \>5 pH was defined as decreased estrogen activity13. The effect on the primary outcome VHI index was investigated.

Eligibility Criteria:
Inclusion Criteria:

- age over 40 years, FSH value above 25 pg/ml, LH value above 20 pg/ml, E2 value below 15 pg/ml, endometrial thickness of 5 mm or less, and absence of menstruation for 12 months.

Exclusion Criteria:

* patients receiving Hormone Replacement Therapy (HRT), genital organ malignancy, breast cancer, patients with vaginal bleeding of unknown cause, history of thrombophlebitis and thromboembolism, thrombophilia, acute or chronic cardiovascular diseases, estrogen and hyaluronic acid allergy, vaginal infection, acute or chronic cardiovascular diseases, and liver diseases. Patients eligible to participate in the study were required to report at least one of the following symptoms: vaginal dryness, burning or irritation, lack of lubrication during intercourse, sexual discomfort or pain during intercourse, dysuria, or recurrent urinary tract infection.
F15 Recharge Free Axonics SNM System Clinical Study

Multicenter, prospective, non randomized, single arm evaluation of patients with overactive bladder (OAB) and/or fecal incontinence (FI) employing the Axonics recharge free SNM System.

A clinical evaluation to comply with new European Medical Device Regulations (EU MDR) guidelines. Multicenter, prospective, non-randomized, single arm study for OAB and/or FI to assess the safety and performance of the Food and Drug Administration (FDA) approved Axonics recharge free sacral neuromodulation (SNM) System, model 4101. The product is currently marketed under the name F15 in the United States.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Primary indication of overactive bladder (OAB) (urinary urgency incontinence (UUI)/ urinary frequency (UF)) or fecal incontinence (FI) who are not candidates for, or who have failed conservative treatment
3. Willing and capable to provide written informed consent and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year.

Exclusion Criteria:

1. Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (exclusion of neurological conditions such as multiple sclerosis)
2. Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements
3. Previously underwent an external sacral neuromodulation (SNM) trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder)
4. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
5. A female who is breastfeeding
6. A female with a positive urine pregnancy test
Diet, Immunometabolism and Non-alcoholic Fatty Liver Disease

This study will assess the impact of 8-hour time restricted eating (8 hours of eating, 16 hours fasting) combined with a Mediterranean diet on metabolism and inflammation in adults with non-alcoholic fatty liver disease (NAFLD).

Non-alcoholic fatty liver disease (NAFLD), defined as the accumulation of fat in the liver that is not related to alcohol intake, is the number 1 global cause of chronic liver disease. Excessive consumption of energy, saturated fat, and simple sugars is a key contributor to hepatic lipid accumulation and obesity-induced metabolic inflammation, reflecting cross-talk between immune and metabolic pathways. Moreover, dietary factors including saturated fatty acids, cholesterol, and their derivatives, as well as gut-derived metabolites, can prime innate immune cells to induce an exaggerated pro-inflammatory response upon re-exposure to such stimuli and may contribute to chronic low grade inflammation.

Dietary strategies focusing on replacing inflammatory dietary triggers with monounsaturated fats, fiber and complex carbohydrates have been shown to improve metabolic dysfunction, but how this relates to a rewiring of the innate immune system is less clear. Time-restricted eating (TRE) is another dietary strategy which has been shown to elicit beneficial effects that reduce the risk of chronic metabolic disease and consolidates eating to a 6-10 hour period daily. Early TRE (eTRE), wherein eating occurs from morning to early afternoon, is associated with greater cardiometabolic health benefits than eating late in the evening. This includes improved insulin sensitivity, glucose tolerance and lipid metabolism, and reduced inflammatory markers.

This study will determine the impact of an 8-week intervention of 8-hour eTRE combined with an anti-inflammatory Mediterranean diet on the metabolic and immune phenotype of individuals with NAFLD, a population at high risk of progressive cardiometabolic decline and chronic inflammation. By focusing on improving both nutrient quality and nutrient timing, a greater understanding of the interaction between systemic metabolism and immune cell rewiring will be gained.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Age 18-65 years, from all ethnic groups, capable of providing informed consent to participate
* Obesity (body mass index \>30kg/m\^2) and of stable body weight (±3% for ≥3 months)
* Fasting blood glucose \<7.0 mmol/L and HbA1c \<6.5%.
* Liver fat \>10% (CAP score \>238 dB/m) and no fibrosis (liver stiffness score 2-7 kPa) as assessed by liver elastography (FibroScan)

Exclusion Criteria:

* Impaired renal function
* Abnormal hematocrit
* History of cardiovascular events
* Uncontrolled hypertension
* Type 2 diabetes
* Medications or supplements known to affect glucose or lipid metabolism
* Active inflammatory, autoimmune, infectious, gastrointestinal, or malignant disease
* Uncontrolled neurological or psychiatric disease
* Iron deficiency anemia, (hemoglobin \< 12g/dl men, \< 11g/dl women)
* Fatty acid supplements and consumers of high doses of anti- antioxidant vitamins (A, C, E, b-carotene)
Safety Study of ExAblate for the Treatment of Uterine Fibroids

The objective of this Phase IV study is to evaluate the safety of the ExAblate treatment of uterine fibroids using the enhanced sonication techniques, based on the current commercially-approved treatment guidelines. Treatment may include up to 100% of individual fibroid volume, within established serosal and sacral treatment margins.

The Enhanced sonication is one of the various sonication modes that may lead to increased thermal dose volume of each sonication without additional safety risks. This is an additional treatment tool available in the ExAblate system for the treatment of uterine fibroids.

The safety profile of the Enhanced Sonication was investigated under an FDA-regulated IDE study. FDA granted approval of Enhanced Sonication with the requirement to perform a post-approval study to collect additional safety data when treating up to 100% of individual fibroid volume.


Eligibility Criteria:
Inclusion Criteria:

* Women age 18 or older
* Symptomatic uterine fibroids, defined as those resulting in scores of 21 or higher, based on patient responses to questions 1-8 of the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)
* Women who have given written informed consent
* Women who are able and willing to attend all study visits.
* Patient is pre or peri-menopausal (within 12 months of last menstrual period).
* Patient should be family complete.
* Able to communicate sensations during the ExAblate procedure.
* Uterine fibroids, which are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone).
* Fibroids(s) clearly visible on non-contrast MRI.
* Fibroid enhances on MR contrast imaging.

Exclusion Criteria:

* Women who are pregnant, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment.
* Patients who are breast-feeding.
* Patients with active pelvic inflammatory disease (PID).
* Patients with active local or systemic infection.
* Patients experiencing chronic leg or lower back pain within the last 6 months.
* Contraindication for MRI Scan:

  * Severe claustrophobia that would prevent completion of procedure in the MR unit
  * Weight greater than 250 lbs (113Kg)
  * Implanted ferromagnetic materials and/or devices contraindicated for MR scan
  * Known intolerance to MRI contrast agent (e.g. Gadolinium or Magnevist)
  * Any other contraindication for MRI Scan
* Extensive abdominal scarring in the beam path (that cannot be avoided by redirection of the beam).
* Dermoid cyst of the ovary anywhere in the treatment path.
* Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia.
* Intrauterine device (IUD) anywhere in the treatment path.
* Undiagnosed vaginal bleeding.
* Pedunculated fibroids.
* Uterine size \>24 weeks.
Did MRI Appearance of Supraspinatus Muscle Atrophy Changes After Repair of All Kind of Rotator Cuff Tear?

There are two purpose of this study, first is to find whether arthroscopic rotator cuff repair is changing the appearance of supraspinatus muscle atrophy in each and every patient. Second, is to find how much approximate change one can expect depending on age and tendon retraction

Retrospective review of 209 patients having both preoperative and immediate postoperative MRI done. Both preoperative and immediate postoperative occupancy ratio calculated and from that change in occupancy ratio calculated for each and every patient. Patient were divided in two major group according to age that is \<60 years and \>60 years and 3 subgroups of mild, moderate and severe depending on preoperative supraspinatus tendon retraction on coronal view of MRI. Postoperative occupation ratio was compared with preoperative occupation ratio within the subgroups and change in occupation ratio was used for comparison between the subgroup. Change in occupation ratio was also used for comparison between 2 major groups

Eligibility Criteria:
Inclusion Criteria:

1. Patients with degenerative rotator cuff tear who underwent single-row arthroscopic rotator cuff repair in our hospital.
2. Patients with preoperative MRI and postoperative MRI within 1 week of surgery in our hospital.
3. Patients with minimum grade 1 supraspinatus atrophy in preoperative MRI.

Exclusion Criteria:

1. Patients with preoperative MRI from outside hospital.
2. Patients with isolated subscapularis tear.
3. Patients with previous operation on the same shoulder joint.
4. Patients with MRI images that were not usable due to poor quality or absence of appropriate Y-view.
Electrical Vestibular Nerve Stimulation (VeNS) in the Management of Parkinson's Disease

Parkinson's disease burdens an increasing number of elderly populations in the country.

Parkinson disease is a chronic, progressive neurodegenerative disorder, affects approximately

1% of the population by the age of 65 years and 4% to 5% of the population by the age of 85 years. Mild cognitive impairment in Parkinson's disease leads to Parkinson's disease dementia (PDD) for which currently there is no drug therapy. The existing treatments for PD were associated with side effects and does not offer complete cure. Hence there is a need of alternative therapy which can prevent or delay the onset of PD with less or no side effects. Vestibular stimulation is known to modulate cognitive processing, enhance learning and spatial memory.

Vestibular dysfunction is present in PD patients. So long term vestibular stimulation may be effective in enhancing cognition by reducing the cognitive, neurodegenerative, neuroinflammatory changes and behavioral deficits observed as predictors of Mild Cognitive Impairment in Parkinson's disease Dementia. In this project, the plan is to administer electric vestibular nerve stimulation to PD patients which might be effective and ideal treatment with minimum or no side effects in the management of Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Fulfilled the Hoehn \& Yahr Classification of Disability 79,80 stage 1-2
* Ambulate with or without an assistive device for at least 50 feet
* Were able to get up and down from the floor with minimal assistance or less and
* Score of 24 or above on the Folstein Mini-Mental State Exam

Exclusion Criteria:

* Decline in immune function such as pneumonia or systemic infection
* Progressive degenerative disease besides PD
* Spinal fusion or other orthopedic surgery in the past six months
* Mental disease/psychosis such as dementia
* Greater than minimal assistance required for gait and transfers
* Inability to make regular time commitments to the scheduled intervention sessions
* Experience with regular practice of any form of vestibular stimulation within the past year
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.


Eligibility Criteria:
Inclusion Criteria:

1. Participant is \< 21 years of age
2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:
3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment

Exclusion Criteria:

1. Participant has a known pregnancy

   Below exclusion criteria apply only to:

   Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)
2. Has had intermittent dialysis within previous 24 hours
3. Has had a kidney transplant within previous 30 days
4. Has had a liver transplant within previous 1 year
5. Has had a stem cell transplant within previous 1 year
6. Has had therapeutic hypothermia within previous 24 hours
7. Has had plasmapheresis within the previous 24 hours
8. Has a Ventricular Assist Device
9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Rifampicin Resistance in S. Aureus During and After Treatment for Latent Tuberculosis

Two commonly used treatments for latent tuberculosis infection are either 4 months rifampicin or 6-9 months isoniazid. The invistigators will study the risk of acquisition of rifampicin resistance in commensal Staphylococcus aureus in persons treated with rifampicin versus in persons treated with isoniazide. Through repeated swab cultures before, during, and after treatment the investigators will also investigate potential accumulation of mutations associated with rifampicin resistance over time. Finally, household contacts to persons with rifampicin-resistant S. aureus will be examined to investigate whether onward transmission of rifampicin-resistant S. aureus occurs within households.

The use of rifampicin for treatment of latent tuberculosis has gained popularity due to a shorter treatment course compared with isoniazide (4 versus 6-9 months) since this can lead to a higher proportion of treatment completion. An estimated 25% of the global population is latently infected with tuberculosis. Hence, a shift towards rifampicin instead of isoniazide, which has a more narrow antibacterial spectrum, could have a large impact on the prevalence of rifampicin resistance among commensal bacteria with pathogenic potential, such as Staphylococcus aureus (S.aureus).

The investigators will investigate the risk of acquisition of rifampicin resistance in commensal S.aureus during out-patient treatment for latent tuberculosis using 4 months rifampicin versus 6-9 months isoniazide at Skåne University Hospital in Malmö, Sweden.

Swabs will be obtained from the nose, throat, groin and possible wounds for culture and resistance testing before, during and after cessation of treatment for latent tuberculosis. Whole genome sequencing will be used to analyze accumulation of mutations over time and to determine if it is the primarily detected S.aureus that develop resistance or if the individual is colonized by new, rifampicin-resistant S.aureus over the course of treatment. Household contacts to persons with rifampicin-resistant S.aureus will be examined to investigate onward spread of bacteria within a household.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with latent tuberculosis
* prescribed either 4 months rifampicin or 6-9 months isoniazide
* informed consent

Exclusion Criteria:

* none