cyrilzakka/clinical-trials huggingface dataset:
Assessment of the Effect of Periodontal Disease Prediction System on Oral Hygiene Motivation

The aim of this trial is to evaluate the effect of patient specific periodontal disease prediction (PDP) system, a part of motivational interview, (MI) on probing depth (PD), Rustogi modified Navy Plaque Index (RMNPI), and papillary bleeding index (PBI) scores in patients with periodontitis following non-surgical periodontal therapy.

A total of 120 participants included in our study and were then randomly assigned to three groups: a) conventional method (CM) (n=40), b) three-dimensional animation (3DA) (n=40), and c) Periodontal Disease Prediction (PDP) interaction (n=40). PD, PBI, and RMNPI values were recorded before periodontal therapy (T0). Following periodontal treatment, individuals in the CM group were instructed on oral hygiene via a model and brochure. Individuals in the 3DA group were informed using 3D video visuals. Participants in the PDP group were informed in a computer-based three-dimensional manner, providing projections of their current status and potential future gingival recessions after viewing the first and second parts of the 3D animation. Clinical periodontal measurements were repeated at 3, 6, and 12 months post-treatment. Data obtained after the study were analyzed using appropriate statistical methods. It was concluded that the proposed approach in this project could enhance periodontitis individuals' awareness about periodontal disease and personal oral hygiene especially for interdental cleaning over a long period. By this way, this PDP system can lead clinical benefits in reducing the recurrence of periodontal disease. It was hypothesized that patients in the PDP group could achieve significantly better plaque control and have lower bleeding scores compared to patients in the control groups, which include traditional oral hygiene motivation and three-dimensional video education.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 30 to 60 years.
* No prior periodontal treatment or oral hygiene education.
* Simplified Oral Hygiene Index (OHI-S) greater than 3 (indicating poor oral hygiene).
* Diagnosed with 'Stage III' 'Grade B' periodontitis.
* At least 20 natural teeth present (excluding third molars).
* Minimum of 12 years of education.
* Not a dentist or dental student.
* No systemic diseases affecting memory or cognitive function.
* No physical disabilities that could hinder the performance of oral hygiene procedures.

Exclusion Criteria:

* Presence of diffuse dentinal hypersensitivity.
* Acute infections.
* Faulty restorations.
* Root caries complicating oral hygiene.
* Full-mouth fixed or removable dentures.
* Ongoing orthodontic treatment.
Comparison Between Two Ss-OCT Biometry

Since recently a second swept-source optical coherence tomography (ss-OCT) optical biometry device was launched (Anterion, Heidelberg Engineering). Aim of this study is a retrospective data collection of patients who were measured with both ss-OCT optical biometry devices and to assess the limits of agreement of the two devices.

Retrospective comparison of two ss-OCT biometry devices concerning comparability of measurements of axial eye length, anterior chamber depth, lens thickness and keratometry.

This a retrospective study including data acquired from patients that attended pre-surgical examination as it is the standard in the investigator's hospital.

The IOL Master 700 (Carl Zeiss Meditec AG, Jena) and the Heidelberg Anterion (Heidelberg Engineering, Germany) are biometry devices that use swept-source optical coherence tomography technology in combination with a multidot-keratometer, that obtain two-dimensional images of ocular structures.

The difference between the two devices resides in the wavelength of the infrared laser: 1200-1400nm for the Anterion and 1050nm for the IOL Master 700.

The SS-OCT devices provide a scan depth of 44mm and a resolution in tissue of 22 μm for the IOL Master 700 and of 14x16.5 mm and 30 μm for the Heidelberg Anterion.

Eligibility Criteria:
Inclusion Criteria:

* age-related cataract

Exclusion Criteria:

* nystagmus
* physical inabilities that could interfere with fixation
* dens cataract
* macular or corneal pathologies that could compromise fixation during the measurements.
A Pilot Study of Cognitive-Behavioral Therapy for Rumination Disorder (CBT-RD)

The primary aim of this study is to pilot cognitive behavioral therapy (CBT-RD) for 10 individuals ages 10 and older who have rumination disorder

Rumination disorder (RD; also known as "rumination syndrome") is characterized by the repeated regurgitation of food during or soon after eating, which typically occurs at least a few times per week, frequently daily, with subsequent re-chewing, re-swallowing, or spitting out of the regurgitated material. Diaphragmatic breathing is a widely used technique for rumination as a competing response to the abdominal wall contraction hypothesized to trigger regurgitation. However, the efficacy of diaphragmatic breathing remains unknown and has mainly been delivered simply through a one-session instruction with an occasional follow-up.

In the absence of evidence-based treatments for RD, Dr. Jennifer Thomas has contributed to the creation of a manualized treatment, Cognitive-Behavioral Therapy for Rumination Disorder (CBT-RD) informed by published case reports and currently in use at the Eating Disorders Clinical and Research Program (EDCRP) at Massachusetts General Hospital and the Psychological Services Center at Drexel University. CBT-RD targets the habitual contraction of the abdominal wall and preceding events through the use of habit reversal, using primarily diaphragmatic breathing as a competing response.

This study involves a phone screen to determine eligibility, followed by 5-8 sessions of CBT-RD (approximately 50 minutes each). A battery of questionnaires will be administered at pre-treatment, post-treatment, and 3-month follow-up intervals.

Eligibility Criteria:
Inclusion Criteria:

* Age 10 or above
* Experience repeated regurgitation of food during or soon after eating, consistent with rumination disorder
* If applicable, have stable psychiatric medication for the past three months

Exclusion Criteria:

* Currently engage (in past three months) in any regular compensatory behaviors (e.g., self-induced vomiting, laxative/diuretic use)
* Current diagnosis of anorexia nervosa
* Acute suicide risk
* Are currently receiving psychological treatment for rumination disorder
* Co-morbid clinically significant psychological disorder that would require attention beyond the study treatment (e.g., psychotic disorder, substance dependence)
* Current pregnancy
Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment

Radio graphic and Intravascular (IVUS) Evaluation of Venous Morphology During Chronic Cerebral Spinal Venous Insufficiency Treatment

To determine the safety and validity of venous angioplasty and valvuloplasty in the treatment of CCSVI. In addition, it will allow researchers to sub-classify valve morphology in relation to treatment success. This will be evidenced by venous patency forty-eight hours by Doppler ultrasound as well as clinical symptom improvement.

Eligibility Criteria:
Inclusion Criteria:

* Ability to comprehend the nature of the study, including the risks and benefits and execute an informed consent
* Males or Females between the ages of 20 and 60 years of age.
* Voluntary agreement to participate in the study: Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment.

Exclusion Criteria:

* Any implantable/metallic objects that prevents subject from having a magnetic resonance imaging (MRI/MRV) study.
* History of uncontrolled hypertension
* Previous CCSVI treatment
* Presence of hypercoagulable state
* Special Populations. Special groups include, but are not limited to children, prisoners, pregnant women, fetuses, and cognitively impaired individuals who are unable to provide informed consent.
Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy

Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure to remove stones from the kidney by a small puncture wound through the skin. Patients receiving lidocaine infusion had lower pain scores, reduced postoperative analgesic requirements and decreased intraoperative anesthetic requirements. Erector spinae plane block (ESPB) seems to be effective when compared with no block or a placebo block.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) score I-II..
* Body mass index \< 35 kg/m2.

Exclusion Criteria:

* Patient's refusal.
* Known coagulopathy.
* Known peripheral neuropathy or neurological deficits.
* Chronic pain disorders.
* Known allergy to study drugs
Improving Gap Closure Rates Using a Predictive Model

NYU Langone Health outreaches to patients to remind them to schedule their appointments by phone or MyChart message.The proposed study will test different outreach methods using a predictive risk model. The goal is to increase gap closure rate by the end of the year.


Eligibility Criteria:
Inclusion Criteria:

* Patients in the NYU Langone network who are due for gaps in care.

Exclusion Criteria:

* Patients in the NYU Langone network are not due for gaps in care.
Dendritic Cells (White Blood Cells) Vaccination for Advanced Melanoma

The purpose of this study is to investigate a method of using dendritic cells (a kind of white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma cells.

Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production. All patients will be given cyclophosphamide 300mg/m2 IV three days prior to vaccine dose #1 in order to deplete regulatory T cells. All patients will receive mature DC for each dose of vaccine. For each dose all patients will receive autologous dendritic cells pulsed with 2 gp100 melanoma peptides (G209-2M and G280-9V) plus up to an additional 10 unique melanoma tumor-specific peptides. All patients will receive booster doses with mature DC. The DC vaccine will be given intravenously every three weeks for a total of six vaccine doses. Peripheral blood (16 ml) will be taken weekly to monitor the immune response to each peptide by tetramer assay. Apheresis is repeated after vaccine dose #3 and dose #6 in order to collect PBMC for immune monitoring. Restaging is performed after three and six vaccine doses. Patients with stable disease or better (partial response/complete response) after six doses will be eligible to receive additional vaccinations as maintenance therapy every 2 months until progression.

Eligibility Criteria:
Inclusion Criteria:

* Unresectable stage III and stage IV M1a/M1b/M1c melanoma including patients with uveal melanoma
* Age ≥ 18 years
* Life expectancy ≥ 4 months
* ECOG performance status 0-2
* At least 28 days from prior treatment (including adjuvant interferon) except in cases of a BRAF inhibitor (such as vemurafenib); concurrent treatment with a BRAF inhibitor +/- MEK inhibitor is permitted
* Required initial laboratory values (submitted within 14 days prior to registration):

  * WBC \>3,000/mm3
  * Hg ≥ 9.0 gm/dl
  * Platelets \>75,000/mm3
  * Serum Bilirubin \< 2.0 mg/dl
  * Serum Creatinine \< 2.0 mg/dl
* Sexually active women of childbearing potential must use effective birth control during the trial and for at least two months following the trial, and sexually active men must be willing to avoid fathering a new child while receiving therapy.

Exclusion Criteria:

* Prior treatment with more than one line of cytotoxic chemotherapy; prior treatment with one line of cytotoxic chemotherapy is permitted. Prior treatment with targeted therapy (such as ipilumumab, anti-PD1, and BRAF inhibitor) is permitted.
* Active untreated CNS metastasis
* Active infection
* Prior malignancy (except non-melanoma skin cancer) within 3 years
* Pregnant or nursing
* Concurrent treatment with corticosteroids; local (inhaled or topical) steroids are permitted.
* Inability to provide adequate informed consent
* Known allergy to eggs
* Prior history or uveitis or autoimmune inflammatory eye disease.
* Known positivity for hepatitis BsAg, hepatitis C antibody, or HIV antibody.
Comparative Study of Specific IgE Levels to Common Foods and Aeroallergens Measured by EUROIMMUN Allergy and ImmunoCap

The purpose of this study is to determine the correlation of specific IgE levels to common foods and aeroallergens measured by EUROIMMUN Allergy and ImmunoCap

Children aged 0-15 years old who was diagnosed as asthma and/or allergic rhinitis, atopic dermatitis, food allergy, and underwent to measured specific IgE levels to suspicious relevant allergen, were invited to join the study.

Specific IgE levels of each patient was measured by EUROIMMUN Allergy and ImmunoCap.

The levels of specific IgE to Dermatophagoides pteronyssinus, Dermatophagoides farinae, American cockroach, Bermuda, Johnson, Cat dander, Cow's milk, Egg white and wheat were determined the correlation between these two methods.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosed as asthma and/or allergic rhinitis and/or atopic dermatitis and/or food allergy and have to measured specific IgE levels to relevant allergens

Exclusion Criteria:

* Having underlying disease including cardiovascular disease, chronic lung disease and immunodeficiency disease
* Denied to enrolled to the study
Assessment of Ability Related to Vision

To determine the clinical usefulness of a refined third-generation instrument - The Assessment of Ability Related to Vision (AARV) in establishing the amount of disability, charting the detrimental effects of progressive disease and establishing the beneficial effects of treatment

This research study is designed to test the usefulness and repeatability of testing how much disability is caused by vision loss due to glaucoma. We are recruiting 100 patients with glaucoma and 20 healthy (have no eye disease) individuals to be enrolled in this study. The healthy study participants will be enrolled in order to describe how a healthy individual will perform on the test designed to assess one's performance when completing ten activities of daily living.

Clinical testing will be conducted by binocular and monocular visual fields, contrast sensitivity and visual acuity. The NEI-VFQ 15 Quality of Life Questionnaire will be used to measure patients perception of how well they are doing.

Eligibility Criteria:
Inclusion Criteria:

* All patients 18 yrs of age and older
* must understand and respond to spoken English and be fully literate.

Exclusion Criteria:

* Patients with significant neurological problems (like Parkinson's disease), motor problems (like arthritis) or other significant illnesses that may prevent them from completing the testing involved in the study (like advanced heart failure).
* Patients who have received training related to low vision.
Effect of Ultrasonic Activation of Bioceramic Sealer on Postoperative Pain in Lower Premolars

The aim of this study is to clinically compare post-operative pain levels after ultrasonic activation of Ceraseal bioceramic sealer versus non-activated bioceramic sealer for patients with symptomatic irreversible pulpitis related to mandibular premolar teeth.

To clinically compare post-operative pain levels after ultrasonic activation of Ceraseal bioceramic sealer versus non-activated bioceramic sealer for patients with symptomatic irreversible pulpitis related to mandibular premolar teeth.Ultrasonic activation of Ceraseal bioceramic sealer for 20 seconds using non cutting ultrasonic tip.

Eligibility Criteria:
Inclusion Criteria:

* Patients above 18 years old and to 50.
* Male or female.
* Patients seeking root canal treatment.
* Mandibular posterior teeth with Symptomatic irreversible pulpitis with preoperative sharp, moderate, or severe pain with normal periapical radiographic appearance or slight widening in lamina dura.
* Systematically healthy patient (ASA I, II).
* Patient who can understand modified VAS and sign informed consent

Exclusion Criteria:

* Medically compromised patients having significant systemic disorders. (ASA III or IV).
* History of intolerance to NSAIDS.
* Patients with two or more adjacent teeth requiring endodontic treatment.
* External root resorption.
* Internal root resorption.
* Vertical root fracture.
* Periapical lesion.
* Association with swelling.
* Acute peri-apical abscess or acute exacerbation of a chronic abscess.
* Pregnancy.
* Use of ibuprofen in the last 12 hour.
* Bleeding disorder.
* Long term corticosteroid use.
* Mobility Grade II or III.
* Pocket depth more than 5mm.
* Previous root canal therapy.
* Non-restorability.
* TMJ problems, bruxism, clenching or traumatic occlusion.
* Inability to perceive the given instructions
IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.

The purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted.

The purpose of this observational study is to collect data regarding the population of patients whit a Zephyr™ pacemaker implanted, models 5826 and 5820, and active or passive fixation leads , when the Algorithms Acap Confirm, which automatically regulates the Atrial Pulse Width, is enabled.

Eligibility Criteria:
Inclusion Criteria:

* Patient has an indication for implantation of a dual-chamber pacemaker;
* Patient is older than 18 years of age
* Patient has signed the study specific Informed consent document.
* Primo implant.

Exclusion Criteria:

* Patient is pregnant or nursing
* Patient is less than 18 years of age
* Patient is in New York Heart Association (NYHA) class III and IV.
* Patient has a pacemaker replacement;
* Patient is unable to attend the follow-up visits;
Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Pitolisant in Healthy Male Volunteers

The purpose of this study is to better define the absorption and elimination pathways, and circulating metabolites of Pitolisant at steady state using Pitolisant radiolabelled, in healthy CYP2D6 genotyped male subject.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males aged 30 to 65 years.
* Body mass index 18.0 to 35.0 kg/m2.
* Genotyped with regard to their CYP2D6 status.

Exclusion Criteria:

* Participation in a clinical research study within the previous 3 months
* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.
* Regular alcohol consumption in males \>21 units per week.
* Current smokers and those who have smoked within the last 12 months.
* Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of \<90 mL/min using the Cockcroft-Gault equation.
* Use of CYP2D6 inhibitors or inducers in the 28 days prior to IMP administration
Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients

The purpose of this study is to determine whether immunosuppression by tacrolimus, mycophenolate mofetil, and prednisone compared to conversion to sirolimus, mycophenolate mofetil, and prednisone affect the progression of atherosclerosis in renal transplant recipients.

A decision to terminate the study was taken in November 2011 and a communication to that effect sent to all participating sites on November 18. All sites were asked to have patients returned to the sites and have all end of study procedures performed by Dec 31, 2011.

The decision to terminate this study was made following the conduct of an interim analysis which demonstrated that the study did not reach its primary endpoint. The termination of this study was not driven by any safety concerns and had no impact on subject safety and well-being.

Eligibility Criteria:
Inclusion Criteria:

At least one of the following characteristics:

* History of dialysis for at least 3 years.
* History of diabetes for at least 5 years.
* Hypertension or ischemic nephropathy as a cause of the end stage renal disease or loss of the first transplant.
* History of coronary artery disease, stroke, myocardial infarction, or amputation for vascular disease.

Exclusion Criteria:

* History of malignancy within the last 5 years (except adequately treated skin cancer).
* Recipients of non-renal organ transplant.
* Active gastrointestinal disease that may interfere with drug absorption.
* Active HIV, hepatitis B or C infection.
* Women who are pregnant or breastfeeding.
Pre-emptive Paracetamol for Prevention of Intraoperative Shoulder Tip Pain

the aim is to determine the efficacy of Paracetamol in reducing the incidence and severity of intraoperative shoulder pain in patients undergoing cesarean section.

pregnant females scheduled for cesarean section under spinal anesthesia will be enrolled . two groups of patents will be recruited . the study group will receive paracetamol pre operative .

Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women (ASA II) having singleton pregnancy at term (≤ 37 weeks of gestation) aged between 18 and 40 years.

Exclusion Criteria:

* Patients having allergy to study drug,
* gestational diabetes
* cardiovascular or biliary disorders
* asthma
* renal impairment
* preeclampsia
* any chronic pain condition or trauma in the shoulder, forearms or upper limbs
* patients with any contraindication to SA were excluded from the study.
Heat Application to the Sacral Region and Pain Level During the First Stage of Labor

The aim of this study was to determine the effect of hot application applied to the sacral region during first stage of labor on women's pain level and labor process.

It is stated that the pain experienced during labor, which is a physiological process, creates stress and anxiety in women and increases the risk of maternal and neonatal complications. Therefore, keeping labor pain under control is important from an obstetrical perspective. Pain experienced during labor is caused by dilatation of the cervix and uterine contractions, and occurs in different regions at each stage of labor. Due to the descent of the fetal head into the pelvis and the pressure it puts on the lumbosacral plexus, the mother feels pain in her back, waist, legs and hips, especially in the first stage of labor. Although pharmacological and non-pharmacological methods are used in the management of labor pain, they have disadvantages such as experiencing drug-related side effects due to pharmacological methods, causing undesirable effects in the woman and the fetus, the woman not being able to actively participate in the labor and not being able to remember what happened during labor.

Eligibility Criteria:
Inclusion Criteria:

* Women were over 18 years of age
* Primipara
* Volunteered to participate in the study
* Were in the latent phase of labor (cervical dilatation 1-2 cm)
* Had a single fetus in vertex presentation
* Had no history of pregnancy complications
* Had not undergone any intervention in the sacral region were included in the study

Exclusion Criteria:

* Applied pharmacological pain control methods in the first stage of labor
* Had a cesarean section decision at any stage