cyrilzakka/clinical-trials huggingface dataset:
New Periodontitis Treatment Based on Hyaluronic Acid and Melatonin

The aim of the present study is to determine whether the association of Melatonin and Hyaluronic Acid to the antimicrobial TM paste (3% Tetracyclin and 3% Metronidazole) for periodontal maintenance therapy can improve the attachment level (AL) and alveolar bone support for moderate chronic periodontitis.

Local drug delivery agents in periodontology has gained acceptance and popularity compared to systemic drugs due to decreased risk in development of resistant flora, opportunist infection, and side effects.

In order to improve the topical treatment for chronic periodontitis, Melatonin and Hyaluronic Acid have been added to antimicrobial topic paste commercially available.

* A complex matrix composed of Tetracycline, Metronidazole, Melatonin and Hyaluronic Acid have been developed for local treatment of chronic periodontitis.
* Microbiological, physical, chemical characterization of the newly obtained matrix and biocompatibility tests have been performed.
* A randomized clinical trial will be perform on 50 patients with moderate chronic periodontitis recruited based on eligibility criteria and informed consent signed.
* Mechanical debridement of the pockets by scaling and root planning will be performed prior to the adjunctive therapy.
* Extensive clinical examination including charting the remaining teeth, clinical attachment level (CAL), presence of dental plaque (PI), gingival index (GI), calculus (CI), bleeding on probing (BOP), radiographic assessment and identification of periodontal pathogens with micro-IDent® test will be performed at the beginning of the study and 6 month after its completion.
* Each patient will be randomized using sealed envelopes (according to a computer-generated randomization list) to one of the following topical administration (in the periodontal pocket of affected teeth), for 30 consecutive days: Tetracycline and Metronidazole paste (TM), n=25 patients and Tetracycline, Metronidazole, Melatonin, Hyaluronic Acid paste (TM-MHa), n=25 patients.
* A statistical evaluation of data recorded during the entire follow-up period will be performed.

Eligibility Criteria:
Inclusion Criteria:

* moderate chronic periodontitis, that is, \> 2 interproximal sites with AL \> 4 mm (not on the same tooth), or \> 2 interproximal sites with pocket depth (PD) \> 5 mm (not on the same tooth) (1),
* at least 20 teeth present in the mouth,
* no periodontal therapy during the last 6 months,
* no antibiotic during the last 6 months,
* good general health (no systemic condition affecting the course of periodontal disease, including malignancy), pregnancy,
* no allergy to the product components,
* good mental health.

Exclusion Criteria:

* Patients not willing to sign consent form.
* Patients not agreeing with the treatment protocol.
Development and Testing of a Smartphone Application to Reduce Substance Use and Sexual Risk Among Homeless Young Adults

A pilot trial (N=60) will be conducted to test the feasibility and preliminary effectiveness of OnTrack (a smartphone application to self-monitor substance use and sexual behaviors among homeless young adults) plus a brief motivational intervention (BMI), in comparison to treatment as usual (TAU) at Covenant House New York (CHNY) for those with substance abuse problems and who engage in risky sex. Following referral, screening, and eligibility determination, 60 participants will complete informed consent and be randomly assigned to one of two conditions: 1) TAU or 2) OnTrack + BMI. All participants will be assessed at baseline, 2 weeks, 4 weeks, and 6 weeks after baseline to evaluate alcohol consumption, marijuana use, HIV sexual risk behaviors, and other relevant variables.

Homeless young adults have high rates of substance abuse and HIV infection and, therefore, developing effective, acceptable, and sustainable interventions to reduce their substance abuse and sexual risk behaviors is of high public health significance.

HealthCall for Smartphone (HealthCall-S) is a smartphone application originally designed for self-monitoring of alcohol use and other HIV-related health behaviors, and receiving personalized feedback on these behaviors among urban substance-abusing HIV primary care patients. Building upon prior HealthCall-S studies, individual qualitative interviews were conducted with 10 homeless young adults (age 18-21 years) at Covenant House New York (CHNY), the largest provider of crisis shelter and services for homeless young adults (age 18-21 years) in NYC. The purpose of the individual interviews was to obtain reactions to various aspects of HealthCall-S and determine how it could be adapted to better suit the needs and interests of homeless young adults. HealthCall-S has since been adapted to target alcohol use, marijuana use, and sexual risk behaviors among homeless young adults and renamed 'OnTrack.' A pilot trial (N=60) will be conducted to test the feasibility and preliminary effectiveness of OnTrack plus a brief motivational intervention (BMI), in comparison to treatment as usual (TAU) at CHNY for those with substance abuse problems and who engage in risky sex. Following referral, screening, and eligibility determination, 60 participants will complete informed consent and be randomly assigned to one of two conditions: 1) TAU or 2) OnTrack + BMI. All participants will be assessed at baseline, 2 weeks, 4 weeks, and 6 weeks after baseline to evaluate alcohol consumption, marijuana use, HIV sexual risk behaviors, and other relevant variables.

Eligibility Criteria:
Inclusion Criteria:

* 18-21 years of age
* Engaged in unprotected vaginal, anal, or oral sex in the past year
* Drank alcohol in the past year
* Used marijuana on 4 or more days in past month

Exclusion Criteria:

* Actively psychotic, suicidal, or homicidal
* Does not speak English
* Has a vision/hearing impairment that would preclude participation
* Has definite plans to leave the greater New York metropolitan area within the study period
Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease

This study investigates the prevalence and pathophysiology of dental and periodontal involvement in pediatric patients with symptomatic or asymptomatic gastroesophageal reflux (GER) or gastroesophageal reflux disease (GERD). Primary objectives are to compare the prevalence of oral disease in children with and without a diagnosis or symptoms/signs of GERD in a cross-sectional study. Secondary objectives are to examine factors that might lead to the pathogenesis of the dental and periodontal lesions observed in this group of subjects.

The primary hypothesis is to prove that children aged 10-18 years diagnosed with or having symptoms or signs of GERD have a significantly higher amount of dental erosions in comparison to a matched control group.

Secondary hypotheses are that children aged 10 - 18 years diagnosed with or having signs of GER have higher DMFS (Decayed, Missing, Filled permanent tooth Surfaces) rates, higher SBI (Sulcus Bleeding Index) rates, worse Periodontal status, and lower saliva buffering capacity.


Eligibility Criteria:
Inclusion Criteria:

* Ages 9.0 to 18.0 years, of either gender
* Able to give verbal / written assent / consent themselves and/or informed consent from a parent/guardian
* Willing to comply with all study procedures and protocols,
* Willing to get dental photographs and impressions taken
* Willing to sign the "Authorization for Release of Personal Health Information and Use of Personally Unidentified Study Data for Research" form

Exclusion Criteria:

* Subjects suffering from systemic diseases, significant past or medical history with conditions that may affect oral health or oral flora (i.e. diabetes, HIV, heart conditions that require antibiotic prophylaxis)
* Other conditions that may decrease the likelihood of adhering to study protocol,
* Subjects who will leave the area and are unable to complete the study.
Pelvic Floor Activity and Breathing in Women

The pelvic floor and diaphragm work together in many different functions. Two important functions are breathing and continence. The pelvic floor muscles have to lift and squeeze to maintain continence. Breathing, specifically breathing out, makes the pelvic floor lift. The investigators don't know how much the pelvic floor lifts and squeezes during different types of breathing out. The purpose of this study is to measure pelvic floor lift and squeeze during different types of breathing out.

The pelvic floor (PF) activates automatically, both squeezing and lifting, during times of increased intra-abdominal pressure for postural stability and continence. Expiration additionally produces automatic activation of the PF. No study to date has investigated the effects of forced expiration on PF displacement and squeeze pressure. The purpose of this study was to investigate the effects of variations in forced expiration effort on PF muscles' automatic activation.

Eligibility Criteria:
Inclusion Criteria:

* women
* young (age 18-35)
* nulliparous
* pre-menopausal

Exclusion Criteria:

* pregnancy
* history of lower back or pelvic pain
* history of lower back or pelvic surgeries
* incontinence
* history of pelvic floor dysfunction
* diabetes
* endometriosis
* neuromuscular disease
* connective tissue disease
A Virtual Reality Mindfulness-based Intervention for Nurse Managers

A pilot intervention wait-list control study evaluating the effectiveness of a worksite, on-demand virtual reality mindfulness intervention. Outcomes of interest include perceived stress, burnout, work engagement, resilience and respiratory rates. System usability of the VR mindfulness program and integration into the clinical workday will also be assessed for both groups.

This pilot intervention waitlist control study will evaluate the effectiveness of an 8-week on-demand worksite virtual reality mindfulness-based intervention with academic medical center nurse managers and assistant nurse managers. Individual outcome measures will include perceived stress, burnout, resilience, work engagement, weekly respiratory rates, system usability and integration of the intervention into the workday. The study will use a convenience sample of nurse managers and assistant nurse managers recruited from across The Ohio State University Wexner Medical Center. All participants will provide informed consent which will describe the intervention and wait list control groups, the intervention, and the intervention timelines per requirements of the institutional Internal Review Board. After randomization into intervention and waitlist control groups, all participants will complete outcome measures at the same time one week before the initiation of the VR intervention group, one week after the last day of the VR intervention for the intervention group, and again one week after the waitlist control group receives the VR intervention.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Employed as a Nurse Manager or Assistant Nurse Manager at The Ohio State University Wexner Medical Center
* Manage a hospital-based department/unit with supervisory responsibility
* Ability to participate in study for 8 consecutive weeks using VR technology, three times a week for 10-15-minute sessions during work hours

Exclusion Criteria:

* Less than 18 years of age
* Pregnant
* Not employed as a Nurse Manager or Assistant Nurse Manager at The Ohio State University Wexner Medical Center
* Inability to participate in study for 8 consecutive weeks using VR technology, three times a week for 15-minute sessions during work hours.
* Does not have a personal smart phone or computer to access app.
* Inability to read and/or understand English (consent and questionnaires in English)
* Medical or other conditions that would preclude use of Virtual Reality technology such as:
* Epilepsy or neurological conditions where visual stimuli may trigger seizures or other issues, sensitivity to light or motion, current pregnancy, or any injuries that would prevent operating a headset, history of motion sickness or nausea, history of migraines or headaches, history of balance issues or dizziness, pregnancy, recent concussions, or other conditions where dizziness, nausea or headaches are more likely
* Any exclusions determined from the VR Prescreening Questionnaire for Pre-existing Conditions or Prescreening Eligibility Questionnaire.
Vegetative Monitoring During Brainstem-associated Surgery

Intraoperative Monitoring of Heart rate variability, Blood pressure variability, Baroreceptorsensivity etc.


Eligibility Criteria:
Inclusion Criteria:

* age 0-99
* brain tumor

Exclusion Criteria:

* no consent
Solarplast (R) Supplementation Effects Following High-intensity Resistance Exercise

The primary goal of this investigation is to assess whether Solarplast (R) supplementation will improve recovery following heavy resistance exercise in active adults. The primary questions to be addressed are:

Does Solarplast (R) decrease muscle damage and inflammation associated with heavy resistance exercise?

Does Solarplast (R) reduce the decline in performance associate with heavy resistance exercise?

Researchers will compare Solarplast (R) to a placebo (a look-alike substance that contains no active ingredients) to see if Solarplast (R) is effective at improving recovery.

Participants will be asked to:

Take Solarplast (R) or placebo daily for 4 weeks

Visit the laboratory at least once per week to receive their supplement

Report to the lab for 3 consecutive visits following supplementation to complete a heavy resistance training session and follow-up testing.


Eligibility Criteria:
Inclusion Criteria:

* Recreationally-active (participated in at least 2 weight training workouts per week over the previous year) and participates in at least 3h of total structured exercise/week as determined by the health and activity questionnaire.
* Subject is judged by the Investigator to be healthy and free of any physical limitations (determined by health and activity questionnaire)
* Subject has a body mass index of 18.0-34.9 kg/m2, inclusive
* Subject is willing to maintain habitual diet throughout the study period
* Subject is willing to abstain from dietary supplementation throughout the duration of the study.
* Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators

Exclusion Criteria:

* Subject is currently or will be enrolled in another clinical trial.
* Subject is a habitual consumer of tea/antioxidants defined as \> 8 oz/day of either green or black tea within the 14 days prior to the screening visit.
* Subject has a history or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder.
* Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
* Subject is unable to perform physical exercise (determined by health and activity questionnaire)
* Subject is engaged in an extreme diet including but not limited to, Atkins, South Beach, Intermittent Fasting, etc.
* Subject is allergic to the study product or placebo
* Subject is taking any other nutritional supplement or performance enhancing drug (determined from health and activity questionnaire)
* Subject has any chronic illness that causes continuous medical care
* Taking any type of prescription or over-the-counter medication including but not limited to corticosteroids, non-steroidal anti-inflammatory drugs, and antibiotics within the 14 days prior to the screening visit.
PIPAC for Peritoneal Metastases

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel drug delivery system that allows the direct application of chemotherapeutic agents into the peritoneal cavity. It boosts improved distribution, enhanced tissue uptake and repeatability using minimally invasive access. It was devised to palliate the local symptoms of extensive peritoneal metastases (PM) in patients who are not amenable to curative surgery. This study is to determine safety and feasibility of PIPAC in patients with PM from Gastrointestinal (GI) cancer, Hepato-Pancreato-Biliary (HPB) cancer, and other rare malignancies.


Eligibility Criteria:
Inclusion Criteria:

For Unesectable PM Group:

* Age ≥ 21 years old
* ECOG \< 3
* Fit for systemic chemotherapy treatment
* Adequate bone marrow function (haemoglobin ≥ 8.0 mmol/L, neutrophils ≥ 1.5X109/L, platelets ≥ 100X109/L
* Adequate renal function (e-GFR \> 30mls/min for patients undergoing PIPAC with oxaliplatin; e-GFR \> 60mls/min for patients undergoing PIPAC with Doxorubicine/Cisplatin)
* Adequate liver function (Total bilirubin \< 1.5 upper limit of normal; ALT and AST\< 3 upper limit of normal)
* No contraindications to chemotherapy agents oxaliplatin, doxorubicin/ cisplatin
* No contraindications to general anaesthesia and diagnostic laproscopy procedure
* Normal left ventricular ejection fraction (for patients undergoing PIPAC with doxorubicin/ cisplatin)
* Histological/ cytological proof of PM from GI, HPB, Gynaecology, Breast, Sarcoma primaries
* Peritoneal-dominant metastatic disease

For the Extensive PM Group:

All the above mentioned criteria as for the unresectable group, with the addition of the following:

* Not suitable for curative cytoreductive surgery (CRS) \& hyperthermic intraperitoneal chemotherapy (HIPEC) surgery after diagnostic laproscopy - PCI \> 18 in LGI, PCI \> 6 in UGI ECOG \< 3
* In UGI PM patients, progression while on bidirectional chemotherapy

Exclusion Criteria:

* Patient is medically unfit for surgery due to concurrent medical comorbidities, including but not limited to intestinal obstruction, multiple sites of metastases
* Any medical or psychiatric condition(s) which would preclude informed consent
* Patient is pregnant or nursing
* GI PM patients with PCI \>6 but are treatment naive (these patients should undergo standard treatment - bidirectional intravenous and intraperitoneal chemotherapy)
Development and Validation of a Novel Functional Eye-Tracking Software Application for Cancer-related Cognitive Impairment (CRCI)

This study aims to develop and validate a sensitive and non-invasive eye-tracking software application.

This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by the Cancer-related cognitive impairment (CRCI) and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests. The study data will be used to develop machine learning algorithms and validate a software application intended to track the progressive component of the Cancer-related cognitive impairment (CRCI) and associated cognitive changes.

Eligibility Criteria:
Inclusion Criteria:

* For all participants:

  1. Able to provide informed consent.
  2. Visual acuity sufficient to be able to read the consent form with corrective lenses.
  3. Over 18 years of age.
  4. English- or French-speaking.
* For patients only:

  1. Initial diagnosis of breast cancer stage I-IIIA and scheduled chemotherapy
  2. First-time cancer diagnosis.
  3. ECOG performance \< 2
  4. Receiving curative intent chemotherapy: either Adriamycin/Cyclophosphamide for 4 cycles followed by weekly Taxol for 12 cycles or Taxotere/Cyclophosphamide for 4 cycles

Exclusion Criteria:

* For all participants:

  1. Evidence or medical history of neurological/psychiatric issues known to affect movements and oculomotor control.
  2. Presence of comorbid neurological conditions to avoid eye movement anomaly confounds (Strabismus, cranial nerve palsy, stroke-causing hemianopsia).
  3. Diagnosis of macular edema or other pre-existing ocular conditions that would prevent participants from performing the eye movement assessments.
  4. Previous history of cancer or chemotherapy
  5. Distant metastases
  6. Recent (less than three months from enrollment) start of, change of dose, or irregular use of, new prescription drugs known to influence ocular motor visual function, such as benzodiazepines, antipsychotics and anticonvulsants. Occasional use of benzodiazepines for medical procedures is permitted, at the investigator's discretion, but should not occur within a short time period prior to or during an eye movement assessment.
  7. Diagnosis of a substance abuse disorder.
  8. Recreational drug use (e.g., alcohol, marijuana) is a potential exclusion criterion that will be determined on an individual basis as per the discretion of the research team. All recreational drug use will be documented.
The HepatoPancreaticoBiliary Resection Arginine Immunomodulation (PRIMe) Trial

This is a randomized controlled blinded superiority trial to evaluate the impact of perioperative immunosupplementation on immune function following resection for hepatopancreaticobiliary (HPB) malignancy.

This is a 1:1:1 randomized controlled blinded superiority trial to evaluate the impact of perioperative immunosupplementation on immune function following resection for hepatopancreaticobiliary (HPB) malignancy. Two variations of immunosupplementation will be compared to control nutritional supplement containing whey protein with an additional teaspoon (tsp) of placebo oil. These variations will be 1) a powdered formula containing whey protein and arginine (Active A) with an additional tsp of lipid bolus containing omega-3 fatty acids, and 2) a powdered formula containing whey protein and arginine (Active A) with an additional tsp of placebo oil which does not contain omega-3 fatty acids. The control nutritional supplement will be a powdered formula containing whey protein with an additional tsp of placebo oil.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 and over at time of diagnosis
* Resectable presumed liver, pancreas, or bile duct malignancy (i.e., liver metastases, HCC, cholangiocarcinoma, pancreatic or periampullary adenocarcinoma, NETs)as determined by surgeon in clinic
* Anticipated hospital stay at least three days post-surgery
* Ability to tolerate oral intake and comply with protocol requirements

Exclusion Criteria:

* Documented significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids, azathioprine, cyclosporin A). Subjects may be on physiologic doses of replacement prednisone or equivalent doses of corticosteroid (\<7.5 mg daily)
* Subjects with resting hypotension (BP \<90/50 at rest)
* History of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis
* Serious, active, intercurrent chronic or acute illness, or other active illness considered by the investigator as an unwarranted high risk for an investigational product
* Active infection of any site and/or active herpes requiring ongoing treatment
* Known pregnancy or nursing mothers
* Subjects with an allergy to the nutritional supplement or comparator including milk, fish and/or shellfish allergies
* Subjects with religious or other objections to consuming fish or shellfish
* Subjects with severe asthma defined as asthma not controlled with inhaled corticosteroids and additional controllers or by oral corticosteroid treatment (arginine can cause allergic response or make swelling in airways worse)
* Subjects with a known inherited guanidinoacetate methyltransferase deficiency (due to an inability to convert arginine to creatine)
* Subject with known current liver cirrhosis
* Subjects with documented myocardial infarction or life-threatening arrhythmia
* Subjects with known current cardiac failure or coronary artery disease causing unstable angina