cyrilzakka/clinical-trials huggingface dataset:
Oral Bacterial and Viral Mapping by Dental Plaque in Elderly Patients With and Without Alzheimer's Disease(ORal MICrobiology in Alzheimer's Patients)

The neurological disorders that accompany aging represent a major public health problem. The management of these diseases is a major medical and social priority. This project is based on the assumption that the oral cavity represents a privileged observation space to address these issues. The mouth is a site of easy access for painless sampling; there is therefore a major interest in identifying early oral infectious markers of the development or evolution of senile dementia. In addition to the interest of an early oral diagnosis, the mapping of the oral microbial flora in the demented elderly would allow a better understanding, prevention or even control of the evolution of neurodegenerative diseases. The final objective of our approach is to characterize the oral pathogens, or more probably the group of oral pathogens, which are significantly associated with Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 70 years old
* Patient (or trusted person) having read and understood the study information note and signed the informed consent form
* Membership in a social security scheme
* For cases : Diagnosis of possible or probable Alzheimer's disease according to the DSM-V

Exclusion Criteria:

* Presence of a neurodegenerative pathology (excluding Alzheimer's disease for cases)
* Presence of a neurocognitive disorder (excluding Alzheimer's disease for the cases)
* Patient with or having had any kind of cancer, including oral or aerodigestive tract
* Patients with or having had autoimmune diseases (HIV, hepatitis)
* Patients with inflammatory diseases (such as rheumatoid arthritis (RA) or Gougerot-Sjogren's syndrome (GSJ))
* Patients with severe haemopathy
* Patients with severe acute or chronic cardiovascular, renal, hepatic, gastrointestinal, allergic, endocrine, pulmonary, neuropsychiatric pathologies, judged by the investigator to be incompatible with the study, as all these pathologies may interfere with the results of the oral flora sampling
* Patients who have undergone oral surgery in the two months prior to sampling
* Patients treated with oral retinoids, bisphosphonates, oral anticoagulants or anticonvulsants
* Patients who have had anti-cancer or immunosuppressive chemotherapy within the last 6 months
* Patient who has had antibiotic or anti-inflammatory treatment in the last 4 weeks
* A history of treatments (drugs and probiotics) taken in the month prior to sampling will be taken, as well as a record of toxic habits (tobacco, alcohol, other)
Virtual Reality to Enhance Upper Extremity Physical Therapy and Recovery

This is a descriptive study assessing the feasibility of using VR rehabilitation with unilateral (or bilateral) impairment of the arm, wrist and or hand resulting in reduced range of motion, dexterity, and/or strength of the hand.

The purpose of this study is to determine the feasibility of using a virtual reality program to monitor and encourage compliance with musculoskeletal home exercise programs. It hypothesizes that the treatment will display improved compliance, range of motion, and general function for individuals with upper extremity musculoskeletal deficits.

The primary objectives are to: 1. Describe participant compliance with an immersive game-based virtual reality (VR) rehabilitation device for delivering at-home occupational therapy exercises for the wrist and hand in individuals with motor impairments. 2. Describe and compare functional outcomes among participants before and after completing at-home rehabilitation using the VR system.

These objective outcomes will be measured through various standardized tests completed by qualified study team members.

Eligibility Criteria:
Inclusion Criteria:

* DoD Beneficiary
* Exhibiting musculoskeletal impairment requiring continued at-home rehabilitation
* Cleared by research or clinical medical provider for participation
* Participant no longer has active range of motion movement restrictions. They may still have weight bearing restrictions but nothing that will preclude them from moving their hand and digits to their maximum ability.
* Ability to keep hand and arm in the field of view of the VR scene
* Must have demonstrated the ability for the Oculus to track all hand and wrist motions of interest (during an initial screening at baseline)
* Ability to independently don and doff the VR headset, plus start the app (verified in the Occupational Therapy/Physical Therapy clinic)
* Age range between 18-65
* Demonstrate the ability to tolerate wearing the VR headset

Exclusion Criteria:

* History of photo-induced seizures
* History of motion sickness when using VR equipment (especially vestibular effects such as nausea, dizziness, etc.)
* Partial amputations of the arm being assessed (including missing digits as they may not enable tracking by the VR)
Care Ecosystem: Navigating Patients and Families Through Stages of Care, Extension Trial

This is an extension trial of a prior trial (NCT02213458). Both persons with dementia (PWD) and their caregivers were enrolled as dyads. The purpose of this randomized clinical trial is to evaluate the benefits of a program that supports model care for PWD and their caregivers. Whereas the prior trial only delivered care and examined outcomes up to 12-months, this trial extends care and outcome measurement for 5 years or until death, and includes all dyads where the caregiver reported high caregiver burden (Zarit-12 greater than or equal to 17) at pre-randomization baseline for the original trial. Participants were recruited from California, Nebraska and Iowa. Participants determined to be eligible were consented and randomized into one of two groups. Two thirds of dyads were enrolled into Navigated Care that provided them with phone-based assistance in meeting important benchmarks in their care, for example completion of legal and financial planning and strategies for minimizing caregiver burden. One third of dyads were enrolled to a control group, entitled Survey of Care. Outcomes were unchanged from the original trial except for the addition of time to long term care placement and are detailed below.


Eligibility Criteria:
This study will enroll patients as well as their primary caregivers as research participants.

Inclusion criteria for patient participants:

* Patient has a diagnosis of dementia with a progressive course
* Patient has a primary caregiver (identified as having primary responsibility for patient) that is eligible for and agrees to join the study
* Patient is covered by Medicare or Medi-caid or is Medi-pending
* Patient is expected to live at least 3 months based on assessment by the referring provider, the patient's primary care provider, or medical record review
* Patient speaks English, Cantonese, or Spanish
* Patient lives in California or Nebraska or Iowa
* Patient is age 45 or older

Inclusion criteria for caregiver participants:

* Caregiver has primary responsibility for dementia patient that is eligible for and agrees to join the study
* Caregiver speaks English, Cantonese, or Spanish
* Caregiver is a legal adult
* Zarit-12 caregiver burden score greater than or equal to 17 at pre-randomization (baseline); this criteria is specific to this extension trial

Exclusion Criteria:

* Patient resides in a nursing home or skilled nursing facility at time of enrollment
* Participant is enrolled in a similar clinical trial that precludes their participation in the investigator's trial
* Patient is pregnant
Growth Hormone (GH) Deficiency & Insulin Like Growth Factor 1 (IGF-I)/ Insulin Like Growth Factor Binding Protein 3 (IGFBP-3) Ratio

A 35-month cross-sectional observational study was conducted at an outpatient university hospital in Amman, Jordan. We obtained a comprehensive medical and laboratory evaluation for 134 short-statured children (64 boys and 70 girls, aged 4-16 years). Complete and partial growth hormone deficincy (GHD) were defined as peak forwth hormone (GH) response of 5 and 7 ng/ml \[IRMA/ DiaSorin®\], respectively in both clonidine stimulation and insulin tolerance tests. Serum IGF-I, IGFBP-3 and IGF-I/IGFBP-3 ratio were determined for all participants.


Eligibility Criteria:
Inclusion Criteria:

* children presented to Jordan Univeristy Hospital (JUH) outpatient endocrinology clinic for the evaluation of short stature (SS)

Exclusion Criteria:

(i) their parents could not provide written consent for them; (ii) they were lost to follow up; (iii) they could not perform clonidine stimulation tests (CST) or insulin tolerance test (ITT) due to a medical contraindication (e.g. cardiac disorder, seizure disorder); (iv) they had received GH therapy in the past; (v) they were known to have pituitary diseases, hypothyroidism, hypogonadism or discovered to have panhypopituitarism or (vi) they have malnutrition, diabetes mellitus, liver disease, or other chronic illnesses.
The ATLANTIS Trial

The purpose of this study is to test whether addition of aquatic exercise to conventional treatment helps reduce the adverse outcomes of chronic venous insufficiency including CVI resulting from venous thrombosis.

Post-thrombotic syndrome (PTS) develops in approximately 25-60% of patients with acute lower extremity deep venous thrombosis (DVT) depending on severity, chronicity, anatomic level of involvement and efficacy of anticoagulation.The frequency increases with occlusive iliac venous thrombosis. PTS results in significant morbidity and a staggering toll on health careresources . PTS is reduced by early percutaneous endovenous intervention and administration of new oral anticoagulants. There are conflicting results on the efficacy of exercise . In general, exercise has been useful in activation of the muscle pump and improvement of symptoms. There are no data about exercise in a swimming pool. Both walking in water or swimming reduce the effect of joint contact and therefore pain which is particularly useful in patients with arthritis or heavyweight. Furthermore with less effect of gravity, absorption of dependent edema would be faster. Dry skin becomes hydrated and the chlorine of water can exert antiseptic properties. There are no data on the role of aquatic activity in the reduction of measures of venous insufficiency.The purpose of this study is to assess whether encouragement of patients to perform aquatic activity in addition to baseline treatment would positively impact chronic venous insufficiency.

Eligibility Criteria:
Inclusion Criteria:

age\>18 years; a Villalta score of ˃5 or a modified Venous Clinical Severity Score (VCSS) of ˃5 plus ongoing symptoms of ˃3 months despite receiving conservative management (minimum of 2 of the following: compression stockings, leg elevation, physical activity on land and use of non-steroidal anti-inflammatory drugs where appropriate, for the preceding 3 months).

Exclusion criteria consisted of unwillingness or inability to use or no access to a swimming pool; open ulceration; planned intervention for arterial or superficial venous reflux, deep venous thrombosis (DVT), venous stenosis, pelvic congestion syndrome, within the first 3 months of enrolment; or using a swimming pool on a regular basis.
A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer

The purpose of this study is to determine the safety and efficacy of nab-paclitaxel and gemcitabine with or without olaratumab in the treatment of first-line metastatic pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of adenocarcinoma of the exocrine pancreas that is metastatic (Stage IV) and not amenable to resection with curative intent.
* If present, clinically significant or symptomatic amounts of ascites should be drained prior to Day 1.
* Have had no prior systemic treatment for metastatic disease. Prior adjuvant or neo-adjuvant chemotherapy or radiochemotherapy (other than nab-paclitaxel) is allowed if completed ≥3 months prior to enrollment and no lingering toxicities are present.
* Prior radiation therapy for treatment of cancer is allowed to \<25% of the bone marrow.
* Phase 2: archival tumor tissue or be willing to provide a pre-treatment biopsy.
* Measurable or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Discontinued all previous treatments for cancer ≥4 weeks prior.
* Adequate organ function.
* Life expectancy of at least 3 months.

Exclusion Criteria:

* Serious concomitant systemic disorder.
* Have received first line treatment for metastatic pancreatic cancer.
* Received prior treatment with nab-paclitaxel.
* Have known central nervous system malignancy or metastasis.
* Current hematologic malignancies.
* Participated within the last 30 days in a clinical trial involving an investigational product.
* Women with a positive pregnancy test or lactating.
* Have endocrine pancreatic tumors or ampullary cancer.
* Currently enrolled in another clinical trial.
* Have a known additional malignancy that is progressing or required active treatment within the past 1 year.
* Known allergy to nab-paclitaxel or gemcitabine or any ingredient of study drug formulations.
* Are taking certain anti-coagulant medications such as warfarin and are unable to be switched to other similar medicines.
Role of Interleukin-1β and Prostaglandin E2 in Prediction and Outcome of Apnea in Neonates

Our thesis proposed that IL-1β may affect brainstem respiratory control via prostaglandin-dependant mechanism so we investigated the mediator roles of IL-1β and PGE2 levels in predicting apnea in pretertm newborn and their relation to clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born at less than 37 weeks of gestation.
* Neonates aged from birth up to 28 days.
* Neonates diagnosed with apnea of prematurity or exhibiting apneic episodes

Exclusion Criteria:

* Full-term neonates.
* Neonates with major congenital malformations or genetic syndromes.
* Neonates with severe neurological impairments (e.g., intraventricular hemorrhage grade III or IV).
* Neonates with confirmed or suspected sepsis or active infections.
* Neonates receiving steroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other medications known to alter interleukin-1β or prostaglandin E2 levels.
* Neonates with congenital heart diseases.
* Neonates with a history of significant birth asphyxia requiring extensive resuscitation.
* Neonates whose parents or guardians refuse to provide informed consent.
Selective Removal Technique With or Without a Bioactive Material for Deep Caries Lesions

Objectives: To evaluate and compare clinical and radiographic success of the selective removal to soft dentine technique in one step using calcium silicate cement (Biodentine) vs. no indirect pulp capping material in patients with deep caries lesions in mature permanent posterior teeth with normal or reversible pulpitis after a 2 year follow-up. Evaluate the integrity of the resin composite restorations using FDI criteria.

Material and methods: selective removal to soft dentine in one visit will be performed in 104 blinded patients that will be randomly allocated into 2 study arms, 52 patients will constitute the Biodentine group and 52 the No material group. Clinical examination will be performed to obtain pre-, intra- and postoperative data, including vitality test results, periapical status and risk of caries of the patients. Periapical and bitewing radiographs will be taken before treatment (T-0), at 1 month (T-1), 6 months (T-2), 12 months (T-3) and 24 months (T-4). Restorations will be assessed using the FDI criteria at the same follow up periods.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 15 years.
* Parents or guardians of patients under 18 years of age, but over 15 years of age, and patients over 18 years of age who demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and who receive a signed and dated copy of the informed consent form.
* Occlusal or occlusal-proximal caries lesions, Class I or Class II, in molars or premolars with enamel margins and affecting maximum one proximal wall.
* Molar or premolar with deep caries lesion, involving equal to or greater than two thirds of dentin in depth, with a radiographically identifiable band of healthy dentin separating the pulp chamber roof from the caries lesion.
* Normal response to tests of sensitivity (normal pulp) or discomfort when cold stimulus is applied that disappears in a couple of seconds after the elimination of the stimulus (reversible pulpitits).
* Teeth with negative percussion.

Exclusion Criteria:

* Patients immunosuppressed or with severe systemic diseases.
* Teeth with root or cervical resorption.
* Teeth with obliteration of the pulp chamber.
* Periapical or furcal radiolucency.
* Patients with periodontal disease.
* Patients with spontaneous acute pain, prolonged excruciating pain and / or pain that disturbs night sleep.
* Patients who have an allergy to any of the materials used in the treatment.
* Patients with caries lesions that during the treatment of their removal a pulp exposure is performed.
* Patients with inadequate initial radiographs for analysis.
* Evidence of pre-cancerous or cancerous lesions.
* Patients who have taken antibiotics in the last two weeks.
Treatment Of Partial Reversible Chronic Obstructive Pulmonary Disease

Relatively little information is available about the effects of salmeterol/fluticasone combination and fluticasone alone in COPD patients with a partial reversible pulmonary obstruction. The purpose of this study is to compare the effects of salmeterol/fluticasone combination with fluticasone alone delivered via Diskus/ACCUHALER inhaler in subjects with COPD on lung function over a 1 year period.

Multi-centre, double-blind, randomised and stratified parallel group study to compare the efficacy and safety of fluticasone propionate 500 mcg bd versus salmeterol/fluticasone combination 50/250 mcg bd both via Diskus inhaler during 1 year in Chronic Obstructive Pulmonary Disease(COPD) patients with a partially reversible obstruction.

Eligibility Criteria:
Inclusion criteria:

* Established history of chronic obstructive pulmonary disease (COPD).
* Lung function parameters: FEV1/FVC ratio \< 70%, FEV1 between 80% and 30% predicted, a reversibility of airway obstruction of 12% of the initial value with a minimum of 200 mL.
* Signed and dated informed consent.

Exclusion criteria:

* History of asthma or allergy.
* Unstable COPD in the 3 months before the study.
* Interference of non-pulmonary medication or diseases with COPD outcome parameters.
Opioid Consumption in Cystectomy Patients

At the Ohio State University, and across the country, surgical patients admitted to the hospital are over-prescribed a significant amount of opioid medications upon discharge to home. Recent studies reveal that a large percentage of patients prescribed opioid medications after surgery have approximately half of the prescribed medication left over. This study aims to evaluate reported opioid use after surgery in patients undergoing cystectomy in order to better approach the issue with current opioid use and abuse trends while still providing adequate medical care and pain management to patients.

Previous studies show that 67% of patients prescribed opioid medications in urologic procedures and surgeries had leftover opioid medications with a mean use of about half the medications prescribed. A similar study in thoracic surgery patients reported similar results with 71% of patients admitting to taking half or less of their prescribed opioid medications. Recent advancements in cystectomy protocol have already shown promise with reducing hospital length of stay from eight to four days, including the simultaneous reduction of opioid analgesics for pain management, with 4.9 mg morphine equivalents per day when using enhanced recovery techniques compared to 20.67 mg in traditional care. Results of the current prospective study could further support these results and include low to no risk assessments and follow-up phone calls. This study is observational and involves consenting adult patients undergoing cystectomy to pre-operative assessments including the Self Administered Gerocognitive Exam (SAGE) questionnaire, a cognitive test to identify mild-moderate cognitive impairment, and collection of demographic data and medical history. Phone call follow-ups include assessments of post-discharge pain and opioid consumption, and completing verbally an adapted Activities of Daily Living questionnaire. No additional risks have been identified by participating in this study. Participants may not directly benefit from participating in this trial, but the data collected could provide valuable insight into the discrepancy between required opioid pain medications and opioid pain medication prescription for adequate pain management. This insight could then be applied to reevaluate post-discharge pain management procedures and standards of care, therefore curbing opioid use and abuse trends

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing cystectomy
* Capable and willing to consent
* Participants literate in English language

Exclusion Criteria:

* History of drug and/or alcohol abuse/dependency
* Ketamine use during hospitalization
* Illiteracy
* Presence of a clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia
* Any condition that the principle investigator may disqualify the patient
Optimizing Sleep Health in Nurses

The aim of the proposed study is to pilot test two behavioral sleep intervention strategies for improving insomnia among night shift working nurses.

Night shift nurses with insomnia who meet all study criteria will receive one of two insomnia therapies. The specific therapy for insomnia will be determine by chance (like a flip of a coin), with an equal chance to receive either cognitive-behavioral therapy for insomnia or multicomponent relaxation therapy for insomnia, both modified for shift workers. Both therapies will be conducted over telehealth by interventionists trained in behavioral sleep medicine.

Eligibility Criteria:
Inclusion Criteria:

* Current shift working nursing staff in Oregon
* Expect to continue on shift work schedule during the study
* Meets criteria for an insomnia disorder
* Elevated insomnia symptoms
* Have daily access to internet on a smartphone, tablet, or computer; and
* Can read and write in English

Exclusion Criteria:

* People with uncontrolled medical conditions
* Presence of safety risk or condition in which study participation may be ineffective or result in increased risk to safety
* Some current treatments for insomnia
* Permanent day, evening, or rotating shift schedule
* History of seizures or manic episode; or
* Current/expected pregnancy during the study period