cyrilzakka/clinical-trials huggingface dataset:
Reducing Inappropriate Benzodiazepine Use Among Older Adults

The goal of this project is to reduce chronic benzodiazepine use through two approaches: direct patient education or direct patient education paired with additional support and encouragement from a behavioral health care manager.

This is a State of Michigan/Medicaid Match project proposal. These proposed projects are developed to address specific goals for Medicaid policies, procedures, and model programs for Medicaid Recipients in Michigan.

Benzodiazepine use in the United States is common and increases with age, used by 8.7% of patients aged 65-80 years. Benzodiazepines-which include well-known medications such as Xanax, Ativan, and Klonopin-are most commonly used for anxiety and insomnia, even though psychotherapy and alternative medications are now recommended preferentially over benzodiazepines. Use is a particular concern among older adults, given the links between benzodiazepine prescribing and a variety of adverse outcomes including falls, fractures and motor vehicle accidents.

Attempts to reduce benzodiazepine use have met with limited success in the real world, as patients are reluctant to consider the possibility of stopping them and providers are reluctant to even suggest the possibility. In the course of a brief return visit in primary care, providers simply do not have the time or incentive to engage in a potentially difficult, lengthy discussion with patients about reducing or stopping their benzodiazepine.

The goal of this project is to evaluate direct patient education compared to direct patient education paired with additional support and encouragement from a care manager in order to reduce chronic benzodiazepine use. Strategies to help reduce benzodiazepine use are of great interest to providers and our findings would have significance for all providers, and may even conceivably improve the care of patient both inside and outside the Medicaid program.

Eligibility Criteria:
Inclusion Criteria:

* With a prescription BZD supply covering ≥20% of days in the preceding 12 months ("chronic").

Exclusion Criteria:

* Patients with BZD supply \<20% days in past 12 months
* Patients with ICD-10 codes for dementia (derived from encounter diagnosis codes)
* long-term care residents (ICD-10 codes Z59.3 and Y92.199)
A Multicenter Efficacy Study of a Diclofenac+Menthol Gel in Subjects With Ankle Sprain

This Phase III pivotal efficacy study will assess efficacy and onset of pain relief of MFC51123 gel vs. placebo and MFC51123 gel vs. 1% diclofenac gel and 3% menthol gel in participants with an ankle sprain to support topical MFC51123 gel registration.

This is a multi-center, randomized, double-blind, repeat-dose, placebo-controlled, parallel-group trial in participants with ankle sprain. Eligible participants will be randomly assigned to one of four treatment groups (1% diclofenac plus 3% menthol gel, 1% diclofenac plus 0.09% menthol gel, 3% menthol gel or placebo gel with 0.09% menthol). Treatment will be self-administered by participants four times daily on an out-patient basis. Participants will rate pain intensity score (NRS) at rest and on movement, pain relief score (PRS) and cooling and soothing sensations. After leaving the clinic, participants will continue to complete scheduled pain intensity and pain relief assessments and answer questions about cooling sensation by answering questions in a paper diary card. The investigator (or designee) will measure the ankle swelling via the 'figure-of-eight' method on treatment Days 1 (at Baseline), 3, 7 and 10.

Participants will continue treatment until they are pain free or for up to 10 days, whichever occurs first. At the end of the treatment, participants will be assessed for function of the injured joint by the investigator. In addition, the participants will evaluate treatment satisfaction, sensory features of the gel and provide a global assessment of the treatment by using a questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Age: 16-65 years
* Good general and mental health
* Grade I or Grade II acute sprain of the lateral ankle within 24 hours of Visit 1, a pain intensity score of the ankle sprain that is ≥ 5 as measured on an 11-point numerical rating scale, and a peri-malleolar edema (sub-malleolar perimeter difference of ≥ 20mm between injured and uninjured ankle
* Females of child-bearing age practicing a reliable method of contraception

Exclusion Criteria:

* Pregnant or breast-feeding females
* If participant has treated the ankle sprain with treatment such as oral or other topical pain relief medications, massage or physical therapy since experiencing the ankle sprain
* Acute or chronic pain disorders, which may confound the study pain evaluations
* Participant has has injury to both ankles or to both medial and lateral ligaments of the same ankle
* Known or suspected hypersensitivity, allergy, intolerance or contraindication to the use of any of the study medications
* Participant has a medical history of renal or hepatic disease, a current active peptic ulcer or a history of upper gastrointestinal bleeding or perforation related to previous NSAID therapy
Adherence With Fixed Versus Unfixed Glaucoma Therapy

A 6-month, parallel, non-interventional trial investigating the level of adherence and the impact of dosing in open-angle glaucoma patients who receive either unfixed therapy with latanoprost once in the evening and timolol twice daily, or latanoprost/timolol fixed combination therapy once in the evening. All patients participating in this observational study will be monitored for their adherence with the use of Medication Event Monitoring System (MEMS). At the end of treatment periods treatment satisfaction will be assessed with selected questions from the Treatment Satisfaction Survey-Intraocular Pressure survey. This study will monitor objectively, for the first time, adherence and intraocular pressure control with fixed versus unfixed therapy. Finally it will help us to elucidate the impact of dosing (once-a-day versus three-times-daily) on the level of adherence in glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Patient is between 21-80 years old
* Patient has ocular hypertension or open-angle glaucoma Patient receives therapy and is well controlled on fixed or unfixed latanoprost and timolol therapy
* Untreated IOP \>19 mm Hg \<33 mm Hg at baseline (10:00 hour)
* Open normal appearing angles
* Patient had at least a 20% reduction vs untreated baseline on current therapy
* Patient has early or moderate glaucoma (\< 14 decibel; 0.8 or better cupping)
* Distance best corrected Snellen visual acuity greater than 1/10

Exclusion Criteria:

* Contraindication to timolol or prostaglandin therapy
* History of lack of response to any medication (\< 10%)
* Patient does not understand the instructions and will not comply to medications
* Patient can not attend follow up
* Patient is a female of childbearing potential, or lactating mother
* History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
* Sign of ocular infection
* A corneal abnormality that may affect IOP measurements
NI-0401 in Patients With Acute Renal Allograft Rejection

The purpose of the study is to determine the safety and tolerability of NI-0401 and whether NI-0401 can reverse BpACR.


Eligibility Criteria:
Main inclusion Criteria:

* evidence of cellular rejection in a renal biopsy according to Bannff 97 criteria
* rise in Serum Creatinine concentration by \>20% compared to baseline value

Main Exclusion Criteria:

* previous therapy with anti-CD3 mAB(OKT3) or anti-lymphocytes polyclonal antibodies (ATG, Atgam)
* patients with cardiac insufficiency or fluid overload
* severe HLA sensitization (\>50% panel reactive antibodies prior transplantation)
* defined concomitant disease
Ciprofol Versus Propofol for Tracheal Intubation in ICU

The physiological reserves of critically ill patients are relatively low, and the risk of complications related to tracheal intubation in the ICU is higher than in the operating room. ICU tracheal intubation complications account for approximately 40% -45% of patients, including severe hypotension (10% -43%), severe hypoxemia (9% -25%), and cardiac arrest (2% -3%).Ciprofol is a novel 2,6-disubstituted phenol derivative that targeting γ-aminobutyric acid type A (GABAA)-receptor. There are four indications of ciprofol that have been approved by NMPA in recent two years: sedation and anesthesia in non-tracheal intubation procedure/operation, induction and maintenance of general anesthesia, sedation during intensive care, sedation and maintenance in gynecological outpatient surgery. The aim of this study is to compare the effects of propofol and propofol on the circulatory system during tracheal intubation in ICU patients, in order to provide a safer induction sedation regimen for emergency tracheal intubation in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who need to undergo tracheal intubation under sedation after entering the ICU;
* Age range from 18 to 85 years old;
* Patients or their families have a full understanding of the purpose and significance of this trial, voluntarily participate in this clinical trial, and sign an informed consent form.

Exclusion Criteria:

* Patients who are allergic to the study drugs, or patients with contraindications to the study drugs;
* Patients with difficult airways (MACOCHA ≥ 3 points);
* Patients who require emergency intubation due to sudden cardiac arrest;
* Patients who require conscious intubation;
* Patients who can maintain mean arterial pressure (MAP) above 65mmHg using of one or more vasoactive drugs (equivalent (-)-noradrenaline \> 0.3 μg kg min);
* In a state of imminent death;
* Pregnant and/or lactating women; Subject judged by the investigator to have any other factors unsuitable for participation in the study
Topical Treatment With Fresh Human Milk Versus Emollient on Atopic Eczema Spots in Young Children

The aim of this small pilot study is to assess the potential effects and risks of applying fresh human milk locally on eczema spots in children with atopic eczema. This is a split body, controlled, randomized and physician blinded pilot study, of children with atopic eczema with two similar contralateral eczema spots having a mother breastfeeding the child or a sibling. Fresh expressed milk and emollient is to be applied on the intervention spot and emollient alone on the control area, three times a day for four weeks. Severity and area of the eczema spots is evaluated weekly, and samples from milk and the spots were analysed weekly with respect to bacterial colonisation.


Eligibility Criteria:
Inclusion Criteria:

* Children with atopic eczema according to Hanifin and Rajkas criteria with a mother breastfeeding the child or a sibling.
* The eczema spots in the treatment and control areas were to be similar in features and extent as well as being localized on contralateral parts of the body.

Exclusion Criteria:

* Children were excluded if the severity of the eczema spots indicated need for treatment with antibiotics and/or steroids.
MTD, Safety and Efficacy of NYH817G and NYH100P in Monotherapy and Combination in Patients With Advanced Solid Tumors

The objectives of this study are:

Part 1:

* To assess the MTD, safety and efficacy of each NYH817G and NYH100P in monotherapy in patients with advanced solid tumors who have failed approved standard therapies.
* To assess the PK properties and the preliminary effectiveness of monotherapy of NYH817G and NYH100P.

Part 2:

* To assess the MTD, RP2D, safety and efficacy of NYH817G and NYH100P in combination therapy in patients with advanced solid tumors who have failed approved standard therapies
* To assess the PK properties, the preliminary effectiveness and the changes in metabolism of combination therapy of NYH817G and NYH100P.


Eligibility Criteria:
Inclusion Criteria:

* 19+ years old
* Diagnosed with advanced solid tumor histologically/cytologically
* Patient without standard therapies or who have failed approved standard therapies
* Those with a disease that is measurable and/or evaluable with the appropriate imaging examination according to RECIST v1.1
* ECOG performance status 0 to 2
* Patients with the suitable marrow, kidney, liver functions, blood coagulation and glycemic control functions
* Patients whose Life expectancy is over 12 weeks
* Patients who signed the agreement to voluntarily participate in this study

Exclusion Criteria:

* Patients who have received a major surgery, radiotherapy, chemotherapy, biologic therapy, targeted therapy, cancer immunotherapy or metabolic therapy within specified weeks counting from the initial administration of the IPs
* Diagnosed with a malignant tumor other than the relevant disease in the last 5 years from the initial administration of the IPs
* Toxicity level has not been recovered to CTCAE Grade 1 or lower
* Has uncontrolled metastasis to the CNS
* Suspected of having a serious infectious disease, paralysis of intestine, bowel obstruction, interstitial pneumonia or pulmonary fibrosis
* Had serious GI bleed or a disease that may affect the absorption of the oral drug in the past 4 weeks
* Considered as having a serious heart disease by the investigator or a serious internal disease
* Has administered a drug from another study within 4 weeks
* Has administered live vaccines within 4 weeks
* Has abused substance or alcohol within 12 weeks
* Has a serious trauma
* Has a history or currently has a type 1 or 2 diabetes
* Has a history of lactic acidosis
* Has glucose-6-phosphate dehydrogenase deficiency
* Has HIV or active or an active hepatitis B or C
* Has a history of psychological condition that could threaten observation of this protocol
* Has a history of hypersensitive reaction to the main ingredient or component of the IP or biguanide class drugs
* Being pregnant or a lactating woman, or (+) pregnancy test
* A female subject of a childbearing age who plans to get pregnant or disagrees to use recommended contraceptions
* Has not agreed to abstain from alcohol
* Considered as unsuitable for the study for other reason by the investigator
Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis

This is an interventional double-blind randomized controlled trial, to investigate the short and long-term effects of a supervised exercise training program in patients with IPF, depending on alternate patterns of oxygen supplementation during PR.

The investigators hypothesize that PR service with supplemented oxygen supply regardless of hypoxemia may have significantly better short-term effects in patients with IPF. The study will take place in Corfu General Hospital, by the Departments of Pulmonary Medicine and Physiotherapy and Rehabilitation, respectively. Study participants will be divided in two equal arms 1:1 in a double-blind manner. One of the investigators blinded to their clinical data will assign each participant to PR service either i) with constant supplementary oxygen supply FiO2 50% regardless of saturation status Group A) or ii) without oxygen supply unless upon resting or exercise induced hypoxemia (saturation \<88%) (Group B).

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of IPF based on current established criteria
* no exacerbation previous 3 months
* no participation in such program previous 3 months.
* If on treatment with pirfenidone or nintedanib, this will be recorded and patient should be on treatment for at least 3-6 months to achieve stable state.

Exclusion Criteria:

- concomitant diagnosis of congestive heart failure and lung cancer.
Pharmacokinetics Ertapenem Burns

This study will examine the pharmacokinetics of ertapenem in ventilated badly (\> 30% SCT) burn patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 70 years
* Burned on 30 to 60% of their body surface
* Mechanical ventilation
* Hospitalized in the intensive care unit of Nantes University Hospital for less than 8 days.
* Which the family gave consent
* insured

Exclusion Criteria:

* Patients whose family refused to sign the consent for participation.
* Patients allergic to beta lactam
* Patients with renal failure with creatinine clearance \<80 ml.mn-1
* Pregnant women
* Persons protected by the law
Feasibility - Infinitome

The Infinitome Program from Omniscient has the ability to identify abnormal brain networks or connectomes using resting state functional MRI (rs-fMRI). This technology, which visualizes brain networks in three dimensions, was originally developed to ensure neurosurgeons avoid inadvertently lesioning cognitively eloquent brain regions during surgical operations. The potential of Infinitome in identifying connectome dysfunction for neurodegenerative diseases such as Alzheimer's disease has yet to be explored. This diagnostic technique may play a critical role for identifying disease brain networks that may benefit from targeted interventions in clinical trials.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a diagnosis of mild, moderate, or severe Alzheimer's disease
2. Age: 40 - 90 Years
3. Patients who are clinically indicated for an MRI

Exclusion Criteria:

1. fMRI contraindicated (eg. Implantable device, pacemaker, metallic implants, etc.)
2. Subject unable to tolerate sitting for a one hour fMRI
3. Other concerns as determined by the investigator
Rest-exercise Transition Training to Improve Cardiac Vagal Tone

Purpose: to investigate the hypothetical additive value of a sudden rest-exercise training over the cardiac vagal of cardiac patients in a supervised exercise program.

Allocating in the admission for a supervised exercise program all subjects evaluated with low cardiac vagal tone (cardiac vagal index ≤ 1,30), it is expected that from a sample of almost 150 subjects (all over 18 years-old, ranging mostly from 40 to 50), we will compare 50 subjects that adhered to the supervised exercise program ( more than 65% of expected presence). Patients with pacemaker on unable to exercise in the bicycle will be excluded from the study, as well as those who does not adhere to at least more than 65% of the expected presence in the supervised exercise program.

All the sample will be randomized to performed 8 weeks of a specific sudden rest-exercise training and after 8 weeks will discontinue the protocol, or will do the opposite ( 8 weeks of no specific protocol, followed by 8 weeks of specific sudden rest-exercise training). The cardiac vagal will be evaluated at every 8 weeks to measure the cardiac vagal index between both phases. During all the time, all clients will perform aerobic, strength and flexibility exercises as part of the supervised exercise program.

Eligibility Criteria:
Inclusion Criteria:

* cardiac vagal index ≤ 1,30

Exclusion Criteria:

* pacemaker
* low adherence
* cognitive/physical impairment
Bitter Taste Receptors in Oropharynx Cancer

The aim of this work is to investigate the expression of the bitter taste receptors in p16-positive and negative oropharyngeal carcinomas (in comparison to healthy, local tissue).

Goal setting The aim of this work is to investigate the expression of the bitter taste receptors in p16-positive and negative oropharyngeal carcinomas (in comparison to healthy, local tissue).

The hypothesis is that oropharyngeal carcinomas express TAS2Rs and that their stimulation can induce apoptosis. The lower expression of certain TAS2Rs in the tumor cells could represent protection from apoptosis by stimulation with the bitter ligands. Alternatively, it could polymorphisms of the bitter taste receptors, which can influence their function independently of the expression. In order to address the question of general bitter sensitivity in more detail, the investigators are planning to carry out a bitter taste test on the test subjects.

methodology As this is a pilot study, the investigators limit the number of subjects to 10 patients with p-16 positive and negative oropharyngeal squamous cell carcinoma and 10 patients with acute recurrent tonsillitis or other benign pathology in pharynx. The expression analysis is carried out using qPCR and possibly immunohistochemical methods. Taste strips are used for the taste tests.

Cognitive interest The results of this study will provide important insight into the pathophysiology of oropharyngeal cancers and possibly all TAS2R-expressing cancers. In addition, this and further studies can create a theoretical basis for new therapeutic methods for this group of diseases.

Eligibility Criteria:
Inclusion Criteria:

* Oropharynx SCC for the patient group
* signed informed consent for all

Exclusion Criteria:

-
Metal Versus Plastic Stent in Malignant Hilar Biliary Obstruction

The purpose of this study was to compare the difference in the stent patency duration between side-by-side fully covered self-expanding metal stents (SEMS) and side-by-side plastic stents in patients with malignant hilar biliary obstruction.

In the case of distal common bile duct obstruction, the SEMS was reported to be clinically superior to the plastic stent in previous studies. However, there are few studies comparing the two methods in patients with malignant hilar biliary obstruction. In contrast to the distal common bile duct obstruction, the advantage of plastic stents over SEMSs exists, and plastic stents are used commonly in real clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Unresectable malignant hilar biliary stricture requiring biliary drainage through endoscopic procedure

Exclusion Criteria:

* If endoscopy is not possible based on the judgement of the researcher
* Life expectancy less than 6 months
* Acute cholecystitis
* Previous history of percutaneous transhepatic biliary drainage
* Previous history of metal stent placement for malignant biliary stricture
OBE001 Phase 2 Dose-finding Study Versus Placebo in Women Undergoing Embryo Transfer in the Context of IVF-ICSI

The primary objective of this study is to assess the increase in clinical pregnancy rate after administration of a range of single oral doses of OBE001, an oral oxytocin antagonist, compared to placebo.

The study is a prospective, dose-finding, randomised, parallel group, double-blind, placebo-controlled study investigating the efficacy and the safety of the oxytocin receptor antagonist OBE001 in 240 women undergoing embryo transfer following IVF or ICSI.

The four-arm study (OBE001 dose 1, dose 2, dose 3, and placebo) design will allow evaluation of a possible dose-dependent pattern of action of OBE001 and, simultaneously, comparison of active compound with placebo with regard to both efficacy and safety.

Eligibility Criteria:
Key Inclusion Criteria

1. Women with medically indicated IVF or ICSI using her own oocytes.
2. GnRH antagonist protocol, a single injection of hCG for triggering final follicular maturation and luteal phase support with vaginal micronized progesterone.
3. Evidence of uterine contractions by transvaginal ultrasound at baseline.

Key Exclusion Criteria

1. Blastocyst stage or frozen-thaw transfers
2. Clinically significant abnormalities in ECG, vital signs, physical examination or clinical laboratory results
3. Severe endometriosis and/or adenomyosis or risk of ovarian hyper stimulation syndrome