cyrilzakka/clinical-trials huggingface dataset:
Prevention of Oral Malodor With an Oral Sticker Containing Herbal Formula

the use of a herbal formulation containing sage, echinacea,lavender and mastic gum would prevent oral malodor if delivered in an appropriate delivery system to enable slow release of the active ingredients.

Oral malodor (Halitosis, Fetor ex ora) is a common and disturbing condition, affecting according to some studies about one quarter of the population. This condition may start at any time from early childhood through adolescence, adulthood and old age and vary in character and severity.The bacteria responsible for malodor production are for the most part Gram negative oral bacteria (2- 4) such as Porphyromonas gingivalis, Fusobacterium nucleatum and Prevotella intermedia. These bacteria reside on various locations within the oral cavity (e.g. tongue dorsum, interdental space, periodontal pockets, tonsils) and breakdown salivary and oral proteins into their amino acid building blocks. Some of these amino acids (e.g. methionine, cysteine, tryptophan, lysine) are further metabolized yielding malodorous volatile products such as methylmercaptan, hydrogen sulfide, indole, skatole and cadaverine (5-7). These are foul smelling compounds, which are released during exhalation and speech.in our study we intend to use an aprooved mucosal sticker containing carbopol and hydroxypropylcellulose mixed with the herbal ingredients and placed on the palatal mucosa.than mesure the volatile sulfur compounds to observe if the composition has antimalodor effect and for how long. the herbal ingredients are used for many years for medicinal and nutritional purposes. if our hypothesis is right we might have another formulation and method of application to prevent oral malodor

Eligibility Criteria:
Inclusion Criteria:

* random gender, age and healthy people

Exclusion Criteria:

* used antibiotics in the last three months or suffer from systemic disease
Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention

This is a research study to test the application of FDA-approved, non-invasive device (NICaS) that measure the performance of your heart during HD treatment.

The incidence of intradialytic hypotension (IDH) events, reported to occur in 15% to 50% of hemodialysis (HD) treatments, is still high despite major technical advances in HD technology. By definition, excessive reduction in intravascular volume by ultrafiltration and limited vascular refilling from tissues into the vascular space is the cause of IDH. Chronic HD patients exhibit a high prevalence of peripheral vascular and cardiac abnormalities. Specifically, hemodynamic instability during HD can occur due to insufficient reduction in venous unstressed volume, poor diastolic filling under reduced atrial pressures associated with diastolic dysfunction, altered cardiac contractility, and impaired vascular reactivity. An IDH event can lead to myocardial cerebral and other organ ischemia. Long- and short-term adverse outcomes have been associated with IDH, a common HD complication and significant cause of morbidity.

Recent pilot studies suggest that in IDH-prone subjects, measurements of hemodynamic variables during HD can be used to categorize the hemodynamic response into three subgroups: cardiac power index (CPI) reduction with stable total peripheral resistance (TPR), TPR reduction with stable CPI, and reduction in TPR and CPI groups. It is hypothesized that targeted intervention for each subgroup can reduce IDH.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Have been on maintenance hemodialysis at the facility for at least six months
* Have not had un-excused missed treatments for six months
* Is symptomatic to HD treatments
* Males and non-pregnant/non-nursing females, as confirmed via urine pregnancy testing of women of child bearing potential

Exclusion Criteria:

* Patient refusal
* Currently on Midodrine at the start of the Phase 1, Observation period
* Any known contraindications to Midodrine
The Kanyakla Study: a Microclinic Social Network Intervention for Promoting Engagement and Retention in HIV Care

The purpose of this randomized controlled trial is to compare a social network-based behavioral intervention known as microclinics to standard HIV clinical care alone in helping patients receiving HIV care on Mfangano, Remba and Ringiti Islands, Kenya remain adherent to clinic appointments. The study is designed to evaluate the effectiveness of microclinics on reducing gaps in clinical care, HIV viral load and HIV-related stigma, compared to standard HIV clinical care alone. By doing this research study, the investigators hope to learn whether microclinics are a useful social strategy for improving delivery of HIV treatment in rural Kenya.


Eligibility Criteria:
Inclusion Criteria:

* Must be currently receiving combination antiretroviral therapy (cART) or co-trimoxozole prophylaxis from one of the eligible study clinics:

  * Is currently in care at study baseline, defined as having ≥1 medical care visit to receive medications (cART or prophylaxis) during the six months preceeding initiation of study enrollment, OR
  * Initiates pre-ART or ART care for the first time at a study clinic during the six month study recruitment period, OR
  * Transfers from a clinic outside the study area and receives pre-ART or ART care for the first time from a study clinic during the six month recruitment period
* Participants become eligible for study inclusion on the 4th day following a missed clinic appointment, provided the patient has not transferred care to another clinic prior to the 4th day, moved outside the study area or died. Participants who miss a study visit by \>3 days but return to clinic before recruitment takes place are still eligible for study enrollment. Missed visits must have occurred within the previous 90 days at the time of eligibility assessment to meet this inclusion criteria.
* Must currently reside on Mfangano, Remba or Ringiti Island.
* Must be conversant with one of the commonly spoken languages within the study area (i.e. DhoLuo, Swahili or English; prior experience indicates that this represents \>99% of the adult population).
* Must be ≥18 years of age as of the date of study eligibility.

Exclusion Criteria:

* Eligible participants who reside in the Mfangano East sub-location will be excluded from participation in this study. Many of these patients have already participated in the microclinic intervention as part of the Mfangano Island Healthy Network Impact Study.
* Participants planning on moving permanently out of the study area within the next six months will be excluded.
* Participants who, should they be randomized to the intervention arm, would be unwilling to participate in a microclinic will be excluded from study enrollment.
Mindful Movement in Women Receiving Adjuvant or Neoadjuvant Therapy for Breast Cancer

The investigators hypothesize that a personalized yoga program with mindful movement implemented during breast cancer therapy will benefit women in multiple ways. The investigators predict that women participating in the program will experience less weight gain and fatigue and will have an improved quality of life compared to women not participating in the program. The investigators predict that this will be associated with decreased markers of inflammation. The investigators will also evaluate whether there is improved pathologic response rate compared to historical controls. This study will provide pilot data for a larger randomized controlled trial assessing whether program can provide long-term improvement in quality of life, weight maintenance, and the serum and tumor changes correlating with a reduced risk of recurrence and mortality.


Eligibility Criteria:
Eligibility Critera:

* Age ≥ 18.
* Female.
* Newly diagnosed with Stage I-III breast cancer.
* Scheduled to undergo neoadjuvant or adjuvant chemotherapy or neoadjuvant endocrine therapy.
* Not currently regularly practicing yoga (defined as at least once a month).
* Able to read and understand English
* Able to understand and willing to sign an IRB-approved written informed consent document
Impact of Palmitoylethanolamide (PEA) in the Management of Oro-facial Pain

Pain is the most common symptom faced by dentists, whether acute (pulpitis, acute periodontitis, post-surgical, etc.) or chronic (chronic periodontitis, muscle pain, TMJ disorders, BMS, OLP, etc.). The success of therapy depends on the reduction and management of pain. Therefore, over the past few years, the need has emerged, also in relation to the aging population, to analyze new molecules with pain-relieving activity and with low risk of inducing side effects and interactions with other drugs; capable of bringing about the reduction of oro-facial pain; and that lend themselves to prolonged use. Palmitoylethanolamide (PEA) is a bioactive lipid mediator similar to endocannabinoids (eCBs) that has been observed to have anti-inflammatory, analgesic, anticonvulsant, antimicrobial, antipyretic, antiepileptic, immunomodulatory, and neuroprotective activities.

The objective is to clinically study, through a clinical trial, the pain-relieving and anti-inflammatory properties of a PEA-containing nutraceutical agent in the management of patients with orofacial pain, both neuropathic and nociceptive in nature.

A double-blind placebo-controlled study was conducted to evaluate the efficacy of Palmitoyletinolamide (PEA) and determine the statistical significance of its action.

40 patients with both acute and chronic orofacial pain were divided into two groups: study group given a nutraceutical agent containing PEA and a control group given a placebo. A three-month follow-up will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* good general health condition,
* presence of diffuse or localized oro-facial pain of nociceptive nature or postoperative pain,
* presence of diffuse or localized oro-facial pain of neuropathic nature for at least 1 month.

Exclusion Criteria:

* Allergies,
* debilitating systemic diseases,
* pregnancy status
* severe cognitive impairment
Clinical Investigation to Assess the Feasibility of a New Diabetes Management Program

The goal of this interventional study is to assess the adherence to a personalized care plan in patients (12-15 years) with Type 1 diabetes


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 12-15 years of age.
* T1D diagnosis minimum 8 months prior to the Screening/Initiation visit (Visit 0).
* Equipped with Continuous Glucose Monitoring (CGM) System, intermittent or real-time, either alone or associated with an insulin pump system
* Subject and health care provider must use a Remote diabetes management platform for the upload and follow-up of CGM, pump data or HCL data (e.g.: Glooko, Diasend).
* Parent or guardian able and willing to give informed consent for the subject's participation in the investigation.

Exclusion Criteria:

* Initiation of use of HCL System during the last 2 months or during the investigation.
* Use of Medtronic insulin pump.
* Any disease or other medical condition, prior or concomitant medication /treatment

  /intervention, that may affect this clinical investigation or in other ways make the subject unsuitable for participation in this investigation, according to the judgement of the Principal Investigator (PI), or authorized designee.
* Participation in any clinical investigation or study within the previous 30 days, that may affect the safety or performance of this investigation.
* Mental incapacity precluding understanding or cooperation.
* Subject not able to read and communicate in Swedish without an interpreter.
Physical Exercise in Patients With Schizophrenia

Randomised clinical trial on a cohort of subjects with a diagnosis of schizophrenia of legal age, of both sexes, recruited in the mental health clinics of the Salamanca University Assistance Complex and who will be randomly distributed into two groups (intervention and control).

The main objective of the study is to determine the effect of physical exercise on telomere size in patients diagnosed with schizophrenia.

As secondary objectives in this group of patients we will try to:

Evaluate the influence of strength training on cognition and negative symptoms of schizophrenia.

To quantify the impact of strength training on frailty. To determine the effect of strength training on quality of life. To study the possible correlation between physical parameters (frailty) and telomere length.

To establish the importance of polymorphisms in telomerase genes, an enzyme involved in the maintenance of telomere length.


Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age
* have been diagnosed with schizophrenia for at least 5 years

Exclusion Criteria:

* are unable to read and understand the patient information sheet and sign the informed consent form.
Metformin and Systemic Inflammation in HIV

The purposes of this study are to find out if: metformin can be combined with anti-HIV drugs to reduce systemic inflammation measured by the determination of cytokines and other series of serum markers. To determine if the concomitant administration of metformin with TARA improves the immune function on the CD4 T cell count and its relation with the CD8 T cells, during the treatment and after its interruption.

To this end, in the present study, patients with prediabetes (who meet the fasting impaired glucose criteria) will be identified and treated with metformin or placebo for 8 weeks, receiving stable TARA and with a CD4 + level\> 200 cells / μL.

40 patients from the HIV Unit of the Civil Hospital of Guadalajara "Fray Antonio Alcalde" will be included in this study and the intervention will last 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Both sexes,
* Age ≥18 years of age
* With a diagnosis of HIV-1 infection,
* That they are receiving TARE for at least 12 months (time necessary to establish a stable reservoir),
* Patients with undetectable viral load (\<40 copies / mL) for at least 12 months,
* Have a CD4 + level\> 200 cells / μL,
* That they do not have a diagnosis of co-infection with HCV or HBV,
* Patients who do not have a severe alcohol intake (\<21 glasses / week in men and \<14 glasses / week in women),
* Patients who do not use drugs during the last 90 days prior to the screening visit, or during the study,
* Who wish to participate voluntarily in the study and give their written consent.

Exclusion Criteria:

* Individuals with a known hypersensitivity / allergy to metformin.
* Patients with contraindications to the use of metformin \*.
* Individuals who are actively involved in an experimental therapy study or who have received experimental therapy in the last 6 months.
* People suffering from stage IV-V chronic kidney disease, uncontrolled heart failure or active infections.
* Individuals with diabetes mellitus (according to the criteria of the American Diabetes Association \*).
* Patients with indication for the use of statins, aspirin or immunomodulators.
Synchronization to Improve Non-Adherence to Cardiovascular Medications

The aim of this study is to evaluate if synchronizing when patients with diabetes and/or coronary artery disease fill their prescriptions improves long-term adherence to these medications.


Eligibility Criteria:
We will enroll patients 18 years of age and older who within 6 months of study enrollment have filled ≥ 2 medications intended for long-term use (i.e. maintenance medications) by mail order at CVS Caremark. At least 1 of these 2 medications of must be for the treatment of diabetes or cardiovascular disease. In addition, these medications must be delivered on two or more unique delivery dates, there must be at least one refill remaining for all eligible medications and either all or none of their prescriptions must be enrolled in the ReadyFill@Mail program (see Intervention Description for details).
A Study Comparing the Dulaglutide Pen and the Semaglutide Pen

In this study participants will try out two different types of drug injection pens (dulaglutide and semaglutide) on a practice pad and decide which device they prefer. No study drug will be administered.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes
* Self-injection naïve to all injectable treatment (for example, diabetes therapies and other medical conditions)
* Injection naïve to performing all injectable treatment (for example, diabetes therapies and other medical conditions) to others

Exclusion Criteria:

* Currently diagnosed with gestational diabetes and/or type 1 diabetes
* Cognitive or physical difficulties that could interfere with ability to understand the training, perform the injection tasks, or complete the study questionnaires as judged by the investigator
* Is a health care practitioner who is trained in giving injections
A Clincal Study of Max-40279-01 in Patients With Advanced Colorectal Cancer

This include two parts, part 1 is a dose optimizing study and part 2 is a randomized, controlled study.

This study is a study of Max-40279-01 in patients with advanced colorectal cancer. This study include two Parts, the Part 1 will assess the safety and efficacy of the preset two dose level of Max-40279-01, and recommend a dose level of Max-40279-01 for stage 2. The part 2 is a randomized, controlled study ,and designed to compare the efficacy and safety of max-40279-01 to regorafenib or best support care(BSC) in pretreated advanced colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Males and/or females over age 18
2. Histologically and/or cytologically documented local advanced or metastatic colorectal adenocarcinoma.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Expected survival \>3 months.
5. previously treated with standard, approved therapies, including two lines of chemotherapy (fluoropyrimidine,oxaliplatin and irinotecan based), a biological VEGF inhibitor, and, if RAS wild-type, an EGFR inhibitor. Patients with MSI-H/MMR-deficient tumors also must have received an immune checkpoint inhibitor, if available and approved. In addition, patients with BRAF mutant tumors must also have received a BRAF inhibitor, if available and approved.
6. Signed informed consent form.

Exclusion Criteria:

1. Known uncontrolled or symptomatic central nervous system metastatic disease.
2. Adverse events (with exception of alopecia, peripheral sensory neuropathy grade ≤ 2 and those listed in specific exclusion criteria) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.3.0) at the time of randomization.
3. Inadequate organ or bone marrow function.
4. Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
5. Pregnant or breast-feeding woman.
6. Known allergies, hypersensitivity, or intolerance to Max-40279-01 the excipients of these treatments The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
DenCT Shoulder Bone Quality Evaluation

The objective of the study is to evaluate the preoperative bone quality assessment based on CT to later establish a scale for the decision of stemless shoulder arthroplasty.

The primary endpoint is the collection of the preoperative CT scan with a calibration phantom at each site and the surgeon's intraoperative evaluation of bone quality. Therefore, this study is not centered around a specific device and any primary shoulder arthroplasty system from Zimmer Biomet including anatomical, hemi, or reverse, stemmed or stemless configurations can be used for the target population. The indications of this study are the shoulder joint diseases such as osteoarthritis and the irreparable rotator cuff tears which are needed with TSA/RSA. The subjects should be also met the inclusion/exclusion criteria. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be older than 18 years and skeletally mature.
* Patient must undergo the SHA, TSA, or RSA according to the Instructions for Use (IFU).
* Patient must be anatomically and structurally suited to receive shoulder arthroplasty implants.
* Patient is a candidate for lateral or bi-lateral shoulder arthroplasty due to one or more of the following:
* Non-inflammatory degenerative joint disease including osteoarthritis.
* Avascular necrosis of the humeral head.
* Autoimmune disease including rheumatoid arthritis.
* Irreparable rotator cuff tears.
* Correction of functional deformity.
* Patient must be able and willing to sign the IRB/EC approved informed consent.
* Patient must be able to undergo a preoperative CT scan
* Patient must be willing to share their CT images with sponsor

Exclusion Criteria:

* Patient is a candidate for shoulder arthroplasty due to one or more of the following:
* Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
* Revision TSA/RSA after the prior TSA/RSA.
* Patient has experienced the traumatic fractures to the implant site.
* Patient is unwilling or unable to give consent
* Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study, e.g., any neuromuscular disease compromising the affected limb.
* Patient is known to be pregnant or breastfeeding.
* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non- compliant).
* Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions.
* Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site.
* Patient has rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram.
A Prospective Registry to Assess the Effectiveness and Local Tolerability of Intravesical Valrubicin in Subjects With Non-muscle Invasive Bladder Cancer (NMIBC)

The purpose of this study is to observe and describe the effectiveness and local tolerability of intravesical treatment with valrubicin for non-muscle invasive bladder cancer (NMIBC) in a cohort of subjects treated under routine practice conditions.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 years of age and older
* Diagnosed with NMIBC
* Prescribed intravesical valrubicin to treat NMIBC
* Understood and signed Informed Consent to participate

Exclusion Criteria:

* None
Cardioprotective Effects of Endogenous Erythropoietin in Patients Undergoing Coronary Artery Bypass Surgery

Several studies have highlighted the cardioprotective effects of acute normovolemic hemodilution during cardiac surgery. The aim of our study is to show that an increase in endogenous erythropoietin (EPO) might explain the cardioprotective effects of acute normovolemic hemodilution against ischemia-reperfusion phenomena.

The major physiologic function of EPO is thought to be the induction of erythropoiesis. However, a growing body of evidence indicates that EPO has tissue-protective effects and prevents tissue damage during ischemia. In an ex vivo proof-of-concept, protective effects of EPO have been shown in human myocardium.

Several studies have demonstrated that acute normovolemic hemodilution before aortic cross clamping decreases perioperative myocardial damage. We hypothesized that the onset of acute anemia increases the endogenous EPO concentration, which explains the cardioprotective effects of acute normovolemic hemodilution.

Eligibility Criteria:
Inclusion Criteria:

* patients between 18 and 80 years old undergoing CABG with or without cardiopulmonary bypass

Exclusion Criteria:

* emergencies
* redo operations
* combined surgery
* men with Hb\< 120g/dL and women with Hb\< 110g/ dL
* patients with preoperative creatinine\> 2.2 mg/dL
* poor ventricular function (EF \< 50%)
* subjects with a pulmonary disease, hepatic disease
* subjects with carotid stenosis