cyrilzakka/clinical-trials huggingface dataset:
Day Long Prevention of Oral Malodor With a Palatal Patch (SmellX) Containing A Herbal Formula

In a previous study the prevention of halitosis by the herbal formula and delivery system (SmellX), were established both in vitro and clinicaly. The duration of relief was established as long as 8 hours. In this study the investigators intend examine the day long efficacy of SmellX.

Oral malodor is a common complaint among dental patients. This condition derives in most cases form the putrefactive activities of oral microorganisms, primarily anaerobic Gram negative bacteria. These bacteria reside on various locations within the oral cavity (e.g. tongue dorsum, interdental space, periodontal pockets, faulty and leaky restorations and tonsils) and breakdown salivary and oral proteins into their amino acid building blocks. Some of these amino acids (e.g. methionine and cysteine) are further metabolized yielding malodorous volatile sulfide compounds (VSC) such as methylmercaptan and hydrogen sulfide.The tongue dorsum and especially its posterior portion are considered the key location for this process. Therefore, the treatment regiment includes in most cases a daily use of tongue scrapers and mouthwashes. Indeed, a recent Cochrane systematic review found tongue scrapers to have short-term efficacy in controlling halitosis.

However, the use of tongue scrapers is unpleasant and induces in many cases a strong gag reflex, and apparently has very little effect on bacterial load of the tongue.

Furthermore, some mouthwashes have been shown to cause adverse side effects such as tooth staining. In a previous study we performed a set of related experiments on a new sustained release delivery system in the form of an adhesive tablet containing an herbal formulation. The adhesive tablet is applied to the palate. This places it right above, and in direct contact with the tongue dorsum, thus allowing a sustained release of the active ingredients directly to the target site. The ingredients of the herbal formulation have been previously shown to reduce malodor production in a salivary incubation assay. We tested the effect of this system on oral malodor production and VSC levels in a young healthy population, and the antimicrobial effect of its active ingredients on three known oral pathogens (Streptoccocus mutans, Porphyromonas gingivalis and Candida albicans. In this study we intend to examine a day long protocol to achieve a relief from oral halitosis for 24 houres.

Eligibility Criteria:
Inclusion Criteria:

* random gender
* age
* healthy people

Exclusion Criteria:

* used antibiotics in the last three months
* suffer from systemic disease
A Preventive, Multidisciplinary Primary Care Intervention Organized Around a Therapeutic Garden: Acceptability to Patients Suffering from Cardio-neurovascular Pathology and to Those Involved in the Action.

A preventive, multidisciplinary primary care intervention organized around a therapeutic garden: Acceptability to patients suffering from cardio-neurovascular pathology and to those involved in the action.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old;
* living in the vicinity (+-20 km) of Gap, Laragne-Montéglin, Veynes and Clermont-Ferrand;
* having been invited to take part in the intervention by the caregivers of the medical structures
* suffering from an ALD based on CNAM medical criteria (stroke, AOMI, rhythm disorders, valvular heart disease, congenital heart disease, stage I and II heart failure), severe hypertension, chronic coronary disease)

Exclusion Criteria:

* heart failure based on CNAM medical criteria (ALD n°5) stage III and IV according to NYHA classification ;
* with a contraindication to physical activity ;
* living in an institution;
* unable to walk more than 100 m independently;
* Alzheimer's disease or other dementias based on CNAM medical criteria ;
* with an unlabelled cognitive impairment limiting comprehension.
Immediate Complications According to Ultrasound-guided Central Venous Catheters Insertion Site: a Non-inferiority Randomized Clinical Trial

Ultrasound (US)-guided central venous catheterization is now considered standard of care according to recent clinical evidence, at least considering jugular vein approach. Recent trials suggested that even US-guided subclavian approach could be more effective that landmark technique. However, studies comparing both sites employing US are still lacking.

We, therefore, designed a non-inferiority randomized controlled trial to compare these sites, both using US guidance, according to immediate complications following central venous catheterization.


Eligibility Criteria:
Inclusion Criteria:

* critically ill patients; central venous access indicated.

Exclusion Criteria:

* cardiac arrest; at least one side of each vein available for insertion; pacemaker insertion; pulmonary artery catheter insertion; non-corrected coagulopathy; thrombolytics in the past 24 hours.
Guideline - Based Nursing Plan for Dysphagia After Stroke

Research purposes:1, investigate the nursing management is the head nurse for swallowing disorder after stroke care management status; Compared with the existing research, the difference between guidelines and evidence-based nursing plan and the analysis of the influencing factors.2, the investigation nursing personnel for swallowing disorder after stroke nursing implementation status; Compare the difference between its and department management requirements and to analyze its influencing factors.3 patients with swallowing disorder after stroke or their caregivers for swallowing disorder after stroke care needs of semi-structured interviews.

Research purposes:1, investigate the nursing management is the head nurse for swallowing disorder after stroke care management status; Compared with the existing research, the difference between guidelines and evidence-based nursing plan and the analysis of the influencing factors.2, the investigation nursing personnel for swallowing disorder after stroke nursing implementation status; Compare the difference between its and department management requirements and to analyze its influencing factors.3 patients with swallowing disorder after stroke or their caregivers for swallowing disorder after stroke care needs of semi-structured interviews.Study design.This subject adopts the mixed methods research design, the three parts to complete. Research focuses on the 3 armour hospital for ten. The first part first USES the literature analysis method, systematic review of swallowing disorder after stroke related guidelines and research. According to the guidelines and involved in the study of swallowing disorder after stroke care issues related to design the head nurse questionnaire, then cross-sectional investigation understand swallowing disorder after stroke clinical nursing management present situation in our country. According to the regional distribution plans to choose 10 3 armour hospital survey, about 15 head nurse.The second part first USES the literature analysis method, systematic review of swallowing disorder after stroke related guidelines and research. According to the guidelines and involved in the study of brain 4 cross-sectional survey) 108%Understanding of the brain in our country。Hospital survey,About 250 nurses. The third part USES the qualitative research in the design of phenomenological research methods, through face-to-face semi-structured interviews, collect data, understand the needs of patients and their caregivers, guide the nursing measures of existing. Selection of founding of neurology ward patients as the research and interview object, about 20 cases need to sample.

Eligibility Criteria:
Inclusion criteria:

1. Cerebral apoplexy diagnosed by CT or MRI;
2. Drinking water from depression \> grade 3;
3. Be clear and able to communicate;
4. Volunteer for the study.

Exclusion criteria:

1. If you have serious basic diseases such as cardiovascular and cerebrovascular diseases, you cannot cooperate with the examination.
2. The patient refused to accept the investigator.
Chronic Hand Eczema - Self-management and Prognosis

Hand eczema is a common disease which often gives a chronic course thus affecting many functions in daily life. The body of evidence related to self-management of chronic hand eczema is poor. Better methods to support self-management of patients with chronic hand eczema may potentially improve the prognosis of a disease which is both a tremendous burden to the individual and to the society. The purpose of this trial is to evaluate the effect of a newly designed guidance programme offering individual counselling compared to conventional information with written information sheets.

Detailed description of the trial and the intervention can be found in the publication:

Mollerup A, Veien NK, Johansen JD. Chronic hand eczema--self-management and prognosis: a study protocol for a randomised clinical trial'. BMC Dermatol. 2012 Jun 12;12:6. doi: 10.1186/1471-5945-12-6.

PMID: 22691871 \[PubMed - indexed for MEDLINE\] Free PMC Article

Eligibility Criteria:
Inclusion Criteria:

* Patients clinically diagnosed with hand eczema at the first medical consultation at the outpatient ward, Copenhagen University Hospital Gentofte or at a private dermatologic practise in Aalborg, Denmark
* Patients who have given a signed informed consent to participate

Exclusion Criteria:

* Patients who cannot reply to a questionnaire in Danish
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)

The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis

A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults

Eligibility Criteria:
Inclusion Criteria:

* 18 to 90 years of age inclusive
* Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after
* Has pyuria with \>/= 10 WBCs (white blood cell) and has a positive urine culture within 48 hours of enrollment containing \>/=10 to the fifth CFU (colony forming unit ) /ml of a recognized uropathogen known to be susceptible to IV study therapy (CAZ-AVI and doripenem)
* Demonstrates either acute pyelonephritis or complicated lower UTI without pyelonephritis

Exclusion Criteria:

* Urine pathogen is a Gram-positive pathogen or a uropathogen resistant to CAZ-AVI or doripenem
* Patient's urine culture at study entry isolates more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI
* Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
* Patient is immunocompromised
* Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality
ARMOR (Analyzing Renal Mechanisms of Creatinine Excretion in Patients On tesaglitazaR)

This is a prospective 24-week, randomized, parallel-group, multi-center, active-controlled (pioglitazone 45 mg) open-label study designed to assess the effects of tesaglitazar 2 mg per day on components of renal excretion of creatinine in type 2 diabetics. The study comprises a 2-week enrollment period, followed by a 24-week double blind treatment period and an 8-week follow-up period


Eligibility Criteria:
Inclusion Criteria:

* Provision of a written informed consent
* Men or women who are \>=45 years of age
* Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
* Diagnosed with type 2 diabetes
* Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents

Exclusion Criteria:

* Type 1 diabetes
* New York Heart Association heart failure Class III or IV
* Treatment with chronic insulin
* History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
* History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
* Creatinine levels above twice the normal range
* Creatine kinase above 3 times the upper limit of normal
* Received any investigational product in other clinical studies within 12 weeks
* Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
Florbetapir Calibration to the Centiloid Scale

This study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.


Eligibility Criteria:
Inclusion Criteria:

* Cognitively Normal Subjects

  * Males or females ≥ 21 and ≤ 45 years of age
  * Mini-mental state examination (MMSE) ≥ 29
* Clinically Diagnosed AD Subject

  * Males or females ≥ 50 years of age
  * Meet clinical criteria for dementia due to probable AD
  * MMSE ≥ 16 and ≤ 26
* Possible AD Subject

  * Males or females ≥ 50 years of age
  * Meet clinical criteria for dementia due to possible AD
  * MMSE ≥ 16 and ≤ 26
* MCI Subject

  * Males or females ≥ 60 years of age with cognitive impairment (not dementia)
  * MMSE \>24 and \<29
* At Risk Elderly Subject

  * Cognitively normal males or females that are known ApoE4 carriers and ≥ 75 years of age
  * MMSE ≥ 27

Exclusion Criteria:

* Have had or currently have a diagnosis of neurodegenerative disorders other than AD
* Have a current serious or unstable illness that could interfere with completion of the study
* Subject has a known brain lesion, pathology or traumatic brain injury
* Have received or participated in a trial with investigational medications in the past 30 days
* Have had a radiopharmaceutical imaging or treatment procedure within 7 days of study imaging session
* Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
Influence of Chronic Hypoxia on Oxidative Phenotype in Patients With Chronic Obstructive Pulmonary Disease

In addition to chronic airflow obstruction, patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from skeletal muscle dysfunction which is a prominent and disabling feature and also an independent determinant of survival. Muscular impairment involves loss of muscle oxidative phenotype (OXPHEN: a slow-to-fast shift in fibre types and reduced oxidative capacity). Since hypoxia obviously is a key feature of COPD, the aim of this study is to elucidate the role of hypoxia in loss of muscle OXPHEN.

Thus, OXPHEN and expression levels of its key regulators will be determined in the baseline biopsies for association with the degree of hypoxemia. In addition, expression levels of the key OXPHEN regulators will be measured in pre/post exercise biopsies.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD confirmed according to GOLD score.
* Hypoxemia group: resting arterial paO2 \<55 mmHg.
* Normoxemia group : resting arterial paO2 \> 67 mmHg

Exclusion Criteria:

* Unstable cardiorespiratory status (acute respiratory failure)
* Oxygen treatment started
* Inclusion in a pulmonary rehabilitation program in the last 6 months
* Anticoagulant treatment
Health Management Training to Enhance Influenza Vaccine Immunogenicity

The goal of this study is to assess the immunogenicity of inactivated influenza vaccination (IIV) in healthy elderly volunteers aged 50 years and older receiving one of two different health management trainings.

We will obtain preliminary data on the time it takes to achieve a protective immune response, durability of response and occurrence of influenza in the following influenza season. Promising results in this age group will provide preliminary data for expanded future studies in the elderly.

Eligibility Criteria:
General Inclusion criteria are the following:

* age 50 years or older
* Infectious Disease tests - negative HIV test; hepatitis B surface antigen; anti-hepatitis C virus (HCV)
* Routine Laboratory tests
* able and willing to complete the informed consent process
* able and willing to participate for the planned duration of the study, including availability for follow-up telephone contact

General Exclusion criteria

* self report of any medical conditions for which the Center for Disease Control (CDC) states should not be vaccinated with IIV
* self-reported vaccination with the seasonal influenza vaccine for the current 2010-2011 influenza season (vaccination with the H1N1 influenza vaccine before, during, or after the study will not be exclusionary)
* history of hypersensitivity to any influenza vaccine components including thimerosal or egg
* history of Guillain-Barre syndrome
* self-reported treatment with immunomodulator/immunosuppressive drugs (interleukins (IL), corticosteroids (oral or inhaled)), G(M)- cerebrospinal fluid (CSF)) in 4 weeks before enrollment or self reported history of IL-2 administration within 5 years
* self-reported use of theophylline preparations or warfarin because of the theoretical possibilities of enhanced drug effects and toxicities following influenza vaccination
* any clinically significant abnormalities found during a routine physical examination
* self-reported history of any autoimmune disease
* acute febrile illness on the day of intended immunization - immunization deferred until illness resolved
* self report of current alcohol, substance abuse, or systemic/psychiatric illness that potentially could interfere with compliance and ability to make study visits (such as severe attention deficit hyperactivity disorder (ADHD) and current major depressive episode)
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis

This is a phase I trial investigating the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel combined with intravenous FOLFOX therapy for gastric cancer patients with peritoneal metastasis.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically diagnosed as gastric adenocarcinoma
* Imaging scans or diagnostic laparoscopic findings suggestive of peritoneal metastasis
* HER-2 negative tumor
* Laboratory tests adequate for chemotherapy (within 2 weeks of enrollment)
* Absolute Neutrophil Count: ≧ 1,500/mm³
* Hemoglobin level: ≧ 8.0g/dL
* Platelet Count: ≧ 10×104/mm³
* AST (GOT), ALT (GPT): ≦ 100U/L
* Total Bilirubin: ≦ 2.0mg/dL
* Creatinine Clearance (CCl): ≧ 50mL/min
* ECOG 0 - 2

Exclusion Criteria:

* Patients with other major medical disease or malignant tumors other than gastric cancer
* Contraindication to 5-FU, Oxaliplatin, Leukovorin or Paclitaxel
* Pregnant, breast-feeding women or with birth plan
* History of gastrointestinal surgery
* Patients refusing treatment
A Phase1 Study of VIB9600

Overall design: Single-center, randomized, blinded, placebo-controlled single- and multiple-ascending dose study in healthy adult subjects.

This first-time-in-human (FTIH) SAD and MAD studies in healthy adult subjects will be conducted at one site in the United States of America (USA) on IV and SC VIB9600.

Study acquired from Horizon in 2024. Originally Viela Bio was the sponsor.

Eligibility Criteria:
Key Inclusion Criteria:

1. Healthy male and female subjects aged 18 through 65 years at the time of consent.
2. Body mass index (BMI) of 19.0 through 35.0 kg/m2 at screening and minimum weight of 50 kg.
3. Females must have been surgically sterilized.
4. Nonsterilized male subjects who are sexually active with a female partner of childbearing potential must use a male condom with spermicide from Day 1 through to the final follow-up visit.
5. Able and willing to comply with the requirements of the protocol.

Key Exclusion Criteria:

1. Concurrent enrollment in another clinical study involving an investigational treatment.
2. Received administration of an investigational drug or participated in a device trial within 3 months prior to screening (Visit 1).
3. Subject is a participating investigator, sub-investigator, study coordinator, or employee of the participating site, or is a first-degree relative of the aforementioned.
4. History, or a reason to believe that a subject has a history, of drug or alcohol abuse within the 2 years prior to screening.
5. Positive test for drugs of abuse.
6. Donation of blood or blood products in excess of 500 mL within 3 months prior to screening. Not agreeing to refrain from blood or blood product donations during study participation.
7. Receiving any of the prohibited concomitant medications:

   1. Any immunotherapy or immunosuppressive therapy
   2. Chronic use of steroid medications
   3. Immunoglobulin or blood products
   4. Live vaccines
   5. Anticoagulants
   6. Aspirin