cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial to Assess the Safety and the Anti-caries Efficacy of COL 101 (Arginine) Non-fluoride Dentifrices in Comparison With 0.24% Sodium Fluoride (1100 Ppm F) Dentifrice Control in 10 to 14-year-old Children

The objective of this study is to assess the safety and to evaluate the anti-caries efficacy of COL101 (arginine) non-fluoride dentifrices compared to a 0.24% sodium fluoride dentifrice in 10-14 year-old children over a one year period.


Eligibility Criteria:
Inclusion Criteria:

* Subjects meeting all criteria below will be included in the study:

  1. Subject assent and parental/guardian informed consent for voluntary participation.
  2. Willingness and ability to use the assigned products according to instructions, availability for all appointments and likelihood of completing the clinical trial.
  3. Children ages 10-14 years at baseline.
  4. Presence of permanent second molars or evidence of at least one permanent second molar erupting as indicated by cuspal break through the mucosa.
  5. Good general health as evidenced by a review of the medical history.
  6. Subjects who, at study entry, have present two or more active caries lesions (ICDAS scores of 2 or greater) in permanent teeth and previous caries experience (DMFT \>1), D= Decayed is defined as ICDAS scores of 3 or greater

Exclusion Criteria:

* Subjects presenting any of the criteria below will be excluded from the study:

  1. Presence of fixed or removable prosthetic appliance or orthodontic treatment involving more than four permanent teeth.
  2. Use of medication that could increase the risk of developing dental caries, i.e.

     medications that reduce saliva flow and those with high sugar content.
  3. Long-term antibiotic therapy.
  4. Children with a confirmed diagnosis of cognitive and/or motor impairment.
  5. Severe malocclusion.
  6. Subjects who, at study entry, have present severe caries (ICDAS 5 or 6) on five or more permanent teeth.
  7. Evidence of moderate to severe periodontal disease.
  8. Participation in any other clinical study within the 30 days preceding the start of the clinical study.
  9. Known history of allergies or other adverse reactions to arginine, or oral care products, or their ingredients.
  10. Self-reported history of being currently pregnant, intending to become pregnant during the trial period or breast-feeding.
Safety and Efficacy Study of Avastin in Locally Advanced Metastatic or Recurrent Non-small Lung Cancer (NSLC) Participants

The purpose of this non-interventional study is the collection and documentation of data on safety and efficacy of intravenous (IV) bevacizumab (Avastin) in addition to platinum-based chemotherapy for first-line treatment in participants with unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology with focus on adenocarcinoma and elderly patients in daily routine.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to (\>=) 18 years
* Histologically confirmed predominantly non-squamous NSCLC that is unresectably advanced, metastatic or recurrent (with or without adenocarcinoma)
* No contraindications to Avastin® according to the current Summary of Product Characteristics (SmPC) for Avastin®
* Therapeutic decision for Avastin® as first line treatment in combination with platinum-based chemotherapy was taken individually and independent of the non-interventional trial.

Exclusion Criteria:

N/A
Using an Internet Study to Improve Adherence for Psoriasis Patients

To evaluate whether participation in an Internet-based intervention helps improve short-term and long-term psoriasis treatment outcomes, in particular, adherence.

An investigator-blinded, prospective study of subjects with mild to moderate psoriasis will be conducted. Forty subjects ages 18 years and older will be enrolled.The Internet-based survey will be piloted to evaluate its effect on adherence to topical psoriasis medication. Subjects randomized in a 1:1 ratio to the Internet-survey group will log their impression of the state of their psoriasis on a weekly basis. Subjects in both the intervention and control groups will receive standard-of-care topical fluocinonide 0.05% ointment to be applied to affected areas on the skin twice daily. Adherence to fluocinonide will be assessed using Medication Event Monitoring System (MEMS®) caps, electronic monitors affixed to the medication containers. Investigators and subjects will be blinded to the adherence data until the final (Month 12) treatment visit.

Eligibility Criteria:
Inclusion Criteria:

* Any male or female 18 years or older of age with a diagnosis of mild to moderate psoriasis by a dermatologist will be eligible for participation.
* Less than 20% of body surface involvement for psoriasis.
* Subject is capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed.
* The subject is able to complete the study and comply with study instructions, including attending all study visits.
* In general good health with no other skin disease, disease state or physical condition which would impair evaluation of psoriasis or which would increase health risk by study participation

Exclusion Criteria:

* Individuals younger than 18 years of age.
* Known allergy or sensitivity to topical fluocinonide.
* Inability to complete all study-related visits, or inability to complete the Internet survey due to inadequate Internet access.
* Introduction of any other prescription medication, topical or systemic, for psoriasis while participating in the study. Subjects who are on systemic anti-inflammatory treatments for psoriasis must be on a stable dose for at least 3 months prior to enrollment.
* Any skin condition or disease that may require concurrent therapy or may confound evaluations
* Current enrollment in any research study involving an investigational drug
The Effects of Physiologic Oxygen Tension on Clinical In Vitro Fertilization Outcomes

Primary Aim

* Evaluate whether human embryo exposure to physiologic levels of oxygen during culture improves the percentage of women who deliver a baby following in vitro fertilization and embryo transfer.

Hypothesis to be tested: Physiologic oxygen tension during embryo culture, which approximates the oxygen tension in the fallopian tube and uterus, improves live birth rate in clinical In Vitro Fertilization Embryo Transfer (IVF-ET).

Secondary Aims

Evaluate whether human embryo exposure to physiologic levels of oxygen during culture during in vitro fertilization and embryo transfer

* improves embryo cleavage
* improves clinical pregnancy rate
* reduces multiple pregnancy rate
* reduces miscarriage rate

Hypothesis to be tested: Physiologic oxygen tension during embryo culture, which approximates the oxygen tension in the fallopian tube and uterus, improves embryo cleavage and clinical pregnancy rates and reduces miscarriage rates in clinical IVF-ET.

Study Design

This will be a multi-center, prospective, double-blind clinical trial of physiologic (5%) oxygen tension in culture media vs. standard of care, atmospheric (SOC, 20%) oxygen tension with 840 eligible couples recruited to participate. The randomization scheme will be coordinated through the central data coordinating center (DCC-Yale) and the randomization will be stratified by age group of the woman (18-34, 35-37, 38-40 and 40-42) and each participating site.

Treatment

Couples will be randomized to either have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere or in the currently widely used atmospheric (20%) oxygen atmosphere.

Eligibility Criteria:
Inclusion Criteria:

The critical inclusion criteria will be the diagnosis of infertility and the need for in vitro fertilization as determined by the treating clinician. (We do not plan to alter the standard of care for the indication for IVF at any of the sites.)

* Couple's age must be between 18 and 42 years old
* Patient and partner are scheduled to undergo in vitro fertilization for treatment of infertility
* Couple able to participate in a research project and A) Able to understand study requirements B) Willing to sign informed consent C) Able to return for required follow-up D) Have access to telephone

Exclusion Criteria:

Critical exclusion criteria for this trial will be medical conditions which may complicate treatment or no plans to undergo embryo transfer, as in patients banking embryos prior to cancer therapy. In addition, donor egg and frozen embryo transfer cycles will be excluded.

* Medical contraindication to egg retrieval or pregnancy
* Inability to participate in a research project (Non-English speaking or unable to read or write and/or concurrent participation in any other interventional trial)
* Couple with more than three previous failed IVF cycles
* Donor egg and frozen embryo transfer cycles
VENEK: Healing in Different Vein Harvesting Methods During Aortocoronary Coronary Artery Bypass Graft Surgery (CABG)

The VENEK trial is a randomized, prospective trial to compare economic parameters, quality of life and wound healing after endoscopic vein harvesting versus open vein harvesting.

The VENEK trial is a randomized, prospective trial to compare economic parameters, quality of life and wound healing after endoscopic vein harvesting versus open vein harvesting.

Eligibility Criteria:
Inclusion Criteria:

* Age over 60 years
* Admission at Herzzentrum Dresden - Herzchirurgie for bypass-operation (OP) with planned veinectomy
* Eligibility for different modes of planned intervention according to study protocol
* Signed patient informed consent

Exclusion Criteria:

* Varicose crural veins
* Emergency patients
* Combined operational procedures
* Preoperative complete immobilization
Dexamethasone and Dexmedetomidine as an Adjuvant to Spinal Anesthesia for Elective Caesarean Sections

The main objective of our study is to evaluate analgesic effect of intrathecal dexamethasone and dexmedetomidine in elective caesarean sections


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists classII-III adult female patient (age :18 -40 years old )
* Elective cesarean section under spinal anaesthesia
* Gestational age \> 37 weeks
* BMI less than 30 kg/m2

Exclusion Criteria:

* Patient refusal
* unable to give consent
* age \< 18 or \> 40
* BMI more than 30 kg/m2
* known allergy to the study medication
* coagulopathies or on anticoagulant medications
* diabetic neuropathy
* patients with psychiatric disorders
Navigator Program for Homeless Adults

Individuals experiencing homelessness often have complex health and social needs. This population also faces disproportionate systemic barriers to accessing health care services and social supports, such as not having primary care providers, needing to meet other competing priorities, and difficulties affording medications. These barriers contribute to discontinuities in care, poor health outcomes, and high acute healthcare utilization after hospitalization among this population. This randomized controlled trial aims to evaluate the effect of a case management intervention (the Navigator program) for individuals experiencing homelessness who have been admitted to hospital for medical conditions. This study will examine outcomes over a 180-day period after hospital discharge, including follow-up with primary care providers, acute healthcare utilization, quality of care transitions, and overall health.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Have an unplanned admission for any medical cause to the General Internal Medicine service, any Medicine subspecialty service, the Cardiac Intensive Care Unit, and the Medical Surgical Intensive Care Unit
* Identified as being homeless at the time of admission or anytime during the index hospital admission. This includes patients who are: unsheltered (absolutely homeless and living on the streets or in places not intended for human habitation), emergency sheltered (staying in overnight shelters for people who are homeless, as well as shelters for those impacted by family violence), or provisionally accommodated (whose accommodation is temporary or lacks security of tenure).

Exclusion Criteria:

* Unable to provide informed consent to the study
* Previously received services from the Homeless Outreach Counsellor within 90 days of admission
Reducing the Effects of Malaria in Children by Administering Repeated Preventive Doses

The general goal of the project is to assess the infectious status and immunity of mothers and children living in a malaria region. A major part of the study involves administering an effective antimalarial, sulfadoxine-pyrimethamine (Fansidar®), to children at the same timepoints as vaccinations, i.e. at age 3, 9 and 15 months. The main objective is to study safety, efficacy, and consequences of such a strategy in particular the ability to reduce the risk of anemia.

More than 1.5 million deaths of African children under 5 years of age are due to Plasmodium falciparum malaria. There is an urgent need for available and affordable strategies to control malaria morbidity in childhood.

Malaria control measures have been assessed for their potential to reduce intensity of infection in order to decrease the risk of malaria. It has been shown that malaria prevention using drugs is potentially capable to reduce malaria morbidity, school absenteeism, and all-cause mortality. However, prevention using drugs in the first years of life can also result in the loss or delay of acquired resistance which can lead to a rebound phenomenon (i.e. an increased risk of severe malaria after the therapy ended). In a recent study on intermittent treatment with Fansidar® at 2, 3, and 9 months of age, the number of malaria cases during the first 12 months of life was significantly reduced and no rebound effect was observed. This study has demonstrated that the intermittent administration of Fansidar® is safe and has beneficial effects for the children. However, the effectiveness decreased some months after discontinuing the drug. The promising effect of the intermittent administration of fansidar shown in this study needs to be confirmed in areas of different endemicity such as Lambaréné, Gabon. It is assumed that a more extended intermittent application of Fansidar® than performed in the above example would likely result in a longer period of protection from malaria, and the extended intermittent administration of Fansidar should not lead to rebound effects resulting in a higher occurrence of malaria.

The framework of this study offers a unique opportunity to study characteristics of infectious disease of importance in the Lambaréné area and the development of resistance against microbes at the maternofetal (mother/foetus) interface. Comparable studies will simultaneously take place in two associated study sites (Kumasi and Tamale) with different malaria endemicity in Ghana, West Africa.

Comparison: Comparison of malaria attacks in children with and without intermittent Fansidar® treatment with drug administration at months 3 and 9 (alongside with routine vaccinations delivered through child vaccination programme) and an additional administration at month 15.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Permanent residence in the study area

Exclusion Criteria:

* Allergy/hypersensitivity to sulfonamides or pyrimethamine
* Signs of severe hepatic or renal dysfunction not due to malaria
Efficacy of Serious Game Interventions on HCV Education for HIV Patients

Hepatitis C transmission has a high rate of infection and re-infection among PLWH men who have sex with men (MSM), and co-infection increases liver and HIV morbidity.

The MSM group has a low level of awareness and perception of hepatitis C, and lacks health beliefs and prevention behaviors about hepatitis C. In the absence of hepatitis C cognition and health belief, it should be possible to use the health belief model to intervene and design teaching programs to improve the effectiveness of hepatitis C prevention and treatment. In the past, hepatitis C prevention education mostly focused on people who inject drugs (PWID), and was taught in traditional teaching methods. However, the common cause of hepatitis C infection among drug addicts is the sharing of needles and equipment. Education is mainly based on drug harm reduction and prevention education, while the MSM group is infected with hepatitis C mainly through risky sexual behaviors. The hepatitis C prevention education of drug addicts is adopted The content is clearly not applicable to the MSM population. Due to the stigma of PLWH's MSM in the society, individual cases will be subject to prejudice, discrimination and unfair treatment, and they are worried about being excluded from outsiders. Therefore, it is necessary to provide a learning environment with a sense of privacy, security and respect.

Serious Games is an educational game that provides a ubiquitous way of learning, using smartphones as a teaching tool, allowing learners to maintain a sense of privacy. Positive outcomes in cognitions, attitudes and behaviours related to health promotion and disease management. In terms of sexually transmitted diseases prevention measures, game content can be formulated for specific ethnic groups, and sensitive topics can be placed in the game. Without being exposed to real risks, players can simulate the consequences of various risks and corresponding prevention methods to prevent Motivate learners to solve problems and learn motivation, and give clear feedback, thereby increasing the knowledge of hepatitis C, health beliefs and the effectiveness of preventive self-efficacy.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected men who have sex with men aged 20-45
* Can communicate in appropriate language and understand the research content
* Able to use smartphone products

Exclusion Criteria:

* Unable to fully participate in this study
Effect of Acute Statin Treatment in Patients Undergoing Percutaneous Coronary Intervention

The goal of this study is to determine if one dose of simvastatin will decrease the inflammatory response to coronary intervention. Also to determine if one dose of simvastatin affects endothelial function (activity of the artery) as measured by noninvasive peripheral artery tonography.

The objective of this study is to determine if acute pretreatment with simvastatin, an HMG-CoA reductase inhibitor will reduce the post inflammatory response after percutaneous coronary interventions (PCI), and/or change endothelial function as assessed by peripheral arterial tomography (PAT). Percutaneous coronary intervention (PCI), commonly known as coronary angioplasty or simply angioplasty, is a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease.

Patients will be pretreated with simvastatin 80 mg prior to undergoing PCI. Endothelial function will be assessed before and after treatment via PAT. Our working hypothesis is patients pretreated with simvastatin, will have 1) attenuated inflammatory response, as noted by decreased levels of serum high sensitivity CRP and IL-6 and 2) improved endothelial function as compared to patients not pretreated with statin therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing PCI/angiography
* No previously known side effects of statins
* Patients who sign an informed consent
* Age \> 18 years old

Exclusion Criteria:

* Patients with ST elevation myocardial infarction
* Patients with cardiogenic shock
* Patients with hypersensitivity to statins
* Patients with unexplained muscle pain
* Patients with acute liver disease
* Patients receiving cyclosporine, antifungal azoles, macrolide antibiotics, niacin, fibrates\> 1 quart grapefruit juice/day or nefazodone
* Patients with creatinine \> 2.0
* Patients with known malignancy
* Ejection Fraction \< 25%
* No coronary care unit patients
* No outpatients
Vortioxetine Intravenous Infusion at Initiation of Oral Treatment With Vortioxetine in Patients With Depression

The purpose of this study is to evaluate the efficacy and safety of vortioxetine given as a single intravenous dose of 25 mg at initiation of an oral vortioxetine regimen of 10 mg/day for 7 days

The study consists of a 7-day double-blind Treatment Period (Day 0 to Day 6)

Eligibility Criteria:
Inclusion Criteria:

* The patient has recurrent MDD, diagnosed according to DSM-5® and confirmed using the Mini-International Neuropsychiatric Interview (MINI).
* The patient has a MADRS total score ≥ 30 at the Screening Visit.
* As part of standard of care treatment, the patient is to be admitted to hospital due to the severity of the depressive symptoms and is willing to remain hospitalized for the duration of the study treatment period.
* The patient has had the current MDE for ≥3 months but less than 12 months.
* The patient has received treatment for the current episode with an SSRI/SNRI monotherapy (citalopram, escitalopram, paroxetine, duloxetine, venlafaxine, sertraline) at an approved dose for at least 6 weeks.

Exclusion criteria:

-The patient has any current psychiatric disorder or Axis I disorder (DSM-5® criteria), established as the primary diagnosis, other than MDD, as assessed using the MINI or another diagnostic interview

Other in- and exclusion criteria may apply
Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

The primary objective of this study is to compare the nighttime symptom relief of fluticasone furoate nasal spray and oral fexofenadine


Eligibility Criteria:
Inclusion criteria:

* Informed consent.
* Outpatient.
* Females of child-bearing potential must use appropriate contraception.
* Diagnosis of seasonal allergic rhinitis to mountain cedar.
* Adequate exposure to allergen.
* Able to comply with study procedures.
* Literate.

Exclusion criteria:

* Significant concomitant medical condition.
* Use of corticosteroids, allergy medications, or other medication that affect allergic rhinitis
* Positive pregnancy test.
* Allergy to any component of the investigational product.
* Tobacco use
* Contact lens use
* Has chickenpox or measles or recent exposure
* Other clinical trial drug exposure in last 30 days
* Affiliation with clinic site
Faecal Microbiota Transplantation for Patients With Diabetes Mellitus Type 1 and Severe Gastrointestinal Neuropathy

A randomised, double-blinded and placebo-controlled intervention study. The study aim to evaluate the feasibility, safety and pilot-efficacy of faecal microbiota transplantation as a treatment of severe gastrointestinal neuropathy in patients with diabetes mellitus type 1.

Diabetes type 1 may cause damage to nerve cells in the gut causing neuropathy that leads to changes in gastric and intestinal motility. This change predisposes to an abnormal amounts and composition of bacteria in the gut, probably leading to uncontrollable diarrhea and severely impaired quality of life. Transferal of intestinal microbiota from a healthy donor to a patient is called faecal microbiota transplantation (FMT). FMT may potentially change the bacteria in the gut and reduce gastrointestinal symptoms. However, FMT may also have potential side effects, especially in persons with autonomic neuropathy and delayed transit through the gut.

Eligibility Criteria:
Inclusion Criteria:

Adult (≥ 18 years old), male or female patients with DM1 for at least 5 years and average of or above 40 points in the questionnaire: Gastrointestinal syndrome rating scale - irritable bowel syndrome version (GSRS-IBS).

Exclusion Criteria:

* Inability to understand Danish or the trial procedures
* Known or anticipated pregnancy
* Known severe renal insufficiency
* Antibiotic use in the prior 4 weeks
* Treatment with morphine
* Ongoing infection with Clostridioides difficile or pathogenic intestinal bacteria or parasites
* Known gastrointestinal disease or GI infection
* Patients diagnosed with intestinal stricture
* Patients with other known disorder that can cause gastroparesis
* Patients with planned MR scan within 4 weeks
* Patients with pacemaker/ICD
* Previous abdominal surgery
* Changes in medicine that affects the GI tract in the prior 4 weeks