cyrilzakka/clinical-trials huggingface dataset:
Antimicrobial Agent for Reducing Bacteria in Aerosols and Oral Cavity

The primary objective of this study will be to evaluate the effect of two week pre-surgical rinsing with an antimicrobial mouthrinse containing 0.2% w/v Chlorhexidine digluconate on the total number of plaque bacteria in the mouth 3 days post implant surgery. The study will be conducted at Eastman Clinical Investigation Centre (ECIC), University College London (UCL) Eastman Dental Institute. Participants will be those who require a single and simple surgical implant to be placed, and will be recruited from new patient referrals within the Eastman Dental Hospital


Eligibility Criteria:
Inclusion Criteria:

* Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
* Aged between 18-64 years old.
* Understands and is willing, able and likely to comply with all study procedures and restrictions
* Good general and mental health with, in the opinion of the investigator or medically qualified designee:

  1. No clinically significant and relevant abnormalities in medical history or upon oral examination.
  2. Absence of any condition that could affect the participant's safety or well being or their ability to understand and follow study procedures and requirements.
* Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception
* Dental Health

  1. Good overall oral health in the opinion of investigator.
  2. A minimum of 20 permanent teeth.
  3. Requiring a single and simple implant (single tooth replacement with no bone augmentation required for implant placement).
* Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception.

Exclusion Criteria:

* Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
* Women who are breast-feeding
* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
* Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
* Previous participation in this study
* Recent history (within the last 1 year) of alcohol or other substance abuse
* Use of antibiotics within 14 days prior to the Baseline visit or Implant surgery visit.
* An employee of the sponsor or the study site or members of their immediate family
Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation

To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery has no significant effect on electrophysiological parameters of DBS micro-electrode recordings

Deep brain stimulator (DBS) implants are used in the treatment of medically refractory movement disorders such as Parkinson's disease, essential tremor and dystonia. Because of the uniqueness of each individual brain, the surgery to implant a DBS electrode requires detailed anatomic and physiological information for each patient. The anatomic data is obtained before surgery via a Magnetic Resonance Imaging (MRI) scan of the patient's brain. Physiological data is obtained during the operation via micro-electrode recording of the patient's brain and neurological examination of the patient. Therefore, DBS surgery can be uncomfortable to patients, as it can be very time consuming and requires the patient to be awake and attentive.

The specific aims of this project are:

1. To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery has no significant effect on electrophysiological parameters of DBS micro-electrode recordings.
2. To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery have no significant effects on neurological findings and/or patient cooperation during neurological examination.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who has agreed to undergo DBS implantation.

Exclusion Criteria:

* Patients who fail recommendation for DBS surgery discussed in Vanderbilt University Movement Disorder Clinical Conference.
* Patients not consented for DBS surgery.
* Patients or legal guardians not able to provide informed consent.
"Pharmacoepidemiological Evaluation of Autophagy Inhibition in Treatment of HCV Patients Resistant to Standard Therapy. Pilot Study"

The purpose of this study is to assess the efficacy of Chloroquine comparing with placebo for treatment of non- response HCV patients.. In this triple blind pilot study, 20 patients with confirmed chronic hepatitis C will be randomize into treatment group (Chloroquine 150 mg daily, for 8 weeks) or control group (placebo once daily, for 8 weeks). Patients who have receiving anti neoplastic, anti viral or Immunomedullator drugs during 6 months prior to study, have co-infection Hepatitis A,C,D or HIV, severe liver or renal dysfunction, are pregnant or breast fed, or refuse to sign informed consent will be excluded.. At the end of therapy (12 weeks) and at baseline, first, second and third month after receiving drug and placebo HCV Virus load, CBC LFT and biochemical parameters will be evaluated and compared between groups.


Eligibility Criteria:
Inclusion Criteria:

* patients who failed to achieve a decline of 2 log HCV RNA IU/ml after 12 weeks of treatment
* who never achieved undetectable HCV RNA during treatment of a minimum duration of 24 weeks

Exclusion Criteria:

* Receiving anti neoplasm, anti viral or immunomedulator drugs during 6 months prior to study
* coinfection with Hepatitis A,C,D viruses or HIV
* Severe dysfunction of liver and kidney
* pregnancy
* breast feeding
* refusing to give informed consent
* active Alcohol user
* presence of decompensate cirrhosis
Efficacy and Safety of Synera in Osteoarthritis Pain

Knee osteoarthritis (OA) can result in significant pain and limitation of function. A number of topical non-steroidal anti-inflammatory drugs have been shown to reduce pain in this condition. This study examines a different topical approach, utilizing a topical anesthetic agent, to evaluate if application of such an agent would provide relief of exercise-induced knee pain in people with knee OA.

Subjects participated in two visits each at least 1 week apart, where they underwent two exercise interventions - a baseline exercise without treatment and a experimental exercise with intervention (Synera patch or Inactive patch). Participants rated their pain on a NRS-11 1 minute, 5 minutes, and 60 minutes after both exercises, as well as 6 hours after the experimental exercise, before bedtime, and the following morning. Subjects were randomized to receive either Synera at the first visit and the inactive patch at the second visit or the inactive patch at the first visit and Synera patch at the second visit.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women, age 40 years and above
2. Meet American College of Rheumatology criteria for knee OA
3. Knee pain most days of the week for the past month
4. Knee pain \> 5/10 after exercise intervention
5. Capable of undertaking exercise intervention
6. Stable cardiovascular function
7. Able to return for all clinic visits
8. Able to read and understand the informed consent document

Exclusion Criteria:

1. Use of a walker to ambulate or inability to ambulate
2. Other forms of arthritis
3. Other major causes of pain that could be expected to interfere with assessment of pain during this trial, e.g., recurrent migraine, back pain, fibromyalgia
4. History of myocardial infarction
5. Blood Pressure \> 140 systolic/100 diastolic
6. Scheduled for and likely to need joint replacement surgery in the next 3 months
7. Any medical condition that in the judgment of the investigator would make the participant not suitable for the study
8. Sensitivity to lidocaine, topical or injectable analgesics/anesthetics.
Evaluation of Clareon Vivity/Vivity Toric

This study seeks to generate clinical data from subjects previously implanted with the Clareon Vivity/Vivity Toric Intraocular Lenses (IOLs) or Clareon Monofocal/Clareon Toric IOLs. This study will assess key performance endpoints to support clinical benefits statements with model-specific data.

Both eyes of a subject must qualify for enrollment into this study. A total of 2 scheduled visits are planned. The visits include a Screening visit (Visit 0) and a visit after screening (Visit 1). The subject must be 90-180 days post second eye implant at the time of Visit 1. Visit 1 should occur 1 to 14 days after Visit 0. Subject participation is expected to last approximately 2 weeks.

Eligibility Criteria:
Key Inclusion Criteria:

* Understand and sign an approved Informed Consent form
* Previously implanted in both eyes with Clareon Vivity/Clareon Vivity Toric or Clareon Monofocal/Clareon Toric IOLs for at least 3 months and up to 6 months (90 to 180 days) after second eye implant.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* History of clinically significant ocular co-morbidities that would affect surgical outcomes based on investigator expert medical opinion.
* Subjects who were targeted to monovision defined as ≥ 1.50 Diopter (D) of anisometropia.
* Clinically significant PCO (posterior capsule opacification) affecting vision.
* Other protocol-defined exclusion criteria may apply.
Inhibitory Control and Pediatric Weight Management

The purpose of this pilot study is to explore the benefits of supplementing the Kurbo online program with a cognitive training game (PolyRules!) among youth ages 7-13 with overweight or obesity.


Eligibility Criteria:
Inclusion Criteria:

* Between 7-13 years old at time of enrollment
* Are able to read, write and speak English
* BMI%ile ≥ 85%ile

Exclusion Criteria:

* Concurrently enrolled in another weight loss intervention, are currently taking anti-obesity medications, or are undergoing bariatric surgery
* Have type 1 or type 2 diabetes
* Have severe cognitive delays
* Have visual/hearing impairments
Effectiveness of Auricular Acupuncture in Reducing Dental Anxiety and Pain Perception During Orthodontic Extractions Among Adolescents

This prospective, randomised, double-blinded cross-over study aims to compare the effectiveness of auricular acupuncture (AA) with placebo sham acupuncture (PSA) in reducing dental anxiety, pain perception and physiological responses to stress and anxiety among adolescents during orthodontic extractions.

Adolescents aged between 10-19 years old who are undergoing orthodontic treatments requiring bilateral premolar extractions will be invited to complete a validated questionnaire to record their dental anxiety level, oral health knowledge, attitudes, practices, demographic and socio-economic factors. During orthodontic extractions, physiological responses including heart rate and oxygen saturation will be measured with a fingertip pulse oximeter throughout the process.

The participants will be allocated randomly to one of the two groups in the study.

Group 1-- auricular acupuncture in their first orthodontic extraction visit and placebo sham acupuncture in their second orthodontic extraction visit.

Group 2-placebo sham acupuncture in their first orthodontic extraction visit and auricular acupuncture their second orthodontic extraction visit.

Both acupuncture interventions will be carried out by a Hong Kong registered Chinese medical practitioner. The acupuncture needles are kept in place for 20 minutes to exert its effect before the dental extraction. Placebo sham acupuncture will not cause any harm, but the acupuncture points have no reported effect on stress relief.

The extraction of premolars will be performed by a Hong Kong registered dentist. Local anesthesia is injected to numb the respective site, then the premolar will be removed with forceps, followed by stopping the bleeding by biting firmly on gauze.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing orthodontic treatment and require bilateral extraction of premolars.
* Have parental consent signed by their parent or guardian.
* Medically fit with either ASA I or II status
* Have not taken any medications, especially anxiolytics and antidepressants
* The premolars to be extracted should be fully erupted and without any signs of ankylosis.
Acceptance and Commitment Therapy and Exercise for Older Adults With Chronic Pain

The objective is to investigate on the effectiveness of Acceptance and Commitment Therapy and Exercise in:

(Primary outcomes)

1. Increasing psychological flexibility
2. Reducing pain interference
3. Increasing quality of life
4. Increasing physical functioning

   (Secondary outcomes)
5. Reducing psychological distress - depression \& anxiety

Chronic pain is classified as persistent or recurrent pain for more than 3 months associated with physical disability, depression and poor psychosocial functioning among older adults; causing a dependence on medication and decreasing their quality of life. There are various treatment options from chronic pain, but the benefits on pain outcomes are minimal and rather short term. Psychological interventions, such as acceptance and commitment therapy (ACT), have shown positive effect on older adults with chronic pain. Using the three core elements of psychological flexibility, older adults are encouraged to establish a different relationship with pain: 1) be present; 2) do what matters; and 3) open up. Growing studies are exploring the application of biopsychosocial model in pain management, using multidisciplinary interventions. This RCT aims to explore the effectiveness of combining ACT and exercise with two arms: 1) art and exercise; and 2) treatment as usual.

Eligibility Criteria:
Inclusion Criteria:

* age 60 years or above; and
* have depressive symptoms of mild level or above (PHQ \> 5)
* have chronic pain (\>3 months)
* able to give informed consent to participate

Exclusion Criteria:

* known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia
* (temporary exclusion criteria) imminent suicidal risk difficulty in communication
* have had stroke, fracture, cardiovascular disease, cardiovascular surgery, artery disease, surgery on vertebrae, and knee replacement in the past 6 months
* physical activity prohibited by a medical professional
Village-Integrated Eye Worker Trial II - Pilot

The vast majority of blindness is avoidable. The World Health Organization (WHO) estimates that 80% of cases of visual impairment could be prevented or reversed with early diagnosis and treatment. The leading causes of visual impairment are cataract and refractive error, followed by glaucoma, age-related macular degeneration (AMD), and diabetic retinopathy (DR). Loss of vision from these conditions is not inevitable; however, identifying at-risk cases and linking cases with appropriate care remain significant challenges.

Worldwide, eye health care systems must determine optimal strategies for reaching people outside of their immediate orbit in order to reduce visual impairment. Visual impairment can be reduced by case detection of prevalent disease like cataract and refractive error, or by screening for early disease like glaucoma, AMD, and DR and preventing progression. Systems around the world have developed numerous approaches to both case detection and screening but there is very little research to support the choice of allocating resources to case detection or screening and little data exists on the cost effectiveness of the various approaches to each.

VIEW II Pilot is a cluster-randomized trial to determine the effectiveness of different approaches to community-based case detection and screening for ocular disease. Communities in Nepal will be randomized to one of four arms: 1) a comprehensive ocular screening program, 2) a cataract camp-based program, 3) a community health worker-based program, and 4) no program.

Specific Aim 1: to determine whether screening leads to increased visual acuity compared to the cataract camp approach.

Specific Aim 2: to determine whether a community health volunteer program increases the rate of cataract surgery compared to a no program.

Eligibility Criteria:
Inclusion Criteria(community-level):

* Wards in the Chitwan and Nawalparasi districts that participated in the VIEW trial and have not received a cataract camp in the past 6 months.

Inclusion Criteria (individual-level):

* Individuals aged 50 and older will be eligible to participate in the screening program, cataract camp programs, and the FCHV program
Text for Prenatal Health Study

Currently little is known about the health beliefs and behaviors of pregnant adolescents. The goal of this pilot study is to educate pregnant adolescents via social media about nutrition and fitness during pregnancy and to evaluate their health beliefs and behaviors before and after receiving this information. Data collected will provide new information on which to base subsequent research and can be used to inform nutritional guidelines or public health programming for this vulnerable age group.

The purpose of this pilot study is to find out if receiving electronic health information (e.g. text messages and Facebook posts) during pregnancy changes how pregnant teens think about their prenatal health and if fetal and maternal health outcomes can be improved. This study aims to:

1. Assess the impact of providing health information to pregnant adolescents (through Facebook and text messages) on fetal and maternal health outcomes across pregnancy.
2. Assess maternal nutrition knowledge using a brief questionnaire before and after the social media intervention.
3. Evaluate adolescent beliefs, attitudes and influences on dietary, physical activity, and life choices by asking teens to participate in interviews and focus groups.
4. Evaluate adolescent beliefs, attitudes and influences on dietary, physical activity and life choices through the perspective of healthcare providers by interviewing allied health workers at the adolescent pregnancy clinic.

Eligibility Criteria:
Inclusion Criteria:

* English speaking pregnant adolescents who have enrolled in the "Vitamin D Status Impacts Inflammation and Risk of Infections during Pregnancy" study (Clinical Trials ID: NCT01815047) and indicated interest on the consent form to participate in additional studies will be eligible to participate in this study. In order to participate, adolescents will have agreed to be contacted for future studies. Adolescents who are \< 18 y, carrying a single fetus and between 12-30 weeks of gestation will be eligible to participate in this study.
* Healthcare providers (\> 18) who work at the adolescent maternity clinic and interact with pregnant adolescents will be eligible to participate in this study. This would include nurses, midwives, nutritionists, physicians, and social workers of all ages and genders.

Exclusion Criteria:

* Exclusion criteria for this study include adolescent males and females who are not pregnant and do not speak English. Additionally, adolescents participants will be excluded if they have been diagnosed with eating disorders, malabsorption diseases, HIV infection, and diabetes (criteria outlined in parent study protocol; Clinical Trials ID: NCT01815047)
* Healthcare providers who do not speak English will not be eligible to participate in this study.
Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer

In this observational pilot study urine samples will be collected from women receiving neoadjuvant chemotherapy with doxorubicin for triple negative breast cancer to determine whether: 1) exposures bisphenol and phthalate levels change over the course of neoadjuvant chemotherapy, and 2) levels differ between black women and those of other racial groups.

The hypothesis is that bisphenol and phthalate levels will be similar to those of the general US female population at the time of diagnosis, however levels will increase during treatment due to exposure to plastics in the medical setting. The investigators also hypothesize that because of differences in personal care product use, black women may have higher urinary levels of bisphenols and phthalates prior to starting chemotherapy.

Triple-negative breast cancer (TNBC) is an aggressive breast cancer subtype that does not express estrogen, progesterone, or the human epidermal growth factor (HER2/neu) receptors, and has a low overall survival rate compared to other types of breast cancer.

Unlike hormone and HER2/neu positive breast cancers, targeted therapies are not available for TNBC. Thus, the systemic chemotherapeutic agent doxorubicin is widely used for the treatment of TNBC. However, doxorubicin resistance is common, and leads to poorer treatment outcomes.

Understanding factors that contribute to doxorubicin resistance is critical to improving cancer treatment outcomes among women with TNBC. Pre-clinical in vitro studies indicate that exposure to endocrine disrupting chemicals, such as bisphenols and phthalates, contribute to doxorubicin resistance, but these findings have not been evaluated in humans.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of stage I - III triple negative breast cancer
* scheduled to receive a neoadjuvant chemotherapy regimen including doxorubicin
* receiving treatment at the George Washington University Cancer Center

Exclusion Criteria:

* diagnosis of other types of breast cancer
* not scheduled to receive doxorubicin as part of the neoadjuvant chemotherapy regimen
* not planning to receive neoadjuvant chemotherapy at the George Washington University Cancer Center
Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations

The purpose of this study is to evaluate the long-term safety and clinical utility of IPX203 in the treatment of participants with advanced Parkinson's disease (PD) who have motor fluctuations.

This is a 9-month, multicenter open-label safety extension study. Participants who have successfully completed Study NCT03670953 \[A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 with Immediate-Release (IR) Carbidopa-Levodopa (CD-LD) in Parkinson's Disease Patients with Motor Fluctuations\] may have the opportunity to enroll in this open-label study.

Eligibility Criteria:
Inclusion Criteria:

* Successfully completed Study IPX203-B16-02
* Able to provide written informed consent prior to the conduct of any study-specific procedures.
* Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit (Visit 1).
* Agrees to use a medically acceptable method of contraception throughout the study and for 6 weeks after completing the study.

Exclusion Criteria:

* Intends to use any doses of Rytary® or Duopa™ during this study.
* Plans to use an investigational treatment other than IPX203 during the course of this study.
* Neurosurgical ablation treatment for PD is planned or anticipated during the study period. Implantation of a deep brain stimulator (DBS) for the treatment of PD is permitted during this study.
* Participants who, in the opinion of the clinical investigator, should not participate in the study.