cyrilzakka/clinical-trials huggingface dataset:
3M Oral Rinse Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes

The primary objective of this study is to evaluate the incidence of oral tissue sloughing through self-report by study subjects and by professional dental examinations.

The primary objective of this study is to evaluate the incidence of oral tissue sloughing through self-report by study subjects and by professional dental examinations. Adverse events will be tracked through study dental examinations and subject diaries with twice daily use of the 3M Oral Rinse used in combination with toothpaste containing one of three levels (no, medium, high) of Sodium Lauryl Sulfate (SLS).

Determine the subjects' acceptance of sloughing and/or other side effects

Eligibility Criteria:
Inclusion Criteria

1. Able to understand and willing to sign the informed consent;
2. Willing to agree to maintain confidentiality of the study and study materials;
3. 3M employee aged 18 years and older;
4. Willing to return to the study facility for scheduled study visits and recalls;
5. Agree not to use other oral hygiene products (non-study toothpaste, non-study toothbrush, mouth rinse, chewing gum);
6. Agree to the study instruction and schedule

   Exclusion Criteria:
7. A member of the Medical Clinical Affairs (MCA) staff or Panda product team for the device under investigation;
8. Have a dental appointment scheduled during study duration for professional cleaning;
9. Is pregnant, nursing, or planning to become pregnant within the study duration;
10. History of antibiotic therapy within the previous 30 days or have a condition that is likely to need antibiotic treatment over the course of the study (e.g., cardiac conditions requiring antibiotic prophylaxis such as heart murmurs, pacemakers, or prosthetic heart valves and prosthetic implants);
11. History of using a prescription antimicrobial mouth rinse during the past 3 months;
12. Currently taking medications which may alter gingival appearance/bleeding;
13. Currently using anticonvulsants, calcium channel blockers, or other medications with side effects known to impact oral health;
14. Participation in any other clinical study within the last 30 days;
15. Resides in the same household with a subject already enrolled in the study;
16. Known history of sensitivity to oral hygiene products;
17. Currently using tobacco products (cigarettes, chewing tobacco) or vaping products (ecigarettes);
18. History of diabetes;
19. Have removable partial/full dentures;
20. Have orthodontic appliances;
21. Have medical or oral conditions that may compromise the subject's safety or interfere with the conduct and outcome of the study;
22. Have known sloughing within the last 3 weeks;
23. Have dry mouth;
24. Have widespread caries or chronic neglect;
25. Have gross pathological changes of oral soft tissues;
26. Have advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive alveolar bone loss);
27. Unsuitable for enrollment in this study based on the professional opinion of the dental examiner based on the oral exam or other reasons not specified in the protocol
Buprenorphine Dose Alteration Study - 1

The purpose of this study is to examine the effects in buprenorphine dose alterations in opioid dependent individuals being maintained on buprenorphine.


Eligibility Criteria:
Please contact site for information.
Comparison of Duration of Treatment Interruption With or Without Curcumin During the Off Treatment Periods in Patients With Prostate Cancer Undergoing Intermittent Androgen Deprivation Therapy

This was a placebo-controlled, double-blind, randomized trial designed with the aim of establishing whether curcumin influenced the duration of treatment interruption and rate of prostatic specific antigen(PSA) progression, compared with placebo among men with prostate cancer receiving intermittent androgen deprivation therapy.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with prostate cancer in biopsy
* among patients with biochemical recurrence after treatment(radical prostatectomy, radiation therapy, focal therapy, etc.) for localized prostate cancer or metastatic prostate cancer at the time of diagnosis, who received intermittent androgen deprivation therapy(IAD)
* patients who off-treatment for the first time by receiving androgen deprivation therapy(ADT) for more than 6 months and PSA nadir remained stable for more than 3 months

Exclusion Criteria:

* previous history of IAD
* patient with other serious or ongoing medical or psychiatric disease other than prostate cancer
* hypersensitivity or suspicious of curcumin
* history of taking health supplements containing curcumin for prostate cancer treatment before 6 months of clinical trial participation
Comparison Between Colorectal Stents and Primary Surgery in Obstructive Colonic Cancer. A Randomized, Controlled Study

To evaluate wether colorectal stenting carry a significant clinical advantage

Randomized controlled comparison between stents and primary surgery in obstructive left colonic obstructive carcinoma outside palliative situations.

Eligibility Criteria:
Inclusion Criteria:

* obstructive stenosis due to left colorectal cancer

Exclusion Criteria:

* previous colorectal cancer
* other colorectal location
Hybrid Pump Technology

Prostheses can be suspended from the amputated limb using a variety of techniques, such as straps and suction. Suspending the prosthesis by creating a vacuum between the prosthetic socket and limb using a pump has benefits over other techniques including improved limb health and mobility. A new pump design will be tested by prosthesis users in the laboratory to verify its functionality during walking.

Human subject testing will involve a cross-sectional, repeated measures study consisting of a single 3 hour visit wherein participants will initially stand and then continuously walk at their self-selected speed for ten minutes on a level treadmill with the prototype under two randomly presented conditions of the mechanical system: 1) fully functional, and 2) locked to restrict axial displacement. After written informed consent is obtained, information on socket comfort and mobility capability will be collected. A load-cell will be installed proximal to the prototype and in-line with the prosthesis to measure instantaneous socket-reaction moments.

Eligibility Criteria:
Inclusion Criteria:

* Ability to stand quietly and walk for 10 minutes continuously without an assistive device (e.g. cane or walker) and without undue fatigue or health risks
* Pre-classified clinically to be at least a limited community ambulator of Medicare Functional Classification Level (K)2
* Residual limb in good health
* At least six months experience with a definitive prosthesis that utilizes vacuum assisted suspension

Exclusion Criteria:

* Pathologies aside from amputation or taking medicine that would influence walking or balance
* Poor prosthetic fit or poor residual limb sensation
Standardized Evaluation of Subcutaneous Glucose Monitoring Systems Under Routine Environmental Conditions

The purpose of this study is to assess accuracy and reliability of the SPIDIMAN continuous glucose monitoring (CGM) sensor system with regard to values as measured by Super GL and compare these results with similar evaluations of the Medtronic MiniMed 640G system, the Abbott FreeStyle Libre Flash Sensor and the DexCom G4 Platinum Sensor in patients with type 1 Diabetes.

The study is a single-center open-label study in patients with type 1 diabetes treated with continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI) therapy. The study will include a total of 12 subjects.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained after being advised of the nature of the study
* Male or female aged ≥18 years
* Type 1 diabetes for at least 6 months according to the World Health Organization (WHO) definition
* Treatment with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) for at least 3 months
* Body Mass Index (BMI) \< 35 kg/m²
* Willing and able to wear 5 CGM devices for the duration of the study and undergo all study procedures.
* HbA1c ≤ 86 mmol/mol

Exclusion Criteria:

* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
* Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
* Any mental condition rendering the subject incapable of giving his consent
* Subject is using a medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration
* Subject may not use acetaminophen (paracetamol) while participating in the study
* Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study.
* Subject is actively enrolled in another clinical trial
* Known adrenal gland problem, pancreatic tumour, or insulinoma
* Inability of the subject to comply with all study procedures
* Inability of the subject to understand the patient information.
* Subject donated blood in the last 3 months
Behavioral Treatment of Drug Abuse in Severe and Persistent Mental Illness (SPMI) Patients

The main purpose of this study is to determine if the multifaceted treatment for substance abuse in dual disordered patients is more effective in reducing drug use than a supportive control treatment. The researchers will also determine if adding a case management component (Critical Time Intervention; CTI) to the intervention will increase treatment engagement and retention.

Drug and alcohol abuse by people with severe and persistent mental illness (SPMI) is one of the most significant problems facing the public mental health system. We have been conducting a project to develop a multifaceted treatment for substance abuse in dual disordered patients (Behavioral Treatment for Substance Abuse in Schizophrenia; BTSAS). Results have shown that the treatment is well-accepted by patients and has a significant effect on drug use. While BTSAS has been effective at retaining subjects and fostering reduced drug use, a major problem that occurred was low rates of engagement. The main purpose of this study is to determine if BTSAS is more effective in reducing drug use than a supportive control treatment and to determine if adding a case management component (Critical Time Intervention; CTI) will increase treatment engagement and retention in BTSAS.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of schizophrenia or schizoaffective disorder or a diagnosis of other severe mental disorder including bipolar disorder, major depression, or severe anxiety disorder (by definition, the patient has worked 25% or less of the past year; and/or the patient receives payment for mental disability)
* a diagnosis of current dependence for opiates, cocaine, or marijuana
* ability and willingness to attend treatment sessions for 6 months
* ability and willingness to provide consent to participate
* enrolled in mental health care

Exclusion Criteria:

* documented history of severe neurological disorder or severe head trauma with loss of consciousness
* severe or profound mental retardation as indicated by chart review
* inability to effectively participate in the baseline assessments due to intoxication or psychiatric symptoms on two successive appointments
* had a substantial trial in either intervention of the Evaluation of Behavioral Treatment for Substance Abuse in Schizophrenia protocol (H-20680)
* inability to attend group sessions due to transportation or other logistical problems
* inability to attend scheduled treatment sessions on a regular basis for any reason, or to appropriately participate in research activities due to behavioral or psychiatric problems
A Pilot Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis

The purpose of this study is to evaluate the safety and efficacy using placenta derived decidual stromal cell therapy for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It is hypothesized that the decidual stromal cell therapy is safe to infuse and that they have a positive clinical effect.

Patients with grade 2-4 hemorrhagic cystitis will receive decidual stromal cell therapy at approximately 1-2x10\^6 cells/kg once or at weekly intervals dependent on clinical effect.

Eligibility Criteria:
Inclusion Criteria:

* Hemorrhagic cystitis grade 2-4

Exclusion Criteria:

* Urinary urge without macroscopic hematuria or clots
TYSABRI Global Observational Program in Safety

The Primary objective of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events (SAE) in participants with multiple sclerosis (MS) treated with Tysabri (natalizumab).

The TYSABRI Global Observational Program in Safety (TYGRIS) is a safety observational cohort program designed to obtain long-term safety data in multiple sclerosis (MS) participants treated with natalizumab in a clinical practice setting in the United States or Canada.

Eligibility Criteria:
Key Inclusion Criteria:

* MS patients in the US and Canada receiving TYSABRI under standard clinical care for less than or equal to 3 infusions are eligible to participate in TYGRIS.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Mass Balance Study of FYU-981

To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of FYU-981 after a single 1 mg oral dose of 14C-FYU-981 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Japanese healthy adult subjects
* Body mass index: \>=18.5 and \<25.0

Exclusion Criteria:

* Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study
* Have participated in a \[14C\]-study within the last 12 months prior to dosing of the investigational drug
* Exposure to radiation for therapeutic or diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton) within the last 12 months prior to dosing of the investigational drug
* Occupationally exposed worker
Clamp-crush Technique Versus Harmonic Scalpel in Living Donor Hepatectomy

The purpose of this study is to determine whether clamp-crush technique for liver parenchymal transection is as safe as Harmonic scalpel device. outcomes will include: perioperative mortality, surgery-related complications, blood loss, amount of blood loss during hepatectomy, operating time, transection speed, markers of liver parenchymal injury and hospital stay.


Eligibility Criteria:
Inclusion Criteria:

* Liver right lobe donors

Exclusion Criteria:

-
Observational Study for Left Main Disease Treatment

The purpose of this study is to observe clinical courses for long-term in patients with unprotected LMCA disease and to evaluate comparative results of medical treatment, coronary stenting with drug-eluting stents, and CABG for the treatment of an unprotected LMCA stenosis in the "real world" daily practice.

This study is a multicenter, large clinical registry to evaluate comparative outcomes of medical therapy, PCI with DES, or CABG for patients with unprotected LMCA stenosis in the Asia-Pacific, as recorded in the MAIN-IRIS Registry. Data will be prospectively collected on approximately 5000 subjects who diagnosed LM disease (\>50% by visual estimation) at approximately 65 centers in Korea and Asia-Pacific region. Brief study design is as depicted in the following figure

Eligibility Criteria:
Inclusion Criteria:

* Significant unprotected left main stenosis (\>50% by visual estimation)

  * The LMCA is considered unprotected if there are no patent coronary artery bypass grafts to the left anterior descending artery or the left circumflex artery.
* No limitation of clinical or lesion characteristics
* Age \>18 years
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

* Protected left main stenosis
Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease

The aim of this study is to determine the effectiveness of treatment with raloxifene, an estrogen-like medication approved by the Food and Drug Administration for the treatment of osteoporosis, in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease.

The aim of this study is to determine the effectiveness of treatment with raloxifene, an estrogen-like medication (classified as Selective Estrogen Receptor Modulators (SER's)) approved by the Food and Drug Administration for the treatment of osteoporosis, in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease. Patients who volunteer for this study will need to visit the clinic 7 times (participate) over a period of five months and will receive either raloxifene or a harmless, inactive pill called a placebo. Neither the volunteers nor the study staff will know which type of pill a patient receives. Patients must be generally healthy and have mild-to-moderate dementia. There must be a patient caregiver who can watch for side effects and ensure that the patient takes the study pills on schedule over a period of three months.

Patients will undergo neuropsychological tests and an evaluation of the ability to live independently at each visit as well as laboratory evaluations, such as the taking of blood. Each visit will last approximately 3 hours. A total of 20 patients is being recruited to participate in this study at the University of Wisconsin.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with Alzheimer's disease and without other dementias (diagnosed by study staff or from an outside clinic)
* Mini Mental Status Exam score greater than 15/30

Exclusion Criteria:

* History of deep vein thrombosis or blot clots
* Diabetes
* Active heart disease or stroke
* Liver problems including hepatitis
* Severe vision or hearing problems
* Tobacco use
DAILY: Vitamin D, Aspirin, ExercIse, Low Saturated Fat Foods StudY in Colorectal Cancer Patients With Minimal Residual Disease

To learn if lifestyle changes (such as diet and exercise) combined with daily aspirin and vitamin D can affect the likelihood of advanced colorectal cancer coming back (recurring)

Primary Objective:

To estimate the ctDNA clearance rate of colorectal cancer participants with minimal residual disease after 3 months of optimal lifestyle interventions

Secondary Objectives:

* To evaluate the dynamics of ctDNA allele fractions after 3 months of optimal lifestyle interventions and every 3 months thereafter up to 12 months
* To estimate the recurrence rate at 1 year in subjects who complete 3 months of optimal lifestyle interventions

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at the time of study entry
* ECOG 0-1
* Histologically documented high-risk stage II, stage III, or stage IV colorectal adenocarcinoma with no evidence of disease following definitive local therapy (including surgical resection or ablation)
* No radiographic evidence of disease by contrast enhanced CT chest/abdomen/pelvis
* Presence of detectable ctDNA mutation that matches mutations found in tumor tissue
* Completion of all standard of care adjuvant therapy
* Platelet count \>50,000
* Ability to give informed consent
* Ability to complete all questionnaires involved in study

Exclusion Criteria:

* Concurrent malignancy under active treatment
* Known active gastrointestinal bleeding or peptic ulcer disease
* Known hypersensitivity to vitamin D or aspirin
* CrCl\<30 mL/min within 30 days of starting the intervention
* Current usage of therapeutic anticoagulation (warfarin, Eliquis, Xarelto)
* Inability to safely participate in physical activity in the opinion of the treating oncologist
* Pregnant or nursing women. N.B.: urine pregnancy test will be administered as part of the screening process.
* Persistent hypercalcemia or conditions predisposing to hypercalcemia (i.e., hyperparathyroidism)
* Known symptomatic genitourinary stones
Vaccination Coverage and Uptake in Young People Experiencing or at Risk of Homelessness

This retrospective audit will investigate if young people who are homeless or at risk of homelessness in Melbourne were up-to-date with routine childhood and adolescent vaccines on first encounter with a nurse-led primary health clinic (the Young People's Health Service), and if they commenced and completed immunisation catch-up plans following referral to the Young People's Health Service immunisation nurse.

The purpose of the proposed study is to establish baseline immunisation coverage within the targeted population, then to explore the impact of an immunisation nurse role on immunisation coverage in a population of young people aged 15-24 years who are experiencing or at risk of homelessness.

The Young People's Health Service is a program of the Royal Children's Hospital Department of Adolescent Medicine. The data collected will be sourced solely from the Royal Children's Hospital Electronic Medical Records.


Eligibility Criteria:
Inclusion Criteria:

* Is between the ages of 15-24 years inclusive at enrolment
* Has a signed general consent/referral form to the Young People's Health Service immunisation nurse between 19th February 2019 - 19th July 2020 and scanned into their EMR. Verbal consent is accepted.
* Was referred from a clinic or outreach location attended by the Young People's Health Service (i.e. a service for people experiencing homelessness)

Exclusion Criteria:

* Does not have a signed consent/referral form to Young People's Health Service immunisation nurse