cyrilzakka/clinical-trials huggingface dataset:
FL-REACH: Pilot Trial of a Brief Dementia Caregiver Intervention

The primary aim of this study is to test feasibility of a modified REACH II intervention in an outpatient clinic.

Primary Aim The primary aim of this study is to test feasibility of a modified REACH II intervention in an outpatient clinic.

Hypothesis:

1. The FL REACH intervention can be implemented reliably in this setting, with fidelity to the model and minimal burden on existing clinic structure.

   Secondary Aims Aim 2: Examine the effectiveness of a REACH II translation in an outpatient setting.

   Hypotheses:
2. CG disease knowledge will increase from pre-assessment to post-assessment.
3. Caregiver preparedness for caregiving will increase from pre-assessment to post-assessment.
4. Perceived risk by CG (CR access to dangerous objects + smoking + supervision + wandering + driving + screaming + desire to hit) will be reduced from pre-assessment to post-assessment.
5. Caregivers will demonstrate mastery of skill acquisition related to behavior change strategies.
6. Caregiver burden will decrease from pre-assessment to post-assessment.
7. Caregiver self-rated health will improve from pre-assessment to post-assessment.
8. Caregivers will have initiated the process of advanced care planning by the end of the intervention.
9. All measures will maintain gain in the anticipated direction from baseline measures at 6 months post-assessment.

Aim 3: Identify possible moderators of outcome, such as race/ethnicity, language, dosage or relationship.

This Aim is exploratory. Based in previous evidence, we estimate similar outcomes for all participants regardless of demographic factors, but previous trials have never been attempted in this novel setting. We will examine the data for differential outcomes related to such factors.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age 18-89 2. Identified caregiver or care partner of an individual who has been diagnosed with Alzheimer's disease or another dementia by the memory disorders clinic, and/or who has sought ongoing treatment through the memory disorders clinic 3. Able to provide informed consent 4. Able to engage in the intervention weekly by attending sessions in person at the clinic 5. Able to participate in the intervention in English or in Spanish 6. No previous experience with a caregiver training program in the past (this applies to theory based, structured interventions delivered by professionals, and does not include peer-led support groups that the family may have engaged with)

Exclusion Criteria:

* 1. Under age of 18 or over the age of 89 2. Unable to provide informed consent or subject to a conflict of interest for this study 3. Unable to return regularly to the clinic for sessions 4. Engaged in another caregiver training program concurrently or have completed a multi-week caregiver training program in the past (this exclusion applies to theory based, structured interventions delivered by professionals, and does not include peer-led support groups that the family may have engaged with)
Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD

The novel SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper.

The Primary Endpoints for comparison are based on the objective and subjective parameters.

The objective parameters are pregnancy rate, perforation, expulsion and mal -position rates, changes in the endometrial thickness, rate of complications such as infection and anemia and discontinuation rates after 2 years.

The subjective parameters including Quality of Life (QoL) are: pain during insertion, menstrual characteristics and pain, bleeding in correlation to the bleeding pattern prior to insertion.

The Secondary Endpoints are physician opinion (ease of use in insertion and removal) and subject satisfaction.


Eligibility Criteria:
Inclusion criteria:

* Adult females aged 18-45
* Free and willing to fully comply with treatment process
* Healthy women seeking LARC
* Married or in a steady relationship (at least 1 year)
* Blood hemoglobin \>11.5gr/dL
* Signed informed consent form
* If took COCP at least had one cycle after use of OC

Exclusion criteria:

* Use IUB/IUD as an emergency contraception
* A previously placed IUD that has not been removed
* Pregnancy or suspicion of pregnancy
* Immediately post-abortion or post-partum - unless had at least one free cycle
* Use of other contraception method (condom for either male or female, oral contraceptives, diaphragms, spermicides, hormonal patches, injections or ring, cervical cap)
* History of pelvic inflammatory disease, recent or remote.
* Postpartum endometritis or postabortal endometritis in the past 3 month
* Mucupurulent cervicitis
* Endometrial thickness more than 12 mm on insertion date
* Known anemia (except thalassemia, sickle cell, chronic anemia)
* Severe Mennorrhagia or severe Dysmenorrhea
* History of previous IUD complications
* Dysfunctional uterine bleeding
* Undiagnosed uterine bleeding
* Malignancy or suspected malignant disease of female inner or outer genitalia
* Distortions of the uterine cavity by uterine fibroids or known anatomical abnormalities
* Known intolerance or allergy to nitinol or copper and/or copper IUDs - Wilson's disease.
* Medication that may interfere with the subject's ability to complete the protocol
* Use of injectable contraception in the previous year
* Any other significant disease or condition that could interfere with the subject's ability to complete the protocol
* A history of alcohol or drug abuse
* Known infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
* Pregnancy or pregnancy planned during the year
* Enrollment (less than 30 days after completing another study) in or planned to be enrolled in another study
Prevalence of Lichen Planus

Clinical records of all patients referred to the Department of Oral diseases and periodontology in the period 2021-2023 were retrogradely assesed. The prevalence of patients with the diagnosis of Oral lichen planus and contributing factors were accordingly analyzed.

Clinical records of 111 patients with the clinical or histopathological diagnosis of Oral ichen planus were included in the study. The prevalence of oral lichen planus was calculated and all the contributing factors including age, gender, location, type, skin involvement, presence of peridontal disease, systemic diseases and medications were assesed.

Eligibility Criteria:
Inclusion Criteria:

* All patients clinically or histopathologically diagnosed with Oral Lichen Planus

Exclusion Criteria:

* All patients not clinically or histopathologically diagnosed with Oral Lichen Planus
Yoga Breathing for Fatigue in Patients Undergoing Chemotherapy

The purpose of this study is to determine the feasibility and efficacy of yoga breathing techniques to manage fatigue and other cancer-related side effects, in cancer patients undergoing chemotherapy.

Fatigue is the most common complaint among cancer patients. This pilot study will evaluate the effects of pranayama (ancient yoga breathing techniques) on fatigue and quality of life among 30 patients undergoing chemotherapy, on an every 2, 3, or 4 week schedule, with a fatigue score of at least 4 on a scale of 0 (none) to 10 (most). Patients will be randomized to either pranayama or wait-list control. The pranayama group will learn and practice 3 breathing techniques on a daily basis. The study period will occur during 2 consecutive cycles of chemotherapy (cycle A and Cycle B), and the wait-list control patients will crossover to the treatment arm at the beginning of his/her Cycle B. Fatigue will be measured using the revised Piper Fatigue Scale along with quality of life measures. These study measures will be conducted at baseline, at the end of cycle A, and at the end of cycle B. We hypothesize that pranayama will improve clinical symptoms of fatigue and quality of life among patients undergoing chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of cancer that requires at least 2 further cycles of chemotherapy on an every 14, 21, or 28 day schedule
* A score of at least 4/10 on a 0-10 (0-none, 10-most) visual analog scale for fatigue at the time of enrollment
* Able to read, write and understand English
* Karnofsky Performance Status greater than 60
* Ability to give informed consent

Exclusion Criteria:

* Severe COPD
* Receiving chronic oxygen therapy
* Congestive heart failure: NYHA class 3 or greater
* Transfusion dependent anemia
* Uncontrolled thyroid disease
* Advance kidney disease requiring dialysis
* Advance liver disease
* More than three previous chemotherapy regimens
* Current, ongoing yoga breathing practice
A Study of TAK-360 in Adults With Idiopathic Hypersomnia

Idiopathic Hypersomnia (IH) is a condition where people feel extremely sleepy during the day, especially in the morning, even if they sleep a lot at night. They may have trouble waking up in the morning, no matter how much they sleep (sometimes more than 11 hours per day), and they can't help feeling tired, even after taking daytime naps. Because of this sleepiness, they may have trouble focusing, thinking clearly, or keeping up with daily activities. They may also have symptoms like dizziness or feeling lightheaded. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake.

The main aim of this study is to learn how safe TAK-360 is and how well adults with IH tolerate it. Researchers also want to find out if TAK-360 can help people with IH stay awake and how much TAK-360 is needed to do that.

Participants will be randomly (by chance, like drawing names from a hat) chosen to receive either TAK-360 or a placebo. The placebo looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.


Eligibility Criteria:
Key Inclusion Criteria:

1. The participant weighs greater than or equal to (≥) 40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg/m\^2) \[inclusive\].
2. The participant has a documented, current diagnosis of IH.

Key Exclusion Criteria:

1. The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) \[other than IH\].
2. The participant has medically significant thyroid disease.
3. The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ \[such as basal cell carcinoma\] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor.)
4. The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus antibody (at screening), human immunodeficiency virus (HIV) antibody/antigen (at screening).
5. The participant has a clinically significant history of head injury or head trauma.
6. The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).
7. The participant has a history of cerebral ischemia, transient ischemic attack (less than \[\<\]5 years from screening), intracranial aneurysm, or arteriovenous malformation.
Endocuff Enhanced Colonoscopy: Does it Improve Polyp Detection and Make Rectal Retroflexion Unnecessary

The investigators hope that this project will determine if the Endocuff device is a useful adjunct during colonoscopy by optimizing polyp detection and eliminating the need for the painful rectal retroflexion. As such, by improving polyp detection and eliminating the need for rectal retroflexion, it will directly reduce the likelihood of colon cancer and improve patient comfort respectively.

Every day, 73 Canadians are diagnosed with colorectal cancer. This cancer is the third most diagnosed type of cancer in Canada while being the second and third most deadly cancer for men and women respectively. In addition, it accounts for 12% of all cancer diagnoses and cancer deaths for both sexes in 2020. Fortunately, colorectal cancer incidence and mortality rates have been steadily declining in the recent years. This can be attributed to the development of new screening methods and devices assisting in a more reliable identification of polyps as well as removal during colonoscopy. This is essential to prevent cancer as these usually asymptomatic and harmless clusters of atypical cells can turn into cancers, and become fatal if they can progress to a later stage of their development. The Endocuff is a new colonoscopy assisting device designed to aid physicians to maneuver inside the colon, allowing for increased detection of polyps that stay hidden between folds in the colon. By its flexible and hinged arms, the Endocuff is designed to gently flatten the large colonic folds during withdrawal of the colonoscope, bringing the difficult-to-see mucosa to view. The Endocuff also may assist in the view of the rectum, being the last area of the colon and difficult to assess. Usually, a painful procedure called a retroflexion is used to help see this area. However, this pain can limit the evaluation and impact polyp diagnosis in the rectum. In this study, the investigators aspire to answer these following questions: (1) Can the Endocuff improve polyp detection? (2) Can the Endocuff replace the need for retroflexion in the rectum?

Eligibility Criteria:
Inclusion Criteria:

* Any patient undergoing a colonoscopy during the study period
* Procedure being performed by a gastroenterologist (i.e., surgeons are excluded)

Exclusion Criteria:

* Inflammatory Bowel Disease
* Hereditary Mixed Polyposis Syndrome
* Diverticulitis
* Colonic stricture
* Toxic Megacolon
* Previous Colon surgery, excluding appendectomy
* Radiation therapy to abdomen or pelvis
* Pregnancy/Lactation
* Anticoagulant use
* Suffered stroke or ischemia in previous 3 months
* Being deemed too risky by investigator
* FIT positive
* Poor preparation
Trans Alveolar Pressure Measurement as an Index for Lung Recruitment.

the study is conducted on hypoxic adult patients underwent open heart surgery after arrival to the intensive care unit and stabilization of patients' hemodynamics to assess the efficacy of transalveolar pressure measurement as an index for lung recruitment.

After one hour from the patient's ICU admission and after stabilization of the patient's haemodynamics, alveolar recruitment will be done for hypoxic patients with hypoxic index less than 250.

The recruitment will be started in the adaptive ventilation mode (AVM mode) using modified stepwise staircase recruitment maneuver in which every 2 minutes positive end-expiratory pressure (PEEP) is increased in increments of 2 cmH2O and the driving pressure will be regulated by AVM mode.

The increase in PEEP will be guided by improvement of dynamic compliance, oxygen saturation and transalveolar pressure (PTA) till near overdistention.

Overdistension will be detected if there are decrease in the mean arterial pressure 25% from the base line value reported after stabilization of the patient's haemodynamics, or decreased oxygen saturation or sudden decrease in dynamic compliance, or inspiratory PTA more than15 cm H2O.

Then PEEP is decreased 2 cm H2O every 3 minutes till a decrease expiratory PTA less than 1 cm H2O, or a decrease in dynamic compliance or a decrease in oxygen saturation ≥ 1% from maximum oxygen saturation is observed (the derecruitment point) then return to a PEEP level 2 cm H2O above the derecruitment point (the optimal PEEP).

Alveolar recruitment will be done once.

Eligibility Criteria:
Inclusion Criteria:

* post cardiac surgery hypoxic adult patients

Exclusion Criteria:

1. Patients with contraindications for the use of esophageal catheter including esophageal ulcerations, tumors, diverticulitis, bleeding varices, recent esophageal or gastric surgery, sinusitis, epistaxis and recent nasopharyngeal surgery.
2. Postoperative severe haemodynamic instability on high inotropic support.
3. Ejection fraction less than 35%.
4. Severe restrictive or obstructive lung disease.
5. Extremes of age (\<19 and \> 75 years).
6. Morbid obese patients with BMI \> 40kg/m2.
A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease

This two-part study will evaluate how safe LY3154207 is and the effects it has on the body.

Part A will include healthy participants. Each participant will receive daily doses of LY3154207 or placebo for 14 days. Part A will last approximately 4 weeks including a 17 day stay in the clinical research unit (CRU) and follow-up.

Part B is contingent on the results of Part A. Part B will include participants with Parkinson's disease. Each participant will receive daily doses of LY3154207 or placebo for 14 days. Part B will last approximately 4 weeks including a 17 day stay in the CRU and follow-up.

Both Part A and Part B will require screening within 30 days prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

Part A:

* Overtly healthy males or females, as determined by medical history and physical examination
* Female participants not of child-bearing potential

Part B:

* Have a clinical diagnosis of idiopathic Parkinson's disease for at least 1 year and on stable medication for at least 4 weeks

Part A and B

* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
* Have given written informed consent
* Have a body mass index (BMI) of 18.0 to 29.9 kilograms per square meter (kg/m²)

Exclusion Criteria:

* Have participated, in the last 30 days, in a clinical trial involving an investigational product
* Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; or constituting a risk when taking the study medication; or interfering with the interpretation of study data
Sit Less and Move More: Feasibility Study

Intervention aiming to improve cardiometabolic health by reducing prolonged sitting


Eligibility Criteria:
Inclusion Criteria:

1. are community-dwelling older adults aged 65 years or above,
2. are smartphone users,
3. sit for \>= 6 hours per day
4. are overweight

Exclusion Criteria:

1. are unable to walk independently with/without walking aids due to a physical disability;
2. have health conditions that hinder the adherence to intervention
Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®

To describe the safety findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months.

To describe the immunogenicity findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months

The study is to collect sera from healthy children being administered the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®.

Eligibility Criteria:
Inclusion Criteria :

* Aged ≥ 6 months to \< 36 months.
* Considered to be in good health on the basis of reported medical history and limited physical examination.
* Available for the duration of the study (44 days +4 days).
* Parent/guardian is willing and able to provide informed consent.
* Parent/guardian is willing and able to meet protocol requirements.

Exclusion Criteria :

* Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
* Previous history of influenza vaccination or documented history of influenza infection.
* An acute illness with or without fever (temperature \> 100.4 °F rectal) in the 72 hours preceding enrollment in the trial (defer enrollment).
* Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude).
* Participation in any other clinical trial within 30 days prior to enrollment up to termination of the subject's participation in the study.
* Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth.
* Personal or immediate family history of congenital immune deficiency.
* Developmental delay, neurologic disorder, or seizure disorder.
* Chronic medical, congenital, or developmental disorder.
* Known human immunodeficiency virus (HIV)-positive mother.
* Prior history of Guillain-Barré syndrome.
* Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
Clonidine Versus Midazolam for Premedication

alpha2-agonists like clonidine offer several useful effects that make these drugs an interesting alternative to benzodiazepines for pharmacological premedication. We therefore sought to determine the effect of pre-anesthetic medication with clonidine vs. midazolam in a randomized, double-blind, placebo controlled study. Effects of pre-anesthetic medication were assessed on (1) bispectral index (BIS),(2) sedation score and visual analog scales for anxiety and pain, (3) neuropsychologic tests to assess cognitive function and (4) circulating stress hormones.


Eligibility Criteria:
Inclusion Criteria:

* elective surgery
* ASA physical status I and II
* informed consent
* weight 50 - 100 kg

Exclusion Criteria:

* cardiovascular disease
* pregnancy
* problems of consent due to mentally handicap or language.
Testing of a Candy in Five Different Versions for the Additional Humidification of the Oral Cavity

This study is to investigate whether a candy can increase moisture of the oral cavity and reduce dryness of mouth.

A candy (available on the market from a Swiss manufacturer (Ricola)), free of ingredients that could interfere with the investigation, is tested in five different versions on different days. It is to analyse whether these candies can increase moisture of the oral cavity and reduce dryness of mouth.

Eligibility Criteria:
Inclusion Criteria:

* non- smoker
* no allergies
* no drug- use (except for contraception)
* healthy volunteers (no disease/infection 4 weeks before study participation)

Exclusion Criteria:

* pregnant women
Effect of Electronic and Mail Outreach From Primary Care Physicians for COVID-19 Vaccination Among Elderly Patients

This randomized controlled trial tested the effect of culturally tailored and standard electronic secure messages and mailings from patients' primary care physicians to encourage COVID-19 vaccination among adults aged 65 and older.

This randomized controlled trial tested the effect of culturally tailored and standard electronic secure messages and mailings from patients' primary care physicians to encourage COVID-19 vaccination among adults aged 65 and older. Patients who had not received a COVID-19 vaccination or appointment after previous outreach attempts were randomized to receive (a) an electronic secure message and/or mail outreach from their PCP, (b) similar outreach with additional culturally tailored content, or (c) usual care. The primary outcome was receipt of COVID-19 vaccination during the 8 weeks after the initial study outreach date.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

Received COVID-19 vaccine prior to Study Outreach 1.