cyrilzakka/clinical-trials huggingface dataset:
Safety Study of MT-4666 in Subjects With Alzheimer's Disease

The objective of this study is to evaluate the safety and efficacy of 2 fixed dose of MT-4666 administered once daily for 52 weeks with or without receiving a concomitant acetylcholinesterase inhibitors (AChEIs), in patients with mild to moderate Alzheimer's Disease (AD).


Eligibility Criteria:
Inclusion Criteria:

* Probable Alzheimer's disease consistent with the National Institute on Aging and the Alzheimer's Association Criteria for Diagnosis of Alzheimer's Disease (McKhann et al. 2011).
* MMSE score of ≥ 14 and ≤ 24 at the screening and ≥ 12 and ≤ 26 at the baseline.
* Modified Hachinski Ischemic Score (mHIS) ≤ 4 at the screening
* Appropriate caregiver available
* Subject living at home or in facilities who do not require continuous (24-hour) nursing care.

Exclusion Criteria:

* Diagnosis of any other disease which may cause dementia
* Diagnosis of major depressive disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) within last five years
* History of or current diagnosis of any psychosis
* History of myocardial infarction or unstable angina within six months before screening
* History of cerebrovascular disorder within 18 months before screening
* complication of hepatic disorder or renal dysfunction
Two-period 21 Day Cross-over Study to Compare the Pharmacokinetics of Tiotropium From Two Inhalers

The purpose of this study is to compare the absorption of a test inhalation product with the reference product in healthy volunteers.

Healthy subjects will be enrolled and will receive doses of a test inhalation product and a reference inhalation product for 28 days according to a crossover design. Plasma tiotropium levels will be measured predose and over 24 hours postdose on days 1 and 28.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteer
* Willing and able to give informed consent
* Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic
* Subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration

Exclusion Criteria:

* Evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders
* Any presence or history of a clinically significant allergy including any adverse reaction to study drug
* History of drug or alcohol abuse within the past 2 years
* Smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked)
* Donation or loss of greater than 400 mL of blood within the previous 3 months
* Have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted)
* Have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days)
* Upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months
* If female, nursing, lactating or pregnant
Incidence and Severity of Postoperative Sore Throat And Intubation Response by Using Different Devices for Endotracheal Intubation

Postoperative sore throat (POST) is a common problem following the use of endotracheal intubation during general anaesthesia. It leads to dissatisfaction and discomfort after surgery and can delay a patient's return to normal routine activities. POST has been rated by patients as the eighth most adverse effect in the postoperative period. The incidence of sore throat after endotracheal intubation varies from 14.4-90%. Laryngoscopy and tracheal intubation also leads to hemodynamic stress response. The response can be deleterious in patient with or without cardiac disease. It is related to the degree of manipulation of the airway during endotracheal intubation and has been studied during intubation for some equipment used for endotracheal intubation


Eligibility Criteria:
Inclusion Criteria:

* After signing of the informed consent,
* ASA physical status I and II
* Mallampati class 1\& 2,
* BMI \< 35,
* Undergoing elective surgical procedures (not exceeding two hours in duration) requiring ET intubation

Exclusion Criteria:

* Patients undergoing day case,
* bariatric, cardiac, nasal, oral or head \& neck surgeries,
* requiring placement of throat pack or nasogastric/ orogastric tube,
* patients assigned to rapid sequence induction,
* hoarseness,
* patients with anticipated difficult intubation,
* history of recent upper respiratory tract infection,
* history of difficult intubation
* psychiatric disorders hindering proper evaluation,
* use of steroids (oral or inhalational) or non-steroidal anti-inflammatory drugs within one week of surgery or previous surgery within last two weeks
The Efficacy of Ultrasound-Guided Rhomboid Intercostal Block Versus Serratus Plane Block in Mastectomy.

The aim of this study is to evaluate analgesic efficacy of ultrasound-guided rhomboid plane block or serratus plane block versus Intravenous opioid in patients undergoing modified radical mastectomy.

Breast cancer is the most frequently diagnosed malignancy and is the leading cause of cancer-related death among the female population.

Modified radical mastectomy (MRM) is the standard surgical treatment for cancer breast, which is usually associated with moderate to severe acute postoperative pain. Adequate postoperative pain relief is important to improve functional outcomes and to accelerate recovery and decrease hospital stay.

The postoperative pain may last \>3 to 6 months after surgery and may proceed to chronic pain, with an incidence of 20% to 30%. Because chronic pain has many negative effects on patients, it may decrease the overall quality of life and may be a potential source of chronic opioid use. Therefore, preventing chronic pain is essential in these patients. In this regard, good acute postoperative pain management strategies have a very important role.

Regional anesthesia techniques can provide good postoperative pain management and may cause less incidence of chronic pain.

Many analgesic techniques have been proposed to relieve acute postoperative pain, including intercostal block, local anesthetic (LA) infiltration, block, paravertebral block, serratus plane block (SPB), and rhomboid intercostal block (RIB) to relieve acute postoperative pain

Eligibility Criteria:
Inclusion Criteria:

* Female patients
* Scheduled for unilateral modified radical mastectomy.
* Age 18-65 years
* American Society of Anesthesiologists (ASA) physical status I- II

Exclusion Criteria:

* Patient refusal
* Coagulation disorders
* Body mass index \> 35 kg/m2
* Uncooperative or psychiatric patients
* Infection at the injection site
* Patients with a history of allergy to local anesthetics
* Patients with a history of treatment for chronic pain
* Previous history of breast surgery or other chest surgery
Treatment of Caesarean Scar Pregnancy

The aim of this study is to further demonstrate the safety and effectiveness of transvaginal resection of pregnancy tissue in the treatment of Caesarean Scar Pregnancy (CSP).


Eligibility Criteria:
Inclusion Criteria:

* pre-operative diagnosed as CSP
* hemodynamic stability

Exclusion Criteria:

* cervical pregnancy
* incomplete abortion
* gestational trophoblastic disease
* diagnosis unidentified
Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries

The goal of this clinical trial is to learn if targeted medical therapy will improve symptoms and quality of life in patients with angina and non-obstructive coronary arteries compared to placebo, after the underlying cause of the chest pain has been ascertained by coronary function testing.

Participants will be treated with either medications that target the underlying cause of their chest pain or placebo for 4 weeks after a drug titration phase of 1-3 weeks. They will be asked to complete a series of questionnaires to evaluate their quality of life at the beginning and end of the study.


Eligibility Criteria:
Inclusion Criteria:

* All patients with stable angina referred to the Stanford University Hospital cardiac catheterization laboratory for clinically indicated coronary function testing are eligible for inclusion into the study.

Specific inclusion criteria for randomization:

* Absence of significant epicardial coronary artery disease on angiography
* Fractional flow reserve \> 0.80

And ≥ 1 of the following:

* Epicardial coronary spasm on acetylcholine testing
* Microvascular spasm on acetylcholine testing
* Coronary flow reserve \< 2.5
* Index of microcirculatory resistance ≥ 25
* Myocardial bridge on intravascular ultrasound with dobutamine resting full-cycle ratio ≤ 0.76

Exclusion Criteria:

* Acute coronary syndrome less than one week prior to enrolment
* Cardiomyopathy
* Contraindications to beta-blockers or calcium channel blockers
* Baseline systolic blood pressure \< 95 mmHg
* Baseline heart rate \< 55 bpm
Evaluation of the Effectiveness of a Community Health Management Program for Dry Eye Disease in Middle-Aged and Elderly Individuals

This study evaluates the effectiveness of a community health management program for middle-aged and elderly patients with dry eye disease (DED). By comparing the community-based health management plan with conventional treatment, the study aims to determine the impact on eye health and quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Patients meeting the diagnostic criteria for dry eye disease.
2. Middle-aged and elderly individuals aged 45 years and above.
3. Normal cognitive and expressive abilities.
4. Informed consent and ability to complete the survey.
5. Voluntary participation in the study.

Exclusion Criteria:

1. Patients with other ocular surface diseases, including stye, trachoma, allergic conjunctivitis, etc.
2. Patients with severe cataracts, glaucoma, uveitis, retinal detachment, optic nerve diseases, high myopia, or other conditions.
3. Patients who have undergone eye surgery or have a history of eye trauma in the past three months.
4. Patients who did not sign the informed consent form.
PROMs Comparing Digital & Conventional Workflows

This randomized controlled trial (RCT) analyzed monolithic single-unit implant restorations out of lithium disilicate (LS2) or polymer-infiltrated ceramic networks (PICN) in a chairside digital workflow (Test) and a conventional protocol (Control). The primary outcome was subjective patient perception in terms of PROMs comparing digital and conventional impression techniques as well as patients' satisfaction related to the final implant restoration among difference workflows and materials. The secondary outcome was to investigate the objective evaluation by a dental professional applying the functional implant prosthodontic score (FIPS). The null-hypothesis of this RCT was that both workflows and the two materials for the monolithic implant restorations had comparable results with respect to the defined outcomes.


Eligibility Criteria:
Inclusion Criteria:

-The participants are in the age of more than 20 years old and not more than 80 years old.

* The participants who have a transmucosal implant system (Straumann TL RN/WN, Institut Straumann, AG, Basel, Switzerland) placed in single-tooth gap in the area of premolar or molar regions in the maxilla and mandible with existing interproximal and antagonist contacts.
* The participants' general medical health is healthy or has a well-controlled systemic disease.
* The participants' general oral health has shown no sign of infection or unsuccessfully treated diseases such as chronic periodontitis.

Exclusion Criteria:

* The participants who are smoking more than 10 cigarettes per day.
* The participants with pregnancy.
* The participants with a psychiatric disorder
* The participants with a history of radiation therapy at the head and neck area.
* The participants with a history of chemotherapy.
* The participants with bony pathologies such as osseous dysplasia, odontogenic cyst or tumor, etc.
Comparison Colon Capsule Endoscopy vs Optical Colonoscopy for Colorectal Cancer Screening in Familiar-Risk Population

The purpose of this study is to determine if the adherence to screening in first grade relatives of patients with CCR is higher than optical colonoscopy.

The purpose of this study is to compare the adherence and effectiveness of colon capsule endoscopy (CCE-2) versus conventional colonoscopy to screen first-degree relatives of patients with colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic first-degree relatives (parents, siblings or children) of CRC patients aged less than 60 years or with two or more first-degree relatives of any age.
* Signing of informed consent.

Exclusion Criteria:

* Personal history of adenoma or CRC.
* History of hereditary CRC.
* Chronic inflammatory disease.
* Presence of digestive symptoms.
* Patients with swallowing problems (dysphagia).
* Personal history of gastrointestinal surgery.
* Enteritis radioactive.
* Renal failure.
* Congestive heart failure
* Allergy or other contraindication to Bysacodyl to PEG or phosphates.
* Pregnancy.
* Suspected bowel obstruction or intestinal strictures or fistulas known.
* Colectomy.
* Paralysis with impaired intestinal motility.
* Any other process that the investigator's discretion to make inadequate participation.
Concurrent Aerobic Exercise and Virtual Reality Cognitive Training

The study will implement and test a unique Virtual Reality Cognitive Training (VRCT) combined with concurrent cycling on a recumbent stationary cycle, also known as exergame that seamlessly integrates specific cognitive tasks into a virtual environment and is synchronized with cycling to promote cognition.

The proposed project will implement and test a unique Virtual Reality Cognitive Training (VRCT) combined with concurrent cycling on a recumbent stationary cycle, also known as exergame that seamlessly integrates specific cognitive tasks into a virtual environment and is synchronized with cycling to promote cognition. Cycling through an interesting virtual environment will motivate and engage the older adult to participate in the exercise, and VRCT could augment cycling's effects on cognition. The purpose of this project is to demonstrate the feasibility and efficacy of the exergame intervention on cognition through two phases. In Phase I, a prototype of the VRCT exergame will be developed, followed by a feasibility testing using a single-group mixed methods design. In Phase II a more fully-featured version of the VRCT exergame will be developed followed by a an RCT which will randomize subjects on a 2:1:1 allocation ratio to 3 parallel groups (exergame:cycling only:attention control). Mixed methods will be used to assess outcomes in both phases.

Eligibility Criteria:
Inclusion Criteria:

1. Cognitive complaint (defined as answering yes to the question "Do you feel that your memory or thinking skills have gotten worse recently?)
2. Not engaging in aerobic exercise or cognitive training \>2 days/week, 30 minutes a session in the past 3 months;
3. Age 65 years and older

Exclusion Criteria:

1. Resting heart rate \> 100 or \< 50 beats/min;
2. Dementia (self-report, diagnosis, or scoring \<18 on the modified Telephone Interview for Cognitive Status;
3. Neurological or major psychiatric disorder since memory problem;
4. Significant diseases, symptoms, or other factors that make exercise unsafe
5. Current enrollment in another intervention study
Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear Implant in Adults

Clinical study to evaluate the safety and efficacy of the Cochlear™ Nucleus® CI422 cochlear implant for new cochlear implant adult recipients with broader requirements to be considered an eligible candidate.


Eligibility Criteria:
Inclusion Criteria:

1. Eighteen years of age or older at the time of implantation
2. Moderate low frequency thresholds up to and including 1000 Hz, severe to profound high frequency (above 3000 Hz) sensorineural hearing loss
3. Minimum of 30 days experience with appropriately fit bilateral amplification, fit using the standardized National Acoustics Laboratory (NAL) fitting method described in the Fitting and Use of Hearing Aids section below
4. Aided Consonant Nucleus Consonant (CNC) word recognition score (mean of two lists) between 10% and 50%, inclusive in the ear to be implanted
5. Aided CNC word recognition score (mean of two lists) in the contralateral ear equal to, or better than, the ear to be implanted but not more than 70%
6. Willingness to use bimodal stimulation (i.e., a cochlear implant on one ear and a hearing aid on the contralateral ear) through at least 6-months postactivation
7. English spoken as a primary language

Exclusion Criteria:

1. Duration of severe-to-profound hearing loss greater than 30 years
2. Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age)
3. Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator
4. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
5. Conductive overlay of 15 decibels (dB) or greater at two or more frequencies, in the range 500 to 1000 Hz
6. Deafness due to lesions of the acoustic nerve or central auditory pathway
7. Absence of cochlear development
8. Diagnosis of auditory neuropathy
9. Active middle-ear infection
10. Tympanic membrane perforation in the presence of active middle ear disease
11. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the Investigator
12. Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator
13. Additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the Investigator
The Effect of Exergames on Sleep Quality

University students are at risk of developing insufficient sleep and poor lifestyle behaviors. Sleep-related problems are frequently seen in nursing students. Regular exercise has a positive effect on sleep quality. In recent years, developing technological opportunities have led educators to seek different solutions in education, guidance, and counseling services aimed at protecting and improving the health of individuals. As the popularity of VR technology increases, it has a high potential to increase physical activity and improve sleep quality in university students. In the current literature, studies examining the level of physical activity and sleep quality of nursing students using VR virtual glasses are limited. This study aims to examine the effect of virtual reality exercise applications on nursing students' sleep quality and physical activity. This study was planned as a pre-test and post-test control group study. The study population comprises 60 students from the Department of Nursing and the Faculty of Health Sciences. Since the study population is accessible, no sample calculation will be made, and all students who volunteer to participate in the study and meet the inclusion criteria will be included. Randomization will divide students who meet the inclusion criteria into experimental and control groups. The aim of the study and the application will be explained to the students in the experimental group at the first meeting. They will be asked to sign written informed consent, and they will fill out data collection forms. Three sessions are planned for each student in the experimental group. Each session is planned to be held with an average interval of 96-120 hours (every 4-5 days). Data collection forms will be repeated for the students in the experimental group at the end of the third session. The aim of the study will be explained to the students in the control group at the first meeting. They will be asked to sign written informed consent, and they will fill out data collection forms. At the end of 14 days, actigraphs will be received from the control group, and post-tests will be applied. Descriptive statistics of the study data will be reported by giving numbers, percentages, mean, and standard deviation. Student t-tests, ANOVA or Mann-Whitney U, and Kruskal Wallis tests will be used to compare groups regarding the normal distribution of the data. Pearson chi-square test and Fisher exact chi-square test will be used to compare nominal or ordinal data groups.


Eligibility Criteria:
Inclusion Criteria:

* Being a nursing program student,
* Willingness to participate in the study.

Exclusion Criteria:

* Having any cardiovascular, cerebrovascular, or other physical conditions that could prevent participation in a 30-minute exercise session.
* Being diagnosed with a sleep disorder
* Using medications that effect sleep, the autonomic nervous system, or the cardiovascular system, such as hypnotics
* Having any upper extremity injury or similar condition that would prevent the use of an actigraph device
A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis

This is a randomized, double-blind, placebo-controlled Phase 2A study to evaluate safety, efficacy, PK, and dose response of oral CIN-102 in adults with idiopathic and diabetic gastroparesis. The study will assess three oral doses of CIN-102 versus placebo in three separate cohorts.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 18 to 70 years old.
* Current diagnosis of idiopathic or diabetic gastroparesis OR documented delayed gastric emptying.
* Presence of moderate to severe nausea.
* Body mass index (BMI) between 18 and 40 kg/m2, inclusive.
* Glycosylated hemoglobin level \<11% at Screening.
* Willing to washout from ongoing treatment for gastroparesis.
* Able to understand and willing to comply with all study visits, procedures, restrictions, and provide written informed consent according to institutional and regulatory guidelines.

Exclusion Criteria:

* Other known disorder or treatment which could explain or contribute to symptoms of gastroparesis.
* Positive test for drugs of abuse at the screening or evaluation visits.
* Personal or family history of prolonged heart rate-corrected QT.
* History or evidence of clinically significant arrhythmia.
* History of gastrectomy, fundoplication, vagotomy, pyloroplasty, or bariatric surgery.
* Females who are pregnant, nursing, or planning on becoming pregnant during the study.
Child and Adolescent Registry for Participants With Narcolepsy

CATNAP is a patient registry designed to improve the understanding of the natural history of narcolepsy in pediatric patients. Descriptive statistics on disease characteristics will be performed.

The study has 16 active clinical sites and a virtual site that widens participation to anywhere in the United States. For more information about the study or to access the Online Patient Enrollment System, visit the CATNAP website: https://catnap.healthie.net/welcome or email catnap@pulseinfoframe.com. The Online Patient Enrollment System, CATNAP website, can also be found in the references section.


Eligibility Criteria:
Inclusion Criteria:

* Any child or adolescent with a physician-confirmed diagnosis of narcolepsy
* Age less than 18 years
* Willing to participate in the Registry and complete the informed consent form
* Able to participate in English based registry

Exclusion Criteria:

* Age 18 years or more
* Fail to complete the informed consent form