cyrilzakka/clinical-trials huggingface dataset:
Hypnosis for Sleep Quality for Individuals With Mild Cognitive Impairment

With the long-range goal to identify an efficacious and practical intervention to improve sleep for individuals with MCI, this pilot study will enroll 20 individuals with MCI into either a self-administered hypnosis for sleep program or a sham white noise hypnosis program. Participants will practice hypnosis delivered via audio recording once per day in their own home for 7 weeks. Upon completion of the study, insight will be gained regarding accrual, retention, and feasibility of the intervention and measures. Data from this pilot study is essential to inform and plan a future R01 proposal to determine the efficacy of the self-administered hypnosis intervention to improve sleep quality and duration, as well as other benefits, with individuals with mild cognitive impairment.

Study Objectives

Aim 1: Determine the accrual, retention, adherence and feasibility, and randomization to the self-administered hypnosis program among individuals with MCI. Feasibility will be determined by (1) drop-out rate, (2) participants' rating of the program, and (3) participants' rating of treatment satisfaction. Adherence will be determined through at-home practice logs. Essential experience on accrual and retention data as well.

Aim 2: Determine feasibility of measures: PSQI, actigraphy recordings, and sleep diaries to assess sleep quality and duration, as well as feasibility of secondary self-report outcome measures of insomnia severity, stress, cognition, and pain among individuals with MCI.

Aim 3: Determine perceptions of hypnosis and potential barriers for the MCI population and feedback.

Participant Selection and Recruitment Plan

A sample of approximately 20 individuals with mild cognitive impairment, both male and female, who suffer from poor sleep will be enrolled in the study. A screening checklist will be used for screening participants who are interested.

Potential participants will be identified (1) via advertisements and press releases, (2) via physician and health care provider referral, support groups (3) and (4) targeted mailings. Participant's eligibility will be determined by criteria listed on a screening checklist. The investigator has used these strategies in prior studies and has demonstrated ability to accrue the required number of participants.

Eligibility Criteria:
Inclusion Criteria:

* Self-report of MCI (a score of less than or equal to 3 on the Memory Complaint Scale30) and a score between 7-18 on the Montreal Cognitive Assessment (MoCA) - BLIND Version 8.121
* Self-reported sleep duration of less than or equal to 6 hours per day/night as indicated on the PSQI
* Signed informed consent

Exclusion Criteria:

* Use of any prescription or over-the-counter therapy for sleep
* Severe or unstable medical or psychiatric illness
* Current use of hypnosis for any condition
* Inability to speak or understand English
FastWire REvascularisation of Extremities, (For LOWer Limbs) - Feasibility Study (FREEFLOW)

This study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions (CTOs)

A first-in-human, single-arm, single-center, feasibility study to assess the efficacy and safety of the FastWire System in patients who have a chronic total occlusion in their peripheral vasculature causing an ischemic limb. The enrollment will consist of up to 10 patients meeting the inclusion/exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

1. The patient, or the patient's legal guardian has signed and dated an Informed Consent Form.
2. Aged between 18 years and 85 years (inclusive).
3. Severe claudication assessed as Rutherford category 3 or CLTI assessed as Rutherford category 4 or 5 LEAD.
4. Angiographic confirmation of a de novo, CTO, infrainguinal ligament including above the knee, below the knee, or below the ankle vessels.

Exclusion Criteria:

1. Life expectancy of less than 12 months.
2. Females who are pregnant or lactating (urine test for women of childbearing age).
3. Myocardial infarction or stroke in two months prior to the index procedure.
4. Known, unstable coronary artery disease or other, uncontrolled comorbidity.
5. Any known haemorrhagic or coagulation deficiency.
6. Evidence of active infection, including but not limited to the target limb.
7. Current use of cocaine or other substance of abuse.
8. Patients who have received any thrombolytic therapy in the last two weeks.
9. History of severe allergy or contraindication, to contrast medium or other medications used during or after endovascular therapy.
10. Subject participating in another study involving an investigational drug or device
11. Patient has surgery or vascular intervention planned within 30 days of the index procedure.
12. Patient has had a previous peripheral bypass that includes the target vessel.
13. Patient has had a previous intervention in the target CTO (angioplasty, stenting) including at time of index procedure.
14. Patient tests positive for coronavirus disease (COVID-2019), as per site standard practice.
15. Estimated Glomerular Filtration Rate (eGFR) of less than 30 ml/min.
16. Platelet count \< 50,000.
Exercise in the Fasted State, Glucose Metabolism and Energy Balance

The ability to control our blood glucose (sugar) concentrations after a meal is a strong predictor of the risk of disease. Our bodies respond to glucose ingestion by reducing the amount of glucose from the liver entering the bloodstream. At the same time muscle increases the amount of glucose it take up from the bloodstream. This ensures that our blood glucose levels do not get too high. The investigators want to understand what happens to these processes following exercise after breakfast and after an overnight fast. In addition, the investigators also want to understand whether exercising with or without breakfast influences our appetite, food intake and activity levels later in the day.


Eligibility Criteria:
Inclusion Criteria:

* Males.
* Aged 18-49.
* Individuals free from known cardiovascular, metabolic or joint disease as determined by standard health questionnaire.
* Habitual regularly participating in exercise (minimum of 3 sessions per week on average)
* Non-smoker

Exclusion Criteria:

* Known or suspected food intolerances, allergies or hypersensitivity.
* Any bleeding disorder or taking medication which impacts blood coagulation.
* Known tendency towards keloid scarring.
* Known sensitivity or allergy to any local anaesthetic medicines.
* Any reported use of substances which may pose undue personal risk to participants or introduce bias into the experiment.
* Any other condition or behaviour deemed either to pose undue personal risk to participants or introduce bias into the experiment.
The Clinical Physics Research of Image Guided Adaptive Radiation Therapy for Esophagus Cancer

The purpose of this study is to evaluate the benefit of adaptive radiation therapy (adaptive radiation therapy, ART) for esophageal cancer, using dose tracking technique with online images and deformable registration.

The aim of study is to evaluate the benefit of adaptive radiation therapy(ART) for esophageal cancer. 80 patients with locally advanced esophageal cancer will be treated with 3D-CRT(three dimensional conformal radiotherapy, 3D-CRT)/IMRT(intensity modulated radiotherapy, IMRT), dividing to experimental group and control group (40 patients each). All patients are kVCT(kilo-voltage computed tomography, kVCT) scanned weekly(the fifth fraction in a week) and CBCT (cone beam computed tomography, CBCT) scanned per fraction before treatment. Irradiated dose distribution of each patient is calculated using the CBCT images corrected with validated modelling and accumulate the volumetric dose for all PTV(planning target volume,PTV) and OARs(organs at risk, OAR) using deformable registration algorithm. For the experimental group, replan the treatment when the target volume is not covered by the prescribed dose or OARs is overdose beyond the action level to achieve an optimal dose distribution. Conversely, no action is taken in the control group and the original plan will be used for the full treatment course. Dosimetric parameters (such as the ratio of target coverage, the mean dose of OARs, etc) ,treatment toxicities (such as radiation pneumonitis and esophagitis), PFS（Progress Free Survival,PFS）and OS（Overall Survival, OS）of the two groups will be analyzed and compared in the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with locally advanced esophageal cancer
* ECOG(Eastern Cooperative Oncology Group, ECOG) physical status score：0-2
* Charlson complications index score≤4
* First second forced expiratory volume ≥1 liter
* Patients and their families agreed and signed the informed consent

Exclusion Criteria:

* Previous treatment with other malignant tumor
* Had anti-tumor treatment, including (chemotherapy, radiotherapy, surgery)
* Any taboo disease or condition of radiotherapy and chemotherapy
* With malignant pleural effusion and pericardial effusion
* Participated to other clinical test within 30 days before this experiment
* With uncontrolled seizures or loss of mental self-control
* Drug takers, chronic alcoholism, and HIV/AIDS patients
* Has a history of severe allergic or specific physique
* Researchers think that is unfavorable to the test
Homeopathic Ear Drops for Otitis Media Study

The purpose of this study is to determine if a commercially available homeopathic ear drop preparation is effective in reducing symptoms in children 6 months - 11 years old with acute otitis media in whom the health care provider has recommended that antibiotics not be immediately administered. A total of 150 study patients with otitis media will be randomized to receive homeopathic ear drops, or no ear drops, in addition to receiving standard care. It is postulated that children using the ear drops will have more rapid resolution of symptoms and need fewer antibiotics than those randomized to not receive the ear drops.


Eligibility Criteria:
Inclusion Criteria:

* Age 6 months - 11 years old
* Diagnosed with otitis media by clinician at participating clinic
* Clinician determines that a "watch and wait" antibiotic prescription treatment plan is optimal management

Exclusion Criteria:

* Antibiotic treatment during past 7 days
* Homeopathic treatment within past 30 days
* History of serious chronic illness (e.g. diabetes, autoimmune disease, cystic fibrosis
* Perforated tympanic membrane
* Immediate antibiotic treatment plan decided by examining clinician
Training to Enhance Cognition in Older Adults

This is a planning project with a clinical trial pilot to prepare for a larger fully powered clinical trial. Goals of this pilot project are: to identify and address any modifications of the games required for adaptation to diminished sensory abilities; to optimize training dosage and test timing of retention of effects; and to test and refine the battery of outcome assessments. Primary outcome assessment are tests of attention distraction (subtest from a Useful Field of View Test). This pilot will explore a number of secondary outcome measures including EEG and functional imaging biomarkers of change, measures of general cognitive improvement and measures of function including a driving simulator task.

This is a planning trial to optimize procedures for a larger clinical trial. Participants will be randomized into one of two groups--an active group that has intervention training after initial visit and a wait control group that begins intervention after 12 weeks. All participants will receive in-lab baseline testing including IQ (WASI-II), a medical/psychiatric history questionnaire, a depression screen (Geriatric Depression Scale Short Form) and a pre-training battery that includes selected tests from the NIH toolbox, the Repeatable Battery for Neuropsychological Status (RBANS), a Useful Field of View task (UFOV), a driving simulator task, a dual (motor-cognitive) task, an n-back task with and without distractors(with EEG) and 6 minutes of resting state EEG. Participants will be trained to use the game system and play the game at the pre-training in-lab visit. Participants will be provided with a PC with eye-tracker that has training game software installed. Participants will play intervention training games at home for 8-12 weeks with in-lab assessments (the pre-training battery described above). Participants will be asked to play the training games a minimum of 5 times per week for 30 minutes at a time. Compliance will be monitored daily over a secure internet connection. If a participant has played less than the required time in a given week, a research associate will contact the participant to inquire about potential problems and to encourage the participant to resume or increase training time. The first group of 36 participants will receive post-training assessments at 8 weeks, 12 weeks and 6 months. The second group of 36 participants will have an additional pre-training session with structural and functional imaging and will receive only pre- and post-training assessment.

Eligibility Criteria:
Inclusion Criteria:

1. age 60-80 years old
2. not demented
3. living independently; and (4) fluent in English.

Exclusion Criteria:

1. history of dementia, stroke, head injury involving loss of consciousness
2. current psychiatric or neurological disorders other than depression/anxiety
Investigation of Vitamin D3 Enriched, Reduced-fat Yellow Cheese Efficacy to Prevent Vitamin D Deficiency

The primary aim of the current study was to investigate whether the consumption of vitamin D3 enriched, reduced-fat yellow cheese can counterbalance the expected decrease in serum 25-hydroxyvitamin D concentration during winter in postmenopausal women in Greece, and in what degree it can contribute as a potential food-based strategy for the prevention of vitamin D deficiency. A secondary aim was also to investigate any potential effect of the intervention in several quality of life (QoL) indices in the population of postmenopausal women under study.

Vitamin D status in postmenopausal women is of interest because of the association of low vitamin D status with increased risk of osteoporosis and related fractures. In addition, since there is increasing evidence that the dietary supply is often insufficient to offset the seasonal deficit in sunlight during winter months, fortified food and supplements are becoming important sources of dietary vitamin D intake to achieve optimal vitamin D status, especially in this high risk population. Although most studies have examined the effectiveness of vitamin D enriched milk and yogurt, there have been limited studies also exploring the effectiveness of vitamin D enriched cheese in enhancing vitamin D status and preventing vitamin D deficiency. However, fortification of cheese with vitamin D has certain technological considerations, particularly for reduced-fat varieties considering that vitamin D is a fat soluble nutrient.

The primary aim of the current study was to investigate whether the consumption of vitamin D3 enriched, reduced-fat yellow cheese can counterbalance the expected decrease in serum 25-hydroxyvitamin D concentration during winter in postmenopausal women in Greece, and in what degree it can contribute as a potential food-based strategy for the prevention of vitamin D deficiency. A secondary aim was also to investigate any potential effect of the intervention in several quality of life (QoL) indices in the population of postmenopausal women under study. .

Eligibility Criteria:
Inclusion Criteria:

* subjects are eligible if they are 55-75 years of age
* being at menopause for more than 5 years
* they used to consume cheese daily
* those with a Body Mass Index (BMI) range 20-33kg/m2

Exclusion Criteria:

* having any disease/ pathology that interacts with vitamin D metabolism
* taking medications that interact with vitamin D metabolism or vitamin D supplements for medical reasons (e.g. osteoporosis)
* planned vacation to a sunny holiday destination during the intervention period
* having a cow's milk allergy
* having a drugs and/or alcohol abuse
Single Adductor-canal-block Versus Peri-articular Infiltration on Outcome After Total Knee Arthroplasty

The purpose of this study is to compare the effect of single adductor-canal-block versus single femoral nerve block on the recovery after total knee arthroplasty.

The aim of this study is to assess the effect of different analgesic effects on the outcome of patients undergoing total knee arthroplasty. Patients who will have primary unilateral total knee replacement between September 2016 to June 2018 at Peking Union Medical College Hospital and meet the inclusion criteria will be included. They are randomized into two groups. The total knee arthroplasty is performed by one surgeon and adductor-canal block is performed by one anesthesiologist who is not responsible for follow-up. Patients on both groups will have intravenous patient control analgesia with 1 mg morphine/bolus. One residency is responsible for the follow-up.

Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis
* unilateral total knee arthroplasty
* ASA grade I - II
* normal cognitive function.

Exclusion Criteria:

* patients refuse
* BMI \> 35
* diagnosis other than osteoarthritis
* allergy to the drugs used or contraindication to the intervention
Arousal Training for Social Anxiety Disorder

The primary objective of the study is to examine the safety, usability and preliminary efficacy of a novel arousal-based biofeedback system in alleviating social anxiety. The investigators hypothesize that after 4 weeks of hour-long interventions, participants will show reductions pre- and post-intervention in their Liebowitz Social Anxiety Scale scores.

The investigators plan to conduct a waitlist control trial.

Intervention consists of a combination of computerized cognitive behavioral therapy and arousal-based Virtual Reality Exposure Therapy. During the latter component, the physiological variables of participants, such as pulse rate and EEG, will be continuously monitored and presented as feedback to them. Participants will have to deliver speeches to videotaped audiences while striving to regulate their physiological arousal.

Eligibility Criteria:
Inclusion Criteria:

* Literate in English
* Computer literate
* Able to travel independently
* Agreeable to being video-recorded when going through study protocol
* Liebowitz Social Anxiety Scale score of 31 or more
* Public Speaking Anxiety Scale score of 60 or more
* Alcohol Use Disorders Identification Test (AUDIT) of 8 and below

Exclusion Criteria:

* Has gross visual or hearing impairments
* Has irregular heart rhythm
* On any psychoactive medication
* Involved in any other long-term research study
* Current or previous history of neuropsychiatric disorders (other than depression, which will be assessed by BDI-II)
* Suicide ideation
* Concurrent psychotherapy for any disorder
* Non-responding to a previous psychotherapy
Chlorhexidine-Impregnated Sponge Dressing: A Clinical Trial

The purpose of this study is to compare the use of chlorhexidine-gel-impregnated dressing and the transparent polyurethane film dressing as coverage of the site of insertion of central venous catheter, in the evaluation of catheter colonization in critically ill adults patients.


Eligibility Criteria:
Inclusion Criteria:

Critically ill patients hospitalized carrying a short-term central venous catheter

Exclusion Criteria:

* Use of a central venous catheter with antimicrobial coating
* Suspected or confirmed bacterial infection at randomization
* Known allergic/hypersensitivity reaction to any compounds of the treatment
* Active lesions in the skin where the CVC is located and / or where the dressing of CVC is being conducted;
Reproducibility and Reliability of Epstein-Barr Virus (EBV) DNA/RNA Measures in Nasopharyngeal Swabs

Nasopharyngeal carcinoma (NPC) is a virus-associated cancer that is rare among Caucasians but occurs at an elevated rate among Southern Asians. Rates of NPC are particularly high among individuals with a family history of this disease, but no specific genetic factors have been identified that can serve to guide clinical management of this high-risk population to ensure early detection and treatment of this life-threatening condition.


Eligibility Criteria:
Inclusion Criteria:

* suspect NPC patients

Exclusion Criteria:

-
Evaluation of the Links Between Sleep Disorders and the Risk of Suicide Attempt

Several studies have demonstrated an association between sleep disorders such as insomnia and nightmares to suicidal ideations and behaviors.

Nevertheless, some of these studies are methodologically questionable especially in the exploration of sleep disorders. Furthermore, confounding factors such as depressive symptomatology are not controlled and the measurement of suicidal behavior has often been taken into account as a historical measure, not as a current event, which introduces uncertainties and a lack of precision regarding the temporality of the phenomena.

Today, while the links between sleep disorders and suicidal risk are well known, we have a lack of information on the importance and the role of sleep disorders as a precipitating factor. Indeed, few studies have evaluated the temporal link between sleep disorders and suicidal acts.

The objective of this study is to evaluate the links between acute and chronic sleep disorders and the risk of suicide attempt

Pilot, prospective, monocentric case-control study.

There are 2 groups of subjects :

* group of patients who have made a suicide attempt
* control group with only suicidal ideas

First visit V1 is performed within the first 72 hours of hospitalization. A re-assessment is scheduled 1 month after (V2).

At V1, collected parameters are : chronic sleep disorders, chronotype, specific sleep disorders in posttraumatic stress disorder, nightmares and the distress associated, childhood trauma, cognitive dysfunction, suicidal ideation and psychopathologic assessment.

At V2, we assess evolution of sleep disturbances and suicidal ideation.

Eligibility Criteria:
Inclusion Criteria

Criterion specific to the studying group :

- Subjects hospitalized and whose indication of hospitalization is a suicide attempt by voluntary drug intoxication or phlebotomy during the last 72 hours, without any history of attempted suicide

Criterion specific to the control group:

- Subjects hospitalized since less than 72 hours, and whose indication of hospitalization is the presence of suicidal ideas, without any history of attempted suicide

Exclusion Criteria:

* Pregnant of lactating women
* Diagnosed dementia pathology
* Proven intellectual disability
* Patient whose physical or mental state does not allow the passing of the tests of the study
* Under protective measures (guardianship/supervision)
* Refusal to participate in the study
* Diagnosed with chronic or severe psychiatric illness (psychotic disorder, bipolarity)