cyrilzakka/clinical-trials huggingface dataset:
Use of tAN® in Alcohol Withdrawal Management

This research study is being conducted to learn if Transcutaneous Auricular Neurostimulation (tAN®) may be effective in treating alcohol withdrawal syndrome. Transcutaneous Auricular Neurostimulation (tAN®) works by delivering small electrical stimulations to the Vagus and Trigeminal nerves. This study will be conducted over the course of five days. Participants will be enrolled within 24 hours of entering treatment for alcohol withdrawal management. A total of 60 individuals will be enrolled and randomly assigned to either active (treatment with the device + treatment as usual) or sham (treatment as usual) group. Data will be collected on alcohol craving, use of comfort medications, sleep, and mood.

This study will explore whether the use of a non-invasive Transcutaneous Auricular Neurostimulation (tAN®) device, Sparrow® Link, can be used to relieve symptoms of alcohol withdrawal symptoms and reduce the need for comfort medications during alcohol withdrawal management. This study will recruit 60 participants randomized to either active tAN® + Treatment as Usual (TAU) or sham tAN® + TAU, 30 participants in each arm. Data will be collected four times a day for 5 days, exploring ambient alcohol craving, mood, and sleep using Ecological Momentary Assessment (EMA; Wear-IT framework). Data for stress response, sleep and physical activity will also be collected using a fitness activity tracker (Garmin Vivosmart 4). In addition, the Clinical Institute Withdrawal Assessment, Revised (CIWA-AR) will be administered daily as well. Transcutaneous Auricular Neurostimulation has proven effective in reducing symptoms of opioid withdrawal and it is hypothesized that with the similar withdrawal symptom profile of alcohol withdrawal should prove effective in reducing symptoms of alcohol withdrawal as well.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 18 years old to 65 years old
2. Entering an inpatient substance use treatment program for alcohol withdrawal management.
3. Score a 27 or higher on the WHO-ASSIST V3.0
4. Is proficient in English
5. Score of a 4 or higher on the Prediction of Alcohol Withdrawal Severity Scale (PAWSS)
6. Able to provide written informed consent.
7. Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

1. Age \< 18 or \> 65
2. Requires medical tapering from benzodiazepines or opioids.
3. Has a history of epileptic seizures or seizures due to alcohol withdrawal.
4. Has a cardiac pacemaker, cochlear prosthesis, neurostimulator or other device for which tAN® would be contraindicated.
5. Has abnormal ear anatomy or an ear infection is present.
6. Is pregnant.
7. Has any serious medical disease or condition which, in the judgment of the Principal Investigator or his/her designee, would make study participation unsafe, or would make intervention compliance difficult.
ViSiGi LUX Bariatric Sizing and Calibration System

This study investigates the new ViSiGi LUX.

ViSiGi is used during numerous gastric and bariatric procedures. The new device, ViSiGi LUX functions as the FDA-cleared ViSiGi but has the added visualization of NIR lights.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* able to consent
* candidate for robotic bariatric surgery

Exclusion Criteria:

* esophageal stricture that does not allow passage of the device
* conditions that would preclude gastric or bariatric surgical procedures
* pregnant patients
Comparison of the Performance of the Infiniti Vision and the Series 20000 Legacy Phacoemulsification Systems

To compare the efficiency of the Infiniti vision system and the Series 20000 Legacy System phacoemulsification units during routine cataract extraction.


Eligibility Criteria:
Inclusion Criteria:

* Cataract
* Eligible for cataract extraction with primary implantation of a posterior chamber IOL
* 2 to 3+ cataract density

Exclusion Criteria:

* Preoperative ocular pathology that can affect visual acuity
* Corneal irregularities such as keratoconus, corneal dystrophy, corneal opacities.
* Previous intraocular or corneal surgery.
* Other ocular surgery at the time of the cataract extraction.
* Surgical Exclusion Criteria:
* Significant intraoperative intraocular bleeding
* Detached Descemet's membrane
* Implantation of the intraocular lens in the anterior chamber or sulcus
A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

This is a randomized, controlled, examiner-blind, parallel group, four week clinical study comparing brushing plus flossing to brushing alone in 60 healthy adults with pre-existing gingivitis.


Eligibility Criteria:
Inclusion Criteria:

In order to be included in the study, each subject must:

* be at least 18 years of age;
* be physically able to floss their teeth;
* have a minimum of 18 natural teeth (teeth that are grossly carious, fully crowned, or extensively restored will not be included);
* have refrained from performing oral hygiene the morning of the Baseline visit;
* be in good general health;
* have interproximal MGI (Modified Gingival Index) score of \>2.8.

Exclusion Criteria:

Subjects are excluded from study participation where there is evidence of:

* severe periodontal disease;
* discoloration or pigmentation in the gingival tissue;
* meaningful misalignment of front teeth;
* fixed facial orthodontic appliances;
* use of antibiotics within two weeks of the Baseline Visit and at any time during the study;
* any diseases or conditions that could be expected to interfere with the subject safely completing the study.
The Effects of Educational Program Using APP on Pre-Discharge Knowledge, Skills and Anxiety of Wound Care

The purposes of this study were to understand the effects of mhealth App on wound care knowledge, wound care skills, and anxiety related to dressing change when compared to traditional health education before patients discharged from hospital.

1. Research design:

   This study employed a single-blind experimental design. Study participants were randomized into the experimental and control groups. Participants in the experimental group used the mHealth App as intervention while those in the control group received normal verbal instructions. The levels of wound care knowledge, skills, and anxiety related to dressing change in the two groups were compared before intervention (T1), after intervention (T2), and before discharge (T3).
2. Study setting \& samples:

The recruitment site of this study was conducted in a plastic surgery ward at a 1500-bed university hospital located in Southern of Taiwan. Samples were recruited either hospitalized patients or their primary caregivers from March to December 2016. Inclusion criteria were of Taiwanese nationality, were aged 20 years and above, had a wound classification score of 6-10 points according to Strauss (2000), required self-care of wound at home, and had a habit of using smartphones. Exclusion criteria included special care conditions, such as (1) other comorbidities (such as severe infection or severe compression injuries with comorbid open fractures) and (2) being a special patient, such as one with mental illness. Sample estimation based on the F test of MANOVA statistics was carried out using the G Power 3.1 software. Each group had at least 31 samples (effect size = 0.25, ∝ = 0.05, power = 0.85). A total of 76 participants satisfied the inclusion criteria for this study. There were 6 patients who were not willing to participate in this study; therefore, 35 participants were randomized enrolled in each of the experimental and control groups.

Eligibility Criteria:
Inclusion Criteria:

* aged 20 years and above.
* wound classification score of 6-10 points according to Strauss (2000).
* required wound self-care at home or care by their primary caregivers.
* had a habit of using smartphones.

Exclusion Criteria:

* other comorbidities (such as severe infection or severe compression injuries with comorbid open fractures).
* being a special patient, such as one with mental illness.
Eye Dryness Evaluation in Primary Sjögren's Syndrome

The objective of this observational study is to develop new tools to assess primary Sjögren's syndrome (pSS) symptoms and to measure the severity of eye involvement in these patients.

All clinical trials evaluating the efficacy of immunomodulatory drugs in pSS are negative. This could be due to a lack of sensitivity of the outcome measures used so far to define the response. In this study, investigator will evaluate the feasability, tolerability, and performance of new tools to assess disease evolution:

* investigator will develop a webapp to measure the intensity of the symptoms at home on a daily basis (ecological assessment)
* investigator will evaluate new ophthalmologic procedures, already used in other conditions but never in pSS, which assess the severity of eye involvement in the disease
* investigator will develop an automated method to score the severity of ocular surface lesions in the disease.

Patients with a diagnosis of pSS will be included in the study, will undergo detailed ophtalmologic examination, and will then use a webapp, installed on their smartphone, to score their symptoms everyday during 3 months.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of pSS according to ACR/EULAR classification criteria

Exclusion Criteria:

* patient does not possess a smartphone with web connection
* patient unable to sign an informed consent
Venlafaxine PK Following Bariatric Surgery

This study is being conducted to evaluate how the body absorbs and processes the immediate release (IR) and sustained release (XR) medication venlafaxine (Effexor®). Subject who are 1-3 years post gastric bypass or sleeve gastrectomy surgery will be invited to participate. Non-surgical controls will also be enrolled based on a matching criteria to post gastric bypass subjects. Participants will be asked to complete two 12-hour study days approximately 11 days apart. This study will enroll up to 30 participants.


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female
2. Age 18-65 (inclusive, at time of informed consent)
3. No tobacco use in the past three months.
4. Underwent Roux-en-Y Gastric Bypass or Sleeve Gastrectomy weight loss surgery 12-36 months prior to study OR has not had a weight loss surgery but matches the gastric bypass patients on age, gender, and BMI. Criteria for matching will be established at the beginning of the study in consultation with the statistical team and addressed as needed with the input of the biostatistician.
5. Ability to read, write and understand English

Exclusion Criteria:

1. Taking a medication that has a clinically significant interaction with venlafaxine or an interaction that may alter the study data.
2. Hypersensitivity to venlafaxine or any excipient contained within the dosage forms
3. Inability to tolerate repeated blood draws.
4. Any history of bipoloar disorder or a psychotic disorder.
5. Current major depressive disorder or current suicidality.
6. Alcohol or substance dependence in the past year.
7. Currently pregnant or lactating or unwillingness to use medically accepted contraception during study
8. Taking a medication which significantly alters gastrointesinal transit time or significantly reduces acid secretion (e.g. routine use of proton pump inhibitors, H2 antagonists, sucralfate).
9. Medical conditon which may increase participant risk with venlafaxine or uncontrolled hypertension at the discretion of the examining provider.
10. Hepatic insufficiency as defined by any hepatic enzyme greater than 3x the upper limit of normal or other hepatic laboratory abnormalities at the discretion of the medical provider.
11. Renal impairment as evidence by a calculated creatinine clearance of less than or equal to 70ml/min or other abnormality on a renal panel that the medical provider feels puts the participant at risk.
12. Poor or ultra-rapid Cytochrome P450 2D6 metabolizer.
13. Self reported history of viral hepatits or HIV.
14. Positive urine drug screen unless documented prescription of a non-interacting medication.
Exploring the Feasibility of a Digital Service to Improve Nutrition and Hydration Status of Older Adults

Trial Design: This is a feasibility randomised controlled trial.

Aim: The study aims to assess the feasibility of conducting a randomised controlled trial using a digital health tool (Keep-On-Keep-Up Nutrition, KOKU-Nut) to improve dietary intake in community-dwelling older adults.

Objectives:

1. Is it feasible and practical to run KOKU-Nut study as a powered randomised controlled trial.
2. Adherence to the intervention, motivations, barriers and facilitators of engaging with KOKU-Nut

Study population:

Community-dwelling adults aged 65 and older

Intervention:

Participants in the intervention group will be asked to engage with KOKU-Nut at least 3 times a week throughout the 12-week period. A crib sheet and contact details for the research team will be available if participants require additional support to help with technical issues.

Control:

Participants will continue with usual care and receive a leaflet developed by Age UK about the importance of a healthy lifestyle.

Timing and duration 3 month intervention with interviews carried out approximately one week after the intervention period

Background:

Dietary patterns can play an important role in health in older age. Apps that encourage dietary change are available and commonly used in younger populations, however; few are designed for the nutritional and technical requirements of older adults. Keep-On-Keep-Up Nutrition (KOKU-Nut) is the latest development of the digital tool and includes nutritional games based on the Eatwell guide to nudge older adults to improve their diet with a specific focus on protein, fibre and fluid. The innovation process has brought together researchers, clinicians, software designers and older users to co-develop the digital tool.

In this study, researchers will test the practicality of KOKU-Nut as an intervention before further larger studies are conducted to assess it's effectiveness.

The aim of this study is to assess the feasibility of conducting a randomised controlled trial using this digital health tool (KOKU-Nut) to improve dietary intake in community-dwelling older adults. Participants will be randomised to receive usual care and an information booklet about living a healthy lifestyle or to the intervention group and asked to engage with KOKU-Nut 3 times a week for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years or older
* Living independently in the community
* Have access to the internet (to complete online dietary assessment)
* Willing to use an iPad or tablet (their own or one provided) for the duration of the study

Exclusion Criteria:

* Unable to communicate in English
* Have a known cognitive impairment
Mitomycin-c Application for PRK

To evaluate the safety and efficacy of 5 seconds mitomycin-C (MMC) application during photorefractive keratectomy (PRK) for patients with low myopia.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria was ablation depth less than 65 µm,
* a stable refractive error for at least 1 year
* corrected distance visual acuity (CDVA) of 0.1 LogMAR or better.

Exclusion Criteria:

* Patients with keratoconus suspect,
* excessive dry eyes,
* impaired wound healing processes,
* lenticular changes,
* corneal dystrophy,
* history of ocular surgery,
* anterior or posterior uveitis,
* glaucoma and retinal diseases were excluded.
Translation of Neck Disability Index Into Local Pakistani Languages of Pakistan

The aim of the study is to translate the neck disability index (NDI) questionnaire into Pushto, Punjabi, Sindhi and Balochi versions and o test the validity \& reliability of translated versions of NDI among neck pain patients in Pakistan.

The Neck Disability Index is a state-unambiguous instrument for the description of a disability. It is revised from the Oswestry Low Back Pain Questionnaire It contains 10 items mentioning various activities (personal care, lifting, driving, work, sleeping, concentration, reading, recreation) and pain (pain intensity, headache) with 6 conceivable answers for each item. Patients are educated to choose only one answer which most closely suits their condition at the current time. The score of each item ranges between 0 (no pain and no functional limitation) and 5 (worst pain and maximal limitation) that lead to the total score of 0 (no disability) to 50 (totally disabled), as 0-4 points (no disability), 5-14 points (10-28% disability), 15-24 points (30-48% disability), 25-34 points (50-64% disability) and 35-50 points (70-100% disability). The meantime to fill the questionnaire is 3-7.8 minutes. The NDI showed high validity and reliability for patients with neck pain.

By this study, the accuracy and reproducibility of the translated versions of NDI questionnaires will be enhanced and thus can create a useful measure to obtain data from culturally/linguistically diverse people belonging to different ethnic background as in Pakistan. It will create trustworthiness among clinicians and researchers to utilize the tool as a measure of what it is supposed to measure.

Eligibility Criteria:
Inclusion Criteria:

* Mechanical neck pain
* Participants belonging to Urdu, Pushto, Punjabi, Sindhi and Balochi speaking class
* Participants from inpatient and outpatient department of hospitals
* participants should complete the questionnaire in their respective language without the help

Exclusion Criteria:

* Healthy Individuals
* Pathological neck pain
* Traumatic cervical or neck injuries
* Participants with disability due to any structural/ congenital cause
Effect of a Functional Exercise Program Associated With Low Level Laser Therapy on Fibromyalgia

The purpose of this study is to investigate the effects of a functional exercise program associated with Low Level Laser Therapy (LLLT) on pain, functional capacity and quality of life of individuals with fibromyalgia. Half of participants will receive functional exercise and LLLT, while the other half will receive functional exercise and placebo LLLT.


Eligibility Criteria:
Inclusion Criteria:

* being female;
* age between 30 and 50 years;
* have an ovulatory cycle;
* height between 1.50m and 1.80m, body mass between 50 and 80 kg and BMI in the range of 18.5 to 29.9 kg / m2;
* present a clinical diagnosis of fibromyalgia, signed by a rheumatologist according to the current criteria of the American College of Rheumatology;
* is at least 6 months without any physical exercise;
* do not present musculoskeletal conditions that prevent them from performing the evaluation and proposed physical activity, except FM;
* not having diabetes mellitus and uncontrolled blood pressure;
* they do not present an inflammatory rheumatic condition or serious cardiovascular and / or pulmonary disease that prevents them from performing the evaluation and the proposed physical activity;
* Not having psychiatric illness or having malignant tumors;
* is not pregnant
* did not present dengue, zika or chikungunya in the last year;
* and finally not to be hypersensitive to light.

Exclusion Criteria:

* not attend for more than two consecutive exercise sessions
* at any time and for any reason expressing an intention to leave the study
* present a health problem that prevents them from continuing to carry out the proposed exercises
The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2

Subjects who have documented exposure to SARS-CoV-2 (COVID-19) will receive 4 doses of PUL-042 Inhalation Solution or 4 doses of a placebo solution by inhalation over 10 days. Subjects will be followed for the incidence and severity of COVID-19 over 28 days. Subjects will be tested for infection with SARS-CoV-2 at the beginning, middle and end of the study.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have recent exposure to SARS-CoV-2 (such as repeated or extensive exposure to an infected individual(s) or cohabiting with a SARS-CoV-2 positive individual).
2. Subjects must be 50 years or older if the exposure is due to cohabitation.
3. Subjects must be free of clinical signs or symptoms of a potential COVID-19 diagnosis (Ordinal Scale of Clinical Improvement score of 0) with a SARS-CoV-2 infection symptom score (fever, cough, shortness of breath, and fatigue) of 0 in each category.
4. Spirometry (forced expiratory volume in one second FEV1 and forced vital capacity \[FVC\]) ≥70% of predicted value.
5. If female, the subject must be surgically sterile or ≥ 1 year postmenopausal. If of child-bearing potential (including being \< 1years postmenopausal) and, if participating in sexual activity that may lead to pregnancy, the subject agrees to use an effective dual method of birth control (acceptable methods include intrauterine device, spermicide, barrier, male partner surgical sterilization, and hormonal contraception) during the study and through 30 days after completion of the study.
6. If female, must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study. A pregnancy test must be negative at the Screening Visit, prior to dosing on Day 1.
7. If male, must be surgically sterile or, if not surgically sterile and if participating in sexual activities that may lead to pregnancy, be willing to practice two effective methods of birth control (acceptable methods include barrier, spermicide, or female partner surgical sterilization) during the study and through 30 days after completion of the study.
8. Ability to understand and give informed consent.

Exclusion Criteria:

1. Previous infection with SARS-CoV-2.
2. Receipt of any vaccine for the prevention of COVID-19 (single or multiple doses).
3. A SARS-CoV-2 infection symptom score greater than 0 in any of the 4 catergories (fever, cough, shortness of breath or fatigue) at the time of screening (Ordinal Scale for Clinical Improvement score of 0).
4. Known history of chronic pulmonary disease (e.g., asthma \[including atopic asthma, exercise-induced asthma, or asthma triggered by respiratory infection\], chronic pulmonary disease, pulmonary fibrosis, COPD), pulmonary hypertension, or heart failure.
5. Any condition which, in the opinion of the Principal Investigator, would prevent full participation