cyrilzakka/clinical-trials huggingface dataset:
mDiet - Ecological Momentary Intervention of Diet Via Mobile Technology

This is a NCI funded study which will develop and evaluate a cell phone application (mDIET) that can be used as an assessment and intervention tool to improve dietary behaviors and thus reduce weight in overweight and moderately obese (BMI 25-34.9) men and women ages 25-55.

This research will develop a technologically advanced system for monitoring and intervening on diet behaviors (e.g., food intake, weight). Interventions aimed at dietary change are missing a comparable, portable tool. Mobile technologies can help fill this gap by providing portable connectivity to expert systems that create specific tailored diet goals based on participant profiles. The expert system can 'push' intervention messages throughout the day during critical point-of-decision moments to aid in decision making among users. The portable device can 'pull' information through prompts and easy-to-use recording. This ecological momentary assessment + ecological momentary intervention format may further encourage healthy behaviors by prompting at critical decision points to improve dietary behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be included if they:

  * Are age 25-55
  * Are overweight or moderately obese
  * Are with a BMI between 25.0-34.9 (as defined by the NIH report on Obesity (NIH 1998)
  * Are able to read (completion of at least the 6th grade) and speak English
  * Provide consent
  * Do not intend to become pregnant or move out of the county for the duration of the intervention (16 weeks).
* Participants will also be required to have a cell phone that is capable of supporting the mDIET application.
* Participants may be otherwise healthy or have one or more risk factors for CVD, including uncomplicated Type 2 diabetes but will not be enrolled if they have diagnosed CVD.

Exclusion Criteria:

Participants will be excluded from the study if they have any of the following conditions:

* An eating disorder
* Are currently pregnant
* Have a strict dietary regimen prescribed by their doctor that will not allow them to comply with intervention guidelines related to dietary changes.
Efficacy of Lyophilized Food Extracts for Skin Prick Tests and Atopy Patch Test at Different Storage Time

Comparison the result of skin prick tests and atopy patch test of lyophilized food extracts at different storage time (0, 3 and 6 months) after preparation

Skin prick test were performed with lyophilized food extracts (cow milk, egg white, egg yolk, wheat, soy and shrimp) at different storage time (0, 3 and 6 months) after preparation.

Atopy patch test were performed with lyophilized food extracts (cow milk, egg white, egg yolk, wheat, soy and shrimp) at different storage time (0, 3 and 6 months) after preparation

Eligibility Criteria:
Inclusion Criteria:

* mild to moderately severe food allergy patients
* At least positive skin test to one kind of common food (commercial extract)
* Stop antihistamine or corticosteroid (if more than 20mg/day) for at least 7 days

Exclusion Criteria:

* Dermographism
* Severe systemic disease such as autoimmune disease, immune deficiency, malignancy
* Severe dermatitis or large area involment
* pregnancy
Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain

The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed.

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Eligibility Criteria:
Inclusion Criteria:

- osteoarthritis of the hip or knee taking a regularly scheduled regimen of hydrocodone/ acetaminophen for their osteoarthritis OA pain.

Exclusion Criteria:

* currently have condition requiring a stable regimen of acetaminophen (APAP).
* a history of chronic conditions, other than OA of the hip or knee joints, requiring frequent, intermittent analgesic therapy.

Other protocol-specific exclusion/inclusion criteria may apply.
Hypofractionated Radiation Fractionation in Breast Cancer Patients with Implant-Based Reconstruction

It is a randomized trial to assess the safety and efficacy between hypofractionation radiation and conventional radiation in women who have undergone mastectomy and immediate breast reconstruction. The investigators will evaluate reconstruction complication, radiotherapy side effects, cosmetic and oncologic outcomes.

Patients with breast cancer frequently have requirement for breast reconstruction after mastectomy. For patients with limited autologous tissue availability, implant-based reconstruction remains an effective alternative. Due to the absence of high-level evidence, collaborative efforts between surgical and radiation oncology teams are advised to determine the optimal sequencing and techniques for integrating reconstruction surgery with radiotherapy. The ongoing Alliance A221505 and FABREC phase III randomized controlled trials are comparing the incidence of reconstructive complications following hypofractionated and conventional fractionation radiotherapy. FABREC trial recently showed the hypofractionated regimen did not significantly improve change in physical well-being（PWB), domain of the Functional Assessment of Cancer Therapy-Breast (FACT-B) quality-of-life assessment tool, compared with the conventional fractionation radiotherapy. This trial added to the increasing experience with HF PMRT in patients with implant-based reconstruction.

In 2019, the European Society for Radiotherapy and Oncology (ESTRO) provided guidelines for target delineation based on the position of the implant in breast reconstruction to minimize the irradiation of normal tissues. Existing studies on the risk of complications from irradiating expanders and implants have yielded inconsistent conclusions, with each approach having its own advantages and disadvantages.

Our study aims to compare the incidence of reconstructive complications between hypofractionated and conventional fractionation radiotherapy after implant-based reconstruction surgery to provide high-level evidence for medium-dose hypofractionated radiotherapy after immediate implant-based reconstructive surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Pathological diagnosis of stage I-III breast cancer (non-T4), \>18 years old; 2. Complete breast cancer resection (including skin-sparing and nipple-sparing total resection) 3. According to the guidelines of the Chinese Anticancer Society, postoperative adjuvant radiotherapy is required; 4. Undergo immediate reconstructive surgery (tissue dilator or permanent implant)

Exclusion Criteria:

1. Auto-reconstruction surgery
2. Clinical or pathological T4
3. Both sides need radiotherapy
4. Have a history of chest radiotherapy
5. Pregnancy/lactation
6. Participate in other drug clinical trials
NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis

The purpose of the research is to test out a new form of treatment that examines stimulation of a nerve in the participant's ear. This is called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (taVNS) which means that the participant will receive stimulation through the ear. The taVNS device looks like an ear bud used with a smart phone or computer. The study team is investigating whether or not taVNS can treat neurologic symptoms of COVID-19 which are termed NEUROCOVID. Some symptoms the participant may experience are new onset anxiety, depression, vertigo, loss of smell, headaches, fatigue, irritability, etc. This study is entirely online and all assessments will be completed virtually.


Eligibility Criteria:
Inclusion Criteria:

* COVID positive
* At home
* Afebrile
* Anxiety
* Depression
* Vertigo
* Anosmia
* Headaches
* Irritability
* Cognitive Processing

Exclusion Criteria:

* Damage to left ear anatomy
* Unstable hemodynamic effects
* Ischemic or hemorrhagic stroke after developing COVID
* Unable to give consent, follow instructions
* Unable to read or write or speak English
* No access to home WiFi
TCM Health Preservation for Depression

This study aims to evaluate the feasibility and preliminary effects of Traditional Chinese Medicine (TCM) health preservation for depression on depressive symptoms reduction and other health-related outcomes among Hong Kong Chinese adults with depression. Participants in intervention group will receive TCM health preservation course for six weeks (6 sessions, 2 hours each) and practice TCM health preservation during the 6-week follow-up period. Participants in the control group (waitlist control) will receive usual care. After the follow-up assessment, TCM health preservation courses for depression will be provided to them for compensation.


Eligibility Criteria:
Inclusion Criteria:

* Hong Kong Chinese adults aged 18-years-old to 65-years-old;
* diagnosed with moderate level of depression (a score of 10\~20), evaluated by the Patient Health Questionnaire-9 (PHQ-9);
* can communicate in spoken Cantonese and written Chinese;
* willing to provide written informed consent and be able to adhere to the study protocol.

Exclusion Criteria:

* being pregnant or during the lactation, or plan to get pregnant;
* new onset or change of antidepressant medication or dosage in the last 3 months;
* PHQ-9 score≥20, meaning a severe level of depression;
* with a previous or present diagnosis of psychotic disorders as screened by the Chinese version of the Structured Clinical Interview for DSM-IV;
* the score of Hong Kong Montreal Cognitive Assessment less than 22;
* significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥3);
* with diagnosis of illness which can interfere the individuals to participate or adhere to the modified lifestyle;
* with diagnosis of medical conditions, which are not suitable to modify diet or do physical activities recommended by physicians;
* joining in another clinical trial during the study period;
* with any major medical condition that causes depression based on the judgement of the investigator.
Family Based Prevention of Alcohol and Risky Sex for Older Teens

An online, interactive web-based program for older teens and their parents is designed to address teen alcohol use and teen relationships. The parent-teen dyad both participate in the web-based program and engage in off-line discussion activities. This intervention promotes communication skills, refusal skills, and helps teens consider how to make healthy choices. A total of 411 family dyads (one parent, one teen) were recruited.

This purpose of this study is to develop an interactive, web-based prevention program for parents and older teens that focuses on teen use of alcohol and teen relationships. The study is designed as a randomized controlled trial.

Specific Aim 1: To adapt two parent-based prevention strategies (Family Matters and Parent Handbook) to provide a family-based approach for addressing older teen alcohol related risk behaviors and sexual risk behaviors and sex in combination with alcohol use (hereafter called alcohol and/or sexual risk behaviors) using the web as the program delivery mode.

Specific Aim 2: To test whether exposure to the program leads to expected changes in targeted teen beliefs and behaviors, including reductions in alcohol and/or sexual risk behaviors.

Specific Aim 3: To examine whether program effects on teen alcohol and/or sexual risk behaviors are mediated through changes in intermediate program targeted beliefs (parents and teen) and behaviors (e.g., parent-teen--communication). Program fidelity and process measures may also mediate these outcomes.

Phase I integrates and adapts the two parent-based approaches and creates a web-based interactive delivery of materials. Expert panels, focus groups, and usability assessments will inform the process. Phase II is an RCT with 400 families with the web-based intervention. Surveys will be conducted at baseline, and for three follow-up periods (6, 12, \& 18 months). Analyses will examine teen outcomes related to alcohol and/or sexual risk behaviors. Changes in mediators directly impacted by the program for both teens and parents will be examined. Process and fidelity information will be collected and assessed.

A web-based prevention strategy supporting parents and teens, is significant and timely. Parents and teens will use the internet to make health decisions. This program is uniquely different from other programs be-cause it addresses teens at high risk for alcohol and/or sexual risk behaviors. Further, the strategy involves both parents and teens through an interactive framework. The approach utilizes the strengths of Family Matters which promotes specific exercises and activities between parents and teens and the strengths of the Parent Handbook which addresses issues of importance to this age range.

Eligibility Criteria:
Inclusion Criteria:

* One parent and the teen both had to enroll in the study.

Exclusion Criteria:

* Non-English speaking
Usability of Levodopa Cyclops™ vs INBRIJA® in Parkinson's Patients

Currently there is one Levodopa inhaler on the market, the INBRIJA® inhaler. When looking at the user instructions for the INBRIJA®, multiple steps are necessary including preparing and cleaning the inhaler. The Levodopa Cyclops™ inhaler also requires steps to be ready-for-use, however there are less steps required to reach this 'ready-for-use' state. This is mainly because the medicine (Levodopa) is already prefilled in the inhaler. Moreover, the Levodopa Cyclops™ is a single-use inhaler and cleaning steps are not necessary. Since both inhalers should be used during off episodes, there might be a preference for one inhaler over the other due to the instructions. An off episode might impair the ability and length to successfully operate an inhaler due to mental or mobility issues. This study investigates if Parkinson patients have a preference for one of the inhalers based on handling steps, ease-of-use, understandability.

Sixteen Parkinson's patients, who are ≥ 18 years of age, regularly suffering from predictable off episodes, able to understand the inhaler user instructions (no cognitive dysfunction) and who did not previously participate in the Parkinson DPI-1,2,3,4 or 5 study or in a study using INBRIJA®.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Parkinson's disease by a neurologist;
* At least 18 years of age;
* Regularly suffering from predictable off episodes despite medication;
* Recognizable off episodes for themselves and others;
* Signed informed consent

Exclusion Criteria:

* Not able to understand an inhalation instruction of either the Levodopa Cyclops™ or the INBRIJA® (within a maximum of 20 minutes of explanation per inhaler);
* Cognitive dysfunction, which precludes good understanding of instructions and/or informed consent;
* Previously participated in the Parkinson DPI-1, DPI-2, DPI-3, DPI-4 or DPI-5 study (prior knowledge of the inhalation maneuver of the Levodopa Cyclops™)
* Having experience with using the INBRIJA® inhaler.
Does a Ketogenic Diet Causes Ketosis in Patients on Intensive Care?

The purpose of this study is to assess if an enteral ketogenic feed will cause a ketotic state in critically ill patients on intensive care.

This pilot study is a prospective, single-centre, unblinded, parallel-group, randomised controlled, Phase IIb trial comparing standard enteral nutrition with an enteral ketogenic feed. The trial has a simple, pragmatic design and will be analysed on an intention-to-treat basis. It aims to recruit 10 patients from a single University teaching hospital adult general ICU. The anticipated recruitment period is 4 weeks.

Adult patients admitted to intensive care and expected to require enteral feed via a nasogastric tube for at least 5 days and who fulfil other eligibility criteria will be allocated at random to receive either standard feed (Nutrison Protein Plus Multi Fibre) or a ketogenic enteral feed (Nutrison KetoCal 4:1).

The primary endpoint will be increase in ketone body concentration in serum. Secondary endpoints will include, time taken to achieve a ketotic state, ketone levels in critical care patients who are not absorbing enteral feed, glucose levels in patients on a ketone feed, triglyceride and cholesterol levels, creatinine kinase levels and development of a metabolic acidosis.

Adult ICU patients will be eligible to be included in this study if they are expected to require enteral feed via a nasogastric or nasojejunal tube or established percutaneous jejunostomy for at least 5 days. Practically, this will be achieved by screening ventilated patients as they will require enteral feeding Major exclusion criteria include contraindications to ketogenic feeds, contraindications to enteral feeding, a new (\< 5 days) percutaneous jejunostomy.

The intervention will continue until 14 days if the patient still requires enteral nutrition or until able to commence a normal diet orally.

Eligibility Criteria:
Inclusion Criteria:

* Adults who require mechanical ventilation within 72 hours of admission to intensive care

Exclusion Criteria:

* Known intolerance to the ketogenic diet
* Contraindication to standard protocolised enteral feeding
* Pregnancy
* Severe liver disease (known decompensated liver cirrhosis, previous liver transplant, acute hepatitis (bilirubin \>100, ALT \>500)
* Severe metabolic acidosis (pH \< 7.2, HCO3 \< 15mmol/L) that has not been corrected prior to enrolment in the study
* Patients predicted to stay less than 24 hours on intensive care
Exploring Whether Self-affirmation Promotes Reduced Alcohol Consumption in Response to Narrative Health Information

This study tests the effects of a self-affirmation manipulation on (i) acceptance of a health message detailing the risks of alcohol consumption, (ii) engagement with the health message and (iii) alcohol consumption at 7-day follow-up. Half of the participants complete a self-affirmation manipulation, where they reflect on their most important values, whereas the other half complete a control equivalent, where they reflect on their least important values. Immediately post-intervention, all participants then receive information about the risks of alcohol consumption and complete measures of message acceptance and engagement with the materials. Seven days after intervention, participants self-report their alcohol consumption in the previous 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Drinkers

Exclusion Criteria:

* Male
* Non-drinkers
Long Term Complaints After Elective Repair for Small Umbilical or Epigastric Hernias

The purpose of this study is to compare the long-term complaints after ventral hernia repair after insertion of different types of mesh compared with primary suture. Also recurrence of hernia will be discussed.

The purpose of this study is to compare the long-term complaints after ventral hernia repair after insertion of different types of mesh compared with primary suture. Based on a questionnaire selected patients will be invited to clinical examination for recurrence and more detailed interview.

Eligibility Criteria:
Inclusion Criteria:

* operated for ventral hernia from the year 2004 to the year 2009

Exclusion Criteria:

* liver cirrhosis
* pregnancy
* combined hernia
* operation for ventral hernia and other operation
* laparoscopic operation
* acute operation
* recurrence of hernia
In Vitro Maturation (IVM) of Human Oocytes

The objectives of this study are to evaluate the clinical efficacy of Natural in vitro Fertilization and in vitro maturation.

Collection of one mature egg from a follicle in the ovary without gonadotropin medications (natural cycle IVF) results in low pregnancy rates. One way to improve natural cycle IVF is to combine this procedure with the removal of immature eggs from the ovary and mature these eggs in the laboratory ( in vitro maturation-IVM). The in vitro mature eggs are fertilized and the resultant embryos are cultured using conventional IVF techniques.

Eligibility Criteria:
Inclusion Criteria:

1. Each subject must be female.
2. Each subject must have an indication for COH and IVF with or without ICSI.
3. Each subject must be willing and able to provide written informed consent for the trial
4. Each subject must be 25 to ≤42 years of age at the time of signing informed consent.
5. Each subject must have a normal cervical smear result (no atypical or abnormal cells, or in case of atypical squamous or glandular cells, no signs of malignancy; corresponding to Papanicolaou \[PAP\] I or II) obtained within 12 months prior to signing informed consent must be available

Exclusion Criteria:

1. Subject with premature ovarian failure
2. Subject with endocrine abnormalities such as hyperprolactinaemia or thyroid dysfunction
3. Subject with malformation or absence of uterus
4. Subject has tested positive for Human Immunodeficiency Virus (HIV) or Hepatitis B (by local laboratory; results obtained within 1 year prior to signing ICF are considered valid).
5. Subject with contraindication or allergy/hypersensitivity to hCG, estrogen and progesterone
CPVI Plus Renal Sympathetic Modification Versus CPVI Alone for AF（Atrial Fibrillation） Ablation

The study is designed as a randomized control trial. The purpose of this study is to observe the efficacy and safety of atrial fibrillation ablation, comparing circumferential pulmonary vein isolation (CPVI) plus renal sympathetic modification (RSM) with CPVI alone.

Basic studies suggested that sympathetic nerves over-activity played an important role in the pathophysiological changes of arrhythmia occurrence. Present studies of renal ablation show a new method to decrease sympathetic nerves activity. Circumferential pulmonary vein isolation (CPVI) is an accepted ablation method for atrial fibrillation. The investigators plan to evaluate the efficiency and safety of CPVI plus renal sympathetic modification for atrial fibrillation ablation comparing with CPVI alone. The trial is going to recruit 100 patients randomized into two groups (CPVI+RSM group VS CPVI group = 50:50) with a follow-up duration of 4 years. The investigators aim to observe the relapse of atrial tachyarrhythmia lasting more than 30 seconds, the incidence of composite cardiovascular events after renal sympathetic modification, and safety and efficacy of the intervention, comparing with CPVI alone.

Eligibility Criteria:
Inclusion Criteria:

* • ≥ 18 years old, and ≤ 75 years old of age

  * more than half a year history of atrial fibrillation, no matter paroxysmal or persistent, with clinical symptom or ECG proved
  * be ineffective to at least one kind of anti-arrhythmic drugs treatment
  * echocardiography has done to except structural heart diseases such as congenital, valvular heart diseases and kinds of cardiomyopathy
  * estimated glomerular filtration rate (eGFR) of ≥ 45ml/min
  * is competent and willing to provide written, informed consent to participate in this clinical study

Exclusion Criteria:

* • transesophageal echocardiography found thrombus in left atrial appendage

  * past history of atrial fibrillation surgical maze procedure
  * estimated glomerular filtration rate (eGFR) of \< 45mL/min
  * has the history of renal restenosis or renal stents implantation
  * has experienced AMI（acute myocardial infarction） (old myocardial infarction is not excluded), unstable angina pectoris, cerebrovascular accidents, and alimentary tract hemorrhage within 3 months
  * patients with sick sinus syndrome
  * pregnant women
  * mental disorders
  * patients that have allergy to contrast agent
  * patients that do not go with follow-up
  * others such as researcher considers it is not appropriate to be included into the study