cyrilzakka/clinical-trials huggingface dataset:
A Feasibility Study of a Health Coaching Programme for Middle-aged Adults With Cardiometabolic Risk

Cardiometabolic disease has been an increasing trend globally and remains the major cause of morbidity and mortality. Health coaching, a process of goal-oriented and client-centered partnership that is health-focus and through client enlightenment and empowerment, are generally effective for chronic disease management and prevention of complication. However, there is inconclusive result on the effects of health coaching in the primary prevention of cardiometabolic diseases. Therefore, this study aimed to assess the feasibility and acceptability of a theory-guided health coaching programme for middle-aged adults with cardiometabolic risk.

A single group pretest-posttest feasibility study was conducted. The health coaching programme included four monthly health coaching sessions for three months. Feasibility of the study was measured by eligibility rate, enrollment rate, adherence rate, and attrition rate. Intervention acceptability was measured by satisfactory survey after completion of health coaching intervention. Feasibility of outcome measures was measured by the completion of outcome measures assessment at baseline and 6 months after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* aged 40-64 years;
* have a non-laboratory INTERHEART risk score (IHRS) of 16 or higher;
* can communicate in Cantonese;
* able to give informed consent.

Exclusion Criteria:

* previous diagnosis of transient ischemic attack, stroke, myocardial infarction, atrial fibrillation, coronary heart disease, heart failure, dementia, chronic renal failure and diabetes;
* currently on medication to control hyperlipidemia, diabetes or hypertension;
* with eye or retinal disease;
* diagnosis of terminal disease with an expected life expectancy less than 12 months;
* currently participating in any other clinical trial;
* currently participating in any other structured lifestyle-based or exercise-based programme.
Electrical Pharyngeal Stimulation for Dysphagia Therapy in Tracheostomized Stroke Patients

The purpose of this study is to evaluate whether electrical pharyngeal stimulation in addition to standard care can enhance short-term swallow recovery in tracheostomized dysphagic stroke patients and thereby facilitate earlier decannulation compared to sham treatment plus standard care.

Readiness for decannulation is assessed after three days of either real or sham electrical pharyngeal stimulation. In case a patient cannot be decannulated at that time point, there is an open-label follow-up treatment phase, in which every patient in the sham treatment arm gets another three days of real electrical pharyngeal stimulation to not deprive any patient of a potentially beneficial treatment.

Eligibility Criteria:
Inclusion Criteria:

* severe dysphagia due to acute stroke
* completely weaned from mechanical ventilation
* impossibility of decannulation because of severe dysphagia with ongoing aspiration

Exclusion Criteria:

* preexisting dysphagia
* comorbidities that can possibly cause dysphagia
* psychiatric comorbidities
* pacemaker or other implanted electronic devices
The Effects of Topical Corticosteroid Use on Insulin Sensitivity and Bone Turnover

The investigators believe that the emerging epidemiological evidence connecting topical use of corticosteroids to the development of type 2 diabetes and osteoporosis point to potentially massive, yet clinically unacknowledged problems associated with topical corticosteroid treatment. Using state-of-the-art methodology, the present study will delineate the impact of topical corticosteroid use on insulin sensitivity and bone turnover markers in patients with atopic dermatitis and, thus, provide important data that may have implications for millions of people using topical corticosteroids.


Eligibility Criteria:
Inclusion criteria

* Age 18-75 years
* AD according to the Hanifin and Rajka Criteria24
* AD for at least 3 years
* BMI ≤ 30 kg/m2
* Haemoglobin A1c (HbA1c) ≤ 42 mmol/mol (6.0%)
* Normal haemoglobin (men: 8.3-10.5 mmol/L and women 7.3-9.5 mmol/L. A 5% deviation will be allowed if the patient besides this is healthy)
* Informed consent
* In general patients should not be diagnosed with diseases that may affect or be affected by the study/treatment (evaluated by a doctor) (such as untreated skin infections, acne vulgaris (beside face region), a skin barrier defect, such as Netherton's syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous Graft Versus Host Disease, congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression, and Protopic ointment should not be applied to lesions that are considered to be potentially malignant or pre-malignant. Further patients should not suffer from kidney or liver disease/insufficiency. See the SPC for Protopic and Betnovate.)

Exclusion criteria

* Diagnosed diabetes mellitus
* Other chronic inflammatory diseases (including but not limited to rheumatoid arthritis, inflammatory bowel disease etc) beside AD and non-treatment demanding rhinitis or asthma (treated within the last 4 weeks)
* Pregnancy (a urine test will be done at every visit and birth control is required, see below\*)
* Breast feeding
* Treatment with drugs that might affect the glucose metabolism beside TCS within a month prior to the project
* Daily smoker, alcoholic, or drug abuser
* Hypersensitivity to Protopic or Betnovate
Comparison of the Effect of Total Intravenous Anesthesia and Inhalation Anesthesia on Cancer Cell Cytotoxicity, Micrometastasis and Recurrence of Tumor in Patients Undergoing Breast Tumor Resection

The purpose of this study is to compare the effect of total intravenous anesthesia and inhalation anesthesia on cancer cell cytotoxicity, micrometastasis and recurrence of tumor in patients undergoing breast tumor resection. Using propofol-remifentanil in total intravenous anesthesia group and sevoflurane -remifentanil in inhalation anesthesia group.


Eligibility Criteria:
Inclusion Criteria:

* patient between 20 and 65 of age with ASA physical status Ⅰ-Ⅲ
* breast cancer patients with no sign of local invasion (adjacent organs) and distant metastasis revealed by imaging studies
* surgery performed by the same surgical team

Exclusion Criteria:

* ASA physical status Ⅳ
* hepatic and renal impairment
* diabetes or other endocrine disorders
* body mass index \> 35 kg/m2
* immune disorders or immunosuppressive therapy
* steroid treatment in the last 6 months
* inflammation
Values Interventions for Increasing Engagement With What is Feared in Individuals With Specific Phobias

Exposure is considered the therapy of choice for specific phobias (SPs). Nevertheless, therapy engagement is extremely limited. SPs are maintained through avoidance of feared stimuli and as such willingness to approach what is feared constitutes a key factor that could explain limited treatment engagement. Values interventions, a key element of acceptance and commitment therapy (ACT), might be one way to increase engagement, yet to this date limited research exists in this area. For the purposes of the current study, two brief values interventions were developed: (a) a personal and (b) a prosocial one. These will be compared to (c) a no-instructions control in increasing willingness to approach and approach behaviour towards phobic stimuli. Ninety participants with flying phobia will be randomly allocated to one of the three groups. To measure willingness to engage with feared stimuli and approach behaviour two behavioural approach tasks using novel technologies (virtual reality), which aimed to expose participants to situations analogous to real life, were developed. Willingness and behavioural approach towards airplanes at a one month follow up will also be assessed.

Therefore, it is hypothesised that:

1. Participants in either of the two values intervention groups will have greater willingness to engage and approach behaviour towards feared stimuli compared to those in control, during the study tasks.
2. Participants in either of the two values intervention groups will have greater willingness to engage and approach behaviour towards feared stimuli compared to those in control at follow up.

   Additionally, as prosocial values provide an evolutionary advantage, the second study aim was to identify if they lead to greater engagement with phobic stimuli compared to personal ones. Therefore, it was also hypothesised that:
3. Participants in the prosocial values group will have greater willingness to engage and approach behaviour towards feared stimuli compared to those in personal values group, both during the study tasks and at follow up.
4. Participants in the prosocial values group will have greater willingness to engage and approach behaviour towards feared stimuli compared to those in personal values group at follow up.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Meeting the Diagnostic and Statistical Manual for Mental Disorders 5
* Good knowledge of the Greek language (adequate comprehension level, reading level, and verbal communication)

Exclusion Criteria:

* Severe heart disease
* High blood pressure
* Photosensitive epilepsy
In Vitro Organoid Drug Sensitivity-Guided Treatment for Metastatic Pancreatic and Gastric Cancer

The goal of this study is to evaluate the consistency between in vitro tumor organoid drug sensitivity and the therapeutic efficacy of in vivo drug treatment.

Participants are required to provide one of fresh tumor tissues (including ascites, pleural effusion, biopsy tissues, palliative surgery specimens, etc.) for the purpose of culturing tumor organoids.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 75 years old.
2. Metastatic pancreatic cancer with progression after second-line or higher treatment, metastatic gastric cancer with progression after third-line or higher treatment, or metastatic pancreatic or gastric cancer patients who cannot tolerate standard treatment regimens.
3. Able to provide fresh tumor tissue specimens for organoid culture, including: ascites, pleural effusion, tumor biopsy tissues, tumor surgical specimens, etc.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.
5. Adequate organ function, including the following:

   * Bone marrow: Absolute neutrophil count (ANC) in peripheral blood ≥ 1.5 x 10\^9/L, platelets ≥ 100 x 10\^9/L, hemoglobin ≥ 80 g/L.
   * Liver: Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ≤ 3 times ULN. If liver metastases are present, aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ≤ 5 times ULN.
   * Kidney: Creatinine clearance ≥ 45 mL/min (using the standard Cockcroft-Gault formula) or ≤ 1.5 times ULN.
6. At least one measurable or evaluable lesion.
7. For women: Must be sterilized, postmenopausal, or using highly effective contraception during treatment and for 3 months after treatment; must not be pregnant or breastfeeding during treatment.
8. Patient compliance and geographic proximity to ensure adequate follow-up.

Exclusion Criteria:

1. Any unstable systemic disease (including systemic active infections requiring treatment, liver disease, kidney disease, or metabolic diseases, acute cerebral infarction or cerebral hemorrhage, etc.) that, in the investigator's judgment, may impair patient safety or the patient's ability to complete the study due to severe comorbidities.
2. Significant cardiovascular events: Congestive heart failure \> NYHA class 2; unstable angina, active coronary artery disease (CAD) (myocardial infarction more than 1 year before the study is allowed); severe arrhythmias requiring treatment (use of beta-blockers or digoxin is allowed) or uncontrolled hypertension, etc.
3. Significant history of neurological or psychiatric disorders, including epilepsy, dementia, etc.
4. Pregnant or breastfeeding women; those of childbearing potential who are unwilling or unable to use effective contraception.
5. Other situations that the investigator judges may affect the conduct and determination of the clinical research results.
Post-Procedural Manual Manipulation for Infant Ankyloglossia

The goal of this randomized control trial is to determine the impact of post-frenotomy manual manipulation on revision rates and breastfeeding outcomes. We hypothesize that post-frenotomy manipulation will reduce the rate of sublingual frenulum regrowth, and subsequently frenotomy revision rates, thereby improving breastfeeding performance.

Infants with ankyloglossia undergoing frenotomy will be randomized into two groups: the intervention group (post-frenotomy manipulation) and the control group (no intervention). Parents in the intervention group will be instructed to perform tongue stretching and suck "re-training" exercises four times daily for 2-3 weeks, beginning 24 hours post-procedure. To monitor adherence and assess any complications, investigators will conduct a follow-up phone call one week after the procedure. Parents in the control group will not be instructed to perform any post-procedural manipulation. All participants will have a mandatory in-person follow-up 2-3 weeks postoperatively, during which breastfeeding outcomes and the need for frenotomy revision will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* infants less than 90 days old with ankyloglossia who undergo outpatient frenotomy using cold-steel scissors and will be exclusively or partially breastfed.

Exclusion Criteria:

* infants older than 90 days, those who will be exclusively bottle fed, infants who undergo concomitant lip tie release, those who undergo laser frenotomy, and infants who have previously undergone a frenotomy.
* infants with a gestational age of less than 36 weeks, those in the NICU or post-partum unit, infants who didn't receive the vitamin K injection, and those with congenital anomalies or medical conditions affecting breastfeeding
Laser Acupuncture on Pain, Range of Motion and Function in Patients with Patellofemoral Pain Syndrome

Patellofemoral pain syndrome (PFPS) is among the most prevalent forms of knee discomfort. The main complaint is typically anterior knee pain, which gets worse while jumping, bending knee, going up or down stairs, or sitting for long periods of time with bent knee. Teens and early adulthood are commonly affected by patellofemoral pain syndrome, with a higher frequency in females. In healthy general populations, the prevalence of patellofemoral pain syndrome is 22.7%, and in teens, it is 28.9%.

The treatment goals of patellofemoral pain syndrome are to reduce pain, increase muscle strength, increase flexibility, and correct the patellar movement tract. Conservative methods should be used before invasive methods when treating PFPS. One of the ways that people with PFPS may benefit from improved knee function and long-term pain reduction is by strengthening their quadriceps muscles, which primarily reduce force in the patellofemoral joint. Conservative methods described in the literature include the following: modifying activities; electrophysical modalities like biofeedback; therapeutic ultrasound; neuromuscular electrical stimulation; thermotherapy; interferential current; transcutaneous electrical nerve stimulation (TENS); knee braces; strengthening the hamstring, anterior tibialis, and gluteal muscles; stretching for iliotibial band and lateral retinaculum.

Eligibility Criteria:
Inclusion Criteria:

* Patients with patellofemoral pain syndrome (positive Clarkes sign and Waldron test)
* Age from 18 to 25 years
* Patients suffering from pain which aggravated by prolonged sitting, stair climbing, running, squatting, kneeling, hopping\\jumping, overuse activities and relieved by rest for at least 3 months
* Visual analog scale (VAS) greater than 3 points in daily activity
* The ability to participate in the study and follow the treatment schedule.

Exclusion Criteria:

* Physiotherapy in the last 12 months
* Intra-articular injection in the last 3 months
* Other knee disorders such as: (osteoarthritis, previous knee surgery, history of knee arthroplasty, or traumatic injury related joint deformity)
* BMI greater than or equal 30
* Pregnancy
* Pacemaker insertion
* Photosensitivity
* History of using oral analgesic or NSAIDs in the previous 4 weeks,
* History of malignancy, psychiatric disorder, mental retardation, neurologic dysfunction, diabetes mellitus, or uncontrolled hypertension.
Gastric Volume Following Sips of Water Intake

We aim to observe whether drinking of sips of water within 1 hour before surgery significantly affects the gastric volume.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 65 years old undergoing elective surgery under general anesthesia

Exclusion Criteria:

* History of gastric surgery
* Anatomical anomaly, diseases, or mass in the stomach
Complete Easy Rub Comparative Efficacy Study

The aim of this trial is to assess Complete Easy Rub compared to a competitor multi-purpose solution in terms of lens cleanliness, subjective response and ocular response, when lenses are worn bilaterally on a daily wear basis for two months.

The hypotheses for this trial are:

* Lens cleanliness measures between solutions will be no different.
* Subjective ratings between solutions will be no different.
* Ocular response between solutions will be no different.


Eligibility Criteria:
Inclusion Criteria:

* Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
* Be at least 18 years old, male or female;
* Willing to comply with the wearing and clinical trial visit schedule as directed by the investigator;
* Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses;
* Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
* Able to successfully wear one of the lens types to be used in this study on a daily wear (DW) basis in conjunction with any multi-purpose contact lens care solution (not including hydrogen peroxide-based systems) for at least one month prior to allocation of test or control solution;

Exclusion Criteria:

* Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses;
* Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants;
* Use of, or a need for, concurrent category S3 and above ocular medication at enrolment and/or during the study;
* Use of, or a need for, any systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant's ocular health/physiology or contact lens performance either in an adverse manner or beneficial manner at enrolment and/or during the study
Systemic Normothermia in Intracerebral Hemorrhage (ICH)

Patients with a supratentorial intracerebral hemorrhage will be randomly assigned to either the experimental group which will keep them at a normal body temperature or the standard of care group. The investigators propose to test the hypothesis that prophylactic forced normothermia in patients with ICH leads to less systemic inflammation and decreased perihematomal edema.

This is a randomized device efficacy trial. Patients with a supratentorial intracerebral hemorrhage (ICH) admitted to the Cleveland Clinic Neurointensive Care Unit within 1 day of symptom onset and who have not experienced episodes of temperature elevation will be enrolled after consent. Patients randomized to the experimental arm, will have Artic Sun cooling pads applied to the torso and thighs for five days. The Arctic Sun device will keep the body temperature at the normal range of 35.5 - 37.5 degrees Celsius. Patients randomized to the active comparator arm will receive a standard of care treatment at the discretion of the treating physician. Patients will have hourly measurement of blood pressure, heart rate, respiratory rate, urine output, temperature (from the urinary catheter) shivering scale, and nursing neurological assessment. Glasgow coma scale, NIH Stroke Scale Score (NIHSS), telemetry monitoring and labs will also be performed daily. The investigators will also collect demographic information about the patients (i.e. age, gender, medical risk factors) and information regarding their current disease process.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with spontaneous supratentorial ICH \>20 cc
2. Age 18 to 85 years of age
3. Consent from the patient or surrogate decision maker
4. Within 24 hours of onset of ictus

Exclusion Criteria:

1. Hemorrhage secondary to trauma, Arterio-venous malformation (AVM), aneurysm or Arterio-venous dural fistula
2. Moribund state and deemed unlikely to survive until study completion (5 days)
3. Patients with a don-not-resuscitate (DNR) order
4. Known infection at the time of admission (elevated white blood cell count (WBC) with identified infection source).
5. Evidence of a blood dyscrasia
6. Pregnancy
7. Renal failure (CCR \< 50 ml/min)
8. Contraindications for a brain MRI scan
9. Infratentorial ICH
10. Warfarin-induced intracerebral hemorrhages NOT corrected to International Normalized Ratio (INR) \< 1.4 within 24 hours
11. Episode of fever \> 38.5 degrees Celsius prior to enrollment
Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Anesthetized Children

Extravasation is an unintentional injection or leakage of fluids in the perivascular or subcutaneous space. Extravasation can be associated with tissue injury with various level of severity and long term consequences. Currently the confirmation of intravenous location of the Intravenous (IV) catheter requires close observation of the insertion site with sufficient infiltration in the perivascular area to allow detection of swelling, discoloration and discomfort. Under Anesthesia direct observation is frequently prohibited. IV sodium bicarbonate (SB) is used frequently to treat different metabolic conditions and is known to cause a temporary elevation of exhaled carbon dioxide. This study aim is to evaluate the safety and efficacy of intravenous SB as a detector of intravenous placement of an IV line in anesthetized patients.

Patients and Methods: The study has three parts, in part 1, the safety of subcutaneous injection of sodium bicarbonate was evaluated in 6 rats. In each animal the macroscopic and microscopic effects were evaluated and a safe dilution was determined. In the second part of the study the investigators will evaluated the efficacy of IV diluted SB to detect the proper location of IV catheters. 20 adult patients age 20 to 50 years will be enrolled. Patients all under general anesthesia with standard controlled ventilation via endotracheal tube. The correct placement of IV catheter will be confirmed by easy aspiration of blood from newly placed IV catheter. In each patient a bolus of 50 cc of 0.5 meq/cc SB or volume equivalent of normal saline will be injected in random order. The data collection will include patient's demographics, the presence or absence of an increase in the expired end-tidal carbon dioxide, onset and peak changes of end-tidal carbon dioxide as well as the hemodynamic changes after each injection.


Eligibility Criteria:
Inclusion Criteria:

* Healthy (American Society of Anesthesiologists \[ASA\] I or II) volunteers

Exclusion Criteria:

* respiratory disease
* active smoking
* cardiovascular disease
* renal disease
Hepatocyte Growth Factor and Cardiovascular Autonomic Function

In this study, we tested the hypothesis that elevated HGF is associated with insulin resistance and cardiovascular autonomic dysfunction in type 2 diabetic patients not receiving insulin treatment.


Eligibility Criteria:
Inclusion Criteria:

* Type-2 diabetes

Exclusion Criteria:

* Type-1 diabetes