cyrilzakka/clinical-trials huggingface dataset:
Telephone Counseling and Numberless Scales to Overcome Barriers to Adolescent Weight Loss

This study tests the feasibility and acceptability of a numberless behavioral digital scale (BDS) intervention combined with motivational interviewing (MI) to affect lifestyle changes to promote weight loss in adolescents who are obese. Half of the participants will receive this intervention, while the other half will use a digital scale along with the standard adolescent weight loss program.

The proposed pilot project seeks to enhance motivation for lifestyle change in adolescents who are obese. It will test a novel intervention that combines modified MI-based counseling and BDS. We will test the feasibility of the intervention over a 12-week period, with 24-week follow-up compared to use of standard digital scale. All participants will undergo the standard adolescent weight loss program, which includes monthly clinic visits with dietary and physical activity counseling. The MI intervention will include modified MI, brief weekly telephone reinforcement, and use of a BDS. The BDS with its mobile app offers daily feedback through colors, daily missions to promote healthy habits, and weekly healthy tips from nutritionists. In addition to the primary outcome of feasibility (daily weighing) investigators will also explore the intervention's effect on motivation, psychological outcomes and various aspects of feasibility and acceptability.

Eligibility Criteria:
Inclusion Criteria:

* Age between 12 and 18 years
* BMI greater than or equal to 95th percentile for age and sex group or BMI greater than or equal to 35 kg/m\^2
* Participant (not parent) is able to read and understand English (app is in English)
* Smartphone device with Wi-Fi and app capability
* Willingness to be randomized to any condition

Exclusion Criteria:

Age 19 years or older

* Developmental delay
* Inability to provide informed consent
* Any medical condition that, in the opinion of the PI, would place the participant at increased risk
* Use of an investigational agent in the 30 days prior to signing informed consent
* History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would , in the opinion of the PI, make it difficult for the participant to comply with study procedures or follow instructions
* Females who are pregnant or lactating, by verbal report
* Pre-existing conditions (i.e paralysis, heart failure, severe autism or mental retardation, psychosis, etc.)
* Prisoners
* Lack of transportation
Evaluation of the Biop Colposcopy System's Safety and Performance (Accuracy of Its Registration Procedure)

This is a multi-center, prospective, non-randomized, confirmatory study to evaluate the safety and performance of the Biop Digital Colposcope and the accuracy of the image registration procedure between the Biop Digital Colposcope unit and the Biop Micro Colposcope probe unit.

This is a multi-center, prospective, non-randomized, confirmatory study to evaluate the safety and performance of the Biop Digital Colposcope and the accuracy of the image registration procedure between the Biop Digital Colposcope unit and the Biop Micro Colposcope probe unit.

The Biop Digital Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. The images from the digital colposcope are to be viewed on a color display. The digital colposcope is intended for use in hospitals, clinics, and doctor's offices.

The Biop Micro Colposcope probe unit is an imaging tool intended to be placed in the vagina for acquisition of images of the cervix. It is intended as an adjunct to the Biop Digital Colposcope. It should NOT be used as a substitute for a thorough colposcopic evaluation. The Biop Micro Colposcope Probe unit is not intended for use on the vulva and vagina.

It is anticipated that it will take approximately 3 months to complete active enrollment. Study duration for each subject is 1-2 days, including screening, enrolment and procedure. The study will be completed when the final study subject has completed the procedure.

1. Performance - to confirm that average image registration error is less than or equal to (≤) 2mm.
2. Safety - to evaluate the safety of the Biop Digital Colposcope in women undergoing cervical colposcopy procedures.

Eligibility Criteria:
Inclusion Criteria:

* Females, ages 22 to 65 years old
* Referred for colposcopy, following abnormal cervical cytology
* Subject provides signed informed consent

Exclusion Criteria:

* Currently pregnant or nursing
* Currently menstruating
* Currently has intrauterine device (IUD)
* Diagnosed with diseases that may influence the color of the tissue, e.g., hepatitis, polycytemia vera.
* Diagnosed with pathologies that affect blood coagulation, the immune system or undergoing any treatment that interfere with coagulation or the immune system
* HIV-positive status
* Psychological instability, inappropriate attitude or motivation
* Use of any additional experimental drug or device or participation in another clinical study within the past 30 days
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of UC for at least 3 months prior to baseline.
* Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS).
* Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC.
* If female, must meet the contraception requirements.

Exclusion Criteria:

* Participants with a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis).
* Participants with a previous colectomy.
* Participants with current evidence of toxic megacolon.
* Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).
Effect of Quadratus Lumborum Block With Compound Lidocaine and Esketamine on Pain After Colorectal Surgery

Purpose:

To explore effects of ultrasound-guided quadratus lumborum block with compound lidocaine and esketamine on postoperative pain after colorectal surgery.

Poor post-surgical pain control is a leading factor that hinders the physicalrehabilitation, and causes acute cognitive impairment and chronic painsyndrome. Recently, the multimodal analgesia strategies to minimise opioidrelated side effects are highly desirable in open surgical procedures. Quadratus lumborum block is a novel technique. Although ropivacaine is most commonly used forthis technique, the analgesic duration remains not dissatisfied. Compared with ropivacaine, compound lidocaine injection has a better and longer analgesic activity since it contains menthol and ethanol with appropriate concentrations. However, whether compound lidocaine injection is efficiency in the quadratus lumborum block for abdominal surgery lacks investigations. Herein, we will evaluate the efficacy of ultrasound-guided quadratus lumborum block (USG-QLB) with compound lidocaine injection and esketamine for postoperative analgesia in patients undergoing colorectal surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is scheduled to undergo colorectal cancer surgery under general anesthesia
2. Subject's American Society of Anesthesiologists physical status is I-III.
3. The subject's parent/legally authorized guardian has given written informed consent to participate

Exclusion Criteria:

1. Subject has a diagnosis of bronchial asthma, coronary heart disease, severe hypertension, renal failure or liver failure.
2. Subject has a diagnosis of Insulin dependent diabetes.
3. Subject is allergy and contraindication to local anesthetics or any components of local anesthetics.
4. Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre- existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.
5. Subject has any contraindication for the use of patient-controlled analgesia (PCA).
6. Subject is pregnant or breast-feeding.
7. Subject is obese (body mass index \>30kg/m\^2).
8. Subject is incapacity to comprehend pain assessment and cognitive assessment.
High Flow Nasal Oxygenation and Gastric Insufflation in Anesthetized Patients

Transnasal humidified rapid-insufflation ventilatory exchange(THRIVE), or also termed high flow nasal oxygenation (HFNO) is a method of supplying heated, humidified high concentrations of oxygen via nasal cavity.

The purpose of this study is to investigate the effect of HFNO on gastric insufflation in paralyzed anesthetized patients undergoing laryngologic surgery.

HFNO can be used during intraoperative period. HFNO reduces the risk of desaturation and prolongs the safe apnea time, compared with conventional oxygenation.

In laryngeal microsurgery, HFNO therapy make possible to perform tubeless anesthesia, providing perfect exposure of structure of the vocal cords.

HFNO have a risk for low level of positive pressure can make gastric distension, but gastric reflux or aspiration were not occurred during rapid sequence induction for emergency operation.

The purpose of this study is to investigate the effect of HFNO on gastric insufflation in paralyzed anesthetized patients undergoing laryngologic surgery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology physical status classification I and II
* Patients scheduled for laryngeal microsurgery under general anesthesia

Exclusion Criteria:

* gastroesophageal reflux
* gastric pathology
* pregnancy
* major cardiovascular, pulmonary, or cerebrovascular disease
* severe obesity (body mass index\>35 kg/m2)
Renal Denervation in Treatment Resistant Hypertension

The purpose of this double-blind, randomized and sham controlled study is to investigate the blood pressure lowering effect of renal denervation by catheter based ablation in the renal arteries in patients with milder forms of treatment resistant hypertension. The effect on blood pressure will be evaluated by 24-hour ambulatory blood pressure measurements at baseline and after 3 and 6 months of follow up. Secondary endpoint evaluation comprises hemodynamic assessment by applanation tonometry and the cold pressor response.


Eligibility Criteria:
Inclusion Criteria:

* Systolic daytime (24 hour-ambulatory blood pressure measurement) \> 135 mmHg and \< 145 mmHg.
* Stable (for at least 1 month and with no planned changes for the next 6 months) antihypertensive therapy with at least 3 antihypertensive drugs, including a diuretic.
* Documented adherence to present antihypertensive therapy

Exclusion Criteria:

* Pregnancy
* Non compliance
* Heart failure (NYHA Class III-IV)
* LV ejection fraction \< 50 %
* Renal insufficiency (eGFR\<30 ml/min)
* Unstable coronary heart disease
* Coronary intervention within 6 months
* Myocardial infarction within 6 months
* Claudication
* Orthostatic syncope within 6 months
* Secondary hypertension (except CKD)
* Significant valvular heart disease
* Clinically significant biochemical abnormalities (electrolytes, haemoglobin, hepatic function, thyroid)
* Second and third degree AV block
* Macroscopic haematuria
* Renal artery anatomy not suitable for renal artery ablation (Stenosis, diameter \< 4 mm, length \< 2 cm or severe calcifications)
* Moderate/severe obstructive sleep apnoea (AHI \> 15) if CPAP treatment has not been attempted
EVLP to Evaluate the Eligibility for Transplantation of DCD-Lungs

The procurement of organs from donors after cardiocirculatory death (DCD) is an accepted strategy to increase organ supply.

Aim of the investigation: to compare the clinical outcome after transplantation of subjects receiving lungs procured from donors after cardiocirculatory death reconditioned and assessed by EVLP, with that of subjects receiving lungs procured from brain death donors.

Eligibility Criteria:
Lung donors:

* subjects with brain death according to neurological or cardiocirculatory criteria
* age below 65 yrs
* absence of massive lung contusion, aspiration, pneumonia, sepsis
* absence of infection, malignancy

Recipients:

* subjects to undergo single or bilateral lung transplantation
* informed consent to participate in the study
Comparative Effectiveness and Tolerance of Subliminal Subthreshold Transscleral Cyclophotocoagulation

Glaucoma, progressive optical neuropathy, is the leading cause of irreversible blindness in the world. Glaucoma treatment aims to lower intraocular pressure (IOP) by using medication, laser and surgery. Patients suffering from refractory and advanced glaucoma with impaired visual field who are not good candidates for surgery, cadenced subcleral transscleral cyclophotocoagulation (CPCTSI) is commonly used to reduce IOP. The CPCTSI consists in delivering short bursts of energy (in cycle) to the ciliary body, thus reducing production of aqueous humor. The energy gusts develop sequentially to a photocoagulating state in the pigmented epithelium. They are spaced by rest periods that allow surrounding tissue to cool down and remain below photocoagulative threshold, thus avoiding damage to surrounding tissue. Some studies have shown that the risk of complications increases with higher energies. Complications associated with CPCTSI include prolonged intraocular inflammation, pain, intraocular hemorrhage, hypotonia, phthysis, decreased vision and sympathetic ophthalmia. Severity of these complications depends on collateral damage inflicted on surrounding tissues: ciliary muscles, unpigmented epithelium and stroma of ciliary body. Currently, CPCTSI with a cycle ratio of 25% and 31.3% are used in surgical routine in ophthalmology. Cycle ratio is ratio between duration of gusts and total duration of cycle (gusts and rest periods). At St. Joseph's Hospital, both cycle ratios are used and the choice is operator dependent. However, using CPCTSI with a 25% cycle ratio could have fewer complications while maintaining similar efficacy. To our knowledge, there are no studies comparing these two cycle reports, although they are commonly used in practice. Our objective is to compare the CPCTSI with a cycle ratio of 25% and 31.3%.


Eligibility Criteria:
Inclusion Criteria:

* Patients with refractory and advanced glaucoma, defined as IOP \> 21 mmHg according to maximum tolerated medical treatment, with or without pre-glaucoma surgical procedures and a visual field \> 6 MD
* Patients treated in the GHPSJ ophthalmology department by a CPCTSI with cycle ratios of 25% or 31.3% between January and July 2017
* Patients who are poor candidates for additional filtration surgery or implantation of glaucoma drainage devices.

Exclusion Criteria:

* Patients who underwent intraocular surgery in the 2 months prior to CPCTSI
* Patients who have undergone conventional transscleral laser diode cyclophotocoagulation
* Patients who object to use of their data for this research.
An Implementation Trial to Improve Access to Pulmonary Rehabilitation in People With COPD

People with chronic obstructive pulmonary disease (COPD) experience distressing breathlessness and high health care utilisation. There is compelling evidence that pulmonary rehabilitation improves symptoms and reduces hospitalisation, but is delivered to \<10% of patients who would benefit. The investigators developed a low cost model of pulmonary rehabilitation that can be delivered entirely at home. The HomeBase model had equivalent outcomes to centre-based pulmonary rehabilitation in a phase II efficacy trial, with higher completion rates. The investigators hypothesise that a patient centred model offering a choice between home or centre-based pulmonary rehabilitation may increase program completion rates, with improved outcomes for patients and the health system.

This is a cluster randomised implementation trial investigating whether offering a choice of home or centre-based pulmonary rehabilitation can reduce hospitalisation, improve pulmonary rehabilitation completion and enhance patient outcomes in people with COPD. 14 pulmonary rehabilitation programs located across Australia will each recruit 35 people with COPD. Intervention centres: People with COPD will be offered the choice of centre-based pulmonary rehabilitation or the HomeBase model. Comparison centres: Only the existing centre-based model will be offered. The primary outcome is all cause, non-elective hospitalisation at 12 months. Other outcomes are symptoms, exercise capacity and quality of life at 8 weeks and 12 months; and health care costs at 12 months for full economic evaluation.


Eligibility Criteria:
Inclusion criteria for pulmonary rehabilitation programs:

• Outpatient pulmonary rehabilitation programs that admit at least 50 people with COPD each year.

Inclusion criteria for participants:

* Diagnosis of COPD confirmed on spirometry
* Able to read, write and speak English
* Able to provide informed consent.

Exclusion Criteria:

* Attended pulmonary rehabilitation within 1 year
* Comorbidities which preclude exercise training.
Pay-it-forward RCT for Gonorrhea and Chlamydia Testing

This is a randomized controlled trial which will evaluate dual gonorrhea/chlamydia test uptake and other outcomes in men who have sex with men (MSM) in three trial arms - 1) a pay-it-forward testing arm, 2) a pay-what-you-want testing arm, and 3) standard of care arm.

At both of the program sites, MSM partaking in HIV and syphilis testing will be offered dual gonorrhea/chlamydia testing. First, all men will be provided a brief (5 minute) introduction to gonorrhea and chlamydia testing using a pamphlet. Program organizers will then explain the pay-it-forward program to each man separately. Briefly, men will be told that the hospital list price of gonorrhea and chlamydia testing was 150 RMB ($24 USD), but previous men attending the clinic had donated money to cover the cost of his test. Thus, each man could receive a free gonorrhea and chlamydia test, then decide whether to donate money (pay-it-forward) for future men to receive the same option. Men will be assured that donating is completely optional and advised to pay any amount that is feasible for them. Each man's gonorrhea and chlamydia test fees will be covered by a combination of the initial funding pool from the program organizers and the donations from previous participants. Men will also be shown a postcard with a message written by a previous pay-it-forward contributor. Messages will contain information encouraging men to be tested/slogans to promote sexual health and testing (i.e. taking ownership of their health). They will be told that they could also write a postcard message for a future participant.

Men will then decide whether or not to receive combined urine gonorrhea/chlamydia testing. Program organizers will inform participants of their test results via WeChat. Patients with positive test results will be counseled and directed to the WeChat page of designated hospitals where they could make an appointment to receive treatment and follow-up.

Eligibility Criteria:
Inclusion criteria:

* born biologically male
* age 16 years or older
* report previous anal sex with another man
* willing to provide mobile phone number for results notification

Exclusion criteria:

* tested for both gonorrhoea and chlamydia in the past 12 months with no high-risk sexual behavior following testing
* previous participation in pay-it-forward program
Effect of Irbesartan on Insulin Sensitivity in Chronic Heart Failure

To test whether treatment with the angiotensin II receptor antagonist Irbesartan improves insulin sensitivity and metabolic profile in patients with chronic heart failure.

In CHF impaired insulin sensitivity is a common finding characterised by elevated fasting insulin levels and impaired effectiveness of insulin to utilise glucose in peripheral tissues, mainly in skeletal muscle tissue. Additionally, impaired insulin sensitivity, i.e. insulin resistance, progresses in parallel to severity of CHF and relates to major clinical symptoms such as reduced exercise capacity and muscle fatigue. In survival analyses, insulin resistance is a significant predictor of mortality, independently of and additionally to other established prognostic markers such as age, NYHA class, peak oxygen consumption, or LVEF. These findings indicate that insulin resistance is involved in CHF pathophysiology. Importantly, insulin resistance in CHF occurs independently of ischemic etiology. In ischaemic heart disease, however, insulin resistance as part of the metabolic syndrome is also an important prerequisite for the development of arteriosclerosis. Accordingly insulin resistance was found worst in CHF patients with ischemic etiology compared to patients with CHF due to dilated cardiomyopathy and those with ischaemic heart disease without heart failure. On the basis of these findings we hypothesise that therapeutically improving insulin sensitivity may have additional beneficial effects on energy utilisation and therefore improve clinical symptoms such as reduced exercise capacity and muscle fatigue.

Eligibility Criteria:
Inclusion Criteria:

1. ambulatory patients with symptomatic chronic heart failure (NAHY II-IV)
2. ischemic etiology
3. LVEF ≤ 45%
4. standard medical treatment for CHF (such as diuretics, beta blockers, ACE inhibitors, aspirin or warfarin). Patients should be treated with ACI inhibitor for at least 12 months prior to enrolment into the study. Patients should not be treated with angiotensin II receptor antagonists during the study other than the trial medication. Further medical treatment such as spironolactone, amiodarone and others are allowed if the patient is on a stable dose at the beginning of the trial. Dosages should be kept stable during the trial except adjustment is judged necessary for clinical reason.
5. Patient should be hospitalised due to deterioration of the cardiac disease at least once in the last 12 months under ACE-I therapy.
6. age \> 21 years
7. informed consent

Exclusion Criteria:

1. hospitalisation with intervention within 2 weeks of intended randomisation
2. unstable IHD or Myocardial infarction \< 2 months
3. open diagnosed diabetes mellitus / antidiabetic treatment with insulin, metformin, sulfonylurea, glinides
4. COPD treated with steroids