cyrilzakka/clinical-trials huggingface dataset:
Cognitive Behavioural Therapy for Obesity

The purpose of this study is to evaluate the effectiveness of a cognitive behavioural treatment (CBT) designed to help obese patients lose weight and to maintain their weight losses over time. It is hypothesized that CBT will result in greater sustained weight loss.

The primary aim of the present study is to improve the maintenance of weight loss, and hence the physical, psychological and social well-being, of obese patients who have sought weight loss treatment. To do so, it will implement a cognitive-behavioural treatment (CBT) with motivational enhancement strategies specifically designed to target weight maintenance. It is hypothesized that the maintenance-oriented CBT approach will result in sustained weight loss, as well as improved physical, psychological and social well-being.

Eligibility Criteria:
Inclusion Criteria:

* The participants will be recruited from among patients referred to the Metabolism and Obesity Service of Royal Prince Alfred Hospital.
* The inclusion criteria include: 18-65 years of age and a body mass index (BMI: kg/m2) between 30-45.

Exclusion Criteria:

* psychiatric conditions (i.e., current psychosis, severe depression, mental retardation, and drug or alcohol abuse)
* or physical conditions (i.e., significant hepatic or renal dysfunction and significant cardiovascular disease such as heart failure, stroke and transient ischaemic attacks) that would preclude full participation in the study;
* current treatment for obesity;
* current treatments known to affect eating or weight (e.g., medications);
* pregnancy.
Validation of Sleep Monitoring Algorithm Based on Smart Watches

In recent years, wearable devices are booming to enable not only the health monitoring but also the sleep efficiency assessment. To validate the algorithm of sleep staging and efficiency, this study will use a dedicated prototype to acquire photoplethysmogram (PPG), body movements, skin temperature, and galvanic skin response by recruiting 35 subjects. PSG will be used as gold standard for statistical analysi.

Sleep efficiency has a great impact on the performance of work and learning during the day. If persons lack of sleep for a long time, they might be prone to memory loss and emotional instability. Traditionally, polysomnography (PSG) has been proved as golden results to assess the sleep efficiency. However, to accomplish the assessment, subjects are asked to sleep in a certified sleep laboratory or a sleep centers for nights. Under the supervision of nurses, subjects are put many adhesive electrodes on the body and connect wires to PSG, which causes discomfort. In recent years, wearable devices are booming to enable not only the health monitoring but also the sleep efficiency assessment. To validate the algorithm of sleep staging and efficiency, this study will use a dedicated prototype to acquire photoplethysmogram (PPG), body movements, skin temperature, and galvanic skin response by recruiting 35 subjects. PSG will be used as gold standard for statistical analysi.

Eligibility Criteria:
Inclusion Criteria:

1. Forty male or female subjects are recruited from those visiting Department of Medicine for health check up
2. Subjects aged 20 to 65

Exclusion Criteria:

1. Refuse to participate
2. Arrhythmia
3. Active infection
4. Active neurologic event
5. Shift worker
6. Substance abuse
7. Fitted with implantable medical electronics, such as cardiac pacemakers and defibrillators
Brain Imaging Biomarkers for Response to Spinal Cord Stimulation in Patients With Chronic Low Back Pain

In this protocol, "Brain imaging biomarkers for response to Spinal Cord Stimulation in patients with chronic low back pain," the investigators plan to perform brain mapping studies in 42 patients who are undergoing spinal cord stimulation (SCS) for chronic low back pain (CLBP) as part of the participants normal clinical care during a 2-year period. This imagining study is completed for research purposes. There is no standard of care imaging for the participants. This study requires two visits in total. During the baseline visit, participants will undergo imaging acquisition protocol and corresponding assessments. Participants will have another follow-up visit (potentially remotely) for final assessments two weeks after the SCS treatment. The objective of the study is to investigate potential imaging biomarkers that can predict response to the SCS treatment. Specifically, the investigators hypothesize that the connectivity of a certain region of the brain (specifically the subgenual cingulate) prior to SCS may serve as a possible pre-operative imaging-based biomarker on response to SCS. The findings of the study may further enhance investigators understanding of the connectivity between brain areas that are critical to the therapeutic response to SCS in CLBP patients and that can be used as a putative biomarker to select patients who may respond to SCS.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 21 years of age at time of consent
* Subject has been recommended to undergo an SCS trial for chronic back with or without leg pain by their pain management physician
* Chronic low back pain as defined by persistent low back pain despite prior treatments that continues for 12 weeks or longer
* Subject signs a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided

Exclusion Criteria:

* Subject is a woman who is not using adequate contraception, is pregnant or breastfeeding or intends to become pregnant during the course of the study
* Subject has previously undergone a spinal cord stimulation trial or is already implanted with an active implantable device(s) to treat their pain (Implantable Pulse Generators (IPGs), implantable drug pump, etc.) or pacemaker or implantable cardiac defibrillator
* Subject is currently abusing alcohol or illicit drugs
* Contraindications to MRIs or the need for recurrent body MRIs
* Presence of cardiac pacemakers/defibrillators, implanted medication pumps, intra-cardiac lines, any intracranial implants (e.g., aneurysm clip, shunt, cochlear implant, electrodes) or other implanted stimulators
A Study to Evaluate AXR-159 Ophthalmic Solution in Patients With Dry Eye Disease

Protocol AXR201701 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 stages (Stage 1: AXR-159 Ophthalmic Solution (30 mg/mL or 50 mg/mL); Stage 2: AXR-159 Ophthalmic Solution (3 mg/mL, 30 mg/mL or 50 mg/mL) in approximately 430 patients diagnosed with dry eye disease (DED).

Protocol AXR201701 is designed with 2 stages. For both Stages 1 and 2, patients with signs and symptoms of DED will be randomly assigned to receive either a single concentration of AXR-159 Ophthalmic Solution or AXR-159 Ophthalmic Solution Vehicle.

A screening visit will be followed by a baseline period where subjects will dose with AXR-159 Ophthalmic Solution Vehicle for 14 days. At the end of the baseline period patients who still exhibit signs and symptoms of DED will be enrolled into a 3-month double-masked treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age or older at screening visit
* Best-corrected visual acuity (BCVA) of 20/100 or better (Snellen equivalent), using the logarithm of the minimum angle of resolution (LogMAR) in each eye
* Reported history of dry eye for at least 6 months
* Corneal fluorescein staining score ≥ 2
* Eye dryness score ≥ 40
* Total Ocular Surface Disease Index (OSDI) score \> 18

Exclusion Criteria:

* Uncontrolled ocular disease (except for dry eye disease/keratoconjunctivitis sicca) or uncontrolled systemic disease
* Patient has glaucoma, ocular hypertension, on IOP-lowering medications or have previously undergone any glaucoma laser or surgical procedure.
* Corneal abnormality or disorder that impacts normal spreading of the tear film (keratoconus, pterygia, scarring) or compromised corneal integrity
* BCVA worse than 20/100 in either eye
* Current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye
* Keratoconjunctivitis sicca secondary to destruction of conjunctival goblet cells
* Patients with clinically significant inflammation of the lid margin such as anterior blepharitis or ocular rosacea
* Recent (within the past 3 months) ocular surgery, trauma or herpes
* Use of contact lenses in either eye within one month prior to the screening visit or anticipated use during the study
Cap-assisted Water Immersion Versus Water Immersion Colonoscopy

Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. Cap attached to the colonoscope tip may improve insertion and shorten cecal intubation time. The investigators would like to assess whether combination of cap-fitted colonoscopy and water immersion insertion is feasible and safe method of diagnostic colonoscopy. The primary endpoint is cecal intubation time and the investigators suppose that the use of cap is able to shorten it significantly. Patient comfort during colonoscope insertion, water consumption, length of the scope while reaching the cecum, need for external compression, need for positioning of the patient and endoscopist´s difficulty with colonoscopy are assessed.


Eligibility Criteria:
Inclusion Criteria:

* outpatient diagnostic colonoscopy
* bowel prep with macrogolum
* initial 2 mg of midazolam i.v.
* signed informed consent form

Exclusion Criteria:

* planned therapeutic intervention
* colorectal surgery in history
* known inflammatory bowel disease or colorectal cancer
* refusal of sedation
Survey of Post-Acute Inpatient Rehabilitation Safety Concerns in Participants With Cancer

This trial studies a survey of post-acute inpatient rehabilitation safety concerns in participants with cancer. Collecting patients' feedback via surveys may help doctors to learn more about the safety concerns that patients have when they are discharged from the acute inpatient cancer rehabilitation unit.

PRIMARY OBJECTIVES:

I. Assess patients' perceptions regarding safety after acute inpatient rehabilitation at discharge and after approximately one month from discharge date.

SECONDARY OBJECTIVES:

I. Assess patient's perception of factors impacting continuity of care at discharge and after approximately one month from discharge date.

II. Determine the frequency of reported falls and the circumstance surrounding reported falls during hospitalization and within approximately one month from discharge date.

III. Determine the frequency of reported near falls and the circumstance surrounding reported near falls within approximately one month from discharge date.

IV. Identify demographic and clinical characteristics associated with feeling safe and unsafe.

OUTLINE:

Participants complete surveys over 15 minutes at 1-2 days before discharge and at 1 month after discharge.

Eligibility Criteria:
Inclusion Criteria:

* All patients who are discharged from the acute cancer inpatient rehabilitation unit to personal residence (house, apartment, condominium, hotel, assisted living, etc.)
* Patients who provide informed consent
* English-speaking participants

Exclusion Criteria:

* Patients discharged to another hospital or health facility (Skilled Nursing Facility \[SNF\], Long Term Acute Care Hospital \[LTACH\], inpatient hospice, etc.)
* Patients with moderate to severe cognitive deficits as determined by speech language pathologist and/or rehabilitation physician
* Patients who were re-hospitalized at any time during study period (since completion of first survey in the hospital and discharged from the hospital until approximately one month after discharge
* Patients who were readmitted to acute inpatient rehabilitation service and previously completed both surveys
Primary Vitrectomy for the Treatment of Retinal Detachment in Highly Myopic

Purpose:

To assess the functional and anatomical outcome of primary vitrectomy without scleral buckling for rhegmatogenous retinal detachment (RRD) in highly myopic eyes with axial length over 30 mm.

Methods Design: Retrospective single center series. Setting: University Hospital. Patients: High myopic patients treated with primary vitrectomy without scleral buckling for a rhegmatogenous retinal detachment.

Outcome measures: Anatomical success rate with complete reattachment of the retina without silicone oil tamponade and postoperative best-corrected visual acuity (BCVA).


Eligibility Criteria:
Inclusion Criteria:

* retinal detachment secondary to peripheral breaks (retinal tears, atrophic retinal hole)
* secondary to posterior breaks (MH, PVT).

Exclusion Criteria: retinal detachment secondary to

* severe eye injury,
* diabetic retinopathy,
* retinopathy of prematurity,
* uveitis.
Bifidobacterium Animalis Subsp. Lactis in Prevention of Common Infections in Healthy Children Attending Day Care Centers

Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common infections (gastrointestinal and respiratory) in healthy children who attend day care centre

This study is a prospective, randomized, double blind, placebo- controlled parallel study in healthy children attending day care centers.

The study will investigate the effect of supplementation with the probiotic strain Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and respiratory infections and absence from day care due to infections.

The test product is a sachet containing 1 gram of powder. The test product will contain minimum 1 billion CFU (colony forming units) of probiotic per serving. The placebo product is an identical product except for the absence of probiotics.

The study includes 3 months (90 days) of intervention period. The study product will be consumed daily in the evening together with a meal.

The consumption of the study products will be taken under the surveillance of the parents.

During the entire intervention period the subjects are not allowed to consume any probiotic products other than the study products supplied to them by the study personnel.

Data on infections will be recorded in a diary, filled in and administered by the parents and diary recorded by referring physician (on-call log).

All infections are to be diagnosed by the local physician. The incidence of infections will be analyzed based on the information recorded in the diaries (parent's \& physician's).


Eligibility Criteria:
Inclusion Criteria:

* Healthy children attending day care at kindergartens located in the Zagreb's city centre
* Age from 1 year to 7 years
* Attendance at daycare centers: \> 3 days per week
* Signed informed consent by the parents

Exclusion Criteria:

* Immunodeficiency
* Receiving probiotic and /or prebiotic products prior to enrolment (2 weeks prior to study start)
* Neoplasms
* Severe chronic disorders
Perioperative Collection of Temperatures and Hypothermia

Accidental perioperative hypothermia is a frequent complication of anesthesia that favors the occurrence of infections, bleeding and perioperative cardiovascular accidents, and is responsible for perioperative excess mortality. Although preventive measures are widely used, it remains very frequent in France. This observation led a group of experts to draft, under the aegis of the Société Française d'Anesthésie et de Réanimation (SFAR), several recommendations aimed at improving the prevention of perioperative accidental hypothermia.

Perioperative hypothermia is defined as a core body temperature below 36.0 ° Celsius.

This study aims to evaluate the impact of hypothermia prevention training on the proportion of hypothermic patients in the operating room.


Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years old
* surgeries performed at the Centre Léon Bérard

Exclusion Criteria:

* Digestive endoscopy, interventional radiology, brachytherapy (operating rooms outside the central operating room)
* Patient who decline to participate in the study
* Active systemic infection
* Hyperthermic Intraperitoneal Chemotherapy (HIPEC) or Intrathoracic Chemotherapy (HITeC)
* Deprivation of liberty
* operation performed under local anesthesia only
Impact of Medications Review on Potentially Inappropriate Medications and Clinical Outcomes Among Hospitalized Older Adults

The goal of this randomized controlled trial is to assess the effectiveness of a pharmacist-led medication review using the locally developed Malaysian Potentially Inappropriate Prescribing Screening tool in Older Adults (MALPIP), an explicit criteria in hospitalized older adults. The main questions it aims to answer are:

1. The effectiveness of the intervention in reducing the number of PIMs and chronic medications after discharge
2. The impact of the intervention on quality of life, falls events, emergency department visits, readmissions and survivals

Researchers will compare the control group to see if there is corresponding changes to the outcomes specified above.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 60 years and above
* Taking more than five regular drugs
* Having at least one chronic medical condition
* Ability to understand and speak Malay, English, or Mandarin language

Exclusion Criteria:

* Admitted for end-of-life care
* Diagnosed with terminal illness
* Diagnosed with active cancer
* Participated in another drug trial
* Refused or unable to give consent
* Visited the Emergency Department without admission to ward
* Readmitted and have been previously enrolled in the trial
A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).


Eligibility Criteria:
Inclusion Criteria:

* Disease classification criteria: Participant meets the diagnostic criteria of probable or definite idiopathic inflammatory myopathies (IIM) based on 2017 The European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for adult IIM at least 6 weeks prior to first administration of the study intervention
* If a participant is on regular or as needed treatment with low potency topical glucocorticoids (GC) that are allowed in the study or topical tacrolimus (TAC) to treat skin lesions, the dose and frequency should be stable for greater than or equal to (\>=) 4 weeks prior to first administration of the study intervention as well as maintained at the same dose until Week 52 of the study
* Antibody positivity criteria: Any 1 of the myositis-specific antibodies (MSAs) positive: dermatomyositis (DM): anti-Mi-2 (Mi-2/nucleosome remodeling and deacetylase \[NuRD\] complex), anti-transcription intermediary factor 1-Gamma (TIF1-Gamma), anti- nuclear matrix protein 2 (NXP-2), anti-small ubiquitin-like modifier-1 activating enzyme; anti- antimelanoma differentiation-associated gene 5 (MDA-5) antibodies. Or immune-mediated necrotizing myopathy (IMNM): anti- signal recognition particle (SRP) and anti- 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) antibodies. Or anti-synthetase syndrome (ASyS): anti- histidyl- ribonucleic acid \[tRNA\] synthetase (Jo-1), anti- threonyl-tRNA synthetase (PL7), anti- alanyl-tRNA synthetase (PL12), anti- isoleucyl-tRNA synthetase (OJ), and anti- glycyl-tRNA synthetase (EJ) antibodies. If all MSAs are negative or more than 1 MSA is positive within different subtypes (defined by the central laboratory) at screening, the tests should be repeated during the screening period. If the same results are observed at retesting, the participant should not be enrolled in the study

Exclusion Criteria:

* Has a juvenile myositis diagnosis and now \>=18 years old
* Has cancer-associated myositis defined as cancer diagnosis within 3 years of myositis diagnosis except for cervical carcinoma in situ and non-melanoma skin cancer (squamous cell carcinoma, basal cell carcinoma of the skin)
* Has comorbidities (example, asthma, chronic obstructive pulmonary disease \[COPD\]) which have required 3 or more courses of oral GC within 1 year prior to screening
* Has a history of primary immunodeficiency or secondary immunodeficiency not related to the treatment of the participants IIM
* Has experienced myocardial infarction (MI), unstable ischemic heart disease, or stroke within 12 weeks of screening
Digitally Enhanced Smoking Cessation for High Risk Smokers

This is a research study, is testing a program to improve lung health through smoking cessation and providing education around lung screening.

In this research study involves Studying the Enhanced Smoking Cessation Approaches to Promote Empowerment (ESCAPE) program compared to usual care.

The ESCAPE program was developed help women with HIV quit smoking. Women in the ESCAPE program quit smoking and stayed quit for longer (up to 3 months). For this study, investigators have added a lung screening to the ESCAPE program and want to test if this will improve lung health through increasing quit rates and lung screening.

.

* This is a research study, is testing a program to improve lung health through smoking cessation and providing education around lung screening. The research study procedures include: screening for eligibility and study interventions including participation in counseling and completion of questionnaires by e-mail, phone or in-person.
* This research study involves participating in either the Enhanced Smoking Cessation Approaches to Promote Empowerment (ESCAPE) program or the usual care. Participants will be randomized into one of two groups:

  * ESCAPE: The ESCAPE program provides 8 counseling sessions over the phone, provides nicotine replacement therapy at no cost, and education about lung screening
  * Usual Care: The usual care program will include 1 counseling session, nicotine replacement therapy at no cost referral and enrollment in quitworks
* Participants will be in this research study for up to 6-months.
* It is expected that about 250 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* 55 to 77 years of age
* No previous history of lung cancer
* ECOG performance status \< 2
* ≥ 30 pack year smoking history
* Smoke ≥ 5 cigarettes/day
* Own a mobile phone with access to a video call application
* Has a primary care provider (PCP)
* Provide contact information for the PCP
* Active health insurance
* Has not had LDCT screening
* English speaking
* Can complete an interview

Exclusion Criteria:

* Hospitalization for severe mental illness within the last year.
* The following special populations will not be included

  * Adults unable to consent
  * Individuals who are not yet adults (infants, children, teenagers)
  * Pregnant women
  * Prisoners