cyrilzakka/clinical-trials huggingface dataset:
Brief Behavioural Economic Intervention for Smoking Cessation

The goal of this clinical trial is to test the effectiveness of brief behavioural economic intervention in promoting smoking cessation among smokers in the community.

Smoking cessation services are free and effective but underused in Hong Kong. Active referral to smoking cessation services has consistently been found effective in promoting service use and successful quitting as a stand-alone strategy or when combined with other interventions. Participants who received active referral are introduced about the cessation services in Hong Kong and offered connection to the services of their choices. Contacts of participants who agreed to be referred are transferred to the selected cessation providers, who will subsequently contact the participants for further treatment.

The current active referral intervention uses an opt-in approach, where participants are required to actively choose to be connected to the services. By leveraging behavioural economic principles, a simple yet promising strategy to strengthen the active referral intervention is to utilize an "opt-out" approach, where participants are automatically referred to the service unless they actively decline the referral. By making referral to smoking cessation services as the default choice, the investigators aim to increase the uptake of these services and thus improve smoking cessation outcomes. Additionally, mobile messaging informed by behavioural economics principles can serve as nudges to prompt smokers to initiate quitting and utilise cessation services.

The clinical trial aims to test the effectiveness of opt-out referral, with or without behavioural economic-based mobile messaging, compared to opt-in referral, in promoting smoking cessation. The trial will be nested within the 15th "Quit to Win" Smoke-free Community Campaign organised by the Hong Kong Council on Smoking and Health.

Eligibility Criteria:
Inclusion Criteria:

1. Hong Kong residents aged 18 years or above
2. Smoke cigarette or heated tobacco product or e-cigarette daily in the past 3 months
3. Exhaled carbon monoxide level ≥4 parts per million or a positive salivary cotinine test
4. Able to communicate in and read Chinese
5. Own a smartphone with a mobile instant messaging app installed

Exclusion Criteria:

* Participating in another smoking cessation programme or using any smoking cessation drug or nicotine replacement therapy
Motivational Interviewing on Healthy Lifestyle Behaviors and Quality of Life in on Menopausal Women

Background: This study aims to determine the effect of motivational interviewing on healthy lifestyle behaviors and quality of life in menopausal women.

Methods: This is a randomized controlled empirical study. The study was conducted with a total of 136 women, including 68 for experimental group and 68 for control group. The data were collected using an introductory information form, the Health Promoting Lifestyle Profile II (HPLPL II) and the Menopause-Specific Quality of Life (MENQOL). Women in the experimental group received 6 sessions of motivational interviewing and 2 follow-up interviews in two family health centers (FHCs) from the researcher. No intervention was applied to women in the control group. The data were analyzed using number, percentage, mean, standard deviation, chi-square test, Bonferroni test, independent samples t test and repeated ANOVA.


Eligibility Criteria:
Inclusion Criteria:

1. being literate;
2. being able to make a conscious decision to participate in the study, being able to communicate verbally, and being able to sign a consent form;
3. having had menopause naturally and within the last 3 years;
4. being sexually active;
5. having no hormone replacement therapy.

Exclusion Criteria:

1. unwilling to continue the study;
2. having a psychiatric diagnosis according to the FHC records.
Balance Training With tDCS for CAI

The purpose of this research study is to examine the efficacy of non-invasive brain stimulation in addition to balance exercise for chronic ankle instability (CAI), a condition that develops following an initial ankle sprain, usually because of loose or unstable ankle joints.


Eligibility Criteria:
Inclusion Criteria:

* Subjects should be neurologically sound
* Subjects should have abilities to maintain a single-leg stance at least for 10 seconds.
* A history of ankle sprain
* A history of ankle joint giving ways
* Current feelings of ankle joint instability

Exclusion Criteria:

* Individuals with a clinically defined neurological disorder, with an increased risk of seizure for any reason, with a history of treatment with Transcranial Magnetic Stimulation (TMS), deep brain stimulation for any disorder will be excluded.
* Patients with cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed will be excluded.
* A history of balance or vestibular disorder
* A history of previous surgeries to the musculoskeletal structures in either limb of the lower extremity
* A history of a fracture in either limb of the lower extremity requiring realignment
* A history of acute injuries to the lower extremity joints in the previous 3 months, which impacted joint integrity and function (i.e., sprains, fractures) resulting in at least 1 interrupted day of desired physical activity
* A history of herniated disc
* Poorly controlled headache
* Hypersensitivity to electrical or magnetic stimulation
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoner
Does the Use of a Moisture Chamber Decrease the Incidence of Corneal Abrasions in Critically Ill Pediatric Patients?

The purpose of this study is to identify the incidence of scratches on the surface of the eye in children who cannot blink due to medication use and to identify how best to reduce the risk of a scratch on the surface of the eye when patients are using specific medicines.

Critically ill children may require neuromuscular blockade as a treatment modality. These children require careful eye care to prevent corneal abrasions. However, current evidence does not exist to guide best practices on eye care. This research study will evaluate 2 types of eye care therapy. The eyes will be randomly assigned to the control or experimental eye care therapy group. The control eye will receive lubricating ointment every 6 hours. The experimental eye will receive lubricating ointment every 6 hours and have a plastic covering to create a moisture chamber. Using daily fluorescein staining to detect corneal abrasions, each child will be studied for up to 9 days. Children who develop corneal abrasions will be discharged from the study and the primary care team will be notified. The two groups will then be compared to determine the therapy associated with the lowest incidence of corneal abrasions.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 42 weeks post-conceptual age and less than 18 years
* Anticipated need for neuromuscular blockade therapy for at least 24 hours

Exclusion Criteria:

* Use of continuous neuromuscular blockade therapy for more than 36 hours (early intervention study)
* Past medical history of abnormal blink reflex or incomplete lid closure
* History of daily eye drop use
* Facial trauma
* Alteration in periorbital skin integrity prohibiting eyelid closure or effective creation of a moisture chamber
* Known allergy to eye lubricant
Effects of Drugs on Responses to Brain and Emotional Processes

To study the effects of a psychostimulant on responses to affective touch in individuals with a range of autistic traits


Eligibility Criteria:
Inclusion Criteria:

* BMI between 19 and 30 (no one under 130 lbs)
* Smokers smoking less than 25 cigarettes per week
* Have used ecstasy no more than 40 times with no adverse responses.

Exclusion Criteria:

* High blood pressure
* Any medical condition requiring regular medication
* Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
* Individuals with a history of dependence on stimulant drugs.
* Women who are pregnant or trying to become pregnant
Effect of Transcutaneous Electroacupuncture on Functional Abdominal Bloating/Distension

Functional abdominal bloating/distension (FAB/D) is a common functional bowel disorder that lacks effective treatment options. Transcutaneous electroacupuncture (TEA) as a new therapeutic method has great effect on functional gastrointestinal diseases such as functional dyspepsia and functional constipation. Research on TEA for FAB/D has not yet been explored.

Functional abdominal bloating/distension (FAB/D) is a common functional bowel disorder that lacks effective treatment options. Rome IV was introduced in 2016. Studies have shown that bloating may affect about 30% general population and 96% of patients with functional gastrointestinal disorders (FGID).Transcutaneous electroacupuncture (TEA) as a new therapeutic method has great effect on functional gastrointestinal diseases such as functional dyspepsia and functional constipation. Research on TEA for FAB/D has not yet been explored. Thirty patients who fulfilled the Rome IV diagnostic criteria of FAB/D in the department of the second affiliated hospital of Xi'an jiaotong University.Inclusion criteria included: Symptoms of recurrent abdominal fullness, pressure, or a sensation of trapped gas (bloating), and/or measurable (objective) increase in abdominal girth (distention) more than 6 month；the main symptoms appeared in the past 3 months；Not taking related drugs; aged 18-65 years old；From January 2020 to December 2021; Sign informed consent. All patients were randomly assigned to 3 groups and received TEA at Zusanli (ST36) and Neiguan (PC6) with 3 diffrent parameter for 4weeks. The symptom severity score, abdominal girth, electrogastrogram (ECG) and orocecal transit time (OCTT) ,heart rate variability (HRV) ,rectal sensitivity and intestinal flora were recorded at baseline and after 2-week treatment, respectively. The symptom severity score was repeated at baseline and after 4-week treatment. Through the comparison of the index before and after TEA treatment to identify optimal stimulation parameters and explore its possible mechanism. The study was proved by the medical ethics committee of the Second Affiliated Hospital of Xi'an jiaotong University.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of Functional bloating/distension with Rome IV;
2. Aged 18-65 years old；

Exclusion Criteria:

1. Have taken drugs that may affect gastrointestinal motility in the past week;
2. Have taken antibiotics and probiotics in the past month;
3. The history of gastrointestinal surgery;
4. Helicobacter pylori is not cleared；
5. Pregnant and breastfeeding women;
6. Skin allergies.
Duloxetine vs Placebo in the Treatment of General Anxiety

To see if duloxetine 60 to 120 mg once daily (QD) is better than placebo in the treatment of generalized anxiety disorder (GAD).

duloxetine 60 to 120 mg once daily (QD) and placebo 11 weeks

Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients at least 18 years of age presenting with generalized anxiety disorder (GAD) based on the disease diagnostic criteria The patient must suffer from GAD and not from an adjustment disorder or anxiety disorder not otherwise specified (NOS). Symptoms of GAD should not be situational in nature.
* Females of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who are not breastfeeding; test negative for pregnancy at the time of enrollment based on a urine pregnancy test; and agree to use a reliable method of birth control during the study and for 1 week following the last dose of study drug.
* Must have a Clinical Global Impressions of Severity (CGI-Severity) score of greater than or equal to 4 at Visit 1 and Visit 2.
* At Visit 1, patient must have a Covi Anxiety Scale (CAS) score of greater than or equal to 9, no item in the Raskin Depression Scale (RDS) may be greater than 3, and the CAS must be greater than the RDS.
* Must have a Hospital Anxiety and Depression Scale (HADS) anxiety subscale score of greater than or equal to 10 at Visit 1.

Exclusion Criteria:

* Any current and primary DSM-IV Axis I diagnosis other than GAD.

  * Patients diagnosed with or who have a history of major depressive disorder (MDD) within the past 6 months or
  * Patients diagnosed with or who have a history of Panic Disorder, Post-Traumatic Stress Disorder (PTSD), or an eating disorder within the past year or
  * Patients who have been diagnosed with Obsessive Compulsive Disorder (OCD), Bipolar Affective Disorder, psychosis, factitious disorder, or somatoform disorders during their lifetime.
* The presence of an Axis II disorder or history of antisocial behavior, which, in the judgment of the investigator, would interfere with compliance with the study protocol.
* Benzodiazepine use 14 days prior to Visit 2.
* Patients judged clinically to be at serious suicidal risk, or patients who, in the opinion of the investigator, are poor medical or psychiatric risks for study completion.
* Have received treatment within the last 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry.
Long-term Follow-up Study of Male Adults With Hemophilia B Previously Treated With Etranacogene Dezaparvovec (CSL222)

The primary purpose of this study is to assess the long-term safety and efficacy in male adults with hemophilia B who were treated with CSL222 (CSL222) in parent studies CSL222_2001 (NCT03489291) or CSL222_3001 (NCT03569891).


Eligibility Criteria:
Inclusion Criteria:

Received treatment with CSL222 in Study CSL222_2001 or Study CSL222_3001, and completed participation in Study CSL222_2001 or Study CSL222_3001 or at least 5 years have passed since receiving CSL222.

Exclusion Criteria:

Not Applicable
Childhood Metabolic Markers of Adult Morbidity in Blacks

Blacks are at increased risk for obesity, type 2 diabetes mellitus and cardiovascular disease. A common pathogenetic link among these entities is insulin resistance/hyperinsulinemia.

The specific aims of this project are: 1) to compare skeletal muscle lipid content (SMLC) in black vs white children by computed tomography (CT) scan of the mid-thigh, and assess the relationship to in vivo insulin sensitivity; 2) to test the hypothesis that free fatty acid (FFA) - induced insulin resistance is associated with larger increases in intramyocellular lipid (IMCL) in black vs white adolescents; 3) to examine if β-cell insulin secretion in prepubertal black children is more sensitive to the stimulatory effect of FFA than in whites; and 4) to test if the β-cell in black obese adolescents is more susceptible to the lipotoxic effect of FFA compared with whites. The methods to be used are: the well- established CT method as well as Magnetic Resonance Spectroscopy (1H-MRS) to assess SMLC and IMCL; intralipid infusion to elevate circulating FFA levels; the hyperinsulinemic-euglycemic clamp with stable isotopes and indirect calorimetry to measure insulin sensitivity and substrate turnover; the hyperglycemic clamp to assess insulin secretion; DEXA and whole body MRI for body composition assessments.


Eligibility Criteria:
Inclusion Criteria:

Protocols 1 \& 4:

* Age 11-17 years
* Male or Female
* Healthy
* Obese, BMI ≥ 95 percentile
* Pubertal/Tanner Stage II-V
* African American or White American, based on self identity with no admixture for 3 generations

Protocol 2:

* Age 11-17 years
* Male or Female
* Healthy
* Normal Weight, BMI 10- 95 percentile
* Pubertal/Tanner Stage II-V
* African American or White American, based on self-identity with no admixture for 3 generations

Protocol 3:

* Age 8-12 years
* Male or Female
* Healthy
* Normal Weight, BMI 10-95 percentile
* Prepubertal/Tanner Stage I
* African American or White American, based on self-identity with no admixture for 3 generations

Exclusion Criteria:

* Medications which interfere with metabolism
* Hemocue \< 12 gm/dl in pubertal subjects and \<11gm/dl in prepubertal subjects
* Positive serum pregnancy test
* Recent significant weight change or dieting
* Presence of disease (i.e.diabetes, hypothyroidism, genetic dyslipidemia, etc)
Impact of Cancer on Memory Functioning: Understanding Disorders Using Approaches in Neuropsychology and Neuroimaging

The purpose of this study is to investigate memory problems in patients with cancer.


Eligibility Criteria:
Inclusion Criteria for patients:

* Patients aged 45 and over
* Patients from Grade 3 'end of primary schooling "minimum (scale Barbizet)
* Non-Metastatic Breast Cancer
* Adjuvant Chemotherapy: FEC, including Docetaxel Protocols
* No major cognitive impairment
* No previous neurological
* Lack of personality disorders and psychiatric disorders evolutionary
* Having signed the informed consent of study participation

Inclusion Criteria for control group:

* Women from the general population aged 45 and over, and matched in age and cultural level in patients
* Topics of Grade 3 'end of primary schooling "minimum (scale Barbizet)
* No prior cancer
* No major cognitive impairment
* No previous neurological
* Lack of personality disorders and psychiatric disorders evolutionary
* Participating in the IMAP Protocol No. ID-BCR: 2007-A00414-49 or IMAP+(n° ID RCB 2011-A01493-38)(see how the study below) have signed forms no objection and consent to study participation

Exclusion Criteria:

Traduction (français \> anglais)

* Metastatic
* Cancer of the breast other than primitive
* Patients with paraneoplastic syndrome
* Patients under 45 years
* Patients whose achievement is below level 3 'end of primary schooling "(scale Barbizet)
* Patients with adjuvant chemotherapy is associated with targeted therapy
* Patients who have received other cancer treatments (chemotherapy or radiotherapy brain)
* Contraindication to the implementation of an MRI (claustrophobia, metal objects in the body)
* disorders of higher functions existing in the administration of chemotherapy
* Neurologic earlier
* Pathology psychiatric evolutionary
* Refusal of participation
* Patients unable to meet the cognitive tests
* Drug use
* Heavy drinking
A Nutrition/Hygiene Education Program for the Prevention of Child Malnutrition in Rural Kenya

This study will determine if an education program about hygiene and child feeding practices, taught by local village community health workers, will improve child growth and decrease the prevalence of childhood malnutrition in a rural region of Kenya.


Eligibility Criteria:
Inclusion Criteria:

* Child of a mother living in the catchment area of the study who delivered during the enrollment period
Biosimilarity Study of Subcutaneous Pegfilgrastim in Healthy Volunteers

This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between pegfilgrastim formulation, produced by Megalabs (test product) and Neulastim® (reference product) Amgen.


Eligibility Criteria:
Inclusion Criteria:

* Healthy eligible participants able to read, understand and sign the latest version of the Informed Consent Form (ICF) approved by the Research Ethics Committee (CEP)
* Males aged between 18 and 55 years
* Be characterized as a healthy research participant, based on medical history general physical examination and vital signs, laboratory tests and electrocardiogram (ECG),
* Not indicating any evidence of disease
* Body weight between 60-100 kg;
* Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 Kg / m2;
* Negative test for coronavirus

Exclusion Criteria:

* Present one or more flu-like symptoms such as: fever (body temperature greater than or equal to 37.8 ° C), cough, dyspnoea, myalgia and fatigue, respiratory symptoms, gastrointestinal symptoms (such as diarrhea) within 7 days prior to the hospitalization period (all periods);
* Direct and significant medical contact with people who tested positive for coronavirus testing within 14 days prior to the hospitalization period (all periods);
* Living in the same household as people who are in the risk group with the worst prognosis for coronavirus infection, such as individuals over 60, individuals with respiratory problems, immunosuppressed or those with chronic diseases, such as heart or diabetes (all periods).
* Participants diagnosed with malignant disease in the last 5 years, with the exception of successfully treated basal cell carcinoma;
* Participants with a previous diagnosis of severe asthma, sickle cell anemia, idiopathic urticaria or anaphylaxis;
* Participants with chronic diseases and, therefore, who regularly use medications;
* Being a smoker or quitting less than 6 months ago;
* Participants who consume more than 5 cups of tea or coffee a day and who cannot abstain during the trial period;
* History of alcohol and illicit drug abuse
* Electrocardiogram (ECG) findings that, at the investigator's discretion, may compromise participation in the trial;
* History or presence of gastrointestinal or liver diseases or any other condition that interferes with the absorption, distribution, excretion or metabolism of the drug;
* Use of lithium 2 weeks before and / or after medication administration;
* Participants who are hypersensitive or contraindicated to use any of the components of the formulation;
* Research participants who have participated in clinical trial protocols in the last 12 (twelve) months (Resolution CNS 251, of August 7, 1997, item III, subitem J);
* Have donated blood (\> 500 mL) or have undergone major surgery in the 3 (three) months preceding the date of signing the informed consent form;
* Have received any vaccine in the 3 (three) months preceding the date of signing the informed consent form;
HKT-500-US12 In Adult Patients With OA Knee Pain

The objective of this study is to characterize the analgesic properties of single dose study of HKT-500 in subjects with pain caused by mild to moderate OA of the knee

A Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects with Pain Caused by Mild to Moderate Osteoarthritis of the Knee

Eligibility Criteria:
Inclusion Criteria:

* male or female 45 years of age or older
* with osteoarthritis of the knee

Exclusion Criteria:

* subject is a woman of childbearing potential
* who has a positive urine pregnancy test,
* is lactating, or who is not surgically sterile
Noninvasive Continuous Blood Pressure Monitoring for Cesarean Delivery

Noninvasive continuous blood pressure monitoring for preventing post-spinal hypotension during cesarean delivery: A randomized controlled trial

The aim of this study was to find out whether the incidence of hypotension during surgery can be reduced in the case of non-invasive, continuous blood pressure monitoring using the ClearSight System in patients undergoing cesarean section under spinal anesthesia, compared to the case of using conventional noninvasive blood pressure monitoring

Eligibility Criteria:
Inclusion Criteria:

* Adult mothers who are pregnant with single fetuses over 35 weeks gestational age undergoing planned cesarean delivery under spinal anesthesia

Exclusion Criteria:

* Multiple fetal pregnancy

  * Preexisting hypertension or pregnancy-induced hypertension

    * Underlying heart disease

      * Underlying cerebrovascular disease

        * Known fetal anomaly

          * Contraindicated in spinal anesthesia

            * Any sign of onset of labor

              * Body weight \<45 kg or body weight\> 90 kg

                * Height \<145cm or height\> 180cm

                  * All other cases in which researchers determine to be inappropriate for this clinical trial