cyrilzakka/clinical-trials huggingface dataset:
Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) With Atomoxetine in Young Adults and Its Effects on Functional Outcomes

This study will evaluate atomoxetine's efficacy in treating attention-deficit/hyperactivity disorder (ADHD) symptoms and atomoxetine's effect on functional outcomes in young adults.

A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

This study also has an observational community sample arm in which patients will complete all the efficacy measurements via web-based self reporting.


Eligibility Criteria:
Inclusion Criteria:

* positive attention-deficit/hyperactivity disorder (ADHD) diagnosis with at least moderate severity
* male or female 18 to 30 years of age
* must be able to swallow capsules
* must be able to communicate effectively in English
* must not have cognitive impairment
* be reliable to keep appointments for clinic visits and all related tests

Exclusion Criteria:

* patients diagnosed with obsessive-compulsive disorder, bipolar affective disorder, or psychosis
* females who are pregnant or breastfeeding
* patients with dementia or traumatic brain injury
* patients with a history of severe allergy to atomoxetine
* have untreated hypertension or thyroid problem
* have serious medical illness including any heart, liver, kidney, respiratory, blood, endocrine, or neuromuscular diseases
Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants

The purpose of this study is to evaluate the safety and efficacy of an intramuscular injection of BK1310 in healthy infants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants aged ≥2 and \<43 months at the first vaccination of the study drug (recommended: ≥2 and \<7 months). Those who are applicable of the following conditions must be carefully observed before the enrollment: infants with known underlying disease such as cardiovascular disease, renal disease, hepatic disease, blood dyscrasia, respiratory disease or developmental disorder. Infants who developed fever within 2 days after any previous vaccination. Infants with history of convulsions.
* Written informed consent is obtained from a legal guardian (parent)

Exclusion Criteria:

* With past diagnosis of immunodeficiency or currently under immunosuppressive treatment
* Have close relatives (the third degree of kinship) diagnosed with congenital immunodeficiency
* Possibility of anaphylaxis due to food or pharmaceuticals
* With diagnosis of thrombocytopenia and/or coagulopathy or currently under treatment of the antiplatelet agents and/or anticoagulant agents.
* With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis
* With experience of Hib, diphteria, pertussis, tetanus or polio vaccination.
* Administered a live vaccine within 27 days before the first vaccination of the study drug, or inactivated vaccine or toxoid within 6 days before vaccination
* Administered transfusion, immunosuppressant (excluding drugs for external use), or immunoglobulin formulation
* Administered corticosteroid 2 mg/kg per day or more as prednisolone (excluding drugs for external use)
* Participated in other studies within 12 weeks before obtaining consent
* With the gestational age \<37 weeks or weighed less than 2500 grams at birth.
* Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment.
Suppressed Anger, Blood Pressure and Mortality Follow-up

To re-examine the relationship between suppressed anger, elevated blood pressure and all-cause as well as coronary heart disease (CHD) mortality using data from the Life Change Event Study (LCES) conducted on a representative sample of the Tecumseh Community Health Study (TCHS), n=696, men and women, aged 30-69 in 1971-1972.

DESIGN NARRATIVE:

The psychosocial data (e.g. anger-expression, stressful life events) and some medical data (e.g. blood pressure, smoking) were collected in 1971/72, while additional information about other medical risk factors was collected in 1968/69. Mortality ascertainment and cause of death was completed by the end of 1989, through TCHS staff, using the National Death Index (NDI). The estimated cumulative 18-year mortality rate as of 1989 for the Tecumseh cohort of the same age as the LCES sample was 26 percent for males and 16 percent for females. Approximately 144 deaths were expected. Out of the total TCHS cohort deaths, 35 percent were estimated to be due to CHD. Research questions tested included: (1) did suppressed anger predict coronary heart disease mortality as well as all-cause mortality; (2) was the relationship between suppressed anger and mortality modified by other risk factors (e.g. blood pressure, marital stress, gender); (3) were there certain anger-coping strategies among married couples which increased mortality risk for one or both members of the marital pair.

Analyses were done at three levels: for the whole sample, separately for males and females, and for a subgroup of 192 married couples it was done by 'pairs'. To determine univariate association between anger-coping types and all-cause mortality, the percent deceased was compared among persons grouped according to their anger responses. For the situation-specific and total suppressed anger indices, the distribution of scores was divided into thirds. The significance of each association was tested using chi-square statistics. Logistic regression was employed to test for the significance of the association between anger-coping measures and mortality controlling for sex, age, education, marital stress, relative weight, smoking, systolic blood pressure, CHD status, bronchitis, and FEV1 scores. Logistic regression was also used to determine whether any of the risk factors, particularly blood pressure, gender and marital stress, significantly modified the relationship between suppressed anger and mortality. The design and measures of this study had the potential to further identify specific person-situation characteristics associated with higher risks of total as well as cause specific mortality which then could be used to make more knowledgeable recommendations for health behavior interventions.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Intervention to Change Handwashing Behaviour in India

The research will test the hypothesis that a scalable behaviour change intervention can improve hand-washing practices in rural Indian households. The intervention will be designed using a social marketing approach and will use motivational messages targeting key audiences rather than educational messages about germs and disease which previously have been found ineffective. The intervention will be designed for low-cost, scaleable delivery using a series of visits to target villages by a two-person team on a motorbike. The key goal of the study is to determine the effectiveness of a scaleable, social marketing intervention to promote hand-washing with soap.

The study will take the form of a cluster-randomized, controlled intervention trial. Villages will be randomized to receive either the intervention or no intervention. The primary outcome measure will be the proportion of key events (defecation, faecal contact or food handling) accompanied by hand-washing with soap. These data will be collected by direct observation. A secondary outcome measure will be the number of soap movement episodes. These data will be collected in a sub-sample of households by using electronic motion detectors embedded in bars of soap. Additionally, questionnaires will be used to collect data on social norms, self-reported soap use and habitual soap use. All data will be collected pre and post-intervention.


Eligibility Criteria:
Inclusion Criteria:

* households with children of primary school age or younger

Exclusion Criteria:

* households without school-aged or younger children
Study to Evaluate the Safety, Pharmacokinetics and Tolerability of BMS-708163

The primary objective is to assess the safety and tolerability of a single oral dose of BMS-708163 in healthy young male subjects and in elderly male and female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Panels 1- 8 and Panels 14-15: healthy male subjects between the ages of 18 to 45
* Panels 9 and 10: healthy elderly males and females ages 60 and greater
* Panel 11: healthy males between the ages of 46-59
* Panel 12: males and/or females either healthy or with mild cognitive impairment (MCI) between the ages of 60 and 74
* Panel 13: males and/or females, healthy or with Alzheimer's disease (AD) or MCI that were 75 years of age or greater
* Acceptable medical history, physical examinations, vital signs, electrocardiograms, hemoccult stool tests, and clinical laboratory evaluations
The Construction of Precision Medicine in Chinese Medicine

"Precise medicine" is also called "personal medicine". With the development of big data database, genetic testing and artificial intelligence, the concept of precision medicine has been applied to the diagnosis, treatment and prevention of different diseases. Traditional Chinese medicine (TCM) has traditionally emphasis on personalized medicine, according to each person's body constitution, through discriminatory treatment and personalized treatment methods. Chinese medicine doctors collect patients' information to distinguish the type of TCM pattern, and then according to the different types of diagnosis of traditional Chinese medicine to decide of using herbs, acupuncture, massage and other treatment strategies. However, lacking of objective data of traditional Chinese medicine, the current research on precision medicine in Chinese medicine is still limited. The aim of this study is to establish a big database of traditional Chinese precision medicine, and use the patients with hypertension as the population to conduct research on precision medicine in Chinese medicine.This study will combine the TCM body constitutional questionnaire, tongue diagnosis, pulse diagnosis, Chinese medicine immunoassay and genetic testing. In addition, the information providing by the medical electronic medical record system of China Medical University Hospital will be connected, which include modern medical diagnosis, treatment, blood and biochemical analysis and imaging. We will combine the big data analysis and artificial intelligence interpretation technology to explore the correlation between different TCM syndrome types and gene variations in patients with hypertension and establish a database of TCM precision medicine. We will also conduct the education training and symposium to train TCM precision medical talents and promote public understanding of TCM precision medicine. This project will establish a database of traditional Chinese medicine precision medicine to provide the correlation between different TCM pattern types of patients with hypertension, the reaction to different herbal medicine, and gene mutation, and provide reference for TCM clinicians.


Eligibility Criteria:
Inclusion Criteria:

1. Primary hypertension
2. Older than 20 year-old

Exclusion Criteria:

1. Past history of cancer
2. Hemodialysis
3. Hypertension caused by renal diseases or endocrine disorders
4. Pregnancy
5. Patients can not received investigation of body constitution, TCM tongue examination and pulse examination
A Phase III Study to Assess the Immunogenicity and Safety of Eutravac (DTap-HB Combined Vaccine) With DTaP and Hepatitis B Vaccines in Healthy Infants

To evaluate and compare the immunogenicity of Eutravac (Diphtheria-Tetanus-acellular Pertussis \[DTaP\] Hepatitis B \[HB\] combined) vaccine with separate but simultaneous administrations of DTaP and HB vaccine each administered to healthy infants, as measured by seroprotection/vaccine response rates 4-8 weeks post-final immunisation.


Eligibility Criteria:
Inclusion Criteria:

* Were healthy, male or female infants born at full term pregnancy (≥37 weeks) with a birth weight ≥2.5 kg to mothers with a negative HBsAg serology, documented prior to giving birth as per routine, site-specific ante-natal care procedures.
* Signed parental or legally acceptable representative's informed consent was obtained

Exclusion Criteria:

* Evidence of an acute febrile illness with axillary temperature ≥37.5℃ on the day of the vaccination. Infants with symptoms of minor illness eg, mild gastroenteritis, mild upper respiratory tract infection and who did not have a temperature ≥37.5℃ on the day of the vaccination could be included at the Investigator's discretion
* History of diphtheria, tetanus, pertussis or hepatitis B disease
* History of any vaccine-related hypersensitivity or anaphylactic reaction after previous administration of Euvax B
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids

The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with hypercholesterolemia. The primary hypothesis is that enlicitide decanoate is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.


Eligibility Criteria:
Inclusion Criteria:

* Has a history of a major atherosclerotic cardiovascular disease (ASCVD) event and LDL-C ≥55 mg/dL OR, if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event and LDL-C ≥70 mg/dL.
* Is treated with a moderate- or high-intensity statin OR is treated with low-intensity statin with documentation of intolerance to a moderate or high-intensity statin OR is not receiving statins with documentation of statin intolerance
* If on any lipid-lowering therapies (LLTs), should be on a stable dose with no planned medication change.

Exclusion Criteria:

* Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
* Has a history of heart failure or heart failure hospitalization within 3 months before first study visit
* Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program
* Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout
Comparison of the Effectiveness of Single-Dose Methotrexate Protocol With Letrozole + Single-Dose Methotrexate in the Medical Treatment of Patients Diagnosed With Ectopic Pregnancy

The objective of the study is to compare the effectiveness of single-dose methotrexate and letrozole + single-dose methotrexate in treating ectopic pregnancy, focusing on treatment success, changes in ß-hCG levels, hemogram and biochemical markers, surgical intervention due to rupture, fertility preservation, and reduction of maternal morbidity, mortality, and healthcare costs. This is a prospective study conducted on 60 ectopic pregnancy patients at Van Yuzuncu Yil University from June 2021 to September 2022. Thirty patients received single-dose methotrexate, while the other thirty received letrozole + single-dose methotrexate. Inclusion criteria were ß-hCG \<5000 mIU/mL, ectopic mass \<3-4 cm, no persistent abdominal pain, no fetal cardiac activity, and no contraindications to the treatments. Outcomes measured included treatment success, blood parameter changes, and the need for surgical intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with ectopic pregnancy according to the diagnostic criteria
* Patients with β-hCG levels \<5000 mIU/ml,
* Patients without serious or persistent abdominal pain
* Patients without fetal cardiac activity observed
* Ectopic mass size smaller than 3-4 cm
* Patients without contraindications for methotrexate and letrozole

Exclusion Criteria:

* Ruptured ectopic pregnancies
* Hemodynamically unstable patients
* Patients with acute abdomen or intra-abdominal bleeding
* Patients with fetal cardiac activity
* β-hCG levels below 500 mIU/mL or above 5000 mIU/mL
* Patients non-compliant with treatment
* Ectopic pregnancy size over 40 mm
Online Training for the Reconstitution of Fosun/BioNTech

The COVID-19 vaccine by BioNTech requires specific, delicate storage and dilution procedures to be stringently followed for safety and effectiveness. Training should be completed prior to undertaking dilution procedures. Currently, the nursing and pharmacy curricula do not have content on specialized vaccine reconstitution techniques. E-learning has become an essential component of teaching and learning due to COVID. Yet, optimal online learning module development for clinical procedural skill acquisition and appropriate online formative assessment has not been adequately explored. To bridge this training gap for Hong Kong nurses and pharmacists, this project aims to develop a video-based online learning programme, coupled to a randomized controlled study to determine the effectiveness of online vaccine reconstitution training. The module, a supplement to the current teaching curriculum, will train students from both Nursing and Pharmacy disciplines. Outcome measures include formative assessment of student performance, which can be used to inform the design and content of experiential content in healthcare professional curriculums. If this learning platform is shown to be effective, the scope could be extended to other disciplines (not limited to healthcare) where learning complex procedural tasks are necessary for the absence of instructor-led teaching.


Eligibility Criteria:
Inclusion Criteria:

* Students currently enrolled in the Bachelor of Pharmacy and Bachelor of Nursing programmes (Years 1 to 4) at The University of Hong Kong

Exclusion Criteria:

* Students not from the aforementioned programmes and years of study
Comparison of Cilostazol-based Triple Antiplatelet Therapy Versus Dual Antiplatelet Therapy for Outcomes of below-the Knee Endovascular Intervention in Patients With Critical Limb Ischemia (TAP CLI Study)

* Prospective, randomized, controlled, multi-center study
* A total of 390 subjects with critical limb ischemia will be included according to inclusion and exclusion criteria.
* Patients will be randomized in a 1:1:1 manner into triple antiplatelet therapy (TAP: aspirin, clopidogrel, cilostazol) group, dual antiplatelet therapy (DAP: aspirin, clopidogrel) A group, or DAP (aspirin, cilostazol) B group.
* All patients will be treated with angioplasty for critical limb ischemia.
* Patients will be followed clinically for 1 year after the procedure.
* Ankle-brachial index and Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 19 years old
* Patients with critical limb ischemia (Rutherford 4 \& 5)
* Successful below-the knee endovascular intervention.

Exclusion Criteria:

* Major bleeding event within recent 3 months or high risk of major bleeding
* Patients requiring anticoagulation
* Allergic reactions to antiplatelet drugs
* Acute limb ischemia
* Severe hepatic dysfunction (3 times normal reference values)
* Pregnant women or women with potential childbearing
* Life expectancy \< 1 year due to comorbidity
* Previous amputations in the target limb
Effect of Induced Trunk Extensors Fatigue on Balance and Lumbar Position Sense in Adolescents

this study will be conducted to investigate the effect of trunk extensors induced fatigue on balance and lumber position sense in adolescents

Fatigue can be defined as, decrease in the power generation capacity of the muscles from the beginning of the movement due to internal homeostasis breakdown caused by an increase in energy production demanded by an external stimulus that lead to general decrease in physical performance related to a rise within the real/perceived difficulty of a task or exercise, as well as the inability of the muscles to keep up with the specified level of strength during exercises. Either Adolescents spending long time using smartphone, they are more likely to have their spine in an incorrect posture causing damage to the surrounding skeletal structures as well as to ligaments which affect the proprioception input of the spine. Muscle fatigue is an important condition that impairs sensorimotor integration, proprioception, and thus postural control. Muscle fibers and Golgi tendon organ activity decrease with fatigue, resulting in changes in joint proprioception and afferent output from joint and muscle receptors. Fatigue of postural muscles such as lumbar extensor and abdominal muscles impairs postural control and may form the basis for injuries. Fatigue can also impair the proprioceptive and kinesthetic properties of the joints. this study aims to investigate how the trunk extensor muscles respond to a fatigue inducing exercise, especially concerning balance and trunk lumbar position sense for understanding and preventing musculoskeletal injury and lowering risk in health adolescents in primary care and to contribute to preventive rehabilitation. Sixty-eight normal adolescent boys will participate in this study

Eligibility Criteria:
Inclusion Criteria:

* Only boys will be included.
* Their age will range from 16 to 18 years old.
* Never trained any specific sport before.
* They have a normal body mass index (BMI) between 16.4 to 24.8 kg/m2 according to
* No history of low back (pain intensity 0-1 cm) according to 10 cm visual analog scale (VAS)
* Physical fitness of all participants will be (minimally active) according to International Physical Activity Questionnaire- Short Form (IPAQ-SF)

Exclusion Criteria:

* Visual or hearing defects.
* Congenital abnormalities.
* Musculoskeletal abnormalities.
* Recent trauma.
* Cardiac and respiratory problems.
* Smoker participant.
* Low back pain.
Treatment Outcome of Supervised Exercise and Home Exercise in Patients with Symptomatic Disc Displacement with Reduction

The aim of the study is to evaluate the treatment outcome of supervised exercise and home exercise in patients with symptomatic disc displacement with reduction.

This study will help the clinical practitioner to choose better exercise option in patients with symptomatic disc displacement with reduction in order to avoid clicking sound.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-70 years
2. Both genders
3. TMJ clicking sounds fulfilling RDC/TMD for symptomatic disc displacement

   1. Clicking sounds during jaw opening and closing
   2. Interincisor distance ≥ 5mm wider during mouth opening
   3. Clicking suppression with protruded mandible
   4. Clicking presence in at least two of three repetitions
4. NRS score ≥ 4 for TMJ clicking sound severity
5. TMJ clicking sound frequency: once a week or more

Exclusion Criteria:

1. Major psychiatric disorders
2. Ongoing treatments related to symptoms
3. Active rheumatologic disease
4. Malignant disease
Evaluation of a Smartphone Application, GoCheckKids™ as a Photo Screening Tool in a Pediatric Population

Objective: Prospective evaluation of GoCheckKids™, a smartphone application ('App') as a photo screening device in a pediatric population to detect amblyopia risk factors (ARFs)

Method: Photorefraction images are captured using up to 4 different devices with GoCheckKids™ App and patients are evaluated with cycloplegic refraction.


Eligibility Criteria:
Inclusion Criteria:

* Age 12 months to 6 years inclusive.
* Informed consent given by parent or legal guardian.

Exclusion Criteria:

* History of ocular surgery and any condition that would preclude the ability of the investigator to obtain a reliable image and measurement