cyrilzakka/clinical-trials huggingface dataset:
Training Program and Mobile Health Message on Promoting Family Holistic Health

In this study, the investigators would use the training workshops as a capacity build method to deliver the holistic health knowledge for the trainers and ambassadors implementing and assisting the community-based programs for the public. The investigators hypothesize that the training workshops and mobile health messages would promote the health awareness and the health of the participants. The investigators would expect the participants influence the health behavior and attitude of their family members.

Holistic health is an integration and interaction of physical and psychosocial health. Positive psychology is a science of happiness, which focuses on positive emotions and personal strengths. It is used as a preventive and complementary medicine, which also is crucial component in family holistic health (happiness, harmony and health). Healthy diet can help to achieve energy balance and healthy weights. Sufficient daily consumption of fruit and vegetables, as well as limitation on the intake of sugar, salt and fat could prevent major diseases, such as cardiovascular diseases and certain cancers. Physical activity is believed to contribute to physical and mental health, as well as social well-being. However, physical inactivity was found to be a local and worldwide issue. and most Hong Kong people are having sedentary lifestyle. Studies show that the increase of physical activity and healthy diet reduce the risk of chronic diseases, and improve cardio-pulmonary functions; whereas sedentary behaviors increase the risk.

The Project team will schedule the training workshops for the trainers and ambassadors implementing and assisting community-based programs for the public. The investigators hypothesize that the training workshops and mobile health messages would promote the health awareness and the health of the participants. The investigators hypothesize that the training workshops promote the participants' knowledge and enhance the participants' behaviors related to family holistic health, such as positive psychology, physical activity and healthy diet. The investigators would expect the participants influence the health attitude of their family members.

Eligibility Criteria:
Inclusion Criteria:

* Chinese speaking
* able to complete study questionnaire

Exclusion Criteria:

* not fit the inclusion criteria
The Effect of Gabapentin on the Sensation and Impact of Tinnitus

This study evaluated the effectiveness of gabapentin in treating tinnitus in two populations: Tinnitus with associated acoustic trauma and tinnitus without associated acoustic trauma. The hypothesis was that gabapentin would decrease both subjective and objective features of tinnitus in the trauma group, but would be less effective in the non-trauma group.'

Methods. A prospective, placebo-controlled, single-blind study of the effect of gabapentin on tinnitus was employed. Audiograms and personal histories were used to categorize tinnitus etiology as either secondary to acoustic trauma, or not associated with acoustic trauma. Participants were restricted to those with moderate-to-severe tinnitus for at least one year. All participants received gabapentin in a graduated ascending-descending dose series over 20 weeks (peak dose of 2400 mg/day).

Results. There was a significant improvement in tinnitus annoyance for the trauma group (p = 0.05). Other subjective aspects of tinnitus were not significantly affected in either group. Between-subject variability of therapeutic response was considerable. Nevertheless, considering subjective loudness ratings, 4/19 non-trauma participants, and 6/20 trauma participants showed an improvement of 20 percent or better. Considering psychoacoustic loudness estimates, 4/19 non-trauma and 6/20 trauma participants showed a 15 dB (HL) improvement. Evenly dividing each group into high and low responders revealed significant improvement in loudness at 1800 and 2400 mg/day for the trauma high-response subgroup (p = 0.007). No significant improvement was obtained for other subgroups.

Eligibility Criteria:
Inclusion Criteria:

* non-pulsatile tinnitus present \> 1 year
* Tinnitus Handicap Questionnaire score \> 30
* ability to perform psychophysical matching procedure

Exclusion Criteria:

* evidence of depression
* renal insufficiency
* conductive hearing loss
The Effect of Medical Cannabis on Tics, Premonitory Urge and Psychiatric Comorbidity in Adults With Tourette Syndrome

Medical cannabis (MC) is a standard treatment in Israel to adults with resistant Gilles de la Tourette syndrome (GTS). While small randomized control trials assessed THC efficacy on tics and premonitory urge, only small retrospective studies assessed MC efficacy and tolerability in GTS. Herein, By using an open-label, prospective design, our aim is to determine the preferred method of use, efficacy and tolerability of 12 weeks of treatment with MC in adult patients with GTS.

Gilles de la Tourette syndrome (GTS) is a childhood onset neuropsychiatric disorder characterized by the presence of multiple motor and one or more phonic tics continuing for at least one year. In Israel, although consumption of cannabis is outlawed, there is an option to allow patients to consume the drug under supervision. Medical Cannabis (MC) consumed by inhalation of smoked or vaporized dried female buds, or subligual oil extract of whole plant, has been an approved treatment by the Ministry of Health (MOH) for resistant GTS since 2013. Previous studies suggested that MC has a good effect on tics, quality of like and with good tolerability among patients with resistant GTS.

In the current study, we prospectively followed-up patients eligible for MC according to MOH restrictions, at our GTS clinic at the Tel-Aviv Sourasky Movement Disorders Unit (MDU). Each subject signed a written informed consent before inclusion in the trial. Also, since driving under the influence of cannabis is forbidden by the Israeli law, patients were instructed and gave their oral commitment to avoid driving. The study was approved by the research ethics (Helsinki) committee at our center. MC was consumed as oil extract, vaporized, or smoked dried buds. The treating neurologist (S.A.) and patient together decided on the method of consumption during the visit before initiating treatment. Patients were assessed 4 and 12-weeks following treatment initiation to gather data regarding treatment efficacy, tolerability and SEs.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65 years
* Diagnosis of GTS confirmed by the treating neurologist based on the DSM-V criteria
* Eligibility to receive MOH MC license for GTS
* Provided written informed consent

Exclusion Criteria:

* Regularly use cannabis in any form for self-medication prior to entering the study
* Pregnant or lactating women
* Have a tic disorder other than GTS
* Have concurrent physical or mental disease that could interfere with the study
The PAH Disability and Bothersomeness Questionnaire

To develop a patient-reported questionnaire to investigate the impact of PAH (pulmonary arterial hypertension) on patients' daily lives in terms of bothersomeness and disability.

A 3-steps study protocol was initiated in 2011 to develop a patient reported outcome measure (PROM) in PAH.The first two steps have been completed (qualitative study and Delphi consensus study) leading to the development of a provisional 37-items questionnaire. A reduction of items in this provisional questionnaire and the validation of the final questionnaire are the goals of the current study.

Eligibility Criteria:
Inclusion Criteria:

* patients with idiopathic and heritable PAH;
* patients over 18;
* male and female;
* NYHA Functional Class I, II, III \& IV;
* Written consent signed
* Patients with a good understanding of the French - language
* Patient affiliated with a social security scheme

Exclusion Criteria:

* Patients under 18 years of age
* Patients with other pathologies associated with PAH (Group 1)
* Patients with other forms of pulmonary hypertension (groups 2, 3, 4 and 5)
* Non-consenting patients
* Patients who do not have a good understanding of the French language
Stroke Adverse Outcome is Associated With Nosocomial Infections: PCTus- Guided Antibacterial Therapy in Severe Ischemic Stroke Patients (STRAWINSKI)

Development of stroke associated pneumonia (SAP) has a detrimental effect on stroke outcome. Biomarker-guided antibiotic treatment of patients at high risk for pneumonia may help to improve stroke outcome. Therefore, the investigators will evaluate whether intensified infection monitoring via Procalcitonin guiding an early standardized antibiotic treatment improves functional outcome after stroke compared with standard therapy based on current guidelines.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* stroke onset within the last 40 hours before randomisation
* clinical diagnosis of a severe (NIHSS \> 9), non-lacunar stroke in the middle cerebral artery territory
* consent given by the patient or by his/her legitimate representative where patients are incapable of giving consent themselves

Exclusion Criteria:

* CT evidence of an intracerebral haemorrhage or a lacunar infarct as the probable cause of the current illness
* Antibiotic use within the last 10 days
* Suspected life expectancy of \< 3 months
* Participation in other interventional trials (on pharmaceuticals or medical devices)
* Pregnancy, lactation
* Pre-stroke mRS score ≥ 4
Postoperative Respiratory and Activity Monitoring

This study plans to learn more about specific breathing and activity recommendations for patients after surgery. Participants will be monitored after abdominal surgery to identify what activities help them breathe better and reduce complications after surgery.

Investigators will study adults undergoing elective abdominal surgery with at least moderate risk for postoperative pulmonary complications.

Participants will be monitored on their chest and thigh with devices that record their breathing pattern (breath volume and frequency) and body position and movements. These monitors will be placed on their skin in the Post-Anesthesia Care Unit (PACU) and will stay on for three days, or until the patient is able to ambulate freely or until their hospital discharge, whichever comes earlier. Investigators will analyze the association between the frequency, duration and intensity of various activities (e.g., sitting, walking) and breathing and other clinical complications, in combination with medications received and other hospital course events.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 or older
* Must be undergoing abdominal surgery
* Must be high-risk for PPCs (ARISCAT score equal to or greater than 26)

Exclusion Criteria:

* Anyone under 18
* Anyone not undergoing abdominal surgery
* Anyone that is not high-risk for PPCs (ARISCAT score less than 26)
MOWI Home-Based Pilot

The goal of this study is to conduct a program of pilot research aimed at developing and evaluating a technology-assisted wellness intervention for older adults with obesity.

The national epidemic of obesity is also affecting older adults, and is associated with an increased risk of disability, nursing home placement and early mortality. Conventional weight loss programs have the potential to reduce body fat, but are difficult to access for older obese adults due to transportation and mobility challenges. The overarching goal of this study is to conduct a program of pilot research aimed at developing and evaluating a technology assisted wellness intervention for older adults with obesity.

Study Timeline:

September 2018 to April 2021:

Goal: Conduct a study of improving weight and physical function in older adults with obesity at home using video-conferencing. An mHealth obesity wellness intervention (MOWI) will integrate a fitness device with a weekly individual dietician-led nutritional session, along with twice weekly physical therapist led group exercise session performed in a person's home.

Participation Duration: Three times weekly for 6 months. We shall also have participants return to the center once monthly

Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 years
* Body Mass Index (BMI) ≥ 30kg/m\^2 OR Waist circumference ≥88cm in females or ≥102cm in males
* Have Wi-Fi high speed internet
* Able to obtain medical clearance from doctor
* Have less than a 5% weight loss in past 6 months
* No advanced co-morbidity
* No exercise restrictions
* Not involved in other research studies that may interfere with participation

Exclusion Criteria:

* Severe mental or life-threatening illness
* Dementia
* Substance use
* History of bariatric surgery
* Suicidal ideation
* Unable to perform measures
* Reside in nursing home
* No advanced co-morbidity
* No exercise restrictions
* Not involved in other research studies that may interfere with participation
A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus.

This trial is conducted in Asia. The aim of the trial is to compare the efficacy and safety of liraglutide 1.8 mg/day to liraglutide 0.9 mg/day in Japanese subjects with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Male or female Japanese subjects at least 20 years of age at the time of informed consent
* Type 2 diabetes subjects (diagnosed clinically) for at least 6 months prior to screening
* HbA1c 7.5-10.0% \[58 mmol/mol-86 mmol/mol\] (both inclusive)
* Subjects on stable therapy with one OAD (oral antidiabetic drug) (stable therapy is defined as unchanged medication and unchanged dose) for for at least 60 days before screening according to approved Japanese labelling

Exclusion Criteria:

* Treatment with insulin within 12 weeks prior to screening
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before screening
* Screening calcitonin equal or above 50 ng/l
* History of pancreatitis (acute or chronic)
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
* Subjects presently classified as being in New York Heart Association (NYHA) Class IV
* Within the past 180 days any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
* Diagnosis of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer, polyps and in-situ carcinomas)
* Any condition which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
Cemented vs Non-cemented Semiendoprosthesis in the Treatment of Proximal Femoral Fractures

The hip semiendoprosthesis is an acceptable method to treat the proximal femoral fractures. Traditionally, the cemented version of the semiendoprosthesis has been used for this indication. However, the cementing carries a risk of fat embolism during the pressurization of the cement. The fat embolism can be avoided when using the non-cemented semiendoprosthesis. In this study we want to find out whether there are any differences in the treatment results between the cemented and non-cemented semiendoprostheses when treating the proximal femoral fractures.


Eligibility Criteria:
Inclusion Criteria:

* A proximal femoral fracture

Exclusion Criteria:

* Rheumatoid arthritis
* Pathologic fracture
* Severe dementia (preventing the informed consent)
An Integrative Platform for Promoting Children's Emotional Health

The general objective of the study is to test an online platform for the promotion of emotional health in children

The project aims at implementing an integrated online therapeutic platform that will be accessed by youth, parents and clinicians. The main original feature is the integration of state of the art online/mobile and gaming technologies into a unique platform that allows easy access to personalized, accessible and validated prevention.

The platform aims to allow access to attractive, easily accessible and evidence-based prevention for youths. The system will be validated in the second step as an integrative, multi-componential and adaptive platform for the prevention of emotional disorders in youth. The platform includes tools that were separately tested in laboratory conditions and found to be effective: the REThink therapeutic video game and the online REThink Parenting and Rational Parent Coach mobile programs.

Eligibility Criteria:
Inclusion Criteria:

* children aged 8 to 12 years
* scores above average at any subscale of Childhood Trauma Questionnaire
* parental consent provided
* for the parental intervention: no changes in children's main outcomes following the REThink intervention

Exclusion Criteria:

* intellectual disability or physical limitations precluding the use of the online platform
* presence of a mental health disorder in the children or their enrolled parent
Consumer Perceptions of Waterpipe Tobacco Packaging and Digital Marketing Claims

The purpose of the study is to evaluate the impact of marketing claims commonly found on waterpipe, also known as hookah, tobacco packages and in digital marketing on young adults' willingness to try hookah tobacco. Participants will complete two tasks, in random order. Participants will view six sample waterpipe tobacco packages, randomized at the package level to contain a prohibited or potentially-prohibited claim or not (Packaging Task). In the other task, they will view 10 digital marketing advertisements (i.e. Instagram posts or website pages) either with or without prohibited or potentially-prohibited claim, randomized at the advertisements level (Digital Marketing Task).

Background/Objectives The Food and Drug Administration (FDA) has begun to prohibit certain claims on Waterpipe Tobacco (WT) packaging and advertising. Under Section 911 of the Family Smoking Prevention and Tobacco Control Act, manufacturers and retailers are prohibited from making unauthorized modified risk tobacco product (MRTP) claims, including statements that the product or its smoke: (1) results in reduced harm; (2) contains a reduced level of a substance or presents a reduced exposure to a substance; (3) does not contain or is free of a substance; and (4) statements that use modified risk descriptors such as light, mild, low, or similar descriptors. Some prohibited claims are easily identifiable, but others are more difficult to identify due to lack of specificity in the law and the implicit nature of some claims. Evidence is needed specific to WT packaging and marketing to determine which claims may be associated with consumer harm misperceptions to inform future regulatory actions. The study will address this gap by assessing how such claims influence consumer perceptions and behavioral intentions.

Eligibility Criteria:
Inclusion Criteria:

* United States (U.S.) Resident
* Has used waterpipe tobacco within the past year (self-report)
* Has not used waterpipe tobacco within the past year but it susceptible to use (self- report)

Exclusion Criteria:

* Younger than 18 or older than 29
* Non U.S. Resident
* Has not used waterpipe tobacco within in the past year and is not susceptible to use (self-report)
Early Lung Cancer Detection in Patients With Sputum Cytology and Autofluorescence Bronchoscopy in People at High Risk of Lung Cancer

Lung cancer is the commonest malignant disease with a 5-year survival of 14%. In Hong Kong, it accounts for about 30% of all cancer death. The poor prognosis of lung cancer is due largely to the late clinical presentation of the disease. In order to improve the prognosis of lung cancer, an obvious approach is to develop sensitive methods for detecting lung cancer at much earlier stages when treatment is more likely to be curative.

However, the best way for identifying early lung cancer is still need to be determined. We hypothesis that by examining specimens that contain shed bronchial epithelial cells i.e. sputum, lung cancer can be sampled in its earliest possible phase. And by using autofluorescence bronchoscopy, a system specifically designed to detect early lung cancer/pre-invasive lesions, to identify the source of abnormal cells, we may able to detect eraly lung cancer and followed by curative treatment to improve the prognosis of this disease.


Eligibility Criteria:
Inclusion Criteria:

* Current or ex-smokers who have smoked at least 20-pack-years (e.g. 1 pack per day for 20 years or more)
* Informed consent

Exclusion Criteria:

* Known malignant disease
* Unstable major medical disease
* Bleeding disorder
* Unwilling to have a bronchoscopy
* Women currently pregnant or nursing
* Known reaction to xylocaine, a local anaesthesia agent used for bronchoscopy
Malaria Transmission and Immunity in Highland Kenya

The purpose of this study is to see why malaria epidemics occur in highland areas in Kenya. A better understanding of factors contributing to malaria may be necessary for malaria vaccine planning. These factors include interactions between age, where malaria is passed from mosquitoes to people, immune system (how the body fights infection) responses and other factors that contribute to malaria in epidemic-prone areas. About 6400 people from the villages of Kapsisiywa and Kipsamoite will participate. Study procedures will include in home surveys, which will involve a census and an interview by researchers. Blood samples and smears will be collected from some volunteers in both communities to understand how the body protects itself from malaria and to check for malaria parasites. Twice each month, random houses will be selected from 3 places in the village to measure the number of mosquitoes in the home. Participants may be involved in the study for up to 4 years.

The purpose of this study is to see why malaria epidemics occur in highland areas in Kenya. A better understanding of factors contributing to malaria may be necessary for malaria vaccine planning. These factors include interactions between age, where malaria is passed from mosquitoes to people, immune system (how the body fights infection) responses and other factors that contribute to malaria in epidemic-prone areas. About 6400 people from the villages of Kapsisiywa and Kipsamoite will participate. Study procedures will include in home surveys, which will involve a census and an interview by researchers. Blood samples and smears will be collected from some volunteers in both communities to understand how the body protects itself from malaria and to check for malaria parasites. Twice each month, random houses will be selected from 3 places in the village to measure the number of mosquitoes in the home. Participants may be involved in the study for up to 4 years.

Eligibility Criteria:
Inclusion Criteria:

Active surveillance of clinical malaria -Individuals of any age who live in the area (Kipsamoite or Kapsisiywa) for more than 6 months of the year, or, if they are new to the area, who plan to live in the area for more than 6 months of the year (permanent residents).

Passive surveillance of clinical malaria

-Any individual living within the boundaries of the 2 study areas (Kipsamoite and Kapsisiywa)

Exclusion Criteria:

Active surveillance of clinical malaria

* Declining to participate in the study
* Will be gone from site more than 1 week per month
* Not available for weekly symptom check or bimonthly blood sample collection

Passive surveillance of clinical malaria

* Declining to participate in the study
* Participation in active surveillance study
Explore Active Surveillance Mode of the Community's Adverse Event Following Immunization(AEFI)

The investigators would remind the guardians of observation after immunization via sending short message and collect the information of AEFI by two ways, short message/telephone and website questionnaire.

The investigators will compare the rate between active and inactive surveillance of AEFI

Eligibility Criteria:
Inclusion Criteria:

* According with the regular vaccination
* Immunization the acellular pertussis diphtheria tetanus vaccine and Measles and rubella combined vaccine

Exclusion Criteria:

* Disapproval the AEFI information