cyrilzakka/clinical-trials huggingface dataset:
A Study of Docetaxel Monotherapy or DOXIL and Docetaxel in Patients With Advanced Breast Cancer

The purpose of the study is to evaluate whether the time to progression for the DOXIL and docetaxel combination therapy group was superior to that of the group treated with docetaxel monotherapy in participants with advanced breast cancer.

This is a randomized (the study medication is assigned by a random order), active control (study medication will be compared with available standard care of treatment), parallel-group (each treatment group will be treated simultaneously at the same time and each participant only receives one treatment regimen as assigned), open-label (both the investigator and the participant know the intervention received by the participant), multicenter study designed to determine if women with locally advanced or metastatic breast cancer, who were previously treated with prior anthracycline therapy in the neoadjuvant (administration of treatment before surgery) or adjuvant setting (administration of treatment after surgery), and who also had a disease-free interval of at least 12 months since the end of their last cytotoxic therapy, would benefit from the addition of DOXIL to docetaxel therapy. Approximately 751 participants will be randomly assigned to either receive docetaxel monotherapy or DOXIL in combination with docetaxel therapy. Treatment is to continue until disease progression or the occurrence of unacceptable treatment related toxicity. Safety evaluations will include assessments of adverse events which will be recorded from the first study related procedure until 30 days after the last dose of medication; clinical laboratory tests and tests for cardiac function (multiple gated acquisition scan/echocardiogram and electrocardiogram) which will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Females with locally advanced or metastatic breast cancer who received prior anthracycline therapy in the neoadjuvant or adjuvant setting, and had at least a 12-month disease-free interval since the end of their last cytotoxic therapy, were eligible for the study
* Participants who received prior hormonal therapy, or no more than 1 cytotoxic chemotherapy regimen (anthracyclines, taxanes, or antitubulin agents were not permitted), or both for advanced disease
* Participants with normal cardiac function, as evidenced by a normal left ventricular ejection fraction

Exclusion Criteria:

* More than 1 prior cytotoxic chemotherapy regimen for advanced breast cancer
* Treatment of advanced breast cancer with an anthracycline, paclitaxel, docetaxel, vinorelbine, or vinblastine (prior treatment of advanced breast cancer with 1 regimen that included alkylating agents or antimetabolite agents was acceptable)
* Less than 2 months since the last dose of trastuzumab
* Less than 3 weeks since last dose of tamoxifen or fulvestrant, or less than 1 week since the last dose of other hormonal therapy
* Radiation to areas of disease within 30 days before study enrollment
* History of New York Heart Association Class II or greater cardiac disease or other clinical evidence of congestive heart failure
Determinants of Daily Physical Activity Level in Patients With Cystic Fibrosis - Pilot Study Protocol

The aim of the study is to analyze the determinants (barriers and facilitators) of the daily physical activity level in a population of patients with cystic fibrosis. A population of patients will be included in order to realize an assessment of their daily physical activity level over an entire week. A specific questionnaire, designed from 3 different questionnaires, will be associated to the physical activity evaluation and will allow to asses psycho-social and environmental factors.

Physical activity (PA) is a major component of the management of patients with cystic fibrosis (CF). Regular PA is associated, in cystic fibrosis as in other pathologies, with health benefits and a greater life expectancy. However, the literature shows an absence of consensus for the daily PA level reached by CF patients, and also for the determinants of this PA level. It appears that CF patients tend to have a reduced PA level, compared to international guidelines. Some determinants have already been mentioned, like physical, psychological or organizational factors. But these factors have not been considered in a multifactorial way, by also considering social and environmental factors, and are rarely associated with objective PA level measurement or only reported in paediatric population. A better comprehension of these determinants of daily PA level represents an important issue for the optimization of interventions designed for the promotion of PA in cystic fibrosis.

For this study, a population of CF patients will realize an evaluation of their daily PA level based on accelerometry (by wearing a portable device over 7 days). During the PA assessment, patients will have a questionnaire to fill in, delivered with the sensor. The objective assessment of PA level will be analyzed with regard to various parameters from different dimensions: individual, clinical, psycho-social and environmental. Individual and clinical parameters will be collected from patients' data routinely assessed for the management of patients. Psycho-social and environmental parameters will be assessed with a specific questionnaire, specifically designed from 3 different questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cystic fibrosis confirmed by the identification of genetic mutation and/or positive sweat test
* regular follow-up in CF centers ;
* age higher than 6 years old
* stable clinical status, away from exacerbation period or antibiotic treatment.

Exclusion Criteria:

* transplant patient or patient waiting for a transplant
* inability to fill in the questionnaire or to complete the planned evaluations
* ongoing participation in another research protocol (interventional study)
* refusal to participate in the study
* patient under legal protection.
Lean and Obese: Dietary Inflammation

In the Lean and Obese Dietary Inflammation (LODI) study, the primary goal is to determine the effect of short-term intake of high dietary fat (5 days) compared to low fat intake (5 days) in a cross-over design in older adults (men and women) with normal body weight or obesity. Inflammation will be examined by measuring serum endotoxin and other markers, as well as the fecal microbiota.

In the Lean and Obese Dietary Inflammation (LODI) study, short-term intake of a high-fat diet (HFD) that is also high in saturated fatty acids will be examined compared to a low-fat diet (LFD) in individuals who are normal body weight (BMI 19.5-24.9) or who have obesity (BMI of 30 - 40 kg/m2). To characterize persons at baseline, this study will examine body composition, and serum glucose, endotoxin, inflammation and intestinal permeability during fasting and in response to a mixed meal. Also, while it is known that long term intake of foods affects the microbiota, it is unclear whether short-term consumption of a HFD will shift towards a pro-inflammatory gut microbiota compared to a low fat intake. This will be tested in a cross-over design (5 days on a HFD, washout, and 5 days on a LFD) with order randomly assigned in older adults (50+ years of age) who have obesity or are normal weight, and will also be examined by estimated visceral adipose tissue level.

Eligibility Criteria:
Inclusion Criteria:

* Men or Women
* Age 50-79 years (only postmenopausal women \> 2 years)
* Body mass index (20-25 kg/m2; and 30-40 kg/m2)\*

Exclusion Criteria:

* Diagnosed with, active, or history of liver cirrhosis, chronic or persisting hepatitis
* Diagnosed with, active, or history of cancer
* History of gastrointestinal disease or surgical procedure for weight loss.
* Diagnosed with immune diseases, type 2 diabetes, pancreatitis, or infectious diseases
* Any surgery in the past 6 months
* Currently using or have used antibiotics continuously \> 3 days in the past 3 months
* Regular use of medications for that affect the gastrointestinal tract, cholecystitis, urinary tract infection, severe organic diseases including coronary heart disease, myocardial infarction, infectious diseases including pulmonary tuberculosis and AIDS
* Known allergy or intolerance to any ingredients in the dietary intervention program
* Alcohol or illicit drug abuse
* Current Smoker or have quit smoking in the past 3 months
* Recent colonoscopy (within the previous two months)
* Inability to follow any of the experimental diets (including low or high fat diet) or to perform the collections required for this study
* Participants will also be excluded if they have extreme dietary habits, extreme levels of physical or athletic activity, or by changes in body weight \>5 lbs. during the last 6 months
* Uncontrolled hypertension or uncontrolled hyperlipidemia in abnormal ranges.
* Participation in another clinical research trial that may interfere with the results of this study.

  * As needed, BMI (kg/m2) will be adjusted accordingly for Asian lean and obese definitions
Effects of Urban Afforestation Activity on Mood, Stress, and Anxiety

This single-group pretest-posttest clinical trial aims to evaluate the effects of a single-session afforestation activity on mood, stress, and anxiety in a sample of adults.

The participants will perform an afforestation activity for a single session of 90 minutes. The therapist will direct the participants' attention to the visual, auditory, olfactory, and tactile features of the surrounding environment.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 18 and 65 years.
* Any sex and gender.

Exclusion Criteria:

* Intake of any psychotropic medication.
* Other severe or medically unstable diseases that may interfere with participation.
* Severe cognitive impairment (Mini-Mental State Examination score \< 17 out of 30 points).
* Severe mental disorders in the acute phase or symptomatic phase.
* Severe intellectual disability.
* Behavioural alterations as this may interfere with their participation.
DP13 SAD & MAD in Healthy Male Subjects

Primary Objectives:

1. To determine the safety and tolerability of single and multiple oral doses of DP13 in healthy male subjects
2. To assess the pharmacodynamics of single and multiple ascending oral doses as well as dosing regimen of DP13 on suppression of serum aldosterone in healthy male subjects

Secondary Objectives:

1. To determine the single and multiple oral dose pharmacokinetics of DP13 in healthy male subjects
2. To determine the dose-dependent pharmacodynamic selectivity of DP13 in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

1. BMI between 18.0 and 30.0 kg/m2, inclusive
2. body weight between 60 and 95 kg, inclusive
3. good health as determined by medical history, physical examination, vital signs assessment, 12-lead ECG, clinical laboratory evaluations
4. normal stress response
5. sodium value within the normal laboratory reference range
6. potassium value within the normal laboratory reference range
7. written informed consent

Exclusion Criteria:

1. unwilling to consent or whose partner is unwilling to consent to use a barrier method of contraception
2. blood donation within 3 months prior to screening or plasma donation within 7 days prior to screening or platelet donation within 6 weeks prior to screening
3. consumption of more than 28 units of alcohol per week or significant history of alcoholism or drug/chemical abuse within the last 12 months prior to screening
4. use of tobacco or nicotine-containing products within 3 months
5. use of any of the following within 14 days of first dose: non-prescribed systemic or topical medication; any herbal remedy; any vitamin supplement; any mineral supplement
6. receipt of any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes
7. receipt or intent to receive: any prescribed systemic or topical medication within 14 days of first dose administration
8. an abnormality in heart rate, blood pressure, temperature or respiration rate at screening and prior to first dose that in the opinion of the investigator increases the risk of participating in the study
9. a positive urine drugs of abuse screen
10. an abnormality in the 12-lead ECG at screening and prior to first dose that in the opinion of the investigator increases the risk of participating in the study
11. a medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome
12. participation in another clinical study
Topical Oestrogens and Antimuscarinics In The Treatment Of Detrusor Overactivity

Despite the great number of reports about the efficacy of oestrogens or antimuscarinics on OAB symptoms, so far no author has tried to investigate whether the concomitant administration of these two drugs, acting on two different pathophysiological mechanisms, could have a synergic effect reducing the rate of non-responders to treatment.


Eligibility Criteria:
Inclusion Criteria:

* All post-menopausal women with symptoms of overactive bladder and urodynamically proven pure detrusor overactivity

Exclusion Criteria:

* concomitant urodynamic stress incontinence
* documented recurrent urinary tract infections
* previous antimuscarinic treatment
* previous pelvic surgery
* concomitant systemic HRT
* history of breast or endometrial cancer
* neurological disease
* clinical contraindications to treatment with oestrogen or antimuscarinics
* patients included in other ongoing clinical trials
fMRI Study of Brain Mechanisms Related to Emotions

The purpose of the study is to better define and understand the brain mechanisms related to emotional and cognitive dimensions using odorous stimuli, gustatory stimuli, visual stimuli and auditory stimuli using functional Magnetic Resonance Imaging (fMRI).


Eligibility Criteria:
Inclusion Criteria:

* right-handed
* Healthy Volunteers

Exclusion Criteria:

* those applied for an magnetic resonance examination
Providing Evidence-Based Approaches for Caregiver Stress Study

The purpose of this preliminary study is to examine the effects of adult day service use on subjective and physiological measures of stress in 50 Black informal caregivers for individuals with dementia (IWD). The PI of the proposed study has substantial training in primary data collection and complex-survey secondary data analysis, she also has the fundamental knowledge to investigate how sociocultural and behavioral factors can influence psychosocial stress. The proposed study will enroll participants from adult day service (ADS) nationally, to examine the effects of adult day service use on subjective and physiological measures of stress in 50 Black informal caregivers. The proposed study extends the current science on the use of ADS on subjective and physiological stress by 1) examining differential impacts of ADS specifically on subjective measures of stress for Black caregivers, 2) evaluating the impact of ADS use on physiological measures of stress among Black caregivers; and 3) examining the relationship between subjective indicators and physiological processes for Black caregivers.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older (male or female)
* Self-identify as Black and/or African American,
* Lives with a family member with a physician diagnosis of Alzheimer's disease or related dementia
* Primary responsibility for care of the family member who has been diagnosed with Alzheimer's disease or related dementia
* Utilize Adult Day Services at least two times a week for family member with Alzheimer's disease or related dementia

Exclusion Criteria:

* Either caregiver of client is in active treatment for a terminal illness or are in hospice.
Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling

All existing medical literatue regarding axial length (AL) changes after scleral buckling surgery for retinal detachment, descibes changes after solid silicone buckling. In this hospital, the investigators use only silicone sponge buckling, which has different properties and a different buckle profile. there are no studies in the literature describing tha AL changes after sponge buckling, or whether the AL change is less or more than with solid silicone buckles. The investigators wish to determine whether the AL change profile with their silicone sponge is significantly different, and if so, whether this is clinically important in determining the better choice of buckle material to be preferred.


Eligibility Criteria:
Inclusion Criteria:

* Patients at least 6 months after succesful retinal detachment surgery
* with silicone sponge scleral buckling
* currently attached
* with IOL Master pre-surgery Axial Length measurement

Exclusion Criteria:

* patients with failed surgery and currently detached
* patients with vitreos silicone oil tamponade
* patients with radial or other non-circumference buckles
* patients with unclear media not amenable to IOL Master exam
Study to Evaluate Safety/Duration in Stomach of Extended Release Capsules Containing Memantine Hydrochloride in Healthy Adults

To assess how long memantine hydrochloride (HCl) (50 mg) extended release capsules stay in the stomach as determined by imaging assessment (MRI or abdominal ultrasound).

To evaluate the safety of a memantine HCl extended release capsule formulation

This is a single centre, open label, single dose study in healthy adult subjects.

Eligible individuals will be admitted to an inpatient unit in two or more cohorts. Enough eligible individuals will be admitted allowing for the enrollment of the Sentinel (n= 2) and Main Group (total of n=8 in Main), and an optional Supplemental Group (n= 6), if required.

All enrolled subjects will be dosed with a single administration of an extended release capsule containing memantine hydrochloride (LYN-057), 50 mg. Dosing will be conducted in an inpatient clinical unit, with access to an acute care facility. Subjects will remain in the inpatient unit for 7 days after dosing. During this time, subjects will undergo intermittent imaging assessments for gastric retention \[magnetic resonance imaging (MRI) and abdominal ultrasound (U/S)\], safety assessments, blood sampling for evaluation of memantine pharmacokinetics (PK), and faecal collections for assessments of formulation components and bowel movement characteristics.

Subjects will return to the clinic for PK sampling and safety assessments on Days 10, 15, 22 and Day 29 (End of Study Visit). In addition, some subjects may continue to perform faecal collection and/or may undergo imaging assessments on Day 10 based on clinical criteria. On Day 29 (End of Study Visit), subjects will undergo final safety and PK assessments and will be discharged from the study.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female subjects
2. Body mass index of 18.0 to 30.0 kg/meters-squared
3. Suitable scores for two swallowing questionnaires
4. Demonstrate normal swallowing and gastrointestinal passage for capsule, as assessed while undergoing imaging studies
5. Must provide written informed consent

Exclusion Criteria:

1. Participants who have previously been enrolled in this study
2. History of any drug or alcohol abuse in the past 2 years
3. Current smokers and those who have smoked within the past 12 months
4. Individuals with clinically significant medical history relating to the gastrointestinal tract and potential complications, thereof
5. Individuals with a positive test for HIV, hepatitis B or hepatitis C
6. Individuals who are contraindicated based on memantine HCl
7. Serious adverse reaction or serious hypersensitivity to components of the study formulation or patency capsule
8. Individuals who have received any experimental agent within 30 days (or 5 half-lives), whichever is longer, prior to the date of dosing
9. Individuals with contraindication to MRI imaging
10. Individuals with functional constipation, irritable bowel, or functional diarrhea, as evaluated by standardized questionnaire
11. Individuals with contraindications to elective X-ray based on known or expected radiation exposure
Optimal Duration of Early Intervention for Psychosis

A total of 160 subjects, who aged 18-35 and had completed the first 2 years of case management in the EASY programme will be randomized in 1:1 ratio into either (1) receiving an additional year of case management, or (2) terminating case management for the next 12 months. The current study aims to investigate whether an additional year of case management in year 3 will confer additional benefits in outcome, in terms of functioning, symptoms, quality of life and health economics.

Psychotic disorders involve disturbances in perceptual, cognitive and motivational processes central to the human life experience, which resulting in long-term and pervasive functional disability. In order to achieve the best possible long-term community outcome of psychotic disorders, early intervention service is set up, focusing on the first few years (the critical period) of the illness.

In Hong Kong, early intervention for psychotic disorder was provided since 2001. The integrated Early Assessment Service for Young people with psychosis (EASY) provide specialized care to early psychosis patients up to age 25. Evaluation of the EASY programme using a matched historical control suggesting that early intervention is a promising approach to promote community care for patients with psychosis.

In the current service, case management for patients will terminate after two years, and the patients will make transition to general psychiatric care afterwards. It is not clear whether the provision of additional case management in the community (e.g., for another year) will significantly enhance outcome further.

The proposed study aims to investigate the effectiveness of providing community based case management for an additional year for patients with psychotic disorders by using a randomized controlled design. The study recruit patients who had completed the first 2 years of case management in the EASY programme and randomized them to receive either an additional year of case management, or to terminate case management for the next 12 months. The hypothesis is that better outcome are found in patients who had 3-year case management compared with those who had only 2 years.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, psychosis not otherwise specified or delusional disorder
* Received EASY service for 2 years following a first-episode psychosis
* Cantonese-speaking Chinese
* Ability to understand the study and to provide written informed consent

Exclusion Criteria:

* Organic brain disorder
* Known history of intellectual disability
* Drug-induced psychosis