cyrilzakka/clinical-trials huggingface dataset:
Exercise and Low Back Pain

Evaluation of the effectiveness of an individually educated exercise program for the lower back at home in employees over a period of 20 weeks.

We hypothesize that regular exercise for the lower back results in greater improvements of low back strengths compared to controls.


Eligibility Criteria:
Inclusion Criteria:

* men and women
* age between 18 and 67 years

Exclusion Criteria:

* beeing currently involved in an exercise program for the lower back
* known drug or alcohol abuse
* any disease that excludes the participation in an exercise program
* clinical relevant acute or chronic infections
* pregnant women
Effect of Local Application of Boron on Diabetic Foot Ulcers

Boron as a naturally occurring element has some metabolic and inflammatory actions. The antibacterial activity against gram negative bacteria is also known. Boron deficiency is shown to be related with impaired wound bone healing in rats. Therefore, special wound care formulas containing boron may have some positive effect on wound healing of the patients with diabetic foot ulcers.

Local treatment of diabetic foot ulcers:

1. Classification of International Working Group of the Diabetic Foot (IWGDF)
2. pre-treatment measurements including diameter and area
3. pre-treatment laboratory values including fasting glucose, hemoglobin, hemoglobin A1c, leucocyte count and c-reactive protein
4. pre-treatment wound culture
5. treatment either by placebo gel containing polymer of carbopol ultrex (1%) or by formulation gel: addition of borate as sodium penta boric acid pentahydrate 3% (w/v) and two different copolymer as pluronic block namely F68 2% (w/v) and f127 2% (w/v).
6. post-treatment measurements and values

Eligibility Criteria:
Inclusion Criteria:

* diabetic food ulcer classified byInternational Working Group of the Diabetic Foot (IWGDF) as grade 1 and 2

Exclusion Criteria:

* previous vascular surgery on the side that the ulcer is present
* uncontrolled diabetes mellitus
* presence of osteitis, abscess, osteomyelitis, gangrene on the side that the ulcer is present
* diabetic food ulcer classified byInternational Working Group of the Diabetic Foot (IWGDF) as grade 3
Study of Subcutaneous Versus Intravenous Administration of Bortezomib in Patients With Multiple Myeloma in China

Intravenous injection is the standard administration route of bortezomib; however, subcutaneous administration is an important alternative. We want to compared the pharmacokinetic of subcutaneous versus intravenous bortezomib at the approved 1•3 mg/m2 dose and twice per week,on days1, 4, 8 and 11 of 21-day cycles, schedule in newly diagnosed patients of multiple myeloma.

The new diagnosed multiple myeloma patients are randomized to receive bortezomib by standard intravenous bolus (n=10) or subcutaneous injection (n=10) at the recommended dose and schedule (1.3 mg/m2), days 1, 4, 8, 11;eight 21-day cycles).

Patients discontinued treatment due to progressive disease, insufficient efficacy, unacceptable toxicity, or serious protocol violation. Dose modifications are specified for unexpected pharmacokinetic observations or toxicity. Bortezomib-related neuropathic pain and/or peripheral sensory neuropathy were managed using established dose-modification guidelines.

Blood samples for pharmacokinetic/pharmacodynamic analysis are collected on days 1 and 11, cycle 1:before bortezomib administration, and at 2, 5, 15, 30, and 60 min, and 2, 4, 6, 10, 24, 32, 48, and 72 hours post-dosing. Pharmacodynamic analyses were performed using a whole-blood 20S proteasome specific activity inhibition assay.

Eligibility Criteria:
Inclusion Criteria:

* Must be Multiple Myeloma Proved by Laboratory Tests
* Must have the ability to observe the efficacy and events
* Patient must have the ability to understand and willingness to provide written informed consent in the study and any related procedures being performed

Exclusion Criteria:

* If have uncontrolled intercurrent illness including ongoing or active infection,heart failure,unstable angina pectoris,or psychiatric illness/social situations that study requirements
* If have severe side-effects on bortezomib
Pre- and Postoperative Cognitive Behavior Therapy for Patients Accepted for Bariatric Surgery

The purpose of this study is to investigate the relationship between the potential predictive psychological variables and success after bariatric surgery. The investigators will also investigate the purpose of a pre- and postoperative psychological intervention.

Bariatric surgery is the treatment of choice for morbid obesity, but it does not lead to equal results in every patients. Research about personality factors involved in successful outcome after bariatric surgery has led to contrasting results. The existing literature about potential predictors of success after bariatric surgery is far from conclusive. The investigators want to evaluate preoperatively by standardized diagnostic interviews (MINI, SCID-II) and rating scales and questionnaires to assess co-morbid psychopathology. The same evaluation will be done after 1,2 and 5 years. The investigators will look for a relationship between psychological variables and success after bariatric surgery, including amount of weight loss, psychiatric comorbidity, quality of life and employment. The investigators will also investigate the purpose of an pre- and postoperative psychological intervention. Patients on a waiting list for bariatric surgery are randomised to an intervention- and a control group. The intervention is based on cognitive behavior therapy and mindfulness, 6 weeks preoperative and two weeks postoperative programme. Outcome measures are amount of weight loss, psychiatric comorbidity, quality of life and employment.

Eligibility Criteria:
Inclusion Criteria:

* Patients on a waiting list for bariatric surgery at Haugesund hospital

Exclusion Criteria:

* Patients with psychosis and suicidality
* Suicidal attempts the last two years
* Or suicidal thoughts or plans.
Don't Go There: A Geospatial mHealth App for Gambling Disorder

The goal of this project is to develop and to test the efficacy of a novel mHealth app for gambling disorder. The app capitalizes on smartphones' global positioning software (GPS) that recognizes a user's location to within 15 feet. Users will receive an alert of this go near a gambling venue. The project will conduct a 12-week pilot randomized clinical trial to test the short-term efficacy of the app with gambling disorder individuals.


Eligibility Criteria:
Inclusion Criteria:

* Currently meets DSM-5 criteria for gambling disorder
* At least 4 non-online gambling episodes in past 60 days
* Wagering at least $100 total over past 60 days
* Willingness to accept random assignment
* English speaking
* Android phone user

Exclusion Criteria:

* Age \<18 years old
* Severely disruptive behavior
* Serious uncontrolled psychiatric behavior that requires acute psychiatric care
* Decline permission to collect zero permission data from smartphone.
Active Body and Mind Intervention for Older Adults

This study aimed to examine the effectiveness and acceptability of wearable activity trackers with self-regulatory techniques for promoting physical activity (PA) in older adults. In addition, this study aimed to investigate the impact of a multicomponent PA intervention on life satisfaction, happiness, eudaimonic well-being, and depressive symptoms, reflecting different dimensions of psychological well-being, in older adults.

Fifty-nine participants living in retirement communities were voluntarily assigned to a 12-week multi-component PA intervention program or an attention control group. Participants in the intervention group were asked to take three 45-min supervised group exercise lessons per week and wear wearable activity trackers during the weekdays for 12 weeks. Four components of psychological well-being were assessed at baseline and the end of the intervention including life satisfaction, happiness, eudaimonic well-being, and depressive symptoms. The intervention effect on each component of psychological well-being was analyzed using linear mixed models after controlling for potential confounders. Participants' experiences of using the wearable activity tracker were assessed after the 12-week intervention through an 8-item questionnaire and individual interviews

Eligibility Criteria:
Inclusion Criteria:

* aged 65 or older,
* able to speak and read English fluently
* able to walk for 10 feet without human assistance

Exclusion Criteria:

* conditions preventing them from doing exercises
Fructose Rich Diet and Endothelial Function

Cardiometabolic diseases have been associated with high consumption of sweetened beverages. These products are responsible for the largest portion of the total consumption of fructose in the diet and it is suggested that excessive intake of this monosaccharide may contribute to the development of risk factors for these diseases due to differences in metabolism relative to glucose. However, there is a lack of data in the literature demonstrating the deleterious effects of excessive fructose consumption on vasodilation and whether aerobic training may be able to prevent or mitigate these damages in humans. Therefore, the aim of the study will be to verify the effect of 4 weeks of high fructose diet associated with aerobic training on uric acid levels and its influence on markers related to oxidative stress and vasodilatation. Twenty-one sedentary men and women, aged between 19 and 35 years, will be submitted to 4 weeks of intervention. In a randomized way, subjects will be divided into 3 groups: high fructose diet, high glucose diet and high fructose diet and exercise. Blood samples will be taken before, in the middle and after the intervention to verify the concentrations of uric acid, superoxide dismutase enzyme, thiobarbituric acid, nitrite / nitrate, lipid profile, glucose, insulin, C-reactive protein and endothelin-1. In addition, flow-mediated dilatation, insulin resistance index, pancreatic beta cell functional capacity index, oral glucose tolerance test, 24-hour blood pressure, heart rate variability and body composition will be analyzed. The comparisons will be performed through the Generalized Estimates of Equations, adopting the factors group and time. The Bonferroni post-hoc will be used to identify differences. The accepted level of significance will be 5%.


Eligibility Criteria:
Inclusion Criteria:

* Men and women;
* Not engaged in regular exercises;
* Aged between 19 and 35 years;
* Body mass index (BMI) of less than 30kg / m².

Exclusion Criteria:

* Individuals with BMI below 18kg / m² and greater than 30kg / m²;
* Smokers;
* Dyslipidemic;
* Diabetic;
* Hypertensive;
* Alcohol use;
* Appetite suppressants use;
* Medications use;
* Supplements use;
* Chronic disease that impedes the performance of physical exercise.
Preliminary Study on Eye Features of Patients With Malignant Tumors

Based on the theory of traditional Chinese Medicine, this study collects eye features of white eyes through the White Eye Imaging Health Care System under visible light and establishes a database of eye-eye features corresponding to the disease. The computer image analysis and artificial intelligence technology are used to visualize the eye. The features were extracted and classified, and the corresponding changes in the characteristics of the traditional Chinese medicine and the disease were analyzed statistically to establish an analytical model corresponding to the disease.

1. Collecting the white-eyed eye features of 500 patients with malignant tumors and 500 non-tumor patients by the white-eye shadowless imaging acquisition system under visible light, and establishing eye-catching images of malignant tumor patients and healthy people of different diseases. Feature database.
2. Based on the collected four-dimensional eye-eye diagram, using computer image analysis and artificial intelligence technology to extract and classify the eye-eye features of the white eye, and statistically analyze the correlation between the eye-eye features and the malignant tumor. The relationship between the characteristics of the white eye and the corresponding change of malignant tumor.

Eligibility Criteria:
Inclusion Criteria:

* Malignant tumor patients with clear pathological diagnosis;

  * Those who have no serious primary diseases of the cardiovascular, cerebrovascular, respiratory, endocrine, urinary, blood and other systems;

    * The main organs (hematopoiesis, heart, lung, liver, and kidney) have no obvious abnormal function; ④Age ≥18 years old, ≤75 years old; ⑤ No serious eye disease;

      * The patient volunteered to participate in this study.

Exclusion Criteria:

* Patients with severe blood loss (because when the bleeding exceeds 300ml, the white eye color of the patient is often pale white);

  * Poor patient compliance; ③ pregnant and lactating women;

    * Can't cooperate with inspection properly; ⑤ Cannot read or understand the scale.
Dietary Linoleic Acid for Secondary Prevention of Coronary Heart Disease and Death in the Sydney Heart Study: an RCT

The substitution of polyunsaturated fatty acids (PUFA) for saturated fatty acids (SFA) is a cornerstone of worldwide dietary advice for coronary heart disease (CHD) risk reduction. However, clinical CHD benefits specific to the omega-6 PUFA linoleic acid (LA), and distinct from omega-3 PUFAs, have not been established. The Sydney Diet-Heart Study (SDHS; 1966-1973) was a randomized controlled secondary CHD prevention trial testing whether selectively increasing omega-6 LA from safflower oil in place of SFA reduced CHD and improved survival. A full analysis of mortality outcomes has not been published. The investigators recovered the original SDHS dataset, which included detailed longitudinal dietary, smoking and coded mortality data, permitting evaluation of smoking relapse rates, and all-cause, CVD and CHD mortality outcomes by nutrient intake and duration of diet exposure. Data recovery also permitted the first complete meta-analysis of LA intervention trials on mortality outcomes.

Objectives are (1) to evaluate whether increasing dietary linoleic acid alters CVD and CHD mortality, and (2) to assess whether changes in smoking relapse rates contribute to observed mortality differences.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of myocardial infarction, angina, or coronary insufficiency
* Willingness to attend Coronary Clinic in Sydney Australia on a regular basis
The Distribution of Body Constitutions Among Hong Kong Elderly Population: A Cross-sectional Study

Hong Kong, similar as other developed economic entities, has been faced big challenges from increasing medical burden and aged population. Based on the updated estimates of domestic health expenditure by Food and Health Bureau HKSAR, the total health expenditure amounted to HK$112,144 million in 2012/13 with increasing approximate 4 times than 1992/93. According to the data from Census and Statistics Department, in 2010, there was still 13% population aged above 65 years, while in 2039, this percentage will be elevated to 28% (http://www.censtatd.gov.hk/hkstat/sub/so20.jsp). In other words, every three individuals will contain a person aged above 65 years in the future 30 years. Therefore, how to release the medical burden resulted from aged tendency of population is the critical question in optimizing the treatment expenses.

Our aims in the cross-sectional study are to 1) estimate the number and percentage of nine body constitutions among population aged 65 and over in Hong Kong 2) identify the associations between nine body constitutions and other predetermined factors such as gender, weight, diet, body mass index (BMI), blood pressure, quality of life scale scores, et al.


Eligibility Criteria:
Inclusion Criteria:

* aged 65 and over
* capable of consenting and have agreed to participate, ambulatory, and not receiving treatment modalities, which, if omitted, may result in immediate life threatening risk such as chemotherapy or radiotherapy for cancer, or dialysis for renal failure

Exclusion Criteria:

* neurological disorders such as dementia
Memantine and Naltrexone Treatment for Opioid Dependence

The goal of this study is to test the efficacy of memantine (a noncompetitive NMDA receptor antagonist) as an adjunct to the maintenance treatment with naltrexone in detoxified heroin-dependent individuals.

The primary aim of this study is to test the efficacy of memantine, a noncompetitive NMDA receptor antagonist, in reducing early attrition and improving outcome in opioid-dependent individuals maintained on naltrexone.

This double-blind, 12-week trial will include heroin-dependent patients who completed detoxification. Participants will be randomly assigned to one of three conditions: naltrexone and placebo, naltrexone and memantine (15 mg bid), or naltrexone and memantine (30 mg bid). Naltrexone will be taken 3 times each week at the clinic, while memantine or placebo will be taken at home. In addition, twice each week patients will receive a psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. The goal of the psychosocial intervention is to improve compliance with medication and maintain abstinence. Baseline assessments will be taken and compared to those completed at study visits, which will occur 3 times each week.

Eligibility Criteria:
Inclusion:

* Adult, aged 18-60.
* Meets DSM-IV criteria for current opiate dependence disorder of at least six months duration, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear.
* Able to give informed consent.

Exclusion:

* Pregnancy or breastfeeding
* Failure in a sexually active woman to use adequate contraceptive methods
* Active medical illness that might make participation hazardous, such as untreated hypertension, acute hepatitis with SGOT or SGPT levels \> 2 times normal, unstable diabetes, or chronic organic mental disorder (e.g., AIDS dementia)
* Active psychiatric disorder that might interfere with participation or make participation hazardous, including DSM-IV schizophrenia, bipolar disorder with mania or psychosis, and depressive disorder with suicide risk or 1 or more suicide attempts within the past year.
* History of allergic reaction to buprenorphine, naloxone, memantine, naltrexone, clonidine, or clonazepam
* Currently prescribed or regularly taking opiates for chronic pain or medical illness
* Current participation in another intensive psychotherapy or substance abuse treatment program or currently prescribed psychotropic medications
* Current participation in a methadone maintenance treatment program and/or regular use of illicit methadone ( \> 30 mg per week)
* History of accidental drug overdose in the last 3 years or any other significant history of overdose following detoxification, defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received
Study of the Efficacy of 24 Chromosome Preimplantation Genetic Diagnosis (PGD)

The purpose of this study is to determine if 24 chromosome preimplantation genetic diagnosis (PGD) increases implantation and delivery rates in couples attempting to conceive through in vitro fertilization (IVF).

FISH based PGD techniques have provided little improvement in implantation and delivery rates. We believe that the use of 24 chromosome PGD, as compared to control (no PGD) will show a benefit to patients. This study is a randomized clinical trial that seeks to validate 24 chromosome PGD.

Patients that meet the eligibility criteria will be randomized prior to embryo transfer. In order to be randomized, the patient must have blastulated embryos suitable for biopsy on day 5. Half of the patients will received 24 chromosome PGD and will have 2 PGD normal embryos transferred. Half the the patients will receive no PGD and the 2 morphologically best embryos will be transferred. Follow up on pregnant patients will be a blood draw at approximately 9 weeks gestation and buccal swabs collected from the infant(s).

Eligibility Criteria:
Major Inclusion Criteria:

1. Age of female partner of \< 43 years
2. Normal day-three FSH level (\< 15 mIU/mL)
3. Normal uterine cavity
4. Sufficient ejaculated spermatozoa in male partner for ART
5. Maximum of one prior failed IVF cycle

Major Exclusion Criteria:

1. FSH level ≥ 15 mIU/mL
2. BMI greater than 32 kg/m2
3. Contraindication to gonadotropin stimulation
4. Unevaluated Ovarian mass
5. Need for surgical sperm removal
6. Any contraindication to undergoing in vitro fertilization
7. Age greater than 43 years
8. Presence of hydrosalpinges which communicate with the endometrial cavity
9. Clinical indication for PGD (undergoing IVF with PGD to rule out a known genetic defect)
Operability and Implementation of a Patient Motion Monitoring System Using Wireless Body Worn Sensors

In this observational study, a motion monitoring system including body-worn sensors, communication portals, data capture system, and algorithms will be tested with geriatric patients in Garrison Geriatric Education and Care Center (Lubbock, TX). The study is part of a long-term effort to improve the quality of life and safety of geriatric patients by using autonomous systems that can alert care givers of mobility issues and falls.

Medical monitoring systems have become an important area of research and development due to the possibility of allowing improved quality of life and care while reducing overall medical costs.

Significance of the study:

The study is significant because it will allow researchers to understand the efficacy of the autonomous sensor system used with actual residents of a geriatric care center. This study is one of the first attempts to monitor movements of geriatric residents as they go about their activities of daily living. This type of system has the potential to improve the quality of life and safety of geriatric patients.

Goals:

The development of autonomous patient monitoring technologies that will eventually improve the quality of life and safety of patients in geriatric care facilities and other environments.

Determine the performance and usability of the wearable sensor system in a geriatric care facility with actual residents going about their daily lives.

Specific Aims:

1. Determine performance of motion data collect ion system for monitoring geriatric residents as they go about their daily life in a geriatric center
2. Determine tolerability of wearing sensors by geriatric residents
3. Understand how medical staff interacts with monitored residents and the sensor devices
4. Determine if the sensor system's algorithms can identify falls

Objectives:

1. Analyze the motion data generated by the system to determine system performance. The list of performance metrics will include: (a) system up-time, (b) continuity of data collection (c) sensor device failure rate, (d) sensor device battery life (e) simultaneous collection of data when multiple monitored residents are in the same localized area.
2. Assess the tolerability of wearing the devices over the course of a day using a survey administered to residents.
3. Assess the usability of the sensor system using a survey administered to care givers.
4. Compare events flagged as falls by system algorithms with the fall log produced by Garrison staff, cross-verified against personal fall logs, to determine the ability of the system to detect falls.

Eligibility Criteria:
Inclusion Criteria:

1. At least 30 day resident of Garrison.
2. Deemed mentally competent by primary care provider to make decisions regarding their daily shoe wear.
3. A resident prone to falls is eligible.
4. Willing to wear shoes and offer high level of compliance to study
5. Able to provide informed consent
6. Able to complete survey
7. Age range: 45-85 yrs

Exclusion Criteria:

1. Unwilling to participate 2. Not mentally competent to provide informed consent

-