cyrilzakka/clinical-trials huggingface dataset:
An Evaluation of a Mind-Body Medicine Training Program for Parole Services Division Staff

The goal of this study is to evaluate the effectiveness of a mind-body medicine training program on parole services staff. The main questions it aims to answer are:

* Will participation in the training increase resilience; empathy; the belief that one can cope with difficult situations; and decrease symptoms of depression, stress, anxiety, and burnout?
* What is the personal and professional impact of the training program?

Sixty staff members of the Indiana Department of Correction Parole Services Division will do the following:

* Attend an initial 4-day mind-body medicine training. Mind-body techniques taught in the training include: meditation; a breathing exercise; biofeedback; guided imagery; expressing oneself through drawings and writing; movement to reduce stress; and family trees to explore family dynamics.
* Attend a 2-day practicum. The 2-day practicum will teach staff the ways in which they can share the skills they have learned one-on-one with parolees and families of parolees.
* Attend 4 biweekly sessions of 2-hour group consultation sessions. The consultations will support the use of the mind-body skills with the parolees.

Participants will also do the following:

* Fill out standardized questionnaires online before and after the training program in order to measure changes in resilience; empathy; the belief that one can cope with difficult situations; and symptoms of depression, stress, anxiety, and burnout.
* Fill out an additional online questionnaire three months after the consultation sessions to determine how trainees are using the mind-body skills in their work.
* Participate in an online group interview to determine how trainees are using the skills and how the training has affected them personally and professionally.


Eligibility Criteria:
Inclusion Criteria for Mind-Body Medicine Training :

* Being a staff member of the Division of Parole Services
* English Speaking
* Being 18 years of age or older
* Able to fully participate in the training and the small groups included in the training

Exclusion Criteria for Mind-Body Medicine Training:

• None: It is expected that all parole staff will be able to fully participate in the training and the small groups included in the training

Inclusion Criteria for Focus Group Participation :

* Completion of the Mind-Body Medicine Training
* Currently supervising parolees
* Teaching or using mind-body skills with their supervised parolees
* Being 18 years of age or older
* English speaking.

Exclusion Criteria for Focus Group Participation:

• None, as long as the trained staff meet the inclusion criteria.
Study of WAL0921 in Patients With Glomerular Kidney Diseases

This is an adaptive prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of WAL0921 in subjects with glomerular kidney disease and proteinuria, including diabetic nephropathy and rare glomerular kidney diseases (primary focal segmental glomerulosclerosis \[FSGS\], treatment-resistant minimal change disease \[TR MCD\], primary immunoglobulin A nephropathy \[IgAN\], and primary membranous nephropathy \[PMN\]). Subjects in this study will be randomized to receive the investigational drug WAL0921 or placebo as an intravenous infusion once every 2 weeks for 7 total infusions. All subjects will be followed for 24 weeks after their last infusion.


Eligibility Criteria:
Inclusion Criteria:

* Adults, age 18-75 years
* Diagnosis of one of the following glomerular kidney diseases: diabetic nephropathy; primary focal segmental glomerulosclerosis; treatment resistant-minimal change disease; primary IgA nephropathy; primary membranous nephropathy
* eGFR greater than or equal to 30 mL/min/1.73 m2

Exclusion Criteria:

* Currently pregnant or planning to become pregnant
* History of organ transplantation
* History of alcohol or substance use disorder
* Acute dialysis or acute kidney injury within 6 months of Screening
* Any prior or current medical condition that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all study requirements
LARS in Ovarian Cancer Patients

Background:

Low anterior resection syndrome (LARS) is a common functional disorder after low anterior resection impacting quality of life. Data on LARS derives nearly exclusively from rectal cancer studies. Therefore, the study was designed to assess LARS in advanced epithelial ovarian cancer (EOC) patients, who underwent rectal resection and to compare it with a female rectal cancer cohort.

Methods:

A cross-sectional multi-centre analysis was performed for female patients suffering from either rectal or EOC who received a low anterior resection as part of their therapy regimen. None of the patients received pre- or postoperative radiotherapy. LARS was defined by using the validated LARS score and its severity was divided into "no", "minor" and "major LARS".


Eligibility Criteria:
Inclusion Criteria:

* low anterior resection because of ovarian or rectal cancer

Exclusion Criteria:

* neoadjuvant or adjuvant radiotherapy
The Impact of Ocular Diseases on Driving: a Prospective Study

The purpose of the study was (1) to determine thresholds for discriminating speed in peripheral fields of patients with dry AMD and (2) to examine the driving skills of licensed drivers with early dry AMD using a driving simulator and to investigate how their healthy counterparts perform on the same driving tasks. We hypothesized that speed discrimination may be better in patients with dry AMD than in healthy control subjects.

This observational study has two goals:

1. to establish if patients affected by dry AMD have a different speed discriminating threshold using peripheral vision fields than their healthy counterparts.
2. to determine if the driving skills of AMD and glaucoma patients differ from healthy controls.

Two tasks will be used: 1) A speed discrimination test. (Glaucoma patient are not asked to perform this task as it assesses the peripheral visual fields, which is affected by the disease.) 2) A driving simulation session. Participant will undergo both tests on the same day, no later than a month after the initial recruitement visit.

For both diseases, patients will be compared to healthy controls matched for age and gender, but also to a younger control group. The latter group was added in order to take into account the normal aging impact on driving skills (visual and cognitive).

Our hypothesis is that AMD patient will show a better speed discriminating threshold than matched control and maybe better or equal to the younger control groups. We also hypothesize that driving skills involving peripheric speed awareness, such as passing another car, will be enhanced in the AMD group when compared to glaucoma patients and age-matched control group.

Eligibility Criteria:
Inclusion Criteria:

* Best-corrected visual acuity (BCVA) had to be at least 20/50 (6/15).
* Binocular visual field (VF) should not be less than 120° along the horizontal meridian and 20° above and below the same meridian.
* Valid driving license
* Diagnosis of bilateral dry AMD (AMD group) or open-angle glaucoma (glaucoma group)

Exclusion Criteria:

* Diplopia
* Cognitive impairment
* Other ocular diseases
Comparison Between White Light Endoscopy and Bright Narrow Band Imaging in Diagnosis Colonic Adenomas.

Removal of colorectal adenomas prevents the occurence of colorectal cancers. The use of chromo-endoscopy has been shown to improve the detection of flat adenomas. Narrow band imaging enables endoscopists to accurately describe the pit pattern of adenomas. By comparing White Light Endoscopy and Bright Narrow Band Imaging it will show if there is any comparable advantage to using one or the other for lesion detection and assessment.

Removal of colorectal adenomas prevents occurrence of cancers \[1\]. It is recognized that colonoscopy can miss colorectal adenomas and early cancers \[2\]. There is a need to further improve performance of colonoscopy. The use of chromoendoscopy has been shown to improve detection of flat adenomas \[3\]. Narrow band imaging was introduced in year 2006. It is similar to chromoendoscopy in that it provides more mucosal details. This enables endoscopists to accurately describe the pit pattern of adenomas. NBI has been used as a substitute to chromoendoscopy.

In pooled analysis, NBI is comparable to chromoendoscopy in their sensitivity and specificity in the diagnosis of malignant colorectal adenomas \[4\]. Unfortunately, the use of NBI has not been shown to conclusively improve rate of colorectal adenoma detection. Two of 3 randomized trials that compared WLE to NBI showed a higher adenoma detection rate with the use of NBI \[5, 6\]. In a study by Rex et al., the rate was however similar with either modality. In a pooled analysis, NBI was only marginally better than WLE \[7\].

The effective use of NBI depends on the quality of bowel preparation and the experience of endoscopist. In the presence of fecal matters, NBI tends to be dark and detection of small adenomas becomes difficult. The prototype bright NBI coupled with high definition resolution is likely to overcome this drawback of original NBI.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic subjects undergoing screening colonoscopy, age \> 50, average risk subjects and, ability to provide a written consent to trial participation.

Exclusion Criteria:

* personal history of inflammatory bowel disease, colon adenoma or cancer
* family history of FAP or Familial nonpolyposis syndrome
* first degree relatives having diagnosed to have colorectal carcinoma
* no colonoscopy in past 5 years
The Effect of Education Given to Patients With Heart Failure on Self-care, Drug Compliance and Quality of Life.

This study was planned as a randomized, controlled, experimental study to evaluate the effects of transtheoretic model-based education on self-care, drug compliance and quality of life in patients with heart failure. The number of samples required for the study was determined by the power analysis made in the GPower 3.1 package program. Assuming that there may be losses in follow-up and considering that non-parametric tests can be performed, the research group will consist of a total of 72 people, 36 in each group, with an increase of 20%. Patients with heart failure who do not have communication barriers to affect cognitive functions, can use tele-health applications (Smartphone and application), volunteers aged 18 and over and agree to participate in the study will be included in the intervention and control groups. The data of the study, "Socio-demographic Characteristic Data Form", "Question Form Regarding the Disease", "European Heart Failure Self-Care Behaviors Scale-12", "Beliefs About Medication Adherence Scale," in which socio-demographic characteristics and information about the disease were questioned. (IUHIO)'' and ''Minnesota Life with Heart Failure Questionnaire''.

The patients in the intervention group will be trained through tele-health practices for at least 25-30 minutes on a transtheoretical basis, every 2 weeks in the 1st month and once a month in the following months. Tele-health applications include phone monitoring, SMS notification and application applications. Educational topics based on model-based self-care behaviors; It will include regular exercise, nutrition-weight monitoring, fluid intake-edema control, smoking cessation, regular drug use, regular rest, vaccination. Educational principles will be shared with patients by SMS from time to time during the education process. Treatment compliance levels and self-care behaviors of both groups of patients will be re-measured from the first week to the 6th month after the training, and any difference will be analyzed using statistical methods.

Eligibility Criteria:
Inclusion Criteria:

* Have no communication barriers to affect cognitive functions,
* Ejection-Fraction over 20
* Diagnosed with Heart Failure for at least 6 months
* Able to use tele-health applications (smartphone and application)

Exclusion Criteria:

* Patients with communication difficulties
* Patients who cannot use tele-health applications
Efficacy Trial of Life Simulation Game to Routinize Adolescent HIV Testing

This study will aim to assess the acceptability, usability and efficacy of using state-of-the-art video game technology to increase HIV testing among adolescents and young adults (AYA) ages 13-24. AYA often lack awareness of their personal risk of contracting HIV and where to go for testing and care. This lack of awareness has contributed to poor uptake of HIV testing among AYA despite engagement in high risk behaviors. The goal of this project is to harness this strong motivation to play games to increase HIV testing. Previous games for behavior change have yielded early success for increasing target behaviors among their sample populations, yet research on increasing HIV testing among AYA through gaming has been limited. This intervention builds on prior formative work and is designed to offer AYA personally-tailored risk messages and supports their accessibility to HIV testing and prevention services through an innovative gaming approach that is sharable over social media with in-game rewards for sharing the game with peers. The specific aim of this study is to determine the efficacy of a life-simulation game in changing HIV testing, knowledge, and risk behaviors among AYA at risk for HIV.


Eligibility Criteria:
Inclusion Criteria:

* age 13-24
* self-reported HIV negative or unknown status
* self-reported ever sexually active
* resident of the DC metropolitan region which includes the District of Columbia, Maryland and Virginia for at least the next 6 months
* Is able to provide informed consent or assent
* able to complete all study procedures in English
* has own mobile phones and be willing to use them for the study.
Comparison Between Two Different Parameters of Argon Plasma Coagulation in the Treatment of Chronic Radiation Proctitis: Historical Control Trial.

There is a wide variability of options for treatment of chronic radiation proctitis. However, studies are still limited, usually case reports from a single center and few are comparative studies between methods. Therefore, the choice of treatment is determined by availability and local expertise for each method. The variability of treatment options range from anti-inflammatory medical treatment, sucralfate, short chain fatty acids, antioxidants and hyperbaric oxygen to such endoscopic and surgical treatments. Surgery is usually the last therapeutic option due to the high morbidity and mortalityassociated. Various endoscopic treatment modalities have been reported. Formalin topic is effective in up to 48% of patients with chronic radiation proctitis.

The endoscopic treatment with argon plasma (APC) is low cost, easy to apply and transportation, safe and effective in the treatment of rectal bleeding in patients with chronic radiation proctitis. Currently, the APC is the preferred endoscopic modality.

Most studies on the use of APC in radiation proctitis showed benefit. The APC controls the mild to moderate rectal bleeding in 80% to 90% of cases and improves symptoms of urgency, diarrhea and tenesmus in 60% to 75% of cases.

APC is usually applied with a power of 40-60W and 1.2-2.5 L/min of gas flow by using a electrosugical generator coupled with an argon delivery unit. However, high gas flow have been associated to high rates of complication such as rectal stenosis and deep rectal ulcer.

In this context, the present study aims to compare the effectiveness and safety between two different paramenters of argon plasma coagulation (40-50W and 2.0 L/min of gas flow vs 40W and 1.2 L/min of gas flow) in the treatment of patients with symptomatic chronic radiation proctitis.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* endoscopic diagnosis of chronic radiation proctitis
* previous pelvic radiotherapy
* presence of colonic or rectal telangiectasias
* patients must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* other causes of rectal bleeding besides chronic radiation proctitis diagnosed by complete colonoscopy , such as colorectal cancer , inflammatory bowel disease and polyps larger than 1 cm
* use of oral anticoagulants
Cilostazol-Simvastatin Drug Interaction Study

This is a randomized, open-label, single \& multiple-dose, parallel study to investigate the effect of cilostazol on the disposition of simvastatin \& pravastatin in healthy male volunteers

Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trial Center of Ajou University Medical Center on the day before dosing (Day -1).

On Day 1, Subjects will be dosed simvastatin 40 mg or pravastatin 20 mg. Pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 24 hours after dosing.

From Day 2 \~ 7, Subjects will be dosed cilostazol 100 mg twice a day. On Day 8, Subjects will be dosed simvastatin 40 mg or pravastatin 20 mg with cilostazol 100 mg twice a day. Pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 24 hours after dosing.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 20 - 45 years
* With in 20% of ideal body weight, {Ideal body weight=\[height(cm)-100\]\*0.9}
* Agreement with written informed consent

Exclusion Criteria:

* Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)
* Inadequate result of laboratory test (especially, AST/ALT \> 1.25 x UNL, Total bilirubin \> 1.5 x UNL)
* Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test
* Taking OTC(Over the counter)medicine including oriental medicine within 7 days
* Clinically significant allergic disease (Except for mild allergic rhinitis and dermatitis seems to be not need for medication)
* Subject with known for hypersensitivity reaction to Cilostazol, Simvastatin or Pravastatin
* Previous whole blood donation within 60 days or component blood donation within 30 days
* Previous participation of other trial within 90 days
* Continued taking caffeine (caffeine \> 5 cup/day), drinking (alcohol \> 30 g/day) and severe heavy smoker (cigarette \> 1/2 pack per day)
* An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result
Interactive E-health Database for the Identification of Potential Interactions Among Drugs Prescribed to CKD Patient

The aim of the current project is the development and implementation of an e-health database of drug interactions (drug-drug, drug-food, drug-alcohol and drug-herbal products interaction) to CKD patients in order to achieve a holistic approach to patient care and personalized medicine. The study will be conducted in the University of Ioannina (cooperation between the Department of Nephrology and the Laboratory of Physiology). Data will be collected form 150 CKD patients (Stages 1-5 pre-dialysis, undergoing dialysis, kidney transplantation). Sixty patients will be selected for the pilot study which will include blood and urine tests and specific polymorphism analysis (pharmacogenetic tests). Pilot implementation of the e-health database will be undertaken by health professionals of the Department of Nephrology (University Hospital of Ioannina) to test the system in realistic setting (usability, efficiency and efficacy) in order to make the necessary changes prior to full scale deployment.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* CKD diagnosis according to KDOQI Guidelines
* absence of active malignancy
* absence of decompensated heart failure New York Heart Association (NYHA) IV
* absence of liver cirrhosis
* patient's consent

Exclusion Criteria:

* Age\<18 years
* active malignancy
* decompensated heart failure NYHA IV
* liver cirrhosis
* patient's refusal to participate in the study
Temozolomide 12 Cycles Versus 6 Cycles of Standard First-line Treatment in Patients With Glioblastoma.

The purpose of this study is to show if prolonging treatment with temozolomide to 12 cycles improve progression-free survival in patients with glioblastoma included in this study, randomized according to o6-methylguanine-DNA-methyltransferase (MGMT) methylation status and residual disease or not, to receive an additional 6 cycles of temozolomide.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and sign the informed consent document .
2. Age greater than or equal 18.
3. Patients with glioblastoma according to WHO classification (glioblastoma ) who received chemo- radiotherapy and temozolomide -based chemotherapy ( Stupp scheme ) and have completed 6 cycles of adjuvant temozolomide (with or without bevacizumab) in the context of standard treatment without presenting progression of disease.
4. Availability of tumor tissue from the first surgery for centralized histological review , for determining the MGMT study if you have not done in the center of origin. (If they were made in the center of origin the result of the center will be accepted ).
5. Stable dose of dexamethasone in the inclusion never above corticoids dose received in cycle 6 of the adjuvant .
6. Index greater than or equal 60 % Karnofsky.
7. All patients must show no progression of disease in a brain nuclear magnetic resonance (NMR) as defined in RANO established criteria before randomization .
8. Basal NMR study on a maximum of 6 weeks prior to inclusion, in which no progress is observed and is permitted to manage the care 6th cycle ( NMR performed after the 6th cycle of adjuvant is also acceptable as long as no progression was observed).
9. Adequate bone marrow reserve : hematocrit greater or equal 29% , white blood cell\> 3,000 , RAN greater or equal 1,500 cells / ul , platelets greater or equal 100,000 cells / ul.
10. Creatinine \<1.5 times the upper limit of normal (ULN) of the laboratory performing the analysis.
11. Serum bilirubin \<1.5 / ULN; SGOT , SGPT \< 2.5 times the upper limit of normal of the laboratory performing the analysis. Serum \< 3/ULN alkaline phosphatases .
12. Effective contraceptive method in patients and their partners.

Exclusion Criteria:

1. Less than 5 years of any previous invasive neoplasia. In situ cervical carcinoma or basal cell skin carcinoma accepted.
2. Concomitant treatment with other investigational agents (other concomitant bevacizumab) .
3. Presence of any clinically significant gastrointestinal abnormalities that may affect the decision , transit or absorption of study drug , such as the inability to take medication in tablets by mouth.
4. Presence of any psychiatric or cognitive disorder that limits understanding or written informed consent and / or impair compliance with the requirements of this protocol.
5. Concurrent disease that prevents the continuation of temozolomide treatment.
6. Presence of leptomeningeal dissemination.
7. Pregnant or breastfeeding.
8. Positive patients receiving combination antiretroviral therapy in HIV