cyrilzakka/clinical-trials huggingface dataset:
A Study of FK199B to Compare Efficacy With Zolpidem by Polysomnography in Patients With Insomnia

This study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) by polysomnography in patients with insomnia, excluding patients with schizophrenia or manic-depressive psychosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient is diagnosed as a primary insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
* Patients complaining of insomnia continuously for 4 weeks or longer
* Patient's usual bedtime is between 9 p.m. and 12 a.m. for the 4 week period prior to initial screening
* Patient on most occasions sleeps for a total of ≥3 and \<6.5 hours over the 4 week period prior to initial screening
* Patient's usual wake time after sleep onset in a single night is ≥45 minutes per night for the 4 week period prior to initial screening
* Patients have a body weight of ≥45 kg and ≤85 kg, a BMI of ≥18.5 and \<30

Exclusion Criteria:

* Patients with schizophrenia or manic-depressive psychosis
* Patients with insomnia caused by physical diseases including chronic obstructive pulmonary disease, bronchial asthma, fibrositis syndrome, chronic fatigue syndrome, rheumatic disease, climacteric disturbance, and dermatitis atopic
* Patients with circadian rhythm sleep disorder
* Patient works night shifts
* Patients with alcoholic sleep disorder
* Patients with alcohol or drug dependence or a history of these
* Patients with insomnia related with drugs including antiparkinson, antihypertensive, or steroid drugs
* Patients with sleep apnea syndrome
* Patients with restless legs syndrome or periodic limb movement disorder
* Patients with epileptic insomnia
* Patients smoke on average 40 or more cigarettes a day
* Patients who had received psychotropic drugs other than hypnotics (including anxiolytic or antidepressant drugs for hypnotic effect) within a 4 week period prior to the initial screening
Focused Shock Wave Therapy Outcomes in Peyronie's Disease and Erectile Dysfunction

The purpose of this research is to determine the pure or additional effects of penile shockwave therapy with low intensity linear shock wave machine for penile curvature (and/or erectile dysfunction) vs patients' undergoing other treatments (including Xiaflex therapy, patients that have undergone older generations of SWT, or medical treatment).


Eligibility Criteria:
Inclusion Criteria:

* Peyronie's Disease (PD) at any stage
* The presence of penile plaque or pain at erection or curvature
* PD therapy with or without simultaneous intralesional Xiaflex injection.

Exclusion Criteria:

* Prior penile surgery or LiSWT.
* Erective Dysfunction (ED) not responding to phosphodiesterase-type five inhibitors or intracavernosal injections.
* Unwillingness or inability to provide informed consent.
* Having active or life-threatening coagulopathies ore using anti-coagulation /anti-platelet medications
Invasive Pulmonary Aspergillosis and Severe Influenza

Invasive pulmonary aspergillosis (IPA) has been reported in critically ill patients with influenza infection with a highly variable incidence between 1 to 21%. Studies investigating IPA in critically ill patients with influenza infection suffer limitations in their methods. It remains unknown whether patients with influenza are more at risk of IPA than other patients hospitalized in intensive care unit and whether patients with influenza who develop IPA have specific risk factors for this infection.

Our study aims to determine the incidence of IPA in a large multicenter cohort and to identify risk factors for IPA in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Infection with influenza A or B
* Admission to one of the participating sites

Exclusion Criteria:

* age \< 18
* patients with invasive pulmonary aspergillosis prior to intensive care admission
* consent withdraw
Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids

This is a pilot randomized, blinded, placebo-controlled trial of a noninvasive, FDA approved treatment for uterine fibroids called MR Guided Focused Ultrasound (MRgFUS). Our hypothesis is that MRgFUS provides superior relief of fibroid symptoms compared with the placebo, a sham MRgFUS treatment. The investigators will recruit 20 premenopausal women with symptomatic uterine fibroids to participate in the trial. Participants will be randomly assigned in a 2:1 ratio to the active treatment arm (MRgFUS) versus the sham MRgFUS treatment. Participants will remain blinded to their group assignment for 3 months. After 3 months, participants will be told their treatment group and those assigned to the sham group will be offered complimentary MRgFUS if they desire it. Women will be excluded if they are inappropriate candidates for a 3 month delay in fibroid treatment, such as those with significant anemia. The investigators will assess the change from baseline to 1 and 3 months after treatment in fibroid symptoms, quality of life, fibroid volume measured by MRI, and hematocrit.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Premenopausal
* Symptomatic fibroids
* Fibroids accessible for focused ultrasound treatment

Exclusion criteria:

* Desires future fertility
* Current pregnancy
* Hematocrit \<30%
* Emergency room visit in last 3 months for fibroid symptoms
* History of venous thromboembolism
* Fibroids that are: \>10cm, non-enhancing with contrast
* Adenomyosis
* Contraindications to undergoing MRI
* Unexplained menstrual irregularity
Study of 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma

When colon or rectal cancer has spread to the liver, the cancer in the liver can sometimes be removed surgically. However, the cancer has a chance or reoccurring in the liver or elsewhere in the body. This study will determine if giving chemotherapy treatment before the surgery can reduce the chances that the cancer will come back.

When colon or rectal cancer has spread to the liver, the cancer in the liver can sometimes be removed surgically. However, the cancer has a chance or reoccurring in the liver or elsewhere in the body. This study will determine if giving chemotherapy treatment before the surgery can reduce the chances that the cancer will come back.

Eligibility Criteria:
Inclusion Criteria:

* stage IV colorectal cancer isolated to the liver
* one measurable lesion
* metastases are completely resectable or amenable to ablation
* Karnofsky \>70
* Adequate bone marrow function
* adequate hepatic function
* adequate renal function
* informed consent

Exclusion Criteria:

* primary tumor not controlled by locoregional treatments
* bilateral portal vein and/or hepatic artery involvement
* previous chemotherapy directed at treatment of metastatic colorectal cancer
* underlying acute or chronic liver disease
* Gilbert's disease
* patients receiving phenytoin or phenobarbital prophylaxis
* presence of any concurrent medical or psychiatric condition that serves as a contraindication to surgery or chemotherapy
* pregnancy
* malignancy other than basal cell or squamous cell carcinoma of the skin within the preceding 5 years
* use of another investigational medication concurrently or within 4 months of enrollment
Personal Health Libraries for Formerly Incarcerated Individuals

This is a randomized pilot study to test the acceptance and use of PerHL among formerly incarcerated individuals

Eligible participants will be enrolled after providing informed consent .Participants will then complete a baseline assessment. After the interview, eligible participants will be randomly assigned to the intervention or control group. The research assistant (RA) will be blinded to the randomization allocation until after the consent process. For the purposes of this study, permuted block randomization with random block sizes of 2, 4 and 6 will be used.

Intervention: Those randomized to the intervention arm will have access to PerHL. The intervention group will watch a demonstration by the RA and will practice using PerHL for 10-15 minutes, i.e. taking a picture of a document and uploading to PerHL, entering specific information, voice recording an appointment reminder. The RA will be responsible for providing technical support and assist with the need for initial support, e.g. phone-call or text-based support. At baseline, participants will be asked to provide a list of every organization they visited that may have health and health-related social information on them and receive consent to request their information to be sent to the participant and the study team on their behalf.

Control: Participants randomized to the control arm will receive the standard of care patient portal (Epic®MyChart). The RA will give them an informational pamphlet outlining key features of the patient portal and guide them through the steps for signing up for a MyChart account, assist them to sign up, add the standard patient portal MyChart app to their phone, and provide them with the MyChart technical support hotline.

Study Procedures: During the intervention phase, all participants will meet with the RA at baseline, 1- and 3 months. During the study, each participant will be asked to provide at least 5 verified locators who are likely to have knowledge of their whereabouts throughout follow-up. Each participant will be provided with $50 payment to participants for each completion of surveys at baseline, 1, 3 months. In addition, participants will be given $10 each month to travel to a location with free wireless so their information can be uploaded to the cloud and a list of available locations. In total, each participant will receive $180 for participation.

For the 1- and 3-month follow-up period, the RA will ask participants to bring information collected and uploaded in PerHL and additional information that is important to the participant but was not uploaded.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* English-speaking
* have at least one chronic condition
* engaged in primary care in the community
* have been released from a correctional facility in the past year.

Exclusion Criteria:

* visual impairments
* cognitive impairments
* language barriers
* planned relocation
Assessing the Stability of Transcranial Magnetic Stimulation Plasticity Responses

The overall goal of this proposed study is to assess the reliability of plasticity measured by transcranial magnetic stimulation (TMS) interleaved with intermittent theta-burst stimulation plasticity measures and to assess the influence of an acute bout of aerobic exercise on TMS plasticity measures.


Eligibility Criteria:
Inclusion Criteria:

* Adult males and females aged 18-70 years old.
* Primary language is English
* Exercise clearance

Exclusion Criteria:

* Presence of cognitive, neurologic or orthopedic conditions that could affect performance of the testing and training procedures
* History of migraines
* History of fainting spells of unknown or undetermined etiology that might constitute seizures
* History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG or family history of treatment resistance epilepsy
* Any current history of psychiatric illness
* Any unstable medical condition
* No medication is an absolute exclusion from TMS. Medications will be reviewed by the Principal Investigator and a decision about inclusion will be made based on the following:
* The subject's past medical history, drug does, history of recent medication changes or duration of treatment, and combination with other central nervous system active drugs.
* The published TMS guidelines review medications to considered with TMS (Rossi, Hallet, Rossini, Pascual-Leone, \& Safety of TMS Consensus Group, 2009)
* Any metal in the brain, skull or elsewhere unless approved by the responsible MD
* Any medical devices (i.e. Cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagal nerve stimulator)
* Intracranial lesion
* Substance abuse or dependence within the past six months
Evaluation of Group Health Teaching With Video in Diabetic Patients

Objective:Health videos and group education to allow patients to a correct understanding of diabetes and insulin treatment.

Method:

Standards and number of patients: The patients received subcutaneous insulin injection, estimated 30 people enrolled.

Experimental Design and Methods:

1. Screening out-patient treatment with insulin use, HbA1c\> 8% or poor postprandial glucose (PPG)
2. At the time of the visits, invite the patient to participate in the Video group education on insulin therapy By answering some questions about insulin injections, such as: do not know how to perform; afraid of the pain; fear of inconvenience, give patients time to complete the questionnaire.

Diabetes is a long-term chronic disease. The patients need to correct "knowledge and action" lifestyle in order to achieve effective blood glucose control. Upon the general control of diabetic patients in Taiwan, however, glycosylated hemoglobin (HbA1c) is not satisfactory. One of the important reasons is the low rate of insulin injection. For the use of insulin, the patient has many misconception. The patients in the clinic need to spend a lot of time to explain and description, but the results are not necessarily good. So we hope that in this part of the health education activities through organized groups Videos to assist doctors and patients as a bridge of communication, to enhance diabetes doctor thus contributing to glycemic control results.

Eligibility Criteria:
Inclusion Criteria:

1. Willing to sign the informed consent
2. Age over 20 years old
3. HbA1c\>8% or PPG) \> 200 mg/dl even under insulin therapy

Exclusion Criteria:

1. Vegetation status
2. Inability of visual or hearing contact with the video program
Impact of Body Composition on Bisoprolol and Ramipril Pharmacokinetics in Patients With Chronic Heart Failure

The purpose of this study is to determine if cachexia and changes in body composition influence pharmacokinetics of bisoprolol and ramipril and the accuracy of equations for renal function estimation.

Patients with chronic heart failure on treatment with bisoprolol and/or ramipril will be included. Study will consist of two study visits: baseline visit (V1) and visit which will be performed at least 6 months after baseline (V2). At both visits same procedures will be performed. On the day of the visit, patients will be asked to take their morning dose of bisoprolol and/or ramipril after the withdrawal of the first morning plasma sample. Additional 3 to 5 plasma samples will be taken within 5 hours post bisoprolol and/or ramipril dose in order to determine pharmacokinetic profile of both drugs. Body composition will be measured by bioimpedance and dual-energy X-ray absorptiometry. Renal function will be measured by clearance of intravenously administered iohexol. Biochemical parameters, muscle strength, fatigue and anorexia will be assessed in order to determine presence of cachexia.

Changes in body composition will be correlated with changes in pharmacokinetic parameters of bisoprolol and ramipril. Pharmacokinetic parameters in cachectic patients will be compared to pharmacokinetic parameters in non-cachectic patients. Parameters of body composition will be correlated with the difference between measured and estimated renal function.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic heart failure of New York Heart Association Functional Classification (NYHA) class II and III
* On treatment with bisoprolol for at least 3 days and/or ramipril for at least 4 days before V1
* Able and willing to provide freely given written informed consent

Exclusion Criteria:

* Chronic renal disease with estimated glomerular filtration rate calculated by Modification of Diet in Renal Disease (MDRD) equation \< 40 mL/(min x 1,73 m2) at V1 or V2
* Liver disease or increased serum liver enzymes (bilirubin \> 1.5 x normal, gamma-glutamyl transpeptidase (GGT) \> 2.5 x normal, aspartate transaminase (AST) \> 2.5 x normal, alanine transaminase (ALT) \> 2.5 x normal) at V1 or V2
* Absence of bisoprolol or ramipril steady state concentrations at V1 or V2 or withdrawal of bisoprolol and/or ramipril in-between both visits
* Acute decompensation of heart failure in less than 4 weeks before V1 or V2
* Addition, withdrawal or change in dose of drugs that importantly influence bisoprolol or ramipril pharmacokinetics in-between V1 and V2
* Unable to understand and comply with protocol or to give informed consent
Pilot Study Comparing NatroxTM Topical Oxygen Therapy to A Placebo in the Management of Non-Healing Leg Ulcers

The purpose of this study is to determine the effectiveness of the NatroxTM Topical Oxygen device versus a placebo in patients with non-healing leg ulceration in conjunction with standard best practice.

Patients will be screened for two weeks before enrollment to assess whether their ulcers are "non-healing", defined as a reduction in wound surface of \< 25% after two weeks of standard best practice wound care . On enrolment and randomisation to active or placebo treatment the patient will be treated for six weeks or until 100% epithelialisation, whichever is the sooner, and then treatment will revert to standard best practice, defined as moist wound healing plus compression where appropriate. The reference ulcer will be followed up at two weeks and then at six weeks after the end of the active treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Patients with superficial venous and mixed aetiology leg ulcers on a flat plane in surface area between 4-50cm2
* Patients with diabetes may be included providing they have good metabolic control
* Patients who understand the trial, agree to adhere to the treatment and are able to give consent
* Patients who can be followed by the same investigating team for the whole period of their participation in the study

Exclusion Criteria:

* Patients who present with wounds which are clinically infected and require antimicrobial therapy. Patients who have been treated for a wound infection with antimicrobial therapy (systematically or topically) may be included providing the wound is no longer assessed as infected and there is a two week wash-out period after the last treatment before the patient is reassessed against the inclusion and exclusion criteria
* Patients with a known sensitivity to any of the components of the evaluation device
* Patients with known or suspected malignancy in the wound or surrounding tissue
* Patients whose wounds show a percentage decrease in surface area of \>25% during the two week screening period
* Patients who do not have the physical or mental capacity, or a significant other with the ability to change the NatroxTM battery pack on a daily basis
* Patients who present with more than 10% of the wound surface area covered in hard eschar
* Patients who are actively treated with immunosuppressive or cortico-steroidal medication
* Patients who are participating in another clinical trial
* Patients with a known history or poor compliance with medical treatment
* Patients who have been in this trial previously and have withdrawn
* Patients who are unable to understand the aims of the trial and do not give informed consent
Long-term Outcomes Associated with Juvenile-onset Mycosis Fungoides and Lymphomatoid Papulosis

To follow up with all our participants with juvenile-onset mycosis fungoides, check on their status, and ask them or their parents about long term outcomes associated with their condition.

Primary Objective -To characterize the long-term outcomes associated with juvenile-onset mycosis fungoides (jMF) and lymphomatoid papulosis (lyp). The study will consider metrics such as 5-year and 10-year overall survival, and overall disease activity.

Secondary objective

-To characterize treatments and associated comorbidities.

Eligibility Criteria:
Inclusion Criteria:

-To be eligible, participants had to be diagnosed with jMF or lyp before age 20. In the case of participants below the age of 18, parents and not the children will be contacted for participation (children are exempt from participation as their parents may answer our study questions).

Exclusion Criteria:

-Participants older than 20 years of age at diagnosis
Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation in Chronic Stroke

Comparison of real transcranial direct current stimulation (tDCS) and sham tDCS combined with robot training for upper extremity rehabilitation in subjects with chronic stroke - delayed start study.


Eligibility Criteria:
Inclusion Criteria:

* Hemiplegic patients secondary to first cerebrovascular accidents
* Onset ≥ 6 months
* Fugl-Meyer Assessment score ≥ 19
* Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion Criteria:

* Severe upper extremity pain that could interfere with rehabilitation therapy
* Neurological disorders other than stroke that can cause motor deficits
* Uncontrolled severe medical conditions.
Safety and Effectiveness of the Device "Nit-Occlud® PDA-R"

The purpose of this study is to evaluate the safety and the effectiveness of the device "Nit-Occlud® PDA-R" in the percutaneous closure of patent ductus.

During the years 2003 to 2008, the Cardiological Medical Center "Kardiozentrum" evaluated 1136 patients with echocardiographic studies, 14.7% of the patients were diagnosed with patent arterial duct. The PDA is an abnormal communication between the aorta and pulmonary artery. Untreated it can rise the intrapulmonary pressure and lead to serious complications like cardiac insufficiency.

The incidence of ducts as an isolated heart disease is between 3.6 and 7% of all congenital heart diseases at sea level, and 10 - 14% at high altitude; rising up to 20% in cities at more than 2.500 m about sea level. The ducts at high altitude are generally wider and larger than at sea level.

One treatment alternative is a percutaneous transluminal implantation of a permanent implant which closes the defect. The device under investigation "Nit-Occlud® PDA-R" is developed for closure of the PDA with a minimal diameter of 2-8 mm.

The device performs the function of generating the defect occlusion by the body itself. The implant stimulates the body to generate an epithelium over the implant so that the PDA closes.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and echocardiographic compatibility with PDA without associated heart disease requiring surgical solution
* Minimum diameter of the PDA 2 to 8 mm
* Systolic pulmonary pressure measured during cardiac catheterization, not on pass 2/3 of the values of the systolic systemic pressure
* Weight higher than 10 kg, regardless of age
* Patients who were diagnosed and recruited during the period 2009 - 2010
* Patients with trisomy 21 also fulfill the previous criteria, the number of patients with T21 will not exceed 10% of the entire group of patients.
* letter of consent signed by parents or legal guardian

Relative Exclusion Criteria:

* Infections that occur during acute bacteremia, viremia, which can be treated
* Febrile syndrome
* Tooth decay
* Once the acute solved considering the patient's inclusion into the study

Exclusion Criteria:

* Pregnant women
* Pulmonary hypertension, increased to 2 / 3 of systemic pressure
* Eisenmenger syndrome
* Other associated heart disease, requiring surgical solution
* Immuno-compromised patients
* Pathology oncology
* Hematologic or coagulation disorders
* Allergy to contrast medium
* Atypical or calcified Ductus
* Parents or legal guardians who do not accept the risks of catheterization
* Parents or legal guardians and patients who do not accept to sign the letter of consent or who revoke the consent.
* Patients who participated in another clinical investigation during the last 3 months