cyrilzakka/clinical-trials huggingface dataset:
The Effects Upon the Bladder of Transcutaneous Tibial Nerve Stimulation in Acute Traumatic Spinal Cord Injury

The purpose of this research study is to evaluate the effects upon the bladder of electric stimulation of the leg's tibial nerve in people with acute spinal cord injury with an intervention called transcutaneous tibial nerve stimulation (TTNS).

In this study, TTNS will be used to help neurogenic bladder in SCI. First, acute SCI subjects which respond to TTNS will be identified as seen on urodynamic studies (USD). Then, responders will be invited to participate in a randomized control trial of a 2-week protocol of TTNS to test for safety and efficacy during inpatient rehabilitation to evaluate bladder changes based upon pre- and post- urodynamic testing, as well as 2-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment within 6 weeks of injury
* Neurologic level rostral to T10 (T9 and above). This is a significant neurologic level because the bladder remains innervated at these levels, without damage to the nerve cell bodies of the bladder within the spinal cord.
* Location and transportation available for follow-up appointments

Exclusion Criteria:

* History of peripheral neuropathy or premorbid symptoms of peripheral neuropathy
* Known etiologies that may cause peripheral neuropathy (i.e. diabetes mellitus, hypothyroidism, autoimmune diseases, alcoholism, hx of chemotherapy, etc.)
* History of genitourinary diagnoses (i.e. prostate hypertrophy, overactive bladder, cancer, etc.)
* Pregnancy
* History of central nervous system disorder (i.e. prior SCI, stroke, brain injury, Parkinson's disease, MS, etc.)
* Morbid obesity
* Ventilator dependent respiration
* Significant autonomic dysreflexia during baseline urodynamic study.
Comparative Study, Safety and Efficacy, Ahmed Glaucoma Drainage Device, Model M4 Model S2 in Neovascular Glaucoma

Objective: Prospectively evaluate the safety and efficacy of the Ahmed Glaucoma Drainage Device, model M4 compared with the model S2.

Method: Mexican patients with Neovascular Glaucoma will be randomly included for each group (M4 and S2). They will be operated using conventional techniques and creating a sub-episcleral tunnel to place the valve's tube in the anterior chamber. They will be monitoring for one year and the results will be evaluated with respect to a postoperative reduction in pressure, changes in visual acuity, the need for drugs and complications, in addition to the demographic characteristics of each group.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of Neovascular glaucoma
* High IOP despite topical treatment

Exclusion Criteria:

* Pregnant women
* Mental disorders
* Previous glaucoma surgery
* Patients older than 18 years
A Randomized Comparison Trial Examining the Impact of a Family-based Cooking Workshop

Increasing fruit and vegetable intake is important to health but children's vegetable intake remains low. In younger age groups parents act as gatekeepers by providing access, availability, persuasion and modelling. This study aimed to enhance parent vegetable serving behaviour and child vegetable intake through an 8-week social cognitive theory-based family cooking program.


Eligibility Criteria:
Inclusion Criteria:

* a family unit consisting of at least one parent and one child
* parents aged between 25 and 55 years of age
* children aged between nine and 13 years of age.

Exclusion Criteria:

* ability to comprehend English
* Participation of both the parent and the child
Usefulness of an Ultraportative Ultrasound Device in the Management of Intra Hospital Emergencies

Estimate if the use of a portable cardiac echograph for intra-hospital Emergencie improves the performances diagnose in the bed of patient in department of conventional medicine.

The concordance between the initial medical diagnosis (previous the utilsation of portable echograph) and the final diagnosis (after portable echograph utisation) will be evaluated. These evaluation will be performed after retrospective review of the medical files


Eligibility Criteria:
Inclusion Criteria:

* respiratory or cardiac distress

Exclusion Criteria:

* pulmonary or cardiac patient transplant morphologic abnormalities Patient in rescucitation care unit
A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians

The South Asian Community, people with origins in India, Pakistan, Bangladesh, Maldives, Nepal, Sri Lanka, or Bhutan, are more likely to get diabetes, get diabetes at younger ages, and do worse health-wise once they have diabetes than the general population. This study will test the feasibility and community acceptability of a culturally appropriate lifestyle intervention for the prevention of diabetes in the South Asian community. The outcomes of this project could be used to plan larger interventions to prevent diabetes in South Asians, a rapidly growing segment of the US population.


Eligibility Criteria:
Inclusion Criteria:

* Self-identified as being of South Asian origin
* Live in or near Atlanta, Georgia
* BMI greater than 22 kg/m2 calculated from standardized weight and height measurements (a BMI of greater than 22 kg/m2 is indicative of overweight in the South Asian population)
* A confirmed age greater than or equal to 25 determined by checking a valid photo identification (driver's license, passport, etc.)
* No prior diabetes diagnosis (physician diagnosis or on diabetes medication)
* A high risk of developing diabetes (pre-diabetes) as defined by a casual capillary glucose greater than or equal to 120 (measured during screening)
* Fasting glucose of 100-125 mg/dL (impaired fasting glucose tolerance) and/or 2-hour post-load glucose of 140-199 mg/dL (impaired glucose tolerance), measured at baseline visit
* No history of heart disease, serious illness, or conditions that may impede or prohibit participation and are not currently pregnant

Exclusion Criteria:

* Capillary glucose less than 120
* Fasting glucose less than 100 mg/dL or greater than 125 mg/dL OR 2 hour post-load glucose less than 140 mg/dL or greater than 199 mg/dL
* Age less than 25 years
* BMI less than 22 kg/m2
* Pregnancy
* History of heart disease or diabetes (other than gestational diabetes)
* Current functional difficulties
* Severe lung disease or cancer
* Failure to pass cardiovascular stress test
Preliminary Assessment of Added Diagnostic Value of Dual Energy CT Images Using Data Acquired on a Spectral Detector CT

Study hypothesis: Post-processed SDCT images provide additional diagnostic value over conventional CT datasets.

The CT examination would be a clinically-necessary, standard-of-care CT performed as per the clinical indication. The protocol and scan parameters for the CT exam will be similar to that of an equivalent scan performed with any other CT scanner. There would be no additional scanner of injection of any drug specifically for the study. The conventional CT images generated by the scanner will be used for clinical purposes as routinely practiced.


Eligibility Criteria:
Inclusion Criteria:

* a patient scheduled for a clinically indicated CT scan for one or more of the following body regions/organ systems:
* head and neck
* body (chest and abdomen/pelvis)
* cardiovascular structures.
* these scans may be without contrast, with contrast enhancement, or CT angiograms.

Exclusion Criteria:

* under the age of 18 years old
* standard exclusion criteria for CT scans
Evaluation of the Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) Low-frequency on Craving in Smoking Dependence

The fight against smoking is a public health priority. Without help, fewer than 5% of des smokers are abstinent at 12 months after smoking cessation.

Despite well-managed attempts at smoking cessation with nicotine substitutes, the rate of success at 12 months in patients dependent on nicotine is only 18%. Moreover, other therapeutic strategies (acupuncture, hypnosis...) have not proved to be effective.

The investigators propose a new therapeutic strategy for smoking cessation, which is based on associating nicotine substitutes (to reduce physical symptoms of weaning from nicotine) with rTMS at 1 Hz to the right DorsoLateral PreFrontal Cortex (DLPFC) for 2 weeks (to diminish craving for tobacco). The principal objective is to improve the success rate for smoking cessation attempts in patients who are highly dependent on nicotine, and who have failed using usual smoking cessation strategies.


Eligibility Criteria:
Inclusion Criteria:

* Adult 18-65 years old
* Wishing to stop smoking
* Highly dependent on nicotine (score ≥ 7 on the Fagerström self-questionnaire)
* History of at least 2 failed attempts to stop smoking despite recommended treatments (nicotine, vareniciline, bupropion)

Exclusion Criteria:

* Abstinence in the 3 previous months
* Absence of effective contraception for women
* Progressive chronic disease
* Ongoing psychiatric disorders
* Current addiction to other substances or cessation of less than one year
* Current treatment with psychotropic agents
* Epilepsy and other contra-indications for rTMS (pacemaker, metallic clips or other electronic implants, head trauma, intracranial hypertension).
* Contra-indications for transdermal nicotine substitutes (recent myocardial infarction, unstable or worsening angina, Prinzmetal angina, severe heart rhythm disorders, recent stroke, skin disorders that could interfere with the use of transdermal treatments, hypersensitivity to one of the constituents).
* Personnel working in the psychiatric and addictology unit of the CHU (conflict of interest)
Locoregional Recurrence After Neoadjuvant Versus Adjuvant Chemotherapy

Neoadjuvant chemotherapy (NACT) for early-stage breast cancer is associated with an increased risk of locoregional recurrence (LRR). However, few studies have conducted subgroup analyses of patients with various molecular subtypes, which are one of the determinant factors for treatments. The aim of the study is to investigate whether the risk of LRR after NACT varies across tumor subtypes. The investigators retrospectively reviewed the medical records of female breast cancer patients who underwent breast-conserving surgery at three institutions between January 1, 2004, and Dec 31, 2018.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent breast-conserving surgery for invasive breast cancer between 2004 and 2018

Exclusion Criteria:

* Total mastectomy
* No pre- or postoperative chemotherapy
* No radiation therapy
* Bilateral breast cancer
* Male breast cancer patients
* Secondary breast cancer
* Metachronous or synchronous cancers
Inhibitor Masking Device & Sodium Channel, Voltage Gated, Type IX Alpha Subunit (SCN9) Gene Expression

To evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device. To determine if there is a higher incident of expression of the sodium channel, voltage gated, type IX alpha subunit (SCN9) gene in those subjects with disturbing tinnitus than subjects that are not disturbed by tinnitus.

Up to 50 million Americans have tinnitus on a regular basis with between 2-3 million suffering from tinnitus where it affects daily living. The Inhibitor™ Tinnitus Masking Device is a new tinnitus treatment device recently available in the United States for use of temporary relief of tinnitus. The device emits an ultra high frequency sound for 60 seconds via bone conduction when applied to the mastoid. Patients reporting tinnitus will be provided the opportunity to demonstrate the device to observe any changes in their tinnitus. The device may be demonstrated up to 5 times. The investigators will be recording the the degree and duration of change in tinnitus perception following treatment with the Inhibitor™ Tinnitus Masking Device. Patients may provide a genetic sample (typically via saliva sample) to look for expression of a particular genetic marker that may be associated with tinnitus. The investigators will be collect samples from both people with tinnitus and those without tinnitus to use as a control.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years,
* has tinnitus

Exclusion Criteria:

* Pacemaker,
* pregnancy,
* metal implants in head or neck,
* thrombosis, migraines/headaches,
* metal bonded retainer, surgeries within the last 6 months which patient is still recovering from,
* any medical reason your physician would advise against the use of this device,
* under 18 years
Frontal Cortex and Gait Freezing in Parkinson's Disease: Rehabilitation Impact

This project will relate our new quantification of Freezing of Gait (FoG) in Parkinson's disease, using body worn inertial sensors (Aim I), with abnormalities in state-of-the-art, resting state, functional brain connectivity (Aim II), and determine the number of subjects needed for a future, randomized clinical trial to test the efficacy of our novel, Agility Boot Camp (ABC) rehabilitation intervention for FoG (Aim III). The technological approaches to these aims are cutting edge and will allow us to develop sensitive behavioral and brain biomarkers for gait disorders in Parkinson's disease (PD) for use in future clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Aged 50-90 years old.
* No musculoskeletal or peripheral or central nervous system disorders (other than idiopathic Parkinson disease, iPD) that could significantly affect balance or gait .
* Capable of following directions.
* iPD subjects: United Kingdom Brain Bank criteria, i.e., bradykinesia and at least one of the following: rest tremor, muscular rigidity, and postural instability not cause by visual, vestibular, cerebellar or proprioceptive dysfunction. Unilateral onset, response to levodopa.

Exclusion Criteria:

* Inability to stand or walk for 2 min without an assistive device
* Recent changes in medication
* Excessive use of alcohol or recreational drugs,
* Contraindications to MRI scans (eg, claustrophobia, metal in body)
* Intervention subjects will be excluded if: 1) participating in a vigorous exercise program more than 2 x/week, 2) A medical condition that contraindicates exercise participation.
* Idiopathic PD subjects: Same as above and deep brain stimulation electrodes. Significant tremor that would interfere with MRI scan.

Control subjects:

* Will be matched for age and gender to iPD group.
Assessment of the Lipid Lowering Effect of Rosuvastatin Compared to Atorvastatin in Subjects With Coronary Heart Disease

The purpose of this study is to compare the efficacy between two lipid lowering treatments, rosuvastatin (10-40 mg) and atorvastatin (20-80 mg) in reducing low-density lipoprotein cholesterol (LDL-C) levels after 16 weeks of treatment in patients with coronary heart disease


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older, established coronary heart disease with a previously performed PCI, previous treatment with clopidogrel, ongoing statin treatment, LDL-C\>2.9 mmol/L, signed informed consent.

Exclusion Criteria:

* Ongoing treatment with clopidogrel for more than 12 weeks after randomisation, hypersensitivity to any of the study drugs, active liver disease, moderate or severe renal impairment, hereditary for or known muscular or neuromuscular disease and/or increased serum CK, pregnancy or lactation or of childbearing potential not practising an adequate method of contraception, use of concomitant medication with possible interaction with
Exercise Plus Activity Strategy Training for Osteoarthritis

Purpose: To study the effects of two different rehabilitation programs for people with osteoarthritis of the hip or knee.

Hypothesis 1: Participants who received Activity Stratgey Training will report less pain and physical disability at 8-weeks and 6-months follow-up.

Hypothesis 2: Participants who receive Activity Strategy Training will have a greater increase in physical activity as measured by a wrist-worn accelerometer.

Hypothesis 3: Participants who receive Activity Stratgey Training will report greater improvements in health-related quality of life.

We are testing the effectiveness of a targeted intervention for older adults with hip and/or knee osteoarthritis (LE-OA) using an occupational therapy treatment approach to promote activity engagement. We believe that it is necessary to tailor this intervention to the specific needs of older adults with LE-OA. Based on the literature, exercise is a necessary component of an intervention for older adults with LE-OA. However, this should also be coupled with an Activity Strategy Training (AST) component designed to promote lifestyle changes and thus more lasting effects. The AST component is based on occupational therapy principles and will include behavioral and environmental strategies to increase activity engagement.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 62 years
* Meet ACR clinical criteria for either hip or knee OA
* Ambulatory (with or without assistance)
* Requiring assistance or report difficulty in \>=1/4 activities of daily living
* Ability to speak English

Exclusion Criteria:

* Knee/hip surgery within the previous 9 mos.
* Current participation in physical/occupational therapy
* Any contraindication to exercise activities
* Cognitive impairment
* Inability to provide informed consent
21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation

The purpose of this study is to determine the irritancy potential of azelaic acid pre-foam formulation.

This is the standard patch test over 21 days of exposure of the test product,its vehicle and a positive as well as a negative control.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* male ore female subjects
* aged 18 - 65 years
* ability to understand and fulfill the study requirements

Exclusion Criteria:

* affected skin in designated test area
* pregnancy or lactation
* not willing to comply with study requirements
Biological Half Life of DLBS1033 in Healthy Volunteers

DLBS1033 is bioactive protein fraction which extracted from Lumbricus rubellus earthworm. This earthworm comes from Pengalengan, West Java, Indonesia. DLBS1033 possesses 8 major proteins with molecular weight below 100 kDa, so its named as Lumbricus Low Molecular weight Proteins (LLP). This enzyme can be transported to the bloodstream via intestinal epitel. As a drug that consists of serin protease enzyme, suspected that the mechanism of action of lumbrokinase, especially as fibrinolytic and antithrombotic. One study of DLBS1033 concluded that plasmin-antiplasmin (PAP) complex is a sensitive parameter for evaluating fibrinolytic effect of this drug. But, until now there is no clinical study that evaluate pharmacokinetic of this drug. As a pilot study, the aim of this study is to evaluate biological half life of DLBS1033.


Eligibility Criteria:
Inclusion Criteria:

* Male
* 18-55 years old
* Body mass index between 18-25 kg/m2
* Normal physical examination
* Patient still have the ability to undergo examinations and give written informed consent
* Plasmin-antiplasmin complex (PAP complex) level between 0-514 ng/ml

Exclusion Criteria:

* Patient with cardiovascular disease, hypertension, diabetes mellitus, and dyslipidemia
* Creatinin serum more than 1,5 x ULN
* SGOT and SGPT more than 3 x ULN
* Blood pressure ≥ 140/90 mmHg
* Fasting blood glucose \> 126 mg/dL
* Alcohol patients
* Took any medications (including traditional medicine, supplement and vitamin) in 1 week before the study)
* Patient has bleeding history which unclear etiology
* Hemoglobin \< 10 g/dL
* Thrombocyte count \< 100.000/microliter
* Heavy smoker (Bringman Index \> 600)
The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer

This randomized pilot phase I trial studies how well sargramostim after cryotherapy works in treating patients with prostate cancer. Biological therapies, such as sargramostim, use substances made from living organisms that may stimulate the immune system in different ways and stop tumor cells from growing. Cryosurgery, also known as cryotherapy, kills tumor cells by freezing them. Giving sargramostim after cryotherapy may work better in treating prostate cancer.

PRIMARY OBJECTIVES:

I. Determine an unknown normal immune response (T cell and B cell) to post-cryotherapy treatment for prostate cancer.

II. Detect the altered immune response (T cell and B cell) post-GM-CSF (sargramostim) response and post-cryotherapy for the prostate cancer.

Patients are randomized to 1 of 2 treatment arms.

ARM I (TREATMENT): Patients undergo cryotherapy on day 0 and receive sargramostim subcutaneously (SC) on days 1, 3, 5, 8, 10, and 12.

ARM II (CONTROL): Patients undergo cryotherapy on day 0.

After completion of study treatment, patients are followed up for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with prostate cancer that elect to undergo primary cryotherapy of the prostate
* Patients who are diagnosed with clinical stage T1a -T2c prostate cancer
* Gleason score sum of less than or equal to 7
* Prostate-specific antigen (PSA) \< 20 ng/dl
* Patient will read, understand and sign the informed consent and Health Insurance Portability and Accountability Act (HIPAA) agreement
* Patients must have a life expectancy of at least one year

Exclusion Criteria:

* Known hypersensitivity to granulocyte macrophage colony stimulating factor (GM-CSF) or yeast
* Anticipated blood donation within the next 90 days
* Magnetic resonance imaging (MRI), computed tomography (CT) and bone scan evidence of metastatic prostate cancer regardless the PSA level; (the indication for which is clinically driven and at the discretion of the treating physician)
* Any history of current or within the past 48 hours of acute or chronic bacterial, fungal or viral infectious disease
* Documented excessive leukemic myeloid blasts in the bone marrow or peripheral blood (\>= 10%) in the past 6 months
* Previous organ transplant
* Immunosuppression including primary, secondary, iatrogenic and idiopathic
* Other serious diseases (hematological, hepatic, renal, respiratory, central nervous system, autoimmune or psychiatric)
* Enrollment in other studies for any disease in the past 30 days
* Diagnosis of cancer that in not considered cured, except basal cell carcinoma (BCC) of skin
* Prior transurethral resection of the prostate with a large tissue defect (at the discretion of the investigator)
* History of abdominoperineal resection for rectal cancer, rectal stenosis, or other major rectal pathology
* Patient currently receiving lithium, steroid, chemotherapy or radiotherapy treatment
* Patients with a Hemoglobin of less than 12%