cyrilzakka/clinical-trials huggingface dataset:
PENS or TENS for Pain in Liver Cancer

This study evaluates the effect of percutaneous electrical nerve stimulation (PENS) and transcutaneous nerve stimulation (TENS) for pain relieving in patients with liver cancer. Patients will randomly allocated into PENS group, Tens group and control group.

PENS and TENS have been reported with analgesic effect in patients with pain, including cancer pain, lower back pain, neck pain, stomachache and so on. Effect and mechanism of PENS on pain relieving has been widely researched. With additional electrical stimulation in certain frequency and intensity to conventional acupuncture, pain controlling effect has been largely enhanced. However, invasive operation limits its application and acceptability, especially on pancreatic cancer. TENS is an advanced technique generated from PENS, which is much more welcome for its noninvasive character. Further more, its analgesic effect on cancer pain has been proved by several multi-central, randomized, clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Primary liver cancer with pain;
* Haven't underwent neurolytic celiac plexus block in the past 1 month;
* With anticipatory survival of more than 3 months.

Exclusion Criteria:

* Metastatic liver cancer;
* Can not tolerate a flat or side lying or sitting prostrate for 30 min;
* performance score\>3;
* Who has been recruited in other clinical trial for pain relieving;
* Who underwent radiotherapy or local radioactive seeds implantation for pain relieving in the past month;
* Imaging diagnosed with encephalic tumor or metastasis;
* Who with cardiac pacemaker or metal stand;
Genetic Determinant of Foveolar Hypoplasia in Parents of Albinos Children

Fovea plana could be the phenoyipic translation of a genetic anomaly in one of the genes identified in albinisme


Eligibility Criteria:
Inclusion Criteria:

* children with albinism
* father and mother of children with albinism

Exclusion Criteria:

* sign of albinism except fovea plana in father or mother of children with albinism
* ophthalmological abnormalities making access to the fundus with OCT impossible
Epidural Contrast Flow Patterns of TESI Using the Inferior-Anterior Position as the Final Needle Tip Position.

The purpose of this study is to describe the contrast flow patterns in the epidural space using the inferior-anterior approach with continuous fluoroscopic guidance, and determine how well this approach correlates with appropriate contrast flow patterns and with analgesia at follow up. This knowledge may prove useful in guiding physician practice patterns in the non-surgical management of low back pain.

Hypothesis: The investigators hypothesize that there will be suitable (ventral/anterior) epidural contrast spread based on inferior-anterior needle-tip position, particularly with appropriate needle tip position.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* History of lumbosacral radiculopathy or lumbar herniated nucleus pulposus
* Scheduled for TFESI at GW Spine and Pain Center

Exclusion Criteria:

* Pregnant or plan on becoming pregnant
* Have undergone TFESI in the past year
* Opioid habituation
* Lumbo-sacral stenosis
* Lumbar surgery
* Lumbar spondylolisthesis
Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune Study

Intravenous cyclophosphamide is considered to be the standard of care for treatment of proliferative lupus nephritis. However, its use is limited by potentially severe toxic effects. Cyclosporine A has been suggested to be an efficient and safe treatment alternative to cyclophosphamide. In a randomized, multicenter, open-label, controlled trial the investigators sought to compare the efficacy of oral cyclosporine A with intravenous pulse cyclophosphamide to induce durable remission in patients with lupus nephritis III-IV.

Lupus nephritis occurs in 30-40% of adults with systemic lupus erythematosus and is associated with increased morbidity and mortality. Focal and diffuse proliferative forms of lupus nephritis are known to progress to chronic renal failure unless treated by immunosuppressive drugs. Cyclophosphamide and glucocorticoids are considered to be the standard of care for patients with proliferative lupus nephritis. However, cyclophosphamide may cause a number of toxic effects, such as bone marrow suppression, premature gonadal failure, hemorrhagic cystitis, opportunistic infections, and malignant disease. Hence, efforts are being made to find alternative therapeutic approaches. Cyclosporine is a potent immunosuppressive agent with a more selective mode of action through its unique effect on T cell mediated responses, and is widely used to treat a spectrum of autoimmune and glomerular diseases. Several retrospective series and one randomized trial provided evidence that Cyclosporine A could represent an efficient and safe therapy for proliferative lupus nephritis. In a randomized, multicenter, open-label, controlled trial we compared the efficacy of oral cyclosporine A with intravenous pulse cyclophosphamide to induce durable remission in patients with proliferative lupus nephritis.

Eligibility Criteria:
Inclusion Criteria:

* the diagnosis of systemic lupus erythematosus (by meeting 4 criteria of the American College of Rheumatology)
* renal biopsy documenting lupus nephritis according to the classification of the World Health Organization (WHO) or the updated International Society of Nephrology/Renal Pathology Society (ISN/RPS) as proliferative glomerulonephritis class III (focal) or IV (diffuse)
* clinical activity as defined by presence of at least two of the following:

  * abnormal proteinuria (more than 500mg of protein in in a 24-hour urine specimen)
  * abnormal microscopic hematuria, or
  * C3 hypocomplementemia (the latter two were defined according to the norms in the laboratories of the participating centers)

Exclusion Criteria:

* treatment with cyclophosphamide or cyclosporine A ever before
* treatment with other immunosuppressive drugs (such as azathioprine or mycophenolate mofetil) or high dose glucocorticoids (≥ 80mg of prednisone or methylprednisolone) within the last 3 months
* persistent elevation of serum creatinine (≥140 μmol/l)
* pregnancy or lactation
* bone marrow insufficiency with cytopenias not attributable to SLE, and 8severe coexisting conditions, such as infection, liver disease, active peptic ulcer etc.
Effect of Nitrate Supplementation on Blood Pressure and Microvascular Function of Resistant Hypertensive Patients

Arterial hypertension (AH) has been identified as an important public health problem and considered a new epidemic with high mortality and morbidity. High blood pressure (BP) levels increase the chances of coronary artery disease (CAD), heart failure (HF), stroke, chronic renal failure (CRF) and death. Beetroot powder may be an easier way to increase the availability of nitric oxide and consequently vasodilation in these patients. However, studies are needed to evaluate its benefits in patients with AH.


Eligibility Criteria:
Inclusion Criteria:

* Resistant hypertension, with a diagnosis described in the medical record, without changing medications or increasing doses in the last 30 days.

Exclusion Criteria:

* neoplasms
* heart failure
* use of medications with nitrate in their formula
* patients undergoing renal denervation
The Study of Plum-blossom Needling Enhancing Efficacy of Aminolevulinic Acid-photodynamic Therapy for Actinic Keratosis

Background Limited in the depth of absorption and penetration of photosensitizers, ALA-PDT treatment is not strong enough for thickening significantly AK lesions. Pre-study has proved that plum-blossom needling facilitates delivery of topical ALA into the dermis. It could help ALA to diffuse a little more broadly in superficial dermis and obtain similar clinical effect with a much lower cost.

Objective We sought to investigate whether plum-blossom needling (PBN) would enhance the efficacy of ALA-PDT for AKs.

Methods Two hundred and fifty patients, previously diagnosed as having AKs of the face and scalp, were randomized distribution into two groups. The PBN-ALA-PDT group underwent vertical skin tapping with PBN before applying 10% ALA cream and narrow-band light-emitting diode (LED) irradiation (mean 633 nm, with a standard deviation \[SD\] of 10 nm; 100-200 J/cm2). The ALA-PDT group received ALA cream and irradiation only. During the next 1 year period of follow up, patients were clinically evaluated for new AKs.


Eligibility Criteria:
Inclusion Criteria:

* (1) Clinical diagnosed with AK (OLSEN classification grade I, II, III), aged \> 18 years (Because no dosing or adverse event data are currently available on the use of topical aminolevulinic acid in patients \<18 years of age, children are excluded from this study); (2) All patients are unfit and reluctant to undergo surgery for any reasons, and volunteered to participate in the study and ability to understand and the willingness to sign a written informed consent. Patents are willing to pay for the treatment, and agreed to take a picture of the skin lesions.

Exclusion Criteria:

* (1) Those who had ALA-PDT and any other studies that affect this study within 12 weeks ; (2) There are other facial diseases that may affect the efficacy evaluation, such as other photodermatosis; (3) Take phototoxic or photosensitizer within 8 weeks; (4) clinical and / or pathological prove that the tumor has invaded other organs or tissues; (5) Serious immunocompromised persons; (6) scar constitution; (7) Patients are known to have skin photosensitivity, porphyria, or allergies to ALA, light or lidocaine; (8) Persons are suffering from severe internal diseases, mental and mental illness, infectious diseases or pregnant or lactating women.
STUDY OF ELECTRICAL STIMULATION IN PULMONARY FUNCTION IN INTENSIVE CARE UNIT

Introduction: The Mechanical Ventilation (MV), a support method used in Intensive Care Units (ICU), reaches approximately 90% of critical patients whose withdrawal process represents 40% of the total time of their use. For this purpose Transcutaneous electrical diaphragmatic stimulation (TEDS), which by means of electrodes placed in motor action points on the phrenic nerve tend to provide improvement of the diaphragm muscle function. Objective: To analyze the effect of two protocols of transcutaneous electrical diaphragmatic stimulation on the ventilatory and cardiorespiratory parameters of critically ill patients. Method: Clinical, longitudinal, prospective, quantitative, single center trial will be performed with 30 (thirty) participants in invasive mechanical ventilatory support, randomly divided into three groups: Experimental Group 1 (GE-1; n = 10) where they will be submitted to the TEDS protocol; Experimental Group 2 (GE-2; n = 10), where they will be submitted to the TEDS protocol based on the studies of Cancelliero et al. (2012); Control Group (GC; n = 10) where they will not be submitted to TEDS. All groups will receive physiotherapeutic care from the staff of the adult ICU of the FHCGV. The interventions will consist of ten sessions of Physical Therapy in each participant in the afternoon shift, for ten consecutive days, 1 time a day. For the TEDS procedure, the Orion TENS II (Orion-SP-Brazil) model will be used, the Wright analogue respirometer (Spire-SP-Brazil) will be used for the minute volume evaluation (V'). The variables of systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and peripheral oxygen saturation (SpO2) will also be monitored in order to verify if the TEDS application interferes with the hemodynamic variables of these patients. The data collected will be linked to Microsoft Office Excel® 2010 software and later transformed into tables and graphs. The information collected will be submitted to statistical analysis through the statistical package SPSS 22.0, applying the descriptive statistics for the characterization of the sample and then selecting the specific tests for the respective variances, adopting a level of significance of p≤0.05 for statistical inferences.


Eligibility Criteria:
Inclusion Criteria:

* Individuals of both sexes aged 60 years and older up to 80 years,
* in invasive MV for more than 48 hours,
* with respiratory drive,
* using MV in the mode of intermittent mandatory synchronized ventilation (VMIS) or (VPS),
* connected to the orotracheal tube or via tracheostomy,
* hemodynamically stable,
* neuromuscular junction of the entire diaphragm,
* absence of sedatives.

Exclusion Criteria:

* presence of pacemaker, hyperthermia (temperature\> 38 ° C),
* use of neuromuscular blockers,
* use of thoracic drains, generalized edema,
* cutaneous lesion in the area of intervention with TEDS.
Comparative Effects of a2 Skim Milk on Mild Cognitive Impairment in Older Adults

The aim of the study is to compare the effects of powdered skim milk containing A2 β-casein only versus conventional powdered skim milk containing A1 and A2 β-casein milk on cognition, inflammation, and dietary intake in adults aged 65-75 years.


Eligibility Criteria:
For inclusion in the study, participants must meet all of the following criteria:

1. Adults aged 65-75 years;
2. Complaint of memory loss for more than 6 months;
3. Base on the Chinese version of Mini Mental State Examination (MMSE), cognitive ability score is lower than the standard cut-off value according to age and education levels: MMSE score≤ 17 points if years of education is 0 year; ≤ 20 points if 6 years or less of education; ≤ 24 points if more than 6 years of education
4. Living and social functions are reduced: activities of daily living (ADL) score ≤18;
5. Not meeting the diagnostic criteria for dementia (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition), Alzheimer Disease (National Stroke Institute for Neuropathic Speech Disorders and Association for Alzheimer Disease and Related Disorders); no mental disorder, brain damage, or other physical disorders that can lead to cognitive impairment.
6. Agreed not to participate in another interventional clinical research study during the present study;
7. Signed informed consent

Participants must be excluded from the study if they meet any of the following criteria:

1. \<65 years; or \>75 years
2. Neurological examination showed focal signs of central nervous system disorder such as hemiplegia, dysesthesia, aphasia; history of cerebrovascular diseases (including hemorrhagic and ischemic types), internal brain trauma or fracture;
3. Asthmatic bronchitis, severe hypertension, angina and severe infection;
4. Mental disorders such as depression and anxiety; endocrine system diseases (such as hyperthyroidism, hypothyroidism, systemic lupus erythematosus, rheumatoid arthritis);
5. Newly diagnosed, progressing or advanced tumors;
6. Visual, reading, hearing impairment or language communication difficulties that significantly affect cognitive function tests;
7. History of alcohol dependence and abuse of psychoactive substances (e.g., antipsychotics, benzodiazepines, cholinesterase inhibitors, sedatives), or use of drugs that affect cognitive function;
8. Neurological diseases (e.g. Parkinson's disease, epilepsy);
9. Antibiotic treatment in previous 2 weeks;
10. Administered immunosuppressive drugs in the 4-weeks preceding screening;
11. Allergy to milk or dairy;
12. Diagnosed lactose intolerance;
13. Other diseases that investigators judged as unsuitable to participate the study.
HIV-1 Resistance at Screening for HIV Prevention Studies

MTN-009 is a multi-site, cross-sectional study that will provide an estimate of the prevalence of ARV resistance in the population of women who present to study sites to be pre-screened or screened for participation in an HIV prevention trial. To date, a comprehensive surveillance of HIV drug resistance in newly diagnosed women of reproductive age has yet to be undertaken. The primary goal of MTN-009 is to assess the frequency of HIV drug resistance mutations among women who test HIV-positive when presenting to screen for participation in HIV prevention trials.

MTN-009 is a multi-site, cross-sectional study that will provide an estimate of the prevalence of ARV resistance in the population of women who present to study sites to be pre-screened or screened for participation in an HIV prevention trial. To date, a comprehensive surveillance of HIV drug resistance in newly diagnosed women of reproductive age has yet to be undertaken. The primary goal of MTN-009 is to assess the frequency of HIV drug resistance mutations among women who test HIV-positive when presenting to screen for participation in HIV prevention trials. Secondary aims include the identification and evaluation of behavioral indicators including self or sexual partner(s) exposures to antiretroviral (ARV) drugs as risk factors for drug resistant HIV infection, as well as the characterization of the degree of immunodeficiency and risk of disease progression by quantifying plasma HIV-1 RNA and CD4-positive T cells among women who test HIV-positive when presenting to screen for participation in an HIV prevention trial. Exploratory aims include the identification of polymorphic or subtype-specific sequence changes in HIV-1 that may impact susceptibility to ARVs, and the estimation of the proportion of HIV-positive women who have chronic versus recent HIV infection.

The finding of significant resistance, or lack thereof, to ARV-based study products delivered vaginally or taken orally may guide decisions related to future microbicide and PrEP studies. In addition, MTN-009 will provide valuable comparison data for the resistance data obtained in MTN-015, the MTN seroconverter study.

Eligibility Criteria:
Inclusion Criteria:

* Present to an MTN-009 study site to pre-screen or screen for an HIV prevention trial
* Age 18-40 years, verified per site standard operating procedures (SOP)
* Able and willing to provide written informed consent for participation in MTN-009
* Able and willing to provide adequate locator information, as defined in site SOPs

Exclusion Criteria:

* Any condition that, in the investigator's opinion, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achievement of the study objectives
Naglazyme After Allo Transplant for Maroteaux-Lamy Syndrome

This is a single center study in which Naglazyme® will be given weekly for two years in patients with Maroteaux-Lamy syndrome, also known as mucopolysaccharide VI (MPS VI), who have previously been treated with an allogeneic transplant.


Eligibility Criteria:
Inclusion Criteria:

* Mucopolysaccharidosis type VI (MPS VI, Maroteaux-Lamy syndrome) treated with a prior allogeneic transplant \>2 years previously
* Persons currently receiving Naglazyme may be accepted into the study
* Age \> 2 years
* \>10% engrafted based on most recent testing
* Willing to commit to traveling to the University of Minnesota every 6 months
* Written informed consent with parent/guardian consent for children \< 18 years of age or persons unable to consent with minor assent if appropriate

Exclusion Criteria:

* History of cardiac or pulmonary insufficiency or those requiring continuous supplemental oxygen
* Pregnant or breastfeeding
* Any condition that, in the view of the investigator, places the patient at high risk of poor treatment compliance or of not completing the study
Can Antioxidants Affect Pregnancy Rate in Patients With Expected Low Number of Egg Retrieval in IVF Cycles?

The aim of the study is to evaluate the effect of antioxidants on IVF outcome in infertile patients undergoing IVF who are expected to produce low number of eggs compared to a control group. The investigators assumed that the conception rate is higher in those patients taking some antioxidants supplementation. The patients will be given antioxidant drug one month before starting IVF trial once daily by mouth. Uniform protocol of stimulation will be done during the cycle by a type of short protocols known as the antagonist protocol. Egg retrieval will be done under anesthesia. pregnancy test will be done 2 weeks after embryo transfer. The investigators will also assess the number and quality of eggs on the day of egg pick up. In addition, the researchers will assess the number of first and second grade embryos that are put on the day of embryo transfer.

The primary aim of this study is to assess the value of antioxidant intake on the pregnancy rate in IVF/ICSI (invitro-fertilization/intracytoplasmic sperm injection) cycles in poor responders. when the participants fulfill the eligibility criteria, informed consent will be taken. Block randomization will be done and the patients are allocated to one of two groups. The first group will take the antioxidant tablet daily orally for one month before the IVF/ICSI cycle. the other group will take placebo following the same regimen as the study group. Antagonist protocol will be done for all participants. Ovum pick up will be done under general anesthesia when one or more oocytes reaches 17 mm. The researchers will do embryo transfer on day 2 or 3 after ovum pickup. pregnancy test will be in blood after 2 weeks of embryo transfer.

Eligibility Criteria:
Inclusion Criteria:

Infertile females undergoing IVF/ICSI cycles Poor responders are identified with

1. A previous poor ovarian response (less than 3 oocytes with a conventional ovarian stimulation protocol)
2. An abnormal ovarian reserve test which is considered altered in case of antral follicle count less than 5 follicles or AMH (anti-mullerian hormone) less than 1.5 ng/ml.
3. FSH (follicle stimulating hormone) value more than 10 IU/mL .

Exclusion Criteria:

1. Any endocrine or metabolic disorders such as diabetes and thyroid dysfunction
2. Any significant uterine anomaly, uterine cavity distortion, fibroids, hydrosalpinx or advanced endometriosis of stage III to IV
3. Severe oligo-astheno-teratozoospermia or azoospermia are excluded, as well.
Secondhand Smoking in Asthmatic Children

This study will investigate the interaction between GSTP1 / TNFa polymorphisms and passive smoking in children with asthma/wheezing. Contemporary second hand-smoke exposure will be confirmed by laboratory testing.


Eligibility Criteria:
Inclusion Criteria:

* Subjects 1-18 years old with doctor diagnosed asthma/wheezing

Exclusion Criteria:

* Premature birth (\< 36 gestation weeks)
* Asthma-like symptoms due to other conditions (infectious, congenital, mechanical)