cyrilzakka/clinical-trials huggingface dataset:
Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis

Primary Objectives:

1. To determine whether a 4 week reduction in dietary fructose intake improves hepatic steatosis in overweight children who have a baseline high fructose consumption and hepatic steatosis.
2. To determine if a 4 week reduction of dietary fructose improves fasting plasma triglycerides, free fatty acids, very low-density lipoprotein, insulin and glucose as well as post-prandial levels in response to a high fructose meal.
3. To determine if a 4 week reduction of dietary fructose improves markers of oxidative stress.

Study Design: A blinded randomized study comparing glucose beverages to isocaloric fructose beverages administered over 4 weeks.

Planned Sample Size: Phase 1) 96 subjects Phase 2) 40 subjects

Patient Population: Overweight Hispanic children with non-alcoholic fatty-liver disease age 11 to 18 years who are stable and not taking any chronic medication with no recent acute illnesses.

Definitions:

* BMI \>95th %tile for age and gender
* Self-identified as Hispanic/Latino
* Baseline hepatic fat fraction \> 10% (Have nonalcoholic fatty liver disease)
* Sweetened beverage intake of at least 24 ounces/day

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 85th %tile
* Self identified as Hispanic
* Age 11-18 years
* Baseline hepatic fat fraction \>8%
* Self reported sugar beverage intake of at least 24 oz (equivalent to 3 sugar sweetened drinks per day).

Exclusion Criteria:

* Currently attempting weight gain or weight loss
* Cirrhosis visible on baseline MRI
* Renal insufficiency found on screening labs (creatinine \> 2)
* Recent acute illness within past 4 weeks (defined by fever \> 100.4ºF)
* Pregnancy
* Chronic illness requiring medication including diabetes
* Fasting glucose \>120 on screening labs
Instrumented Data Exchange for Ataxia Study

This research study is testing body-worn sensors to measure movement during simple tests of coordination, in order to evaluate the progression and severity of ataxia.


Eligibility Criteria:
Inclusion Criteria:

* SCA 1, 2, 3, 6, and FA with mutations in the pathogenic range confirmed from genetic testing
* SCA: aged 18-75 years
* FA: aged 12-30, diagnosed between ages 5-25
* community dwelling
* physically/cognitively capable of consenting/assenting and complying with the protocol based on investigator's judgement
* able to walk independently 10 yards without an assistive device
* able to sit or stand unassisted for 30 seconds
* no other neurological or musculoskeletal disorder that could affect mobility
* no other history of head injury, vestibular function, stroke, or other disorders that could affect mobility
* willing and able to participate in a 2-year study
* consent to be video recorded while performing study assessments

Exclusion Criteria:

* dementia that limits subjects' ability to follow directions
* pain that limits mobility
* SCA: enrolled in a clinical drug trial
Behavioral Economic Intervention to Improve HIV Behaviors in Sexual Minority Individuals

This research study is testing a new behavioral therapy called Episodic Future Thinking or EFT can help people reduce drug use and risky sexual behaviors while helping them adhere to their HIV prevention medication (PrEP). Participants will be randomly assigned to one of two groups. One group will receive standard care, which includes counseling on HIV prevention, drug use reduction, and sexual health. The other group will receive standard care plus a new program called Episodic Future Thinking (EFT), where participants will think about and plan for their future goals using a mobile app and counseling sessions. Study procedures that are not part of regular care include filling out surveys, providing blood, urine, and swab samples for testing, and using the EFT app.

Phase 1 of the study will involve a formative evaluation of the Episodic Future Thinking (EFT) intervention among (n=10) sexual minority individuals (SMIs) utilizing qualitative interviews. (This phase of the study data will not be reported on ClinicalTrials.gov, since it is not part of the randomized controlled trial).

Phase 2 of the study will utilize a two-arm pilot randomized controlled trial of Episodic Future Thinking plus standard of care (intervention) vs. standard of care only (control) condition to improved HIV-related behaviors (PrEP adherence, sexual risk behaviors and methamphetamine use) among sexual minority individuals.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 - 34 years of age
* HIV negative (assessed via Rapid HIV Antibody Test)
* Identify as gay, bisexual or transgender
* Recent (past 3 months) methamphetamine use
* Currently prescribed and taking HIV PrEP medication
* Self-reported HIV PrEP nonadherence in the past three months
* Urine screen test for PrEP nonadherence
* Self-reported condomless anal sex or a STI in the past three months
* Able to attend all study visits
* Fluent in English

Exclusion Criteria:

* Currently receiving treatment for any substance use disorder,
* HIV positive
* Having a medical or psychiatric illness that in the opinion of the PI would interfere with study participation
* Unable to provide informed consent
* Unable to attend protocol directed study visits
* Any plans that would preclude study completion (e.g. surgery, major medical treatments such as chemotherapy, incarceration, travel/moving out of San Antonio, Texas)
Investigating Mechanisms Underlying Spinal Cord Stimulation Efficacy Using Virtual Reality and Full Body Illusion

The study hypothesis is that spinal cord stimulation (SCS) combined with virtual leg illumination (provided through a wearable headset (OculusRift, OculusVR, Irvine, CA) and a custom-designed virtual reality leg scenario) will lead to controlled analgesia induction, boosting analgesic effects obtained with standard SCS treatments and will further be associated with changes in the perception of the affected body part.

Epidural spinal cord stimulation (SCS) is an approved treatment for truncal and extremity neuropathic pain. The mechanisms underlying the efficacy of SCS are unknown. Recent advances in cognitive neuroprosthetics using virtual reality allow for modulation of body perception and bodily experience, which has also been shown to modulate pain perception. The present research proposal plans to merge expertise in cognitive neuroprosthetics with neuromodulation techniques in order to test the analgesic properties of the combination of epidural spinal cord stimulation with a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation). The investigators propose to study this hypothesis prospectively in 25 patients with implanted SCS systems for the treatment of chronic neuropathic pain. Primary outcomes will be pain reduction (based on subjective, functional and physiological measures) and changes in body perception (based on subjective and objective measures). The present study will generate a proof-of-concept for the application of neuro-visual stimulation for the treatment of chronic pain and will form the basis for future NIH funding application.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-and older at the time of enrollment
2. Patients carrying a diagnosis of CPRS type 125 or chronic refractory neuropathic leg pain following FBS4
3. Patients who have implanted epidural SCS
4. The SCS implantation for at least three months prior to enrollment
5. Patients with efficacious SCS as defined by ≥ 50% pain improvement after switching SCS from an OFF state to an ON state ('optimal' stimulation efficacy)
6. Patients willing and able to provide informed consent

Exclusion Criteria:

1. Patients who are unable to effectively or efficiently communicate for example patients suffering from speech deficits (dysarthria, aphasia) or are non-English speaking.
2. Patients with history of prior cranial surgery, significant brain lesions for example intracranial tumors, strokes etc.
3. Non efficacious response to SCS \<50% pain improvement with optimal stimulation parameters
4. Evidence of untreated psychiatric disorders or drugs/alcohol abuse.
5. History of seizures
Non Culprit Functional Evaluation With 3D Angio QFR in STEMI PCI Procedure

Reliability of 3D angio QFR functional evaluation of all non culprit lesions \>50% in STEMI patients during first acute procedure

3DAngio QFR is an angiographic based tool for coronary stenosis functional assessment: it is validated versus Adenosine FFR(ADOFFR) by several studies (FAVOR, VIRTU-1) ; in particular post contrast QFR (cQFR) showed a very good correlation with ADOFFR. Furthermore ADOFFR in non culprit vessel in acute stage of STEMI correlates well with ADOFFR of the same non culprit lesion in staged procedure. Aim of the study is to find a valid correlation between cQFR in acute study and ADOFFR in the staged procedure. A positive result may lead to a fast, easy and cost effective acute functional non culprit lesions evaluation during acute procedure for STEMI patients, selecting those,if any, to be treated immediately or in a staged procedure.

Eligibility Criteria:
Inclusion Criteria:

* STEMI/NSTEMI pts with at least 1 non culprit lesion \> 50%
* Age \> 18 years
* Able to provide signed informed consent
* Angiographic inclusion criteria:
* Indication for FFR in at least one stenosis:
* Diameter stenosis of 50%-90% by visual estimate
* Reference vessel size \> 2 mm in stenotic segment by visual estimate

Exclusion Criteria:

* Severe asthma or severe chronic obstructive pulmonary disease
* Severe heart failure (NYHA≥III)
* S-creatinine\>150µmol/L or GFR\<45 ml/kg/1.73m2
* Allergy to contrast media or adenosine
* Atrial fibrillation

Angiographic exclusion criteria:

poor coronary opacification marked overlapping marked tortuosity angio acquisition protocol incomplete
Cognitive and Emotional Impairment After Stroke

Cognitive and emotional symptoms are often seen in the acute phase of a stroke. The prevalence of such symptoms later and the mechanisms explaining the symptoms are not fully known. The causes of poststroke dementia are likely to be multifactorial (Cerebrovascular Diseases 2006). The investigators want to include all patients with first ever stroke without significant cognitive decline prior to the stroke (IQCODE cut-off 3,7) and follow them up for one year. At baseline we will make stroke classifications, measure neurological deficits according to NIHSS, evaluate cognitive and emotional function and make registrations of vascular risk factors, including precerebral color duplex scan with measurement of IMT in CCA. The investigators will then randomize the patients into multifactorial vascular-risk-factor-intervention in the hospital or care as usual in the primary health care. 8-12 months after stroke onset, survivors will undergo new examinations to evaluate neurological, cognitive and emotional functions, as well as MRI and SPECT.


Eligibility Criteria:
Inclusion Criteria:

* First ever stroke or TIA
* No cognitive decline (IQCODE \< 3,7)
* Survived the acute stroke
* Expected to live at least for one year after stroke

Exclusion Criteria:

* Cognitive decline
Remifentanil as Intravenous Patient-controlled Analgesia (IVPCA) During Labour

Remifentanil is a ultra short-acting synthetic opioid. It is rapidly metabolized by non-specific blood and tissue esterases. We wanted to investigate the efficacy and safety of remifentanil used as analgesia during labour. Intravenous patient controlled analgesia (ivpca) were used to administer remifentanil. Doses used were 0,15-1,05 mikrogr/kg, with a lock-out time of 2 minutes. 41 women were included in the study. Blood-pressure, heartrate, SaO2, respiration rate and sedation were recorded every 15.minute. Fetal heart rate was recorded for the whole periode of treatment (CTG, STAN). Vaginal contraction pain were assessed by the parturients every 15.minute using a Visual Analogue Scale (VAS). Midwives also recorded their impression of the parturients pain. The parturients level of sedation were recorded by anesthesiologist and midwife every 15.minute. Apgar scores were registered at 1, 5 and 10 min after delivery. Umbilical cord blood analysis regarding blood gases and concentration of remifentanil were performed. After delivery, both mother and midwife evaluated efficacy and safety; Global satisfaction score, if the remifentanil doses were sufficient, nausea, vomiting, level of sedation and dizziness.

Primary and secondary outcome measures presented under "results"

Eligibility Criteria:
Inclusion Criteria:

Healthy women (ASA I-II), in active labour, one fetus with no suspected pathology, expecting normal childbirth, informed consent.

Exclusion Criteria:

Failure to obtain informed consent, received opioids within last 8 hours before study start, serious side-effects mother and abnormal fetal heart rate.
Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy Volunteers

The primary objective of the study is to compare in healthy subjects, the GI tolerability of bioequivalent doses of Bafiertam™(monomethyl fumarate) and its pro-drug Tecfidera® (dimethyl fumarate).

Secondary objective of this study is to compare the safety and tolerability of Bafiertam™ and Tecfidera® when administered orally following bioequivalent dose regimens in healthy subjects.

Subjects randomized (1:1) to either Bafiertam (monomethyl fumarate) or Tecfidera (dimethyl fumarate) will enter a double-blind titration period where they will receive either Bafiertam 95 mg twice daily (BID) or Tecfidera 120 mg BID for 7 days. Following the titration period, they will enter a maintenance period in which they will receive Bafiertam 190 mg BID or Tecfidera 240 mg BID for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Males or non-pregnant females.
2. Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the PI/Sub-Investigator.
3. Body Mass Index within 18.0 - 34.0 kg/m2, inclusive

Exclusion Criteria:

1. Known history or presence of any clinically significant hepatic, renal/genitourinary, Gastrointestinal (GI), cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator.
2. Clinically significant history or presence of any clinically significant GI pathology unresolved GI symptoms, or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within 7 days prior to first study drug administration, as determined by the PI/Sub-Investigator.
3. Presence of any significant physical or organ abnormality as determined by the PI/Sub-Investigator.
4. Subject with abnormal baseline laboratory values deemed to be clinically significant by the Investigator.
5. Lymphocyte count \<1.5x 10\^9/L.
6. Known history or presence of: Alcohol abuse or dependence within one year prior to first study drug administration; Drug abuse or dependence; Hypersensitivity or idiosyncratic reaction to DMF, its excipients, and/or related substances; Progressive multifocal leukoencephalopathy (PML); Fanconi syndrome; Flushing (e.g., warmth, redness, itching, and burning sensation); Low white blood cell count (lymphopenia);
Using the Drug Thalidomide to Stimulate T Cells in HIV-Infected People

Despite treatment with anti-HIV drugs, people infected with HIV continue to have problems with their immune systems. This study will evaluate whether the drug thalidomide, which stimulates the immune system's T cells, can improve immune system function in people with HIV.

In patients with chronic HIV infection, HIV replication and abnormalities in immune function persist following treatment with highly active antiretroviral therapy (HAART). Specifically, costimulatory T cell interactions are impaired. The immune modulatory drug thalidomide was recently found to costimulate T cells. Pharmacologic T cell costimulation may compensate for the T cell deficiencies in people with HIV disease and improve immune function. This study will test whether thalidomide treatment enhances HIV and cytomegalovirus (CMV)-specific immunity in patients with HIV and CMV, and will evaluate the effect of thalidomide on HIV replication.

In this study, 40 HIV and CMV infected patients on HAART and 40 HIV uninfected CMV seropositive controls will be randomly assigned to low dose thalidomide or placebo treatment for 28 days. T cell responses and HIV replication and genetic diversification will be assessed.

Eligibility Criteria:
Inclusion Criteria

* HIV-infected for at least 5 years prior to study entry
* CD4 count of 300/mm3 or above
* Pre-HAART nadir CD4 count of 300/mm3 or less
* CMV infection
* HAART for 12 months prior to study entry
* Same effective HAART regimen for 3 months prior to study entry
* HIV viral load less than 200 copies/ml
* Clinically stable

Exclusion Criteria

* Active opportunistic infection
* Females of childbearing potential
Efficacy of Iontophoresis in Treating Lateral Epicondylitis Patients

This study is conducted To evaluate the effect of magnesium sulfate on pain intensity, muscle power, hand grip and function ability in patients with lateral epicondylitis.

This study is conducted To evaluate the effect of magnesium sulfate on pain intensity, muscle power, hand grip and function ability in patients with lateral epicondylitis.

BACKGROUND:

Lateral epicondylitis (LE) (tennis elbow) is a tendinopathy of the forearm extensor muscles, often caused by overuse or repetitive use (mostly of the extensor carpi radialis brevis), forced extension or direct trauma in the epicondyle . LE has an approximate rate of 40% and a prevalence of 1-3% of the general population . It mostly affects people 40 years and older. Some studies indicate that men and women are equally affected; others report a higher percentage of affected women .

HYPOTHESES

It will be hypothesized that:

There will be no statistically significant effect of magnesium sulfate on pain intensity, muscle power, hand grip and function ability in patients with lateral epicondylitis.

Definition of terms Lateral epicondylitis: pain and tenderness over the lateral epicondyle of the humerus, and pain on resisted dorsiflexion of the wrist, middle finger, or both .

Iontophoresis: is a technique used to enhance transdermal penetration of substances through the application of electric current .

RESEARCH QUESTION:

This study will be conducted to answer the following question:

What is the effect of magnesium sulfate on pain intensity, muscle power, hand grip and function ability in patients with lateral epicondylitis?

Eligibility Criteria:
Inclusion Criteria:

* • Their age will be ranged between 20-50 years with both gender

  * Pain on the lateral side of the elbow for at least 4 weeks
  * Tenderness over the lateral epicondyle
  * At least two positive provocative tests: Mill test and Thomson test

Exclusion Criteria:

* • History of injection, surgery, physical therapy in the elbow area in the last 3 months

  * Previous elbow surgery
  * History of radius/ulna fracture
  * History of cervical and shoulder problems
  * Having bilateral symptoms
  * Concomitant medial epicondylitis
  * Malignancy
  * Pregnancy
  * Systemic rheumatologic disease or systemic infection
  * Inserted cardiac pacemaker
  * Presence of coagulation disorders
  * Cognitive dysfunction
Validation of a Cognitive Remediation Program for Bipolar Disorders

This study evaluates the effect of a new cognitive remediation program designed for patients suffering from a bipolar disorder, on cognitive functions, psychosocial functioning and neural processes. In this double-blind (patient, outcomes assessor) controlled randomized trial the investigators compare patients receiving the ECo program for bipolar disorders, to patients benefiting from the broadly used cognitive remediation program CRT and to patients receiving supportive psychotherapy. Patients are treated for 3 months and monitored for 9 months.


Eligibility Criteria:
Inclusion Criteria:

1. Type I or type II Bipolar Disorder diagnosis, according to DSM-IV-TR criteria
2. No Manic or Major Depressive episode during the last three months
3. No or few residual depressive symptoms (HDRS-17 ≤ 12)
4. No or few residual manic symptoms (YMRS ≤ 8)
5. Stable dose of medication for the last two months
6. Cognitive complaint expressed by the patient and impairment observed by the patient's regular psychiatrist
7. Informed consent form read, initialed and signed
8. Patient registered on the social welfare system

Exclusion Criteria:

1. Other diagnosis than Bipolar Disorder on axis I of the DSM-IV-TR
2. Rapid Cycling Bipolar Disorder diagnosis
3. Addiction or substance abuse (except tobacco) during the twelve last months
4. Physical or neurological disorder that can lead to cognitive impairment
5. Engagement in a research protocol either currently or over the last month
6. Neuropsychological assessment or Rorschach Inkblot Test evaluation during the last six months
7. Ineligibility for Magnetic Resonance Imaging \[MRI\] (e.g. claustrophobia, metallic implants, pace-maker, etc.)
An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.

The study is being conducted to evaluate the efficacy, and safety of Lutetium (177Lu) Oxodotreotide Injection in Subjects With advanced gastrointestinal pancreatic neuroendocrine tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. 18\~75 years old,male or female；
3. ECOG performance status 0 or 1
4. Unresectable locally advanced or metastatic gastrointestinal neuroendocrine tumors ( GEP-NETs ) of low and medium grade ( G1 or G2 ) confirmed by histopathology ;

Exclusion Criteria:

1. Central nervous system metastasis is known. Patients who have previously received treatment ( radiotherapy or surgery ) for brain metastases and have no clinical symptoms can be enrolled if the pre-randomized pre-imaging is confirmed to be stable for at least 24 weeks.
2. There are clinical symptoms or diseases of the heart that are not well controlled.
3. Diabetes ( fasting blood glucose \> 2 × ULN ) that cannot be well controlled after optimal medical support treatment.
4. Severe urinary incontinence, hydronephrosis, severe micturition dysfunction or indwelling catheter for any reason
Serum Levels of Insulin- Like Growth Factor and Fertility

this study will try to determine whether serum levels of insulin like growth factor are higher in fertile women than infertile women.

this study will try to determine whether serum levels of insulin like growth factor are higher in fertile women than infertile women.The women will over 40 years old.

Eligibility Criteria:
Inclusion Criteria:

* 40-55 years old
* healthy

Exclusion Criteria:

* pregnant women
* breast feeding
* menopause
* vegetarian