cyrilzakka/clinical-trials huggingface dataset:
Functional Imaging of the Therapeutic Effect of Pregabalin in Treatment for Neuropathic Pain

Functional Imaging of the therapeutic effect of Pregabalin in treatment for neuropathic pain in patients with Diabetic Polyneuropathy using proton Magnetic Resonance Spectroscopy (MRS):

The aim of our study is to investigate the effect of Pregabalin as a treatment for neuropathic pain in a homogeneous study population, using proton MRS (1H MRS) focusing on four regions of interest (bilateral thalami, rostral anterior cingulated cortex (rACC) and dominant dorsolateral prefrontal cortex (DLPC).

spectrum measurements at: thalamus left thalamus right rostral anterior cingulated cortex dominant dorsolateral prefrontal cortex

measurements: gamma-aminobutyric acid (GABA) glutamate (Glu) glutamine (Gln) N-acetylaspartate (NAA) Choline-containing compounds (Cho) Creatine plus phophocreatine (total creatine: Cr) Myo-inositiol (Ins) Choline (Cho) Glucose (Glc) Lactate (Lac)

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients with painful DPN
* Patient willing to provide informed consent
* Type 1 or type 2 diabetes with HbA1c ≤ 11%
* Stable antidiabetic medication for 30 days prior to randomization
* Duration of painful DPN ≥ 3 months
* Visual analogue scale (VAS) score ≥ 4

Exclusion Criteria:

* Creatinine clearance ≤ 60mL/min
* Presence of other clinically significant or disabling chronic pain condition
* Active malignancy
* Evidence of an active disruptive psychiatric disorder or other known condition that might influence the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator
* Life expectancy less than 1 year
* Existing or planned pregnancy
* Extreme fear for entering MRI
* General contraindication for MRI (pacemaker, etc...)
* Patients participating in other clinical trials
* Age \<18 years
* Prior use of potential retinotoxins
* Prohibited medications without proper wash-out period (\>7days, depending on the type of medication):

  * medications and supplements commonly used for relief of neuropathic pain
  * antiepileptics
  * antidepressants (except for stable regiments of SSRIs for treatment of anxiety or depression)
  * NSAID
Comparison of CT Angiography With Conventional Angiography and Intravascular Ultrasound in Heart Transplant Patients

The overall goal of this study is to determine if non-invasive imaging with state of the art CT coronary angiography can be used to screen for transplant coronary artery disease in the setting of heart transplant.

Our current protocol at UCSF for heart transplant patients involves screening with stress tests as well as coronary angiograms with intravascular ultrasound to assess the diameter of the lumen of the coronary arteries and to assess wall thickness.

Our hypothesis is that state of the art CT coronary angiography can be used to acquire data regarding the coronary arteries in the setting of heart transplant and be used to risk stratify patients with regards to the developments of transplant coronary artery disease.

Specific Aim 1- To test the hypothesis that coronary CTA can accurately measure cross-sectional vessel wall area using conventional coronary angiography with intra-vascular ultrasound as the standard of reference.

Specific Aim 2- To test the hypothesis that coronary CTA can accurately measure cross-sectional vessel wall thickness, vessel area and luminal area using conventional coronary angiography with intra-vascular ultrasound as the standard of reference.

Secondary Aim - To asses the correlation of cross-sectional vessel wall area, vessel wall thickness, vessel area, luminal area and vessel wall index with global and regional left ventricular function using coronary CTA.

Eligibility Criteria:
Inclusion Criteria:

1. Patient referred for coronary angiography and IVUS as part of their standard clinical care;
2. Patients must be 18 years of age or older.
3. Any ethnic background is acceptable.

Exclusion Criteria:

1. Patients with contraindications for the use of iodinated contrast (allergic reaction, renal failure, multiple myeloma, etc) will be excluded.
2. Patients with heart rate higher than 65 bpm and contraindications for the use of beta-blockers, listed below:

   Systolic blood pressure \< 90mmHg Decompensated congestive heart failure; COPD or asthma in use of bronchodilator; Second or third degree heart block; Severe aortic stenosis, defined by a pressure gradient higher than 50 mmHg and/or the presence of symptoms.
3. Patients with contraindications for the use of nitroglycerin, listed below:

   Severe anemia; Increased intracranial pressure; Known hypersensitivity; Use of Sildenafil Citrate (Viagra®)
4. Children and pregnant women will be excluded because of risks associated with radiation exposure.
5. Patients must have no atrial fibrillation, as this will interfere with cardiac gating for the examination.
6. Patients unable to give informed consent will be excluded as well.
7. Patients with a coronary stent placed.
Efficacy of Mobile Phone Short Message Service (SMS) Reminder and Consultation on Asthma Control

Asthma is the disease being studied. The main objective of this study is to assess the clinical efficacy of mobile phone short message service (SMS) reminder and consultation on the self-management and outcomes of poorly controlled asthma which is first diagnosed in a time period of 3 months. The secondary objective is to explore the cost-benefit and cost-effectiveness of the proposed intervention.

Aims: The main aim of this study is to assist asthma patients to practice asthma self-management at home by sending reminders and responding to patients' consultations with mobile phone short message service (SMS), which will eventually help them to control their asthma, and prevent asthma exacerbation. Thus, the ultimate goal of this proposed study is to improve patient health outcome via enhancing patient-physician interaction through mobile phone short message service (SMS) that is low-cost and could be followed easily by the patients and their physicians.

The hypothesis is that asthma patients who receive weekly text message reminders to educate them and reinforce adherence will have better asthma outcome, such as asthma control, while the intervention integrating patient consultation and reminders by SMS improve asthma outcome even more. The investigators further hypothesize that these subjects under intervention will have an improvement in secondary measures including quality of life and patient satisfaction. The investigators also anticipate that such an approach in asthma management will be cost-effective.

After examined for their eligibility and recruited into this study at outpatient service, all participants have their case records which contain their baseline data and receive the same standard asthma education(including basic knowledge about asthma, how to use their medicine, what to do when an asthma attack happens and when to come back for their disease review and so on). Each patient is given a paper asthma diary and a peak expiratory flow(PEF) measurer for free. In addition, they are told what intervention they will receive and revised face-to-face one month after the beginning of intervention. After the 3-month study period, when they return to the hospitals, they will return the asthma diaries, be asked to fill in the questionnaires and take pulmonary function tests.

Eligibility Criteria:
Inclusion Criteria:

1. Physician diagnosed uncontrolled or partly-controlled asthma by Global Initiative for Asthma(GINA) standard.
2. At least 6 months asthma history.
3. Ownership of a mobile phone and currently using the text messaging service.
4. Age between 18 and 65 years old.
5. Willingness to participate in this study.
6. Willing to sign the written informed consent to take part in the study.

Exclusion Criteria:

1. Inability to provide written informed consent or to fill in the paper asthma diary.
2. A history of smoking cigarettes for greater than ten pack years.
3. Other current or a history of severe comorbidity.
4. Being in other clinical trials.
PACAP38´s (Pituitary Adenylate Cyclase-Activating Polypeptide) Headache Inducing Characteristics and Effects on the Cerebral Blood Flow

To investigate headache score and accompanying symptoms during and after infusion of PACAP38 i migraine patients

To investigate headache score and accompanying symptoms during and after infusion of PACAP38

Changes in regional cerebral blood flow (rCBF) in the area supplied by middle cerebral artery (MCA), blood flow in MCA, diameter of the superficial temporal artery (STA) and radial artery (RA)

Eligibility Criteria:
Inclusion Criteria:

* Healthy migraine patient without aura
* Aged 18-50
* 50-100 kg
* Fertile women must use safe contraceptives (IUD, oral contraceptives, surgical sterilisation and long lasting gestagen.

Exclusion Criteria:

* Tension type headache more than five times/month
* Other primary headaches
* Daily medication except contraceptives
* Drug taken within 4 times the halflife for the specific drug except contraceptives
* Pregnant or lactating women
* Exposure to radiation within the last year
* Headache within the last 48 hours before start of trial
* Hypertension
* Hypotension
* Respiratory or cardiac disease
Computerized Interventions for College Students' Cognitive Functioning and Mental Well-being

The present study will explore the effectiveness of a computer based neurobehavioral intervention in improving cognition and emotion regulation in a college freshmen population. It will increase understanding of emotion-regulation and cognition at a neural-circuit level and aid development of new interventions for emotion regulatory problems.


Eligibility Criteria:
Inclusion Criteria:

* internet access

Exclusion Criteria:

* lifetime psychotic disorder,
* past-year substance dependence
Topical Timolol Gel for the Treatment of Infantile Hemangiomas

We plan to conduct a study, to see how safe and effective timolol maleate 0.5% gel-forming solution is for infantile hemangiomas (IH) and the response of hemangiomas to timolol maleate 0.5% . Our hypothesis is that timolol will inhibit and possibly reverse growth of appropriate infantile hemangiomas.

Subjects will be assigned to open label timolol maleate 0.5%. Parents will be instructed to place 1 to 2 drops twice a day in the center of the hemangioma. Subjects are expected to use the study drug as directed every day for a 4 month period.

Subjects will be assessed at baseline, 2 weeks, 4 weeks, and every 4 weeks thereafter for a total of 5 months. Physical exam, photographs to compare size and color intensity, and a scale of improvement will be completed at each visit. Parents will complete a quality of life questionnaire regarding their child's hemangioma and its impact on quality of life.

Subjects who have evidence of worsening would be removed from the study and transferred to the clinic for evaluation and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Written informed permission for study participation and the use of the patient's images are obtained from the patient's parent(s) or guardian(s),

  * The patient is between 7 days and 6 months of age at the time of enrollment,
  * and a proliferating HOI not requiring systemic therapy is present anywhere on the body, Multiple hemangiomas may be treated on same child, if the hemangioma meets this criteria.

Exclusion Criteria:

* patients who are not otherwise generally healthy;
* at risk for imminent ulceration, life-threatening, function-threatening, or ulcerated;
* patients who have previously received systemic, intra-lesional or topical corticosteroids, imiquimod, vincristine, alpha-interferon, propranolol or other beta blockers;
* patients who have previously been treated for his/her HOI, including any surgical and/or medical procedures;
* patients whose mothers have been breastfeeding the patient while also being treated with beta-blockers, systemic corticosteroids, vincristine or alpha-interferon;
* patients who have previously experienced any anaphylactic reactions; patients with an unclear diagnosis of HOI;
* patients participating in another clinical study or living in the same household as an infant already participating in this study;
* patients born prematurely who have not yet reached his/her term equivalent age; and patients with parent(s) or guardian(s) who cannot be contacted by telephone in case of emergency.
Screening Nutritional Status of Hospitalized Patients

This study investigated the results of the nutritional status of hospitalized patients with Nutritional Risk Screening 2002 (NRS-2002) and Subjective Global Assessment (SGA) screening and compared the effects of two screening method in predicting malnutrition.

In the cross-sectional study demographic data, body mass index (BMI), length of hospital stay (LOS), and cause of hospitalization of hospitalized patients were recorded. For the nutritional assessment all patients were screened with NRS 2002 and SGA within the first days of admission to the patients. The primary predictors of interest in our study were the NRS 2002 and SGA results of patients.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* non-bed-dependent
* non-critİcal service patients

Exclusion Criteria:

* \< 18 years old,
* hospitalized due to surgical operation,
* pregnant women,
* breastfeeding women,
* bed-dependent,
* suffered an advanced disease that required palliative care.
Post-marketing Safety and Efficacy Surveillance of Motherwort Injection

This study aims to provide evidence concerning the safety and efficacy of motherwort injection in real-world settings.


Eligibility Criteria:
Inclusion Criteria:

* Meet the clinical indications for the use of motherwort injection
* Voluntarily participate in this study
* Fulfill ethical requirements.

Exclusion Criteria:

* None
Evaluation of a Specialized Yoga Program for Persons With Spinal Cord Injury (SCI)

The purpose of this randomized controlled study is to evaluate psychological variables, mindfulness, and pain in the context of a specialized yoga program for individuals with SCI. Participants will be randomized to either a wait-list control condition or to a specialized yoga program condition.


Eligibility Criteria:
Inclusion Criteria:

1. have an SCI or a spinal related condition,
2. be 18 years of age or older,
3. be able to speak and read English,
4. commit to two weekly, one hour yoga classes for six weeks,
5. be referred from a clinician on the inter-disciplinary team,
6. have a sitting tolerance of one hour,
7. be able to participate in gentle physical activity in that time,
8. be aware of and understand his/her health contraindications (is able to practice safely),
9. provide a note from their physician indicating that it is safe for them to participate in a physical activity intervention, such as yoga.

Exclusion Criteria:

1. are not medically stable,
2. have pre-existing medical contraindications,
3. have cognitive limitations or language comprehension issues that would impact participation (determined by care team),
4. have had a regular yoga practice in the last six months.
Targeting the Gut Microbiome to Investigate the Pathways of Progression From Obesity to Metabolic Diseases in an At-risk Population.

Studies of the human gut microbiome have suggested that treatment or prevention aimed at the obese microbiome could influence the development of obesity-associated metabolic disturbances.

The objective of this project is to explore if a dietary intervention in 60 obese women with the probiotic Lactobacillus paracasei ssp paracasei F19 or flax seed fibres targeting the gut microbiome, can reduce insulin resistance, low-grade inflammation or dyslipidaemia, and to explore the interaction between the human genome and the gut microbiome.

The study is based on the following hypotheses:

* Treatment with the probiotic Lactobacillus paracasei ssp paracasei F19 and flax seed fibres will lower the metabolic risk profile in the intervention groups compared with placebo.
* The effect on the metabolic risk markers can be correlated with changes in the gut microbiota (measured in faeces).

After completion of the dietary intervention, the participants are offered a 10-week weight reduction program. Those who participate in the weight-loss program are invited to an optional follow-up visit in connection with the last visit at the clinical dietician, for the purpose of exploring the effect of weight loss on the gut microbiota and obesity-associated metabolic disturbances.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal
* BMI between 30-45 kg/m2
* Waist circumference \> 80 cm
* High leukocyte count

Exclusion Criteria:

* Medically-treated Type 2 diabetes or dyslipidaemia
* Use of antibiotics during the last 3 months
* Use of pro- or prebiotic supplements during the last 6 weeks
* Illnesses related to the gastro-intestinal tract
* History of psychiatric diseases (incl. depression)
* Liver disease
* Alcohol abuse
Intracoronary Injection of Epo After Myocardial Infarct "Intra-CO-EpoMI"

Primary endpoint: Is intracoronary injection of a single dose of darbepoetin alpha, during reperfusion in patients hospitalized for ST segment elevation myocardial infarction (STEMI), able to reduce infarct size ?

In in vivo studies, many experiments evidenced infarct size reduction, due to anti-apoptotic compounds, when given during reperfusion, after cardiac ischemia. In humans, post-conditioning offers such a protection, as the investigators have previously showed (Staat P et al. Post-conditioning the human heart. Circulation. 2005 112(14):2143-8).

Infarct size reduction could lead to a reduced rate of complications (heart failure, rhythmic complications) and finally, morbidity and even mortality. This protection depends on anti-apoptotic properties (Zhao ZQ et al. Inhibition of myocardial injury by ischemic postconditioning during reperfusion: comparison with ischemic preconditioning. Am J Physiology Heart Circ Physiology 2003 Aug; 285(2):H579-88). Many drugs have been proposed to be able to mimic this phenomenon. Among them, many are efficient but toxic in vivo or difficult to manage (insulin, morphin). One of the most promising agent could then be erythropoietin (EPO) (Opie LH et al. Postconditioning for protection of the infarcting heart. Lancet. 2006; 367(9509):456-8). In order to target ischemia-reperfusion injuries, EPO impact is better and better demonstrated (e.g.: Mudalagiri NR. Erythropoietin protects the human myocardium against hypoxia and reoxygenation injury via phosphatidylinositol-3 kinase and ERK1-2 activation. Br J Pharmacol. 2007 Oct 22). The purpose of the study is to test this hypothesis in humans, on the onset of the reperfusion, after myocardial ischemia (acute myocardial infarct). EPO could contribute to protect myocardium against ischemia-reperfusion injury. This impact could rely on anti-apoptotic properties.

Multiple Centers.:

5 centers located in France:

* Montpellier
* Clermont-Ferrand
* Lyon
* Marseille
* Nîmes

Study design: Open-label, placebo-controlled, single-blinded. Patient in treatment group will receive intracoronary single bolus of EPO (150 µg), as soon as significant reperfusion is obtained (as measured by TIMI flow 2 or 3). In control group, placebo will be used. Placebo must be presented exactly the same as the drug.

Length of Treatment: One shot during reperfusion procedure.

Follow-up Period: 72nd hour post-admission for plasma kinetics of cardiac enzymes 5th to 7th day after revascularization procedure for MRI measurements, and echocardiography3th month post-MI MRI, echocardiography3th month: phone contact.

Sample Size: 27 patients in each arm, 54 patients total.

Eligibility Criteria:
Inclusion Criteria:

* ACS with persistent ST elevation
* First episode
* Symptoms onset \< 12 hours
* Eligible for angioplasty
* Culprit coronary artery occluded (TIMI flow 0-1) at admission, and then adequately reperfused (TIMI flow 2-3) prior to EPO injection

Exclusion Criteria:

* Cardiogenic shock
* Cardiac arrest
* Currently receiving EPO
* Pregnancy
Randomized Control Trial of a Topical Anesthetic to Evaluate Pain and Anxiety During Venipuncture

The purpose of this study is to evaluate the amount of anxiety and pain felt by children during procedures that require a needle stick after using a topical anesthetic or placebo cream.

Pediatric patients frequently receive eutectic mixture of local anesthetics (EMLA) or other anesthetic medications prior to venipuncture. However, the time for the anesthetic to take affect is approximately 60 minutes. Another anesthetic medication besides EMLA is lidocaine 4% topical anesthetic cream (LMX4), which has a shorter acting time (30 minutes) compared to the EMLA, making it a more desirable medication when urgent labs are required. This medication is being evaluated to assess the anxiety and pain associated with venipuncture in 15 minutes versus the approved 30 minutes of pediatric patients treated as an inpatient or outpatient in the local Emergency Department, compared to standard care (no prior treatment).

Eligibility Criteria:
Inclusion Criteria:

* children ages 5-18 years of age
* treated as an inpatient or outpatient at Lehigh Valley Hospital within the past 24 hours
* venipuncture order, and that order is their initial venipuncture order (required within 30 mins)

Exclusion Criteria:

* known allergy to EMLA, LMX4 or any of their ingredients
* known sensitivities to local anesthetics of the amide type, lidocaine or prilocaine
* G6PD deficiency
* methemoglobinemia or concomitant administration of methemoglobin-inducing agent
* brain injured or disoriented (Glasgow Coma Scale \<15)
* cognitively impaired (Mini Mental Status Exam \<28)
* active skin conditions at venipuncture site including frequent rashes, eczema or unexplained bruising