cyrilzakka/clinical-trials huggingface dataset:
Retrospective Evaluation of Safety and Efficacy of Daptomycin Used in Patients With Serious Gram-positive Infections

Before Daptomycin (Cubicin ®) approved by the U.S. FDA in 2003, There were large-scale clinical trials conducted that included more than 1,000 subjects and than Daptomycin got complicated skin and soft tissue infections (CSSSI) indication. After 2004, Daptomycin got new indications about bacteremia and endocarditis due to success outcomes in the clinical trial which included infected in blood flow and endocardial infected patients.

All subjects in Daptomycin clinical trials are European and American race. It is necessary that collecting safety and efficacy data of Daptomycin in Taiwan race. I will intent to evaluate the safety and efficacy of Daptomycin which were used in patients with serious gram-positive infections retrospectively. And the outcome could be a reference for Daptomycin future using.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients who were prescribed daptomycin from 1st January 2009 to 31st December 2010 for gram positive infections as deemed necessary by his/her treating physician. And patients received Daptomycin therapy for at least 3 days.

Exclusion Criteria:

* Patients received Daptomycin therapy for over 3 days
Laparoscopic Guided Peri-wound Transversus Abdominis Plane Block With Bupivacaine Versus Local Wound Infiltration on Post-op Opioid Use in Laparoscopic Sleeve Gastrectomy

The goal of this randomized controlled trial is to compare laparoscopic guided peri-wound Transversus Abdominis Plane Block and bupivacaine versus local wound infiltration effect on reducing post-op opioid use in Laparoscopic Sleeve gastrectomy. The main questions it aims to answer are:

• Can laparoscopic guided peri-wound Transversus Abdominis Plane Block reduced post operative morphine usage when comparing with local wound port site infiltration.

Participants will be randomize into 2 group

* peri-wound Transversus Abdominis Plane Block
* local wound port site infiltration


Eligibility Criteria:
Inclusion Criteria:

* patient undergoing LSG at Sringarind hospital as indicated by Thai guideline

Exclusion Criteria:

* Allergic/contraindicated to bupivacaine, morphine, fentanyl, NSAIDs or Nefopam
* Unable to describe pain score Opioid addict
* denied consent
Matcha Green Tea Effects at Rest and During Moderate-intensity Exercise in Females

Intake of the green tea catechin epigallocatechin (EGCG) increased fat oxidation during walking. It is also known to reduce blood pressure and improve body composition. This research will expand the insight on the effects by Matcha green tea supplementation and address the effects on heart rate variability, substrate oxidation at rest, and cardiovascular responses at rest in addition to metabolic and physiologic responses for a 1-hr walk in healthy females.

Intake of the catechin epigallocatechin (EGCG) increased fat oxidation during walking. It is also known to reduce blood pressure and improve body composition. EGCG is the most abundant and potent bioactive compound (50-80% of the total catechin content) found in Matcha green tea (MGT) and is usually consumed as a drink or in a capsulated from unfermented tea leaves. MGT polyphenols have antioxidant and anti-inflammatory properties, providing numerous health benefits, such as the reduced risk of type 2 diabetes and obesity. MGT supplementation (3g over a 24hr period) has been shown to enhance fat oxidation during 30-min brisk walking as well as lower respiratory exchange ratio in females. Understanding the effectiveness of the bioactive compounds found in natural food sources in improving human health is key to informing the general population and the public health policies preceding them; the daily consumption of drinks and food naturally high in EGCG content could be recommended as an essential part of a healthy lifestyle. This research will expand the insight on Matcha green tea supplementation address the effect on heart rate variability, substrate oxidation at rest, and cardiovascular responses at rest in addition to metabolic and physiologic responses for a 1-hr walk in healthy females.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* non-smokers
* not taking any supplements
* no known allergy to green tea

Exclusion Criteria:

* smokers
* known high blood pressure
* on medication
Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis

The purpose of the study is to see if statin therapy will optimize myocardial response to cardiopulmonary bypass during aortic valve replacement (AVR) for aortic valve stenosis (AVS) (Phase I) and optimize left ventricular reverse remodeling following AVR (Phase II). Preliminary evidence indicates that perioperative statin therapy reduce mortality and morbidity following cardiac surgery. Pleiotropic effects of statins may induce myocardial preconditioning and optimize myocardial and systemic responses to cardiopulmonary bypass during AVR. Furthermore statin therapy after AVR may contribute to an optimal left ventricular reverse remodeling.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 70 years and \< 80 years
* Severe aortic valve stenosis
* Indication for aortic valve replacement by bioprothesis
* Ejection fraction \> or = 50%
* Without treatment with statin- No renal failure
* Informed consent signed

Exclusion Criteria:

* Ischemic heart disaese
* Concomitant surgery to aortic valve replacement
* Emergency surgery- Known intolerance for statin
* Pregnant woman
Compliance of Compression Therapy in Healed Venous Ulcerations

This study seeks to determine if compliance with compression therapy is increased in patients with healed venous insufficiency ulcerations when lower levels of compression therapy are prescribed. This study will measure compliance with compression therapy at low levels of compression. It will also seek to determine if compression therapy aids in the prevention of venous insufficiency ulcer recurrence.

This study looks to determine if patients with a history of venous insufficiency and recently healed venous insufficiency ulcerations are compliant with lower levels of compression therapy. It also seeks to evaluate the efficacy of compression therapy in the prevention of recurrence of venous insufficiency ulcerations.

Eligibility Criteria:
Inclusion Criteria:

* Recently healed venous insufficiency ulcerations
* History of venous insufficiency
* Patient from UH Richmond Wound Care Center (recently discharged/healed venous ulcerations)

Exclusion Criteria:

* Children
* Patients with diagnosed arterial insufficiency or ABI less than 0.5
* Patients that are diagnosed with Congestive Heart Failure and not cardiac cleared
* Patients with paralysis or incapacitated physically or mentally (due to inability to apply compression stockings)
Efficacy and Safety Study of Multiple Doses of VIT-2763 in Adults With Transfusion-dependent Beta-thalassemia

The main purpose of this study is to evaluate the efficacy of 3 multiple doses of VIT-2763 as measured by the reduction in red blood cell (RBC) transfusion burden from Week 13 to Week 24, to identify the most efficacious and safe dose.

All patients giving written informed consent will undergo a 12-week screening period to determine eligibility for study entry. At Day 1, patients who meet the eligibility requirements will be randomized in a double-blind manner to 1 of 4 treatment groups: VIT-2763 60 mg (once daily), 60 mg (twice daily), or 120 mg (twice daily) or placebo.

The randomisation will be stratified (balanced allocation across treatment groups) according to β0/β0 genotype (yes/no).

The duration of the treatment with VIT-2763 or placebo is 24 weeks, after which patients will undergo a 12-week post-treatment follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Body weight ≥40.0 kg and ≤100 kg at screening
* Documented diagnosis of beta-thalassemia or Hb E/beta-thalassemia
* Red blood cell (RBC) transfusion dependence, defined as at least 6 RBC units in the 24 weeks prior to randomization and no transfusion-free period for ≥35 days during that period
* Ability to understand the requirements of the study and provide written informed consent

Exclusion Criteria:

* Documented diagnosis of Hb S/beta-thalassemia, alpha-thalassemia, or delta beta (δβ)-thalassemia, or hereditary persistence of foetal Hb.
* History of partial or total splenectomy within 4 months prior to screening.
* History of myocardial iron overload
* Chronic liver disease or history of liver cirrhosis
* Clinically relevant renal disease
* History or clinically important finding of cardiac disorders
* History of clinically significant lung disease
* Uncontrolled hypertension (\> Grade 1 according to NCI CTCAE current version)
* Unable to take and absorb oral medications.
* Pregnancy or breastfeeding
* History of drug or alcohol abuse within 2 years prior to screening
* History or concomitant solid tumors and/or hematological malignancies unless resolved in the ≥5 past years.
Effectiveness of Two Different Body Positions During Facemask Ventilation in Obese Patients

It is important to provide enough oxygen to the patients who are asleep during surgery. One way to do this is by using a mask placed over the face to help them breathe. When it becomes difficult getting enough oxygen into the patient's body using the mask, it's called difficult mask ventilation. There can be different reasons for this, and having a higher BMI is one of them. Body physique is assessed by Body Mass Index (BMI). This calculation gives an indication of a person's weight relative to their height.

There is some evidence in the research literature to suggest that when the patient is positioned in a way that helps their airway, like using a device to lift their head and torso 25 degrees , it might help the process of getting enough oxygen work better. The study aims to determine if patients with high BMI can breathe better using a face mask while they are in a head elevated position compared to lying flat on their back.

Facemask ventilation is an important technique applied by anesthesiologists after induction of general anesthesia and before tracheal intubation. It is also used as a rescue maneuver in situations where a patient's consciousness is compromised affecting oxygenation. Obesity is well known to be one of the difficult predictors for facemask ventilation. In fact, the occurrence of difficult facemask ventilation is more frequent in obese patients than non obese. One of the maneuvers described to optimize the effectiveness of facemask ventilation in the general population is positioning the patient in a 25 degree head elevated position. A previous study has demonstrated improvement in facemask ventilation in obese patients with BMI from 30 to 40 kg/m2 in the head elevated position, compared to supine. However, it is not yet determined if this is applicable to patients with a BMI above 40 kg/m2. Adult obese patients with BMI of at least 40 kg/m2 will be randomized to be ventilated after induction of general anesthesia via a face mask while in one of the positions: supine or head elevated, while the volume of air that enters and exits the lungs is measured. Participants will then be changed to the second position, ventilated in the same manner and measures obtained again.

Do patients with class 3 obesity positioned in the head elevated position can be better ventilated with a face mask and positive pressure, compared to the supine position?

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 40 kg/m2
* age \> 18 years
* scheduled for elective surgery under general anesthesia
* have the ability to comprehend the rationale for the study and provide consent

Exclusion Criteria:

* pregnancy,
* risk of aspiration of gastric content
* patients using glucagon-like peptide(GLP)-1 agonists
* emergency cases
* upper airway disease or airway anatomical abnormalities
* presence of major cardiovascular, respiratory, or cerebral vascular disease
* if the provider anesthesiologist indicates an awake technique to secure the airway
Hyperglycemia and Oxidative Stress in the Human Brain With Diabetes

The purpose of this study is to use an MRI exam to measure the concentrations of glutathione (GSH) and Vitamin C (Asc) in the brains of normal healthy persons and type 2 diabetic persons. The study will look at the relationship between chronic hyperglycemia and the levels of these naturally occurring chemicals in the brain.

Cerebral GSH and Asc concentrations are modulated by increased oxidative stress induced by hyperglycemia in diabetes and reflect changes in the cerebral antioxidant defense system. Inhibition of cellular uptake of Asc by hyperglycemia further hampers maintaining adequate antioxidant capacities. Reduced concentrations of these antioxidants might serve as good indicators of increased susceptibility to oxidative damage, impaired cellular uptake or the antioxidant, and further, as sensitive in vivo biomarkers to assess early manifestations or progression of diabetic complications and the efficacy of the antioxidant therapy in the human brain. Specific aims (1) to determine cerebral concentrations of GSH and Asc in the living brain of healthy controls and type 2 diabetic patients; (2) to quantify the effect of chronic hyperglycemia on cellular uptake of Asc across the blood-brain barrier.

Eligibility Criteria:
Inclusion Criteria:

* Good health except for having type 2 diabetes
* Being treated with diet, insulin, or oral hyperglycemic agents
* Male or non pregnant female
* Non-smoker
* HbA1c 8 or above
* Able to provide informed consent

Exclusion Criteria:

* Presence of mental illness
* Co-existing chronic inflammatory condition or neurological disease or diseases associated with abnormal glutathione metabolism
* BMI over 35
* Smoker
Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use"

To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee and hip.


Eligibility Criteria:
Inclusion Criteria:

* Subject has been diagnosed, according to American College of Rheumatology guidelines, with osteoarthritis of the hip or knee and requires non-steroidal anti-inflammatory drugs (NSAIDs) to control their osteoarthritis pain and have access to a touch-tone telephone.

Exclusion Criteria:

* Subject has had surgery on index joint.
* Subject has history of rheumatoid arthritis or fibromyalgia syndrome.
* Subject has active gastrointestinal or cardiovascular disease.
The Smart City Active Mobile Phone Intervention (SCAMPI)

Physical inactivity is still a major public health problem. Active transportation i.e. walking or cycling for transport can contribute to greater total physical activity. The specific aim of this study is to evaluate if a 12-week mobile phone application can increase time spent in active transportation (cycling or walking) and in moderate-to-vigorous physical activity in Swedish adults aged 20-65 years.


Eligibility Criteria:
Inclusion Criteria:

* 20-65 years of age
* living in Stockholm or its suburbs
* being able to understand Swedish sufficiently well in order to understand the purpose of the study and the content of the intervention

Exclusion Criteria:

* having a disease prohibiting them from participation in moderate physical activity such as walking or cycling
Virtual Reality to Reduce Delirium

Delirium has been long considered as a major contributor to cognitive impairments following a critical illness. Currently, both pharmacologic and non-pharmacologic prevention and treatment strategies are used in the intensive care unit, despite these strategies remaining controversial. However, with previous studies showing the feasibility of using virtual reality (VR) within the critical care setting, the investigators propose to use this technology to investigate the effect of 360-degree immersive virtual reality stimulation on the incidence of delirium in the ICU.

Stimulation will be provided for 30 minutes, three times a day, evenly spaced between 7:00 AM and 7:00 PM, using a commercially available head-mounted display. The investigators hypothesize that by providing relaxing virtual environments to patients through a head-mounted display and headphones, the incidence of delirium will be lower compared to the control group receiving no VR stimulation. Secondary outcomes will include evaluating the movement patterns and intensity between the intervention and control group, and between patients with and without delirium, using inertial measurement units and an under mattress bed sensor. It is hypothesized that it will be possible to detect difference in movement patterns between groups and identify patterns indicating the presence or absence of delirium. Secondary objective also include the evaluation of the effect of VR on duration of delirium. Here it is hypothesized that the duration of delirium will be shorter in participants receiving the VR stimulation compared to those in the control group. Physiological parameters (e.g. heart rate, respiration rate, oxygen saturation, etc.) will also be recorded during the stimulation to further understand what, if any, effect VR has.


Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent (by the patient, relatives, or authorized representative)
* No severe visual or auditory impairments (strabismus, macular degeneration, retinopathy)
* Estimated length of stay \>24 hours
* Can keep eyes open for at least 30 seconds
* German or French speaking

Exclusion Criteria:

* Known psychotic disorders associated with delusions (e.g. schizophrenia)
* Recent history of major depression
* Admission for drug overdose
Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas Patients With Crohn's Disease

Objectives:

Primary: To demonstrate the safety of allogeneic UC-MSCs administered by injection for complex perianal fistulas in patients with Crohn's disease

Secondary: To determine the efficacy of a single/multiple allogeneic UC-MSCs injection in improving complex perianal fistula complications and (re-epithelialization of the external openings).

Design and Investigation:

Number of Patients: 5 (including a consideration of 20% \[1 patient\] dropout from the trial) Dosage and mode of administration

Dosage: Two million cells per milliliter (2M/mL) with a total of 60 million PF2020-CELL (UC-MSCs) will be injected locally around the fistula tract, with a separation of 1 cm between injections. All patients will receive a total of 60 million cells per visit for 5 consecutive visits, with a 4-week interval between the injections. If the patient is completely healed during any course of stem cell injections, subsequent stem cell treatments can be discontinued. However, patients will still be required to undergo regular follow-up examinations, including physical examinations and other medical tests, until the study is completed.

Mode of administration: The procedure involves localizing the fistulous tract, performing curettage and closing the internal opening, and the injection of PF2020-CELL (UC-MSCs). The indicated dose of PF2020-CELL (UC-MSCs) will be injected starting from the tissues around the internal orifice or orifices and then progressing towards the external opening.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women age 18 years and above.
* Diagnosis of perianal fistulae associated with Crohn's disease refractory to medical therapy.
* Presence of perianal fistula(s) with a maximum of 2 internal openings and a maximum of 3 external openings based on clinical assessment.
* Fit for surgery.

Exclusion Criteria:

* Informed consent refusal.
* Pregnancy or breastfeeding women.
* Current diagnosis of active cancer or remission for less than 5 years.
* Evidence of active sepsis or significant localised infection.
* Patients with HIV, HBV, HCV or treponema infection, whether active or latent.
* Patients with documented allergies.
* Patients who have received infliximab or any other biologics in the 4 weeks before the cell treatment administration.
* Patients currently receiving, or having received within 1 month prior to enrollment into this clinical trial, any investigational drug.
* Patients with any other co-morbidity/ co-pathologies which is deemed as contraindication to stem cells infusion (infection, administration of steroids).
Correlation Between Thermal Patterns of Infrared Thermal Imaging and Clinical Phenotype in Patients With Postherpetic Neuralgia

Postherpetic neuralgia (PHN) is the most frequent complication of herpes zoster(HZ) and is defined as pain persisting for \>1month after the healing of herpetic skin lesion or pain persisting for \> 3 months following the onset of HZ. PHN manifests as spontaneous throbbing, stabbing, or burning, usually accompanied by various abnormal sensory symptoms , which affect 5-20% of patients with HZ. Due to the lack of accurate and objective auxiliary examination tools, it is difficult for diagnosis and treatment of PHN. As a non-invasive examination method, infrared thermal imaging (IRT) can play a role in the diagnosis and treatment of neuropathic pain by objectively reflecting the changes and distribution characteristics of human body surface temperature. However, there are few studies on the relationship between clinical phenotype and thermal infrared image temperature changes in PHN patients, and the relationship between the thermal pattern of skin temperature and the duration of disease and treatment progress in PHN patients has not been fully elucidated. This study was conducted to investigate the relationship of thermal imaging data with the duration of the disease, clinical phenotype, treatment effect, in order to explore the role of infrared thermal imaging in the diagnosis and treatment of PHN. Methods：all PHN patients will included. At each visit, a pain NRS score was performed, and clinical phenotypes were tested and labeled, including: allodynia, numbness, itching, heat sensation, cold sensation, and the most painful area(MPA). Infrared thermal imaging was performed, the Average Relative Temperature (ART) within the affected area and the contralateral area was compared. The relationship between the temperature change and duration of the disease, clinical phenotype, treatment effect was assessed.

patients with the follow conditions were excluded: 1)The skin area was lesions because of other disease(trauma, inflammation, skin scar, skin disease, tumor, etc.); 2) history of psychiatric diseases, chronic pain. 3) inabilities to complete IRT examination.

Eligibility Criteria:
Inclusion Criteria:

* 1) patients\>18 years-old 2) pain lasts at least 1 month after lesion crusting 3) Agreed to participate the research

Exclusion Criteria:

* 1))the skin area was lesions because of other disease(trauma, inflammation, skin scar, skin disease, tumor, etc.); 2) history of psychiatric diseases, chronic pain. 3)inabilities to complete IRT examination. 4) Disagree to participate to the research
Effect of Sedatives on Regional Cerebral Oxygen Saturation

Compare the changes of regional cerebral oxygen saturation during midazolam or dexmedetomidine sedation for spinal anesthesia in the elderly patients who undergoing femur surgery.

Compare the changes of regional cerebral oxygen saturation during midazolam or dexmedetomidine administration (target bispectrl index 75-80) for spinal anesthesia in the elderly patients over 65 years who undergoing femur surgery.

Eligibility Criteria:
Inclusion Criteria:

* patinets who undergoing femur surgery under spinal anesthesia

Exclusion Criteria:

* previous cerebrovascular disease, uncontrolled cardiovascular disorder, uncontrolled pulmonary disease