cyrilzakka/clinical-trials huggingface dataset:
Au-Ag-Cu2O NG With PTT Anti Drug-resistant Microbial Keratitis

This clinical study was conducted to evaluate the efficacy and safety of gold-silver cuprous oxide composite nanogels combined with photothermal therapy system in the treatment of severe drug-resistant bacterial keratitis ineffective by traditional antibiotic treatment in human eyes, and to provide translational applications. Based on the clinical evidence, a more effective and safe innovative treatment plan for corneal diseases has been developed.


Eligibility Criteria:
Inclusion Criteria:

1. The monocular cases of severe infectious keratitis admitted to our center were diagnosed as fungal keratitis according to their medical history, physical signs and surface secretions smear examination of corneal ulcer lesions (severe was defined as subjects with visual acuity \< 0.15, deep stromal infiltration or involvement diameter \>2mm, with extensive infiltration around or with extensive suppuration)
2. After more than 2 weeks of active treatment with antibiotics, there was no effect
3. The researchers communicated with the subjects in detail, and the subjects cooperated well and they voluntarily participated and signed informed consent

Exclusion Criteria:

1. Allergic to the drug in this test.
2. Pregnant and lactating women.
3. The medical history suggests serious heart, lung, liver, kidney dysfunction.
4. Patients with other factors that would affect the results of this result.
5. No signed informed consent.
Oral Dexamethasone as an Intervention for Postoperative Pain and Nausea Management in Total Knee Arthroplasty

This study aims to determine if oral dexamethasone provides clinically significant improvement in postoperative outcomes, specifically nausea and pain scores.

Protocols in perioperative pain management during total joint arthroplasty (TJA) have contributed to early discharge after surgery. As practices move to favor ambulatory surgery in total joint arthroplasty changes must be made to postoperative pain and nausea management. Spinal anesthesia has been essential in managing associated ambulatory TJA, however, nausea and vomiting are known detrimental side effects. The use of systemic steroids has also been shown in the literature to reduce pain scores, length of stay, the need for antiemetics, and increase the distance of ambulation without increasing the rate of surgical site infection or prosthetic joint infection. As more same-day total joint replacement is incorporated into practice, an oral alternative may prove beneficial.

Eligibility Criteria:
Inclusion Criteria:

* adult patients age 18 and older who will be undergoing joint replacement

Exclusion Criteria:

* Patients with uncontrolled diabetes ( HbA1C, \>7.5%), impaired hepatic function (Child class, \>B), impaired renal failure (Glomerular filtration rate \<60 mL/min/1.73 m2), chronic narcotic use, alcohol and/or opioid dependence, patients with a known adverse reaction to corticosteroids, and patients unable to give informed consent.
LATE LUTEAL PHASE VS. CONVENTIONAL EARLY FOLLICULAR PHASE START IN IVF

To compare cycle outcomes after scheduling with the standard early follicular phase (EFP) versus late luteal phase (LLP) in patients undergoing GnRH antagonist cycles.

Objective To compare cycle outcomes after scheduling with the standard early follicular phase (EFP) versus late luteal phase (LLP) in patients undergoing GnRH antagonist cycles.

Design Multicentric prospective non-randomized study

Setting Two university-affiliated private assisted reproduction centers.

Patient(s) Regularly cycling women aged ≤40 years with fewer than one previous IVF attempts were enrolled. Previous low responses to controlled ovarian hyperstimulation, ovarian surgery, or polycystic ovary were exclusion criteria.

Intervention(s) Twenty patients started controlled ovarian stimulation (COS) after spontaneous menses; similarly, twenty patients started stimulation on the Friday previous to a spontaneous menses (at the end of late luteal phase), regardless of cycle day.

Main Outcome Measure(s) Primary outcome: number of mature oocytes retrieved. Secondary outcomes: fertilization rate, viable embryo rate per oocyte retrieved, cancellation rate, and clinical pregnancy outcomes from FET cycles.

Eligibility Criteria:
Inclusion Criteria:

* Regularly cycling women aged ≤40 years with fewer than one previous IVF attempts were enrolled

Exclusion Criteria:

* Previous low responses to controlled ovarian hyperstimulation, ovarian surgery, or polycystic ovary were exclusion criteria
Effect of RO6871765 and RO7011785 on Immune Response With the Stimulation of Peripheral Blood Mononuclear Cells (PBMCs) in Chinese Healthy Volunteers and Chronic Hepatitis B Patients

This is an exploratory study to characterize the ex vivo immune response to RO6871765 or RO7011785 stimulation of peripheral blood mononuclear cells (PBMCs) extracted from healthy volunteers and chronic hepatitis B (CHB) patients.


Eligibility Criteria:
Inclusion Criteria:

All population:

* Chinese population
* Adequate hematological function: platelet count greater than or equal to (\>=) 100\*10\^9 per liter (/L), hemoglobin (Hb) \>= 12 grams/deciliter (g/dL) (male) or \>= 11 g/dL (female), white blood cell (WBC) count \>= 4\*10\^9/L and \<= 11\*10\^9/L

Healthy volunteers:

* Absence of evidence of any active or chronic disease
* Negative hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B envelope antigen (HBeAg), hepatitis B envelope antiody (HBeAb) and hepatitis B core antibody (HBcAb)
* Adequate liver function: transaminases alanine aminotransferase (ALT) \<= 1.0 times the upper limit of normal (ULN)

Treatment naïve CHB patients:

* HBsAg-positive (\>=250 international unit/milliliter \[IU/mL\]), compensated liver function, non-cirrhotic
* HBeAg-positive, HBV DNA \>= 200,000 IU/ml or equivalent copies/mL, ALT \>1.5 times the ULN and ALT \<8 times the ULN

HBeAg-negative nucleoside/nucleotide analogue-treated CHB patients:

* Subjects who HBeAg-seroconverted on nucleoside/nucleotide analogue therapy (treatment for 1 to 3 years prior to enrollment) with HBV DNA \<90 IU/mL or below a detection level acceptable by both the sponsor and investigator for at least the preceding 6 months; HBeAg negative and HBeAb positive
* HBsAg-positive (\>=250 IU/mL), compensated liver function, non-cirrhotic -ALT \<= 1\*ULN

Exclusion Criteria:

* Use of steroids or other immune suppressive agents within the last 4 weeks that would impact the number/functions of white blood cells (WBC)
* Any other diseases or clinical laboratory finding giving reasonable suspicion of a disease or condition (including, but not limited to, cancer, lupus erythematosus, rheumatoid arthritis, or other autoimmune disease) that could confound the result of the study
* Positive Hepatitis A immunoglobulin M (IgM) antibody, Hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV) at screening
* Significant acute infection, example; influenza, acute gastrointestinal symptoms or any other clinically significant illness within 2 weeks
* Previous/concurrent treatment with interferon-based therapy for CHB
Thermal Imaging to Diagnose and Monitor Suspected Bacterial Infections

The purpose of this study is to test the feasibility of using thermal images to diagnose bacterial pneumonia instead of a chest x-ray in the future. More specifically, the objectives of this study are: 1) to determine if thermal imaging, using a commercial thermal camera can detect areas of heat emitted from the chest in similar locations to where a chest X-ray shows focal consolidation consistent with bacterial pneumonia; 2) to evaluate whether changes in heat emitted from the chest changes over time if it is possible to obtain serial images of the chest.


Eligibility Criteria:
Inclusion Criteria:

* Subject sent for a clinical chest X-ray (not research) to rule out pneumonia
* Thermal images obtained using FLIR ONE within 4 hours of the chest x-ray
* Signed informed consent obtained
* Subject is a patient at a participating clinic at Massachusetts General Hospital

Exclusion Criteria:

* None
Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart

This study is designed as an open, prospective, single arm, multicenter study in order to investigate patient satisfaction, perception and compliance for the novel Navina Smart, a transanal irrigation (TAI) system. Approximately 30 male and female subjects who are currently practicing TAI, will be followed during a 4-week period of use of Navina Smart. Observational data on satisfaction, perception, compliance, bowel regimen, TAI therapy and TAI frequency will be collected via patient reported outcome (PRO) questionnaires.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent
2. Males and females, aged 18 years and over
3. Practice TAI since at least 2 months and at least two times per week
4. Able to read and fill out a paper PRO questionnaire as judged by the principal investigator or a sub-investigator

Exclusion Criteria:

1. Any confirmed or suspected diagnosis of anal or rectal stenosis, active inflammatory bowel disease, acute diverticulitis, severe diverticulosis, colorectal cancer, ischemic colitis, history of life-threatening autonomic dysreflexia, bleeding disorders, unspecified peri-anal conditions
2. Untreated rectal impaction
3. Any radiotherapy to the pelvis
4. Any current treatment with anticoagulants (not including aspirin or clopidogrel)
5. Any current treatment with long-term systemic steroid medication (not including inhalation agents and/ or local topical treatment)
6. Any prior rectal or colonic surgery (not including anal procedures \>3 months ago, e.g. haemorrhoid excision)
7. Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks
8. Overt or planned pregnancy
9. Ongoing symptomatic urinary tract infection as judged by the principal investigator or a sub-investigator
10. Diagnosed psychiatric illness, considered as unstable by the principal investigator or a sub-investigator
11. Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
12. Previous enrolment in the present study
13. Participation in another clinical study within the last 30 days that may interfere with the present study
Effectiveness of the "Tecaretherapy" in Patients With Lateral Elbow Tendinopathy

This RCT aims at investigating the effectiveness of the "Tecaretherapy" in patients with lateral elbow tendinopathy.

60 patients will be randomized into one of the following 3 groups:

* "Conventional physiotherapy treatment (CPT)" (massage, eccentric exercises, stretching);
* "CPT + Tecare" (idem CPT group + tecaretherapy during the eccentric exercises)
* "CPT + Placebo Tecare" (idem "CPT + Tecare" group but with an inactive Tecare device) The treatment will include 18 30-minute sessions

This RCT aims at investigating the effectiveness of the "Tecaretherapy" in patients with lateral elbow tendinopathy.

60 patients will be randomized into one of the following 3 groups:

* "Conventional physiotherapy treatment (CPT)" (massage, eccentric exercises by means of an isokinetic dynamometer, stretching);
* "CPT + Tecare" (idem CPT group + Tecaretherapy during the eccentric exercises)
* "CPT + Placebo Tecare" (idem "CPT + Tecare" group but with an inactive "Tecare" device) The treatment will include 18 30-minute sessions.

The "Tecaretherapy" consists in using a specific device providing high frequencies (between 300 kHz and 1 MHz) supposed to accelerate the tissues healing process.

Outcome sessions will be organized at baseline, after the first 9 sessions, at the end of the treatment as well as 3 and 6 months after the initial treatment session.

Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from a chronic lateral elbow tendinopathy confirmed by echography

Exclusion Criteria:

Patients:

* with contra-indications for a Tecaretherapy (Pace maker, insuline pump, pregnancy, infection, fever, cancer, thrombophlebitis)
* reporting injections and/or shockwaves in the past (for the tendinopathy)
* with an associated neurogenic dysfunction
Exercise and Diet in Type 2 Diabetic Women

The purpose of this study was to evaluate the effects of 12 weeks' increased daily physical activity versus diet restriction on regional fat distribution, insulin sensitivity and adipokines including retinol binding protein-4 (RBP-4), leptin, adiponectin, and a new marker, adiponectin to leptin ratio (AL ratio), in type 2 diabetic women.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patient
* BMI\>23kg/m2
* Female

Exclusion Criteria:

* The patients with co-morbidity such as heart failure, chronic kidney disease or liver cirrhosis
Evaluation of the Risk for Radiographic and Clinical Nonunion in Patients With Previous Bisphosphonates Therapy.

Dose and duration of bisphosphonate therapy will increase the likelihood that patients experience delayed healing of non-union fractures.

We intend to review the UWHealth patient database to identify individuals with delayed or nonunion fractures. Subsequently, we will collect associated medical information related to fractures such as age of osteoporosis diagnosis, BMI, previous bisphosphonate treatment, type and location of fracture, time to complete union, other treatment needed for nonunion etc. With this information, we will evaluate the risk of delayed and nonunion fractures in patients previously receiving bisphosphonate treatment compared to a normal population. We also will investigate other potential causes of delayed or nonunion fractures in this population.

Eligibility Criteria:
Inclusion Criteria:

* Men and women older than 60 years old with delayed or nonunion low trauma fracture between 01/01/2000 - 12/31/2011.

Exclusion Criteria:

* None
Combined Therapy for Hepatocellular Carcinoma >3-<5 cm

The purpose of this study is to compare the safety and efficacy of combined therapy with conventional transarterial chemoembolization (cTACE) + microwave ablation (MWA) versus only TACE or MWA for treatment of hepatocellular carcinoma (HCC) \>3-\<5 cm.

This study aims to compare the safety and efficacy of combined therapy with conventional transarterial chemoembolization (cTACE)+microwave ablation (MWA) versus only TACE or MWA for treatment of hepatocellular carcinoma (HCC) \>3-\<5 cm.

This randomized controlled trial screened 278 patients with HCC \>3-\<5 cm. Patients were randomized into three groups: 90 underwent TACE (Group 1); 95 underwent MWA (Group 2); and 93 underwent combined therapy (Group 3). Patients were followed-up with contrast-enhanced CT or MRI. Images were evaluated and compared for treatment response and adverse events based on modified response evaluation criteria in solid tumor. Serum alpha-fetoprotein (AFP) concentration was measured at baseline and during every follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

1. Solitary HCC \>3-\<5 cm
2. Absence of extra-hepatic metastases
3. Absence of a history of encephalopathy or refractory ascites
4. Child-Pugh class A or B cirrhosis.

Exclusion Criteria:

1. Poor patient compliance
2. Child-Pugh class C cirrhosis
3. Severe coagulation disorders
4. Portal vein thrombosis
5. Renal impairment (6) previous local ablation therapy of HCC
Use of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation

Oocyte donation is a well established procedure in assisted reproduction treatments (ART). It is demonstrated that the use of hormonal substitution therapy, for the synchronization of the cycles between the recipients and the donors, provides good results, similar to the ones obtained with the natural cycle. In the patients - recipients with preserved ovarian function, the recipient's natural cycle is annulled, thus preventing the spontaneous Luteinizing Hormone surge. Simultaneously and while waiting for the suitable donor, her endometrium is prepared. When the donation occurs and fertilization with the husband sperm takes place, her cycle is stimulated again in order to synchronize her window of implantation with the donor's ovulation.

Two different medications are commonly used to inhibit spontaneous ovulation: either GnRHa agonist or GnRH antagonists. The present study consists of the comparison between the single dose GnRH agonist (Decapeptyl 3,75 IM) and the 7 day dosage of GnRH antagonist (Cetrotide 0,25 mg). The administration of GnRHa is used fundamentally as a long liberation formulation, administered in a single intramuscular injection (IM), which is more practical in terms of use. Nevertheless, the unnecessary persistence and the potentially unfavorable action of GnRHa during the luteal phase and early gestation have questioned its use. The recovery of the Hypophysarian function begins only 8 weeks after the single injection of long liberation of triptorelina 3.75 mg. The GnRH antagonist (Cetrotide 0,25 mg) makes the hypofisary inhibition shorter than with the analogues and can prepare similar endometrium characteristics as a natural cycle. The recipients will be assigned randomly to a group of treatment or another.


Eligibility Criteria:
Inclusion Criteria:

* infertile females with preserved gonadal function
* ages 18 - 43 years old

Exclusion Criteria:

* BMI: \> 28
* recurrent miscarriages
* severe male factor
* important miomas
* \> 44 years old
6-week Safety and PD Study in Adults With NAFLD

IN THIS PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, 3 ARM, PARALLEL- GROUP STUDY, SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS WILL BE ASSESSED IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE


Eligibility Criteria:
Inclusion Criteria:

* BMI at least 28 kg/m2
* Type 2 diabetes and/or metabolic syndrome

Exclusion Criteria:

* Liver disease
* Type 1 diabetes
* Recent heart attack or stroke
* Inability to have an MRI scan
Reducing Potentially Inappropriate Medication Prescribing for Older Patients in the ED

This research is being conducted to learn which implementation strategy of EQUIPPED is most effective to improve prescribing practices of ED providers toward older Veterans and determine the factors influencing implementation of this program to reduce the prescribing of PIMs to older adults upon discharge from the ED. The study has three research aims. The procedures for these research aims are described below:

* Aim 1 - Examining the Impact of Passive Provider Feedback vs. Active Provider Feedback Through a Randomized Trial
* Aim 2 - Determination of Factors Affecting Organizational Adoption of EQUIPPED
* Aim 3 - Micro-Costing the Active and Passive Feedback Versions of the EQUIPPED Intervention

Enhancing Quality of Prescribing Practices for Older Adults Discharged from the Emergency Department (EQUIPPED is a multi-component program to reduce the prescribing of potentially inappropriate medications (PIMs) to older adults upon discharge from the Emergency Department (ED). It has three core components: 1) provider education, 2) Electronic Health Record (EHR)-based clinical decision support (CDS) including pharmacy quick order sets to facilitate provider order entry, and 3) provider audit and feedback with peer benchmarking. In order to inform a Veterans Affairs (VA) system-wide approach to improve prescribing safety for older Veterans, the investigators will conduct a study to determine best practices for influencing provider prescribing behavior in order to decrease PIMs prescribed for older Veterans at the time of ED discharge. The overall goal of this project is to determine which EQUIPPED implementation strategy (active or passive feedback) is most effective to reduce prescribing of PIMs for older Veterans discharged from the ED.

Eligibility Criteria:
Inclusion Criteria:

* Prescribers at VA Medical Centers that are implementing EQUIPPED
* Members of the EQUIPPED implementation team at enrolled sites

Exclusion Criteria:

* Providers at VA Medical Centers that are not part of the upcoming EQUIPPED implementation trial.
Pediatric Laser Acupuncture and Renal Biopsy

The purpose of this study is to test if treatment with laser therapy in pediatric patients undergoing renal biopsies will improve patient satisfaction of the overall procedure. In this study, the participant will receive a laser acupuncture treatment targeting either kidney acupoints or targeting "sham" points not associated with the kidney; the participant will not get both. Both treatment sessions are given by a certified medical acupuncturist. The patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure. All medication will be administered without regard for which group the participant has been randomized, as the treatment team will also be blinded.

Hypothesis:

We will test the hypothesis that treatment with laser acupuncture in patients undergoing renal biopsies will improve patient satisfaction of the overall procedure.

Specific Aims:

Specific Aim 1: Determine whether the use of laser acupuncture improves patient's overall satisfaction of renal biopsy.

Specific Aim 2: Determine whether the use of laser acupuncture decreases the amount of sedative medication given during renal biopsy.

At University of California San Francisco, there are approximately 100 pediatric renal biopsies per year. All of these patients receive sedation, which is prescribed and supervised by the pediatric pain and palliative care team, with either ketamine or fentanyl and versed. Child life is involved; however, many children still experience anxiety and/or pain with the procedure. Use of a modality such as aculaser which may decrease these symptoms could enhance their experience.

The term "laser" stands for light amplification by stimulated emission of radiation. In laser acupuncture, a low power, cold light produced by a low-level laser diode is used to stimulate an acupuncture point. As it is non-invasive, laser acupuncture is thought to be safer than needle acupuncture, especially in the setting of patients with blood-borne infectious diseases. In a systematic review analyzing the evidence to support the effectiveness of laser acupuncture, randomized control trials in which adults with soft tissue injury, acute or chronic pain condition, or any systemic illness were included. This review reports moderate level of evidence for treatment of myofascial pain and post-operative nausea/vomiting and limited evidence of the clinical effectiveness of treating chronic tension headaches. Of note, no complications of the use of aculaser were reported in this review (1).

1. Baxter GD, Bleakley C, McDonough S. Clinical effectiveness of laser acupuncture: a systematic review. J Acupunct Meridian Stud. 2008 Dec;1(2):65-82.

Eligibility Criteria:
Inclusion Criteria:

* older than 6 years old
* admitted for a transplant or native kidney biopsy performed by pediatric nephrology

Exclusion Criteria:

* Prisoners
* Pregnant females
* Those who are unable to participate with the visual analog scale