cyrilzakka/clinical-trials huggingface dataset:
Study Comparing Tigecycline to Imipenem/Cilastatin in Complicated Intra-Abdominal Infections in Hospitalized Subjects

Purpose: To provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, ≥ 8 years of age and a weight of ≥ 35 kilograms
* Subjects with selected culture-positive infections caused by a multiple antibiotic-resistant pathogen presumed to be susceptible to tigecycline
* Subjects who have failed or are intolerant of other available appropriate antibiotic therapies or whose pathogens are resistant to other available antibiotics

Exclusion Criteria:

* Subjects who are moribund with an expected survival of less than 2 weeks.
* Subjects who have been designated as "Do Not Resuscitate", unless it is anticipated within a reasonable degree of medical certainty that they can achieve benefit from potentially curative antibiotic therapy
* Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds related to this class of antibacterial agents
SORT OUT X - Combo Stent Versus ORSIRO Stent

The aim of the Danish Organisation for randomised trials with clinical outcome (SORT OUT) is to compare the safety and efficacy of the ComboTM stent and Orsiro™ stent in the treatment of unselected patients with ischemic heart disease, using registry detection of clinically driven events.

Randomized Clinical Comparison of a Combined Sirolimus Eluting and endothelial progenitor cell COMBO Stent with a Sirolimus-eluting OSIRO stent in Patients Treated with Percutaneous Coronary Intervention.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents at Rigshospitalet or one of the three heart centers in Aarhus, Odense and Aalborg can be included in the study.
* The patients will be treated in accordance with the criteria applicable at the individual sites.
* The investigators plan to include 3,140 patients.

Exclusion Criteria:

* Age \< 18 years
* The patient does not wish to participate
* The patient is not able to consent to randomization (eg intubated patients)
* The patient do not speak Danish
* The patient is already included in this study
* The patient is already participating in other stent studies
* Life expectancy \<1 year
* Allergic to aspirin, clopidogrel, prasugrel or ticagrelor
* Allergic to sirolimus
Effect of Initial Empirical PEEP Setting on the Esophageal Pressure-guided PEEP Titration in ARDS

Esophageal manometry was used as surrogate of pleural pressure to titrate positive end-expiratory pressure (PEEP) in ARDS patients. However, Absolute values of esophageal pressure (Pes) could be affected by the PEEP setting. In moderate to severe ARDS patients, the end-expiratory Pes changed differently with PEEP adjustment. and the esophageal phenotypes could be divided into type I and type II. with Type I （ΔPes≥30%ΔPEEP）and Type II（ΔPes\<30%ΔPEEP）.


Eligibility Criteria:
Inclusion Criteria:

- aged over 18 all the moderate to severe ARDS patients invasive mechanical ventilation

Exclusion Criteria:

* aged\<18 contraindication to esophageal catheter
Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies

This study will evaluate the clinical performance of massively parallel sequencing (MPS) using the MaterniT21 PLUS LDT in the detection of fetal aneuploidy in circulating cfDNA extracted from a maternal blood sample obtained from women pregnant with a multiple gestation who were at increased risk for fetal aneuploidy.


Eligibility Criteria:
Inclusion Criteria:

* Subject was pregnant with a multiple gestation and received NIPT with the MaterniT21 PLUS LDT and a valid test result is available;
* Subject was 18 years of age or older at the time of NIPT;
* Subject provides signed and dated informed consent in English;

Exclusion Criteria:

* Subjects' treating physician is not located in the United States.
Study About the Response to the Administration of a Third Dose of mRNA-1273 Vaccine (COVID-19 Vaccine Moderna) in Renal Transplants With Immunological Failure Initial to Vaccination

The objective will be to analyze the development of cellular and humoral immunity against SARS-CoV-2 after administration of a third dose of mRNA-1273 (Moderna) vaccine in patients who have remained seronegative after the full standard (two-dose) regimen.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years;
2. Male or female sex;
3. Renal transplant with stable renal function in the last 2 months prior to study inclusion.
4. Had received a full schedule of vaccination for SARS-CoV-2 with mRNA1273 vaccine (Moderna) and remained seronegative at 2 weeks after the second dose.
5. Patient giving written informed consent.

Exclusion Criteria:

1. Renal transplantation \< 3 months;
2. Pregnancy or lactation status;
3. Rejection treated within the last 6 months;
4. Presence of humoral immunity to SARS-CoV-2 defined as the presence of specific IgM/IgG.
Randomised Study of High-flux Haemodialysis and Haemodiafiltration

The most common forms of renal replacement therapy currently in use are high flux haemodialysis (HF-HD) and haemodiafiltration (HDF). Although these techniques appear similar to the patient, there are important differences in what happens to the blood as it travels through the dialysis machine.

During HDF, the machine controls hydrostatic pressure across the dialyser to remove additional water together with toxins from the blood and this fluid volume is continually replaced with an ultra-pure solution. HDF has a theoretical advantage removing more waste substances, especially larger molecules, from the blood than HF-HD which may be of benefit to the patient in the medium to long term.Despite the theoretical advantages, trials have so far been unable to find any significant difference in death rates or the development of health problems among patients on HDF or HF-HD.

It is therefore important to examine other factors which may help doctors and patients to decide which treatment to use. The investigators have designed a study which aims to answer three main questions:

1. Does HDF make patients feel better?
2. Is blood pressure more stable on HDF in comparison with HF-HD?
3. Are Phosphate levels and other blood parameters better controlled with HDF than HF-HD?

The investigators will do this by randomly assigning patients on HF-HD to receive 2 months of either HF-HD or HDF with as equivalent treatment prescriptions as possible and without the patient knowing which treatment they are receiving. After two months the patients will switch to the alternative form of dialysis for a further two months. During the study the investigators will ask the patients how long it took them to recover from the preceding session of dialysis, assess the frequency of symptomatic low blood pressure and also perform blood tests at set intervals to measure specific blood parameters.


Eligibility Criteria:
Inclusion Criteria:

* Receiving HF-HD for at least 3 months
* Reliable vascular access (i.e. use of the same fistula, graft or tunnelled central venous catheter for at least 1 month)
* Aged 18 or older

Exclusion Criteria:

* Currently receiving HDF
* Emergency hospital admissions within the preceding 4 weeks
* Life expectancy less than 6 months
* Neoplasia
* Unable to give informed consent
* Unable to perform QoL questionnaire or self report recovery post-dialysis time
UVX as an Adjuvant in the Treatment of Fungal Keratitis

In this study, investigators want to find the effect of adjuvant collagen cross-linking in the treatment of fungal keratitis


Eligibility Criteria:
Inclusion Criteria:

* fungal keratitis documented by culture or confocal scanning without any previous treatment

Exclusion Criteria:

* Previous treatment
* Thinning at presentation
* Perforation
* Associated with other microbial or viral keratitis
Compare the Efficacy and Safety of 48-week Treatment With Clevudine 30mg Versus Lamivudine 100mg for CHB Infection

The purpose of this study is to compare the efficacy and safety of 48-week treatment with Clevudine 30 mg qd versus lamivudine 100 mg qd for chronic hepatitis B infection.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is between 18 and 60, inclusive.
2. Patient is HBV DNA positive with DNA levels at screening \>= 3 x 1,000,000 copies/mL.
3. Patient is documented to be HBsAg positive for \> 6 months and HBeAg positive.
4. Patient has AST and ALT levels which are \>= 1 times and \<= 10 times the upper limit of normal (x ULN).
5. Patient has bilirubin levels \<= 1.5 x ULN or bilirubin levels \> 1.5 x ULN with diagnosis of Gilbert's disease and conjugated bilirubin within normal limits.
6. Women of childbearing age must have a negative urine (b-HCG) pregnancy test before start of trial treatment.
7. Patient is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
2. Patients previously treated with lamivudine, lobucavir, adefovir, famciclovir, or any other investigational nucleoside for HBV infection.
3. Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
4. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
5. Patient is co-infected with HCV or HIV.
6. Patient has evidence of decompensated cirrhosis or hepatocellular carcinoma (alpha fetoprotein).
7. Patient is pregnant or breast-feeding.
8. Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases. For males, condoms should be used. Females must be surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal, or using at least a medically acceptable barrier method of contraception (i.e., IUD, barrier methods with spermicide or abstinence).
9. Patient has a clinically relevant history of abuse of alcohol or drugs.
10. Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
11. Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to Screening Visit.
12. Subjects who are taking any traditional Chinese medication, or has been taking any traditional Chinese medication within the last 2 weeks prior to Screening Visit.
13. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
Study of Lenvatinib (E7080) in Participants With Advanced Hepatocellular Carcinoma (HCC)

The purpose of this study is to determine maximum tolerated dose (MTD), efficacy, safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 when is administered continually once daily in participants with advanced hepatocellular carcinoma.


Eligibility Criteria:
Inclusion criteria:

1. Histologically or clinically confirmed diagnosis of advanced HCC.
2. Eastern Cooperative Oncology Group-Performance Status (ECOG-PS): 0-1.
3. Adequate laboratory values/organ function tests.

Exclusion criteria:

1. Simultaneous or metachronous cancers.
2. Pericardial, ascites, or pleural effusion requiring drainage.
3. Brain metastasis/meningeal carcinomatosis presenting clinical symptoms or requiring treatment.
4. Malabsorption syndrome.
5. Artery-portal vein shunt or artery-vein shunt preventing proper diagnosis of tumor.
6. Use of drugs known to inhibit cytochrome P3A4.
Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes

The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological success, and time to cessation of otorrhea.

The results at the time of the interim analysis met the futility criteria and the study was subsequently stopped.

Eligibility Criteria:
Inclusion Criteria:

* Parent or guardian: Read and sign the informed consent. When required by the Institutional Review Board, child must agree to sign an approved assent form;
* Presence of otorrhea (visible by parent or guardian) of 21 days or less in duration;
* Presence of patent tympanostomy tubes;
* Refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities;
* Parent or guardian: Agree to comply with the requirements of the study, administer the study medication as directed, complete required study visits, and comply with the protocol;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* NOT otorrhea-free for at least seven days following tympanostomy tube surgery;
* Menarcheal females;
* Previous otologic surgery, except tympanic membrane, within one year of study entry;
* History of/or current acute or chronic non-tube otorrhea (through existing perforation of the eardrum);
* Current acute otitis externa, malignant otitis externa, or other conditions which could interfere with evaluation of the study drug;
* Diabetic (controlled or uncontrolled);
* Use of prohibited medications;
* Other protocol-defined exclusion criteria may apply.
DARWeb: an Online Psychosocial Intervention for Children With Recurrent Abdominal Pain and Their Families.

Chronic and recurrent pain is a very important issue in the society, and its treatment is challenging.

In children, one of the most common pain problems is recurrent abdominal pain. This problem can affect up to 12% of the children population, and can interfere on daily activities of both children and parents. Recurrent abdominal pain in children is also associated with other health problems, and can be related to problems in adulthood. Unfortunately, the current health system does not have an effective treatment for these children and their families. This is why the investigators propose an online intervention, DARWeb, for people in this situation.

DARWeb provides an innovative solution using Information and Communication Technology to facilitate access. It is also innovative because it is directed towards secondary prevention, in contrast to the majority of current treatments available for pain problems that are focused in reducing the impact of pain when it is already severe. Thus, the objective of DARWeb is to provide information and teach strategies to children and their parents that help them to cope with pain and prevent pain interference in their daily lives (in the short, medium and long term).

With this project, the investigators plan, first, to create a new version of their treatment program (DARWeb V2) from the results of the pilot study. Second, the investigators will test the effects of DARWeb V2 through a randomized clinical trial with a large sample, and they will assess the short, medium and long term effects. In addition, the investigators want to study which of the variables that are addressed in their intervention are responsible for the potential changes observed.

The investigators expect that their treatment program will be effective to reduce pain in the short, medium and long term.


Eligibility Criteria:
Inclusion Criteria:

* 9 to 15 years
* Recurrent abdominal pain (abdominal pain at least once at month during a period of three months)
* Low level of disability

Exclusion Criteria:

* Identifiable organic cause.
* Disability preventing them to follow an online intervention.
* Not having a computer with Internet access.
* Not being able to read in Spanish language.
Mind-Body Skills Groups for Behavioral and Emotional Problems in War-Traumatized Male Adolescents in Gaza

The purpose of this study is to determine whether war-traumatize male adolescents with behavioral and emotional problems who participate in mind-body skills groups will have improvement in behavioral and emotional problems, aggression, and posttraumatic stress disorder (PTSD) symptoms, compared to a wait list control group.

Mind-body skills incorporate meditation, guided imagery, breathing techniques, autogenic training, biofeedback, genograms, and self-expression through words, drawings, and movement in a small group setting. These groups have been used in war-traumatize populations in Kosovo, Gaza and the United States. This study will be investigating the effect of the mind-body skills groups on boys with behavioral and emotional problem at a high school in Gaza to determine if there is improvement in behavioral and emotional problems, aggression, and posttraumatic stress disorder. The results will be compared to a control high school with boys who will not be attending mind-body skills groups and who have experienced similar levels of trauma and also have behavioral and emotional problems.

The mind-body skills groups will be held for 2 hours once a week for 10 weeks and then once a month for 10 months. Measures will be taken at baseline, after the 10 week mind-body skills group program and again at 10 month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Criteria for eligibility for the study will include having a baseline self-reported score of 18 points or higher on the Strengths and Difficulties Questionnaire which indicates high to very high levels of emotional and behavioral problems

Exclusion Criteria:

* None
Southern California Nutrition Incentive Program

The specific aims of this proposal are to implement SCNIP in 6 Northgate Gonzalez Markets across San Diego, Orange and LA counties (2 in each county), and determine which level of financial incentive rebate (specifically, $10/month, $20/month, or $40/month) optimally increases the purchase and consumption of SNAP eligible fruits and vegetables.

The University of California San Diego (UCSD) Center for Community Health, in collaboration with Northgate Gonzalez Markets and its regional partners, will implement a Food Insecurity Nutrition Incentive program in Los Angeles, Orange and San Diego Counties - the Southern California Nutrition Incentive Program (SCNIP). This program will develop, implement and evaluate a multi-tiered model that will enable low-income, SNAP-eligible consumers to make healthier food choices and purchase more fruits and vegetables. This model will include: tier 1) an innovative fruit and vegetable financial incentive rebate program that utilizes the consumer's Northgate Gonzalez Market customer loyalty card, electronic benefit transfer (EBT) card, and electronic wallet (e-wallet); tier 2) fruit and vegetable promotions that include discount pricing; and tier 3) SNAP-Ed programming (e.g., in-store cooking classes, tours, and healthy food self-labeling system) to educate and support the purchasing behaviors of SNAP-eligible families. Through the use of the customer loyalty card, EBT card, and e-wallet, the rebate program will be able to track the purchase of SCNIP eligible fruits and vegetables and provide a rebate at the point-of-sale that can be used to purchase additional fruits and vegetables, thus increasing the purchasing power of SNAP-eligible families for healthy food options. Earned and dispensed rebate dollars will be stored on the e-wallet enabling the tracking of purchasing behaviors and dollars spent on healthy fruits and vegetables in this program. With this data, we will be able to determine what level of financial incentive rebate ($10/month, $20/month, or $40/month) (tier 1) optimally increased SNAP families' per capita spending on fruits and vegetables in conjunction with the fruit and vegetable promotions (tier 2) and nutrition education activities (tier 3).

Eligibility Criteria:
Inclusion Criteria:

* Northgate Gonzalez Market customer who currently receives SNAP benefits and has a valid EBT card
* 18 years of age or older
* Speaks and reads in English or Spanish
* Shops at the selected Northgate Gonzalez Market regularly, at least two times per month

Exclusion Criteria:

* Does not receive SNAP benefits
* Unable to complete surveys in English or Spanish
* Another immediate family member living in the same household is already recruited into the study
Phase 1B Study of KSP/QRH Dimer for Detection of Neoplasia in the Esophagus

The overall aim of this feasibility study is to develop new technologies for improved detection of Barrett's neoplasia using the scanning fiber endoscope (SFE) imaging system. This study will combine the use of a fluorescent-labeled peptide dimer that bind specifically to pre-cancerous mucosa in the esophagus for use as a novel imaging agent to guide endoscopic biopsy or endoscopic mucosal resection (EMR). This Phase 1B study will be used to provide early evidence of efficacy for the topical application of a peptide dimer that binds to molecular targets, including EGFR and HER2, that are specific for esophageal dysplasia. A dimer is needed because cancer in the esophagus is genetically heterogeneous. QRH binds specifically to Epidermal Growth Factor Receptor (EGFR), and KSP binds specifically to Human Epithelial Growth Factor Receptor (HER2). The study will look at peptide binding in subjects with known or suspected Barrett's esophagus.


Eligibility Criteria:
Inclusion Criteria:

* Has known or suspected Barrett's esophagus
* Scheduled for a clinically-indicated, upper endoscopy
* Subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities)
* Age 18 to 100 years
* Willing and able to sign informed consent

Exclusion Criteria:

* Subjects with known allergy or negative reaction to the near infrared fluorophore IRDye800CW, or derivatives
* Subjects on active chemotherapy or radiation treatment
* Pregnant or trying to conceive
Outcomes of Meniscus Root Repair Using a Transtibial Pullout Technique

The results of this study will optimize the care for patients with a meniscus root tear. Surgeons will be able to determine if MRR (meniscus root repair) with transtibial pullout technique is an effective treatment and will identify potential risk factors for poor clinical outcomes. In addition, investigators will determine if MRR is successful in delaying the radiographic progression of arthritis in the involved compartment.

The loss of attachment at the root of the meniscus impairs the ability to maintain hoop strain when the tibiofemoral joint is loaded. This loss of hoop strain is responsible for the increased pressure on the articular cartilage.

This new awareness has prompted surgeons to consider surgical repair for treatment of meniscal root avulsions. Despite this recent focus on results of surgical repair, prospective studies are lacking, and the optimal surgical indications and technique have not been optimized.

Eligibility Criteria:
Inclusion Criteria:

1. Meniscus root avulsion tear (defined as meniscus posterior horn root avulsion or full thickness tear within 9 mm of the root attachment)
2. Age 18-65
3. Ligament injury with concomitant reconstruction is acceptable
4. Malalignment with corrective osteotomy is acceptable

Exclusion Criteria:

1. Subchondral collapse on pre-op MRI
2. Extrusion greater than 3 mm
3. Intra-op Outerbridge grade 3 or greater chondromalacia
4. Intra-op poor quality meniscus tissue
5. Mal-alignment greater than 5 degrees without corrective osteotomy
6. Obesity with BMI over 40
7. Kellgren Lawrence \> grade 2
8. Worker's compensation status