cyrilzakka/clinical-trials huggingface dataset:
Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

The purpose of this study is to assess the effect of a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) compared to usual care for the treatment of ABSSI (Acute Bacterial Skin and Skin Structure Infections)


Eligibility Criteria:
Inclusion Criteria:

* Admitted patients who meets the clinical definition for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
* Known or suspected gram-positive infection.

Exclusion Criteria:

* Known or suspected gram-negative infections, anaerobic infections, or fungemia
* Known or suspected infections that are severe, life threatening or are not included in the ABSSSI Food and Drug Administration (FDA) guidance
* Injection drug users with a fever
* Severe neurological disorder leading to immobility or confined to a wheelchair
* Bilateral Lower extremity involvement of the suspected infection.
Evaluation of Efficacy of Coadministration of FOV1101-00 and Prednisolone Acetate in Patients With Mild Ongoing Ocular Allergic Inflammation

This is a phase 2 study that will consist of 3 visits during a 3 week period conducted at up to 5 sites. The purpose of this study is to determine how effective the combination of Pred Mild® and FOV1101-00 is compared to either Pred Forte® alone or to vehicle alone in the prevention of eye allergies. Study subjects will be randomized to one of the following:

* FOV1101-00 concentration 1 and Pred Mild®
* FOV1101-00 concentration 2 and Pred Mild®
* Vehicle of FOV1101-00 and Pred Forte®
* Vehicle of FOV1101-00 and Vehicle of FOV1101-00


Eligibility Criteria:
Inclusion Criteria:

* history of ocular allergies and a positive skin test reaction to allergens within the past 24 months and a history of chronic eye irritation;

Exclusion Criteria:

* active ocular infection; clinically significant blepharitis; follicular conjunctivitis; iritis; any type of glaucoma; ocular surgery within past 3 months; pregnancy or nursing
Evaluation of Nasal Biomarkers for Objective Assessment of Disease Severity in Respiratory Disorders

This research study is an observational, single site study quantifying expression of biomarkers of respiratory disease in nasal fluid using the ABEL microsampler device. The primary objective of this study is to compare biomarker expression between healthy controls and participants with respiratory disorders such as chronic obstructive pulmonary disorder (COPD), hayfever, chronic sinusitis, asthma and rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* All participants:
* 18 years of age or older
* The participant must be able to comprehend and sign an approved Informed Consent Form and other applicable study documents.
* Healthy volunteers:
* No significant sinonasal/pulmonary symptoms or prior diagnoses of sinonasal/pulmonary conditions as determined by pre-enrolment questionnaires.
* Case goup:
* Participants must be previously diagnosed with rhinitis, chronic sinusitis, asthma, or COPD by a medical professional.

Exclusion Criteria:

* Less than 18 years of age at the time of enrolment.
* Volunteers who are actively pregnant
* Prior history of adverse reaction or contraindicated to diagnostic testing including fingerprick blood sampling, pulmonary testing, nasal swab/sampling.
* Any other conditions limiting the volunteer's ability to complete study requirements in the judgement of the investigator/clinician
* Any nasal anatomical issue or finding which may limit the safe insertion of the ABEL collection device, as determined by investigator/clinician
* History of nasal surgery or trauma within the last 3 months
Internet-based Reiki for Tinnitus 2021

The objectives of the study will be 1) to develop and show the feasibility of an internet-based Reiki therapy as an intervention for tinnitus, 2) to deliver Reiki therapy for tinnitus as a potential treatment, 3) to maintain a meaningful cohort of participants over a 6-month protocol, and 4) to collect pilot data on the potential benefit of internet-based Reiki therapy on tinnitus-related quality of life. Patients will also be provided with information on other potential tinnitus therapies.

Reiki is a wellness practice of energy healing that began in Japan and is now practiced throughout the world. The principle of Reiki is that everything in the universe consists of energy including the human body, and deviations of this energy can lead to disease. Reiki does not have a religious doctrine and is accepted by people of all backgrounds and belief systems. Reiki is considered by practitioners to be a great tool for stress reduction and relaxation (International Association of Reiki Practitioners).

Many people use Reiki for wellness. Reiki is not a cure for a disease or illness, but it may assist the body in creating an environment to facilitate healing. According to the Center for Reiki Research, Reiki is an effective approach for reducing pain, depression, and anxiety. Tinnitus is a pain percept, and it is likely Reiki may reduce pain and anxiety in patients with tinnitus.

The aims of the study are to show the feasibility of an internet-based Reiki therapy as an intervention for tinnitus. Home based therapy can reduce the stress of receiving therapy in an unfamiliar environment. Home-based therapy can also allow the participants to regain more control their surroundings, making them more likely to benefit from relaxation and stress relief benefits of Reiki.

Specific Aim 1: The first aim is to show that our Reiki therapy can be delivered to tinnitus patients on an internet-based platform This aim will be achieved if the investigators can recruit patients into the study and deliver internet-based therapy over the 6 months of the protocol while retaining a meaningful 30 percent of our cohort.

Specific Aim 2: The second aim is to show that participants perceive a benefit from the therapy protocol. This aim will be studied by retaining a meaningful cohort of participants and by analyzing data from the questionnaire results for the Tinnitus Handicap Inventory (THI) and Tinnitus Functional Index (TFI) before treatment, at 3 months and after 6 months of treatment and comparing them to the participants' baseline questionnaires. Data from the questionnaires will be used to determine sample size needed for a larger blinded control study.

Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaking patients with unilateral or bilateral tinnitus

Exclusion Criteria:

* People under the age of 18
* People without internet access
Study of Effectiveness of Adding the Health Promotion and Rehabilitation for Treatment for Alcohol and Drug Abusers

The purpose of this study is to evaluate the effect of adding the Health Promotion activities and rehabilitation to the usual alcohol and drug interventions on the outcome for alcohol and drug abusers compared to the usual intervention alone.

Background: Alcohol and drug abuse are followed by tremendous physical, psychological and social problems as well as early death. Heavy smoking, poor nutrition, physical inactivity and chronic diseases (co-morbidity) are often part of these problems and illnesses.

There seems to be a large potential for a better outcome by including smoking cessation, physical training, diet and nutrition as well as co-morbidity in a multi-disciplinary setting - a potential not used yet. This Very Integrated Program (VIP) is inspired from the rehabilitation offered to patients with chronic diseases and surgical patients having a likewise unhealthy lifestyle and similar co-morbidity.

Aim: to evaluate the effect of adding the VIP program to the usual alcohol and drug intervention on the outcome for alcohol and drug abusers compared to the usual intervention alone.

The VIP project consists of 3 steps:

1. To map the health status and estimate the potential improvement for 400 alcohol and drug abusers
2. To pilot test the VIP program
3. To evaluate it compared to the daily routines for 260 alcohol and drug abusers with a poor health status in a randomised controlled trial.

Main outcome: Change from abuser to non-abuser. Secondary outcomes are health status; quality of life, use of health services, time return to work (or similar activity level), harm reduction, and cost-effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* alcohol or drug dependency

Exclusion Criteria:

* withdrawal of informed consent
* missing competence to give informed consent
* pregnant or nursing women
Study on Serum Metabolomics of GDM

This study aims to collect serum samples from healthy non-pregnant women, pregnant women with and without Gestational Diabetes Mellitus (GDM). We will analyze the metabolite changes among the three groups using clinical metabolomics and identify potential biomarkers and metabolic pathways. This study will provide scientific evidence for early clinical diagnosis, prevention, control, and treatment research of GDM.


Eligibility Criteria:
Inclusion Criteria:

* No obvious abnormalities in all inspection items
* No history of diabetes
* No particular dietary habits
* No previous history of other mental illnesses
* No history of drug abuse or allergies
* No history of smoking or drinking

Exclusion Criteria:

* Pregnancy complications such as uterine fibroids, hyperthyroidism/hypothyroidism, and antiphospholipid antibody syndrome
* Critical illnesses such as cardiovascular disease or abnormal liver/kidney function
* Personal history of syphilis, HIV positive, and other infectious diseases
* Artificial insemination or IVF pregnancy
* Multiple pregnancy (twins or more)
* Patients participating in other clinical studies
* Other reasons that researchers think are inappropriate
Immune Responses in Oncology Patients to Novel Coronavirus Vaccines (IROC)

The goals of this study are to assess initial or booster vaccine performance (safety and efficacy) and to collect serum and peripheral blood mononuclear cells (PBMCs) pre and post-vaccination to assess immune and other response parameters following immunization in cancer patients receiving either the Pfizer (BTN162b2), Moderna (mRNA-1273), or the Janssen (Ad26.COV2.S) vaccines.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide written informed consent and HIPAA authorization
2. Patients deemed eligible and willing to receive a COVID-19 vaccine by treating physician per standard of care.
3. Subjects must be ≥ 18 years old at the time of consent.
4. Diagnosis of cancer and fall into one of the groups below:

   1. Group 1: Patients with solid tumors receiving courses of cytotoxic therapy.
   2. Group 2: Patients with hematological cancers receiving courses of cytotoxic chemotherapy.
   3. Group 3: Patients with solid tumors receiving tyrosine kinase inhibitors (TKIs) or other targeted therapies, but not cytotoxic regimens within 3 months.
   4. Group 4: Patients with hematologic cancers receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months.
   5. Group 5: Patients receiving immune checkpoint inhibitors.
   6. Group 6: Patients who underwent allogeneic stem cell transplant within 12 months.
   7. Group 7: Patients who underwent cellular therapy, including Chimeric antigen receptor t-cells (CAR-T) cells or t-cells with engineered t-cell receptors (TCRs) within 12 months.
   8. Group 8: Patients in remission who have received cellular therapy more than 12 months in the past, including allogeneic, autologous or engineered cellular approaches.
   9. Group 9: Patients with cancer in remission for at least 2 years not receiving active cytotoxic cancer chemotherapy (hormonal therapy is permitted).
   10. Group 10: Patients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants
   11. Group 11: Patients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants
   12. Group 12: Patients who have a cancer diagnosis but do not fall into group 1-11

3. Estimated survival of 8 weeks or more following enrollment on the study.

Exclusion Criteria:

1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active COVID-19 infection or influenza-like-illness. If subjects have previously tested positive for COVID-19 infection, they are eligible to participate in this study after 90 days
2. Unwilling or unable to follow protocol requirements.
Molecular Pathology Research Project of Glioma

Evaluate the diagnostic value of TERT promoter mutation in differ glioma subtypes and expend the application of the diagnostic algorithm to surgical practice

A total of 976 gliomas were enrolled in this study. First, in order to evaluate the diagnostic value of TERT promoter mutation in differ glioma subtypes, we conducted a retrospective cohort study included 753 frozen tissue samples of patients with different grades of glioma. According to WHO CNS5, all recommended alteration including IDH, 1p/19q, TERT, EGFRamp and 7+/10- were profiled using multiple approaches and a permanent diagnosis was obtained for each patient. Exploring the feasibility of the molecular pathology model of patients with glioma via retrospective research. Compare with the existing molecular pathology system, analyze the combination of IDH and TERT mutations and the feasibility of stratifying the prognosis of patients with glioma.

Moreover, to expend the application of the diagnostic algorithm to surgical practice, we developed a fast detection assay that could detect hotspot somatic mutations in IDH and TERT within 25 minutes and can discriminate TERT and IDH mutations from wild-type alleles with a minimum variant allele frequency (VAF) of 0.2% and 0.5%, respectively. We further validate the simplified diagnostic algorithm on frozen tissue of 223 patients with glioma in another retrospective cohort and performed this assay to evaluate the accuracy of the rapid assay.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Glioma
* Glioma patient with long-term follow-up data and intact clinical data

Exclusion Criteria:

* Glioma patient without Informed Consent Form
* Glioma patient without long-term follow-up data or intact clinical data
Functional Modeling of the Pediatric Airway

The investigators hypothesize that a functional computational model that simulates the mechanical and aerodynamic behavior of the upper airway in children with Pierre Robin Sequence (PRS) and laryngeal lesions (e.g. subglottic stenosis or SGS) can be used as an effective diagnostic and treatment planning tool.


Eligibility Criteria:
Inclusion Criteria:

1. Micrognathia, Suspected or Diagnosis of PRS, defined (Gorlin) as:

   micrognathia (mandibular hypoplasia), cleft palate and airway obstruction, and/or

   Diagnosis of SGS defined (Bluestone) as:
   * subglottic airway diameter of 4 mm or less in a term neonate;
   * subglottic airway diameter of 3.5 mm or less in a premature neonate;
   * inability to pass an endotracheal tube of expected size for age
2. Informed consent by parent or legal guardian
3. Age \< 18 years at enrollment
4. Scheduled for clinically indicated endoscopic upper airway evaluation
5. Ability to comply with study visits and study procedures as judged by the site investigator

Inclusion criterion also included for Specific Aim 2 (Longitudinal):

Subjects must be scheduled for an operative procedure to correct or bypass upper airway obstruction (i.e. mandibular distraction, endoscopic airway surgery, laryngotracheoplasty, cricotracheal resection, or tracheostomy) OR recently (within past 4 weeks) diagnosed as having an anomaly not currently requiring surgical management.

Exclusion Criteria:

1. Acute, intercurrent respiratory infection, defined as an increase from baseline in cough, wheezing, or respiratory rate with onset in the preceding week.
2. Physical findings at screening that would compromise the safety of the participant or the quality of the study (i.e. fever, increased respiratory rate above baseline, significant acute emesis, or alteration in baseline neurologic status).
3. For research CT scans any sedation risk, such as Bronchopulmonary Dysplasia (BPD) with upper airway obstruction, residual oxygen requirement, and an unsecured airway.

Control data will be collected from clinically indicated neck or maxillofacial CT imaging data that include the entire airway with no noted airway obstructions or airway abnormalities.
A Study of Avastin (Bevacizumab) in Combination With Thoracic Radiation and Chemotherapy in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer.

This single arm study will evaluate the feasibility of treatment with 2 dose levels of Avastin in combination with concurrent thoracic radiation and chemotherapy in patients with locally advanced unresectable non-squamous non-small cell lung cancer. Two cohorts of patients will receive 3 cycles of Avastin treatment (7.5mg/kg and 15mg/kg iv every 3 weeks, respectively), concurrently with thoracic radiation and chemotherapy (cisplatin and etoposide). Once a preferred dose has been established, this dose will be applied to a 3rd cohort, who will then receive maintenance treatment with Avastin as a single agent for 6 additional cycles. The anticipated time on study treatment is \<3 months for cohorts 1 and 2, and 3-12 months for cohort 3, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>= 18 years of age;
* non-squamous non-small cell lung cancer, locally advanced and unresectable;
* ECOG performance status 0 or 1;
* no prior thoracic or head and neck radiation;
* no prior surgical resection for current lung cancer.

Exclusion Criteria:

* malignancies other than non-small cell lung cancer within 2 years prior to inclusion, except for basal cell cancer of the skin, squamous cancer of the skin, or cancer in situ of the cervix;
* prior systemic therapy for non-small cell lung cancer;
* clinically significant cardiovascular disease;
* history of \>= grade 2 hemoptysis;
* current or recent use of aspirin (\>325mg/day) or full dose anticoagulants or thrombolytic agents for therapeutic purposes.
CO2-Angiography-Study to Evaluate Diagnostic and Safety to Patients With Peripher Arterial Stenotic or Occlusive Disease.

This randomized study focuses on the diagnostic quality and safety of CO2 application as contrast medium through an innovative injector of AngioDroid in angiography interventions in patients with peripheral arterial occlusive diseases.

CO2-angiography was used as an intra-arterial contrast agent since the 1970s particularly in patients who were hypersensitive to iodinated contrast material or whose renal function was compromised. It is in fact an effective and low-risk alternative to iodine-enhanced conventional angiography because it is not associated with nephrotoxicity or allergic reactions. The image quality influencing the diagnostic validity seems to be a restriction. Now, with the availability of high-resolution DSA and a reliable gas delivery system, CO2 angiography is more and more widely used for vascular imaging and endovascular procedures. Our study will specifically examine the image quality and safety of carbon dioxide gas as intra-arterial contrast agent using the innovative Artis Zeego Q angiography-system of Siemens Healthineers with the automated CO2-injection system of Angiodroid.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Male, female
* Patients with indication for percutaneous transluminal angioplasty of iliacal- or femoropopliteal arteries

Exclusion Criteria:

* Children and adolescents \< 18 years
* Diagnostic angiography, CT- or MRI-angiography during the past 3 months
* Patients with reduced renal function (S-creatinine \> 1,2 mg/dl)
* Incapacitated patients
* Severe COPD
* Known atrium- or ventricular septal defect with right-left-shunt
* Current participation in other interventional studies
Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilrastim for Neutrophil Recovery After Autotransplant

This is a phase 2 clinical trial comparing time to neutrophil recovery after autotrasplant using generic pegfilgrastim vs brand-name pegfilgrastim.

Thirty consecutive adults with lymphoma or myeloma receiving autologous peripheral blood stem cell transplant will be included in this phase 2 clinical trial. Patients will be allocated 1:1 in two groups: one subcutaneous 6 mg dose of generic pegfilgrastim (control group) or one 6mg dose of brand-name pegfilgrastim (intervention group) both at day +1 after the autotransplant. Daily complete blood counts were collected and time to neutrophil (\>0.5x10\^3/microL) and platelet recovery (\>20x10\^3/microL) will be obtained. The investigators will describe the proportion of adverse events and median time to neutrophil and platelet recoveries. Median or mean time to neutrophil recovery and time to platelet recovery will be calculated and compared with Mann-Whitney-Wilcoxon test or student T.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing autologous peripheral blood stem cell transplantation
* Patients with multiple myeloma or lymphoma
* Adults (\>18 years)
* Both genders
* Eastern Cooperative Oncology Group (ECOG) \<=2

Exclusion Criteria:

* Alanine Aminotransferase or bilirubin values \>2.5 times the superior normal limit
* Creatinin \>2.2mg/dL
* Fever \>37.6°C
* Active infection
* Hepatitis B, C or HIV infection
* Congestive heart failure (ejection fraction \<40%)
Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of SBP in Patients With LC

Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear which drug is most effective. Our aim of study is to compare the efficacy of the three current antibiotics for the treatment of SBP in patients with liver cirrhosis.

The primary hypothesis is that the efficacy of all the antibiotics will not significantly different. This is non-inferiority trial.

Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear which drug is most effective. Our aim of study is to compare the efficacy of the three current antibiotics for the treatment of SBP in patients with liver cirrhosis.

The primary hypothesis is that the efficacy of all the antibiotics will not significantly different. The expected success rates (infection resolution rates) are 83%, 87%, and 78% for cefotaxime, ceftriaxone, and ciprofloxacin. This is non-inferiority trial. The level of significance is 5%. The power of this stuy is 80%. Non-inferiority margin is 15%. Therefore 87 patients for each group are needed.

Eligibility Criteria:
Inclusion Criteria:

1. Liver cirrhosis patients with ascites
2. Ascitic fluid PMN cell count \>250/mm3
3. Age: 16\~70 years old

Exclusion Criteria:

1. Allergic to 3rd generation cephalosporin or quinolone
2. Antibiotics within 2 weeks
3. Open abdominal surgery within 4 weeks
4. Evidence of 2ndary peritonitis, intrabdominal hemorrhage, pancreatitis, Tb peritonitis, or peritoneal carcinomatosis
5. HCC with portal vein thrombosis
6. Pregnant woman
7. HIV positive