cyrilzakka/clinical-trials huggingface dataset:
Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma

This is a Phase 2, open-label, multicenter, efficacy and safety study of quarfloxin in patients with low or intermediate grade neuroendocrine cancer. The purpose of this study is to evaluate the rate of clinical benefit response to quarfloxin treatment including the reduction in secretory symptoms of flushing and/or diarrhea or the reduction quantifiable hormones or other biochemical tumor markers.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed low or intermediate grade neuroendocrine carcinoma including carcinoid and islet cell cancer. Patients with neuroendocrine tumors associated with MEN1 syndrome are eligible.
* Measureable disease by RECIST
* Unresectable or metastatic disease
* Secretory symptoms of diarrhea or flushing or both attributed to their carcinoid tumor and/or quantifiable hormones or other biochemical markers
* Males and females 18 years of age or older.
* Zero to two prior cytotoxic chemotherapy regimens.
* Patients may be receiving concomitant octreotide Sandostatin®
* Patients must have central IV access, or agree to the insertion of a central IV line.
* All previous cancer therapies, radiation, and surgery, must have been discontinued at least 21 days prior to the start of treatment.
* Acceptable liver function
* Acceptable renal function
* Acceptable hematologic status
* ECOG Performance Status ≤1.
* Anticipated survival of at least 6 months.
* Able to maintain a patient diary.
* For men and women of child-producing potential, use of effective contraceptive methods during the study and for one month after discontinuation of treatment.
* Ability to understand the requirements of the study, provide written informed consent and agree to abide by the study restrictions and return to the clinic for required assessments.

Exclusion Criteria:

* Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid or small cell carcinoma.
* Pregnant or nursing women.
* Severe chronic obstructive pulmonary disease with hypoxemia or an uncorrectable pulmonary compromise.
* Seizures not controlled by anticonvulsant therapy.
* Participation in any investigational drug study within 28 days before quarfloxin administration or currently receiving investigational therapy.
* Patients with a second malignancy requiring active treatment.
* Active symptomatic bacterial, fungal, or viral infection including active HIV or viral hepatitis.
* Prior treatment with quarfloxin.
* Clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis.
* Patients who have exhibited allergic reactions to a similar structural compound or formulation.
* Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any of the study's endpoints.
Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias

This protocol focuses on the evaluation of the GE noninvasive blood pressure parameter in subjects with dysrhythmias and normal sinus rhythm. The study follows the recommendations of the ANSI/AAMI SP10 Standard.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* a patient who is undergoing a specialized procedure such as a surgical procedure or cardiac catheterization, or during critical care monitoring in which a central arterial catheter is in place to determine systolic, diastolic, and/or mean arterial blood pressure values.
* ability to monitor ECG, NIBP and/or pulse oximetry
* presence of atrial fibrillation, atrial flutter, or normal sinus rhythm

Exclusion Criteria:

* any subject deemed too unstable, at the clinician's discretion, to participate in the study
* any subject with a cardiac or vascular malformation that results in an abnormal waveform inappropriate to be considered a reference standard
* any subject with a cardiac anomaly that would cause a disparity between aortic pressures and the periphery.
* presence of peripheral vascular disease in arms
* inability to perform a minimum of 4 fast flushes (two at the study beginning and two at the study end) on an arterial catheter or line in order to determine a frequency response. The volume of fluid will not exceed a total pre-specified by the Principal Investigator or designee.
* if the baseline arm to arm mean difference is \> 10 mmHg, then the differences will be recorded and evaluated by the Principal Investigator for possible subject exclusion from the data analysis.
* subjects who, at the clinician's discretion, could not tolerate approximately 5 to 12, but possibly up to 25 repeated blood pressures on each arm
Breathwork for Chronic Musculoskeletal Pain

This project is a single-site, single-arm, clinical feasibility trial examining the impact of a single-session, 2-hour connected consciousness breathing with breath retention (CCBR) training for chronic musculoskeletal pain.

CCBR is a breathwork style that involves breathing with no pause between inhalation and exhalation (also known as circular breathing). This breathing pattern is maintained for a given period of time, ranging from 5 minutes to over 2 hours. In the proposed project, the CCBR training will begin with a 15-minute introduction to CCBR, followed by an hour and 15 minutes of therapist-guided CCBR practice. The final 30 minutes will be used to discuss participant experiences during the CCBR practice. CCBR training sessions will occur in-person and in a small group format (5 participants each).

Eligibility Criteria:
Inclusion Criteria:

* having received a professional diagnosis of clinical levels of chronic pain
* being able to not commit to another (new) treatment during the course of the study
* understanding English instructions fluently
* Being 18 and above

Exclusion Criteria:

* having learned to practice breathwork any time in the past
* being unable to perform most basic tasks due to pain or pain treatment.
Immunologic Action of a Single Dose Cholecalciferol

Vitamin D receptors are expressed in activated different immune cells. It is not known, which immune cell type is targeted by exogenous vitamin D. Here, vitamin D-deficient individuals will receive once 100.000 I.U. vitamin D3 either intramuscular or subcutaneous in a double-blind placebo controlled setting. Immune cells will be monitored from the blood over time.

Vitamin D-deficient individuals will receive once

* double-blind, placebo controlled 100.000 I.U.vitamin D3
* intramuscular or subcutaneous

Blood will be taken over time and

* immune cells (T cells, B cells, myeloid antigen presenting cells) are characterized by flow-cytometry
* vitamin D-metabolites will be monitored

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* 18-60 yrs
* 25-hydroxyvitamin D serum below 50 nmol/L
* women only: effective contraception

Exclusion Criteria:

* 25-hydroxyvitamin D serum above 50 nmol/L
* body-mass index \<18 or \>30 kg per m2
* planned UV-exposure (UV-index \> 5)
* hypersensitivity to vitamin D
* history of hypercalcemia, kidney stones, kidney insufficiency, sarcoidosis, pseudohyperparathyroidism concomitant vitamin A- and/or vitamin D treatment
* treatment with immunosuppressants, immunomodulators, phenytoin, barbiturate, thiazide-diuretics, glycosides
* immobile patients
* out of normal range on screening visit (calcium,phosphate,creatinin,hematology)
* psychiatric hospitalization
* pregnancy / breast-feeding
* dependency / relationship on sponsor
* concomitant participation in other clinical trials (30 days before)
* drug or alcohol abuse
* lack of compliance
Risk Factors for Pyogenic Liver Abscess With Carbapenem-resistant Klebsiella Pneumoniae: A Matched Case-control Study

Pyogenic liver abscess (PLA) is a complication of infectious disease, and the most common pathogen of PLA is Klebsiella pneumoniae, while PLA caused by Carbapenem-resistant Klebsiella pneumoniae (CRKP) has become a threat to public health. For achieving a better therapeutic outcome of CRKP related PLA, it is very important to figure out the basic characteristics and risk factors of CRKP-PLA.

A retrospective cohort study was performed in which 15 PLA patients carriage of K pneumoniae were screened at the Xiangya hospital of central south university (changsha, China). The colonization and clinical infection isolates were analyzed by antimicrobial susceptibility testing to identify CRKP. All admission patients diagnosed with PLA who developed CRKP were included, 5 adults PLA patients with CRKP infected and 10 adults PLA patients with Carbapenem sensitive Klebsiella pneumoniae (CSKP) infected were conducted. Univariate and multivariate logistic regression was carried out using a stepwise selection method to compare prognostic factors between CRKP and CSKP groups.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older. at least one positive culture reported by the clinical microbiology laboratory for CRKP or CSKP during the hospital length of stay.

Klebsiella pneumoniae were isolated and identified in the blood or pus with antibiotic drug sensitivity results.

Exclusion Criteria:

* Less than 18 years old. patients with missing data without a drug sensitivity results.
Oral Care as a Preventive Measure of VAP; Miswak Versus Chlorhexidine and Toothbrush.

Dental plaque score calculation and swabs of Oropharynx and teeth were collected on admission. For group I, Miswak stick was used 4 hourly for oral care. For group II, 0.12% Chlorhexidine/ toothbrush were used 4 hourly

The selected patients were randomized into 2 groups by the conventional method of randomization. For each patient the following parameters were collected: patient data; age, gender; history of smoking; chronic health problems; history of drugs as steroids, chemotherapy, current antimicrobial therapy; and the primary cause of hospital and ICU admission and mechanical ventilation.

Clinical examination included assessment of disease severity on admission by Acute Physiology and Chronic Health Evaluation (APACHE II) scoring system, oral and dental examination, and dental plaque score calculation. Oropharyngeal and dental swabs were collected on admission.

The preventative VAP bundle was applied to all patients in both groups. For group I, Miswak was used for oral care, patient's teeth were brushed every 4 hours using a Miswak stick after scraping of half an inch bark from the stick end then Miswak tip was washed and compressed to make it brush like. Both buccal and lingual surfaces of teeth were brushed using mechanical method for plaque removal (in direction away from gingival margin,). The patient's tongue was brushed when possible and lip moisturizer was applied as needed. The brush like end of sewak stick was cut and replaced daily.

For group II, the patient's teeth were brushed every 4 hours using a soft toothbrush with 0.12% Chlorhexidine solution. Both buccal and lingual surfaces of teeth were brushed using mechanical method for plaque removal (in direction away from gingival margin,). The patient's tongue was brushed when possible and lip moisturizer was applied as needed. The toothbrush was boiled for one minute every day.

Patients in both groups were monitored for the efficacy of oral care in term of plaque score and halitosis. Colonization of trachea, OPH, and dental plaque by potential respiratory pathogens (PRPs) as Staphylococcus aureus, Pseudomonas, Klebsiella, Proteus, Acinetobacter and E. coli species was identified by culturing of OPH swab, dental swab and endotracheal tube (ETT) aspirate on inclusion into the study and every 4 days thereafter till ICU discharge, 3 weeks of ICU stay, or death. Secondary endpoints included time to VAP and its incidence, duration of MV, ICU discharge, and mortality rate.

VAP was diagnosed when patient developed; new and/or progressive infiltrates in chest radiograph plus two or more of the following; leucocytosis ≥ 12000/mm3 or leucopenia ≤ 4000c/mm3, fever \> 38oC or hypothermia \< 36oC, or mucopurulent secretion as evident by gross inspection. The clinically diagnosed VAP was confirmed by quantitative endotracheal aspirate at a cut off value ≥105 colony forming unit (cfu) /ml.

Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated

Exclusion Criteria:

* None
Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient

To make intravenous (IV) ganciclovir available to immunocompromised patients with life-threatening or sight-threatening Cytomegalovirus (CMV) infection, where the symptoms of the disease are too severe to allow admission to a controlled clinical study of ganciclovir therapy. To determine the safety and tolerance of 2 - 3 weeks induction course of ganciclovir IV followed by a maintenance course of ganciclovir IV for an indefinite duration. To tabulate the patient's clinical response.


Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Cytomegalovirus (CMV) disease who meet the criteria for a treatment IND protocol, or other clinical studies, including controlled clinical studies of anticytomegalovirus therapy in peripheral CMV retinitis in patients with AIDS.
* Mild to moderate CMV infections who fail to meet the severity criteria. CMV syndrome (i.e., cytopenia, increased liver enzymes, fever, viremia, viruria) is not considered immediately life-threatening.
* Transplant patients in whom trial reduction of immunosuppressive drug treatment is feasible.
* Children with congenital or neonatal CMV where there is not a documented primary or acquired immunodeficiency.
* Hypersensitivity to acyclovir or ganciclovir.
* Receiving antimetabolite treatment that cannot be discontinued.

Concurrent Medication:

Excluded:

* Antimetabolites.
* Alkylating agents.
* Nucleoside analogs (topical ophthalmics are permitted).
* Interferon.
* Foscarnet.
* Cytokines.

Patients with the following are excluded:

* Cytomegalovirus (CMV) infection who meet the criteria for a treatment IND protocol, or other clinical studies, including controlled clinical studies of anticytomegalovirus therapy in peripheral CMV retinitis in patients with AIDS.
* Mild to moderate CMV infections who fail to meet the severity criteria. CMV syndrome (i.e., cytopenia, increased liver enzymes, fever, viremia, viruria) is not considered immediately life-threatening.
* Transplant patients in whom trial reduction of immunosuppressive drug treatment is feasible.
* Children with congenital or neonatal CMV where there is not a documented primary or acquired immunodeficiency.
* Hypersensitivity to acyclovir or ganciclovir.
* Receiving antimetabolite treatment that cannot be discontinued.

Patients must qualify as follows:

* Previously enrolled in compassionate use study (ICM 1257/1257A) or have terminated from another Syntex ganciclovir study.
* Diagnosis of AIDS and life-threatening Cytomegalovirus (CMV) infection.
* Diagnosis of other immunodeficiencies other than AIDS, with life-threatening or sight-threatening CMV disease.
Irinotecan and Anlotinib for Epithelioid Sarcoma

Epithelioid sarcoma is a rare soft tissue sarcoma characterized by SMARCB1/INI1 deficiency. Much attention has been paid to the selective EZH2 inhibitor tazemetostat, where other systemic treatments are generally ignored. To explore alternative treatment options, we studied the effects of irinotecan-based chemotherapy in a series of epithelioid sarcoma patients.


Eligibility Criteria:
Inclusion Criteria:

* (1) Grade 2 or 3 ES confirmed histologically using the American Joint Committee on Cancer (AJCC) system ;
* (2) patients presented with measurable lesions using the Response Evaluation Criteria In Solid Tumors (RECIST1.1) and were not amenable to surgical resection or radiotherapy;
* (3) primary or secondary metastatic disease;
* (4) received more than two courses of the VIA regimen;
* (5) no concurrent treatment was given while on the VIA regimen;
* (6) follow-up information and evaluation after chemotherapy were available.

Exclusion Criteria:

* less than 4 cycles of treatment;
* medical records were not complete.
Danish Multicenter Scapholunate Ligament Study

Comparison of two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. A randomized multicenter study.

This multicentre study aim to compare two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. The investigators compare patient reported, clinical and radiological outcomes up to 10 years after treatment of complete dynamic or static but reducible SL ligament lesions. The participants are randomized to two treatments. Effect parameters before and after intervention are compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years (both included).
* Symptomatic SL instability (VAS score ³3, QDASH score ³ 20).
* \> 6 weeks since symptomatic hand trauma (chronic SL lesions).
* SL gapping on radiographic stress views or SL gapping (³2mm) on static PA views.
* Complete SL ligament lesion confirmed by wrist arthroscopy

Exclusion Criteria:

* Geissler grade 1-3 SLL injury (evaluated by arthroscopy).
* Concomitant complete luno-triquetral (LT) ligament injury (evaluated by arthroscopy).
* Lesion of TFCC leading to DRUJ instability (evaluated by arthroscopy).
* Radiocarpal or midcarpal arthritis evaluated by arthroscopy.
* Previous fracture in carpus or intraarticular radius fracture with step off (³2 mm), disposing to posttraumatic arthritis.
* Adverse effects after extra articular radial fractures (dorsal angulation ³10 grader).
* Peroperatively non-reducible scaphoid flexion/SL gap.
* Terminal illness or severe medical illness: ASA score higher than or equal to 3.
The Immunogenicity of Simultaneous Administration of Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Vaccine

The immunogenicity of simultaneous administration of quadrivalent influenza vaccine and pneumococcal vaccine was unknown. The purpose of present study is to compare the immunogenicity of simultaneous administration of influenza vaccine and pneumococcal vaccine with that of separate administration.

The immunogenicity of simultaneous administration of quadrivalent influenza vaccine and pneumococcal vaccine was unknown. We compare the immunogenicity of simultaneous administration of quadrivalent influenza vaccine and pneumococcal vaccine with that of separate administration.

162 Participants are randomly assigned to one of the two study groups; Simultaneous administration group: receive injections of pneumococcal vaccine and influenza vaccine simultaneously.

Sequential administration group: receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.

We compare the immunogenicity of the two groups.

Eligibility Criteria:
Inclusion Criteria:

* adults aged ≧65 years who had never received pneumococcal vaccine and quadrivalent influenza vaccine of 2015/2016 season

Exclusion Criteria:

* a sensitivity to pneumococcal and influenza vaccine
* received other inactivated vaccine within 14 days
* received other live vaccine within 28 days
* the presence of conditions known to impair pneumococcal vaccine response
* having malignant disease
* taking oral corticosteroids or immunosuppressive agent
* history of splenectomy
* history of an acute febrile illness or signs of severe acute illness at the time of vaccination
* other inappropriate condition to receive vaccination
* suffering an acute illness requiring antibiotics or steroids within the past month
* not expected to survive 12 months were also excluded
Apremilast Therapy for Acute Gouty Arthritis

The purpose of the study is to learn about a possible new medicine, apremilast, for treating acute gout and compare how it works to indomethacin, a medication that has been used to treat gout for over 50 years.

In order to learn about apremilast, half the participants in this study will receive apremilast and half the participants in this study will receive indomethacin.

This study will measure the severity and duration of acute gout attacks in research participants, as well as measures of quality of life and any side effects or adverse reactions to the medication.

There will be three study visits: a screening/baseline visit on Day 1, a visit to evaluate response to treatment with study medication at Day 7, and a follow-up visit at Day 21.

WITHDRAWN

Eligibility Criteria:
Inclusion Criteria:

* Must understand and voluntarily sign the informed consent
* Must have the diagnosis of gout proven by identification of urate crystals from body fluids
* Must be male age \>18 years at the time of consent
* Must be able to adhere to the study visit schedule and other protocol requirements
* Must meet the following laboratory criteria:

  * Hemoglobin \> 9.0 g/dL
  * White blood cell (WBC) count \> 3000/μL and \< 14,000/μL
  * Platelet count \>100,000/μL
  * Serum creatinine \< 2.0mg/dL
  * Total bilirubin \< 2.0 mg/dL
  * Aspartate transaminase (AST) and alanine transaminase (ALT) \<1.5 X upper limit of normal
* Males, including those who have had a vasectomy, must agree to use barrier contraception (latex condom) when engaging in sexual activity with a female of child-bearing potential (FCBP) while on study medications and for 84 days after taking the last does of the medication

Exclusion Criteria:

* Inability to provide voluntary consent
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study or confounds the ability to interpret the data from the study
* Females
* Systemic fungal infection
* History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment in the past 2 years
* An active infection at presentation
* Use of any investigational medication within 4 weeks prior to start of study or 5 pharmacokinetic/pharmacodynamic half-lives, whichever is longer
* Any use of corticosteroids, cyclosporine, methotrexate, cyclophosphamide, azathioprine, mycophenolate within 4 weeks prior to start of study
* Any clinically significant abnormality on 12-lead ECG screening
* Malignancy or history of malignancy (except for treated and cured basal-cell skin carcinomas \> 3 years prior to screening)