cyrilzakka/clinical-trials huggingface dataset:
Treatment of Acute Leukemia Relapse After Allotransplantation

Patients with relapse of acute leukemia often only receive supportive therapy. Our hypothesis is that a combination therapy can stabilize the disease for patients with early relapse after allogeneic stem cell transplantation. The investigators will combine 5-azacitidine 100 mg daily subcutaneously (days 1-3), valproic acid (continuous therapy from day 1), All-trans retinoic acid (days 1-14) and hydroxurea (continuous treatment from day 15 of first cycle. Azacitidine and ATRA can be repeated with 5 weeks intervals, donor leukocyte infusions on day 10 is allowed from the second cycle.


Eligibility Criteria:
Inclusion Criteria:

* AML relapse within one year after transplantation
* Blood and marrow sampling being possible
* Expected survival at least 4 weeks
* No expected drug interactions
* Informed consent possible

Exclusion Criteria:

* Intolerance to any study drug
* Serious kidney or liver disease
* Informed consent not possible
* Previous pancreatitis
3D Printed Model Simulator or Virtual Reality Software for Training Fiberoptic Intubation Skill

Fiberoptic-assisted intubation is an advanced skill that requires learners' practice as well as clinical experience during the anesthesiology residency training period. Current training methods including airway simulators and virtual reality software are used by medical schools worldwide.

The objective of this study is to compare the learner's fiberoptic intubation performance between training with a 3D-printed simulator and a virtual reality software.

Fiberoptic-assisted intubation (FOI) is an essential skill of an anesthesiologist. It requires comprehensive knowledge of the airway anatomy and the proper and skillful use of a fiberoptic bronchoscope.

Fiberoptic-assisted intubations are usually performed in emergency situations and during difficult airway patient encounters. These situations are not ideal for learners to properly practice the skill.

The process of acquiring FOI skills includes teaching by experienced instructors, self-practice using commercially-available airway simulators, and practicing on virtual reality software.

The airway simulators and virtual reality software have their advantages and disadvantages.

In this randomized study, the investigators will compare the fiberoptic intubation skill among anesthesiology residents after self-training on a custom-made 3D simulator and self-training on a virtual reality software.

Eligibility Criteria:
Inclusion Criteria:

* Second-year anesthesiology resident

Exclusion Criteria:

* Refuse to participate
Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism

Approximately 4 to 5 million men in the U.S. are testosterone-deficient. Enclomiphene (trans-clomiphene) citrate (Androxal) was evaluated to determine if Androxal increased serum testosterone levels in men with secondary hypogonadism. Subjects were randomly assigned to 1 of 4 treatments groups. Appropriate amounts of medications were dispensed at each visit. Subjects took their medications orally or by rubbing it onto the skin (depending on the treatment assignment) once daily for up to 6 months. Treatment visits occurred at approximately 4-week intervals for Months 1, 2, and 3 and then at 6-week intervals for Months 4, 5, and 6.


Eligibility Criteria:
Inclusion Criteria:

* Total serum testosterone concentrations \< 300 ng/dL at baseline

Exclusion Criteria:

* Presence or history of prostate cancer
* Elevated PSA \> 3.5 ng/mL

Additional inclusion and exclusion criteria may apply.
Sorafenib in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Sunitinib or Bevacizumab

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with metastatic kidney cancer that has not responded to sunitinib or bevacizumab.

OBJECTIVES:

Primary

* To determine the tumor burden reduction rate in patients with sunitinib malate- or bevacizumab-refractory, metastatic clear cell renal cell carcinoma treated with sorafenib tosylate.

Secondary

* To determine the safety of sorafenib tosylate in these patients.
* To record the duration of tumor reduction, time to disease progression, and overall survival of patients treated with sorafenib tosylate.

OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed renal cell carcinoma with a component of clear cell histology

  * Metastatic disease
* Disease progression, as defined by RECIST criteria, after prior treatment with sunitinib malate or bevacizumab

  * Patients must have received ≥ 1 course (4 weeks) of sunitinib malate or ≥ 2 doses of bevacizumab AND have RECIST-defined objective progression during or within 4 months after completing treatment with sunitinib malate or bevacizumab
* Measurable disease by RECIST criteria
* CNS metastases allowed provided patient has undergone prior surgery and/or radiotherapy AND has no evidence of further CNS disease progression by CT scan or MRI ≥ 2 weeks after treatment of CNS metastases

PATIENT CHARACTERISTICS:

* ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
* WBC ≥ 3,000/μL
* Absolute neutrophil count ≥ 1,500/μL
* Platelet count ≥ 75,000/μL
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST/ALT ≤ 2.5 times ULN
* Creatinine ≤ 2.0 times ULN
* Negative pregnancy test
* No significant cardiovascular disease, including any of the following:

  * Congestive heart failure (New York Heart Association class III-IV heart disease)
  * Active angina pectoris requiring nitrate therapy
  * Uncontrolled dysrhythmias
  * Cardiovascular event within the past 6 months (e.g., transient ischemic attack/cerebrovascular accident, myocardial infarction, or vascular surgery)

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 2 weeks since prior systemic therapy, radiotherapy, or major surgery and recovered
* No prior sorafenib tosylate
* No other concurrent investigational agents
* No other concurrent anticancer therapy
* No concurrent prophylactic growth factors
Xenon-anesthesia on Patients Undergoing Major Liver-resection

The aim of this study is to compare the postoperative outcome of patients undergoing major liver resection under xenon- compared to desflurane-anesthesia.

The aim of this study is to compare the postoperative liver function and additional outcome parameters of patients undergoing major liver resection under xenon- compared to desflurane-anesthesia. Xenon is known to maintain hemodynamic stability and consecutive tissue perfusion. Together with its potential for ischemic pre-conditioning, we hypothesize a protective effect of xenon on post-operative liver failure and ischemia/reperfusion injury.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 3 segments liver resection
* ≥ 18 years
* Both gender
* American Society of Anesthesiologists (ASA) classification I-III
* Written informed consent prior to study participation

Exclusion Criteria:

Subjects, fulfilling one or more of the following exclusion criteria will not be included in the study:

* Severe pulmonary or airway disease
* Severe liver disease, accompanied by a Child-Pugh class \>A
* Allergy/hypersensitivity to study medications
* ASA ≥ IV
* Patients susceptible to malignant hyperthermia
* Women who are pregnant, breast-feeding or women of childbearing potential not using adequate contraceptive methods
* Patients with preeclampsia or eclampsia
* Patients legally unable to give written informed consent.
* Patients with risk of high oxygen demand
* Patient with seriously impaired cardiac function
* All contraindications for xenon anesthesia according to the summary of product characteristics LENOXe
* Patient participates in a parallel interventional clinical trial during this study or receives an investigational drug within 30 days prior to inclusion into this study
A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus

This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Patients will be randomized to one of 6 groups to receive RO4998452 at doses of 2.5mg, 5mg, 10mg, 20mg or 40mg po daily, or placebo daily. Patients pre-treated with stable metformin will continue to take their usual dose of metformin throughout the study.The anticipated time on study treatment is \<=3 months


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* type 2 diabetes, diagnosed for \>=3 months;
* either treated with diet, exercise and stable metformin, or with diet and exercise alone.

Exclusion Criteria:

* type 1 diabetes mellitus;
* currently or within 2 months prior to screening treated with an oral or injectable anti-diabetic agent except stable doses of metformin;
* currently or within 6 months prior to screening treated with any PPARgamma agonist;
* uncontrolled hypertension;
* significant pre-diagnosed diabetic complications requiring treatment.
Thermography and Burning Mouth Syndrome

Medical thermography is a noninvasive technique that allows an examiner to visualize and estimate the temperature of the body . This technique allows for an evaluation of the functionality of the structures, which is why it is considered a physiological test and records the variation in the surface temperature of the human body based on the infrared radiation emitted by the surface of that body .Subjects with burning mouth syndrome (BMS) have altered sensitivity and pain thresholds for thermal stimuli compared to a control group An objective of this study is to standardize temperature values derived from thermograms of the tongue in BMS .

An objective of this study is to standardize temperature values derived from thermograms of the tongue in BMS

Subjects will make one visit to our clinic with burning mouth syndrome and control healthy . They will be asked to acclimate to room temperature for at least 20 minutes. Subjects are requested not to consume hot drinks or food for at least an hour before imaging and not to use any skin preparations. During the tests, infrared thermal images were taken immediately after subjects protruded their tongues forward and downward to the desired position

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent signed he patients were diagnosed with BMS according to the criteria of the International Classification of Headache Disorders

Exclusion Criteria:

* Fibromyalgia
* Fever
* Reflux
* Cancer,
* Oral infection,
* Pregnant or breastfeeding women
INJECT: A Pilot Study of Intra-tumoral Injections in Metastatic Urological Cancers

The purpose of this study is to plan for future clinical trials in patients with metastatic urological cancers. Diluted iodinated contrast will be injected intra-tumorally under CT fluoroscopy guidance into bone, lymph node, soft tissue and liver metastases in subjects with metastatic prostate cancer, urothelial carcinoma, or renal cell carcinoma. Pre- and post-injection CT images will be obtained to determine the injection parameters needed for optimal distribution throughout metastases of a given size. A biopsy of the metastatic site will also be obtained to validate expression of the receptor CD155.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of adenocarcinoma of the prostate, renal cell carcinoma or urothelial carcinoma. Small cell or neuroendocrine tumors of the prostate are also permitted.
2. Radiographic evidence of at least one bone, lymph node, soft tissue, or liver metastasis, that is amenable to iodinated contrast injection, as judged by the study radiologist
3. Adequate laboratory values:

   1. Platelets ≥ 100,000
   2. INR ≤ 1.3
4. Age \> 18 years.
5. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. History of intercurrent or past medical or psychiatric illness that would make participation in a research biopsy protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).
2. Cr \>2.0
3. History of iodinated contrast allergy
4. For patients undergoing research only biopsy: Requirement for anticoagulation with heparin, low molecular weight heparin, clopidogrel, rivaroxaban, dabigatran, apixaban, warfarin, Aggrenox, fondaparux, ticagrelor, etc (aspirin and other NSAIDs are ok but should be held prior to biopsy in accordance with institutional standard of care)
5. Any other contraindication to CT with iodinated contrast, as CT with contrast will be used in the study.
Impact of Labour Kinesiotherapy in the Quality Life of Auxiliary Nursing in the Surgery Center

The quality of life and daily activities can be affected by muscleskeletal pain and one of the forms of assessment is through the SF-36 questionnaire. The investigators know that the working kinesitherapy is a way to improve the quality of life.

The activities in the work routine can cause pain and negatively affect quality of life. There is the hypothesis that gymnastics may be used for pain and injuries relating to repetitive movement at work. Objective the study is assess the impact of labor kinesiotherapy in the quality of life of the operating room nursing assistants.

Eligibility Criteria:
Inclusion Criteria:

* professional nursing assistants allocated in the surgical center at least one year
* both genders
* who agreed to participate in the study by signing the informed consent

Exclusion Criteria:

* persons submitted on any surgery in the last six months
* with illness or muscle-skeletal disabilities
* or who couldn't attend all sessions for vacations or scale
The Timing of Emergency Endoscopy for Esophagogastric Variceal Bleeding in Cirrhosis

This study is a prospective, multi-center and observational clinical study. Investigators would like to explore the optimal emergency endoscopy timing in cirrhosis patients with esophagogastric variceal bleeding (EGVB) by evaluating and comparing the efficacy and safety of emergency endoscopy performed at different times ( within 6 hours or between 6 and 24 hours after gastroenterologic consultation ) and its impact on the short-term prognosis.

Between July 2021 and April 2022, patients with cirrhosis undergoing emergency endoscopy due to EGVB are enrolled consecutively according to the following criteria: (1) age≥18 years; (2) A definite diagnosis of cirrhosis (confirmed by medical history, laboratory examination and imaging examination); (3) The cause of bleeding was identified as esophageal and/or gastric vein rupture. Exclusion criteria are as follows: (1) End-stage diseases of major organs (such as heart failure, chronic obstructive pulmonary disease, end-stage renal disease, and malignancies other than hepatocellular carcinoma); (2) The subject (or legal representative/guardian) refused to sign the informed consent.

Patients were divided into urgent-endoscopy group (\< 6h) and early-endoscopy group (6h-24h) according to the time interval from gastroenterologic consultation to the start of emergency endoscopy.

Investigators will collect patients' data of baseline character, treatment, postoperative and follow-up. All patients will be followed up until death or the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* age≥18 years
* A definite diagnosis of cirrhosis (confirmed by medical history, laboratory examination and imaging examination)
* The cause of bleeding was identified as esophageal and/or gastric vein rupture

Exclusion Criteria:

* End-stage diseases of major organs (such as heart failure, chronic obstructive pulmonary disease, end-stage renal disease, and malignancies other than hepatocellular carcinoma)
* The subject (or legal representative/guardian) refused to sign the informed consent
Accuracy of Noninvasive Pulse Oximeter Sensor (MightySat RX)

In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.


Eligibility Criteria:
Competent non-smoking adults

Inclusion Criteria:

* Subjects must understand and consent to be in the study.
* American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).

Exclusion Criteria:

* Subjects who have any systemic disease at all.
* Subjects who do not understand the study and the risks.
* Smokers.
* Subjects who are pregnant.
* Subjects having either signs or history of peripheral ischemia.
* Others deemed ineligible by the clinical staff.
Effect of Pulsing Electrical Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study

To determine if pulsed electric field therapy reduces lower leg and foot pain associated with diabetic neuropathy and lessens the need for medication.

The MedRelief device sends a sub-threshold electric signal through the skin using electrodes as means of signal delivery. The signal or waveform, frequency and strength were created to match the characteristics of signals the body generates to help natural healing.

A multi-center, randomized, open-label study involving 23 patients with chronic diabetic peripheral neuropathy meeting study entry criteria. Subjects will be randomly assigned to receive one of two treatments using an FDA cleared MedRelief device: (1) a MedRelief SE 55 device set on "pulsed" mode at 10 microsecond burst intervals 4150 Ha, or (2) a MedRelief SE 55 device set on "continuous" mode at 4150 Hz. Subjects will wear the device on target foot each night for a minimum of 6 hours over a two week (15 day treatment)period.

Subjects will complete a daily pain diary, medication form, and device use form. Subject global assessments and physician global assessments will occur at baseline, study visits Day 7, Day 15 and Day 21 (end of study).

Response to therapy will include pain reduction, improvement in sensation, improved response to vibratory stimulation and reduction of edema in study subjects.

Eligibility Criteria:
Inclusion Criteria:

* currently diagnosed with diabetes mellitus
* confirmed diagnosis of diabetic peripheral neuropathy
* age 18 years to 75 years
* both males and females are eligible for study participation
* HgA1c level under 9
* Physician confirmed stable glycemic control for 3 months prior to enrollment
* baseline pain level over previous month of 5
* willing to sign IRB approved consent and follow study visit requirements
* if female of childbearing age willing to undergo urine pregnancy test

Exclusion Criteria:

-
A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR)

RENOIR Study: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe Rheumatoid Arthritis (RA)

This study is a Phase 2 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis.

Eligibility Criteria:
Key Inclusion Criteria:

* Aged 18 years or older
* A diagnosis of Rheumatoid Arthritis based on ACR/EULAR 2010 classification criteria, for at least 3 months before participating in the trial
* Must be receiving treatment with at least 1, but not more than 2 csDMARDs for at least 3 months and be on stable dosages for at least 8 weeks prior to joining and throughout the trial
* Have had an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic DMARD (csDMARD), biologic DMARD (bDMARD), or targeted synthetic DMARD (tsDMARD) treatment

Key Exclusion Criteria:

* History of an inflammatory joint disease other than Rheumatoid Arthritis
* Prior exposure to a PD-1 or PD-L1 agonist, antagonist, or modulator
* History of cancer within the last 5 years (except for some skin cancers)
* Any known or suspected condition that would compromise immune status
* Pregnant or breastfeeding women
Lower Limb Compression Prevents Hypotension After Epidural in Labor

The goal of this study is to determine whether the use of sequential compression devices (lower limb compression) can reduce the rate of maternal hypotension after epidural, and therefore reduce the incidence of fetal heart tracing complications during labor.

Maternal hypotension during epidural anesthesia in laboring patients can cause a number of problems for both mother and fetus. Despite standard anesthesia protocols designed to minimize the occurrence of hypotension during epidural placement, approximately 30% of laboring patients will still experience clinically significant hypotension. Maternal hypotension can affect placental blood flow causing fetal bradycardia and academia, as well as maternal symptoms such as dizziness, nausea, and vomiting. Therefore, there is a need for improved management of women in labor at time of epidural placement to avoid negative consequences for mother and fetus. We plan to investigate whether the use of lower limb compression devices at the time of epidural would decrease maternal hypotension.

Pregnant women who request epidural anesthesia during labor will be recruited and enrolled in this single site, randomized controlled trial. Patients will be randomized into either control or sequential compression device (SCD) groups. Following epidural, blood pressures will be measured at 1, 5, 15, 30, 45, and 60 minutes and rates of hypotension with subsequent fetal heart tracing abnormalities will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Women with pregnancy at term (greater than or equal to 37 weeks 0 days gestation)
* Singleton gestation
* In labor (spontaneous or induced)
* Requested epidural for pain management

Exclusion Criteria:

* Any diagnosis of hypertension or cardiovascular disease
* Any contraindications to lower extremity compression including deep venous thrombosis in past 6 months, infected leg wound, or deformity of lower extremity
* Any contraindications to epidural placement including severe thrombocytopenia and spinal deformity