cyrilzakka/clinical-trials huggingface dataset:
Phase I/II Trial of Sodium Stibogluconate in Myelodysplastic Syndrome

Sodium stibogluconate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

This was originally designed as a phase I/II trial studying the side effects of sodium stibogluconate and how well it works in treating patients with myelodysplastic syndromes. Unfortunately, due to funding issues, the phase II portion was never conducted.

Patients receive sodium stibogluconate IV over 30 minutes on days 1-5 and 15-19. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who respond to treatment may continue therapy until disease progression.

Patients undergo bone marrow aspiration, biopsy, and peripheral blood sample collection periodically for correlative laboratory studies.

After completion of study treatment, patients are followed up at 8 weeks.

The phase II portion of this trial was never conducted due to lack of funding.

Eligibility Criteria:
Inclusion Criteria:

* Documented myelodysplastic syndromes (MDS), including therapy-related MDS
* Meets 1 of the following criteria:

  * Refractory to prior azacitidine or decitabine
  * Did not tolerate treatment with azacitidine or decitabine due to cytopenias or other side effects
  * Not a candidate for azacitidine or decitabine due to cytopenias or other medical conditions that would contraindicate nucleoside analogues
  * Refused treatment with azacitidine or decitabine
* Life expectancy ≥ 16 weeks
* Not pregnant or nursing
* No B12 deficiency, folate deficiency, or pyridoxine responsive anemia as confirmed by relevant laboratory testing
* No prolongation of QTc or ventricular ectopic beats on EKG
* No evidence of cardiac disease
* No active infection AND afebrile
* More than 21 days since prior azacitidine or decitabine
* More than 21 days since other prior treatment for MDS (e.g., thalidomide, valproic acid, or other agents as part of a clinical trial)
* Prior cytokines (e.g., erythropoietin, G-CSF, and GM-CSF) allowed
* Prior chemotherapy and/or radiotherapy for solid tumors or lymphoma allowed provided there is no evidence of active disease from the prior malignancy

Exclusion Criteria:

* Prior treatment for leukemia (e.g., acute myeloid leukemia, chronic myelogenous leukemia, acute lymphocytic leukemia, or chronic lymphocytic leukemia)
* Concurrent cytokines
* Concurrent antileukemic treatment, including bone marrow transplantation and radiotherapy
Clinical Proposal for the Comparison of Intraperitoneal Anesthetic to Injected Local Anesthetic

The purpose of this study is to determine if pre-incisional lidocaine injection, instilled liquid bupivacaine, intra-abdominal aerosolized bupivacaine, or post-operative bupivacaine injection is superior in post-operative pain control in laparoscopic bariatric surgical patients.

The research objective is to compare our standard post-operative port site injection of 0.5% bupivacaine against pre-incisional port site injection of 1% lidocaine against the instillation of streamed bupivacaine 0.5% against the instillation of aerosolized 0.5% bupivacaine as it relates to post-operative analgesia usage and pain scale scores. The null hypothesis will be that there is no difference between the four arms of the study in regards to pain score and analgesia usage.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients between 18 and 65 years of age.
2. Patients undergoing elective bariatric surgery.

Exclusion Criteria:

1. Patients allergic to bupivacaine or any other local anesthetics (amides \& esters).
2. Patients who have used opiates or opiods within 15 days prior to surgery.
3. Patients converted to open gastric bypass.
Vascular Changes in Patients With Aotic Isthmus Stenosis After Interventional Therapy

This controlled clinical study investigates arterial blood pressure and vascular remodling before and 4 weeks after catheter interventional treatment of re-stenosis of the aortic isthmus (Recoarctatio Aortae).

Patients with treated aortic isthmus stenosis during their first year of life often develop a Recoarctatio Aortae (re-stenosis of the aortic isthmus) in the long term followed by arterial hypertension. The Recoarctatio Aortae can be treated during a cather intervention by balloon dilatation or stent implantation. Patients with arterial hypertension often develop vascular remodeling with increased central systolic blood pressure and increased pulse pressure. Vascular remodling predics cardiovascular events and increases mortality. Vascular remodeling can be assessed non-invasively by using scanning laser doppler flowmetry (SLDF)), pulse wave analysis and measurement of flow-dependent vasodilation. In this controlled clinical study we investigate arterial blood pressure and vascular remodling before and 4 weeks after catheter interventional treatment of Recoarctatio Aortae.

Eligibility Criteria:
Inclusion Criteria:

* male and female persons with Recoarctatio Aortae and planned interventional therapy (balloon dilatation or stent implantation)
* adequate contraceptive methods in females with childbearing potential

Exclusion Criteria:

* other secondary causes for hypertension
* treatment resistent arterial hypertension or uncontrolled hypertension (office BP ≥ 180/110 mmHg)
* history of hypertensive enzephalopathy or intracerebral bleeding
* diabetes mellitus
* cataract
* known renal, respiratory, hepatic, gastrointestinal, endocrine, metabolic, immunolic, hematologic, oncologic, neurologic or psychiatric diseases besides the diagnosis of artoic isthmus stenosis
* one of the following diseases or conditions during the last 6 months: myocardial infaction, instable angina pectoris, cardiac insufficiency
* pregnant or lactating woman or inadequate contraception (pearl-index ≥ 1%)
* participation in another clinical study
* drug or medication abuse
* inadequate adherence or other condition preventing the patient from study participation (in the eyes of the treating physician)
The Use of Lignocaine and Bupivacaine Mix in Adult Safe Male Circumcision

Using routinely collected data to compare different concentrations of locally applied anaesthetic drugs and determine which concentrations give better pain control during voluntary medical Male circumcision.

The objective of this study therefore was to assess self-reported pain and adverse events when using two different concentrations of lignocaine and bupivacaine mixture while performing routine safe medical circumcision (SMC).

Methods Design This was an observational analytical study.

Setting At an urban high volume SMC site in a resource limited setting, over a 6 weeks period.

Participants Adult males aged18 - 49 years presenting for routine voluntary SMC were recruited for enrollment. All men were offered voluntary HIV counseling and testing before the surgery, received group counseling /health education on HIV prevention, were offered HIV testing, individual counseling where necessary to address questions and to clarify any queries, and free condoms were available. All participants were screened for contraindications to SMC such as active sexual transmitted infections (STI), commonly manifesting as urethral discharge or penile ulcers.

Ethical consideration All participants after they were counselled and provided written informed consent. Ethical approval was obtained from the Makerere College of Health Sciences Ethics and Research Committee.

Lignocaine and Bupivacaine (LiB) mixtures and procedure Lignocaine 2% and bupivacaine 0.5% were procured locally, from suppliers licensed and approved by the national drug authority (NDA), and was within the expiry date. The 4-4-2 mix was 4cc of Lignocaine 2%, 4cc of 0.5% bupivacaine and 2cc of water for injection, all drawn into a 10cc syringe. The 3-3-4 mix was 3cc of Lignocaine 2%, 3cc of bupivacaine 0.5% and 4 cc of water for injection.

We assigned participants to the two groups (each group on alternative weeks). We administered additional local analgesia for those who experienced break-through pain during the procedure. We recorded the mix ratio, the time the procedure commenced and ended using a stop clock, presence of break-through pain during SMC, and pain at 30 and 60 minutes after SMC (post-operative). We encouraged clients to report pain and a visual analogue score (VAS) pain chart was used to estimate pain intensity. Post-operative pain was graded as mild if the VAS score were 0-5, moderate if scores were 6-8 and severe if 9-10. We monitored the clients in the recovery room for additional post-operative pain and oral analgesia were given when and if was needed.

Other adverse events: participants were observed for central nervous system (CNS) toxicity, convulsions, coma and respiratory depression and cardiovascular system (CVS) toxicity Bradycardia pulse rate \< 60bpm (beats per minute)

Eligibility Criteria:
Inclusion Criteria:

* all adult male aged18 and 49 years

Exclusion Criteria:

* severe comorbid states such as sickle cell disease
* uncontrolled diabetes
* hypertension
* active sexually transmitted infections and genital ulcers
* in addition known allergy to lidocaine or bupivacaine
Biomarkers in Neurodegenerative Diseases

The general purpose of this observational study is to examine biomarkers associated with the pathology of neurodegenerative diseases to potentially develop novel therapeutic approaches.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of MCI, AD, DLB, FTLD, PDD, TEA, TLE, SCA, HAND, ALS, PLS, or normal control.
2. Age 18 or older
3. Reliable informant with frequent contact with participant
4. Mini Mental State Exam (MMSE) ≥15 AND/OR Clinical Dementia Rating (CDR) less than 2
5. Able to undergo extensive psychometric testing

Exclusion Criteria:

1. Any conditions that could account for cognitive deficits in addition to a neurodegenerative disease, including but not limited to:

   * Past or present diagnosis of Korsakoff's syndrome
   * Alcohol or substance abuse preceding dementia \& still present within 5 years of onset
   * Present untreated vitamin B12 or folate deficiency
   * Present untreated hypothyroidism
   * Past or present head trauma with persistent deficits
   * Present untreated syphilis
   * Past or present multiple sclerosis or another neuro-inflammatory disorder
   * Past or present vascular or multi-infarct dementia
   * Past or present diagnosis of huntington's disease
   * Past or present normal pressure hydrocephalus
   * Past or present central nervous system (CNS) lesions deemed to be clinically significant
   * Unresolved or present subdural hematoma
   * Past or present Ischemic Vascular Dementia
   * Past or present intracerebral hemorrhage
   * Present systematic liver disease
   * Present renal insufficiency requiring dialysis
   * Present encephalitis or meningitis
   * Present anxiety disorder (not due to dementia and requiring medication more than 3x per week)
   * Present severe periventricular white matter disease or greater than grade 4 white matter lesions
   * Present lacunar infarcts deemed to clinically significant
   * Present cortical stroke
   * Present respiratory condition requiring oxygen
2. Present significant systemic medical illness, such as cancer requiring chemotherapy or end stage cardiac insufficiency
3. Present inability to safely scan in an MRI
4. Present pregnancy or lactation - Female participants will be asked to confirm that they are not pregnant and do not plan to become pregnant.
5. Present current medication likely to affect CNS functions:

   * Benzodiazepines (no triazolam, but other short-acting benzodiazepines are OK)
   * Antidepressant therapy with amitriptyline or doxepin or tx not stable during past year
   * Neuroleptics in the phenothiazine and haloperidol families (atypicals OK)
   * Narcotics (codeine is OK, but hold 24 hours before neuropsychological testing)
   * Anti-seizure medication outside of therapeutic ranges
   * Antihistamines (\> 3x per week; hold 24 hours before neuropsychological testing)
Predictors Favoring the Role of Exclusive Enteral Nutrition in Active Crohn's Disease

To idetify the factors favoring the use of enteral nutrition would be helpful to select preferred patients suitable for enteral nutrition.

Crohn's disease (CD) is a chronic, transmural inflammatory disorder affecting the whole alimentary tract from mouth to anus. Over the past decades, the incidence of CD is either high and stable or low but rising in the worldwide. Although the precise etiopathogenesis of CD remains unknown, a number of lines of evidence showed that inappropriate diet was one of the reasons responsible for the onset of CD, and diet therapy has been gaining increasing attention in the therapeutic work-up of CD.

Due to reduced intake and high intestinal losses, over three quarters of CD patients would suffer weight loss. Involvement of small bowel in CD patients made their nutrition status much poorer than ulcerative colitis (UC) patients. Therefore, nutrition support is of great value in the management of CD. It is widely accepted that enteral nutrition could help pediatric CD patients to reach clinical and endoscopic remission, with similar efficacy but less side effects than corticosteroids. However, the value of enteral nutrition in adult active CD is still controversial, with an unstable remission rates ranging from 8% to 100%. Varied characteristics and compliance of enrolled patients might explain this wide range. Considering this, idetification of factors favoring the use of enteral nutrition would be helpful to select preferred patients suitable for enteral nutrition.

In this study, we will observe the role of enteral nutrition in active adult CD. The age, gender, serum CRP, albumin, fecal calprotectin, nutritional risk screening 2002 (NRS2002), involved intestinal segments and other items will be correlated with the changes of Crohn's disease activity index (Best CDAI) and CRP in order to idetify the factors favoring the use of enteral nutrition.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as active CD based on clinical presentation, endoscopic and pathology results
* Has the willing to receive enteral nutrition

Exclusion Criteria:

* No exposure to Glucosteroids or immunosuppressions
* Complete intestinal obstruction
Gabapentin Versus Transdermal Fentanyl Matrix for Chronic Neuropathic Pain

Gabapentin is a first line medication and fentanyl is second line medication in neuropathic pain. But, there is no head to head study on the efficacy of those medication in neuropathic pain.

The hypothesis of this study is that the efficacy of the transdermal fentanyl matrix is not inferior to the gabapentin in neuropathic pain.


Eligibility Criteria:
Inclusion Criteria:

* patients are 20 years of age or older
* patients had chronic pain for more than 3 months and average pain score for last 3 days is not less than 4 (NRS)
* neuropathic pain caused by the spinal stenosis (radiating pain, motor or sensory change
* positive MRI finding or radiculopathy was confirmed by the EMG/NCS or not less than 12 points in the S-LANSS score assessment
* patients who can make out the questionnaire
* patients have agreed with the informed consent

Exclusion Criteria:

* patients who have experience with gabapentin, pregabalin, fentanyl matrix, long-acting strong opioid (CR oxycodone, SR morphine)
* patients who have other causes of neuropathy such as hypothyroidism, Vit B12 deficiency, connective tissue disease, etc.
* patients who have other disease which causes more pain compared with neuropathic pain
* patients with a history of drug or alcohol abuse
* patients who are pregnant or have the possibility of pregnancy
* patients who are unable to use a transdermal system due to skin disease
* patients with a serious mental disease
* patients with a history of hypersensitivity to opioid analgesics
* patients with a chronic pulmonary disease or respiratory depression
* patients combined with industrial accidents or traffic accidents
* at investigator's discretion, any condition where a subject cannot take part in the clinical study on the ground of warning, cautions, and prohibition in study investigator's brochure
Acute Effects of Inspiratory Muscle Exercise on Glucose Level and Glucose Variability in Patients With Type 2 Diabetes.

Type 2 diabetes is associated with respiratory muscle weakness and autonomic neuropathy. The exercise of inspiratory muscles has been investigating in various clinical situations and may cause similar benefits as the conventional exercises. The assessment of glucose variability has been used as an alternative tool to evaluate the others mechanisms than the absolute values of glucose levels, special during the exercise. However, the effect of inspiratory muscle exercise on glucose levels and glucose variability is not clear yet. The aim of the proposed research is to evaluate the acute effects of inspiratory muscle exercise using a high load of 60% of MIP on glucose levels and glucose variability in patients with type 2 diabetes.

High-intensity exercise of inspiratory muscle was able to reduce glucose levels in previous studies, but the mechanisms underlying this reduction remain largely unknown. The present study will investigate this phenomenon, and whether confirmed, the inspiratory muscle loading would be a new approach for lowering glucose levels and glucose variability in type 2 diabetes.

The subjects with type 2 diabetes will be recruited from the ambulatory of the Hospital de Clinicas de Porto Alegre. The patients will be randomized to inspiratory muscle exercise with a high intensity load (MIP 60%) or to exercise with a load placebo (MIP 2%), on two different days. The subjects will come in the laboratory for three days consecutively during 2 weeks. On the first day will be placed the CGMS device. On the second day will be the controlled ventilation protocol with subsequently inspiratory muscle exercise, using 2% or 60% of MIP as randomized a priori. On the third day the CGMS will be removed. Individuals who are using beta-blockers will be advised to withdraw the medication 24 hours before the protocols. During all protocols will be recorded the continuous blood pressure to assess heart rate and blood pressure variabilities, both time and frequency domains will be analyzed. Also, the calf blood flow, inspiratory pressure, end-tidal carbon dioxide and oxygen saturation will be taking.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes;
* HbA1c from 7,5 to 10%;

Exclusion Criteria:

* Subjects taking insulin;
* Pregnant women;
* Subjects taking betablocker only
* Documented arrythmia
* Documented fibrillation
* GFR\<30
* Documented pulmonary disease or asthma,
* Current smoking;
* Varicose vein problems;
* Musculoskeletal disease.
Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess

This clinical trial compares the use of moxifloxacin versus ceftriaxone in the treatment of primary pyogenic liver abscess. The trial will include nonpregnant adults presenting with primary liver abscess based on clinical diagnosis and computed tomography. The trial aims to determine whether the use of moxifloxacin can effectively treat primary pyogenic liver abscess and shorten hospitalization. This regimen has the additional benefit of avoiding nephrotoxic agents, such as aminoglycosides, used frequently in treatment of pyogenic liver abscess. Development of antibiotic resistance to colonized bacteria in the gastrointestinal tract will also be evaluated using stool cultures.


Eligibility Criteria:
Inclusion Criteria:

* Age greater or equal to 20 years.
* Clinical diagnosis of liver abscess, supported by an abdominal CT scan, documenting the presence of liver abscess, in the absence of biliary tract stones (except for gallstones without biliary tract dilatation), biliary tract dilatation and biliary tract tumors. Clinical diagnosis of liver abscess includes symptoms of fever, chills, right upper quadrant abdominal pain or knocking tenderness.
* Read, understood and signed informed consent form.

Exclusion Criteria:

* Presence of septic metastatic infections to the CNS or eye at presentation.
* Cultures positive for an organism resistant to study drugs.
* APACHE II score greater or equal to 20.
* Co-existent disease considered likely to affect the outcome of the study (e.g., biliary tract stones and malignancy).
* Patients with ruptured liver abscess
* Severe hepatic insufficiency (Child-Pugh C) or elevated serum transaminases (GPT) to greater than 5 times the upper limit of normal.
* Patients who are pregnant or lactating.
* Known hypersensitivity to b-lactams or fluoroquinolones.
* Known prolongation of the QT interval.
* Patients with uncorrected hypokalemia.
* Patients receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents
* Severe, life-threatening disease with a life expectancy of less than 2 months.
* Pre-treatment with a systemic antibacterial agent for \> 24 hours prior to enrollment within 5 days prior to enrollment.
* Participated in any clinical investigational drug study within 4 weeks of screening.
* Previously entered in this study.
Utilization of the Mirror During Pelvic Exams

This is a prospective cohort study to determine if using a birthing mirror during the patient's pelvic examination decreases patients's degree of vulnerability and discomfort.

In Obstetrics and Gynecology and its gynecologic subspecialties, the pelvic examination is routine practice for screening and diagnostic purposes. Nevertheless, due to their intimate nature, pelvic examinations may result in loss of control, embarrassment, discomfort and anxiety.

The mirror pelvic exam has been a proposed technique to decrease patient anxiety and improve comfort during an already uncomfortable examination. However, little research has focused on this modality to date.

The purpose of this study is to investigate whether the mirror pelvic exam decreases the level of vulnerability and discomfort experienced during the pelvic examination.

Eligibility Criteria:
Inclusion Criteria:

* New patients undergoing a pelvic exam performed by a physician at Cincinnati Urogynecology Associates, TriHealth

Exclusion Criteria:

* Existing patients
* Unwillingness to participate in the study
* Physical or mental impairment that would affect the subject's ability to visualize the mirror during examination or to complete questionnaires
* Inability to understand English