cyrilzakka/clinical-trials huggingface dataset:
Methemoglobinemia in Young Patients With Hematologic Cancer or Aplastic Anemia Treated With Dapsone

RATIONALE: Gathering information about how often methemoglobinemia occurs in young patients receiving dapsone for hematologic cancer or aplastic anemia may help doctors learn more about the disease and plan the best treatment.

PURPOSE: This research study is looking at methemoglobinemia in young patients with hematologic cancer or aplastic anemia treated with dapsone.

OBJECTIVES:

* Define the incidence of methemoglobinemia in patients with hematologic malignancy or aplastic anemia who received dapsone prophylaxis through a retrospective chart review encompassing the last 15 years.
* Identify major risk factors for developing methemoglobinemia.

OUTLINE: Medical charts are reviewed. Of particular interest is demographic information, reasons for beginning dapsone prophylaxis, duration of dapsone prophylaxis, dapsone dosing, methemoglobin level, and treatment with methylene blue.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of hematologic malignancy or aplastic anemia

  * Treated within the past 15 years with dapsone prophylaxis during treatment of primary disease

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients With Onset of Type 1 Diabetes

Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells; as a result, patients with T1DM are dependent on exogenous insulin to control their blood glucose continuously. Bone marrow-derived mesenchymal stem cells has been shown in many animal studies their potential cure for T1DM,which could not only address the need for β-cell replacement but also control of the autoimmune response to cells which express insulin. Therefore it is need to study the safety and efficacy of autologous bone marrow mesenchymal stem cells in treatment of newly diagnosed patients with T1DM.

Autologous transplantation of Bone marrow mesenchymal stem cells(approximately 2.5 x 106 cells/kg body weight) intravenously

Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide written informed consent from patients or Child guardian
2. Confirmed diagnosis of type 1 diabetes by ADA criteria less than 18 weeks •

Exclusion Criteria:

1. Body Mass Index \>30
2. Presence of acute stage as Active infection,recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.
3. Severe Organ damage(e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).
4. Infectious diseases, e.g. HIV infection, or hepatitis B or C infection
5. Presence of malignancy
Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance

This study aims to learn about the needs and feelings of women who are infertile. Being infertile means not being able to have a child without the help of a third party. There are other options for building a family. The researchers are interested in the participants' thoughts about these options and want to learn about the experiences of infertile women due to cancer treatment as well as women who are infertile due to other causes. The researchers hope that what they learn will allow them to better care for infertile women in the future.

As part of this study, you will be asked to fill out a series of questionnaires. These questions will ask about your feelings, sexual function, quality of life, and ideas about reproductive options. We will also ask some questions about you, your health, and your medical history. You can choose to answer these questions either at one of your doctor visits or over the telephone. You can decide the best way to complete this assessment.

Eligibility Criteria:
Inclusion Criteria:

Study group of gynecologic cancer survivors and BMT/SMT cancer survivors:

* History of a primary diagnosis of gynecologic cancer or history of any primary malignancy treated with BMT/SCT
* No evidence of disease for at least one year
* At least 18 years of age not greater than 49 years of age at time of study recruitment
* No other cancer history
* Have impaired fertility: lack of uterus but intact ovaries or lack of ovaries or lack of ovarian function based on the FSH determination but intact uterus
* Have not started or have not completed childbearing
* Able and willing to provide informed consent
* Ability to comprehend and complete questionnaire in English

Comparison Group of non-cancer infertile women awaiting egg (oocyte) donation:

* No cancer history
* At least 18 years of age not greater than 49 years of age at time of study recruitment
* In ovarian failure and on a waiting list for egg (oocyte) donation
* Have not started or have not completed childbearing
* Able and willing to provide informed consent
* Ability to comprehend and complete questionnaire in English

Exclusion Criteria:

* Inability to participate in an informed consent process
* Patients with a psychiatric disorder precluding response to the survey
Vitamin D Metabolism and the Williams Syndrome

The Williams syndrome is a disease in which supravalvular aortic stenosis, an elfin facies, mental retardation and other congenital defects are sometimes associated with abnormal vitamin D and calcium metabolism. Whereas some patients have been reported to show increased sensitivity to vitamin D or an exaggerated response of serum 25-hydroxyvitamin D {25(OH)D} to administration of vitamin D and to have hypercalcemia caused by increased circulating 1,25-dihydroxyvitamin D{1,25(OH)2D} in infancy and early childhood, most patients have normal calcium metabolism and normal values for circulating 25(OH)D and 1,25(OH)2D. We propose to carry out further studies of vitamin D metabolism to elucidate the mechanism(s) for abnormal vitamin D metabolism. We will determine the response of serum 1,25(OH)2D to administration of 1,25(OH)2D3. Measurement of the 1,25(OH)2D in the patients compared to normal subjects will be the primary outcome.


Eligibility Criteria:
Age 18 years to 50 years of age, patients and normal subjects
Effects of Alkaline Phosphatase on Renal Function in Septic Patients

Septic shock is the most common cause of death in patients requiring intensive care. The kidney is one of the first organs to fail, stressing the importance to search for clinical interventions that may protect the kidneys during sepsis.

Alkaline phosphatase functions as a host defence molecule and is present in many cells and organs (e.g. intestine, placenta, liver, kidney and bone). Alkaline phosphatase has a dual mode of action. First, it binds to and, subsequently, dephosphorylates lipopolysaccharide (LPS). Second, the enzymatic reaction product monophosphoryl-LPS is a non-toxic substance for mammals which acts as a partial antagonist on the LPS receptor complex. In several animal studies, administration of alkaline phosphatase attenuates the inflammatory response and reduces mortality.

It is unknown whether these results can be extrapolated to septic patients . We studied the effects of alkaline phosphatse administration on kidney damage and function in patients with severe sepsis or septic shock.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Proven or suspected Gram-negative bacterial infection
* Two out of four Systemic Inflammatory Response Syndrome (SIRS) criteria existing for less than 24 h
* Acute onset of end-organ dysfunction in the preceding 12 h

Exclusion Criteria:

* Prior therapy with alkaline phosphatase
* Known allergy for cow milk
* Probable death within 24 h
* Chronic renal failure requiring hemodialysis or peritoneal dialysis
* Acute pancreatitis with no established source of infection
* HIV seropositive
* Pregnant or lactating
* Confirmed Gram-positive or fungal sepsis
* Treatment with immunosuppressants including high doses of glucocorticosteroids
Impact of Continuous Defocused CO2 Laser Vaporisation on the Histological Malignant Transformation of Erosive Oral Lichen Planus in Patients

Oral Lichen Planus (OLP) is a common condition with its erosive variant occasionally presenting a management challenge to the clinician. In addition it can have debilitating consequences on the patients' quality of life. The malignant transformation of OLP has been well documented. The aims of this work were to measure the number of patients developing malignant transformationof OLP to squamous cell carcinoma (SCC) comparing patients undergoing traditional symptomatic treatments with those patients that were treated by CO2 laser from 2004 - 2011. Outcome measures were rated by incisional biopsy (histology Report).


Eligibility Criteria:
Inclusion Criteria:

* Oral lichen planus
* Histological confirmation of diagnosis
* Patient willing for treatment

Exclusion Criteria:

* Patient just does not want to participate as control/study group
Is Routine Use of Histopathological Examination Necessary After Cholecystectomy ?

Cholecystectomy has been made with benign conditions usually. The aim of this study is to compare the macroscopic evaluations of the cholecystectomy specimens with it's histopathological examinations.

Cholecystectomy is one of the most frequently performed surgery in the world and often made with benign conditions. Routinely cholecystectomy specimens sent for histopathologic examination. The histopathologic examination of the cholecystectomy specimens are benign in most of the cases and the incidental malignancy of the gallbladder is 2-2.9% in the literature. The histopathologic evaluations of the gallbladder come with additional workload for pathology and surgery departments. Also there is additional cost for the patients. Because of that the idea of selective histopathologic examination has been raised.

Eligibility Criteria:
Inclusion Criteria:

* Subject has cholelithiasis

Exclusion Criteria:

* Subject has acute cholecystitis
* Subject has perforated gallbladder
* Subject has malignancy
* Subject has polyps in the gallbladder
* Subject has increasing wall thickness of the gallbladder
* Subject has malignancy in the preoperative ultrasonography in the gallbladder
* Subject has pregnancy
A Study To Investigate And Describe The Treatment Patterns And Effect Of Tofacitinib Indicators For Patients With Rheumatoid Arthritis

This study is to investigate and describe the treatment patterns and effect of tofacitinib indicators for patients with Rheumatoid Arthritis (RA) assessing real world patient data entered in the Corrona RA Registry on or after November 2012


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the Corrona RA Registry and initiated tofacitinib on or after November 2012
* Initiate tofacitinib (defined as first ever use of tofacitinib) at the Corrona enrollment visit or at a Corrona follow-up visit from November 2012 onward.
* Have CDAI measured at baseline
* Have at least a 6-month follow-up visit and CDAI measured at the 6-month follow-up visit

Exclusion Criteria:

* There are no exclusion criteria for this study
Evaluation of the Arthritis Foundation Tai Chi Program

The primary goal of this study is to assess the effectiveness and feasibility of the arthritis foundation (AF) Tai Chi Program for People with Arthritis. Arthritis, the most prevalent chronic condition in the US and a leading cause of disability, is characterized by chronic pain and progressive impairment of joints and soft tissues. Promoting physical activity is a key public health strategy to addressing arthritis management, but more scientific data regarding effectiveness and feasibility are need to support the promotion of the AF Tai Chi Program as an exercise intervention for people with arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Self-Reported doctor diagnosed arthritis
* Age 18 years or older
* Able to move independently without assistance

Exclusion Criteria:

* Pregnancy
* Non-English speaking
* Cognitive impairment
* Serious medical conditions: History of MI, stroke, prescribed beta-blockers, surgery in past 6 months, uncontrolled hypertension, chest pain, diabetes mellitus
* Severe impairment of physical functioning
* Participation in Tai Chi exercise in last 3 months
Clinical Trial to Evaluate the Pharmacokinetic Characteristics of DW5221 and DW5221-R

A bioequivalence study to compare and evaluate the pharmacokinetic characteristics and the safety after administration of DW5221 and DW5221-R in healthy adult m ale volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy Male Volunteers who are ≥19 years old
* Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 and

Exclusion Criteria:

* Clinically significant Medical History
Anti-Restenosis After AMI by Erythropoietin

The EPOC-AMI study is to assess the safety and the efficacy of systemic administration of erythropoietin for inhibition of neointimal hyperplasia after stent implantation in the patients with acute myocardial infarction

Stents coated with sirolimus or paclitaxel have been shown to significantly reduce restenosis in selected coronary lesions. However, the potential risk of late stent thrombosis forces prolonged treatment of dual anti-platelet regimen to all the patients after implantation of drug eluting stents. Patients with acute myocardial infarction may have uncertain clinical characteristics, such as occult bleeding focus or further need for surgical procedures. Thus, bare metal stent is considerably alternative for primary PCI after AMI and there remain an appreciable number of patients at risk for restenosis. Use of systemic pharmacological therapy to inhibit coronary stent restenosis of bare metal stent has been largely unsuccessful. We have reported that erythropoietin could enhance reendothelialization leading to inhibition of in-stent restenosis by directly protecting endothelial apoptosis and mobilizing endothelial progenitors. The EPOC-AMI study is designed to assess the safety and the efficacy of systemic administration of erythropoietin aiming inhibition of neointimal hyperplasia after stent implantation in the patients with acute myocardial infarction.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute myocardial infarction within 12hrs of symptom onset.
* Succeeded reperfusion due to primary PCI accomplished bare metal stent

Exclusion Criteria:

* Patients with cardiogenic shock (e.g. systolic BP\<80mmHg,use of catecholamine, use of IABP)
* Patients with anemia required transfusion
* Patients who are unwilling or unable to comply with the trial protocol
Work Ability-Productivity Among Clinical Health Workers Endometriosis Study

A qualitative multicentre study protocol. The prospective research explores clinical health workers with a diagnosis of endometriosis, experiencing regular pain and their perceptions of work ability-productivity.

Endometriosis has a significant impact on women at work physically, psychologically, and socially. Notably, pain is the most common reported concern, and considerably reduces work ability and productivity. However, previous research has principally focused on general workers, discounting the varied nature of work roles. Health workers appear to have an increased occupational risk of developing the condition, when compared with other shift workers and the general working population. Taking these findings into account, the prospective WORK ACHES study explores the relationship between clinical health workers' regular endometriosis pain, and their perceptions of work ability-productivity during such events.

This multicentre qualitative study will invite employees with a diagnosis of endometriosis and working in clinical settings, to participate in the study. Recruitment will be carried out through study posters displayed in staff areas and occupational health departments, as well as snowballing methods. Semi-structured interviews will take place via Microsoft Teams to discuss participants' experiences of endometriosis pain at work and their work ability-productivity while symptomatic. Thematic analysis will be performed to interpret the data.

The study has sought ethical approval from Birkbeck University of London's ethics Committee, the Integrated Research Application System and the Health Research Authority. Following the completion of the study, a summary of findings will be shared with participants and agreed hospitals. The full study report will also be disseminated to all parties involved and accessed through the University of London's library thesis collection and published in relevant specialty journals.

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 18-65 years.
* Employed working within a clinical setting health role.
* English speaking.
* Currently working full or part time hours.
* Diagnosis of endometriosis (as reported by participant, as medical records will not be accessed for the purpose of this study).
* Experiences regular endometriosis associated pain.

Exclusion Criteria:

* Painful comorbidities.
* Unemployed women.
* Pregnant women.
Comparison of Multiple Oxygenation Targets With Different Oximeters in Chronic Obstructive Pulmonary Disease (COPD) and Non-COPD Patients- Impact on Oxygen Flows

The oximeter is an instrument for monitoring patients receiving oxygen therapy. It displays pulse oxygen saturation (SpO2), which is a reflection of arterial oxygen saturation (SaO2). An accurate SpO2 value is essential for optimal management of the O2 flow delivered to patients. Several factors can influence this measurement and the choice of ventilatory support: the type of oximeter used, skin pigmentation and the oxygenation goal.

The objective of our study is to evaluate the impact of the oxygenation goal and the oximeter used on oxygen flows in patients with COPD (or with hypercapnia, or at risk of hypercapnia) and in patients without COPD (in particular pneumonia, pulmonary fibrosis and other pathologies) Our hypothesis is that the SpO2 target and oximeter used will have an impact on oxygen flows and that these effects will be synergistic in these different populations.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* On conventional oxygen therapy with SpO2 between 88 and 100% with the usual oximeter and nasal cannula.
* SpO2 \< 92% in ambient air with the usual oximeter

Exclusion Criteria:

* No availability of the SpO2 signal with the usual oximeter
* False nails or nail polish
* Severe anemia documented on the last blood count during the current hospitalization (Hb \< 80g/L)
Endothelial Function Study Before Cardiovascular Surgery

The aim of this clinical trial is to evaluate the effect of chronic obstructive pulmonary disease (COPD) and/or obstructive sleep apnea syndrome (OSAS) on the endothelial function, before cardiovascular surgery, compared to non COPD non OSAS patients undergoing also a cardiovascular surgery, by an observational physiological study.

An interim analysis will be performed when 100 patients will be included.

Secondary objectives of this clinical trial :

* To evaluate the effect of COPD and/or OSAS on the systemic inflammation, insulin-resistance and oxydative stress, in comparison with non COPD non OSAS patients.
* To evaluate the effect of COPD and/or OSAS on the inflammation and oxydative stress of the adipose tissue, in comparison with non COPD non OSAS patients.
* To validate the STOP-BANG questionnaire in patients undergoing a cardiovascular surgery

Eligibility Criteria:
Inclusion Criteria:

* Men or women between 18 and 80 years old
* Patient with planned coronary artery bypass graft surgery
* Patient with planned peripheral vascular surgery
* Patient with aortic surgery

Exclusion Criteria:

* Patient with aortic or mitral valvular replacement
* Patient with emergency peripheral valvular surgery
* Patient with emergency coronary artery bypass graft surgery
* Patient with evolutive malignancy disease
* Pregnant or lactating women
* Patient with inadvisable bronchodilator (used for functional respiratory) exploration
Evaluation of Potentially Bioactive Foods With Respect to Cardiometabolic Test Variables

The overall goal is to increase the knowledge that can be used for the development of food products with antidiabetic properties, with the aim of facilitating healthier food choices for people. More specifically, the primary aim of this project is to evaluate the effects of different varieties of quinoa on postprandial glucose tolerance and subjective appetite markers. The crossover, randomised dietary intervention study will be conducted in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* BMI of 20-28
* age between 18-40 years
* Healthy
* consume a diet in accordance with Nordic Nutrition Recommendations

Exclusion Criteria:

* not vegan
* metabolic diseases (such as diabetes)
* Gastro intestine tract problems or irritable bowel syndrome
* known food allergies of intolerances
* smoker
* antibiotics should not have been consumed during the last 4 weeks
* probiotics should not have been consumed during the last 4 weeks
Cardiac Catheterization in Cardiac Arrest

This is a pilot study that will lead to a large randomized control trial (RCT), to assess whether early versus late or no cardiac catheterization is associated with improved outcomes in out-of-hospital cardiac arrest (OHCA) patients.

A pilot multicenter RCT.

The objectives of the study are:

To assess whether early (within 12 hours) cardiac catheterization is associated with improved survival, neurologic and cardiovascular outcomes in OHCA patients.

Patients will be randomized 1:1 to early cardiac catheterization, performed as early as possible, within 12h post return of spontaneous circulation (ROSC) following OHCA, or to standard practice, which may include medical management without cardiac catheterization or late cardiac catheterization after completion of therapeutic hypothermia. Percutaneous coronary intervention (PCI) is recommended for culprit lesions found on diagnostic angiography. All patients will undergo therapeutic hypothermia started as soon as possible with target temperature below 36°C according to local practice. Other medical management will be according to standard of care

Eligibility Criteria:
Inclusion Criteria:

* Glasgow Coma Scale score \<8 on hospital admission following OHCA of presumed cardiac cause.
* Initial rhythm ventricular tachycardia (VT) / ventricular fibrillation (VF), who achieved ROSC sustained for \>20 consecutive minutes

Exclusion Criteria:

* ST-elevation on any of the ECGs post resuscitation
* Hypothermia \<30°C
* Interval from ROSC to screening of \>12h
* Suspected or known acute intracranial hemorrhage or stroke