cyrilzakka/clinical-trials huggingface dataset:
The Utility of Ischemia Modified Albumin (IMA) in Sepsis

The purpose of this study is to determine if levels of ischemia modified albumin (IMA) in blood are elevated in patients with suspected infection and are predictive of severity of illness in patients with sepsis.

In order to compare subjects with infection to those without infection who are representative of the ED population at each site, a group of non-infected control patients will be enrolled. Each hospital will enroll subjects with age (by decade) and sex matched controls to reflect the population of subjects suspected of infection.

Sepsis is an unconquered challenge in medicine, affecting people of all ages and demographics. Severe sepsis affects approximately 751,000 patients in the United States per annum, with healthcare costs approaching $16.7 billion dollars a year. Mortality from severe sepsis and septic shock approaches 30 - 70 % with 215,000 deaths annually. Thus, sepsis is a disease with healthcare dollars and mortality rates approaching those of heart disease and cancer.

Identifying patients with sepsis, and in particular hypoperfusion, is a challenge to the clinician. A variety of clinical and laboratory findings are helpful, but there is no single test to identify sepsis or assess its severity.

Ischemia and reactive oxygen species play a significant role in the pathogenesis of sepsis. Moreover, there is evidence to suggest that septic shock results in dysfunction of autoregulatory mechanisms and misdistribution of blood flow, precipitating both regional and global ischemia. A method that can help rapidly assess hypoperfusion would be clinically useful. Ischemia modified albumin (IMA) is a potential marker for ischemia in acute coronary syndrome patients; thus, it is hypothesized that IMA may be also useful as a prognostic biomarker for clinical identification of infection and the severity of illness in patients with sepsis.

Eligibility Criteria:
Inclusion Criteria for Sepsis Subjects:

* 18 years of age or older
* Able to provide informed consent
* Clinical suspicion of infection

Exclusion Criteria for Sepsis Subjects:

* Active chest pain of suspected cardiac origin
* ST elevation myocardial infarction or dynamic ST changes on EKG
* Pregnant women
* Cocaine use
* Liver disease
* Unable to speak or understand the English language

Inclusion Criteria for Control Subjects:

* 18 years of age or older
* Emergency Department presentation as a result of a non-infectious etiology as determined by the treating clinicians
* Able to provide informed consent

Exclusion Criteria for Control Subjects:

* Suspected Infection
* Temperature \>100.4°F
* Pregnant women
* Possible cardiac, intestinal or cerebral ischemia
* Liver disease
* Any source of inflammation as part of their presentation
* cancer, any type
Outcomes in Spontaneous and ART Twin Pregnancies

During the last decades, assisted reproductive technique has been transformed from a miracle to real and has become widely used for treatment human infertility.

this was associated with increased the rate of twin pregnancies

Twin pregnancies are associated with an increased risk of maternal mortality \& morbidity and an increase in the incidence of neonatal morbidity and mortality compared to singleton pregnancy.

The heterogeneous results reported so far can also depend on differences in the studied populations and/or in the management approach to twin pregnancy, variability in data regarding neonatal and maternal outcomes.

Evidence on pregnancy outcomes of twins conceived by artificial reproductive technology (ART) compared with those naturally conceived (NC) is conflicting, A 2004 systematic review and a large 2008 study both were praised that in cases of twin pregnancy after assisted conception the perinatal mortality is significantly lower, when compared with those spontaneously conceived .

Eligibility Criteria:
Inclusion Criteria:

* Twin delivered \>24-week gestational age
* weight ≥ 500g
* Diachronic diamniotic twins.

Exclusion Criteria:

* Intrauterine fetal deaths
* Higher-order multiple pregnancies
* Deliveries complicated by early vanishing fetuses
* Twin pregnancies reduced to singleton
* Triple pregnancy reduced to twin.
Rituximab-Induced Hypogammaglobulinemia in Multiple Sclerosis

B cells are considered major contributors to multiple sclerosis (MS) pathogenesis, a role that has taken on renewed importance with the advent of B-cell-depleting therapies. Rituximab is being increasingly utilized as an off-label treatment option across MS patients .

In addition, there have been increasing reports of rituximab causing hypogammaglobulinaemia and antibody deficiency across a variety of conditions including MS and related neuroinflammatory disorders.

Therefore, the purpose of this study is to evaluate the rate of hypogammaglobulinemia in rituximab-treated MS adult patients and to assess the correlation with vaccination response during the treatment.

This is a prospective study which will be conducted in an educational medical hospitals in Sari, Iran.Adult patients with diagnosis of multiple sclerosis compatible with 2017 McDonald criteria and history of treatment with rituximab at least 3 times( 18 month) , enrolled to this study.Demographic patients' characteristics, including age, sex, vital sign, past medical history, drug history, will be recorded. Disease duration prior to rituximab, total rituximab dose, prior immunomodulatory drugs, Adverse drug reactions, the time interval between the last rituximab infusion and need for intravenous immunoglobulin replacement therapy and infections are recorded. Moreover, we will assess IgG and IgM levels, VZV titer at before rituximab administration and 6, 12, 18, months following the initiation of next dose of rituximab.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of multiple sclerosis compatible with 2017 McDonald criteria
2. history of treatment with ritximab at least for 18 month
3. written informed consent

Exclusion Criteria:

1. history of IVIG intake in 3 past month
2. history of plasmapheresis in 3 past month
3. unknown vaccination history
4. any indication for concurrent use of immunomodulator or immunosuppressor drug
Prediction of Relapse Risk in Stable Systemic Lupus Erythematosus

Whether and when systemic lupus erythematosus (SLE) patients with stable disease should withdraw glucocorticoid (GC)? How about the relapse risk? What are the risk factors for disease flare? All the above are unclear. Long-course GC treatment has a lot of side-effects even in a sustaining low dose. The aim of this study is to explore the relapse risk after GC withdrawal in SLE patients with stable disease more than one year and to establish a predictive model for flare risk stratification.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with a relapsing-remitting course. For patients in remission, glucocorticoid (GC) is used to be maintained in a low dose for a long time in fear of disease flare. Long-term GC could bring a lot of side-effects even in a low dose. Whether and when patients with stable disease should withdraw GC? How about the relapse risk? What are the risk factors for disease flare? All the above remain unclear. The aim of this study is to explore the relapse risk after GC withdrawal in SLE patients with stable disease and to establish a predictive model for risk stratification. Meanwhile the investigators aim to testify the effects of hydroxychloroquine in preventing SLE relapse. This study is an open-labeled randomized controlled clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* SLE diagnosis fulfilled the Systemic Lupus International Collaborating Clinic revision of the American College of Rheumatology Classification Criteria for SLE
* Disease stabilized ≥ 1 year
* SELENA-SLEDAI ≤ 3
* Anti-double strand DNA negative by IF measurement and ≤ 200IU/ml by ELISA method
* Complement 3 (C3) ≥ 0.5\*lower limit of the normal range, and fluctuation of the C3 is less than 10% within the last year
* 24 hour urine protein ≤ 0.5g
* Prednisone (or equivalent) ≤ 7.5mg/d for more than 6 months
* No use of immunosuppressants including CsA, MMF, CTX, FK506, LEF, MTX in recent 6 months. But hydroxychloroquine (HCQ) is permitted and should be in use
* Never use biologic agents including Rituximab, Belimumab, Epratuzumab and so on
* No severe organ involvement in recent 2 years including lupus encephalosis, diffused alveolar hemorrhage, thrombotic thrombocytopenia purpura, rapid progressive glomerulonephritis, severe thrombocytopenia, severe hemolytic anemia, myocardial involvement, myeleterosis or severe peripheral neuropathy

Exclusion Criteria:

* Active SLE
* In pregnancy or breastfeeding, plan for pregnancy
* Plan or has been on a surgery in recent 6 months
* Current infection
* History of malignancy
* Severe organ dysfunction or other complications
* Unable to follow up
* Inappropriate to be enrolled
* Psoriasis, porphyria, arrhythmia or eye diseases that contradict with HCQ usage
LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Urinary Tract Infection (cUTI)

The purpose of the study is to evaluate whether LYS228 can be developed for the treatment of complicated urinary tract infections


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 18 to 85 years of age with suspected and/or bacteriologically documented complicated UTI judges by the investigator to be serious (required patient to be hospitalized for treatment with intravenous antibiotics)

Exclusion Criteria:

* Urine Gram stain that demonstrated that a Gram-positive organism was present, or if urine culture results were available, demonstrated Gram- positive organisms were present at ≥10E5 CFU/mL
* Urine culture result available at enrollment and demonstrating more than 2 different species of microorganisms regardless of the colony count
* Urine culture result available demonstrating fungal UTI with colony count \>10E3 CFU/mL
* Patient had received prior antibiotics within 72 hours before the initiation of study therapy
* Patients with estimated glomerular filtration rate \< 30mL/min calculated based in study qualified formula
Effect of a New Formulation of Torasemide (Prolonged Release)on Myocardial Fibrosis in Patients With Heart Failure.

Torasemide is a loop diuretic (pyridine-sulfonylurea)with a wide experience in the treatment of oedema associated to heart failure, kidney or liver disease and either in the treatment of arterial hypertension (alone or combined with other anti-hypertensive drugs). It has been developed a new formulation of Torasemide (Torasemide prolonged release).

The aim of this trial is to study the effects of Torasemide prolonged released in comparison with furosemide, in the reduction of myocardial fibrosis in patients with chronic heart failure (Class II-IV of the New York Heart Association Classification.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 18
* Patients with chronic heart failure class II-IV (NYHA)due to arterial hypertension
* Patients clinically stable who required diuretic treatment
* Patients with left ventricular hypertrophy diagnosed by echocardiogram
* Patients without ischaemic cardiopathy or non recent disease
* Signed Informed Consent

Exclusion Criteria:

* Heart Failure due to aortic stenosis or hypertrophic myocardiopathy
* Recent coronary syndrome (less than 3 months)
* Recent myocardial infarction (less than 6 months)
* Unstable angor pectoris
* Severe cardiac arrhythmia
* Pregnancy or breastfeeding
* Aldosterone antagonists (last 6 months)
* Current loop diuretic treatment over study doses (torasemide \> 10mg/day furosemide \> 40 mg/day)
* known hypersensitivity to study drugs
* Liver disease (SGPT or AST \> twice upper normal limt)
* Renal impairment (Serum creatinine \> 2,5mg/dl)
* Insulin-dependent diabetes
* Patient included in another simultaneous study
* Lactose intolerance
* Lithium Concomitant treatment
* Chronic treatment with NSAIDs
* Concomitant treatment with aminoglycoside antibiotics,etacrynic acid
The Evaluation of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of QDX in Healthy Korean Male Subjects

To evaluate pharmacokinetic/pharmacodynamic characteristics and safety of QDX after single oral administration in healthy Korean male subjects


Eligibility Criteria:
Inclusion Criteria:

* Participants who have fully understood this clinical trial via detailed explanation, are willing to voluntarily participate in this study, and agree to give written informed consent which is confirmed from IRB.
* Healthy male participants aged between 19 and 45 years at screening
* Those whose body weight is over 50kg, and BMI is between 18.0 and 27.0
* Participants who have demonstrated at least a 100 percent (%) increase in dermal blood flow in 30 minutes after capsaicin challenge as part of the screening procedures.

Exclusion Criteria:

* Those who have a clinically significant disease of liver, kidney, digestive, respiratory, endocrine, neurologic, blood/tumor, cardiovascular system, or history of those diseases
* Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs (containing Topiramate etc.)
* Those who have a hereditary galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption syndrome
* Those who have irritating skin, wounds, eczema, and wounds on the area where capsaicin is applied
Induction FOLFIRINOX Followed by Chemoradiation in Locally Advanced Pancreatic Cancer

There is no a clear consensus regarding the optimal treatment strategy of locally advanced pancreatic cancer. There is a potential role for neoadjuvant therapy to treat micrometastatic disease with chemotherapy, as well as for the treatment of local disease with radiotherapy. The investigators evaluated the safety and efficacy of induction FOLFIRINOX followed by a high weekly dose of gemcitabine concurrent to radiation therapy in patients with borderline resectable and unresectable locally advanced pancreatic cancer (LAPC).

Continued optimization in multimodality therapy and an accurate patient selection remain crucial points for the appropriate treatment of patients with pancreatic cancer. In all patients an accurate pre-treatment staging was performed, including multilayer CT scan, positron emission computed tomography (PET-CT) with 18F-2-fluoro-2-deoxy-D-glucose (FDG) and laparoscopy with peritoneal washing. Patients with the evidence of metastatic disease were excluded, and thus only a small number of patients was consequently enrolled with this approach.The induction phase of the treatment plan was designed to administer FOLFIRINOX protocol (oxaliplatin 85 mg/mq and irinotecan 180 mg/mq plus leucovorin 400 mg/mq followed by bolus FU 400 mg/mq on day 1, then FU 2,400 mg/mq as a 46-hour continuous infusion) every 14 days for four cycles. In the combined phase of the treatment radiotherapy target volumes were established by CT scan and PET-CT scan. Concurrent chemotherapy consisted of gemcitabine at the dose of 600 mg/mq weekly. Four weeks after the completion of radiochemotherapy, restaging including CT scan and PET-CT scan was performed. Tumor response was defined in accordance with the World Health Organization (WHO) definition through CT scan and PET-CT scan. Surgery was considered in patients whose tumors were technically resectable. After resection, patients were evaluated every three months by means of a standard surveillance protocol that included history and physical examination, cross-sectional imaging and measurement of serum markers, and the intervals were extended to six months after two years

Eligibility Criteria:
Inclusion Criteria:

* proven cytological or histological diagnosis of pancreatic ductal adenocarcinoma;
* borderline resectable or unresectable pancreatic tumours;
* no previous radiochemotherapy to abdomen;
* 0-I Eastern Cooperative Oncology Group (ECOG) performance status;
* adequate cardiac, liver and kidney function and a good bone marrow reserve.

Exclusion Criteria:

* resectable and metastatic disease;
* previous or concomitant malignant disease;
* one or more of the following clinical conditions: infection, pregnancy or breast-feeding, liver failure, kidney failure, Pa O2 \< 65 mmHg, Pa carbon dioxide (CO2) \> 40 mmHg, mental disability.
The Effect of Rectal and Sublingual Misoprostol Administration in Postpartum or Intrapartum Haemorrhage at Elective Caesarean Delivery: a Randomized Controlled Trial

The investigators hypothesis in this study is that administration of rectal and sublingual misoprostol decreases intrapartum and postpartum haemorrhage.


Eligibility Criteria:
Inclusion Criteria:

1. live and singleton pregnancy
2. Elective caesarean
3. Gestational week greater than 37 weeks
4. patient between 18-44 year old

Exclusion Criteria:

1. -multiple pregnancy
2. Preeclampsia
3. Gestational diabetes
4. Macrosomia
5. Oligohidraamnıos
6. Polihidraamnıos
7. Myoma
8. Morbid obesity
9. Coagulatıon defect (such as HELLP syndrome)
REal World Information on Cardiovascular Drug Management Patterns in Acute Coronary Syndrome paTients

RE-ACT is a national, multi-centre, observational, prospective, longitudinal cohort study which will include patients hospitalized for ACS within 24 hours of symptom onset and who have a final diagnosis of ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI). This study aims to describe the short-term (at the end of the first month after index event) antithrombotic management patterns in a "real-life" setting for patients hospitalized with an acute coronary syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Provision of subject informed consent
* Patients hospitalized and diagnosed with STEMI or NSTEMI
* Hospitalized within 24 hours of onset of symptoms or transferred from another hospital within 24 hours of the onset of symptoms

Exclusion Criteria:

* STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or GI bleeding or post-PCI.
* STEMI and NSTEMI occurring in patients already hospitalized for other reasons.
* Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances).
Tension Type Headache, Myofascial Release Therapy , Post Isometric Relaxation Technique

COMPARATIVE EFFECTS OF MYOFASCIAL RELEASE THERAPY AND POST ISOMETRIC RELAXATION TECHNIQUE ON PAIN AND FUNCTIONAL DISABILITY IN PATIENTS WITH TENSION-TYPE HEADACHE

Tension-type headache (TTH) is the most common type of primary headache, typically presenting as a bilateral, non-throbbing headache with mild to moderate intensity. Patients with tension-type headache often report band-like tightness and increased tenderness of the pericranial muscles. Use of myofascial release technique and post isometric relaxation technique is believed to reduce the pain and improve the functional disability.

Eligibility Criteria:
Inclusion Criteria:

* • Age range 25-45years14

  * Both male and females
  * Suffer from tension type headache more than three months
  * Head pain on bilateral location
  * may suffer from photophobia, phonophobia
  * Pericranial tiredness
  * not getting enough exercise or sleep

Exclusion Criteria:

* • History of teeth clenching or grinding

  * Cardiovascular disease
  * Pregnancy
  * arthritis in the neck
  * being overweight
Long-term Antibiotics for Treatment and Prevention of Otitis Media in Aborignal Children

This clinical trial was conducted in a population where tympanic membrane perforation occurs in 60% infants in the first year of life. Nasopharyngeal colonisation (nasal contamination) with pathogenic bacteria occurs within weeks of life and predicts persistent middle ear infection throughout childhood. The trial aimed to assess whether twice daily antibiotics commencing at first detection of middle ear effusion would cure the infection and/or prevent disease progression, compared to placebo.

The study was conducted in three remote Aboriginal communities in the Northern Territory of Australia. The annual birth cohort was 45.

Aboriginal infants were seen as soon as possible after birth, and at 2 weekly intervals until middle ear effusion was detected by pneumatic otoscopy and tympanometry. Following consent, infants were randomised to either amoxycillin(50 mg/kg/d BD) or placebo equivalent for up to 24 weeks, or until normal middle ear status was detected at 2 consecutive monthly scheduled examinations. At monthly examinations the infant also had a general health check, parents were interviewed, child's medical record was reviewed, and nasopharyngeal swabs were collected.


Eligibility Criteria:
Inclusion Criteria:

* Australian Aboriginal
* Living in participating remote community
* Less than 12 months of age

Exclusion Criteria:

* Less than 32 weeks gestation
* Chronic condition requiring continuous antibiotic
* Ear, nose or throat abnormality
Collecting Stem Cells in Patients With Waldenstrom's Macroglobulinemia

RATIONALE: Collecting and storing stem cells to study in the laboratory may help doctors learn more about collecting stem cells from patients who have undergone treatment for Waldenstrom's macroglobulinemia.

PURPOSE: This laboratory study is collecting stem cells from patients with Waldenstrom's macroglobulinemia.

OBJECTIVES:

* Harvest and store adequate CD34+ stem cells from patients with Waldenstrom's macroglobulinemia (WM) for potential future use in transplantation strategies.
* Evaluate the ability to harvest stem cells after therapy for WM (e.g., fludarabine-based chemotherapy) by evaluating the number of days to adequate harvest.
* Collect aliquots of stem cells for future research analysis as part of a WM database project.

OUTLINE: Patients undergo collection of autologous stem cells beginning on day 4 or 5 and continuing until an adequate number of stem cells are collected. Cells are then cryopreserved.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of Waldenstrom's macroglobulinemia (WM)
* Less than 30% lymphoplasmacytoid cells in bone marrow by histopathology
* Received prior chemotherapy for WM

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* WBC \> 2,000/mm³
* Platelet count \> 50,000/mm³
* LVEF ≥ 50%
* No organ dysfunction that would preclude future transplantation

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Anaesthesia for Ophthalmic Surgery: How "Retro" is the Peribulbar Block?

Ophthalmic surgery on the posterior section of the eye can either be performed under general anaesthesia or under local aneasthesia. The local anaesthesia is performed by injecting local anaesthetics behind the eye. There are two techniques: Either the needle is placed into the muscle cone formed by the four recti muscles - this is called intraconal or retrobulbar block, or the needle is placed outside of the muscle cone - this would be called extraconal or peribulbar. In our hospital the investigators usually perform the peribulbar block since it is easier to perform and has a smaller risk to injure the eye. The investigators however realize that the parabulbar block is sometimes very efficient and sometimes not, thus requiring a second or third injection. Now investigators are able to visualize where the local anaesthetics spreads with the help of ultrasound imaging. The aim of the study is to observe and to describe the incidence of intraconal spread of local anaesthetics when a peribulbar block is performed.


Eligibility Criteria:
Inclusion Criteria:

-informed consent

Exclusion Criteria:

* coagulation disorder
* INR over 1.5 and/or a platelet count less than 75 X 109/L,
* pathological myopia,
* inability of the patient to lie down for the operation for more than 2 hours
* lack of informed consent.