cyrilzakka/clinical-trials huggingface dataset:
Heparin Like Effect in Acute Variceal Bleeding

This study attempts to clarify the pathophysiology of haemostasis in relation to the evidence of sepsis in liver disease, and compares the accuracy of various available laboratory tests in assessment of these patients. Further research is needed for proper understanding of the influence of sepsis on coagulation disorders in acute variceal bleeding in cirrhosis, to correctly identify the type and optimal quantity of blood product requirement in at risk patients.

Thromboelastography (TEG) /Sonoclot has been proposed as a superior tool to rapidly diagnose and help guide resuscitation with blood products. Secondly, the study of derangement in coagulopathy after the onset of sepsis is of paramount importance because of increased mortality after the onset of sepsis. In the present study, patients with cirrhosis who present with acute variceal bleeding, will be included in the study cohort, and will undergo a baseline diagnostic workup as described. They will be followed for development of any signs of infection after hospitalization. Then the effect of sepsis on their coagulation and thrombin generation response swill be assessed. Thus the effect of sepsis on the progression and outcome of coagulopathy in patients with acute variceal bleeding will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Cirrhosis with acute variceal bleeding.

Exclusion Criteria:

* Patients with evidence of sepsis at presentation.
* Current therapy: Recent blood or blood component transfusion in the last 2 weeks.
* HIV positive/ AIDS patients
* Patients requiring antiplatelet therapy,
* Renal insufficiency requiring dialysis
* Active malignancy within the last 5 years
* Patient with other neurological disease and metabolic disorders, unbalanced heart failure and/or respiratory failure or end-stage renal disease
* Administration of anticoagulants, antifibrinolytics,
* Not willing to participate in the study
Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

The purpose of this study is to determine the safety and effectiveness of different dose regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at the time of signing the informed consent form
* Must be able to adhere to the study visit schedule and other protocol requirements
* Must have a documented diagnosis of B-cell CLL
* Must be relapsed or refractory to at least 1 regimen for treatment of CLL. At least one of the prior treatments must have included a purine analog-based or bendamustine-based regimen
* Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.

Exclusion Criteria:

* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
* Active infections requiring systemic antibiotics
* Systemic treatment for B-cell CLL within 28 days of initiation of lenalidomide treatment
* Alemtuzumab therapy within 120 days of initiating lenalidomide treatment
* Prior therapy with lenalidomide
* History of grade 4 rash due to prior thalidomide treatment
* Planned autologous or allogeneic bone marrow transplantation
* Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging.
* Uncontrolled hyperthyroidism or hypothyroidism
* Venous thromboembolism within 12 months
* ≥ Grade 2 neuropathy
* Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
* Disease transformation \[i.e. Richter's Syndrome (lymphomas) or prolymphocytic leukemia\]
* Participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating lenalidomide therapy
Correlation Between State-Trait-Anxiety-Inventory and Heart Rate Variability

The purpose of the study is to investigate whether there is a correlation between the vegetative stress evaluated by the State-Trait-Anxiety-Inventory (STAI-Test) and the measurement of heart rate variability (HRV). A subgroup analysis will also be performed to determine whether premedication contributes to a lower STAI score and/or heart rate variability. The primary outcome will be the parameter of frequency-based analysis Low Frequency (LF) and High Frequency (HF), and the STAI score. Secondary outcomes are the parameters Low Frequency/High Frequency-ratio (LF/HF-ratio), Standard deviation of normal-to-normal (NN) intervals (SDNN), Root Mean Square of successive differences" (RMSSD) and mean heart rate, age, gender, if they are smokers and if they work in shifts.


Eligibility Criteria:
Inclusion Criteria:

* Subjects between 18 and 65 years
* Elective surgery with a low risk of bleeding
* American Society of Anesthesiologists (ASA) classification 1-2
* metabolic equivalent of task (MET) \> 4

Exclusion Criteria:

* Pre-existing cardiac conditions such as heart failure, arterial hypertension,
* diabetes
* any central nervous system diseases
* cardiac pacemaker
* renal and hepatic insufficiency
* regional or peridural anesthesia
* Pregnancy, lactation
* Drugs that directly influence the autonomic nervous system
Beat the Blues: Treating Depression in African American Elders

The specific primary aims of the study are to:

1. Test the immediate effect of the intervention at 4-months on depression in urban African American older adults (primary trial outcome; between group comparison). Hypothesis: Participants in the intervention group will report fewer depressive symptoms in comparison to control group participants receiving usual care.
2. Test the maintenance effect of the intervention at 8-months on depression (within group comparison). Hypothesis: Participants in the intervention group will maintain reduced symptom presentation from 4 to 8 months.
3. Evaluate acceptability (social validity) of the intervention and extent of engagement in activities by study participants (both intervention and wait-list control subjects).

A secondary aim of this study is to assess the feasibility of conducting a clinical trial embedded in a community service setting and its dissemination using a community-academic partnership. We also propose three exploratory aims. First, we seek to evaluate the mechanisms of action, or pathways, by which treatment gains are obtained (Gitlin et al., 2000). Given that behavioral activation represents conceptually the key active ingredient of the proposed intervention, we plan to evaluate its mediational effect. Second, we seek to evaluate whether the intervention has a differential treatment effect based on a study participant's gender, age, and living arrangement (alone or with others). Given that previous research suggests that participant characteristics may moderate depressive symptoms and treatment outcomes, these exploratory analyses will provide insight as to whether this particular treatment benefits some groups more than others. Third, we seek to evaluate whether the intervention has short and long-term effects on quality of life, functional difficulty, and self-efficacy to manage day-to-day tasks. Previous research has shown that depressive symptoms exacerbate functional decline such that minimizing distress may have the added value of enhancing function and perceived efficacy for this group over time.


Eligibility Criteria:
Inclusion Criteria:

* African American
* ≥55 years of age
* English speaking
* Cognitively intact (MMSE \>24)
* Depressed as measured by a score ≥5 on the PHQ-9
* Must have a telephone
* Planning to live in the area for 8 months

Exclusion Criteria:

* Not African American
* \<55 years of age
* Does not speak English
* MMSE\<24
* Not depressed as measures by a score of \<5 on the PHQ-9
* Does not have a telephone
* Does not plan to live in the area for 8 months
Role of Placental Invasion Index in Decision Making of Placenta Accreta

This study will be conducted on women who have a diagnosis of placenta previ and using ultrasound to make the placenta invasion index and compare the accuracy of the diagnosis during the caesarean section whether it is accreta or not with determining the site and depth of invasion

This study will be conducted on women who have a diagnosis of placenta previ and using ultrasound to make the placenta invasion index and compare the accuracy of the diagnosis during the caesarean section whether it is accreta or not with determining the site and depth of invasion and whether there is injury occurred in the urinary system and Determining the amount of blood transfusion and admission of intensive care, or whether the patient death

Eligibility Criteria:
Inclusion Criteria:

* all placenta previa and low laying placenta will be included

Exclusion Criteria:

* patient with sever attack
A Dynamic Evaluation of Chronic Heart Failure Prognosis: the MECKI Score

The project is dedicated to the improvement of our capability to provide a precise and personalized prognosis in heart failure (HF) patients in stable conditions. The Metabolic Exercise test data combined with Cardiac and Kidney Indexes (MECKI) score is one of the 3 HF prognostic models recommended by the 2021 European HF guidelines and it is considered the most powerful prognostic tool available. MECKI score integrates cardiopulmonary exercise test (CPET) data with easy-to-obtain clinical, laboratory, and echocardiographic variables. It is based on 6 parameters: peak oxygen intake (peakVO2), minute ventilation/carbon dioxide production (VE/VCO2 slope), hemoglobin (Hb), Left Ventricle Ejection Fraction (LVEF), kidney function by Modification of Diet in Renal Disease (MDRD) formula, and sodium (Na+).

The aim of the present project is to assess the day-by-day MECKI score variability, CPET parameters interobserver variability, characterization of HF patients who change MECKI score values in 6 and 12 months, and the prognostic meaning of time dependent MECKI score changes.

This is a low-intervention multicenter clinical trial aim at evaluating the role of time dependent prognostic parameters changes, moving from the single shot evaluation to dynamic analysis. Each participant center will perform patients' recruitment and follow up. At the baseline visit, CPET-related variables, echocardiographic, ECG, therapy and blood chemistry data will be collected. The baseline CPET will be repeated within 2 weeks. Patients will perform 4 follow up visits at 6, 12, 18 and 24 months after the baseline visit. At every study step, study procedures aimed to calculate MECKI score will be performed:

* Echocardiography (Left Ventricle Ejection Fraction - LVEF)
* Blood sample (Na+, MDRD, Hb)
* Maximal ramp protocol CPET (peakVO2, minute ventilation/carbon dioxide production (VE/VCO2) slope - VE/VCO2 slope)

Eligibility Criteria:
Inclusion Criteria:

* Previous or present HF symptoms (NYHA functional class I-IV, stage B and C of ACC/AHA classification)
* history or presence of left ventricular ejection fraction (LVEF)\<40%
* unchanged HF medications for at least three months
* ability to perform a CPET
* no major cardiovascular treatment or intervention scheduled

Exclusion Criteria:

* History of pulmonary embolism
* moderate-to-severe aortic and mitral stenosis
* pericardial disease
* severe obstructive lung disease
* exercise-induced angina
* significant ECG alterations, or presence of any clinical comorbidity interfering with exercise performance
Registry of Patients Referred for Heart Transplantation

Main goal of the study is the risk stratification of patients with advanced heart failure referred for orthotopic heart transplantation (OHT) according to HFSS score, other risk factors and biological markers and verification of their prognostic value in Polish population.

PART I 23.10.2008- 31.12.2005 Creation of the Polish national registry of patients referred for cardiac transplantation and after heart transplantation - including urgency of qualification and prognosis.

Main goal of the study is the risk stratification of patients with advanced heart failure referred for orthotopic heart transplantation (OHT) according to HFSS score, other risk factors and biological markers and verification of their prognostic value in Polish population.

All patients with advanced heart failure referred as potential candidates for OHT in all active transplantation centers were included in the registry.

PART II 1.01.2006 -30.11.2007 Since 2006 only patients which were definitely enlisted on the waiting list for heart transplantation were included in the registry

Clinical and laboratory data were recorded in the internet based form. Clinical data included the etiology of the disease, NYHA class, duration of symptoms pharmacological therapy, left ventricular ejection fraction, Ergospirometric maximal oxygen uptake (V02 max) results and right heart catheterization results , ecg data of leading heart rhythm and QRS duration \>=0,12 s and other were stored Sodium ,NTproBNP levels and hs CRP plasma levels were recorded during first 48 hours of hospitalization. All patients were followed in a prospective cohort study until the end point : death or OHT , observations were censored at the end of the study. The urgency of OHT and death data was recorded by information from participating centers and national death registry quarries.

Primary end point : Death for all causes or urgent (UNOS 1) heart transplantation Secondary end point: Death without transplantation Death or heart transplantation

Substudy POLKARD HF registry - genetic polymorphism substudy Study start date 01.04.2004 end 30.10.2007

Study population: All consecutive patients included into POLKARD HF registry, who agreed to participate and signed ICF related to the substudy.

Estimated size 350 - 450 patients.

Aims: To describe the potential impact of selected candidate genes polymorphisms on the heart failure prognosis and the survival of patients after orthotropic heart transplantation

Eligibility Criteria:
Inclusion Criteria:

* men and women aged \>10 years with advanced heart failure
* referred as potential candidates for orthotropic heart transplantation

Exclusion Criteria:

* refusal to participate in the registry
* not enlisted for heart transplantation (since 2006)
Gabapentin Versus Estrogen for the Treatment of Hot Flashes

To compare the efficacy and safety of gabapentin, estrogen and placebo in the treatment of hot flashes and other climacteric symptoms.

HRT is associated with an increased risk of thrombo-embolic events, breast cancer and cardiovascular events. Safe, effective, and well-tolerated alternative therapies for hot flashes are needed. Gabapentin is a gamma-aminobutyric acid (GABA)-analog that we have reported is associated with a reduction in the frequency of hot flashes in postmenopausal women who were taking gabapentin for other indications. However, it is not known whether the efficacy of gabapentin in the treatment of hot flashes and other menopausal symptoms is comparable to that of estrogen, the gold standard. For this study, 60 subjects are to be recruited and randomized into 3 arms of 20 each (gabapentin, estrogen and placebo).We will perform an analysis of the results after all 60 subjects have been recruited, screened, enrolled and completed the study. The investigators of the study continue to be blinded to the study groups and their randomization. To determine if gabapentin approaches the efficacy of estrogen in the treatment of hot flashes,postmenopausal women between ages 35 and 60 with 7-20 moderate-severe postmenopausal hot flashes/day will be randomized into a double-blinded placebo controlled trial of estrogen, gabapentin and placebo. All patients must meet stringent inclusion and exclusion criteria. Pre- and post-study hot flash diaries, depression and climacteria scales will be collected. Patients are required to undergo physical examination and blood work and to complete a daily hot flash and medication compliance records. Hot flash frequency and composite score for hot flashes will be calculated for the three groups based on the hot flash diary. Side effects, climacteric scale and depression scales will also be used.

Eligibility Criteria:
Inclusion Criteria:

1. Menopausal women between ages 35-60
2. Must experience 7-20, moderate-severe hot flashes/day or 50-140 moderate-severe hot flashes/week for greater than two months
3. Must have had a bilateral salpingo-oopherectomy for \>12 months or amenorrhea\>6 months or #4 (below)
4. Has an FSH\>30 mIU/ml
5. Must have a signed informed consent
6. Able to function independent in all activities of daily living and be capable of reliable documentation

Exclusion Criteria:

1. Any contraindication to estrogen and progesterone replacement therapy
2. History of an MI, stroke, and/or functional decline.
3. Fails to record data in the hot flash diary\>3 days during the 2 week baseline period.
4. Unable or willing to make required visits at the specified times over the course of therapy.
5. History of any malignancies or undiagnosed vaginal bleeding.
6. History of chronic liver, gallbladder, chronic renal, cardiac or endocrine diseases
A Focus Group Study to Explore Smoking Triggers and Acceptability of Just-in-time Adaptive Intervent

This research intends to identify common smoking triggers and barriers to quitting smoking; understand useful and effective strategies for smoking cessation; and explore the feasibility and acceptability of mobile phone-based interventions among low-income smokers.

This research intends to identify common smoking triggers and barriers to quitting smoking; understand useful and effective strategies for smoking cessation; and explore the feasibility and acceptability of mobile phone-based interventions among low-income smokers.

Specific research questions of this research project are:

1. What are the common smoking triggers and barriers to quitting smoking for low-income smokers?
2. What are the preferred and useful smoking cessation strategies based on low-income smokers quitting experience?
3. What is the feasibility and acceptability of using a) text messages, b) virtual reality programs, and c) just-in-time adaptive smoking cessation interventions among low-income smokers?

Eligibility Criteria:
Inclusion criteria:

1. between 18 and 89 years old
2. current smokers
3. reside in Denver Metropolitan Area
4. have a personal cell phone
5. have a household income at or lower than 200% of the federal poverty level; and
6. ability to read and speak English or Spanish (since a large proportion of the low-SES population in Denver are Spanish speakers).

Exclusion criteria:

1. Unable to provide informed consent;
2. age ≥ 89 years;
3. unable to speak or understand English, or Spanish.
A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis

Spontaneous bacterial peritonitis (SBP) is a common and frequently fatal complication of end-stage liver disease with a mortality of up to 10% primarily due to the development of kidney failure. Current standard practice is to treat this infection with broad spectrum antibiotics and salt-poor albumin administration on day one and three of treatment. In this study the investigators test the hypothesis that the administration of a second dose of albumin at 48 hours only to patients with renal insufficiency is as effective at preventing kidney failure as administering the second dose to all patients at 72 hours. In addition, a kidney function determined approach to albumin dosing may lead to substantial cost and resource saving from decreased albumin use without compromising treatment efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75
* Evidence of end stage liver disease / cirrhosis
* Documented SBP (ANC \> 250 or positive ascites culture
* Ability to provide informed consent
* Serum Creatinine \> 1.0 mg/dL and/or Total Bilirubin \> 4.0 mg/dL

Exclusion Criteria:

* Nonportal hypertensive ascites (i.e. malignancy)
Effect of Weight Reduction on Immunity

This study included two groups of premenopausal healthy obese women. Experimental group underwent a weight loss program involved a low calorie diet plus anti-obesity drugs and moderate physical activity and control group underwent an ad libitum diet. At baseline and after a 10-15% weight loss lymphocyte subgroups were analyzed and compared between two group.

TCD3 and NKC CD16/56 were decreased significantly. Hence this weight loss program impaired viral immunity

Eligibility Criteria:
Inclusion Criteria:

* BMI \>=30
* female
* healthy
* no smoking
* not lactating
* not pregnant
* no medication use

Exclusion Criteria:

* pregnancy
* any disease
* any medication use
* iron and zinc deficiency
* any supplement use
4 Week Treatment With Three Oral Doses of BI 10773 in Patients With Type 2 Diabetes

Primary objective: safety and tolerability of BI 10773 in male and female patients with type 2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773


Eligibility Criteria:
Inclusion Criteria:

* Male and postmenopausal or hysterectomised female patients with type 2 diabetes
* Age \>18 and \< 70 years
* BMI \>18.5 and \<40 kg/m2

Exclusion Criteria:

* Antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent;
* Fasted blood glucose \> 240 mg/dl (\>13.3 mmol/L) or a blood glucose level above 400 mg/dl (22.2 mmol/L) postprandially;
* HbA1c \> 8.5 %
Neoadjuvant Chemotherapy for Pancreatic Cancer Followed by GS and GnP

The effect of neoadjuvant chemotherapy for pancreatic cancer was gradually established. However it has been not clarified which regimen of neoadjuvant treatment for pancreatic cancer is the best.

gemcitabine plus S-1 versus gemcitabine plus nab-paclitaxel

Eligibility Criteria:
Inclusion Criteria:

elective pancreatectomy for pancreatic cancer

Exclusion Criteria:

a previous cancer surgery a body weight loss of \>10% during the 6 months before surgery the presence of distant metastases seriously impaired function of vital organs because of respiratory, renal, or heart disease.