cyrilzakka/clinical-trials huggingface dataset:
Variability of Hemoglobin Levels After Kidney Transplantation

The purpose of this study es to determine hemoglobin variability in kidney transplant recipients with chronic renal anemia.

The primary endpoint of the study is hemoglobin level variability. For determination of this variability, the following patterns of hemoglobin level change will be established:

* Target range hemoglobin (TRH): patients with hemoglobin values in the range of 11.0-12.0g/dl throughout the study period.
* Low hemoglobin (LH): patients with levels below 11.0g/dl
* High hemoglobin (HH): patients with levels above 12.0g/dl
* Low-amplitude fluctuation with low hemoglobin (LALH): patients with at least one measurement of hemoglobin levels \<11.0g/dl and at least one measurement in the range of 11.0-12.0g/dl, but without hemoglobin measurements \>12.0g/dl.
* Low-amplitude fluctuation with high hemoglobin (LAHH): patients with at least one measurement of hemoglobin levels \>12.0g/dl and at least one measurement in the range of 11.0-12.0g/dl, but without hemoglobin measurements \<11.0g/dl.
* High-amplitude fluctuation (HAH): patients with at least one measurement of hemoglobin levels \<11.0g/dl and at least one measurement \>12.0g/dl.

Secondary objectives:

* To determine potential factors influencing hemoglobin variability.
* To assess the influence of hemoglobin variability on cardiovascular risk of patients according to the REGICOR function at the end of the study period.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \> or = 18 years.
* Kidney transplant recipients with chronic renal failure stage 3 (glomerular filtration rate: 30-59ml/min/1.73m2), 4 (glomerular filtration rate: 15-29ml/min/1.73m2) or 5 (glomerular filtration rate: \<15ml/min/1.73m2) at the start of the study follow-up period.
* Diagnosis of anemia and drug treatment initiated or changed subsequent to June 29, 2010 (date on which the latest recommendation by European Renal Best Practice on the target range for hemoglobin levels were published)
* Patients capable of giving their informed consent to participate in the study and who agree to participate by signing the informed consent form.

Exclusion Criteria:

* Patients whose medical history lacks measurements of hemoglobin levels every three months (±1 month) during the year of study follow-up.
Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development

Malnutrition is considered one of the most prevalent risk factors for morbidity and mortality in children under five. An estimated 20% of children in the developing world are malnourished \[1\] and poor nutrition is linked to more than half of all child deaths worldwide \[2\]. Malnutrition in early childhood may lead to cognitive and physical deficits and may cause similar deficits in future generations as malnourished mothers give birth to low birth weight children \[3\]. In addition, malnutrition increases susceptibility and incidence of infections and is associated with diminished response to vaccines.

The MAL-ED Project is designed to determine the impact of enteric infections/diarrhea that alter gut function and impair children's nutrition, growth and development to help develop new intervention strategies that can break the vicious enteric infection-malnutrition cycle and reduce its global burden.

The overall objective of the MAL-ED Project is to quantify the associations of specific enteric pathogens, measures of physical and mental development, micronutrient malnutrition, gut function biomarkers, the gut microbiome, and immune responses in very young children in resource-limited settings across eight sites that vary by culture, economics, geography, and climate.

The central hypothesis of the MAL-ED Project is that infection (and co-infection) with specific enteropathogens leads to impaired growth and development and to diminished immune response to orally administered vaccines by causing intestinal inflammation and/or by altering intestinal barrier and absorptive function. Data analyses will test for associations between enteropathogen infections and growth/development to help illuminate:

* which micro-organisms or mixed infections are most frequently associated with growth faltering and poor development; and
* at what age specific infections cause the most disruption to growth and development and impair immune response.


Eligibility Criteria:
Inclusion Criteria:

* Less than 17 days old.

Exclusion Criteria:

* Mother is less than 16 years of age.
* Mother has another child inthe MAL-ED study.
* Pregnancy resulted in multiple birth (e.g., twins).
* Child has a severe disease requiring hospitalization for something other than for a typical healthy birth.
* Child has a severe or chronic condition diagnosed by a medical doctor (e.g., neonatal disease, renal disease, chronic heart failure, liver disease, cystic fibrosis, congenital conditions).
* Child has enteropathies diagnosed by medical doctor.
* Mother is living and unable to provide informed consent.
Quick Recognition of Aortic Dissection

This is an observational study that establishes a cohort of patients with high risk chest pain who have been identified by CTA for aortic dissection. We then used this cohort to validate the accuracy of identifying aortic dissection based on extremity oximetry and Doppler waveforms.


Eligibility Criteria:
Inclusion Criteria:

* High risk chest pain with CTA

Exclusion Criteria:

* shock
* coma
* severe peripheral vascular diseases
Rejuvenate Modular Outcomes Study

This study will be an evaluation of the Rejuvenate® Modular Hip System for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibility criteria. Subjects will be evaluated for freedom of hip revision at 5 years and clinical outcomes for up to 10 years after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient has signed an IRB approved, study specific Informed Patient Consent Form.
* Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
* Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
* Patient is a candidate for a primary cementless total hip replacement.
* Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
* Patient's operative femur templates to Rejuvenate® Modular Stem size 7-12.

Exclusion Criteria:

* Patient has a Body Mass Index (BMI) ≥ 40.
* Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
* Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
* Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
* Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
* Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.
* Patient has a known sensitivity to device materials.
* Patient is a prisoner.
Comparison of Continuous Femoral Nerve Block and Adductor Canal Block After Total Knee Replacement Therapy

The blockade of the femoral nerve (FNB) is the most common postoperative pain therapy after total knee replacement. Because of motor-driven weakness of the quadriceps muscle induced by femoral nerve block mobilization of Patients is difficult even dangerous (falls) and hospital stays are extended.

An alternative method could be an adductor canal block (ACB). Anatomical studies of the adductor canal demonstrated that the adductor canal contains the saphenous nerve, a pure sensory nerve for medial and anterior aspects of the knee and the tibia without any motor function.

This prospective, double-blinded, randomized study investigates the effect of FNB and ACB on quadriceps motor weakness and analgesia determined by Numeric Rating Scale (NRS).

We expect the ACB to be superior in muscle strength but equal in pain score. Both groups receive an additional anterior sciatic nerve block for complete sensory block of the operated knee


Eligibility Criteria:
Inclusion Criteria:

* patients with knee replacement therapy and general anaesthesia
* informed consent
* preoperative "timed up and go" test performable

Exclusion Criteria:

* emergency patients
* BMI \> 40 kg/m2
* American Society of Anaesthesiologists physical status (ASA) 4-5
* severe chronic obstructive pulmonary disease (COPD)
* rheumatic arthritis, diabetic Polyneuropathy, M. Parkinson
* nerve injury of lumbosacral plexus
* coagulopathy with bleeding tendency
* not capable of speaking or understanding german or english
HIIT Improves Survival of Heart Failure Patients

BACKGROUND Global burdens of heart failure (HF) are increasing in modern societies. High-intensity interval training (HIIT) increases peak oxygen consumption (VO2peak) in HF patients, which was hypothesized to improve the survival of HF patients.

OBJECTIVES The cohort study aimed to highlight the effect of HIIT on long-term survivals of HF patients.

METHODS 329 HF patients, enrolled between 2009 and 2016, received multidisciplinary disease management program (MDP). They had cardiopulmonary exercise test for peak exercise capacity (VO2peak), echocardiographic examination for left ventricular ejection fraction (LVEF), LV end-diastolic diameter (LVEDD), and LV end-systolic diameter (LVESD), b-type natriuretic peptide (BNP), and quality of life questionnaire. HF patients with LVEF≤ 40% (HFrEF) and HF patients with LVEF\> 40% (HFpEF) underwent≥ 36 times of HIIT. HFrEF and HFpEF patients were classified as the MDP group. Generalized estimating equation (GEE) was used to estimate the interaction between time and VO2peak, LVEF, LVEDD, LVESD, and BNP during the follow-up. Survival analysis was conducted to assess effects of HIIT on the long-term survival of HF during at end of the study.


Eligibility Criteria:
Inclusion Criteria:

From January 1st, 2009 to December 31st, 2016, HF patients, defined according to the European society of cardiology, with stable clinical status greater than 4 weeks after optimal treatment were enrolled in the study.

Exclusion Criteria:

Those, who were ≥ 80 years and \< 20 years, unable to perform exercise caused by other non-cardiac disease, pregnant, future cardiac transplantation within 6 months, uncompensated HF patients, pacemaker patients, and renal patients with estimated glomerular filtration rate \< 30 ml/min/1.73m2, were not candidates in the study. Patients had absolute contraindications for cardiopulmonary exercise test (CPET) and aerobic activities, suggested by the American College of Sports Medicine (ACSM), were also excluded in the study.
PDL Anesthesia Versus Local Infiltration

The literature concerning the success and pain scores of PDL injection technique compared with other techniques remains controversial; whereas some studies found no significant difference in pain scores between local infiltration and PDL injection, other older studies found that pain during administration of PDL injection was described by the majority of patients either as greater than local infiltration6, or as negligible or as a less painful injection compared with other injection techniques. The aim of this study was to evaluate the efficacy of and patients' subjective responses to the PDL injection technique as compared to the traditional infiltration injection, for the non-surgical extraction of one posterior maxillary permanent tooth.

Aim: The aim of this study was to evaluate the efficacy of and patients' subjective responses to the periodontal ligament (PDL) anesthetic injection as compared to the traditional infiltration injection, for the non-surgical extraction of one posterior maxillary permanent tooth. Methods: All patients scheduled for non-surgical symmetrical maxillary posterior permanent teeth extraction in the Department of Oral and Maxillofacial Surgery (OMFS) at the University of Jordan Hospital, Amman, Jordan, over a-seven-month period, were invited to participate in this prospective randomized double blinded, split mouth study. Every patient received the recommended volumes of 2% lidocaine with 1:100.000 epinephrine for PDL injection on the experimental side, and for local infiltration on the control side. A Visual Analogue Scale (VAS) and a Verbal Rating Scale (VRS) were used to describe the pain felt during injection and extraction, respectively. Statistical significance was based on probability values of \<0.05 and measured using Chi-Square and Student-t tests, and Nonparametric Mann-Whitney and Kruskal-Wallis tests.

Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria were: patients who were fit for surgery under LA (classified by the American Society of Anaesthesiologists (ASA) as ASA I-ASA III); patients exhibiting full understanding of given oral instructions; and bilateral symmetrical posterior maxillary permanent teeth referred for non-surgical extractions under LA.

Exclusion Criteria:

Exclusion criteria were: the presence of acute dento-alveoalr infection; patients requiring conscious sedation or general anesthesia; patients unwilling to participate in the study; patients with ASA greater than III; patients on anti-inflammatory or recreational drugs; and patients requiring more than two additional injections in one or both sides for incomplete anesthesia.
HA Residents With PVD, Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) With and Without Supplemental Oxygen Therapy (SOT)

To study the effect of SOT in patients with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live \>2500m on pulmonary artery pressure (PAP) and other hemodynamics by echocardiography and in relation to blood gases at 2840m with and without SOT.

Patients with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who permanently live at HA \>2500 (PVDHA) will have echocardiografy to assess PAP, cardiac output and other hemodynamics and arterial blood gas to assess SaO2, PaO2 and PaCO2 near their living altitude in Quito at 2840m whilst breathing ambient air or SOT at 10l/min flow via a face mask with reservoir.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18-80 years old of both genders,
* Residence \> 2500m of altitude
* diagnosed with precapillary PH (mean pulmonary artery pressure (mPAP) \>20 mmHg, pulmonary artery wedge pressure (PAWP) ≤15 mmHg and pulmonary vascular resistance (PVR) ≥2 wood units (WU) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines
* Patients stable on therapy
* New York Heart Association (NYHA) functional class I-III
* Provided written informed consent to participate in the study.

Exclusion Criteria:

* Age \<18 years or \>80 years
* unstable condition
* Patients who cannot follow the study investigations, patient permanently living \< 2500m.
* Patients with moderate to severe concomitant lung disease (FEV1\<70% or forced vital capacity \<70%), severe parenchymal lung disease, severe smokers (\>20 cigarettes/day)
* Severely hypoxemic patients at Quito permanently have persistent oxygen saturation by pulseoximetry (SpO2) \<80% on ambient air.
* Patients with chronic mountain sickness (Hemoglobin \> 19 g/dl in women, \>21 g/dl in men)
* Patient with a non-corrected ventricular septum defect
* Relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin\<11 g/dl)
Stabilometry After Pressure Release of the Flexor Digitorum Brevis Muscle Versus a Non-emission Laser.

In this study we will test the effects of pressure release on the Flexor digitorum brevis muscle on stabilometric variables that support static equilibrium.

In this study we will test the effects of pressure release on the Flexor digitorum brevis muscle on the stabilometric variables that support static balance. To test the effects on balance.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* Must have latent trigger point in Flexor Brevis Digitorum muscles with no other pathologies.

Exclusion Criteria:

* Previous lower extremities surgery.
* History of lower extremities injury with residual symptoms (pain, "giving-away" sensations) within the last year.
* Leg-length discrepancy more than 1 cm
* Balance deficits (determined by oral questionnaire regarding falls)
Lung Bioavailability With Continuous or Discontinuous Nebulization

To compare the continuous and sicontinuous delivery of drug with AKITA.


Eligibility Criteria:
Inclusion Criteria:

* no lung disease
* no allergy

Exclusion Criteria:

* smoker
An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)

This study looks at the effect on basal and pentagastrin-stimulated acid output of 40 mg Esomeprazole (Nexium) administered orally and intravenously as a 15-minute infusion to people with symptoms of Gastroesophageal Reflux Disease (GERD)


Eligibility Criteria:
Inclusion Criteria:

1. Heartburn on at least 2 days of the past 7 days prior to screening, with or without a history of EE or a documented diagnosis of GERD within 6 months prior to screening, with or without a history of EE.
2. Body mass index (BMI) of ≥18.5 and ≤35 kg/m2. \[BMI will be calculated using the following formula: weight (kg)/height (m)2.\]
3. Able to communicate with the investigator and to understand and comply with the requirements of the study.

Exclusion Criteria:

1. History of esophageal, gastric, or duodenal surgery, except for simple closure of an ulcer.
2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
3. Any significant "alarm symptoms", within the past 6 months, such as, unintentional weight loss, gastrointestinal bleeding, jaundice or any other sign indicating serious or malignant disease.
4. Abnormal lab test results, as indicated in the protocol.
5. Other diseases, as indicated in the protocol.
Comparison of an Easy to Read Advance Directive Versus a Standard Advance Directive

The purpose of this study is to compare the acceptability, usefulness, self-efficacy and comprehension of an easy-to-read advance directive form versus a standard advance directive form written at a post graduate reading level.

Advance directives are forms that allow patients to document their medical treatment preferences and to designate another person to help make medical decisions if they were to become too sick to make their own decisions. Most patients, even seriously ill older adults, do not fill out advance directive forms. Since the mean reading level in the US is at the 8th grade level (5th grade for elders) and since most advance directive documents are written beyond a 12th grade reading level, many patients may not be able to read, much less complete, the standard advance directive forms.

This study hypothesized that an advance directive form written at a 5th grade reading level (AD-Easy) that included culturally appropriate graphics explaining the text, and also included questions concerning patients' values, would be preferred over the standard advance directive form being used in California (AD-Standard).

The participant's literacy level and baseline knowledge of advance directive topics were assessed. Participants were then stratified by literacy level to be randomized to first attempt to read and complete either the AD-Easy or the AD-Standard. Then the participant's acceptance of the forms, self-efficacy or confidence with treatment decisions, attitudes about the form's utility, and post form review comprehension were assessed. Participants then crossed over to review the alternate form and were asked to state which form they preferred to take home. Six months later participants were called and asked if they had thought about their medical treatment preferences, spoken to their family, friends, or doctor about their treatment preferences, or if they filled out the advance directive form.

Eligibility Criteria:
Inclusion Criteria:

* Over 50 years
* Primary physician in the General Medicine Clinic at San Francisco General Hospital, San Francisco, CA
* English- or Spanish-speaking

Exclusion Criteria:

* Blind
* Deaf
* Delirious
* Demented
Cryotechnique as a Diagnostic and Therapeutic Tool of Endobronchial Tumors

This study was to assess the diagnostic yield and the safety of bronchoscopic cryotechniques in the management of endobronchial tumors.

Novel flexible cryoprobes were introduced for tissue sampling during bronchoscopy. Employing this approach, the sample is collected when frozen, with the tissue attached to the frozen end of the probe. This approach enables the retrieval of larger tissue samples from endobronchial lesionsEndobronchial cryotherapy is employed to treat individuals with obstructive central bronchial lung cancers. It has been demonstrated to effectively recanalize obstructed respiratory passages, alleviate symptoms, and improve the quality of life for patients in advanced stagesThis study aimed to assess the effectiveness and safety of using bronchoscopic cryotechniques for diagnosing and treating endobronchial malignancies.

Eligibility Criteria:
Inclusion Criteria:

* patients with radiologically suspected endobronchial masses

Exclusion Criteria:

* Patients with contraindications to bronchoscopy.
* uncorrected coagulopathy (if the international normalized ratio (INR) is more than 1.5).
* severe refractory hypoxemia (even after administering the highest possible dose of oxygen, the partial pressure of oxygen ("PaO2") stays below 70 mm Hg.
* hypoventilation with hypercapnia (type 2 respiratory failure).
* severe pulmonary hypertension \> 55 mmHg by echocardiography.
* hemodynamic instability.
Hemolysis in Patients With Hereditary Spherocytosis (HS)

In the present study the investigators are going to explore the oxidative status of HS-RBC and its contribution to hemolysis

The oxidative status of cells, which is determined by the balance between pro-oxidants, such as the reactive oxygen species (ROS), and antioxidants, is a major regulator of cellular functions. Impaired balance between pro- and antioxidants causes oxidative stress which may result in oxidation of proteins, lipids and DNA with the final outcome of premature cell aging and apoptosis \[1,2\]. Oxidatively stressed red blood cell (RBC) have been observed in various congenital and acquired hemolytic anemias, including thalassemia, sickle cell anemia, congenital dyserythropoietic anemia, G6PD deficiency and paroxysmal nocturnal hemoglobinuria (PNH) as well as in myelodysplastic syndrome (MDS). Although the primary etiology is different in these anemias, oxidative stress mediates several of their pathologies, mainly hemolysis \[3\].

Hereditary Spherocytosis (HS) is a genetic disorder of the RBC skeleton with primary deficiency in spectrin, ankyrin-1, band 3 or protein 4.2 associated with chronic hemolytic anemia \[4\]. Secondary protein deficiencies resulting from oxidative stress are often observed and may be involved in the clinical manifestations of the disease \[5\].

Eligibility Criteria:
Inclusion Criteria:

* patients \> 5 years
* with documented family history of HS
* patients should have clinical and laboratory findings, consistent with mild to severe HS, diagnosed on the basis of spherocyte morphology, elevated MCHC (33-38 g/dl), with a mean value of (35.47 g/dl), increased osmotic fragility , splenomegaly and non-immune mediated hemolysis.

Exclusion Criteria:

* non