cyrilzakka/clinical-trials huggingface dataset:
Immature Platelet Fraction as a Promising Biomarker in Prediction Outcome of HELLP Syndrome

Immature platelet fraction is a non-invasive test of real time thrombopoiesis. High IPF% has been suggested as an indicator of thrombocytopenia due to rapid platelet consumption. IPF% is able to discriminate between patients with TTP/HUS or SPE/HELLP

Thrombotic microangiopathy (TMA) syndromes are extraordinarily diverse. Thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS) are the two most well known, and are considered to be the most serious. TTP-HUS occurs more commonly in women and among women is commonly associated with pregnancy.

Nevertheless, there are other pregnancy conditions that may manifest with TMA, including preeclampsia, eclampsia, HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), in addition to acute fatty liver of pregnancy, antiphospholipid syndrome, and systemic lupus erythematosis.

Assessment of immature platelets was introduced as a non-invasive test of real time thrombopoiesis. They are newly released in the circulation with a larger size \& greater RNA content than mature platelets, and can be measured by automated haematology analyzer equipped with reticulocyte detection channel and described as immature platelet fraction (%-IPF) and immature platelet count (A-IPC).

A high %-IPF has been suggested as an indicator of thrombocytopenia due to rapid platelet consumption, while a low %-IPF is characteristic of bone marrow suppression states. %-IPF/A-IPF has the competency to be performed routinely and, therefore, can provide therapeutic and diagnostic feedback in the life threatening conditions.

The present study aimed to show the utility of estimating %-IPF and A-IPC using a reticulocyte detection channel CBC autoanalyzer as a simple reproducible blood analysis to be employed in the differential diagnosis of pregnancy-associated thrombotic microangiopathic conditions.

Eligibility Criteria:
Inclusion Criteria:

* Older than 20 years of age
* Pregnant with singleton intrauterine pregnancy
* More than 20 weeks of gestation

Exclusion Criteria:

* Congenital malformation and fetuses with chromosomal or genetic syndrome.
* Recent blood transfusion.
* Refusal to participate in the study.
* BMI \<18.
* Placental abnormalities like velamentous insertion.
* Multiple pregnancies.
* Known kidney disease.
* History of auto immune disease.
The Effect of Continuous Positive Airway Pressure on Diastolic Function in Patients With Obstructive Sleep Apnea

The association of obstructive sleep apnea (OSA) and cardiac diastolic dysfunction have been reported, and improvement of diastolic function after continuous positive airway pressure (CPAP) in OSA patients was observed. However, more detailed analysis of diastolic function by supine bicycle exercise echocardiography is lacking. The investigators hypothesized that 3 months of CPAP therapy in OSA patients will significantly improve diastolic functional parameters measured by exercise stress echocardiography. Patients with severe OSA (Apnea-hypopnea index \> 30) will be included in this study, and randomized to CPAP versus sham-CPAP group by 1:1 ratio. Supine bicycle exercise echocardiography, pulse wave velocity, 24 hours ambulatory blood pressure (BP), central BP will be checked before and after CPAP therapy and parameters will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Patietns≥20 and ≤75 years-old
* Patients who diagnosed as obstructive sleep apnea and AHI\>30 on polysomnography

Exclusion Criteria:

* Age \< 20 years-old
* Left ventricular dysfunction (LVEF\<50%) or structural heart disease on transthoracic echocardiography
* Diabetes mellitus
* Significant cardiac valvular disease (≥moderate)
* Severe hypertension (\>180/110mmHg)
* Moderate or severe kidney disease (eGFR \< 60 mL/min )
* Clinically significant liver disease
* History of coronary artery disease
* malignancy or autoimmune disease
* Acute/chronic infection status
* Pregnant status
* Patients taking anxiolytics or sedatives
A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03526299 In Healthy Adult Volunteers

The purpose of this study is to investigate safety and toleration of multiple inhaled doses as well as the time course of PF-03526299 concentration in the blood following dosing by dry powder inhaler.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects and females of non-childbearing potential between the ages of 21 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs).
* Subjects who had a normal chest X-ray in the previous 6 months prior to Screening

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 21 drinks/week for males and 14 drinks/week for females.
Preoperative Heart Rate Variability and Baroreflex Sensitivity in ASO Patients During Various Sleep Stages

The goal of this study is to evaluate the possible preoperative predictive value of altered heart rate variability (HRV) and baroreflex sensitivity in different sleep stages for postoperative adverse cardiac events (i.e. arrhythmia or myocardial ischemia needing hospitalization or medication, myocardial ischemia assessed by enzyme release, myocardial infarction, sudden cardiac death, stroke) in arteriosclerosis obliterans patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 40 years
* ASO
* Elective vascular surgery patient (i.e. infra-inguinal bypass procedure)

Exclusion Criteria:

* Other than sinus rhythm
* Lack of co-operation
* Major surgery less than 3 months preoperatively
* Sleep apnoea
* Dialysis treatment
* CABG less than 3 years earlier
Peri-Transfusion QOL Assessments (PTQA): A New Paradigm of Transfusion Decision Support for Patients With MDS

This research study is evaluating how to best tailor blood transfusion decisions to match the quality of life changes experienced by individual patients with MDS.

Each patient with MDS reacts differently to blood transfusions; some will feel better after transfusion, while others may not. The main purpose of this survey study is to determine whether it is possible to use quality of life changes - as measured by a validated questionnaire - experienced by individual patients to help physicians and patients with MDS make decisions regarding future blood transfusions. This research is being done because the investigators hope to help doctors better understand the impact of blood transfusions on the quality of life of each patient.

The study uses a standardized MDS-specific quality of life questionnaire that participants will fill out before and after an upcoming transfusion. The investigators will compare the scores of these questionnaires and notify both the participant and provider if the participant has experienced any changes (positive or negative) in his/her quality of life before and after transfusion. The investigators' hope is that doctor-patient teams will use this quality of life information to determine whether the participant should continue receiving transfusions, decrease the frequency of transfusions, or stop receiving transfusions altogether if not needed.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years of age
* Patients with MDS
* Patients approaching an Hb of 8.5 g/dL during enrollment period OR
* Patients with \>1 transfusion scheduled during an 8-week period
* Ability to read and understand English

Exclusion Criteria:

* Age \<18 years
* Cr \> 2
* Known CHF
* Unstable Angina
* Hb level below 7.5 g/dL or above 8.5 g/dL
* No plan for future transfusion.
* Patient enrollment will happen after patient has consented and scheduled their first/next transfusion.
* Patient will not be enrolled if no future transfusions are scheduled.
High Blood Pressure and Sleep Apnea in Diabetic Macular Edema

Macular edema remains a major cause of vision impairment in diabetic patients. Its pathogenesis is multifactorial and incompletely understood. Systemic factors seam to play a role in this pathogenesis, including high blood pressure. The objective of the study is to evaluate the effect of an intensified intervention on blood pressure and sleep apnea with that of conventional treatment in patients with type 2 diabetes and diabetic macular edema.

Patients with type 2 diabetes and macular edema involving the center of the macula in both eyes will be randomly assigned to receive conventional treatment in accordance with national guidelines or to receive intensive treatment, with a systematic screening for sleep apnea and /or uncontrolled high blood pressure, and intensified intervention on both anomalies if detected. The primary outcome will be the percentage of patients having a sustained 50% or more-decrease in retinal thickening at 1 year. Secondary outcomes will be the percentage of patients having a 2 ETDRS lines or more-increase in visual acuity at one year, number of ocular interventions in each group, prevalence of sleep apnea and uncontrolled high blood pressure in the intervention group.

Eligibility Criteria:
Inclusion Criteria:

* Patient with type 2 diabetes, aged 18 years or more
* Bilateral diabetic macular edema involving the center of the macula with central retinal thickness 300 µm or more

Exclusion Criteria:

* Patient with type 1 diabetes
* Tractional macular edema
* Patient with renal insufficiency : clearance of creatinin \< 30 ml/min according to COCROFT or MDRD, patient under dialysis
* Other causes for macular edema (uveitis, epiretinal membrane)
* Proliferative diabetic retinopathy requiring panretinal photocoagulation at inclusion
* Cataract surgery or panretinal photocoagulation during the 6 months before inclusion, laser photocoagulation at the posterior pole or intra ocular steroid injection during the 3 months before inclusion
* Any ocular condition precluding access to the posterior pole, or ocular pathologies not related to diabetes (age related macular degeneration venous occlusion...)
* Previous vitrectomy in the eyes
* Pregnant or breast-feeding female
Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy

Head and neck cancer has a negative impact in swallowing function and quality of life. Rehabilitation has proven its usefulness after radiation therapy (RT), but some studies suggest that interventions should be initiated prior to RT sessions. This study aims to evaluate the effects of prophylactic rehabilitation on swallowing and quality of life. The study pretends to establish a preventive rehabilitative program with the target of reducing RT side effects and improve patients' quality of life.

Head and neck cancer has a negative impact in swallowing function and quality of life. Although current diagnostic and therapeutic protocols try to preserve swallowing and speaking, acute or late dysphagia as well as a poor quality of life are frequent in these patients.

Some studies have reported an improvement in swallowing function after an exercise based intervention following radiation therapy (RT), regardless the need of concomitant chemotherapy (RT-QT). Other studies focus the interest in the use of prophylactic exercises to prevent or minimize post-swallowing dysfunction.

Patients receiving RT or RT-QT refer worsening of their quality of life, especially during the first days after treatment. One study suggests that rehabilitation prior to cancer treatment could potentially improve quality of life. However, this observation should be contrasted with a randomized study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced head and neck cancer receiving radiotherapy

Exclusion Criteria:

* Candidates to surgical treatment
* Previous head and neck cancer
* Dysphagia due to causes other than cancer
* Previous head or neck radiation therapy.
A Dose-Finding Study of Tebapivat to Assess Efficacy, and Safety in Participants With Sickle Cell Disease (SCD)

The main purpose of this study is to compare the effect of tebapivat versus placebo on anemia and to detect a dose-response for hemoglobin (Hb) response in participants with SCD.


Eligibility Criteria:
Key Inclusion Criteria:

* Documented diagnosis of SCD (HbSS, HbSC \[combined heterozygosity for hemoglobins S and C\], sickle hemoglobin \[HbS\]/β0-thalassemia, HbS/β+-thalassemia, or other sickle cell syndrome variants).
* Hemoglobin ≥5.5 and ≤10.5 grams per decilitre (g/dL). Hemoglobin concentration must be based on an average of at least 2 Hb concentration measurements (separated by ≥7 days) collected during the screening period.
* If taking hydroxyurea, the hydroxyurea dose must be stable for at least 90 days before randomization. Discontinuation of hydroxyurea requires a 90-day washout before providing informed consent.

Key Exclusion Criteria:

* Receiving regularly scheduled red blood cell (RBC) transfusion therapy (also termed chronic, prophylactic, or preventative transfusion); episodic transfusion in response to worsened anemia or vaso-occlusive crisis (VOC) is permitted. Additionally, a participant who requires episodic transfusion(s) may not have received a transfusion(s) within 60 days before providing informed consent or during the screening period.
* \>10 sickle cell pain crisis (SCPCs) in the 12 months before providing informed consent.
* Receiving anabolic steroids that have not been stopped for at least 4 weeks before randomization. Testosterone replacement therapy to treat hypogonadism is allowed; the testosterone dose and preparation must be stable for ≥10 weeks before randomization.
* Hospitalized for an SCPC and/or other vaso-occlusive event within 14 days before providing informed consent or within 14 days before randomization. If an SCPC occurs during the screening period, the screening period may be extended with Medical Monitor approval.
* Receiving treatment with voxelotor, crizanlizumab, or L-glutamine within 90 days before randomization.
* Platelet count \<lower limit of normal (LLN) for the local laboratory or \<150×109/liter (L) (whichever is lower) during screening. Platelet transfusions received within 28 days before consent or during screening.
* Receiving treatment with hematopoietic stimulating agents within 90 days before randomization.
* Prior exposure to gene therapy or prior bone marrow or stem cell transplantation, including any conditioning regimen.
Additive Value of Physiology Coronary in Clinical Practice

The important evidence of coronary microcirculation for the management of patients with coronary artery disease is only increasing. Thus, in recent years, a number of studies have shown that the demonstration of coronary microvascular disease (CMVD) contributes to cardiovascular morbidity and mortality increases independently of epicardial damage. This has been shown in stable coronary artery disease with screening for CMVD when there is no significant epicardial involvement and allowing the implementation of an adapted treatment then reducing the symptoms and improving the quality of life of our patients. (1). The prognostic nature of CMVD has also been identified in stable disease after coronary angioplasty (2) but also in patients with infarcts reperfused by coronary angioplasty (3).

The complete exploration of the epicardial and microvascular coronary vascularization is grouped under the name of the subspecialty: coronary physiology. Thus, an internationally recognized algorithm for exploring coronary physiology has been published (4).

However, this algorithm is still little followed. The PRINCIPE registry aims to assess the prevalence of CMVD with the use of a standardized algorithm for exploring coronary physiology by coronary angiography in our center in current practice.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients over 18 years of age
* Having a coronary angiography
* Presenting in pain or having performed a positive ischemia test
* Affiliated with social security
* Non-opposition to participation

Exclusion Criteria:

* Adult patient protected by law (article L1121-8)
* Person deprived of liberty (article L1121-8)
* Pregnant woman
Changing Minds - Supporting Depressed Elderly People With an Individually Tailored Service Model

Depression is one of the leading causes of emotional suffering in later life. It has been estimated that 2-5% of community-dwelling elderly people suffer from major depression, but according to recent studies, as much as 25 % have clinically significant depressive symptoms.Typically, depressive symptoms in the elderly are treated solely with antidepressants.

The aim of this project is to study the effects of a comprehensive psychosocial intervention on the psychological well-being, quality of life and use of services in depressed elderly people. In addition, the processes of intervention are studied from the perspective of the participants as well as the service system. The research is conducted in collaboration with the city of Espoo. The design of the study combines clinical trial with qualitative process analysis.


Eligibility Criteria:
Inclusion Criteria:

* age 60+

Exclusion Criteria:

* severe memory disease
Transcranial Direct Current Stimulation (tDCS) As A Treatment For Cigarette Craving and Cognitive Deficits in Schizophrenic

This is a study of the effects of tDCS on smoking, craving for cigarettes, cognition, and psychiatric symptoms in schizophrenic patients who are current smokers or have a history of regular cigarette smoking. It assesses smoking with CO monitoring, nicotine and nicotine levels, and craving with QSU scale and response to craving slides. Cognition is measured by MCCB, symptoms are measured by PANSS and hallucination scale.

This is a double-blind sham-controlled study with active tDCS 2ma or 20 minutes over 5 days, and sham tDCS for 40 seconds on each sham occasion.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia spectrum disorder History of cigarette smoking

Exclusion Criteria:

* Seizure disorder or current treated neurological illness Current Acute exacerbation of psychotic state
Impact of Preoperative Endoscopic Ultrasound-guided Fine-needle Aspiration in Cholangiocarcinoma Patients

Primary objective of this study is to evaluate the number of patients with positive LN detected by EUS and precluded from further surgical interventions.

Secondary objective of this study is to evaluate the EUS-related adverse events.

Cholangiocarcinoma (CCA) is a rare malignancy originating from the bile duct epithelium. The incidence of CCA ranges from 0.5-2.5 cases per 100.000 people in West-European countries and 1.6 cases per 100.000 people in the United States of America. CCA is classified based on anatomical site and is divided into intrahepatic (iCCA), perihilar (pCCA) and distal (dCCA). Survival is limited, as CCA is often recognized in a relatively late stadium in which potential curative treatment is not an option anymore.

Currently, surgical resection is the only potentially curative treatment. The resectability of CCA depends on multiple factors: e.g. biliary extension, vascular involvement and presence of metastatic disease. Patients with metastatic disease, including both distant lymph nodes and metastases, are ineligible for surgical resection and palliative treatment should be initiated instead. Therefore, correct lymph node (N) staging is crucial. N staging depends on CCA subtype and differs between the 7th and 8th edition of The American Joint Committee on Cancer (AJCC) staging system. The most important difference between the two staging systems is the location of the regional (N1) versus distant lymph nodes (N2) in the 7th edition for pCCA and dCCA, while in the 8th edition distant N locations are considered M1 metastases and the number of lymph nodes determines the N stage. In both editions N locations in iCCA are subdivided for the left and right sided liver segments.The AJCC staging system is used to determine treatment and is correlated to survival. The 5-year survival for patients with regional or non-regional positive lymph nodes is worse compared to patients with negative lymph nodes.

To identify distant and lymph node metastases Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) is performed. However, it is difficult to accurately identify suspicious lymph nodes on both CT and MRI since sensitivity and specificity is 61% and 88% respectively for CT and 64% and 68% respectively for MRI. To assess lymph node staging more accurately, Endoscopic Ultrasound (EUS) with Fine Needle Aspiration (FNA) might be of added value. Only a few retrospective studies have described the yield of preoperative EUS for CCA. It is clear that EUS is an effective technique for lymph node staging for CCA, but data is inconsistent about the exact value and impact of EUS on clinical decision making.

Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, a patient must meet the following criteria:

* Suspected resectable CCA
* Patient underwent EUS preoperatively

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from inclusion:

• History of treated CCA
Spinal Cord Injury Neuroprotection With Glyburide

To assess the safety and efficacy of using oral Glyburide (Diabeta) as a neuroprotective agent in patients with acute cervical or thoracic traumatic spinal cord injury.

This study will include subjects between 18 and 80 years who have experienced acute traumatic cervical or thoracic spinal cord injury. Subjects will begin an oral drug regimen of Glyburide with the initial dose being within 8 hours of the injury and again every 6 hours after for 72 total hours of treatment. The daily dose of 3.125mg on day one and 2.5 mg on days 2 and 3 will be used to determine if the investigational drug provides any neuroprotection when given soon after injury. If indicated, the subject will also have surgical intervention for spinal cord decompression surgery and spinal stabilization. Participants will have labs drawn regularly, and ECGs done throughout their hospital stay. Adverse events will be monitored daily through day 14 of participation or hospital discharge (whichever is earlier). Study participation will last for 365 days (+/- 30 days), with post-hospitalization follow-up occurring on days 28, 42, 84, 182, and 365.

Eligibility Criteria:
Inclusion Criteria:

* No life threatening injuries resulting from the traumatic accident
* No evidence of sepsis
* Acute cervical or thoracic SCI with ASIA Impairment Scale Grade A, B, or C od admission.
* Non-penetrating SCI at neurologic level from C2 to C8 or T1 to T12

Exclusion Criteria:

* Unconsciousness or other mental impairment that prevents neurological assessment within the first 8 hours
* Acute SCI with ASIA Impairment Scale grade D or E
* Currently involved in another non-observational SCI research study or receiving another investigational drug
* History of hypersensitivity to sulfonylureas, in particular glyburide, or any of its components
* Any condition likely to result in the patient's death within the next 12 months
* Severe renal disorder from the patient's history (e.g. dialysis) or baseline eGFR of \< 30 mL/min/1.73 m2
* Known severe liver disease, or ALT \> 3 times upper limit of normal or bilirubin
* Blood glucose \<55 mg/dL at enrollment or immediately prior to administration of DiaBeta, or a clinically significant history of hypoglycemia
* Acute ST elevation myocardial infarction, and/or acute decompensated heart failure, and/or QTc \> 520 ms, and/or known history of cardiac arrest (PEA, VT, VF, asystole), and/or admission for an acute coronary syndrome, myocardial infarction, or coronary intervention (percutaneous coronary intervention or coronary artery surgery) within the past 3 months
* Known G6PD enzyme deficiency