cyrilzakka/clinical-trials huggingface dataset:
Basic Study of Combination Therapy Based on APCC-induced FVllI Activation in Hemophilia A Patients With Inhibitors

Using whole blood samples and plasma samples obtained from some hemophilia A patients with inhibitors, the investigators will perform the coagulation assessment in the co-presence of aPCC and factor VIII by comprehensive coagulation assays and flow chamber analysis under blood flow conditions.

Comprehensive coagulation assays using recently popular rotational thromboelastometry (ROTEM), factor Xa/thrombin/plasmin generation test, and coagulation wave analysis and recently developed flow chamber system under blood flow conditions (T-TAS®) will be used. A bypassing agent, aPCC (Feiba®) and recombinant factor VIII (Advate®) will be added ex vivo to whole blood and plasma samples from patients with hemophilia A with inhibitors to compare with the coagulation effects of aPCC in the presence of factor VIII and those of aPCC in its absence under the conditions close to the physiological condition. Furthermore, the difference in the coagulation effects by the difference in inhibitor epitopes will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hemophilia A with inhibitors (Inhibitor titer; \>0.5 Bethesda U/ml)
* Patients with agreement consents with the patients signatures

Exclusion Criteria:

* Patients that do not fill the conditions described above
Canadian Observation Trial in CF Patients Undergoing Treatment With Ivacaftor

Specific aims:

1. To elucidate the biological mechanism that leads to pulmonary and nutritional improvement in CF patients following treatment with ivacaftor using advanced techniques to assess changes of the pulmonary and nutritional status
2. To examine the relation between the individual response to ivacaftor and the presence of modifier genes associated with CF disease severity,
3. To assess altered CFTR function using new available in vivo tests,
4. To validate newly developed in vivo sweat tests with well established functional tests,
5. To establish correlation between the CFTR response to Vx-770 measured in a new ex vivo method (organoids) and the actual clinical and/or functional response in individual patients,
6. To examine response in other CF-specific features such as aqua wrinkling.
7. To examine if sleep/activity level changes.
8. To establish a biorepository to enable further investigations.


Eligibility Criteria:
Inclusion Criteria:

* any patient being prescribed ivacaftor

Exclusion Criteria:

* only relates to specific tests
Electrode-Based Sensor for Non-Invasive Fetal Heart Rate Monitoring With Improved Reliability

The specific goal of the proposed research is to develop a reliable, non-invasive fetal and maternal heart rate and contraction monitor that is unaffected by obesity and requires less nursing intervention than the tocodynamometer and Doppler ultrasound.

The majority of obstetric deliveries in the US undergo electronic monitoring and continuous uterine activity and fetal heart rate (FHR) monitoring is the standard of care. Typically, external transducers are employed, the reliability of which depends on their proper positioning, which may be disturbed by patient or fetal movement. The tocodynamometer (strain gauge, toco for short) provides frequency and timing of contractions, but requires transmission of tension from the uterus to the sensor. Fetal heart rate is acquired with an external Doppler ultrasound transducer. The reliability of this monitor depends on the ability to obtain a window to the fetal heart.

In some patients, particularly the obese, the toco and ultrasound may fail to monitor consistently. In others both transducers require frequent repositioning by the nursing staff, and the Doppler may erroneously report maternal heart rate instead of fetal.

The alternative uterine activity monitor is an intrauterine pressure catheter (IUPC), which is placed through the cervical os in the adequately dilated patient with ruptured membranes. While this monitor usually provides a more reliable signal than the toco, as well as quantitative information regarding intrauterine pressure, it is invasive and there is an increased risk of infection. The alternative FHR monitor is via fetal scalp electrode (FSE), which is applied transvaginally to the fetal presenting part, also requiring adequate cervical dilation and ruptured membranes. While the FSE usually provides a more reliable signal, it is similarly invasive and increases risk of infection.

Maternal obesity (defined as BMI at presentation ≥ 30) is an ever-increasing problem in the US, and is even more prominent in the obstetric suite. Meanwhile, obese women have an increased risk for labor problems, infections and other complications. Noninvasive labor monitoring, while preferable to reduce the infection risk, is particularly unreliable in this population.

Eligibility Criteria:
Inclusion Criteria:

* Parturients presenting to Labor \& Delivery for labor at term (\>36 weeks completed gestation)
* Single viable fetus in cephalic presentation
* With FSE or IUPC for obstetric indications

Exclusion Criteria:

* Multi fetal gestation
* Contraindication to FSE or IUPC placement
* Insufficient abdominal space for all required sensors
Calizumab Combined With Bevacizumab and Capecitabine in the Treatment of Head and Neck Squamous Cell Carcinoma

This is a prospective, one-arm exploratory second-line study of carrilizumab combined with bevacizumab plus capecitabine in relapsed metastatic squamous cell carcinoma of the head and neck.

This is a prospective, single-center, single-arm, phase II clinical study. The study was intended to include histologically or cytologically determined squamous cell carcinoma of the head and neck, which the investigators assessed as metastatic. After the patients signed informed consent and met the screening criteria, the second-line patients received carrilizumab combined with bevacizumab and capecitabine until disease progression, intolerable toxicity, death, or the subject's decision to withdraw from the study for a maximum of two years.

Radiographic evaluations were performed using RECIST v1.1, and baseline evaluations were conducted within 28 days prior to enrollment. Tumor imaging evaluation was performed every 6 weeks (±3 days) from the first administration of the drug in the study. After reaching CR, patients entered the maintenance treatment period of carrilizumab. After 48 weeks, tumor imaging evaluation was performed every 12 weeks (±7 days). Imaging tests before signing the ICF, if within 28 days before starting treatment, can be used as screening tests.

During the study, participants will receive safety follow-up from the first dose of carrilizumab until 30 days after the last dose).

Experimental drugs: carrilizumab, bevacizumab, capecitabine

Administration regimen:

1. Carrilizumab: 200mg/ cycle, three weeks as a treatment cycle, the first day of each cycle, intravenous drip;
2. Bevacizumab: 7.5mg/kg, intravenous infusion on the first day of each cycle, every 3 weeks for 1 cycle (Q3W);
3. Capecitabine: 1250mg/m2, three weeks as a treatment cycle, oral twice a day (once in the morning and once in the evening; Stop the drug for 1 week after 2 weeks of treatment.

Duration of test plan and inclusion time:

1. Program selection time: 22 months.
2. Duration of the planned study: 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically determined, the investigators assessed patients with relapsed or metastatic squamous cell carcinoma of the head and neck. Including nasopharyngeal cancer, oral cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, etc.
* The age range is between 18 and 85.
* Expected survival \> 6 months.

Exclusion Criteria:

* Patients with uncured malignancies other than recurrent or metastatic squamous cell carcinoma of the head and neck diagnosed within 5 years prior to initial administration (excluding radical cutaneous basal cell carcinoma, cutaneous squamous epithelial carcinoma, and/or carcinoma in situ after radical excision).
* Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that target another stimulus or synergistic inhibition of T cell receptors (e.g., CTLA-4, OX-40, CD137).
* Known allogeneic organ transplantation (except corneal transplantation) or allohematopoietic stem cell transplantation.
* other.
Post Marketing Study in Haemophilia B Patients Using Nonafact® (Human Coagulation Factor IX)

In this postmarketing study, the safety of Nonafact® (human coagulation factor IX) is evaluated in previous treated and untreated patients with severe, moderate or mild haemophilia B.

The clinical efficacy and safety of Nonafact® has been shown in two pre-authorisation studies. Marketing authorisation for the EU was granted 3 July 2001. The Post Marketing Study, which evaluates the clinical efficacy, immunogenicity and safety of Nonafact®, is set up according to CPMP/BPWG /198/95, rev. 1 (Final, London, 19 October 2000) 'Note for guidance on the clinical investigation of human plasma derived factor VIII and IX products'

Eligibility Criteria:
Inclusion Criteria:

* Haemophilia B (mild, moderate or severe), Haemophilia B Leyden or symptomatic carriers of Haemophilia B and Haemophilia B Leyden
* Above the age of six, at the moment of inclusion
* Tested positive for HAV and HBV antibodies, induced by infection or vaccination, and negative for HBsAg
* Informed consent signed by the patients or his legally accepted representative

Exclusion Criteria:

* Under the age of six, at the moment of inclusion
* Tested negative for HAV and HBV antibodies
Acceptance and Feasibility of Hepatitis c Screening Strategies in Social Insertion Centers

Hepatitis C virus (HCV) infection is one of the leading causes of chronic liver disease worldwide. It is a progressive disease that without treatment leads to the development of cirrhosis in approximately 10-20% of patients. With this study the investigators intend to evaluate the efficacy defined as the rate of HCV diagnostic tests performed within a decentralized diagnostic strategy by means of home self-testing compared to the one performed in situ in the population served in Social Insertion Centers (CIS) with alternative prison sentences, in order to study the prevalence and characteristics associated with HCV infection in this population, which is known to be at risk for this disease, and to offer them treatment and cure.

A randomized study will be designed in which all persons attending the Social Insertion Center to serve alternative sentences to prison will be invited to participate on a voluntary basis, with prior informed consent. In order to study the prevalence of these persons compared to persons in open system, the latter will be offered, with prior informed consent, to take the diagnostic test in situ at the CIS premises. All persons will be given a survey with sociodemographic and clinical variables to identify predictor factors.

People with alternative sentences to prison will be informed of the study and, according to the randomization code, will be: a) given an envelope with all the necessary material to carry out the test at home and send it to the hospital for processing or, b) be tested on site at the CIS premises by the CIS nurse, who will also send it to the hospital for processing within 30 days by the Central Laboratory of the University Hospital of the Canary Islands.

Eligibility Criteria:
Inclusion Criteria:

* All persons attending the Social Insertion Center for the first time with alternative sentences to prison and in open system.
* Signed informed consent.

Exclusion Criteria:

* Refusal of the patient to participate in the study.
* Minors under 18 years of age and over 79 years of age.
Multifactorial Risk Stratification in Stroke Patients With Cardiac Disease

Prospective registry for multifactorial risk factor assessment, enrolling consecutive ischemic stroke/transient ischemic attack patients with structural, inflammatory, or arrhythmogenic cardiac disease, who are admitted to our University Hospital.

The prospective registry shall provide new insights into the multiple associations, and respective therapeutic implications of cardio-vascular risk factors and stroke. For that reason consecutive patients with ischemic stroke/transient ischemic attack (brain, spinal cord, or retinal) and structural (e.g. patent foramen ovale), septic or aseptic endocarditis or myocarditis, or supra-ventricular or ventricular arrhythmia, who are admitted to our University Hospital, are enrolled. Multifactorial assessment of risk factors is based on medical history, laboratory biomarkers, electrocardiogram incl. cardiac autonomic function analysis, and (long-term) cardiac rhythm monitoring, as well as transthoracic and transesophageal echocardiography. Inclusion of follow-up visits permit longitudinal and prognostic evaluation of routine diagnostic and therapeutic interventions for secondary stroke prevention (e.g. implantable loop recorders or interventional closure of patent foramen ovale).

Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke or transient ischemic attack (brain, spinal cord, or retinal)

Exclusion Criteria:

* Acute intracranial hemorrhage
(Men Who Have Sex With Men) MSM Community Intervention Trial

The purpose of this study is to evaluate the effectiveness of the community based comprehensive HIV/STIs intervention among MSMs in China.

National sentinel surveillance data show that HIV infections are increasing fast among men who have sex with men(MSM) in China. In some cities HIV prevalence among MSM is higher than 10%.It is urgent for China to explore innovative intervention to reduce HIV/AIDS transmission among this population.

The purposes of this study are:

1. To evaluate the effectiveness of comprehensive interventions to decrease the HIV/STIs incidence among MSM population in China. The comprehensive intervention components include male circumcision, POL intervention, HIV testing and counseling and condom promotion.
2. To determine the acceptability of male circumcision among MSM population in China.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or above
* Male have oral sex or anal sex within 6 months with a man
* Accept questionnaire survey and blood test
* Can participate in three surveys in one year
* HIV Negative
* No mental disease and can understand informed consent

Exclusion Criteria:

-
Effect of Urine Alkalinazation on Urinary Inflammatory Markers in Patients With Cystinuria

It has recently been described the presence of a urinary inflammatory signature in patients with cystinuria, the most common cause of renal lithiasis of genetical origin. These data are very innovative in this pathology but deserve further studies to establish the specificity of this inflammatory signature in patients with cystinuria compared to other nephropathies and other renal lithiasis diseases. Moreover, the effect of the usual treatment of cystinuria (namely urine alkalanization) on urinary inflammatory biomarkers deserves to be tested.

The objectives of the present study are: i) To study the urinary inflammatory profile by mass spectrometry (a very efficient tool to detect and identify proteins) in patients with cystinuria and in patients with lithiasis of other origin and in patients with inflammatory renal disease ; ii) To study the potential effect of urine alkalinazation with potassium citrate (usual treatment according to European recommendations) on the inflammatory signature of patients with cystinuria. To this aim, urine of non treated cystinuric patients will be collected before treatement initiation and 3 months after the start of the alkalizing treatment.


Eligibility Criteria:
Inclusion Criteria:

* age superior or equal to 18 years
* patient able to understand the information note and to sign the informed consent
* patient with an Health coverage
* no current urinary tract infection (assessed by a cytobacteriological examination of the urine)
* For the cystinuria group: patient with cystinuria not yet treated or for whom the alkalizing treatment or the cystein binding thiol agents have been discontinuated for at least 3 months AND with an estimated GFR (using the MDRD formula) greater than 60 ml/min/1.73m2.
* For the control groups: patient presenting either a renal lithiasis not due to cystinuria, or an inflammatory renal pathology confirmed by an anterior renal biopsy (glomerulonephritis or interstitial nephritis) AND with an estimated GFR (using the MDRD formula) greater than 30 ml/ min/1.73m2.

Exclusion Criteria:

* Cystinuric patient already treated (whatever the treatment)
Contamination of Bacillus Species Sepsis.

Bacillus species are ubiquitous gram-positive spore-forming organisms. They rarely cause disease in the immunocompetent and are more frequently isolated as a culture contaminant. However, Bacillus Species can cause severe systemic infections in immunocompromised patients including preterm infants.

The purpose of this study is to identify the risk factors of these infections.

Non-anthrax Bacillus Species bacteria can be responsible for food poisoning and local infections. Rarely, they lead to severe infections like blood stream infections and meningitis especially in immunocompromised patients like preterm infants.

Bacillus Cereus is the most common members of the genus Bacillus. Only few reports studied these systemic infections in premature neonates. In order to identify the risk factors for severe Bacillus Species infections, we studied retrospectively eleven cases of these infections in our NICU and reviewed series and report cases in literature.

Eligibility Criteria:
Inclusion Criteria:

* cases of Bacillus Species sepsis
* cases of Bacillus species meningitis
* with significant change in clinical status
* Bacillus Species is the only organism isolated

Exclusion Criteria:

* Bacillus Species isolated with other organisms and Bacillus Species without clinical change were considered to be contaminants
The Clinical Outcomes Following Transfer of Blastocysts Cultured From Thawed Cleavage Stage Embryos

Recent improvements in cell culture systems have led to a shift in in vitro fertilization (IVF) practice from early cleavage stage embryo transfer (ET) to blastocyst transfer. Blastocyst culture and transfer could theoretically provide better synchronization between the embryo and the uterine endometrium. The purpose of this study is comparing pregnancy rates and implantation rate following transfer of thawed cleavage embryos and blastocysts cultured from thawed cleavage embryos.

The proposal of this study approved by our institutional review boards and institution's ethical committee, and all participants will sign a written consent before enter to study. All patients will be randomly divided into two groups of thawed cleavage embryo transfers and transfers of blastocysts from thawed cleavage embryos. Embryos will be transferred in hormone replacement cycles. Preparation of the endometrium will be started in the second day of menstruation and will be continued according to their transfer type (blastocyst or cleavage). βhCG will be assessed 14 days after embryo transfer. Treatment cycle outcomes will be compared between 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* The patients with first type of infertility
* Age ≤ 37 years
* Long ovulation induction protocol

Exclusion Criteria:

* Any previous surgery on the uterus and ovaries
* Uterine factor infertility
* Sever Male factor infertility (TESE, TESA ،Oligoteratozoospermia)
* Recurrent abortion
* The women with poor ovarian reserve
Corelab Remotely Echocardiographic Imaging Acquisition in Cardiac Resynchronization Therapy Candidates

Purpose of the observational study is to assess the capability of a satellite tele-echocardiography (STE) system to acquire and transmit echocardiographic images and clips to an echocardiographic core laboratory (ECL) in a real time mode without loss of quality. Additionally the prognostic efficacy of specific echo parameters in the cardiac resynchronization therapy response will be evaluated.

CORELAB-CRT is a prospective multi center Italian observational study. All echo images and clips will be transmitted by using an integrated satellite transmission system. All echo assessments performed in accordance to the centers clinical practice will be also used to investigate the prognostic efficacy of echo parameters in term of response to the cardiac resynchronization therapy (CRT). All commercially available multi-chamber CRT-D devices from any manufacturers are allowed in this observational study.

Any compatible market released right atrial, right ventricular and left ventricular lead from any manufacturer is allowed.

The echocardiography device models used to perform echo imaging for all patients participating in this analysis are GE Vivid 7, GE Vivid 9 and GE Vivid I, according to the model used in the clinical practice of the hospital.

Eligibility Criteria:
Inclusion Criteria:

1. NYHA class II, III and ambulatory IV with:

   * QRS complex duration ≥120msec;
   * Ejection fraction ≤35%.
2. Optimized medical treatment;
3. Patient in sinus rhythm;
4. Patient is willing and able to sign an informed consent form.

Exclusion Criteria:

1. Unstable angina, or acute myocardial infarction, coronary-aortic bypass graft or percutaneous transluminal coronary angioplasty within the past 3 months;
2. Cerebral vascular attacks or transient ischemic attack within the last month;
3. Chronic atrial arrhythmias, paroxysmal atrial fibrillation events;
4. Patients already implanted with an ICD or a CRT device;
5. Pacemaker dependency or ventricular pacing percentage ≥10%;
6. Valvular disease with an indication for surgical correction ≤12 months survival expectancy;
7. Mechanical right ventricular valve;
8. Patient is enrolled in or intends to participate in another clinical trial that may have an impact on the study endpoints;
9. Pregnancy or breastfeeding;
10. Previous heart transplant;
11. Refusal of study informed consent;
12. Expected lack of compliance during follow-up;
13. Patient is less than 18 years of age;
14. Patient's life expectancy is less than 6 months in the opinion of physician.