cyrilzakka/clinical-trials huggingface dataset:
Caffeine as Respiratory Stimulant in Preterm Infants

comparison between rate of occurance of apnea of prematurity AOP when using high and low dose caffeine

Caffeine is one of the widely used medications in the neonatal care units and in spite of its widespread use in preterm infants, there has been little information about the optimal efficient dose in those patients Caffeine therapy for treatment of apnea of prematurity (AOP) is well established over the past few years, yet the optimal loading and maintenance dose of caffeine in preterm infants is not well-studied AOP is a common complication of preterm birth, which affects more than 80 % of neonates with a birth weight less than 1,000 g. Methylxanthine (MGs), including caffeine and theophylline, are a mainstay in the treatment and prevention of AOP The efficiency of caffeine, as a preferred methylxanthine, to stimulate respiration has been well proven as it has a significant favorable impact on neonatal morbidity as bronchopulmonary dysplasia (BPD) and patent ductus arteriosus (PDA) ligation. Also, the results of previous studies revealed that caffeine enhances respiratory muscle strength and lung function followed by easier weaning of mechanical ventilation in premature infants. Besides, a rapid and sustained increase in diaphragmatic activity and tidal volume was reported in preterm infants followed by caffeine administration Previous studies have shown that caffeine citrate was generally well tolerated by premature neonates in clinical trials and declined the incidence of apnea in this population compared with placebo. Also, caffeine is related to superior outcomes due to its lower toxicity and it is a preferred drug for apnea in preterm infants with respiratory problems. It has also a significant function as a noninvasive respiratory support. It facilitates the transition from invasive to noninvasive support, reduces the duration of positive airway pressure support and decreases the risk of BPD in preterm infants The optimum caffeine dose in preterm infants with AOP has not been well studied as well as heterogeneous reports on the optimal loading and maintenance dose of caffeine in several studies in terms of benefits and risks. Many investigations have been conducted about various dosing regimens in the improvement or prevention of respiratory disorders of premature infants. These dosage regimens, although, have been associated with varying degrees of success The aim of this study is to determine if the use of caffeine in doses higher than the currently standard dose can decrease the frequency of apnea in preterm infants without causing significant side effects

Eligibility Criteria:
Inclusion Criteria:

* • Preterm infants with a gestational age \<32 weeks in room air or CPAP (prophylactic).

  * Preterm infants with gestational age 32-34 weeks who exhibited apnea of prematurity within the first 10 days of life in room air or CPAP

Exclusion Criteria:

* • Major congenital malformations.

  * Chromosomal anomalies.
  * Preterm infants on mechanical ventilation.
  * Preterm infants on NIPPV.
Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV

This Phase 2a study involving Tenofovir Disoproxil Fumarate (TDF) will provide extended safety data for high-risk men. Secondarily, the study will assess the feasibility of conducting the trial and evaluate the preliminary effectiveness of TDF 300 mg as an HIV prevention method when taken once a day.

TDF has been selected for investigation as prophylaxis against HIV in high-risk men because of its unique pharmacologic profile. In addition to the convenience of being a once daily single tablet, TDF's safety profile is comparable to placebo among HIV infected persons, it has striking anti-HIV potency, and it has low potential for selection of resistant viruses. TDF is cleared from the body by the kidneys and is not metabolized by the liver. Therefore, TDF has limited potential to have pharmacokinetic interactions with other hepatically metabolized drugs. Each of these properties is necessary given the realities of the intended target populations. Moreover, initial prevention studies in simian models have provided encouraging results. Finally, the drug's sponsor is supportive of investigating the potential use of TDF as a preventive, as well as therapeutic agent, will provide TDF for the study, and is willing to make a good faith effort to make TDF available for public health use should it prove to be effective for HIV prevention.

Eligibility Criteria:
* Be willing and able to give informed consent
* Be 18 years or older
* Be willing to use study product as directed
* Be willing to adhere to follow-up schedule
* Be willing to participate in the study for up to 12 months
* Be in general good health (no active, serious infections that require parenteral antibiotics, no active clinically significant medical conditions, including heart disease, diabetes, asthma, alcoholism, and cancer)
* Meet at least one of these three high risk criteria: \*Sex with sex worker/bar girl in last 3 months;

  * Sex with 2 or more women in last 3 months;
  * Sexually transmitted disease (STD) in last 3 months
* Have absence of HIV antibodies by rapid test (at screening and enrollment visit)
* Have absence of hepatitis B (HB) surface antigen (sAg)
* Have adequate renal function (serum creatinine \<1.5 mg/dL)
* Have adequate liver function (hepatic transaminases (ALT \<54 U/L and AST\<46 U/L)
* Have adequate serum phosphorus (\>2.2 mg/dL)
* Not be intending to relocate out of the area for the duration of the study participation and does not have a job or other obligations that may require long absences from the area
* Not be receiving an experimental HIV vaccine
Antenatal Ultrasound Diagnosis of Periventricular Pseudocysts and Postnatal Outcome

The present study aims to improve the information given to the parents during the screening of periventricular pseudocysts in the Pluridisciplinary Center of Prenatal Diagnosis, with retrospective cases screened during the last 5 years in university hospital of Bordeaux.

Antenatal ultrasound screening for periventricular pseudocysts is steadily increasing, enabled in part by technological advances in ultrasound equipment.

Most of studies dealing with periventricular pseudocysts and subsequent neurodevelopment are based on neonatal screening, mostly performed in neonatal units.

Current data in the literature on the postnatal outcome of children screened antenatally are scarce; there are only 5 cohort studies with small numbers on the subject.

The present study aims to improve the information given to the parents during the screening of periventricular pseudocysts in the Pluridisciplinary Center of Prenatal Diagnosis, with retrospective cases screened during the last 5 years in university hospital of Bordeaux.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient diagnosed with a periventricular cyst during a prenatal ultrasound at Bordeaux University Hospital between January 1, 2016 and December 31, 2020.
* Patient affiliated with or benefiting from a social security plan.
* Oral informed consent.

Exclusion Criteria:

* Subarachnoid cyst
* Blake's pouch cyst
* Choroid plexus cyst
* Periventricular leukomalacia
* Poor understanding of French
* Patient under legal protection.
Morbimortality of Covid-19 in Patients With Chronic Inflammatory Rheumatism Treated With Immunosuppressants

A retrospective monocentric study with large active files of patients monitored for rheumatoid arthritis, spondyloarthritis and systemic lupus erythematosus with as main endpoint the morbimortality of Covid-19 in these patients (number of patients hospitalized in conventional units and/or in intensive care and/or deceased). The results will be compared with those of the general population based on the epidemiological data of Covid-19.


Eligibility Criteria:
Inclusion Criteria:

* Patients with rheumatoid arthritis on conventional synthetic DMARD (csDMARDs) +/- biological DMARD (bDMARDs) or targeted synthetic DMARD (tsDMARDs) +/- corticosteroid therapy meeting ACR/EULAR 2010 classification criteria
* Patients with spondylarthritison biological DMARD or targeted synthetic DMARD +/- conventional synthetic DMARD +/- non-steroidal anti-inflammatory drugs meeting ASAS classification criteria
* Patients with systemic lupus erythematosus on hydroxychloroquine +/- conventional synthetic DMARD +/- corticosteroid therapy +/- biological DMARD meeting ACR/EULAR 2019 classification criteria

Exclusion Criteria:

-
Effect of Thoracic Epidural Anesthesia on Left Ventricular Functions: a Strain Echocardiography Study

Post-thoracic surgery pain management thoracic epidural catheter is the most commonly used method.

Thoracic epidural anesthesia, in which cardiac sympathetic nerves (T1-T5) are involved in neural blockade, is the focus of our research. Many studies have shown a decrease in inotropic status (intrinsic function) after blockade of cardiac sympathetic innervation with thoracic epidural anesthesia (TEA).We want to examine the cardiac effects of TEA with strain echocardiography, which is an advanced echocardiography method. Therefore, we aimed to investigate the effect of TEA on left ventricular functions with strain echocardiography.

The study was designed as an observational study. Our study will be conducted for 12 months after receiving ethical committee approval. 23 patients are planned to be included in the study. TTE will be performed when the patients arrive at the preoperative room for the operation. Then, thoracic epidural anesthesia will be performed. After the block, all usual medications, except ACE inhibitors, will be continued according to hospital protocol for 15 days of surgery. Patients will be given up to 2 mg midazolam and 7 ml/kg 0.5% isotonic 15 minutes before the epidural catheter is administered. A TTE will be performed before the epidural catheter is placed. After appropriate local anesthesia, the epidural catheter will be placed while the patient is in a sitting position. The puncture will be performed between t6-t7 and t8-t9 using the midline approach with the "loss of resistance" technique. The catheter will be inserted 3-4 cm into the epidural space and an epidural lidocaine bolus (10 ml at 2% concentration) will be administered while the patients are in the supine position. TTE will be performed again after 15 minutes. At these stages, hemodynamic values will also be recorded. We want to examine the cardiac effects of TEA with strain echocardiography, which is an advanced echocardiography method. Therefore, we aimed to investigate the effect of TEA on left ventricular functions with strain echocardiography.

Eligibility Criteria:
Inclusion Criteria:

Elective payment options ASA I-III Ages 18-75

Exclusion Criteria:

1. Refusal at enrollment
2. Request for withdrawal from the study
3. Inability to give informed consent
4. Emergency surgery
5. Bleeding diathesis
6. Presence of contraindications to the LA agents used in this study
7. Use of chronic opioids
8. Psychiatric disorders
9. Presence of infection at the injection site
Collection of Blood and Urine From Patients Undergoing Radiation Therapy

Background:

-Research in NCI's Radiation Oncology Branch depends on the availability of blood and urine samples from patients receiving radiation therapy.

Objectives:

-To explore the effects of radiation therapy on gene expression in white blood cells, to measure radiation damage in red blood cells and to examine changes in hormone levels in the blood and urine after radiation therapy.

Eligibility:

-Patients 18 years of age and older who are receiving radiation therapy.

Design:

* Blood and urine samples are collected when participants enter the study.
* Additional samples may be collected at different times during and after treatment. Ideally, samples are obtained before, at the completion of, and 1 month following radiation therapy. Blood samples usually will be collected during routine patient monitoring procedures and will not require an additional needle stick.
* A total of 300 patients will be studied at the NCI in Bethesda, MD, Johns Hopkins University in Baltimore and the University of Pennsylvania in Philadelphia.

BACKGROUND:

Evolving research initiatives in the Radiation Oncology Branch (ROB) NCI, depend upon the availability of blood and urine samples from patients receiving radiotherapy.

Examples of planned studies include an exploration of the effects of radiotherapy on peripheral leukocyte phenotype, peripheral blood protein and metabolism changes as well as measurements of matrix metalloproteinases (MMP) in urine.

OBJECTIVES:

This protocol provides a means of acquiring blood and urine samples in patients receiving radiation therapy for a variety of conditions.

ELIGIBILITY:

Patients seen in the radiation oncology clinic will be asked to donate blood and/or urine before, during and after their treatment.

DESIGN:

This is a pilot, exploratory study to evaluate the effects of ionizing radiation in blood and/ or urine.

On most occasions, the blood samples will be obtained as a component of routine patient monitoring and will not necessitate an additional venipuncture.

Blood and urine samples will be processed and stored in the Radiation Oncology Branch and Basic Research Laboratory, CCR, NCI, for use in the research efforts of the branch.

Eligibility Criteria:
* INCLUSION CRITERIA:

  1. Patients must be co-enrolled in a NIH CC protocol in which radiation will be administered.
  2. Patients must a candidate for, or currently receiving radiotherapy.
  3. Age greater than or equal to 18 years.
  4. Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

1. Patients who have unobtainable data regarding previous radiation therapy.
A Real-world Study: Efficacy and Safety of Anlotinib for Advanced Non-small Cell Lung Cancer(NSCLC)

A real-world study: Efficacy and safety of Anlotinib for advanced non-small cell lung cancer：This study aims to observe and explore the efficacy and safety of anlotinib in patients with advanced non-small cell lung cancer in the real world, and to summarize the treatment experience of a broad population.

A real-world study: Efficacy and safety of Anlotinib for advanced non-small cell lung cancer：This study aims to observe and explore the efficacy and safety of anlotinib in patients with advanced non-small cell lung cancer in the real world, and to summarize the treatment experience of a broad population.This study is a non-interventional, prospective, observational, real-world case study and all registered data are collected from real clinical practice cases. Adult patients diagnosed as advanced non-small cell lung cancer and treated with anlotinib were included. At least one tumor lesion has not been subjected to local treatment such as irradiation in the past, and can be accurately measured, the longest diameter is ≥10 mm.The primary endpoint was progression-free survival (PFS) and the secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR) and safety.If the last patient reaches the main evaluation index or has intolerable toxic reaction, the observation will be finished, and the first one will prevail.Through Electronic Data Capture System (EDC) system, electronic case report form (eCRF) is used to replace paper-based case report form to collect and manage clinical trial data.

Eligibility Criteria:
Inclusion Criteria:

1. Age: ≥18 years old, no gender limit.
2. Diagnosed as advanced non-small cell lung cancer.
3. At least one tumor lesion has not been subjected to local treatment such as irradiation in the past, and can be accurately measured, the longest diameter is ≥10 mm.
4. Doctors evaluate the benefits of receiving Anlotinib treatment.
5. The patient voluntarily joins the project and signs the informed consent. If any of the above items is "No", the patient is not suitable for this study.

Exclusion Criteria:

1. Those who have been confirmed to be allergic to anlotinib and/or its excipients.
2. Patients with anlotinib contraindications.
Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain

A pilot multicenter randomized controlled trial will be conducted to evaluate the clinical effectiveness, cost-effectiveness, and safety of Doin (conduction exercise) with acupuncture for chronic neck pain patients compared to acupuncture alone.

A pilot multicenter randomized controlled, parallel, assessor-blinded trial will be conducted to evaluate the comparative clinical effectiveness and cost-effectiveness of Doin (conduction exercise) with acupuncture for chronic neck pain patients with acupuncture alone as assessed by pain and functional disability scales, monitor its safety, and assess the feasibility of and serve as the basis for a full-scale, multicenter trial.

Eligibility Criteria:
Inclusion Criteria:

* Onset of at least 6 months previous for neck area pain
* Current neck area pain of Numeric Rating Scale (NRS) 5 or higher
* Patients who have agreed to voluntarily participate in the clinical trial and given written informed consent

Exclusion Criteria:

* Pathologies of non-spinal or soft tissue origin or high severity which may cause neck or radiating arm pain (e.g. malignant tumor, spinal infection, inflammatory spondylitis, fibromyalgia, rheumatic arthritis, gout)
* Progressive neurologic deficit or severe neurologic symptoms (e.g. cauda equina syndrome, progressive muscle weakness)
* Other chronic diseases which may interfere with treatment effect or interpretation of results (e.g. cardiovascular disorder, renal disease, diabetic neuropathy, dementia, epilepsy)
* Current intake of steroids, immunosuppressant medicine, psychiatric medicine or other medication which may interfere with treatment results
* Patients considered unsuitable or unsafe to receive acupuncture (e.g. patients with hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, severe diabetes with high risk of infection, severe cardiovascular diseases)
* Patients who were treated with invasive interventions such as acupuncture or injections, or with medicine that may potentially influence pain such as NSAIDs (nonsteroidal antiinflammatory drugs) within the past week
* History of cervical surgery within the past 3 months
* Pregnancy or plans of pregnancy
* Severe psychopathy
* Participation in other clinical studies
* Inability to give written informed consent
* Other reasons rendering trial participation inappropriate as judged by the researchers
Analysis of Injectate Spread During Erector Spinae Block

The primary purpose of this study was to identify the ESPB spread level in the craniocaudal direction when performed at the T2 level. The secondary purpose was to determine the incidence of spread into epidural, paravertebral, intercostal, and intravascular injections with ESPB

The ESPB requires ultrasound guidance which enables visible local anesthetic spread underneath the erector spinae muscles. The spinalis, longissimus thoracis, and iliocostalis muscles comprise the ES muscles, which run vertically along both sides of the vertebral column from the sacrum up to the skull base. The ESPB can be performed in the cervical, thoracic, and lumbar regions. Among them, upper or mid thoracic ESPB has been used more widely compared to cervical and lumbar regions. Previous cadaveric studies on the ESPB at the T5 level using computed tomography (CT) reconstruction or direct dissection demonstrated the extensive craniocaudal distribution of methylene blue ranging from T1 to T8 vertebral segments deep to the ES muscles and variable involvement of epidural, paravertebral, and intercostal spaces. The ESPB performed at the T2 level of the cadaver demonstrated an injected dye distribution ranging from C4 to T10. Also, 36% of cadavers showed the spread of an injected dye to the ventral, dorsal ramus, paravertebral space, and even the contralateral side. The exact mechanism of action of ESPB remains unclear. A recent study suggested that the analgesic effect of ESPB could be obtained by blocking the ventral and dorsal ramus of the spinal nerves by passing through the costotransverse foramen. However, in clinical practice, we can encounter highly variable clinical outcomes or sensory block after the ESPB. The study of the physical spread of the injected agent can be used to predict the clinical result and elucidate the possible mechanism of action of ESPB.

Eligibility Criteria:
Inclusion Criteria:

* Cervical facet joint arthrosis
* Cervical foraminal stenosis
* Cervical herniated intervertebral disc
* myofascial pain syndrome of upper back muscle

Exclusion Criteria:

* Allergy to local anesthetics or contrast medium
* Pregnancy
* Prior history of cervical spine surgery
* Coagulation abnormality
The Pharmacological Basis for the Increase in Visual Time Constants Induced by Single Oral Doses of Sildenafil

Sildenafil and similar drugs have been used for several years to treat erectile dysfunction. It has been noticed that in some people, sildenafil causes a subtle increase in the length of time that visual images that we see are retained by the retina. It is thought that this might be due to an effect of sildenafil on inhibiting an enzyme called phosphodiesterase type 6 (PDE6) which is present in the retina. By giving single oral doses of sildenafil and a similar drug called tadalafil which has less effect on PDE6, we hypothesise that this is the mechanism of the change in vision caused by sildenafil. By performing computerised visual test, we plan to compare the effects of sildenafil, tadalafil and placebo tablets on vision in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Male
* 18-55 years

Exclusion Criteria:

* Significant medical or psychiatric illness
* Cardiac disease
* Hyper or hypotension
* Renal disease
* Liver disease
* Stroke
* Sickle cell anaemia
* Multiple myeloma
* Leukaemia
* Bleeding disorders
* Peyronie's disease
* Priapism
* Subjects receiving prescribed medications
* Subjects with known visual abnormalities other than refractive errors, including retinitis pigmentosa, optic neuropathy