cyrilzakka/clinical-trials huggingface dataset:
Spironolactone in Covid-19 Induced ARDS

This study intended to evaluate the effects of commonly used diuretic, spironolactone, on oxygenation in covid-19 ARDS patients.


Eligibility Criteria:
Inclusion Criteria:

* Hemodynamically stable
* Hypoxemia, i.e. p/f \<150
* Admitted to ICU within 48 hours
* Not moribund has a life expectancy greater than 24 hours

Exclusion Criteria:

* Age criteria
* Pregnancy
* Unwillingness to participate
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury

Objectives The primary focus for scientific investigation is to conduct a multi-center observational study to determine if intracranial pressure (ICP) monitoring to direct treatment of patients with moderate traumatic brain injury (TBI) improves medical practice and patient outcomes in China.

Design and Outcomes This is a prospective observational cohort multi-center study with blinded evaluation of outcome. It is a 2-group design. Neurologic outcome is evaluated by extended Glasgow outcome score(GOSE) at 6 months.

Interventions and Duration This is an observational study. The decision of intracranial pressure monitoring is made by the relatives of patient. Management of all patients will be consistent with protocols presently being used in the study hospitals. For patients who received ICP monitoring, the management will also be based specifically on the presence of intracranial hypertension. Each patient will be evaluated at 6 months post injury on neurological outcomes.

Sample Size and Population 832 patients with moderate traumatic brain injury will be collected on this study.


Eligibility Criteria:
Inclusion Criteria:

* History of head trauma
* 18 ≤ age ≤ 70 years
* Abnormal head CT scan (skull fracture, intracranial hematoma, brain contusion, cerebral infarction, brain edema, hydrocephalus, etc.)
* Glasgow coma scale at admission: 9-12
* Arriving at hospital within 24 hours after injury
* Systolic blood pressure ≥100 millimeter of mercury
* No pregnant

Exclusion Criteria:

* Refusing follow up visit
* Penetrating head injury, spine or spinal cord injury
* Surgical treatment in other hospital before admission
* Cardiopulmonary resuscitation after injury or in need of blood transfusion due to active bleeding
* Consciousness disorder caused not by head trauma (alcoholism, drug overdose, etc.)
* Prior history of head trauma or stroke
* Multiple injuries, with severity score of other parts\>18
* Rhabdomyolysis, with blood creatine kinase (CK)\>5000 international unit/L
* Injury of aorta, carotid artery or vertebral artery
* Serum creatinine (female)\>1.2mg/dL (106μmol/L), serum creatinine (male)\>1.5mg/dL (133μmol/L)
* Glomerular filtration rate (eGFR) \<60 milliliter/min
* Body mass index (BMI) \<18.5kg/m2 or \>40kg/m2
* Estimated survival time less than 1 year
* Participating in other on-going clinical researches
* Other systemic diseases: uremia, liver cirrhosis, malignant tumor, mental illness, drug, or alcohol dependence, etc.
Distribution of Trigger Points in Patient Who Have Myofascial Pain Disorder

Myofascial pain alone covers 45.3% of the diagnosis of TMJ. It is defined as palpation sensitivity and regional muscle pain. Clinically muscle pain connects to myofascial trigger points.These trigger points are hypersensitive points located in a tense band of the skeletal muscle, which can be described, causing provoked or spontaneous pain. They are divided into two as active and latent. Those who cause spontaneous pain are active, and those who provoke pain are considered latent.Spasm in the chewing muscles with myofascial pain reduces the patient's pain threshold and quality of life.

Therefore, patients with spasm and TMJ pain in the masticatory muscles should be examined for head and neck muscles, the presence of myofascial trigger points should be determined and the head and neck muscles should be included in physical therapy.

The aim of this study was to determine the presence of myofascial trigger points in patients presenting with pain in the masticatory muscles and TMJ region, and to determine the relationship between the presence of trigger point and the degree of pain.


Eligibility Criteria:
Inclusion Criteria:

* Will be conducted in volunteers who applied to our clinic with complaint of TMJ

Exclusion Criteria:

* Diagnosed rheumatoid diseases and fibromyalgia.
* Psychiatric drug users.
* Patients who use muscle relaxants.
* TME pathology
CTEPH Predictors Following Acute Pulmonary Embolism

Identify risk factors for developing chronic thromboembolic pulmonary hypertension after acute pulmonary embolism.

Determine echocardiographic predictors of chronic thromboembolic pulmonary hypertension.

Determine the radiological predictors of chronic thromboembolic pulmonary hypertension in CT pulmonary angiography.

Chronic thromboembolic pulmonary hypertension(CTEPH) is considered to be a long-term complication after acute pulmonary embolism (PE) characterized by persistent perfusion defects of pulmonary arteries caused by fibrotic remodeling. Its pathophysiology has not been fully elucidated yet, although it has been accepted that the increased pulmonary vascular resistance is caused by obstruction of pulmonary arterial vessels by organized thromboemboli and by vascular remodeling of small un obstructed vessels. (1) Although CTEPH had been thought to develop in relatively few patients post-pulmonary thromboembolism, the latest data suggest an unexpectedly high incidence of approximately 4%. (2) In addition, although there are well-defined risk factors for pulmonary thromboembolism, the risk factors for CTEPH have not yet been sufficiently defined. (3) For that reason, the determination of risk factors is of great importance for the early diagnosis of patients with CTEPH, with its high mortality and morbidity. The clinical presentation of CTEPH is characterized by non-specific symptoms and include exercise intolerance, dyspnea, fatigue, chest pain, and syncope (at exercise). These symptoms are also consistent with other more common cardiopulmonary conditions such as asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease, coronary artery disease, cardiac arrhythmia or heart failure not caused by chronic pulmonary thrombi. (4) These non-specific symptoms are commonly reported by patients who suffered from an acute PE and therefore, the possibility of CTEPH can be frequently considered . The diagnostic management of CTEPH is complex. In many patients pulmonary perfusion scintigraphy, transthoracic echocardiography and conventional pulmonary angiography with determination of pulmonary hemodynamics need to be performed before the diagnosis of CTEPH can be refuted. (5)

Eligibility Criteria:
Inclusion Criteria:

All adult patients of both gender more than 18 yrs admitted at chest department and diagnosed by CT pulmonary angiography as acute pulmonary embolism during a period of one year will be recruited in the study.

About 80 patients as the average number of patients admitted per month is 7.

Exclusion Criteria:

Patients with congenital or acquired heart diseases. Patients with chronic chest diseases. Patients previously diagnosed chronic thromboembolic pulmonary hypertension by V/Q scan.
Prolapse and Pregnancy Assessment

Pelvic organ prolapse (POP) is one of the most common indications for gynaecological surgery. In 1997, more than 225000 inpatient surgical procedures for POP were undertaken in USA (22.7 per 10000 women) at an estimated cost of more than one billion dollars. In the UK, the disorder accounts for 20% of the women on the waiting list for major gynaecological surgery. Vaginal birth, advancing age and increasing body mass are the most consistent risk factors. Furthermore a racial and congenital predisposition has been reported. The cause of this disorder is likely to be multifactorial and attributable to a combination of factors, varying from patient to patient.

Controversy exists as to whether the pregnancy per se rather than the mode of delivery alters the risk of POP. Caesarean section appears to protect against the development of prolapse. However, when a caesarean section is undertaken during the active stage of labour it may not be completely protective. Ideally prospective longitudinal studies are needed to study the impact of pregnancy and childbirth on pelvic organ prolapse. Unfortunately, studies to date, are small with poor follow-up and have only assessed objective outcome rendering it difficult to draw conclusions. The primary objective of our study was to objectively assess the impact of pregnancy and childbirth on pelvic organ support using the Pelvic Organ Prolapse Quantification (POPQ)System.


Eligibility Criteria:
Inclusion Criteria:

* Singleton Pregnancy

Exclusion Criteria:

* Multiple pregnancies
* Previous prolapse surgery
* Medical disorders including diabetes mellitus
* Inflammatory bowel disease
* Collagen disorders
Etoposide in Treating Young Patients With Relapsed Ependymoma

RATIONALE: Drugs used in chemotherapy, such as etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well etoposide works in treating young patients with ependymoma.

OBJECTIVES:

Primary

* Determine the response rate in young patients with relapsing and/or refractory ependymoma treated with a rapid schedule of intravenous etoposide.

Secondary

* Determine the possibility of second surgery or additional radiotherapy in these patients.

OUTLINE: This is a multicenter study.

Patients receive etoposide IV over 1 hour on days 1-3, 8-10, and 15-17. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients whose tumor becomes resectable after courses 3 or 6 undergo surgical resection.

After completion of study treatment, patients are followed periodically for approximately 5 years.

PROJECTED ACCRUAL: At least 14 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed intracranial ependymoma at first, second, or third relapse

  * Anaplastic (malignant) or low-grade ependymoma (cellular, papillary, clear cell, or mixed variants)
* Unequivocal evidence of tumor recurrence or progression by MRI scan after failing conventional treatment (e.g., primary surgery and adjuvant radiotherapy) for initial or recurrent disease
* Unresectable disease OR not amenable to complete surgical resection
* Measurable enhancing or non-enhancing disease on baseline scan performed within the past 2 weeks

  * Patients who have undergone prior surgery must have residual measurable disease

PATIENT CHARACTERISTICS:

* Lansky performance status 30-100%
* Life expectancy ≥ 8 weeks
* Absolute neutrophil count \> 1,000/mm\^3
* Platelet count \> 100,000/mm\^3
* Serum total bilirubin normal
* AST \< 2 times upper limit of normal
* No unrelated medical condition (e.g., renal or liver impairment) that would preclude chemotherapy treatment
* No active infection
* No known HIV positivity

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No radiotherapy within the past 6 weeks
* No chemotherapy within the past 4 weeks
* Prior IV etoposide allowed
Utility of Brain Natriuretic Peptide (BNP) in Patients With Type IV Cardio-renal Syndrome Admitted to the Intensive Care Unit (ICU)

Admission BNP was a useful marker for diagnosing and predicting type IV cardio-renal syndrome type IV in patients with chronic kidney disease admitted to the ICU for acute heart failure in a retrospective study. Therefore, we aim to prospectively investigate the utility of serum BNP in evaluating the treatment adequacy and predicting future cardiac events in patients with type IV CRS.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged \> 18 years, Patients with chronic kidney disease (Serum Cr \> 2.0, Documented medical history of chronic kidney disease

Exclusion Criteria:

* Cardiopulmonary resuscitation, Do-not-resuscitate state, Acute kidney injury, ICU stay \< 1 day
Mid-Infrared Spectroscopy as a Real Time Diagnostic Tool for Chronic Endometritis

The Investigator propose to develop an in-vitro technique for the measurement and analysis of freshly excised biopsies during hysteroscopy procedure in patients with suspected Chronic Endometritis (CE) condition. Furthermore, the investigator propose to develop a discrimination model between the CE and inflammatory CE types using the measured spectroscopic data from freshly excised biopsies.

It is common practice that, following hysteroscopy, the clinician needs to wait for about two weeks before the results of the histology are returned and the clinical treatment is initiated. In this research, the investigator intent to show that the mid infrared ATR (Assisted Reproductive Treatment) spectroscopy method will provide the physician with sufficient information about the CE inflammation status in a considerably shorter period of time to allow immediate initiation of the appropriate treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo hysteroscopy for the evaluation of abnormal bleeding or abnormal cervical or uterine findings.
* Patients scheduled for any histological evaluation including endometrial biopsy, dilatation and curettage (D\&C), biopsy/excision of uterine polyp or fibroid or any other cervical or uterine lesion.
* Age 18 and over.

Exclusion Criteria:

* Pregnant women, minors and lack of judgment women will not included
* At the request of the examined woman
Long-term Safety Study of the GORE® HELEX® Septal Occluder

The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).

The GORE® HELEX® Septal Occluder is an approved medical device indicated for the transcatheter closure of atrial septal defects (ASDs). The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs). This is an FDA Condition of Approval Study. All subjects enrolled in this study will be followed for long-term safety and efficacy of the occluder device through 5 years.

Eligibility Criteria:
Inclusion Criteria:

* ASD less than or equal to 18 mm.

Exclusion Criteria:

* Conditions that would confound treatment of ASD or complicate distinguishing onset of adverse events.
* Unable to accommodate device delivery catheter.
¡Si, Yo Puedo Control Mi Diabetes!: A Diabetes Self-management Education Program for Hispanic/Latinos

The purpose of the study is to evaluate the effectiveness of the íSi, Yo Puedo Controlar Mi Diabetes! (Yo Puedo) diabetes self-management education program.


Eligibility Criteria:
Inclusion Criteria: Self-identification as Hispanic/Latino, over the age of 18 years of age, diagnosis of type 2 diabetes and willingness to participate in the diabetes self-management education class.

Exclusion Criteria: non-diabetic persons, non English-speaking Hispanic/Latinos with type 2 diabetes

-
Long-limb or Distal Gastric Bypass for Superobesity - Randomized Study

The main study objective:

To evaluate long-limb gastric bypass (150 cm alimentary limb) vs. "distal" gastric bypass (common channel 150 cm) in the treatment of superobesity (BMI 50-60 kg/m2).

The main study hypothesis:

Distal bypass accomplish an estimated 10-20 % larger weightloss than long-limb gastric bypass 1 year after surgery. Patients subject to distal bypass have more gastrointestinal side effects and more extensive nutritional deficiences compared to long-limb gastric bypass.

Technical data will later be published in detail

Eligibility Criteria:
Inclusion Criteria:

* BMI 50 - 60 kg/m2 at admission for evaluation for bariatric surgery
* BMI 48 - 62 kg/m2 at study inclusion
* informed consent
* scheduled for bariatric surgery

Exclusion Criteria:

* previous bariatric surgery
* previous major abdominal surgery
* previous history or established urolithiasis
* viral hepatitis, liver cirrhosis of any kind
* factors making the patient not eligible to understand and commit to the study protocol (severe psychiatric disease or drug/narcotic abuse)
Brain Penetrance of 2-HOBA in Humans

The purpose of this study is to confirm that 2-HOBA crosses the blood brain barrier and to compare blood and cerebrospinal fluid levels of 2-HOBA after a single oral dose.

Consenting volunteers between 40 and 70 years old with no morbidity, including males, and females who are not pregnant will be recruited for the study. Three volunteers will be enrolled with a reasonable sampling of ethnicities from the Nashville area, and an effort will be made to recruit males and females. The study will be conducted by the Vanderbilt Clinical Research Center (CRC).

Briefly, the three volunteers will be studied at a single dose level. Baseline assessments will be performed, and then each volunteer will be given a single oral dose (550 mg) of 2-HOBA. Ninety minutes after the dose, a lumbar puncture will be performed to obtain cerebrospinal fluid and a blood sample will be collected. 2-HOBA levels will be measured in cerebrospinal fluid and blood samples from this timepoint to assess the ability or orally ingested 2-HOBA to cross the blood brain barrier.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals between 40 and 70 years old;
* Men and women who are not pregnant at the time of study; and
* Not taking any medication 24 hours prior to and during the study.

Exclusion Criteria:

* Inability to give informed consent;
* Current use of anticoagulant medications, such as warfarin (Coumadin), dabigatran (Pradaxa), or rivaroxaban (Xarelto), due to high risk of bleeding complications. Volunteers taking aspirin or clopidogrel (Plavix), will not be excluded, but will be asked to get clearance from their prescribing physician before stopping the drug 24 hours prior to the procedure;
* Need to discontinue any drug that is administered as standard of care treatment;
* Unwillingness or inability to use approved birth-control methods (pre-menopausal women); and
* History of lumbar surgery, fibromyalgia, current lower back pain, or scoliosis.
Treatment of Non Union of Long Bone Fractures by Autologous Mesenchymal Stem Cell

Treatment of nonunion, delayed union and malunion fractures of long bones remains problematic. The definition of nonunion is a failure of the fracture to heal in six months in a patient in whom progressive repair had not been observed radiographically between the third and sixth month after the fracture. First of all good surgical techniques are stable immobilization must be obtained and local sepsis excluded. Then stimulation of the callus is required. Numerous techniques have been developed ranging from invasive interventions (including internal fixation with the use of bone graft or bone graft substitutes) to non invasive procedures (ultrasound and pulsed electromagnetic fields).

Recently, autologous cell therapy was presented as an interesting approach. The concept of such therapies is based on the effect of stem cells presented in the bone marrow and able to be transformed in osteoblast cells. The purpose of this study is to find if mesenchymal stem cells can stimulate bone regeneration in nonunion and delayed union fractures to reduce later surgeries required to augment the healing process and to accelerate the time to healing.

Treatment of nonunion, delayed union and malunion fractures of long bones remains problematic. The definition of nonunion is a failure of the fracture to heal in six months in a patient in whom progressive repair had not been observed radiographically between the third and sixth month after the fracture. Nonunion is a serious complication of a fracture, occurring in 2-10% of patients, as it is associated with high economic and health burden. Many cases are subsequently approached by multiple surgical and nonsurgical modalities. Various devices, under the name of "bone growth stimulators" have been used to enhance healing of the fracture. Recent studies, demonstrated the efficacy of mesenchymal stem cells in regeneration of bone and cartilage tissue. In this study percutaneous injection of mesenchymal stem cells to the site of fracture is performed as an outpatient procedure or during an operative exposure to evaluate its efficacy in enhancing bone regeneration. In the case of small size of bone gap, mesenchymal stem cells are injected into the callus of fracture site through an outpatient procedure under the guide of fluoroscopy. If there is a large bone gap, through a surgical management, mesenchymal stem cells seeded on bone matrix are placed at the site of fracture. Patients are followed by X-Ray examination 1,2,6, and 12 months after treatment.

Eligibility Criteria:
* Inclusion criteria:
* Both genders are eligible
* Nonunion or delayed union diagnosed with X-Ray examination.
* More than 4 cm distance to joint
* Provided written informed consent
* Exclusion criteria:
* Multiple major fracture or untreated major fracture
* Infected fracture
* HIV, hepatitis B or hepatitis C infection at the time of screening
* Pregnant or lactating women
* Diagnosis of cancer
* Active treatment with immunosuppressive drugs or anticoagulant agent
* Known allergic reaction to components of study treatment and/or study injection procedure
Epidemiology of Occult Hepatitis C Virus Infection in Patients Born Before 1969 in the Hospital Setting: a Spontaneous Opportunistic Screening Initiative.

The goal of this monocentric prospective observational study is to evaluate the prevalence of unknown hepatitis C virus chronic infection in general population born before january 1st 1968 in Italy.

The main questions it aims to answer are:

what is the prevalence of hepatits C virus infection in general population born before January 1st, 1968? What rare the characteristics of these patients compared to the general population? What is the prevalence of patients tested HCV positive who are referred to the Hepatology Outpatient Clinic for further evaluation? What is the prevalence of patients with HCV infection detected during the study and treated with direct antiviral agents during follow up?

Participants will be tested with a point of care screening test (Meridian, Bioscience) able to detect anti-HCV antibodies to detect the presence of antibodies against HCV.


Eligibility Criteria:
Inclusion Criteria:

* Patients born before January 1st 1968 who lived in Italy referred to any departments of the Policlinico A. Gemelli

Exclusion Criteria:

* Patients born after january 1st 1968
* Known infection of hepatitis C virus
* Previous treatment against hepatitis C virus