cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial of Nebulized Surfactant for the Treatment of Moderate to Severe COVID-19

Lung surfactant is present in the lungs. It covers the alveolar surface where it reduces the work of breathing and prevents the lungs from collapsing. In some respiratory diseases and in patients that require ventilation this substance does not function normally. This study will introduce surfactant to the patients lungs via the COVSurf Drug Delivery System

The hypothesis behind the proposed trial of surfactant therapy for COVID-19 infected patients requiring ventilator support is that endogenous surfactant is dysfunctional. This could be due to decreased concentration of surfactant phospholipid and protein, altered surfactant phospholipid composition, surfactant protein proteolysis and/or oedema protein inhibition of surfactant surface tension function and/or oxidative inactivation of surfactant proteins. Variations of these dysfunctional mechanisms have been reported in a range of lung diseases, including cystic fibrosis and severe asthma, and in child and adult patients with ARDS. Our studies of surfactant metabolism in adult ARDS patients showed altered percentage composition of surfactant PC, with decreased DPPC and increased surface tension-inactive unsaturated species, and decreased concentrations of both total PC and phosphatidylglycerol (PG)

The SARS-CoV-2 virus binds to the angiotensin converting enzyme-2 (ACE2) receptor, which is preferentially expressed in the peripheral lung ATII cells. Consequent viral infection of ATII cells could reduce cell number and impair the capacity of the lungs to synthesise and secrete surfactant. This, however, has not yet been demonstrated empirically in COVID-19 patients. If this is the case, then exogenous surfactant administration to the lungs is potential one treatment option to mitigate disease severity in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Confirmed COVID-19 positive by PCR
* Within 24 hours of mechanical ventilation (ETI arm) or within 24 hours of needing either CPAP or NIV (CPAP/NIV arm)
* Assent or professional assent obtained

Exclusion Criteria:

* Imminent expected death within 24 hours
* Specific contraindications to surfactant administration (e.g. known allergy, pneumothorax, pulmonary haemorrhage)
* Known or suspected pregnancy
* Stage 4 severe chronic kidney disease or requiring dialysis (i.e., eGFR \< 30)
* Liver failure
* Anticipated transfer to another hospital, which is not a study site within 72 hours.
* Current participation or participation in another study within the last month that in the opinion of the investigator would prevent enrollment for safety purposes.
* Consent Declined
Aortic Balloon Counterpulastion in Myocardial Infarction Related Shock

The role of intra aortic balloon counterpulsation in patients experiencing acute myocardial infarction with shock is not established. We hypothesised that use of such a device would lead to improved outcomes in these patients.

Patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) with cardiogenic shock (CS) are often treated with Intra-aortic balloon pump counterpulsation (IABP) although the evidence to support this is limited. We conducted a prospective, randomised clinical trial, of IABP as an addition to PCI centred therapy, in patients with AMI complicated by CS.

45 patients with AMI and CS undergoing PCI were randomised to care with or without IABP. Over 4 days, APACHE II scores, haemodynamic parameters, inflammatory markers and BNP levels were collected to assess the impact of IABP treatment on CS triggered multi organ dysfunction syndrome (MODS).

Eligibility Criteria:
Inclusion Criteria:

* Acute myocardial infarction
* Cardiogenic shock

Exclusion Criteria:

* Absent peripheral pulses
* Mechanical complications of myocardial infarction
Election of the Optimal Moment of Colecistectomy After Mild Biliary Pancreatitis

Introduction Acute pancreatitis is the third gastrointestinal cause of hospital admission. It is estimated that 35-60% have a biliary origin, and most of them are mild.

After a mild acute biliary pancreatitis (ABP), there is a high risk of recurrence of others biliary events. 15-20% of patients will suffer another pancreatitis, cholangitis, choledocolithiasis, or cholecystitis. Therefore, is necessary a definitive treatment.

Although it is suggested to perform cholecystectomy early, there is still insufficient scientific evidence on this subject. All publications have biases and do not allow establish recommendations. In addition, the usual clinical practice tends to postpone the cholecystectomy, because of doubts about the safety of early intervention and for hospital logistical reasons. On the other hand, is discussing if early cholecystectomy carried out more persistence of residual cholelithiasis, explains for the pathophysiology of the ABP.

Finally, it is important to mention, that in our environment 25% of the patients with an ABP are more than 75 years old. There are not any trial that includes this age group.

Objectives Demonstrate that early cholecystectomy is feasible in all patients, including elderly patients, and decreases the number of readmissions for other biliary events.

Material and Methods It is being done a multicenter prospective randomized trial. After an ABP, patients are randomized in two treatment branches. Group A is cholecystectomy within the first week after the ABP. Group B four weeks later.

There are collect data from demographic information, comorbidities, biliary events before the surgery, residual choledocolithiasis, difficulty of the surgical technique, postoperative complications and patients are follow-up for 6 months.

To obtain a representative sample of the population, we consider it appropriate to include all age groups, including patients older than 75 years.

Expected results With this study we pretend to demonstrate that early cholecystectomy is feasible and safe. It does not increase the number of residual choledocolithiasis, and prevents readmissions for new biliary events.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Diagnosis of acute mild biliary pancreatitis according to Altanta 2012 criteria.
* Signed informed consent. Exclusion Criteria
* ASA IV.
* Alcohol abuse or chronic pancreatitis.
* Not having assessed the presence of residual choledocolithiasis (cholangioNMR / intraoperative cholangiography)
* Pregnancy.

Exclusion Criteria:

-
Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia

This study is a multi-center, randomized, active-controlled, double-blind, non-inferiority, phase III clinical trial evaluating efficacy and safety of once-daily mosapride (UI05MSP015CT) in patients with functional dyspepsia.

Patients with functional dyspepsia were randomly assigned (1:1) to receive either UI05MSP015CT (15 mg once daily before breakfast, study group) or mosapride (5 mg three times a day before each meal, control group) and corresponding placebo t.i.d. or q.d. for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>19 years
2. Diagnosis of functional dyspepsia meeting Rome III criteria
3. At least three moderate or severe symptoms included in the Symptom Score
4. No structural lesions of upper gastrointestinal tract

Exclusion Criteria:

1. History of dyspepsia unrelated to functional dyspepsia or diseases
2. History of gastrointestinal surgery
3. History of malignancy in the previous 5 years
4. Psychiatric disorders including major depressive disorder and anxiety
5. Liver cirrhosis or abnormal liver laboratory findings
6. Advanced chronic kidney disease
7. Uncontrolled hypertension
8. Uncontrolled diabetes
9. Pregnancy and lactation
10. Recent history of taking medication affecting the gastrointestinal system
Role of the NLRP3 Inflammasome in Escherichia Coli and Staphylococcus Aureus Bacteria

Our previous studies delineate a novel pathway of immune activation in animals that the investigators have named Anti-Virulence Immunity (AVI). Using a mice model of bacteremia, the investigators have demonstrated that Escherichia coli Cytotoxic Necrotizing Factor 1 (CNF1) activity is sensed by the immune system. This immune sensing results in a rapid bacterial clearing during bacteremia triggered by uropathogenic E. coli-expressing CNF1. The investigators already confirmed the involvement of one inflammasome using macrophages isolated from Knock-out mice. The investigators have recently determined the conservation in human monocytes of the interleukin -1beta maturation triggered by CNF1 and observed the heterogeneous capacity of monocytes to respond to the CNF1 treatment depending on the donors. Here, to determine the importance in natura of AVI the investigators will analyze the blood content of patients presenting E. coli and S. aureus bacteremia. The DNA of monocytes isolated from patients will be extracted and various genes implicated in the activity of various inflammasomes will be sequenced to identify mutations that could explain the susceptibility to bacteremia or a specific clinical presentation, i.e. requirement of a management in ICU because of organ failure.


Eligibility Criteria:
Inclusion Criteria:

* Patient with S. aureus or E. coli bacteriostatic bacteremia defined by at least one positive blood culture bottle
* Patient requiring a blood test as part of his bacteremia
* not subject to a judicial protection measure
* Signature of the non-opposition of consent (for minor patients signed by one of the parents or the representative of the parental authority)
* Affiliation to social security

Exclusion Criteria:

* Immunocompromised patient defined by:

  * current immunosuppressive therapies: corticosteroids, chemotherapy, biotherapy
  * solid organ transplant patient or hematopoietic stem cell transplant
  * chemotherapy-induced neutropenia
  * Congenital immune deficiency
* bacteremia related to a peripheral or central catheter
* Urinary obstruction not lifted within the first 24 hours of management
* Intra-abdominal infection collected undrained in the first 24 hours of management
* primary infectious focus represented by mechanically ventilated pneumonia
* Pregnant or lactating woman
Hydrogen Inhalation for Health and Exercise Performance

In this randomized double-blind, placebo-controlled, crossover pilot trial, we evaluated the effects of 7-day H2 inhalation on exercise performance outcomes and serum hormonal and inflammation profiles in a cohort of young men and women.

All participants were allocated to receive either gaseous hydrogen (4%) or placebo (room air) by 20-min once-per-day inhalation for 7 days, with wash-out period of 7 days to prevent the residual effects of interventions across study periods. The primary treatment outcome was the change in running time-to-exhaustion from baseline to day 7. Additionally, assessment of other exercise performance endpoints and clinical chemistry biomarkers were performed at baseline and after 7 days after each intervention.

Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 -35 years Body mass index 20 - 25 kg/m2 Free of major diseases Physically active Must be able to give written informed consent

Exclusion Criteria:

Use of any dietary supplements within 4 weeks before study commences Abnormal values for lab clinical chemistry (\> 2 SD)
Text Message Stop Smoking Among Young Population

Smoking cessation is a priority for preventing smoking-attributable disease and reducing its burden. Quitting smoking at any age confers substantial and immediate health benefits, including reduced risks of stroke, cardiovascular disease and smoking-related cancers, and quitting smoking by the age of 30 reduces the risk of dying from tobacco-related diseases by almost 90%. The World Bank suggests that if adult cigarette consumption were to decrease by half in the year 2020, approximately 180 million tobacco-attributable deaths could be avoided. Therefore, promotion of smoking cessation has been proposed as a primary focus of tobacco control efforts, especially in developing countries where smoking prevalence and cigarette consumption are both still relatively high

most risk factors are associated with more than one disease, and targeting those factors can reduce multiple causes of disease. Since smoking has 9% contributions on the leading global risk towards mortality in the world and this risk factor has resulted in multiple causes of disease for example, lung cancer, heart disease, stroke, chronic respiratory disease and other conditions therefore by quantifying the impact of this risk factors on diseases, may help to decrease the number of burden disease that is caused by smoking. University students age of 18 -24 are among the group of age that has the highest prevalence on smoking, thus it is necessary to targeting the high-risk people, who are most likely to benefit from the intervention. Population-based strategies seek to change the social norm by encouraging an increase in healthy behavior and a reduction in health risk. University students are in transition between the adolescence and early adulthood and developed unhealthy behaviors like cigarette smoking

Eligibility Criteria:
Inclusion Criteria:

* Smokers aged 18 - 24 years old
* Owned a mobile phone with text messaging capabilities
* Intention to quit
* No current use of nicotine replacement treatment or bupropion in the past month
* Not in treatment for any substance abuse disorder within the past year

Exclusion Criteria:

* Not a smoker
* No desire to quit smoking-
* Who unwillingly to participate in this study
Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair

Patients with intrauterine adhesions (Asherman's Syndrome) and persistent thin endometrial lining in in vitro fertilization (IVF) treatment programs, particularly those resistant to standard therapies, present a significant clinical challenge. The aim of this trial is to assess if intrauterine administration of platelet rich plasma (PRP) improves endometrial lining thickness in patients with thin lining or Asherman's Syndrome.

BACKGROUND:

There is a need for new and more effective therapies for patients with intrauterine adhesions (Asherman's Syndrome) and persistent thin endometrial lining in in vitro fertilization (IVF) treatment programs, particularly for patients resistant to standard therapies

HYPOTHESIS:

Platelet rich plasma stimulates cellular processes involved in endometrial regeneration relevant to management of a thin lining or intrauterine scarring.

PRIMARY AIMS:

- To measure the change in endometrial lining thickness

SECONDARY AIMS:

* To determine if fertility is improved in patients receiving platelet rich plasma (PRP):

  1. In patients with thin lining undergoing frozen embryo transfer (FET), to determine:
* clinical pregnancy rate

  2. In patients with Asherman's Syndrome, to determine:
* the chance of spontaneous pregnancy

Any adverse effects of study arm will be monitored and reported as appropriate.

Eligibility Criteria:
Inclusion Criteria:

* Persistent thin lining \< 6mm on \>1 cycle in previous IVF or FET cycle OR moderate-to-severe Asherman's syndrome

Exclusion Criteria:

* Age \<18 years old or \>43 years old,
* Pregnancy,
* Diagnosis of cancer,
* Hb \<11 g/dL, platelets \<150,000/mm3,
* Anticoagulation,
* NSAIDs in the 10 days before procedure
* Any significant comorbidity or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
* Incision in the uterus: myomectomy; cesarean section
Evaluation and Treatment of Patients Spinal Blood Vessel Abnormalities

Arteriovenous malformations (AVM) are abnormally formed blood vessels that can be located throughout the brain and spinal cord. Patients with abnormalities of the blood vessels located in and around the spinal cord can develop many neurological problems. Some problems include, weakness, pain, difficulty walking, paralysis, and even death.

The treatment for these AVMs depends on their location, the type of malformation, the area of the spine involved, and the condition of the patient at the time of treatment. The treatment is aimed at stopping the neurologic problems from worsening and possibly correcting the existing problems. There are two commonly used treatments for AVMs, surgery and embolization (blocking off of blood flow to the AVM).

However, researchers have limited experience treating these conditions because they are rare. In addition, it has been difficult to classify different kinds of AVMs and to develop new treatments for them.

This study is designed to increase researchers understanding of AVMs by admitting and following patients diagnosed with the condition. By increasing the amount of patients studied diagnosed with spinal blood vessel abnormalities, researchers can begin to develop new management plans for patients with AVMs.

Spinal Arteriovenous Malformations are rare lesions that frequently effect young patients and adults in their most productive years. They cause progressive myelopathy, ultimately causing paraplegia or quadriplegia if untreated. Because they are rare lesions, experience with treating them in sufficient numbers to permit classification of them, investigation of the pathophysiology of myelopathy, and the introduction of new techniques for treatment has been possible in only a very few centers in this country. One essential element of investigation of them is selective spinal arteriography. Since selective spinal arteriography was first introduced for these lesions here at the NIH in the mid 1960's by Drs. John Doppman and Giovanni DiChiro, the NIH has been such a center of expertise for patients with spinal arteriovenous malformations. Because of this, NIH has been, and is, a national referral center for these patients. However, there has never been an approved protocol at the NIH for investigation or treatment of these patients. The purpose of this proposal is to present a plan of investigation and treatment which will serve as a protocol under which to admit these patients and to permit continued accrual of clinical experience with them that will serve to guide others in the management of these patients.

Eligibility Criteria:
* INCLUSION CRITERIA:

Adult greater than or equal to 18 years with known or suspected spinal AVM and capacity to provide written informed consent.

Child ages 4-18 with known or suspected spinal AVM and with parent/guardian informed consent.

EXCLUSION CRITERIA:

Unable to tolerate MRI and/or spinal arteriography.

Child less than 4 years.
Study in Healthy Volunteers to Investigate the Effects of Ketoconazole on the Pharmacokinetics of NKTR-118

Study in healthy volunteers to investigate the effects of Ketoconazole on the Pharmacokinetics of NKTR-118

An Open-label, 1-sequence, 3-period, 3-treatment, Crossover Study to Assess the Effects of Ketoconazole on the Pharmacokinetics of NKTR-118 in Healthy Subjects

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures.
* Male and female (nonchildbearing potential, nonlactating)healthy volunteers aged 18 to 55 years inclusive, with suitable veins for cannulation or repeated venipuncture.
* Female volunteers must have a negative pregnancy test at screening and at admission, must not be lactating, and must be of nonchildbearing potential.
* Male volunteers should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after dosing with the IP. The female partner should use contraception during this period.
* Volunteers must have a BMI between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg.

Exclusion Criteria:

* Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, or major physical impairment), as judged by the Investigator.
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IP.
* Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator.
* Significant orthostatic reaction at enrollment as judged by the Investigator.
* Abnormal vital signs, after 10 minutes supine rest as defined in protocol.
CONTAIN COVID-19: Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients

This is a randomized, blinded phase 2 trial that will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms requiring oxygen supplementation.

A total of 300 eligible subjects will be randomized in a 1:1 ratio to receive either convalescent plasma (CP) from people who have recovered from COVID-19 containing antibodies to SARS-CoV-2 or a placebo control, Lactated Ringer's Solution (LR) or saline solution (SS). Hospitalized COVID-19 patients aged ≥18 years of age with respiratory symptoms within 3 to 7 days from the onset of illness OR within 3 days of hospitalization will be eligible to participate.

Eligibility Criteria:
Inclusion Criteria

1. Patients ≥18 years of age
2. Hospitalized with laboratory confirmed COVID-19
3. One or more of the following respiratory signs or symptoms: cough, chest pain, shortness of breath, fever, oxygen saturation ≤ 94%, abnormal CXR/CT imaging)
4. Hospitalized for ≤ 72 hours OR within day 3 to 7 days from first signs of illness
5. On supplemental oxygen, non-invasive ventilation or high-flow oxygen
6. Patients may be on other randomized controlled trials of pharmaceuticals for COVID -19 and patients who meet eligibility criteria will not be excluded on this basis.

Exclusion Criteria

1. Receipt of pooled immunoglobulin in past 30 days
2. Contraindication to transfusion or history of prior reactions to transfusion blood products
3. Invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
4. Volume overload secondary to congestive heart failure or renal failure
5. Unlikely to survive past 72 hours from screening based on the assessment of the investigator
6. Unlikely to be able to assess and follow outcome due to poor functional status
Efficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma

This study will be a randomized, placebo controlled, double blind study to measure the safety and efficacy of a new, injectable asthma medication, omalizumab, in a group of minority with moderate to severe asthma who are not adequately controlled with use of inhaled or oral steroids. Primary endpont will be change in asthma symptom utility index. Secondary endpoints will be changes in asthma Quality of life, asthma exacerbation rate, and lung function over the 12 week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-30
* Minority Patients
* Moderate or Severe allergic asthma (as defined by the National Asthma Education and Prevention Guidelines(7)\]. Allergic asthma will be defined as elevated IgE level (\> 100 IU/ml) and skin test sensitivity to at least one common aeroallergen
* asthma control score greater than 1.5 (5) at randomization visit with use of equivalent of at least 1000 mcg fluticasone daily or systemic steroid use
* FEV1 50-90% predicted at screening and randomization visit

Exclusion Criteria:

* Active smoking within one year and/or greater than 10-pack year history of smoking
* Women of childbearing age must be using effective contraception
* Malignancy diagnosed within the past 5 years
* Underlying lung disease other than asthma
* Inability to comply with study protocol