cyrilzakka/clinical-trials huggingface dataset:
BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

This 6-month open label study will evaluate the long term safety of bosentan (via oxygen saturation) and efficacy (exercise capacity) in patients who have completed the BREATHE-5 study (PAH related to Eisenmenger physiology). Treatment duration is 6 months.

This is a multicenter, open-label, single -arm study with bosentan, initial dose of 62.5 mg b.i.d., with a target dose of 125 mg b.i.d. All patients will be assessed for eligibility during the baseline visit (same as Week 16, end of study BREATHE-5 visit), and will have the option to enter into the open-label extension study at a starting dose of 62.5 mg b.i.d., for safety reasons. Visit 2 is required as a safety visit to assess oxygen saturation (SpO2) after 1 week of bosentan treatment. Patients will return for Visit 4 after 4 weeks of treatment, and the dose will be up-titrated to 125 mg b.i.d. or maintained at 62.5 mg b.i.d. at the judgement of the investigator. Data will be collected for a total of 24 weeks or until the sponsor decides to stop the study. If the results from Study AC-052-403 or AC-052-405 demonstrate significant safety issues, this extension study may be terminated at the sponsor's request.

Eligibility Criteria:
Inclusion Criteria:

1. Patients stable with PAH upon completion of the BREATHE-5 randomized, double-blind, placebo- controlled 16-week study.
2. For female patients, only non-pregnant women who are surgically sterile, postmenopausal or have documented infertility (over 50 years of age and amenorrheic for at least 1 year), or those of childbearing potential using one of the following methods of contraception: Barrier-type devices (e.g., condom, diaphragm) used ONLY in combination with a spermicide. A double-barrier method is recommended; intrauterine devices (IUDs); oral or implanted contraceptives, if used in combination with a barrier method.
3. Patients providing written informed consent.

Exclusion Criteria:

1. Patients who withdrew prematurely from BREATHE-5, AC-052-405.
2. Patients who are pregnant or nursing.
3. Patients who are receiving epoprostenol or prostacyclin analogues, or are expected to receive any of these drugs during the study.
4. Patients with AST and/or ALT values greater than 3 times the upper limit of normal.
5. Patients with hemoglobin or hematocrit that is more than 30% below the normal range (patients with secondary polycythemia are permitted in the study).
6. Patients with systolic blood pressure \< 85 mm Hg.
7. Patients taking phosphodiesterase inhibitors, other endothelin receptor antagonists or are receiving another investigational product.
8. Patients active on organ transplant list.
9. Patients who are receiving or expected to receive glyburide, cyclosporin A or tacrolimus.
10. Patients not able to comply with the protocol or adhere to therapy.
OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients

While there are indications that 28 days of miltefosine is not sufficient for treating CL by L. aethiopica, a better understanding of what happens in terms of parasite clearance and drug dosing is lacking. In this study, longitudinal measurements of parasite and drug concentrations during treatment are done to monitor parasite kinetics as well as pharmacokinetics. This data will be crucial to provide more information on duration and dosing of miltefosine in CL patients globally, and in Ethiopia and pediatric patients in particular.

In this project, parasite dynamics and miltefosine pharmacokinetics in the skin and blood during routine durations of miltefosine treatment (4-8 weeks) are studied with the aim to provide evidence to optimize miltefosine dosing for treatment of CL. By also studying these factors in children who get allometric miltefosine dosing, data which can be used to adapt the current allometric dosing scheme specifically to children with CL will be produced. Exploratory objectives will look into searching for more objective outcome assessment measures, resistance, helminth infection and nutritional status as potential factors affecting treatment response.

Eligibility Criteria:
Inclusion Criteria:

* Clinical or parasitological (microscopy or PCR) confirmation of leishmaniasis
* Age \>2
* Clinical decision to start miltefosine treatment as systemic treatment
* In case of females of child-bearing age: willing to take contraceptive for 6 months (parenteral or IUD or implant)
* Willing and able to provide informed consent
* Willing to be hospitalized for the duration of treatment

Exclusion Criteria:

* Currently on treatment or having received modern treatment for leishmaniasis in the last 3 months
* Pregnant (pregnancy test at D0) or breastfeeding
* Unlikely to come for follow-up visits
* Abnormal lab values Hemoglobin \<5.0g/100mL Platelets \<50 x 10\^9/L White blood count \<1 x 10\^9/L ASAT/ALAT \>3x upper normal range Creatinine above the normal limit
Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL

BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and reduced delayed cardiotoxicity in animal models compared to reference standards. This cytotoxic agent has structural similarities to mitoxantrone as well as general similarities to anthracyclines (such as the tricyclic central quinoid chromophore7).

This phase III study will compare the efficacy and safety of the combination BBR 2778, fludarabine, and rituximab with the combination fludarabine and rituximab in patients with relapsed or refractory indolent non-Hodgkin's lymphoma.


Eligibility Criteria:
Inclusion Criteria

1. Histologically confirmed relapsed or refractory indolent non-Hodgkin's lymphoma (NHL)
2. Any stage (Ann Arbor staging, Appendix 15.7), with or without B symptoms
3. CD 20+ lymphoma (confirmed by immunochemistry)
4. Measurable disease.
5. Atleast 1 prior therapy.
6. Age ≥ 18 years
7. Life expectancy of at least 3 months
8. ECOG performance status (PS) of 0 or 1
9. Adequate cardiac function defined as LVEF ≥ 50% by MUGA scan
10. Adequate renal function
11. Adequate hepatic function
12. Adequate bone marrow function
13. Recovery from all acute toxicities from prior therapies (except alopecia and grade 1 peripheral neuropathy).

Exclusion Criteria

1. Prior treatment with a cumulative dose of doxorubicin equivalent exceeding 450 mg/m2
2. Radiotherapy, chemotherapy or other therapies for NHL within 4 weeks of treatment start
3. Systemic corticosteroids to treat NHL within 5 days prior to first dose of study treatment.
4. Radioimmunotherapy (RIT) within 3 months of treatment start
5. Known hypersensitivity to the excipients or the study drugs that the patient will receive
6. Known Type I hypersensitivity or anaphylactic reactions to murine proteins or to any component of rituximab
7. Major thoracic and/or abdominal surgery in the preceding 4 weeks, from which the patient has not fully recovered (patients who have had minor surgery and one week's recovery period may be enrolled)
8. HIV-related lymphoma
9. Active CNS involvement
10. Clinically significant cardiovascular abnormalities
11. Serious (NCI CTCAE grade 3-4) intercurrent infection at randomization, infection requiring oral antibiotics, or deep-seated or systemic mycotic infections.
12. Investigational study drug within 30 days before randomization. Patient must have recovered from all side effects of other investigational therapy.
13. Clinical symptoms suggesting unresolved HIV, HBV or HCV infection. .
14. History of another malignancy except: curatively treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in remission, or any other cancer from which the patient has been disease-free for 5 years
15. Pregnant or lactating women
16. Potentially fertile men and women and their sexual partners not willing to use adequate contraception as defined by the Investigator during the study and for 6 months after the last day of study drug administration
Mid-transverse Process to Pleura Block in Pediatric Thoracotomy

The aim of this study is to assess the effectiveness of analgesia of US guided MTP block in pediatrics undergoing thoracotomy.

Pain following surgery is a universal phenomenon which up to now is often underestimated and undertreated especially in pediatrics. Any postoperative analgesic technique should meet three criteria, which are effectiveness, universal applicability and safety.

Thoracotomy is widely known to cause severe acute pain. This pain can be very distressing for both children and their parents. If not treated properly, it may acutely cause ventilation-perfusion disorder and hypoxemia, together with a change in lung mechanics. It may lead to a delay in recovery, with some long-term sequelae. As a part of multimodal analgesia, many regional blocks have been described.

Regional anesthesia techniques are increasingly used in all surgical settings. Even in the context of thoracic surgery, new peripheral regional anesthesia techniques are being tested as alternatives to those already used. This proliferation of new techniques is explained, on the one hand, by the evolution of surgical techniques, which are becoming less and less invasive, and on the other hand, by the frequency and severity of the complications induced by thoracic epidural anesthesia and paravertebral block - currently the gold standards in context of pediatric setting.

Paravertebral block (PVB) has gained more popularity than other regional analgesic techniques including epidural for perioperative analgesia in pediatric surgery. Thoracic PVB provides adequate postoperative analgesia with favorable adverse effects. The use of thoracic PVB is associated with decreased pain severity and opioid consumption in both adults and children.

Many clinicians hesitate to apply the PVB technique due to the risk of serious complications such as pneumothorax. Therefore, the safest and most effective methods are being tried by clinicians. In a study conducted on cadavers claimed that mid-transverse process to pleura (MTP) block (an injection point midway between the pleura and posterior border of the transverse process) provides a paravertebral block due to the paravertebral spread of the local anesthetic agent through fenestrations and septations in the superior costotransverse ligament. They thought that MTP block may be as effective as PVB in postoperative pain management with less risk of possible complications.

Eligibility Criteria:
Inclusion Criteria:

* The study will include 50 pediatric patients of both sexes aged from 5 to 15 years old with American Society of Anesthesiologists physical status I\& II undergoing elective open thoracotomy.

Exclusion Criteria:

* Refusal of parents.
* Repeated thoracotomy.
* Emergency surgery.
* Mechanically ventilated patients.
* Bleeding disorders.
* Allergy to study drugs.
* Infection at the site of the needle puncture.
ED50 of Esketamine for Laser Treatment in Children

There is limited research on the combined use of esketamine and alfentanil for anesthesia during facial laser treatment in pediatric patients, and the effective dosage of esketamine for inhibiting body movement remains unclear. We explore the effective dose of esketamine combined with alfentanil for the inhibition of body movement during facial laser treatment in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* age between 3 years and 12 years old
* patients scheduled for laser treatment of facial lesion

Exclusion Criteria:

* patients with airway infection during the last 1 month
* patients with cardiac or pulmonary disorder
* patients with hepatic or renal disfunction
* patients with neurologic or psychiatric disorder
Blood Markers Predict Effect of Normobaric Hypoxia at Rest and During Exercise in Patients With Pulmonary Hypertension

To study the effect of acute normobaric hypoxia during exercise in patients with pulmonary hypertension on blood markers (serum markers of iron and red blood cell homeostasis and micro-RNAs known to be associated with PH).


Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature (Appendix Informed Consent Form)
* PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion Criteria:

* resting partial pressure of oxygen \<8 kilopascal at Zürich altitude on ambient air
* exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study
* inability to follow the procedures of the study
* patients who take nitrates
* other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
The Novel US-C-A-B Protocol: Curriculum Implementation and Evaluation of Proficiency

Ultrasound is a frequently used diagnostic tool in the emergency department and suggested to have a role during resuscitation. The aims of this study were to develop a novel, resuscitative ultrasound-circulation-airway-breathing (US-C-A-B) protocol, to implement a short curriculum and to assess the feasibility.

The US-C-A-B protocol was built in an advanced life support-compliant manner. It involved a 3-part assessment: (1) C: subxiphoid 4-chamber view of the heart; (2) A: tracheal ultrasound; and (3) B: bilateral lung sliding. It could be used for direct confirmation for the C-A-B and searching the possible cause of cardiac arrest.

A half-day curriculum was designed, and comprised of one-hour didactics and 3-hour small-group hand-on training. Assessments were performed, including a written test, the US image acquisition and a satisfaction survey. From August 1, 2014 to March 31, 2016, the multi-center emergency physicians who attended the US-C-A-B curricula were enrolled prospectively.

Ultrasound is a frequently used diagnostic tool in the emergency department and suggested to have a role during resuscitation. The aims of this study were to develop a novel, resuscitative ultrasound-circulation-airway-breathing (US-C-A-B) protocol, to implement a short curriculum and to assess the feasibility.

The US-C-A-B protocol was built in an advanced life support-compliant manner. It involved a 3-part assessment: (1) C: subxiphoid 4-chamber view of the heart; (2) A: tracheal ultrasound; and (3) B: bilateral lung sliding. It could be used for direct confirmation for the C-A-B and searching the possible cause of

Eligibility Criteria:
Inclusion Criteria:

* The enrolled participants were emergency physicians of the National Taiwan University Hospital (NTUH), the Far-Eastern Memorial Hospital (FEMH) and the Chang-Kung Memorial Hospital (CKMH), three teaching hospitals in Taiwan.

Exclusion Criteria:

* Not emergency physicians.
Airway Pressure Release Ventilation as a Preventative Strategy

The early initiation of Airway Pressure Release Ventilation in multi-system trauma patients decreases the incidence and severity of acute lung injury and Acute Respiratory Distress Syndrome and allows faster recovery of lung function.


Eligibility Criteria:
Inclusion Criteria:

* Trauma patients age 16 or older
* Trauma patients requiring ventilatory support within 48 hours of injury
* Those with anticipated ventilatory support ≥ 24 hours
* Subject or authorized representative (AR) has signed an informed consent form (ICF)
* Subjects age 16 or 17 who have signed an assent document and/or AR has signed an ICF

Exclusion Criteria:

* Significant chronic lung disease defined as lung pathology requiring home O2 use
* Chronic heart disease defined as NYHC III or higher
* Persistent bronchopulmonary air leak
* Contraindications to permissive hypercapnia (ex. Intracerebral bleeding, brain tumor, fulminant hepatic failure, and hemodynamic instability)
* Pulmonary artery occlusion pressures ≥ 18 mmHg
* Severe neurologic injury that may prevent the patient from having a reasonable opportunity for weaning as determined by the clinical study team
* Immuno-compromised patients secondary to drugs or disease
* Neuromuscular disease that impairs ability to ventilate spontaneously (ex. Spinal injury at or above C5, ALS, Guillain-Barre syndrome, Myasthenia Gravis)
* History of pneumonectomy
* Pregnancy
* Burns with TBSA ≥ 20%
* Acute MI as the cause of ALI/ARDS
* All other contraindications to APRV
* Patients who cannot be randomized within 12 hours of intubation
Cardiac and Pulmonary Assessment in Egyptian Patients With Rheumatoid Arthritis

To determine cardiac and pulmonary involvement in RA patients To assess the correlation between cardiopulmonary findings in RA patients with disease activity.

To compare between diaphragmatic ultrasonography and PFT i.e. spirometry as a screening tool for restrictive pulmonary disorders.

To assess correlation between anterior chest wall ultrasound and pulmonary function test in RA patients.

Rheumatoid arthritis (RA) is a chronic inﬂammatory autoimmune disease with systemic manifestations targeting primarily synovial joints and periarticular tissues, with a 1-3% prevalence, it is the most prevalent form of inflammatory arthritis.(1,2) Although synovitis is the pathological hallmark of RA, numerous extra-articular symptoms and comorbidities are probably present.(3) Cardiovascular and pulmonary system diseases are the two main causes of death in RA patients, and their symptoms are the most serious.(2,3) Patients with RA have a 50% greater risk of CV mortality and a two-fold increased risk of myocardial infarction, which is the most common cause of death in this population. (4) Echocardiographic examination is considered a good predictive tool for some cardiac conditions with early findings while no clinical signs is yet found on these patients. (5) The second major cause of death in patients with RA is respiratory disease, which occurs in 30-40% of patients.(6) Sometimes the disease is silent until it has lung complications, which come before joint problems. RA may affect the lung interstitium, airways, and pleurae, while pulmonary vascular involvement is less frequent.(7) Diaphragmatic ultrasound can be used to determine the prevalence of interstitial lung disease involvement in RA as a restrictive disorder. The association between pulmonary function tests (PFTs), potential risk factors, and clinical correlation must be calculated.(8)(9) Anterior chest wall (ACW ) joints undergo joint changes and can be involved along the course of RA yet seems to be underestimated(1) Ultrasonography of ACW can detect those changes even before being clinically evident (10)

Eligibility Criteria:
Inclusion Criteria:

* Any patient satisfying 2010 ACR/ EULAR RA classification criteria

Exclusion Criteria:

* Patients with definite diagnosis for any other systemic autoimmune disorders
A Study to Evaluate the add-on Efficacy and Safety of Opicapone 50 mg or an Extra Dose of L-DOPA 100 mg for the Treatment of Wearing-off in Patients With PD

A Study to evaluate the add-on efficacy and safety of opicapone 50 mg or an extra dose of L-DOPA 100 mg for the treatment of wearing-off in patients with PD.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (2006) or according to the Movement Disorder Society (MDS) Clinical Diagnostic Criteria (2015).
2. Disease severity Stage III (H\&Y staging) at ON.
3. Treated on a stable regimen for at least four weeks before screening with immediate-release L-DOPA/DDCI, three to four intakes per day, and up to maximum daily dose of 600mg L-DOPA.
4. Signs of wearing-off phenomenon with average total daily OFF-time while awake of at least 1 hour, including the early morning pre-first dose OFF (i.e. the time between wake-up and response to the first L-DOPA/DDCI dosage), despite optimal anti-PD therapy (based on Investigator's assessment).

Exclusion Criteria:

1. Non-idiopathic PD (atypical Parkinsonism, secondary \[acquired or symptomatic\] parkinsonism, Parkinson-plus syndrome.
2. Severe and/or unpredictable OFF periods, according to Investigator judgment.
3. Average total daily OFF-time while awake of \>5 hours, including the early morning pre-first dose OFF, despite optimal anti-PD therapy (based on Investigator's assessment).
4. Treatment with prohibited medication: entacapone, tolcapone, monoamine oxidase (MAO) inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation, rasagiline up to 1 mg/day or safinamide up to 100 mg/day), apomorphine or antiemetics with antidopaminergic action (except domperidone) within the last four weeks before screening.
5. Previous or planned (during the entire study duration) deep brain stimulation or stereotactic surgery (e.g. pallidotomy, thalamotomy).
Trial of Fish Intake Advice in Pregnancy

The overall goal of this project is to establish a pilot study to develop and refine an intervention to promote consumption of fish low in mercury and high in n-3 PUFA among pregnant women. The investigators will demonstrate our ability to recruit pregnant women, influence their fish consumption, and measure changes in nutrient and toxicant biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* Currently pregnant 12-22 weeks
* Singleton pregnancy
* Consuming fish \<=2 times per month

Exclusion Criteria:

* Inability to answer questionnaires in English
* Plans to leave study area prior to delivery
* Would never eat fish (e.g. vegan, allergy to fish)
Allogeneic Stem Cell Transplant With Alpha/Beta T AND B Cell Depletion for Hematologic Malignancies

This is a single arm pilot study for patients using α/β T cell-depleted peripheral Stem Cell Transplantation (PSCT) in with alternative donor sources with hematologic malignancies receiving alternative donor (unrelated or partially matched related) mobilized peripheral stem cells (PSCs) using the CliniMACS system for T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and graft versus host disease (GVHD), and one year leukemia free survival.


Eligibility Criteria:
Inclusion Criteria:

1. Leukemias/lymphomas

   * Acute myeloid leukemia, primary or secondary Disease status: remission or \<10% bone marrow blasts
   * Myelodysplasia
   * Acute lymphoblastic leukemia Disease status: in hematologic remission
   * Chronic myelogenous leukemia Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase.
   * Mixed lineage or biphenotypic acute leukemia
   * Lymphoblastic lymphoma Disease status: remission
   * Burkitt's lymphoma/leukemia: Disease status- in remission
2. Acceptable organ status clearance
3. No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic
4. Signed informed consent.
5. Negative pregnancy test for females of childbearing potential.

Exclusion Criteria:

1. Patients who do not meet disease, organ or infectious criteria.
2. No suitable donor
3. Received previous allogeneic transplant

Donor must be either unrelated, mismatched up to one antigen/one antigen and one allele or a related, HLA match other than a sibling.