cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the IPS System for TLD Therapy in Patients With COPD

Targeted Lung Denervation (TLD) Therapy will be a safe method to ablate the airway nerve trunks that travel parallel to and outside of the main bronchi and into the lungs to achieve targeted lung denervation and potentially improve breathing and quality of life for patients suffering from COPD.

Use of the IPS System will be technically feasible in accessing the target treatment location and delivering RF energy to the target treatment location.


Eligibility Criteria:
Inclusion Criteria:

* FEV1 30% to 60%
* Patient is diagnosed with COPD
* Positive relative change in FEV1 of greater than 15%
* Patient 40 years of age or older at the time of consent
* Smoking history of at least 10 pack years
* Non-smoking for a minimum of 6 months prior to consent and agrees to continue not smoking for the duration of the study

Exclusion Criteria:

* Documented history or current evidence of pulmonary hypertension Documented history or current evidence of polycythemia level of greater
* Documented history or current evidence of congestive heart failure
* Patient has an SaO2 less than or equal to 88% or a PaO2 less than or equal to 7.3 kPa (55 mm Hg) on room air
* Patient has a PaCO2 \> 8.0 kPa (60 mm Hg)
* Prior lung transplant, LVRS, LVR, median sternotomy, bullectomy or lobectomy
* Pulmonary nodule requiring surgery
* History of recurrent respiratory infections (more than 3 hospitalizations within 1 year of enrollment)
* Presence of a pacemaker, internal defibrillator or other implantable electronic devices j. Active respiratory infection within the past 4 weeks k. COPD exacerbation within the past 4 weeks l. Myocardial infarction (MI) within the last 6 months m. Unstable or life threatening arrhythmia within the last year n. Malignancy treated with radiation or chemotherapy within the last 2 years o. Documented history of other respiratory diseases (cystic fibrosis, tuberculosis, vocal chord dysfunction, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis)
Post COVID-19 Vaccination Analysis in Healthcare Worker Recipients

This research study is studying how healthcare worker recipients react after receiving vaccinations for COVID-19. The objective of the study is to evaluate the immune response to COVID-19 vaccination. The immunity will be evaluated over time by measuring serum semi-quantitative SARS-Co-V2 IgG from blood specimens and analyzing vaccine reaction data. SARS-CoV-2 is the name for the virus responsible for COVID-19 infections. IgG, immunoglobulin G, is an antibody found in the blood that protects against bacterial and viral infections. Study subjects will also be asked to report physical reactions they may have experienced related to vaccinations.

As some of the first recipients of SARS-CoV-2 vaccines under emergency authorization use, healthcare workers represent a diverse subpopulation, that are now moving through the immune response to the Pfizer and Moderna mRNA vaccines. As individual responses may vary, this provides an opportunity to evaluate levels of IgG response in relation to age, gender, comorbidities and other factors that may influence immunity. We recognize that, though this is only part of the immune response that may be protective for severe COVID-19 disease, it is a first step in understanding the level and durability of post vaccination SARS-CoV-2 antibodies.

This small, pilot study will evaluate the immune response over time by measuring serum semi-quantitative SARS-CoV-2 IgG from healthcare vaccinees at various timepoints. A high-level review of reactions related to the vaccinations will be performed with the same population of healthcare workers.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent for study
* Current employee or active member of the medical staff of Huntington Hospital, Pasadena, CA, (must have valid hospital identification)
* Must have completed vaccination regimen (two doses if required) no more than 8 weeks ± 5 days before enrollment
* Must have completed, valid vaccination card, if vaccinations received at a center other than Huntington Hospital
* Able to read English, sign consent form and complete on-line surveys

Exclusion Criteria:

* Huntington Hospital employees on leave of absence
* Anyone not able/willing to provide blood specimens and respond to surveys for the 52-week study period
Bruxism and Underlying Psichological Factors

The aim of this study was o determine the relationship between self-reported bruxism (SB) and some psychological factors (i.e: Anxiety State-Trait; Stress Reactivity Index, Beck Depression Inventory). A consecutive sample of 101 patients that reported at least 2 of the 6 items of Bruxism self-reported index, were explored clinically for quantifying the number and severity of worn teeth, and also the severe and location of the muscular pain according to an standardized inventory.

The Bruxism Self-Reported Index was that reported by Pintado et al.

Pintado MR, Anderson GC, DeLong R, Douglas WH. Variation in tooth wear in young adults over a two-year period. J Prosthet Dent. 1997;77:313-320.

The muscular pain was assessed by the last version of the Research Diagnostic Criteria reported by the Schiffman et al in 2014

Schiffman E, et al ; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network\* and Orofacial Pain Special Interest Group†. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported Bruxism

Exclusion Criteria:

* Refused patients
Physical Exercise Influence Among Overweight and Obese Pregnant Women

Objective: To evaluate the association between physical exercise for obese or overweight women and the maternal, perinatal outcomes and perception of these women about their quality of life.

Methods: A randomized controlled clinical trial with 78 pregnant women. Overweight or obese (BMI ≥ 26 kg / m²), gestational age between 14 and 24 weeks and from age 18 years were included. They will be divided into two random groups: one which will an exercise program under supervision and guidance received from home exercises (study group) and another that followed the standard routine prenatal care service (control group). Both groups will receive standardized nutritional counseling by the department of nutrition and dietetics and a questionnaire measuring quality of life WHOQOL-short at 14 - 24 weeks and at 36 weeks of pregnancy. The intervention results will be analyzed by intention to treat. A P value less than 0.05 will be used to determine statistical significance.

Objective: To evaluate the association between physical exercise for obese or overweight women and the maternal, perinatal outcomes and perception of these women about their quality of life.

Methods: A randomized controlled clinical trial with 78 pregnant women. Overweight or obese (BMI ≥ 26 kg / m²), gestational age between 14 and 24 weeks and from age 18 years were included. They will be divided into two random groups: one which will an exercise program under supervision and guidance received from home exercises (study group) and another that followed the standard routine prenatal care service (control group). Both groups will receive standardized nutritional counseling by the department of nutrition and dietetics and a questionnaire measuring quality of life WHOQOL-short at 14 - 24 weeks and at 36 weeks of pregnancy. The intervention results will be analyzed by intention to treat. A P value less than 0.05 will be used to determine statistical significance.

Eligibility Criteria:
* Overweight or obese (BMI ≥ 26 kg / m²),
* Gestational age between 14 and 24 weeks and from age 18 years
* No contraindication for physical exercise on pregnancy
Randomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer

This randomized phase III trial studies the success rate of definitive radiation therapy (dRT) for prostate cancer (PCa) with or without planning based on PSMA PET. PSMA- PET-based dRT, may improve radiation therapy planning and patient selection for dRT, and potentially improve its outcome compared to dRT without PSMA PET (standard dRT).

PRIMARY OBJECTIVE:

I. To compare the outcome of patients with unfavorable intermediate (IR) and high-risk (HR) prostate cancer (PCa) after standard dRT versus prostate-specific membrane antigen (PSMA) positron emission tomography (PET)-based dRT.

OUTLINE: Patients are randomized to 1 of 2 arms. In both arms, no other primary treatment should be given before RT.

Arm I: Patients do not undergo PSMA PET for dRT planning. Patients undergo standard of care dRT at the discretion of the treating radiation oncologist.

Arm II: Patients undergo PSMA PET for dRT planning. Patients then undergo dRT at the discretion of the treating radiation oncologist, who receives the PSMA PET result and images.

After completion of dRT, clinical follow-up of patients with their treating radiation oncologist will be obtained for 5 years. The investigators will rely on the medical records obtained from the treating physicians as the primary source of outcome data.

Eligibility Criteria:
Inclusion Criteria:

* Adult male 18 years or older
* Histopathologically-proven PCa
* Unfavorable IR to HR disease:

  * Prostate specific antigen (PSA) \>= 10 ng/mL
  * Or cT-stage \>= 2b
  * Or Gleason grade 3 (4+3=7) or higher
  * Or Gleason grade 2 (3+4=7) AND \>= 50% positive biopsy cores
  * Or Decipher Score \>= 0.45
* Treating radiation oncologist intends to incorporate PSMA PET findings into the radiotherapy plan, if patient undergoes PSMA PET (intervention arm 2)
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

* Less than 18 years old at the time of investigational product administration
* Extra-pelvic metastasis (M1 disease) on any imaging or biopsy done before randomization
* Prior PSMA PET
* Prior pelvic RT
* Contraindications to radiotherapy (including active inflammatory bowel disease)
* Concurrent or prior surgery or systemic therapy for PCa at the time of randomization
Neuraxial Anaesthesia: Does BMI Relate to Ease of Neuraxial Anaesthesia?

Neuraxial anaesthesia can be more difficult and associated with more complications if the patient's bony landmarks are difficult to palpate. They are more likely to be difficult to palpate if a patient has a high Body Mass Index (BMI), (\>30kg/m2). The depth that the spinal or epidural needle must be inserted is usually longer in these patients with high BMIs. We wish to palpate the backs of at least 100 such patients to see how many of them have impalpable bony landmarks. We then wish to use ultrasound to measure the distance from skin to the posterior epidural complex to discover if this length is longer than the standard needle length. If it is longer in the majority of people we study, we will recommend changing standard practice to start using a longer needle for all first attempts at neuraxial anaesthesia in this patient population.

Complications rates including failure are higher in obese patients undergoing anaesthesia procedures. Anaesthetists have adopted the use of ultrasound to assist in overcoming these difficulties. Neuraxial ultrasound is proving to be beneficial in those patients in whom identification of interspinous spaces is difficult and most of these patients are obese.

In our institution, there is a 'standard practice' for neuraxial procedures, with a 'standard' needle used for first attempts (Whitacre 25G 90mm for spinal, Tuohy 18G 80mm for epidural). If the operator has not reached the desired space (spinal or epidural) with the needle inserted to 8cm, a longer needle is then considered for further attempts. This exposes the patient to at least one extra neuraxial needle insertion. Studies have shown that increased needle insertions and redirections are associated with increased complications.

We hypothesised that a large number of patients with BMI\>30kg/m2 would have a depth of spinal/epidural space that is greater than the length of the 'standard' needle used. Therefore we suggest that practice should change to use the longer needle or a combined spinal-epidural on the first attempt in these patients.

To test our hypothesis, we will assess the ease of palpation of the following anatomical landmarks: anterior and posterior iliac crests; lumbar spinous processes; scapulae; and sacral cornua. We will then perform neuraxial sonography of the lumbar spine, measuring depth to epidural space. Finally we will measure waist circumference in those patients with BMI \<30kg/m2.

Eligibility Criteria:
Inclusion Criteria:

* Recorded BMI \>30kg/m2; ability to give consent; non-emergency cases.

Exclusion Criteria:

* Previous metal work to lumbar spine.
Assessment of PaO2/FiO2 Ratio Pre and POst INTubation

We designed this study to dtermine whether invasive mechanical ventilation (MV) would have an impact on the reclassification of patients with acute hypoxemic respiratory failure (AHRF) -treated previously with non-invasive respiratory support- into categories of severity (mild, moderate, and severe). Our hypothesis is that the assessment of PaO2/FiO2 ratio on PEEP greater or equal to 5 cmH2O after intubation, in patients labeled as mild/moderate/severe AHRF while on non-invasive respiratory support, would identify that a marked proportion of patients would change the degree of severity after a brief period of invasive MV

Current criteria for definition of the acute respiratory distress syndrome (AHRF) are inadequate for inclusion of patients into clinical trials due to: (i) the lack of standardization for measuring the oxygenation defect (as assessed by the PaO2/FiO2 ratio) and (ii) the inclusion of non-intubated patients into the mild category of severity. We questioned whether the PaO2/FiO2 (P/F) ratio calculated before endotracheal intubation in non-intubated patients who otherwise meet AHRF criteria, would still meet the severity threshold once patients are intubated.

We will examine at 24 after intubation and initiation of MV whether adult patients with AHRF remained in the same AHRF category of severity (mild, moderate, severe) or do not meet the PaO2/FiO2 criterion for AHRF. If our hypothesis is supported, it would suggest that stratification of patients labeled based on P/F ratio while treated with non-invasive respiratory support is of limited utility for testing specific therapies for AHRF in non-intubated patients.

This is a high quality screening, longitudinal, defined population, retrospective study.

Eligibility Criteria:
Inclusion Criteria:

* Patients meeting criteria for AHRF while they are on non-invasive respiratory support.
* We will only include patients who had arterial blood gases (ABG) within a time-frame of the last 5 hours of NIV and the first 5 hours of invasive MV.
* We will only include patients treated with high-flow oxygen nasal cannula (HFNC), or continuous positive airway pressure (CPAP), or bilevel positive pressure (BiPAP).

Exclusion Criteria:

* Patients who never required HFNC, or CPAP, or BiPAP before intubation.
* Patients with no ABG during the last 5 hours of NIV before intubation.
* Patients with no ABG during the first 5 hours after initiation of invasive MV.
* Patients treated with inhaled pulmonary vasodilator only before or only after intubation.
Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease

This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed CT-P13 (infliximab) or Remicade (infliximab) for treatment. CT-P13 (brand names Inflectra and Remsima) is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows:

* To characterize the population and drug utilization patterns of patients treated with CT-P13 for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade
* To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade
* To assess the effectiveness of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade

The study will be conducted in accordance with legal and regulatory requirements with scientific purpose, value and rigor following generally accepted research practices described in Guidelines for Good Pharmacoepidemiology Practices (GPP), Good Epidemiological Practice (GEP), Good Practices for Outcomes Research, International Ethical Guidelines for Epidemiological Research, European Medicines Agency (EMA) European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology, and FDA Guidance for Industry. Data sources will be validated and will consist of the hospital medical records and monitoring will be organized on a regular basis. Data for the study will be entered into a web based electronic data capture (EDC) system at enrolment and then approximately every 3 months (at a minimum) thereafter up to 2 years. Adverse events will be encoded according to MedDRA 17.1 or later. The sample size will be approximately 2500 patients recruited over a 30 month period and followed up to 2 years. No inferential analyses are planned. Statistical analysis will be descriptive in nature.

Eligibility Criteria:
Inclusion Criteria:

1. At least 12 years of age at the time of initial confirmed diagnosis of CD or UC and at least 18 years of age at the time of enrolment to the study.
2. Patients who are prescribed CT-P13 or Remicade for the treatment of CD or UC prescribed according to the corresponding summary of product characteristics (SmPC) as determined by the Investigator. Patients with stomas or surgery/pouch will be included.

Exclusion Criteria:

1. Any reported contraindications for CT-P13 or Remicade, according to the SmPC.
2. Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrolment.
3. Prior history of failure to respond to Remicade or CT-P13.
Long-term Safety and Effectiveness of AUGMENT® Injectable Bone Graft Compared to Autologous Bone Graft

The objective of this long-term study is to evaluate the long-term effectiveness and safety of AUGMENT® Injectable Bone Graft vs. autologous bone graft. The study involves evaluation of subjects originally treated under protocol BMTI-2009-01 or BMTI-2010-01 or treated with autograft under protocol BMTI-2006-01.

Subjects will be asked to consent and return to provide long-term follow-up data at or after 60 months (5 years) have elapsed since their original surgery as a subject in protocol BMTI-2009-01 or BMTI-2010-01.

STUDY HYPOTHESIS: The effectiveness and safety profile for AUGMENT® Injectable Bone Graft is maintained and remains comparable to that of autologous bone graft over long-term subject follow-up.

REGULATORY PHASE: Post-approval study


Eligibility Criteria:
Inclusion Criteria:

1. Must be willing and able to provide informed consent and be available for the planned follow-up evaluations and radiologic tests; and
2. Must have been included in the Augment Injectable propensity score matching population from the Augment Injectable summary of safety and effectiveness data (SSED).

Exclusion Criteria:

1) Subjects that were excluded from the safety analysis in the BMTI-2009-01 or BMTI-2010-01 study. These subjects were consented, but never treated as part of the BMTI-2009-01 or BMTI-2010-01 protocol.
Anticoagulation Regimens in Pregnant Patients With Prosthetic Heart Valves

Pregnancy is associated with increased risk of thrombosis among women with mechanical prosthetic heart valves.However, the best anticoagulant treatment strategies for pregnant patients with prosthetic heart valves have been controversial. In this study the investigators wanted to identify the most effective and safe regimen among different anticoagulant regimens.

Four different anticoagulant treatment regimens for pregnant patients with prosthetic heart valves have been described. In the first arm warfarin is stopped and enoxaparine is started in 1mg/kg dose twice a day which is monitored by weekly anti-Xa levels (between 0.7-1.2) during the first trimester and followed by only warfarin after first trimester. In the second arm, if the patient's warfarin consumption is more than 5 mg before pregnancy, warfarin dose is decreased to 2.5 mg during the first trimester combined with enoxaparine in 1mg/kg dose twice a day; adjusted by measurements of anti-Xa levels (between 0.5-1) weekly until the end of 12th week of pregnancy . In the third arm warfarin dose is decreased to 4 mg during the first trimester combined with enoxaparine given in a similar manner. If the patient's therapeutic warfarin dose is less than 5 mg before pregnancy, warfarin is continued in the same dose during all the pregnancy in the 4th arm. All patients are followed by serial transesophageal echocardiography performed at 0,3,6 and 9. months of pregnancy. Informed consent is taken from all patients. After delivery the babies are examined by a experinced pediatrician and pediatric cardiologist for any congenital anomalies.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients with prosthetic heart valves

Exclusion Criteria:
The Effect of Mifepristone on Uterine Fibroids and Breast Tissue

Uterine fibroids are a benign but common condition among women in reproductive age. It is one of the most common reasons for hysterectomy since it often causes bleeding problems sometimes leading to anemia. Several alternative treatment regimens have been investigated that could replace surgery. The antiprogesterone, mifepristone, is one of the most promising drugs that have been tested. In addition to the inhibiting effect on the growth of uterine fibroids antiprogestins have been proposed to have an antiproliferative effect on breast tissue.

The purpose of the present study is to evaluate the effect of mifepristone on the volume of uterine fibroids. The study will also address the effect of mifepristone on the breast tissue

Other purposes of this study include:

* To develop a new non-surgical method for treatment of uterine fibroids
* To study the effect of mifepristone on the size of uterine fibroids
* To evaluate factors regulating fibroid growth by comparison with untreated fibroids and normal myometrium
* To study the effect of mifepristone on the amount of blood loss and pelvic pain in patients with fibroids
* To study the effect of mifepristone on proliferation of breast tissue

Eligibility Criteria:
Inclusion Criteria:

Uterine fibroids requiring treatment

* Good general health
* Willing and able to participate after giving informed consent

Exclusion Criteria:

* Need for immediate surgery
* Concomitant hormonal treatment (HRT)
* History of malignant disorder of the breast
* Any contraindication for mifepristone

Criteria for retrospective exclusion:

Subjects may be excluded from analysis if one of the following applies:

* Any violation of the study protocol
* Lack of essential data