cyrilzakka/clinical-trials huggingface dataset:
Alveoscopy, Endoscopic Confocal Microscopy and Lung Rejection, Parenchymal Lung Diseases in Vivo

Lung transplantation is indicated when end-stage lung diseases no longer respond to available standard therapy, making life expectancy short and associated with disability. Acute and chronic rejection are common complications following transplantation, indicating screening bronchoscopies and transbronchial biopsies at three month intervals the first two years, in addition to clinically indicated procedures when rejection or infection is suspected. Transbronchial biopsies carry associated risks (bleeding, pneumothorax). Chronic rejection is characterized by progressive obliteration of distal airways (Bronchiolitis Obliterans-BO-). BO requires open lung biopsy for diagnosis. Alternatively, a clinical surrogate (Bronchiolitis Obliterans Syndrome), characterized by decline in Forced Expired Volume in 1 second not explained by acute rejection or infection is used for diagnosis. The new technique of confocal endo-microscopy enables sub-surface visualization of tissue in vivo during bronchoscopic procedures using a probe-based confocal microscope, integrated to a standard endoscope. Bronchiolar and alveolar structures can be visualized at a cellular and nuclear level, and these images can be saved and reviewed. This new technology could potentially identify acute and chronic rejection, thus offering and alternative to transbronchial biopsies. We expect to describe a new alternative to diagnose acute and chronic rejection using confocal microscopy images obtained endoscopically, obviating complications of transbronchial biopsies.

Endoscopic confocal endomicroscopy can detect and classify common bronchiolar and alveolar pathological conditions in real time. Specifically, we hypothesize that confocal endomicroscopy images of bronchiolar and alveolar structures during standard bronchoscopy could help to recognize and classify the presence/absence of acute rejection and/or bronchiolitis obliterans syndrome in lung transplant recipients. This technology could also identify the histological characteristics lung diseases such as interstitial, obstructive or vascular end stage lung diseases, and thus lead to more efficient, safer and more accurate diagnosis of these lung conditions during routine bronchoscopies.


Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years
2. Any patient undergoing surveillance or clinically indicated bronchoscopies during or after lung transplantation
3. Any patient undergoing bronchoscopy prior lung transplant

Exclusion Criteria:

1. Unwilling to consent
2. Unable to safely tolerate a bronchoscopic procedure
Influence of Respiratory Mechanics on Diaphragmatic Dysfunction in COPD Patients Who Have Failed NIV (RHYDIAN)

Although non-invasive mechanical ventilation (NIV) is the gold standard treatment for patients with acute exacerbation of COPD (AECOPD) who develop respiratory acidosis, failure rate are still high ranging from 5% to 40%. Recent studies have shown that the onset of severe diaphragmatic dysfunction (DD) during AECOPD increases risk of NIV failure and mortality in this subset of patients. Although the imbalance between the load and the contractile capacity of inspiratory muscles seems the main cause of AECOPD-induced hypercapnic respiratory failure, data regarding the influence of mechanical derangement on diaphragmatic performance in this acute phase are lacking. With this study we aim at investigating the impact of respiratory mechanics on diaphragm function in AECOPD patients who experienced NIV failure. AECOPD with respiratory acidosis admitted to the ICU of the University Hospital of Modena from 2017-2018 undergoing mechanical ventilation (MV) due to NIV failure were enrolled. The study protocol consisted of two consecutive phases; in the first step measurements of static respiratory mechanics and end expiratory lung volume (EELV) were performed after 30 minutes of MV in volume control mode. In the second step transdiaphragmatic pressure (Pdi) was calculated by means of a sniff maneuver (Maximal Pdi) after 30 minutes of spontaneous breathing trial. Linear regression analysis and Pearson's correlation coefficient was used to asses the association between Maximal Pdi values and static and dynamic mechanical features and the association between Maximal Pdi and Pdi/Maximal Pdi.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* AECOPD with respiratory acidosis admitted to the Respiratory Intensive Care Unit of the University Hospital of Modena (Italy) undergoing endotracheal intubation due to NIV failure.

Exclusion Criteria:

* history of neuromuscular disease,
* presence of chest wall deformities,
* coexistence of interstitial lung disease,
* presence of pulmonary edema,
* severe hemodynamic instability,
* septic shock,
* evidence of lobar pneumonia or bilateral parenchymal consolidation at chest X-ray on admission,
* contraindication to NIV,
* previously assessed diaphragmatic palsy,
* intracranial hypertension,
* known pregnancy,
* need for immediate endotracheal intubation,
* neurologic impairment,
* lack of collaboration,
* unreliable maneuver to calculate maximal transdiaphragmatic pressure.
Acute Fetal Response to Prenatal Yoga

Prenatal yoga has become a popular means of exercise during pregnancy.

In 2012, yoga was reported to be practiced by approximately 20 million Americans, out of which 82% are women practitioners. The effects of yoga on the fetus have not been demonstrated. The purpose of this study is to evaluate the acute fetal response to yoga exercises by assessing fetal well-being via ultrasound and non-stress testing among healthy women. The investigators hypothesize that yoga during pregnancy does not have any acute negative effects on fetal behavior as assessed by umbilical artery Dopplers and fetal heart rate or maternal vital signs.

Eligibility Criteria:
Inclusion Criteria:

* Uncomplicated singletons pregnancies
* Gestational age between 28 0/7 and 36 6/7 weeks
* No known fetal anomalies
* Women with no prior experience with yoga
* Currently receiving routine prenatal care
* No contraindications to exercise
* Able to read and understand English
* Well dated pregnancy

Exclusion Criteria:

* Pregnant minors less than 18 years of age
* Multiple gestations
* Those patients that have been advised by their doctor not to exercise during this pregnancy (i.e. Vaginal bleeding, history of preterm delivery less than 34 weeks, cervical insufficiency, cerclage in place, placenta previa, any chronic medical conditions)
* Congenital fetal anomalies or intrauterine growth restriction
* Cigarette smokers
* Chronic narcotic dependence
Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)

This study is designed to compare the efficacy of ertapenem and piperacillin/tazobactam with respect to the clinical response in baseline microbiologically evaluable patients; and to evaluate the tolerability and safety of ertapenem compared to piperacillin/tazobactam.

Original label approved November 2001

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients (greater or equal to 18 years of age)
* Intraoperative/Postoperative Enrollment: Upon visual confirmation of an intra-abdominal infection.
* Preoperative Enrollment: Patients may be enrolled preoperatively if they meet certain criteria

Exclusion Criteria:

* Failure to meet all inclusion criteria.
* Patients who are considered unlikely to survive the 6-8 week study period.
* Pregnant or nursing women, or fertile women not practicing adequate methods of contraception.
Wellness Program for Elementary School Personnel

The goal of the project is to develop, implement, and evaluate, through a randomized controlled trial at a worksite, an intervention to promote increased physical activity behavior and healthier eating behavior to reduce overweight and obesity among elementary school personnel.

BACKGROUND:

The dramatic increase in the prevalence of overweight and obesity among adults in the United States during the past two decades is related to increased cardiovascular disease, hypertension, dyslipidemia, diabetes, and other chronic diseases. With 63.9% of working-age adults employed, worksites are targets for prevention and intervention programs to control overweight and obesity. Worksite interventions have the potential to reach a large number of individuals in a common and shared environment.

DESIGN NARRATIVE:

This is a group-randomized trial involving 20 elementary schools in Jefferson Parish public schools. Schools will be the unit of randomization; 10 schools will be randomly allocated to implement the intervention, and 10 schools will serve as controls. The primary aim of the program is to reduce mean body weight. Secondary aims relate to changes at both the individual level and the environmental level. The intervention will address the two major determinants of overweight and obesity: physical activity and diet. A School Wellness Committee at each site will be instrumental in identifying and implementing components of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults with no contraindications to participating in an intervention to improve eating and exercise behaviors
* Healthy adults with no contraindications to participating in any of the measurement procedures

Exclusion Criteria:

* Inability to participate in routine physical activity
Improving Outcomes In Diabetic Patients During CABG Surgery By Optimizing Glycemic Control

This study seeks to determine whether varying the dose of insulin and glucose in diabetic patients during coronary bypass surgery will improve outcomes in these patients.

Our previous study has shown that maintaining serum glucose between 120-180mg/dl in the perioperative period during CABG surgery in diabetic patients improves outcomes. The purpose of this trial is: (1) to determine whether outcomes can be improved by altering the content of glucose or insulin in these solutions (2)to determine the effect of these solutions and glycemic control on the inflammatory response of arterial and venous conduits used during surgery, (3) to determine whether the beneficial effects of improved glycemic control can be correlated with changes in the inflammatory response.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic CABG patients

Exclusion Criteria:

* Renal and hepatic failure
Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder

AGA-004 - The objective of the study is to determine safety, effectiveness and clinical utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus. AGA-007 - The objective of this study is to evaluate the long term safety and effectiveness issues that may not have have been adequately addressed during AGA-004.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a demonstrated patent ductus arteriosus
* Body weight \> 5 Kilograms

Exclusion Criteria:

* Pulmonary vascular resistance above 8 Woods units or a Rp/Rs \>0.4.
* Additional cardiac or non-cardiac abnormality that can reasonably be expected to significantly affect the patient's health adversely in the next two years, i.e.: cancer, Eisenmenger's syndrome, other serious congenital heart disease.
* Pelvic vein or inferior vena cava thrombosis
* Sepsis (local/generalized) or any type of infection that cannot be successfully treated prior to device placement.
* History of repeated pulmonary infection
* Demonstrated intracardiac thrombi on echocardiography • Inability to obtain informed consent
Safety and Efficacy of KPI-121 in Subjects With DED

The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2 drops instilled in each eye four times daily (QID).

This is a Phase 3, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and efficacy of KPI-121 0.25% ophthalmic suspension versus vehicle in subjects with dry eye disease.

Eligibility Criteria:
Inclusion Criteria:

* Have a documented clinical diagnosis of dry eye disease in both eyes

Exclusion Criteria:

* Known hypersensitivity or contraindication to the investigational product(s) or components
* History of glaucoma, IOP\>21 mmHg at the screening or randomization visits, or being treated for glaucoma in either eye.
* Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within 30 days prior to screening.
* In the opinion of the Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.
Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)

This is a post-trial access (PTA) open-label, single-arm study in Multiple Myeloma participants who continue to derive clinical benefit from elranatamab monotherapy in the Pfizer-sponsored elranatamab Parent Studies.

This is a single-arm elranatamab post-trial access study. Participants will receive elranatamab. All participants will receive elranatamab until disease progression, unacceptable toxicity, withdrawal of consent, study termination or, elranatamab becomes commercially accessible in the participant's country.

Eligibility Criteria:
Inclusion Criteria:

* Participants must agree to follow the reproductive criteria as outlined in the protocol
* Participants have completed a qualifying Parent Study, were still receiving elranatamab when the Parent Study terminated or completed, and are deriving clinical benefit from elranatamab (as determined by the investigator).

Exclusion Criteria:

* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Participants not previously enrolled or who have discontinued study treatment in a Parent Study are ineligible for participation in this study.
ACT for HIV-Positive Men

The purpose of the current study is to examine the feasibility and effectiveness of acceptance and commitment therapy, a specific form of cognitive-behavioral therapy, for treating general mental health concerns among HIV-positive men.

The purpose of the current study is to examine the feasibility and effectiveness of acceptance and commitment therapy, a specific form of cognitive-behavioral therapy, for treating general mental health concerns among HIV-positive men.

Eligibility Criteria:
Inclusion Criteria:

* identify as a man
* be at least 18 years old
* has been diagnosed with HIV by a healthcare professional

Exclusion Criteria:

* has engaged in self-harm within the last three months
* has attempted suicide within the last year
* has had an active plan to attempt suicide within the last 30 days
* is currently diagnosed with any eating disorder
* has experienced hallucinations or delusions within the last 30 days
* has used narcotics within the last 7 days (heroin, meth, crack cocaine, opioids)
First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

This trial is conducted in Europe. The aim of this trial is to assess safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0195-0092 (somapacitan) compared to placebo in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking male subjects
* BMI (body mass index) between 18.0 and 28.0 kg/m\^2, both incl.
* Body weight 50 to 100 kg, both incl.

Exclusion Criteria:

* Strenuous exercise within 4 days prior to dosing
* Receipt of any investigational medicinal product within 3 months prior to randomisation
Twelve Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Adults

The primary purpose of this study is to evaluate the effectiveness in adults, of four different strengths of resiquimod gel applied to common wart(s) three times a week for twelve weeks.

A second purpose is to evaluate the safety of the drug.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of common warts
* Two forms of birth control

Exclusion Criteria:

* Pregnant or breast feeding
* Other types of wart(s), ie. plantar
* Currently participating in another clinical study
* Chronic viral hepatitis B or C
Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy

To evaluate the efficacy and safety of Huaier Granule for prevention of recurrence and metastasis of hepatocarcinoma after radical hepatectomy.

A Multicenter, Randomized, Paralleled control Clinical Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma after Radical Hepatectomy,to evaluate the efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 18 and ≤ 75 years, both male and female;
* Radical hepatectomy has been performed for hepatocellular carcinoma;
* The hepatocellular carcinoma has been confirmed by pathological examination;
* Barcelona clinic liver cancer(BCLC) stage A or B;
* Not receiving any preoperative anticancer drug;
* The liver and kidney function satisfies the following conditions within 15 days after surgery (excluding day 15): aspartate aminotransferase(AST), glutamic-oxalacetic transaminase(ALT)\<3 upper limit of normal(ULN), total bilirubin≤2ULN, serum creatinine \<1.5 ULN;
* Other laboratory tests meet the following requirements within 15 days after surgery (excluding day 15): Hb≥9g/dl, platelet count≥60×109/L, absolute neutrophil count\>1.0×109/L;
* The expected survival time ≥ 12 weeks;
* The subjects volunteer to sign the informed consent.

Exclusion Criteria:

* Hepatocellular carcinoma patients who received non-radical hepatectomy;
* Non-hepatocellular carcinoma patients;
* Those with Child-Pugh C;
* Pregnant or lactating women;
* Those with active bleeding due to various reasons;
* Those with HIV infection or AIDS-associated diseases;
* Those with severe acute and chronic diseases;
* Those with severe diabetes;
* Those with serious infectious diseases;
* Those who can not take drugs by oral route;
* Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
* Conditions that are considered not suitable for this study investigators
Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.

The purpose of this study is to compare two different thromboelastometry (ROTEM) trigger levels for administration of human fibrinogen concentrate (Haemocomplettan P) in the treatment of perioperative dilutional coagulopathy during major pediatric surgery. The study hypothesis is that administration of fibrinogen concentrate triggered by a ROTEM FibTEM MCF \< 13 mm might reduce the total amount of transfused red cell concentrate during 24 hours after start of surgery as compared to a trigger level of ROTEM FibTEM MCF \< 8 mm.


Eligibility Criteria:
Inclusion Criteria:

* Males and Females
* Age 6 months to 17 years
* Scheduled for elective scoliosis surgery or major craniofacial surgery
* Written informed consent has been obtained
* Intraoperative hypofibrinogenemia according to definition of treatment groups

Exclusion Criteria:

* Preexisting congenital or acquired coagulation disorder
* Medical history of estimated increased bleeding tendency
* Ongoing coagulation therapy
* Clinical signs or diagnosis of acute thromboembolism
* Intolerance of study drug
* Participation at another clinical trial
* Pregnant or lactating women
Quality of Life in Patients After Pharyngolaryngectomy

Laryngeal cancer is an indication for a laryngectomy (separation of the airways and digestive tract). Laryngectomy causes a permanent disruption of self-perception. Communication, social interactions, diet andaesthetic appearance are altered. Its modifications disrupt the quality of life of patients and must be taken into account as soon as possible in patient cares.

The aim of the study is to describe quality of life in patients with laryngectomy.

Eligibility Criteria:
Inclusion Criteria:

* male or female
* with laryngectomy
* agreeing to participate in the study

Exclusion Criteria:

- less than 18 years old
ACL Versus ALL + ACL Study

The aim of the study is to show a reduction of a re-rupture rate with an ACL (antero crusader ligament) + ALL (anterolateral ligament) combined technique compared to a classical Kenneth-Jones ACL (antero crusader ligament) reconstruction technique.

The aim is to evaluate the rate of re-rupture and to analyze knee function through scores analysis as International Knee Documentation Committee Subjective Knee (IKDC), Knee injury and osteoarthritis outcome score (KOOS), Lysholm-Tegner, and by objective measurements of laximetry and rotation.

This study should include 2 groups of 296 patients with isolated ACL (antero crusader ligament) with clinical rotation :

* operated by a conventional patellar tendon technique (first group)
* operated by a technique combining a ALL (anterolateral ligament) and ACL plasty for the second group

Eligibility Criteria:
Inclusion Criteria:

* Patients with total isolated antero crusader ligament (ACL) rupture who are candidates for surgical reconstruction
* Patients between 18 and 35 years old
* Patients with weekly sporting activities
* Patients with chronic rotatory instability with a positive pivot shift
* Patients who have been informed and do not object the research

Exclusion Criteria:

* Patients with multi-ligament knee involvement
* Patients under 18 years old or over 35 years old
* Patients with a BMI of under 18.5 or over 30
* Patients with any contraindication to general anaesthesia
* Professional sportsmen/women
* Patients with congenital malformation or a rheumatic disease
* Patients with repeated antero crusader ligament (ACL) rupture
* Patients with serious ligament disease in the contralateral knee
* Patients who refuse to take part in the study
Effects of Parmigiano Reggiano on Skeletal Muscle Damage in Older Adults

Aging is associated with the loss of muscle mass and function (sarcopenia) and reduced tissue regenerative capacity.

Eccentric exercise (ECC) is a model of RET that can be used with the elderly, due to the ability of the muscle to combine high muscle strength production with low energy cost. ECC contractions are significantly more damaging to the muscles and produce greater muscle strength, for these reasons there is a greater risk of inducing muscle damage before the muscle is able to adapt.

Parmigiano Reggiano (PR) has some peculiar bromatological characteristics. The proteins contained in it, and in particular the potentially bioactive peptide sequences, can rapidly provide the amino acids necessary to promote muscle growth and repair during exercise. Furthermore, PR can be an important source of fatty acids, of which a significant amount of short-chain fatty acids (SCFA) which are known to have important clinical effects on body composition and metabolic health and can have a systemic anti-inflammatory effect.

Therefore, the central hypothes is that PR consumed during RET can provide more energy substrates and improve muscle recovery. To date, no studies have studied its function on recovery from exercise nor in the elderly.


Eligibility Criteria:
Inclusion Criteria:

* age \>60 years old or \>18 and \< 30 years old
* BMI \>18 and \<30 kg/m2
* stable body weight in the past 3 months
* valid medical certifacate for practice of physical activity

Exclusion Criteria:

* diabetes or pre-diabetes as for ADA guidelines
* chronic diseases (cardiovascular, liver, respiratory, cancer, etc)
* acute inflammatory status
* regular practice of intense physical activity (\>2 sessions/week)
* treatment with steroids in the past 3 months
* regular use of \>50g/die of Parmigiano Reggiano