cyrilzakka/clinical-trials huggingface dataset:
Protein Biomarker Discovery and Validation in Chronic Obstructive Pulmonary Disease (COPD) And Asthma

The purpose of the study is to better understand proteomics of asthma and COPD, and response to therapy. There are two Phases to this study broken into two arms. In Phase I, we propose is to use discovery proteomics and techniques to identify protein expression signatures. Subjects who complete Phase I are eligible, but not required, to enroll in Phase II. In Phase II, we propose to establish and validate the predictive value of protein signatures for treatment responses using inhaled corticosteroids.

There are two Phases to this study broken into two arms. In Phase I, our propose to use discovery proteomics and high throughput techniques to identify protein expression signatures. The total planned size of Phase I is 100 patients. Patients will be divided into two arms based on disease status (COPD or asthma). Active smoking will be defined as daily use of cigarettes, pipes, cigarillos or cigars at time of entry into the study and through duration of study. No active smoking defined as never smoking or having stopped smoking for 5 years or greater.

In the Phase II, we aim to establish and validate the predictive value of proteomic signatures for therapeutic responses using inhaled corticosteroids. For Phase II, subjects who completed Phase I are eligible, but not required to participate in Phase II.

Eligibility Criteria:
Inclusion Criteria:

* Criteria for Asthma

INCLUSION

* History consistent with asthma: episodic wheezing, shortness of breath, or cough
* Airway lability recognized by at least 12% improvement in Forced Expiratory Volume (FEV1) after 2 puffs of beta2 agonist Age \>18yrs
* FEV1 \>40% predicted
* Never smoker, current smoker, or quit smoking ≥5 years ago Criteria for COPD

INCLUSION

* History consistent with COPD: dyspnea with exertion, productive cough, progressive course
* Smoking history of at least 20 pack years
* Current smoker or quit smoking ≥5 years ago
* Age \>18yrs
* FEV1: Forced Vital Capacity (FVC) ratio \< 0.70 following 2 puffs of albuterol
* FEV1 greater than 50% predicted

Exclusion Criteria:

* Exclusion for Asthma EXCLUSION

  * Other respiratory illness other than asthma
  * Chronic infectious process
  * Significant other medical illness
  * Inability to consent
  * Pregnancy Exclusion for COPD EXCLUSION
  * Other respiratory illness other than COPD
  * Chronic infectious process
  * Significant other medical illness
  * Inability to consent
  * Pregnancy
A Trial Investigating Lu AF28996 in Healthy Adult Participants

The purpose of this study is to investigate repeated doses of Lu AF28996 in healthy participants and co-administered with two other compounds, and in a separate cohort following co-administration with antibiotics, to see how well the doses are tolerated and what the body does to the drug after administering it.

The study has 2 parts: Part A and Part B.

Part A will consist of 2 cohorts (Cohorts A1 to A2), with 8 participants per cohort and will receive single doses of Lu AF28996 alone and in combination with enzyme inhibitors.

Part B will consist of one cohort (Cohort B1), with 8 participants who will all receive single doses of Lu AF28996 alone and in combination with amoxicillin/clavulanic acid.

Eligibility Criteria:
Inclusion Criteria:

* The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms per meter squared (kg/m\^2) at the Screening Visit and at the Safety Baseline Visit.
* The participant has a resting supine pulse ≥50 and ≤100 beats per minute (bpm) at the Screening Visit and at the Safety Baseline Visit.
* The participant has a resting supine systolic blood pressure ≥90 and ≤140 millimeters of mercury (mmHg) and a resting supine diastolic blood pressure ≥50 and ≤90 mmHg at the Screening Visit and at the Safety Baseline Visit.
* The participant has a normal circadian rhythm, defined as a person who usually wakes between 6:00 and 9:00 a.m. and goes to sleep between 9:00 p.m. and midnight.

Exclusion Criteria:

* The participant is a member of the site staff or of their immediate families or is a subordinate (or immediate family member of a subordinate) to any of the site staff.
* Part B only, the participant is a woman of childbearing potential AND is using oral hormonal contraceptives.
* The participant has previously been enrolled in this trial.
* The participant has previously been dosed with Lu AF28996.

Note: Other inclusion and exclusion criteria may apply.
Diaphragmatic Ultrasound to Predict the Therapeutic Effect of High-flow Nasal Cannula Oxygen Therapy

Follow-up was conducted for every patient requiring high-flow nasal cannula oxygen therapy in district 1 of the Intensive Care Department of Chenzhou NO.1 People's Hospital. Patients who met the inclusion criteria but did not meet the exclusion criteria were included for observation. Respiratory parameters, diaphragmatic activity, and variation rate of diaphragmatic thickness were recorded at the beginning of high-flow nasal cannula oxygen therapy, 1 hour after treatment, 3 hours after treatment, 6 hours after treatment, 9 hours after treatment, and 12 hours after treatment. Throughout the procedure, a panel of experts assessed whether the patient needed endotracheal intubation; If yes, the study was terminated; if no, high-flow nasal cannula oxygen therapy was continued, and observation and evaluation were continued until the end point of the study (12 hours after treatment). If patients or their family members do not want to continue to participate in the study during the study, they will be considered as withdrawal. If patients suffer from sudden malignant arrhythmia or cardiac arrest during the study, resulting in death or transfer to other hospitals or other departments during the study, patients will be excluded. Data from dropped and excluded patients were not included in the final statistical analysis. After the data of 269 patients were collected, the study was concluded, and the results and conclusions were derived by statistical analysis.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old, less than 75 years old,BMI≥18.5kg/m2
2. Mild to moderate type I respiratory failure (100mmHg\< PaO2/FiO2≤300mmHg)
3. Mild ventilation dysfunction (pH≥7.3)
4. Mild respiratory distress (respiratory rate \> 24 times/min)
5. High-flow nasal cannula oxygen therapy is required
6. The patient and immediate family members agree and sign a written informed consent.

Exclusion Criteria:

1. Patients with severe type II respiratory failure, severe asthma and massive hemoptysis
2. Moderate to severe consciousness disorder, GCS score ≤12 points
3. Cardiogenic pulmonary edema and cardiogenic dyspnea caused by heart failure, heart valvular disease, myocarditis, etc
4. Hemodynamic instability, SBP\< 90mmHg, or MAP\<65mmHg
5. BMI \< 18.5kg/m2
6. Nasal bleeding, nasal space occupying lesions, etc., can not be high-flow nasal cannula oxygen therapy through the nose or nasal obstruction
7. Patients with severe hypoxemia, severe ARDS and other conditions requiring immediate tracheal intubation
8. The patient or family member refuses to participate or does not agree to sign the written informed consent
9. The patient has participated in other research projects with interventions
Estimation of Disability Adjusted Life Years in Reunion Island and Comparison to Metropolitan France and Other Countries in the Indian Ocean Zone

AVIRON study aims at estimating the burden of various causes of death and morbidity in the Reunion Island population.

The identification of health priorities on a given territory is a major field of the research in Public health. The World Health Organization leads since the 1990s the "Global Burden of Disease" study. This study has for objective to estimate the burden of various causes of death and morbidity in a given population. It defines a standardized measure allowing the comparisons between the various countries. The measure developed internationally is the Disability-adjusted life year (DALY).

For the Indian Ocean zone, the international study provides values of DALYs for Madagascar, Seychelles and Mauritius. The estimation of DALYs for Reunion Island are based on data of mainland France and does not take into account specificities from Reunion Island. To better define Public health priorities, it seems essential to decline this measure at the regional level.

Eligibility Criteria:
Inclusion Criteria:

* The whole population of Reunion Island

Exclusion Criteria:

* People not living in Reunion Island
Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study

Over 600,000 hysterectomies are performed annually in the United States. Despite increasing use of less invasive approaches, the majority of hysterectomies are still performed via traditional laparotomy, which can be associated with generally slower recovery and longer lengths of post-operative hospitalization. Rapid Recovery Protocols (RRP) seek to optimize post-surgical morbidity outcomes by returning a patient to normal physiology as quickly as possible following surgery.

Subjects will be randomly assigned to one of two groups: Rapid recovery protocol (regional anesthesia, pain control options with emphasis on nonsteroidal anti-inflammatory drugs (NSAIDS) over narcotic pain medications, early ambulation, and early enteral feeding) or standard of care (traditional laparatomy and supportive care).

Eligibility Criteria:
Inclusion Criteria:

* Women who are being seen at the Women's Health Center by the Gynecologic Oncology group at the University of Minnesota if planned surgery includes an exploratory laparotomy

Exclusion Criteria:

* \< 19 years old
* Pregnant
* Undergoing a procedure other than laparotomy
* Scheduled to be discharged the same day of surgery
* Chronic narcotic pain medication user
* American Society of Anesthesiologists (ASA) score of \> or = 3
* Any condition that would exclude women from undergoing regional anesthesia
Mechanisms of Treatment Change in Panic Disorder and Agoraphobia

The primary goal of the present study is to identify mechanisms of therapeutic change of two theoretically contrasting therapeutic procedures: The first phase consists of comparing the outcome of the capnometry-assisted breathing therapy (BRT) with cognitive restructuring (CT). During the second phase participants of both interventions will undergo in-vivo exposure.

The primary goal of the present study is to identify mechanisms of therapeutic change of two theoretically contrasting therapeutic procedures: While the rationale of breathing training is based on the assumption that hypocapnea (lower than normal levels of pCO2) is responsible for the development and maintenance of panic disorder, the rationale of cognitive interventions is that the primary mechanism in PD is the cognitive misinterpretation of benign bodily sensations. Further, while breathing training should induce a low-anxiety state (through parasympathetic activation) and, therefore, facilitate habituation to fearful situations, voluntary increases in arousal through hyperventilation (sympathetic activation) has been suggested to facilitate cognitive restructuring during exposure.

In order to study mechanisms that potentially produce clinical improvement, the investigators propose a 2-phase therapeutic intervention: The first phase consists of comparing the outcome of the capnometry-assisted respiratory training (CART) with cognitive restructuring (CT). During the second phase participants of both interventions will undergo in-vivo exposure therapy.

With the data collected from the study, the investigators will test the following hypotheses: (a) CART will produce more reduction in psycho-physiologically relevant measures of panic symptoms compared to CT, while cognitive restructuring will produce more reduction in cognitive parameters of panic symptoms; (b) CART will influence the response to voluntary hyperventilation tests by leading to faster recovery compared to CT. Improvement in respiratory psychophysiology will be correlated with improvement in panic symptom severity; (c) Breathing techniques during exposure will lead to a lower-anxiety state, facilitating but not inhibiting fear extinction as suggested by the safety aid theory

Eligibility Criteria:
Inclusion Criteria:

* A current DSM-IV diagnosis of panic disorder with agoraphobia that is designated by the patient as the most important source of current distress
* Patients must be willing to engage in exposure to fearful situations and sensations

Exclusion Criteria:

* A history of bipolar disorder, psychosis or delusional disorders, current substance abuse or dependence

Medical Exclusion Factors:

* Patients with severe unstable medical illness, or serious medical illness for which hospitalization may be likely within the next three months
* Patients with a history of seizures, angina, myocardial infarction, congestive heart failure, clinically significant arrhythmias, transient ischemic attacks, cerebrovascular accidents, diabetes mellitus, significant asthma, emphysema, or chronic obstructive pulmonary disease
Effects of Arzoxifene on Bone Mass and the Uterus

The purposes of this study are to determine:

* The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women.
* The effects of arzoxifene on the uterus (womb) in postmenopausal women.
* The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density.
* The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease risk.
* The safety of arzoxifene and any side effects that might be associated with its use.


Eligibility Criteria:
Inclusion Criteria:

* Female
* 45 to 60 years of age, inclusive
* At least 2 years since last menstrual cycle
* Intact uterus (womb).

Exclusion Criteria:

* Existing fracture of the spine.
* Bone disorders, other than low bone mass
* History of cancer in the last 5 years. Also, any history, at any time, of breast cancer or cancer of the lining of the uterus.
* Abnormal or unexplained vaginal bleeding.
A Study to Evaluate the Safety and Efficacy of THR-317 for the Treatment of Diabetic Macular Oedema (DME)

This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST) in subjects with centre-involved diabetic macular oedema (DME).


Eligibility Criteria:
Inclusion criteria:

* Male or female aged 18 years or older
* Type 1 or type 2 diabetes
* Centre-involved DME with CST ≥ 340µm on Spectralis SD-OCT or ≥ 320µm on non-Spectralis SD OCT, in the study eye
* Reduced vision primarily due to DME, with BCVA between 72 and 23 ETDRS letters read at 4 meters (20/40 and 20/320 Snellen equivalent) in the study eye
* Anti-vascular endothelial growth factor (anti-VEGF) treatment naïve study eye or poor response to prior anti-VEGF treatment in the study eye
* Non-proliferative diabetic retinopathy, or stable proliferative diabetic retinopathy without neovacularisation at the disc
* Written informed consent obtained from the subject prior to screening procedures

Exclusion criteria:

* Concurrent disease in the study eye, other than DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results
* Previous treatments / procedures in the study eyes as follows, or their planned use during the THR-317 treatment period for up to 30 days after the last injection: panretinal or focal / grid laser photocoagulation \[3 months\], anti-VEGF treatment \[any time for anti-VEGF naïve subjects; 4 weeks for subjects with a poor response to anti-VEGF treatment\], intra-ocular or peri-ocular corticosteroids \[4 months\], steroid implant \[any time\], intra-ocular surgery \[3 months\], vitrectomy \[any time\]
* Any active ocular / intra-ocular infection or inflammation in either eye
* Aphakic study eye
* Untreated diabetes
* Glycated haemoglobin A (HbA1c) \> 12%
* Uncontrolled hypertension in the opinion of the Investigator
* Pregnant or lactating female or female of child-bearing potential not utilising an adequate form of contraception or male of reproductive potential not utilising contraception suggesting lens / zonular instability
Using Intravenous Heparin Versus Standard of Care Subcutaneous Heparin to Prevent Clots After Surgery

This study plans to learn more about what is the best treatment to prevent blood clots in patients in intensive care units (ICU's). The investigators know that patients who are in ICU's have a higher than normal risk of getting blood clots in the veins of their arms or legs. This can be very dangerous as the clot may move into the lungs. To prevent this, the standard treatment is to give low dose heparin subcutaneously 3 times a day (usually 5000 units at each dose). In this study the investigators are randomizing patients to receive either standard of care or low dose intravenous heparin in a continuous infusion.

Macro- and micro-thrombosis both contribute significantly to morbidity and mortality in the surgical intensive care unit. Pulmonary embolism (PE) is a common and preventable cause of death in critically ill patients, with a mortality rate of up to 10%. Up to 95% of cases of PE originate from deep venous thrombosis (DVT). There are multiple pharmacologic and non-pharmacologic methods of DVT prophylaxis.The current standard of care in thromboprophylaxis in the surgical intensive care unit (SICU) at the University of Colorado Hospital is low-dose subcutaneous heparin (SCH). However, there is little evidence that this is the optimal prophylactic treatment. In fact, a database search of ICD-9 diagnoses made in 2005 suggests that the incidence of DVT in SICU patients, the majority who receive subcutaneous heparin, is approximately 7%. Surgical ICU patients are at high risk of developing DVT during their hospital stay and likely need more aggressive anticoagulation. Intravenous heparin, given at a low dose and titrated to a measurable endpoint PTT (partial thromboplastin time), may offer several benefits over the current standard of care, subcutaneous heparin. This method of treatment would offer more aggressive anticoagulation and allow dosage to be adjusted frequently based on each patient's changing coagulation status.

Eligibility Criteria:
Inclusion Criteria:

* A signed informed consent;
* Age between 18 and 80 years
* The patient is admitted to the surgical intensive care unit at the University of Colorado Hospital

Exclusion Criteria:

* Predicated SICU stay less than 5 days;
* Pregnancy;
* Breast feeding;
* Initial platelet count \< 30,000;
* Currently eligible for treatment of thromboembolism;
* Prior organ transplant;
* Cardiopulmonary bypass within previous 30 days;
* Advanced directive precluding participation;
* Already receiving pharmacologic agent for DVT prophylaxis;
* Prior diagnosis of heparin-induced thrombocytopenia;
* Heparin allergy
Cognitive-Behavioural and Hypnotic Treatment of Chronic Primary Insomnia Among the Elderly

The present study examines the short- and long-term clinical efficacy of cognitive-behavior therapy and pharmacological treatment in patients suffering from late-life primary insomnia. 46 subjects suffering from chronic primary insomnia were randomized into either cognitive-behavior therapy (CBT, n=18), hypnotics (7.5 mg Zopiclone, n=16), or placebo treatment (n=12). All active treatments lasted 6 weeks with follow-ups conducted at 6 months. Ambulant clinical polysomnography (PSG) and sleep diaries were used on all three assessment points.


Eligibility Criteria:
Inclusion Criteria:

* age 55 years or older
* fulfilment of the DMS-IV criteria for insomnia, including difficulties initiating sleep, maintaining sleep, and/or early morning awakenings with no ability of return to sleep
* duration of at least 3 months
* complaints of impaired daytime functioning.

Exclusion Criteria:

* use of hypnotic medication the last 4 weeks before project start
* use of antidepressive or antipsychotic medications
* signs of dementia or other serious cognitive impairment defined by a score under 25 on the Mini-Mental State Examination
* presence of a major depressive disorder or other severe mental disorder as identified by a clinical assessment based on The Structured Clinical Interview for DSM-IV (SCID-I)
* presence of sleep apnea defined as (A/H index \> 15) or periodic limb movements during sleep (PLM index with arousal \> 15),
* working nightshifts and unable or unwilling to discontinue this work pattern,
* willingness or inability to stop taking sleep medication before start
* having a serious somatic conditions preventing further participation
The ShortCut™ Continued Access Study Protocol

A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).

The continued access study will be used to collect additional safety and effectiveness data of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets, and to demonstrate coronary artery ostia patency following leaflet split, in patients who are at risk for TAVR-induced coronary artery ostium obstruction following a ViV procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved ViV indication due to a failed bioprosthetic valve.
2. Patient is at risk for TAVR-induced coronary artery ostium obstruction.
3. Written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations, prior to initiation of any study mandated procedure.

Exclusion Criteria:

1. An excessive aortic valve leaflet Calcium morphology, such as diffuse massive calcification at the targeted leaflet for splitting or anatomy not suitable for the use of the ShortCut™ device, as determined by the CT measurements.
2. Carotid or vertebral artery disease that, in the opinion of the local Heart Team, should be treated; or treatment of carotid stenosis ≤ 1 month prior to index procedure.
3. CVA or TIA ≤ 6 months prior to index procedure.
4. History of a myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
5. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance.
6. LVEF \< 30%.
7. Ongoing severe infection or sepsis.
8. Patient has renal insufficiency or is on chronic dialysis.

8. Need for emergency surgery for any reason. 9. Life expectancy is less than 1 year.