cyrilzakka/clinical-trials huggingface dataset:
24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003 and Placebo MDI

Randomized, Phase IIIb, Two-period, Two-treatment Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe COPD after 4 Weeks of Treatment with PT003 and Placebo MDI


Eligibility Criteria:
Inclusion Criteria:

* At least 40 years of age and no older than 80 at Screening
* Women of non-child bearing potential or negative serum pregnancy test at Screening, and agrees to acceptable contraceptive methods used consistently and correctly Screening until 14 days after final visit
* Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
* Current or former smokers with a history of at least 10 pack-years of cigarette smoking
* Pre- and post-bronchodilator FEV1/FVC ratio of \<0.70
* Post-bronchodilator FEV1 must be \<80% predicted normal value, calculated using NHANES III reference equations, and the measured FEV1 must also be ≥750 mL if FEV1 \<30% of predicted normal value

Exclusion Criteria:

* Significant diseases other than COPD, i.e., disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study
* Women who are pregnant or lactating
* Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma
* Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Screening or during the Screening Period
* Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Screening or during the Screening Period
* Subjects who have clinically significant uncontrolled hypertension.
* Subjects who have cancer that has not been in complete remission for at least five years
* Subjects with abnormal liver function tests defined as AST, ALT, or total bilirubin ≥1.5 times upper limit of normal at Screening and on repeat testing
* Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible
* Subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator. Subjects with a trans-urethral resection of prostate (TURP) or full resection of the prostate within 6 months prior to Screening are excluded from the study
* Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator
ProAlgaZyme Novel Algae Infusion: Applications in Immunodeficiency

The purpose of this study is to determine the safety and effects in HIV patients of supplementation (4-20 fl. oz. daily) with ProAlgaZyme, a novel fermentation product of a freshwater algae ecosystem, on markers of immune status, dyslipidemia, inflammation and oxidative stress alone or in combination with HAART (highly-active antiretroviral therapy).

HIV infection and interventions such as HAART (highly-active antiretroviral therapy) are associated with dyslipidemia and increased markers of inflammatory and oxidative stress. These effects can hasten the progression towards AIDS and present serious cardiovascular complications. Therapeutic agents that can provide immune support with minimal side effects and/or reduce the adverse effects of HAART are in high demand worldwide. Such agents may help HIV patients to live a better quality of life, and may potentially improve the compliance with traditional therapies including HAART. This study is a single-center open-label design to evaluate the safety of ProAlgaZyme novel algae infusion and its effects in varying dosages on markers of immune status, dyslipidemia, inflammation and oxidative stress in patients with HIV or HIV/HBV co-infection, who may also be taking HAART.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as HIV +ve or HIV/HBV +ve
* Either/or:

  * had not taken antiretroviral drugs before (pre-HAART patients)
  * were treated with triple drug therapy for at least 3-6 months

Exclusion Criteria:

* Obese
* Taking any cholesterol-lowering medications 30 days prior to the start of enrollment and during the course of the study.
* Enrolled in another clinical study in the past 6 months.
Study of AeroForm Tissue Expander for Breast Reconstruction

This study is intended to support previous positive results of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction

The objective of this study is to provide performance and safety data to support the clinical use of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction in a patient population with a broad selection criteria

Eligibility Criteria:
Inclusion Criteria:

1. Subject is female between the ages of 18 - 70.
2. Subject has elected two stage breast reconstruction with tissue expanders.
3. Subject's tissue is amenable to tissue expansion.
4. Subject is able to provide written informed consent.
5. Subject is able and willing to comply with all of the study requirements.
6. Subject has the physical, perceptual and cognitive capacity to understand and manage the at home dosing regimen.

Exclusion Criteria:

1. Subject has residual gross malignancy following mastectomy.
2. Subject has a current infection at the intended expansion site.
3. Subject has clinically significant radiation fibrosis at the expansion site.
4. Subject has planned radiation at the intended expansion site during the time the expander is implanted.
5. Subject has any co-morbid condition determined by the Investigator to place the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes).
6. Subject is currently participating in a concurrent investigational drug or device study.
7. Subject is a current tobacco smoker.
8. Subject is overweight with a BMI \> 33.
9. Subject has currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.
10. Subject is pregnant or planning to become pregnant during the study period.
11. Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.

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Expanded Access for LJPC-501

The primary objective of the study is to provide access to LJPC-501 for distributive shock patients who remain hypotensive despite receiving fluid and vasopressor therapy.

Primary Objective

The primary objective of the study is to provide access to LJPC-501 for distributive shock patients who remain hypotensive despite receiving fluid and vasopressor therapy.

Secondary Objective

The secondary objective of the study is to assess the safety of LJPC-501.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be adults ≥ 18 years of age who remain hypotensive despite fluid therapy and vasopressor therapy and who received or are receiving a total sum norepinephrine (NE) equivalent unit dose of \> 0.2 µg/kg/min for at least 2 hours prior to LJPC-501 infusion.
* Patients must have central venous access and an arterial line present, which is expected to remain for the duration of the LJPC-501 infusion.
* Patients must be adequately volume resuscitated in the opinion of the treating investigator.
* Patients must have clinical features of distributive shock documented by either estimated or measured CI \> 2.3 L/min/m\^2 determined by echocardiogram or another cardiac output monitoring modality OR a concurrent CVP \> 8 mmHg and ScvO2 \> 70%.
* Patient or legal surrogate is willing and able to provide informed consent per local guidance and patient/legal surrogate is willing to comply with all protocol requirements.

Exclusion Criteria:

* Patients with a MAP \> 80 mmHg.
* Patients diagnosed with acute occlusive coronary syndrome requiring intervention.
* Patients who have been on ECMO \< 6 hours.
* Patients in liver failure with a MELD score ≥ 30.
* Patients not mechanically ventilated with a history of asthma or who are currently experiencing bronchospasm requiring the use of inhaled bronchodilators.
* Patients with acute mesenteric ischemic or history of mesenteric ischemia.
* Patients with Raynaud's phenomenon, systemic sclerosis, or vasospastic disease.
* Patients with an expected lifespan of \< 24 hours.
* Patients with active bleeding AND an anticipated need for transfusion of \> 4 units PRBCs within 48 hours of the initiation of LJPC-501.
* Patients with active bleeding AND hemoglobin \< 7 g/dL.
* Patients with an ANC \< 500 cells/mm\^3.
* Patients with a known allergy to mannitol.
* Patients who are currently participating in an investigational interventional trial.
* Women who are known to be pregnant at the time of Screening or have a positive serum or urine β-hCG, if of childbearing potential.
Biologic Association Between Metabolic Magnetic Resonance-positron Emission Tomograph (MR-PET) and Tissue Measures of Glycolysis in Brain Tumors of Infiltrating Glioblastoma Cells

The purpose of this project is to validate a new combined MRI and PET imaging technique as a biomarker or measure of glycolysis in brain tumors. To accomplish this, the investigators propose obtaining image-guided measures of tissue pH and biopsied tissue in tumor areas selected for bulk resection surgery. Investigators will then correlate the imaging measurements with pH, RNA expression, protein expression, and bioenergetics measurements of key glycolytic enzymes.

Patients who are scheduled for resection of glioblastoma multiforme (GBM) as part of standard care will be invited to take part in the study. All patients will undergo FDG-PET scan for the study using standard clinical imaging techniques, along with standard brain MRI plus up to approximately 15 minutes of investigational MR imaging sequences to permit calculation of \&#34;glycolytic index\&#34; as an experimental GBM imaging biomarker. Following pH measurements, the patient's clinical biopsy/tumor resection will take place as planned for clinical care. Tissue samples resected during the clinical procedure will be obtained and processed using immunohistochemistry techniques for further assessments, including RNA sequencing and bioenergetics analysis.

The current study will investigate the central hypothesis that biopsied tumor tissue undergoing high levels of glycolysis via RNA expression, protein expression, and bioenergetics analyses can be reliably detected, correlates with direct measure of tissue pH, and is strongly associated with a "glycolytic index" created by combining 18F-FDG PET, amine CEST-SAGE-EPI, perfusion MRI and diffusion MRI. In addition, the investigators will investigate whether metabolic differences identified from this imaging modality may identify infiltrating non-enhancing tumor cells.

FDG: 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose CEST: chemical exchange saturation transfer SAGE: spin and gradient echo EPI: echo planar imaging IHC: immuno-histochemical rCBF: regional cerebral blood flow rCBV: relative cerebral volume DSC: dynamic susceptibility contrast ADC: apparent diffusion coefficient MCT: Monocarboxylate transporters

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Patients with newly diagnosed or recurrent glioblastoma clinically indicated for resective surgery

Exclusion Criteria:

* Patients who cannot obtain an MRI or FDG PET scan with contrast
* Those with ferromagnetic implanted devices that might produce a safety hazard (e.g. infusion pumps, pace makers, aneurysm clips, etc.) will be excluded from the study along with subjects with severe claustrophobia or who have severely compromised renal function (GFR \< 30).
The Efficacy of the Longeviti ClearFit Implant in Craniectomies for Post-Operative Monitoring in Chronic Subdural Hematomas

Chronic subdural hematomas are frequent neurosurgical issues that are most often treated with burr hole craniectomies to drain the subdural fluid. At the chronic stage, a subdural hematoma is more liquified and easily washed out through burr hole openings. However, it often requires frequent imaging and monitoring to ensure that fluid does not reaccumulate in the subdural space, that the washout was adequate, and that further intervention/repeat intervention is not required, particularly if the patient develops acute changes in neurologic status or lacks improvement in initial symptomatology. Therefore, these patients require multiple repeated CT head images during their inpatient and post-operative follow-up course. This leads to high radiation doses to patients and high-cost burden. The Longeviti ClearFit Cover was developed to allow for ultrasound imaging through the implanted cover. The skull's acoustic properties prevent ultrasound from being used through the bone, therefore limiting its use in post-operative neurosurgical patients. Using ultrasound would remove the need for high radiation doses with CT, could be done very quickly and easily at bedside or in the clinic to check subdural space or ventricle size, and is much lower cost. This ClearFit implant would be utilized in place of a burr hole cover, typically titanium, that is implanted in most other cases. The aim of this study is to prospectively assess patients with surgically treated chronic subdural hematomas via craniectomy that have the craniectomy site covered with the Longeviti ClearFit, compared retrospectively to a matched cohort of patients that had their craniectomy site for the same procedure covered with the typically used titanium/metal. This will allow us to determine if this new implant results in reduced need for repeated CT imaging by utilizing bedside clinician-performed ultrasound and reduces overall cost for patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>18 years old; patients determined by surgeon to have a chronic subdural hematoma that is treated with craniectomy that would allow for implantation of a ClearFit cover

Exclusion Criteria:

* Pediatric patients, patient with allergy to the material the implant is made with (polymethylmethacrylate)
Markers of Recovery in StrokE Study (MORSE)

Our current biological understanding of stroke recovery in humans is extremely limited and this lack of knowledge is a major challenge in reducing stroke disabilities and deficits. Evidence of neural repair in humans can be gleaned indirectly through functional outcome measures, but we propose that metabolomics may also provide a minimally invasive window into human brain repair. This study will integrate clinical imaging and molecular biomarkers as a diagnostic tool in further understanding stroke recovery mechanisms.

Our long-term goal is to improve and hasten recovery following a stroke with translational research, which would combine the use of neuroimaging and identify neural repair metabolites. The objective and sequential step in fulfilling our long-term goal, is to identify differential expression of select stroke plasma biomarkers of neural repair, and image CST integrity in patients with good and poor recovery following an ischemic stroke. Diffusion tension imaging (DTI), will be used to image the neural repair as it occurs, further enhancing our understanding of stroke recovery. There are currently no known plasma biomarkers of neural repair. Identification of such biomarkers would be extremely valuable for designing stroke recovery drugs and timing rehabilitation therapies.

Eligibility Criteria:
Inclusion Criteria:

* Imaging confirmed ischemic stroke within 7 days of stroke onset
* Age \> 18 years
* NIHSS ≥ 1 on arm item OR NIHSS = 0 on arm item but \< 3/5 strength on MRC scale in distal joint (flex/ext elbow or grip/ext hand)
* Pre-stroke modified Rankin Scale (mRS) \< 3

Exclusion Criteria:

* Active malignancy (not thought to be cured or in remission)
* Anemia (HCT \< 25)
* Sepsis
* Suspected bacterial endocarditis
Antenatal Educational Intervention for Improvement of Breastfeeding

This randomized controlled trial addresses the impact of simple antenatal breastfeeding educational interventions on breastfeeding rates and practice in a tertiary hospital setting.

Hypothesis: A single antenatal encounter, which includes breastfeeding educational material and individual instruction with a lactation counselor, can improve the initiation, duration and exclusivity of breastfeeding compared to routine antenatal care or the use of educational material alone

Breastfeeding rates in many developed countries, particularly in terms of exclusive and predominant breastfeeding, often fall short of the recommended practice advised by the World Health Organization and the American Academy of Pediatrics. Despite increasing awareness of the many advantages of breastfeeding the challenge remains to implement programs that can effectively improve short and long-term breastfeeding rates.

The Singapore National Breastfeeding Survey 2001 (Foo et al, 2005) demonstrated an encouraging breastfeeding initiation rate of 94.5%. However only 21.1% continued to breastfeed at 6 months with fewer than 5% breastfeeding exclusively.

The formal preparation of expectant mothers for breastfeeding is not part of routine antenatal care in many practices. We feel that it may prove beneficial especially in an environment with a low prevalence of breastfeeding. The aim of this trial is to demonstrate the impact of single-encounter antenatal education combining educational material with individual instruction, on breastfeeding initiation and duration and on infant feeding practice, compared with routine antenatal care and educational material alone in a tertiary hospital setting.

401 women are randomized into 3 predetermined groups and are exposed to specific antenatal education materials targeting breastfeeding techniques; the control group receives routine antenatal care. Data regarding breastfeeding rate, quality and duration is collected over a 1 year period.

Comparisons: breastfeeding initiation rate, duration and type among women receiving lactation counseling with educational material, educational material without individual counseling, and routine antenatal care without educational intervention

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* gestation of at least 36 weeks at recruitment
* no uterine scar
* the absence of any obstetric complication that would contraindicate vaginal delivery.

Exclusion Criteria:

* refusal to participate in trial
* contraindications to labour, vaginal delivery, breastfeeding
Administration of Hydrocortisone in Young Healthy Male Volunteers

The misuse of cortisone or hydrocortisone for doping purpose in sport has been widely reported in the literature, but to date, no formal testing procedure is available and applicable in an anti-doping laboratory to detect hydrocortisone doping abuse , i.e., administration by systemic way.

The investigators therefore propose to identify biomarkers that clearly distinguish between an authorized local administration of hydrocortisone and a prohibited systemic administration, by studying the impact of 5-day administration of hydrocortisone per 2 different routes.

Clinical research with two groups of ten volunteers one group with 5 days with local administration (cream, applied to healthy skin) one group with 5 days with systemic route of administration (per os)

Eligibility Criteria:
Inclusion Criteria:

* male subjects

  * aged 18 to 30 years
  * 18 \< BMI \< 28
  * participating in regular physical activity (3-5 times/week)
  * subjects not on medication

Exclusion Criteria:

asthmatic subjects or history of respiratory or cardiac pathology; use of corticosteroids in the past 6 months; high blood pressure; ulcerated lesions of the skin, acne, rosacea; Infectious state (bacterial, viral, and fungal infections); diabetic subjects; ulcerative history and other gastrointestinal disorders; lactose allergy; galactose intolerance; ulcerative colonic pathology; myastenia gravis; live vaccine kidney failure
Effects of Prone Position After Major Abdominal Surgery

Evaluation of postoperative prone position after major abdominal surgery. A randomized clinical trial of 100+100 patients and further add a voice/speech/singing protocol.

Evaluation of postoperative prone position after major abdominal surgery. A randomized clinical trial of 100+100 patients and further add a voice/speech/singing protocol.

The patients will be randomized to the standard ERAS-protocol, enhanced recovery after surgery with or without adding periods of prone position after surgery.

They will be followed by protocol both as a momentum effect (experimental study) on POD 2-5 and also POD 7.

The aim is evaluation of prone position in order to improve the ventilation and hopefully diminish the risk of for example pneumonia and thromboembolism.

Inclusion criteria Patients referred to the Department of Surgery for major abdominal surgery of the esophagus, gastric- or pancreas surgery aim to cure.

Exclusion criteria Patients unable to understand Swedish in writing or speaking, preoperatively unable to perform a prone position.

The participation is voluntary and demands an inform consent from the patient operated upon.

The primary outcome is oxygen saturation and lung complications after surgery.

The secondary outcome is measurement of lung volumes, patient experience (7th graded Lickert scale), days of hospital care, 30 days complications etc.

Further investigations are perioperative properties as BMI, other forms of surgery, etc., and continues measurement of blood pressure, respiration frequency, heartrate, tubes and drainages, postoperative analgesic, blood samples with signs of bleeding, inflammation, infection.

Eligibility Criteria:
Patients eligable for abdominal surgery aim to cure with:

Inclusion Criteria:

- malignancy of the esophagus, gastric- or pancreas

Exclusion Criteria:

-.not able to understand Swedish in writing or speaking

- preoperatively unable to perform a prone position
A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601

This study is designed to provide ganaxolone to those patients deriving significant benefit from current treatment in protocol 1042-0601.


Eligibility Criteria:
Inclusion Criteria:

* subjects who have completed all study visits from previous protocol 1042-0601 and have been deemed eligible by the Investigator as:
* having had no major adverse events thought to be drug related
* deriving benefit from ganaxolone treatment
* be properly informed of the nature and risks of the study and give written informed consent prior to study entry
* must be willing to use a medically acceptable method of birth control and if female of child-bearing potential, have a negative qualitative serum pregnancy test

Exclusion Criteria:

* significant medical or surgical condition at screening or that develops during protocol participation that might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic systems, or other conditions that would place the subject under increased risk
* unwilling to use a double-barrier method of birth control or submit to a serum pregnancy test
* history of chronic non-compliance with drug regimens
* females currently breastfeeding
* AST or ALT levels greater than 3 times the upper limit of normal at screen
* Inability to withhold grapefruit or grapefruit products during the study