cyrilzakka/clinical-trials huggingface dataset:
Does the Use of Continuous Glucose Monitoring (CGM) in the Immediate Postpartum Period in Women With Pregestational Diabetes Admitted to the Hospital Decrease Hypoglycemic Episodes

This study will examine whether continuous glucose monitoring in patients hospitalized in the immediate postpartum period is more effective than traditional point of care glucose testing in identifying patients with hypoglycemia.

This is a prospective cohort study of women with type 1 and type 2 diabetes in the postpartum period. After obtaining informed consent, a CGM device (Dexcom sensor and transmitter) will be placed by research personnel upon presentation to labor or in prenatal clinic if seen within 3 days of planned induction of labor or planned cesarean section. Patient will be assisted in getting the Dexcom G6 app on their cell phone to be the receiver of glucose data. Patients who are currently using the Dexcom CGM for routine monitoring of their glucoses, will be allowed to continue using their own sensor and transmitter. Upon presentation to Labor and Delivery, patients will be assisted in activating the Share App on their cell phone. Labor and Delivery Nursing Staff will be given a Samsun phone with the Follow app in order to receive glucose data. The Samsung phone will be transferred to the Mother/Baby Unit with the patient after delivery.

Glucose values from the CGM device will then be available to nursing through the Samsung phone. Nursing will be able to see current glucose data on their patient and would receive alarms to indicate hypoglycemia or impending hypoglycemia. Nursing will be provided with instructions for how to access the CGM follow app and how to appropriately respond to the alarms. Nursing will continue to perform standard of care blood glucose monitoring per routine protocol but will also obtain a finger stick to validate a blood glucose level whenever a low CGM alarm sounds. Low blood glucose values \<70 mg/dl will be treated per local institutional nursing policy. Monitoring of glucose levels through the CGM device will continue throughout their postpartum hospital stay. This is typically 2 days for a vaginal delivery, 3 days for a cesarean section. Patients who do not use CGM as part of their routine care, will have their CGM sensor and transmitter removed prior to discharge from the hospital.

Following discharge from the hospital, there will be no additional long term follow-up.

Data we plan to collect for analysis includes: type of diabetes (DM1/DM2), point of care glucose values, number of hypoglycemic events, number of times treated for hypoglycemia.

Eligibility Criteria:
Inclusion:

1- Individuals in the third trimester of pregnancy admitted to the hospital with diabetes type 1 or diabetes type 2, own a smart device (which will serve as a receiver for the CGM device)

Exclusion:

1. Patients less than 18 years of age
2. non-English speaking patients
3. gestational diabetes
4. extensive skin changes/diseases that inhibit wearing a sensor on normal skin, known allergy to adhesives
A Trial of Comparing the Pathology Status of Lymphoseek®-Identified Sentinel Lymph Nodes Relative to the Pathological Pathology Status of Nonsentinel Lymph Nodes in Nodal Staging of Subjects With Known Cancer of the Cervix Who Are Undergoing Lymph Node Dissection

Prospective, open-label, within-patient, multi-center study of Lymphoseek in the detection of lymph nodes in subjects with known cancer of the cervix. All subjects will receive a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m.


Eligibility Criteria:
Inclusion Criteria:

* Subject has provided written informed consent with HIPAA authorization
* Has cervical cancer and is a candidate for surgical intervention, with lymph node dissection being a part of the surgical plan.
* Is at least 18 years of age at the time of consent
* Has an ECOG performance status of Grade 0 to 2
* Has the following International Federation of Gynecology and Obstetrics (FIGO) IA2-IIA1staging. Subjects with a single enlarged/suspicious node on PET/CT will still be considered eligible as consistent with FIGO guidelines.
* If of childbearing potential, the subject has a negative pregnancy test within 48 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year

Exclusion Criteria:

* The subject has had preoperative chemotherapy, immunotherapy, or radiation therapy within the 30 days prior to Lymphoseek administration
* Has had previous surgery or radiation to node basins that would be involved in the ILM procedure
* Has a known allergy to dextran
* Is breast-feeding or pregnant
* Before the administration of Lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical
* Is scheduled for surgery and/or another invasive procedure other than the primary surgical intervention within the 3 days after Lymphoseek administration
* Has received an investigational product within the 30 days prior to Lymphoseek administration
First-day Computed Tomography: Does it Has a Role in the Assessment of Patients With Inhalation Lung Injury?

A major risk factor for death in burn victims is inhalation lung injury. Diagnostic criteria and severity grading are not well understood. After an inhalation injury, the mucociliary escalator is impaired by induced mucosal hyperemia, which includes Edema, increased mucous production, and airway exudation, and these insults worsen airway narrowing which interferes with ventilation. Multimodal therapy and quick bronchoscopic diagnosis improve patient outcomes. Early identification and classification of inhalation injuries improve patient outcomes. Chest CT may be employed as an alternative to or supplement to the bronchoscopy as well as a diagnostic and prognostic tool. In this study, the diagnostic and prognostic value of bronchial wall thickening as a radiological CT finding in inhalation lung damage and the radiologist score (RADS) were evaluated.

Forty-eight patients with inhalation lung injury were included in the study as the case group, and ten patients without ILI were chosen as the control group. Both groups were recruited from the burn and plastic department. A fiberoptic bronchoscope was performed during the first 12 hours of a suspected ILI to confirm the diagnosis. After performing an initial chest X-ray, computed tomography was used to calculate the radiologist score (RADS) and the thickness of the bronchial walls (BWT).

Eligibility Criteria:
Inclusion Criteria:

* any patient with a suspected inhalational lung injury

Exclusion Criteria:

* less than 18 years old,
* patients who had their CT scan after 24 hours after their admission
* patients who couldn't finish all of the study steps.
* patients that are known to have any parenchymal lung disorders.
Immediate Conversion From Tacrolimus to Everolimus in Stable Maintenance Renal Transplant Recipients

The purpose of this study is to investigate safety and tolerability of an immediate conversion from Tacrolimus to everolimus in stable renal allograft recipients.

Interest in developing CNI-free regimens using other agents such as the proliferation signal inhibitor everolimus.


Eligibility Criteria:
Inclusion criteria

* Primary or secondary renal transplantation in the past 12-36 months.
* Current immunosuppressive therapy consisting of Tacrolimus together with MMF +/-corticosteroids.
* Moderately impaired renal function

Exclusion criteria

* Multi-organ recipients or previous transplantation with an organ other than a kidney.
* Acute rejection episodes in the last 6 months.

Other protocol-defined inclusion/exclusion criteria may apply.
Efficacy and Safety of Ba679BR Powder Inhalation in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study to investigate the efficacy and safety of Ba679BR powder inhalation during the continuous once/day administration to the patients with COPD using oxitropium bromide (Tersigan® aerosol) as the comparator drug.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of COPD (chronic bronchitis, and emphysema) with stable symptoms:

* Screening FEV1.0 ≤70% of predicted normal vale and screening FEV1.0/FVC ≤70% (the baseline FEV1.0 should also be ≤70% of predicted normal value on the initial day of administration)
* Smoking history ≥ 10 pack-years (a peak-year is 20 cigarettes per day for one year or equivalent)
* Male or female patients 40 years of age or older

Exclusion Criteria:

* History of bronchial asthma
* History of an atopic disease such as allergic rhinitis
* Total blood eosinophil count ≥ 600/µL
* Patient treated with antiallergic drugs or anti-histamine drugs
* Patients using oral corticosteroid medication at unstable doses (i.e. less than one month on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisolone per day
* Patients using inhaled steroid, oral β2 stimulant, theophylline preparation, expectorant or macrolide antibiotic at unstable doses (i.e. less than one month on a stable dose)
* Patients using an ACE inhibitor at unstable doses (i.e. less than one month on a stable dose)
* Patients with known narrow-angle glaucoma
* Patients with known symptomatic prostatic hypertrophy
* Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system
* Patients with significant diseases who in the opinion of the investigator were not eligible for the study
* Patients with clinically significant abnormal baseline laboratory test values (hematology, blood chemistry, urinalysis). Patients with serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT) twice the upper limit of the normal range, bilirubin 150% or creatinine 125% of the upper limit of the normal range were excluded
* Patients with a recent history (i.e. within the 3 months prior to the screening visit) of myocardial infarction or heart failure
* Patients with any cardiac arrhythmia requiring drug therapy
* Patients who were treated with Patients who were treated with β-blockers-blockers
* Patients with regular use of daytime oxygen therapy
* Patients with known active tuberculosis or with obvious sequela of tuberculosis
* Patients with a history of cancer within the last 5 years. Patients with treated basal cell carcinoma were allowed
* Patients with a history of cystic fibrosis or bronchiectasis
* Patients with upper respiratory tract infection in the past one month prior to the screening visit or during the baseline period
* Patients who had taken an investigational drug within one month or six half lives (whichever is greater) prior to the screening visit
* Pregnant or nursing women or women of childbearing potential
* Other than the above, patients who in the opinion of the investigator were not eligible for the study
The Effect of Crossword and Word Search Puzzles on Nursing Students' Parenteral Medication Administration Knowledge

This study was conducted in a pretest-posttest parallel-group, randomized controlled design.The population of the study consisted of students (n=220) enrolled in the Fundamentals of Nursing course at the Faculty of Nursing of a public university in the 2022-2023 academic year.According to the exclusion criteria, 56 students were excluded from the study. One hundred sixty-four students who met the inclusion criteria were randomized to the intervention I (n = 82) and control groups (n = 82) by stratified block randomization after the completion of baseline measures. The study was completed with 164 students. The theoretical lecture was carried out by a researcher who was an expert faculty member in Fundamentals of Nursing. All students completed the pretest after attending the theoretical lecture. In the laboratory practice after the theoretical lecture, all students were divided into small groups and practiced parenteral medication administration skills one-to-one under the guidance of the instructor. Students in the intervention group received hard copies of the puzzles at the end of the laboratory practice. All students completed the posttest again at the end of the laboratory practice. Students were supervised during the tests and were not allowed to consult any books, the internet, or any other source of information.


Eligibility Criteria:
Inclusion Criteria:

(1) Register for the Fundamentals of Nursing course for the first time.

Exclusion Criteria:

1. not communicate in Turkish
2. graduate from any health-related university in the past.
Oregon Center for Complementary and Alternative Medicine in Neurological Disorders

The mission of the Oregon Center for Complementary and Alternative Medicine in Neurological Disorders (ORCCAMIND) is to facilitate research and education on the effectiveness and mechanisms of action of complementary and alternative medicine (CAM) therapies in the treatment of neurological disorders. The integration of conventional medicine and CAM communities is critical for the success of ORCCAMIND. Thus, ORCCAMIND is composed of six institutions: Oregon Health Sciences University; National College of Naturopathic Medicine; Western States Chiropractic College; Oregon College of Oriental Medicine; the Linus Pauling Institute at Oregon State University; and the Portland Veterans Affairs Medical Center.

ORCCAMIND will initially focus on the use of CAM antioxidants and stress reduction as treatments for neurodegenerative and demyelinating diseases because many of these diseases have oxidative injury as a causative or contributory factor and several CAM approaches have direct or indirect anti-oxidant effects. Through the Career Development Program the Developmental Research Program and the activities of the Education and Information Core, we will also foster and promote research into other CAM approaches for neurologic diseases that extend beyond anti-oxidant therapies. ORCCAMIND will achieve its goals by carrying out 4 Research Projects and maintaining 4 Core facilities that integrate the research strengths of conventional medicine and CAM practitioners and researchers. ORCCAMIND draws its strength from the multi-institutional support and the quality of all its investigators. The investigators join ORCCCAMIND with extensive experience with clinical trials, patient care, externally funded basic and clinical neuroscience research, and training programs, including federally-funded training grants. ORCCAMIND is a bold initiative that integrates basic and clinical research scientists, conventional neurologists and CAM practitioners. It will promote the exploration of new areas of CAM research and lead research on CAM therapies for neurological disorders.

See brief summary

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)

This study is researching aflibercept high dose (HD), referred to as "study drug", with an experimental dosing regimen. The study is focused on participants with nAMD and DME that have been previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications.

The aim of the study is to see how safe and effective aflibercept HD injections are when given as frequently as every 4 weeks. The study is also looking at what side effects may happen from taking the study drug.


Eligibility Criteria:
Key Inclusion Criteria for Participants with nAMD:

1. ≥50 years of age
2. History of choroidal neovascularization (CNV) lesions secondary to nAMD in the eye study, requiring continued anti-VEGF treatment, as determined by the investigator.

   Key Inclusion Criteria for Participants with DME:
3. ≥18 years of age
4. History of DME with central involvement (in the central subfield on Spectral domain optical coherence tomography \[SD-OCT\]) in the study eye, requiring continued anti-VEGF treatment, as determined by the investigator

   Key Inclusion for All Participants:
5. Previously treated with ≥3 anti-VEGF IVT injections in the study eye in the 5 months (\~150 days) prior to visit 1

Key Exclusion Criteria for Participants with nAMD:

1. Evidence of CNV due to any cause other than nAMD in either eye

   Key Exclusion Criteria for Participants with DME:
2. Evidence of macular edema due to any other cause other than diabetes mellitus in the study eye
3. Active proliferative diabetic retinopathy (DR) in the study eye

NOTE: Other protocol defined inclusion / exclusion criteria apply.
Influence of a Medicinal Cannabinoid Agonist on Responses to Food Images and Food Intake

The purpose of this study is to examine the influence of a medicinal cannabinoid agonist versus placebo on behavioural and gut peptide responses to food images and food intake.


Eligibility Criteria:
Inclusion Criteria:

For healthy volunteers:

1. 20 ≤ BMI ≤ 25
2. Age 18-60
3. Right handed
4. Stable body weight for at least 3 consecutive months at start of study and no history of behavioural, therapeutic or surgical treatment aiming at or leading to weight loss/gain

For obese subjects:

1. BMI \> 30
2. Age 18-60
3. Right handed
4. Stable body weight for at least 3 consecutive months at start of the study and no behavioural, therapeutic or surgical treatment aiming at or leading to weight loss/gain for at least 3 consecutive months

For FD patients:

1. FD diagnosis according to 'Rome III' criteria
2. Age 18-60
3. Right handed
4. 5% weight loss since onset of symptoms

Exclusion Criteria:

1. Medical conditions (current or history):

   * Abdominal/thoracic surgery except appendectomy
   * Gastrointestinal, endocrine (especially diabetes), or neurological diseases
   * Cardiovascular, respiratory, renal or urinary diseases
   * Hypertension
   * Food or drug allergies
   * Head trauma with loss of consciousness
2. Psychiatric disorders:

   * Eating disorders
   * Psychotic disorders
   * Major depressive disorder
   * Somatoform disorder
3. Medication use:

   * No history of cannabis use or any other drug of abuse for at least 12 months prior to the study
   * All medication except oral contraception;
4. Known allergy to dronabinol and/or sesam oil
5. Pregnancy, plans to conceive or refusal to take adequate precaution to avoid pregnancy
6. Subjects who refuse to abstain from driving during the study
Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)

Determining the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of advanced or metastatic pancreatic cancer.

This was a randomized, double-blinded, placebo-controlled, Phase 3 study, in which approximately 310 participants with advanced or metastatic adenocarcinoma of the pancreas who have failed, or were intolerant to first-line chemotherapy, were to be randomized (1:1) to one of the following treatment groups:

* Treatment A (N = 155): Capecitabine + ruxolitinib
* Treatment B (N = 155): Capecitabine + placebo

Treatment consisted of repeating 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and ruxolitinib/placebo was self-administered daily for each cycle. Treatment for all participants continued as long as the regimen was tolerated, and the participant did not meet discontinuation criteria. Participants who discontinued study treatment before study termination were monitored for safety up to 30-35 days from the end of treatment. All participants were followed for survival until study termination or the safety follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the pancreas.
* Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
* ≥ 2 weeks elapsed from the completion of previous treatment regimen and participants must have recovered or be at a new stable baseline from any related toxicities.
* Radiographically measurable or evaluable disease
* Modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:

  1. mGPS of 1: C-reactive protein \>10 mg/L and albumin ≥35 g/L
  2. mGPS of 2: C-reactive protein \>10 mg/L and albumin \<35 g/L

Exclusion Criteria:

* Received more than 1 prior regimen for advanced or metastatic disease.
* Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment.
* Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
* Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), or ruxolitinib, or any of their excipients.
* Prior treatment with a JAK inhibitor for any indication.
Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.

Study to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.

A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female.
* Age ≥ 18 years old at screening visit

Exclusion Criteria:

* Any ocular or systemic condition.
* Patient with one blind eye.
* Visual acuity of 20/40 in any eye.
* Use of ocular or systemic medications.
* Contraindications or sensitivity to any component of the study treatments.
* Contact lens users.
* Ocular surgery within the past 3 months..
* Women who were not using an effective means of contraception or who were pregnant or nursing.
* Participation in any studies of investigational drugs within 90 days previous to the inclusion.