cyrilzakka/clinical-trials huggingface dataset:
CREON for the Treatment of Post-RYGB Hypoglycemia

Hypoglycemia is an increasingly recognized complication of Roux-en-Y gastric bypass (RYGB) that is poorly understood and difficult to treat. Investigators hypothesize that after RYGB some patients have incomplete carbohydrate absorption in the small intestine which leads to inconsistent glucose levels and hypoglycemia during oral consumption of a meal. Investigators further hypothesize that pancreatic enzyme supplementation with (Creon) during meals and snacks will improve carbohydrate absorption and lead to more stable glucose levels in patients with post-RYGB hypoglycemia.

Primary Objective: Evaluate the feasibility and safety of Creon in the treatment of post-RYGB hypoglycemia as add-on therapy to a diet higher in protein and lower in carbohydrate.

Secondary Objective: Evaluate utility of continuous glucose monitoring (CGM) in monitoring hypoglycemia as an adjunct to standard venous blood testing using a glucometer in post-RYGB hypoglycemia.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 years and older
* At least 6 months post-RYGB surgery
* Clinical history of post-surgical hypoglycemia evident by subjective symptoms (i.e. tachycardia, sweating, hunger, confusion) and glucose monitoring demonstrating a venous blood sugars \< 70 mg/dL
* Women must be postmenopausal, surgically sterile, not heterosexually active or heterosexually active using highly effective method of birth control
* Women of childbearing potential must have negative pregnancy test
* Subjects must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and be willing to participate in the study
* Willing and able to adhere to restrictions and follow instructions specific to this study
* Adequate compliance in performing self-monitoring blood glucose (SMBG) testing at least three or more times per week and taking assigned medication dose as instructed

Exclusion Criteria:

* Current or past history of type 1 or type 2 diabetes
* Known hypersensitivity to Creon
* Known hypersensitivity to pork-derived products
* Liver function studies 2 times the upper limit of normal (ALT \& AST) and/or a GFR \< 90
* History of fibrosing colonic strictures
* History of gastroparesis, dysphagia, chronic abdominal pain, gastric outlet obstruction, chronic pancreatitis
* History of stomach, small intestine or colon surgery other than Roux-en-Y gastric bypass
* An active cancer of any type requiring concurrent treatment
* History of gout or hyperuricemia
* Current anemia requiring iron replacement
* Any clinically significant condition that in the opinion of the investigator would make participation not in the best interest or safety of the subject or could prevent limit or confound the specific endpoints assessments
* Not participating in any other research study
* Known history of drug or alcohol abuse within 6 months of screening visit
* Pregnancy or lactation (breastfeeding)
* Informed consent withdrawal by subject
Yoga on QOL Physiological Distress&Fatigue, on Patients Affected by Breast Cancer in Adjuvant Radiotherapy

The study aims to investigate, through serial measurements of some biomarkers, the potential mechanisms through which yoga impacts on QOL and fatigue.

The study aims to assess QoL, fatigue and physiological distress (cortisol and proinflammatory markers) with blood sampling on day 1,15 and last of radiotherapy, at 1-3-6 months after the end of radiotherapy.

Patients with breast cancer who will undergo radiotherapy will be randomly assigned to the yoga group (YG) or the control group (CG).

Patients in the YG will participate in 2 weekly yoga classes during the 5 weeks of radiation therapy. The classes will be coordinated with the treatment program and will be held in the vicinity of the radiation therapy center.

Eligibility Criteria:
Inclusion Criteria:

* Women with stage 0-III breast cancer who have undergone adjuvant daily radiotherapy for 5 weeks in Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori (IRST) Department of Radiation Oncology of Meldola.

Exclusion Criteria:

* Patients with documented diagnosis of mental disorders (eg Schizophrenia)
* Patients with stage IV disease
* Patients with active or non-canalised deep vein thrombosis
* Patients not undergoing surgery for the basic oncological disease
* Patients with mobility problems (eg unable to get up from the chair)
* Patients who have practiced yoga or are practicing yoga in the 6 months before the cancer diagnosis.
* Patients diagnosed with lymphedema
The EFFECT of SIMULATION-BASED TRAINING on POSTPARTUM HAEMORRHAGE MANAGEMENT SKILLS

This study was planned to determine the effect of simulation-based training using two different reality levels-visually enhanced mental simulation (VEMS) and hybrid simulation-on postpartum haemorrhage (PPH) management skills in nursing students.

This study will be conducted to determine the effect of simulation-based training using two different reality levels-visually enhanced mental simulation (VEMS) and hybrid simulation-on postpartum haemorrhage (PPH) management skills in nursing students. PPH is one of the leading causes of postpartum maternal mortality and its effective management requires the knowledge, skills and coordination of the healthcare team. However, it is difficult for nursing students to acquire these skills directly in the clinical environment due to rare observation and structural limitations in education. Simulation-based education stands out as an important method to develop such critical clinical skills.

In this randomised comparative study, 4th year students studying at Bandırma Onyedi Eylül University, Department of Nursing who have completed the course of Women's Health and Diseases Nursing in the spring semester of the 2024-2025 academic year will be included in the study. The sample size was calculated by G\*Power analysis and a total of 64 students were randomly assigned to two groups. One of the intervention groups will receive PPH management training with VEMS method and the other will receive PPH management training with hybrid simulation. The training programme will be conducted within the scope of a structured curriculum including theoretical training, skills training and simulation applications.

'Participant Information Form', "Postpartum Haemorrhage Management Observation Form" and "Student Satisfaction and Confidence in Learning Scale" will be used to collect data. The skill levels of the students will be evaluated by two independent observers, and learning satisfaction and self-confidence levels will be measured through the scales.

The findings of the study are expected to provide important contributions in evaluating the effect of simulation-based training on PPH management skills. In particular, it is investigated whether the low-cost and highly applicable VEMS method is effective in terms of student satisfaction, confidence in learning and skill development as an alternative to traditional simulation approaches. The results obtained from the study may provide evidence-based recommendations to increase the efficiency of simulation applications in nursing education.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research
* To have a grade point average of 2.00 and above

Exclusion Criteria:

* Not participating in all stages of the training programme
* Incomplete completion of data collection tools
* Wanting to leave the research.
Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer

The purpose of this study is to evaluate the safety and clinical activity of cemiplimab and the combination of cemiplimab/fianlimab in microsatellite unstable localized or locally advanced colorectal cancer diagnosed in patients age 70 or greater.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥70 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
* Have histologically proven localized or locally advanced mismatch repair deficient (dMMR) or microsatellite unstable (MSI-H) colorectal cancer.
* Must not have received any prior systemic treatment or radiation.
* Must be agreeable to endoscopic, and CT surveillance for a total of 24 months.
* Patient's acceptance to have a tumor biopsy.
* Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
* For both Women and Men, must use acceptable form of birth control while on study.
* Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* Have received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
* Have expected to require any other form of systemic or localized antineoplastic therapy while on study.
* Have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.).
* History of prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies for any reason in the 5 years proceeding their colorectal cancer diagnosis.
* Currently using any chronic systemic steroids.
* History of severe hypersensitivity reaction to any monoclonal antibody.
* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
* Active autoimmune disease.
* Any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft.
* Patient is on supplemental home oxygen.
* Has clinically significant heart disease.
* Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures
* Unwilling or unable to follow the study schedule for any reason
Motion Characteristics of the Foot and Ankle as Measured by Durometer Readings

The purpose of this study is to determine the motion characteristics of the foot and ankle with a durometer as a method of measurement.

This study will assess and establish the motion characteristics of the foot and ankle with the use of a durometer as a measure of motion patterns.

The durometer is a device commonly used in materials testing that measures displacement through the use of a piezoelectric sensor configured to detect motion a in the form of a reflected wave back from the surface being tested.

Eligibility Criteria:
Inclusion Criteria: Logan student, staff, or faculty with no history of ankle injury; 2. Age 18 - 60 yoa Exclusion Criteria: 1. Logan student, staff, or faculty with no history of ankle surgery 1. No visual or vestibular condition that would affect balance; 2. Systemic illness that have an adverse effect on balance; 3. Local infection, injury or other malignancy affecting the lower extremity; 4. Any unstable joints of the lower extremity; 5. Any manipulation to the foot ankle joints within 48 hours; 6. Prescription or herbal muscle stimulants, relaxants, etc.; 7. Pregnancy
Efficacy and Tolerance of Ultrasound-guided Needling and Lavage of Calcific Tendinitis of the Rotator Cuff Performed With or Without Subacromial Corticosteroid Injection

Calcific tendinitis of the rotator cuff is a common cause of chronic pain of the shoulder. Needling and lavage of the calcification is one of the therapeutic options after failure of conservative management with physiotherapy and anti-inflammatory drugs. Needling is usually followed by a corticosteroid injection in the subacromial bursae in order to prevent acute pain reaction due to the intervention. However, the relevance of this injection has never been proven. Moreover, corticosteroid could prevent the inflammatory reaction induced by the needling and thus the body's natural calcium resorption processes. Finally, corticosteroids could have deleterious effect on the tendon structures and favour local infection. Our hypothesis is that corticosteroid have no significant effect on acute pain after needling and therefore should not been performed systematically after needling.


Eligibility Criteria:
Inclusion Criteria:

* Shoulder pain for at least 3 month
* Positive Hawkins, Yocum and/or Neer test for impingement
* Calcific deposit \>= 5 mm on shoulder x-ray in one the tendon of the rotator cuff

Exclusion Criteria:

* Allergy to lidocaïne or methylprednisolone acetate
* Acute pain suggestive of resorption of the calcification with ill-defined - calcification on X-Ray
* Other shoulder diseases : ostearthritis of the gleno-humeral or acromio-clavicular joint
* Sonographic findings of rotator cuff tear
* Subacromial steroid injection in the previous month
* Uncontrolled diabetes
* Pregnant women
* Contraindication for the use of nonsteroidal antiinflammatory drugs or paracetamol/acetaminophene
The Effect of Education Given to Prospective Fathers on Daily Care of the Baby and Father-Infant Attachment

I am conducting an experimental study examining the bonding between father and baby.

The experimental group and the control group (1st group and 2nd group) will be formed by randomly selecting the spouses of women who applied to Afşin State Hospital and Elbistan State Hospital Gynecology Polyclinic. Fathers in the first group will be met face-to-face with powerpoints and visuals, and training will be provided. It is planned to provide a total of 3 educations by contacting fathers at the time of birth and 2 months after birth. The scope of the 1st education is planned to be about attachment, father-infant attachment, the benefits of father-infant attachment to the baby and the father and how this bond can be strengthened. Care and feeding of the baby is planned within the scope of the second education. In the third education, it is planned to inform the father about spending quality time with the baby and its importance. As a result, the first education will be focused on more about attachment and its importance, the second education will focus on the importance of the father's participation in the care of the baby and the information about care, and the last education the importance of the father's taking care of the baby and spending time with him. Fathers in the second group will be given a training brochure at the end of the 6th month, after the scale is applied. If the baby's health is affected by possible adverse events at birth, that father will be excluded from the study. After the birth with the fathers, when the baby reaches 6-12 months, face-to-face or phone calls will be applied and the father-infant attachment status will be analyzed by statistical analysis. The study will be done as pre-test and post-test. Güleç D. and Kavlak O. examined the validity of the father-infant Attachment Scale in Turkish society, and they came up with a questionnaire consisting of 19 questions in total.

Detail added (15.06.2021): Power analysis was performed with the study from 5 control groups from 5 experimental groups. A total of 58 workers, consisting of 29 experimental and 29 control groups, were found sufficient for the study

Eligibility Criteria:
Inclusion Criteria:

* Spouse must be in the 3rd trimester of pregnancy
* Father should be father for the first time
* The family must be a citizen of the Republic of Turkey,
* The father's education level must be at least high school and its equivalent.
* Father's age should be between 18-40.
* Father has to have a job (Active employment).

Exclusion Criteria:

* Baby must be healthy
* Parents do not have any psychological problems,
Comparison of Office-based KTP and CO2 Laser Outcomes in Patients With Vocal Cord Lesions.

The purpose of this study is to test the outcomes of a CO2 laser device called AcuPulse Duo on vocal lesions and compare them to the most commonly used Aura KTP laser in order to determine which device has the best results. The CO2 laser device is an already FDA approved device. However, there have been no studies comparing the two devices for this use.

A flexible laryngoscope is passed through the patient's nose. Energy from the laser is delivered through a fiber. This unique quality allows the physician to thread the fiber through an endoscope and deliver energy. KTP is uniquely effective because the laser uses green light, which has an affinity with blood vessels. This means that the energy from the laser is absorbed more easily by blood vessels than other tissue. Targeting the blood supply of a lesion causes the lesion to slough off, leaving the surrounding tissue undamaged. However, the properties of the KTP are not necessarily ideal, in that it penetrates deep into the vocal fold, risking scar formation. On the other hand, the CO2 laser is absorbed by water found in soft tissues and is independent of tissue color. It is very precise and causes less damage of the deep tissues, which results in less swelling and faster recovery. The absence of a long healing process means that most patients can resume their normal activities even on the same day The CO2 laser is the preferred laser for use in the operating room. The purpose of the study is to evaluate the fiber-based version of the CO2 laser in the office setting.

Eligibility Criteria:
Inclusion Criteria:

* Presence of laryngeal papillomatosis, hemorrhagic polyps, or leukoplakia/dysplasia of the vocal folds requiring in-office treatment.
* Has the capacity to provide consent

Exclusion Criteria:

* Accutane (Isotretinoin) within the past 6-12 months
* History of keloid formation
* Demonstration of excessive or unusually prolonged erythema
Comparing Ropivacaine Adductor Canal Blockade by Surgeon Versus Anesthesiologist

The purpose of this study is to evaluate the efficacy of two methods of administering an adductor canal block (ACB) following total knee arthroplasty (TKA); intraoperative surgeon performed intra-articular adductor canal block (IACB) and anesthesiologist ultrasound guided ADC in the post-anesthesia recovery unit (PACU).


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis
* ASA I - III
* Spinal anesthesia
* All patients will have cemented total knee utilizing a medial parapatellar approach with posterior stabilized or cruciate retaining implants. A tourniquet will be used in all cases.
* Patients must be between 18 and 80 years of age.
* Active and valid email address for the participant.

Exclusion Criteria:

* Allergy to anesthetics or study analgesic medications.
* Contraindication to regional anesthesia
* Non-english speaking
* ASA IV or greater
* Renal insufficiency with Cr \> 2.0 or hepatic failure
* General or epidural anesthesia
* Sensory/motor disorder involving the operative limb
* Patients who consume preoperative opioids for pain control.
* Pregnant women
* Mentally disabled patients and patients with psychiatric disorders that would prevent them from properly understanding and evaluating an informed consent process.
* Prisoners
Angioplasty of Left Main - lAriboisiere Registry

In patients with unprotected left main disease (ULMD), angioplasty is emerging as an alternative technique. The investigators aimed to determine the rate of major cardiovascular events in patients treated by angioplasty for ULMD in a "real world" registry.

Current guidelines recommend coronary artery bypass graft surgery as the "gold standard" treatment in patients with unprotected left main disease. However, patients with ULMD and high surgical risk score or favourable anatomy are still referred for angioplasty. Recently, several studies and registries comparing surgery and percutaneous intervention with drug eluting stents report similar results regarding cardiovascular death and myocardial infarction in patients with multivessel coronary artery disease including unprotected left main disease.

The aim of the study is to evaluate major cardiovascular events in a "real world" registry.

Eligibility Criteria:
Inclusion Criteria:

* stable or unstable angina and/or documented ischemia
* 50% de novo ULMD referred for angioplasty

Exclusion Criteria:

* acute coronary syndrome with ST elevation,
* cardiogenic shock or out of hospital cardiac arrest
Study Comparing a Soybean Oil-Based With an Olive Oil-Based Lipid Emulsion in ICU Patients Requiring TPN

Many hospitalized patients who are malnourished or not eating receive intravenous feeding or total parenteral nutrition (TPN). Despite improving nutrition, TPN may increase the risk of infections and hospital complications. We do not know why TPN increases hospital complications, but it may be caused by the high sugar or fat content in TPN solutions.

This study compares the effect of a soybean oil-based versus an olive oil-based lipid emulsion in healthy volunteers and in critically ill patients. In healthy volunteers, your blood sugar levels, blood vessel function, and your ability to fight infections will be examined. In ICU patients, we examines whether use of the olive oil-based lipid emulsion may decrease the risk of infection and hospital complications.

Eligibility Criteria:
Inclusion criteria:

* Age: 18 - 80 years when initiating PN
* In medical/surgical ICU
* Has central venous access to administer PN
* Anticipated to receive PN ≥ 5 days

Exclusion criteria:

* Enrolled in an investigative study within the last 30 days prior to study entry
* Female patients: pregnant or breast feeding
* Has clinical sepsis (defined as mean arterial pressure (MAP) \< 60 mmHg on ≥ 2 occasions and unstable BP despite pressor support) within 24 hours prior to study entry
* Has known cirrhosis or total bilirubin ≥ 10.0 mg/dL
* Has chronic renal failure (defined as requirement for hemodialysis or peritoneal dialysis therapy), or creatinine ≥ 3.5 mg/dL without continuous renal replacement therapy (CRRT), or requires acute post-operative dialysis
* Has an active malignancy (defined as requiring chemotherapy, radiation, and/or surgical intervention within 90 days prior to study entry) (excluding non-melanoma skin cancer)
* Has known AIDS
* Has a terminal illness (life expectancy \< 7 days)
* Has undergone organ transplantation
* Has received PN with lipid within 48 hours prior to study entry
* Has mental disability to understand the scope and possible consequences of the study and the legally authorized representative is unavailable
* Has a baseline serum triglyceride \> 400 mg/dL
Impact of Pulmonary Rehabilitation on Direct Healthcare Costs in Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to study the direct cost of illness study of COPD patients who participated in a Pulmonary rehabilitation program for 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* COPD

Exclusion Criteria:

* None
The Effects of Physical Exercise Training in Patients With Chronic Obstructive Pulmonary Disease

The purpose of the present project is to investigate the physiological effects of two different types of exercise training in COPD patients. The patients will be examined before, during and after 8 weeks of training to evaluate the effect of different types of skeletal muscle stimulation on health related quality of life, 6 min walking distance, flow mediated dilation, and histological properties of skeletal muscle cells, regarding oxidative capacity, fiber type, purinergic receptor amounts and measures of systemic inflammation. The study will test the hypothesis that:

Resistance training is superior to endurance training in patients with COPD


Eligibility Criteria:
Inclusion Criteria:

* FEV1/FVC fixed ratio \<0.70, FEV1: \<60% of predicted and MRC \> or equal to 3
* Arterial oxygen saturation at rest\> 90%, BMI \>18, LVEF\> 45.
* Age: 40 - 80 years

The medical treatment will be continued unchanged during the study and additional prednisolone and /or antibiotic treatment will be prescribed in case of acute exacerbation.

Exclusion Criteria:

* Unstable ischemic heart disease, severe heart valve failure, pulmonary emboli, severe heart failure, severe infections, musculoskeletal disorders, malignant disease, contraindicated medicine as MAO inhibitors and anticoagulants.