cyrilzakka/clinical-trials huggingface dataset:
Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery

In this randomized clinical trial, patients with undergoing open heart valve surgery will be enrolled into the study. Participants will be divided into two groups based on the priming solution type. The first group will receive hydroxyethyl starch (HES) 130/0.4 additive to ringer lactate (RL) and the second group will be given only RL as priming solution. All patients will be observed closely during postoperative days. Through follow up, bleeding/coagulopathy, renal function, hepatic function, and cerebral oxygenation will be recorded in both groups.

Cardiopulmonary bypass (CPB) pump is a device for circulating blood in the body while the heart is undergone surgery. For providing circulating volume in the body we need to add about 1.5 to 2 lit fluids as priming solution in the CPB pump. Some fluids mainly included crystalloids, colloids, starch, and gelatin in an only fluid or in a combined formula. During CPB time, the blood dilution is caused by adding prime solution into the circulating volume, and consequently it decreases blood viscosity. Moreover, in addition to a decrease in hematocrit level, coagulation factors and plasma proteins can dramatically decreased. These processes may lead to bleeding events and tissue hypoperfusion and organ damages. To decrease complications, some modalities such as adding colloids to crystalloids have been implemented. On the other hand, any regimen for priming solution has its shortcomings need to be considered based on patient condition and surgical issue.

In this double blinded randomized clinical trial study, we aimed to compare the the effects of six percent HES 130/0.4 and RL as priming solutions on coagulation factors, renal function, hepatic function, and cerebral oxygenation in patients undergoing open heart valve surgery.

Eligibility Criteria:
Inclusion Criteria:

patients who provided written informed consent and had no heart failure (LVEF \>55%), no hepatic failure (defined as aspartate aminotransferase (AST) \>40 mg/dL and/or alanine aminotransferase (ALT) \>40 mg/dL), no prior history of cardiac surgery, serum creatinine \<1.5 mg/dL, no episode of drug-induced acute kidney injury within preoperative 5 days, no severe carotid stenosis in both or one of them, no emergency valvular stenosis, no infective endocarditis, no severe right ventricular failure, no hemoglobin \<10 mg/dL, no body mass index \>40 kg/m2, no heparin-induced thrombocytopenia, no cancer, no severe pulmonary valve insufficiency, no pulmonary function test \<65% before heart valve surgery

Exclusion Criteria:

included consent withdrawal by the patient or by his/her proxy, allergic reaction to the drugs, the aortic cross clamp time greater than 120 minutes, on-pump time greater than 150 minutes, the performance of the retrograde autologous priming.
Muscle Inflammation and Fat Infiltration in Patients Affected by FSHD

Facioscapulohumeral muscular dystrophy (FSHD) is the second most common muscular dystrophy with approximately 500 patients in Denmark. It is characterized by weakness and wasting of the facial muscles, the muscles in the shoulder region and of the legs.

The primary aim of this study is to investigate possible links and order between inflammation and fat infiltration in the muscles in patients with FSHD.

Approximately 15 patients with FSHD will be recruited for repeated MRI-scans during a year where the inflammation and fat infiltration in the muscles can be quantified.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed FSHD

Exclusion Criteria:

* All contraindications for undergoing an MRI scan
The Effects of Cinnamon on Postprandial Blood Glucose, and Insulin in Subjects With Impaired Glucose Tolerance

To study the effect of cinnamon on postprandial blood glucose, and plasma concentrations of insulin in subjects with impaired glucose tolerance.

Ten subjects with impaired glucose tolerance were assessed in a crossover trial. A standard 75 g oral glucose tolerance test (OGTT) was served with placebo or cinnamon capsules. Finger-prick capillary and venous blood samples were taken before and 15, 30, 45, 60, 90, 120, 150, and 180 min after the start of the OGTT to measure glucose, and insulin.

Eligibility Criteria:
Inclusion Criteria:

* Patients were selected for the study on the basis of the following inclusion criteria: diagnosis of impaired glucose tolerance for \< 12 months before enrollment. Glucose tolerance status and fasting blood glucose levels were evaluated using the criteria established by the American Diabetes Association.

Exclusion Criteria:

* Subjects who had thyroid disorders, or used insulin, oral hypoglycemics, and insulin-sensitizing drugs within 60 days before enrollment were excluded.
Weight Loss-Independent Metabolic Effects of Roux-En-Y Gastric Bypass in Diabetes

For this purpose, we will compare the effects of targeted 16-18% (with a range of 16-25%) weight loss induced by Roux-en-Y Gastric bypass (RYGB) surgery with the same weight loss induced by a low-calorie diet (LCD) on liver and skeletal muscle insulin sensitivity, beta-cell function, and 24-hour metabolic homeostasis in obese subjects with or without T2D.


Eligibility Criteria:
Inclusion Criteria:

For RYGB group:

* Scheduled for this bariatric surgery
* Body Mass Index (BMI) 34-55 kg/m²
* Type 2 Diabetes
* Signed informed consent

For Low-Calorie Diet group:

* BMI 34-55 kg/m²
* Type 2 Diabetes and Non-Diabetics
* Signed informed consent

Exclusion Criteria:

For both RYGB \& Low-Calorie Diet groups

* Regular use of tobacco products
* Previous intestinal resection
* Pregnant or breastfeeding
* Evidence of significant organ system dysfunction or disease other than T2D
* Use of any medication that might, in the opinion of the investigator, affect metabolic function
* Exercise ≥90 minutes per week
Multicenter Registry of Very Early and Late Clinical Outcomes to Everolimus-eluting Cobalt-Chromium Stent In Patients With ST Elevation Myocardial Infarction

To compare early and late clinical outcomes with everolimus-eluting cobalt-chromium stent in patients with ST-elevation acute myocardial infarction, as well as identify the characteristics and efficacy of CoCr-EES.

Also, OCT sub-analysis will be conducted


Eligibility Criteria:
Inclusion Criteria:

1. Patients with STEMI who are able to undergo CoCr-EES implantation.
2. Patients with no history of PCI in the target vessel
3. Patients who are 20 or older at the time of informed consent
4. Patients who provided written informed consent by himself/herself
5. Patients who are judged by their treating physician to be able to undergo PCI with CoCr-EES
6. Patients for whom thrombus aspiration prior to CoCr-EES implantation can be recommended
7. Patients who meet all the following vascular inclusion criteria i.Patients with target lesion in native coronary artery ii.Patients with visual maximum vessel diameter of the target stent site in target lesion
8. Patients were obtained finally revascularization of TIMI 3 by visual observation in the target vessel
9. Patients who are able to treat with CoCr-EES the diameter 2.5mm or more and 3.5mm or less and the length of 8mm or more and 28mm or less.

Exclusion Criteria:

1. Patients participating in the other ongoing registry or clinical study(except post-marketing surveillance of CoCr-EES), or receiving treatment which may impact on endpoints of this study.
2. Patients presenting with cardiogenic shock
3. Patients for whom 12-month and 36-month CAG and clinical follow up is considered difficult (patient's residence should also be taken into account)
4. Patients with responsible lesion in left main trunk
5. Patients with renal insufficiency or with chronic renal failure with serum creatinine level of 2.0mg/dL or higher at visit
6. Patients on hemodialysis
7. Patients with a known history of adverse drug reactions to aspirin, or clopidogrel or prasugrel (This may not apply if safety of ticlopidine is confirmed as an alternative drug.)
8. Patients who are below the age of 20
9. Women who were positive in pregnancy test or wish to become pregnant during study duration
10. Patients who newly developed AMI attributable to the prior stented site
11. Patients with a known history of allergy to drug, polymer, metal, and other materials used in CoCr-EES
12. Patients diagnosed with hepatic insufficiency
13. Patients with target lesion in saphenous vein graft
14. Patients with active malignant tumor
Cognitive Behavioral Therapy for Trauma-Related Insomnia in Veterans

Understanding the effectiveness of Cognitive Behavioral Therapy for trauma-related insomnia (CBT-I) is important because sleep difficulties often persist after traditional post-trauma treatments are completed and other trauma-related symptoms have resolved. The objective of this study is to examine whether CBT-I will equivocally reduce problems falling and staying asleep (insomnia) related to military-related PTSD when administered in person versus through telephone therapy to veterans living in rural areas.

Rural populations are at a disadvantage in receiving treatment because of lack of access to healthcare services. Telemedicine uses technology (e.g., telephones) to provide distance counseling to the populations who lack access to health care. Thus, telephone-counseling strategies could provide broad access to interventions for management of trauma-related insomnia.

Veterans who live more than 30 miles from Veterans Affairs (VA) PTSD specialty services will be offered participation in this study. All veterans receive 6 weeks of individual CBT-I for trauma-related insomnia. Participants will be randomized to one of two treatment conditions: (1) CBT-I in person or (2) CBT-I via telemedicine (defined as receiving treatment by telephone). No changes will be made to the CBT-I, other than mode of delivery, for the telemedicine group.

Through this study the investigators hope to demonstrate the effectiveness of CBT-I for trauma-related insomnia can be delivered effectively to rural veterans in person and via telemedicine.


Eligibility Criteria:
Inclusion Criteria:

* Veterans living 30 or more miles from VA PTSD specialty services
* Diagnosis of PTSD or subthreshold PTSD symptoms
* Trauma-related insomnia

Exclusion Criteria:

* Primary sleep disorder other than insomnia(e.g., Restless Leg Syndrome)
* Psychosis
* Active alcohol dependence
* Active drug dependence
Optimal Time for Staple/Dressing Removal

The medical literature does not provide sufficient information or recommendation regarding the optimal time to remove the staples and the bandage after a cesarean section. The goal of this study is to compare 5 groups of patients:

1. staple removal on POD 4 and dressing removal on Post Operative Day (POD)1
2. staple removal on POD 4 and dressing removal on Post Operative Day (POD)4
3. staple removal on POD 7 and dressing removal on Post Operative Day (POD)1
4. staple removal on POD 7 and dressing removal on Post Operative Day (POD)7
5. staple removal on POD 4 and dressing removal on Post Operative Day (POD)7

Since there is no definite protocol for staple and dressing removal, we will adapt the above protocol each for a 3-4 month period of time. Patients will be contacted to either return for a follow up visit or to answer a telephone survey.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing a cesarean section at our facility

Exclusion Criteria:

* patients lost to follow up
Psychological Mechanisms Linking Food Insecurity and Obesity

The current pilot study will examine emergent hypotheses by investigating the role of psychological mechanisms in the relationship between food insecurity and obesity. This objective will be achieved via a cross-sectional, observational pilot study collecting quantitative and qualitative data.

This pilot study will investigate an emergent risk factor for obesity: food insecurity, which is defined as the limited or uncertain availability of nutritionally adequate and safe foods. While paradoxically linked, numerous studies have shown a significant association between food insecurity and obesity. Moreover, recent narrative works have developed new, untested hypotheses linking food insecurity and obesity positing the causal role of psychological mechanisms. Given this, this mixed method pilot study will collect new psychological data in a sample of food secure and food insecure adults with and without obesity to examine the connections between food insecurity, body weight, and psychological constructs. The overarching objective of the study is to gather pilot data to identify potentially new intervention targets that will be used in future studies to more rigorously investigate the relationship between food insecurity and obesity.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-49 years
* BMI ≥ 20.0 kg/m2
* Able to read and write using the English language
* Willing to provide written informed consent

Exclusion Criteria:

* Pregnancy
Effect of Suprascapular Nerve Block and Axillary Nerve Block After Arthroscopic Rotator Cuff Repair

The goal of this clinical trial is to verify the effect of suprascapular nerve block and axillary nerve block in relieving postoperative pain after arthroscopic rotator cuff repair.

Are there differences in visual analog pain scale and patient's satisfaction? Are there differences in mean plasma pain related cytokines? The participants will undergo preemptive ultrasound guided suprascapular nerve block and axillary nerve block using each 0.75% ropivacaine 10mL or each 0.9% saline 10mL.


Eligibility Criteria:
Inclusion Criteria:

* a definite rotator cuff tear that needed repair seen on preoperative magnetic resonancce imaging (MRI)
* acceptance of arthroscopic surgery including rotator cuff repair
* age same as or more than 20 years
* acceptance of preemptive regional block and PCA, and blood testing

Exclusion Criteria:

* did not undergo arthroscopic rotator cuff repair
* stopped PCA before 48 hours postoperatively because of associated side effects
* a history of previous ipsilateral shoulder operation or fracture
* a concomitant neurologic disorder around the shoulder
* a failure of blood sampling including hemolysis, etc.
Functional Status, Morbidity and Mortality in Cemented Versus Press-Fit Hemiarthroplasty

Hemiarthroplasty (half of a hip replacement) is the most common treatment for displaced fractures of the femoral neck in the elderly and is associated with a better functional outcome and fewer reoperations than internal fixation. Currently, the operative management of displaced femoral neck fractures favors the use of cemented implants. This technique is believed to be more stable in the immediate post-operative period, but there is limited evidence of a decreased morbidity and mortality with cemented versus press-fit stems (uncemented). In 2006, a meta-analysis concluded that the evidence was too limited to recommend a cemented or press-fit hemiarthroplasty.

In this investigation, the morbidity, mortality and functional outcome associated with cemented and press-fit hemiarthroplasty will be compared prospectively. We propose that the use of press-fit hemiarthroplasty in the treatment of displaced subcapital fractures of the femoral neck would be associated with a decreased risk of adverse peri-operative outcomes, and that the functional results of cemented and press-fit hemiarthroplasty will be equivalent at one year.


Eligibility Criteria:
Inclusion Criteria:

* older than 55 years
* non-pathologic, displaced subcapital femoral neck fracture
* designated for surgical reconstruction with a hemiarthroplasty by the attending surgeon
* able to ambulate ten feet prior to presentation

Exclusion Criteria:

* unable to walk ten feet prior to hip fracture
* multiple extremity trauma
* pathologic fracture of the hip (including malignancy)
* clinically recognized acute myocardial infarction within thirty days prior to enrollment
* previously participated in the trial
* symptoms associated with anemia
* pre-existing metabolic bone disease
Effects of Low Protein Diet Supplemented With Ketoanalogues on Preservation of Kidney Function in Incremental Dialysis

The investigators hypothesized that combination of incremental hemodialysis and ketoanologues will better preserve residual kidney function and maintenance of nutritional status among the incident ESRD patients during the early initiation of chronic dialysis. This hypothesis has been a new concept of chronic hemodialysis initiation for End stage renal disease (ESRD) patients

The investigators plan to conduct the first randomized Phase IIA clinical trial to investigate the efficacy of incremental hemodialysis and moderately low protein diet combined with ketoanologues supplementation on preservation of residual kidney function, inflammatory status and nutritional parameters among incident chronic dialysis patients

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at screening
* Stable CKD stage 5 not yet on dialysis with residual kidney function 5-10 ml/min/1.73m2 by CKD-EPI equation
* Urine output ≥ 800 ml/day
* Willing to participate in the study and can provide inform consent

Exclusion Criteria:

* Rapid glomerular filtration rate (GFR) progression defined as a decline of eGFR \>10 ml/min/1.73m2 by CKD-EPI equation in the prior 6 months before enrollment
* Presence of wasting diseases, cancer cachexia, tuberculosis, AIDS wasting syndrome
* Other active infection/inflammation determined by CRP \>10 mg/L
* Severe gastrointestinal problem: persistent nausea/vomiting, dysphagia, chronic diarrhea, severe malabsorption
* Conditions at baseline requiring withdrawal from the study including severe protein energy wasting by SGA and MIS score, prior kidney transplantation with immunosuppressive agents or other serious medical conditions.
* Pregnancy
* Uncontrolled hypercalcemia (persistent serum Ca ≥10.5 mg/dl)
* BMI ≥ 35 kg/m2
* Hypersensitivity to the active substances or to any of the excipients of Ketosteril
* Disturbed amino acid metabolism
A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the Screening Visit.
* During the 28-day screening period, the participant (and their parent/caregiver, when applicable) must adequately complete the headache eDiary (≥23 of the 28 days) following the day of the Screening Visit.
* During the 28-day screening period, the participant must have ≤14 headache days, of which at least 4 are migraine days as documented in the eDiary.

Exclusion Criteria:

* History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes (previously referred to as complicated migraine), such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, recurrent painful ophthalmic neuropathy, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration, e.g., \>60 min).
* History of moderate or severe head trauma or other neurological disorder or systemic medical disease that is, in the investigator's opinion, likely to affect the functions of the central nervous system.
* Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania are excluded.
* Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance.

Other inclusion and exclusion criteria may apply.
CtDNA to Predict Response to Chemo-Immunotherapy and Detect Minimal Residual Disease in Non-Small Cell Lung Cancer

The purpose of this study is to determine if a blood test called circulating tumor DNA (ctDNA) can be used to predict how well patients will respond to treatment and if there is any cancer left after surgery. The investigators will also study if a drug called pembrolizumab can help prevent the cancer from coming back in patients who are ctDNA-positive or who have evidence of cancer after treatment and surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Eligible participants must be males or females ≥18 years of age on day of signing the informed consent form.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
3. Participants with histologically confirmed Stage IB (≥4 cm), II, or IIIB (N2) NSCLC (as per the 8th American Joint Committee on Cancer (AJCC)) who are considered resectable by a multidisciplinary team and who are going to be treated with neoadjuvant treatment including chemotherapy, immunotherapy, and in some cases radiation before surgery
4. Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
5. Participants must have tumor tissue available for programmed cell death ligand 1 (PD-L1) immunohistochemical (IHC) testing performed by a third-party analyzing lab during the screening period:

   1. Either a formalin-fixed, paraffin-embedded (FFPE) tissue block or unstained tumor tissue sections, with an associated pathology report, must be submitted for biomarker evaluation prior to randomization. The tumor tissue sample may be fresh or archival if obtained within 6 months prior to enrollment
   2. Tissue must be a core needle biopsy, excisional or incisional biopsy. Fine needle biopsies obtained by endobronchial ultrasound (EBUS) are not considered adequate for biomarker review and randomization. Core needle biopsies obtained by EBUS are acceptable for randomization.

Exclusion Criteria:

1. Presence of locally advanced, unresectable, or metastatic disease. Mediastinal lymph node samples at levels 4 (bilaterally) and 7 are required for clinical staging to assess nodal involvement in participants with mediastinal adenopathy on positron emission tomography-computed tomography scan (PET/CT).
2. Participants with known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) translocation
3. Previous exposure to anti-cancer therapy, including chemotherapy, radiotherapy or immunotherapy, and previous exposure to immunosuppressive drugs within 3 weeks before neoadjuvant treatment
4. Participants with impaired decision-making capacity .