cyrilzakka/clinical-trials huggingface dataset:
Comparison of Multiple Percutaneous Needle Aspiration Versus Incision and Drainage in Small Breast Abscesses: Pain, Cosmesis, and Early Breastfeeding Outcomes

This study aims to compare the effectiveness of multiple percutaneous needle aspiration (MPNA) versus incision and drainage (ID) for the management of small breast abscesses in breastfeeding women. The trial evaluates three key outcomes: post-procedure pain levels, cosmetic satisfaction, and the timing of breastfeeding restoration. The study is conducted at the Department of Surgery, Bahawal Victoria Hospital Bahawalpur, enrolling 110 lactating women aged 18-45 years with abscesses ≤5 cm in diameter. Participants were treated with either MPNA or ID based on clinical decision and patient preference. Pain levels were assessed using a standardized scale, cosmetic outcomes were evaluated via patient-reported satisfaction, and breastfeeding restoration was monitored at baseline, one week, and one month post-treatment. Findings indicate that MPNA is associated with lower pain scores, better cosmetic satisfaction, and faster resumption of breastfeeding compared to ID, suggesting MPNA as a preferred first-line treatment for small breast abscesses.


Eligibility Criteria:
Inclusion Criteria:

* Married breastfeeding women Age: 18-45 years Diagnosed with breast abscess (≤5 cm in diameter)

Exclusion Criteria:

* Complicated abscesses Compromised immune system History of prior surgical interventions for breast abscess Unwilling to participate in the study
Leukocytes and Perioperative Cardio Vascular Events

To analyze whether non-cardiac surgery in high-risk cardio-vascular patients induces a quantitative change in one or several leukocyte subpopulations and whether such changes are associated with perioperative cardio-vascular events.

Annually, there are more than 200 million surgeries worldwide (Weiser et al., 2016; Weiser et al., 2008). The POISE study revealed 5% of patients undergoing a non-cardiac surgery suffer perioperative myocardial infarcts going along with a perioperative mortality rate of about 11,6% (Devereaux et al., 2011). Possibilities to preoperatively identify patients at risk are limited (Devereaux und Sessler, 2015; Gillmann et al., 2014) and prophylactic interventions are not yet established or controversial (Devereaux und Sessler, 2015).

Selected leukocyte subpopulations have been demonstrated to be associated with higher risk for cardiovascular events (Berg et al., 2012; Cheng et al., 2008; Engelbertsen et al., 2012; Kotfis et al., 2015; Rogacev et al., 2011; Rogacev et al., 2012).The aim of this study is to analyze whether surgical stress (non-cardiac surgery) induces a quantitative change in one or several of these leukocyte subpopulations and whether quantitative changes are associated with perioperative cardiovascular events. Therefore, high-risk cardio-vascular patients scheduled for non-cardiac surgery will be recruited. Blood will be drawn at predefined time points before surgery and up to three days postoperatively. Leukocytes will be analyzed by flow cytometry. During 30 day follow up adverse cardiovascular events will be recorded. ECGs will be recorded preoperatively and on post-OP day 3. High-sensitive cardiac Troponin T will be measured prior to the operation and on post-OP day one to three. The patient chart will be screened for cardio vascular events up to day 30. A telephone interview will be performed to detect cardiovascular events after discharge until post-OP day 30.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Coronary heart disease
* Non-cardiac surgery
* Inpatient treatment
* Informed consent

Exclusion Criteria:

* 17 years of age or younger
* Known pregnancy or breastfeeding
* Missing informed consent
* Ambulatory or day-case surgery
* Emergency surgery
* Acute or chronic leukemia
* Current leukocytosis
* Current aplasia or leukopenia
* Current GM-CSF treatment
* Carotid artery surgery
* History of splenectomy or indications of splenectomy
* Cortisone treatment within past 14 days
* History of organ transplantation
* Current immunosuppressive medication
* Chemotherapy completed less than 14 days ago
* Intraoperative dexamethasone application
* Entity which is part of the composite endpoint diagnosed within past 28 days
A Retrospective Analysis of Cerefolin NAC® in Cognitively Impaired Patients

This retrospective analysis of de-identified data from 700 charts of consecutive patients from this patient population is to investigate the prevalence of hyperhomocysteinemia and associated metabolic abnormalities in this naturalistic grouping of patients with various stages of cognitive loss and diagnosed with various types of dementia.

A single-center, retrospective review of the medical charts of 700 de-identified elderly patients who underwent evaluation and treatment for cognitive loss including analysis of:

Laboratory values of interest: homocysteine, methylmalonic acid, CRP, BNP, CO2, TSH, Fe/TIBC, RPR/TPPA/FTA-ABS, and if available, folic acid and B12 levels ordered by primary care providers.

Neuropsychological tests of executive function, memory and affect:

* Wechsler Memory Scale-Revised (WMS-R) or Fourth Edition (WMS-IV)

  * Logical Memory -Delayed Recall, Scaled Score
  * Visual Reproduction-Delayed Recall, Scaled Score
* Shopping List Test, Delayed Recall
* Trailmaking A and B Tests
* Verbal Absurdities subtest of the Stanford Binet, Form L-M
* Proverbs Test
* Memory Orientation Screening Test
* Folstein Mini-Mental State Exam
* Geriatric Depression Scale, 15 items

Sub-group analysis of MRI volumetrics and PET scans when available. Sequentially pulled from June 1, 2009 to September 2011

Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 55 and 89 years old
* Meeting criteria for Mild Cognitive Impairment or dementia with a minimum MOST score of 5 but not over 23
* Has a minimum of 3 months evaluation
* Able to undergo testing for cognition and complete the GDS

Exclusion Criteria:

* Known allergy/intolerance to any ingredient in Cerefolin NAC®
* Substantial impediments to adherence, such as severe dementia without caregiver to administer medication
* Inability to swallow pill-form medication
* Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
* Hcy score lower than 11
Remote Information Counseling for Elders

The purpose of this study is to provide testing methods of delivering nutrition and physical activity services for weight loss.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 40 to 64 years.
2. One or more CHC visits in the past 12 months.
3. Body-mass index of ≥30 and \<50.
4. English speaking.
5. Access to telephone.
6. A permanent address.
7. Willingness to be randomized.
8. Willingness to have computer installed in home.

Exclusion Criteria:

1. Any serious medical condition likely to hinder accurate weight measurement, or for which weight loss is contraindicated or could cause weight loss (e.g., cancer).
2. Current diagnosis of psychosis or bipolar disorder.
3. Unstable or recent onset of cardiovascular disease within 6 months or presence of congestive heart failure
4. Illness that might be associated with weight change, such as asthma (because of treatment with corticosteroids), psychosis
5. Use of medications that might cause weight gain such as hypoglycemic oral medicines or insulin, anti-depressants, and weight loss medications.
6. Unwilling or unable to provide informed consent.
7. Receiving disability insurance.
8. Pregnant or nursing in past 6 months, or plans to become pregnant within 12 months.
9. Enrolled in a weight loss program or study or member of household enrolled in study.
10. Residence outside of Marion County, Indiana.
11. Residence relocation plans within 12 months.
12. Planned or prior bariatric surgery.
13. Substance abuse.
14. History of treatment for eating disorder.
15. Unstable weight with loss or gain of ≥ 5% in last 3 months.

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A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus

This trial is conducted in Africa, Asia, Europe, North America and South America. The purpose is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus inadequately controlled with oral anti diabetics.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age greater than or equal to 18 years at the time of signing informed consent
* Subjects diagnosed with type 2 diabetes mellitus
* HbA1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis
* Body mass index greater than or equal to 20 kg/m\^2
* Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
* Stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening: a) Biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose documented in the subject medical record), b) Other OAD(s) allowed: sulphonylurea, glinides, pioglitazone, and DPP4-inhibitors (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subjects medical record)

Exclusion Criteria:

* Screening calcitonin greater than or equal to 50 ng/L
* Renal impairment estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m2 as per CKD-EPI value to be defined as listed in the classification CKD-EPI using IDMS for serum creatinine measurement on the day of screening
* Impaired liver function, defined as ALAT or ASAT greater than or equal to 2.5 times upper limit of normal
* Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma
* History of pancreatitis (acute or chronic)
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening
* Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
ZOLEDRONIC ASSOCIATED With Hight Hypofractionated Radiotherapy Dose in Bone Metastases Vertebral Prostate Adenocarcinoma

This study will determine the delayed neurotoxicity (12 months) of a hypofractionated high dose irradiation (3 Gy x 9) associated with zoledronic acid.

The administration of zoledronic acid repeat dosages defined under the Authorisation on the Market.

All patients receive a total dose of 27 Gy divided into 3 fractions of 9 Gy performed at least 48 hours apart each, for a treatment to J1, J3 and J5.


Eligibility Criteria:
Inclusion Criteria:

Adenocarcinoma of the prostate metastatic Age\> 18 years3.

* Life expectancy\> 12 months;
* Performance Index status \<3 PSA ≥ 4 ng / ml Zoledronic acid treatment in progress as recommended by the Authority for the Marketing Creatinine clearance above 30 ml / min Lack of maintenance causing disabling pain not lying down long (30 minutes) No history of radiotherapy to the region to be irradiated Absence of neurological signs compression Distance between the metastasis and spinal cord ≥ 5 mm Absence of metastases unstable metastatic epidural spinal cord compression or may require surgery before radiotherapy

Exclusion Criteria:

* Concomitant treatment with a drug testing, participation in another clinical trial within \<30 days
* Presence of central system nervous desease (symptoms or progressive), Patient with a severe neurological disease, current manifestations of peripheral neuropathy\> grade 2 NCI-CTC V4 Existence of another severe pulmonary disease, liver or kidney, digestive likely to be exacerbated by treatment,
* Untreated with zoledronic acid
* Treatment with a bisphosphonate other than Zoledronic acid
* Clinically significant hypersensitivity to zoledronic acid, other bisphosphonates or to any excipients in the formulation of Zometa.
* Creatinine clearance below 30 ml / min
* History of another primary cancer (except basal cell skin cancer)
* Or demented patient with altered mental status who can not obtain informed consent. / Persons deprived of liberty or under guardianship
* Pain not resulting in maintaining the prolonged supine position (30 minutes)
* PSA below 4 ng / ml
* History of radiotherapy in localized tumor site
* Distance between the metastasis and spinal cord \<5 mm
* Monitoring impossible because of psychological, sociological or because of geographical distance.
Postoperative New-onset Proteinuria and Adverse Outcomes.

We aimed to assess the association between postoperative new-onset proteinuria, all-cause mortality, and decline in kidney function in Chinese people who underwent surgery. The exposure variable was the dipstick proteinuria values from the initial postoperative urinalysis within 30 days after surgery, categorized as negative, trace, 1+, and ≥2+. The primary outcome was 30-day mortality. The secondary outcomes included 1-year mortality and composite kidney outcome assessed using the postoperative estimated glomerular filtration rate.


Eligibility Criteria:
Inclusion Criteria:

* surgery patients

Exclusion Criteria:

* kidney or urinary surgery
* missing urinalysis results
* dipstick proteinuria indicated a value of "≥ trace" at least once preoperatively
* with dialysis, end-stage renal disease, or with urinary tract infection at baseline
* missing follow-up information
The Early Strength Training Program in Post-transplant Liver Cases

Liver transplantation (LT) is a current life-saving procedure performed as an open-abdominal surgery for patients with end-stage liver diseases (ESLD). However, a high risk of post-surgical complications is relevant to major intra-abdominal interventions. In managing post-LT recovery, it is important to consider the extending pre-transplant physical status of ESLD patients concerning an impaired exercise capacity, a prolonged period of deconditioning, fatigue and muscle weakness, which leads to global motor impairment and decreased functional capacity.

Sarcopenia and physical deconditioning are known as the hallmark features of ESLD. The quality and the quantity of skeletal muscle mass have been closely correlated with post-transplantation mortality in individuals undergoing LT. In addition to chronic deconditioning or myopathy related to chronic liver failure, post-transplant immunosuppressive medication contributes to increased risk for age-related decline in muscular strength and physical ability. It reportedly persists impaired physical function including reduced muscle strength, which have been consistently associated with impaired quality of life after a liver transplant.

Exercise interventions in solid-organ recipients provide improvements in physical function including skeletal muscle strength. The literature has defined many types of exercise-based interventions including aerobic and resistive training or physical activity counselling in improving physical performance tasks, muscle strength and physical domain of quality of life in postoperative liver transplanted adults. Although there are studies in improving muscle performance and functional status, no study conducted in the post-transplant early period and an optimal exercise regimen for post-liver recipients. In the present study, it will be provided a framework for a possible change in practice aiming to improve muscle strength and functionality in liver recipients through a strength training exercise intervention at the early post-transplant period. The purposes of this trial were: 1) to evaluate the feasibility and safety of a strength exercise training program on functional mobility and quality of life of liver transplanted individuals and 2) to initiate physiotherapy protocols in this population. A key component of this approach was that it was individualized, providing one-to-one therapy with tailored progression specific to a person's individual mobility goals.


Eligibility Criteria:
Inclusion Criteria:

* Liver recipients were eligible to participate if they were 1) over 18 years old, 2) completed the pre-operative evaluation procedure, 3) post-op hemodynamically stabled and had spontaneous breathing, 4) able to read, write and understand Turkish language.

Exclusion Criteria:

* Study exclusion criteria were having unstable cardiovascular disease, a primary lung pathology requiring regular bronchodilator treatment, neuromusculoskeletal complication and/or limitation which requiring the use of assistive device, being a multi-organ transplant recipient and difficulty in following verbal orders.
The Effect of Stress Ball Application on Stress, Anxiety and Comfort During Chemotherapy in Women With Breast Cancer

This research was conducted as a randomized controlled study to determine the effect of stress ball application on stress, anxiety and comfort in women with breast cancer receiving chemotherapy.

The research was conducted as a randomized controlled study. A total of 74 patients were randomly assigned to the stress ball group (n=37) and the control group (n=37).

Eligibility Criteria:
Inclusion Criteria:

* who is literate in Turkish,
* who was diagnosed with stage 1, 2 and 3 breast cancer
* who had the second cure or above chemotherapy receiving treatment
* over 18 years of age
* female
* platelet level \>50,000 mm3
* not having any physical problems squeezing a stress ball

Exclusion Criteria:

* those who did not agree to participate in the study
* those who received chemotherapy for the first time,
* those who had any physical disability to squeeze a stress ball
* Any receiving intravenous treatment from both arms,
* having had a unilateral or bilateral mastectomy and having a problem squeezing a stress ball,
* having any psychiatric disease,
Engaging Older Adults in Fall Prevention Using Motivational Interviewing (MI)

This mixed-methods, two-arm, randomized controlled trial will evaluate the impact of Motivational Interviewing (MI) as a follow-up care to patients who received fall prevention recommendations at Oregon Health \& Science University Internal Medicine and Geriatrics Clinic provided over 12 months.

The goal of this mixed-methods, two-arm, randomized controlled trial of MI intervention for fall prevention is to evaluate the impact of Motivational Interviewing (MI) as a follow-up care to patients who received fall prevention recommendations at Oregon Health \& Science University Internal Medicine and Geriatrics Clinic provided over 12-months. Older adult participants (older than 65) who are at increased risk for falling will be enrolled into the study. Patients will be randomly assigned to two groups: MI and the standard of care group. All participants will have a baseline and 6-months study visit that will include self-report and physiologic assessment. In addition, all participants will receive study measurement phone call at 3-, and 12-months. MI will be provided via video, phone, or in-person one week after the initial visit and then monthly for 6 months. All MI sessions will be recorded and encounter notes will be completed. Purposefully selected participants' MI sessions will be transcribed for qualitative analysis.

Eligibility Criteria:
Inclusion Criteria:

* Oregon Health \& Science University (OHSU) Internal Medicine and Geriatrics Clinic patients
* 65 years old or older
* Moderate-to-high risk for falling using the STEADI fall screening and management algorithm
* Cognitively oriented (Mini-Cog≥ 3)
* Able to converse audibly and coherently in English
* Living independently in the community
* Able to receive study phone calls
* Ambulatory with or without assistive device use

Exclusion Criteria:

* Cognitively impaired patients (Mini-Cog\< 2)
* Patients who have sensory difficulty with verbal communication (hard-of-hearing despite the use of hearing aids or speech is hard to understand despite a talking device)
* Living in institutions with 24-hour care such as skilled nursing facilities
* Unable to stand without assistance by others
* Life-expectancy of less than 3-months
* Patients participating in other studies that may impact fall-related behavior change
Platelet Function After Cardiac Surgery.

Intraoperative cell salvage is commonly used in cardiac surgery to reduce the administration of allogeneic red blood cells and thus improve the outcome for the patient. When processing the salvaged blood, however, a large part of the patient's plasma is washed out. This is a disadvantage with regard to an optimal coagulation situation after cardiac surgery.

There are currently various cell saver systems on the market. According to the manufacturers, the plasma is returned to the patient in different quantities as part of the processing procedure. Thus, it can be assumed that in addition to red blood cells, platelets (part of plasma) are retransfused and contribute to an optimized coagulation. Unfortunately, there is a lack of studies in this regard in the cardiac surgery population.

The investigators aim to study the performance of two different cell saver devices regarding preservation of platelet number and function.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Elective high risk cardiac surgery with cardiopulmonary bypass usage
* Cardiopulmonary bypass time \> 120 minutes
* Written informed consent

Exclusion Criteria:

* Preoperative use of oral or intravenous anti-coagulants or antiplatelet agents (except aspirin)
* Inability to understand and sign the informed consent form (e.g. language problems, dementia, mental disorders).
Sphenopalatine Ganglion Block to Treat Shoulder Pain After Thoracotomy

The purpose of this pilot study is to evaluate the utility of sphenopalatine ganglion (SPG) block to manage ipsilateral shoulder pain (ISP) after thoracotomy. This will be an open label preliminary pilot study to determine if SPG block has potential utility to manage ISP in post-thoracotomy patients. The primary outcome variable will be reduction of shoulder pain.

This is an open label preliminary pilot study which will evaluate the utility of sphenopalatine ganglion (SPG) block to manage ipsilateral shoulder pain (ISP). It will determine if SPG block has potential utility to manage ISP in post-thoracotomy patients One hundred (100) patients will initially be consented in this study. Patients have to develop ISP and have a pain VAS \>= 5. The study is seeking ten (10) eligible participants.

Patients will be followed after the SPG block(s), and the duration of pain relief will be monitored by serial assessments of the VAS. This assessment will occur for the initial SPG block and for all follow-up blocks, if performed. The follow-up assessments will only involve having the patient rate the ISP using a verbal VAS; This will take less than a minute of patients time. In addition, all patients will have PRN access to standard systemic analgesics as routinely ordered by the surgical service Safety assessments will be performed on all subjects. Blood pressure, heart rate and respiratory rate will be obtained every 15 minutes after each SPG block for 90 minutes. Dr. Grant will monitor the subjects for 90 minutes after each SPG block.

Eligibility Criteria:
Inclusion Criteria:

* Any type of open thoracotomy or video-assisted thoracoscopic surgery (VATS)
* Presence of post-operative ISP, VAS\>5/10
* American Society of Anesthesiologists Class 1 - 4
* No allergy to lidocaine

Exclusion Criteria:

* American Society of Anesthesiologists Class 5
* Allergy to lidocaine
* Nasal pathology (e.g., deviated septum)
* Bleeding diathesis
* Any patient who the PI feels will be unable to comply with all protocol related procedures
* Shoulder pain prior to thoracotomy