cyrilzakka/clinical-trials huggingface dataset:
The Use of Bioimpedance to Determine Pre-Clinical Lymphedema in the Post-Operative Breast Cancer Patient

Primary Objective: To determine whether early intervention (with garment sleeve and gauntlet) in patients with pre-clinical lymphedema can halt the progression of lymphedema.

Secondary Objectives:To evaluate whether bioimpedance is an accurate, reliable method to measure pre-clinical and clinical lymphedema.

Tertiary Objective: To determine whether bioimpedance analysis is better than the gold standard of volume displacement to measure lymphedema.

The successful completion of this study will address whether bioimpedance analysis is a reliable, accurate method to measure pre-clinical and clinical lymphedema. In addition, we intend to evaluate whether bioimpedance analysis is better than the gold standard of volume displacement for measuring lymphedema. And most importantly, we will evaluate whether a short trial of compression garments in women identified to have pre-clinical lymphedema can actually halt the progression of disease. Bryn Mawr Hospital would propose to publish the research and findings of this study, which may have future bearing on the post-operative therapeutic management of subjects with pre-clinical lymphedema following axillary surgery.

Study Design:Randomized, Pilot Study

Primary Objective: To determine whether early intervention (with garment sleeve and gauntlet) in patients with pre-clinical lymphedema can halt the progression of lymphedema.

Secondary Objectives:To evaluate whether bioimpedance is an accurate, reliable method to measure pre-clinical and clinical lymphedema.

Tertiary Objective: To determine whether bioimpedance analysis is better than the gold standard of volume displacement to measure lymphedema.

Eligibility Criteria:
Inclusion Criteria:

* are female
* have operable, early stage breast cancer stage 0 - IIIA
* undergo axillary evaluation with either sentinel lymph node biopsy or axillary lymph node dissection
* are aged \> 18 years of age at the date of enrollment
* are willing to sign an informed consent form

Exclusion Criteria:

* are male
* have had a bilateral axillary surgery
* do not undergo axillary evaluation
* are a minor
* cannot consider the issues involved in making an informed and autonomous decision.
Safety Study of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension

The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of subcutaneous (SC) PL-3994, relative to placebo in subjects with controlled hypertension. Including in this evaluation is the effect PL3994 has on blood pressure.

Uncontrolled hypertension, including both hypertensive urgency and hypertensive emergency, is commonly seen in emergency rooms and other urgent care settings. Current standards of care include intravenously administered drugs, which can be difficult to titrate and require ongoing monitoring. This study examines the effect of PL-3994 on patients with controlled hypertension who are receiving antihypertensive medications.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have had a diagnosis of essential hypertension for at least 1 year, per subject verbal history
* Subject must be on a stable dose of at least one, but not more than 3 antihypertensive medications for at least 3 months, per subject verbal history.
* Subject must have a systolic blood pressure at screening between 100 and 150 mmHg, and diastolic blood pressure must not exceed 105 mmHg.

Exclusion Criteria:

* Subject weight greater than 100 kg or less than 50 kg.
* Any significant medical condition or abnormal safety laboratory results which, in the judgement of the Investigator would place the subject at significant risk.
CoolSculpting the Flanks

Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flanks.


Eligibility Criteria:
Inclusion Criteria

* Male or female subjects \> 22 years of age and \< 65 years of age.
* Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
* No weight change exceeding 5% of body weight in the preceding month.
* Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
* Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in their diet or exercise routine during the course of the study.
* Subject has read and signed the study written informed consent form.

Exclusion Criteria

* Subject has had a surgical procedure(s) in the area of intended treatment.
* Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
* Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
* Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
* Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
* Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
* Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
* Subject is taking or has taken diet pills or supplements within the past month.
* Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
* Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
* Subject is pregnant or intending to become pregnant during the study period (in the next 8 months).
* Subject is lactating or has been lactating in the past 6 months.
* Subject has a history of hernia in the areas to be treated.
* Subject is unable or unwilling to comply with the study requirements.
* Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
* Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
The Relationship Between Phonological Awareness Skills And Home Environment Literacy in Cochlear Implant Users

The aim was to examine the relationship between home literacy of parents whose has children who use cohlear implant and family demographic characteristics and phonological awareness skills of children with cochlear implant.

This study was designed to determine the relationship between home literacy of parents whose has children who use cohlear implant and family demographic characteristics and phonological awareness skills of children with cochlear implant.To collect data from the parents, "Demographic Questionary" which is prepared by the researchers, "Early Literacy Home Environment Scale (ELHES)" (Karaahmetoğlu \& Turan, 2017), and "Family Literacy Scale" (Kılıç, Doğan \& Özden, 2017) were used in the study. To collect data from the children with cochlear implant users, "The Turkish Early Language Development Test (TEDİL) " (Topbaş \& Güven, 2013), and "The Early Childhood Phonological Sensitivity Scale (PASECP)" (Sarı \& Acar, 2013) were used in the study.

This study was carried out with follow-up patients in the Audiology, Language and Speech Disorders Clinic of xxx University - Medical Faculty, Department of Otorhinolaryngology. The study was performed with the approval of Ethics Committee, and written informed consent was obtained from all patient families (138955/ July 2021). There are 23 cochlear implant users and, 23 their family. Children ranging in age from 5 to 7 who also have 5-6 years old language skills without any neurological problems were included in the study.

SPSS 25.0 (IBM) was used program for statistical analysis. The differences of the numerical measurements used in the research according to the binary demographic categories were analyzed with the Mann Whitney U test, and the analysis of the differences according to the multiple categories was analyzed with the Kruskal Wallis H test. The significance level (α=0.05) was used.

Eligibility Criteria:
Inclusion Criteria:

* language skills were between 60 and 72 months; not enrolled in primary school; regular use of unilateral or bilateral cochlear implants;regular training in an auditory rehabilitation center

Exclusion Criteria:

* The study excluded individuals who did not meet the inclusion criteria for the control and study groups.
Effectiveness of Steroid Injection in Treating Patients With Lateral Epicondylitis

The aim of this study is to evaluate the effectiveness of steroid injection and immobilization versus no immobilization in treating patients with lateral epicondylitis.


Eligibility Criteria:
Inclusion Criteria:

* age 18 to 65 years
* confirmed lateral epicondylitis
* had not received any treatment prior to enrolment

Exclusion Criteria:

* symptoms lasting less than 6 weeks
* history of acute trauma, fracture, and/or surgery within 12 months
* patients who had received corticosteroid injection, physiotherapy, splint or casting during the past 6 months
* bilateral involvement and history of cervical disk herniation, radiculopathy or abnormal electrophysiologic study
A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer

The purpose of this study is to provide continued treatment with alectinib or crizotinib as applicable to participants with ALK- or RET positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure.


Eligibility Criteria:
Inclusion Criteria:

* Participants enrolled in a Roche-sponsored alectinib trial who are experiencing a clinical benefit from alectinib or crizotinib treatment at the time of discontinuation from the parent trial and for whom a switch to commercial supply is not feasible
* Collected study termination data, including efficacy and safety data, as required by the parent study on the electronic Case Report Form (eCRF)
* For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 3 months after the last dose of study drug
* For men: agreement to remain abstinent or use a contraceptive method that results in a failure rate of \< 1% per year during the treatment period and for at least 3 months after the last dose of study drug.

Exclusion Criteria:

* Evidence of lack of clinical benefit in parent trial during the screening phase of this rollover study
* Permanent discontinuation of alectinib or crizotinib for any reason during the parent study or before first dose of study drug in the rollover study
* Evidence of an adverse event for which the parent protocol stipulates permanent discontinuation
* Pregnant or breastfeeding women
* Ongoing serious adverse event that has not resolved to baseline level or Grade ≤1 prior to first dose of study treatment in the rollover study
* Treatment interruption for more than 21 days due to an adverse event since the last administration of alectinib or crizotinib in the parent trial. Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator
* Administration of strong/potent cytochrome P450 (CYP) 3A inhibitors or inducers within 14 days prior to the first dose of treatment on this study and while on treatment with crizotinib
* Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; these conditions should be discussed with the participant before trial entry
Index of Microcirculatory Resistance After Drug-Eluting Stent Implantation With High Dose Atorvastatin Loading

Pre-treatment with statins decreased the incidence of cardiac enzyme increase after percutaneous coronary intervention (PCI) and distal embolization suspected to cause post-PCI myocardial damage. This study evaluates the effect of high dose atorvastatin pre-treatment on post-procedural index of microcirculatory resistance (IMR) values that are introduced for assessing the status of the microcirculation.

One hundred patients with non-ST elevation acute coronary syndrome will be randomly assigned to either high dose atorvastatin pre-treatment group(80 mg loading within 24 hours plus 40mg busting within 2 hours before PCI) or control group(atorvastatin 10mg administration within 24 hours before PCI). An intracoronary pressure/temperature sensor-tipped guidewire is used. Thermodilution curves are obtained during maximal hyperemia. The IMR was calculated from the ratio of the mean distal coronary pressure at maximal hyperemia to the inverse of mean hyperemic transit time. Creatine kinase-myocardial band(CK-MB) and CRP level will be measured at baseline and at 12\~24 hours after PCI.

Eligibility Criteria:
Inclusion Criteria:

* Patients of Non-ST elevation acute coronary syndrome planed to elective percutaneous coronary intervention

Exclusion Criteria:

* ST elevation myocardial infarction
* Cardiogenic shock
* Congestive heart failure with pulmonary edema
* Severe left ventricular dysfunction (LVEF \< 30%)
* History of previous coronary revascularization therapy
* chronic total coronary occlusion
* 3 vessel disease
* Target lesion at distal segments or branches
* Ostial lesion
* Excessive coronary calcification or thrombi
* Elevated transaminase
* Renal dysfunction (serum creatinine \> 2.0mg/dL
* History of myopathy
* Contra-indication to anti-platelet therapy
* Not indicated for percutaneous coronary intervention
* Other co-morbidity with life expectancy less than 1 year
Continuous Glucose Monitoring in Neonatal Hyperinsulinism

The investigators are studying the accuracy of Dexcom G6 continuous glucose monitors placed on babies with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit. The participants will wear the device for 10 days on their lateral thigh. Whenever blood sugars are checked by glucometer, the investigators will also record the continuous glucose monitor sugar. Additionally, if the continuous glucose monitor alarms for a low sugar or an impending low sugar, the investigators will check the blood sugar by glucometer and, if verified to be low, treat the low blood sugar accordingly.


Eligibility Criteria:
Inclusion Criteria:

* Age: 0-90 days old
* Gestational Age: \> 28 weeks gestational age
* Diagnosis of hyperinsulinism based on critical sample and/or glucagon challenge

Exclusion Criteria:

* Diffuse skin disease such that placement of a Dexcom G6 sensor would be difficult to secure
* Infants colonized or infected with multi-drug resistant organisms (i.e. MRSA, VRE, ESBL producing bacteria)
* Infants on hypothermic protocols
* Infants expected to remain in the NICU \<24 hours
* Infants enrolled in a competing clinical trial
* Family/team have decided to limit or redirect from aggressive NICU technological support
* Ward of the state
Affective Dysregulation (AD) in Children With ADHD Treated by Guanfacin

Early onset, high prevalence and persistence, as well as developmental comorbidity make affective dysregulation (AD) in childhood one of the most psychosocially impairing and cost-intensive mental conditions. Despite continuous research, there is still a substantial need for optimization of individual treatment strategies in order to improve outcomes and to reduce subjective and economic burden. Here we want to study the change of psychopathological markers of affective dysregulation (AD) treatment of affective dysregulation (AD) in children with Attention Deficit Hyperactivity Disorder (ADHD) treated by Guanfacine. These children did not respond to methylphenidate treatment. The results will allow the generation of a hypothesis for a randomized clinical trial to investigate the efficacy and safety of Guanfacine for the treatment of AD in children.


Eligibility Criteria:
Inclusion Criteria:

* male and female patients (aged 6 to 17 years)
* clinical diagnosis of ADHD (F90.0) or comorbid ADHD and Oppositional defiant disorder (ODD) (F90.1)
* patients with ADHD who did not respond to stimulants
* DADYS is an instrument to assess AD and has a domain for disruptive behaviors. Inclusion criterion for the study is a score of at least moderate (middle) severity in the DADYS parents version this domain
* IQ must be at least 70
* Patients receiving or intended to receive Guanfacin
* Written informed consent by the custodian and the children

Exclusion Criteria:

* unipolar depression, bipolar disorder, schizophrenia or any other psychotic disorder
* current substance abuse
IC-BASAROTs: New Practice Method for More Accurate Bed-side Assessment of Individual Energy Expenditure

Assessment of resting energy expenditure (REE) by indirect calorimetry (IC) in 1400 healthy individuals for arithmetical transformation into an bedside tool to estimate energy requirements in dietary practice (BASAROTs). A multinational, multicenter, prospective cross-sectional study.

The assessment of energy expenditure is the basic requirement for any nutritional therapy. Nevertheless, there is still no accurate, scientifically validated and practical bedside tool.

The reference method for energy expenditure measurement is indirect calorimetry (IC). High costs, time requirements and the need for trained personal are main reasons for its limited use in clinical practice. Also arithmetical calculations, such as the Harris-Benedict equation, are not widely accepted.

In general energy expenditure is often estimated by so called rules of thumbs, a method requiring only one multiplication with body weight (for example: 25 kcal/kg body weight). Sex, age and BMI are usually not considered, although they are independent predictors of energy expenditure. Thus, energy expenditure estimations are often inaccurate, especially in older and overweight/obese persons.

Therefore, it is important to develop a bedside tool that is more accurate but simple enough to be accepted by practitioners. In 2004, the Austrian Society of Clinical Nutrition published the first BMI, aged and sex adapted rule of thumbs, called BASAROTs (BMI Age Sex Adjusted Rule Of Thumbs). Those were, however, based on results of the Harris Benedict equation.

The main objective of the present study is, therefore, to replace the existing BASAROTs by BASAROTs based on actual measurements of resting energy expenditure by indirect calorimetry (IC-BASAROTs).

Eligibility Criteria:
Inclusion Criteria:

* female, male
* 18 years to 85 years
* Body Mass Index: 14,0 - 49,9 kg/m²
* Eastern Cooperative Oncology Group (ECOG) Performance Status (Grade 0 or 1)
* normal thyroid function
* subjective health in dependence of BMI (underweight, normal weight, obesity, morbid obesity)

Exclusion Criteria:

* implanted pacemaker
* amputations
* paresis (mono- and diparesis)
* Asian or African descent
* above-average physical activity (competitive sport)
* present or suspicion of malignant neoplasms (tumors, metastases, hemato-oncological diseases)
* severe diseases (organ diseases, neurological diseases)
* severe dementia (MMSE \< 20 points)
* pregnancy
* participation in other trials
* subjects with expect non-compliance to protocol guidelines
* intake of:
* lithium compound
* neuroleptics: Olanzapine (Zyprexa ®), Clozapine, Sertindole, Ziprasidone, Haloperidol, Thioridazine
* anticonvulsant (Carbamazepin, Valproic Acid, Topiramate)
* noradrenalin-reuptake-inhibitor (NARI): Reboxetine , Atomoxetine
* tricyclic antidepressants (Amitryptiline, Clomipramine, Doxepin, Imipramine, Trimipramin)
* Lorcaserin
* interferon-alfa, interferon-beta
* Baclofen
* Orciprenaline
* Amiodarona
* Insulin
* corticoid therapy (oral)
Pilot Deprescribing N-of-1 Trials for Beta-blockers in HFpEF

In this study, we will test the feasibility of N-of-1 trials for deprescribing beta-blockers in patients with Heart Failure with Preserved Ejection Fraction. To achieve this objective we will conduct 16 4-period N-of-1 trials (on vs. off) and subsequently interview participants to better understand feasibility and pragmatism. The N-of-1 trials will be iteratively refined in real-time based on this feedback.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory adults ≥65 years of age with Heart Failure with Preserved Ejection Fraction (HFpEF) according to ACC/AHA guidelines: (signs and symptoms of Heart failure \[HF\] and ejection fraction \[EF\] ≥50%)
* Taking Beta blocker

Exclusion Criteria:

* Alternate Causes of HFpEF Syndrome:

  1. Severe valvular disease
  2. Constrictive pericarditis
  3. High output heart failure
  4. Infiltrative cardiomyopathy
* Other compelling indication for beta blocker:

  1. Prior EF \< 50%
  2. Hypertrophic cardiomyopathy
  3. Angina symptoms
  4. Acute coronary syndrome, myocardial infarction or coronary artery bypass surgery in prior 3 year
  5. History of ventricular tachycardia
  6. Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year
  7. Sinus tachycardia \> 100 beats per minute (bpm), atrial arrhythmia with ventricular rate \>90 bpm, systolic blood pressure \> 160 mmHg
* Clinical instability (N-of-1 trials are appropriate for stable conditions only)

  1. Decompensated HF
  2. Hospitalized in past 30 days
  3. Medication changes or procedures in prior 14 days (to prevent confounding from other interventions), at PI discretion
* Estimated life expectancy \<6 months
* Moderate-severe dementia or psychiatric disorder precluding informed consent
* Any condition that, in Principal Investigator's opinion, makes the patient unsuitable for study participation
Association Between Multiple Coagulation-related Factors and Lymph Node Metastasis in Patients With Gastric Cancer: A Retrospective Cohort Study

We initially selected a total of 1128 patients with primary gastric cancer who presented at Shandong Provincial Hospital between January 2018 and October 2022, and retrospectively collected their clinical and pathological data. And retrospectively analyzed preoperative baseline characteristics, preoperative laboratory tests, and postoperative pathological results for these patients


Eligibility Criteria:
Inclusion Criteria:

1. patients with primary gastric malignant tumors,
2. patients who underwent radical resection of gastric cancer,
3. patients with a postoperative pathology of adenocarcinoma or signet ring cell carcinoma according to the WTO pathological classification,

Exclusion Criteria:

1. patients who have distant metastases, such as liver or lung metastases, were found on preoperative ultrasound and computed tomography (CT) examinations,
2. patients who have received preoperative neoadjuvant chemotherapy,
3. patients who take anticoagulant drugs (such as aspirin) prior to surgery,
4. patients who had any previous coagulation disorder.