cyrilzakka/clinical-trials huggingface dataset:
Omitting Biopsy of SEntinel Lymph Node With Radiation After Neoadjuvant Chemotherapy in Breast Cancer (OBSERB) Trial

The OBSERB study is a multi-center, non-blinded, pragmatic, parallel, randomized controlled trial in which patients with cT1-3N1 and ycN0 breast cancer.

The OBSERB study aims to compare the oncologic outcomes of radiotherapy without sentinel lymph node biopsy versus sentinel lymph node biopsy for the management of breast cancer which showed the cN1 was conversed as ycN0 after neoadjuvant chemotherapy.

To verify whether, the radiotherapy without SLN can be applied, when the cN1 was conversed as ycN0 after neoadjuvant chemotherapy.

To verify whether, the additional treatment decision can be established based on only the biology of primary tumor without the pathologic information of axillary lymph nodes To verify whether, the patients' quality of life can be improved by a less invasive surgical procedure, when the cN1 was conversed as ycN0 after neoadjuvant chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. women aged \> 20 years
2. cT1-3N1M0, primary invasive
3. initially confirmed ALN by fine needle aspiration cytology before neoadjuvant chemotherapy
4. completion of neoadjuvant chemotherapy
5. tumors negative for LN metastasis confirmed by imaging after neoadjuvant chemotherapy

Exclusion Criteria:

1. synchronous distant metastases
2. previous other malignancy
3. bilateral breast cancer
4. previous primary systemic therapy
5. pregnancy or breastfeeding
6. pre-operative radiological evidence of multiple involved or suspicious axillary nodes
7. patient with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.
Intermittent Theta Burst Stimulation on Anhedonia in Depression

Study comparing the efficacy of two TMS patterns (intermittent theta-burst stimulation, iTBS, and repetitive transcranial magnetic stimulation, rTMS) in treating anhedonia and their associated brain network mechanisms.

Anhedonia is a core feature in major depressive disorders, severely affecting up to 70% patients and remaining untreated after traditional antidepressants therapies. In previous work, the investigators provided clinical evidence for the therapeutic efficacy of personalized rTMS in treating anhedonia. However, the key practical question is whether personalized, connectivity-guided iTBS performs comparably to the existing standard rTMS about the clinical efficacy.

This study was designed as a double-blind controlled trial to investigate the intervention effect of iTBS stimulation on anhedonia in depressed patients. 33 subjects were included, 17 participated in conventional 10 Hz-rTMS treatment and 16 in iTBS treatment. Using the subjects' MRI imaging data of the nucleus accumbens (NAcc) as a seed point, individualized left dorsolateral prefrontal cortex (lDLPFC) targets were calculated from brain imaging data. Patients received once-daily treatment for 15 days.

Clinical symptoms, behavioral and EEG assessments were performed before and after treatment. Clinical assessments included The Hamilton Anxiety Scale (HAMA), the Hamilton Depression Rating Scale (HAMD), the Beck Depression Inventory (BDI), the Temporal Experience of Pleasure Scale (TEPS), and Apathy Evaluation Scale (AES); behavioral and EEG data were collected by the Monetary paradigm. One month after the end of the intervention, follow-up BDI, TEPS, and AES symptom data were collected by electronic scales. This study focused on the analysis of scale, behavioral, and EEG data of subjects .

Eligibility Criteria:
Inclusion Criteria:

diagnosed by more than two clinical psychiatrists, using the DSM-5 diagnostic criteria for depression.

the Self-Report Apathy Evaluation Scale score was more than 37 and the The Temporal Experience of Pleasure Scale score was less than 76.

consistent medical therapeutic plan for ≥4 weeks or no history of antidepressant drugs before rTMS treatment.

aged between 16 and 50 years old.

Exclusion Criteria:

participants with unstable physical conditions, pregnancy or those that were breastfeeding.

metal implants on or inside the head. increased intracranial pressure from cerebral infarction or brain injury. a history of substance abuse or major psychiatric diseases other than depression and current use of psychoactive drug.
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)

This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of IgPro20 (subcutaneous Ig) treatment in adult subjects with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of IgPro20 subcutaneous (SC) doses in comparison to placebo in adult subjects with DM, as measured by responder status based on Total Improvement Score (TIS) assessments.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects ≥ 18 years of age
* Diagnosis of at least probable idiopathic inflammatory myopathies (IIM) per European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria which includes confirmation of dermatomyositis (DM) rash/manifestation, disease activity defined by presence of DM rash / manifestation or an objective disease activity measure
* Disease severity defined by Physician global activity visual analog scale (VAS) with a minimum value of 2.0 cm on a 10 cm scale and MMT-8 ≤ 142 or CDASI total activity score ≥ 14.
* Corticosteroid daily dose less than that or equal to 20 mg prednisolone equivalent

Exclusion Criteria:

* Cancer-associated myositis
* Evidence of active malignant disease or malignancies diagnosed within the previous 5 years
* Physician Global Damage score ≥ 3, or clinically relevant improvement between Screening Visit and Baseline
A Primary Care, EHR- Based Strategy to Promote Safe and Appropriate Drug Use

This study seeks to evaluate a low-literacy strategy in a primary health care setting for promoting safe and effective prescription medication use among English and Spanish-speaking patients with diabetes.

The investigators hypothesize that in comparison with patients receiving standard care, the patients that received the Electronic Health Record (EHR) strategy will 1) demonstrate better understanding of how to safely dose out their medication regimen; 2) have fewer discrepancies in their medication lists; 3) take their medication regimen more efficiently; 4) have greater adherence to their medication regimen.

The strategy takes advantage of health information technology to assist patients with Medication Therapy Management (MTM) tasks, intervening with a set of low-literacy MTM printed tools triggered by the Electronic Health Record (EHR) in a primary health care clinic. Patients at the University of Illinois at Chicago (UIC) Medicine Clinic who are randomized to the intervention arm will be given three printed tools, one when they check in to the clinic and the other two when they check out. The Electronic Health Record (EHR) triggers the printing of these tools, and the receptionist hands them to the patient. Patients receive either English or Spanish language materials depending on the preference determined in the screening process and stored in their EHR.

Specific Aims

1. Refine and Field Test an EHR strategy for generating and distributing low literacy prescription information for English and Spanish-speaking patients
2. Assess the process of the EHR intervention and its fidelity for providing prescription information for patients at the point of prescribing and dispensing medications.
3. Evaluate the effectiveness of the EHR strategy to improve medication understanding, reconciliation, regimen consolidation, and adherence compared to standard care.

In addition, we will be powered to also investigate our strategy's impact on intermediary clinical outcomes including systolic blood pressure, HbA1c, and LDL cholesterol.

Eligibility Criteria:
Inclusion Criteria:

* 18-years old or older;
* have a diagnosis of diabetes mellitus either by ICD-billing codes or indicative medications;
* are prescribed at least (3) chronic condition medications according to the EHR medication list;
* are English or Spanish-speaking;
* have no imminent intention to move or change clinics within the next year;
* score 4 or higher on the six-question screener based on the Mini-Mental Status Exam;
* are primarily responsible for administering their own medications;
* prescribed a new chronic condition medication (including refills, and change in titrations) during their clinic visit and day.

Exclusion Criteria:

* under age of 18 years-old;
* does not speak English or Spanish;
* dependent on assistance for medication administration;
* scored less than 4 on the six-question screener;
* not prescribed a new medication or changed medication at clinical appointment;
A Study to Investigate the Effect of Rifampicin on the Uptake and Breakdown of ACT-246475 in Healthy Subjects

The study will investigate the effect of rifampicin on the uptake and breakdown of ACT-246475 in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure
* Healthy male and female subjects aged between 18 and 65 years (inclusive) at Screening
* Body mass index of 18.0 to 30.0 kg/m2 (inclusive) at Screening
* Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at screening and on Day -1 of the first period
* Hematology and coagulation test results not deviating from the normal range to a clinically relevant extent at Screening and on Day -1 of the first period
* Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day- 1 of the first treatment period and must agree to consistently and correctly use a highly effective method of contraception

Exclusion Criteria:

* Previous exposure to ACT-246475.
* Previous exposure to rifampicin within 3 months prior to Screening.
* Known hypersensitivity to P2Y12 receptor antagonists or rifampicin, or to any of the rifamycins, or any of their excipients
* Loss of 250 mL or more of blood within 3 months prior to Screening
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
* Family or personal history of prolonged bleeding (e.g., after surgical intervention) or bleeding disorders (e.g., thrombocytopenia, clotting disturbances), intracranial vascular diseases, stroke, reasonable suspicion of vascular malformations, or peptic ulcers
* Known platelet disorders (e.g., Glanzmann thromboasthenia, von Willebrand disease, platelet release defect)
Multidirectional Isometric Assessment of the Hip

With the exception of the shoulder, the hip is among the most frequently injured areas in swimmers. Despite this, hip injuries are often overlooked in training and prevention programmes. Such neglect can cause significant damage to muscles, particularly the adductors, and the joint itself, potentially requiring arthroscopic surgery or even leading to secondary injuries in related structures such as the knee. Furthermore, hip strength and range of motion directly affect swimmers' underwater kicking speed. Although hip assessments are common in other sports, like football, for injury prevention and performance analysis-both dynamically and isometrically-isometric testing is particularly recommended due to its higher reproducibility.

Therefore, this study aims to validate a multidirectional isometric hip test in swimmers and examine agonist-antagonist muscle ratios in young advanced swimmers.

A comparative analysis will be conducted on 30 elite swimmers. This will include a descriptive analysis of the group and comparative analyses between breaststroke/non-breaststroke swimmers and between genders. Maximum isometric contractions of both lower limbs will be measured using a Chronojump force sensor (Boscosystem, Barcelona, Spain).

Athletes will stand on a step positioned centrally within a rack or cage, either laterally or frontally depending on the movement assessed (ABD-ADD or flexion-extension, respectively). They will grip the appropriate supports with their hands and perform three maximal efforts of each movement lasting 3 seconds, without compensatory actions (any attempt with compensations will be discounted). There will be a 20-second rest between attempts. All three attempts will be recorded.

To assess measurement reliability, tests will be repeated after 48 hours for subsequent comparison.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 14 and 18 years.
* Swimmers who train at least 15 hours weekly.
* Swimmers who have participated in the national championship this season.

Exclusion Criteria:

* Swimmers with any current hip or lower limb pathology.
* Swimmers who have required hip surgery.
* Swimmers who, for any other reason, are unable to complete an isometric maximal strength test.
* No ability to perform the Multidirectional Isometric Assessment of the Hip without compensatory movements.
* Refusal to sign informed consent (or legal guardian's consent for minors).
Comparing Naproxen to Sumatriptan for Emergency Headache Patients

2/3 of patients discharged from an emergency department after treatment for an acute headache will still be bothered by headache within 24 hours of emergency department (ED) treatment. The goal of this study is to compare two medications, naproxen and sumatriptan, to determine which is better for the treatment of recurrent headache within 24 hours of emergency department discharge.

Two-thirds of the five million headache patients who present to US emergency departments (ED) annually are suffering an acute exacerbation of a primary headache disorder. Of these acute primary headaches, migraine is the most frequently encountered disease entity in the ED, accounting for 60% of primary headaches, followed by tension-type headaches, which represent 10% of all primary headaches seen in the ED. About ¼ of all acute primary headaches seen in the ED cannot readily be given a specific diagnosis3. Multiple parenteral treatments are used to treat acute primary headaches1, but to date, regardless of specific headache diagnosis, no medication eliminates the frequent recurrence of headache after ED discharge. To date, it is unknown which medication patients should be given when discharged from an ED after treatment for a primary headache. This study will compare two oral headache treatments to determine which one relives pain more effectively.

Specific aims:

1) To determine which of two oral medications is more efficacious for all acute primary headache patients who are discharged from an ED.

Primary hypotheses:

In the 48 hour period following ED treatment for a primary headache, sumatriptan 100mg will relieve pain better than naproxen 500mg, as measured by an 11-point numerical rating scale for pain.

Eligibility Criteria:
Inclusion Criteria:

* Treated in the emergency department for acute primary headache

Exclusion Criteria:

* Allergy, intolerance, or contra-indication to one of the study medications
The Importance of Adrenomedullin (AM) on ACTH-Cortisol-Glucose Axis

Hyperglycemia is frequent manifestations of the human metabolic response to systemic inflammatory response syndrome (SIRS),sepsis and septic shock, and are implicated in the clinical outcome.

Adrenomedullin is elevated in SIRS, sepsis and septic shock and has been demonstrated the inhibitory role on insulin and adrenocorticotropic hormone secretion.

Our hypothesis is that: AM elevation after SIRS could be the responsible to maintain hyperglycemia

Studies in cultured vascular endothelial cells and vascular smooth muscle cells demonstrate that cytokines strongly stimulate adrenomedullin production and release.

Adrenomedullin has been measured in a wide range of clinical researches. Of all conditions investigated, the greatest increment in plasma adrenomedullin has been observed in septic shock. It appears that AM is directly responsible for the hypotension characteristic of septic shock. Studies have shown that administration of AM and AMBP-1 before the onset of sepsis (i.e., pretreatment) prevents transition from the hyperdynamic phase to the hypodynamic phase in the progression of sepsis, attenuates tissue and organ damage, and reduces sepsis-induced mortality.

Two groups described the effects of AM on the pituitary. Taken together, these studies suggest that AM has a role in inhibiting ACTH release.

Mulder et al. first reported the stimulatory effects of adrenomedullin on insulin secretion from isolated rat islets. In direct contrast to this, Martínez et al. clearly demonstrated the inhibitory role of adrenomedullin on insulin secretion in vitro.

Eligibility Criteria:
Inclusion Criteria:

* Children above 2 years, submitted to elective cardiopulmonary bypass (CPB, only interatrial or ventricular communication) with no endocrine disease or infection.

Exclusion Criteria:

* Children with endocrine disease, undernutrition, with some medication that might interfere in the study (corticosteroids.
Training in Subacromial Impingement Syndrome

A randomized controlled trial comparing a comprehensive supervised training regimen with a validated home-based regimen for subacromial impingement syndrome.

The purpose of the study is to compare a comprehensive supervised training regimen (STR) based on latest evidence including heavy slow resistance training with a validated home-based regimen (HTR). We hypothesized that the STR would be superior to the HTR.

Randomised control trial with blinded assessor. 126 consecutive patients with subacromial impingement syndrome were recruited and equally randomised to 12 weeks of either supervised training regimen (STR), or home-based training regimen (HTR). Primary outcomes were Constant Score (CS) and Shoulder Rating Questionnaire (SRQ) from baseline and 6 months after completed training. Results were analyzed according to intention-to treat principles.

Eligibility Criteria:
Inclusion Criteria:

* Subacromial impingement syndrome

Exclusion Criteria:

* Ongoing claim with the Labour market insurance, insurance company or comparable institution.
* Ongoing application for job revalidation or health related pension.
* Radiating neck pain.
* Ultrasound verified complete rotator cuff tendon lesion, as defined by hypoechoic or anechoic full thickness defect of the tendon, or absence of the tendon.
* Periarthritis humeroscapularis.
* Acute luxation or fracture of the shoulder.
* Ongoing steady analgetic treatment of other concomitant painful condition, unrelated to the patients shoulder problem.
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial

The present study seeks to examine the implementation process of culturally tailoring screening and brief intervention for both chronic pain and opioid misuse/opioid use disorder in three American Indian and Alaska Native (AI/AN) serving clinics. The investigators also will assess staff perspectives on this implementation as well as a survey to understand clients at these sites who have chronic pain and opioid misuse/opioid use disorder.

Given the health disparities in AI/AN populations and lack of access to quality care for comorbid chronic pain and opioid misuse/OUD, the proposed study seeks to build upon the strong relationships between the research team and the AI/AN communities. There is a dearth of prior research examining chronic pain, opioid misuse/OUD, and other comorbid conditions (mood disorders, anxiety disorders, other SUD) in AI/AN populations. Using CBPR methods, the investigators will work with the OPTIC Collaborative Board to develop a culturally centered implementation intervention to improve screening and brief interventions with AI/AN clients with chronic pain and opioid misuse/OUD (Phase I, Aim 1). Specifically, in collaboration with the community partners and the OPTIC Collaborative Board, the investigators will develop a provider training to increase provider skills and self-efficacy to focus conversations on managing chronic pain (rather than trying to eliminate it) and improving client functioning within cultural frameworks of wellbeing. The goal is to develop, implement, and evaluate culturally centered implementation strategies to increase screening and brief intervention for chronic pain, opioid misuse/OUD in clinics serving AI/AN communities. The investigators will conduct a type III effectiveness-implementation trial over the course of 24 months at each clinical site utilizing EMR data and longitudinal staff surveys to test the implementation outcomes (Phase II, Aim 2) as well as patient surveys to test effectiveness outcomes (Phase II, Aim 3) . The investigators hypothesize that the culturally centered approach will increase rates of screening and brief intervention, and ultimately improve outcomes among AI/AN clients with chronic pain and OUD who receive treatment in primary care. The investigators also will assess staff perspectives on this implementation as well as a survey to understand clients at these sites who have chronic pain and opioid misuse/opioid use disorder for the purpose of identifying areas of treatment needs, and examining the efficacy of a provider-level implementation intervention delivered at the sites from which our participants will be sampled.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent
* have English comprehension and proficiency
* receiving services at one of our participating study sites
* report current chronic pain and/or opioid misuse/opioid use disorder
* self-identify as American Indian/Alaska Native

Exclusion Criteria:

* if they have a psychiatric, cognitive, or medical condition that interferes with the consenting process
Metabolic Disorders in Polycystic Ovarian Syndrome

The purpose of this study is to elucidate the significance of adipocytokine in women with PCOS among adiposity, hyperandrogenism and insulin resistance.

Polycystic ovary syndrome (PCOS) is the most common endocrinopathy in women of reproductive age with a probable prevalence of 5% to 10%. PCOS is characterized by chronic anovulation, menstrual irregularities, evidence of hyperandrogenism (either clinical, manifested as hirsutism, acne, male pattern balding, or biochemical, manifested by elevated serum adrenal and/or ovarian androgen concentration). Fifty percent of all patients with PCOS are obese, and the presence of obesity affects the clinical manifestations of PCOS. The underlying pathogenic mechanisms appear to involve insulin resistance and hyperinsulinemia, the magnitude of which is greater in obese than in non-obese women with PCOS.

Eligibility Criteria:
Inclusion Criteria:

* 1. Oligomenorrhea ( less than 6 times spontaneous MC per year) or Amenorrhea. 2. Hyperandrogenism (either clinical or biochemistry. 3. PCO by ultrasound. 4.After menarche, before menopause.

Exclusion Criteria:

* 1. hormone therapy in the past 6 months. 2. Pregnancy in the past 6 months 3.Acute illness found in the past 3 months. 4.Systemic disease including autoimmune disease, malignancy, hepatic, renal or CVS disease, and ever received chemotherapy or immunosuppressive agents.