cyrilzakka/clinical-trials huggingface dataset:
Concordance of the IHC4 Score Performed in Local or Central Laboratory to Endopredict in ER+/HER2- Breast Cancer

Retrospective observational, multicentric study assessing the immunohistochemistry (IHC) based test IHC4 score in infiltrating early breast cancer: comparison of the score performed in local laboratory vs in a central laboratory and concordance with a molecular gold standard classifier (EndoPredict).

The IHC4 prognostic signature is an algorithm based on a combination of biomarkers evaluated in immunohistochemistry and anatomical-clinical parameters. Immunohistochemistry is routinely performed as a diagnostic procedure for estrogen receptor (ER; H-score 0-300), progesterone receptor (PR; % of marked cells), HER2 (positive vs negative status) and Ki67 (% of marked cells evaluated by counting). Clinical parameters include lymph node status (0N+, 1-3N+, \>3N+, \>3N+), tumour size in mm (≤10mm, 11-20, 21-50, \>50mm), histologic grade (1, 2, 3), patient's age at diagnosis (\<65 years, ≥65 years), and type of treatment (anti-estrogen or aromatase inhibitors).

The method for reading and scoring conditions is very precise and currently guarantee the validity of the test (validated centrally in TransATAC). However, there is not yet an open access web platform available for the calculation of the IHC4 score, due to the prior need for homogenisation of the interpretation of immunochemistry (standardisation of the protocol) to generate a reliable and validated IHC4 under decentralised "real life" conditions. There is currently few published data on the weight of technical parameters (antibody clones, automaton type, etc.) or interpretation methods (scoring) in the calculation of the IHC4 score (IHC4 robustness). However, only one study, published recently, shows a good tolerance of the test to variations in technical protocol or reading.

In this context, a study coordinated by the GEFPICS group, composed of expert pathologists in breast cancer, has been set up to better define the robustness and the scope of IHC4 score. These project will assess 2 main aspects: (i) validate the local "real life" technique for the calculation of the IHC4 score; and (ii) homogenise the IHC reading method (especially for Ki67), on a cohort of cases from the GEFPICS, tested in a prognostic molecular signatures.

Eligibility Criteria:
Sample selection criteria:

1. Prior information of the patient.
2. Histologically proven invasive breast cancer,
3. ER-positive breast cancer, according to the following criteria: ER ≥10 % (local assessment)
4. HER2-negative tumor by IHC (score 0 or 1+) and/or fluorescent in situ hybridization (FISH)/chromogenic in situ hybridization (CISH) negative (local assessment)
5. IHC staining slides for ER, PR, KI67 and HER2 carry out on surgical resection according to local protocol available,
6. In situ hybridization (ISH) staining for HER2 carry out on surgical resection, in case of IHC 2+ for HER2 immunostaining
7. EndoPredict test results available (EPclin),
8. Formalin-fixed and paraffin-embedded (FFPE) block from surgical resection of the primary tumor available,
9. Patient ≥18 years old.
Evaluation of the Accuracy, Safety and Robustness of a Single-input-single-output (SISO) Model-based Predictive Closed-loop System to Guide Patient-individualized ICU Sedation

The aim of this study is to investigate the accuracy, safety and robustness of a single-input-single output (SISO) model-based predictive closed-loop system to guide patient-individualized ICU sedation.


Eligibility Criteria:
Inclusion Criteria:

* patients in the immediate post-operative phase after an coronary artery reconstruction surgery.
* age \>= 18 years
* informed consent obtained before the surgery

Exclusion Criteria:

* severe renal failure defined by the RIFLE Classification levels Risk, Failure and End-stage Kidney Failure
* severe hepatic failure defined by a bilirubin level of \>= 3 mg/dl and/or a prothrombin level of \< 50% before the surgery
* low ejection fraction defined as \< 40%
* age \< 18 years
* postoperative bleeding so that a new surgery is necessary
* history of cardiovascular accident (CVA)
* history of COPD
* age \> 75 years
* postoperative cardiac index \< 2.2 for more than 2 hours
* SvO2 \< 60% for more than 2 hours
* hypotension with a MAP \< 60 mmHg for more than 2 hours
* sedation agents other than remifentanyl and propofol including also Catapressan, Risperdal, Etumine
* Remifentanyl dose exceeding 0.5 µg/kg/min.
* absence of informed consent
Reducing Depression Self-stigma and Increasing Treatment Seeking Intentions Among Youth

Young people with depression, especially those of underserved minority groups, avoid treatment due to stigma and discrimination. Social contact is a form of interpersonal contact with members of the stigmatized group and the most effective type of intervention for improvement in stigma-related knowledge and attitudes.

In a prior study, the investigators developed short video interventions to reduce stigma and increase treatment seeking among people with depression. The videos vary by protagonist race/ethnicity (Latinx, non-Latinx Black, non-Latinx White) who share their experiences with depression, challenges, and recovery process. The investigators would like to test the efficacy of these videos using Prolific (a crowdsourcing platform). Specifically, the investigators are interested in conducting a randomized controlled trial (RCT) to test the efficacy of these videos as compared to a vignette control condition on reducing self-stigma and increasing help-seeking intentions and behavior at baseline, post, and 30 day follow-up among youth with depressive symptom scores on the PHQ-9≥ 5.

In a randomized control trial (RCT) with pre-, post-intervention, and 30-day follow-up assessments, we aim to 1) test the efficacy of brief social video interventions, varying protagonist race/ethnicity, as compared to vignette control in reducing self-stigma and increasing treatment-seeking intentions and behavior among 1600 Prolific users ages 18-25 with depressive symptoms (PHQ-9≥ 5), and 2) explore whether matching to protagonist race/ethnicity increases intervention efficacy. We hypothesize that 1) Brief social contact-based video interventions will reduce self-stigma towards depression and increase treatment-seeking intentions and behavior compared to vignette control, and 2) The participants whose race/ethnicity match the protagonist will have greater changes in self-stigma and treatment-seeking than participants with unmatched protagonists, i.e., matching moderates the intervention's effects.

Eligibility Criteria:
Inclusion Criteria:

* Endorsing mild to severe depressive symptoms (Patient Health Questionnaire (PHQ-9) score of 5 or greater)
* Ages 18-25
* US Residents
* English speaking

Exclusion Criteria:

* Not endorsing mild to severe depressive symptoms
* Age less than 18 or greater than 25
Proactive Ethics Intervention to Improve Intensive Care Unit (ICU) Care

The primary aim of the study is to demonstrate the value of a preemptive approach to ethics consultation in an ICU. The investigators hope to answer the question: Will proactive ethics interventions by a skilled and experienced ethicist, participating in treatment discussions with physicians and nurses, as well as discussions with patients/surrogates, improve the quality of ICU care experienced by patients requiring prolonged treatment in the ICU (5 days or longer) by increasing their perceived quality of care and reducing the length of stay in the ICU by non-survivors?

The study is a randomized trial of the use of an ethics consultant to address latent or manifest ethical issues in patients who remain in the ICU for five days or more, as compared to usual care. The investigators are testing the hypothesis that expanding the role of ethics consultations in the ICU to make them proactive will improve the process and outcomes of patient care by shortening the length of stay in non-survivors, and reducing suffering and unwanted and/or unnecessary aggressive treatments.


Eligibility Criteria:
Inclusion Criteria:

* Adult (over 18 years of age)
* Under treatment for five days or more in the ICU

Exclusion Criteria:

* Under the age of 18
* Non-English Speaking
Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD)

The primary goal of this proposal is to collect motor and functional outcomes specific to FSHD over time. By collecting measures specific to FSHD, this will help ensure the best level of clinical care is being provided. Also, the hope is to speed up drug development by gaining a better understanding of how having FSHD impacts motor function and other health outcomes (i.e. breathing, wheelchair use, etc.) and how big a change in motor function would be clinically meaningful to those with FSHD.

Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD) will have approximately 450 FSHD participants followed for a minimum of 3 years. A subset of MOVE FSHD participants, approximately 200, will participate in the MOVE+ sub-study which includes whole body MRI and reachable workspace, as well as optional muscle biopsy and wearable device (US participants only).


Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed FSHD (types 1 or 2) or clinical diagnosis of FSHD with characteristic findings on exam and an affected parent or offspring.

Exclusion Criteria:

* Unwilling or unable to provide informed consent.
* Any other medical condition which in the opinion of the investigator would interfere with study participation.
Development of a Clinical and Biological Database in Rectum Cancer

A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to Rectum Cancer.

In France, colorectal cancer is the second major cause of cancer-related death with 17 000 cases per year. Rectal carcinoma represents 40% of colorectal cancers.

Locally advanced rectal carcinoma raises the issue of both the oncological control, local and general, and the therapeutic morbidity. Currently, pre-operative radiochemotherapy associated with radical proctectomy (TME) is the standard treatment. Radiochemotherapy improves the local control but with enhanced postoperative morbidity and poor functional results.

Moreover, some patients have no downstaging (around 1/3) and the metastatic risk remains about 30%.

Then, compliance to adjuvant chemotherapy is generally poor after radical proctectomy.

Tumor response to preoperative treatment is the major prognostic factor which reveals tumor aggressiveness. Nevertheless, at present, there are no predictive markers of tumor response.

Progresses in rectal cancer management are related to sharing biological and clinical resources with scientific community.

A clinical and biological collection will allow to :

* develop research programs on predictive markers to pre-operative radiochemotherapy or prognostics factors to disease recurrence
* optimize diagnostic and follow-up tests
* develop new biomarkers to improve patient's therapeutic management

In this context, the Montpellier Cancer Institute (ICM) decided to initiate a biological collection biomedical research dedicated to the tissular and blood samples of patients with colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patient treated at the Montpellier Cancer Institute, whatever the treatment received (systemic cancer treatment or radiotherapy or surgery)
* Age \> 18 years
* Signed informed consent

Exclusion Criteria:

* Patient not affiliated to Social Protection system
* Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
* Patient under guardianship
Assessment of Cardiac Functional Reserve in Heart Failure With Preserved Ejection Fraction (HF-PEF)

This study will compare the ability of the heart to increase its contractile performance during stress in patients with a history of heart failure without systolic dysfunction and in controls.

There will be two groups of 20 subjects recruited in a collaborative effort by UWHC and University of Pennsylvania. This project will require one visit approximately 3-5 hours in length. The subject will fill out a symptom questionnaire. A small gauge angiocath will be place to establish intravenous access. Single-lead ECG and blood pressure are monitored for the duration of the protocol. Tonometry (non-invasive measurement of the pulse) and echocardiographic images will be obtained at baseline. After baseline data are obtained, dobutamine will be infused at escalating doses of 2, 4, 8, and 16 µg/kg/min IV at ≤30-minute intervals. After 5 minutes of infusion at each dose, echocardiographic and tonometry data will be recorded. If 85% or more of predicted target heart rate is reached, the final study data collection and safety imaging will be performed and the dose not increased further.

Eligibility Criteria:
Inclusion Criteria:

* mentally stable and willing to give informed consent
* sinus rhythm on resting ECG
* systolic blood pressure \> 90 mmHg
* ejection fraction \> 45% assessed within the last year
* stable heart failure for at least one month prior to study

Exclusion Criteria:

* unstable angina or hemodynamic instability
* known severe coronary artery disease without surgical or percutaneous revascularization
* angina pectoris with usual activities
* history of myocardial infarction in the previous six months, significant valvular abnormalities, pulmonary hypertension, COPD or pulmonary emboli, intracardiac thrombus, sustained ventricular tachycardia induced by dobutamine in the past, or known allergy or other intolerance to dobutamine
* uncontrolled hypertension
* pregnant women
* permanent pacemaker with pacemaker dependency
* known poor echocardiographic images
Dextrose Containing Fluid and the Postoperative Nausea and Vomiting in the Gynecologic Laparoscopic Surgery

The investigators tested the hypothesis that administration of intravenous dextrose as a maintenance fluid in gynecologic laparoscopic surgery would reduce the incidence and severity of postoperative nausea and vomiting (PONV) compared with normal saline solution in the same dose.

A prospective randomized double blinded controlled study was conducted. Eighty six participants were randomized to dextrose solution (n= 42) or normal saline solution (n= 44). The Bellville postoperative nausea and vomiting scores were recorded until 24 hours after surgery.

Postoperative nausea and vomiting (PONV) is a major complication in laparoscopic gynecologic surgery. There are limited data and conflicting results from previous studies related to the types of intravenous fluid and a reduction in PONV. The incidence of nausea is slightly greater than the incidence of vomiting (50% vs. 30%). General anesthesia increased the likelihood of PONV 11 times compared with other types of anesthesia. Laparoscopic surgery can further increase the incidence of PONV to 80%.Identified risk factors of PONV included female, history of motion sickness, nonsmoking, younger age, general anesthesia, use of volatile anesthetics and nitrous oxide, opioids, duration of anesthesia, and types of surgery (cholecystectomy, laparoscopic, gynecological). Adequate intravenous fluid hydration is another effective strategy for reducing the baseline risk for PONV (Evidence A2). Previous studies showed that there was no difference in efficacy between crystalloids and colloids when similar volumes were used in surgeries associated with minimal fluid shifts. While liberal intravenous fluid administration, such as 30 ml/ kg of sodium lactate solution, reduced the incidence of PONV after gynecologic laparoscopy compared to another group receiving 10 ml/kg of sodium lactate solution, this strategy did not reduce the PONV in other surgical procedures such as thyroidectomy. Among crystalloid solutions, results from previous studies were conflicting regarding the benefit of intravenous dextrose administration to reducing the PONV. Hypovolemia with and without hypoglycemia after overnight fasting were believed to exacerbate PONV.

The investigators hypothesized that intraoperative infusion of dextrose solution could reduce the incidence and severity of PONV. The investigators proposed to determine the relationship between types of fluid administration and antiemetic requirement and serum glucose in paricipants scheduled for the gynecologic laparoscopy.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* elective surgery
* Gynecologic laparoscopic surgery
* give informed consent

Exclusion Criteria:

* pregnancy
* DM
* congestive heart failure
Effects of Using Custom Photobiomodulation Therapy for the Treatment of Osteoarthritis of the Fingers and Rhizarthrosis

Osteoarthrosis (OA), a multifactorial degenerative process, is responsible for joint pain and functional limitation. In the hand, more specifically in the proximal and distal interphalangeal joints of the fingers, it is one of the sites of greatest manifestation of the disease. Numerous treatments, whether drug, rehabilitation or surgery, have been proposed with the aim of both interrupting the natural evolution of the disease and alleviating or stopping the symptoms. This study aims to evaluate the effectiveness of personalized Photobiomodulation Therapy (PBT) with regard to alleviating symptoms and improving the quality of life of these patients with the disease.


Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiological diagnosis of OA of the fingers of the hand and Rizarthrosis
* Patients with pain for at least 3 months
* Patients undergoing treatment and rehabilitation for finger OA and rhizarthrosis
* Patient with good understanding of the Portuguese language who agrees to participate and sign the ICF

Exclusion Criteria:

* Posttraumatic arthritic changes
* Systemic inflammatory arthritis (Rheumatoid Arthritis, Lupus Erythematosus, Psoriasis...)
* Patients with local or systemic, acute or chronic infections
Total Energy Expenditure and Fat Oxidation in 2 Year Old Children

The purpose of the study is to determine energy expenditure and fat oxidation in 2 year old children.


Eligibility Criteria:
Inclusion Criteria:

* 1.5-2.5 years of age
* Mother is a participant of the Glowing study (NCT01131117)
* Healthy without taking medication that can affect study outcomes, as determined by the PI

Exclusion Criteria:

* None listed
Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease

The primary objective of the study is to evaluate the clinical efficacy of BIIB054 via dose response using the change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score.

The secondary objectives of the study are to evaluate the dose-related safety of BIIB054, to evaluate the clinical efficacy of BIIB054 via MDS-UPDRS total score, to assess the pharmacokinetic (PK) profile of BIIB054, to evaluate the clinical efficacy of BIIB054 based on MDS-UPDRS subparts, to evaluate the pharmacodynamic effects of BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals and to evaluate the immunogenicity of BIIB054.


Eligibility Criteria:
Inclusion Criteria

* Diagnosed with Parkinson's disease (PD) within a maximum of 3 years prior to Screening.
* Score of ≤2.5 on the Modified Hoehn and Yahr Scale.
* Has not received any medication for the treatment of the motor symptoms of PD for at least 12 weeks prior to Day 1 and, in the opinion of the Investigator, is not expected to require PD treatment for at least 6 months following Day 1. Maximum total duration of prior PD regimens should not exceed 30 days. Stable (at least 8 weeks) dosages of medications that are used to treat conditions other than PD tremor are allowed. Further guidance will be provided by the study's Medical Monitor on a case by case basis.
* Screening dopamine transporter (DaT)/ single-photon emission computed tomography (SPECT) results consistent with neurodegenerative Parkinsonism (central reading).
* All women of childbearing potential and all men must practice highly effective contraception during the study and for 6 months after their last dose of study treatment.

Exclusion Criteria:

* Presence of freezing of gait.
* Montreal cognitive assessment (MOCA) score \<23 or other significant cognitive impairment or clinical dementia that, in the opinion of the Investigator, would interfere with study evaluation.
* History of or screening brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality, as read by central reader.
* History of severe allergic or anaphylactic reactions, or history of hypersensitivity to BIIB054 or any of the inactive ingredients in the drug product or to radioligands or iodine used in the study.
* Participation in any active immunotherapy study targeting alpha-synuclein.
* Use of allowed medications not previously specified at doses that have not been stable for at least 8 weeks before Day 1, and/or that are not expected to remain stable for the duration of the study.
* Clinically significant abnormal laboratory test values at Screening, as determined by the Investigator.
* Blood donation (1 unit or more) within 8 weeks before Day 1 (must also refrain from donating blood for the duration of the study).

NOTE : Other protocol defined Inclusion/Exclusion criteria may apply
Effects of Watermelon Juice on Heart Rate Recovery and Post-exercise Muscle Soreness

The purpose of this study was to determine the effects of a pre-exercise, single practical dose of watermelon juice, Gatorade, sugar water or water on heart rate recovery, blood lactate levels, and 24-hour post exercise muscle soreness.


Eligibility Criteria:
Inclusion Criteria:

* ages of 21-50 healthy adults

Exclusion Criteria:

* Suffering from injury
* Chronic inflammatory conditions
* Required dietary supplement use
* Required medication which affects blood pressure
* Smoking
* Pregnant woman
* Allergy to watermelon
Cardiovascular Assessment in Patient Recovered From COVID-19 and Recovery of Autonomic Nervous System in Association With the Severity of the Disease

The goal of the study is to assess autonomic nervous system and cardiovascular controll during orthostatic challenge in 90 patients recovered from COVID-19 and devided into three groups depend on severity of the morbidity.


Eligibility Criteria:
Inclusion Criteria:

* age over 18
* spontaneous sinus rhythm
* signed informed consent

Exclusion Criteria:

* no spontaneous sinus rhythm
* pregnancy
Use of Sucrose to Relieve Pain During Eye Exams in Infants

The purpose of this study is to see if an oral sucrose solution can comfort premature infants during their necessary eye exams. The investigators believe that the use of this solution prior to the eye exams will lead to a decrease in pain as measured by a rise in heart rate and a fall in oxygen saturation. In addition this will lead to a decrease in events in the 12 hours following examination. Events include episodes when the infants temporarily stop breathing, have a drop in their heart rates, or have a drop in their oxygen levels.


Eligibility Criteria:
Inclusion Criteria:

* All premature infants admitted to the Neonatal Intensive Care Unit requiring serial dilated examinations to assess for retinopathy of prematurity will be candidates for this study. This includes all infants with a birthweight of less than 1500 g and infants between 1500 g and 2000 g who require supplemental oxygen.

Exclusion Criteria:

* Any infant who is unable to safely suckle 0.5 cc of fluid will be excluded from the study. This includes infants that are being maintained on ventilators and those with serious gastrointestinal complications that may be exacerbated by an oral fluid bolus.
* Any infant being maintained on narcotics for any reason will not be eligible for the study.
* All infants with major congenital anomalies will be excluded.