cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Safety, Pharmacokinetic, and Biological Activity of INCB059872 in Subjects With Sickle Cell Disease

The purpose of this study was to evaluate the safety and tolerability, and the pharmacokinetic and biologic activity of INCB059872 in participants with sickle cell disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SCD (sickle cell SS) confirmed through hemoglobin electrophoresis.
* Must be red blood cell (RBC) transfusion-independent (not currently on regularly scheduled transfusions) for ≥ 3 months from the time of first dose of study drug.
* No RBC transfusion within 30 days of first dose of study drug.
* Hydroxyurea (HU) refractory

  -Must not have received HU therapy during the 3 months before receiving study drug.
* Creatinine clearance ≥ 60 mL/min based on the institutional formula.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Any unresolved toxicity ≥ Grade 2 from previous therapy except for stable chronic toxicities not expected to resolve.
* Pregnant or nursing women or participants expecting to conceive or father children within the projected duration of the study, starting with screening visit through completion of safety follow-up.
* Received an investigational study drug within 28 days or 5 half-lives (whichever is longer) before receiving the first dose of study drug (requirement may be waived with medical monitor approval).
* Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
* Prior receipt of LSD1 inhibitor therapy for any indication.
Long-term Cardiovascular Risk in Cured Cushing's Patients

The purpose of this study is to determine whether subjects who have been affected by Cushing's disease in the past maintain some different characteristics compared with subjects who have never been diagnosed with the disease.


Eligibility Criteria:
Inclusion Criteria:

* patients who have been cured of Cushing's disease at least 5 years ago.

Exclusion Criteria:

* patients who have been cured of Cushing's disease more than 15 years ago.
Effect of Music Intervention on Anxiety in Cancer Patients Undergoing Initial Radiation Therapy

This prospective randomized trial evaluated the effect of music interventions on anxiety and nervousness during 10 consecutive days in individuals undergoing their first radiation therapy session.

A total of 100 participants were enrolled and randomly assigned to either the music group or nonmusic group (n = 50 each). Investigators ensured an equal distribution of men and women, without considering the cancer type. To minimize confounding factors and prevent shared learning experiences or communication between the two groups, the participants in the experimental and control groups were scheduled for treatment at different times throughout the year (from January 1, 2022 to December 31, 2022). Anxiety assessment questionnaires were administered before the treatment began and after 2 weeks of treatment. Physiological parameters, including heart rate, systolic and diastolic blood pressure, and blood oxygen levels, were monitored before and after 2 weeks of treatment. In the music intervention group, the patients received music intervention during RT for 10 consecutive days and listened to music for approximately 10-15 minutes in each session. The music period was then followed by a 10-day period without music during treatment to evaluate the differences in the same individuals. In contrast, the control group did not receive music intervention throughout their entire RT period. Investigators observed the music intervention group for 2 weeks to ascertain any differences.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing RT for cancer for the first time
* patients with clear consciousness and normal hearing
* patients willing to respond to the questionnaire after the research process and purpose were explained to them.

Exclusion Criteria:

* patients who had previously undergone RT
* patients with diminished mental capacity or inability to satisfactorily participate in this study
* patients with moderate to severe hearing impairment.
The Prognostic Value of Pupil Near Response in UWS Patients

Previous studies suggest that the stimulus of pupil near response (PNR) may be a conscious perception of a blurred image. Moreover, PNR is a reflex that can be objectively observed and with no motor output, suggesting it might be a more convenient index for consciousness evaluation and consciousness recovery in patients with disorders of consciousness (DOC). We thus hypothesized that PNR+ patients (patients show PNR during the assessment) would have better prognosis than PNR- patients (patients fail to show PNR during the assessment).Based on this hypotheis, researchers will assess pupil near response in patients with unresponsive wakefulness syndrome (UWS) and compare the prognosis difference between PNR+ patients and PNR- patients to assess its prognosis value.

PNR assessments will be conducted in patients with Unresponsive Wakefulness Syndrome (UWS) diagnosed by the Coma recovery scale-revised (CRS-R).An objective index,the ratio of pupillary constriction (pupil diameter change after a stimulus presentation divided by the resting state pupil diameter) will be used as the measure of PNR's presence (positive results indicate the presence of PNR,whereas negative results indicate the absence of PNR).According to the presence of PNR,patients will be divided into 2 groups,one includes patients who show PNR during the PNR assessment (PNR+),the other includes patients who fail to show PNR during the PNR assessment(PNR-).3 months later,a follow-up will be conducted to obtain their prognosis in the form of another CRS-R assessment.Patients diagnosed as Minimally Conscious State (MCS) will be considered as favourable prognosis,patients diagnosed as UWS will be considered as unfavourable prognosis.Their prognosis difference will then be compared to see PNR's effect on their prognosis (consciousness recovery). And for they couldn't show conscious visual behaviors (visual behaviors in CRS-R which indicate MCS) in the first CRS-R,their difference between visual prognosis (difference between each group's proportion of patients showing conscious visual behavior diagnosed by CRS-R in the follow up) will be compared to see PNR's capability to predict prognosis in patients without voluntary eye movements (conscious visual behaviors in CRS-R require voluntary eye movements).

Researchers expect to see the PNR+ group have better prognosis in both comparison.

Eligibility Criteria:
Inclusion Criteria:

* unresponsive wakefulness syndrome (diagnosed by CRS-R)
* normal or corrected to normal vision before the incidence (myopia did not exceed 300 degrees Fahrenheit, farsightedness was less than + 2.00 d)
* positive pupil light reflex.

Exclusion Criteria:

* nystagmus and drooping eyelids
* unstable vital signs
* under sedation during PNR test.
Study of Seroprevalence of Anti-SARS-CoV2 Among Children of Hospital Workers in AP-HP

The purpose of this study is to define seroprevalence of anti-SARS-CoV2 among children of Hospital Workers in APHP, particularly exposed population, according to parents' SARS-CoV2 serological status.


Eligibility Criteria:
Inclusion Criteria:

Hospital workers :

1. Individuals aged over 18, having a professional activity at the APHP (employees, interns, volunteers)
2. Affiliated to a social security regimen
3. Have at least one child under the age of 18 living in the same house.
4. have signed consent

Child (ren), spouse and other member (s) residing at household:

Child (ren), spouse and any other member residing in the household of a professional of the Paris Center Hospitals meeting the inclusion criteria above.

Exclusion Criteria:

Refuse to participate in research
Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke

A feasibility study to evaluate the initial safety and performance of the RapidPulseTM Aspiration System in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO) in the intracranial ICA, M1, M2, basilar or vertebral arteries.

The purpose of this prospective, open label clinical trial is to assess the initial safety and performance of the RapidPulseTM Aspiration System as frontline approach for patients with acute ischemic stroke due to large vessel occlusions identified within 24 hours of symptom onset (or last seen normal). The study will enroll up to a maximum of 50 subjects in 2 centers in Georgia. Subjects will undergo mechanical thrombectomy procedure and will have post-operative assessments completed at 24 hours and on Day 5-7 or upon hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Clinical diagnosis of acute ischemic stroke with symptom onset (or last seen normal) within 24 hours
* Large vessel occlusion (LVO) involving the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 or M2 segments, basilar or vertebral artery
* Target occlusion can be accessed by the Medtronic React 71 aspiration catheter

Exclusion Criteria:

* Known or suspected intracranial atherosclerotic disease (ICAD)
* Tandem occlusions
Mast-Cell Stabilizing Effects of Olopatadine

To assess the effects of olopatadine of the release of mast cell histamine


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic and not using any topical or systemic medication

Exclusion Criteria:

* Age
Effects of Sea Buckthorn Oil and Lutein on Eye Health

Low macular pigment optical density has been associated with increased risk of age-related macular degeneration, an important cause of vision problems in the elderly population. Dry eye is multifactorial disease of tears and the ocular surface associated with symptoms of dryness, grittiness, burning and redness of eyes. The risk of dry eye increases with age. The aim is to investigate the effects of sea buckthorn oil complemented with lutein on eye health, specifically on the macula.


Eligibility Criteria:
Inclusion Criteria:

- macular pigment optical density equal to or less than 0,40 OD

Exclusion Criteria:

* diabetic retinopathy
* macular changes associated with high blood pressure
* signs of macular degeneration: classes 2, 3 and 4 according to the Rotterdam study (Mol Vis 2012: 657-74)
* severe eye diseases, exluding cataract. The intervention will begina after surgery and recovery from cataract
Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial)

The study will investigate whether liver transplantation provides increased survival, low side effects and good quality of life in patients with bile duct cancer where the tumor cannot be removed by normal surgery. Analyzes of blood and tissue samples from the tumor will be investigated to see if the analyzes can indicate who may have recurrence of the disease after liver transplantation. Furthermore, the effect of chemotherapy on normal liver and tumor tissues in the liver that are removed during transplantation will be investigated..


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified diagnosis of Intrahepatic Cholangiocarcinoma (iCCA)
* First time iCCA or liver only recurrence after previous liver resection for iCCA
* Disease deemed not eligible for liver resection based on tumor location or underlying liver dysfunction
* No vascular invasion, extrahepatic disease, or lymph node involvement detected on imaging
* No signs of extrahepatic metastatic disease according to positron emission computed tomography (PET-CT) scan
* Patient must be accepted for transplantation before progressive disease on chemotherapy.
* Twelve months or more time span from the diagnosis of iCCA and date of being listed for liver transplantation
* No signs of extrahepatic metastatic disease according to CT or magnetic resonance (MR) scan within 4 weeks prior to the faculty meeting at the transplant unit
* At least 18 years of age
* Good performance status, Eastern Cooperative Oncology Group (ECOG) 0 or 1
* Signed informed consent and expected cooperation of the patients for the treatment and follow up
* Received at least 6 months of chemotherapy or locoregional therapy

Exclusion Criteria:

* Major vascular involvement of the tumor
* Perforation of the visceral peritoneum
* Weight loss \>15% the last 6 months
* Patient BMI \> 30
* Other malignancies, except curatively treated more than 5 years ago without relapse
* Known history of human immunodeficiency virus (HIV) infection
* Prior history of solid organ or bone marrow transplantation
* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
* Known hypersensitivity to rapamycin
* Prior extrahepatic metastatic disease
* Women who are pregnant or breast feeding
* Any reason why, in the opinion of the investigator, the patient should not participate
Pronation in COVID-19 Patients Undergoing Non Invasive Respiratory Support

Pronation seems feasible and effective in improving blood oxygenation in patients with COVID-19 pneumonia. Data are lacking on the effects of pronation on clinical outcome in this subset of patients.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria

* patients aged ≥18 and \< 80 years old
* acute respiratory failure

Exclusion Criteria:

* endotracheal intubation performed within the first 24 hours from admission,
* ceiling of escalation of intensive care
* do not intubate order as expressed by patient willing or upon clinical judgement
* missing core data at medical record analysis (clinical features at baseline, pronation information, type and time of ventilatory support required, mortality, need for tracheostomy, length of respiratory intensive care unit and hospital stay).
Omission of Axillary Surgery in Breast Cancer Patients

The treatment and prognosis of breast cancer (BC) are dependent on its molecular subtype and nodal burden. In early BCs with favourable molecular subtype, the incidence of axillary node involvement is low. However, these patients are still subjected to an axillary operation, which can result in additional cost, operating time and morbidities. Similarly, in patients with limited nodal burden of 1-2 metastatic nodes, there is emerging evidence that these patients may need sentinel lymph node biopsy (SLNB) only, instead of an axillary clearance (AC), which has more surgical morbidities.

We aimed to determine if axillary surgery could be safely tailored in BC patients based on their molecular subtype and nodal burden, without compromising their oncological outcomes. This could in turn reduce the morbidities associated with the axillary surgery,

Total 350 patients will be enrolled. 50 patients with early BC and favourable molecular subtype will be enrolled in a pilot study A (SentiOMIT), whereby SLNB is omitted. For eligible patients who declined study A and other stage I-II patients, with preoperative N0 status, undergoing upfront surgery but did not meet the inclusion criteria of Study A, these patients will be enrolled into study B (SentiMACRO) to undergo SLNB.

In study B, the patients will be categorized based on SLNB into 3 groups with 100 patients in each arm: B1 with pN0, B2- 1-2 metastatic nodes and B3- \>/=3 metastatic nodes. In Study B, we aim to investigate if the B2 group (100 patients) can be treated with a less invasive procedure of SLNB alone instead of AC, without affecting oncological outcomes. B1 and B3 are controls.

The outcomes for study A and B include short term outcomes such as morbidity rates, cost and operating time savings. Long term outcomes include recurrence and survival rates. This study will allow individualisation of axillary surgery based on the patient's molecular subtype and nodal burden, to benefit patients' care.


Eligibility Criteria:
Inclusion Criteria:

* female patients aged \>/=55 years old
* unifocal cancer on imaging
* breast tumour size based on imaging of \</=3cm
* no evidence of axillary adenopathy on imaging
* patients with strongly positive ER and PR and negative HER2 on biopsy
* grade 1-2 tumour on core biopsy
* patient who opt for mastectomy

Exclusion Criteria:

* patients with T3/T4 or stage IV disease, patients with preoperative known N+ disease, bilateral breast cancers, patients planned for neoadjuvant chemotherapy, patients with other malignancies.
Adjuvant Chemotherapy in High Risk Stage II Colon Cancer

* Benefit of adjuvant chemotherapy after curative surgery for stage II Colon Cancer is still debated. Several high-risk features may help to stratify stage II cancer patients into groups that will truly benefit from adjuvant chemotherapy. However, those factors are rather subjective, and no specific trial has been designed to answer the high-risk stage II colon cancer question directly.
* Immunoscore® Colon, an in vitro diagnostic test, which quantifies the density of CD3+ and CD8+ T lymphocyte populations in the center the tumor (CT) and its invasive margin (IM) using immunohistochemistry and automated image analysis. Immunoscore® has been extensively validated as a prognostic biomarker in early stage CC patients. This unique diagnostic assay measuring host immune response at the tumor site may inform the decision to administer adjuvant chemotherapy in resected Stage II and III CC patients.
* This randomized trial is studying how observation compares to adjuvant chemotherapy (investigator's choice) in stage II colon cancer patients with high-risk features and High-Immunoscore®. The trial would represent a unique opportunity to classify stage II CC patients based on their tumor microenvironment with the aim to provide efficient patient stratification to improve clinical care.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years old
2. Pathologically confirmed adenocarcinoma of the colon
3. Complete resection of the primary tumor without gross or microscopic evidence of residual disease
4. Histologically proven stage II: T3-T4 N0
5. At least one of the following factors:T4 staging,Number of examined lymph nodes \< 12,poor differentiation (except MSI-H),LVI or PNI,tumor perforation or occlusion
6. Treatment within 7 weeks following surgery
7. ECOG PS 0-1
8. No prior chemo, immuno or radiotherapy
9. Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.

Exclusion criteria

1. Have a birth plan during the clinical trial;
2. Severe cardiovascular diseases such as cerebrovascular accidents occurring within 6 months, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4), and arrhythmia requiring drugs Intervention;
3. Dementia, mental state changes or any mental illness that may interfere with understanding or making informed consent or completing a questionnaire;
4. Subjects with ≥1 peripheral neuropathy according to CTCAE V version 4.03;
5. Allergy or hypersensitivity history of the drug or drug ingredient used in this test;
6. Excluding other malignant tumors, cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or any other part of the carcinoma in situ;
7. Have received any other test drug treatment or participated in another interventional clinical trial within 30 days of the screening period;
8. The investigator believes that it is not suitable for inclusion.
Breakfast Size and Weight Loss in Overweight/Obese Adults

EFFECT OF HIGH CARBOHYDRATE AND HIGH PROTEIN BREAKFAST ON WEIGHT LOSS, GHRELIN, HUNGER AND CRAVING SCORES IN OBESE MEN AND WOMEN. D Jakubowicz, M Boaz, J Wainstein, O Froy

Background: Obesity underlying endocrine, metabolic and eating behaviour features promotes weight gain, increase of hunger, and carbohydrate (Carb) craving. Restrictive diets either in calories or Carb produce withdrawal effect, that further exacerbate Carb craving resulting in rapid return of obesity. Meal timing and composition has shown to play a pivotal role in appetite regulation through several hormonal systems such as ghrelin. The investigators hypothesized that to be successful; a weight loss strategy must change the hormonal environment to increase satiety while reducing hunger and craving.

Objectives: To assess weight loss, satiety, hunger, cravings and ghrelin response to two isocaloric diets. Additionally, these outcomes were measured in response to meal challenge.

Methods: In this randomized, treatment controlled clinical trial, 146 obese, sedentary adults with impaired glucose tolerance will be assigned to Low carb diet (LCHbd) or an isocaloric diet with a high carb, high protein breakfast (HCPbd),1400 kcal for women and 1600 kcal for men. LCHbd breakfast will provide 300 kcal with carb: protein: fat of 13:40:48. HCPbd breakfast will provide 600 kcal with 50:20:30. From baseline until week 16 participants will take part in a supervised weight loss diet, followed until week 32 by a maintenance period. Anthropometric measures, OGTT for glucose and insulin, VAS-measured hunger and satiety and Food Craving Inventory Analysis will be performed at baseline, week 16 and week 32.


Eligibility Criteria:
Inclusion Criteria:

* adult
* male and female
* obese
* sedentary
* glucose intolerant/insulin resistant

Exclusion Criteria:

* pregnant/lactating
* malignancy
* taking weight loss medications
* know eating disorder
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer

The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 years-old
* Patient is female with known menopausal status (postmenopausal or premenopausal/perimenopause)
* Patient with histologically confirmed HR+/HER2- early breast cancer (immunohistochemical ER and/or PR≥10%)
* Histologically confirmed invasive breast cancer with anatomic stages of IIA-IIIC stage (T2-4N0-3M0), of which stage IIA only included T1N1M0
* Patients with or without neoadjuvant or adjuvant chemotherapy/ radiotherapy were eligible for inclusion
* From operation to enrollment should not exceed 12 months
* Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

* metastatic disease (Stage IV) or inflammatory breast cancer
* Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
* Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
* A history of allergy to the drugs in this study；
* Unable or unwilling to swallow tablets
* History of gastrointestinal disease with diarrhea as the major symptom.
Management of Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Antiretroviral (ARV) Combination Therapy Including Raltegravir (MK-0518-138)

To evaluate the management of HIV-1 participants treated with antiretroviral combination therapy including the integrase inhibitor raltegravir, all across the country of France.


Eligibility Criteria:
Inclusion Criteria:

* Participant Infected With HIV-1.
* Participant for whom raltegravir therapy has been decided and started less than 30 days prior to inclusion in the study.
* Participant who has received oral and written information about the study and who has agreed to the computer processing of his/her personal data.

Exclusion Criteria:

* Participant taking part in a clinical trial to assess raltegravir.
* Participant in whom raltegravir treatment was started more than 30 days ago.