cyrilzakka/clinical-trials huggingface dataset:
Effects of Remimazolam on Quality of Recovery After Ambulatory Surgery

Remimazolam is a novel ultra-short acting benzodiazepine with rapid onset of effects, short maintenance and faster recovery time. Due to its recent development, few studies have investigated the effect of remimazolam on postoperative recovery mainly focusing on physiologic endpoints, recovery time and possible adverse events. Although these parameters are crucial and need evaluation, the investigators ignore quality of recovery from participant's perspective. For this purpose, various measurment tools have been developed for psychometric evaluation of QoR score.

To date, there has not been a study investigating the impact of remimazolam on quality of recovery (QoR). This study evaluates the effect of remimazolam on QoR of participants undergoing general anesthesia using remimazolam-remifentanil total intravenous anesthesia (TIVA) for hysteroscopy as day surgery basis. Herein, the investigators used the translated Korean version of the 15-item Quality of Recovery-15 (QoR-15K) questionnaire, which was previously validated in Korean surgical participants.

Eligibility Criteria:
Inclusion Criteria:

* Adult woman scheduled for ambulatory gynecological surgery under general anesthesia
* American Society of Anesthesiology grade 1 or 2

Exclusion Criteria:

* Underlying diseases: liver, kidney, brain nervous system, glaucoma
* Patients with BMI greater than 30 and less than 18.5
* Patients diagnosed with sleep apnea
* Alcohol or drug dependent patients
* Patients with severe or acute respiratory failure
* Lactose intolerance
* Dextran 40 hypersensitivity
* Patients in shock or coma
Validation of Ferromagnetic Tracer in Melanoma Sentinel Node

This study has been designed to validate a non-radioactive method to identify the sentinel lymph node using a superparamagnetic iron-oxide (SPIO) tracer respect to the traditional isotopic method. Both methods are used in every included patient and each patient is its own control.

* Injection of the isotopic tracer in standard form and in the usual preoperative period (hours-day).
* Identical injection in three-four punctures of 2 mL of Sienna+ ® and local massage of 5-10 minutes.
* Optional: colorant injection in standard form. Local massage of 5-10 minutes.
* After 20 minutes: transcutaneous measurement with SentiMag®
* Valuing territories (lymphoscintigraphy information?)
* Surgical identification measures:

  1. st with SentiMag®
  2. nd with gamma detection probe
* Ex vivo check and HRD record

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years of age),
* with diagnosis of cutaneous melanoma and
* in which SLNB is indicated as a staging method, and
* with cN0 result after clinical-echographic-cytohistological evaluation.

Exclusion Criteria:

* Previous treatment with systemic therapy.
* Recent previous surgery (\<3 months) in the area susceptible of lymphatic drainage from the melanoma.
* Intolerance or hypersensitivity to iron or dextran compounds.
* Impossibility of use of radioisotope.
* Existence of pathology related to elevation of organic iron (hemosiderosis, hemochromatosis, iron deficiency anemia of metabolic or circulatory origin).
* Implantation of pacemakers or partially or totally metallic thoracic implants.
* Treatment with iron chelators (deferasirox, deferoxamine, ...).
Evaluate the Accuracy of Raman IVD Analyzer in the Diagnosis of Gliomas During Surgery

Compare the data obtained from the Raman analyzer and paraffin pathology examination on the same external brain tissue sample. Evaluate the effectiveness and safety of the Raman analyzer for intraoperative diagnosis gliomas of brain resection tissue samples, using paraffin pathological examination results as clinical reference standards.

Based on statistical calculations,108 positive samples and 148 negative samples will be included in the trial in all trial centers. Compare the results between the Raman analyzer and the paraffin pathological. And calculate the sensitivity, the specificity, and other indicators of Raman analyzer.

During surgery, core or marginal tissue samples were taken from subjects. The test samples size:0.2cm\<length diameter ≤ 2cm. The sample testing result is based on the Raman test points. Then take the same tissue sample for paraffin pathological diagnosis.

Statistical description of all data, including baseline data, all efficacy indicators, and all safety data. The measurement data give the mean, standard deviation, minimum, maximum, median,25 quantile and 75 quantile; Provide frequency and composition ratio for counting data. The baseline data was analyzed using the Full Analysis Set (FAS); The effectiveness analysis adopts FAS and PPS; The security analysis uses the Security Dataset (SS).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old, regardless of gender;
* Patients who plan to undergo brain lesion tissue resection surgery or have preoperative clinical diagnosis of gliomas and plan to undergo biopsy;
* Patients with clinical diagnosis of initial solitary gliomas, or initial solitary intracranial masses or initial non occupying lesions that do not exclude gliomas (such as intracranial metastatic lesions, intracranial infectious lesions, intracranial demyelinating lesions, central nervous system lymphoma, etc.), who have not received radiotherapy or chemotherapy in the past based on their medical history;
* The patient or their guardian can understand the research purpose, demonstrate sufficient compliance with the trial protocol, and sign an informed consent form;
* It is possible to obtain tissue samples with a length diameter greater than 0.2cm. Patients diagnosed with initial solitary glioma should take core or marginal tissue, while patients diagnosed with initial single intracranial mass or initial non mass lesions but maybe with gliomas should be taken core tissue.

Exclusion Criteria:

* Investigator judge that it is not suitable for inclusion.
Molecular Imaging of Fulvestrant Effects on Availability of ER Binding Sites

The dose of fulvestrant to optimally downregulate estrogen receptors (ER) is currently subject of debate. Effects of fulvestrant on the ERs may be evaluable by molecular imaging using positron emission tomography with the ER-specific FES tracer. In this pilot study we will evaluate the effects of the new dose of fulvestrant (500mg i.m.)on the availability of ER binding sites in 15 metastatic breast cancer patients.

The estrogen receptor (ER) is expressed in approximately 70% of the breast carcinomas. In these patients signaling via the ER induces proliferation and cell survival of malignant cells. Fulvestrant can inhibit this signaling route by blocking the receptor and decreasing ER-expression by increasing its turn-over rate.

The historical standard dose of fulvestrant was 250mg every 28 days i.m.; however studies performing serial biopsies showed that ER-downregulation was suboptimal. Recently the standard dose has been set to 500mg i.m. on day 1; 14; 28 and every 28 days thereafter. Although slightly more effective than the 250mg dose, still questions remain with respect to the required dose to establish maximal downregulation of ER-signaling.

Immunohistochemistry only provides static information, i.e. the level of ER-expression. However, dynamic information evaluating the effects of fulvestrant on occupancy of ERs, may also be valuable.

Whole-body imaging of the availability of ER binding sites using FES-PET may prove valuable to evaluate the effects of fulvestrant on the ER non-invasively in individual patients. This potentially allows adjustment of dosing in individual patients to aid therapy efficacy.

In this pilot-study we will evaluate 15 metastatic breast cancer patients. All patients will undergo FES-PET/CT at baseline, FES-PET after 1 month, and FES-PET/CT after three months. Hormone- and fulvestrant levels will be measured in all patients. Whenever possible, tumor biopsies will be performed to correlate to FES-PET results.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients with a history of histological proven ER-positive primary breast cancer and, whenever available, histological proven ER-positive recurrence. 2. Post-menopausal status (age ≥ 45 years with amenorrhea for \> 12 months or prior bilateral ovariectomy 3. Documentation of a negative pregnancy test must be available for women less than 2 years after menopause 4. Progressive disease after 2 lines of hormonal therapy 5. No previous fulvestrant treatment 6. ER-antagonists should be discontinued for 5 weeks prior to FES-PET to prevent false negative FES-PET results. The use of aromatase inhibitors is allowed 7. ECOG performance status 0, 1 or 2 8. Life expectancy \> 3 months 9. Creatinine clearance ≥ 30 ml/min 10. Age ≥ 18 years 11. Signed written informed consent 12. Able to comply with the protocol

Exclusion Criteria:

* 1. Evidence of central nervous system metastases 2. Presence of life-threatening visceral metastases 3. \> 3 lines of endocrine therapy for metastatic disease 4. \> 2 lines of chemotherapy in metastatic disease
Rituximab (Rituxan) for the Prevention of EBV-LPD Epstein Barr Virus (EBV) Lymphoproliferative Disorder Post T Cell Depleted Unrelated and HLA Mis-matched Related HSCT

The purpose of this study is to determine if we can prevent Epstein Barr Virus lymphomas by the monthly administration of an (antibody) protein against B lymphocytes called Rituximab. Although this medicine has been approved by the Food and Drug Administration to treat patients with other types of lymphomas, and has been used to treat a small number of patients with EBV lymphomas and other types of B-cell leukemias, it has not been approved to try and prevent EBV-lymphomas. Use of Rituximab to try to prevent EBV-lymphomas is therefore experimental.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be a recipient of aT cell depleted unrelated or HLA mis-matched related HSCT for the treatment of a malignancy or immunodeficiency disease.
* Patients must have an ANC \> or = to 1500 cells/ul on the day of first treatment.
* Patients with acute or chronic leukemia, or MDS prior to transplant must be in remission defined as \<5% blasts in the bone marrow.
* Patient with must be in remission.
* Patient must be Hepatitis B surface antigen negative pre transplant.
* Patients must have adequate cardiac function defined as a left ventricular ejection fraction at rest of \>50% documented pre-transplant.
* Patient may be of either gender and of any ethnic background.
* Patient may be of any age. There is no upper age restriction.
* Patients or their guardians must be able to understand the nature and risk of the proposed study and be able to sign consent.

Exclusion Criteria:

* Karnofsky score \<70%
* Female patients who are pregnant or lactating.
* Evidence of EBV-LPD or circulating EBV copy number \>1000.
* Active uncontrolled bacterial or fungal infection.
* Prior history of Hepatitis B infection or Hepatitis B surface antigen positivity pre transplant.
* HIV-1,2 sero-positive patients.
* Patients or guardians not signing informed consent.
* Patients with prior allergic reaction to Rituximab or other murine monoclonal antibody.
* Patients taking other investigational agents under another protocol unless discussed and approved in advance by Genentech and the IDEC Therapeutic Director.
Telerehabilitation Exercise: Effects on Maternal Quality of Life, Fetal and Neonatal Health.

Gestational diabetes mellitus (GDM) occurs when blood sugar levels rise during pregnancy, typically between 24-28 weeks, affecting about 2-18% of all pregnancies. It is a common metabolic disease that can lead to health risks for the mother, fetus, and child, and can negatively impact the mother's quality of life. This study aims to explore how a telerehabilitation exercise program affects the quality of life of mothers with GDM and the health of fetus/neonate.

Gestational diabetes mellitus (GDM) significantly impacts maternal quality of life (QoL) and fetal/neonatal health. According to the World Health Organization, quality of life (QOL) is a person's view of their status in life within their culture and value system. Pregnancies with GDM, negatively affect personal, familial, and social life, leading to poorer QOL. GDM causes medical issues for the mother and fetus and harms the mother's psychological well-being, reducing her QOL. Due to the increasing prevalence of GDM and the importance of improving QOL for affected women, this study examines impact of telerehabilitation exercise on quality of life of pregnant women. Awareness about the importance of exercise in managing gestational diabetes mellitus (GDM) is crucial. Regular physical activity can help control blood sugar levels, reduce insulin resistance, and improve overall health for both the mother and fetus leading to better pregnancy outcomes.Telerehabilitation offers convenience, accessibility, and personalized support, allowing patients to exercise from home with continuous healthcare provider monitoring.It is a cost-effective, flexible, and safer alternative to traditional exercise methods, especially beneficial for managing gestational diabetes.

The control group will recieve routine medical care and the experimental group will recieve structured telerehabilitation exercise protocol. The results of both groups will be recorded and compared to assess the effectiveness of using telerehabilitation in the treatment of women with GDM in improving their quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 20 to 35 years
* Gestational age between 20-28weeks
* diagnosed with Gestational diabetes mellitus through oral glucose tolerance test (OGTT)
* Primigravida and multigravida
* able to do 6 6-minute walk tests under a severity level of 6 on the Borg scale of breathlessness.
* Patients or caregivers have and able to use an electronic device (PC, tablet or smartphone)
* Who signed informed consent

Exclusion Criteria:

* Previously diagnosed T1DM or T2DM
* High-risk pregnancy conditions contraindicating exercise as per ACOG guidelines
* Patients taking insulin regularly.
* Patients with fetal anomalies diagnosed at 20 th week.
* Multiple gestation (twin or triplets).
Parenting Skills for Mothers With Borderline Personality Disorder (BPD)

The first disorder-specific parenting training program for mothers with Borderline Personality Disorder (M-BPD) is evaluated in a randomized controlled trial.

The training program is expected to have positive effects on parenting behavior, decrease the risk of maltreatment of the child, and improve emotion regulation in mothers at post treatment and at 6-month follow-up compared to a control group (treatment as usual; TAU).

Additionally, disorder-specific aspects of dysfunctional parenting behavior as well as BPD-specific aspects of child maltreatment are compared to a clinical control group (mothers with anxiety and/or depression, M-AD/D) and a healthy control group (M-CON).

To assess the differential development of parenting, the risk of maltreatment and emotion dysregulation in untreated M-BPD are compared to M-CON. The investigators expect the difference to increase over time, indicating a worsening in BPD parenting.


Eligibility Criteria:
Inclusion criteria for mothers with BPD:

1. diagnosed with BPD (assessed via SCID-PD)
2. running or completed therapy for BPD symptoms
3. child between 6 months and 6 years
4. living with child or regular (weekly) contact

Exclusion criteria for the mothers with BPD

1. Acute child endangerment
2. maternal acute suicidality
3. maternal psychotic symptoms (assessed via SCID-CV)
4. maternal acute alcohol or drug dependency (assessed via SCID-CV)
5. maternal diagnosed intellectual disability.

Inclusion criteria for mothers with depression and/or anxiety disorders:

1. diagnosed with acute affective or anxiety disorder (assessed via SCID-CV)
2. child between 6 months and 6 years
3. living with child or regular (weekly) contact

Exclusion criteria for mothers with depression and/or anxiety disorders:

1. Acute child endangerment
2. maternal acute suicidality
3. maternal psychotic symptoms (assessed via SCID-CV)
4. maternal acute alcohol or drug dependency (assessed via SCID-CV)
5. maternal diagnosed intellectual disability
6. lifetime diagnosis of BPD (assessed via SCID-PD)

Inclusion criteria for healthy control group:

1. child between 6 months and 6 years
2. living with child or regular (weekly) contact

Exclusion criteria for the healthy control group:

1. Acute child endangerment
2. maternal acute suicidality
3. maternal psychotic symptoms (assessed via SCID-CV)
4. maternal acute alcohol or drug dependency (assessed via SCID-CV)
5. maternal diagnosed intellectual disability.
6. lifetime diagnosis of BPD (assessed via SCID-PD)
7. any acute mental disorder (assessed via SCID-CV)
8. current psychotherapy
Current Situation on the Consumption of Hypnotic Substances at the Pharmacy

In France, consumption of hypnotic drugs is high. In this context, and given the planned regulatory modifications, it seems essential to make an inventory of the consumption of drugs taken for a hypnotic purpose. This study aims to identify the substances (medical or not) used for a hypnotic purpose in the adult population going to a pharmacy.


Eligibility Criteria:
Inclusion Criteria:

* Adult going to the pharmacy and who accepts to complete the questionnaire

Exclusion Criteria:

* Minor
* Who is not able to complete a questionnaire
* Who does not accept to complete the questionnaire
Applying mHealth to Tobacco-related Health Disparities

The purpose of this study is to better understand what happens when someone attempts to quit smoking.

Investigators will provide participants with nicotine patches, smoking cessation treatment that will include brief counseling sessions (10-15 minutes each), and text messages sent to their provided study phone throughout the day. These messages will be short (1-3 minutes long) and will ask participants to do things like focus on the present moment, pay attention to their breathing, and be aware of their current thoughts. Participants will be asked to wear equipment throughout the day that will measure their physiology and smoking behavior. Mobile Health (mHealth) is a general term for the use of mobile phones and other wireless technology in medical care.

The key outcome and hypothesized mechanisms (i.e., lapse and stress) will be measured objectively and automatically using AutoSense. AutoSense is a type of human sensing technology that allows investigators to detect smoking behavior and stress objectively through a chest strap and wrist bands worn by participants. Ecological momentary assessment (EMA) will assess acute precipitants such as negative affect, craving, self-efficacy, motivation, alcohol consumption, etc. Questionnaires will assess other predictors and mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Smoked a minimum of 3 cigarettes per day over the past year
* Expired carbon monoxide reading ≥ 6
* Motivated to quit within the next 30 days
* Valid home address
* Functioning telephone number
* Can speak, read, and write in English
* At least marginal health literacy

Exclusion Criteria:

* Contraindication for the nicotine patch (e.g., heart attack, angina, skin allergies) unless a doctor's note is provided
* Endorse current psychosis
* Have a pacemaker or implanted device
* Physically unable to wear equipment and provide a good reading of physiological measures
* Current use of tobacco cessation medications
* Current use of of smoking products other than cigarettes and e-cigarettes
* Involvement in a smoking program or currently trying to quit
* Pregnancy or lactation
* Another household member being enrolled in the study
* No prior experience with a smart phone
* The study staff or principal investigator (PI) have serious concerns about the participant's ability to engage in and/or complete the study protocol.
Safety and Efficacy of Remote Ischemic Conditioning for Spontaneous Intracerebral Hemorrhage

The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning in treating acute intracerebral hemorrhage.

Spontaneous intracerebral hemorrhage is a major cause of disability and mortality among different types of stroke, and few effective treatment options are available. Therefore, it is essential to develop new approaches to improve the prognosis of these patients. Recently, remote ischemic conditioning (RIC), a method that involves inducing multiple brief episodes of ischemia and reperfusion in the limbs, has been indicated to exert neuroprotective effects in experimental stroke. The underlying neuroprotective mechanism triggered by RIC induces gene expression, alters pathways, promotes neurogenesis and blood vessel development, reduces oxidative stress and neuronal apoptosis, and inhibits proinflammatory signals. Previously, several clinical trials have shown that single or repeated RIC treatments for cerebrovascular diseases are feasible and safe. Therefore, we hypothesize that RIC could improve functional outcome in patients with intracerebral hemorrhage. We design this prospective, multicenter, randomized controlled trial to evaluate the efficacy and safety of RIC in treating intracerebral hemorrhage.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years.
2. Supratentorial intracerebral hemorrhage confirmed by brain CT scan.
3. No disability in the community before ICH (premorbid mRS≤ 1).
4. NIHSS score ≥ 6 and GCS ≥ 8 upon presentation.
5. Able to commence RIC treatment within 24 hours of stroke onset.
6. Systolic blood pressure ≤ 180 mmHg before randomization.
7. Signed and dated informed consent is obtained.

Exclusion Criteria:

1. Definite evidence of secondary ICH, such as structural abnormality, brain aneurysm, brain tumor, thrombolytic drug.
2. Hematoma with a mid-line shift, cerebral herniation or isolate intraventricular hemorrhage.
3. Already booked for surgical treatment.
4. Life expectancy of less than 180 days due to comorbid conditions.
5. Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban or coagulopathy (defined as INR, APTT, and PT beyond the upper limit of normal range).
6. Any soft tissue, orthopedic, or vascular injury, wounds or fractures in healthy upper limb which may pose a contraindication for application of RIC.
7. Severe hepatic and renal dysfunction, or ALT/AST \>3 times upper limit of normal, or serum creatinine \>265umol/l.
8. Known pregnancy or breastfeeding.
9. Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.
10. A high likelihood that the patient will not adhere to the study treatment and follow up regimen.
11. Patients unsuitable for enrollment in the clinical trial according to investigators decision making.
COMPLEMENT Study- A First in Human Study of Metabolic Neuromodulation Therapy

The purpose of this research study is to collect information about a new treatment for Type 2 Diabetes Mellitus (T2DM), using a medical device called the Metabolic Neuromodulation System which is intended to help regulate blood glucose levels in patients whose (T2DM) is not well controlled despite treatment with multiple medications. The medical device delivers low-level radiofrequency energy through the wall of the blood vessel to the liver to disrupt the nerves that lead to the liver. Previous research has shown that disrupting these nerves may lead to a lowering of blood sugar levels.

Prospective, First-in-Human (FIH), multi-center, non-randomized trial to evaluate the initial safety and performance of hepatic sympathetic denervation to aid in glycemic control.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Uncontrolled T2DM, as evidenced by HbA1c levels, on a consistent oral anti-hyperglycemic drug regimen of at least two different drug classes
* Documented status of stable lifestyle modifications

Exclusion Criteria:

* Diagnosed type 1 diabetes mellitus
* History or diagnosis of proliferative retinopathy or advanced autonomic neuropathy
* Estimated glomerular filtration rate (GFR) \< 60mL/min/1.73m2