cyrilzakka/clinical-trials huggingface dataset:
Study of NPC-08 is to Treat for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme

The purpose of this study is to evaluate whether NPC-08 is safety and efficacy in the treatment of newly-diagnosed malignant glioma and recurrent glioblastoma multiforme.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged between 18 and 65 years;
* Radiographic evidence on cranial MRI of a single contrast-enhancing unilateral supratentorial cerebral tumor;
* Karnofsky Performance Score of 60 or higher;
* Willing to practice an effective method of birth control for at least 12 months after wafer implantation surgery;

Exclusion Criteria:

* More than one focus of tumor or tumor crossing the midline, as assessed by coronal cranial MRI scan;
* Prior radiotherapy to the brain;
* Prior chemotherapy for the malignant glioma before the baseline evaluation, or patients who were being treated with chemotherapeutic agents;
* Known hypersensitivity to nitrosoureas;
* Participation in any other investigational protocol in the previous 6 months for any type of malignancy;
Effects of Phytoestrogen From Pueraria Mirifica in Improvement of Serum Lipid Parameters in Postmenopausal Women

The goal of this clinical trial is to learn about the effects of phytoestrogen from Pueraria Mirifica in improvement of serum lipid parameters. The primary question it aims to answer are:

• phytoestrogen from Pueraria Mirifica can reduce serum triglyceride, total cholesterol, LDL and increase HDL or not

Participants will receive capsules which composed of dry weight 50 mg of Pueraria Mirifica twice a day for 2 months. Researchers will compare with diet control\&life style modification to see if there is the improvement of serum lipid parameters

The secondary question it aims to answer are:

* phytoestrogen from Pueraria Mirifica can reduce menopausal symptom score or not
* phytoestrogen from Pueraria Mirifica can reduce body mass index(BMI) or not
* phytoestrogen from Pueraria Mirifica can reduce waist circumference or not
* phytoestrogen from Pueraria Mirifica can reduce blood pressure or not
* phytoestrogen from Pueraria Mirifica effects to creatinine, BUN, eGFR or not
* phytoestrogen from Pueraria Mirifica effects liver function enzymes or not

Eligibility Criteria:
Inclusion Criteria:

1. Natural menopause, last menstrual period more than one year ago.
2. Abnormal lipid profile parameters The criteria set for this research are:

   * LDL\>130 mg/Dl or
   * TG\>150 mg/Dl or
   * Total cholesterol\>200 mg/Dl or
   * HDL-C less than 50 mg/Dl. (Latest blood results not more than 6 months)
3. Willing to participate in the project

Exclusion Criteria:

1. Have ever received lipid-lowering medication or hormone replacement therapy or SERMs. During the past 6 weeks
2. have had surgery on the ovaries or uterus before
3. have a history of cancer within a 5-year period
4. have diabetes or uncontrolled high blood pressure, including HbA1c \>9, Systolic blood pressure \>180 or Diastolic blood pressure \>110
5. Endocrine system disease such as thyroid
6. Ever had an organ transplant
7. Regularly use drugs, marijuana, or drink alcohol.
8. has a psychiatric disorder
9. have other serious medical conditions that require close monitoring
10. Inconvenient to follow up until the end of the research.
Comparison of Quality of Life and Changes Experienced by Patients After Epilepsy Surgery

Epilepsy is one of the most common chronic neurological diseases. According to data from the World Health Organization (WHO), it affects 0.5 to 1% of the population, or around 70 million people world-wide and around 600,000 in France. There are several more or less severe forms of epilepsy depending on the type of epileptic seizures and the frequency of these seizures. About 30% of epileptic patients respond poorly to well-conducted medical treatment, which makes the number of so-called "drug-resistant" patients estimated at between 100,000 and 150,000 patients.

Epilepsy surgery is possible in some cases of drug-resistant epilepsy and can lead to complete seizure control. Beyond the impact on the control of seizures, surgery can have an impact on the lives of patients at the psychological, emotional and cognitive level, with consequences on their socio-professional but also personal life. Thus the impact on the daily life of patients after epilepsy surgery can vary greatly from one patient to another and the personal feelings of operated patients do not always seem to correspond to the objective elements collected by doctors. 2.3 The investigators want to retrospectively assess the satisfaction and quality of life of patients operated on for more than 2 years based on their epileptological results (frequency of seizures).


Eligibility Criteria:
Inclusion Criteria:

* Patient operated in the context of epilepsy surgery dating back more than 2 years in the epileptology center of the Toulouse University Hospital.
* Patient covered by a social security scheme.
* Patient having given his non-objection to participate in the research.

Exclusion Criteria:

* Minor under the age of 15 at the time of the questionnaires.
* Serious psychiatric pathology unrelated to epilepsy surgery.
* Severe intellectual disability limiting responses to self-questionnaires.
* Language barrier.
* Patients under guardianship and protection of justice.
Predictive Value of Doppler RSI for Prediction of AKI in Septic Patients in ICU

Acute kidney injury (AKI) Diagnosis is based on rising creatinine. Intrarenal vasoconstriction occurs earlier and measuring flow resistance in the renal circulation (Renal Resistive Index (RRI)) could become part of vital organ function assessment using Doppler ultrasound.

The aim of this study is to predict AKI in septic patients in ICU by measuring RRI on admission by comparing two groups of patients, first group with RRI of normal value (0.6-0.7) and the other group with high RRI more than 0.7 and both with normal renal function on admission.

Patients who have criteria of sepsis, with normal renal function on admission will undergo Renal Doppler Ultrasound examination to measure Renal resistive index.

Patients will be divided into 2 groups:

1. Group (A) patients with renal resistive index between 0.6 and 0.7 (normal RRI).
2. Group (B) patients with renal resistive index more than 0.7 (high RRI).

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have criteria of sepsis on admission which include two or more of SIRS which include: (Temperature \>38°C or \<36°C, Heart rate \>90/min, Respiratory rate \>20/min or PaCO2 \<32mmHg (4.3kPa) and White blood cell count \>12000/mm3 or \<4000/mm3 or \>10% immature bands.) in addition to suspected or confirmed infection.
2. Patients who have normal renal function on admission.

Exclusion Criteria:

1. Currently recovering from an AKI at the time of inclusion and Renal impairment on admission.
2. Patients with obstructive renal failure, renal artery stenosis were excluded from this study.
3. Patients on chemotherapy and/or radiotherapy.
4. Pregnancy.
Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness

Informal caregivers provide a majority of care for patients during serious illness. Lack of preparation and completion may leave caregivers less capable of caring for a loved one or making crucial decisions influencing care.

This study will examine whether a preparation and completion intervention reduces caregiver anxiety, depression, anticipatory grief, and burden and improves patient quality of life and health care use.

The investigators propose a randomized control trial to evaluate an intervention of preparation and completion with Veterans and their caregivers during serious illness. Specific aims are to 1) Evaluate the impact of the caregiver Outlook intervention on caregiver anxiety, depression, anticipatory grief, completion, and burden; 2) Evaluate the impact of the home versus in hospital, emergency department, or nursing facility; 3) Evaluate the impact of the intervention session's qualitative content, examining variation associated with selected demographic variables, quality of family communication, and stage of illness on change.

Caregivers in the first group ("Treatment", or "Preparation and life completion") will meet with a facilitator three times for a period of forty-five minutes each. In the first session, subjects will be asked to discuss issues related to relationship life review.

In session two, participants will be asked to speak in more depth about issues such as regret and forgiveness. In the final session, subjects will focus on legacy and celebration. Caregivers in the second group ("attention control" or "relaxation meditation") will meet with a facilitator three times for a period of forty-five minutes each and be asked to listen to a non-guided relaxation compact disk (CD) or participate in a guided relaxation exercise.

Participants in both groups will receive pre and post-test measures administered by a blinded interviewer. Outcome measures will be measures by the Functional Assessment of Cancer Therapy - General (FACT-G), Quality of life scale, FACIT-sp sub-scale, Anticipatory Grief Scale, Caregiver Reaction Assessment, the Qual-E completion and preparation sub-scales, and patient days at home.

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced cancer/Congestive heart failure/COPD/End stage renal disease who have a primary caregiver. Caregivers of Durham VAMC patients with advanced disease.

Exclusion Criteria:

* No caregiver present.
* Caregiver with Cognitive impairment/inability to speak on phone/non-English speaking
ICU Biobank: Understanding Post-Intensive Care Syndrome (PICS)

The goal of this observational study is to explore the development and progression of Post-Intensive Care Syndrome (PICS) in adult ICU patients by establishing a biobank of biological samples and outcome data. This biobank-based research is designed to investigate the physical, cognitive, and psychological health outcomes of ICU survivors and their relationship with potential biomarkers. The study population includes adult ICU patients aged 18-65, who have stayed in the ICU for at least 48 hours.

The main questions it aims to answer are:

What is the incidence of PICS and its main components? What risk factors are associated with the development of PICS six months post-ICU discharge? What are the long-term effects of ICU admission on quality of life, cognitive health, and physical function?

Participants will:

Provide blood samples during ICU admission and at follow-up visits at 4-5 weeks, 6 months, and 10-12 months after discharge.

Complete assessments measuring quality of life, cognitive health, anxiety, depression, PTSD symptoms, physical function, and pulmonary function.

Participate in three follow-up visits at the ICU Recovery Clinic after discharge to monitor PICS symptoms and recovery progress.

This study does not involve an intervention but will gather data that could improve our understanding of PICS and inform strategies for post-ICU care. The data collected will be crucial for identifying PICS biomarkers and will contribute to developing targeted, personalized interventions for ICU survivors in the future.


Eligibility Criteria:
Inclusion Criteria:

* ICU stay of at least 48 hours
* Age between 18 and 65 years at the time of ICU admission
* Written informed consent

Exclusion Criteria:

* Transfer from another ICU outside of the Medical University of Vienna
* Patient with a legal guardian
* Homelessness
* Place of residence outside of Austria
Evaluation of the Safety and Performance of the Very High Power-Short Duration QDOT

The aim of the present study is to compare the safety and short-term performance between THERMOCOOL SMARTTOUCH SF-5D QDOT system used with fast ablation mode and the standard Thermocool Smartouch SF in treatment of patients with atrial fibrillation (AF).

The very high power-short duration (vHPSD) catheter, is a novel CF catheter optimized for temperature-controlled ablation with microelectrodes and 6 thermocouples for real-time temperature monitoring during ablation. The associated vHPSD algorithm modulates power to maintain target temperature during these vHPSD lesions (90 W, 4 s). In preclinical models, vHPSD ablation with this novel catheter has improved atrial linear lesion contiguity, transmurality, and durability and has substantially reduced radiofrequency ablation times, but with a safety profile similar to those of standard irrigated radiofrequency ablation catheters.

The QDOT -FAST study demonstrated the clinical feasibility and safety of vHPSD ablation. Procedure and fluoroscopy times were substantially lower than historical standard ablation with point-by-point catheters.

The aim of the present study is to compare the safety and short-term performance between THERMOCOOL SMARTTOUCH SF-5D QDOT system used with fast ablation mode and the standard Thermocool Smartouch SF in treatment of patients with atrial fibrillation (AF).

Eligibility Criteria:
Inclusion Criteria:

* Male and female \>18 years old.
* Subjects must provide written informed consent to participate in the study.
* Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.

Exclusion Criteria:

* Pregnant women.
* Patients with iodine contrast media allergy
* Patients with renal failure (GFR \<60ml/min)
Non-Invasive Neuromodulation in Children With Neurodevelopmental Disorders

Children with neurodevelopmental disorders have a delay in acquiring the skills that are assumed considering the phases of typical psychomotor development. Added to this difficulty and main element of concern on the part of their families, there are another series of signs that appear with some frequency and that, despite being unnoticed against other major problems represent basic and fundamental factors in the correct development and performance such as constipation problems and sleep disorders.

The aim of the study consists of to evaluate the effectiveness and safety of the non-invasive neuromodulation device applied in people with neurodevelopmental disorders, in relation to constipation problems and in the quality of sleep.

While the application is being sent to the ethics committee, we will hold a series of informative talks for the centre's staff who, in one way or another, will be involved in the development of the project.

At the same time, information letters will be sent to the parents or legal representatives of the children who will a priori be part of the project, as well as the corresponding informed consent. In addition, they will be sent the screening documents that will allow us to confirm if the selected subject has constipation problems and/or sleep disorders.

The intervention period per subject will be 12 sessions, distributed in three sessions per week (Monday, Wednesday, and Friday), estimating that the intervention can be completed after one month.

During school hours, the participants will receive their own treatment, agreed by their multidisciplinary team with common and personal objectives for the subjects, so that there will be no interruption of their usual routine.

Two weeks after the intervention, a new assessment will be carried out to assess whether the possible changes recorded during the intervention phase have been maintained.

Eligibility Criteria:
Inclusion Criteria:

* Sensory-motor alteration.
* Be schooled in the Center of the City San Juan de Dios of Las Palmas de Gran Canaria.
* Meet the criteria established by the Rome IV constipation scale.
* Informed consent signed by the family, guardian or legal representative.

Exclusion Criteria:

* No contraindications to treatment with NXSignal: Pacemaker, internal bleeding, do not apply electrodes on skin in poor condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and/or phobia to electricity.
* Epilepsia.
* Subjects who modify eating habits and/or water intake.
Paediatric Subjects - Special Survey

This study is conducted in Japan. The aim of this study is to collect safety and efficacy data when using insulin aspart in children with diabetes under normal clinical practice conditions.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with diabetes requiring insulin therapy

Exclusion Criteria:

* Subjects who had treatment history of insulin aspart
Screening for Coronary Artery Disease After Mediastinal Irradiation

Survivors of Hodgkin Lymphoma (HL) are known to have an increased risk of developing late treatment sequelae such as cardiovascular events due to coronary artery disease. At present no active screening is performed in these patients since it is not known whether screening and subsequent treatment by means of revascularization is effective in reducing the risk of cardiovascular events in symptomatic individuals. In the trial the efficacy and therapeutic consequences of screening for coronary artery diasease by multi-slice CT (MSCT) among asymptomatic HL survivors will be evaluated.

Objectives:

1. to determine whether MSCT as a screening method of HL survivors treated with mediastinal irradiation accurately identifies asymptomatic significant coronary artery disease.
2. to establish the prevelance of coronary abnormalities in HL survivors treated with mediastinal irradiation
3. to determine the frequency and type of intervention
4. to evaluate the acceptance of screening and asses quality of life among Hl survivors.

Study polulation:

50 long term survivors of HL, previously treatef with mediastinal irradiation without present evidence of cardiovascular disease

Intervention:

CT-coronary angiography and calcium score, to be performed as a screening method (to indicate further diagnostic treatent procedures)

Eligibility Criteria:
Inclusion Criteria:

* history of Hodgkin Lymphoma(all stages) with at least 10 disease free survival
* current age between 35-60
* mediastinal irradiation as part of HL treatment, radiotherapy data available
* written informed consent

Exclusion Criteria:

* current treatment for cardiovascualr disease, excelt hypertension hypercholesterolemia or cardiac murmurs
* known or sypmtomatic heart failure
* impaired kidney function (Cockcroft \< 55 ml/min)
* known contrast allergy
* invasive angiography in past 2 years
* presence of life threatening disorder
The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer

A Multi-Center, Open-label Phase Ib-II Trial of the Combination of GX-188E Vaccination and Pembrolizumab in Patients with Advanced, Non-Resectable HPV-Positive Cervical Cancer

This is an open-label Phase Ib-II trial to evaluate the safety and efficacy of GX-188E (IM administration using Ichor TDS-IM device) + pembrolizumab (P) in patients with advanced HPV-16+ or HPV-18+ cervical cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be female and age ≥ 18 years (19 years for Korean sites)
2. Patients with histologically confirmed advanced or metastatic HPV-positive (HPV-16 or HPV-18) cervical cancer, who have disease progression after treatment with all available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
4. Life Expectancy of at least 6 months
5. Patients must agree to provide either an archival tumor tissue sample or fresh biopsy sample for baseline biomarker tissue analyses, including staining for PD-L1. If archival tissue is not available and the patient does not have biopsy-accessible tumor lesions, the patient will be excluded.

Exclusion Criteria:

1. Patient has disease that is suitable for local therapy administered with curative intent.
2. Patient has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
3. Patient is expected to require any other form of antineoplastic therapy while on study; including systemic chemotherapy, radiation therapy (except for palliative purposes) biological therapy, or immunotherapy not specified in this protocol.
4. Patient has a history of active central nervous system (CNS) metastases and/or carcinomatous meningitis.
5. Patients have received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher immune-related Adverse Event (irAE)
6. Patients with active autoimmune disease requiring systemic immunosuppressive treatment within the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
7. Patients has had an allogeneic solid organ or allogeneic bone marrow transplant
Axis(TM) Solvent-dehydrate Dermal Allograft in the Treatment of Pelvic Organ Prolapse.

The goal of this study is to assess improvement in subjects who have undergone Axis Dermis, biologic mesh for pelvic organ prolapse repair. \[describe participant population/health conditions\]. The main question\[s\] it aims to answer are:

* Is the leading edge of the prolapse above the hymen
* Does subject notice a bulge Participants will undergo Axis Dermis pelvic organ prolapse repair procedure.

This is a prospective single-arm study of 50 subjects undergoing pelvic organ prolapse repair using the Axis™ Dermis biologic mesh. They will be followed for a period of 3 years. A subgroup analysis is for patients with uterine prolapse and vaginal mesh hysteropexy.

Clinical examination including vaginal wall retraction with or without pelvic ultrasound, POP-Q, and also specific validated questionnaires at baseline, 1 month, 6 month, 12 month, 24 month and 36 month visits will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with preoperative stage II or greater prolapse on the Pelvic Organ Prolapse Quantification System Assessment (POP-Q)
* Subjects who have bothersome vaginal bulge based upon symptoms.
* Subjects who undergo any type of Axis Dermis surgery (anterior, posterior, total, with or without a uterus).

Exclusion Criteria:

* Subjects who are unable to follow-up.
* Subjects who cannot complete the validated questionnaires.
* Subjects that lack competency of the English language.
* Subjects who decline to be part of the clinical trial.
* Subjects who do not sign an informed consent.