cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Sodium Oligomannate in the Prevention of PSCI

Post-stroke cognitive impairment (PSCI) is a common complication of stroke, and seriously affect the quality of survival and the survival time in patients with stroke, PSCI is still lack of effective prevention and treatment measures, the study found that gut microbiota are closely associated with stroke and cognitive diseases, sodium oligomannate can improve cognitive function of mild-to-moderate alzheimer's disease (AD) , The Expert Consensus 2021 on the Management of Post-stroke cognitive impairment states that the role of sodium oligomannate in PSCI needs to be investigated in large sample clinical trials. This study intends to explore the efficacy and safety of sodium oligomannate in the prevention of PSCI in patients with acute ischemic stroke and cognitive impairment, so as to provide a potential intervention for the prevention of PSCI.

This clinical study was a randomized (1:1), double-blind, single-center, parallel controlled clinical study. The study period was 6 months to evaluate the efficacy and safety of sodium oligomannate in the prevention of PSCI in patients with ischemic stroke. Patients with acute ischemic stroke were recruited. After signing informed consent, patients who met the inclusion/exclusion criteria were randomly assigned in a 1:1 ratio to receive treatment in the trial group (receiving sodium oligomannate) or the control group (receiving placebo capsule). A total of 116 patients were enrolled.And safety assessment and survival follow-up were performed at 4 weeks, 12 weeks and 24 weeks, and efficacy assessment was performed at 12 weeks and 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 1.The first occurrence of ischemic stroke, which met the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018, was confirmed by CT or MR; 2. The onset of illness was less than 7 days after admission, aged 18-80 years; 3. Clear consciousness, able to cooperate with cognitive and other tests, NIHSS score ≤15; 4. Before onset, the patient's cognitive level was normal, daily life and social activities were normal; 5. Stay in the current place of residence for more than 3 years; 6. With cognitive assessment, MoCA \< 22 (years of education \< 12, +1) after correction, and signed the informed consent.

Exclusion Criteria:

* 1.Unable to cooperate with neuropsychological examination due to various reasons (such as consciousness disorders, vision disorders, hearing disorders, etc.); 2. Combined with other diseases (such as intracranial mass, demyelinating disease, intracranial infection, neurodegenerative disease, epilepsy, severe heart, liver, kidney, blood system or other system diseases, etc.); 3. Used antibiotics 3 months before onset; 4. A history of alcohol abuse, drug use, or serious mental illness (including major depression (HAMD \> 10)) before onset of illness, 5. No stool was collected within 7 days of onset.
Evaluation of Proton Therapy in Pediatric Cancer Patients

This is a Phase IV clinical trial observing and evaluating the safety of proton therapy in children. Protocol therapy is not being done as part of this clinical trial. The radiation targeting, planning, prescribed dose, fractionation, schedule, and use of other forms of therapy will be done per other therapeutic protocols at St. Jude Children's Research Hospital (SJCRH) at the discretion of the treating physicians associated with those trials.

For the clinical trial being described in this registration, participants will be observed to collect data for baseline assessment of disease and patient characteristics. This will be done before proton therapy on other trials followed by serial standard-of-care clinical assessments to evaluate acute and late complications, disease control, treatment-related mortality, and overall survival.

PRIMARY OBJECTIVE:

* To estimate the incidence of radiation associated grade 3 and grade 4 non-hematologic toxicities at 1, 3, 5, and 10 years in a radiated region specific manner after the initiation of proton therapy.

SECONDARY OBJECTIVES:

* To estimate the incidence of necrosis, vasculopathy, and symptomatic and permanent neurologic deficits at 1, 3, 5, and 10 years after the initiation of proton therapy in children treated for central nervous system (CNS) tumors in an irradiated region directed manner.
* To estimate the incidence of treatment-related mortality at 5 and 10 years after the initiation of proton therapy.
* To estimate the incidence of subsequent malignancies at 5 and 10 years after the initiation of proton therapy in an irradiated region directed manner.
* To estimate the incidence of fracture and osteonecrosis at 1, 3, 5, and 10 years after the initiation of proton therapy in children treated for musculoskeletal tumors in an irradiated region directed manner.

Eligibility Criteria:
Inclusion Criteria:

* The patient is planned for treatment or has been treated with proton therapy at St. Jude Children's Research Hospital on or after November 18, 2015.

Exclusion Criteria:

* Patients who are currently pregnant will not be enrolled in the study as radiation has teratogenic or abortifacient effects. In the rare case that a patient was previously pregnant as a young adult, the patient will be considered eligible for enrollment.
Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis

The study will investigate the efficacy and safety compared to placebo and the safety compared to ustekinumab of brodalumab in adolescents with moderate to severe plaque psoriasis. The study will also investigate if brodalumab affects development of vaccination-induced immune responses.

The study will run over 62-64 weeks (including screening, treatment, and safety follow-up) for each participant, but with the primary endpoint measured at Week 12.


Eligibility Criteria:
Key Inclusion Criteria:

* Subject was diagnosed with chronic plaque psoriasis at least 6 months before randomisation.
* Subject has a diagnosis of moderate-to-severe plaque psoriasis as defined by PASI ≥12, sPGA ≥3, and body surface area ≥10% at screening and at baseline.
* Subject, in whom topical therapy is not adequate, and who is a candidate for systemic therapy.
* Subject has no evidence of active or latent tuberculosis according to local standard of care.

Key Exclusion Criteria:

* Subject is diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions (e.g., eczema).
* Subject has been vaccinated with a tetanus toxoid-containing vaccine ≤18 months prior to first dose of investigational medicinal product (IMP). For EU and UK: Subject has been vaccinated with a TT-containing vaccine within 5 years prior to the first dose of IMP.
* Subject has developed or experienced either Guillian-Barre syndrome, encephalopathy, Arthus-type hypersensitivity, or severe allergic reactions in connection with previous Tdap or Td vaccine.
* Subject with chronic or recurrent infections, or active infection, systemically treated within 4 weeks prior to first dose of IMP.
* Subject has a known history of Crohn's disease.
* Subject has any active malignancy or a history of any malignancy within 5 years.
* Subject has a history of suicidal behaviour and has suicidal ideation with some intent to act or specific plan and intent.
* Subject has a history of depressive disorder with severe episode(s) within the last 2 years.
* Subject has received anti-IL-12/23p40 for less than 12 months prior to the first dose of IMP or has previously no response to anti-IL-12/23p40 therapy.
* Subject has previously received anti-IL-17 therapy.
The Effect of Cooling With a Bed Topper and Linen on Itch in Clinical Routine

This single-blinded (only patients blinded) study is to assess the effect of cooling beddings on itch.

The primary objective is to test whether or not the use of the cooling beddings during 3 days can add at least 20% improvement in (nocturnal) itch as measured by the 0-10 NRS in comparison to a control group that does not use the cooling beddings.

Itch is the most common skin-related symptom. Staying/sleeping in a bed with a cooling properties could have a positive effect on (nocturnal) itch intensity, sleep quality and daytime performance in consequence. A mattress topper and bed linen with cooling effects that are commercially available (https://www.oba.ch/cool_gel_topper) by the OBA AG (Basel), which is the supplier of beds and bedding items of the University Hospital Basel, has been used in clinical routine. This single-blinded (only patients blinded) study is to assess the effect of cooling beddings on itch and to better rationalize the beddings 'use. No comparative data is available and the design is purely exploratory. The primary objective of this study is to test whether or not the use of the cooling beddings during 3 days can add at least 20% improvement in (nocturnal) itch as measured by the 0-10 NRS in comparison to a control group that does not use the cooling beddings.

Eligibility Criteria:
Inclusion Criteria:

* Mean itch intensity NRS \> 5 in the past 3 days
* Literacy and ability to read
* Inpatient stay required for \> 3 nights

Exclusion Criteria:

* Age \< 18 years
* Illiteracy
* Cognitive impairment (exclusion in case of mild cognitive impairment according to the Montreal-Cognitive Assessment (MOCA))
* The duration of the hospitalisation is foreseen to be shorter than 3 days
* Para- and Tetraplegia
* Hemisensory syndrome
* Core body temperature \>38°C
* Use of other bedding \> 8 hours or 2nd time request
* Use of an occlusive therapy
FDG Tumor Heterogeneity During Chemoradiation as a Predictor of Response in Patients With Cervical Cancer

In this study, 50 evaluable patients will undergo one FDG-PET study during their chemoradiation, in addition to the standard of care pretreatment and 3-month post-treatment clinical FDG-PET/CT or FDG-PET/MR scans. From all FDG-PET studies, tumor volume, SUVmax, FDGhetero, and texture maps will be obtained. Evaluating the changes in tumor SUVmax and heterogeneity during treatment will aid in better understanding the role of these biological parameters in inadequate response to chemoradiation. Other researchers, using MRI imaging, have evaluated changes in the cervical tumor volume during treatment. The investigators expect there will be variation in how cervical tumors shrink and change during chemoradiation and therefore we are going to use multiple measures in addition to tumor volume to evaluate cervical tumor metabolic heterogeneity. Being able to predict at diagnosis the patients who are at higher risk for persistent disease following chemoradiation would allow for future studies where these high risk patients could be specifically targeted with more aggressive therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patient must have biopsy-proven cervical cancer (FIGO stage-Ib2-IVb).
* Patient must be at least18 years of age.
* Patient must be planning to receive chemoradiation therapy with cisplatin.
* Patient must have non-pregnant status if a female of childbearing potential. Women who have had a tubal ligation at least 12 months prior to study entry or a hysterectomy will be considered NOT of childbearing potential. Postmenopausal women must have been amenorrheic for at least 12 consecutive months to be considered NOT of childbearing potential.
* Patient may have distant metastatic disease provided the estimated survival is at least 1 year.
* Patient's tumor(s) must be FDG avid on baseline standard of care FDG-PET/CT or PET/MR imaging that was performed at Barnes-Jewish Hospital Clinical PET Facility.
* Patient must be able and willing to give informed consent.
* If the patient will be scanned on the PET/MR for the mid-treatment scan, they must be determined to be safe for exposure to the magnetic field. This will be determined the day of imaging by the technologist with the use of a screening form. If a patient is not safe for the PET/MR scanner, their mid-treatment images will occur on the PET/CT scanner in the Center for Clinical Imaging Research.

Exclusion Criteria:

* Patient must have no other active cancer at the time of diagnosis of cervical cancer.
* Patient cannot have received treatment for any malignancy, with the exception of non-melanoma skin cancer, in the past 5 years.
* Patient must not be an uncontrolled diabetic with a glucose of ≥ 200mg/dl at the time of PET imaging.
Retro-prospective Observational Study on Risk of Progression in CP-CML Patients Eligible for TKI Discontinuation

The purpose of this study is to investigate the safety profile of TKI discontinuation in clinical practice, with particular regard on the risk of progression after treatment discontinuation.

This study will enroll approximately 3000 CP-CML patients that must have a history of at least 4 years of TKI treatment and at least 18 months of DMR. Events developing in patients after the end of discontinuation and TKI resumption will be considered as linked to the discontinuation if they will develop within 36 months from the end of discontinuation. This rule will apply also to subsequent TD attempts. In case of a second or subsequent discontinuation attempt after the failure of a previous one (for molecular relapse), patients must have re-achieved a DMR with TKI therapy resumption and must keep DMR for at least 18 months before another TD.

Collection of data will be retrospective and prospective, as each center will collect the data for 24 months. Patients who discontinued before the opening of this study will contribute to the retrospective cohort, while those who will discontinue after it will contribute to the prospective cohort. Patients who discontinued before the opening of this study but will continue their discontinuation after it, will contribute to both cohorts. For patients prospectively recruited, monitoring of disease status will be performed to assess the maintenance of the molecular remission during the study period.

Patients with an atypical BCR-ABL1 fusion gene, which does not allow the use of Q-RT-PCR, will be monitored by qualitative PCR and will be analyzed separately. For these patients, negativity of nested qualitative RT-PCR will be considered a surrogate of DMR of patients monitored by Q-RT-PCR, while loss of negativity of first-round qualitative PCR will be considered a surrogate of loss of MMR (i.e. molecular relapse). Accordingly, for patients monitored by qualitative PCR, TKI resumption after TD will be provided in case of a new positivity of first-round PCR.

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Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated IRB/IEC-approved informed consent for the prospective cohort patients.
2. Age \>= 18 years.
3. Male or female patients with CML diagnosed in chronic phase (CP).
4. At least 4 years of TKI treatment.
5. At least 18 months of DMR.

Exclusion Criteria:

* Allogeneic hematopoietic stem cell transplantation.
* CML diagnosed in AP or BC
Development & Testing of a Decision Aid for LVAD Placement

The goal of this project is to develop a patient-centered decision aid for decision-making about end-stage heart failure treatment. This study seeks to create a decision aid that presents outcomes, risks, projected experiences, and uncertainties about Left Ventricular Assist Device (LVAD) placement to help patients make values-based decisions about placement. The investigators propose a mixed methods design involving a literature search of clinical evidence, semi-structured patient interviews, and quantitative data from a multi-site trial of patients receiving the decision aid compared to patients not receiving the aid.


Eligibility Criteria:
Inclusion Criteria:

* LVAD Candidates (NYHA Class III and IV patients with an acceptable surgical risk/benefit ratio for LVAD implantation and with good psychosocial support, coping mechanisms, and financial resources, as determined by "clearance" from the transplant social worker)
* LVAD Patients
* LVAD Decliners
* LVAD Caregivers

Exclusion Criteria:

* subjects who lack the capacity to give informed consent
Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer

Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have metastatic kidney cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

OBJECTIVES:

I. Determine the objective response rate to bryostatin 1 in patients with advanced renal cell carcinoma.

II. Assess the toxicities of this treatment regimen in this patient population. III. Determine the time to disease progression in patients receiving this treatment regimen.

IV. Determine the overall survival of this patient population treated with this regimen.

OUTLINE:

Patients receive bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progresssion.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic renal cell carcinoma
* Bidimensionally measurable disease
* Clear evidence of progression if only site of measurable disease is within previous radiation port
* Previously irradiated brain metastases allowed, if not life threatening, symptoms controlled for 3 months, and not requiring corticosteroids

PATIENT CHARACTERISTICS:

* Age: 18 and over
* Performance status: ECOG 0-1
* Life expectancy: Greater than 3 months
* WBC at least 3,000/mm3
* Platelet count at least 100,00/mm3
* Bilirubin no greater than 1.5 mg/dL
* Creatinine no greater than 2.0 mg/dL OR creatinine clearance greater than 50 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for 1 month before, during, and for 3 months after study
* No active bacterial or viral infection
* No serious underlying medical condition that would interfere with compliance
* No other malignancy within the past 5 years except basal cell carcinoma of the skin
* No dementia or altered mental status that would prevent informed consent

PRIOR CONCURRENT THERAPY:

* No more than 1 prior therapy with biologic response modifiers
* No prior chemotherapy for advanced disease
* No other concurrent chemotherapy
* No concurrent steriods (except topical use)
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy
* At least 4 weeks since major surgery (including nephrectomy)
* No other concurrent experimental agents
Liver Cancer Prognosis Investigation Study

This prospective cohort study is designed to explore the role of environmental, clinical, and genetic risk factors in the progression and prognosis of primary liver cancer (PLC). We will recruit 5000 patients with newly diagnosed, previously untreated PLC. The eligible patients will be asked to complete a baseline survey at the time of initial admission and be followed up every 3 to 6 months after discharge.

Primary liver cancer (PLC) is highly malignant and is particularly prevalent in China. Multiple factors are involved in the development and progression of PLC. Several large-scale, prospective cohort studies have been established to identify environmental and genetic risk factors for the development of PLC in the general population. However, few cohort studies have focused on determining risk factors beyond clinical prognostic factors for the progression of PLC in patients with PLC. Therefore, we will conduct a prospective cohort study to examine the role of environmental, clinical, and genetic risk factors in the progression and prognosis of PLC. We plan to recruit 5000 patients with newly diagnosed, previously untreated PLC. A baseline survey will be conducted at the time of initial admission, with follow-up at 3 and 6 months after discharge for all patients and thereafter every 3 months for patients treated with interventional therapy and every 6 months for patients receiving surgery and other therapies. We will collect information on patients' demographics characteristics, clinical diagnosis and treatment, lifestyle, nutritional status, psychological and mental status, quality of life, anthropometric data, body composition, routine laboratory tests and examinations, and disease progression through structured questionnaires, physical examinations, and medical record reviews. Deaths will be ascertained through medical records, death certificates, and next-of-kin. Additionally, we will collect blood, urine, stool, and liver tissue samples.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years,
* Diagnosed with primary liver cancer (ICD-10: C22) (Referring to the diagnostic criteria in the "Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition)" and the "2024 CSCO Guidelines for the Diagnosis and Treatment of Biliary Malignancies),
* Have not received any anti-tumor treatment (e.g., surgery, ablation, interventional therapy, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc),
* Signed informed consent.

Exclusion Criteria:

* Have a history of other malignant tumors,
* Have a history of other serious chronic diseases (e.g., heart failure, liver failure, kidney failure, etc.),
* Expected survival time is no more than 3 months,
* Severe physical or mental disability.
Improvement of Nutrition, Digestion, and Respiration in Children in Vietnam Using Oral Nutritional Supplementation

Evaluating the effect of using Oral Nutritional Supplementation toward nutrition status, digestive disorders, upper respiratory disorders, and picky eating in children aged 24 - 59 months.

Evaluating the effect of using Oral Nutritional Supplementation toward improving the nutritional status (anthropometric index, the prevalence of malnutrition) in children aged 24 - 59 months after four months of using the nutritional product.

Evaluating the effect of using Oral Nutritional Supplementation for digestive disorders (diarrhea and constipation), upper respiratory infection and picky eating in children aged 24 - 59 months.

The research involves a randomized controlled clinical trial (RCT), expected from 2023 to 2024 with 1000 children aged 24-59 months. The study will be conducted at schools and homes: 1000 children divided into 2 groups. One group will use the product for 4 months ( with the amount of use: twice per day, 180ml each time). The product will be distributed to the students through the schools. Monitoring will be performed carefully by the commune and district Health Department and the Centers for Disease Control and Prevention weekly. The study aims to evaluate the effect of nutritional products toward nutritional status ( anthropometric index, the prevalence of micronutrients), digestive disorders, and picky eating in children aged 24-59 months.

The nutritional product produces a high amount of energy that provides ≥ 380 kcal/360 ml; 2 bottles equal to 180ml x 2 times/day will provide 28-37,3% energy requirement for children aged 2-4 years old. The product includes fat composition which provides 38-44% energy requirement including 1899 mg medium chain triglyceride (MCT), α Linolenic Acid, Linoleic Acid and 26 types of micronutrients and minerals including some essential micronutrients such as Calcium 110- 130% recommended nutrition needs (RNNs), Iron 58-59,3% RNNs, Vitamin A 91-110% RNNs, Zinc 25-28,9% RNNs, Vitamin D3 54% RNNs, Selen 66-77,6% RNNs, Vitamin K1 27-31,7% RNNs, Folic Acid 72-108% RNNs. Including other compositions such as 2'FL HMO (74 mg), Choline (79mg), Taurine (31,2mg)

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 24 and 59 months old live in 6 selected communes in Yen Bai province.
* The family volunteered for the child to participate in the study
* Z-score height for age \<-1 and Z-score weight for height \<1
* Participated in the screening and met the selection criteria

Exclusion Criteria:

* Lactose intolerance
* Intellectual disability or suffering from acute and chronic infectious diseases.
* Z-score height for age, Z-score weight for height and Z-score weight for age \<-4
* Planing to move out of the selected trials areas in next 6 months