cyrilzakka/clinical-trials huggingface dataset:
A Study of HS-10516 in Patients With Advanced Clear Cell Renal Cell Carcinoma

The aim of the Phase Ia portion is to identify the maximum tolerated dose or maximum acceptable dose MTD/MAD of HS-10516. The phase Ib portion will evaluate the preliminary efficacy of HS-10516 in ccRCC.

This is a Phase Ia/Ib open label multicenter study of HS-10516 in Chinese patients aged 18 years or older with advanced clear cell renal cell carcinoma who have failed or are unavailable/intolerant to standard of care. HS-10516 as a single agent, is administrated orally once daily. The aim of phase Ia, a dose escalation study, is to identify the MTD/MAD of HS-10516. The goal of Phase Ib, a dose expansion study, is to evaluate the safety, pharmacokinetics and antitumor efficacy of HS-10516.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female from 18 to 75 year-old
2. Histologically confirmed locally advanced or metastasis clear cell renal cell carcinoma whose standard treatment failed or proven unavailable or intolerant
3. Has at least one non-CNS target lesion per RESIST v1.1
4. Has an Eastern Cooperative Oncology Group performance status of 0-1
5. Has a life expectancy of ≥ 12 weeks
6. Should use adequate contraceptive measures throughout the study
7. Females subject must not be pregnant at screening
8. Has the ability to understand and willingness to sign a written informed consent before the performance of the study

Exclusion Criteria:

1. Received or being received treatment as follows:

   1. Hypoxia-induced factor inhibitors
   2. Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study treatment.
   3. Cytotoxic chemotherapeutic drugs, investigational drugs or other systematic anti-tumor therapies within 3 weeks before the first dose of study treatment
   4. Colony-stimulating factors (CSFs) within 4 weeks before the first dose of study treatment
   5. Local radiotherapy within 2 weeks prior to the first dose of study treatment; more than 30% of bone marrow radiotherapy or large-area irradiation within 4 weeks before the first dose of study treatment.
   6. Major surgery within 4 weeks prior to the first dose of study treatment.
2. Has a pulse oximetry reading less than 92% at screening, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
3. Has failed to recover from a ≥ grade 2 adverse event due to prior anti-tumor therapy
4. Has another malignancy or a history of another malignancy
5. Has inadequate bone marrow reserve or organ dysfunction
6. Has a clinically significant bleeding events or tendency within 1 month prior to the first dose of study treatment
7. Has severe infections within 4 weeks prior to the first dose of study treatment
8. Has digestive system diseases may influencing ADME of study drug
9. Has a history of severe hypersensitivity reaction, or proven allergic to HS-10516 or its metabolics
10. Has any disease or condition would compromise subject safety or interfere with study assessments by investigator's decision
Walk Together: A Family-Based Intervention for Hypertension In African Americans

The goal of this study is to determine the feasibility and acceptability of a novel family-based hypertension self-management intervention, Walk Together, adapted from an existing empirically-supported dyadic intervention, for implementation in primary care.

Hypertension is the driving risk factor for disparities in mortality and life expectancy between African Americans and Whites. Hypertension self-management (including blood pressure monitoring, diet, exercise, and other lifestyle changes) is critical for improving hypertension control, and prior interventions have emphasized promoting patient-level behavior change to improve self-management adherence. Though family members make substantial contributions to hypertension self-management for African Americans, family support is consistently underutilized by current hypertension self-management interventions. Family-based interventions for improving self-management are effective for other chronic conditions, including for African Americans. Evidence has demonstrated the unique and important role of family support in African Americans' hypertension management, and African Americans' preferences for the direct involvement of family in hypertension interventions. The study team will develop a family-based hypertension self-management intervention ("Walk Together") for African Americans with uncontrolled hypertension that integrates community-based participatory perspectives in the specifics of the intervention. The study team will pilot trial the culturally-adapted intervention in a primary care setting in order to examine the feasibility and acceptability of the Walk Together protocol.

Eligibility Criteria:
Inclusion Criteria:

* Black or African American
* Age 18 to 75
* Two blood pressure values ≥ 130/ ≥ 80 in 12 months prior
* Available family support person to join the intervention who agrees to participate
* English-speaking

Exclusion Criteria:

* Family support person is under the age of 18
* Documented cognitive impairment in patient's medical record
* Presence of severe psychiatric condition (i.e., current psychotic disorder or suicidality)
* Participation in prior hypertension health education intervention
* Prior participation in formative study activities (i.e., study focus groups)
Development of a Prediction Platform for Adjuvant Treatment and Prognosis in Resected Pancreatic Cancer Using Organoid

The investigators create organoid from the pancreatic cancer tissue obtained via EUS-FNA and EUS-FNB within the pancreatic cancer diagnostic process. And also the investigators create organoid from the pancreatic cancer tissue obtained after surgery as part of the pancreatic cancer treatment process. Check for the reactivity to anti-cancer drugs through cell viability assay after treating with various anti-cancer drugs, such as anti-cancer drugs used as adjuvant chemotherapy for pancreatic cancer to the organoid. Also, perform genomic analysis on each organoid, and then check if there are any unique genomic mutations for each organoid. By recognizing the relationship between the unique genomic mutations and reactivity to the anti-cancer drug within pancreatic cancer patients eligible for surgery, the investigators aim to strategize appropriate adjuvant chemotherapy after surgery, thus developing a platform to predict the outcomes of each patient.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years old or older
2. Newly discovered pancreatic cancer and not a relapse
3. Diagnosed with pancreatic cancer via EUS-FNA, EUS-FNB before surgery
4. Patients who can undergo surgery for pancreatic cancer
5. Diagnosed with pancreatic cancer from the final tissue pathology diagnosis after surgery
6. who is in need of adjuvant chemotherapy after surgery
7. Able to make decisions for oneself for participation
8. Has obtained voluntary consent in written form (if 70 years of age or older, receive consent from the guardian as well)

Exclusion Criteria:

* None
Bicuspid Aortic Valve Stenosis and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI

Early development of calcified aortic valve disease (CAVD) is a commonly occurring complication in patients with a bicuspid aortic valve (BAV, an aortic valve consisting of two leaflets instead of three). In general, CAVD is characterized by progressive narrowing of the aortic valve, with involvement of altered calcium metabolism. CAVD progression in fact may lead to necessity of valve replacement, since to date, no other therapies have been shown effective in the treatment of CAVD.

The primary objective of our study is to test the hypothesis that supplementation of vitamin K2 will slow down the calcium metabolism in CAVD. Vitamin K2 is essential in the activation of matrix Gla Protein (MGP), an important inhibitory factor in the regulation of calcification.

In this randomized controlled trial, 44 patients will be allocated to either the vitamin K2 or placebo group. To assess the calcification process in a detailed manner in these patients, a Positron Emission Tomography (PET) scanner using a tracer (18F-fluoride \[NaF\]) that has been shown to bind to regions of newly developing microcalcification in aortic valve tissue is used.

We expect that vitamin K2 supplementation will reduce the calcium metabolism in the aortic valve on 18NaF-PET (primary endpoint) and slow progression of CAVD as measured by the calcium score on CT and echocardiography after 18 months (secondary endpoints), when compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* known bicuspid aortic valve
* calcified mild to moderate aortic valve stenosis on prior echocardiography
* informed consent provided

Exclusion Criteria:

* absence of calcified aortic valve stenosis on echocardiography
* presence of severe aortic valve stenosis
* history of aortic valve repair or replacement
* accepted atrial fibrillation
* use of oral anticoagulants
* claustrophobia
* presence of a pacemaker, ICD or ferromagnetic materials in the body
* life expectancy \<2 years
* Pregnancy (current or wish for near future)
* soy allergy
* use of vitamin K-containing supplements
Study Of SU011248 (Sunitinib) Given In A Continuous Daily Regimen In Patients With Advanced Renal Cell Cancer

To evaluate the anti-tumor activity of SU011248 (sunitinib) in cytokine-refractory metastatic renal cell carcinoma (RCC) when administered in a continuous treatment regimen


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven renal cell carcinoma with metastases.
* Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST).
* Failure of 1 prior cytokine-based therapy for metastatic disease. Patients treated with IFN-á alone must have received IFN-á for at least 4 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Resolution of all acute toxic effects of prior therapy or surgical procedures to grade 1.
* Adequate organ function

Exclusion Criteria:

* Prior treatment with any systemic therapy other than 1 cytokine-based therapy.
* Previous treatment on a SU011248 (sunitinib) clinical trial.
* Major surgery, radiation therapy, or systemic therapy within 4 weeks of starting the study treatment.
* Diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated with no evidence of recurrent disease for 12 months.
* History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan.
* Any of the following within the 12 months prior to starting the study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
* Ongoing cardiac dysrhythmias of grade 2, atrial fibrillation of any grade, or QTc interval \>450 msec for males or \>470 msec for females.
* Hypertension that cannot be controlled by medications (\>150/100 mmHg despite optimal medical therapy).
* Ongoing treatment with therapeutic doses of Coumadin (however, low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
* Known human immunodeficiency virus (HIV) infection.
Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19

This study is a pilot randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of melatonin in adult outpatients suspected to be afflicted with COVID-19.

This study is a pilot randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of melatonin in outpatient adult patients suspected to be afflicted with COVID-19. Participants will be enrolled as outpatients within 72 hrs of onset of COVID-19 symptoms. The study will evaluate the safety of the intervention through 28 days of follow-up as compared to the control arm as assessed by cumulative incidence of serious adverse events (SAEs), cumulative incidence of Grade 3 and 4 adverse events (AEs), and/or discontinuation or temporary suspension of the investigational medication (for any reason). Additionally, the study will aim to evaluate the clinical efficacy of melatonin as compared to placebo as assessed by hospitalization, COVID-19 related symptoms and mortality. The ultimate goal is to determine in an adequately powered study if the anti-inflammatory and antioxidant actions of Melatonin can reduce the severity and prevent progression of COVID-19 when started in mild disease.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female adult ≥18 years of age at time of enrollment.
* Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study.
* Subject provides written informed consent prior to initiation of any study procedures.
* Understands and agrees to comply with planned study procedures.
* Agrees to the collection and storage of saliva samples per protocol.

Exclusion Criteria:

* Severe chronic liver disease
* Severe chronic kidney disease or requiring dialysis
* Pregnancy or breast feeding.
* Allergy to the study medication
* Currently taking melatonin
* Currently taking high dose (\>500 mg/day) Vitamin C
Noninvasive Transcranial Direct Current Stimulation to Improve Executive Functions in Stroke Patients. MODUL-EXE Clinical Trial.

This study will examine the possible effects of tDCS (Transcranial Direct Current Stimulation) treatment to the left DLPFC on executive functions in patients with an acute stroke affecting the frontal lobe or the basal ganglia. The study will include 40 acute stroke subjects. Participants will undergo a global cognitive assessment with the MoCA test and a specific assessment of executive functions with the abbreviated Wisconsin test, the five digit test and the digit span evaluation (a subtest from the Wechsler intelligence scale for adults-IV). Participants will then undergo real or sham stimulation with anodal tDCS combined with cognitive training of the main executive functions: working memory, inhibitory control and cognitive flexibility. After a 10-session intervention, a the baseline cognitive assessment will be repeated and subsequently, a follow-up of up to 12 months will be carried out.


Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiological diagnosis, by means of cranial MRI or CT scan, of ischemic/hemorrhagic stroke, involving the frontal cortex or its subcortical connections (basal ganglia), in one or both hemispheres.
* The stroke occurred during the 3 months prior to inclusion in the study.
* Cognitive impairment with a dis-executive profile demonstrated by a score \> 26 in the Spanish version of the MoCA test, adjusted for the number of years of formal education.
* Patients with functional independence prior to the stroke, defined as a modified rankin scale score \< 3 points.
* The patient gives informed consent.

Exclusion Criteria:

* Presence of other pathologies that may be a potential cause of disability or cognitive impairment.
* Moderate or severe aphasia that hinders communication.
* Severe sensory and/or motor impairments that prevent the completion of the evaluation and/or intervention processes.
* Presence of extensive vascular leukopathia (leukoaraiosis grade 3, 4).
* History of epilepsy or seizures.
* Presence of severe systemic pathology, including cardiac, hepatic or renal failure, active neoplasia.
* Failure to meet any of the inclusion criteria recorded in the Screening for electrical stimulation of the University of Göttingen.
* Presence of:

  1. Pacemaker.
  2. Electrical and/or metallic implants.
  3. Pregnancy.
  4. Anticonvulsant medication.
  5. Tattoos in the area of electrode placement.
Dose-Escalation Study of SCD-101 in Sickle Cell Disease

The purpose of this study is to determine the safety and clinical effects of SCD-101 when given to adults with sickle cell disease.

This is single site, dose- escalation study of SCD-101 in participants with homozygous sickle cell disease (S/S) or S/beta 0 Thalassemia. All participants will be monitored for safety, tolerability, and dose-limiting toxicities.

The study is divided into two parts. Part A is an open-label, non-randomized, non-placebo-controlled dose escalation study with a 28-day treatment phase and 14-day follow-up phase with five cohorts . Part B is a randomized, placebo-controlled, confirmatory 2x2 crossover cohort with a 28 day washout between periods, and a 28-day follow-up phase.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18-55 years of age
2. Homozygous sickle cell disease or S/beta 0 thalassemia
3. Hemoglobin F ≤10%
4. Hemoglobin ≥ 6.0 g/dL and ≤ 9.5 g/dL
5. Female participants of child bearing potential and male participants whose partner is a female of child bearing potential must be willing to use approved contraception during the trial and for 3 months following the end of treatment. Only barrier methods or complete abstinence are acceptable for this study. Participants using hormonal contraception (including morning-after-pill) and IUD are excluded unless willing/able to change to an acceptable form of contraception.
6. Ability to adhere to the study visit schedule and other protocol requirements
7. Ability to understand and the willingness to sign an informed consent document

Exclusion Criteria:

1. Red blood cell transfusion within 3 months of enrollment
2. Hydroxyurea treatment within 6 months of enrollment
3. Painful or other acute sickle cell event that required a hospitalization within 4-weeks of enrollment
4. AST and/or ALT \>3x upper limit of normal and/or creatinine \>2x upper limit of normal or any other significant renal or hepatic impairment
5. Estimated creatinine clearance (CrCl) \< 60 mL/min (Cockcroft- Gault formula) at screening.
6. QTc interval of \>470 msec at trial entry and participant with congenital long QT syndrome.
7. No other significant sickle cell or non-sickle cell illness that would confound the results of the trial
8. Any condition that, in the view of the investigator, places the participant at risk because of participation in the trial, or may influence the result of the trial or the participant's ability to participate in the trial
9. Participant pregnant or nursing an infant or planning pregnancy during the course of the trial
10. History of allergic reactions attributed to sorghum or compounds of similar chemical or biologic composition (such as Nicosan, Niprisan, Jobelyn or Xickle).
11. Other investigational drug use within 3 months of enrollment
12. PROMIS Fatigue Questionnaire 8a T-score ˂ 44.3
Semantic Rehabilitation for Patients With Primary Progressive Semantic Aphasia

This project aims to measure the effect of a semantic rehabilitation protocol for patients with primary progressive semantic aphasia and using the SCED methodology.

The damage on the semantic system is at the heart of the clinical picture of semantic primary progressive aphasia (PPA), a neuro-evolutionary pathology. In other words, patients gradually lose access to concepts, general knowledge, word memory and meaning. In the absence of effective pharmacological treatment to reduce the symptoms evoked by patients and improve their quality of life, the arguments in favour of speech and language therapy are multiplying.

Numerous lexico-semantic multimodal indication therapies have been described in scientific studies. The most studied is semantic rehabilitation through the analysis of semantic features, which has shown its effectiveness in the context of vascular and post-traumatic aphasia.

However, there are only few studies and applications in neuro-evolutionary pathologies such as semantic PPA and those studies are complicated by methodological biases. It has been shown that relearned knowledge is more likely to be retained and transferred to everyday life (generalisation) if the material used is specific to the needs of each individual. Given the heterogeneity of clinical profiles in neuro-evolving pathologies and the inter-individual variability, the personalised approach should be favoured.

To evaluate the effect of semantic therapy in patients with semantic PPA, this study therefore proposes to use the SCED (Single Case Experimental Design) methodology. In addition to allowing an individual analysis, this methodology has the advantage of corresponding to a high level of evidence due to the acquisition of repeated measures and the randomisation of the introduction of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of primary progressive semantic aphasia according to the criteria of Gorno-Tempini et al (2011) (Appendix A)
* Being in the mild to moderate stage of dementia (MMSE score between 10 and 28) (Crum et al., 1993; Derouesné et al., 1999)
* Common French
* Being affiliated to a social security scheme
* Being over the age of 18 years old

Exclusion Criteria:

* Have significant uncorrected visual and/or hearing impairment
* Have a history of brain injuries, major head trauma
* Have untreated psychiatric disorders
* Have significant motor and/or comprehension problems that make it impossible to take part in the study
* Chronical use of drugs and/or alcohol
* Under guardians or curators
* Severe depression (Beck's depression scale score \> 9) (Beck \& al., 1961)
International Plastic Bronchitis Registry

The purpose of the international plastic bronchitis registry is to understand the natural course and long term health outcomes of subjects diagnosed with plastic bronchitis due to different types of casts. This provides essential data for identifying best practices and treatments. The secondary aim is to understand the structure of casts and mechanism of their formation.

Plastic bronchitis (PB) patients have casts removed during bronchoscopy as part of their routine care or that they are able to expectorate (cough out) casts naturally. The casts are normally discarded. Patients that agree to participate in the registry ship the airway casts and medical history to Dr. Bruce Rubin's Research Laboratory at Virginia Commonwealth University Richmond Virginia, USA.

The lab evaluates the biopolymer composition and structure of the airway casts by immunohistochemistry in order to identify microscopic differences between expectorated casts of subjects with plastic bronchitis and sputum from other populations (cystic fibrosis,chronic obstructive pulmonary disease , and normal airways). The lab also conducts in vitro evaluation of clearability, adhesivity, cohesivity, and inflammatory mediator concentrations to better understand the nature of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Plastic bronchitis