cyrilzakka/clinical-trials huggingface dataset:
TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma

It is an exploratory clinical study aimed to evaluate the efficacy and safety of TACE combined with Lenvatinib in the treatment of patients with BCLC stage B and C HCC.Treatment will continue until the death or intolerable toxicity or patients withdrawal of consent,and the target sample size is 54 individuals.

This is a prospective, single-center and single-arm exploratory clinical study designed to evaluate the efficacy and safety of TACE combined with Lenvatinib in the treatment of patients with BCLC stage B and C hepatocellular carcinoma.Treatment will continue until the death or intolerable toxicity or patients withdrawal of consent,and the target sample size is 54 individuals.

Eligibility Criteria:
Inclusion Criteria:

- 1. Histopathologically or clinically confirmed unresectable hepatocellular carcinoma.

2. Age ≥ 18 years at time of study entry. 3. Child-Pugh scores \<7. 4. Performance status (PS) ≤ 2 (ECOG scale). 5. BCLC stage B, some patients in stage C (Vp2-3). 6. The patient and/or his family agreed to join the clinical trial and sign the informed consent form.

Exclusion Criteria:

* 1. Have received TACE or other local treatment for liver cancer (except bridged liver transplantation).

  2. Main portal vein tumor thrombus or complicated with extrahepatic metastasis. 3. Tumor burden≥70% , diffuse liver cancer or tumor is not suitable for mRECIST standard evaluation.

  4. Have received systemic chemotherapy, sorafinib or other targeted therapy or immunotherapy.

  5. Estimated life expectancy of \<3 months. 6. There is a significant decrease in white blood cells and platelets in peripheral blood, severe coagulation dysfunction and can not be corrected：the neutrophil\<1.5×109/L, PLT\<50×109/L. The INR\>2.3.

  7. Renal dysfunction：serum creatinine (SCR) \>176.8 μmol/L（2 mg/dL）or creatinine clearance rate (Ccr) \<30 mL/min.

  8. Serious heart, lung, brain or other important organ diseases. 9. Pregnant or lactating women. 10. cannot cooperate with TACE operation and sign informed consent form.
Establishment of an Algorithm for a Clinical Classfication of Hypoosmolar Hyponatremia

The prospective clinical diagnosis of hyponatremia is often very difficult- but requirement for an appropriate and riskless treatment of hyponatremia. This study try to establish an algorithm handling a prospective clinical categorization of hyponatremia and approving together the start of an appropriate symptomatic therapy.


Eligibility Criteria:
Inclusion Criteria:

* hypoosmolar hyponatremia with serum sodium concentration ≤129 mmol/l and serum osmolality ≤ 280 mosm/kg;
* age \> 18 years;
* letter of agreement.

Exclusion Criteria:

* gravidity and lactation;
* restricted decision-making-ability
The Effects of β-Hydroxy-β-methylbutyrate Free Acid and High-Intensity Interval Training

Objectives: 1) Determine the effect of 4-weeks of high intensity interval training (HIIT) and free acid form β-Hydroxy-β-methylbutyrate (HMB-FA) on VO2peak, lactate threshold, critical power, anaerobic working capacity and neuromuscular economy in a population of endurance trained individuals. 2) Determine the effect of 4-weeks of HIIT and HMB-FA on changes in skeletal muscle physiological cross-sectional area (PCSA=Volume/Fascicle length) and muscle quality (MQ=echo intensity) in the rectus femoris and vastus lateralis.

Subjects: Fifty males and females between the ages of 18 - 35 will be recruited to participate in this study. Subject will be randomized to one of three groups: a control group (CTL), an HIIT only group (HIIT) or a group which will take the amino acid metabolite HMB and perform HIIT (HMB-HIIT). Individuals assigned to CTL will undergo baseline testing. They will then be asked to continue their normal exercise routine for 4 weeks and will undergo post-testing after this time period.

Study Protocol: Two testing sessions, on nonconsecutive days, will occur at least 72 hours prior to the start of the training period. The same testing protocols will be repeated at the end of the 4-week training period. Testing protocols include performance testing (VO2peak, lactate threshold, critical power, anaerobic working capacity and neuromuscular economy) and anthropometric measures (physiological cross-sectional area and muscle quality). The training protocol for individuals in the experimental groups will consist of 4-weeks of high intensity interval training with three sessions per week on an electronically braked cycle ergometer. Individual work -loads will be calculated based on the outcomes from each participant's preliminary testing.


Eligibility Criteria:
Inclusion Criteria:

* Recreationally-trained individuals with a VO2peak\>40 ml∙kg-1∙min-1.
* Free of any physical limitations as determined by the Confidential Medical and Activity questionnaire and/or PAR-Q
* Between the ages of 18 and 35

Exclusion Criteria:

* Inability to perform physical exercise, as determined by the Confidential Medical and Activity questionnaire and/or PAR-Q
* Any chronic illness that causes continuous medical care
Risk Factors for Poor Tolerance of Ureteral Double-J Stent

The placement of a Ureteral Double-J Stent as an emergency treatment or preparation for endoscopy after Colic nephritis is very frequent. It is often poorly supported, most often by young patients. A rich symptomatology is related to the probe responsible for a limitation of activities that can have a strong socio-economic impact. The objective of this study is the identification of the predictive factors of poor tolerance.


Eligibility Criteria:
Inclusion Criteria:

* patient over 18 years old
* patient who need Ureteral Double-J Stenting

Exclusion Criteria:

* patient under 18 years old,
* Iterative change,
* understanding disorder,
* inability to answer the questionnaire,
* refusal of the patient,
* long-term Ureteral Double-J Stenting (more than 6 month),
* active cancer.
The Effect of Acupuncture on Blood Pressure and Heart Rate Variability (HRV)

This research is designed to study the effects of needle acupuncture on blood pressure and HRV by stimulating certain acupuncture points and meridians.

Outcome measurements include blood pressure and heart rate variability.

Eligibility Criteria:
Inclusion Criteria:

* Male or female suffering from mild hypertension (systolic BP between 130-165 mmHg, diastolic BP between 90-120 mmHg).

Exclusion Criteria:

* Individuals with heart, kidney, thyroid disorders, diabetes, chronic disease or illness, neurological diseases, skin or bleeding disorders,
* Currently taking prescription or OTC medications and/or herb/supplements that effect BP or autonomic tone will not be recruited into the study.
* In addition, individuals who have a pacemaker and/or are pregnant will not be recruited in the study. A health history questionnaire was used to screen subjects.
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance

The purpose of this study is to determine if the combination of the three anti-cancer drugs carboplatin, paclitaxel, and ramucirumab is helpful in shrinking tumors or delaying tumor growth in participants with non-small cell lung cancer. This study will also assess whether it is safe to combine these drugs.


Eligibility Criteria:
Inclusion Criteria:

* Advanced non-squamous NSCLC (Stage IV or recurrent after initial curative intent therapy) in adults age 18 or older
* Prior exposure to 4-6 cycles of Pem/Carbo/Pembro and PD after at least 18 weeks of maintenance Pemetrexed, Pembrolizumab or the combination of the two.
* PS 0-1

Exclusion Criteria:

* Presence of a driver mutation that is susceptible to targeted therapy
* Other active invasive malignancy requiring ongoing therapy
* Grade 2 or higher sensory neuropathy
* Evidence of untreated brain metastases
* History of bleeding diatheses or recent, antecedent hemoptysis (\> 1/2 teaspoon in prior 2 months)
Building Capacity of OT Students to Address Children's Mental Health During Fieldwork (OTFW)

The study involved a one-group (n=19) mixed methods design using using pretest-posttest surveys and qualitative analysis of written reflections was used to explore the meaning and outcomes of participation in the building capacity process.

To explore the meaning and outcomes of a four-month building capacity process designed to promote knowledge translation of a public health approach to mental health with children and youth among occupational therapy students completing a Level II Fieldwork experience in school-based practice.The study involved a one-group (n=19) mixed methods design using using pretest-posttest surveys and qualitative analysis of written reflections was used to explore the meaning and outcomes of participation in the building capacity process.The building capacity process expanded student knowledge of a public health approach to mental health resulting in increased awareness and application of embedded strategies addressing mental health during a Level II Fieldwork experience in a school settings.

Eligibility Criteria:
Inclusion Criteria:

* Occupational therapy (OT) students completing a Level II Fieldwork experience during Fall 2016 in a school setting
* OT students meeting the above criteria who agree to participate in the study

Exclusion Criteria:

- OT students completing a FW experience in settings other than schools during Fall 2016
Study of Median Lobe Prostatic UroLift Procedure

The purpose of this study is to evaluate the safety and effectiveness of using UroLift in subjects with a prostatic median lobe enlargement due to benign prostatic hyperplasia (BPH).

Study Objectives: Evaluate the safety and effectiveness of the UroLift® System when used in symptomatic benign prostatic hyperplasia (BPH) subjects with an enlarged median lobe.

Study Design: Prospective, multicenter, non-blinded, single arm (non-randomized) study.

Sample Size: A total of no more than 48 subjects will be enrolled. Subject Population: Males age of 50 years or older diagnosed with lower urinary tract symptoms (LUTS) with enlarged median lobe.

Eligibility Criteria:
Inclusion Criteria:

* Enlarged median lobe (ML) contributing to obstruction of the prostate
* BPH

Exclusion Criteria:

-
Safety for 24 Weeks Intake of Korean Red Ginseng in Adults

Korean Red Ginseng appears to adverse events in adults taking 24 weeks Placebo and comparative assessment. And exploratory as Korean Red Ginseng blood sugar control, reduce body fat, URTI prevention, cardiovascular risk, renal function, cholesterol, improve, fatigue, and determine the impact on biological age.


Eligibility Criteria:
Inclusion Criteria:

1. 19 years or older
2. agree to participate in this test, voluntarily signed by the parties to a written agreement
3. In the case of women of childbearing age and confirmed negative pregnancy test, you agree to contraception during the trial period applying human characters

Exclusion Criteria:

1. Pregnant and lactating mothers
2. Patients with a history of hypersensitivity to contain ingredients that caused the test food
3. patients with severe renal disease (serum creatinine levels greater than 1.5 times if the upper limit of normal
4. Patients with severe hepatic disease, such as cirrhosis (if AST or ALT greater than three times the upper limit of normal)
5. autoimmune diseases (multiple sclerosis, lupus, rheumatoid arthritis, etc.) patients with
6. patients with uncontrolled diabetes (for HbA1c 8.0% or more)
7. Sulphonylureas, diabetic patients being treated with Insulin
8. , uncontrolled hypertension (systolic blood pressure of 150mmHg or higher or if diastolic blood pressure greater than 100mmHg)
9. uncontrolled hyperlipidemia patients (if LDL-cholesterol is 160mg / dL or higher)
10. patients with uncontrolled thyroid dysfunction
11. patients with a dementia or psychiatric problems
12. treated with systemic steroid screening visit within 1 weeks ago
13. before the screening visit 4 weeks continuously for more than two weeks, the mentally ill and insomnia patients receiving antipsychotic medication within
14. taking the medicine within 4 weeks before the screening visit
15. taking the other investigational drugs or human test food application within four weeks before the screening visit
16. taking health supplements other than vitamins and minerals within 2 weeks before randomization
17. which means in other clinical care ∙ Psychiatric Disorders diseases, cardiovascular diseases, or gastrointestinal diseases, malignant tumors such as a medical condition that is likely to affect the test result is determined to be unfit to test patient participation
Dose Escalation Trial of Intra-Tumoral Injection of NIS Measles Virus in Combination With Atezolizumab

This a Phase 1 study designed to determine the maximum tolerated dose (MTD) and toxicity of attenuated Measles virus (MV-NIS) combined with Atezolizumab in patients with recurrent and metastatic NSCLC.

Phase 1, dose escalation study of the combination of intra-tumoral MV-NIS and systemic atezolizumab in patients with recurrent and metastatic NSCLC. After the dose escalation phase of the trial, a dose expansion cohort was planned to further investigate safety, clinical and immune responses at the MTD. A standard 3+3 design was to be used for the dose escalation part of the study. Starting at dose level 1, three patients were to be treated per dose level. MV-NIS was to be administered once intra-tumorally (IT) on Day 1 of treatment in 3 escalating dose cohorts, starting at dose level 1 x 10e8

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of metastatic lung cancer, with histologic confirmation of the primary NSCLC histology and with at least one lesion amenable for intra-tumoral injection of MV-NIS.
* Patient meets the FDA-approved indication for Atezolizumab treatment in NSCLC.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
* Ability to provide informed consent.
* Adequate hematological, liver and kidney function.
* Must be willing to implement contraception throughout study and for the 8 weeks following last study drug administration.

Key Exclusion Criteria:

* Any of the following prior therapy: Chemotherapy ≤ 3 weeks prior to registration. Biologic therapy ≤ 4 weeks prior to registration. Radiation therapy ≤ 3 weeks prior to registration
* Other concurrent investigational therapy (utilized for a non-FDA-approved indication and in the context of a research investigation).
* Pregnant women.
* Nursing women.
* Men or women of childbearing potential who are unwilling to employ adequate contraception during treatment and 8 weeks following the completion of study drug treatment.
* Allergy to measles vaccine or history of severe reaction to prior measles vaccination.
* History of organ transplantation.
A Dissemination Trial of the Positive Parenting Program to Reduce Child Maltreatment in South Carolina

This is a population-based evaluation of the effectiveness of the Triple-P-Positive Parenting Program. Triple-P is a system of parenting programs with multiple levels that aims to provide parents with parenting skills and support.

Eighteen counties in the state of South Carolina will be randomized to the dissemination of the Triple-P system or to a waitlist control condition. University of South Carolina staff will train health care professionals in the nine dissemination counties to use the Triple-P parenting programs. Triple-P is a parenting program that uses a tiered system of interventions of increasing strength depending on parents' and children's differing needs, ranging from media and information-based strategies, to two levels of moderate-intensity intervention using a brief consultation format, to two more intensive levels of parent training and behavioral family intervention targeting parenting skills and other family adversity factors such as marital conflict, depression and high levels of parenting stress. The evaluation of the dissemination of Triple-P will rely on two methods: the analysis of aggregate data on child maltreatment, injuries and hospitalizations, and annual surveys of families to examining parenting education, practices, and child behavior.

Eligibility Criteria:
Inclusion Criteria:

* Counties in South Carolina
The Effect of phoSPHocreatine on mEdical Emergency Team (Met) tREated Patients

Unexpected deaths and unplanned intensive care unit (ICU) admissions are common during hospital stay and are often preceded by warning abnormalities in patients' vital signs. These abnormalities trigger Medical Emergency Team (MET) activation and up to 15% of patients visited by the MET is admitted to the ICU with an overall hospital stay after the MET intervention of approximately 2 weeks. Phosphocreatine (PCr) is a natural energy-buffering molecule associated with signals of mortality reduction in patients with acute cardiac conditions (according to meta-analytic finding from our group) and with encouraging beneficial effects on other acute organ failures (e.g. brain). The investigators designed a multi-center, randomized, placebo-controlled trial to confirm the promising beneficial effects of PCr in hospitalized patients. The investigators expects a reduction in hospital stay (measured as an increase in days alive and out of hospital at 30 days) when PCr is added to standard treatment in patients requiring MET intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Admitted in hospital (but outside ICU)
2. Age\>=18 years
3. Written informed consent
4. Serum creatinine \<=2 mg/dl
5. Patient with impending or underlying cardiac failure or cardiac arrest, irrespectively of the primitive organ failure, and the Medical Emergency Team (MET) is called upon at least one of the following:

   1. Threatened airways;
   2. Respiratory arrest;
   3. Respiratory rate \<5 or \>36 breaths per min;
   4. Pulse rate \<40 or \>140 beats per min;
   5. Systolic blood pressure \< 90 mm Hg;
   6. Sudden fall in level of consciousness;
   7. Fall in Glasgow coma scale of \> 2 points.

Exclusion Criteria:

1. Age \< 18 years;
2. Ongoing cardiac massage;
3. Current hospital admission from a care nursing facility;
4. Planned discharge to a care nursing facility;
5. Reasons for withdrawal of life-sustaining therapy;
6. History of kidney transplantation;
7. Solitary kidney (by any reason);
8. Serum Creatinine \> 2 mg/dl;
9. Immediate need for ICU admission;
10. Known allergy to PCr;
11. Pregnancy;
12. Previous enrollment and randomization into this trial;
13. Administration of PCr in the previous 30 day.
Comparison of MECHANISM of Early and Late Vascular Responses Following Treatment of ST-elevation Acute Myocardial Infarction With Two Different Everolimus-eluting Stents: Randomized Controlled Trial Between Biodegradable Polymer and Durable Polymer Stent (MECHANISM-AMI-RCT)

To place two different everolimus-eluting stents (EES), a bioabsorbable polymer EES (Synergy®) and a permanent-type polymer EES (Xience®), randomly to the ST-elevation acute myocardial infarction (AMI) and to observe and compare the early and chronic vascular responses using the frequency domain optical coherence tomography (FD-OCT). The primary endpoint is the 2-week strut coverage rate by FD-OCT.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with new coronary lesion indicated for PCI using DES
2. Patients whose age at acquisition of consent is 20 to less than 85 years
3. Patients who themselves or whose representatives showed the written consent
4. Patients who will undergo cardiac catheterization 2 weeks later (staged PCI on the other vessel or confirmatory angiography at the treated site)

Exclusion Criteria:

If the following exclusion criteria are satisfied, the patient should not be enrolled in this study even after acquisition of patient's consent:

1. When the follow-up after 12 months is considered difficult (the patient's residence should also be considered)
2. When there is no obvious ACS finding in angiography (decisions should be left to operator)
3. Patients with shock
4. Patients whose culprit lesion is the left main coronary trunk
5. Lesion with the reference vascular diameter of \<2.0 mm or ≥4.5 mm visually
6. AMI that occurred newly at the site where a stent has already been placed
7. Chronic renal failure in which the serum creatinine concentration at visit is ≥2.0 mg/dL
8. Patients undergoing hemodialysis
9. Tumor-bearing patients whose life prognosis is expected to be within 2 years
10. Patients for whom the surgical operation requiring withdrawal of antiplatelet drug is scheduled within 3 months
11. Female patients during pregnancy or scheduled to be pregnant
12. Patients with a past history of the side effect of aspirin, clopidogrel or prasugrel (when the patient is confirmed for the safety of ticlopidine, this does not apply even if there is the side effect of clopidogrel or prasugrel)
Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs

The purpose of this study is to assess the safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic gastroenteropancreatic or pulmonary neuroendocrine Tumors (NET).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of grade 1/2 advanced pulmonary or gastroenteropancreatic neuroendocrine tumor
* Progressive disease within last 12 months (only patients with nonfunctional tumors)
* Documented liver metastasis
* Measurable disease per RECIST determined by multiphase MRI or triphasic CT

Exclusion Criteria:

* Previous treatment with radiolabeled somatostatin analogs within 12 months prior to reporting baseline symptoms
* Previous treatment with mTOR inhibitors or pasireotide
* Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
* Women who are pregnant or lactating

Other protocol-defined inclusion/exclusion criteria may apply
Drug-drug Interaction (DDI) Study to Assess Effect of Itraconazole and Rifampicin Upon Olorofim

This is a Phase 1, single-centre, fixed-sequence, open label, drug-drug interaction study in 2 groups of healthy subjects.

Group A: to evaluate the effects of itraconazole, a strong inhibitor of cytochrome P450 3A (CYP3A), upon the pharmacokinetics of olorofim .

Group B: t o evaluate the effects rifampicin, a strong inducer of CYP3A, upon the pharmacokinetics of olorofim .


Eligibility Criteria:
Inclusion Criteria:

* males or females of any ethnic origin between 18 and 55 years of age
* subjects weighing between 50 and 100 kg, with a body mass index (BMI) between 18 and 32 kg/m2.
* subjects in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations

Exclusion Criteria:

* Female subjects of child-bearing potential.
* Male subjects (or their partners) who are not willing to use appropriate contraception during the study and for 3 months after end of dosing.
* Female subjects who are pregnant or lactating.
* Subjects who have received any prescribed systemic or topical medication within 14 days of first dose administration
* Subjects who have used any non-prescribed systemic or topical medication within 7 days of first dose administration
* Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of first dose administration
* Subjects with or history of clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatry, respiratory, metabolic, endocrine, ocular haematological or other major disorders as determined by the investigator