cyrilzakka/clinical-trials huggingface dataset:
Intra-hepatic Chemotherapy in Patients With Liver Metastases From Breast Cancer and Limited Extrahepatic Disease

This is a phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic capecitabine and in patients with a HER2-positive tumour in combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases from breast cancer.

Only patients with limited extrahepatic disease are included.


Eligibility Criteria:
Inclusion Criteria:• Informed consent

* Age \> 18 years
* Performance status 0-1; expected survival ≥ 3 months
* Patient with histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the breast
* Liver metastases not suitable for local treatment
* Extrahepatic disease should be determined by PET-CT-scan.
* No progression on treatment with capecitabine.
* Prior treatment with taxane (adjuvant or for metastatic disease)
* Metastases \< 70 % of the liver
* Neutrophile granulocytes \> 1.5 x 109/l og thrombocytes \> 100 x 109/l
* Bilirubin \< 2.0 x UNL (upper normal limit).
* Creatinine-clearance \> 30 ml/min.
* INR \< 1.6.
* If the patient is HER2-positive:Baseline LVEF ≥ 50 %

Exclusion Criteria:

* History of chemotherapy within the 4-week period prior to the start of trial medication
* Other current or prior malignant disease except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin.
* Previous treatment with oxaliplatin
* Cytotoxic or experimental treatment within a 14 days period before start of trial medication
* The patient is not allowed to participate in other clinical trials.
* Any clinical symptoms suggesting peripheral neuropathy \< or equal to grade 2 or CNS metastases (In case of clinical suspicion on CNS metastases a MR or CT scan should be performed within 4 weeks before inclusion
* Other severe medical conditions e.g. severe cardial disease or AMI \< 1 year
* Presence of diseases which prevent oral therapy.
* Patients with uncontrolled infection
* Pregnant or lactating women
* Women capable of childbearing not using a sufficient non-hormonal method of birth control
* Patients not able to understand the treatment or to collaborate.
* Prior serious or unsuspected reaction after treatment with fluoropyrimidine
* Known prior hypersensitivity reactions to the agents

If the patient is HER2-positive:

* Dyspnoea in due to complication related to malignant disease e.g.lung metastases with lymphangitis or other conditions with need of supportive oxygen.
High Intensity Interval Training Versus Moderate Continuous Training in Heart Failure With Preserved Ejection Fraction

The purpose of this study is to determine whether high intensity interval training (HIIT) is superior to moderate continuous training in increasing cardiopulmonary capacity in heart failure with preserved ejection fraction patients.

High intensity interval training (HIIT) has been proved to increase oxygen consumption, having superior cardiovascular effect when compared to moderate continuous training (MCT) in post-infarction patients (Wisloff et al.) Aerobic training also had shown positive effect on oxygen consumption and diastolic function in subjects with HFPEF when compared to usual care (Edelmann et al).

However, the comparison of HIIT and MCT on improving functional capacity and diastolic function in HFPEF patients has not yet been study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with heart failure with preserved ejection fraction (HFPEF) of any etiology that have functional class of the New York Heart Association (NYHA) between I and III, left ventricular ejection fraction \> 50% and who meet clinical and echocardiography criteria for HFPEF according to the consensus statement on the diagnosis of heart failure with normal left ventricular ejection fraction by the Heart Failure and Echocardiography Associations of the European Society of Cardiology (Paulus et al.). Patients should be clinical stable for the last 3 months and under optimized pharmacologic treatment, being capable of walking without limitations.

Exclusion Criteria:

* Patients with exercise-induced unstable ventricular arrhythmias, unstable angina, moderate to severe valvular heart disease, severe pulmonary disease, severe anemia, cognitive limitations to understand study protocol, use of pacemaker, autonomic neuropathy, cardiovascular event for less than 3 months, congenital heart disease, terminal illness with less than 1 year of life expectancy, peripheral arterial disease with intermittent claudication or osteoarticular conditions limiting exercise will be excluded.
Genetic Polymorphism and OROS-Methylphenidate Treatment in Attention Deficit Hyperactivity Disorder(ADHD)

The purpose of this study is to examine whether genetic polymorphisms in drug transporters were associated with the side effects of OROS-methylphenidate medication in attention deficit/hyperactivity disorder(ADHD).

20 to 30% of children with attention deficit/hyperactivity disorder(ADHD) do not respond or could not tolerate methylphenidate treatment. Drug transporters such as multidrug resistant proteins(MDR) plays important role in the clearance of psychotropic drugs and their metabolites from brain tissue. It suggested that methylphenidate was a P-glycoprotein(encoded by MDR1 gene)substrate and showed inhibitory effects on the P-glycoprotein efflux function. Single nucleotide polymorphisms(SNP)in the MDR1 gene were analyzed in children and adolescents with OROS-methylphenidate treatment. The hypothesis is that MDR1(ABCB1) polymorphisms are associated with the side effects of OROS-methylphenidate.

Eligibility Criteria:
Inclusion Criteria:

* ADHD
* Must be able to swallow a capsule

Exclusion Criteria:

* Pervasive developmental disorder
* Mental retardation
* Psychotic disorder
* Bipolar disorder
* Suicidality
* Neurological disorder
* Concurrent psychiatric treatment
The Effect of Transcutaneous Electrical Nerve Stimulation on Pain During Propofol Injection

Propofol, an intravenous sedative agent, frequently produces pain during injection. This study was designed to investigate whether transcutaneous electrical nerve stimulation could reduce pain during propofol injection.

in minimizing propofol injection pain.

Twenty min after transcutaneous electrical nerve stimulation, the electrodes were removed and propofol 0.5 mg/kg was administered at the rate of 0.5 ml/sec using syringe pump. Propofol injection pain was evaluated by a study blinded anesthesiologist using a four point scale: 0=no (negative response to questioning), 1=mild pain (pain reported only in response to questioning without any behavioral sings), 2=moderate pain (pain reported in response to questioning and accompanied by a behavioral signs or pain reported spontaneously without questioning, 3=severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal or tears).

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* American Society of Anesthesiologists physical status classification \> 3
* Patient with a history of allergy to drugs
* Patient who takes opioid, sedative, anticonvulsant
* Patient with a history of neurologic disease and psychological disorders
* patient with skin problem
* Patient with pacemaker or electric medical device
* pregnancy
A Study of Laparoscopic Middle Hepatic Vein Guidance and Traditional Anatomic Hemihepatectomy

The study, entitled "RCT study of laparoscopic middle hepatic venous guidance versus conventional ananatomical hemihepatectomy", was designed to compare the efficacy of two different ananatomical hemihepatectomy procedures under laparoscopy.

Backgroud \& Aim:Hepatectomy is the main way to treat all kinds of liver surgical diseases, which can be divided into anatomic hepatectomy and non-anatomic hepatectomy.Among them, anatomic hepatectomy is suitable for primary liver cancer, hepatolithiasis and other benign and malignant diseases;It can be divided into hepatic venous guidance and non-hepatic venous guidance hepatectomy (traditional ananatomical hepatectomy).The aim of this study was to observe and compare the perioperative period and follow-up results of the two different laparoscopic surgical resection methods, and to provide high-level evidence-based medicine evidence for the selection of surgical methods for laparoscopic anatomical hemihepatectomy.

Eligibility Criteria:
Inclusion Criteria:

1. the site was limited to the patients who were suitable for dissecting hemihepatectomy；
2. the type of disease was limited to hepatocellular carcinoma；
3. the patients were generally able to tolerate anesthesia, the liver reserve function was good, and the patients were suitable for laparoscopic surgery；
4. child-pugh grade A, no severe liver cirrhosis, portal hypertension, no extrahepatic and extrahepatic metastasis and main vascular invasion；
5. the subjects who participated in this study indicated that they were willing to accept the two surgical methods and agreed to be randomly divided into groups during the operation；
6. 18 ≤ age ≤ 70, male or female.

Exclusion Criteria:

1. preoperative liver function Child-pugh grade B or C;
2. patients with poor general condition and could not tolerate pneumoperitoneum or anesthesia;
3. patients with severe liver cirrhosis, portal hypertension and lesions invading liver porta;
4. patients with other treatment methods such as radio frequency ablation in addition to dissecting hepatectomy;
5. repeated abdominal operations resulting in severe abdominal adhesion, unable to perform laparoscopic hepatectomy; male and female are not limited
Pair Antiplatelet THerapy in Ischemic Stroke With Intracranial Artery Stenosis

The goal of this clinical trial is to learn about efficacy and safety of dual antiplatelet therapy in ischemic stroke with intracranial artery stenosis. The main question it aims to answer are:

whether aspirin combined with clopidogrel for 3 month is better than 1 months for patients with non-cardiogenic cerebral infarction with intracranial artery stenosis.

Participants will get dual antiplatelet therapy (aspirin plus clopidogrel) for 1 month or 3 months within 7 days of the first stroke.

Researchers will compare experimental group (3 months dual antiplatelet therapy) with comparison group (1 month dual antiplatelet therapy), to see if experimental group would reduce stroke recurrence or mortality, and increase bleeding and other adverse prognosis.


Eligibility Criteria:
Inclusion Criteria:

1. Age 40 \~ 80 years old;
2. Patients diagnosed as non-cardiogenic cerebral infarction according to the WHO definition of stroke, with MRA/CTA/DSA confirmed intracranial artery stenosis ≥50% (intracranial carotid artery, M1 and proximal M2 segment of middle cerebral artery, A1 and A2 segment of anterior cerebral artery, P1 and P2 segment of posterior cerebral artery, intracranial vertebral artery and basilar artery);
3. First stroke onset within 7 days;
4. NIHSS score ≤5;
5. Patients or family members sign informed consent forms;

Exclusion Criteria:

1. Patients receiving thrombolysis or endovascular therapy;
2. Patients with recurrent stroke;
3. Patients has undergone major surgery or major trauma within the past 30 days;
4. History of gastrointestinal bleeding, active peptic ulcer, intracranial hemorrhage or other hemorrhagic diseases;
5. Contraindications or intolerances to the use of antiplatelet therapeutics;
6. Platelet count \<100\*109/L, hemoglobin\<110g/L;
7. Patients with severe organ insufficiency or other serious disease (e.g., severe cardiopulmonary failure, advanced tumor, severe dementia);
8. Patients intolerant to MRI scan are replaced by CT or DSA;
9. poor compliance, unable to meet the requirements of the study.
A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis

This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of active or active/chronic ISN/RPS 2003 Class III or IV proliferative LN as evidenced by renal biopsy performed within 6 months. Participants may co-exhibit Class V disease in addition to either Class III or Class IV disease
* Urine protein to creatinine ratio greater than or equal to (\>/=) 1 on a 24-hour collection
* Other inclusion criteria may apply

Key Exclusion Criteria:

* Pregnancy or breastfeeding
* Severe renal impairment or the need for dialysis or renal transplantation
* Receipt of an excluded therapy, including any anti-CD20 therapy less than 9 months prior to screening or during screening; or cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening
* Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation
* Known active infection of any kind or recent major episode of infection
* Intolerance or contraindication to study therapies
* Other exclusion criteria may apply
Effect of Motor Control Exercise Combined With Laser Or TENS on Pain, Range of Motion, and Functional Disability on Obese Patients With Low Back Pain

This randomized study aimed to assess the impact of MCE in conjunction with LLLT and MCE in conjunction with TENS on pain levels, ROM, and functional disability in obese patients with LBP.

Sixty obese male and female patients with LBP participated in this study. After providing informed consent, they were randomly divided into two equal groups, with Group A receiving MCE combined with LLLT and Group B receiving MCE combined with TENS.

Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria were the following:

* patients aged 40 to 77 years
* non-athletic, have a BMI \> 25
* complaining of LBP.

Exclusion Criteria:

The exclusion criteria were the following:

* vertebral fractures
* surgical spinal fixation
* rheumatic disorders
* any underlying medical condition that may be causing back pain, including:
* malignancy
* viscerogenic causes
* infection, systemic disease of the muscles and skeletal system,
* sensory dysfunction
* neuromuscular diseases like multiple sclerosis.
The HIEnome Study: Genome Sequencing for Perinatal HIE

Perinatal hypoxic-ischemic encephalopathy is a rare severe condition in which neonates present with encephalopathy and a clinical history suggestive of prenatal or perinatal hypoxic-ischemic injury. Emerging evidence suggests that genetic conditions are frequently identified in cases of perinatal HIE; however, it is unclear which neonates with this diagnosis warrant genetic testing. This study will offer clinical genome sequencing to neonates with HIE who are undergoing total body cooling (therapeutic hypothermia) and their parents.


Eligibility Criteria:
Inclusion Criteria:

* Delivery ≥35w0d gestation
* Diagnosed with moderate or severe HIE, or HIE with seizures
* Undergoing total body cooling / therapeutic hypothermia
* Able to provide blood or buccal samples during birth hospitalization
* Admitted to Texas Children's Hospital Main, West, or Woodlands NICU

Exclusion Criteria:

* Parents/family not willing to allow participation
* Inability to collect sufficient neonatal blood samples (in some circumstances, a buccal swab may be used as backup)
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)

The purpose of the study is to evaluate how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks prior to the first administration of study intervention
* Total body surface area (BSA) greater than or equal to (\>=)10 percent (%) at screening and baseline
* Total psoriasis area and severity index (PASI) \>=12 at screening and baseline
* Total investigator global assessment (IGA) \>=3 at screening and baseline
* Candidate for phototherapy or systemic treatment for plaque psoriasis

Exclusion Criteria:

* Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
* Current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
* A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Known allergies, hypersensitivity, or intolerance to JNJ-77242113, deucravacitinib or to any of the excipients or components of the study intervention
* Major surgical procedure, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgical procedure, or has a surgical procedure planned during the time the participant is expected to participate in the study
Perceptions on Expected Outcomes of Immunotherapy in Advanced Cancer Patients With Poor Performance Status

To better understand your feelings and expectations about immunotherapy

Primary Objective:

1. To compare expectations of survival benefit from immunotherapy between advanced cancer patients with poor performance status (PS) and their oncologists. We hypothesize that, compared to their oncologists, patients will have expectations for greater likelihood of survival beyond 2 years.

Secondary Objectives:

1. To compare expectations of therapeutic benefit of immunotherapy between advanced cancer patients with poor PS and their oncologists. We hypothesize that, compared to their oncologists, patients will have expectations for greater likelihood of cure, quality of life improvement, and lower likelihood of adverse events.
2. To qualitatively describe the priorities and preferences for information of advanced cancer patients with poor PS when considering immunotherapy treatment.
3. To evaluate the associations between discrepant expectations with patients' sociodemographic and clinical characteristics.
4. To compare patient and oncologist expectations with actual treatment outcomes and survival.

Eligibility Criteria:
Inclusion Criteria:

1. Patients being considered for or within 2 months of starting immunotherapy for advanced cancer
2. Patient ≥18 years of age
3. ECOG ≥2
4. Cognitively able to understand consent and complete questionnaire as determined by the interviewer at the time of study enrollment
5. English speaking
6. Willing to participate in the study and sign informed consent
7. The study will include medical oncologists that treat advanced cancers

Exclusion Criteria:

1. Treatment for curative intent
2. Presence of Delirium (as determined by score \>13 on MDAS 46, appendix A)
Best Cardiac Output During Cardiopulmonary Bypass

The purpose of this study is to determine whether the patients cardiac output measured before cardiopulmonary bypass (CPB), is more sufficient to secure the patients oxygen needs than the estimated cardiac output from Ficks principle, and thereby prevent organ failure.

For more than 50 years, CPB has been used to mechanically support the functions of the heart and lungs. In early studies, systemic oxygen uptake, calculated using Ficks global principle, was used to assess the efficiency of CPB. Using this measure of efficiency, a pump flow rate in liters per minute, based on the product of the body surface area (BSA) and a constant of 2.4 was found adequate to perfuse the body during normothermia. Ficks global principle is still used together with other methods to secure adequated perfusion under CPB.

The purpose of this study is to determine whether the patients cardiac output measured before CPB, is more sufficient to secure the patients oxygen needs than the estimated cardiac output from Ficks principle, and thereby prevent organ failure.

The hypothesis is that the patients cardiac output is a better marker for the optimal cardiac output than the estimated cardiac output.

Eligibility Criteria:
Inclusion Criteria:

* patients admitted for scheduled cardiac surgery during cardiopulmonary bypass
* Aged 18-90 years
* LVEF \> 50 %
* written consent from the patients

Exclusion Criteria:

* Former cerebral emboli
* Former head trauma
* known stenosis of the arteria carotis
Perfusion and Collaterals Imaging With C-arm CT

Single-center, single-arm pilot study to evaluate the ability of C-arm computed tomography imaging to assess perfusion parameters, collateral vessels, recanalization and brain ischemia in patients with suspected or proven ischemic stroke or brain ischemia in the neuro-angiography suite.

In neurovascular disease, and stroke in particular, physicians often want to be able to detect regions of ischemia in the brain and the recanalization status of cerebral blood vessels. Perfusion and collateral vessel imaging is a possible approach for doing this. These imaging techniques are able to differentiate ischemic core in parenchymal tissue in the brain versus salvageable penumbra tissue around the core. Also the recanalization status of blood vessels can be evaluated using this technique. This study wishes to investigate if the x-ray C-arm in the treatment room can generate perfusion and collateral images of clinical value during treatment, using a technique known as C-arm computed tomography. If this study shows that to be the case, then it might be feasible in the future to bypass CT or MR perfusion/collateral imaging for some patients when they arrive at the hospital, since all this imaging can be done in the treatment room. In the future, this imaging approach may have the potential to simplify and improve patient workflows and reduce the time between hospital arrival and treatment for these patients and could also potentially compensate for missing imaging information.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has suspected or proven ischemic stroke or brain ischemia.
2. Subject requires diagnostic and/or interventional imaging in the neuro-angiography suite.
3. Subject or subject's legally authorized representative has signed an institutionally approved research informed consent form.
4. Subject ≥ 18 years old.

Exclusion Criteria:

1. Subject or subject's legally authorized representative is unable or unwilling to consent to the study.
2. Subject with documented contrast medium injection contraindication due to severe kidney disease or allergy.
Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) Assay

Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of an age of 18 to 70 years inclusive;
* Fitzpatrick Skin Type I, II and/or III for SPF testing;
* Good health as determined from the CRO Subject History Form (SHF);
* Signed and dated Informed Consent Form;
* Signed and dated Health Insurance Portability and Accountability Act (HIPAA) Form;
* An unambiguous minimal erythema dose (MED).