cyrilzakka/clinical-trials huggingface dataset:
Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL

The purpose of this study is to evaluate the efficacy and safety of Basiliximab in combination with pegaspargase in the treatment of relapsed/refractory NK/T-cell lymphoma.

The investigators previously found that CD25 was elevated in patients who were resistant to chemotherapy, and CD25 can mediate resistance, which can be reversed by targeting CD25 therapy. Thus, the purpose of this study is to evaluate the efficacy and safety of Basiliximab in combination with pegaspargase in the treatment of relapsed/refractory NK/T-cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Pathology confirmed diagnosis of NK/T-cell lymphoma.
* Previously treated with pegaspargase-based regimens.
* PET-CT or MRI scan with at least one measurable lesion.
* ECOG score of 0-3 points.
* The lab tests within 1 week before enrollment meets the following:

  * Blood routine: Hb≥80g/L, PLT≥50×10e9/L.
  * Liver function: ALT, AST, TBIL≤2 times the upper limit of normal.
  * Renal function: Cr is normal.
  * Coagulation: plasma fibrinogen≥1.0g/L.
  * Cardiac function: LVEF≥50%, ECG is normal
* Sign the informed consent form.
* Voluntary compliance with research protocols.

Exclusion Criteria:

* Patients with a history of pancreatitis.
* Active infection requires ICU treatment.
* Concomitant HIV infection or active infection with HBV, HCV.
* Serious complications such as fulminant DIC.
* Significant organ dysfunction:

  * respiratory failure
  * NYHA classification≥2 chronic congestive heart failure
  * decompensation Hepatic or renal insufficiency
  * high blood pressure and diabetes that cannot be controlled
  * cerebral vascular events within the past 6 months.
* Pregnant and lactating women.
* Had a history of autoimmune diseases, and disease was active now. Those who were known to be allergic to drugs in the study regimen.
* Patients with other tumors who require treatments within 6 months.
* Other experimental drugs are being used.
Antiplatelet Secondary Prevention International Randomised Trial After INtracerebral HaemorrhaGe (ASPIRING)-Pilot Phase

ASPIRING is an investigator-led, multicentre, prospective, randomised, open-label, blind outcome (PROBE), parallel group, clinical trial. The pilot phase will explore the feasibility of conducting a trial of starting antiplatelet monotherapy versus avoiding antiplatelet therapy for reducing all serious vascular events for adults surviving symptomatic stroke due to spontaneous intracerebral haemorrhage (ICH). The pilot phase will involve \~120 patients at \~30 hospitals in China, Australia and New Zealand.

The participant eligibility criteria specifically identify adults with history of symptomatic spontaneous ICH. Randomisation occurs if a participant and their doctor are uncertain about whether to start or avoid antiplatelet monotherapy at least 24 hours after ICH symptom onset. The intervention is a pragmatic policy of starting antiplatelet monotherapy (one antiplatelet drug available in local standard clinical practice, chosen by patient's physician pre-randomisation). The control group adopts a policy of avoiding antiplatelet therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Patient age ≥18 years.
2. Symptomatic stroke due to spontaneous (non-traumatic) ICH.
3. Patient is at least 24 hours after ICH symptom onset.
4. Patient and their doctor are both uncertain about whether to start or avoid antiplatelet monotherapy.
5. Consent to randomisation from the patient (or personal / legal / professional representative if the patient does not have mental capacity).

Exclusion Criteria:

1. ICH due to head injury, in the opinion of the investigator.
2. ICH due to haemorrhagic transformation of an ischaemic stroke, in the opinion of the investigator.
3. Patient is already taking antiplatelet therapy, or full dose anticoagulant therapy, after ICH.
4. Patient is pregnant, breastfeeding, or of childbearing age and not taking contraception.
5. Patient and carer unable to understand spoken or written local language.
Vitamin B12a Vasoplegic Syndrome

The study team will evaluate the medication Hydroxocobalamin (B12a) for treatment of low blood pressure after cardiac surgery.

If subjects meet the criteria for inclusion in the study based on the subjects blood pressure the subject will be randomized to receive the study drug or a placebo. Subjects blood pressure will be monitored closely for the first 30 minutes and then have standard intensive care unit (ICU) care afterwards. Kidney dysfunction will be assessed for changes in urine production and laboratory values that are followed as a part of standard postoperative care. Study coordinators will obtain these values from subjects medical records for 7 days and subjects will be contacted by phone for follow up after 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Any patient for whom we are able to obtain consent ahead of their procedure
* Patients presenting for a procedure in which cardiopulmonary bypass will be required
* Considered high risk for vasoplegic syndrome
* Has no contraindications to arterial line or PA catheter placement
* Develops high-dose vasopressors for 30 min or longer and refractory hypotension consistent with vasoplegic syndrome within 24 hours of coming off cardiopulmonary bypass.

Exclusion Criteria:

* Age\<18 years
* Known pregnancy or patients without a documented pregnancy test if not menopausal.
* Known prior anaphylactic or allergic reaction to B12a
* CKD stage 4 or worse
* ECMO (extracorporeal membrane oxygenation) prior to study consent.
* Patients currently on cardiopulmonary bypass
The Effects of Pilates on Posture and Physical Fitness Parameters in 5-6 Years Old Children

The purpose of this non-randomized controlled study was to investigate the effects of Pilates on posture and physical fitness parameters in 5-6 years old healthy children.

As a result of this study, pilates can be applied as an alternative exercise that improves posture and physical fitness in children.

The purpose of this non-randomized controlled study was to investigate the effects of Pilates on posture and physical fitness parameters in 5-6 years old healthy children.

As a result of this study, pilates can be applied as an alternative exercise that improves posture and physical fitness in children.

This study will answer whether pilates practice has an effect on posture and whether pilates has an effect on physical fitness parameters.Demographic information of the participants was recorded. Postural assessments were evaluated by the New York Posture Rating (NYPR) chart test and fitness was evaluated by the Eurofit test battery.

Eligibility Criteria:
Inclusion Criteria:

* Attending Aydın Bahçeşehir Kindergarten,
* Being allowed by her family to participate in the study
* Being a volunteer,
* Not having a diagnosed physical or mental illness that would prevent her from exercising.

Exclusion Criteria:

* Not being a volunteer,
* Having a health problem that prevents exercise.
Revive AIS Patients ImmeDiately

This is a multicenter, prospective registry clinical study to evaluate the real-world efficacy and safety of intra-arterial treatment for acute ischemic stroke using Revive SE device on the basis of standardised medical treatment.

This is a multi-center, prospective, single-arm observational study to evaluate the real-world efficacy and safety of intra-arterial treatment for acute ischemic stroke patients using Revive SE device on the basis of standardised medical treatment.The device selection before treatment is based upon doctors who are blinded to the protocol. The primary outcomes are reperfusion rate immediately after intervention (mTICI score ≥II b ) and mRS Score at 90 days after intervention.

Eligibility Criteria:
Inclusion Criteria:

1. age over 18 years;
2. clinical diagnosis should be acute ischaemic stroke;
3. no more than 6 hours after onset;
4. IV tPA thrombolysis, if needed, should start within 4.5 hours after onset；
5. Pre-stroke mRS ≤2;
6. ICA/M1/M2/A1/A2/VA/BA occlusion confirmed by CTA/MRA/DSA;'
7. written informed consent form given

Exclusion Criteria:

1. . history of intracranial hemorrhage.
2. . life expectancy \<90 days;
3. . history of major surgery or severe trauma in the past 10 days;
4. . Uncontrolled hypertension (defined as: SBP\>185mmHg or DBP ≥110 mm Hg at 3 continuous measurements with interval of at least 10 minutes confirm the SBP\>185mmHg or DBP ≥110 mm Hg)
5. . PLT\<40\*10\^9/L；
6. . blood glucose \<2.7mmol /L or \>22. 2 mmol /L；
7. . concomitant use of oral anticoagulation drugs, and INR \>3.0；
8. . ASPECTS score ≤5；
9. . conventional angiography indicates poor collateral circulation (ACG Score ≤ 1).
Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized Prostate Cancer

HYPO-RT-PC boost is is an open-label, multicentre, phase II trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk localized prostate cancer.

HYPO-RT-PC boost is is an open-label, multicentre, phase II trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk localized prostate cancer. 76 participants will be enrolled in the study.

Specific aims of the study are:

* To study the feasibility of ultra-hypofractionation target lesion boost for node-negative very high-risk prostate cancer together with lymph node irradiation (primary outcome).
* To study the effectiveness of ultra-hypofractionated target lesion boost for high-risk prostate cancer.
* To study the feasibility of defining focal boost during concomitant androgen deprivation therapy with advanced functional imaging methods.

Eligibility Criteria:
Inclusion Criteria:

* Life expectancy \>5 years
* Age ≥18 years
* World Health Organization (WHO) performance status 0-2
* Histological evidence of prostate cancer
* Classified as very high-risk according to national guidelines (2-3 of following high risk criteria: T3 / Gleason grade 8 /Prostate-specific antigen (PSA) 20-49 μg/L or and/or Gleason score 9-10 and/or PSA ≥40 μg/L
* At least one Prostate Imaging-Reporting and Data System (PI-RADS) 4-5 lesion on diagnostic Magnetic resonance imaging (MRI)
* Patients must be able to comply with the protocol
* Signed informed consent
* Adequate laboratory findings: haemoglobin (Hb) \>90 g/L, absolute neutrophil count \>1.0x10\^9/l, platelets \>75x10\^9/l, bilirubin \<2.0 x upper limit of normal (ULN), alanine aminotransferase (ALAT) \<5x ULN and creatinine \<2.0x ULN)

Exclusion Criteria:

* Regional or distant metastasis
* Any contraindications for MRI
* PSA \>150 ng/ml
* Previous pelvic radiotherapy
* Prior prostate surgery including transurethral resection of the prostate (TURP)
* Endocrine treatment (past or present)
* Other malignancies than prostate cancer and basalioma in the past five years
* Serious disease state that makes study inclusion and treatment unsuitable
* Severe lower urinary tract symptoms (International Prostate Symptom Score (IPSS) ≥20)
Perceptions of Cervical Cancer Among Asian Americans

The goal of this research study is to learn about the beliefs, practices, and knowledge about cervical cancer among Asian American young adults. Researchers want to develop materials that will educate Asian Americans about cervical cancer and encourage them to get screened for this disease.

Survey:

If you agree to take part in this study, you will complete a survey about your health practices and knowledge about cervical cancer and HPV. You will also be asked to provide some personal history on yourself such as your age, gender, birthplace, ethnicity, relationship status and educational level. Female participants will be asked to indicate if they have received an HPV test (also called a "Pap" test) within the last 3 years. The survey will take about 5-10 minutes to complete and will be filled out on the same day as the focus group.

Focus Group:

You will also take part in a discussion group called a "focus group." A trained focus group leader will guide you and 8-10 others through a series of questions. He/she will lead a discussion to hear comments, opinions, and observations on a brochure and poster about cervical cancer and HPV. Groups will be made up of participants of the same gender (that is, all male or all female) and ethnic group (Filipino, Korean, or Vietnamese). Each discussion group will last about 2 hours and may be audiotaped so that the discussion may be transcribed and analyzed. You will only be called by your first name and you are not required to use your real name during the focus group discussion. You will not be identified by the audiotape recordings.

Length of Study:

When the focus group discussion is over, you will be off-study.

This is an investigational study. Up to 60 participants will be enrolled on this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Self identified as Korean, Filipino, or Vietnamese
2. Individuals 18-29 years of age
3. Have a high school education or less (but not less than 4th grade)
4. Able to read and speak English and one of these languages: Korean, Vietnamese, or Tagalog
5. Lower socioeconomic status, defined as: for a household of 1, not more than $18,620 annual income, for a household of 2, not more than $24,980, for a household of 3, not more than $31,340, for a household of 4, not more than $37,700, for a household of 5, not more than $44,060, for a household of 6,not more than $50,420, for a household of 7, not more than $56,780 NOTE: The CDC has granted some flexibility with these income guidelines
6. Not currently pregnant

Exclusion Criteria:

1) Household income greater than 200% of the federal poverty level
Remote Simultaneous Medical Interpreting and Medical Outcomes

All new patients to the general medicine clinic who were not primarily English speaking were randomized, after consenting, to receieve either remote simultaneous medical interpreting or usual and customary interpreting services. Patient charts were followed for one year after enrollment to assess medical outcomes, including patient satisfaction, diabetes management, lipid management, depression screening and management, vaccine administration.

All Spanish-speaking ER patients were similarly enrolled. They were followed for one ER visit and their knowledge of exit instructions was assessed, as well as their satisfaction with care.


Eligibility Criteria:
Inclusion Criteria:

* Limited English-speaking
* English-speaking
* New patient in medicine clinic
Metabolism and Sleep Apnea Treatment

The purpose of this research study is to see if obstructive sleep apnea (OSA) is associated with abnormalities in fat metabolism. Through this research study, the Investigator will evaluate how fat is metabolized in people with and without sleep apnea, what substances the fat tissue releases, and how these substances might change the way the body uses energy and sugar.


Eligibility Criteria:
Aim 1 Group:

Inclusion criteria:

* Age between 18-70 years
* Ability to provide consent

Exclusion criteria

* Body Mass Index (BMI) \> 40 kg/m2
* Prevalent myocardial infarction, coronary revascularization, heart failure, and stroke
* Type 1 or Type 2 diabetes mellitus
* Current or prior use of PAP or oral appliance therapy for OSA
* Use of oral corticosteroids
* Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression)
* Other sleep disorders (e.g., circadian rhythm disorder, self-reported habitual sleep duration \< 6h)
* Use of supplemental oxygen during wakefulness or sleep
* Central sleep apnea, obesity hypoventilation syndrome or Cheyne-Stokes respiration based on the home sleep test
* Resting awake Oxygen Saturation (SpO2) \< 90%

Aim 2 Group:

Inclusion criteria:

* Age between 18-70 years
* Ability to provide consent
* Moderate-to-severe OSA (AHI ≥ 15/h);
* Demonstration of Positive Airway Pressure (PAP) use of \> 4 h/night on 70% of the nights during 1-week run-in period
* Successful completion of all of the procedures for Aim 1.

Exclusion criteria:

* BMI: ≥ 40 kg/m2
* Type 1 or Type 2 diabetes mellitus
* Current use of PAP or oral appliance therapy for OSA
* Commercial driver or report of motor vehicle accident or near-miss due to sleepiness within the 2 previous years
* Epworth sleepiness score of 18 or more
* Use of oral corticosteroids
* Participation in another clinical trial
* Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression)
* Other sleep disorders (e.g., circadian rhythm disorder, self-reported habitual sleep duration \< 6h)
* Use of supplemental oxygen during wakefulness or sleep
* Central sleep apnea, obesity hypoventilation syndrome or Cheyne-Stokes respiration based on the home sleep test
* Resting awake SpO2 \< 90%
Whole Body PET-MRI in Paediatric and Adolescent Lymphoma

Children and adolescents with Hodgkin lymphoma currently undergo multiple investigations including a separate PET and MRI scans during their treatment.

Investigators want to investigate if a combined PET-MRI scan could give the same information.

Children who join our study will have an extra scan twice during their treatment

Children and adolescents with Hodgkin lymphoma currently undergo multiple investigations including a separate PET and MRI scans during their treatment.

Investigators want to investigate if a combined PET-MRI scan could give the same information.

Children who join our study will have an extra scan twice during their treatment

Routine whole body clinical MRI will be performed according to current clinical standard of care. Axial and coronal imaging from the maxilla to proximal femurs will be performed using a combination of T1 and T2 weighted sequences, with and without gadolinium administration.

Eligibility Criteria:
Inclusion Criteria:

1. Suspected or histologically confirmed Hodgkin lymphoma
2. Male or female participants
3. Age 0-20 years inclusive
4. Entered into the EuroNet PHL-C1 trial, LP1 trial or successor Euronet trials, including Euronet PHL C2 due to open from 2013 onwards or planned to receive chemotherapy regimens of said trials without being formally entered into the trial.
5. Participant/Guardian/Parental written informed consent

Exclusion Criteria:

1. Participants with contraindications to MRI (including cardiac pacemakers or non-MRI compatible intracranial vascular clips)
2. Participants who are pregnant or nursing
Treatment of Fecal Incontinence and Chronic Constipation With Low-volume Irrigation

The aim of this study is to investigate the efficacy of low-volume irrigation on bowel function among patients with fecal incontinence and/or chronic constipation (of heterogenous origin).

The aim of this study is to investigate the efficacy of low-volume irrigation on bowel function among patients with FI and/or CC (of heterogenous origin). Further, the aim is to investigate if low volume irrigation can change the negative impact that symptoms of FI and/or CC (of heterogenous origin) have on the patients' daily activities and QoL. Additionally, the aim is to investigate the short-term and long-term discontinuation rates in relation to treatment with low-volume irrigation. Finally, the aim is to investigate the daily time-consumption, the practical challenges and the side effects related to low-volume irrigation. The study period is six weeks and the participants will be instructed to irrigate once daily with Qufora IrriSedo MiniGo.

This study is an interventional study. Patients with FI and/or CC of heterogenous origin, seen in the Nurse-led Clinic for Bowel Dysfunction at the Pelvic Floor Unit, Aarhus University hospital, will be included. Patients will be offered transanal irrigation as a treatment option. Patients presenting with Bristol stool type 6-7 should be offered conservative treatment to optimize the stool consistency. If patients can be regulated to a Bristol stool type 1-5, they can be invited to participate in the study. If necessary, regulation of the stool consistency in patients presenting with Bristol stool type 1-2 is an option, before introducing transanal irrigation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with FI, CC or co-existing FI and CC of heterogenous origin.
* Positive Rome IV criteria for constipation and/or positive Rome IV criteria for fecal incontinence.
* Patients with Bristol stool type 1-5 as their primary stool consistency.
* 18 years.
* Ability to understand written and spoken Danish (due to questionnaire validity).

Exclusion Criteria:

* Prior use of transanal irrigation or mini enema.
* Patients with chronic diarrhea (Bristol stool type 6-7).
* Patients with neurogenic bowel dysfunction.
* Participation in research conflicting with the current study.
* Diseases treated with rectal or anal surgery (except minor rectal or anal surgery).
* Physical disability that affects the ability to use QuforaÒ IrriSedo MiniGo.
* Major psychiatric diagnoses.
* Patients with constipation with a chronic opioid use or other medications inducing constipation.
* Pregnancy or plans to become pregnant.
A Phase III Confirmatory Study of K-877 Extended Release Tablet

To investigate the efficacy and safety of K-877 Extended Release (ER) 0.2 mg/day or 0.4 mg/day (once daily) for 12 weeks in dyslipidemia, using K-877 Immediate Release (IR) 0.2 mg/day (twice daily) as a control.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with dyslipidemia had to be age 20 years or older at written informed consent
2. Patients who have received dietary or exercise guidance from 12 weeks or more prior to Screening
3. Patients with the fasting serum TG \>= 200 mg/dL twice consecutively at Screening

Exclusion Criteria:

1. Patients with a fasting serum TG \> 1000 mg/dL at Screening
2. Patients who require administration of prohibited drugs during the clinical trial period after written informed consent
3. Patients with uncontrolled thyroid disease
4. Patients with type 1 diabetes and uncontrolled diabetes \[HbA1c(NGSP) \>= 8.0 % at Screening\]
5. Patients with uncontrolled hypertension (SBP \>= 160 mmHg or DBP \>= 100 mmHg)
6. Patients with an AST or ALT three times the upper limit at Screening
7. Patients with an CK five times the upper limit at Screening
8. Patients with cirrhosis or those with biliary obstruction
9. Patients with acute myocardial infarction within 3 months before obtaining informed consent
10. Patients with heart failure class III or higher according to NYHA cardiac function classification
11. Patients with malignant tumor or those who are judged to have a high risk of recurrence
12. Patients with a history of serious drug allergies (anaphylactic shock, etc.)
13. Pregnant women, lactating women, women planning to become pregnant or lactating during the study period, or pregnant women who do not use specific contraceptive methods
14. Patients who have collected 400 mL or more of whole blood within 16 weeks, or 200 mL or more of whole blood within 4 weeks, or blood samples (plasma and platelet components) within 2 weeks before Screening
15. Patients who have received K-877 (pemafibrate)
16. Patients who participate in other clinical trials at the time of written informed consent and who received medication or who have received clinical trials other than placebo for less than 16 weeks
17. Patients who have been determined inappropriate by the investigator, etc