cyrilzakka/clinical-trials huggingface dataset:
An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis

This is a Phase 2, open-label, extension study to assess the safety and tolerability of AK002, given monthly for up to 26 doses.


Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent.
2. Completed Study AK002-003, defined as having received 4 infusions of study drug and followed through Day 113 (±3 days) in Study AK002-003 or discontinued from treatment due to high eosinophil counts prior to infusions 2, 3, or 4 and willing to begin extended dosing on or about Day 113 (for AK002-003 completers) or within 6 months of last dosing for patients discontinued from treatment.
3. If patient is on pre-existing dietary restrictions, willingness to note any changes that occur from the Baseline diet, throughout the study.
4. Able and willing to comply with all study procedures.
5. Female patients must be either post-menopausal for at least 1 year or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity until the end of the study, or for 120 days following the last dose of study drug, whichever is longer.
6. Male patients with female partners of childbearing potential must agree to use a highly effective method of contraception until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant at any time during study participation.

Exclusion Criteria:

1. Poor tolerance to previous administration of AK002 in the opinion of the Investigator.
2. Known hypersensitivity to any constituent of the study drug.
3. Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk.
4. Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment in the study, during the treatment period, or vaccination expected within 5 half-lives (4 months) of study drug administration. All types and formulations of vaccines (including live attenuated vaccines) authorized by FDA or other regulatory authority for the prevention of COVID-19 may be administered before, during, or after this study. The vaccine should not be administered within 7 days prior to and within 7 days after the administration of AK002 so that any side effects caused by either of the 2 medications can be more easily determined.
5. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
6. Any other reason that, in the opinion of the Investigator or Medical Monitor, makes the patient unsuitable for enrollment.
7. Diagnosis of Hypereosinophilic Syndrome (HES), based on standard criteria (blood eosinophils \>1500/µL with involvement of either the heart, nervous system, and/or bone marrow).
Improving Continuous Renal Replacement Therapy Outcomes in Neonates and Infants Through Interdisciplinary Collaboration

To date, little knowledge exists related to the use of hemodialysis (HD) in infants and has been limited to mainly single center studies. The CARPEDIEM (CArdio-Renal PEdiatric Dialysis Emergency Machine) device, which can be used to provide hemodialysis in infants, has been launched in the United States. This study/registry is designed to obtain data on critically ill infants who require HD using the CARPEDIEM device to understand the indications for initiation, best practice in prescribing and performing treatment, expected treatment course, and outcomes of a dedicated infant continuous renal replacement therapy (CRRT) machine.

This is a retrospective and prospective, multicenter observational quality improvement study and research registry. Infants undergoing renal replacement therapy utilizing CARPEDIEM for hemodialysis will be enrolled in the study for observation. There are two arms to this study, one for quality improvement and one for research purposes. Patients enrolled in this study have the option to participate additionally in either biospecimen collection, long term follow up after CARPEDIEM, or both. Urine specimen will be collected from fresh voids, but all blood specimen will be obtained from residual clinical specimen. Investigators hope to gain more information into use, treatment course, and outcomes from infants requiring treatment with the CARPEDIEM device.

Eligibility Criteria:
Inclusion Criteria:

* Treated with CARPEDIEM as part of standard of care at a participating institution within the United States

Exclusion Criteria:

* Parents/legally authorized representative unable or unwilling to provide consent
A Trial of Neoadjuvant Everolimus Plus Letrozole Versus FEC in Women With ER-positive, HER2-negative Breast Cancer

This open, randomized pilot feasibility trial is to evaluate the feasibility and effect of neoadjuvant everolimus plus letrozole versus neoadjuvant fluorouracil, epirubicin plus cyclophosphamide (FEC) in treating postmenopausal women with ER-positive, HER2-negative breast cancer. Forty postmenopausal stage M0, ER-positive, HER2-negative invasive breast cancer women who had a primary tumor \> 2cm by imaging or an axillary lymph node \> 2cm by imaging were randomly (1:1) enrolled to receive neoadjuvant everolimus plus letrozole for 18 weeks or neoadjuvant FEC for 6 cycles before surgery. The primary objective is to determine the feasibility of neoadjuvant everolimus plus letrozole in postmenopausal patients with ER-positive, HER2-negative breast cancer. Secondary aims are to compare the ultrasound response rate, pathological complete response (pCR) rate, breast-conserving surgery rate, toxicities, and changes in the percentages or counts of peripheral blood CD4+ T cells, CD8+ T cells, tumor-specific CTLs, T helper cells (Th), regulatory T cells (Treg), and NK cells and changes in tumor Ki67 index (pre- versus post- neoadjuvant therapy).


Eligibility Criteria:
Inclusion Criteria:

* The patients signed the written informed consent
* The patients present with non-metastatic unilateral invasive ER-positive, HER2-negative breast cancer with a primary breast tumor \> 2cm by imaging or an axillary lymph node \> 2cm by imaging.
* Postmenopausal women with age less than 70 years old.
* The patients have no history of hormone therapy, chemotherapy, breast cancer surgery and radiotherapy.
* The patients have normal cardiac functions by echocardiography.
* The patients' ECOG scores are ≤2.
* The patients can swallow pills.
* The results of patients' blood tests are as follows:

  * Hb≥90g/L;
  * WBC≥4E+9/L;
  * Plt≥100E+9/L;
  * Neutrophils≥1.5E+9/L;
  * ALT and AST ≤ triple of normal upper limit;
  * TBIL ≤ 1.5 times of normal upper limit;
  * Creatinine ≤ 1.5 times of normal upper limit.

Exclusion Criteria:

* The patients have other cancers at the same time or have the history of other cancers except controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix uterus;
* The patients have active infections that were not suitable for chemotherapy;
* The patients have severe non-cancerous diseases.
* The patients have bilateral breast cancers or multifocal breast cancers or inflammatory breast cancers.
* The patients have a history of previous treatment with mTOR inhibitors.
* The patients are undergoing current administration of anti-cancer therapies, or are attending other clinical trials.
* The patients are in some special conditions that they cannot understand the written informed consent, such as they are demented or hawkish.
* The patients have allergic history or contraindication of any of the interventional drugs.
Moxonidine Effects on Neuropeptide Y

Treatment with monotherapy of moxonidine 0.6 mg daily in treatment-naïve subjects with mild or moderate hypertension

Treatment with 0.6 mg moxonidine daily in treatment-naïve subjects with mild or moderate hypertension according to guidelines (Stage 1: Systolic Blood Pressure =140-159 mmHg, Diastolic Blood Pressure =90-99 mmHg, and Stage 2: systolic blood pressure=160-179 mmHg, diastolic blood pressure=100-109 mmHg) that require monotherapy and reevaluation after 12 weeks

Eligibility Criteria:
Inclusion Criteria:

* treatment-naïve subjects with mild or moderate hypertension according to Joint National Committee 7 and European Society Hypertension / European Society Cardiology 2008 (Stage 1: Systolic Blood Pressure =140-159 mmHg, Diastolic Blood Pressure =90-99 mmHg, and Stage 2: Systolic=160-179 mmHg, Diastolic=100-109 mmHg) that require monotherapy

Exclusion Criteria:

* age beyond 25-75 years,
* not taking currently anti-hypertensive medication
* not taking anti-diabetic or lipid lowering medication and other diseases or conditions that may influence blood pressure, heart rate and catecholamines' and Neuropeptide Y levels, including anemia, fever, stage III hypertension, coronary artery disease, recent (less than 6 months) myocardial infraction or stroke, heart failure, secondary hypertension, diabetes mellitus, abnormal thyroid status or other obesity-related endocrinopathies, pregnancy, kidney failure, alcohol abuse, malignancies, depression or other psychiatric illnesses, such as schizophrenia,
Attitudes Associated to Prescription of ADHD Drugs Among Child and Adolescent Psychiatrists in Region Skåne.

Each year Region Skåne in Sweden gathers information on drug prescriptions within the region. The last ten years a significant pattern of uneven prescription rates of ADHD drugs to people up to 17 years of age are noticed in the different districts. These regional differences are noticed in other regions in Sweden as well and internationally.

The convention on the rights of the child became an institutional law in Sweden in 2020 and it emphasises that each child has the right to equal care and treatment. Therefore it is of importance to analyse how the variations in prescriptions rates arise and if we as healthcare providers can influence it. Our study is a collaboration between Region Skåne and the university of Lund and is a part of a larger study of the regional variations of prescriptions of ADHD drugs. Previous research informs us that a complex interplay of multiple factors can be behind variations in prescription rates among medical doctors and not the least subjective experiences and attitudes.

Our study performs semistructured interviews of Region Skånes child and adolescent psychiatrists with questions specifically regarding their own experiences and attitudes that might influence their prescription behavior.

The intention is to gather information that can guide future research questions.


Eligibility Criteria:
Inclusion Criteria:

* child and adolescent psychiatrist in Region Skåne

Exclusion Criteria:

* part of the research group
The Effect of Grounding During Pregnancy

The study was planned as a randomized controlled trial. The research data included a pregnant informed form, leg cramps evaluation form, Pittsburgh Sleep Quality Index, Visual Analog Scale for fatigue, Pregnancy-Related Anxiety Scale, Short Form-12 Quality of Life Scale, food consumption record form, and pregnancy follow-up form will be used. Questionnaires will be evaluated every two weeks, and the intervention will continue for four weeks in total for each pregnant woman.

The aim of the research is to investigate the effect of grounding on muscle cramps, sleep quality, fatigue, anxiety, and quality of life in pregnant women. The study was planned as a randomized controlled trial. The study is going to perform in the Obstetrics and Gynecology Clinic of Ege University Medical Faculty Hospital. The research will be carried out by face-to-face interview method. The research data included a pregnant informed form, leg cramps evaluation form, Pittsburgh Sleep Quality Index, Visual Analog Scale for fatigue, Pregnancy-Related Anxiety Scale, Short Form-12 Quality of Life Scale, food consumption record form, and pregnancy follow-up form will be used. The pregnant women included in the study will be divided into two groups as intervention and placebo groups by randomization and will be asked to take a walk for 30 minutes every day with a grounding/sham grounding pole. Questionnaires will be evaluated every two weeks, and the intervention will continue for four weeks in total for each pregnant woman.

Eligibility Criteria:
Inclusion Criteria:

* Between 27-34 weeks of pregnancy,
* Having leg cramps,
* Normal blood levels of calcium and magnesium in her current pregnancy,
* No risky pregnancy, or chronic disease (heart disease, hypertension, thyroid diseases, diabetes mellitus, kidney disease, etc.)
* Not having multiple pregnancies,

Exclusion Criteria:

* Risky pregnancy, chronic disease (heart disease, hypertension, thyroid diseases, diabetes mellitus, kidney disease, etc.),
* Emerging Rheumatic Disease,
* Varicose veins in the legs,
* Diagnosed with restless legs syndrome,
* Pregnant women with blood levels of Calcium and Magnesium below the normal level will be excluded from the study.
Renin-angiotensin-aldosterone System (RAAS) Blockade and Contrast Induced Nephropathy

The aim of the current study is to evaluate prospectively whether concomitant administration of renin-angiotensin-aldosterone system (RAAS) blockers (namely ACE-I and ARBs') influence the change in estimated glomerular filtration rate or GFR (eGFR) after administration of contrast media in patients undergoing non-emergent coronary angiography.

Contrast-induced nephropathy (CIN) is defined as an absolute or relative increase in serum creatinine compared to the baseline values, together with exposure to a contrast agent and exclusion of alternative explanations for renal impairment. Most frequently the renal impairment develops 48 hours post exposure. Although RAAS blocking agents are widely used among patients requiring contrast studies, data regarding the effect of these agents on the development of CIN are sparse and inconsistent. Patients undergoing percutaneous coronary intervention are frequently treated with RAAS blocking agents. Despite the not infrequent occurrence of CIN following percutaneous coronary intervention (PCI) no guidelines are available on the topic of the cessation of the RAAS inhibitors prior to the procedure.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years,
* chronic therapy with ACE-I and/or ARBs' (confirmed by electronic records in their medical file) and
* planned coronary angiography

Exclusion Criteria:

* chronic utilization of NSAIDS and Cox-2 selective inhibitors,
* chronic treatment with mineralocorticosteroid receptor blocker, and
* administration of contrast within 14 days prior to the enrollment.
Safety Study of Ranibizumab Eye Injections to Treat Choroidal Neovascularization That Was Caused Other Than by Age-Related Macular Degeneration.

The purpose of this study is to determine whether ranibizumab is effective in the treatment of choroidal neovascularization secondary to causes other then wet macular-degeneration.


Eligibility Criteria:
Inclusion Criteria:

* active choroidal neovascularization

Exclusion Criteria:

* pregnancy,age-related macular degeneration, current eye infection or recent eye surgery, participating in other eye studies
The Effective and Safety of Thalidomide in TI

This is an exploratory experiment, aims to explore the effective and safety of thalidomide in the treatment of TI to improve the hemoglobin level, improve the quality of life, reduce blood transfusion, so as to avoid the adverse reactions caused by transfusion,60\~100 patients will be enrolled.

The project is a single arm research of thalidomide in TI,patients volunteered to participate in this trial and met the following inclusion criteria will be enrolled: age from 18\~65, Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less. Subjects should take thalidomide 50mg per day. During this time, hepatic and renal function, hematologic function, electrocardiogram and the adverse reactions were closely observed. According to the protocol, the blood routine, peripheral blood reticulocyte count, nucleated red blood cell count, hemoglobin electrophoresis and other indicators were evaluated in screening-period visit,1-month visit, 3-months visit , 6-months visit ,9-months visit, 12-months visit and 15-months visit.

Eligibility Criteria:
Inclusion Criteria:

* Patients meeting all of the following criteria will be considered for admission to the trial:

  * Diagnosis of NTDT;
  * Ages 18-65 years;
  * ECOG: 0\~2 scores;
  * If not blood transfusion,the level of HB\<90g/dl, or blood transfusion to maintain the HB;
  * Sign an informed consent agreeing to the clinical trial participation.

Exclusion Criteria:

* Patients presenting with any of the following criteria will not be included in the trial:

  * Patients received hydroxycarbamide, Yisui Shengxue Granule in three months;
  * Women during Pregnancy, breastfeeding or those of childbearing age who do not want to take contraceptive measures;
  * Patients had comorbidities like severe heart or lung diseases, liver dysfunction, cerebrovascular, cardiovascular, liver, kidney, tumor or other serious primary diseases;
  * Patients Allergic to the drug ingredients;
  * Patients with any Mental problem;
  * Patients had Participated in other drug clinical trials in the past 1 month;
  * Patients had a history of venous or arterial thrombosis;
  * In certain circumstances that the researchers determined it was not suitable for the research.
Impact of Vagus Nerve Stimulation on Post-Aerobic Activity Recovery in Post SARS-CoV-2 Patients

Chronic fatigue, weakness, dyspnea, headaches, cognitive dysfunction, stress, sadness, anxiety, sleep disturbances, and orthostatic intolerance are among the symptoms of acute Covid-19 in patients, and these symptoms persist for more than 12 weeks after recovery. Extended Covid-19 syndrome, also known as Post-Covid-19 syndrome, is described as

Therapeutic exercises are an evidence-based method for the maintenance of musculoskeletal, cardiovascular and neurological well-being and the prevention and treatment of chronic diseases. The effects of therapeutic exercises on the human body varied according to the frequency, intensity, duration and type of exercise.

Increasing physiological and psychological recovery after exercise can lead to results such as better performance and reducing the risk of injury. Therefore, various methods are used to facilitate post-exercise recovery.

The best-known and most widely used post-exercise recovery method is active cooling, also known as active rest or cool-down. Active cooling; It is defined as any activity that includes voluntary, low/moderate intensity exercise or movement performed within one hour of exercise. Passive rest, on the other hand, is defined as no or minimal voluntary/intentional exercise movement.

Eligibility Criteria:
Inclusion criteria:

* Covid
* be between 18-45 years old
* Having pulmonary involvement in the covid process

Exclusion criteria:

* Being a professional in any sport
* Having a cardiopulmonary, orthopedic, neurological and metabolic disease
The Efficacy of Hydrolyzed Guar Gum ( PHGG) in the Treatment of Patients With Irritable Bowel Syndrome (IBS)

This study objective is to assess the short and long term effects of partially hydrolyzed guar gum (PHGG) administration on clinical symptoms of IBS and quality of life of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Fulfillment of the Rome III criteria for IBS.
* Aged 20-68 years at the time of screening.
* Provision of written informed consent.
* Commitment of availability throughout the 6 months study period.

Exclusion Criteria:

* Major abdominal surgery in the past.
* The presence of any active (organic)GI disease.
* Past or present major medical or psychiatric illness.
* Any concomitant disease.
* Alarming symptoms (rectal bleeding, weight loss, etc.)
* Pregnancy.
* Family history of colorectal carcinoma or inflammatory bowel disease (IBD).
* Abnormal laboratory studies (blood biochemistry , liver enzymes,complete blood count), abnormal thyroid function.
* Non-adjusted diet in the case of lactose or gluten intolerance.
* Recent travel to regions with endemic parasitic diseases.
Effects of Remote Ischemic PreConditioning in Off-pump Versus On-pump Coronary Artery Bypass Grafting(RIPCON)

Purpose Remote ischemic preconditioning (RIPC) with transient upper limb ischemia reduces myocardial injury in patients undergoing On-pump coronary artery bypass (CABG) surgery with cross-clamp fibrillation or blood cardioplegia for myocardial protection. The molecular mechanisms leading to these effects are yet not fully understood. The purpose of the present study is to validate previous studies and gather further evidence for RIPC during CABG with blood cardioplegia, furthermore to determine, whether or not RIPC is still operative during Off-pump coronary artery bypass surgery (OPCAB), finally to elucidate intra-cellular mechanisms involved in myocardial protection by RIPC and their possible systemic mediators.

Remote ischemic preconditioning (RIPC) protocol before CABG (study arm A) or OPCAB (study arm B) consists of 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 minutes of reperfusion after induction of anesthesia before coronary artery bypass surgery. For myocardial molecular analyses, left ventricular biopsies are taken before induction of cardioplegic cardiac arrest (A) or first coronary incision (B), and 5 to 10 minutes after aortic unclamping during reperfusion of the myocardium (A) or 5 to 10 minutes after the completion of the last anastomosis (B). Blood samples are taken prior to RIPC and during the first three postoperative days.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed triple vessel coronary artery disease
* Indication for surgical coronary revascularisation
* Written informed consent
* Age ≥ 18 years

Exclusion Criteria:

* Age \> 80 years
* Instable angina/acute coronary syndrome
* Emergency surgery
* Recent myocardial infarction within 7 days prior to surgery
* Recent major infection/sepsis within 7 days prior to surgery
* Significant hepatic, renal oder pulmonary disease
* Other concomitant surgical procedures