cyrilzakka/clinical-trials huggingface dataset:
Cord Blood Nesfatin-1 and Irisin in the Intrauterine Growth Restricted Fetuses

: The aim of this study is to investigate Cord blood irisin and nesfatin-1 levels in pregnancies with intrauterine growth retardation and to determine whether they are associated with abnormal fetal doppler findings or not.

This study was conducted at Yüzüncü Yıl University Medical Faculty Obstetrics and Gynecology Clinic. The study group included 34 pregnant women ranged from 18 to 45 years old who have intrauterine growth retardation and underwent ceseraen section. 32 pregnant women who had no abnormality on prenatal follow-up and underwent elective ceserean seciton served as control group. The maternal age, height, weight, body mass index (BMI), systolic and diastolic blood pressures were recorded in both groups of patients. Maternal serum total blood count and biochemical parameters were obtained from the laboratory parameters. Gestational week at birth, birth weight, sex, 1st and 5th minute APGAR scores were recorded. Blood samples were collected from all the cases during the cesarean section for measurmenet of nesfatin-1 and irisin by doubly clamped umbilical cord. Blood samples were immediately centrifuged in sterile tubes and maintained at -80 ° C until assessed.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with intrauterine grwoth rectricted fetuses.
* Healthy pregnancies

Exclusion Criteria:

* Pregnant women with chronic medical conditions
* multiple pregnancies
* fetuses with fetal malfomations or genetic syndromes
* pregnant women older than 45 years old
Radiation Therapy Followed by Surgery in Treating Patients With Early-Stage Breast Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving CT-guided accelerated radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This clinical trial is studying giving radiation therapy followed by surgery to see how well it works in treating patients with early-stage breast cancer.

OBJECTIVES:

* is to investigate the impact of a short fractionated schedule given preoperatively on local control, cosmesis and breast fibrosis.
* To further design optimal treatment strategies for individual breast cancer patients treated with breast-conserving therapy (BCT) on the basis of biological parameters, including the expression profile of the primary tumor, for both m-RNA as for micro-RNA, with first, a focus on radiotherapy responsiveness and second, on local recurrence rate, distant metastases and survival.
* proteomics will be studied in fine-needle aspiration samples. A classifier can be build (genomic or proteomic or any kind of molecular signature) to identify responders and non-responders
* quality of life

OUTLINE: Patients undergo image-guided preoperative accelerated partial-breast irradiation (PAPBI) 10 times over 12 days (10 x 4 Gy) and later in the study 5 times 6 Gy. Six weeks after completion of image-guided PAPBI, patients undergo surgery.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of unifocal cT1-2 (1-3 cm) pN0 M0 breast cancer
* Must have undergone a sentinel node procedure prior to irradiation

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Study of Anlotinib in Patients With Gastric Cancer(ALTER0503)

The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with Gastric Cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated informed consent;
2. Pathologically confirmed advanced gastric adenocarcinoma (including Gastroesophageal junction adenocarcinoma) with measurable lesions outside stomach (RECIST 1.1)
3. Advanced stomach cancer patients who have failed to the second line or higher line chemotherapy treatment
4. \>=18 years old；ECOG PS：0\~1；Estimated life expectancy \>3 months
5. Main organs function is normal;

Exclusion Criteria:

1. Patients who have been treated with anlotinib previously;
2. Patients who have been treated with other VEGFR-TKI small-molecule drugs previously, such as sunitinib, Sorafenib, famitinib, Apatinib, Regorafenib, ect
3. Patients suffering from other malignancies currently or within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer \[ Ta (non-invasive carcinoma), Tis (carcinoma in situ) and T1 (carcinoma invasion into lamina propria) \]
4. Systemic anti-cancer therapy scheduled 4 weeks prior to assignment or during this study，including cytotoxic therapy，signal transduction inhibitors，immunotherapy(or received mitomycin C within 6 weeks before this study). Extended field radiotherapy(EF-RT) used within 4 weeks prior to assignment or limited field radiotherapy used to assess tumor lesions within 2 weeks prior to assignment;
5. CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous treatments，excluding alopecia and Grade 2 or lower neurotoxicity induced by oxaliplatin;
6. Patients with a clear tendency of gastrointestinal bleeding;
7. Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea etc.)
8. Patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2 or higher dyspnea \[Grade 2 dyspnea refers to Shortness of breath with a small amount of activities, affecting Instrumental activities of daily life\])
9. Patients with any severe and/or unable to control diseases;
10. Patients underwent major surgical treatment，open biopsy or significant traumatic injury within 28 days prior to assignment;
11. Patients with any physical signs of bleeding diathesis or medical history, no matter how serious degree they are; Patients with any CTCAE Grade 3 or higher bleeding events occurred within 4 weeks prior to assignment; Patients with non-healing wounds，ulcers or fractures;
12. Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;
13. Patients with drug abuse history and unable to get rid of or Patients with mental disorders
14. Brain metastases patients with symptoms or symptoms controlled \< 2 months;
15. Patients participated in other anticancer drug clinical trials within 4 weeks or Patients participating in other clinical trials now;
A Long-term Follow-up Study Evaluating Intravenous Injection of EXG001-307 in Patients With Type 1 SMA

An Open-label, Long-term Follow-Up Study to Evaluate the Safety and Tolerability of Gene Therapy with EXG001-307 in SMA1 patients ,who joined the parent study (EXG001-307-102)

This study plans to enroll type 1 SMA patients who have previously received EXG001-307 treatment in the parent trial EXG001-307-102 to observe the long-term safety and efficacy of gene therapy with EXG001-302.

The first year of long-term follow-up will be conducted every 3 months ; In the second year, follow-up visits will be conducted every six months, with telephone follow ups at 15 and 21 months during this period; From 3 to 5 years after gene therapy, follow up by phone every six months and follow on on site once a year.

Eligibility Criteria:
Inclusion Criteria:

1. Previously received treatment with EXG001-307 in trial EXG001-307-102;
2. Parents or guardians understand the research procedure and sign the ICF; Good compliance and willingness to follow research procedures. Voluntarily participate in this clinical trial.

Exclusion Criteria:

1. Parents or guardians are unwilling or unable to participate in long-term follow-up studies.
Drug-drug Interaction Study of KL1333 in Healthy Subjects

A Phase I, Open-label, Fixed-sequence, Crossover, Drug-drug Interaction Study to Investigate the Inhibition Potential of KL1333 on CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in Healthy Subjects

This will be a Phase I, open-label, fixed-sequence, crossover study to investigate the effect of coadministration of KL1333 on the PK of repaglinide, caffeine, omeprazole, midazolam, bupropion, dextromethorphan, and flurbiprofen in healthy male and female subjects. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the first dose administration. Subjects will be admitted into the clinical research unit (CRU) on Day -1 and be confined to the CRU until discharge on Day 19. Subjects will return to the CRU for a follow-up visit 5 to 7 days after the last dose.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females, of any race, between 18 and 65 years of age, inclusive.
2. Weight ≥50 kg and body mass index between 18.0 and 32.0 kg/m2, inclusive.
3. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhaemolytic hyperbilirubinaemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and check-in as assessed by the investigator.
4. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Appendix 4.
5. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
6. Able to perform all protocol-specified assessments and comply with the study visit schedule.

Exclusion Criteria:

1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator.
2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, including KL1333 or its excipients, unless approved by the investigator.
3. History of gastroesophageal reflux disease, gastric erosions, peptic ulcer disease, or gastrointestinal bleeding episodes.
4. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs including cholecystectomy (uncomplicated appendectomy and hernia repair will be allowed).
5. History of malignancy of any organ system other than localised basal cell carcinoma of the skin, treated or untreated, within 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases.
6. History of clinically significant illness or surgery within 4 weeks prior to screening, as determined by the investigator.
Transcranial Direct Current Stimulation in Reduction of Pain and Postoperative Opioids Consumption After Spine Surgery

The experience of pain derives from changes in brain excitability. Therefore, modulating the excitability of cortical areas involved in pain processing may become an attractive option in the context of multimodal analgesia during the postoperative period.

The combination of analgesic drugs acting on different mechanisms can potentiate the effects of analgesia. Moreover, the understanding of pain physiology at the molecular level supports the development of new specific drugs. Indeed, new neurophysiological models of pain processing by the brain are becoming exquisitely refined and are supported by electrophysiological and functional brain imaging studies. One of the interesting concepts that stemmed from these studies is the evidence that the experience of pain is reflected in the central nervous system by widespread activations and excitability changes within a network of interconnected cortical areas and subcortical structures. The network processing of noxious information and their limbic and emotional consequences has been termed the "pain matrix." The continuous observation of the activity and excitability changes that parallel the pain experience led to the development of a new therapeutic approach: the use of central nervous system stimulation techniques.

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent to participate in the study.
* postoperative spine surgery patients(discectomy and/or laminectomy).
* American society of anesthesiology scores I to II patients.

Exclusion Criteria: the participant who has any history of:

* an adverse reaction to brain stimulation.
* a seizure
* an unexplained loss of consciousness
* a stroke
* serious head injury
* surgery to their head
* any brain related, neurological illnesses
* any illness that may have caused brain injury
* frequent or severe headaches
* metal in your head (outside the mouth) such as shrapnel, surgical clips, or fragments from welding
* any implanted medical devices such as cardiac pacemaker's or medical pumps
* taking any analgesic medications in the past 24 hours
* pregnancy
* anyone in your family has epilepsy
A Pilot Study of a Home-Based Walking Intervention for Pancreatic Cancer Patients

Despite evidence regarding the benefits of physical activity in various cancer patient populations, the effects of a home-based walking program for pancreatic cancer patients have been under-explored. The aims of the proposed pilot project are to: (1) Assess the feasibility of implementing a 12-week, home-based walking program among pancreatic cancer patients; and (2) Examine the effects of a 12-week, home-based walking program on quality of life (QOL) and symptoms among pancreatic cancer patients.

Among cancer patients, physical activity interventions can lead to improvements in QOL and reductions in fatigue and pain. While pancreatic cancer patients may have physical restrictions that limit their participation in moderate to high-intensity exercise activities, empirical evidence suggests that even low-intensity, home-based walking programs can confer benefits for cancer patients. In this pilot study, 50 patients will be randomly assigned to receive either the walking intervention program or usual care (UC). Assessments of quality of life, distress, and symptom burden will be completed at baseline (pre-intervention) and at follow-up (i.e. within 2 weeks post-intervention or approximately 12-14 weeks post-baseline). Data from the proposed pilot study will inform the development of a larger randomized trial designed to improve QOL and reduce morbidity in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Have histologically confirmed adenocarcinoma of the pancreas (including adenocarcinoma subtypes such as signet ring carcinoma, adenosquamous carcinoma, undifferentiated/poorly differentiated carcinoma, and mucinous carcinoma)
* Have an estimated life expectancy of greater than 3 months
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Are undergoing treatment for pancreatic cancer at Fox Chase Cancer Center
* Have borderline resectable or unresectable locally advanced disease or metastatic disease

Exclusion Criteria:

* Patients with islet cell/neuroendocrine or papillary cystic neoplasm
* Patients scheduled to undergo surgical resection for curative intent during study participation
* Patients receiving 3rd-line palliative chemotherapy
* Inability to communicate in English.
The Effect of Using Musical and Lighted Baby Crib Mobile on Newborns' Pain and Stress During Blood Draw

It is widely recognized that the use of non-pharmacological methods in neonatal pain management is low both globally and in our country. Nurses play a crucial role in managing pain through various techniques and in preventing its negative effects on newborns. Toys with sounds, lights, and different features have been found to effectively capture infants' attention. Consequently, it is anticipated that baby crib mobiles, which combine these attention-grabbing features, could serve as effective distractions during needle interventions, potentially reducing pain and stress. However, there is a lack of research on this specific application.

Newborns often undergo needle procedures shortly after birth, such as vitamin K injections, hepatitis B vaccinations, screenings, and routine immunizations. Depending on the baby's condition, these procedures may need to be repeated, and additional blood samples might be required. These painful procedures can cause significant stress for the newborn and may lead to neurocognitive, physiological, metabolic, and behavioral issues. Pain experienced during these procedures can negatively impact the newborn's future reactions to pain. Therefore, inadequate pain management can result in both immediate and long-term adverse effects.

Organizations such as the International Neuropsychiatric Pain Group and the American Academy of Pediatrics advocate for reducing pain in infants during procedures, recommending non-pharmacological methods as the first line of management. These methods, aimed at providing analgesic effects by creating a relaxing environment, are important because they do not have side effects. Some proven non-pharmacological techniques include breastfeeding, skin-to-skin contact, swaddling, music therapy, oral glucose, and pacifier use.

Music therapy is a widely used non-pharmacological method that helps reduce pain perception in newborns. Studies have shown its effectiveness in various settings. For instance, research with premature newborns found that music therapy during central venous catheter placement reduced physiological and behavioral reactions. Another study with 120 healthy newborns reported that having a musical baby crib mobile in vaccination rooms decreased pain levels and crying times. Other studies have similarly highlighted the positive effects of listening to or singing lullabies during painful procedures.

Eligibility Criteria:
Inclusion Criteria:

* born between 38-42 weeks,
* being 0-28 days,
* absence of visual and auditory problems,
* not using any pain reliever or sedative medication in the last four hours,
* parents' willingness to participate in the study,
* parents' knowledge of Turkish,
* parents' ability to read and write.

Exclusion Criteria:

* having a preterm birth,
* having a disease that causes chronic pain,
* having visual or auditory problems,
* using any pain or sedative medication in the last four hours.
The Clinical Efficacy of DFPP in Patients With AAGN

The clinical efficacy of double filtration plasmapheresis(DFPP) in patients with antineutrophil cytoplasmic autoantibody associated glomerulonephritis(AAGN).

This is a single center, prospective, randomized,controlled study to compare the clinical efficacy of double filtration plasmapheresis (DFPP) combined with intravenous cyclophosphamide (IV-CTX) pulse therapy versus IV-CTX pulse therapy in patients with antineutrophil cytoplasmic autoantibody associated glomerulonephritis(AAGN).

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of ANCA associated vasculitis(AAV), using criteria adapted from the disease definitions of the Chapel Hill consensus conference
* serum positive ANCA and the ANCA level ≥100 relative unit/ml
* with renal involvement and serum creatinine≥3 mg/dl
* written informed consent had been provided.

Exclusion Criteria:

* other secondary vasculitis
* anti-glomerular basement membrane(GBM) positive
* severe infection; hepatitis B antigenemia, anti- hepatitis C virus
* immunodeficiency; or immunoglobulin G(IgG)\<2g/l
* life threatening
* renal biopsy show globally sclerotic glomeruli\>60% and normal glomeruli\<10%
* need renal replacement therapy for more than 4w
* received large dose of methylprednisolone(MP),CTX,mycophenolate mofetil(MMF), plasmapheresis or intravenous immunoglobulin(IVIg) therapy.
Tetraspan 6 Percent (%) Combined With Sterofundin ISO Versus Albumin 5 Percent (%) Combined With Sodium Chloride (NaCL)

This investigational study will investigate two different volume replacement regimes in patients suffering from compromised renal function.


Eligibility Criteria:
Inclusion:

* male or female patients
* ≥ 50 years of age;
* patients with compromised renal function, i.e. serum creatinine between 1.5 mg/dl and 3.0 mg/dl;
* patients scheduled for elective intervention;
* patients with an estimated intraoperative volume need of at least 1 l colloids;
* provision of voluntary informed consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations

Exclusion:

* patients of ASA-class \> III;
* patients with daily urine output \< 1 l;
* patients on haemodialysis;
* patients receiving HES during the last 48 hours before first infusion of the investigational products;
* patients suffering from coagulation disorders (i.e. PTT \> 60 sec);
* patients with a hemoglobin \< 9 g/dl;
* patients with known hypersensitivity to HES, albumin or any of the excipients;
* patients suffering from contraindications of the investigational products (i.e. hyperhydration state including pulmonary oedema, renal failure with oliguria or anuria, intracranial haemorrhage, hyperkalaemia, severe hypernatraemia or severe hyperchloraemia, severely impaired hepatic function, congestive heart failure);
* simultaneous participation in another clinical trial; emergencies;
* patients scheduled for brain surgery;
* patients incapable to give informed consent (e.g. patients with dementia, psychiatric diseases or suffering from conditions associated with lack of consciousness)
Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of the trial is to investigate the efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetes (T2DM).


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Subjects diagnosed with T2DM and on unchanged metformin treatment at the maximum tolerated dose (at least 1000 mg/day and up to 3000 mg/day) for at least 90 days prior to screening
* HbA1c 7.5 - 10.5% (53 mmol/mol - 91 mmol/mol) (both inclusive)
* Body Mass Index (BMI) equal to or above 20 kg/m\^2

Exclusion Criteria:

* Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. (Adequate contraceptive measures as required by local law or practice)
* Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. Exception is short-term treatment (equal to or below 7 days in total) with insulin in connection with intercurrent illness
* History of chronic pancreatitis or idiopathic acute pancreatitis
* Screening calcitonin value equal to or above 50 ng/L
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
* Impaired liver function, defined as alanine aminotransferase (ALAT) equal to or above 2.5 times upper normal limit (UNL)
* Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m\^2 per Modification of Diet in Renal Disease (MDRD) formula
* Any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant cardiovascular event as judged by the investigator within 90 days prior to screening
* Heart failure, New York Heart Association (NYHA) class IV
* Uncontrolled hypertension (defined as systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg)
* Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)