cyrilzakka/clinical-trials huggingface dataset:
Study on Neoadjuvant Chemotherapy for Advanced Gastric Cancer

Gastric cancer is the second cause of cancer related death and China has the most gastric cancer patients in the world. Although systemic strategies, including adjuvant chemotherapy, postoperative chemoradiotherapy, perioperative chemotherapy, have evolved and showed benefits these years, the prognosis of advanced gastric cancer is still not satisfactory. Optimal regimens and optimal method administration is still being found. Neoadjuvant chemotherapy has many advantages, including downstaging the tumor, increasing R0 rate, early eradicating of micrometastasis. In previous trials, combination of paclitaxel and s-1 has showed safety and tolerance in recurrent or metastatic gastric cancer. Using liposome as a carrier, paclitaxel has a better histocompatibility and cellular affinity, resulting a improved stability and reduced toxicity. In this phase II trial, we are going to study the safety and feasibility of paclitaxel liposome plus s-1 as neoadjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed gastric cancer
* Disease at clinical stage of resectable or potentially resectable(T3-4, N0-3, M0) by CT and endoscopic ultrasonography (EUS)
* Karnofsky performance status(KPS） ≥ 70
* No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy
* Life expectancy more than 3 months
* Adequate organ function as defined below:White Blood Cell Count （WBC） ≥ 3.0\*10\^9/l, Absolute Neutrophil Count （ANC） ≥ 1.5\*10\^9/l, Hemoglobin ≥ 100 g/l, Platelets ≥ 100\*10\^9/l, Total Bilirubin （TBIL） ≤ 1.5mg/dl, Aspartate Aminotransferase（AST） and Alanine Aminotransferase(ALT) ≤ 2.5×ULN, Alkaline pPosphatase( ALP) ≤ 2.5×ULN, Renal Serum Creatinine \< 1.5mg/dl
* Adequate lung and heart function

Exclusion Criteria:

* ≥ grade 2 neuropathy
* History of malignancy
* With uncontrolled central nervous system metastasis
* Concurrent disease or condition that would interfere with the subject's safety (including current active hepatic, biliary, renal, respiratory disease, acute infection, severe malnutrition, uncontrolled diabetes hypertension et al)
* Severely inadequate intake of water or diet
MRI Gadopiclenol Enhanced Imaging of CNS Tumors

The purpose of this pilot study is to compare a standard of care MRI scan to a non-standard of care MR imaging with portable (0.064 Tesla) MRI following the administration of non-SOC contrast called Gadopiclenol on 10 subjects with known brain tumors.

Participants will be randomized to receive either standard MRI or portable MRI first following contrast injection

This study compares a routine MRI scan with a new portable MRI scanner known as the "Hyperfine" using a contrast dye called Gadopiclenol, the contrast is FDA approved. If participants choose to participate in this study, they will receive two MRI scans on the same day. One on the traditional standard of care MRI scanner and the other on the new portable Hyperfine MRI. The Hyperfine MRI scanner is not FDA approved due to being a very low risk medical device. However, the device is compliant with all of the FDA requirements regarding design control regulations and risk analysis. Participants will only receive one contrast injection that will be used for both scans. The selection of which scan is given first will be randomly selected (50/50 chance). Participation in this study will last two days. The first day participants will receive both MRI scans and the second day participants will receive a phone call from the research staff to check on them.

Eligibility Criteria:
Inclusion Criteria

* Female or male adult patient (18 years and older).
* Patient presenting, at the time of inclusion, with known or highly suspected focal areas of disrupted Blood Brain Barrier (BBB) due to primary or secondary tumor/s. This lesion must have been detected on a previous imaging procedure (computerized Tomography (CT) or MRI).
* Patient scheduled for a routine CNS contrast-enhanced MRI examination for clinical reasons.
* Patient able and willing to participate in the study.
* Patient with health insurance.

Exclusion Criteria

* Patient presenting with acute or chronic Grade III (at least) renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) \<60 mL/min/1.73m² based on eGFR assessment on the day of each MRI.
* Pregnant or breast-feeding female patient (a female patient of childbearing potential must be using a medically approved contraception method until the last study visit).
* Patient with any contraindication to MRI examinations including active implants, passive implants which are MRI incompatible, and metallic foreign bodies.
* Patient with known contra-indication(s) to the use or with known sensitivity to any GBCA.
* Patient having received any contrast agent (MRI or CT) within 3 days prior to study gadopiclenol administration
Investigate the Effect of the CREON2000A on Asthma Control in Children With Mild to Moderate Persistent Asthma

This is a pivotal, 12-month, randomized, sham controlled, parallel group, multicenter, double blind study with an allocation ratio of 1:1. The study population is children between the ages 6 to 17 years, with mild to moderate persistent asthma. The purpose of the study is to determine whether the CREON2000A, an environmental control device, will decrease asthma severity, as measured by the Composite Asthma Severity Index (CASI), in children with mild to moderate persistent allergic asthma over a twelve month period.

The pilot study (Protocol #PA-01-052; Health Effects of CREON2000 in Asthmatic Children. IB ID# GI 1001) offered preliminary evidence that the CREON2000A system may be beneficial in asthma. This study is a follow-up, using children, aged 6 to 17 with mild to moderate persistent asthma, as the subjects of the study. Children are usually treated with fewer controller medications and have fewer confounding co-morbidities making it more likely to detect a therapeutic benefit from an environmental intervention. The study will involve 4 study site visits, 2 home visits, and 7 phone calls. Adjustment of asthma therapy by the site clinician will occur at baseline (Visit 1) and at each follow-up office visit after Visit 1 using a modified algorithm based on the National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP EPR3) guidelines. Enrollment will be over 18 months. The study duration for each subject will be 12 months.

Eligibility Criteria:
Inclusion criteria

1. Males and Females ages 6.0 to 17.0 years.
2. Subjects with a physician diagnosis of mild or moderate persistent asthma.
3. FEV1 ≥ 60% predicted with ≥ 12% improvement after bronchodilator therapy.
4. Must have evidence of; 1) serum specific IgE (immunocap) ≥ .35 or 2) a positive skin prick test to one or more common indoor allergens including standardized house dust mite, cat, dog, cockroach, mouse in the past.

Exclusion criteria

1. Current smokers
2. Passive exposure to environmental tobacco smoke at home or active fireplaces and other sources of air particulates (wood burning stoves, kerosene heaters) at home.
3. Diagnosed by a physician with a chronic lung disease other than asthma.
4. Upper or lower respiratory infection within four weeks prior to enrollment.
5. Known to have any other chronic illness (besides asthma) that is not well controlled at the time of screening (Visit 1).
6. History of a life threatening asthma attack requiring cardiopulmonary support, intubation with ventilatory support, hospitalization in an intensive care unit or hospitalization for asthma within 6 months preceding study screening (Visit 1).
7. Participation in another investigational drug/device study within the past 3 months (not including chart or observational studies)
Effect of Perinatal Emotional Management on Maternal Emotion and Delivery Outcomes

Pregnancy or childbirth is a kind of persistent and strong source of stress for pregnant women. Prenatal and intrapartum negative emotions not only damage the mental health of pregnant women, but also have a negative impact on the mode of delivery, labor, postpartum complications and neonatal outcomes . Due to considerations for the effect on the fetus, there is concern of the use of drug treatment for depression during pregnancy. Therefore, psychological interventions have an important role. According to the WHO global survey in Asia 2007-08, China had the highest overall rate of caesarean section (46.2%), and also had the highest rate of caesarean section without indication (11.7%). The embarrassing "first in the world" of caesarean section rate was causing widespread concern in China. Recently, the Chinese government has launched a project named "promoting the rate of natural childbirth and protecting the health of mother and child", trying to reduce the cesarean section rate especially that without medical indication. Therefore, examining if emotional management is effective in reducing negative emotions of pregnant women as well as decreasing the rate of cesarean section is an important research question. Our study aims to help the pregnant women control their anxiety, depressive feelings and other negative emotions by "emotional self-management group training" and we examine if this can reduce the incidence of depression and improve delivery outcomes.

This study tried to explore the effectiveness of prenatal emotional management on pregnant women' delivery outcomes. All participants filled the Questionnaire (PHQ-9) at the baseline assessment. Then they were randomly assigned into the emotional management (EM) group and the usual care (UC) group. The baseline evaluation began at 31 weeks of pregnancy and the mother was followed up to 42 days postpartum. Each subject received the EM package In the EM, and the UC was given only routine prenatal care. PHQ-9 and Edinburgh Postnatal Depression scale（EPDS）were used for assessment.

Eligibility Criteria:
Inclusion Criteria:

1. never have a baby before,
2. with single fetus, head position and normal pelvic measurements,
3. were receiving regular antenatal care,
4. were able to schedule and fulfill questionnaires independently.

Exclusion Criteria:

1. situation with pregnancy complications,
2. surgical history of diseases,
3. current or previous history of any kind of mental disorders.
The Effects Of Relaxation Training In Women With Primary Dysmenorrhea

The aim of this study was to investigate the effects of relaxation training on menstrual pain severity, menstrual symptoms, impact of quality of life, impact of work/academic performance, impact of social activity level and anxiety level in women with primary dysmenorrhea (PD) complaints.

PD is the cramping pain that comes before or during a menstrual period. Relaxation training contributes to the reduction of stress and pain. Thus, there is a need to investigate the effects of relaxation training in dysmenorrhea.

Eligibility Criteria:
Inclusion Criteria:

* Women with primary dysmenorrhea complaint according to the Primary Dysmenorrhea Consensus Guide,
* Over 18 years of age,
* Having a mean pain intensity of moderate and higher according to the Visual Analogue Scale in the last 6 months,
* Having a regular menstrual cycle (28±7 days),
* Volunteered to participate in the study.

Exclusion Criteria:

* Having a pathological history and radiological findings pointing to secondary dysmenorrhea,
* Using oral contraceptives/antidepressants at least 6 months,
* Receiving hormone therapy,
* Undergoing pelvic surgery,
* Pregnant,
* Giving birth,
* Using an intrauterine device,
* Having neurological, orthopedic and/or rheumatological diseases
* Having a psychiatric disease,
* Having a history of malignancy
Effect of Neutrophil Lymphocyte-platelet Lymphocyte Ratio on Complications in Pediatric Patients

The aim of this study was to investigate the relationship between NLR, PLR and postoperative complications in children undergoing adenotonsillectomy and adenoidectomy.

Between the dates of February 1, 2018 and June 30, 2018, patients between 2-10 years of age, ASA I-II, elective adenotonsillectomy and adenoidectomy under general anesthesia were planned to be included in the study. The number of neutrophils, lymphocytes and platelets will be taken from the hospital registry system taken preoperatively and the NLR and PLR ratios will be calculated.

All patients in the operating room will be started with routine monitoring and anesthesia. Hemodynamic data during surgery will be recorded. The entrance to the operating room (T1), 5 minutes after the start of anesthesia (T5), 15 minutes (T15), 30 minutes (T30) and 45 minutes (T45) will be recorded in the follow-up form of the anesthesia. The fasting period of the patients and the drugs and fluids applied during surgery will be recorded from the anesthesia form. At the end of the operation, the patients who were taken to the recovery room at the end of the surgery will be evaluated with 1 point, 15 minutes, 30 minutes, 1 hour and 4 hours and 6 hours vomiting using the 4 point nausea scale.

Introduction to recovery room using Modified Eastern Ontario Children's Hospital Pain Scale (mCHEOPS), postoperative pain at 15 min, 30 min, 1 hr and 4 hr. Analgesic requirement will be recorded. Bronchospasm, agitation, etc. will be recorded by evaluating whether there are complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective adenotonsillectomy and adenoidectomy under general anesthesia

Exclusion Criteria:

* Immunodeficiency
* Children of parents who do not want to participate in the study
* Use of anticoagulants
* Children with hematological disease
Phase II Trial for Patients With Loco-Regional Esophageal Carcinoma

The purpose of this study is to determine whether bevacizumab can improve the outcome of treatment for patients with esophageal cancer whose disease is confined to the esophagus or the closely surrounding lymph nodes.

Standard treatment is pre-operative chemotherapy and radiation, followed by surgery. In this study, bevacizumab will be added to the pre-operative chemotherapy and radiation, and then bevacizumab will also be administered for a year after surgery. Bevacizumab is a humanized monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer) produced by Genentech, Inc. using recombinant DNA technology. Bevacizumab has been approved by the FDA for the treatment of metastatic colorectal cancer in combination with chemotherapy. Bevacizumab is experimental in the treatment of esophageal cancer and has not been approved by the FDA for the treatment of esophageal cancer. Bevacizumab is an antibody directed against vascular endothelial growth factor, or VEGF. VEGF is a growth factor with a well defined role in normal and abnormal blood vessel formation. It is present in a wide variety of normal tissues, but is produced in excess by most solid cancers (tumors). In the setting of cancer, VEGF promotes the growth of blood vessels that bring nutrients to tumor cells. In studies with laboratory animals, bevacizumab inhibits the growth of several different types of human cancer cells, including colon cancer cells, by blocking the effects of VEGF. By blocking VEGF, your doctors hope that bevacizumab may decrease blood supply to the tumor, and therefore decrease the ability of the tumor to grow and come back after chemotherapy, radiation, and surgery.

Eligibility Criteria:
Inclusion Criteria:

1. No prior treatment for esophageal cancer
2. No prior radiation to the chest or upper abdominal area
3. No prior treatment with an EGFR inhibitor or an anti-angiogenic agent
4. Disease should be limited to the esophagus and regional lymph nodes -

Exclusion Criteria:

1. History of stroke
2. History of heart attack
3. Inadequately controlled high blood pressure
The Effect of a Methylprednisolone Taper on Outcomes Following Total Knee Arthroplasty

Pain control and early range of motion following total knee arthroplasty are essential for patient satisfaction. Intraoperative steroids (dexamethasone) have been shown to have a significant effect in controlling acute pain following total knee arthroplasty. This study aims to evaluate the effect of a post-operative steroid (methylprednisolone) taper in improving functional and patient-reported outcomes following total knee arthroplasty. A taper means taking a high dose of a medication followed by taking lower doses and each following day until the medication is stopped.


Eligibility Criteria:
Inclusion Criteria:

* Patients indicated for primary total knee arthroplasty.
* Access to computer or smartphone for completion of REDCap surveys

Exclusion Criteria:

* Patients less than 18 years of age, patients unable to consent, known diabetic patients and those with an HgbA1c \>6.5 preoperatively, patients who are on chronic steroid treatments, patients with chronic pain on opioid management, patients with allergies to steroids, patients with a history of peptic ulcer disease, patients with a history of heart failure and patients with a history of renal and/or hepatic failure will be excluded. Those that are immunosuppressed as well as pregnant and/or lactating will also be excluded.
Repeated Treatments of QLT091001 in Subjects With Leber Congenital Amaurosis or Retinitis Pigmentosa (Extension of Study RET IRD 01)

The purpose of this study is:

* To evaluate the safety of up to 3 additional courses of oral QLT091001 administered once daily for 7 days in subjects treated previously with a single 7-day course of QLT091001 in Study RET IRD 01
* To evaluate whether up to 3 additional courses of oral QLT091001 administered once daily for 7 days can maintain or improve visual function.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with LCA or RP due to RPE65 or LRAT deficiency who received a 7-day treatment course of QLT091001 and completed the Day 30 visit in Study RET IRD 01
* Subjects who meet any one of the following criteria at least 1 month after start of the 7-day treatment course in Study RET IRD 01:

  * no increase in GVF (in at least 1 eye): Follow-up GVF increased ≤20% from baseline or
  * decrease in GVF (in at least 1 eye): Follow-up GVF decreased below the highest previous response by ˃20% or
  * Considered a reasonable candidate for retreatment, based on the Investigator's discretion, in consultation with the independent DSMB and the Sponsor, based on regression or lack of response in other parameters of visual function (e.g., subjective reports of changes in color vision or adaptation to low light) but who do not meet other (GVF) criteria for study entry

Exclusion Criteria:

* Subjects with any clinically important abnormal physical finding at Screening.
* Subjects who have taken any prescription or investigational oral retinoid medication (e.g., Accutane,® Soriatane®) within 6 months of Day 0 and subjects who did not tolerate their previous oral retinoid medication will be excluded regardless of the time of last exposure.
* Subjects with liver failure, uncontrolled thyroid disease, hypersensitivity to retinoids, or hypervitaminosis A
* Subjects who have taken any supplements containing ≥10,000 IU vitamin A within 60 days of screening
A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer

To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.

Hematuria is the most common presentation of BCa with 8% of patients with microscopic hematuria harboring BCa. VUC is the most widely used urine-based assay for detecting BCa; however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Because of this severe limitation, patients with hematuria will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder.

We propose to improve the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Have documented or reported microscopic hematuria within 3 month of study enrollment
* Willing and able to give written informed consent

Exclusion Criteria (participants must not):

* Have history of BCa
* History of previous cancer (excluding basal and squamous cell skin cancer)
* Have a known active urinary tract infection or urinary retention
* Have active stone disease (renal or bladder) or renal insufficiency (creatinine \>2.0 mg/dL)
* Have ureteral stents, nephrostomy tubes or bowel interposition
* Have recent genitourinary instrumentation (within 10 days prior to signing consent)
* Be unable or unwilling to complete the hematuria evaluation (i.e., cystoscopy and upper tract imaging)
Training Executive, Attention and Motor Skills (TEAMS): Preliminary Studies

Training Executive, Attention and Motor Skills (TEAMS) is a new research program for preschool children with Attention-Deficit/Hyperactivity Disorder (ADHD) that attempts to use game-like activities and physical exercise to promote the growth of neural processes that underlie the core features of the disorder (e.g., hyperactivity, impulsivity) as well as associated areas of difficulty (e.g., socialization, motor skills). These activities are implemented at home and in supervised playgroups at no cost to families and are coupled with extensive parental education about ADHD symptoms and associated impairments.


Eligibility Criteria:
Inclusion Criteria:

1. Be at least 4.0 and less than 6.0 years of age;
2. Receive a T-score on the Hyperactivity scale of the Behavior Assessment System for Children, Second Edition (BASC-2) of at least 65 (1.5 SD above the mean) by either teacher or parent rating, and a score of at least 60 (1 SD above the mean) by the other rater;
3. Meet diagnostic criteria for ADHD-C or ADHD-HI as ascertained using the Kiddie-SADS, which will be administered to the parent.

Exclusion Criteria:

1. Chronic medical illness or is taking systemic medication;
2. Diagnosed neurological disorder;
3. Full Scale IQ below 80 as measured by the Stanford-Binet - Fifth Edition Abbreviated Battery;
4. Diagnosis of autism, pervasive developmental disorder or post-traumatic stress disorder;
5. Determined to be physically aggressive with other children;
6. Parent enrolled in a parent management training program;
7. Not attending school or day
A Study to Design a Model Cohort for Analysis of Dyslipidemia (MK-0653A-204)

This study is being done to provide valid data on the evolution of a cohort of French participants treated with ezetimibe, alone or in combination with a statin, to be used in simulation models for cardiovascular disease (CVD). Patterns of drug use, evolution of risk factors for CVD, cardiovascular morbidity and mortality, and goal attainment in low density lipoprotein cholesterol (LDL-C) levels over time will be analyzed.


Eligibility Criteria:
Inclusion criteria:

* Resident of Continental France
* Treated by ezetimibe either as monotherapy (Ezetrol®), or co-administered with a statin or administered in a fixed combination of ezetimibe and simvastatin (Inegy®)
* Incident treatment with ezetimibe at the time of recruitment into the study

Exclusion criteria:

* Unlikely to be followed-up for the next 6 months after recruitment due to a planned change of residence
* Participating in a clinical trial
* Unable to read the information letter in French and/or unable to participate in the telephone interview in French
Evaluation of TIP Urethroplasty With Spongioplasty-Dartosoraphy Reinforcement in Pediatric Hypospadias

The study aimed to evaluation of Tubularized incised palate urethroplasty with spongioplasty-dartosoraphy reinforcement (group A) through comparing of functional and cosmetic results of this technique with the conventional TIP urethroplasty (group B).


Eligibility Criteria:
Inclusion Criteria:

* lees than 14 years Distal hypospadias urethral plate size more than 6mm glans size more than 14 mm

Exclusion Criteria:

* recurrent cases Proximal; hypospadias