cyrilzakka/clinical-trials huggingface dataset:
A Study of Anlotinib Hydrochloride Capsules in Subjects With Diffuse Large B-Cell Lymphoma

This is an open-label, single-center, single-arm study to evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules in subjects with diffuse large B-cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* 1. ≥18 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, life expectancy≥ 12 weeks.

  2. Histopathologically confirmed diffuse large B-cell lymphoma (DLBCL) . 3. Has received at least 2 lines of systemic treatment. 4. At least one measurable lesion in vertical directions(based on Lugano 2014). 5.Adequate organ system function. 6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ; No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.

  7. Understood and signed an informed consent form.

Exclusion Criteria:

* 1. DLBCL transformed from indolent lymphoma (such as FL), primary testicular DLBCL, primary central nervous system lymphoma, mixed lymphoma (such as B cell lymphoma that cannot be classified between HL and DLBCL) Tumor, etc.), Richter's transformed DLBCL.

  2. Has central nervous system (CNS) invasion. 3. Has received vascular endothelial growth inhibitor, such as sunitinib, sorafenib, pazopanib, imatinib, famitinib, apatinib, anlotinib and so on.

  4. Has other malignancies (except cured skin basal cell carcinoma and cervical carcinoma in situ) within 3 years.

  5. Has a history of immunodeficiency. 6. Has multiple factors affecting oral medication. 7.Has uncontrollable or important cardiovascular disease. 8.Has any severe and/or uncontrolled diseases. 9. Has received surgery, or unhealed wounds within 4 weeks before the first administration.

  10. Has received systemic steroid therapy within 7 days before the first administration.

  11. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear.

  12. Has any bleeding symptoms or treated with anticoagulants or vitamin K antagonists.

  13. Has arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident including transient ischemic attack, deep vein thrombosis and pulmonary embolism.

  14. Has psychotropic substances abuse or a mental disorder. 15. Has received autologous hematopoietic stem cell transplantation within 3 months before the first administration, or have received allogeneic hematopoietic stem cell transplantation, or have graft-versus-host reaction.

  16. Has received other anti-tumor therapy within 4 weeks before the first administration.

  17.According to the judgement of the researchers, there are other factors that may lead to the termination of the study.

  18. Unsuitable for anlotinib hydrochloride.
GERD Treatment With Transoral Incisionless Fundoplication (TIF) Following Hiatal Hernia Surgery

The investigators prospectively studied ninety nine GERD patients following laparoscopic hiatal surgery combined with transoral incisionless fundoplication at two community hospitals. General surgeons and gastroenterologists participated in the study. GERD questions were recorded before and at six and twelve months.

GERD unresponsive to medical therapies can be treated by laparoscopic Nissen fundoplication or endoluminal techniques. The investigators have extensive experience with Transoral Incisionless Fundoplication(TIF). TIF is not indicated in patients with a hiatal hernia larger than 2 cm. Performing a Hiatal Hernia Repair(HHR) in those cases will make a patient eligible for TIF. HHR followed immediately by the TIF procedure under the same anesthetic session is called a Hybrid-TIF (HTIF). The study examines the safety and efficacy of this approach.

Prospective data were collected from patients who underwent HTIF at two 300 bed community hospitals. Questionnaires were administered before the procedure, and mailed at 6 and 12 mos. They were the GERD-HRQL-health related quality of life, RSI-reflux symptom index, and GSRS-gastrointestinal symptom rating scale.

The study continues with the new Esophyx-Z device

Eligibility Criteria:
Inclusion Criteria:

* Patients with typical or atypical GERD who want a surgical solution to control symptoms.
* Patients need a 2-5 cm hiatal hernia and have a BMI of less than 36.

Exclusion Criteria:

* Hiatal hernias larger than 5 cm and BMI greater than 36.
Mesh Repair of Anterior Vaginal Wall Prolapse

The purpose of this study is to determine whether reenforcement with polypropylen mesh compared with traditional anterior colporrhaphy for anterior vaginal wall prolapse results in fewer recurrences.

Anterior vaginal wall prolapse is the most common type of pelvic organ prolapse in postmenopausal women. This anatomic defect has traditionally been repaired with anterior colporrhaphy plication, a series of interrupted stitches being the main surgical component. The procedure is associated with a high recurrence rate, up to 32 % even after using paravaginal repair along with anterior colporrhaphy.It has been sought to resolve the problem of recurrence using artificial mesh as in the repair of abdominal hernias.

Comparison: Anterior vaginal wall repair with or without reinforcement with polypropylene mesh were compared in a prospective randomized study

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with symptomatic anterior vaginal wall prolapse to the hymen or beyond when under strain and referred for reconstructive pelvic surgery

Exclusion Criteria:

* an apical defect indicating concomitant vaginal fixation, or stress urinary incontinence necessitating surgery, or her main symptomatic prolapse component was in the posterior vaginal wall.
GRam Stain-guided Antibiotics ChoicE for Ventilator-Associated Pneumonia (GRACE-VAP) Trial

Background: Optimising the use of antibiotic agents is a pressing challenge to overcoming the rapid emergence and spread of multidrug-resistant pathogens in intensive care units (ICUs). Although Gram staining may possibly provide immediate information for predicting pathogenic bacteria, Gram stain-guided initial antibiotic treatment is not well established in the ICU setting. The investigators planned the GRam stain-guided Antibiotics ChoicE for Ventilator-Associated Pneumonia (GRACE-VAP) trial to investigate whether Gram staining can safely restrict the use of broad-spectrum antibiotics in patients with ventilator-associated pneumonia (VAP), which is one of the most common hospital-acquired infections in ICUs.

Methods/Design: The GRACE-VAP trial is a multicenter, randomised, open-label parallel-group trial to assess the non-inferiority of Gram stain-guided initial antibiotic treatment to guidelines-based initial antibiotic treatment for the primary endpoint of clinical cure rate in patients with VAP. Secondary endpoints include the coverage rates of initial antibiotic therapies, the selected rates of anti-pseudomonal agents and anti-methicillin-resistant Staphylococcus aureus (MRSA) agents as initial antibiotic therapies, 28-day all-cause mortality, ICU-free days, ventilator-free days, and adverse events. Participants are randomly assigned to receive Gram stain-guided treatment or guidelines-based treatment at a ratio of 1:1. In the Gram stain group, results of Gram staining of endotracheal aspirate are used to guide the selection of antibiotics. In the guidelines group, the combination of an anti-pseudomonal agent and anti-MRSA agent are administered. A total sample size of 200 was estimated to provide a power of 80% with a 1-sided alpha level of 2.5% and a non-inferiority margin of 20%, considering 10% non-evaluable participants.

Discussion: The GRACE-VAP trial is expected reveal whether Gram staining can reduce the use of broad-spectrum antibiotics without impairing patient outcomes and thereby provide evidence for an antibiotics selection strategy in patients with VAP.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing mechanical ventilation in the ICU
* Patients undergoing mechanical ventilation for at least 48 hours
* Patients diagnosed as having VAP, which is defined by a modified clinical pulmonary infection score of 5 or more

Exclusion Criteria:

* Patients having an allergy to study medications
* Pregnant patients
* Patients discharged from ICU
* Patients diagnosed as having heart failure or atelectasis
* Patients administered antibiotics for more than 24 hours when they meet the inclusion criteria
* Patients declined to provide full life support
* Patients judged as inappropriate at the discretion of the study physician.
The Effect of Luteinizing Hormone (LH) Supplementation Following Gonadotropin-releasing Hormone (GnRH) Antagonist Administration in Advanced Reproductive Ageing Women Undergoing IVF and Embryo Transfer (IVF/ET)

To explore whether recombinant LH (rLH) supplementation (Leuveris) to recombinant follicle stimulating hormone (rFSH) following GnRH antagonist treatment has an advantage in infertile women with advanced reproductive ageing undergoing IVF-ET.


Eligibility Criteria:
Inclusion Criteria:

* female candidate to IVF
* between 30-45 years old

Exclusion Criteria:

* not included for fertilization
PERIoperative Holistic RIsk Factor SCreening in the Prevention of Persistent Pain

Assessment and management for improved wellbeing after elective surgery (PERISCOP³E-Care) Diagnostic assessment tool evaluation and cut-off determination for participation in a transmural perioperative care program

Adult patients (≥ 18y) who are planned to undergo an elective surgery at the University Hospital Antwerp, will be invited to participate. After signing the informed consent, they will be asked to complete questionnaires (PERISCOP3E-care; Kalkman \& modified-Althaus, DN4, HADS, Stait-trait, NRS, MPIn EQ-5D-5L) that involve screening of the risk to develop persistend postoperative pain (PPSP).

The questionnaires will be completed via a survey link to the RedCap platform. Invites will be send out via the patient's e-mail.

Demograpic data and relevant medical history, surgery history, concomitant medication will be registered.

one month and three months post surgery the patients will be contacted to identicate if they developed PPSP. They will also be asked to complete quesionnaires (MPI, HADS, Stai-Trait, NRS, MPI, DN4). Based on this info, the cut-off value will be defined for the preoperative questionnaire. Analysis will be done for the sensitivity and specificity of the questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Adult patiënts (≥ 18 year)
* planned elective surgery @ University Hospital Antwerp

Exclusion Criteria:

* incapacitated
* cognitive dificit that makes it impossible to complete the questionnaires
* language barrier
Multimodal Investigation of Intracranial Clot Environment

Analysis of peri clot blood collected at the acute phase of stroke in order to understand physiopathological mechanisms involved in the cerebrovascular damage

It has been shown that immune cells accumulate around the clot at the acute phase of stroke. Leukocytes and their specific chemokines and cytokines regulation may impact cerebrovascular integrity.

Eligibility Criteria:
Inclusion criteria:

1. Over 18 years of age,
2. Non-dependent for activities of daily living prior to the onset of the MI (Modified Rankin Score \>2)
3. Having an occlusion of a large arterial trunk proven by imaging (angio-MRI or angio-scanner).

Exclusion criteria:

1. Patients initially admitted but for whom endovascular treatment will not finally be performed (re-infusion, catheterization failure...) will be excluded from the study.
2. Major patients under guardianship or curatorship or patients deprived of liberty
A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease

The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe hand-foot-mouth disease.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of severe hand-foot-mouth disease patients according to hand-foot-mouth disease treatment guidelines 2010 issued by China's Ministry of Health
2. not more than 24 hours of occurrence of severe symptoms
3. age of 1-13 years
4. Patients or their guardians agree to participate in this study and signed the informed consent form

Exclusion Criteria:

1. Suffering from neurogenic pulmonary edema, heart or lung failure.
2. Complicated with other serious diseases such as chronic hepatitis, congenital heart disease, acute or chronic nephritis and blood diseases, etc
3. the history of allergies on Chinese medicine
4. the history of mild increase of blood bilirubin hemolysis (or uric bravery former positive) phenomenon
5. using hormonal therapy
6. Attending other clinical studies on hand-foot-mouth disease
7. Patients or their guardians suffering from mental illness
Behavior During Experimentally Induced Pain

Numerous factors can influence the processing of pain message: the affective or emotional, the sensorial and the cognitive components. Interindividual variations at the emotional and cognitive levels may interfere with the pain message and the consecutive behavior. Some modifications in these components are observed in psychiatric troubles, but their influences on the behavior to pain have not been studied, although they have been studied in some populations characterized as non communicating, with obvious cognitive degradations (subject with dementia, older, newborns,...).In an other study in course, the past pain experience is explored in relation to results to experimental pain tests, emotional and anxious characteristics. This present pilot study aims at studying the infra-verbal behavioural signs during experimentally induced pain in subjects with schizophrenia, major depression, and controls.

The objective is to search for behavioral non verbal indicators of pain during experimentally induced pain (pressure application, ischemia induction).

Included subjects are subjected to experimental pain tests : pressure application (160 kPa) with an algometer to determine the pain with Visual Analogic Scale (VAS), and ischemia induction to determine the time needed to feel pain with an intensity equivalent to 3 with the VAS.

Subjects are filmed during experimentation to identify the corporal mobility signs, facial expression signs and sonorous signs associated to pain stimulation.

Neurophysiological measures complete these observations : surface electromyogram, heart rate measure, blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* subjects with psychiatric trouble : diagnosis of schizophrenia or major depression according to the DSM-IV-TR criteria.
* control subjects : without known psychiatric history.
* age between 18 and 60.

Exclusion Criteria:

* absence of consent, hospitalization under constraint, absence of health insurance.
* inability to answer the questionnaires
* pregnancy
* antalgic or analgesic treatment
* allergy to latex
* non stabilized high blood pressure, bad blood coagulation,
* peripheral neuropathy, nerve lesion, dermatosis at the superior extremities, muscular lesion or pathology at the upper member level
* non treated alcohol dependence
* illegal substance consumption in the past 48 hours
* participation to an other biomedical study during the 2 weeks before inclusion, and until the pain tests, if this study can interfere with the realization of the objectives
Effectiveness of Bisacodyl Suppository Agent for Dose Reduction of Low Dose PEG

Proper bowel cleansing before colonoscopy is an important factor to increase the detection rate of lesions. Low volume polyethylene glycol (PEG) plus ascorbic (PEG-Asc) has reduced the dosage of previous bowel preparation agent, but it still presents discomfort to patients. The aim of this study was to confirm the efficacy and convenience of volume reduction of PEG-Asc by adding bisacodyl suppository at the same day by compared with conventional 2L PEG-Asc.

Eligibility criteria: outpatients between the ages of 20 and 70 years, who were scheduled for colonoscopy between August 2017 and January 2018

Exclusion criteria: patients with a history of gastrointestinal tract surgery, inflammatory bowel disease, severe active colitis, underlying chronic kidney disease, or pregnancy.

Outcome measures: the Boston Bowel Preparation Scale (BBPS)

Eligibility Criteria:
Inclusion Criteria:

* outpatients who were scheduled for colonoscopy between August 2017 and January 2018

Exclusion Criteria:

* History of gastrointestinal tract surgery
* History of inflammatory bowel disease
* History of severe active colitis
* History of chronic kidney disease
* pregnant woman.
Neuropsychobiology of Brain Theta-burst Stimulation: A Mind-body Interface for Depression

This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function, and peripheral biomarkers in MDD patients.

This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function (e.g. functional MRI, PET, and qEEG), peripheral biomarkers (e.g. candidate genetic expression, neuroendocrine, inflammation, and neurotransmissions) in MDD patients.

Eligibility Criteria:
Inclusion Criteria:

* The diagnostic criteria of DSM-IV for MDD
* The range of the age from 18 to 70-year-old
* Physically healthy on medical history, physical examination, and laboratory parameters within normal limits
* Competent for a full explanation of the study and written informed consent is obtained.

Exclusion Criteria:

* Having other current Axis I disorders (except nicotine dependence), patients with psychotic disorders, bipolar disorders, organic mental disorders, and a prevailing strong suicidal risk were excluded
* Pregnant
* History or family history of seizure disorder
* Known neurological disorders or evidence of central nervous system disease based on baseline complete neurological examination, electroencephalography, and magnetic resonance imaging of the brain
* Having ferromagnetic material in the body or close to the head (implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull)
Effects of 3 Months of Controlled Whole Body Vibrations on the Risk of Falls Among Nursing Home Residents

Tiredness, lack of motivation and low compliance can be observed in nursing home residents during the practice of physical activity. Because exercises should not be too vigorous, whole body vibration could potentially be an effective alternative.

The objective of this randomized controlled trial is to assess the impact of 3-month training by whole body vibration on the risk of falls among nursing home residents.

Patients were randomized into two groups: the whole body vibration group which received 3 training sessions every week composed of 5 series of only 15 seconds of vibrations at 30 Hz intensity and a control group with normal daily life for the whole study period.

The impact of this training on the risk of falls was assessed blindly by three tests: the Tinetti Test, the Timed Up and Go test and a quantitative evaluation of a 10-second walk performed with a tri-axial accelerometer.


Eligibility Criteria:
Inclusion Criteria:

* Resident of nursing home
* Able to move

Exclusion Criteria:

* weighing more than 150 kg
* having electronic implants (e.g. pacemaker, brain stimulators)
* having prosthetic hips or knees
* suffering from epilepsy, bleeding disorders, inflammatory abdominal disorders or at high risk of thromboembolism.
M-mode Ultrasonography in the Assessment and Treatment of Pelviperineal Dysfunctions (PerineUM)

Objectives: To analyze the Mode M ultrasound use in the assessment of pelvic floor musculature (PFM) and in the rehabilitation of motor control in pelviperineal dysfunctions that affect the support of pelvic organs, urinary and fecal continence and reproductive and sexual functions.

Methodology: A cross-sectional descriptive study will be followed by a randomized clinical trial. There will be two samples: a sample of volunteers without PFM dysfunction; and a sample of patients with pelviperineal dysfunction derived from health centers in the Region of Murcia. An intra- and interobserver reliability study of transabdominal M-mode ultrasound of PFM will be performed. Then, a cross-sectional descriptive study of the functional behavior of PFM will be used in different functional situations such as: voluntary contraction at maximum force, fast contraction, Valsalva maneuver and forced cough. The following ultrasound variables will be measured: direction and amount of displacement, speed of displacement and time of contraction. Correlations between ultrasound variables and sociodemographic and clinical variables will be analyzed. The randomized clinical trial will compare a PFM contraction awareness treatment based on endocavitary digital contact with a motor learning program based on transabdominal mode M ultrasound biofeedback.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pelvic floor dysfunction derived from the pelvic floor unit of HLA La Vega in the city of Murcia diagnosed by the doctor and without previous training in pelvic floor muscles contraction.

Exclusion Criteria:

* Pregnancy, a history of pelvic floor surgery in the previous year, neurological injury with affectation of the sacral reflex from S2 to S4, previous delivery in a period of less than 6 weeks or known or suspected urinary tract infection.
Postoperative Analgesia by Epidural vs IV Ketamine Concurrent With Caudal Anesthesia in Pediatric Orthopedic Surgery

Preemptive analgesia can improve postoperative pain management. Ketamine may prevent central sensitization during surgery and result in preemptive analgesia. The purpose of this study is to examine the effectiveness of ketamine as a preemptive analgesic as previous studies have shown the involvement of N-methyl-D-Aspartate (NMDA) receptor in neuroplasticity.

After receiving consent inform from parents, 40 children scheduled for orthopedic surgeries will be randomized to one of two groups: epidural group and intravenous group, both will receive 1 mg kg-1 S(+)-ketamine. All patients will receive caudal block anesthesia with marcaine. Cardiovascular monitoring will be assessed during operation. Follow up will continue for 24 hours after caudal block. Duration of analgesia, first time of analgesic request and complications will be recorded by an orthopedic assistant that is blinded to study. Data will be analyzed statistically by Chi square, t test and nonparametric tests.

Eligibility Criteria:
Inclusion Criteria:

* Children aged \< = 12 years
* Children scheduled for elective orthopedic surgery with caudal block
* ASA score \< = 3

Exclusion Criteria:

* Contraindication for caudal block such as vertebral defect or infection at the site of block
* Disagreement of parents
* Patient's age \> 12 years
* ASA score \> = 4