cyrilzakka/clinical-trials huggingface dataset:
Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial

A randomized non-inferiority trial of women with preeclampsia with severe features to determine if the addition of nonsteroidal anti-inflammatory drugs is inferior or non-inferior to standard analgesic bundles in their impact on postpartum hypertension.

Recently published clinical guidelines for the care of women with hypertensive disorders recommended that nonsteroidal anti-inflammatory drugs (NSAIDs) should be withheld from patients with hypertension that persists for more than one day postpartum (1). This recommendation is based in data from the general medicine literature, which suggests a role of NSAIDs in precipitating hypertension in non-pregnant adults (2,3). It may also draw from previously published case reports of post-partum hypertension that were thought to be NSAID induced (4). There has been a paucity of data from the obstetric literature to support or rebuff this recommendation. As the opioid crisis worsens in the United States, additional attention and resources have focused on limiting the use of narcotic medications. The effective employment of non-opioid analgesics has been shown to reduce narcotic use (5). Ibuprofen and other NSAIDs are the most effective and most commonly prescribed analgesics for postpartum pain, but clinicians now find themselves stuck between these recommendations and their efforts to limit unnecessary opioid prescriptions.

The investigators propose a randomized controlled non-inferiority trial of women with preeclampsia comparing a postpartum analgesic protocol that includes NSAIDs, to one that excludes them. The central hypothesis is that NSAID use does not worsen hypertensive diseases of pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Women at \> 23 weeks gestational age undergoing vaginal or cesarean delivery at Barnes-Jewish Hospital with:
* An antepartum diagnosis of preeclampsia with severe features
* Pre-eclampsia with severe features will be defined as:
* Elevated blood pressure ≥ 160/110, or
* Pre-eclampsia in the setting of thrombocytopenia (platelet count \< 100,000), or
* Impaired liver function (AST elevated to twice upper limit of normal), or
* Persistent epigastric pain, or
* Renal insufficiency (serum creatinine of 1.1 mg/dl or doubling of prior value), or
* Pulmonary edema, or
* New onset visual disturbance or headache unresponsive to therapy.

Exclusion Criteria:

* NSAID allergy
* Allergy to acetaminophen
* Antihypertensive use in this pregnancy prior to 20 weeks gestation
* Chronic kidney disease or Acute kidney injury with Creatine clearance less than 60 mL/min
* Inability to obtain consent
* Opioid abuse disorder
* Peptic ulcer disease.
Prospective Observational Study of the Sacubitril-Valsartan Treatment Effectiveness.

The aim of this prospective study is to demonstrate if there is any difference in the treatment response to Sacubitril-Valsartan depending on the ventricular disfunction ethiology in patients with severe systolic disfunction heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old.
* Ejection fraction (EF) ≤ 40%.
* Treated with optimal medical treatment for at least 3 months and remained in functional class II, III or IV.
* Patients with ischemic or non ischemic etiology.

Exclusion Criteria:

* Patients with enolic etiology.
* Patients with any contraindication for taking Sacubitril-Valsartan.
* Patients with EF \>40%.
Efficacy and Safety of Kinetin 0.1% for Treatment of Skin Photoaging

The purpose of the study is to evaluate the change in the severity and clinical signs of skin photoaging among Filipino patients using Kinerase cream (Kinetin 0.1%). This study will recruit 132 subjects from dermatological clinics in a tertiary hospital in the Philippines for a period of 3 months (12 weeks). Changes in severity will be documented using physician evaluation, self-evaluation, and through VISIA complexion analysis system.

This study is a single-arm, open-label, split-face trial in subjects with mild to moderate photoaged facial skin. The study will enroll around 132 subjects from selected private dermatology clinics in a tertiary hospital in the Philippines.

Patients from selected private dermatology clinics of a tertiary hospital will be screened and recruited to participate. They will be provided a written consent form (Appendix I) before they will be included in the study.

Following enrollment, subjects will return for outpatient visits at weeks 4, 8, and 12 for assessment.

The whole study will be conducted from July 2013 to November 2013. The first month would involve recruitment of patients. Qualified patients will start the 12-week treatment period and will be asked to follow up every 4 weeks. The last two months would be for data analysis, interpretation and writing of the scientific report.

Eligibility Criteria:
Inclusion Criteria:

* Filipino and Asian female subjects from private clinics of a tertiary hospital in the Philippines older than 35 years of age and less than 65 years of age.
* Subjects with mild to moderate cutaneous photoaging as assessed by the investigator's assessment 6-point scale.
* Subjects willing to sign an informed consent and adhere to all protocol requirements.

Exclusion Criteria:

* Suspected porphyria, systemic or cutaneous lupus erythematosus, or any other photosensitizing disorder or drug-induced photosensitization
* Chronic or recurring skin disease or disorder
* Any active infectious skin disorder (Herpes simplex, molluscum contagiosum, and facial warts)
* Skin cancer of the facial tissues
* Any laser/IPL/ chemical peel in the 2 months preceding the screening visit
* History of Isotretinoin use, 6 months prior to the screening disease
* Topical tretinoin or adapalene in the 2 months prior to the screening visit
* Used topical alpha-hydroxy acid skincare products in the month preceding the screening visit
* On any anti-aging products and who wish to continue use of their products
* Requiring concurrent treatment that would interfere with the study assessments
* Pregnant or lactating females
Treatment Adherence And Influencing Factors in Children With Helicobacter Pylori Infection During Eradication Therapy

The aim of this study is to describe the current status of treatment adherence in children with Helicobacter pylori infection, understand the medication literacy, medication beliefs of the children, knowledge of H. pylori among caregivers, medication beliefs, medication support, and explore the influencing factors of medication adherence.

Helicobacter pylori infection usually occurs in childhood and persists into adulthood, and is closely related to the occurrence of chronic gastritis, peptic ulcer, and gastric cancer. However, in recent years, the eradication success rate of Helicobacter pylori infection has gradually decreased, while the drug resistance rate has gradually increased, and it is urgent to improve the success rate of first eradication in children. Medication compliance is closely related to drug resistance, so it is necessary to investigate medication compliance and its influencing factors during Helicobacter pylori eradication in children.Children and caregivers who meet the inclusion and exclusion criteria were invited to individually complete questionnaire surveys.

Part One: Children infected with Helicobacter pylori and undergoing treatment were invited to complete the questionnaire surveys independently. The children completed the Medication Literacy Questionnaire, Medication Beliefs Specific Questionnaire, and Medication Adherence Questionnaire.

Part Two: Caregivers of the children completed the survey questionnaires, including a demographic information form, H. pylori knowledge questionnaire, Medication Beliefs Specific Questionnaire, and Medication Support Questionnaire.

Eligibility Criteria:
Children Inclusion Criteria:

* 1.Children aged 8-18 years old
* 2. whose diagnosis meets the diagnostic criteria for Helicobacter pylori infection in the Expert Consensus on Diagnosis and Treatment of Helicobacter Pylori Infection in Chinese Children (2022)
* 3. Children who receive Helicobacter pylori eradication therapy

Children Exclusion Criteria:

* 1.Children are diagnosed with other chronic conditions and take other medications for a long time
* 2.Unable to communicate with readers in Chinese normally

Caregiver Inclusion Criteria:

* 1.Caregivers of children who meet the diagnostic criteria for Helicobacter pylori infection in the Expert Consensus on Diagnosis and Treatment of Helicobacter pylori Infection in Children in China (2022)
* 2.Able to communicate normally

Caregiver Exclusion Criteria:

* 1.Not living with children
* 2.Not familiar with the use of children
Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer

Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries. The clinical phaseⅡtrial is designed to assess the resection rate and pathological complete response of nimotuzumab plus carboplatin and paclitaxel in patients with cervical cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age:18-70 years
2. Histological confirmed Cervical squamous cell carcinoma
3. FIGO Stage: IB2-IIIB
4. Tumor lesions and stages are confirmed by the internal medicine, obstetrics and gynecology inspection, including a pelvic exam and abdominal and pelvic CT,.if necessary, laparoscopy, cystoscopy and pelvic MRI examination will be taken.
5. At least one lesions can be measured
6. No previous therapy
7. ECOG performance status 0-2
8. Life expectancy of more than 6 months
9. Normal hematology:Haemoglobin≥90g/L,white blood cell(WBC)≥4×109/L Absolute neutrophil count≥1.5×109/L,platelet count≥100×109/L, normal renal function: serum creatinine\<1.5mg/dl or creatinine clearance rate\>60ml/min；normal liver function:TBIL≤1.5 ULN, AST and ALT≤1.5 ULN
10. Without lung or heart disease
11. Without active infection
12. Signed informed consent and submit to the organization of research

Exclusion Criteria:

1. Severe systemic or uncontrolled disease, unfit for chemotherapy
2. Neuropathy caused by any reason
3. Psychiatric disease
4. Other malignant tumor
5. Bilateral renal pelvis and ureter hydrocephalus who can't be alleviated by ureteral stent or percutaneous nephrostomy, Abnormal serum creatinine level
6. Infection and severe systemic disease
7. Received other anti EGFR monoclonal antibody treatment
8. Participation in other interventional clinical trials
9. Allergic constitution or history of drug allergy
10. Pregnant or breast-feeding or refused to take contraceptive method
11. Poor compliance
Long-term Assessment of Rhône RéPPOP Care for Overweight and Obese Children.

Childhood obesity is a major public health issue since it is a risk factor of adulthood obesity, cardiovascular disease, psychological disorders, and other chronic conditions.

RéPPOP is a two year personalized pathway for multidisciplinary care for overweight and obese children, close to patients' homes.

Short and medium-term assessments of Rhône RéPPOP care for overweight and obese children show encouraging results. Long-term assessment is needed to confirm these results.

The present study aims to assess the long-term efficiency of Rhône RéPPOP care for overweight and obese children by comparing BMI Z-scores at the start and the end of RéPPOP care to the current BMI. This data will be collected through a telephonic questionnaire by the scientific manager.

The study's secondary objectives are to evaluate patients and their families' lifestyle changes and to improve RéPPOP practices.


Eligibility Criteria:
Inclusion Criteria:

- All overweight and obese children included in RéPPOP care programs from 01/01/07 to 31/12/10

Exclusion Criteria:

* Refusal to respond to the telephonic questionnaire
* Subjects who withdraw their consent to participate in the study
* Subjects aged under 12 years
AURA 1: Augmenting Urinary Reflex Activity: Study 1

AURA 1 (Augmenting Urinary Reflex Activity: study 1) is a study that evaluates the electrophysiological responses of pudendal nerve stimulation using short-duration extracorporeal stimulation


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged ≥ 18 years with urological indications (OAB, UUI, UFS, retention syndromes and pain)
* Meeting criteria for routine SNM (primary or revision surgery) at the discretion of their normal care urologist.
* Ability and willingness to give informed consent
* Willingness to stay overnight in hospital after SNM procedure (as per routine care)

Exclusion Criteria:

* Patient is pregnant, breastfeeding, or plans to become pregnant during the course of the study (pregnancy tests provided in schedule) \[this is an exclusion for SNM in any case\]
* Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints
* Any psychiatric or personality disorder at the discretion of the study physician
* Any neurological condition that may interfere with normal bladder function (e.g., stroke, multiple sclerosis, Parkinson's disease; clinically significant peripheral neuropathy, or complete spinal cord injury)
* Patient has uncontrolled type I or type II diabetes as defined by their routine care clinician or diabetes with peripheral nerve involvement
* Patient has history of other non-pelvic neoplasia within 5 years prior to enrolment, except for a cancer that was determined to be local occurrence only, such as basal cell carcinoma, or is receiving or planning to receive anti-cancer or anti-angiogenic drugs
* Patient has proven major autoimmune disease, e.g. scleroderma or immunodeficiency (including use of biologic immunomodulatory drugs at time of procedure)
* Patient is not suitable for the study as determined by their routine care physician for any other reason
* Patient is enrolled in another interventional study excepting observational studies, e.g. SNM registries or in relation to disease (see below)
* Patient participation in vigorous sporting activities where these cannot be restricted for a period of 24h while the extracorporeal lead is in situ.

Specific urological

• As per routine clinical SNM criteria (see: https://www.nice.org.uk/guidance/ipg6434)

Specific technical

* Patient is significantly obese (defined as BMI ≥ 35) so as to limit electrode lead placement using standard approaches
* Skin, orthopaedic or neurological anatomical limitations that could prevent successful placement of the electrode lead
* Subject with a documented history of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
Intravesical Lactobacillus for Urinary Symptoms Among People with NLUTD Who Use Indwelling Catheters

The objectives of the proposed research among this population are: 1) to define clinically meaningful change (i.e. differentiating states of health and illness) with respect to urinary symptoms, urine inflammation, cultivable bacteria, and the urine ecosystem; and 2) to determine the optimal intravesical Lactobacillus RhamnosusGG (LGG®) dose to be used to reduce urinary symptoms in a future clinical trial.

Urinary tract infection (UTI) is the most common outpatient infection world-wide, and for people with spinal cord injury (SCI) and neurogenic bladder (NB), it is the most common infection, secondary condition, cause for emergency room visits, and infectious cause of hospitalization. Despite its prevalence, attempts to ameliorate UTI among people with SCI are stymied by long-standing diagnostic challenges which arise from evidence gaps around "gold standard" diagnostic tests (urinalysis and urine culture) that have lower sensitivity and specificity for UTI in this population. A high prevalence of chronic inflammation leading to persistence of white blood cells (WBC) in the urine confounds the utility of WBC count, pyuria, and leukocyte esterase as biomarkers for UTI; nitrites in urine indicate the presence of only specific (but not all) organisms, many of which are present to a greater extent in the urine of people with SCI; and people with SCI have a high prevalence of asymptomatic bacteriuria. These physiologic changes render the gold standard diagnostic tests less useful for identifying UTI in persons with SCI.

SA1. Estimate healthy, asymptomatic state variability of urine NGAL (uNGAL), white blood cells (uWBC), nitrite, cultivable bacteria, and the urinary microbiome.

SA2. Estimate the effect of intravesical LGG dose on urinary symptoms (primary outcome), uNGAL, uWBC, nitrites, cultivable bacteria, and the urine microbiome (secondary outcomes).

Eligibility Criteria:
Inclusion Criteria:

* Neurogenic bladder for at least 6 months;
* Utilizing indwelling catheterization for bladder management;
* Women must be premenopausal and not currently menstruating;
* Community dwelling
* physical disability

Exclusion Criteria:

* Use of prophylactic antibiotics;
* Instillation of intravesical antimicrobials to prevent UTI;
* Psychologic or psychiatric conditions influencing the ability to follow instructions;
* Use of oral or IV antibiotics within the past 2 weeks;
* Sexual activity within the previous 72 hours;
* Participation in another study with which results could be confounded.
The Effect of Aspirin on Recurrent Acute Pancreatitis

Recurrent acute pancreatitis (RAP) was defined as two or more occurrences of acute pancreatitis, which was associated with higher percentages of morbidities and mortalities, lower patients' life quality and increased health-care costs. Current interventions, including cholecystectomy and abstain from drinking were reported to be effective methods for preventing the recurrences of biliary and alcoholic etiologies, respectively. However, there were no effective preventions for other etiologies, such as idiopathic etiologies. Non-steroid anti-inflammatory drugs (NSAIDs), including indomethacin, diclofenac and aspirin could inhibiting the inflammatory cascade of pancreatitis. In this study, we aimed at exploring the effects of 100mg aspirin on reducing the occurrences of recurrent acute pancreatitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with with recurrent acute pancreatitis

Exclusion Criteria:

* Less than 2 episodes of acute pancreatitis in the past year
* Latrogenic AP (pancreatitis due to endoscopic retrograde cholangiopancreatography, surgery, or after other invasive treatment). Iatrogenic pancreatitis will not count as an episode of recurrent pancreatitis
* Previous allergy to Non-Steroid Anti-inflammatory Drugs (NSAIDs)
* Regularly taking aspirin or other NSAIDs \>3 doses per week
* Contradictions for the medications of NSAIDs, including Active peptic ulcer disease or gastrointestinal hemorrhage within 3 months or previous peptic ulcer, history of significant hepatic or renal disease, platelet count less than 100X10\^9/L or international normalized ratio (INR) \>1.5)
* Biliary stones
* Receiving endoscopic sphincterotomy and/or pancreatic stent placement and/or cholecystectomy and/or pancreatic surgery after the latest pancreatitis or planning to undergo one of those interventions within preceding 2 years
* Patients with the level of serum triglycerides of \>5.65 mmol/L and did not receive regular lipid-lowering therapy
* Primary hyperparathyroidism has been well-treated after last episode of pancreatitis and recruitment or will be operated in \<2 years
* Patients with previously heavy alcohol consumption (50g/day for men, 40g/day for women) and have not quit drinking, or have significant withdrawal symptoms
* Pregnant or breastfeeding patients
* Inability to give informed consents
rTMS for Adults With Autistic Spectrum Disorder

rTMS over dorsolateral prefrontal cortex is effective in reducing repetitive behaviors in adults with autistic spectrum disorder rTMS over posterior superior temporal sulcus is effective in improving social ability in adults with autistic spectrum disorder

First, we will apply one session intermittent theta burst stimulation over dorsolateral prefrontal cortex, posterior superior temporal sulcus and inion as control with one week interval in adults with autism spectrum disorder. Second, we will apply 5 sessions intermittent theta burst stimulation within one week over dorsolateral prefrontal cortex or posterior temporal sulcus depending on the results of our first phases.

Eligibility Criteria:
Inclusion Criteria:

* adults with autistic spectrum disorder

Exclusion Criteria:

* schizophrenia
* bipolar affective disorder
* major depressive disorder
* any systemic disease especially epilepsy
Pegfilgrastim vs. Filgrastim - Comparison of Mobilized Blood Stem Cells in Patients With Non Hodgkin-lymphoma

The purpose of this study is to compare the ability of pegfilgrastim vs. filgrastim to mobilize peripheral blood stem cells in patients with Non Hodgkin-lymphoma in an intraindividual study

Patients with Non Hodgkin-lymphoma undergoing stem cell mobilization for planned high-dose therapy will be treated with two cycles of chemotherapy (etoposide, ifosfamide, cisplatin, epirubicin), either followed by daily administration of filgrastim (first cycle) or pegfilgrastim (once after the second cycle). The number of circulating cluster of differentiation 34+ cells, colony-forming units and primitive progenitors will be analyzed at corresponding time points. Peripheral blood stem cells will be collected after the second cycle of chemotherapy by leukapheresis. After the second cycle, high-dose therapy with peripheral blood stem cell support will be administered (the protocol will be chosen according to the diagnosis, including total body irradiation-containing regimens).

Eligibility Criteria:
Inclusion Criteria:

* histological diagnosis of non-Hodgkin lymphoma
* planned high-dose therapy with autologous stem cell transplantation
* WHO performance status 0-2
* written consent

Exclusion Criteria:

* allergy against (peg)filgrastim
* life expectancy \<3 months
* other malignant diseases within the last 5 years
* cardial insufficiency (\>= New York Heart Association II°)
* uncontrolled infection
* pregnancy, lactation
* central nervous system lymphoma
* Karnofsky score \<70%