cyrilzakka/clinical-trials huggingface dataset:
Same-day Cervical Preparation Before Dilation and Evacuation

The purpose of this randomized trial is to compare same-day cervical preparation using Dilapan-S™ plus buccal misoprostol to overnight cervical preparation using Dilapan-S™ before D\&E at 16.0 to 20.0 weeks.

Primary objective: To compare D\&E operative time. We hypothesize that same-day Dilapan-S™ plus buccal misoprostol is non-inferior to overnight Dilapan-S™ with respect to operative time.

Secondary objectives: To compare treatment groups for the following: Pre-operative cervical dilation; need for mechanical dilation and ease of dilation if required; ability to complete D\&E without further cervical preparation; ease of D\&E; complications; pain; side effects; patient and provider satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Seeking pregnancy termination from 16 0/7 to 19 6/7 weeks of gestation on the day of enrollment.
* Eligible for pregnancy termination at PPNYC
* Able to give informed consent
* English speaking

Exclusion Criteria:

* Active bleeding or hemodynamically unstable at enrollment
* Signs of chorioamnionitis or clinical infection at enrollment
* Signs of spontaneous labor or cervical insufficiency at enrollment
* Spontaneous intrauterine fetal demise
* Allergy to Dilapan-S™ or misoprostol
Vaccine Social Media Randomized Intervention Trial

This study will assess the effectiveness of social media website devoted to vaccines to change immunization knowledge, perceptions and behavior. If effective, this intervention will represent an innovative, low cost and broadly applicable resource to reduce parental vaccination concerns.

The study has two hypothesis:

1. Parents receiving usual care plus social media website will demonstrate higher early childhood immunization rates to parents receiving either usual plus non interactive website or usual care only.
2. Parents receiving usual care plus social media website will demonstrate positive changes in knowledge, attitudes and beliefs supporting vaccination compared to parents receiving either usual care plus non-interactive website or usual care only.

Participants will be enrolled in the study, stratified based on hesitancy and randomly assigned to 1 of 3 study arms and followed for 1-2 years.

Eligibility Criteria:
Inclusion Criteria:

* Women \>20 weeks Pregnant (including parents of children up to 1 year of age).
* \>18 years of age

Exclusion Criteria:

* Non english speak
* Do not intend to use Kaiser insurance for the child
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

This is a phase III, multicentre, long-term open-label extension of the phase III study: Pearl IIIextension (PGL09-027). During Pearl III (PGL09-026) and subsequent Pearl III extension (PGL09-027), patients have been exposed to a total of 4 cycles of daily 3month open-label treatment with ulipristal acetate 10mg before entering the proposed study Pearl extension 2 (PGL11-024).

This proposed study consists of 4 further consecutive courses of 3 months (84 days) open label ulipristal acetate 10mg once daily treatment each separated by a drug free period.


Eligibility Criteria:
Inclusion Criteria:

* Subject completed visit F - Follow-up of Pearl III extension study (PGL09-027) - without significant deviations.
* Females of childbearing potential are advised to practice a non-hormonal method of contraception.

Exclusion Criteria:

* Subject has a history of uterus surgery (e.g. hysterectomy, myomectomy) or uterine artery embolization in Pearl III extension (PGL09-027) or afterwards that would interfere with the study assessments.
* Subject has taken or is likely to require treatment during the study with drugs that are not permitted by the study protocol.
* Subject is lactating, has a positive pregnancy test at study start or is planning a pregnancy during the course of the study.
* Subject has abnormal baseline findings, any other medical condition(s) or laboratory finding that, in the opinion of the investigator, might jeopardise the subject's safety or interfere with study evaluations.
Controlled Ovarian Stimulation Versus Modified Natural Cycles in Poor Responders

This is a prospective, randomized, single center, phase 4 controlled trial. The study will compare the efficacy of two different strategies for the management of predicted poor response patients under stimulation for IVF/ICSI: up to three MNC cycles (group 1) versus a single GnRH antagonist CFA (group 2).


Eligibility Criteria:
Inclusion Criteria:

* Informed consent form (ICF) dated and signed.
* Age ≥18 and \<45 years old.
* Body Mass Index (BMI) ≥18.5 Kg/m² and \<35 Kg/m².
* Regular menstrual cycles (between 21 and 35 days).
* Two ovaries present.
* Current pregnancy wish.
* Poor responders as defined according to the POSEIDON criteria:

POSEIDON Group 3: patients \< 35 years with poor ovarian reserve pre-stimulation parameters (AFC \<5 or AMH \<1.2 ng/mL); POSEIDON Group 4: patients ≥35 years with poor ovarian reserve pre-stimulation parameters (AFC \<5 or AMH \<1.2 ng/mL).

Exclusion Criteria:

* Simultaneous participation in another clinical study.
* Untreated and uncontrolled thyroid dysfunction.
* Tumors of the ovary, breast, uterus, pituitary or hypothalamus.
* Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
* Ovarian cysts or enlarged ovaries.
* Malformations of the reproductive organs.
* Current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy.
* Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin).
* Patients who undergo preimplantation genetic testing (PGT), fertility preservation or oocyte donation.
Efficacy of Tamsulosin Oral-controlled Absorption System (OCAS) in the Treatment of Distal Ureteral Stones

This is a randomized double blind placebo-controlled study that will assess the efficacy of Tamsulosin oral-controlled absorption system (OCAS) 0.4 mg in the conjunctive medical treatment of distal ureteral stones with a size of 4-10 mm compared to placebo in control group.

* patient will be randomized to receive placebo or Tamsulosin OCAS 0.4 mg 1 tablet OD for a maximum of 28 days or until the ureteral stone is passed and sodium diclofenac 50 mg twice a day, for 10 days.
* All patients will receive 75 mg sodium diclofenac via intramuscular on demand

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient aged =\> 18 years.
* Patients who have distal ureteral stones with a size of 4-10 mm
* Written informed consent has been obtained.

Exclusion Criteria:

* Patients with history of ureteral surgery
* Patients with urinary tract infection
* Patient with diabetes and peptic ulcer
* Patient with renal dysfunction (elevated of serum creatinine level)
* Patients with severe hydronephrosis
* Patients with history of passing stones
* Pregnancy
* Patients who desire to withdraw from the study
μ-opioid Receptor Polymorphism and Opioid Analgesia

In this prospective observational double-blind study, the investigators aim to assess the effect of the single nucleotide polymorphism of the μ-opioid receptor gene (OPRM1, p.118A/G) on the duration of epidural fentanyl labor analgesia.

The single nucleotide polymorphism (SNP), p.118A/G of the µ -opioid receptor gene (OPRM1), may alter pain perception and individual response to opioid analgesia. This SNP leads to a variant µ-opioid receptor in which an asparagine is substituted for aspartate as the 102nd amino acid of the receptor protein (p.Asn102Asp). At the investigators' institution, it is common practice to initiate labor analgesia with epidural fentanyl. No data are available to determine how the µ-opioid polymorphism affects pain perception and response to opioids, such as fentanyl, in the investigators' population. The investigators aim to assess the effect of the single nucleotide polymorphism of the µ-opioid receptor gene (OPRM1, p.118A/G) on duration of epidural fentanyl labor analgesia.

This is a prospective observational and double-blind study. Before initiation of epidural labor analgesia, venous blood will be drawn into coded EDTA tubes. DNA isolation and genotyping of OPRM1:p.118A/G will be performed at the American University of Beirut. In 250 parturients, labor epidural analgesia will be initiated with 100 µg of epidural fentanyl following a test dose of lidocaine and epinephrine. No drugs will be injected until second request of analgesia. Patients will be divided into two groups based on their genetic groups: Group A consists of wild-type homozygote (A118), and Group G includes heterozygote and homozygote carrying the G118 allele. Duration of fentanyl analgesia (primary outcome) will be compared. Data will be presented as a mean ± SD or numbers and percentages. Statistical analysis will be performed with the Student's t-test, Chi-square or Fisher's exact test as appropriate. P value \<0.05 will be considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous parturients ≥ 37 weeks gestation, with ASA I or II, with an uncomplicated course of singleton vertex pregnancy (in spontaneous labor or with spontaneous rupture of membrane), requesting epidural analgesia for pain relief

Exclusion Criteria:

* Advanced cervical dilation (\> 5 cm) at the time of request for epidural analgesia
* Severe medical or obstetric complications (preeclampsia, uncontrolled pregestational diabetes, etc...)
* Multiple gestation
* Contraindication to epidural analgesia
* Local anesthetics or fentanyl allergy
* History of chronic opioid use or recent acute opioid use.
CFTR Modulators in Pregnancy and Postpartum

Observational study on women with Cystic Fibrosis treated with CFTR modulators during pregnancy and postpartum and their children. Registration on maternal health parameters and effects of CFTR-modulators in the newborn infant as well as effects of exposure through mother's own milk.


Eligibility Criteria:
Inclusion Criteria:

Woman with cystic fibrosis who is pregnant and treated with Kaftrio. Newborn infant to the above mentioned woman

Exclusion Criteria:

none
Adjuvant Therapy Omission for Resected NSCLC Patients With Longitudinal Undetectable MRD

Molecular residual disease (MRD) has strong relationship with clinical outcome in multiple solid tumors. Here, the investigators try to verify the negative predictive value of undetectable MRD, which is considered as a superior prognostic factor for resected NSCLC patients, and not requiring excessive adjuvant therapy. Stage IB-IIIA resected NSCLC patients with landmark and longitudinal undetectable MRD are enrolled and under close surveillance in this study.

Stage IB-IIIA resected NSCLC patients will undergo two-round MRD tests after operation, first in 3-7 days and second in 1 month after operation. And patients who confirm two-round landmark undetectable MRD will be enrolled. Enrolled patients will be under close MRD and imaging monitoring without any adjuvant therapy.

Eligibility Criteria:
Inclusion Criteria:

* Stage IB-IIIA non-small cell cancer patients who after complete resection.
* ≥18 years.
* Two-round MRD tests confirm landmark undetectable MRD.
* Expected survival ≥12 weeks.
* Expected survival ≥12 weeks.
* ECOG PS 1-2.
* Willing to accept MRD monitoring every 3 months for a total of 2 years after operation.

Exclusion Criteria:

* Patients who had previously undergone radiotherapy or chemotherapy or any other anti-tumor therapy.
* Patients with a history of other malignancies in the past 5 years.
* Any unstable systemic disease (eg, active infection, high-risk hypertension, unstable angina, congestive heart failure, etc.).
A Study to Evaluate the Benefit of Octagam 5%® in Subjects With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)

This study will evaluate the use of intravenous immunoglobulins (IVIG) at a dose of 1g/Kg/body weight given every three weeks for 6 infusions in pediatric subjects ages 4 - 16 years with moderate to severe PANS. The study will compare biomarkers and behavioral scales before treatment, after the last infusion, 2 months, and at a minimum 6 months post-treatment.

IVIG at an immunomodulatory dose of 1 g/Kg body weight has been known to induce suppression of systemic inflammation and has been used in the treatment of autoimmune diseases. It has been proven beneficial in inflammatory conditions affecting the nervous system.

Eligibility Criteria:
Inclusion Criteria:

* Male and female children, 4-16 years of age
* Diagnosis of moderate to severe PANS based on accepted criteria
* Must be willing to follow study procedures and comply with wash-out period
* If using prophylactic antibiotics, must be on stable dose for 3 months

Exclusion Criteria:

* History of rheumatic fever, including Sydenham chorea (the neurologic manifestation)
* Previous IVIG therapy within the last 6 months
* Allergic reactions to blood products
* Patients who, in the investigator's opinion, might not be suitable for the trial.
* Steroid use
Regional Anesthesia Versus General Anesthesia

Patients undergoing laparoscopic gynecological surgery will receive regional anesthesia or general anesthesia with endotracheal intubation. The investigators aim to evaluate the feasibility and safety of regional anesthesia for laparoscopic gynecological procedures.

Commonly, laparoscopic gynecological procedures are performed under general anesthesia with endotracheal intubation.

The use of regional anesthesia in laparoscopy is reserved to patients declared unfit for general anesthesia because of severe comorbidities or it is applied in combination with general anesthesia to decrease postoperative pain.

Recently, growing literature evidence supports the use of regional anesthesia in patients undergoing laparoscopy.

The combination of minimally invasive surgery with regional anesthesia could increase the advantages of laparoscopic operations (less postoperative pain, shorter hospital stay, etc).

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing gynecological laparoscopic surgery;
* expected surgical time shorter than 90 minutes;
* informed consent to participate in the study.

Exclusion Criteria: none.
EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors

The differentiation among the Gastrointestinal Subepithelial Tumors (SETs) represents a clinical challenge. Endoscopic Ultrasound (EUS) alone may be ineffective in differentiating SETs subtypes, and tissue sampling of these lesions may be technically difficult. EUS Elastography (EUS-E) has been applied to many gastrointestinal diseases, providing a qualitative/semi-quantitative stiffness analysis, but only few studies have examined the role of EUS-E in the diagnosis of SETs. In addition, the use of contrast agents has improved the diagnostic performance of the EUS, especially in the differentiation between GISTs and other gastrointestinal SETs.

The aim of the study is to examine the performance of EUS-E and Contrast Enhanced-EUS (CE-EUS) in distinguishing among different gastrointestinal SETs subtypes. EUS patterns of different techniques will be compared to the final diagnosis gained by the analysis of histopatological specimens (surgical resection or EUS-FNB) or imaging/clinical follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patients with GI SETs scheduled for EUS-FNB
* Patients with age \> 18 but \<85 years

Exclusion Criteria:

* Patients with GI SETs \<15mm
* severe coagulopathy defined as abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma
* severe cardiopulmonary diseases and severe chronic kidney disease defined as glomerular filtration rate (GFR) \< 15 ml/min
* known allergic disposition to SonoVue®
* pregnancy
Study of Parental Ratings of Quality of Life and Body Composition in 5-19 Year Olds While Participating in the Good NEWS 4 Kids Program

This study will compare changes in body composition (lean mass, fat, and bone)and parent ratings of quality of life in 5-19 Year Olds as a function of participation in one of four versions of the Good NEWS 4 Kids Program (GN4K).

Purpose: The objectives of this study are to:

1. Compare the relative efficacy of four variations of the GN4K program in facilitating positive changes in body composition and parental ratings of quality of life.
2. Compare parental ratings of children's behavior to DXA-measured changes in body composition;
3. Compare measurements of scale weight, height, waist/hip ratios and BMI with DXA-measured changes in body composition;
4. Develop a logarithm formula with the use of anthropometric measurements and parental ratings to predict body composition changes

Eligibility Criteria:
Inclusion Criteria:

* Must ensure with medical provider that there are not medical conditions that would preclude participation
* Must be between the ages of 5 and 19

Exclusion Criteria:

* males and females below the age of 5 and above the age of 19
* pregnant or breast feeding
Biomarkers in Blood and Tissue Samples From Patients With Newly Diagnosed Neuroblastoma

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in blood and tissue samples from patients with newly diagnosed neuroblastoma.

OBJECTIVES:

* Determine the expression of neuropeptide Y (NPY) and its receptors (Rs) in human neuroblastoma (NB) tissues.
* Determine whether BDNF/TrkB and TrkAIII stimulate expression of NPY and its Rs.
* Determine whether NPY mediates BDNF- and TrkAIII-induced NB proliferation and survival.
* Determine neurotrophins' angiogenic actions.
* Identify factors released from NB cells upon NPY stimulation (proteomics).
* Determine whether NPY upregulates expression of the identified proteins in NB and their Rs in endothelial cells (ECs).
* Test whether inhibition of the identified pathways reduces angiogenic activity of NB-conditioned media.
* Determine the mechanisms of NYP actions and signaling pathways.
* Test whether blocking NPY-Y2/Y5 pathway reduces NB growth and vascularization in vivo.

OUTLINE: Archived tumor tissue and serum samples are analyzed for neuropeptide Y and its receptors (Y1, Y2, and Y5) expression, neuroblastoma prognostic factors (MYCN, TrkA, TrkAIII, TrkB, BDNF, and NGF), and angiogenic markers by real-time PCR, IHC, ELISA, radioimmunoassay (RIA), mitogenic assay, caspase 3/7 activity assay, western blots, liquid chromatography, tandem mass spectrometry, proteomic assays, and other assays. Results are then analyzed and compared with patients' clinical data, including stage of disease, its phenotype, prognostic markers, age and gender, and response to treatment.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Children with newly diagnosed neuroblastoma or ganglioneuroblastoma
* Samples from the Children's Oncology Group (COG) from patients enrolled in clinical trials in institutions in the USA, Canada, and Australia

  * Paraffin-embedded tumor specimens, RNA isolated from tumor tissues, and patient serum must be available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Sucrosomial Iron on Insomnia in Non-dialysis Chronic Kidney Disease Patients With Iron Deficiency Anemia

Insomnia or sleep disturbance is a common disorder in patients with chronic kidney disease (CKD), but is often unrecognized and undertreated. It is known that sleep disorders may indirectly cause a variety of diseases and affect quality of life. The most common sleep disorders that occur in CKD are insomnia, excessive daytime sleepiness, obstructive or central sleep apnea (SA), and sleep disorders. This study evaluates the effectiveness and safety of Sideral® Sucrosomial Iron and iron chewable tablets 100mg commonly used in health insurance on sleep disorders in patients with CKD and iron deficiency anemia.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 20-80.
2. Chronic kidney disease (CKD) patients.
3. Iron deficiency anemia (male haemoglobin (Hb) ≤13 g/dL; female haemoglobin (Hb) ≤12 g/dL, ferritin ≤100 ng/mL, transferrin saturation ≤25%).
4. Patients diagnosed as chronic insomnia by doctors according to international classification of sleep disorders-third edition (ICSD-3).
5. Subjects who voluntarily participate in the trial plan and complete the consent form after explanation by doctors or project personnel.

Exclusion Criteria:

1. Patients taking iron supplements.
2. Patients with non-chronic insomnia.
3. Patients with alcoholism within one year.
4. People with other serious diseases.
5. Pregnant women or women who are still breastfeeding.
6. Those who are unable to cooperate with the test progress.
7. Patients with autoimmune abnormalities (ex. inflammatory bowel disease).
8. People with non-iron deficiency anemia (ex. thalassemia).
9. Those who are taking sleeping pills or sedatives.
Decrease Obstructive Sleep Apnea (OSA) Sympathetic Tone : Impact of APAP vs CPAP

The present study aims to compare muscle sympathetic neural activity by microneurography after one month treatment of fixed versus auto-adjusting CPAP treatment and its impact on arterial blood pressure

Background: Sleep apnea syndrome (SAS) currently affects 10% of general population. It is characterized by the occurrence during the sleep of the upper airways closure which cause repeated asphyxia. It is a public health problem due to its cardiometabolic complications. Indeed, the absence of SAS treatment increases cardiovascular mortality by 12% at 10 years.

The main physiopathological mechanism is the activation of cardiovascular sympathetic control (the short-term regulation of blood pressure which bring in the sympathetic nervous system) An exposure to intermittent chronic hypoxia (caused by SAS) bring an increased of muscle sympathetic nerve activity (MSNA) contributing to elevated blood pressure Continuous Positive Airway Pressure (CPAP) can partly reduce this risk by decreasing elevation of blood pressure caused by the SAS. It has recently been demonstrated that all CPAP devices are not equivalent. Indeed, the auto-adjusted CPAP treatment induces a reduction in blood pressure lower than the reference treatment fixed CPAP.

To this extent it is interesting to conduct a new randomized trial comparing these two treatments with vascular sympathetic tone. This will be assessed by peroneal microneurography recording.

Objective: Compare Muscle Sympathetic Neural Activity (MSNA) by microneurography after one month of fixed versus auto-adjusted CPAP treatment in OSA patients naive from pressure therapy Methods: Prospective study, single-site, randomized, double-blind, parallel, one month controlled trial. After the diagnosis of sleep apnea, patients will be randomized for one month treatment with fixed ou auto-adjusting CPAP. Measurements of MSNA, heart rate variability and catecholamines will be held before and after treatment.

An interim analysis will be performed after the inclusion of 24 patients based on group sequential design.

Assuming an α error of 5%, a statistical power of 80%, and a unilateral situation : 34 patients per arm will be needed to be enrolled in the study. The enrollment target for the study will be reviewed and may be refined following the study interim analysis and taking account 20% of study drop-out.

Eligibility Criteria:
Inclusion Criteria:

* patient with OSA (AHI ≥20 / h)
* patient with daytime sleepiness
* naive of any pressure treatment of OSA
* patient able to provide written informed consent
* not a vulnerable person or legally protected adult.

Exclusion Criteria:

* pregnancy
* Person deprived of liberty or subject to a legal protection measure.
* Patient with serious heart failure (According to investigator judgment)
* patient with central sleep apnea index above 20% of AHI
* Patient with a significant intercurrent pathology that can influence the results. (According to investigator judgment).