cyrilzakka/clinical-trials huggingface dataset:
PTSD Screening in Pregnant Black Women

This study will compare the effectiveness of two active screening interventions in improving post-traumatic stress disorder (PTSD) symptoms, maternal perinatal care utilization, satisfaction utilization of mental healthcare services, and maternal health and birth-related outcomes for Black pregnant women.

Researchers will examine whether Culturally Responsive Screening, Brief Intervention, and Referral to Treatment (SBIRT) for obstetrics (OB) is more effective in reducing PTSD symptoms compared to brief screening for PTSD. This study will help participating OB clinics to determine the best option for screening for PTSD in Black pregnant persons in their clinic during first-trimester prenatal visits.

The study population will include Black pregnant women receiving medical care in their first trimester of pregnancy. Surveys and chart abstraction will be used in this study to collect data. The approximate study duration for individuals is 4 visits over 12 months.

Eligibility Criteria:
Inclusion Criteria:

* 18+ years old,
* Ability to provide informed consent,
* English-speaking,
* Willingness to participate in the study,
* Self-identification as Black or African American,
* Pregnant and in the first trimester attending initial prenatal care visit,
* Endorsement of at least one traumatic event in their lifetime.

Exclusion Criteria:

* Active suicidality
Extension Study of the Efficacy of the GSK 580299 Vaccine in Japanese Women Vaccinated in the Primary NCT00316693 Study

This extension study is conducted to assess the efficacy of the GSK 580299 vaccine against cervical intraepithelial neoplasia (CIN) lesions, cervical cancer and cytological abnormalities associated with human papillomavirus (HPV)-16 and/or HPV-18 or other oncogenic HPV types for an additional two years. All subjects who participated in the primary vaccination study NCT00316693 and who confirmed their interest in participating in a long term follow up study will therefore be invited to be followed for up to 48 months after administration of the first dose of vaccine. In addition, safety and persistence of the humoral immune response will be evaluated in this study.

This protocol posting deals with objectives \& outcome measures of the extension phase at Months 36 and 48. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00316693).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol;
* Written informed consent obtained from the subject prior to enrolment in the extension study;
* A subject previously vaccinated in the NCT00316693 study.
* Subjects who showed, at the last NCT00316693 study visit (at Month 24) willingness to participate in this extension study.

Exclusion Criteria:

* Use of any HPV vaccine other than the one administered in the NCT00316693 study;
* Use of any investigational or non-registered product other than the study vaccine since last NCT00316693 study visit, or planned use during the study period;
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product;
* Subjects who were diagnosed high grade or missing cytology at Month 0 in the NCT00316693 study;
* Pregnant females and females who were pregnant less than 3 months ago.
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids

The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the safety and efficacy of asoprisnil 10 mg and 25 mg tablets, compared to placebo, administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids, by assessing whether asoprisnil administration prevents surgical and/or invasive intervention in the study population. Women, who meet the predefined uterine bleeding criteria for surgical and/or invasive intervention (hysterectomy, myomectomy, uterine artery embolization) who are willing to undergo surgical and/or invasive intervention if the study medication fails, will be enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women
* History of regular menstrual cycles (21-42 days)
* Diagnosis of uterine fibroid(s)
* Abnormal vaginal bleeding associated with uterine fibroids
* Otherwise in good health
* Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails
* Negative pregnancy test
* Agrees to Double-barrier method of contraception
* Pap smear with no evidence of malignancy or pre-malignant changes
* Endometrial biopsy with no significant histological disorder

Exclusion Criteria:

* Any abnormal lab or procedure result the study-doctor considers important
* Severe reaction(s) to or are currently using any hormone therapy
* History of osteoporosis or other bone disease
* Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months
* History of Polycystic Ovary Syndrome or prolactinoma
* MRI shows significant gynecologic disorder
* Uterine size \> 25 weeks gestation
* Hemoglobin \< 8 g/dL at Day -1
A Study to Evaluate the Pharmacokinetics and Safety Between HCP2202 and Co-administration of Each Component in Healthy Volunteers Under Fed Conditions

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2202 and co-administration of each component in fed condition in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age 19\~54 years in healthy volunteers 18.5 kg/m\^2 ≤ BMI \< 30 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
* 90 mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \<90 mmHg
* agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.
* Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who judged ineligible by the investigator
Effect of Dexmedetomidine on QT Interval in Pediatric Patients Under General Anesthesia

Various medications used in anesthesia have been implicated in the prolongation of QT interval. Recently, there has been an increase in the use of dexmedetomidine in patients presenting for surgeries given its beneficial sedative, anxiolytic, and analgesic properties. It has several desirable properties including minimal respiratory side effects as well as the ability to decrease intraoperative and postoperative analgesic requirements. In many of the patients who present for routine surgical procedures, dexmedetomidine is a common component of their anesthetic care. This is a study to assess the effects of dexmedetomidine on the QT interval in children presenting for surgery.


Eligibility Criteria:
Inclusion Criteria:

* ASA grade 1 or 2.
* Scheduled to receive dexmedetomidine.

Exclusion Criteria:

* Known allergy to dexmedetomidine.
Systematic NT-proBNP and ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm, Sweden - STROKESTOP II

STROKESTOP II will study if the biomarker NT-proBNP together with single-lead ECG can be used as a primary population screening tool for silent atrial fibrillation, and builds on previous results from the STROKESTOP study.


Eligibility Criteria:
Inclusion Criteria:

* Individuals born 1940 and 1941 residing in Stockholm at the time of inclusion

Exclusion Criteria:

* Not fulfilling the inclusion criteria
Changes in Incretines, Gut Hormones and Bile Acids After Roux-en-Y Gastric Bypass

Obesity is an increasing world wide problem. Moreover, the increase in patients who are considered morbidly obese is even higher (Sturm et al, Healt Aff 2004). Conservative approaches such as diets or medication are unsuccessful in the majority of the patients. Additionally, (morbid) obesity leads often to cardiovascular diseases, such as hypertension, dyslipidemia and type 2 diabetes (T2DM). When patients need insulin to regulate their glucose levels, their weight is even more difficult to control. Therefore, bariatric procedures are increasingly performed, with over 8.000 procedures in the Netherlands in 2013. The two most performed types of bariatric surgery in the Netherlands are the Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) and the Laparoscopic Sleeve Gastrectomy (LSG). Within the LRYGB there are different variants available. In a recently initiated randomized controlled trial (RCT) from our centre, a comparison between two variants of RYGB was performed. In this RCT our standard RYGB (s-RYGB:alimentary limb (AL) of 150cm; biliopancreatic limb (BPL) of 75cm) was compared with a RYGB with an long BPL (LBPLRYGB:AL of 75cm and a BPL of 150cm). A LBPLRYGB might improve weight loss and reduction after surgery. The exact mechanism of action is still not fully understood. Stomach volume is decreased and satiety levels often increase, probably due to changes in incretin levels. Passage of foods through the gastrointestinal tract are altered after RYGB. A possible explanation might be found in different levels of incretins (such as GLP-1, PYY and ghrelin) and bile acids (FGF-19 and FGF-21) after bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* General guidelines for bariatric surgery according to Fried (Fried et al, Obes Surg 2007).
* Age \> 18 years
* Patients must be able to adhere to the study visit schedule and protocol requirements
* Patients must be able to give informed consent and the consent must be obtained prior to any study procedures
* Patients who are planned for a LRYGB

Exclusion Criteria:

* Binge-eating or associated eating disorder
* Active drug or alcohol addiction
* Pregnancy and when giving breast feeding
* A medical history of bariatric surgery
* Patients with a language barrier which can inhibit patients to follow the correct medical advice
* Any kind of genetic disorder that can inhibit patients to follow the correct medical advice
Effect of Nebulized Lidocaine on Postoperative Sore Throat

The purpose of this study is to test the hypothesis that use of preoperative nebulized lidocaine is reduced the incidence of postoperative sore throat after endotracheal intubation.

Adult patients undergoing video-assisted thoracic surgery (VATS) requiring double lumen tube (DLT) endotracheal intubation for one-lung ventilation (OLV) were enrolled in the study. Patients were randomized by means of computer-generated order randomization into two groups: Group C (those who received a saline solution as placebo delivered by nebulization) and Group L (those who received lidocaine delivered by nebulization).

At 1, 6 and 24 h after tracheal extubation, an observer blinded to treatments evaluated the patients in terms of sore throat and hoarseness. In addition, Patients' satisfaction, intraoperative and postoperative opioid and analgesics consumption and complaints such as dysphagia, nausea and vomiting were recorded. Hemodynamic variables such as blood pressure and heart rate were also recorded.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing video-assisted thoracic surgery requiring double lumen tube endotracheal intubation for one-lung ventilation
* American Society of Anesthesiologists class 1,2 and 3
* Ability to consent

Exclusion Criteria:

* patients \<18 years old
* body mass index (BMI) \<20 or \>35 kg/m2
* Mallampati grade 3 or 4
* mouth opening \< 3 cm
* preexisting hoarseness or sore throat
* coagulopathy
* patient with upper respiratory tract infection
Isoflavones and Peritoneal Dialysis

The aim of this double-blind randomized clinical trial is to determine the effects of isoflavones on serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients. Forty-four patients from shafa clinic will randomly assign to either isoflavone or placebo group. The patients in isoflavone group will receive 100 mg soy isoflavone (as 2 capsules) daily for 8 weeks, while the placebo group will receive identical placebo. At the baseline and the end of the study,7 ml blood will be collected from each patient after a 12-14-hours fasting and serum concentrations of fructoseamine, carboxymethyl lysine, pentosidine, glucose will be measured. Furthermore, blood pressure measurements will be performed twice with a ten-minute interval between testing


Eligibility Criteria:
Inclusion Criteria:

Continuous Ambulatory Peritoneal Dialysis for 6 months or more Body mass index below 35

Exclusion Criteria:

infections inflammatory diseases liver diseases Clinical diagnosis of cancer receiving glucocorticoid and anti-inflammatory drugs receiving isoflavone supplements Constant consumption of soy or foods containing soy in the diet
Effect of Segmentation Techniques (Manual Versus Semiautomatic) on the Accuracy of the Reconstructed Mandibular Condyle Using CBCT

Effect of Segmentation Techniques (Manual versus Semiautomatic) on the Accuracy of the Reconstructed Mandibular Condyle using CBCT

It will be used to segment the mandibular condyle and asses its volumetric and linear measurements. Therefore, the accuracy of the segmentation techniques of the mandibular condyle will be determined

Eligibility Criteria:
Inclusion Criteria:

* Intact dry human skulls and mandibles.

Exclusion Criteria:

* Presence of fracture, pathological lesions, or skeletal deformities in the condylar area.
Needle-Knife Fistulotomy Vs. Standard Cannulation Trial

Needle-knife fistulotomy (NKF) is traditionally used to achieve biliary access when standard cannulation (SC) techniques are unsuccessful. Based on technical factors and the design of prior studies, the literature suggests NKF should be reserved for expert advanced endoscopists. The aim of this study was to evaluate the efficacy and safety of NKF compared to SC for primary biliary access performed by advanced endoscopists with a range of experience including advanced endoscopy trainees.


Eligibility Criteria:
Inclusion Criteria: older than 18 years of age -

Exclusion Criteria: if unable to provide informed consent, pregnant, hemodynamically unstable, with a prior known history of biliary sphincterotomy or ampullectomy

-
Study to Evaluate the Effect of Xolair(Omalizumab) on Improving the Tolerability of Specific Immunotherapy in Patients With at Least Moderate Persistent Allergic Asthma Inadequately Controlled With Inhaled Corticosteroids

In patients with at least moderate persistent allergic asthma controlled with inhaled steroids, omalizumab (administered per US product label), when compared to placebo, will provide the participants with significantly improved tolerability of specific allergen immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).

Omalizumab is an FDA approved anti-IgE drug used to treat allergic asthma. This study is designed to give omalizumab 13 weeks prior to administering rapid build up of specific allergy shot, with an overlap of omalizumab and cluster therapy for 3 weeks. The cluster therapy will take 4 week to complete with maintenance dosage lasting an additional 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis and history of moderate persistent allergic asthma
* body weight \>/= 20kg and \</= 150kg
* Total serum IgE \>/= 30 and \</= 700IU/mL
* on a stable asthma treatment including corticosteroids for the preceding 4 weeks
* non smoker for at least 1 year prior to visit 1

Exclusion Criteria:

* patients with severe asthma
* history of immunotherapy to any allergen within the past 3 years
* history of anaphylactic allergic reaction
* upper respiratory tract infection
Pan-genome Analysis of Neuroblastoma by Comparative Genomic Hybridization and Correlation With Pathology for the Diagnostic and the Prognostic Classification

Neuroblastoma (NB) is characterized by its wide heterogeneity in clinical presentation and evolution. Recent retrospective studies have revealed by CGH-array that the overall genomic pattern is an important prognostic marker which might be taken into account for treatment stratification.

This protocol deals with a prospective analysis of the genomic profile established by CGH-array on the tumor samples obtained at the diagnosis of all the patients with NB in France, to obtain genomic profiles and being able to determine their prognostic impact in the various protocols of treatment. The objective of this study will be a better therapeutic stratification in the future trials, studies or protocols of treatment.

After diagnosis of Neuroblastoma (NB) or Ganglioneuroblastoma :

* Frozen tumor sample (cell content ≥60%) must be sent for genomic profile determination by CGH-array,
* Blood sample at diagnosis must be sent to evaluate MYCN amplification in plasma,
* In case of NB with a MYCN amplification, blood sample during treatment and follow-up must be sent.

Eligibility Criteria:
Inclusion Criteria:

1. Neuroblastoma or Ganglioneuroblastoma defined by INSS criteria (Brodeur et al. 1993)
2. Age \< 18 years
3. Availability of tumoral sample obtained at diagnosis, prior chemotherapy with tumor cell content ≥ 60%
4. Inclusion in 4 months following the diagnosis
5. All patients treated in French centers (SFCE) for Neuroblastic tumour, including those participate in national or international protocols.

7. Written informed consent 8. Patients with French Social Security in compliance with the French law relating to biomedical research.

Exclusion Criteria:

1. Chemotherapy or radiotherapy before taking tumour samples
2. Refusal of the parents or the legal representatives
Ultrasound Imaging-based Measurement of Intra-osseous Vascular Response

Blood circulation within bone is thought to have a key role in bone growth, in fracture healing and in the development of bone diseases like osteoporosis. Current medical imaging techniques such as conventional ultrasonography fail to detect blood circulation within bone. The investigators propose to develop a new type of ultrasonography called intraosseous functional ultrasonography that will enable the detection and the characterization of blood circulation in solid bone tissue, marrow and soft tissues surrounding bone (muscle for instance). Because most soft tissues are essentially made of water, the speed of sound in soft tissues is close to that in water and it varies only a little between different types of soft tissues. For this reason, clinical ultrasound scanners used for ultrasonography assume that the speed of sound in the human body is the same for all types of soft tissues. This assumption is reasonable in soft tissues, but it does not hold in bone because solid bone tissue is much stiffer than soft tissues. Seismologists have extensive experience in producing images of the structure of the Earth based on the analysis of elastic waves which follow the same laws of Physics as ultrasound waves. The subsurface of the Earth contains layers of solid materials and liquids, consequently it is very similar to a region of the human body containing bone and soft tissues. Therefore the investigators will first work on the adaption of time-tested seismic imaging methods to make ultrasonography of bone possible. Once a correct image of bone is obtained, the investigators will use an ultrasound scanner dedicated to research to repeat this image hundreds of times per second, very much like a slow motion video. Because blood is moving while bone is still, the intensity in the image is being slightly changed where blood is moving. Thus the analysis of these changes makes it possible to detect and characterize blood flow within bone. In this way the investigators expect to be able to detect blood flowing with a speed as low as a few millimeters per second. Finally the sensitivity of the technique to detect and characterize blood circulation in bone will be evaluated in patients at the hospital and in healthy volunteers. The success of this work will help gaining knowledge on the role of blood circulation within bone. In the long term, it may help in the diagnosis of bone diseases.


Eligibility Criteria:
Inclusion Criteria:

* be 18 years old or older
* speaks good French
* have an affiliation to a French Healthcare system (health insurance)
* sign the informed consent

Exclusion Criteria:

* bone fracture at the tibia or at the forearm less than one year ago
* injury or wound still present at the tibia or at the forearm
* pregnant women
* protected persons
Effect of ARC1779 on Cerebral Microembolism in Patients Undergoing Carotid Endarterectomy

The purpose of this study is to determine, in patients undergoing carotid endarterectomy, the effect of ARC1779 Injection on the number of microembolic signals detected by transcranial Doppler immediately after surgery. This study will also evaluate the safety of ARC1779 Injection with respect to bleeding risk in patients in the peri-operative (during surgery) period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients;
* \>/= 18 to \</= 80 years of age;
* Carotid stenosis (either symptomatic or asymptomatic);
* Planned carotid endarterectomy;
* Female patients must be non-pregnant and willing to use effective, redundant methods of contraception (i.e., for both self and male partner) throughout the study and for at least 30 days after discontinuation of study drug treatment;
* Male patients must agree to use a medically acceptable contraceptive (abstinence or use of a condom with spermicide) throughout the study and for at least 30 days after discontinuation of study drug treatment;
* All patients must be capable of understanding and complying with the protocol and must have signed the informed consent document.

Exclusion Criteria:

* Lack of acoustic window allowing TCD recordings;
* Unable or unwilling to consent;
* Metallic prosthetic cardiac valve;
* Recent (\<4 weeks) ischemic stroke involving \>1/3 of the MCA territory;
* Any history of hemorrhagic stroke;
* Thrombocytopenia;
* Coagulopathy;
* Trauma or surgery within preceding 30 days;
* History of bleeding disorder, gastrointestinal ulcers, or other medical problem associated with an increased risk of bleeding;
* Use of warfarin and any chronic antithrombotic therapy other than acetylsalicylic acid and/or dipyridamole; patients previously treated with warfarin are eligible if the drug has been discontinued and the INR prior to randomization has returned to \<1.3;
* Use of clopidogrel, unless it has been discontinued at least 5 days prior to randomization;
* Fibrinolytic or GPIIb/IIIa inhibitor treatment within the preceding 24 hours.