cyrilzakka/clinical-trials huggingface dataset:
Can SIS Using Air Bubbles Replace HSG for Fallopian Tubal Patency After Essure Placement

The study evaluates whether saline infused sonography (SIS) with directed air bubbles for hysterosalpingo-contrast sonography (HyCoSy) is as good as or better than X-ray hysterosalpingography (HSG) for determining whether fallopian tubes are open or closed in patients who are undergoing an Essure confirmation test.

The gold standard for evaluating whether fallopian tubes are open versus closed is the X-ray hysterosalpingography (HSG). HSG is a radiologic procedure that is performed to verify that placement of the Essure tubal ligation inserts have successfully blocked the fallopian tubes. However, this procedure involved exposure to radiation. The saline infused sonography (SIS) with directed air bubbles for hysterosalpingo-contrast sonography (HyCoSy) does not involve radiation and can be done in a physician's office. The HyCoSy air bubble device may be a lower cost, safer alternative procedure if it can be shown to provide similar results for tubal patency.

This study will compare the HyCoSy procedure results with the HSG procedure results in women who require the HSG procedure after receiving Essure tubal ligation inserts for their Essure confirmation test.

Women will be randomized to receive the HycoSy procedure first, followed by the HSG procedure or to the reverse order. Two independent readers will review the video results for both procedures to determine the degree of agreement on tubal patency.

Eligibility Criteria:
Inclusion Criteria:

* Documentation of normal Pap smear within 1 year prior to enrollment into study.
* Written informed consent given
* Need for evaluation of tubal status for post-Essure tubal occlusion
* Negative urine pregnancy test

Exclusion Criteria:

* History of unresolved dysfunctional uterine bleeding (DUB).
* History of a hysterectomy.
* Current urogenital disease.
* History of allergic response to IVP dye (exclusion for HSG).
* Abnormal pap smear.
* Positive urine pregnancy test.
Painful Breastfeeding and Osteopathic Treatment on the Mother-newborn Dyad

Pain during lactation is the first reason to stop breastfeeding. When usual known aids are ineffective, osteopathic treatment is a possible way to decrease the pain and improve the quality and the duration of lactation. The aim of this study is to compare usual known aids alone and usual known aids added to osteopathic treatment of the baby and the mother. The primary outcome is the lactation rate (exclusive or partial) at 1 month after birth

Breastfeeding is recognized to be essential for childhood health and public health. The first reason to stop breastfeeding before the second month after birth is pain during lactation. The second reason to stop breastfeeding is back-to-work, generally two months after birth. Few years ago, osteopathic treatment has been introduced at maternity hospital of Bordeaux when usual known aids are ineffective. The osteopathic treatment is completely integrated in the maternity hospital of Bordeaux but no strong evaluation is available in literature. A pilot evaluation on 27 patients showed a good effectiveness of osteopathic treatment on breastfeeding at 1 months ½ after birth (85% of patients) Breast pain decreased or disappeared after the osteopathic treatment. Another evaluation showed a small rate of lactation (15% of patients) in a non treated group at 1 month ½. In the present study, osteopathic treatment will be added to usual known aids for 40 mother-newborn dyads when pain during lactation is greater than 7 (0 to 10 scale). The experimental group will be compared with 40 "non treated" mother-newborn dyads (only usual known aids in routine care). Among other, breastfeeding and pain during lactation will be evaluated at the maternity hospital discharge and will be repeated at 1 month after birth.

Eligibility Criteria:
Inclusion Criteria:

* Mother 18 yrs and older who chose to breast-feed (exclusive or not)
* Singleton newborn after 37 weeks of gestation, weighing at least 2500 g at birth, after 36 hours of life
* Pain during lactation greater than 7 (scale 0 to 10) in one or both breasts
* Usual known aids ineffective to reduce pain during lactation
* Mother speaking and understanding French
* Mother affiliated or beneficiary to a health system
* Signed informed consent.

Exclusion Criteria:

* Medical contraindication to osteopathic treatment (non stabilized infection, acute neurological pathology, tumor or cancer process, maternal psychiatric disorders)
* Severe congenitale malformation, especially not allowing normal lactation
* Patient under legal protection
* Persons deprived of their liberty by judicial or administrative decision
The Role of Brain Activation and Cerebral Blood Flow in Mental Fatigue.

To assess the changes in brain activation and cerebral blood flow due to mental fatigue in a placebo-controlled study. More specifically we want to assess whether brain activation \[measured with Blood Oxygen Level Dependent (BOLD) functional resonance imaging (fMRI)\] is decreased during a Flanker task in a mentally fatigued state and whether this coincides with a decline in cognitive performance. In addition we also want to evaluate whether cerebral blood flow \[measured with arterial spin labeled (ASL) fMRI\] in a resting state is reduced when mentally fatigued.


Eligibility Criteria:
Inclusion Criteria:

* Healthy (No neurological/cardiorespiratory/psychological disorders)
* No medication
* Non-smoker
* Between 18 and 35 years old

Exclusion Criteria:

* Injuries
* Illness
* Pacemaker, neurostimulator, medication pump or metal implants
* Use of medication or any kind of drugs
* Use of alcohol, caffeine and heavy efforts 24 hours before each trial
* Not eating the same meal the night before and the morning of each trial
Implication of New High Resolution Ultrasonographic Modalities for Diagnosis of Fetal Nervous System Anomalies

The fetal CNS screening examination during the mid-trimester scan in low-risk pregnancies should include evaluation of the fetal head and spine, using transabdominal sonography. Evaluation of two axial planes allows visualization of the relevant cerebral structures to assess the anatomic integrity of the fetal brain.These planes are commonly referred to as the transventricular and transcerebellar planes. A third plane, the so-called transthalamic plane, is frequently added, mostly for the purpose of biometry. Structures that should be noted in the routine examination include the lateral ventricles, the cerebellum, the cisterna magna, and the cavum septi pellucidi (CSP). Head shape and brain texture should also be noted on these views.

The neural system malformation is one of the more common congenital anomalies encountered in pregnancy. They represent about 0.3-1 percent of all live births. During a prenatal anomaly scan, detection of CNS malformations is important, especially since these anomalies have a poor prognosis and are also associated with genetic syndromes or chromosomal anomalies. Such malformations have clinical importance because they are associated with high rates of morbidity and mortality, influencing the neurocognitive and motor development of the survivors, who may have lifelong sequelae. Thus, it's extremely important to assess the fetal CNS during the prenatal period in order to identify any changes in its development and give appropriate advice to parents regarding pregnancy follow-up. Also, it is vital to explore options for fetal therapy and the timing/type of delivery, as well as postnatal treatment and prognosis.

The fetal CNS screening examination during the mid-trimester scan in low-risk pregnancies should include evaluation of the fetal head and spine, using transabdominal sonography. Evaluation of two axial planes allows visualization of the relevant cerebral structures to assess the anatomic integrity of the fetal brain.These planes are commonly referred to as the transventricular and transcerebellar planes. A third plane, the so-called transthalamic plane, is frequently added, mostly for the purpose of biometry. Structures that should be noted in the routine examination include the lateral ventricles, the cerebellum, the cisterna magna, and the cavum septi pellucidi (CSP). Head shape and brain texture should also be noted on these views.

Eligibility Criteria:
Inclusion Criteria:

Suspicion of CNS or spinal malformation at routine screening ultrasound Suspicion of CNS or spinal malformation at nuchal translucency scan Family history of inheritable CNS spinal malformations Previous pregnancy complicated by fetal brain or spinal malformation Fetus with congenital heart disease Monochorionic twins Suspected congenital intrauterine infection Exposure to teratogens known to affect neurogenesis

Exclusion Criteria:

Low risk pregnancy
A Long Term Safety and Efficacy Study of Fabrazyme Replacement Therapy in Japanese Patients With Fabry Disease.

The purpose of this survey is to identify any concerns regarding the following efficacy and safety-related issues in clinical practice with the new drugs "Fabrazyme for intravenous infusion 5mg" and "Fabrazyme for intravenous infusion 35mg" and to confirm the safety of these products in long-term use in the clinical setting.

1. New adverse drug reactions (ADRs) that cannot be predicted from the Precautions (in particular, clinically significant ADRs)
2. The incidence of ADRs under the actual conditions of use of the drug
3. Causal factors that might potentially affect safety
4. Efficacy evaluation in long-term use

This survey will be conducted in accordance with the approval condition established for Fabrazyme:

"To conduct a special surveillance of Efficacy and Safety in long term treatment and Pediatric with the drug."

Medical institutions or physicians will be asked to periodically complete the survey forms for all patients registered. Survey forms include baseline information available, and then data collected every 6 months, as available including: demographic information, concomitant medications/therapy, treatment record, ECG, Echocardiogram, computed tomography scan / magnetic resonance imaging (CT/MRI), Fabry symptoms, labs, functional disorder, blood concentration of GL-3, and anti-agalsidase beta antibody test (IgE testing) to survey whether the productions of antibodies to agalsidase beta is a causal factor of treatment-related reactions.

The survey period shall be approximately 7 years from June 1, 2004 during which survey shall be undertaken as follows:

* The observation period for each patient shall range from 1 to about 7 years after starting treatment
* Registration period: June 1, 2004 to March 31, 2010
* Survey period: June 1, 2004 to March 31, 2011

In institutions for which retrospective surveys are feasible, the survey period will trace back to the date of approval (January 29, 2004), as far as possible.

Eligibility Criteria:
Inclusion Criteria:

* Patients in Japan with the indication of "Fabry Disease" and for whom the usual dosage and administration is 1mg of agalsidase beta (recombinant) per 1 kg body weight each time, administered by intravenous infusion every 2 weeks
* Because the efficacy evaluation of enzyme replacement therapy with Fabrazyme \[agalsidase beta (recombinant form)\] will require the comparison of findings before and after the start of enzyme replacement therapy, the efficacy evaluation set will be defined as including patients using Fabrazyme \[agalsidase beta (recombinant form)\] for the first time in the post-marketing setting and those for whom it is possible to obtain retrospective data for before the start of enzyme replacement therapy.

Exclusion Criteria:

* Patients registered in the post-marketing trials during the post-marketing clinical trial period.
Effect of Electroacupuncture in Patients With Sepsis Associated Brain Injury

To investigate the effect of electroacupuncture on patients with sepsis-associated brain injury.


Eligibility Criteria:
Inclusion Criteria:

1. Age is between 20 and 80 years.
2. Patients meeting the diagnosis of sepsis-associated brain injury.
3. Patients who agreed to accept this trial and signed the informed consent form.

Exclusion Criteria:

1. Patients with a history of brain injury, stroke, epilepsy, cognitive impairment, or mental illness prior to admission.
2. Patients who were also involved in any other interventional study.
3. Due to hearing or vision loss, or any other situation that may seriously interfere with study data collection.
4. Patients who refused to participate in this study.
5. The pregnancy test was positive or is currently breastfeeding.
6. Any other situation that the investigator believed might be detrimental to participant in the study.
Cohort of Respiratory Failure Patients Treated for the First Time With Non-Invasive Ventilation at Home

The effectiveness of NIV is clearly demonstrated but no recent studies describe the prescription based on clinical data and the conditions of using NIV at home according the various respiratory diseases.

The investigators' purpose is that a better knowledge of NIV practices could improve both the quality to support patients at home and the efficacy of the treatment.

The main objective of this study is to analyze the clinical data justifying the prescription of NIV advice according respiratory disease. The secondary objectives are to study comorbidities, treatment failures, survival rate during the study period.


Eligibility Criteria:
Inclusion Criteria:

* No previous experience with domiciliary non-invasive ventilation
* Adult patients, ≥ 18 years of age
* Without tracheotomy
* No evolutive cancer
* No significant psychiatric disease
* Possible medical monitoring

Exclusion Criteria:

* Evolutive cancer
* Inability to understand rationale and/or consent form for study
Excimer Laser Assisted IVC Filter Retrieval

This is a prospective chart review to follow our laser-assisted IVC filter retrieval patients. We intend to validate existing literature and scientific findings by publishing our own clinical experience in difficult IVC filter retrievals.

At Northwestern Memorial Hospital in Chicago, IL USA, IVC filters are successfully removed \>95%. Technical failures, although rare, are usually related to excessive endoluminal scarring at the point of IVC filter implantation. Adjunctive (or advanced) removal techniques are often employed in difficult cases. The excimer laser sheath has been successfully used at Northwestern for patients who had failed all other retrieval techniques.

Before a patient is to undergo an IVC filter removal using the Excimer Laser Sheath they will be consented to participate in the chart review study and become a part of a registry kept at Northwestern Memorial Hospital. The procedure itself is not being used as part of the study. Chart reviews will be completed and data collected on the procedure to remove the filter. Follow up after the procedure by phone call and chart review will be completed at least once, 1 week after the filter removal.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be male and female aged 18 years to 100 years old who were treated with either permanent or retrievable IVC filter placement and were referred to the Interventional Radiology or Vascular Surgery departments for IVC filter retrieval starting December 1, 2011.
* Patients have failed all other traditional methods/attempts at removal of their IVC filter.

Exclusion Criteria:

* Patients who refuse the use of the excimer laser device to attempt to remove their IVC filter.
Cognitive, Emotional, Communicative, and Motor Development in Children Born From IOC

The study focuses on children born after in vitro fertilization (IVF) of cryopreserved oocytes.

* Evaluate whether the cognitive development of children born by IVF of cryopreserved oocytes is comparable to expected peer development.
* Evaluate whether the emotional development of children born by IVF of cryopreserved oocytes is comparable to expected peer development.
* Evaluate whether the communicative development of children born by IVF of cryopreserved oocytes is comparable to expected peer development.
* Evaluate whether the motor development of children born by IVF of cryopreserved oocytes is comparable to expected peer development

Eligibility Criteria:
Inclusion Criteria:

* Live births from pregnancies resulted from fresh and frozen embryo transfer after fertilization of cryopreserved oocytes are included.

Exclusion Criteria:

* Children born from pregnancies obtained from cryopreserved donated oocytes have been excluded.
ANRS HC20 Effectiveness of an Optimized Anti HCV PegIFN-alpha2a + Ribavirin on Sustained Virological Response in Patients With HCV Genotype 1 and 4 Non Responders and Co-infected With HIV

The purpose of this study is to assess the effectiveness of an optimized anti HCV treatment (360μg per week of PegIFN-alpha2a + 18mg/kg/j of Ribavirin for 6 months.

In patients HIV infected, the success rate do not exceed 20% in genotype 1 or 4 patients. In case of treatment failure , patients are rarely re-treated, and liver fibrosis progresses rapidly. The new molecules are not yet available for patients co-infected with HIV, and patients having already undergone a first treatment will likely be among the last to be included in trials evaluating the effectiveness of these treatments.

However, recent studies show that it is possible to propose a new treatment "optimized" to these patients in the hope to obtain better success rate. Provide antiretroviral treatment, use of high doses of Peg-interferon and ribavrine, and supporting patients.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Weight 85 kg below the pre-inclusion visit.
* Documented HIV infection (HIV positive)
* HCV infection documented by a positive PCR
* HCV Genotype 1 or 4
* Compensated liver disease (Child-Pugh below/equal to 6)
* Lymphocytes CD4 above 200/mm3
* Patient not answering a treatment for hepatitis C.
* Patient not covered by dual by Peg-IFN + riba for at least three months (wash out)

Exclusion Criteria:

* Co-infection with HBV (HBsAg positive)
* Neutropenia below 1000/mm3
* Thrombocytopenia below 90000/mm3 or thrombocytosis over 500 000/mm3.
* Hemoglobin below 11 g / dL (men and women)
* Arguments radiological (ultrasound, CT or MRI) of hepatocellular carcinoma cell
* Antiretroviral containing didanosine (ddI) and stavudine (d4T) and zidovudine (AZT) and abacavir (ABC).
Folic Acid Interferes With Radiation Esophagitis

This randomized study compared the incidence and severity of radiation esophagitis with folic acid and with conventional symptomatic treatment.

By prospective randomized controlled study, this study research plans to recruit with diagnosis of lung cancer patients, according to whether there is drug intervention were divided into treatment group and control group, compared two groups of acute radiation esophagitis in the before and after the intervention, extent of occurrence of folic acid and clinical curative effect, so as to verify whether folic acid can be used as an intervention in the treatment of radioactive esophagitis, To explore the safety of folic acid in the treatment of radioactive esophagitis and explore the standardized treatment of radioactive esophagitis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with malignant lung cancer (incluedig Non-small cell lung cancer, small cell lung cancer) diagnosed by histopathology or cytology.
2. TNM Stage N2\~N3 (IASLC International TNM staging standard for Lung Cancer, 8th edition) was indicated by radiotherapy and the patients were treated for the first time.
3. Aged between 18 and 75 years old,no limit on the gender.
4. ECOG≤2 or KPS≥70.
5. No contraindication of Concurrent chemoradiotherapy.
6. Patients without important organ dysfunction,hematology: it is within the normal range according to the standards of each laboratory; Cardiac function: normal range; Liver function: normal range; Renal function: normal range; Pulmonary function: FEV1 \> 50%, mild to moderate impairment of pulmonary function.
7. Patients with good compliance to treatment received and follow-up.

Exclusion Criteria:

1. Prior to treatment, there were other esophageal diseases, such as gastrointestinal ulcer, reflux esophagitis, cardia relaxation.
2. Patients with severe nutritional anemia prior to treatment.
3. The IV stage patients with uncontrolled malignant pleural effusion,with diffuse liver or lung metastasis which lead to liver or pulmonary dysfunction.
4. Patients with severe heart, lung or kidney diseass,such as uncontrolled hypertension, diabetes, unstable angina, a history of myocardial infarction or heart failure, or uncontrolled arrhythmias; There is clearly clinically diagnosed heart valve disease; The active phase of a bacterial, fungal, or viral infection; Mental disorders; Severely impaired lung function.
5. A history of previous tumors complicated with other malignant tumors.
6. The pregnant or breast-feeding patients.
7. Patients with mental and neurological diseases.
Quantitative Magnetic Resonance Imaging (MRI) Sub-Study of MS PATHS

The primary objective is to assess the performance of a new magnetic resonance imaging (MRI) metrics software prototype when used in radiological practice in multiple sclerosis (MS).


Eligibility Criteria:
Key Inclusion Criteria:

* Board-certified neuroradiologists or experienced neuroradiology fellows.
* Employed at a participating MS PATHS institution.
* At least 3 years of experience in interpreting brain MRI scans of MS participants.

Key Exclusion Criteria:

* Inability to comply with sub-study procedures.
* Other unspecified reasons that, in the opinion of Biogen or the MS PATHS Radiology Lead at the institution, make the radiologist unsuitable for participation.
Role of aGVHD Biomarkers on aGVHD Risks

To establish risk rating criteria of biological protein marker, determine the role and consistency of aGVHD biomarkers in aGVHD diagnosis and aGVHD prognosis, and evaluate the the impact on non-relapse mortality and relapse and disease free survival, the multicenter study on aGVHD biomarkers detection in the patients underwent allogeneic hematopoietic stem cell transplantation was performed.

1. To establish standard risk rating criteria of aGVHD biomarkers;
2. To verify the role of aGVHD biomarkers monitored in predicting aGVHD risks;
3. To determine the correlation between aGVHD biomarkers monitored and aGVHD risk;
4. To carry out a observative study in patients with aGVHD treatment about therapeutic protocols and medication efficacy;
5. To predict the correlation between the high-risk patients with aGVHD and non-relapse mortality and disease free survival;

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with hematological diseases.
2. Have underwent first allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies.

Exclusion Criteria:

1. recipients of second allogeneic stem cell transplant.
2. pregnant or breast-feeding women.
3. Serum creatinine \> 2.0 mg/dL or creatinine clearance \< 40 mL/min measured or calculated by Cockroft-Gault equation.
4. human immunodeficiency virus infection
5. active hepatitis b virus, hepatitis C virus infection and need antivirus treatment.
6. Subjects with evidence of relapsed primary disease, or subjects who have been treated for relapse after the allo-HSCT was performed, or graft rejection.
7. allergic history to Janus kinase inhibitors.
8. Severe organ dysfunction unrelated
9. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.