cyrilzakka/clinical-trials huggingface dataset:
The Effects of Naltrexone on Active Crohn's Disease

It is hypothesized that the opioid antagonist naltrexone will improve inflammation of the bowel and quality of life in subjects with active Crohn's disease compared to placebo. In order to test this hypothesis the following specific aims are proposed:

1. Evaluate the effects of low dose naltrexone compared to placebo on the activity of Crohn's disease by the following end points: Crohn's Disease Activity Index (CDAI), pain assessment, laboratory values (CRP and ESR), endoscopic appearance, histology, and quality of life surveys;
2. Examine the effects of naltrexone given over 3 months compared to 6 months for durability of response;
3. Determine the safety and toxicity of low dose naltrexone in subjects with active Crohn's disease, and
4. Study the mechanism by which naltrexone exerts its effect by measuring plasma enkephalin levels of subjects on therapy.

Purpose statement: The purpose of this study is to evaluate the effects of low dose naltrexone in a blinded placebo controlled study to determine the safety and efficacy of this compound in those with active Crohn's disease.

Study design : The study is designed as a double-blind placebo controlled study for 3 months followed by a pseudo cross-over such that all subjects receiving placebo the first 3 months will receive active drug the second 3 months and all receiving naltrexone the first 3 months remain on the drug the last 3 months of this 6 month study.

Eligibility Criteria:
Inclusion Criteria:

* All subjects must give written informed consent
* Male or female subjects, \> 18 years
* Patients must have endoscopic, histologic, or radiographic confirmed Crohn's Disease.
* Patients must have a Crohn's Disease Activity Index (CDAI) of at least 220 at Baseline
* Stable doses of medications for Crohn's disease over proceeding 4 weeks (for aminosalicylates and steroids: prednisone of 10mg or less daily and Entocort 3 mg/ day are allowed), and 12 weeks for azathioprine or 6-mercaptopurine.)

Exclusion Criteria:

* Subjects with ostomies or ileorectal anastomosis from prior surgical colectomy.
* Subjects who received infliximab (Remicade) within 8 weeks of study screening or humira for 4 weeks.
* Subjects requiring steroids either intravenously or prednisone \>10mg /day or Entocort \> 3 mg daily.
* Subjects with short-bowel syndrome.
* Abnormal liver enzymes at screening visit or known hepatitis or cirrhosis
* Hemoglobin less than 10.
* Subjects with cancer (other than skin cancer) in past 5 years.
* Women of childbearing potential unless surgically sterile or using adequate contraception (either IUD, oral or deport contraceptive, or barrier plus spermicide), and willing and able to continue contraception for 3 months after the completion of the study.
* Women who are pregnant or breastfeeding
Combined Inhalational With Intravenous Amphotericin B Versus Intravenous Amphotericin B Alone for Pulmonary Mucormycosis

To assess the safety and feasibility of combined inhalational and intravenous amphotericin B therapy for the treatment of pulmonary mucormycosis. And compare the efficacy of combined therapy with that of intravenous amphotericin B alone.

Pulmonary mucormycosis is a relatively a rare disease with a high mortality. The angioinvasion associated with mucormycosis prevents efficient drug delivery at the diseased site. Inhaled amphotericin B achieves drug levels in lung tissue and has been shown to be useful in several diseases including chronic pulmonary and allergic bronchopulmonary aspergillosis. Further inhaled forms of amphotericin B are associated with less nephrotoxicity and other systemic adverse effects. The role of inhaled amphotericin B in pulmonary mucormycosis has been previously demonstrated in murine models and anecdotal reports. The study hypothesis is that combined therapy with inhalational and intravenous amphotericin B is likely to result in better outcomes as compared with intravenous amphotericin B alone for treatment of pulmonary mucormycosis

Eligibility Criteria:
Inclusion Criteria:

Subjects with a clinicoradiologic suspicion of pulmonary mucormycosis will be enrolled if the diagnosis of mucormycosis is pathologically or microbiologically (smear showing aseptate hyphae, culture or molecular evidence showing Mucorales) confirmed. Cases of disseminated mucormycosis will be included, only if the pulmonary infection is confirmed pathologically or microbiologically from respiratory secretions or biopsy samples

Exclusion Criteria:

* Lack of informed consent
* Hypersensitivity to amphotericin B or any component of the formulation
* Pregnancy
* High likelihood of death within 48 h of enrolment
* Suspected pulmonary mucormycosis without histological or microbiologic proof
Does Body Position Influence Pressure Recording by High-resolution Manometry ?

The anorectal manometry is the gold standard in the evaluation of anorectal function.

Several techniques are currently used (balloons, perfused catheters) and are always performed in the supine position.

Few studies have reported the evaluation of sphincter function in the upright position, whereas symptoms of fecal incontinence occur in this position.

Recently developed, high-resolution manometry, thanks to its many mechanical sensors, allows topographic analysis and evaluation of anorectal function more acurate. In addition, the rigid nature of the probe should allow stability measures / recording, which is not possible with probes perfused catheters example.

We therefore propose to compare anal sphincter pressure in supine and standing, measured in high-resolution manometry.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman over the age of 18 years
* Patient referred for endoscopic ultrasound and anal manometry anorectal HR-3D which is an indication of fecal incontinence or dyschesia

Exclusion Criteria:

* Patient age 18 Less
* Patient trust, guardianship, judicial protection
* No Written Consent
* Lack of social insurance
* History of anorectal surgery
* A presence of anal stenosis
* A setting evidence of anorectal lesion preventing the realization of the Screening
* Motor disability preventing the realization of the anorectal manometry 3D HR-standing situation
Understanding GWI: Integrative Modeling

The investigator proposes to perform a Phase I study assessing safety, efficacy, and biomarker response to the therapeutic interventions of Etanercept followed by mifepristone for veterans with Gulf War Illness. The investigator will conduct and repeat the exercise challenge before treatment and on therapy to assess the impact of the interventions on homeostatic regulation and the dynamic model identified in prior studies.

In the Investigator's prior work, the investigator used an exercise stress model (rest, peak oxygen consumption oxygen uptake, and 7 follow-up sampling points) to measure the mediators of relapse in the context of their interactive homeostatic networks. The investigator surveyed the response of genes and blood-borne biomarkers in order to interrogate and map the regulation of neuro-endocrine-autonomic-immune function in these subjects as compared to GW era sedentary healthy controls. This study is the first to test in the GWI human system of the impact of interventions that hope to permanently re-set the key pathway(s) involved in maintaining a "sick" homeostatic network in Gulf War Illness, discovered in our prior CDMRP and VA funded projects. An open-label Phase I study will be performed with Etanercept (once a week for 4 weeks) followed by mifepristone (once a day for 7 days), followed by a 10-week observation to assess safety, efficacy and biomarker response to maximal exercise. The impact of the interventions will be measured on current computational modeling of dynamic response GWI illness mediators at onset, at 6 weeks (on completion of the medication regimen) and 4 months after baseline; using 20 GWI patients. The response during and after an exercise challenge will be assessed followed by map the homeostatic networks in play over the 24 hours post-exercise in subjects before treatment, after completing the second treatment (week 6) and 4 months after initiating treatment (week 16).

Eligibility Criteria:
Inclusion Criteria:

* Male Veterans who were deployed in 1990 -1991 Gulf War.
* Veterans who currently meet the Kansas Gulf War Study Case Definition for Gulf War Illness.
* Veterans who were in good health based on medical history prior to 1990.
* Veterans who are between 40 to 70 years old
* Veterans who currently do not have exclusionary diagnoses that could reasonably explain the symptoms of their fatiguing illness and their severity.

Exclusion Criteria:

* Major depression with psychotic or melancholic features
* Schizophrenia
* Bipolar disorder
* Delusional disorders
* Dementias of any type
* History or current alcohol abuse
* History or current drug abuse
* Organ failure
* Transplant
* Defined rheumatologic
* Inflammatory disorders
* HIV
* Hepatitis B and C
* Primary sleep disorders
* Steroids
* Immunosuppressives
* Medications that impact immune function such as Enbrel or Methotrexate
* Tuberculosis or past history of tuberculosis exposure, as documented by PPD positivity
Long-term Effect of Moderate and Vigorous Exercise on Incident Diabetes in Obese Subjects

Our previous randomized controlled trial has recruited 220 subjects with central obesity and allocated the subjects to the non-exercise control, moderate exercise and vigorous exercise groups. The purpose of our previous study was to investigate the effect of moderate and vigorous exercise on improvement of fatty liver. Those subjects will be followed up for incident diabetes at 2 year and 10 year since randomization. The subjects will be invited to participate in on-site visit at 2 and 10 year. Questionaire forms will be collected and fasting plasma glucose level and HbA1c were measured. The history of diabetes and anti-diabetic medication will be recorded. The incident diabetes will be evaluated.

Our previous randomized controlled trial has recruited 220 subject with central obesity and NAFLD. Those subjects were allocated into non-exercise control, moderate exercise and vigorous exercise groups, who received lifestyle education alone, moderate intensity exercise and vigorous intensity exercise, respectively. The exercise intervention lasted one year. Those three group subjects will be followed up and evaluated for incident diabetes at 2 year and 10 year since randomization. All the subjects will be invited to participate in on-site visit at 2 and 10 year. Questionaire forms will be collected and fasting plasma glucose level and HbA1c were measured. The history of diabetes and anti-diabetic medication will be recorded. The incident diabetes will be evaluated.

Eligibility Criteria:
Inclusion criteria

1. Subjects with NAFLD determined by 1H MRS (intrahepatic triglyceride content ≥5%);
2. 40-65 years old;
3. Waist circumference \>90cm for men and \>85cm for women

Exclusion criteria

1. Consumed more than an average of 140 grams of ethanol (10 alcoholic drinks) per week in men and 70 grams of ethanol (five drinks) in women during the past six months;
2. A history of acute or chronic viral hepatitis, drug-induced liver diseases, and autoimmune hepatitis;
3. Myocardial infarction in the past six months;
4. Biliary obstructive diseases;
5. Uncontrolled hypertension (i.e. systolic BP\>180 mmHg, and/or diastolic DBP \>100 mmHg);
6. Chronic kidney disease (serum creatinine ≥1.5 mg/dL in men and ≥1.3 mg/dL in women);
7. Heart failure (New York Heart Association III or IV);
8. Currently participating in weight loss programs;
9. Currently pregnant or planning to be pregnant;
10. Having any medical condition that would affect metabolism (i.e. diabetes, known hyperthyroidism or hypothyroidism);
11. Having a medical condition that would limit exercise participation and taking medication that would affect metabolism or weight loss (i.e. thyroid medication and glucocorticoids) or would alter the heart rate response during exercise (i.e. β-blockers);
12. Unable to participate in the follow-up examination.
ACOART RF CLOSURE:Radiofrequency for Varicose Veins of Lower Extremity in China

The purpose of the RCT trial is to determine whether endovenous radiofrequency closure catheter and endovenous radiofrequency closure generator is not inferior to ClosureFast™ and ClosureRFG™ in treating varicose veins of lower extremity.

This trial is a prospective, multi-center, 1:1 randomized using endovenous radiofrequency closure catheter and endovenous radiofrequency closure generator versus ClosureFast™ and ClosureRFG™ to treat varicose veins of lower extremity. And parimary endpoint is Complete closure rate of great saphenous vein at 6 months post-procedure.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years of age
* Patients clinically diagnosed as primary varicose great saphenous veins of lower extremity. And unilateral superficial varicose veins of lower extremity will be treated in this procedure.
* Patients with CEAP classification as C2-C5.
* Voluntarily participate in this study and sign the informed consent form

Exclusion Criteria:

* patients with target vein diameter \< 2mm or \> 15mm.
* the distance between the anterior wall of the vessel and the skin of the target vein under ultrasound is less than 0.5cm.
* patients with aneurysmal dilation at the saphenous femoral junction.
* patients with venous aneurysm (defined as venous hemangioma with a diameter greater than or equal to 2 times the diameter of the adjacent vein).
* thrombosis or thrombophlebitis in the trunk of great saphenous vein.
* the great saphenous vein is so tortuous that radiofrequency closure catheter cannot cross the vein trunk.
* patients with target diseased vessels who have received surgical treatment in the past.
* patients with deep venous thrombosis or a history of pulmonary embolism.
* patients with active implants such as pacemakers or ICD.
* patients with severe hepatic and renal dysfunction (ALT \> normal upper limit 3 times; creatinine \> 225umol/L).
* patients who are contraindications to anesthesia.
* patients with secondary varicose veins caused by deep venous thrombosis syndrome, Cockett syndrome (iliac vein compression syndrome), KT syndrome (venous malformation hypertrophy syndrome), arteriovenous fistula, etc.
* any serious or uncontrollable systemic disease (including uncontrolled hypertension, diabetes, active bleeding signs or severe coagulation disorders, etc.).
* patients with diseases that may cause difficulties in treatment and evaluation (such as malignant tumors, acute infectious diseases, septicemia, general intolerability of surgery, life expectancy less than 12 months, etc.).
* pregnant and lactating women, or those who had a planned birth during the study period.
* patients who have participated in clinical trials of other drugs or medical devices in the past 3 months.
* According to the judgement of the investigator, other situations that are not suitable for enrollment.
Angular Pregnancy - Ultrasound Definition and Correlation With Clinical Outcomes

The aim of this study is to establish clinically meaningful ultrasound-based diagnostic criteria for AP. To this end, the investigators will prospectively collect clinical and ultrasound data from early intrauterine pregnancies and correlate this data with pregnancy outcomes (particularly with risk of miscarriage), to establish whether there are any diagnostic criteria that can be used to make the diagnosis, facilitate increased surveillance of at risk pregnancies and reassure those with normally located pregnancies. The collected data will be used to correlate incidence of angular pregnancy and clinical variables such as maternal age, uterine fibroids, assisted conception, multiple pregnancy, ethnicity, previous uterine and adnexal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Have capacity to understand the study and to provide signed and dated informed consent.
* Willing to comply with all study procedures and be available for the duration of the study including consenting to follow up of the pregnancy outcome by letter, phone or email according to individual preference.
* Age 16 years or over
* Mean gestational sac diameter (GSD) on ultrasound of 2-15mm inclusive
* GS implantation site within the upper half of the uterine cavity on 2D USS

Exclusion Criteria:

* Women with pregnancies of unknown location, ectopic pregnancies or larger GSD than specified in the inclusion criteria.
* Implantation site within the lower half of the endometrial cavity on 2D USS screening.
* Intention to terminate the pregnancy
* Women with unicornuate uteri or unicornuate uteri with rudimentary horns
* Women with uterine fibroids which distort the uterine cavity
Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany

The SYNAGIS Registry was carried out in order to gather comprehensive real-world data on the use of palivizumab in children at high risk for serious respiratory syncytial virus (RSV) disease. This registry was designed as a post-marketing observational study, and conducted with the aim of collecting data on palivizumab administration, the risk factors for complicated RSV disease, frequency of hospitalizations, and drug adherence.

Each participant included in this study was observed during his/her palivizumab prophylaxis during the prevailing RSV season. According to the requirements for non-interventional or observational studies, no diagnostic or monitoring procedures were applied to the participants included in the study other than those which would ordinarily be applied in the course of the individual therapeutic strategy. Only data which were part of routine medical care were collected.

Data collection was conducted initially in season 2002/2003 using paper-based case report forms (CRFs); beginning in season 2008/2009 a protected internet-based data entry platform was used. Both the paper-based CRFs and the electronic system were subject to changes during the whole time of the registry.

Data collection for registry seasons 2002/2003 - 2006/2007 was conducted by use of paper-based CRFs and hospitalization forms. Corresponding results were published in 2011 and are hence depicted together and reported here as a separate reporting group.

Registry seasons 2007/2008 and 2008/2009 were considered transitional years in the process of switching the type of data collection to an electronic CRF (eCRF) system. Although data collection of registry 2007/2008 was still paper-based, it was not included in the original publication and hence, results are reported separately. In season 2008/2009 the mode of data collection was switched from paper-based CRFs to an eCRF system, however, several physicians still used the paper-based CRFs for documentation. In order to use all documentations and lose as few data as possible, results for 2008/2009 are based on a combination of paper-based CRF and eCRF data. Hence, it was decided to keep the results for 08/09 separate from the depiction of the homogenous, eCRF-based results of the following seasons.

Data collection for registry 09/10 - 15/16 was implemented by an eCRF system. Corresponding results are therefore depicted together in one reporting group.

Eligibility Criteria:
Inclusion Criteria:

* Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the Respiratory syncytial virus season
* Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months.
* Children less than 2 years of age and with hemodynamically significant congenital heart disease.

Exclusion Criteria:

* Children with known hypersensitivity to palivizumab or any component of the formulation, or other humanized monoclonal antibodies
A Randomized Controlled Trial of a Video Decision Making Aid to Obtain Informed Consent in the Surgical Intensive Care Unit

To demonstrate that clinical surrogates of SICU patients who view a video decision aid in addition to receiving written and verbal information about procedures and life sustaining therapy in the SICU make more informed decisions than patients and clinical surrogates who receive written and verbal information alone.

Specific Aim 1: To demonstrate that clinical surrogates of SICU patients who view a video decision aid in addition to receiving written and verbal information about procedures and life sustaining therapy in the SICU make more informed decisions than patients and clinical surrogates who receive written and verbal information alone.

Hypothesis 1: Adding a video decision aid to the current informed consent process, for procedures and life sustaining treatments in the SICU, will better inform clinical surrogates of incapacitated patients admitted to the SICU regarding decision making when providing consent for medical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical surrogates of the following patients will be eligible to participate in this opinion survey:

  1. All patients admitted to the SICU and not expected to die within 48 hours.
  2. Patient has been admitted to the acute care surgical service,
  3. The patient is over the age of 50 and does not have decision making capacity.
* Subjects must be over the age of 21 and English speaking to participate in the opinion survey.

Exclusion Criteria:
Esgliteo Post Marketing Surveillance (PMS) in Korean Patients With Type 2 Diabetes Mellitus

The objectives of this study are to monitor the safety and effectiveness of Esgliteo in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have started at first time on Esgliteo in accordance with the approved label in Korea
* Age ≥19 years at enrolment
* Patients who have signed on the data release consent form

Exclusion Criteria:

* Patients with previous exposure to Esgliteo
* Patients with hypersensitivity to the empagliflozin and/or linagliptin or any of the excipients
* Patients with type 1 diabetes or diabetic ketoacidosis
* Patients with estimated Glomerular Filtration Rate (eGFR) \< 45 mL/min/1.73m2, end stage renal disease, or patient on dialysis
* Patients for whom empagliflozin/linagliptin is contraindicated according to the local label of Esgliteo