cyrilzakka/clinical-trials huggingface dataset:
Immunological Follow-up of Patients With Basedow's Orbitopathy

Graves' disease is characterized by the combination of anti-TSH receptor antibodies (Thyroid-Stimulating Hormone or thyroidotropic hormone), specific to this disease, with inconsistent symptoms such as hyperthyroidism, orbitopathy, goiter, or myxedema dermatological involvement. The activation of TSH receptors (RTSH) by these antibodies (known as "TRAK") causes the secretion of thyroid hormones as well as the development of the thyroid gland, responsible for a goiter. The cellular infiltrate responsible for the goiter consists mainly of T-lymphocytes but also of activated B lymphocytes secreting TRAK. Although Graves' disease is antibody mediated, cytokine secretion by Th1 therefore seems essential to pathogenesis. The treatment of orbitopathy requires primarily euthyroidism and the discontinuation of smoking. Despite these measures, moderate to severe attacks may require immunomodulatory treatment to limit local inflammation. This treatment is currently based on a first-line corticosteroid treatment (per os or preferably by weekly intravenous infusions). In the context of inadequate response, the therapeutic strategy is not very well established since some immunosuppressive treatments targeting B-cells or T- cells have been studied but with little benefit.

Many new concepts concerning immune tolerance and autoimmunity have emerged in recent years, particularly in Graves' disease, with sometimes complex cellular interactions. Certain mechanisms could occur either independently or in combination: i) modulation of T cell activation, differentiation and apoptosis; ii) inhibition of BL maturation and immunoglobulin production; iii) alteration of the balance between T helper (Th)-17 and T regulatory lymphocytes (Treg), by promoting Treg differentiation and inhibiting Th17 differentiation.


Eligibility Criteria:
Inclusion criteria:

* Patients aged 18 to 80 years included
* Subjects with Grave's disease and unsuccessful or intolerant to corticosteroid bolus therapy (EUGOGO protocol)
* Subjects with positive TRAKs

Exclusion criteria:

* Current treatment or within 6 months before inclusion by anti-CD20 monoclonal antibodies
* Current treatment or in the month prior to inclusion with corticosteroids \>10 mg/day (oral or intravenous)
Assessment of Prevident Sodium Fluoride 1.1% Toothpaste Using an Intra-oral Remineralization-demineralization Model

This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to evaluate remineralization of early caries lesions.


Eligibility Criteria:
Inclusion Criteria:

1. Male and/or female subjects 18 to 50 years inclusive
2. Minimum of 20 natural uncrowned teeth (excluding third molars) must be present
3. Willing to wear retainer 24 hours per day
4. No active, unrestored cavities
5. Have normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥ 0.2 ml/min respectively) ascertained from a preliminary sialometry
6. Available throughout entire study
7. Willing to use only assigned products for oral hygiene throughout the duration of the study
8. Must give written informed consent
9. Must be in good general health
10. No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study

Exclusion Criteria:

1. Advanced periodontal disease
2. Medical condition which requires premedication prior to dental visits/procedures
3. Not enough teeth to secure the oral retainer
4. Diseases of the soft or hard oral tissues
5. Wear an Orthodontic retainer(s)
6. Impaired salivary function
7. Current use drugs that can affect salivary flow
8. Use antibiotics one (1) month prior to or during this study
9. Positive urine test for pregnancy (a urine pregnancy test will be performed on female subjects of child-bearing potential)
10. Participate in another clinical study one (1) week prior to the start of the washout period or during this 9-week study period
11. Use tobacco products
12. Allergic history to common toothpaste ingredients
13. Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy) as determined by review of medical history
Posterior Wall Osteotomy for Old Acetabular Fracture

Posterior wall osteotomy would be conducted to manage the old acetabular fracture. The outcome was reviewed to assess the feasibility of the surgical procedure.

More and more patients with old acetabular fracture were admitted in our institution during the past years. There is little literature especially depicts the therapeutic principle of the kind of damage. Posterior wall osteotomy would be conducted to eliminate the fragments or callus from the hip joint. Then, the deformed healing acetabulum could become mobile and the reduction may be achieved. However, the surgical procedure is technique demanding and some intraoperative risk may be accompanied.

Surgical time, blood loss, complication and fracture healing would be reviewed to assess the feasibility of the surgical procedure. The function outcome is evaluated with HHS score at the follow up.

Eligibility Criteria:
Inclusion Criteria:

* acetabular fracture
* no surgical procedure has been obtained over 3 weeks
* deformed healing
* receive posterior wall osteotomy
* completed more than one year follow-up

Exclusion Criteria:

* accompanied with other fracture
* pathological fracture
* reject the posterior wall osteotomy
Does End-fire Technique Increase Detection Rate of Prostate Cancer at First Re-biopsy Compared to Side-fire Technique?

Prostate cancer is the most common cancer among men in Sweden. During investigation of suspected cancer transrectal ultrasound with needle biopsies from prostate leeds to diagnosis.

The most common technique today is side-fire where the needle enter the prostate in angle from the probe. In end-fire technique the needle enters the prostate at tip of probe without angle. The difference in techniques side-fire vs. end-fire affects the possibility to reach the ventral and apical aspects of prostate.

Today´s standard is at least five cores from each side of the prostate at first biopsy. If first sample is negative there will usually be another urological exam and a first re-biopsy.

The study aim to compare these two methods in cancer detection. The investigators' hypothesis is that when using end-fire technique at first re-biopsy, investigators find more cancers compared to side-fire.

Patients are prospectively randomized into two groups, both assessing 12 core biopsies according to study protocol.

Primary endpoint is cancer detection. Data will be collected about patient age, PSA-level, prostate size, digital rectal exam, hypoechogenic zones and length of cancers.


Eligibility Criteria:
Inclusion Criteria:

* first re-biopsy
* PSA over 3ng/ml
* T1c to T2a palpatory finding

Exclusion Criteria:

* prostate cancer
* T2b or more advanced cancer
* more than one previous biopsy done
Anorectal Function and Neuronal-glial-epithelial Unit in Healthy Subjects

This study aims to assess the phenotype of the enteric nervous system (enteric neurons) in healthy subjects.

The enteric nervous system (ENS) is composed by enteric neurons and enteric glial cells. There is a cross-talk between ENS and the intestinal epithelial barrier (IEB). ENS and IEB together constitute the neuronal-glial-epithelial unit. This unit has a key role in gut functions. The characteristics and the phenotype of the ENS also change according to age and environmental factors. Similar study is ongoing for patients with Spina Bifida. Anorectal data and phenotype of the neuronal-glial-epithelial unit in healthy subjects is required to assess abnormality of these items in patients with neurological disease including Spina Bifida.


Eligibility Criteria:
Inclusion Criteria:

* subject aged between 18 and 65 years old age and sex matched with the first sixteen patients included and evaluated in the ANOSPIN study
* subject who gave their written consent to participate to the present study
* subject not included in another study
* subject covered by social insurance system

Exclusion Criteria:

* Pregnant or nursing women;
* Anticoagulants therapy or coagulation disorders;
* Past history of anal or rectal surgery
* Crohn disease or ulcerative colitis
* Irritable bowel syndrome according to the Rome III criteria;
* Past history of pelvic radiotherapy
* Pas history of rectal or anal cancer
* Anorectal symptoms : faecal incontinence, constipation, anorectal pain, rectal prolapse;
* CCIS \>5 (faecal incontinence);
* Kess Score \>9 (constipation);
* Colonic irrigation;
* Use of laxatives;
* Abnormal colonic mucosa
* Period of exclusion;
* Patient under guardianship or unable to give their consent;
Music of Choice to Decrease Anxiety During Radiation Treatment

The primary hypothesis of the study is that listening to music will reduce anxiety in female cancer patients during the first radiotherapy treatment session.

Receiving radiotherapy induces anxiety in at least 1/3 of patients who did not have a previously existing anxiety condition1. Female gender is a positive predictive factor for psychosocial decline during radiotherapy. One-fourth of patients disrupt their planned radiotherapy treatment course due to anxiety. Music therapy has demonstrated effectiveness in reducing anxiety when implemented in other medical settings including mechanical ventilation, burn debridement and venipuncture in pediatric patients. There have been some trials which have found a reduction in anxiety when pre-recorded music along with other relaxation techniques have been implemented during radiotherapy. This trial seeks to investigate the benefit of pre-recorded music alone in reducing anxiety experienced during the first radiotherapy treatment session in female cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to receive radiotherapy for malignant tumor
* ECOG Performance Status 0-4
* Fluent in English Language
* Inclusion in this study will not be based on race or ethnicity
* Patients must be deemed able to comply with the treatment plan.
* Patients must provide study specific informed consent prior to study entry.

Exclusion Criteria:

* Prior history of radiation therapy
Investigating Markers of Energy Metabolism in Pregnant Women With Insulin Resistance

The investigators seek to examine the metabolic changes that occur amongst obese and lean pregnant women with normal glycemic control as well as pregnant women with diabetes mellitus (gestational diabetes and pre-existing type 2 diabetes mellitus) compared to non-pregnant age matched controls. Given the adaptive tendency of the maternal body to use alternative energy sources such as ketones and free fatty acids rather than glucose and to shunt glucose and amino acids to the fetus, the investigators hypothesize that the amino acid and fatty acid profile will be reflective of this adaptive change and that maternal insulin resistance will result in alterations in this pattern in both the plasma and CSF. Furthermore, the investigators also hypothesize that maternal degrees of insulin resistance will also be reflected in CSF hormonal changes.

We seek to investigate for the first time whether CSF branched chain amino acid, free fatty acid, and energy regulatory hormone levels are altered in comparison to plasma levels among pregnant and non-pregnant individuals with varying degrees of insulin resistance. Furthermore, we seek to understand the effects of pregnancy on central and peripheral energy metabolism using metabolomic profiling as well as traditional hormonal measurements in maternal blood, urine, cerebrospinal fluid as well as cord blood.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women ages 18-45, pre-pregnancy BMI 18-30 with normal glycemic control scheduled for an elective cesarean delivery at Yale-New Haven Hospital on the Labor and Birth unit
* Pregnant women ages 18-45, pre-pregnancy BMI \>30 with normal glycemic control scheduled for an elective cesarean delivery at Yale-New Haven Hospital on the Labor and Birth unit
* Pregnant women ages 18-45 with diabetes (gestational or pre-existing type 2 DM) scheduled for an elective cesarean delivery at Yale-New Haven Hospital on the Labor and Birth unit
* Non-pregnant, non-diabetic women age 18-45 scheduled for lumbar puncture at the Yale-New Haven Hospital Lumbar puncture clinic
* Able to read and understand English at 6th grade level or higher

Exclusion Criteria:

* Medical disorders other than diabetes. Including psychiatric disorders, alcohol abuse, HIV, hepatitis, renal, hepatic disease, heart disease, active systemic infection, malignancy
* Pregnancy related medical problems including preeclampsia
* Major congenital fetal anomalies
* Smoking and illicit drugs (marijuana, cocaine, benzodiazepines, barbituates)
* Use of weight loss supplements or dieting 6 months prior to study.
* Corticosteroid use within 6 months of study.
* Uncontrolled thyroid disease
* Medications other than multivitamin, folic acid, or diabetic medications.
Continuous Glucose Monitoring Initiation at Hospital Discharge

The purpose of this study is to look at feasibility (the likelihood) of continued use of the FreeStyle Libre 2 Continuous glucose monitor (CGM) when started at the time of hospital discharge in patients with poorly controlled diabetes and to look at the effects of CGM use on blood glucose control and quality of life. Additional information will be collected to determine the barriers to continuing CGM use after discharge. The investigators will also collect information to see how well blood glucose has been controlled after discharge while utilizing the CGM.

VISIT/PHONE CALL WHAT WILL HAPPEN? (estimated time) \[window\]

Screening Visit (\~45 minutes) Review consent form and obtain consent Complete questionnaire, obtain diabetes history Day of Discharge (\~1 hour) Complete FreeStyle Libre 2 CGM education Attach FreeStyle Libre 2 CGM sensor to arm Within 1-3 weeks from discharge Phone Call (\~30 minutes) Questions regarding use of FreeStyle Libre 2 CGM Current diabetes regimen Adverse Events Reminder to take FreeStyle Libre 2 CGM sensor prescription to pharmacy to be filled

1 \& 3 Month Phone Call (\~45 minutes) \[+/- 5 days\] Questions regarding use of FreeStyle Libre 2 CGM Current diabetes regimen Complete questionnaire Adverse Events 6 Month Phone Call (\~15 minutes) \[+/- 10 days\] Questions regarding use of FreeStyle Libre 2 CGM Barriers to FreeStyle Libre 2 CGM use

Validated Instruments: Diabetes self-management Questionnaire (DMSQ)

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Have diabetes (type 1 diabetes mellitus, type 2 diabetes mellitus, cystic fibrosis related diabetes mellitus)
3. Hemoglobin A1c greater than or equal to 8.0% or history of hypoglycemia unawareness
4. Able and willing to sign informed consent form
5. Have a valid telephone number
6. Willing to purchase FreeStyle Libre 2 CGM sensors out of pocket after discharge from hospital (when insurance coverage isn't available)

Exclusion Criteria:

1. Unable to sign informed consent form
2. Have altered mental status
3. Unable to manage diabetes independently at home
4. Have utilized CGM in the past
5. Pregnancy
6. New steroid-induced hyperglycemia
7. Unwilling to participate in the study
8. Have kidney disease requiring hemodialysis
9. Taking high doses of vitamin C daily (greater than 500 mg every day)
Impact of Perioperative Levosimendan on Patients Undergoing Cardiac Surgery With Low Ejection Fraction

to compar levosemindan to other cardiac intropic medications that strengthen the heart in diffrent common adult heart surgery with patients with low ejection fraction(weak heart)

in this study show the effect of levosemindan use during coronary artery surgery ,heart valve surgery and combined coronary and valve surgery in comparison to other traditional medications with patients with low ejection fraction(weak heart)

Eligibility Criteria:
Inclusion Criteria:

1. Valve surgery
2. CABG surgery,
3. combined surgery
4. all patients Ejection Fraction less than 35 ٪ -

Exclusion Criteria:

1. Patients age ≤ 20-70 \< years
2. Aortic and redo surgery
3. any patients with Ejection Fraction more than 35 ٪ -
Effect of Cholesterol Level on Postoperative Acute Kidney Injury of Non-cardiac Surgeries

Preoperative serum cholesterol level may influence occurrence of postoperative acute kidney injury of cardiac surgeries. However, the effect of Preoperative serum cholesterol level for non cardiac surgery remains unknown. This study aimed to explore the effect in non-cardiac surgical population.


Eligibility Criteria:
Inclusion Criteria:

adults elective non-cardiac surgery

Exclusion Criteria:

cardiac surgeries kidney surgeries obstetric surgeries local infiltration anesthesia perioperative data missing
A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-02)

This study will evaluate the efficacy, safety, and tolerability of two doses of rapastinel, 225 milligrams (mg) and 450 mg, compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.


Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
* Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
* Have no more than partial response (\< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
* If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.

Exclusion Criteria:

* DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
* Lifetime history of meeting DSM-5 criteria for:

  1. Schizophrenia spectrum or other psychotic disorder
  2. Bipolar or related disorder
  3. Major neurocognitive disorder
  4. Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
  5. Dissociative disorder
  6. Posttraumatic stress disorder
  7. MDD with psychotic features
* Significant suicide risk, as judged by the Investigator.
Genotypic Resistance Guided Therapy in Helicobacter Pylori Eradication

We aimed to compare the efficacy of genotypic resistance guided sequential therapy vs. empiric therapy in the third line therapy. Factors affecting the eradication rates, including the antibiotic resistance, CYP2C19 polymorphism, CagA and VacA status will also be assessed.

The primary aim of this study is to compare the regimens selected using either one of the method (1) genotypic resistance guided versus (2) medication history guided therapy. (rather than to compare the efficacy of any drugs).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged greater than 20 years who have persistent H. pylori infection after at least two treatments and are willing to receive third line rescue regimens are considered eligible for enrollment.

Exclusion Criteria:

* Patients will be excluded from the study if any one of the following criteria is present: (1) children and teenagers aged less than 20 years, (2) history of gastrectomy, (3)gastric malignancy, including adenocarcinoma and lymphoma, (4) previous allergic reaction to antibiotics (Amoxicillin, Klaricid, Cravit) and prompt pump inhibitors (esomeprazole), (5)contraindication to treatment drugs, (6) pregnant or lactating women, (7) severe concurrent disease.
Effects of ivAED™ Device on "Air-in-line" Alarms and Workflow Disruption

The investigators propose to test the hypothesis, that is, the effectiveness of the ivAED to eliminate air-in-line, comparing two commercially available, standard IV infusion pumps: the Braun Infusomat® Space P and the Becton-Dickenson Alaris™ model 8100 pump (the latter is currently in use as the standard IV infusion pump at Keck Hospital of USC). Testing of an IV infusion pump other the Keck Hospital of USC standard is indicated, as the independent laboratory testing of the Alaris™ 8100 pump found that this model pump is prone to developing air bubbles as the infusion passes through the pump mechanism. These air bubbles can be sufficient to trigger the air-in-line alarm. The Braun Infusomat® Space P IV infusion pump is a market leader like the Alaris™ 8100 pump, was evaluated in independent testing with and without the ivAED™ device, and was NOT found to create bubbles.

There are very few controlled human studies in the literature that assess various existing preventative measures for air embolism. After extensive, independent pre-clinical laboratory testing of the ivAED™ device demonstrating efficacy in removing air-in-line from IV infusions (see Appendix 1), this is the first-in-humans, clinical application of the ivAED™ device.

Testing of the ivAED™ device in patients is justified as that is the only means to determine the impact of the device on clinical IV infusion and nursing workflow disruptions (the primary outcomes of the study). Testing of the device in animals, or in healthy volunteers, or in computer simulations cannot provide this real-world information. In addition, the FDA typically requires that laboratory pre-clinical testing be coupled with clinical testing when applying for approval of new, investigational devices.

The investigators propose to test the hypothesis, that is, the effectiveness of the ivAED to eliminate air-in-line, comparing two commercially available, standard IV infusion pumps: the Braun Infusomat® Space P and the Becton-Dickenson Alaris™ model 8100 pump (the latter is currently in use as the standard IV infusion pump at Keck Hospital of USC). Testing of an IV infusion pump other the Keck Hospital of USC standard is indicated, as the independent laboratory testing of the Alaris™ 8100 pump found that this model pump is prone to developing air bubbles as the infusion passes through the pump mechanism. These air bubbles can be sufficient to trigger the air-in-line alarm. The Braun Infusomat® Space P IV infusion pump is a market leader like the Alaris™ 8100 pump, was evaluated in independent testing with and without the ivAED™ device, and was NOT found to create bubbles.

Eligibility Criteria:
Inclusion Criteria:

* Surgical ICU patients that are receiving IV infusions
* Patients or their surrogates have provided written, informed consent

Exclusion Criteria:

* Patients who do not give consent to our researchers
* Children (patients \<18 years of age)
* Pregnancy
* Prisoners