cyrilzakka/clinical-trials huggingface dataset:
Effect of Immunophenotype on Prognosis of Sepsis

The popuse of this study is to assess the inflammatory immunophenotypes of sepsis patients are significantly correlated with prognosis, which may provide theoretical basis for precise immune regulation of sepsis.

The clinical characteristics and inflammatory/immune markers of sepsis patients were analyzed dynamically and followed up to one year after diagnosis. Through latent category analysis, cluster analysis and other inflammatory immunophenotypes, the clinical characteristics of different inflammatory immunophenotypes and their relationship with the long-term prognosis of sepsis were clarified.

Eligibility Criteria:
Inclusion Criteria:Patients with sepsis 3 diagnostic criteria were admitted to ICU; Aged 18 or above; Within 24 hours of diagnosis.

-

Exclusion Criteria:Malignant tumor; Autoimmune diseases; Diseases of the blood system; HIV infection; History of high-dose glucocorticoid use (hydrocortisone 200mg/d or other hormone with equivalent titer, more than one week); pregnancy

-
Risk of Hospitalization for Severe Hypersensitivity (Including Severe Skin Reactions) in Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments

The purpose of this study is to compare the incidence hospitalization for severe hypersensitivity and cutaneous reactions among patients with type 2 diabetes who are new users of saxagliptin and those who are new users of other oral antidiabetic drugs.

Prospectively designed retrospective database study. This study will be conducted using administrative claims data and electronic medical records that are collected as part of routine clinical practice

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Newly prescribed saxagliptin or an Oral Anti-diabetic Drug (OAD) in a class other than Dipeptidyl peptidase IV (DPP4) inhibitors
* Enrolled in the respective database for at least 180 days prior to first prescription of new OAD
* Have at least one diagnostic code for a type 2 diabetes-related condition

Exclusion Criteria:

* Patients with an inpatient diagnostic code for any of the conditions of interest within the 180-day baseline period
* Patients prescribed a DPP4 inhibitor during the baseline period
Study of Biomarkers of Airway Inflammation (0000-128)

This study will evaluate the effects of inhaled fluticasone on cell counts and inflammatory mediators measured in sputum of healthy volunteers following exposure to inhaled lipopolysaccharide.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects who can have children must have a negative pregnancy test at screening and agree to use two methods of birth control throughout the study
* Male subjects with female partner(s) who can have children agree to use an acceptable method of birth control throughout the study
* Subject is a nonsmoker
* Subject is in generally good health
* Subject is willing to comply with the diet, alcohol, and caffeine study restrictions

Exclusion Criteria:

* Subject is a nursing mother
* Subject has taken oral corticosteroids within 8 weeks or inhaled/nasal corticosteroids within 4 weeks of screening
* Subject has nasal polyps, recent nasal surgery, or an ongoing upper or lower respiratory tract infection
* Subject has a recent history of allergic rhinitis at screening
* Subject has any respiratory disease at screening
* Subject has daily phlegm or a chronic cough
* Subject is unable to refrain from the use of any prescription or non-prescription drugs or herbal remedies during the study
* Subject consumes excessive amounts of alcohol or caffeine
* Subject has had major surgery, or donated or lost 1 unit of blood within 4 weeks of screening
* Subject has a history of stroke, seizures, or major neurological disorders
* Subject regularly uses illicit drugs or has a history of drug/alcohol abuse
* Subject received a vaccination within 3 weeks of screening
Immunogenicity of Gardasil and Twinrix and the Effect of a Dose of Gardasil or Cervarix Given 42 Months Later.

Two human papillomavirus vaccines are now commercially available.

No clinical data exist regarding:

* The immunogenicity and safety of Gardasil and Twinrix when co-administered.
* The immunogenicity and safety of Cervarix when administered to subjects previously vaccinated with Gardasil.

The main objective of the first phase of this clinical trial was:

• To assess and compare the immunogenicity of Gardasil and Twinrix Junior when co-administered or administered at one month interval according to a 0, 6 month schedule to 9-10 year-old girls.

The main objective of the seconde phase of this clinical trial is:

• To determine the effect of a booster dose of Gardasil or Cervarix on HPV antibodies when given 42 months post-vaccination of 9-10 year-old girls with two doses of Gardasil.

Study Design \& Duration:

Experimental Design: Blind for the third HPV vaccine dose, randomized, single centre study with two treatment groups.

Duration of the study:

Participants will be followed for the duration of 10 years post-primary vaccination.

Number of Centres:

One Center.


Eligibility Criteria:
Inclusion Criteria:

* In 2008-2009 received two doses of Gardasil at the age of 9-10 years according to 0, 6 months schedule.

Exclusion Criteria:

* Received less than two doses of Gardasil or received an HPV vaccine outside the study protocol.
Impact of tDCS on Emotional Processing in Major Depression

Background: transcranial direct current stimulation (tDCS) is an innovative treatment for major depression. However, its mechanisms of action are still unclear. Major depression is characterized by impaired processing of emotional information, which returns back to normal after successful antidepressant treatment. In this randomized double-blind study, the investigators aim to assess the effect of tDCS on emotional processing in major depression.

Methods: 40 subjects with major depression (20 active treatment and 20 placebo) will receive ten 30-minutes sessions of active two milliamps or sham tDCS (anode over left dorsolateral prefrontal cortex and cathode over right dorsolateral prefrontal cortex), twice a day for 5 consecutive days. Psychometric assessment of depression (MADRS,Beck Depression Inventory , CGI) and a neuropsychological assessment will be conducted before and after the treatment.

A facial emotion recognition task and an attentional emotional task with measurement of eye-tracking, heart rate, respiratory frequency and skin conductance will be conducted before and after the first session, and after the last session.

The investigators hypothesize that active tDCS will improve emotional processing in major depression, and that this will be observed after 1 and 10 sessions of tDCS.

Conclusions: Studying the impact of transcranial direct current stimulation on emotional processing in major depression could allow to better understand its antidepressant mechanisms

Eligibility Criteria:
Inclusion Criteria:

Healthy controls:

* Age between 18 and 65 years
* Given consent.

Depressed subjects:

* Major depressive episode (no psychotic features) according to Diagnostic ans Statistical of Mental Disorders number 5 (DSM 5.0.)
* Age from 18-65
* Antidepressant stable for the last 4 weeks
* MADRS ≥ 20.
* Given consent

Exclusion Criteria:

Healthy controls:

* Psychiatric disorder
* Addiction except for tobacco addiction
* Ocular disease (except from refraction disorders), neurologic or cardiac disease.
* Neuroleptic or anticonvulsivant treatment
* Presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)

Depressed subjects:

* Other psychiatric disorder except for personality disorders
* Ocular disease (except from refraction disorders), neurologic or cardiac disease.
* Neuroleptic or anticonvulsivant treatment
* Presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)
Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor

The purpose of this study is to determine whether exenatide can cause weight loss in patients with a history of craniopharyngioma or other brain lesion.

Hypothalamic obesity occurs in up to 60% of patients with tumors in the hypothalamic region, most commonly craniopharyngiomas. Hypothalamic dysfunction can be due to tumor infiltration and as a consequence of surgery or radiation therapy. Survivors who develop obesity have greater morbidity and mortality than normal weight survivors. Prevention and treatment of obesity in this population is vital in order to decrease the morbidity and mortality from diabetes, stroke and myocardial infarction.

Exenatide (Byetta®) is a GLP-1 homologue that was FDA approved for treatment of type 2 diabetes in 2005. It also decreases the rate of gastric emptying and increases satiety and has been shown to cause weight loss in some people. Exenatide may improve insulin sensitivity and satiety in patients with hypothalamic obesity but without the risks of bariatric surgery. The investigators hypothesize that treatment with exenatide will lead to weight loss in patients with hypothalamic obesity.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 40 years old
* History of craniopharyngioma or other lesion in the hypothalamic region
* Greater than 6 months post-treatment, including chemotherapy, surgery or radiation
* BMI \>30 mg/m2
* Females must be post-menopausal, surgically sterile or using effective birth control for at least 12 weeks

Exclusion Criteria:

* HgbA1C \>7%
* Use of diabetes medications other than metformin in the past 12 weeks, including exenatide
* Use of weight loss drugs or initiation of a weight loss program in past 3 months
* Impaired renal function or history of kidney transplant
* History of gall stones (unless s/p cholecystectomy), pancreatitis or alcoholism
* Personal or family history of medullary carcinoma of the thyroid or MEN type 2
* History of gastroparesis or other gastric motility problems as exenatide decreases gastric motility
* History of allergic reaction to exenatide or other medication components
* Other significant comorbidities other than pituitary deficiencies
* Currently prescribed warfarin (exenatide may alter warfarin metabolism)
* Pregnant or lactating females
* History of severe hypoglycemia (BG \<60 and requiring assistance from another person)
MUSE-S Headband System for Improving Anxiety and Insomnia Among Breast Cancer Survivors

This early phase I trial evaluates the feasibility and impact of a meditation headband system (MUSE-S) for breast cancer survivors. Anxiety and insomnia are among the most common distresses in breast cancer survivors during and after chemotherapy, in part due to the side effects of chemotherapy, fear of cancer coming back, progression of the cancer, and uncertainty of the future. These distresses impair patients' well-being and quality of life (QOL) in general, and their cancer treatment adherence and effectiveness in particular. Meditation has been demonstrated to be an effective management tool of stress and anxiety and is given the highest level of evidence (grade A) in the systematic review-based guidelines by the Society of Integrative Medicine. The portable, interactive, electroencephalographic (EEG) Muse headband guided meditation has been shown to improve fatigue, QOL, and stress in newly diagnosed breast cancer patients. The MUSE-S Headband System may decrease anxiety and insomnia among breast cancer survivors.

PRIMARY OBJECTIVES:

I. To evaluate the frequency of use of meditation (a stress management technique) among breast cancer survivors.

II. To evaluate the feasibility of a wearable EEG headband, MUSE S, together with smartphone or tablet application (app) to guide breast cancer survivors' interactive meditation and sleep support.

III. To measure the impact of interactive meditation and sleep support through MUSE S among breast cancer survivors during or after chemotherapy on improving symptoms of anxiety and insomnia.

OUTLINE:

Patients wear the MUSE S headband to bed every night for 8 weeks and meditate using the MUSE phone app during day hours for at least 5 minutes over 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-80
* Breast cancer first diagnosed with stage 1-4 breast cancer in the past 10 years
* Patients report experiencing anxiety and insomnia both rated \> 3 on a 0-10 scale (with 0 indicating none) at the time of enrollment
* Patients on anti-anxiety/anti-depressant medication must be on stable dose for 1 month prior to study enrollment and must stay on that same dose throughout the trial
* Has smart phone or tablet
* Patient willing to use Google-based anonymous email account to sign up for MUSE
* Be willing to provide informed consent and complete all aspects of the study
* Have no contraindicating comorbid health condition which would interfere with the proper use of the Muse-S (trademark) system, as determined by the clinical investigators

Exclusion Criteria:

* Pregnant or breastfeeding individuals
* Individuals who have used a regular mindfulness practice or received integrative medicine therapy, including acupuncture/acupressure, mindfulness or stress-reduction programs, massage, and/or energy therapies within the past 60 days
* Currently taking medication for insomnia
* An exclusionary unstable medical or mental health condition as determined by the patient's oncologist
Suctioning Flexible Ureteroscopy With Intelligent Control of Renal Pelvic Pressure

This study evaluates the safety and efficacy of the suctioning flexible ureteroscopy(SF-URS) with automatic control of renal pelvic pressure for the treatment of upper urinary calculi using a prospective, randomized design. Half of participants will receive suctioning flexible ureteroscopy with automatic control of renal pelvic pressure, while the other half participants will receive retrograde intrarenal surgery using the classic flexible ureteroscopy.

Retrograde intrarenal surgery using flexible ureteroscope has become the first-line treatment for renal calculi \< 3.0 cm and is recommended by the European Association of Urology due to its minimally-invasive nature and satisfactory result.

However, high perfusion rate leads to renal pelvic pressure increase, resulting in absorption of liquid, bacteria, and endotoxin into blood, followed by short-term complications such as systemic inflammatory response syndrome(SIRS , 8.1%), sepsis (0-4.5%), renal pelvic and ureteral tumor spread, and long-term complication of renal function impairment. Currently the commonly used flexible ureteroscope sheath (ureteral access sheath, UAS) reduces the renal pelvic pressure to a certain extent, but still can not control and monitor the renal pelvic pressure to reduce the incidence of complications, which, limit the clinical application of ureteroscopy.

Recently, the investigators present a novel technique of SF-URS with automatic control of renal pelvic pressure. In this study, transverse comparison is designed to evaluate the safety and efficacy of the suctioning flexible ureteroscopy with automatic control of renal pelvic pressure for the treatment of renal calculi.

Eligibility Criteria:
Inclusion Criteria:

* Subject has provided informed consent and indicated a willingness to comply with study treatments
* Subject has a diagnosis of renal stones according to computer tomography (CT) results
* Subject is 18-75 yrs of age
* Subject has a single stone \< 3 cm in size, or multiple stones \< 3 cm in cumulative size
* Subject has a serum creatinine level within the normal range for the study center

Exclusion Criteria:

* The patient who do not agree with the intention of the clinical study.
* Subject needs bilateral procedures within one-stage ureteroscopy
* Subject has an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.) and severe hematuria
* Subject has been diagnosed with a urethral stricture or bladder neck contracture
* Subject has a disorder of the coagulation cascade system that would put the subject at risk for intraoperative or postoperative bleeding
* Subject is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d)
* Subject has other diseases and could not tolerate the endoscopic surgery
* Subject has any kind of anatomic abnormality of the urinary system that might have an influence on the surgery
* Subject has been diagnosed with hydronephrosis larger than 3 cm according to the B-scan ultrasonography examination
Pilot Study of Vedic Medicine for Type 2 Diabetes

The purpose of this study is to determine the feasibility and effectiveness of a multimodality Vedic Medicine treatment protocol for the management of newly diagnosed type 2 diabetes.

Maharishi Vedic Medicine (MVM) represents a synthesis of Vedic sciences, including Ayur-Veda, into a single, comprehensive, natural approach to health care. The objectives of this phase II pilot trial are to determine the feasibility, acceptability, and safety of implementing a multi-modality MVM intervention for newly diagnosed type 2 diabetics, and to measure the impact of such a protocol on overall glycemic control.

Eligibility Criteria:
Inclusion criteria:

* Kaiser Permanente members
* Newly diagnosed type 2 Diabetes
* Baseline glycosylated hemoglobin level of 6.0-7.9.

Exclusion criteria:

* Pregnancy or nursing mother
* Currently taking warfarin
* Diagnosis of psychotic disorder or recent hospitalization for depression
* Unable to comply with or attend treatment sessions
Registry for African Americans With Early Rheumatoid Arthritis

The purpose of this study is to better understand the causes of rheumatoid arthritis (RA), particularly in African Americans.

RA is an autoimmune disease in which the body's immune system attacks its own tissues. It occurs in all races and ethnic groups and affects about two to three times as many women as men. Variations in certain genes that play a role in the immune system are associated with a tendency to develop RA. Some individuals without these genetic variations may develop this disease, while others who possess the variations never develop RA. Scientists believe that some environmental factors may play a part in triggering the disease process in people whose genetic makeup makes them susceptible to RA. This registry of African Americans with early RA will provide clinical and x-ray data and DNA to help scientists analyze genetic and nongenetic factors that might predict disease course and outcomes of RA in this population.

Participants in this registry will be enrolled in the study until they reach 5 years in their disease duration. For example, if a participant enters the study after 1 year of having RA, he or she will continue for 4 years. Participants will have three office visits (screening, 3 years' disease duration, and 5 years' disease duration) at which they will complete questionnaires and have blood samples taken, x-rays of their hands and feet, and DEXA scans. Between office visits, the study coordinator will call participants every 6 months to update any changes in medications or health problems.

Eligibility Criteria:
Inclusion Criteria

* African American
* Rheumatoid arthritis for less than 2 years
Arthroscopic Superior Capsular Reconstruction - Study of Different Types of Grafts

Multicentric prospective clinical and radiological comparative study of consecutive patients with irreparable rotator cuff tears to test the hypothesis that there are significant differences in the improvement of the clinical and imaging outcomes of arthroscopic superior capsular reconstruction (ASCR) when a different type of graft is used.

Patients with irreparable rotator cuff tears who meet the eligibility criteria will be enrolled in the study and undergo arthroscopic superior capsular reconstruction using one of the following types of graft: fascia lata autograft, fascia lata allograft, Achilles tendon allograft, bovine pericardium xenograft, swine dermal xenograft, or collagen graft.

All patients will be assessed clinically, radiologically and with an MRI preoperatively and at the 6-months and at the 2-years postoperative evaluations. The range of motion (ROM), shoulder abduction strength, Constant (CS), simple shoulder test (SST) and subjective shoulder value (SSV) scores will be compared from preoperative to 6 months postoperative; from 6 months postoperative to 2 years postoperative (paired-samples t-test, two-tailed) in each group (allotment to groups is performed according to the type of graft used: fascia lata autograft, fascia lata allograft, Achilles tendon allograft, bovine pericardium xenograft, swine dermal xenograft, or collagen graft). The differences in ROM, shoulder abduction strength, CS, SST and SSV scores from preoperative to 6 months postoperative and from 6 months postoperative to 2 years postoperative will be compared between groups. All continuous variables will be compared between the group of patients with graft tears and the group without graft tears (Mann-Whitney U test). All categorical variables and outcome results will be compared between groups (Fisher's exact test). A significant difference will be defined as P\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Rotator cuff tear arthropathy, Hamada stage 1 or 2
* Complete rotator cuff tendon tear involving one or more tendons, with a Patte stage 3 tendon retraction on the preoperative magnetic resonance imaging

Exclusion Criteria:

* Rotator cuff tear arthropathy, Hamada stage 3 or 4
* Complete rotator cuff tendon tear involving one or more tendons, with Patte stage 1 or 2 tendon retraction on the preoperative magnetic resonance imaging
* Proximal humerus fracture
* Acute shoulder dislocation (in the previous 8 weeks)
Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation

This is a prospective, single-arm, phase II study. Patients will be treated with an allogeneic stem cell transplantation (AHSCT) using fludarabine, melphalan and total body irradiation (TBI) conditioning with different melphalan and TBI doses based on patient- and disease-related risk.

Eligible patients will receive an allogeneic stem cell transplantation using a combination of fludarabine, melphalan and total body irradiation (TBI) conditioning regimen and post-transplant high dose cyclophosphamide (PTCY), tacrolimus and mycophenolate mofetil (MMF) for graft-versus-host prophylaxis.

Melphalan and TBI doses will be tailored based on the Hematopoietic Stem Cell Transplant- Composite Risk (HCT-CR), age and Karnofski performance status (KPS). Melphalan dose ranges from 100 -140 mg/m2 while TBI dose ranges from 2-5 Gy.

All patients will be monitored for safety and efficacy up to 2 years post-transplantation.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18-70 years
2. Diagnosis of AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT
3. Has an HLA-matched related (MRD), HLA-matched unrelated (MUD), haploidentical (HAPLO) or 1-Ag mismatched unrelated donor (MMUD)
4. Karnofsky performance \>70%
5. Adequate major organ system function as demonstrated by:

   1. Serum creatinine clearance equal or more than 50 ml/min (calculated with Cockroft-Gault formula).
   2. Bilirubin equal or less than 1.5 mg/dl except for Gilbert's disease. ALT or AST equal or less than 200 IU/ml for adults. Conjugated (direct) bilirubin less than 2x upper limit of normal.
   3. Left ventricular ejection fraction equal or greater than 40%.
   4. Diffusing capacity for carbon monoxide (DLCO) equal or greater than 50% predicted corrected for hemoglobin.
6. Ability to understand and the willingness to sign a written informed consent. a. Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.

Exclusion Criteria:

1. Inability to comply with medical recommendations or follow-up
2. Pregnancy
3. Active/uncontrolled bacterial or viral infection (PI is the final arbiter of this criterion.)
4. Has active CNS or ocular disease involvement within 3 months
5. Patients with primary CNS lymphoma
6. Patients who require modifications of the conditional regimen