cyrilzakka/clinical-trials huggingface dataset:
Gut Microbiome and Metabolic Pathways Changes in Vitiligo

Vitiligo is a chronic depigmenting autoimmune-associated skin disease and a growing psychological health concern because of its low quality of life. Genetics, immunology and environment triggers contribute to the pathophysiology of vitiligo. Identify and decrease the risk factors of vitiligo is very crucial for vitiligo treatment and prevention. Emerging evidence has linked gut microbiome to human autoimmune diseases. Here the investigators will analyze 10,913 metagenomes in stool samples from 100 adult vitiligo patients and gut microbiome associated metabolites in patients serum.

Vitiligo, an autoimmune disease of the skin, is a commonly acquired chronic depigmenting disorder characterized by loss of epidermal melanocytes and progressive depigmentation clinically, affecting from 0.5% to 1% of the world population and about 1% in China Vitiligo can be a psychologically crushing associated with low quality of life, especially in colored skinned individuals. The pathoetiology of vitiligo is multifactorial and has genetic, immunological, and environmental components. Several environment-associated mechanisms have been implicated to explain melanocyte disappearance, including ultraviolet (UV) radiation exposure, repeated mechanical or thermal stress, and exposure to chemicals (especially phenols or catechols), but epidemiologic data remain limited.

Broader gut dysbioses have been identified as potential causes or contributing factors to human autoimmune diseases; however, human studies have not yet identified microbial compositional or functional triggers that are predictive of skin autoimmunity or vitiligo. Metabolites from intestinal microbiota are key determinants of host-microbe mutualism and, consequently, the health or disease of the intestinal tract. However, whether such host-microbe crosstalk influences inflammation in peripheral tissues, such as the skin, is poorly understood.

The investigators will perform a metagenome association study and serum metabolomics profiling in a cohort of vitiligo Chinese individuals.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who volunteered and signed Informed Consent Form；
2. Male or female subjects 3-65 years of age；
3. Clinically confirmed the diagnosis of advanced vitiligo as per the diagnostic criteria for vitiligo specified in Clinical Dermatology;
4. Stable vital signs.

Exclusion Criteria:

1. Patients who had taken systemic or local treatment with vitiligo in the last month;
2. Patients who had taken systemic antibiotics，systemic hormones，cytokines, immunosuppressors in the previous three months;
3. The combination of other autoimmune diseases，gastrointestinal diseases, hepatic diseases, psychiatric and psycho-related diseases, or other skin diseases;
4. The combination of Serious, life-threatening condition such as cardiac diseases, renal diseases, endocrine system disease, cancer, or immunodeficiency diseases;
5. Women of child-bearing potential who are pregnant, plan to become pregnant during the study or are lactating；
6. Any other condition that the investigator deems unsuitable for entering the study.
Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen for Allo-HSCT

venetoclax combining with fludarabine and melphalan as conditioning regimen prior to allogeneic hematopoietic stem cell transplantation for older patients with hematologic malignancies

It was a phase Ⅱ clinical trial of new designed reduced-intensity conditioning regimen for older patients accepting allogeneic hematopoietic stem cell transplantation treatment. The regimen consisted of venetoclax combining with fludarabine and melphalan.

Eligibility Criteria:
Inclusion Criteria:

1. Age older than 50 years
2. Patients diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome according to WHO diagnostic criteria.
3. Patients who achieved complete remission before transplantation.
4. Patients who have alternative donors and plane to accept allogeneic hematopoietic stem cell transplantation treatment.
5. ECOG body status score 0-2.
6. Good organ function level: ANC (neutrophil absolute value \>=1.0x10\^9/L; PLT \>=30x10\^9/L; HB \>=80g/L; Tibil \<=1.5 ULN; ALT / AST \<=2.5 ULN; bun / Cr \<=1.5 ULN; LVEF \>=50%).
7. Patients who voluntarily participate in the clinical trial, understand the research procedure and can sign the informed consent in writing.

Exclusion Criteria:

1. Patients who didn't achieved complete remission before transplantation (bone marrow smear: proportion of primordial cells \>=5%) or any extramedullary recurrence.
2. Patients who were previously known to be resistant to venetoclax.
3. In patients with severe pulmonary insufficiency (obstructive and / or restrictive ventilation disorders), the researchers evaluated the patients who could not tolerate the super pretreatment scheme.
4. Patients with severe liver function impairment and liver function indexes (alt, TBIL) more than 3 ULN were evaluated as intolerant of super pretreatment.
5. In patients with severe renal insufficiency, the renal function index (CR) is more than 2 times of the upper limit of the normal value (ULN), or the 24-hour creatinine clearance rate (CR) is less than 50ml / min, the researchers evaluated that they could not tolerate the super pretreatment scheme.
6. In patients with severe active infection, the researchers evaluated that they could not tolerate the pretreatment.
7. Patients who had allergic reactions or serious adverse reactions in the previous use of pretreatment related drugs could not be included in the study.
8. Other reasons why the researchers could not be selected.
Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function

The primary objective of this study is to examine the efficacy and safety (cardiovascular) of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to IV iron sucrose (Venofer) in subjects who have iron deficiency anemia (IDA) and impaired renal function.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects \> or = to 18 years of age.
* Chronically impaired renal function.
* Screening visit central laboratory hemoglobin \< or = to 11.5 g/dL.
* Screening ferritin \< or = to 100 ng/mL or \< or = to 300 when transferrin saturation (TSAT) is \< or = to 30%.
* If on an erythropoiesis stimulating agent(ESA) a stable dose (+/- 20%) for 4 weeks prior to randomization.

Exclusion Criteria:

* Known hypersensitivity reaction to any component of ferric carboxymaltose (FCM) or Venofer.
* Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
* Requires dialysis for treatment of chronic kidney disease OR is being considered for initiation of dialysis during the time period of this trial.
* No evidence of iron deficiency.
* Any non-viral infection.
* AST or ALT at screening as determined by central labs greater than 1.5 times the upper limit of normal.
* Known positive hepatitis with evidence of active disease.
* Received an investigational drug within 30 days of screening.
* Alcohol or drug abuse within the past 6 months.
* Hemochromatosis or other iron storage disorders.
* Estimated life expectancy of less than 6 months, or for cancer patients, an ECOG Performance Status greater than 1.
* Any other laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
* Pregnant or sexually-active female subjects who are not willing to use an acceptable form of contraception.
VSL#3 Versus Placebo in Increasing the Pathological Major Response Rate in Patients With Rectal Cancer

This is a randomized, double-blind, placebo-controlled phase III study involving 160 patients designed to assess the efficacy of the high potency probiotic preparation VSL#3® versus placebo in increasing the pathological major response rate in patients undergoing concurrent CT and pelvic RT.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Ability to sign informed consent and understand the nature of a placebo- controlled trial.
* Ability to complete questionnaire(s) by themselves or with assistance.
* Life expectancy ≥ 6 months.
* Current diagnosis of cancer that supports the use of continuous definitive or adjuvant external-beam RT to the pelvis to a minimum dose of 4500 cGy delivered with conventional multi-field photon radiotherapy, 3-D conformal photon radiotherapy or intensity modulated photon therapy.
* Will receive concurrent administration of chemotherapy (5-FU, capecitabine, cisplatin, oxaliplatin, carboplatin, and/or mitomycin) during pelvic RT
* The following laboratory values obtained \> 28 days prior to registration:

Hemoglobin \> 10.0 g/dL WBC \> 3,500 Absolute neutrophil count \> 1,500 Platelets \> 100,000

* ECOG Performance Status (PS) of 0, 1 or 2
* Willing to abstain from ingestion of yogurt products and/or any product containing probiotics during study drug treatment.

Exclusion Criteria:

* Current or prior metastases beyond regional lymph nodes.
* Undergone abdominal-perineal resection, Hartmann procedure, or other surgical procedure leaving the patient without a functioning rectum.
* Known allergy to a probiotic preparation.
* Any history of inflammatory bowel disease.

  -\> grade 3 diarrhea, rectal bleeding, abdominal cramping, or incontinence of stool, ≤7 days prior to registration.
* Any medical condition that may interfere with ability to receive protocol treatment.
* Planned use of leucovorin (because of the risk of secretory diarrhea).
* Split-course RT is planned.
* Prior pelvic RT.
* Proton RT.
* Any of the following:

Pregnant women Nursing women Men or women of childbearing potential who are unwilling to employ adequate contraception

* Use of probiotics ≤ 2 weeks prior to registration.
* Use of antibiotics ≤ 1 week prior to registration.
* Planned continuous antibiotic treatment during RT.
* History of gastrointestinal or genitourinary obstruction or porphyria.
Effect of Midazolam on Inflammatory Response and Organ Function in Mechanically Ventilated Sepsis Patients With Different Immune Status

ICU patients always experience all kinds of pain, discomfort and sleep disturbance,especially the sepsis patients. Appropriate sedation and analgesia is must,the newest sepsis guideline strongly recommend that mechanically ventilated sepsis patients need sedation therapy.

Recent studies show than immune dysfunction dose have an important effect on the occurrence and development of sepsis. When the body suffer from the pathogenic microorganism attacking and sepsis, it activate the systemic inflammatory response (SIRS) and compensatory anti-inflammatory response syndrome (CARS). When it is out of balance between SIRS and CARS, the inflammatory response, immune paralysis or immune dysfunction occurs and the mixed anti-inflammatory response syndrome (MARS) exists, and then the multiple organ dysfunction. So, immune dysfunction is thought to be the key factors on the development of the sepsis. Some studies show that the sedation drug such as midazolam, propofol, dexmedetomidine could suppress the inflammatory response effectively and then modulate the immune function.

Several recent studies show that midazolam has the immunoregulation effect and trend of suppress the inflammatory response, but the result is controversy, the possibly reason is the different immune status. Now there is the guideline about the different immune status: the normal immune function means that the value of mHLA-DR is more than 15000 monoclonal antibody; moderate-sever immune suppression means that the value of mHLA-DR is in the range of 5000 and 15000 monoclonal antibody; the immune paralysis means that the value of mHLA-DR is less than 5000 monoclonal antibody.

The purpose of the study is to explore the effect of midazolam to inflammatory response and organ function at mechanically ventilated sepsis patients who have different immune status.


Eligibility Criteria:
Inclusion Criteria:

1. Mechanically ventilated ICU patients, sedation is needed.
2. Sepsis patients.
3. Age 18-80 yrs
4. Anticipated sedation duration is more than 3 days.
5. Agreed to participate the study and assigned the informed consent. -

Exclusion Criteria:

1. Allergic to the Benzodiazepine.
2. Hepatic dysfunction(Child-Pugh is C level).
3. Participated other study.
4. Bad prognosis and possibly become the major reason of patients death, such as sever craniocerebral injury,cardiopulmonary resuscitation,advanced malignant tumor,etc.
5. History of immune system disease, immune treatment (including hormone ) or treatment that could affect immune function (including continuous renal replacement therapy,CRRT).
6. Alcoholic and drug abuse.
7. Tendency for major mental disease or treatment of anti psychotics.
8. Pregnant,lactation woman.
9. Unwilling to assign the informed consent or bad compliance. -
Tailored Asthma Management for Urban Teens

The purpose of this project is to refine and further evaluate an online asthma management and education program for urban teenagers. This project is a continuation of Puff City I, a project piloting and evaluating a tailored, school-based, computerized asthma education program for urban teenagers. In this second phase of research, a new version of software (Puff City II) will be created that will target resistance to change and relapse, and using a tested, theory-based approach to student recruitment, conduct a randomized trial to test the efficacy of this new software.

BACKGROUND:

Teenagers are among an age group that has seen dramatic increases in deaths from asthma. In Detroit, asthma death rates for teenagers are high relative to younger ages, despite a higher prevalence in the latter age group. Early studies suggest that inadequate asthma management plays a significant role in these grim statistics.

DESIGN NARRATIVE:

The study hypothesis is that students randomized to the intervention group will have lower asthma-related morbidity as determined by fewer emergency department visits and hospitalizations at the time of the 12-month follow-up. Based on a second hypothesis of better functional status among students randomized to the intervention group, secondary outcomes include fewer symptom-days, symptom-nights, school days missed, and days of restricted activity at the time of the 12-month follow-up. In addition, it is hypothesized that students in the intervention group will have higher scores on the Juniper Pediatric Quality of Life scale at 12 months. Finally, it is hypothesized that intervention students would exhibit positive changes in adherence behavior, having a rescue inhaler nearby, and smoking at the 12-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* A physician diagnosis of asthma AND recent asthma symptoms, health care utilization for asthma, and/or use of medication (or refills of medication) to alleviate asthma symptoms OR
* No physician diagnosis of asthma AND positive responses to items selected from the International Study of Asthma and Allergy in Children (ISAAC) survey AND asthma symptoms similar to those used in the Expert Panel II for classification of mild intermittent asthma

Exclusion Criteria:

* Does not meet asthma symptom criteria
Bowel Cleansing for Colonoscopy: Comparison Between a Same Day Low-Volume Preparation and a Conventional 4L Split One

The present study is intended to evaluate the effectiveness, tolerability, compliance, and feasibility of the low volume bowel preparation, bisacodyl tablets followed by 2L Polyethylene glycol (PEG) with citrate and simethicone (CS) given the same day of colonoscopy, vs the standard 4L split PEG solution.

Eligible patients will be informed about the aims, procedures, benefits and possible risks of the study prior to sign the informed consent form from day -30 to day-3. They will provide medical history and undergo a physical examination. Patients will be evaluated by a Physician other than the blind Endoscopist. The same responsible person will instruct the patients about administration procedures in both oral and written form. The patients will be assigned to receive one of the dosing schedule bowel preparation according to a computer generated block-randomisation list. Patients will take the study treatment at home according to the given instructions. Patients will return to the clinic for colonoscopy. The colonoscopy will be performed by an Endoscopist who will be unaware of the bowel dose-regimen preparation taken by the patient. Completed colonoscopic exam will be performed with time recorded (intubation and withdrawal from ceacum). The unblind Investigator will ask the patients about safety, tolerability, overall acceptance and compliance.

Eligibility Criteria:
Inclusion Criteria:

* Out-patients undergoing a complete colonoscopy
* Patient written informed consent

Exclusion Criteria:

* Pregnant or lactating women or at a risk of becoming pregnant
* Known or suspected gastrointestinal obstruction or perforation; toxic megacolon; major colonic resection Known or suspected hypersensitivity to the active principle and/or formulations' ingredients
Tolerance Assessment of Tailored 3d-printed TFO With Silicone Interface for the Treatment of Post-burn Face Scar

The purpose of this study is to assess the tolerance of tailored 3d-printed transparent face orthosis used in the medical care of post-burn face scar.

Burn injuries are not a rare affection. According to WHO (World Health Organization), in 2004 there were 11 million peoples in the world who were affected by burn injuries caused by fire and who needed medical cares. This important number ignores non-fire thermal, chemical and electrical burns. Face is one of the most susceptible areas of burn where the prevalence was reported to be 6-60%.

Hypertrophic scars (HS) are frequent consequences of dermal burn with a prevalence of 70% of burned people. HS, which are a dermal fibro-proliferation, are rigid, erythematous and thickened scars associated with pigmentation abnormalities, xerosis, thermal sensitivity, pain and pruritus.

When HS is located on the face, they can cause cosmetic disorder with disfigurement and psychological distress.

Pressure therapy and silicone application are the two recommended non-invasive care for prevention and treatment of hypertrophic scarring after burn. On the face, Pressure Garment Therapy (PGT) cannot exert the required pressure because of concave or flat shape so the use of face mask is the most common form of pressure therapy on the face.

The face mask manufacturing is artisanal, time consuming and variable between all burn centers. They are not very accurate and have difficulties to apply effective pressure on certain face areas such as nasolabial folds.

Our Transparent Face Orthosis (TFO) uses tri-dimensional cam for measurement and 3d-printing technology for manufacturing. We think this way to manufacture the TFO will be more accurate and efficient, less expansive and time consuming. Moreover, the addition of a silicone interface between the TFO and the face will associate silicone application therapy and pressure therapy what should be more effective than pressure therapy alone.

The purpose of this study is to assess the tolerance of tailored 3d-printed transparent face orthosis used in the medical care of post-burn face scar.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Post-Burn Face scar during maturation stage or surgical intervention on post-burn face scar during maturation stage
* Patient agrees to shave beard if necessary for 3D camera measurement
* Patient able to express informed consent
* Affiliation to a social security scheme

Exclusion Criteria:

* Post burn face scar in the sequela stage
* Patient with unbalanced photosensitive epilepsy
* Patient with an unconsolidated fracture of the face's bones or skull
* Patient with a known allergy to silicone
* Pregnant or lactating women
Proteomics Research of Osteosarcoma

Retrospectively collected 400 cases of clinical data and pathological paraffin specimens of osteosarcoma, chondrosarcoma (control) and endogenous chondroma (control) in our hospital from 2008 to 2014, combined with high-pressure cycle-satellite scanning mass spectrometry (PCT-SWATH) Molecular typing of osteosarcoma and prediction of targeted therapy, the establishment of a new molecular classification based on proteomics for osteosarcoma to predict the chemotherapy response and recurrence risk of osteosarcoma. Clinical osteosarcoma patients include as many types as possible: pre-chemotherapy, post-chemotherapy, recurrence, and metastasis. The study did not involve vulnerable groups, and it was taken as a postoperative wax specimen for patients, which had no health, life and other effects on patients. Study application exemption from informed consent.


Eligibility Criteria:
Inclusion Criteria:

* all osteosarcoma patients in our hospital
* received Methotrexate+Doxorubicin+Cisplatin protocol chemotherapy

Exclusion Criteria:

* non-chemotherapy patients
* bio-specimen not completed
Cognitive Behavioral Therapy for Adolescents With Social Anxiety Disorder

The main aim of the present study is to investigate the effectiveness of a disorder specific group cognitive behavior therapy (G-CBT) program for youth SAD, the, Cool Kids Anxiety Program - Social Enhanced (CK-E), developed at Macquarie University, Sidney, Australia.

Furthermore, the study will examine how well this program fares against generic CBT treatment.

The main aim of the study is to investigate the effectiveness of a disorder specific G-CBT program for youth SAD compared to a generic G-CBT program for anxiety disorders.

Reduction in anxiety symptoms is expected for both treatment conditions although we hypothesize better outcome for the enhanced treatment condition.

Approximately 96 adolescents aged 12 to 17 years will be included with data points at pre- and post-treatment, and at 3-month and 1-year follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* Youth between 12 and 17 years of age.
* Social anxiety disorder as the primary disorder measured using the Anxiety Disorder Interview Schedule for DSM-IV, Child and Parent Version (ADIS-IV C/P).

Exclusion Criteria:

* A diagnosed autism spectrum disorder (ASD).
* Untreated Attention Deficit Hyperactivity Disorder (ADHD).
* Psychotic symptoms.
* Current severe self-harm or suicidal ideation.
* Current eating disorder.
* CSR\>5 on depression.
* Received prior CK treatment within the last two years.