cyrilzakka/clinical-trials huggingface dataset:
Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML

An open-label study available to all eligible participants from Study B1371019 and participants originating from Study B1371012 continuing on study intervention with azacitidine with or without glasdegib.


Eligibility Criteria:
Inclusion Criteria:

* Any participant who continues to demonstrate clinical benefit (as determined by the Principal Investigator) from study treatment with azacitidine with or without glasdegib in this Study or from Study B1371012.
* Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Exclusion Criteria:

* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Female participants who are pregnant or breastfeeding (if continuing to receive study intervention);
* Participant has been withdrawn from Study B1371019 and Study B1371012 for any reason (including INT cohort participants required to end study treatment)
Study on the Mechanism of ZhenQiFuZheng in the Treatment of Allergic Rhinitis Based on Intestinal Flora and Metabolites

ZhenQi FuZheng granules has been used to improve the immune function of human body, protect the bone marrow and adrenal cortex function and promote the recovery of positive function in traditional Chinese medicine care, especially with the immune imbalance diseases like post-surgery, chemotherapy and rhinitis. This project intends to establish AR（allergic rhinitis）specimen library, cell and animal model experiment, combining clinical cohort research with applied basic research, further assess the therapeutic mechanism of ZhenQiFuZheng granules in AR. We assume that ZhenQi FuZheng granules could cause the metabolic omics changes of nasal inflammatory factors and nasal secretions in AR patients, thus improving the type 2 inflammation level of allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18-65 years).
* Patients who visited the Department of Otolaryngology of the First Affiliated Hospital of Nanjing Medical University and are diagnosed as allergic rhinitis .

Exclusion Criteria:

* Patients who refused to accept specimen and questionnaire collection.
* Patients who had nasal diseases other than allergic rhinitis, such as nasal papilloma and nasal malignant tumor.
Effects of Zinc Supplementation on Anthropometric Factors, Apelin and Inflammatory Markers in Obese Individuals

To study the effects of zinc supplement on anthropometric factors, Apelin and inflammatory markers in obese individuals, 50 obes person who referred to Diet and Nutrition clinic of Shahid Beheshti University of Medical Sciences will be randomly allocated to receive 50 mg zinc capsules or placebos for 15 weeks; both groups will be advised to adherence the investigators' diet . At the first and the end of the intervention,weight, body mass index (BMI), waist circumference, fat mass and lean body mass, concentration of zinc, albumin, hs-CRP, TNF-α and plasma apelin will be assessed and compared between groups.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 to 45 years
* Non-smoking
* Body Mass Index (BMI) more than 30

Exclusion Criteria:

* Pregnancy, lactation or menopause in women
* History of liver disease, kidney, thyroid, diabetes and other metabolic diseases
* Use of drugs interfering with lipid profile, blood-thinning drugs, beta-blockers
* Patients with immune deficiency
* Use of zinc, calcium and iron supplement in the last 2 months
* Use of weight loss medication or special diet
* Following program to lose weight in recent 2 months
* Recent surgery
Reduced Planning Target Volume (PTV) Margins for the Treatment of Prostate Cancer Using the Calypso 4D Localization System

This prospective study evaluates the clinical utility of a novel real-time localization system allowing for smaller volumes of normal tissue to be included in radiation field and determines dosimetric parameters and adverse effect profiles of radiation therapy using this technology. Subjects will have beacon transponders implanted into the prostate to more precisely localize the position of the organ during radiation therapy. Hypothesis: 1. Treatment with highly targeted radiation therapy can be delivered in a daily treatment time consistent with routine clinical practice. 2. Highly targeted radiation therapy with reduced PTV margin will result in a significant decrease in rectal and bladder volume treated.

This study will seek to establish the clinical feasibility of a novel real-time localization and tracking system for use of reduced PTV margins during intensity modulated radiation therapy (IMRT), which will allow treatment of smaller volumes of normal tissue during radiation therapy. Such a reduction in the PTV margins and the exposure of healthy tissue during treatment may allow for several future improvements in prostate radiotherapy including:

* decreased acute and chronic adverse effects with similar local tumor control
* dose escalation to achieve higher cure rates with similar adverse effects to standard dose treatment
* hypofractionation to shorten the time of, and lower the expense of, treatment without increased adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Low Risk: T1a, T1b, T1c, T2a; Gleason Score less than 7, PSA less than or equal to 10
* Intermediate Risk: T2b, T2c; Gleason Score less than or equal to 7, PSA less than or equal to 15
* Ability to comply with study schedule
* Age 40 or older
* Zubrod PS 0 or 1
* Signed informed consent

Exclusion Criteria:

* Node positive or metastatic prostate cancer
* Prior treatment of prostate cancer with surgery, chemotherapy, cryotherapy or brachytherapy
* History of prior pelvic radiotherapy
* History of abdominoperineal resection
* History of HIV infection
* History of chronic prostatitis or chronic cystitis
* History of bleeding disorder or any active anticoagulation (excluding ASA)
* PT or INR outside normal range for institution
* Active implanted devices such as cardiac pacemakers and automatic defibrillators.
* Prosthetic implants in the pelvic region that contain metal or conductive materials (eg., an artificial hip).
* Patients with maximum anterior-posterior separation through the torso minus the height of the center of the prostate greater than 17 cm (technical reason for Calypso System, see appendix 8).
* Prior history of androgen deprivation therapy has been deleted and these patients are allowed on study.
A Study to Collect Data About Analgesia in Patients With Bone Metastasis

Up to 180 patients with bone metastasis and requiring analgesic treatment will be followed during 4 to 10 weeks. All patients will continue to receive their cancer therapeutic treatments and be treated for pain relief exactly as they would normally be by the Investigator based on their needs. During their regular visits to the Investigator, patients will complete questionnaires and Clinical Pain Assessments.


Eligibility Criteria:
Inclusion Criteria:

* Patients with bone tumors or bone metastasis from any primary cancer origin that is supported by histological or radiological investigations.
* Patients having been or being treated for their bone metastasis and/or their primary cancer.
* Patients who require analgesic treatment for unsatisfactory pain relief.
* Patients will be required to score at least 4 on the WAPS 11-point NRS during the week preceding enrollment.
* Patients undergoing or not a radiotherapy program provided visit procedures are performed before any radiotherapy sessions if scheduled on the same visit days.
* Are men or women of at least 18 years of age.
* Are reliable and willing to make themselves available for the entire duration of the study and are willing to follow study procedures.
* Have given written informed consent approved by the relevant Ethics Committee governing the study site.

Exclusion Criteria:

* Patients having had a major surgery within 28 days prior to signing Informed Consent Document or planning to have a major surgery during the study.
* Patients having a life expectancy \< 3 months according to Investigator judgment.
* Patients having poor nutritional status or whose condition is unstable or who could be rapidly deteriorating in such a way that they would not be able to complete the study.
* Patients with a current or recent history unrelated to their cancer condition, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation in the study.
* Patients having a Karnofsky performance status below 70% or WHO score (Eastern Cooperative Oncology Group (ECOG)/Zubrod score) above 1.
* Are Investigator site staffs directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
* Any other relevant medical disorder likely to interfere with the trial or represent a risk for the patient.
* Patients under legal protection, according to the country law.
* Patients currently enrolled in a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, or in an exclusion period according to the national law.
Study of Specific Viral Immune Responses Induced by SARS-CoV-2 (COVID-19)

SARS-CoV-2, has caused an international outbreak of respiratory illness termed Covid-19. The investigators used peptides derived from SARS-CoV-2 virus, to study viral-specific immune responses. COV-CREM is a French prospective monocentric study that will evaluate viral-specific cell responses in positive patients for SARS-CoV-2 on the basis of (RT-PCR) assay performed in respiratory tract sample tested by our local Center for Disease Control.


Eligibility Criteria:
Inclusion Criteria:

* COVID-19 PCR positive,
* Hospitalized patients with illness of any duration, and/or SpO2 ≤ 92% on room air.
* Cohorte C : patients with cancer (hematological malignancies and solid tumors).

Exclusion Criteria:

* Refusal to participate,
* Any immunosuppressive therapy (i.e. corticosteroids \>10mg of hydrocortisone or equivalent dose) within 14 days before the planned start of study,
* Active or chronic hepatitis B or C and/or HIV positive (HIV 1/2 antibodies patients), or a known history of active Tuberculosis bacillus,
* Active autoimmune disease that required a systemic treatment, with the following exceptions:

  * Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study,
  * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study,
* Prior allogeneic bone marrow transplantation or prior solid organ transplantation,
* Patients currently exposed to chemotherapy, anti-tumor immunotherapy as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy or biotherapy (except for patients in cohort C),
* Previous prescribing of biotherapy or treatment for the management of COVID-19 is not an exclusion criterion,
* Patient under guardianship, curatorship or under the protection of justice.
Bone Metabolism Adjacent to Hip Prosthetic Surfaces. A Clinical F-PET/CT Study

What is the intensity of F-PET uptake adjacent to four analyzed hip endoprosthetic components and in healthy femur and acetabulum, 1, 4 and 9 months after surgery?

A clinical study of 32 patients, age 50-69 years, healthy unless osteoarthritis in one hip, randomized in two groups (16 each) plus a reference group of same 32 patient´s contralateral healthy hip.

Intervention will be surgery with a total hip arthroplasty. The four studied endoprosthetic components are:

* Cemented Exeter stem (Stryker Warsaw, USA) with a ceramic 32 mm head and Palacose cement with gentamycin, applied with 3:rd generation cementation technique.
* Uncemented Lubinus SP-CL stem (Waldemar Link, Hamburg, Germany) with a ceramic 32 mm head.
* Uncemented Delta PF cup (Limacorporate spa, Udine, Italy).
* Uncemented fibrous metal Delta TT cup (Limacorporate spa, Udine, Italy). Both cups will have cross linked Ultra-high-molecular-weight polyethylene (UHWMP).

Clinical score, radiography and uptake of Fluoride tracer will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

- patients diagnosed to have unilateral hip osteo arthritis verified by radiography (Charnley group A) aimed for THA at Gävle hospital and accepting to participate in the study.

Exclusion Criteria:

* any systemic disease (other than osteo arthritis) or medication affecting skeleton methabolism
Efficacy and Safety of Beta-glucan Supplement in Chronic Obstructive Pulmonary Disease Patients

The objectives of this study are to evaluate Efficacy and safety of beta-glucan supplement in chronic obstructive pulmonary disease patients.

There are 72 patients in this study. They are randomly divided into 2 groups which are beta-glucan supplement group and placebo group. The supplement will be taken 1 capsule/day for 12 weeks. Forced expiratory volume in 1 second/Forced vital capacity, Modified Medical Research Council Dyspnea Score, Breathlessness, Cough, and Sputum Scale, 6 Minute Walk Test, Diffusing capacity for carbon monoxide, Tumor necrosis factor alpha, Interleukin-6, C-reactive protein, glutathione, aspartate transaminase, alanine transaminase, alkaline phosphatase, creatinine, and blood urea nitrogen are assessed before and after taking supplement 6 and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years
* Chronic Obstructive Pulmonary Disease with Forced expiratory volume in 1 second/Forced vital capacity after receiving bronchodilator medicine more than 70%
* No exacerbation and uncontrolled disease
* 10 pack-years smoking history 10 pack-years but stop smoking more than 1 years
* Willing to participate in this study

Exclusion Criteria:

* Respiratory infection in 4 weeks
* Lung cancer
* Liver disease or kidney disease
* Lung surgery history
* Take kung supplement in 2 weeks
* Take warfarin, clopidogrel, aspirin, or digoxin
* Allergic to beta-glucan, broccoli, or quercetin
* Cannot use Spirometry
* Pregnancy and lactation
Study to Evaluate Safety and Tolerability of Single Ascending Doses of Multiple Formulations of PF-06650833 in Healthy Subjects Under Fasted and Fed Conditions

This single ascending dose study is the first evaluation of PF-06650833 in humans. The goals are to assess the safety, tolerability and blood levels of ascending doses of multiple formulations of PF-06650833 and to perform a preliminary assessment of the effect of food on exposure, in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Screening supine blood pressure 100 mm Hg (systolic) or 50 mm Hg (diastolic); or 140 mm Hg (systolic) or 90 mm Hg (diastolic) following at least 5 minutes of supine rest. If blood pressure (BP) is 140 mm Hg (systolic) or 90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subject's eligibility.
* Pulse or heart rate (HR) \>100 bpm after at least 5 minutes of rest. If the pulse/HR is \>100 bpm, the pulse/HR should be repeated two more times (separated by at least 2 minutes) and the average of the three pulse/HR values should be used to determine the subject's eligibility.
The Effect of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases

Recent data have shown that the inadequate vitamin D status plays a role in the manifestation of the haematologic tumors and serum vitamin D level has a prognostic role also as it determines the tumor mortality. But data have not proved a causal relationship between the inadequate vitamin D status and the unfavourable outcomes so far. It is also still unknown, whether the normalization of vitamin D status in patient with vitamin D inadequacy is able to improve the prognosis and survival.

In this study the investigators examine the role of the adequate vitamin D substitution in the improvement of the outcomes of haematologic disorders.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old male or female
* chronic lymphoid leukaemia, any Rai stage
* 25-OH-Vitamin-D3 level between 10 and 30 ng/mL

Exclusion Criteria:

* serum calcium \> 2,60 mmol/l
* 24 hour calcium urine excretion \> 0,1 mmol/kg/day
* serum phosphate \> 1,45 mmol/l
* eGFR \< 30 ml/min/1,73m2
* nephrolithiasis
* receiving parenteral vitamin-D3 in past 6 months
* activated vitamin-D3 treatment
A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis

The purpose of this study is to investigate similarity between NI-071 and infliximab(the comparator) in terms of efficacy in patients with Rheumatoid Arthritis not adequately responding to Methotrexate.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a diagnosis of RA as defined by the American College Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria (ACR/EULAR 2010)
2. Patients who received MTX treatment (6- 16mg/week) for 2 weeks for at least 12 weeks prior to the screening visit

Exclusion Criteria:

1. Patients with a following past History or concomitant diseases

   * Other Connective tissue disorders which may interfere the efficacy assessment
   * Chronic or recurrent infectious disease
   * Demyelinating disease
   * Congestive heart failure
   * lymphoproliferative disorder or myelodysplastic syndrome
   * Malignancy
   * Interstitial lung disease
2. Patients with active or latent tuberculosis or history of tuberculosis
High Flow Nasal Canula Oxygen Helps Preoxygenate ARDS Patients

Tracheal intubation in the ICU is associated with significant complications and morbidity. Desaturation is among the most frequent and hazardous complication, occurring in almost one out of four intubations, that may in some instances lead to cardiac arrest; despite appropriate preoxygenation. Non-invasive ventilation may help improve preoxygenation but does not allow for apneic oxygenation and may not be performed in patients with neurological impairment. High flow nasal canula oxygen is increasingly used in the ICU in patients with acute hypoxemic respiratory failure and may be used to improve preoxygenation. It is currently used in our ICU for that purpose. Because high flow nasal canula oxygen is our first line oxyten therapy for patients with acute respirtory distress syndrome, we sought to determine its use as a means to ensure preoxygenation in those ARDS patients that require intubation.

High flow nasal canula oxygen is increasingly used to provide heated and humidified oxygen in patients with acute respiratory failure. One of the major advantages of high flow nasal canula oxygen is the possibility to maintain oxygenation during laryngoscopy and thereby providing high flow apneic oxygenation. In addition, and contrary no non-invasive ventilation, preoxygenation may be used in patients with neurological impairment. Finally, the interest of this device is that it is the same that is maintained throughout the whole management of the patient, from ICU admission to intubation.

Eligibility Criteria:
Inclusion Criteria:

* ARDS according to the Berlin criteria
* use of high flow nasal canula oxygen

Exclusion Criteria:

-
Tributyrin to Promote Gut Health Among Children Undergoing Hematopoietic Cell Transplantation

To determine the safety and tolerability of tributyrin among children undergoing hematopoietic cell transplantation (HCT).

Primary Objectives:

1. Evaluate the safety and tolerability of tributyrin and determine the maximum tolerated dose MTD among children undergoing hematopoietic cell transplantation (HCT).

Secondary Objectives:

1. Determine the effect of tributyrin administration on fecal butyrate concentrations.
2. Measure the effect of tributyrin on gut microbiome composition and measures of gut inflammation and barrier integrity.

Hypotheses

1. Enteral administration of tributyrin will be safe and well-tolerated in children undergoing HCT at doses up to 100 mg/kg/day, with no identified dose-limiting toxicities. The most common adverse events will be gastrointestinal and will occur at frequencies and grades typically observed among children after HCT. No adverse effects will occur that are classified as probably or definitely related to the study product.
2. Tributyrin will result in a dose-dependent increase in fecal butyrate concentrations, with maximal fecal butyrate concentrations exceeding concentrations in baseline fecal samples by at least two-fold in \>50% of subjects at all evaluated tributyrin doses.
3. Compared to historical controls, children receiving tributyrin will have greater preservation of gut microbial diversity and higher abundances of Clostridiales and other putatively beneficial gut anaerobes (e.g., Bifidobacterium, Lactobacillus) after HCT. Additionally, children receiving tributyrin will have lower fecal levels of calprotectin and lactoferrin and lower plasma levels of lipopolysaccharide-binding protein and intestinal fatty acid-binding protein, corresponding to lower levels of intestinal inflammation and improved gut barrier function.

Eligibility Criteria:
Inclusion Criteria:

* Age 2-17 years with standard of care nasogastric tube placement or existing gastric tubes
* Planned allogeneic hematopoietic cell transplantation with myeloablative preparative regimen
* Planned graft-versus-host-disease prophylaxis with calcineurin inhibitor + mycophenoalte mofetil or calcineurin inhibitor + methotrexate

Exclusion Criteria:

* Previous history of hematopoietic cell transplantataion
Evaluation of Two Community Based Screening Strategies for Severe Acute Malnutrition in Children 6-59 Months in Mirria District, Niger

The objective of this study is to determine the efficacity of a community strategy for screening children 06-59 months old for Severe Acute Malnutrition (SAM) conducted by their mothers' compared with a community screening strategy conducted by Community Health Workers.


Eligibility Criteria:
Inclusion Criteria:

* children aged 06-59 months at the time of the study
* children who live in a village in the health district participating in the study

Exclusion Criteria:

* children whose legal guardian refuses to participate in the study