cyrilzakka/clinical-trials huggingface dataset:
Comparison of Gut Microbiota, Inflammation and Symptoms Following Allogeneic HSCT

The purpose of this study is to examine the gut bacteria, levels of peripheral blood inflammation markers, and symptoms in patients with and without chronic graft-versus-host disease (cGVHD) following allogeneic hematopoietic stem cell transplant (allo-HSCT). The hypothesis is that individuals with cGVHD will have lower levels of microbial diversity, higher levels of inflammatory metabolites in stool and peripheral measures, and higher levels of symptoms than individuals without cGVHD.

This study will recruit 40 (20 with cGVHD and 20 without cGVHD) adults from the Bone Marrow Transplant Program at University of Florida Health Shands Cancer Hospital. After signing informed consent, participants will fill out questionnaires and have a blood sample collected from a vein in the arm. Participants will be given a stool collection kit with instruction and will return the sample via the mail. Data will be collected and securely stored in a system used by the cancer center for research. Descriptive statistics will be used to report individual, clinical factors, and symptoms.

Knowledge gained from this study will provide preliminary data for future longitudinal studies to examine biological pathways for the development, severity and/or duration of cGVHD and symptom outcomes in individuals following allo-HSCT impacting quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Group 1: Adults (\> 18 years of age) within 3 months to 3 years of receiving allogeneic hematopoietic stem cell transplant (allo-HSCT) diagnosed with cGVHD;
* Group 2: Adults (\> 18 years of age) within 3 months to 3 years of receiving allo-HSCT without a diagnosis of cGVHD; and
* All participants must be able and willing to complete paper and pencil questionnaires, provide a blood and stool sample, and be able to give informed consent.

Exclusion Criteria:

* Diagnosed with a significant secondary inflammatory disease such as multiple sclerosis, Crohn's disease, rheumatoid arthritis or secondary cancer;
* History of a major psychological disorder requiring psychotropic medications or initiation of antidepressants within 30 days of enrollment;
* Incarcerated or pregnant; or
* Any other condition that in the opinion of the principal investigator (PI) may compromise study participation will not be eligible for participation in this study.
The clonoSEQ® Watch Registry

This is a prospective, multicenter, observational study of adult patients with a diagnosis of acute lymphoblastic leukemia (ALL), multiple myeloma (MM), chronic lymphocytic leukemia (CLL), or non-Hodgkin lymphoma (NHL). This study will enroll up to 528 patients in up to 50 sites in the United States and collect data with regard to use of the clonoSEQ MRD assay in the management of lymphoid malignancies.

Data show that detection of MRD may be important to guide treatment decisions in ALL, MM, CLL, and NHL. However, there remains a lack of real-world evidence for making therapeutic decisions based upon MRD status. This study is designed to understand when in a patient's treatment continuum the assay is used and how clonoSEQ MRD data impact the treatment decisions made by investigators.

All patients enrolled in the study will be followed for at least 2 yrs. Demographic data and disease status will be captured at study enrollment. Patients must be \>/= 18 yrs of age and able to sign informed consent. A given patient is eligible to enroll in the study if the treating physician has made the decision to use the clonoSEQ assay as part of that patient's routine cancer care. Reasons for placing a clonoSEQ order and subsequent decisions made as a result of MRD data will be tracked. Patient treatment will also be tracked over the course of the study in order to understand how clonoSEQ use is incorporated into current treatment regimens.

Participating centers will include sites that actively use clonoSEQ to manage their patients with lymphoid malignancies.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be able to provide written informed consent
2. A decision has been made by the treating provider to use the clonoSEQ Assay as part of routine clinical care
3. Age ≥ 18 years;
4. Documented hematologic malignancy (any of the below):

   1. MM
   2. ALL (B and T-cell subtypes)
   3. B-cell NHL (all sub types)
   4. CLL
   5. Other lymphoid malignancies (upon review and approval by study chair)

Exclusion Criteria:

Patients must not meet any of the following criteria in order to be enrolled into the study:

1. Concurrent enrollment in a clinical trial where treatment decisions and patterns are dictated per protocol
2. A decision has been made by the treating provider to not use the clonoSEQ Assay as part of routine clinical care
Study of Oglemilast for the Treatment of Asthma

The purpose of this study is to determine whether oglemilast is safe and effective in the treatment of allergen-induced asthma.


Eligibility Criteria:
Inclusion Criteria:

* Mild atopic asthma
* Hyperreactivity to methacholine
* Exhibit positive response to standard allergen skin prick test

Exclusion Criteria:

* Pulmonary disease other than asthma
* Asthma exacerbation within 4 weeks
* History of substance abuse
* Active cardiac disease
Effect of Anti-inflammatory (ITIS) Diet in Rheumatoid Arthritis

to study the effect of anti-inflammatory diet on clinical and biological outcomes in rheumatoid arthritis

The investigators would like to evaluate how inflammation occurs in the joints of subjects with arthritis, and identify molecules and bacteria that can predict whether a rheumatic subject will flare. Blood, urine and stool will be evaluated in the laboratory and compared to their own samples after changes in diet. This is an exploratory study, which is meant to gather preliminary data about the quick effects of changes in diet and treatment on molecules in blood/urine and bacteria in stools. These studies can provide clues to the cause of disease and might ultimately lead to new therapies.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed of rheumatoid arthritis
* without changes in treatment in the last 3 months

Exclusion Criteria:

* food allergies
* pregnancy
Optimization and Refinement of Technique in In-Office Sinus Dilation 2

A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA cleared for sale in the U.S.A.


Eligibility Criteria:
Inclusion Criteria:

* Male/Female, 18 year or older
* Diagnosis of Chronic Rhinosinusitis
* Planned Endoscopic Sinus surgery

Exclusion Criteria:

* Cystic Fibrosis
* Severe Polyposis
* Sinonasal tumors
* History of facial trauma precluding access to sinus ostium
* Ciliary Disfunction
* Planned non-sinus surgery (such as rhinoplasty, septoplasty, etc.)
* Pregnant or lactating female
* Inability to tolerate an awake procedure
* Participation in another investigational clinical study involving treatment for chronic rhinosinusitis
Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B

This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures in patients with haemophilia B.


Eligibility Criteria:
Inclusion Criteria:

* Patients with haemophilia B with a FIX activity below or equal to 2%
* Male patients with moderately severe or severe congenital haemophilia B with a FIX activity below or equal to 2% according to medical records
* History of at least 150 exposure days to other FIX products
* Scheduled major surgery

Exclusion Criteria:

* Known history of FIX (coagulation factor nine) inhibitors based on existing medical records, laboratory report reviews and patient and LAR (legal acceptable representative) interviews
* Current FIX (coagulation factor nine) inhibitors above or equal to 0.6 Bethesda Units (central laboratory)
* Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records)
* ALT (alanine aminotransferase) 3 times the upper limit of normal reference ranges at screening (central laboratory)
* Immune modulating or chemotherapeutic medication
Late Stent Strut Apposition and Coverage After Drug-Eluting Stent Implantation by OCT in Patients With AMI

The purpose of this study is to evaluate the incidence of late incomplete stent apposition (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting stent (EES) with bioabsorbable polymer (SYNERGY™, Boston Scientific,Nattick, MA, USA) versus zotarolimus-eluting stent (ZES) with permanent polymer(Resolute Onyx™, Medtronic, Santa Rosa, CA, USA) implantation in patients with AMI at 12 months.

It has been known that persistence of polymer may affect the late/very late safety and efficacy of drug eluting stent (DES) although polymer provides a reservoir for programmed drug release. Newer durable polymers may have enhanced biocompatibility and seem to be associated with improved clinical outcomes. However, they have still been incriminated in the occurrence of inflammation, neo-atherosclerosis, and thrombosis. Therefore, the investigators will evaluate the vascular tissue reaction after different kinds of DES implantation under the high thrombogenic circumstance of acute myocardial infarction (AMI).

Eligibility Criteria:
Inclusion Criteria:

* Acute myocardial infarction including ST-segment elevation myocardial infarction (STEMI) or non ST-segment elevation myocardial infarction (NSTEMI) treated with PCI
* Patient ≥ 18 years of age
* Patient judged suitable to receive anti-platelet drugs of ASA and ticagrelor for at least 12 months after the procedure
* The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic, OCT follow up and provides informed consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
* culprit lesion

Exclusion Criteria:

* The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, abciximab, aspirin, ticagrelor, everolimus, zotarolimus, polymer, platinum chromium, cobalt chromium, contrast media
* Female of childbearing potential unless a pregnancy test is negative or who possibly plan to become pregnant any time after enrollment
* Cardiogenic shock
* Patient with left ventricular ejection fraction \<30%
* Patient with left main disease
* Patient with In-stent restenosis (ISR) at target vessel (either bare metal stent or DES, non-target vessel ISR is permitted)
* Patient with impaired renal function (creatinine \>2.0mg/dL)
* Patient with inadequate OCT images quality due to severe calcification, vessel tortuosity and artifacts
* bifucation lesion needs complex procedure with insert two or more Drug eluting stents.
* lesion length \>30mm
Gene Mutation Spectrum of Malignant Hyperthermia in China

In this study, case information and specimens of patients with malignant hyperthermia(MH) will be collected from all over China, and gene fragment analysis, sanger sequencing method and/or high-throughput whole-genome sequencing will be performed. The MH bioinformatics database will be established to find the pathogenic gene and mutation site of MH in Chinese. Based on the bioinformatics database, the genetic law of MH family will be studied. According to the results of the study, the guideline for the diagnosis and treatment of MH that is in line with Chinese population biology characteristics will be formulated.

When MH cases or suspected cases occur in China, anesthesiologists can seek help through malignant hyperthermia emergency rescue WeChat group in which experts from all over the country will give therapy instructions. Afterwards, the responsible anesthesiologist will complete the case report form (CRF) and collect family history of MH. The quality of CRF is reviewed by the investigator and all the queries are solved within 1\~2 weeks.

Upon obtaining the informed consent, all biological specimens of MH confirmed or suspected patients and their blood relations will be collected in the local hospitals and transported to West China Hospital, Sichuan University in dry ice packaging. All specimens will be checked by the trained investigator, registered and labeled in a standardized manner, and then stored in the biological sample bank of West China Hospital, Sichuan University.

Firstly, investigators will use the method of gene fragment analysis to detect the samples at the diagnostic mutation sites included in the current European malignant hyperthermia group. Secondly, investigators will use sanger sequencing method to verify the mutation variants. If the screening results are negative, then high-throughput whole-genome sequencing will be performed.

The MH bioinformatics database will be established to find the pathogenic gene and mutation site of MH in Chinese. Based on the bioinformatics database, the genetic law of MH family will be studied. According to the results of the study, the guideline for the diagnosis and treatment of MH that is in line with Chinese population biology characteristics will be formulated.

Eligibility Criteria:
Inclusion Criteria:

* Chinese whose malignant hyperthermia susceptibility had been confirmed after a positive clinical manifestation of malignant hyperthermia which defined as their scores of clinical grading scale for malignant hyperthermia are more than 35 and their blood relations.
* Sign informed consent

Exclusion Criteria:

* Patients who have no adverse anaesthetic event, such as those patients referred with a history of exertional heat illness, exertional or recurrent rhabdomyolysis, or a congenital myopathy.
Citrate Versus Heparin Anticoagulation: Effect on Molecules Clearances

Sepsis is responsible for 50% of all acute kidney injury (AKI) in intensive care units (ICUs), contributing greatly to multiple organ dysfunction syndrome (MODS). Special types of continuous renal replacement therapies (CRRT) have been proposed as adjuvant therapies for septic shock due to their ability to remove middle molecular weight molecules such as inflammatory mediators involved in MODS pathophysiology. These therapies are called extracorporeal " blood purification " therapies.

When CRRT is used, an anticoagulation is required to prevent clotting of the extracorporeal circuit, possibly causing bleeding in selected patients. Many anticoagulation strategies have been proposed and the most commonly used in 2013 is still unfractionated heparin. Regional citrate anticoagulation (RCA) is an interesting alternative as it dramatically decreases the bleeding risk.

The investigators hypothesize that the use of citrate with Super High Flux Continuous Veno-Venus Hemodialysis (SHF-CVVHD) would be highly beneficial over time by preserving the filter effectiveness via limiting protein adhesion (which subsequently reduces filter pore sizes (protein cake)), as compared to heparin. Consequently, higher clearances of the inflammatory mediators could be maintained over time with citrate as compared to heparin anticoagulation. In other words, for the same duration of filter use, middle molecular weight molecules and cytokines clearances would be greater with citrate as compared to heparin. To test this hypothesis, the investigators will perform a clinical randomized controlled trial which aim would be to compare middle molecular weight molecules and cytokines clearances in SHF-CVVHD using RCA versus systemic heparin anticoagulation in septic patients with AKI.


Eligibility Criteria:
Inclusion Criteria:

* Male or female critically ill patients over the age of 18 years old
* Acute Kidney Injury requiring CRRT defined using the Risk, Injury, Failure, Loss, End-stage renal disease (RIFLE) classification with criterion I or worse.
* Septic shock as defined by the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference.
* Written informed consent obtained from the patient or a patient's legal representative
* Patient patient's legal representative able to agree to patient's enrollment in the study with informed consent.

Exclusion Criteria:

* Pregnancy
* Participation in another research study protocol
* Known heparin induced thrombopenia or contraindication to heparin
* Pre-existing chronic renal failure on chronic dialysis
* Therapeutic anticoagulation with heparin for another reason (e.g. chonic arrhythmia)
* Severe liver failure (15% prothrombin time)
Effect of Metformin on Insulin Sensitivity and Pan-Arterial Vascular Function in Adults With Metabolic Syndrome

The purpose of this study is to look at how insulin (a hormone that helps the cells get energy from sugar) in our body affects blood vessels (elasticity in the bigger blood vessels and blood flow in the smaller blood vessels in the arm) and how Metformin (a drug that makes you more sensitive to insulin) affects insulin's action on the blood vessels.

In our protocol, we will study vascular function using pulse wave velocity (PWV) augmentation index (AI), flow mediated dilation (FMD) and contrast enhanced ultrasound (CEU) as well as insulin sensitivity (euglycemic clamp) in 50 adults with metabolic syndrome, age 18-60 years. They will each be studied 4 times,before and after two 12-wk interventions (randomly assigned) as follows: 1) Placebos and 2) Metformin . This is a cross-over design.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60

  * No smoking the past 6 months
  * Normal screening labs or no clinically significant values-except those listed below
  * Must have 3 of the following 4 characteristics established by NCEP-AHA-NHLBI

    * Males waist circumference greater than 40 inches, females greater than 35 inches
    * Blood pressure greater than 130/85 or on treatment with one or more antihypertensive agent
    * Fasting plasma triglycerides \>150 or HDL \<40 (males) \<50 (females)
    * Fasting blood sugar \>100 but \<126
  * Subject may participate if on the following drugs, provided the drugs can remain at stable doses throughout the 12 week treatment interval.

    * Ace inhibitor
    * ARB
    * HMG CoA reductase inhibitor
    * Beta blocker
    * Calcium channel blockers
    * Alpha-adrenergic antagonist

Exclusion Criteria:

* Smoking presently or in the past 6 months
* HbA1c ≥ 6.5
* Glucocorticoids-eg: prednisone, dexamethasone
* Any known sensitivity or intolerance to Metformin
* Any chronic GI disorders such as Irritable Bowel Syndrome or Crohns disease
* History of congestive heart failure, ischemic heart disease, severe pulmonary disease, liver or kidney disease.
* History of malignant or metabolic disorders including diabetes
* Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam by PI)
* Hypersensitivity to perflutren (contained in Definity)
* Pregnant or breastfeeding
Community-based Delivery of Integrated Family Planning/HIV Testing and Counseling Services in Uganda

The purpose of this study is to evaluate the feasibility and acceptability of adding HIV testing and counseling (HTC) services to the family planning (FP) services provided by community health workers in Uganda.

The Uganda Ministry of Health is implementing a Village Health Team strategy whereby lay volunteers, called VHTs, provide a government-endorsed platform for all community-based health programming. Where trained, VHTs already offered family planning services, including injectable contraceptives. In this project, VHTs already providing family planning services are trained to offer HIV testing and counseling services (HTC). The goal is to reach individuals whose sexual and reproductive health needs may be underserved by clinic-based services, while also attempting to mitigate some of the barriers to HTC like access and stigma.

The study uses a two-arm post-test only randomized cluster design, with eight pair-matched health centers in two districts randomly assigned to intervention or control arm. VHTs supported by health centers in the intervention arm receive classroom training and supervised practical experience in HTC. Supervision and commodity supply occur through health centers, building on support mechanisms for family planning. External quality assurance is conducted quarterly through health centers as part of program implementation. VHTs receive refresher training after 8 months. VHTs in the intervention arm provide both family planning and HTC services during the study period, and then return to providing family planning only at the end of the project. VHTs in the control arm only provide family planning. HTC and/or family planning services, as applicable, are available to all adults in the communities served by the VHTs.

Eligibility Criteria:
Inclusion Criteria:

* At least six months of experience providing family planning services, including injectable contraceptives
* Attached to one of the eight health centers selected for the study for supervision, commodity supply, and referral management
* All VHTs in the intervention group are trained in HTC service provision and interviewed as part of the evaluation. VHTs in the control group are not interviewed.

Services (family planning and/or HTC) are made available to all adults in VHTs' communities. Data collection involves a client survey. Inclusion criteria for participation in the survey are:

* Age 18 or more
* Female
* Revisit family planning clients of VHTs (will have received family planning services from the VHT more than once)
* Where this service is available, having received HTC from the VHT is not an eligibility criterion

Exclusion Criteria:

* N/A
Acceptability and Feasibility of Cognitive Behavioral Therapy for Treatment-Seeking (CBT-TS) With Deaf Individuals

The current study aims to assess the acceptability and feasibility of an adapted version of Cognitive Behavioral Therapy for Treatment Seeking (CBT-TS) for use with signing Deaf adults. This is a Stage 1A intervention refinement study consisting of a single-arm open pilot trial. Thirty Deaf adults with clinically significant symptoms of alcohol use disorder (AUD), post-traumatic stress disorder (PTSD), depression, anxiety, and/or insomnia, who are not currently engaged in treatment will be recruited from across the United States. All subjects will complete a baseline assessment of their behavioral health symptoms, perceptions towards treatment, and intent to seek treatment prior to engaging in the adapted CBT-TS intervention. The primary clinical outcome, assessed at one-month follow-up, will be whether subjects scheduled professional treatment. Secondary outcomes include changes in subjects' perceptions towards treatment, intentions to seek treatment, and symptom severity from baseline. During the one-month, follow-up assessment subjects will also complete a client satisfaction survey and open-ended questions to provide feedback about the CBT-TS intervention.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* self-identify as Deaf or hard-of-hearing (any degree of hearing loss)
* primary method of communication is ASL or PSE
* positive screen for one or more behavioral health disorders including: AUD (AUDIT \> 16 and alcohol use in the past 30 days exceeds the limit for low-risk drinking established by the NIAAA), PTSD (PCL-5 \> 31), depression (PHQ-9 \> 10), anxiety (GAD-7 \> 10), or insomnia (ISI \> 15)
* no current behavioral health treatment per standardized self-report
* access to video chat technology with internet and webcam.

Exclusion Criteria:

* unable to communicate with the researcher in ASL or PSE
* current alcohol withdrawal necessitating medical evaluation
* current psychiatric impairment necessitating emergency services or inpatient admission (i.e., imminent danger of harm to self or others)
* unable to comprehend the nature of the study
* currently receiving behavioral health treatment for their symptoms.