cyrilzakka/clinical-trials huggingface dataset:
Defibrotide Dose-escalation for SOS Post-HSCT

This research study is being done to determine the safety and tolerability of increasing doses of defibrotide within a single patient with sinusoidal obstructive syndrome (SOS)/veno-occlusive disease (VOD) after hematopoietic cell transplantation (HCT) associated with either kidney and/or lung impairment that has not obtained a complete response (CR) or progressed in severity with standard doses of defibrotide.


Eligibility Criteria:
Inclusion Criteria:

* HCT recipients (Auto or Allograft)
* SOS/VOD as defined by Cairo/Cooke Diagnostic criteria (1) (Table 3) with either renal and/or pulmonary dysfunction as defined by Cairo/Cooke Grading criteria (1) (Appendix I).
* Unresponsive to standard defibrotide therapy as defined by at least one of the following:
* Patients with SOS/VOD failing to obtain a complete response (CR) defined by Grade I or less by Cairo/Cooke Grading criteria (1) (Appendix I). This would therefore include patients with stable disease after at least 14 days of defibrotide or partial response after at least 21 days of defibrotide (25mg/kg/day).
* Progressive disease defined by progression of at least one grade or more from diagnostic grade as defined by Cairo/Cooke Grading criteria (1) (Appendix I) following at least 7 days of defibrotide (25mg/kg/day).
* Age 1 month - 75 years

Exclusion Criteria:

* Patients who did not receive HCT.
* Concomitant systemic anticoagulation (excluding central venous line management, fibrinolytic instillation for central venous line occlusion, management of intermittent dialysis or ultrafiltration of CVVH).
* Active bleeding and/or hemorrhage of at least grade 2 and above.
* History of development of Grade III/IV anaphylaxis probably or directly secondary to defibrotide.
* Female patients who are pregnant or breast feeding.
Assess the Downregulation of HIV-1 When Raltegravir is Added to a Virologically Suppressed HAART Regimen

The purpose of this study is to determine whether or not adding Raltegravir to a fully suppressive antiretroviral regimen will assist in reducing HIV-1 associated chronic inflammation and increase the t-lymphocyte memory cell pool.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. HIV-positive by Western blot or viral load
3. Viral load \< 400 copies/ml
4. CD4+ T-lymphocyte count less than 350 cells/mm3 or change in CD4+ T-lymphocyte count \< 100 cells/mm3 for at least one year on stable HAART with viral load \< 400 copies/ml for the same period of time

Exclusion Criteria:

1. CD4+ T-lymphocyte count greater than or equal to 350 cells/mm3 or rise in CD4+ T-lymphocyte count greater than or equal to 100 cells/mm3 within one year of study entry
2. Viral load \> 400 copies/ml
3. Allergy or resistance to raltegravir
Exploring a Breast Cancer Early Screening Model Based on cfDNA

The goal of this observational study is to use cfDNA multi-omics technology to explore a new breast cancer early detection model to improve the accuracy of early diagnosis in breast cancer patients. The main questions it aims to answer are:

* Evaluate the sensitivity and specificity of the early detection model for breast cancer screening
* Evaluate participants' TeFei™ score Participants will be collected peripheral venous blood before surgery or systemic treatment. The blood will then be sent to the collaboration company for sequencing. The collaboration company will analyze the sequencing results and build a cfDNA multi-omics signature library. Finally, the collaboration company will use deep learning algorithms to train and optimize the feature library.

Researchers will compare the cancer group with a benign control group to determine the model's effectiveness in differentiating between them.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥18 years old and ≤70 years old;
2. Plasma of the participant can be obtained;
3. Willing to sign the informed consent;
4. Meet one of the following criteria:

4.1)Patients diagnosed with invasive breast cancer or carcinoma in situ of the breast for the first time; 4.2)Patients with breast fibroma or breast adenosis and breast fibrocystic hyperplasia;

Exclusion Criteria:

In any of the following situations, subjects should not participate in the trial:

1. Pregnant or lactating;
2. Unable to obtain the participant's plasma;
3. Patients with other types of malignant tumors diagnosed by pathology within 5 years before enrollment;
4. The patients had suspected imaging (B-ultrasound, CT, etc.) of other malignant tumors within the past 1 year after enrollment, but no pathological confirmation;
5. Received any blood product transfusion in the past 30 days;
6. Participants considered by the investigator to be inappropriate to participate in this research-type clinical trial.
Persistency Study After Hib-CRM (Cross-Reacting Material)197 or Hib-TT (Tetanus Toxoid) Vaccines in Chinese Children

Evaluate the persistency of immune response against Haemophilus influenzae type b by assessing anti-PRP antibody levels in children vaccinated with either Hib-CRM197 or Hib-TT booster vaccine approximately 4 years before.


Eligibility Criteria:
Inclusion Criteria:

1. Children previously enrolled in V37_07E1 study and who received the appropriate vaccination.
2. Children whose parent(s) or legal guardian(s) had given written consent after the nature of the study was explained according to local regulatory requirements.

Exclusion Criteria:

1. Any confirmed or suspected current immunosuppressive or immunodeficient condition since the end of V37_07E1 study, based on medical history and physical examination (no laboratory testing required).
2. Treatment with corticosteroids or other immunosuppressive/immunostimulant drugs as defined below:

   i) chronic use of oral and parenteral immunosuppressants (\>= 15 days of use) or other immune-modifying drugs within 60 days prior to the blood sampling (short term usage of topical, inhaled and/or intranasal corticosteroids were allowed) ii) receipt of immunostimulants within 60 days prior to Visit 1
3. Administration of immunoglobulins and/or any blood products up to 3 months before enrollment.
4. Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the blood sampling.
5. Any condition, which, in the opinion of the investigator, might be a contraindication to the execution of the blood draw.
The Effect of Periodontal Treatment on Psoriasis

There is a relationship between psoriasis and periodontal disease. This relationship may be double-sided.

The aim of this randomized controlled clinical study was to determine the effect of non-surgical mechanical periodontal treatment on psoriasis. The study population consisted of 92 periodontitis patients with psoriasis who had untreated periodontal disease. Two randomized groups were formed from these patients. Immediate periodontal treatment (test group, n = 46) and delayed periodontal treatment (control group, n = 46). Clinical periodontal measures, saliva interleukin 2, interleukin 6 and secretory immunoglobulin A levels and PASI scores were performed at baseline and 8th week in control and test group.

Eligibility Criteria:
Inclusion Criteria:

* the presence at least 20 remaining teeth,
* the presence of Stage I or Stage II Periodontitis,
* the presence of diagnosed psoriasis.

Exclusion Criteria:

* patients who had the immune-inflammatory disease and require antibiotic prophylaxis,
* patients who received periodontal treatment prior to 6 months,
* women who were breastfeeding or pregnant,
* patients using medicines such as antibiotics, anti-inflammatory drugs, immune-suppressants.
Carotid Intima-media Thickness in Japan Statin Treatment Against Recurrent Stroke(J-STARS Echo)

Carotid ultrasound can reveal the intima-media complex thickness(IMT), that has been reported to be a marker of atherosclerosis as well as a risk of cardiovascular events, and to be attenuated by 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins) . This substudy of J-STARS will observe the temporal profile of carotid IMT prospectively in the patients with prescription of pravastatin and the control.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke except for cardiogenic embolism, from 1 month to 3 years after onset
* Hyperlipidemia and total cholesterol level of 180-240mg/dl without the prescription of statin within previous 30 days
* Able to visit outpatient department
* Informed consent on the form.

Exclusion Criteria:

* Ischemic stroke of other determined cause according to the TOAST classification
* Ischemic heart disease and necessary to use statin
* Hemorrhagic disorders
* Platelet count \<=100,000/ul within 3 months prior to study start
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\>= 100IU/L within 3 months prior to study start
* Serum creatinine \>=2.0mg/dl within 3 months prior to study start
* A scheduled operation
* The presence of malignant disorder
* Patients whom carotid ultrasound cannot examine because of neck tumor or torticollis
* Patients after carotid endarterectomy or radiation therapy to neck
* Patients whose carotid ultrasound cannot be examined because of neck tumor or torticollis
* Patients after carotid endarterectomy or radiation therapy to neck
Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?

The purpose of this study is to see whether adults who use e-cigarettes every day experience symptoms of nicotine withdrawal when they stop using e-cigarettes for 6 days.

Study Design: The investigators will recruit 120 individuals who are long-term daily and exclusive users of nicotine-containing e-cigarettes. Participants will be asked to use their own e-cigarette as usual during the first week of the study and to then stop their use of e-cigarettes for 6 days. The total study duration will be 14 days. Participants will be instructed to continue abstinence from other tobacco and nicotine products during the entire study. The investigators will use an escalating payment system with bonuses based on breath and urine samples to encourage compliance.

Every day during the study, participants will report e-cigarette and tobacco cigarette use and monitor symptoms of nicotine withdrawal via a phone call to an Interactive Voice Response system. Participants will attend 3 study visits each week to provide urine and breath samples to verify compliance, and to complete brief surveys.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Able to read and understand verbal English fluently
* US citizen or resident alien
* Primarily uses e-cigarette product types of refillable tanks or modified devices
* Uses nicotine-containing e-liquid
* Has baseline urinary cotinine concentration of \> 100 ng/ml
* Has used e-cigarettes daily for the last 2 months
* Has a home or cell phone
* Agrees to abstain from tobacco, marijuana and other illegal drugs during study

Exclusion Criteria:

* Smoked \> 5 tobacco cigarettes in the last month
* Used non-cigarette nicotine, tobacco or quit smoking products on \>5 days in the past month
* Use of cannabis (either marijuana or synthetic cannabis) \> 5 times in the past month or positive test for cannabis use at screening
* Current (last 6 months) Generalized Anxiety Disorder, Major Depressive Disorder, Attention Deficit Hyperactivity Disorder or moderate/severe Substance Abuse Disorder
* Multiple legal, social health, work or school problems in the past month due to alcohol or drug use
* Pregnant or breastfeeding
* Previously a participant in the current study
* Use of prescribed or non-prescribed psychoactive medication \> 5 times in the past month
* Expired carbon monoxide level \> 8ppm
Relationship Between Endoscopic Ultrasound Staging and Degree of Stricture in Esophageal Cancer

The primary objective of this study is to document all cases of EUS in patients with esophageal cancer and determine if the inability to advance the gastroscope beyond the tumor correlates with locally advanced disease stage at Endoscopic Ultrasound.

This will be an observational prospective study. The investigators will aim to enroll 100 male and female adult patients (aged 19 years and over) of all ethnicities/races, who have been referred to Florida Hospital for Endoscopic Ultrasound staging of esophageal cancer. All vulnerable populations will be excluded.

The investigators will be using a standardized data collection form to record presenting symptoms, endoscopy findings, Endoscopic Ultrasound features and final esophageal cancer staging. This is an observational study in which standard of care is being practiced and also as the patients are not placed at additional risk from participating in this study. However, as the investigators are collecting data prospectively, all participants will sign consent. An attempt will be made to see if there is a correlation between stricture tightness encountered at endoscopy (EGD) with advanced disease stage diagnosed at Endoscopic Ultrasound.

Eligibility Criteria:
Inclusion Criteria:

1.All patients aged \> 18 yrs, who can provide informed consent and referred to Florida Hospitals Endoscopy Unit for EUS staging of esophageal cancer.

Exclusion Criteria:

1. Age \< 18 yrs
2. Inability to provide informed consent.
3. Unable to safely undergo endoscopy for any reason
4. Coagulopathy (prolongation of Prothrombin time \> 18 secs, thrombocytopenia \< 80,000 platelets/ml)
5. Limited mental capacity or language skills to the extent simple instructions cannot be followed or information regarding adverse events and follow-up phone visits cannot be provided
6. Non-English speaking without a translator.
Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP3 Post Elimination Monitoring

This study determines the feasibility, diagnostic performance and cost for monitoring of eliminated human African trypanosomiasis (HAT) foci using diagnostic algorithms of serological and molecular high throughput tests with and without previous rapid diagnostic test blood screening for early detection of Trypanosoma brucei gambiense HAT re-emergence.

In the last decade, the prevalence of Trypanosoma brucei gambiense (Tbg) human African trypanosomiasis (HAT) has fallen and HAT has been targeted for elimination. At low disease prevalence, HAT control is increasingly integrated into routine activities of peripheral health centres. However, the weak capacity of fixed health structures to implement control activities, lack of coverage, the unspecific clinical picture of HAT, and the existence of asymptomatic cases and animal reservoirs may result in under detection of HAT. To ensure sustainability of zero transmission and to avoid re-emergence caused by remaining Tbg reservoirs, continued post-elimination monitoring is therefore required.

Health workers performing house to house visits in foci with very low HAT prevalence can easily collect blood on filter paper and send it to regional HAT reference centres for analysis. The objective of the DiTECT-HAT-WP3 study is to determine the feasibility and cost of diagnostic algorithms of serological and molecular high-throughput tests on blood on filter paper for post-elimination monitoring, with or without a previous screening with rapid diagnostic tests.

In villages in low to zero prevalence foci in Democratic Republic (DR) Congo, Côte d'Ivoire and Burkina Faso, a health worker will go from house to house to 1) register all consenting inhabitants in a Personal Digital Assistant; 2) take a blood sample on filter paper 3) perform 3 rapid diagnostic tests. All dried blood spots (DBS) are sent to the reference laboratory for high-throughput testing (ELISA, trypanolysis, loop-mediated isothermal amplification method (LAMP) and real time (RT) -PCR). Subjects positive in at least 1 test - the RDTs or high-throughput tests - are revisited twice for parasitological confirmation.

In each country, blood specimens of 6000 persons will be tested. The relative effectiveness and overall cost of the different diagnostic algorithms will be investigated. We will quantify the break-even point for an imperfect test algorithm by formulating a decision criterion to assess how many false negatives, but particularly how many false positives can be tolerated while still achieving an intervention with a reasonable cost burden. The results will enable us to propose a test algorithm and a threshold to send out specialised mobile teams for stopping HAT re-emergence, without unnecessarily raising the alarm.

Eligibility Criteria:
Inclusion Criteria:

* Permanent resident of village (in low to zero prevalence HAT focus) for minimum 1 year

Exclusion Criteria:

* Previously treated for HAT (irrespective of time elapsed since treatment)
* No informed consent
* \< 4 years old
Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants

The primary purpose of this study is to determine functional target engagement of SAGE-904 using electrophysiological paradigms before and after ketamine administration.


Eligibility Criteria:
Inclusion Criteria:

1. Participant is willing and able to provide 2 forms of identification; at least 1 must have a photo
2. Participant has a body weight ≥50 kilograms (kg) and body mass index ≥18.0 and ≤30.0 kilograms per square meter (kg/m\^2) at screening
3. Participant is healthy with no history or evidence of clinically relevant medical disorders as determined by the investigator
4. Participant has the ability to tolerate the electrode headset for the duration of the testing session

Exclusion Criteria:

1. Participant has a history or presence of any psychiatric disease or condition including suicidal ideation or behavior, has answered YES to any question on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening or admission, or is currently at risk of suicide in the opinion of the Investigator
2. Participant has a history or presence of a neurologic disease or condition, including, but not limited to, epilepsy, closed head trauma with clinically significant (CS) sequelae, or a prior seizure
3. Participant has a family history of epilepsy
4. Participant has a history, presence, and/or current evidence of serologic positive results for Hepatitis B and C, human immunodeficiency virus (HIV) 1 or 2
5. Participant has obstructed venous access and/or has skin disease, rash, acne, or abrasion at venous access site that may affect the ability to obtain a pharmacokinetic (PK) sample or affect the ability to receive the ketamine infusions
6. Participant has had previous exposure to or is known to be allergic to ketamine or any of its excipients
Web-Mediated Risk Assessment for Endoscopic Screening of Colorectal Polyps

Colorectal polyps are risk factors for cancer. Early detection of polyps is critical for colorectal cancer management. However, the diagnosis rate of patients with colorectal polyps is still low. Therefore, we design this study to access whether pre-endoscopic screening risk assessment of genetic and environmental risk factors could improve diagnosis rate of colorectal polyps.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65.
2. Signed informed consent

Exclusion Criteria:

1. Severe back ground disease including malignancy.
2. State after gastric surgery.
3. COPD, CHF, CRF and any disease with respiratory disturbances.
4. Deviation of the nasal septum, lack of venous access at the dorsum of the hand or any other technical problem prevents gastric acid collection or base excess evaluation.
Allogeneic HCT Using Uniform Conditioning Regimen Regardless of Donors (MS, MU, or HF) for AML in Remission

The purpose of this study is to evaluate the effect of various clinical variables including HLA-disparity and NK cell-related variables, upon outcomes of allogeneic hematopoietic cell transplantation (HCT) using uniform conditioning regimen including busulfan, fludarabine, and antithymocyte globulin (ATG) in patients with acute myeloid leukemia (AML) in the first complete remission (CR). The donors for allogeneic HCT include HLA-matched siblings, matched unrelated donors, and haploidentical family donors.

Therefore, the endpoints of the study are engraftment, secondary graft failure, acute and chronic graft-versus-host disease (GVHD), immune recovery, infections, leukemia recurrence, non-relapse mortality, and relapse-free (RFS) and overall survival (OS) of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with non-promyelocytic AML (intermediate-risk or high-risk diseases by NCCN guideline 2016) in the first CR
* Patients should be 16 years of age or more and 75 years of age or less
* The performance status of the patients should be 70 or over by Karnofsky performance scale
* Patients should have adequate hepatic function (bilirubin less than 2.0 mg/dl, AST less than three times the upper normal limit)
* Patients should have adequate renal function (creatinine less than 2.0 mg/dl)
* Patients should have adequate cardiac function (ejection fraction \> 40% on MUGA scan)
* Patients and stem cell donors must sign informed consent
* For hematopoietic cell donor, if a patient has an HLA-matched sibling (65 years or younger), that sibling will be a cell donor. If a patient does not have an HLA-matched sibling but an HLA-A, B, C, DRB1 7-8/8 matched unrelated donor, the unrelated donor will be a cell donor. If a patient has neither HLA-matched sibling nor unrelated donor, an HLA-haploidentical familial donor will be a cell donor.
TRISCEND II Pivotal Trial

Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system

The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic tricuspid regurgitation (TR) despite medical therapy
* TR graded as severe or greater
* Appropriate for transcatheter tricuspid valve replacement per the local heart team

Exclusion Criteria:

* Tricuspid valve anatomic contraindications
* Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months
* Hemodynamic instability
* Refractory heart failure requiring advanced intervention
* Currently participating in another investigational study