cyrilzakka/clinical-trials huggingface dataset:
Persistency Study After aP / Tdap Booster Vaccines in Adult Subjects (V113_01 Extension 1)

The purpose of this study is to evaluate the persistence of immune response against the three pertussis antigens (anti- pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN)) in subjects who received a booster dose of either aP or Tdap study vaccines or Boostrix® during V113_01 study.

There was only one Clinic Visit at day 1. Eligible subjects went undergo a single blood draw after which they were observed for approximately 15 minutes. Approximately 10.0 mL of blood was withdrawn.

No vaccine was administered and no safety data was collected in this study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals previously enrolled in V113_01 trial, who completed the study following study protocol and who received the appropriate booster vaccine per group assignment
* Individuals who voluntarily gave written informed consent after the nature of the study was explained according to local regulatory requirements, prior to study entry
* Individuals who could comply with study procedures including follow-up

Exclusion Criteria:

1. Clinical conditions representing a contraindication to blood draw.
2. Abnormal function of the immune system resulting from:

   * Clinical conditions
   * Systemic administration of corticosteroids per oral (PO)/ intravenous (IV)/ intramuscular (IM) for more than 14 consecutive days within 90 days prior to informed consent.
   * Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
3. Received immunoglobulins or any blood products within 180 days prior to informed consent.
4. Received an investigational or non-registered medicinal product within 30 days prior to informed consent
5. Study personnel as an immediate family or household member
6. Any other clinical condition that, in the opinion of the investigator, could interfere with the results of the study or pose additional risk to the subject due to participation in the study
The Incidence and Risk Factors of Central Nervous System Adverse Events of Lorlatinib in Patients with ALK-positive Advanced Non-small Cell Lung Cancer: a Real-world Study

The goal of this study is to investigate the incidence and risk factors of central nervous system adverse events of Lorlatinib in patients with ALK-positive advanced non-small cell lung cancer.

The goal of this study is to investigate the incidence and risk factors of central nervous system adverse events of Lorlatinib in patients with ALK-positive advanced non-small cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced (stage IIIb/IIIc), metastatic, or recurrent (stage IV) NSCLC confirmed by histology or cytology, who are not eligible for curative surgery and cannot undergo definitive radiotherapy/chemotherapy, according to the 8th edition of the TNM staging classification by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;
* ALK-positive and the test results were based on RT-PCR /FISH /IHC /NGS methods in the laboratory department or testing institution of the hospital
* receiving targeted therapy with Lorlatinib
* age ≥18 years old
* follow-up after receipt of Lorlatinib
* voluntarily participate in the study and sign informed consent

Exclusion Criteria:

* evidence of any severe or uncontrolled systemic illness, including uncontrolled hypertension and active bleeding, active infections including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
* combined with other malignant tumors and received other anti-tumor therapy during the treatment of Lorlatinib
A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder

This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder (IED).

IED is a condition characterized by a failure to resist aggressive impulses. IED is a behavioral defined condition for which effective treatments have not been identified. Research suggests that serotonin (5-HT), a chemical that helps regulate mood and emotions, may play a role in the response to pharmacological IED treatments. This study will examine the relationship between 5-HT receptors and response to treatment with fluoxetine or divalproex. In addition, this study will examine people with IED and those without the condition to determine whether there are differences in their 5-HT receptor and transporter systems.

Participants in this study will be randomly assigned to receive either fluoxetine, divalproex, or placebo for 12 weeks. Scale ratings will be used to assess the aggression levels of participants. Biologic evaluations of the 5-HT system will be conducted throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Intermittent Explosive Disorder (IED)
* In good physical health
* Overt Aggression Scale-Modified (OAS-M) score of 15 or higher at screening
* Willing and able to comply with the study requirements

Exclusion Criteria:

* Life history of bipolar disorder, schizophrenia, organic mental syndrome, or mental retardation
* Current major depressive disorder, with a Hamilton Depression (HAM-D) Scale score higher than 18
* Current alcohol or drug abuse or dependence
* Active medical conditions that will interfere with the study
* Thymoleptic or neuroleptic treatments
* Presence of the following serious and active medical conditions: demyelinating or progressive degenerative disorders; central nervous system infection; progressive degenerative neurological disorder; ischemic heart disease; respiratory, renal, or liver disease; Type I diabetes; malignant neoplasm; hyper- or hypo-coagulopathy; Acquired Immune Deficiency Syndrome (AIDS); or seizure disorder. Participants with a history of more than two febrile seizures prior to 1 year of age are eligible.
* Chronic, ongoing treatment with the following classes of medications: antidepressants, neuroleptics, mood stabilizers, antianxiety agents, hypnotics, narcotics or synthetic narcotics, barbiturates, stimulants, anti-migraine agents, anti-epileptics, non-beta-blocking or Ca-channel blocking anti-arrhythmic agents prescribed to treat cardiac arrhythmia, anticoagulants, immunomodulators, anti-neoplastic agents, or HIV antiviral agents
* Ongoing psychotherapeutic treatment for the treatment of IED or anger that was started less than 3 months before study entry
* Hypersensitivity to fluoxetine or divalproex
* Pregnancy
The Effect of Different Types of Spinal Needles on the Success of the Procedure

The effects of spinal needles with different tip designs on the success of the application and the number of attempts required to get the spinal click feeling.


Eligibility Criteria:
Inclusion Criteria:

* Elective lower abdomen/extremity surgery planned,
* American Society of Anesthesiologists (ASA) I-II risk group,
* without bleeding diathesis
* patients with written consent

Exclusion Criteria:

* Patients for whom spinal anesthesia is contraindicated,
* morbidly obese,
* pregnant
* Patients with a history of allergic reactions to the drugs used in the study.
LGG for Prevention of Infectious Complications During PPI Treatment in Children

Background: Proton pump inhibitors (PPI) are effective for treating gastroesophageal reflux disease (GERD). However, they may be associated with an increased risk of gastrointestinal and respiratory tract infections.

Aim: To determine if Lactobacillus GG (LGG) is an effective adjunct to PPI for reducing the risk of gastrointestinal and respiratory tract infections in children with GERD.

Study design: Randomized, double-blind, placebo controlled trial.

Patients with GERD treated with PPI will be randomly assigned to receive LGG in dose of 10(9) Colony Forming Units (CFU) twice daily for 6 weeks or a comparable placebo twice daily for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* age \<5,
* clinical symptoms of GERD
* treatment with proton pump inhibitors
* signed informed consent

Exclusion Criteria:

* treatment with PPI within the last 4 weeks for at least 2 weeks
* administration of probiotics within 7 days prior to the study
* acute or chronic respiratory tract infections
* acute or chronic gastrointestinal tract infections
* neurological disorders
* immunodeficiency
Non-Invasive Blood Test Cross-Validation Study

The study considers a cross-validation approach to determine the effectiveness of a non-invasive comprehensive metabolic panel (NICMP), relative to the venipuncture method. The NICMP machine learned powered device utilizes a light sensor to capture readings from either palm. The study (n=90) proves an agreement and strong correlation with respect to the NICMP and venipuncture blood draw.


Eligibility Criteria:
Inclusion Criteria:

* Undiagnosed population

Exclusion Criteria:

* Diagnosed population, pregnant women, mental heath/disabled, prisoners, fetus or deceased
Effects of Left Ventricular Pacing Optimilization on Cardiac Perfusion, Contractile Force, and Clinical Performance in Patients With Ventricular Dysfunction and Heart Failure

To compare a surgical approach of LV lead placement for BIV pacing with the conventional transvenous approach by assessment of differences on the effects on cardiac perfusion and relate this to the clinical cardiac function.


Eligibility Criteria:
Inclusion Criteria:

* Heart failure NYHA III or IV
* QRS duration \>120msec or, when paced \> 200msec on 12-lead ECG
* LBBB on ecg
* LV ejection fraction 35% or less
* LV dyssynchony on echocardiography

Exclusion Criteria:

* Severe (drug refractory) heart failure with short (\<6 months) life expectancy.
* Permanent or persistent atrial fibrillation
* Other indications for cardiac surgery within 6 months
* Life expectancy less than one year due to other conditions
* Major contra-indication for general anaesthesia
* Participation in another study
* Pregnancy or the desire to become pregnant during the follow up of the study.
A Study of AT2101 (Afegostat Tartrate) in Adult Patients With Type 1 Gaucher Disease Currently Receiving Enzyme Replacement Therapy

This study was conducted to test the safety and tolerability of afegostat tartrate in participants with type 1 Gaucher disease already receiving enzyme replacement therapy.

This was a Phase 2, open-label study in participants with Gaucher disease, a lysosomal storage disorder. Afegostat tartrate (also known as AT2101 or isofagomine tartrate) is designed to act as a pharmacological chaperone by selectively binding to misfolded β-glucocerebrosidase (GCase) and helping it fold correctly, intended to restore GCase activity. The study consisted of a 14-day screening period, a 28-day treatment period, and a 7-day wash-out period. Participants received 1 of 4 dosing regimens for afegostat tartrate.

Eligibility Criteria:
Inclusion Criteria:

* Had a confirmed diagnosis of type 1 Gaucher disease with a known documented missense gene mutation in at least 1 of the 2 gene-encoding β-glucosidase alleles
* Clinically stable
* Male or female participants, 18 to 74 years old inclusive
* All participants of childbearing potential used adequate birth control
* Provided written informed consent to participate in the study

Exclusion Criteria:

* Clinically significant disease, severe complications from Gaucher disease, or serious illness that precluded participation in the study in the opinion of the Investigator that compromised the safety of the participant or precluded the participant from completing the study
* During the screening period, any clinically significant findings, as deemed by the Investigator
* Partial or total splenectomy (removal of spleen) within the 2 years prior to study entry
* History of pulmonary hypertension or Gaucher related lung disease
* History of allergy or sensitivity to the study drug or any excipients, including any prior serious adverse reaction to iminosugars (for example, N-butyldeoxynojirimycin or miglustat)
* Pregnant or breast-feeding
* Current/recent drug or alcohol abuse
* Treatment with any investigational product in the 90 days before study entry
* Treatment in the previous 90 days with any drug known to have a well-defined potential for toxicity to a major organ
* Presence or symptoms of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
Community Health Workers United to Reduce Colorectal Cancer and Cardiovascular Disease Among People at Higher Risk

The overall goal of this study is to develop a comprehensive, culturally tailored community-based colorectal cancer (CRC) prevention model with a dual emphasis on reducing CRC risk along with its CVD risk factors. The study intervention has two components: Screening, Brief Intervention, and Referral to Treatment (SBIRT) to address CRC screening and a web-based lifestyle program called "Alive!" to address CVD risk factors linked to CRC. The C.H.U.R.C.H. Trial (Community Health workers (CHW) United to Reduce Colorectal cancer and cardiovascular disease among people at Higher risk) has four specific aims: (1) to compare the effect of a CHW-Led SBIRT (Intervention) to Referral As Usual (RAU) (Usual Care) on guideline-concordant CRC screening uptake; (2) to evaluate the effect of a Culturally Adapted CHW-linked Alive! (CACA) program incorporated into the intervention arm on dietary inflammatory score (DIS); (3) to evaluate the effect of CACA on changes in Life Simple-7 (LS7) scores; and (4) to examine the multi-level contextual mechanisms and factors influencing CHW effectiveness, reach, and implementation of CRC screening uptake and CACA activities through a mixed-methods process evaluation. Given the broad reach and influence of Black churches, results from this study can be used to inform future scale up of this multi-pronged intervention.

Colorectal cancer (CRC) is the second most lethal cancer in the U.S with the highest incidence and mortality rates among African Americans (AAs) compared to other racial groups. Despite these disparities, which includes premature mortality, AAs are the least likely to undergo CRC screening, have precancerous colorectal polys removed, and have CRC detected at stages early enough for curative excision. Lower screening rates are linked to the downstream effects of structural inequities such as access to care, knowledge of screening options and benefits, health system mistrust, fear and anxiety. Although reducing the burden of CRC is best accomplished by screening, compelling evidence links inflammatory diets and cardiovascular disease (CVD) risk factors to increased CRC risk. This proposal aims to develop a community-based prevention model to reduce CRC and cardiovascular disease (CVD) risk among AAs.

Eligibility Criteria:
Inclusion Criteria:

1. English-speaking
2. Self-identifying as Black
3. Aged 45 years and older
4. Not up-to-date with CRC
5. Working telephone
6. Can provide informed consent

Exclusion Criteria:

1. Non-English speaking
2. \<45 years old
Body Composition Assessment in Spinal Cord Injury

The purpose of this research is to evaluate different methods of measuring body composition (amount of fat, muscle, bone, and water in your body) and to determine relationships between body composition and other medical problems associated with spinal cord injury (SCI).

A preliminary investigation in our laboratory has demonstrated the advantage of using 4-compartment modeling to assess body composition in SCI adults. In comparing body composition analyses techniques in 20 individuals with SCI, we found Total Error to be 8.0% with Dual X-ray Absorptiometry, 8.4% with hydrodensitometry, 11.5% with bioelectrical impedance analysis, and 21.8% with standard skinfold equations when compared to 4-compartment modeling, the currently accepted gold standard for body composition assessment. To date there is no gold standard for the determination of body composition in SCI individuals.

Eligibility Criteria:
Inclusion Criteria:

* Criteria for participation will include men and women within the age range of 18-65 years old with C5-L2 Motor-Complete (ASIA A\&B)
* SCI of duration greater than 12 months to ensure a homogenous sample.

Exclusion Criteria:

* Persons with uncompensated hypothyroidism, and/or renal disease will be excluded from the study.
* Additionally, individuals with uncontrolled autonomic dysreflexia, recent (within 3 months) deep vein thrombosis
* Pressure ulcers \> Grade II will be excluded.
A Multicenter, Open-label, Phase 1b Study of Carfilzomib, Cyclophosphamide and Dexamethasone in Newly Diagnosed Multiple Myeloma Subjects

The primary objective was to determine the maximum tolerated dose of carfilzomib given twice weekly in combination with cyclophosphamide and dexamethasone for patients with newly diagnosed multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed multiple myeloma
2. Measurable disease, as defined by 1 or more of the following

   * Serum M-protein ≥ 0.5 g/dL, or
   * Urine M-protein ≥ 200 mg/24 hours, or
   * In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) \> 100 mg/L (involved light chain) and an abnormal kappa lambda ( κ/λ) ratio
3. Males and females ≥ 18 years of age
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
5. Adequate hepatic function
6. Left ventricular ejection fraction (LVEF) ≥ 40%
7. Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L
8. Platelet count ≥ 50 × 10\^9/L
9. Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min

Exclusion Criteria:

1. Planned autologous hematopoietic stem cell transplantation (HSCT) for the initial therapy of newly diagnosed multiple myeloma
2. Multiple myeloma of immunoglobulin M (IgM) subtype
3. Prior systemic treatment for multiple myeloma
4. Glucocorticoid therapy within 14 days prior to enrollment that equals or exceeds the equivalent of dexamethasone 160 mg
5. Known amyloidosis
6. Active congestive heart failure (New York Heart Association \[NYHA\] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 6 months prior to enrollment.
7. Known human immunodeficiency virus (HIV) seropositive, hepatitis C infection, and/or hepatitis B (subjects with hepatitis B surface antigen \[SAg\] or core antibody receiving and responding to antiviral therapy directed at hepatitis B are allowed)
8. Significant neuropathy (Grades ≥ 2) within 14 days prior to enrollment
9. Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
Effect of Anti-hypertensive Medications on the Diagnostic Accuracy in Screening for Primary Aldosteronism

To evaluate the effect of anti-hypertensive medication on efficiency of primary aldosteronism screening test, and to determine the appropriate diagnostic cutoff value for Chinese hypertension patients during antihypertensive drugs therapy.

Aldosterone-Renin ratio (ARR)is currently the most reliable means available for screening for primary aldosterone（PA）. However, some antihypertensive drugs may cause false positives and false negatives on ARR. Thus, America PA guidelines suggest that antihypertensive drugs should be withdraw or change therapy before screening.

But withdraw/changing the therapy before ARR is inconvenient for patients.

the investigators prepare to start a prospective study through recruiting hypertension patients who needs ARR screening test, completing the ARR screening before and after withdraw/change therapy.

Eligibility Criteria:
Inclusion Criteria:

* Persistent hypertension \>150/100mmHg, including previously diagnosed grade 2 hypertension but well controlled by 1-2 drugs; newly diagnosed hypertension with 3 days blood pressure \> 150 / 100mmHg
* Resistant hypertension(combined with three antihypertensive drugs and one of them is diuretic but blood pressure is still greater than 140 / 90 mmHg ; or need to combined four anti-hypertensive drugs to control the blood pressure under 140 / 90 mmHg)
* Family history of hypertension with early onset (\< 40 years old)
* Family history of hypertension with early onset (\<40 years old) and cerebrovascular accident
* Hypertension with spontaneous or diuretic hypokalemia
* Hypertensive with adrenal incidentaloma
* Hypertensive with OSAS
* First-degree relatives of PA patients and with hypertension Stable antihypertensive medication therapy for more than 2 weeks, medication including：β-blockers, CCB, ACEi, ARB, MRA, and other diuretics.

Exclusion Criteria:

* Patients hard to change or stop the medication for accomplish the screening test or diagnosis Unwilling to participate the study and refuse to sign on informed consent Patients who was diagnosed with other secondary hypertension Suspected with PA（rein concretion beyond the limit of normal reference range after stoping or changing the medication） Severe renal insufficiency （eGFR\<30 ml/min/1.73m2）; pregnancy
Phase II Study to Evaluate Conventional Radiation Therapy Followed by Radiosurgical Boost in Clinically Localized Prostate Cancer

This phase II study designed to prospectively evaluate the efficacy and morbidity of IMRT with CyberKnife radiosurgical boosts for clinically localized prostate cancer. Patients will be treated with three radiosurgical treatments (6.5 Gy per fraction) followed by IMRT (45 Gy in 25 fractions).

This is a phase II study designed to prospectively evaluate the efficacy and morbidity of IMRT with CyberKnife radiosurgical boosts for clinically localized prostate cancer. Patients with clinically localized prostate cancer will be treated with three radiosurgical treatments (6.5 Gy per fraction to the PTV) followed by IMRT (45 Gy in 25 fractions). Treatment will be completed over a 6-7 week period.

The hypothesis is that for patients with clinically localized adenocarcinoma of the prostate, CyberKnife Radiosurgery delivered to the prostate is efficacious with acceptable toxicity in combination with IMRT.

Subjects will have toxicity evaluation and AUA score on the last day of treatment. At 1 month following treatment, subjects will be assessed for acute toxicity and will fill out AUA form, SF-12, EPIC-26, SHIM and Utilization of Sexual Rx/Devices. At 3, 6, 12, 18 and 24 month intervals (and every 6 months thereafter, through year 5, and annually through year 10, if investigators opt to continue past year 5), subjects will be seen and evaluated, including a history, physical exam, performance status, PSA, toxicity evaluation, and AUA score. In addition, at 6 months, 12 months and annually thereafter, the SF-12, EPIC-26, SHIM and Utilization of Sexual Medications/Devices will be administered. A prostate biopsy will be performed at time of biochemical or local clinical failure, and is encouraged at 2 years following treatment and at time of distant failure. A bone scan will be performed at the time of biochemical failure, or when the subject develops signs of symptoms suggesting metastatic disease.

Acute side effects (≤ 90 days of treatment start) will be assessed using the NCI Toxicity Criteria version 3.0.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate (Biopsy within one year of enrollment)
* Signed Study-Specific COnsent
* PSA within 60 days of registration
* Baseline AUA score is less than 20

Exclusion Criteria:

* Prior Pelvic radiotherapy
* Prior Radical Prostate surgery
* Recent (within 5 years) or concurrent cancers other than non-melanoma skin cancer
* Medical or psychiatric illness that would interfere with treatment or follow-up
* Implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and/or treatment delivery.