cyrilzakka/clinical-trials huggingface dataset:
Immunologic Diagnostic Blood Test in Predicting Side-Effects in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer or Other Diseases

RATIONALE: Studying a diagnostic biomarker test in blood samples from patients who have undergone a donor stem cell transplant for cancer may help doctors plan treatment.

PURPOSE: This clinical trial is studying an immunologic diagnostic blood test to see how well it works in predicting side-effects in patients with hematologic cancer or other disorders who have undergone a donor stem cell transplant.

OBJECTIVES:

* To evaluate the ability of the ImmuKnow® test to predict the onset and severity of acute or chronic graft-versus-host disease and/or measure the clinical effects of treatment.
* To evaluate the ability of the ImmuKnow test to predict the clinical response to immunosuppressive therapy.
* To evaluate the ability of the ImmuKnow test to predict infections among patients.

OUTLINE: Beginning on day 14 after allogeneic hematopoietic stem cell transplantation (HSCT), patients undergo blood sample collection at least once weekly for the first 100 days and then once to twice monthly for up to 1 year, in the absence of graft-versus-host disease (GVHD). If chronic or acute GVHD develops after day 100, more frequent blood sampling may occur. Blood sample collection is coordinated with the time of regular clinic visits to allow for evaluation of the clinical events recorded 2 weeks before and after the blood draw date. Blood samples are analyzed by the Cylex® and ImmuKnow® assays to measure global T-cell immune function and responsiveness to alterations in immunosuppressive post-HSCT therapy. Assay data obtained during the first 3 weeks and other post-transplant periods will be evaluated for possible correlations with clinical endpoints (i.e., GVHD incidence, rate of infection, and response to immunosuppressive therapy) to assess the predictive value of the assay.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of a hematologic cancer or other disease
* Undergoing allogeneic hematopoietic stem cell transplantation

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Randomized Study of Recombinant Human Growth Hormone in Patients on Chronic Hemodialysis or Peritoneal Dialysis

OBJECTIVES:

I. Assess the clinical safety and long term effects of recombinant human growth hormone on a defined range of nutritional indices in malnourished chronic hemodialysis and continuous ambulatory peritoneal dialysis patients.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo-controlled, cross-over study.

Prior to randomization each patient's protein and calorie intake is assessed and optimized as possible. Patients are randomized to receive either placebo or recombinant human growth hormone subcutaneously every other day for 6 months. At the end of this 6 month period, patients undergo a 4 week washout period. After the washout period, patients are crossed-over to the alternate regimen for an additional 6 months followed by another 4 week washout period.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* On hemodialysis or peritoneal dialysis for more than 3 months
* Optimally dialyzed (urea reduction ratio greater than 65%)
* Suboptimal nutritional status identified by one of the following criteria: -Protein catabolic rate less than 0.85 g/kg/d calculated by three point urea kinetic modeling on at least 2 occasions over the past 6 months -Progressive unintentional weight loss of more than 2.5% of the initial or ideal body weight and/or patient weighs less than 90% of ideal body weight -Biochemical parameters of malnutrition defined by two or more of the following measurements over the past 3 months: Serum albumin no greater than 3.7 g/dL Serum transferrin concentration less than 250 mg/dL Serum prealbumin concentration less than 30 mg/dL Serum IGF-1 concentration less than 0.250 mg/mL

--Patient Characteristics--

* No active autoimmune, inflammatory, or infectious disease At least 6 months since any documented malignancy
* No unusual dietary restrictions At least 3 months since peritonitis
Effect of Non Invasive Brain Stimulation on Experimentally Induced Dyspnea (Breathlessness)

Dyspnea is a frequent, mostly unpleasant and long-lasting, but also often undertreated symptom. Transcranial direct current stimulation (tDCS), a new non invasive method to modify brain activation has shown good efficacy in the treatment of pain especially in the clinical context. Given the fact that dyspnea has many common characteristics with pain, especially concerning the brain areas involved in its central processing, we hypothesize that tDCS may also modify the perception of dyspnea. In order to test this, we first shall determine whether tDCS has a significant effect on acutely induced dyspnea in healthy volunteers. In case of promising results of this pilot study, the next step will be the evaluation of the benefit of tDCS in patients with severe dyspnea.

Dyspnea will be induced by breathing through a combination of an external resistive load and a long tube (inducing CO2 rebreathing) (resulting in a sensation of both increased respiratory effort and air hunger). tDCS will be applied during 15 minutes either over the motor/premotor or over the insular cortex (i.e. 2 brain regions that have previously been shown to be involved in dyspnea perception and/or modulation) in 2 parallel groups of healthy subjects. For each study group, the effect of tDCS on dyspnea perception and on respiratory parameters will be compared between 2 active (anodal and cathodal) and a sham tDCS stimulation (placebo).

Eligibility Criteria:
Inclusion Criteria:

* Registered at the National List of persons taking part in clinical research
* Signed consent form
* Subjects of both genders aged of at least 18 years
* Perfect understanding of the instructions and of sensory scaling
* Prior medical examination

Exclusion Criteria:

* Any current or past disease, in particular respiratory, neurological and psychiatric disorders
* Regular use of drugs, especially those having an impact on respiratory, neurological systems (most specifically those with an effect on the central nervous system)
* Unwilling to participate
* Vulnerable people as defined in the provisions relating to biomedical researches and described in the Code of Public Health.
* Unable to cooperate
* Pregnancy or lactation
* No affiliation to a social security system.
Normative Database of the Retinal Nerve Fiber Layer Thickness Measured by the Cirrus HD OCT in Asians

The normal range of retinal nerve fiber layer thickness might be different between Asians and Caucasians. However, the recently developed imaging device such as the Cirrus HD OCT includes only the Caucasian data. So, the investigators want to find its normal range of in Asians.

Characteristics of various ocular parameters are influenced by race. Because the retinal nerve fiber layer (RNFL) thickness is crucial in detecting early glaucomatous changes, its normal range is also important. Even though the normal range of RNFL thickness might be different according to race, the recently developed imaging device such as the Cirrus HD OCT includes only the Caucasian data. In the present study, we want to measure the RNFL thickness using the Cirrus HD OCT in normal Asian eyes and to determine its normal range in Asians.

Eligibility Criteria:
Inclusion Criteria:

* Normal subjects
* Good quality of the OCT images (signal intensity \> 8)

Exclusion Criteria:

* Any ocular history
* DM
Atorvastatin for Reduction of 28-day Mortality in COVID-19: RCT

This randomized placebo-controlled double-blinded clinical trial aims to test the efficacy of administering atorvastatin 40 mg to hospitalized COVID-19 patients for 28 days on the all-cause 28-day mortality.


Eligibility Criteria:
Inclusion Criteria:

* We will include adult patients (≥18 years old) with severe and critical COVID19 admitted to the COVID19 Mansoura University isolation hospital. We will include patients who are PCR-confirmed, clinically or radiologically diagnosed with COVID19.

Cases are defined as severe or critical according to the WHO definition (19); where critical cases have ARDS, or sepsis, septic shock or pulmonary embolism, acute coronary syndrome, or acute stroke, while severe cases have the clinical signs of severe pneumonia and SpO2 \<90% on room air, or RR \<30 breaths/min without any critical criteria.

Exclusion Criteria:

* chronic statin use, serum creatine kinase (sr CK) \> 5 times the upper limit of normal (ULN), serum transaminases \> 5 times ULN, acute hepatic failure, chronic liver disease (Child-Pugh Classification C), history of rhabdomyolysis or myopathies, severe renal impairment not receiving renal replacement therapy (estimated Cr cl\< 30 ml\\min ), pregnant and lactating women, patients who are expected to die within 48 hours, or patients on chronic colchicine, cyclosporines, or ritonavir.
Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more that one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and docetaxel in treating patients who have locally advanced or metastatic cancer of the pancreas.

OBJECTIVES: I. Determine the objective response rate of patients with pancreatic adenocarcinoma treated with combination gemcitabine and docetaxel. II. Determine the toxicity profile of this combination therapy in these patients. III. Assess the survival rate of these patients.

OUTLINE: Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes. Patients receive treatment every other week for 8 weeks (4 courses). Patients may continue treatment in the absence of unacceptable toxicity or disease progression. Patients are followed every 12 weeks until death.

PROJECTED ACCRUAL: This study will accrue approximately 10 patients per month for a maximum of 33 patients.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma or poorly differentiated carcinoma of the pancreas Metastatic disease with at least 1 bidimensionally measurable lesion OR Locally advanced disease that is either recurrent or not amenable to surgery Measurable disease outside of prior radiation port or disease progression within the port

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 125,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT no greater than 2.5 times ULN (less than 3 times ULN if liver metastases) Renal: Creatinine no greater than ULN Other: Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease At least 1 year since prior adjuvant chemotherapy Prior chemoradiotherapy as initial therapy allowed Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics See Chemotherapy At least 4 weeks since prior radiotherapy Surgery: Not specified
Code Blue Outcomes & Process Improvement Through Leadership Optimization Using Teleintensivists-Simulation

This multicenter randomized trial will employ in-situ cardiac arrest simulations ("mock codes") to test whether using telemedicine technology to add an intensive care physician as the "copilot" for cardiac arrest resuscitation teams influences chest compression quality, resuscitation protocol adherence, team function, and provider experience.

Only 15-30% of patients who suffer in-hospital cardiac arrest (IHCA) survive to hospital discharge. Factors associated with lower mortality and improved function include provision of high-quality, minimally-interrupted chest compressions and swift defibrillation of eligible arrhythmias. Unfortunately, resuscitation teams provide suboptimal care to 25-40% of IHCA victims. A dedicated IHCA team "copilot" may improve resuscitation team performance by providing the team leader with parallel analysis, situational awareness augmentation, action checking, protocol verification, and error correction. Critical care physician involvement via a telemedicine link could allow experienced specialists to fill the "copilot" role in a cost and resource-efficient manner, particularly in smaller hospitals with fewer available physicians.

The current study will evaluate how consultation by an off-site intensive care physician via a telemedicine link influences local IHCA teams' quality of care, team function and provider experience during simulated cardiac arrest events ("mock codes").

Eligibility Criteria:
Inclusion criteria (on-site cardiac arrest team):

* Are 18 years of age or older

Inclusion criteria (teleintensivist cardiac arrest team copilot):

* Are 18 years of age or older
* Are a board-certified or board-eligible critical care physician
* Provide clinical care through the Intermountain Healthcare Telecritical Care program

Exclusion criteria (both groups):

* Are under 18 years of age
* Are a member of the study research team
Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Healthy Adult Subjects

TJ003234RAR101 is a first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled, single ascending dose study of TJ003234 in healthy adults to determine whether TJ003234 is safe and tolerated when administered as an intravenous (IV) infusion and to determine the maximum dose tolerated (MTD).


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and willing to sign the informed consent form (ICF)
* Healthy subjects 18-70 years of age
* If of childbearing potential, agree to use protocol-specified contraception
* Body mass index (BMI) 19.0-32.0 kg/m\^2
* Blood pressure ≤ 139/89 mm Hg
* Subjects are able to follow the study protocol and complete the trial

Exclusion Criteria:

* Current use of tobacco or nicotine-containing products or illicit drug use
* History of severe allergic or anaphylactic reaction to a therapeutic drug or severe seasonal allergies
* Any known pulmonary disease
* Use of any prescription, investigational drugs, herbal supplements, or nonprescription drugs within 1 month or 5 half-lives (whichever is longer) prior to study drug administration, or dietary supplements within 1 week prior to study drug administration, unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study
* Abnormal hematological and chemistry laboratory values \>10% above upper limit of normal (ULN) or \>10% below the lower limit of normal (LLN). Absolute neutrophil count (ANC) ≤ 1000 cells/mm\^3
* Use of any biologic drugs in the last 120 days prior to dosing.
* Immunization with a live or attenuated vaccine within 4 weeks prior to study drug administration
* Prior treatment with any biologic anti-GM-CSF or GM-CSF receptor antagonists
* ADA screening positive
* Subjects who have a history of documented autoimmune disease, even if not clinically severe or never treated with systemic steroids or immunosuppressive agents
* A positive alcohol test and/or urine drug screen for substance of abuse at screening or upon check-in to the clinical site
Study of Orphenadrine' in the Treatment of Muscle Cramps in Patients With Cirrhosis

Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes (1) Orphenadrine is an anticholinergic drug with prominent central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and other similar conditions. The combination of anticholinergic effects and CNS penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. \[3,4\]

Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes \[1\].

Although a number of mechanisms for cramps in liver disease have been postulated and have been targeted by medical therapies, a clear picture of the causal events has not emerged. Several agents as vitamin E, human albumin, zinc, taurine, eperisone hydrochloride and branched-chain amino acids have shown some benefit in small uncontrolled studies, although large randomized controlled trials are lacking \[2\].

Orphenadrine is an anticholinergic drug with prominent central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and other similar conditions. The combination of anticholinergic effects and CNS penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. \[3,4\] Orphenadrine is structurally related to diphenhydramine and carries relatively stronger anticholinergic and weaker sedative properties, It is mostly excreted through the kidneys.\[5\]

Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis
* Muscle cramps( ≥3 cramps per week )

Exclusion Criteria:

* • Allergy to orphenadrine

  * Renal impairment
  * Pregnant and lactating women
  * Peripheral vascular disease
  * Peripheral neuropathy
  * Medications as calcium channel blockers, conjugated estrogens and naproxen. Glaucoma Prostatic enlargement
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - TNFi vs Abatacept

This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Eligibility Criteria:
Please see https://docs.google.com/spreadsheets/d/11fIivBOto16Gyb_1xM8AXNHn-EC4v7TiLzCjpbbXF0Q/edit?usp=sharing or Appendix A for full code and algorithm definitions.

Medicare timeframe: 2007 to 2017 (end of data availability).

Inclusion Criteria:

* 1. No prior use of tumor necrosis factor inhibitors or abatacept anytime prior to cohort entry date
* 2. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date

Exclusion Criteria:

* 1. Prior history of dementia measured anytime prior to cohort entry date
* 2. No prior history of rheumatoid arthritis recorded in the 365 days prior to cohort entry date
* 3. Prior history of nursing home admission in the 365 days prior to the cohort entry date
Accuracy of 68Ga-Pentixafor PET/CT for Subtypting Diagnosis in Patients With Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion

To evaluate the accuracy of 68Ga-Pentixafor PET-CT in the classification diagnosis of primary aldosteronism concurrent with autonomous cortisol secretion patient, using AVS and/or postoperative remission as the reference standard for classification diagnosis.

This study is a multicenter, prospective, diagnostic trial involving patients with primary aldosteronism (PA) concurrent with autonomous cortisol secretion (ACS) patients with adrenal nodule (≥1cm) who completed both AVS and 68Ga-Pentixafor PET/CT. We will enroll 97 PA concurrent with ACS patients with adrenal nodule (≥1cm) .The treatment plan was determined according to the AVS results. AVS and/or postoperative remission were used as the reference standard for classification diagnosis to evaluate the accuracy of 68Ga-Pentixafor PET-CT in the classification diagnosis of PA concurrent with ACS patients.

Eligibility Criteria:
Inclusion Criteria:

1. Getting the written informed consent
2. The clear diagnosis of primary aldosteronism；
3. Combined with autonomous cortisol secretion, cortisol after 1mg dexamethasone suppression test (DST) ≥50 nmol/l；
4. Patients who are willing to undergo surgery；
5. Adrenal CT or MRI scan of the adrenal glands with nodule (≥1cm).

Exclusion Criteria:

1. PA patients who meet the by-passing AVS criteria \[i.e., younger than 35 years old, spontaneous hypokalemia, adrenal CT indicated unilateral low-density adenoma (≥1cm), plasma aldosterone \&amp;gt;300pg/ml\]；
2. Suspicion of familial hyperaldosteronism or Liddle syndrome. \[i.e., age \&amp;lt;20 years, hypertension and hypokalemia, or with family history\]；
3. Suspicion of pheochromocytoma or adrenal carcinoma；
4. Patients with actively malignant tumor；
5. Patients who have adrenalectomy history；
6. Long-term use of glucocorticoids；
7. Patients who are allergic to contrast media and cannot tolerate AVS；
8. Pregnant or lactating women; with alcohol or drug abuse and mental disorders；
9. Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV; History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 3 months; Severe anemia (Hb\&lt;60g/L); Serious liver dysfunction or chronic kidney disease aspartate aminotransferase (AST) or alanine transaminase (ALT) ≥3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) \&lt;30 ml/min/1.73 m2); Systemic Inflammatory Response Syndrome (SIRS); Uncontrolled diabetes (FBG≥13.3 mmol/L); Obesity (BMI≥35 kg/m²); Untreated aneurysm; Other comorbidity potentially interfering with treatment；
10. Consider patients with bilateral cortisol hypersecretion such as PBMAH or PPNAD.