cyrilzakka/clinical-trials huggingface dataset:
Correlation Between Spinal Anesthesia and Perfusion Index

Investigation of the correlation between the success of obtaining unilateral spinal anesthesia and the measurement of perfusion index (pi).

Target sites for spinal anesthetics are spinal nerve roots and spinal cord. Differences in the anatomy of the nerve roots may explain the variability that occurs during spinal anesthesia. Spinal anesthesia is the cessation of nerve conduction for a while by injection of local anesthetic drug into the cerebrospinal fluid. It is one of the most effective and oldest regional anesthesia techniques. Unilateral spinal anesthesia, on the other hand, aims to limit the distribution of the spinal block to the operated side for all operations involving only one lower extremity. Reducing the dose of local anesthetic, pencil-point needles, injection speed, lateral decubitus position and non-isobaric anesthetic solution are the main factors in the formation of a unilateral spinal block. It requires slightly longer preparation time compared to standard spinal anesthesia, but provides fewer hemodynamic side effects with higher cardiovascular stability, increased postoperative autonomy and better patient acceptance. Perfusion index (PI) is a numerical value showing the ratio between pulsatile and nonpulsatile blood flow. PI works by measuring changes in finger peripheral perfusion via pulse oximetry. If the procedure is successful in patients undergoing spinal anesthesia, vasodilation occurs in the lower extremities due to sympathetic nerve blockage and perfusion increases. Pulse oximetry perfusion index (PI) was used in our study to indicate vasodilation associated with sympathectomy. We will examine whether the success of unilateral anesthesia in the spinal anesthesia performed in our hospital correlates with the increase of the perfusion index value measured with the finger probe, except for patient-based methods, and whether the perfusion index shows more objectively the block success than other patient-based traditional methods.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who will undergo lower abdominal, urogenital, lower extremity surgery
2. Patients with ASA 1-2
3. Patients aged 18-65

Exclusion Criteria:

1. Patients with ASA3-4
2. Those with peripheral vascular disease
3. Patients with a history of by-pass
4. Patients with aortic stenosis
Impact of Antimicrobial Stewardship Programs in the Global Setting

Antimicrobial resistance is one of the greatest threats to human health, and is driven by inappropriate antimicrobial use. Antimicrobial stewardship programs (ASPs) improve the use of antimicrobials in hospitals. The purpose of this study is to identify the need for and barriers to implementation of ASPs in three hospitals in Sri Lanka, Kenya, and Tanzania.

Antimicrobial resistance is one of the greatest threats to human health, and is driven by the inappropriate antimicrobial use. Antimicrobial stewardship programs (ASPs) improve the use of antimicrobials. The purpose of this study is to identify the need for and barriers to implementation of ASPs in three hospitals in Sri Lanka, Kenya, and Tanzania. The impact of creating a basic ASP will be assessed at each hospital.

Eligibility Criteria:
Inclusion Criteria: All patients admitted to the medical wards -

Exclusion Criteria: None

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Molecular Autopsy Study

This study seeks to incorporate genetic testing into the postmortem examination of cases of sudden unexplained death.

This study seeks to incorporate genetic testing into the postmortem examination of cases of sudden unexplained death, initially in San Diego County with plans to expand nationally and internationally as funding allows. Genetic testing of the index subjects and their parents (or other biological family members if parents are not available) will be assessed for potential heritable causes of sudden death. By combining the wide catchment base of the San Diego Medical Examiner's Office, sequencing expertise of SD-based collaborators, computing power of the San Diego Supercomputer Center and in-house and external genomic analytics, the Scripps Translational Science Institute aims to provide a more complete characterization and understanding of the genetic causes of sudden death. Ultimately, findings from this study will be utilized to identify previously unrecognized mechanism of sudden death allowing for the development of preventative screening programs and potentially life-saving interventions.

Eligibility Criteria:
Inclusion Criteria:

* Index case age between birth - 45 years
* Clinical presentation of sudden / unexplained death (believed to be cardiac in nature OR secondary to a massive unprovoked pulmonary embolism with no prior diagnosis of prothrombotic disease)

Exclusion Criteria:

* Premature death secondary to murder, suicide or external causal event
* Premature death thought secondary to known chronic comorbid medical condition
* Premature death thought secondary to end-organ failure (kidney, liver, lung) other than heart
* Previously diagnosed with hypertrophic cardiomyopathy (HCM)
* Prior myocardial infarction (regardless of stenting or bypass)
* Prior cerebrovascular accident (stroke or TIA)
* History of open heart surgery (for any reason)
* History of severe, untreated hypertensive heart disease
* History of illicit drug use
* History of heavy alcohol abuse
* History of severe pulmonary disease
* History of morbid obesity
Study of Acquired Hemolytic Anemia in Adult Hospitalized Patients

the goal of the study is to identify the most common etiological factors and analyze the clinical presentations and laboratory findings in hospitalized patients with acquired hemolytic anemia associated with non-neoplastic diseases.

And to evaluate short-term outcomes, including morbidity and mortality rates, and to determine correlations between specific etiological factors and patient outcomes in these cases.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and older.
* Patients diagnosed with acquired hemolytic anemia.
* Patients must be hospitalized in the Internal Medicine department at the time of diagnosis of acquired hemolytic anemia during the study period
* Patients (or their legal representatives) must provide informed

Exclusion Criteria:

* Patients with underlying neoplastic diseases.
* Patients with hereditary hemolytic anemia.
* Patients or their representatives who do not consent to participate in the study.
Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk

This study assesses the effect of hormone directed treatment for breast cancer on glucose metabolism.

PRIMARY OBJECTIVE:

I. Assess the impact of endocrine adjuvant therapy with aromatase inhibitors in women with hormone receptor positive breast cancer, on various indices of glucose homeostasis, utilizing oral minimal model assessment, in comparison to healthy post menopausal women and another cohort of women on tamoxifen.

OUTLINE: This is an observational study.

Patients undergo blood sample collection, glucose testing, DEXA scan to measure body composition, complete a questionnaire and have their medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women with hormone receptor positive breast cancer. Post-menopause will be defined as women who experience 12 months of amenorrhea or have undergone bilateral salpingo-oophorectomy.

  * 25 women who are planning to start or are within 6 months of starting treatment with aromatase inhibitors, after consultation in breast clinic and cancer center.
  * 25 women who will be starting Tamoxifen (comparative group)
  * 25 healthy post menopausal women will also be recruited.

Exclusion Criteria:

* Established diagnosis of diabetes

  * Therapy with medications that could affect glucose metabolism
  * Screening fasting glucose ≥ 126 mg/dl, and/or HbA1c ≥ 6.5%
  * History of upper GI surgery that alters gastric emptying or causing malabsorption e.g., bariatric surgery, fundoplication
Targeting Beta Cell Dysfunction With Verapamil in Longstanding T1D

The purpose of this study is to determine whether verapamil can transiently improve beta cell function in those who do or do not secrete proinsulin and little/no C-peptide.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 3 years from Type 1 diabetes diagnosis
2. Males and females 18-50 years of age, inclusive
3. Peak MMTT stimulated C-peptide \< 0.017 pmol/mL
4. Females of child-bearing potential must be willing to use effective birth control for 12 weeks
5. Willing and able to give informed consent for participation
6. HbA1c ≤ 8.5%

Exclusion Criteria:

* Concurrent use of non-insulin therapies aimed to control hyperglycemia or use within the past 30 days of initial qualifying MMTT (V-2). 2. Diagnosis of liver disease or elevated hepatic enzymes, as defined by ALT or AST\> 1.5 x the upper limit of age-determined normal (ULN). 3. Renal disease, as defined by creatinine ≥1.5 mg/dL. 4. Hypersensitivity to verapamil or any component of the formulation. 5. Previous use of verapamil. 6. Known left ventricular dysfunction; bradycardia (HR \<50 BPM) hypotension (systolic pressure \<90 mm Hg); PR interval prolongation on EKG or any bradyarrhythmia (e.g. sick sinus syndrome, Anterior Ventral (AV) block); atrial flutter or fibrillation, and an accessory bypass tract (Wolff- Parkinson- White (WPW) syndrome, Lown-Ganong-Levine syndrome) 7. Uncompensated heart failure, fluid overload, myocardial infarction or evidence of ischemic heart disease or other serious cardiac disease as described in New York Heart Association (NYHA) Class III or IV criteria within the 12 weeks before randomization. 8. Use of beta blockers or medium-high dose statins: any dose of atorvastatin (Lipitor) or rosuvastatin (Crestor); simvastatin \> 10 mg daily; lovastatin \> 20 mg; pravastatin \> 20 mg 9. Use of other medications which may increase the concurrent risk of verapamil use, including medications which utilize the cytochrome p450 enzyme pathway. 10. Females who are pregnant or lactating. 11. Receipt of an immune modulating biologic or investigational drug within 3 months or 5 half-lives before enrollment. 12. History of other clinically significant autoimmune disease except for celiac and stable thyroid disease. 13. Current use of any medication known to significantly influence glucose tolerance (e.g. oral steroids, atypical antipsychotics, diphenylhydantoin, niacin). 14. Any medical or psychological condition that in the opinion of the principal investigator would interfere with the safe completion of the trial. Conditions to consider include history of chronic GERD, chronic constipation, and chronic nausea. 15. Specific to MRI subjects: non-removable ferromagnetic materials or MRI not technically feasible (claustrophobia, movement disorder, obesity).
Patient Function/Fitness and Psychosocial Health in Improving Health-Related Quality of Life in Patients With Stage I-IV Non-Small Cell Lung Cancer

This pilot trial studies patient function/fitness and psychosocial health in improving health-related quality of life and decreasing treatment-related toxicity in patients with stage I-IV non-small cell lung cancer. Studying function/fitness and psychosocial health may help doctors improve conventional therapy in patients with non-small cell lung cancer.

PRIMARY OBJECTIVES:

I. To determine the correlation of patient-reported health-related quality of life (HRQOL) outcomes with clinical/treatment variables as well as a panel of both function/fitness and psychosocial health assessments in non-small cell lung cancer (NSCLC).

SECONDARY OBJECTIVES:

I. To investigate the panel of function/fitness and psychosocial health assessments with patient's smoking history/status as a predictor for treatment related toxicity.

TERTIARY OBJECTIVES:

I. The documentation of the NSCLC lung population from this prospective combined with others.

OUTLINE:

Patients scheduled for surgery, radiation therapy, or chemotherapy complete the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-core 30 (C30) and QLQ-Lung Cancer 13 (LC13) in addition to psychosocial health and smoking status questions from baseline up to 2 weeks prior to the start of treatment, 5-6 weeks after treatment begins, and 5-6 months from the start of treatment. During the same time points, patients also undergo function/fitness assessments including standard health measurements, short physical performance battery (SPPB), 6 minute walk test (6MWT), and a grip strength test.

After completion of study treatment, patients are followed up every 3-6 months.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed lung cancer

Exclusion Criteria:

* Previous or active lung cancer treatment at the time of registration
A Study of ICP-022 in Patients With R/R DLBCL

It is a phase II, multicenter, open-label study is to evaluate the safety, efficacy and pharmacokinetics of a novel BTK inhibitor, ICP-022, in approximately 85 subjects with R/R DLBCL. There will be no control group in this study. Each subject will receive treatment orally every day in 28-day cycles. Each cycle starts immediately after the previously completed cycle without a break between cycles.


Eligibility Criteria:
Key Inclusion criteria：

1. Men and women between 18 and 75 years old,
2. Histologically confirmed diffuse large B-cell lymphoma（DLBCL）with MyD88 L265P and CD79B positive, at least one measurable tumor of greater than 1.5 centimeter in long axis by contrast-enhanced CT/MRI,
3. ECOG performance status of 0-2,
4. Voluntary written informed consent prior to trail screening.

Key Exclusion criteria:

1. History of other active malignancies, unless cured without evidence of relapse or metastasis within 5 years of study entry
2. History of Richter's syndrome
3. Current or history of lymphoma involved central nervous system
4. Prior corticosteroids (at dosages equivalent to prednisone \> 20 mg/day) given with anti-neoplastic intent within 7 days, prior chemotherapy, targeted therapy, radiation therapy, or antibody based therapies or anti-cancer TCM within 4 weeks of the start of study drug.
5. The investigator considers other conditions unsuitable for this study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
The Effects of Yogurt on Gut Microbiome and Metabolism in H. Pylori.

Helicobacter pylori is a common pathogen causing upper gastrointestinal diseases including gastric ulcer and gastric cancer. Recent epidemiological findings have also shown that it is also related to colon cancer, metabolic syndrome, gut dysbiosis, glycemic control and insulin resistance.

The aim of this study is to investigate whether the gut microbiota and insulin resistance of patients with H. pylori infection are abnormal. In addition, whether drinking fermented milk product with probiotic reduces Helicobacter pylori, improves gut microbiota, and increases butyrate-producing bacteria and insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 20 to 70 years old with positive Helicobacter pylori gastric C13 urea breath test (ΔUBT\>10%).
2. Negative gastric Helicobacter (ΔUBT\<2%) matching age, gender, and body mass index.

Exclusion Criteria:

1. Unhealthy habits or poor health status, including habitual smoking, alcoholism, polypharmacy or drug abuses.
2. Patients with acute diseases, such as respiratory tract infection, acute gastroenteritis.
3. In the past three months, those who have had dyspepsia but have not undergone gastroscopy, or have a history of active gastrointestinal ulcers and gastrointestinal bleeding.
4. Those who have had gastrointestinal cancer or have undergone gastrointestinal surgery.
5. Those who are unwilling to delay receiving Anti-H. pylori therapy.
6. Newly diagnosed cancer (except basal cell carcinoma) or cancer treatment in the past 5 years.
7. People who have had cardiovascular disease, respiratory disease, autoimmune disease, mental disease or other chronic diseases that are not well controlled, such as myocardial infarction or stroke, chronic obstructive pulmonary disease, inflammatory bowel disease, Schizophrenia.
8. Diabetes and those who are or need to take drugs.
9. Those who have used the following drugs in the past month: antibiotics, NSAIDs, obesity drugs, steroid therapy, proton pump inhibitors, bismuth agents.
10. In the past month, regularly consume the following foods (at least 2 times a week): probiotics, prebiotics, or any foods containing probiotics, dairy products (yogurt, cheese), Chinese medicine, kimchi, miso, honey, cranberry, spicy food.
11. Fecal occult blood positive, unexplained iron-deficiency anemia, weight increase or decrease by more than 5% within six months.
12. Abnormal liver function index (AST, ALT or ALP greater than 2 times the upper limit of normal), abnormal renal function index (eGFR less than 45 ml/min).
13. Pregnant or breast-feeding women.
Gradual Withdrawal of Low-dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus.

This study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone in systemic lupus erythematosus (SLE) patients with clinically quiescent disease.

Glucocorticoids (GCs) remains the mainstay of treatment in SLE. Prolong used of glucocorticoid can be leading to various organ damage, even in low dose (\< 7.5 mg/day). The rational of tapering GCs in SLE who achieve remission or low disease activity is still debated. Recent trial showed the abrupt discontinuation of GCs in sustained clinical remission of SLE increased rate of flare. This study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone over 24 weeks in systemic lupus erythematosus (SLE) patients with clinically quiescent disease.

Eligibility Criteria:
Inclusion Criteria:

* Aged; 20 years
* Diagnosis of SLE according to Systemic Lupus International Collaborating Clinic (SLICC) classification SLE criteria, 2012.
* Achieved clinically quiescent SLE defined as cSLEDAI-2K = 0 for at least 6 months.
* Current treatment regimen including prednisolone 5mg/day. Prednisolone, antimalarials and/or immunosuppressive therapy had to be stable for at least 4 weeks before randomization.

Exclusion Criteria:

* Pregnant or pregnancy planning
* Unable to follow the schedules
* Overlap with other autoimmune disease, except secondary SjS and APS
* Co-morbid with any other condition which required prednisolone treatment
* Documented adrenal insufficiency
Radiation Therapy in Preventing Metastatic Cancer in Patients Who Have Diagnostic Procedures to Identify Malignant Mesothelioma

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if radiation therapy is effective in preventing metastatic cancer following surgery.

PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in preventing metastatic cancer in patients who have undergone diagnostic procedures to identify malignant mesothelioma.

OBJECTIVES:

* Determine the efficacy of radiotherapy in the prevention of metastatic skin nodules or tumor seeding following invasive diagnostic procedures, such as chest drain insertion, pleural aspiration, pleural biopsy, and thoracoscopy, in patients with malignant mesothelioma.
* Determine whether the nodules that develop after radiotherapy are symptomatic in these patients.
* Compare the quality of life of patients treated with radiotherapy vs standard care alone.

OUTLINE: This is a randomized study.

Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive radiotherapy on 3 consecutive days beginning within 3 weeks after chest drain insertion, pleural aspiration, pleural biopsy, or thoracoscopy and once the wounds have healed.
* Arm II: Patients receive standard supportive care alone. Quality of life is assessed at baseline, and then at 1, 2, 4, 6, 9, and 12 months.

Patients are followed at 1, 2, 4, 6, 9, and 12 months.

PROJECTED ACCRUAL: A total of 44 patients (22 per arm) will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven malignant pleural mesothelioma by chest drain insertion, pleural aspiration, pleural biopsy, and/or thoracoscopy within the past 3 weeks

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* Not specified

Life expectancy:

* At least 3 months

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior systemic chemotherapy for malignant mesothelioma

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior local radiotherapy for malignant mesothelioma

Surgery:

* See Disease Characteristics
* No other invasive procedures to the same chest site during and for 1 year after study
Italian Registry On Multipoint Left Ventricular Pacing

The IRON-MPP is a prospective multicenter, observational registry designed to collect clinical and device data from a large cohort of HF patients treated in clinical practice with a CRT-D device with the ability to deliver Multi Point Pacing.

The purpose of the Registry is to collect data on how MPP-devices are being used by physicians in order to better understand how to improve the clinical care of patients and effectiveness of MPP therapy.


Eligibility Criteria:
Inclusion Criteria:

- Patients implanted with a St. Jude Medical CRT-D system with MPP capability

Exclusion Criteria:

- Patients currently participating in any other clinical investigation
Genetic Risk Factor for Heat Stroke

The goal of this observational study is to examine the effect of the Cystic Fibrosis (CF) Carrier state on the risk for dehydration and other CF-specific fluid-and-electrolyte disorders in male and female adults.

The primary aim of the study is to estimate the risk of electrolyte disorders attributable to the CF carrier state in a genotyped cohort.

This will be accomplished with two smaller projects- Aim 1 and Aim 2.

Aim 1 will consist of 100 CF Carriers and 100 age- and sex-matched controls. Participants in this aim will be asked to complete a Participant Info and Temperature Survey consisting of questions about race, ethnicity, medical history, and how they experience heat.

Aim 2 will consist of a subset of 25 CF Carriers and 25 age- and sex-matched controls from Aim 1. Participants in this aim will be scheduled for a visit to complete a heat challenge. At this visit, they will also complete the Participant Info and Temperature Survey. They will also sit in a sauna at 62 - 63 degrees Celsius for 45 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Previously genotyped as a CF carrier or control
* Comfortable speaking/reading English

Exclusion Criteria:

* Previously genotyped as a CF patient
* Diagnosis of Type 1 or Type 2 diabetes
* History of heart attack, stroke, heart failure, or atherosclerosis
* Currently pregnant
* Currently taking beta blockers or diuretics
* Prisoner status
* Unable to provide own written informed consent