cyrilzakka/clinical-trials huggingface dataset:
Effect of Black Tea Extract Impregnated Gauze on Extracted Socket

Black tea is made from the leaves of a bush called Camellia sinensis. The main difference between green tea and black tea is that green tea is not completely oxidized while black tea is fully oxidized. Immediately after being harvested, the leaves of green tea are heated in order to halt the oxidation process, this ensures that the tea experiences minimal oxidation and stays a bright green color. Black tea, meanwhile, is allowed to fully oxidize after it is harvested. This means that the leaves turn brown or black, with green no longer present anywhere on the leaf. The chemical composition of black tea are tannins, theaflavins, carbohydrates, thearubigins, protein, flavonols, mineral matter, phenolic acids, volatiles, amino acids, methylxanthine. Among these, tannins play an important role in our research which helps in bleeding cessation after tooth extraction. Bleeding after tooth extraction can cause discomfort and thus affect patient's healthcare. Several methods have been proposed to enhance bleeding cessation, including the use of haemostatic agents and natural remedies such as tea. Black tea, in particular, has been suggested to have potential haemostatic properties due to its high content of tannins and flavonoids. However, the efficacy of black tea in promoting bleeding cessation after tooth extraction remains unclear. The purpose of this study is to evaluate the effect of black tea extract on primary bleeding cessation after extraction of molars. The study aims to investigate the potential benefits of black tea in reducing the bleeding time compared to a controlled group which uses normal sterile gauze. Our null hypothesis states that there is no difference in primary bleeding cessation time for black tea extract-impregnated sterile (BTE) gauze and 0.5% povidone iodine-impregnated sterile (PVI) gauze.

This study will be conducted in Oral Maxillofacial and Surgery Department in Polyclinic A, Faculty of Dentistry, Manipal University College Malaysia (MUCM). It involves forty-four randomly selected patients with molar extraction, satisfying the inclusion criteria and exclusion criteria stated. BTE gauze or PVI gauze will be placed at the freshly extracted socket after extraction. The state of bleeding of the socket is observed at 2,5 and 7 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or more
* ASA1 (American Society of Anesthesiologists physical status classification 1) and ASA2 patient

Exclusion Criteria:

* Sensitive to black tea
* Using complementary medical methods (herbal medicine, etc.) within the past month
* History of exposure of surgery site to radiation
* Using any antibiotic, corticosteroid, anticoagulant and contraceptive drug over the past month
Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain

The purpose of the study is to determine the effect of oxytocin given into the spinal fluid on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic neuropathic pain.

Rationale: The investigators anticipate that oxytocin will be effective after spinal injection in humans to acutely relieve chronic neuropathic pain.

Objectives: Determine the effect of intrathecal oxytocin on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic neuropathic pain.

Interventions: A computer generated randomization will be used to determine the group for each subject. Subjects will be randomized to receive an intrathecal injection of saline (placebo) or oxytocin.

Eligibility Criteria:
Inclusion Criteria:

* Weight \< or equal to 240 pounds
* Neuropathic pain for \> 6 months: with primary pain area below the umbilicus

Exclusion Criteria:

* Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug or lidocaine
* Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data
* Pregnancy
* spinal cord stimulators, chronic intrathecal drug therapy, or oral opioid treatment for \> 3 months at a current dose of \> 100 milligram (mg) morphine per day or equivalent.
Intravenous Exenatide (Byetta) During Surgery

The purpose of this project is to study if intravenous Exenatide is effective at maintaining normal blood glucose levels and preventing low blood glucose levels during surgery.

This is a single-center, block randomized, double-blind, placebo-controlled, dose-ranging study. Subjects will be randomized in equal proportions to one of three treatment arms: placebo of normal saline solution, 0.27 ng/kg/min (0.066 pmol/kg/min) IV Exenatide, and 0.41 ng/kg/min (0.099 pmol/kg/min) IV Exenatide. We will use a block number of 30 (please see power analysis) so that balance between each of the three groups will be maintained over the enrollment period. We will stratify the randomization scheme to ensure balance of diabetics and non-diabetics within the groups.

Eligibility Criteria:
Inclusion Criteria:

* Age (\>18 years)
* Weight of \> 50 kg and \< 150 kg
* Ability to provide informed consent
* Elective surgery including:
* Cardiac surgery to include elective CABG with or without single or multivalve repair or replacement and/or single or multivalve repair/replacement requiring CPB and sternotomy (to include subjects who are undergoing first time or redo cardiac surgery)
* Abdominal aortic aneurysm repair
* Carotid endarterectomy
* Esophagectomy
* Cystectomy
* Nephrectomy
* If female, subject must be non-lactating, and, if of childbearing potential, must have a negative urine pregnancy test within 24 hours prior to receiving study drug

Exclusion Criteria:

* Age (\<18 years)
* Inability to provide informed consent
* History or risk of pancreatitis (e.g. ethanol abuse, gall stones)
* Receipt of an investigational drug or device with 30 days prior to surgery
* Use of any concomitant medication listed above on the day of surgery
* Known allergy to Exenatide, fentanyl, midazolam, isoflurane, propofol, heparin or neuromuscular blockers
* Known substance abuse
* Surgical procedure other than:

Cardiac surgery to include elective CABG with or without single or multivalve repair or replacement and/or single or multivalve repair/ replacement requiring CPB and sternotomy (to include subjects who are undergoing first time or redo cardiac surgery)

* Abdominal aortic aneurysm repair
* Carotid endarterectomy
* Esophagectomy
* Cystectomy
* Nephrectomy

  * Insulin dependent diabetes mellitis
  * Anticipated administration of intraoperative steroids
  * Major end organ dysfunction, defined as:
* Current intravenous inotropic agents
* Preoperative use of intra-aortic balloon pump (IABP), left ventricular assist device (LVAD), or extracorporeal membrane oxygenation (ECMO)
* Renal
* Preoperative serum Creatinine \> 2.0 mg/dL
* Hepatic
* History of abnormal hepatic function in the past
* Hematologic
* Preoperative hematocrit (HCT) \< 30%
* Platelet count \< 100,000/mm3
* History of bleeding or clotting disorder
VEGF Signaling Promotes Cell Growth and Metastasis in Hepatocellular Carcinoma in a VEGF Receptor Mediated Pathway

The investigators study the VEGF signaling in HCC cell lines and its mechanism in HCC growth, proliferation and apoptosis.

Several studies have documented the elevated expression of VEGF, VEGFR1 and VEGFR2 in HCC cell lines and tumor tissues. Another study observed a sequential elevation of VEGF in low-grade dysplasia, high-grade dysplasia and early stage HCC. Clinical analyses have discovered the high expression of VEGF is correlated with tumor progression, vascular invasion, distal metastasis and poor prognosis. However, few studies have been conducted to investigate the VEGF signaling in HCC cells and its possible mechanism in regulating HCC growth.Therefore,we try to clarify the mechanism of VEGF signal in HCC growth,proliferation and apoptosis.

Eligibility Criteria:
Inclusion Criteria:

1. hepatocellular patients diagnosed through biopsy;or either dynamic imagine with a diagnosis of hepatocellular carcinoma and alphafetoprotein\>400μg/L；or two or more dynamic imagine with a diagnosis of hepatocellular carcinoma
2. Child-Pugh A or B
3. well preserved renal and hematopoietic Function
4. receive surgical therapy
5. achieve complete section accessed by contrast-enhanced CT

Exclusion Criteria:

1. incomplete section
2. remote metastasis
3. Child-Pugh C
4. combination with other hepatobiliary disease
5. suffer from other tumors concurrently or in last five years
Anti-HIV Medications for People Recently Infected With HIV

It is not known if anti-HIV treatment for recently infected patients improves long-term patient prognosis. The purpose of this study is to determine if a one year course of anti-HIV medications slows progression of HIV disease in adults recently infected with HIV.

Study hypothesis: A one-year course of HAART administered during acute or early seroconversion may slow the progression of HIV infection.

Although some doctors favor starting anti-HIV treatment as soon as possible after patients learn they are infected, it is not known if treatment for recently infected patients results in slower progression of HIV disease. This study will compare the virologic outcomes of recently infected adults who receive highly active antiretroviral therapy (HAART) with those who receive no treatment. This study will also compare the effects of treatment on patients who enroll within 3 months of seroconversion (acute seroconverters) with patients who enroll within 3 to 12 months of seroconversion (early seroconverters).

This study will last at least 3 years. Participants will be randomly assigned to one of two groups. Group 1 will receive HAART for 1 year; Group 2 will receive no treatment. There will be at least 20 study visits over the 3-year study period. Blood collection will occur at all study visits. A physical exam, medical and medication history, and risk behavior assessment will occur at most visits; participants will also be asked to complete an adherence questionnaire at most visits.

Eligibility Criteria:
Inclusion Criteria:

* Documented acute or recent HIV infection (infected in the past 12 months) as defined in the study protocol
* Antiretroviral naive. Participants who have taken antiretrovirals for postexposure prophylaxis are eligible for this study.
* Able to swallow tablets or capsules
* Willing to use acceptable forms of contraception

Exclusion Criteria:

* Physician unable to design a potentially effective HAART regimen based on results of genotypic resistance testing
* Two CD4 counts of less than 350 cells/mm3 obtained at least 7 days apart within 30 days of study entry
* Viral load less than 5,000 copies/ml within 30 days of study entry in participants who have been infected with HIV-1 for more than six months prior to study entry
* Use of systemic cancer chemotherapy, systemic investigational agents, specific antiretroviral medications, or immunomodulators (growth factors, systemic corticosteroids, HIV vaccines, immune globulin, interleukins, interferons) within 30 days prior to study entry
* Current alcohol or drug use that, in the opinion of the investigator, would interfere with the study
* Serious illness requiring systemic treatment or hospitalization until participant either completes therapy or is clinically stable on therapy for at least 7 days prior to study entry
* Currently involuntarily incarcerated for treatment of either a psychiatric or physical (e.g., infectious disease) illness
* Pregnancy or breastfeeding
Lung Impedance Monitoring In Treatment of Chronic Heart Failure

Heart failure is a major clinical problem that is increasing in magnitude and the cost of management of heart failure is escalating. A significant part of this cost is related to unplanned acute presentation to emergency departments and hospitalisation with worsening shortness of breath due to increased fluid content in the lungs.

Many heart failure patients are already fitted with defibrillators to protect them from the risk of fast heart rhythms and sudden death and are followed up in both the heart failure clinics and defibrillator clinics. Recently some of the defibrillators fitted have been equipped with an extra function that can detect and warn of changes in the fluid content of the lungs very early even before the patient starts to complain of any shortness of breath and before any signs of fluid overload are seen clinically. However, it is not known how to deal with these warnings if they occur very early and it is not known whether a medical intervention at his stage is beneficial to prevent progression and eventual hospital admission. In the majority of cases, early warnings of this kind are ignored or this function is disabled at implantation of the device.

The current study will involve patients who have already been fitted with a device with the above capability. The investigators will use the new function to guide management of these patients and compare their outcome with similar patients who are fitted with devices without it. The investigators will attempt to manage early warnings by a predetermined increase in medications in a group of patients and compare their clinical course to a similar group in whom no action is taken.


Eligibility Criteria:
Inclusion Criteria:

* Previously fitted with an ICD or a CRT-D device for primary or secondary prevention (for at least 34 days) with a Medtronic Optivol capable Device
* Previous hospital admission for decompensated heart failure
* Left ventricular systolic dysfunction (EF \<50%)
* Currently compensated heart failure with a functional class of III or better
* All patients will be on optimal medical treatment including a beta blocker, an ACEI (or ARB) and spironolactone unless contraindicated or not tolerated

Exclusion Criteria:

* Decompensated patients who have NYHA class IV or clinical signs of lung congestion at time of evaluation (these patients may be included later if/when their NYHA class improves)
* Patients with a high Optivol fluid index at time of evaluation (these patients may be included later when the Optivol fluid index comes down)
* Patients with advanced renal failure ± dialysis (Chronic Kidney Disease class 4 or 5 with an estimated GFR of \<30 ml/min)
Sequential Segmental Treatment of Emphysema With Upper Lobe Predominance (STEP-UP) Study

This study is designed to demonstrate safety and efficacy in patients with severe upper lobe predominant emphysema. For validity of the study, the results will be compared to patients that receive optimal medical therapy.


Eligibility Criteria:
Inclusion Criteria:

* Heterogeneous emphysema with upper lobe predominance in both lungs
* FEV1 between 20% and 45% predicted
* Residual volume (RV) \> 150% predicted
* Post-rehabilitation 6-minute walk test \> 140 meters

Exclusion Criteria:

* More than 3 COPD related hospitalizations requiring antibiotics in past 12 months
* FEV1 \< 20% predicted
* DLCO \< 20% predicted or immeasurable DLCO
* Body mass index (BMI) \< 18kg/m2 or \> 32 kg/m2
* History of any of the following:

  * Left ventricular ejection fraction (EF) ≤ 40%
  * Stroke
  * Myocardial infarction or acute coronary syndrome in previous year
  * Hospitalization due to left ventricular failure in previous 3 years
Randomized Clinical Trial to Compare a Regimen of Trimethoprim-sulfamethoxazole Plus Rifampicin With a Regimen of Linezolid in the Treatment of Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection

MRSA infections often require systemic antibiotic therapy and represent an important healthcare burden. Currently available treatment options are either only available in parenteral form (vancomycin) or expensive (linezolid). Thus, there is an urgent, unmet need to better investigate in-expensive but highly active alternatives to currently recommended standard treatment options. The purpose of the proposed study is to test the hypothesis that a combination of TMP-SMX and rifampicin is not inferior to linezolid for treatment of MRSA infections.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Patients with clinical signs and symptoms of MRSA-related infection
3. Culture of MRSA (predominant microorganism in culture) susceptible to all of the following:

   * TMP-SMX
   * rifampicin
   * linezolid
4. Patient must give written informed consent to participate in the study.

Exclusion Criteria:

1. Women who are pregnant or nursing
2. Women who refuse to substitute oral contraception during treatment
3. Known or suspected hypersensitivity to linezolid, TMP-SMX or rifampicin
4. Clinical or laboratory evidence of significant impairment of hepatic function, as demonstrated by any of the following criteria:

   * Bilirubin \> 3 x upper limit of normal range
   * AST or ALT \> 5 x upper limit of normal range
   * Acute hepatitis or proven liver cirrhosis by liver histology
5. Treatment with other antimicrobials with activity against MRSA for \> 72 hours prior to study inclusion
6. Patients with a high probability of death within the week following study entry
7. Patients who, in the opinion of the investigator, cannot be relied upon for post-therapy follow-up
8. Patients requiring alternative antibiotic therapy with anti-MRSA activity. However, if another antibiotic treatment without antistaphylococcal activity is necessary, the patient is acceptable for randomization. In that sense, the use of aztreonam (against Gram negative microorganisms) or metronidazole (against anaerobes) is allowed
9. Hemodialyzed patients
10. History of pheochromocytoma, carcinoid syndrome, untreated hyperthyroidism, uncontrolled hypertension, or patients receiving serotonin uptake inhibitors
11. Severe thrombocytopenia (\< 50.000 platelets)
12. Left-sided endocarditis with a poor prognosis (patients aged over 50; cerebral embolism)
13. Chronic osteomyelitis without surgical debridement; superinfected indwelling foreign body, deliberately kept in place
14. Patients with severe sepsis or septic shock due to MRSA bacteremia
15. Patients who receive any of the following drugs, which cannot be substituted or temporarily withdrawn: adrenergic and serotonergic agents, tramadol, pethidine, duloxetine, venlafaxine, milnacipran, sibutramine, chlorpheniramine, brompheniramine, cyproheptadine, citalopram, and paroxetine.
A Study to Evaluate the Drug Levels and Safety of Pegbelfermin in Healthy Overweight and Obese Chinese and Korean Participants

The purpose of this study is to evaluate the safety, tolerability, and drug level of Pegbelfermin in healthy overweight and obese Chinese and Korean participants.


Eligibility Criteria:
Inclusion Criteria:

* Overweight and obese, but otherwise healthy Chinese and Korean participants, as determined by no clinically significant deviations from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
* Additional criterion for Chinese participants: must be first generation Chinese (born in China and not living outside of China for \> 10 years, and both parents are ethnically Chinese)
* Additional criterion for Korean participants: must be first generation Korean (born in Korea and not living outside of Korea for \> 10 years, and both parents are ethnically Korean)
* Must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* BMI ≥ 40 kg/m\^2
* Women who are pregnant or breastfeeding
* History of allergy to pegylated compounds or fibroblast growth factor 21-related compounds

Other protocol-defined inclusion/exclusion criteria apply
Brief Mood Enhancement Intervention

The purpose of the current study is to test the efficacy of two brief, behavioral interventions intended to improve burnout among doctoral-level graduate students (n = 102). Specifically, individuals will be randomly assigned to one of three intervention conditions: 1) Reward: a brief intervention to help participants increase engagement in healthy and rewarding values-driven behaviors, 2) Approach: a brief intervention to help participants identify and decrease emotion-driven avoidance of important goals, or 3) Control: a control condition that involves monitoring only. Multilevel modeling will be used to assess changes in burnout, mood, and stress, following the interventions, controlling for participants' individual baseline levels of these variables.


Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled in any in-person (not online) Ph.D. program in the state of North Carolina
* Demonstrating above average levels of burnout
* Has regular access to the Internet
* Has a Social Security Number
* Is able to read and understand English

Exclusion Criteria:

* Current mania or psychosis
* Current suicidal ideation
* Are currently in psychotherapy, have been in psychotherapy in the past 8 weeks, or are planning to start psychotherapy during the course of the 10-day study
* Have had any changes in psychiatric medications in the past 8 weeks, are not taking medications as prescribed or are planning to change medications during the course of the 10-day study
* Are currently taking benzodiazepines Pro Re Nata (PRN)
* Are under 18 years old
Role of Diet on the Microbiome of the Digestive System

This study is to learn more about how diet affects the microbiome (bacteria and microorganisms) of the digestive system. Researchers want to learn if this, in turn, has an effect on if and how people then develop colorectal cancer.

PRIMARY OBJECTIVES:

I. To evaluate the differences in dietary patterns among individuals reporting to be vegetarian and omnivorous.

II. To compare the difference in stool microbiome pattern in the above mentioned two groups of individuals.

III. To compare somatic mutations in colorectal epithelial cells in the above mentioned two groups of individuals.

SECONDARY OBJECTIVE:

I. To identify and characterize an association between diet, the microbiome and its genotoxic effect on the colorectal epithelial cells and predisposition to colorectal carcinogenesis.

OUTLINE:

Participants complete dietary questionnaire over 30-60 minutes and undergo collection of stool, blood, and tissue samples for analysis via sequencing and laser dissection.

Eligibility Criteria:
Inclusion Criteria:

* GROUP I: Patients presenting for a screening colonoscopy

  * GROUP I: Age of 45 and above
  * GROUP I: Strict vegetarian diet, determined by using diet history questionnaire 3.0 National Institutes of Health (NIH)
  * GROUP I: Non smoker
  * GROUP I: Ability to understand and willingness to sign an informed consent form, complete web based dietary assessment and provide stool, colonic mucosa and blood samples
  * GROUP II: Patients presenting for a screening colonoscopy
  * GROUP II: Age of 45 and above
  * GROUP II: Omnivorous diet
  * GROUP II: Non smoker
  * GROUP II: Ability to understand and willingness to sign an informed consent form, complete web based dietary assessment and provide stool, colonic mucosa and blood sample

Exclusion Criteria:

* • Current smokers (nicotine abuse only)

  * Positive family history of colon cancer or colon cancer related syndromes
  * Recent use of antibiotics in 1 month
  * History of inflammatory bowel disease, and/or radiation enteritis or colitis
  * Pregnant and breastfeeding women
  * Women of child-bearing potential who have positive urine or serum pregnancy test
  * Heavy drinker (defined as more than 14 drinks per week)
  * Currently using anti-flatulence medications, probiotics and/or fiber supplements
  * Major dietary restrictions and/or following a special diet
  * Patient with positive fecal test/symptoms