cyrilzakka/clinical-trials huggingface dataset:
Clinical Study for Assessment of the Efficacy of Gabapentin (Carbatin and Neurontin) in Patients With Neuropathy Pain

The purpose of this study is to assess the efficacy of Gabapentin (Carbatin \& Neurontin) in patients with neuropathy pain.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have been diagnosed the disease of neuropathy pain arising from diabetic peripheral neuropathy, postherpetic neuralgia, traumatic/surgical nerve injury, incomplete spinal cord injury, or trigeminal neuralgia and if they have a mean weekly pain score of at least 4 on the 100-mm visual analog scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ) completed a screening / baseline period before randomization. Additional disease-specific inclusion criteria are listed in Table 1.
* Subjects must be 20 years of age or older.

Exclusion Criteria:

* Subjects who are pregnant, lactating or of childbearing potential not using effective contraceptives.
* Subjects who have a clinically significant or unstable medical or psychiatric condition.
* Subjects who are known of hypersensitivity to Gabapentin.
* Serum creatinine \> 1.5 times the upper limit of normal
* Subjects who have received nerve blocks or acupuncture for pain relief within four weeks before a screening / baseline period.
* Subjects who have the presence of chronic pain other than the target pain being studied (unless the chronic pain is in a different body region than the target pain and its intensity is not greater than that of the target pain).
* Subjects who have received nondrug therapies or any special procedures for the relief of the target pain within two weeks before a baseline visit.
* Subjects who are using the following agents within 30 days prior to screening: antidepressants, opioids, other anticonvulsants, local anaesthetic injections or any investigational drug.
OPTical Coherence Tomography IMAging in Patients With Acute myocardiaL Infarction (OPTIMAL)

The purpose of the study is to investigate the clinical outcomes, safety and cost-effectiveness of intravascular OCT imaging in patients with acute myocardial infarction undergoing percutaneous coronary intervention (PCI). About 4500 patients with acute myocardial infarction (estimated 1500 with OCT guidance and 3000 without OCT guidance during PCI）will be prospectively enrolled in 20 sites in China. The total duration of the study is expected to be 5 years, 2 years for enrolment and 3 years for follow up.

This is a prospective, multi-center, non-randomized, observational registry study of patients with acute myocardial infarction (AMI) that require catheterization. The purpose of this registry is to investigate the clinical outcomes, safety and cost-effectiveness of intravascular OCT imaging in patients with AMI undergoing PCI.The duration of the study is expected to be 5 years, 2 years for enrolment and 3 years for total follow up.The clinical study will be conducted in 20 centers in China.Approximately 4500 subjects (1500 with OCT imaging and 3000 without OCT imaging) will be enrolled in this study.Subjects will be followed up at 1, 3, 6, 12months and every 6 months afterwards up to 5 years. All subjects need to be followed for at least 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with:a.Symptoms of myocardial ischemia lasting for ≥ 30 minutes.b.Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads, or presumed new left bundle branch block. c. NSTEMI
* Referred for primary PCI.
* Are able to provide written Informed Consent prior to any study related procedure.

Exclusion Criteria:

* Patient who is unable to comply with the follow-up schedule.
* Left main occlusion
* Unable to restore TIMI flow grade III before stenting
* Prior coronary artery bypass surgery (CABG)
* Cardiogenic shock
* Patient who has any medical conditions that in the opinion of the investigator will not be appropriate to participate in the study.
* Patient has a life expectancy of less than 6 month due to any condition.
* Age ≤ 18 years
Cardiac Function After Minimally Invasive Aortic Valve Implantation

This is a single-center, open-label, randomized controlled trial. Patients scheduled for aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be eligible. Forty patients will be randomly assigned to either minimally invasive (20 patients) or conventional AVR (20 patients). CE-marked and FDA-approved mechanical and bioprosthetic aortic valves (conventional stented or sutureless bioprostheses) will be implanted. Transthoracic echocardiography will be performed before surgery, and at day 1, 4, and 40. Echocardiographic parameters as well as preoperative clinical characteristics and postoperative clinical outcomes will be registered. Routine blood sampling will be performed pre- and postoperatively. All available data will be collected prospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 by echocardiography
* Referred for medically indicated aortic valve replacement
* Sinus rhythm
* Provide written informed consent

Exclusion Criteria:

* Left ventricular ejection fraction less than 0.45
* Presence of any coexisting severe valvular disorder
* Previous cardiac surgery
* Urgent or emergent surgery
Preemptive and Preventive Use of Paracetamol for Pain Relief After Cesarean Section

The investigators designed a prospective randomized study to investigate the efficacy of intravenous (IV) preemptive versus preventive paracetamol on postoperative pain scores, patient satisfaction, total morphine consumption and the incidence of morphine-related side effects in patients undergoing cesarean section.


Eligibility Criteria:
Inclusion Criteria:

38 weeks pregnancy, elective cesarean section.

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Exclusion Criteria:

morbid obesity, cardiac failure, depression.
Application of Biomarkers in Neurological Diseases

To explore the predictive and diagnostic role of biomarkers in patients with neurological diseases.

With the rise and continuous development of omics technology and bioinformatics technology, some scholars have applied proteomics technology and metabolomics technology to study the brain tissue, plasma and CSF of patients with nervous system diseases, so as to screen out potential biomarkers, with a view to providing new research ideas for pathogenesis and early diagnosis of neurological diseases. At present, the research on some novel biomarkers is still in its infancy, and many key problems remain to be solved. It is necessary to further determine the expression level of biomarkers in normal human body and the characteristics of biomarkers in patients with neurological diseases.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with neurological diseases;
2. Subjects or legal agents agree to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Participating in other clinical investigators;
2. Unwilling to be followed up or poor treatment compliance;
3. Other conditions considered unsuitable for inclusion by the researchers.
Impact of Lung Function Prehabilitation to Postoperative Pulmonary Complications

The aim of this study is to compare the effect of lung function prehabilitation to postoperative pulmonary complications on patient undergoing upper abdominal surgery treated in intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* adults 18 years or older
* scheduled for the upper abdominal surgery under general anesthesia with intraoperative mechanical ventilation
* possess adequate cognitive function to comprehend and follow instructions
* possess sufficient physical capacity to perform structured prehabilitation exercises
* express willingness to participate in the intervention program before surgery

Exclusion Criteria:

* pregnancy
* pre-existing severe pulmonary diseases such as chronic obstructive pulmonary disease (COPD)
* planned laparoscopic procedures
* history of significant neuromuscular impairment (e.g: stroke)
* declined to participate
Prevalence of COVID-19 Infection in a Cohort of Patients Infected by the HIV and Patients Taking PrEP

The purpose of the study is to assess seroprevalence of COVID-19 infection in a cohort of HIV + patients and in a cohort of patients taking PrEP by emtricitabine / tenofovir.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* patients infected by the HIV on treatment
* patients taking PreP (Pre-exposure prophylaxis (PrEP))
* Being affiliated with or benefiting from a social security scheme

Exclusion Criteria:

* Subject to a measure for the protection of justice
Risk Prediction in Aortic Stenosis

The purpose of this study is to test the prognostic value of autonomic markers in patients with aortic stenosis.

Autonomic function will be assessed by presence of severe autonomic failure (defined by combination of abnormal heart rate turbulence and deceleration capacity).

Autonomic function will also be assessed by respiration and repolarization abnormalities.

Eligibility Criteria:
Inclusion Criteria:

* Aortic valve area ≤1.5 qcm or mean aortic gradient ≥25mmHg

Exclusion Criteria:

* life expectancy \<1 year due to non-cardiac causes
Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma

This study is conducted to evaluate the safety and efficiency of Penpulimab combined with AVD in patients with newly- diagnosed advanced classic Hodgkin lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-70 years old (when signing the informed consent form); ECOG score: 0 or 1 point; The expected survival period exceeds 3 months;
2. classic Hodgkin lymphoma (cHL) confirmed by histopathology;
3. The subject must be advanced patient, specifically defined as Ann Arbor stage III-IV or IIB with any of the following high-risk factors: ① maximum diameter of mediastinal mass/maximum diameter of thoracic cavity\>0.33; ② There are large masses with a diameter of\>10cm;
4. Have not received systemic anti classic Hodgkin lymphoma treatment;
5. Measurable disease ;
6. Adequate main organs function
7. Female subjects of childbearing age should agree to use contraceptives (such as Intrauterine device, contraceptives or condoms) during the study period and within 6 months after the end of the study; The serum or urine Pregnancy test was negative within 7 days before the study was included, and must be non-lactating subjects; Male participants should agree to use contraception during the study period and within 6 months after the end of the study period.

Exclusion Criteria:

1. Nodular lymphocyte dominated Hodgkin lymphoma or gray area lymphoma;
2. Classic Hodgkin lymphoma involves the central nervous system;
3. Subjects who have or are suspected to have active autoimmune diseases within the past 2 years, or have previously suffered from autoimmune diseases and are currently at high risk of recurrence and require systemic treatment；
4. Subjects who need to use glucocorticoid (\>10mg/day prednisone Equivalent dose) or other immunosuppressive drugs for systemic treatment within 14 days before the first administration.
5. Inoculate or expect to receive live or attenuated live vaccines or mRNA vaccines within 4 weeks before the first administration;
6. Received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
7. Known to have active pulmonary tuberculosis;
8. Having a history of immunodeficiency, including HIV positive or suffering from other acquired or congenital immunodeficiency diseases;
9. Subjects with a known history of interstitial pneumonia, a history of non-infectious pneumonia, or highly suspected cases of interstitial pneumonia;
10. Patients with evidence of bleeding constitution or medical history; Within 4 weeks before the first medication, any ≥ CTC AE level 3 bleeding events (such as digestive tract bleeding, perforation, etc.) occur;
11. Concomitant diseases and medical history:

    1. Has experienced or currently suffers from other malignant tumors within 3 years.
    2. Multiple factors affecting oral medicine (such as inability to swallow, chronic diarrhea and Bowel obstruction);
    3. Patients with a history of abuse of psychotropic substances who are unable to quit or have mental disorders;
    4. Subjects with any severe and/or uncontrollable disease.
Personalized Feedback Programs for College Students

The purpose of this research study is to evaluate the effectiveness of different forms of personalized feedback intended to help students make their best personal choices to support their health and well-being in college.

Risky substance use among college students is a widespread challenge that requires innovative prevention methods to address. A primary aim of this study is to assess the efficacy of receiving different types of personalized feedback on the substance use and wellbeing of college students. This preliminary efficacy will be evaluated through a multi-part randomized controlled trial comparing four conditions: (1) resources program, (2) on-line Personalized Feedback Program (PFP), (3) on-line Substance Use Feedback Program (based on brief motivational intervention (BMI) principles), and (4) PFP+BMI.

At the first time point, participants will be randomly selected into one of four conditions. Participants have an equal chance of being assigned to any one of the conditions. All participants will complete follow-up surveys at two additional timepoints (30 day follow-up; 3-month follow-up) to determine any changes that have occurred since they took part in their program at Time Point 1.

After the final survey, all participants, regardless of their initial group, will be invited to receive all of the personalized feedback components available across all conditions.

Findings from this study have great potential to enhance the effectiveness of college student substance use prevention programming and improve college student wellbeing.

Eligibility Criteria:
Inclusion Criteria:

* Consent: Voluntary consent must be provided.
* Age: Students over the age of 18 may participate.
* Year in college: Newly enrolled freshmen.
* Enrollment status: Only full-time VCU students will participate.

Exclusion Criteria:

* Age: Under the age of 18
* Year in College: A sophomore, junior or senior
* Enrollment Status: Enrolled part-time
A Phase I Additional Study of Anlotinib on Tolerance and Pharmacokinetics

A Phase I Additional Study of Anlotinib on Tolerance and Pharmacokinetics.To further study the pharmacokinetic characteristics of Anlotinib in the human body, recommend a reasonable regimen for subsequent research.


Eligibility Criteria:
Inclusion Criteria:

* Histological documentation of Advanced solid tumors except the digestive tract tumors,at least one measurable lesion (by RECIST1.1)
* Lack of the standard treatment or treatment failure
* 18-65 years,ECOG PS:0-1,Life expectancy of more than 3 months
* 30 Days or more from the last cytotoxic therapy
* Main organs function is normal
* Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
* Patients should participate in the study voluntarily and sign informed consent

Exclusion Criteria:

* Patients who are used by anlotinib
* Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)
* Brain metastases patients with symptoms or symptoms controlled \< 3 months
* Patients with any severe and/or unable to control diseases，including：

  1. Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg);
  2. Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥480ms) and patients with Grade 1 or higher congestive heart failure (NYHA Classification);
  3. Patients with active or unable to control serious infections;
  4. Patients with cirrhosis, decompensated liver disease, or active hepatitis;
  5. Patients with poorly controlled diabetes (fasting blood glucose(FBG)\>10mmol/L)
  6. Urine protein ≥ ++，and 24-hour urinary protein excretion\>1.0 g confirmed
* Patients with non-healing wounds or fractures
* Patients with any CTC AE Grade 1 or higher bleeding events occurred in the lungs or any CTC AE Grade 2 or higher bleeding events occurred within 4 weeks prior to assignment;Patients with any physical signs of bleeding diathesis or receiving thrombolysis and anticoagulation
* Patients with drug abuse history and unable to get rid of or Patients with mental disorders
* Patients participated in other anticancer drug clinical trials within 4 weeks
* History of immunodeficiency
* Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
Effects of White Rice, Brown Rice, and Black Rice on Postprandial Glucose and Lipid Profiles in Healthy Korean Adults

This study was an open, 5-treatment, 5-sequence, 5-day cross-over randomized design clinical trial. The present study was carried out to compare the effects of white rice, brown rice, and black rice on postprandial glucose and lipid profiles in healthy human subjects, using a white bread as a positive control.

After a 12-hour fast, oral glucose and meal tolerance was measured with blood samples drawn at times 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes and TG was at time 0, 1, 2, 3, 4, 5 and 6 hours.

1. Serum levels of glucose, insulin, and TG were analyzed by biochemical autoanalyzer. The area under the curve (AUC) changes in blood glucose, TG were computed by the trapezoidal method.
2. Glycemic index(GI): the area under the glucose response curve after consumption of a test food divided by the area under the curve after consumption of a control food containing the same amount of carbohydrate and calculated using 50 g glucose as the reference.

Eligibility Criteria:
Inclusion Criteria:

* Males, 19\~60years old
* Bodyweight was more than 50 kg with ideal body weight within ±30%
* triglyceride (TG) levels less than 200 mg/dL
* Fasting blood glucose levels less than 100 mg/dL and an oral glucose tolerance test (OGTT) less than 140 mg/dL
* Able to give informed consent

Exclusion Criteria:

* Major medical illness such as cardiovascular, neurologic, psychiatric, renal, pulmonary and hepatic diseases
* History of disease that could interfere with the test products or impede their absorption such as gastrointestinal disease or gastrointestinal surgery
* Medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Poor vital sign (systolic blood pressure: below 100 mmHg or above 150 mmHg, diastolic blood pressure: below 65 mmHg or above95 mmHg)
* Allergic or hypersensitive to any of the ingredients in the test products; treated with any drug within past 2 weeks
* Participation in any other clinical trials within past 2 months
* Alcohol consumption above 21 units per week or abnormal screening laboratory test
* Being judged by the responsible physician of the local study center as unfit to participate in the study
Does Capnography Prevent Hypoxemia During Endoscopic Retrograde Cholangiopancreatography and Endoscopic Ultrasound?

Subjects undergoing elective ERCP and EUS will receive standard monitoring and sedation. In addition, capnography which measures carbon dioxide levels and can graphically assess respiratory activity will be used. Subjects will be randomized to either a capnography blinded or titration arm. In the capnography titration arm, the endoscopy team would be made aware of capnographic abnormalities as they arise throughout the procedure. In the capnography blinded arm, this information will not be available to the endoscopy team and represents standard of care. It is our hypothesis that using capnography can prevent low oxygen levels known as hypoxemia, during these procedures.

Subjects undergoing elective ERCP and EUS will receive standard monitoring and sedation. In addition, capnography which measures carbon dioxide levels and can graphically assess respiratory activity will be used. Subjects will be randomized to either a capnography blinded or titration arm. In the capnography titration arm, the endoscopy team would be made aware of capnographic abnormalities as they arise throughout the procedure. In the capnography blinded arm, this information will not be available to the endoscopy team and represents standard of care. It is our hypothesis that using capnography can prevent low oxygen levels known as hypoxemia, during these procedures. The primary outcome of our study is the proportion of patients with hypoxemia in the two arms. Review of the literature indicates that the incidence of hypoxemia without supplemental oxygen varies from 30-70%. Our sample size calculation is based on a reduction of the hypoxemia incidence from 40% to 20%. Secondary outcomes will be the proportions of patients with oxygen requirements, major hypoxemia and apnea (lack of respiratory activity via capnography for at least 15 seconds) in the two arms. We will perform a univariable and multivariable analysis to determine the risk factors for apnea.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 or greater
* Subjects undergoing elective ERCP and EUS
* ASA class 1-3
* Inpatient and outpatient
* Able to give informed consent

Exclusion Criteria:

* ASA Class 4 and 5
* Emergent procedures
* Procedures requiring MAC sedation
* Subjects unable to give informed consent
* Subjects on oxygen before procedure
* Subjects on CPAP/BiPAP
* Allergies to fentanyl/demerol/midazolam
Aersosolization During Upper Endoscopy

Given the current Covid-19 pandemic alongside the lack of evidence on aerosolization during upper endoscopy the investigators are conducting a randomized controlled trial seeking to assess both the level of aerosolization that occurs during these procedures along with determining if utilization of an endoscopic patient face-masks reduces the level of aerosolized particles. The protocol includes the use of a commercially available particle counter the investigators are employing for the measurement of aerosols before, during, and after anesthesia assisted upper endoscopic procedures. The investigators are recruiting patients undergoing these procedures with a target of 30 patients undergoing endoscopy without a facemask and 30 patients undergoing endoscopy with one.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing elective upper endoscopic procedures (upper endoscopy, ERCP, endoscopic ultrasound) with monitored anesthesia care at main campus Cleveland Clinic inpatient endoscopy unit.

Exclusion Criteria:

* Any patient requiring endotracheal intubation
* Pregnant patients
* Emergency procedures
* Patients who require use of a facemask before or during the procedure due to medical necessity
* Patients under the age of 18
* Non-English speaking individuals
* Patients unable to provide consent.
* Any procedure done outside the designated procedure room.
* If in the opinion of the anesthesiologist, a subject who was randomized to the control arm requires placement of the procedural mask to augment oxygenation, the subject will be removed from the study