cyrilzakka/clinical-trials huggingface dataset:
A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets

The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fed state.

Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 to 50, inclusive.
* Body weight ranging from 50 to 100 kg and a BMI ≥18 and ≤34 (kg/m2).
* Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, and ECG.
* Females of child-bearing potential must be using an adequate and reliable method of contraception.

Exclusion Criteria:

* Females who are pregnant or lactating.
* Any history of or current drug or alcohol abuse for 5 years.
* History of or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
* Use of an opioid-containing medication in the past 30 days.
* History of known sensitivity to oxycodone, naltrexone, or related compounds.
* Any history of frequent nausea or emesis regardless of etiology.
* Any history of seizures or head trauma with current sequelae.
* Participation in a clinical drug study during the 30 days preceding the initial dose in this study.
* Any significant illness during the 30 days preceding the initial dose in this study.
* Use of any medication including thyroid hormone replacement therapy (hormonal contraception is allowed), vitamins, herbal, and/or mineral supplements, during the 7 days preceding the initial dose.
* Refusal to abstain from food for 4 hours following administration of the study drugs and to abstain from caffeine or xanthine entirely during each confinement.
* Consumption of alcoholic beverages within 48 hours of initial study drug administration (Day 1) or anytime following initial study drug administration.
* History of smoking or use of nicotine products within 45 days of study drug administration or a positive urine cotinine test.
* Blood or blood products donated within 30 days prior to administration of the study drugs or anytime during the study, except as required by this protocol.
* Positive results for urine drug screen or alcohol screen at Check-in of each period, and HBsAg, HBsAb (unless immunized), anti-HCV.
* Positive Naloxone HCl challenge test.
* Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities.
Software for Alternative Communication

The aim of this study is evaluate a software developed for alternative communication designed for people with speech difficulties. The software was executed by 30 volunteers using mobile devices that helped to play the scenarios simulated of communication situations.

Communication is a fundamental element that contributes to the development of the human being, promoting their coexistence in society. However, several factors, among them the Cerebral palsy (CP), can cause changes in muscle tone, causing injury in phono-articulatory which prevent or impair the speech production. This research aims to the development of a mobile application to promote the augmentative and alternative communication for people with CP, which adapt to the characteristics of motor limitations of these users. A mobile application was developed with pictographic resources and a voice synthesis engine, which can be customized according to the level of motor impairment and need for communication of the user. Were recruited 30 volunteers with CP who have speech difficulties and motor impairment. By means of a test script, these volunteers have used the mobile application and evaluated their usability using the questionnaire System Usability Scale (SUS), which contains 10 questions related to the ease of learning, efficiency, ease of memorization, occurrence of runtime errors of execution and level of user satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral Palsy and speech disorder

Exclusion Criteria:

* visual impairment and / or severe cognitive impairment
Evaluation of Attitudes Towards Organ Donation in Individualistic or Collectivistic Countries

People make decisions every day, both for themselves and on behalf of others. In the case of organ donations, despite the opt-out systems used in Singapore where the default is a presumed consent on the part of the individual, the actualized donation rate is lower than expect. This is partially because family members are called in to make surrogate decisions on behalf of the patient, especially patients near brain death or have been certified to be brain dead.

To address the shortfall in organ donations, the investigators plan to run three studies:

* First, the investigators seek to conduct a representative survey of the public's perception towards organ donation. The investigators will focus on their views towards donating their own vs. family members' organs, and to explore the role of cultural influences on decision-making.
* Second, the investigators will conduct the survey focusing on NUS students and the ways they respond to an opt-out, opt-in, or mandatory organ donation system.
* Third, the investigators will conduct the survey on an online platform (MTurk) to gather the views of participants across India and USA about organ donation.

The studies have the potential to improve actualized organ donation rates, as well as to inform the medical community in their communication with family members.


Eligibility Criteria:
Inclusion Criteria:

* Research participants should be above the age of 21, able to understand English fully, and have no active mental disorder or intellectual impairment.

Exclusion Criteria:

* Below the age of 21, unable to understand English fully, or have active mental disorder or intellectual impairment.
Intervention Study to Investigate Supplemental Oxygen in COPD

The purpose of this trial is to study the effects on exercise capacity, physical activity, inflammatory markers and quality of life of supplemental ambulatory oxygen, to be used during physical activity, in patients with COPD who are normoxic at rest but hypoxemic during a six-min walk test.

Our hypothesis is that if patients are able to use supplemental oxygen they will be more physically active and thereby improve health related quality of life.

Study design The study will employ a parallel design for 6 months including 144 patients (72 patients/group). Patients will be randomized to intervention or control group. The intervention comprises supplemental oxygen to be used during physical activity for 6 months. The control group will receive the same physical activity instructions as the intervention group during the 6 months, but they will not be able to use supplemental oxygen during physical activity.

The study will be a prospective, randomized, single-blind multi-centre intervention study with an intention to treat design (last value carry over). Inclusion will continue until 144 patients have fulfilled the 6 months. Patients will be tested at baseline and after 6 months. There will also be a follow-up after 12 months comprising questionnaires. The study will include centers in Sweden Norway, Finland, and Estonia.

Eligibility Criteria:
Inclusion Criteria:

* COPD, Arterial Oxygen Saturation \> 8 kilopascal at rest
* Oxygen Saturation ≤ 88% and a fall in Oxygen Saturation ≥ 4% during a six-minute walk test in ambient air
* No exacerbation within 4 weeks prior to the study
* Post-bronchodilator forced expiratory volume at one second \< 80% predicted and forced expiratory volume at one second /Vital capacity \< 0.7
* Oxygen Saturation ≥ 92 % during a walk test in self-selected pace with supplemental oxygen. Patients should use supplemental oxygen 10 minutes before the test starts.
* Non-smoker (smoke free for ≥ 6 months)
* Interest in being physically active

Exclusion Criteria:

* Arterial carbon dioxide \> 6.5 kilopascal at rest
* Orthopedic, neurologic or mental impairments that would limit physical activity
* Neoplastic disease that is anticipated to influence survival
* Patients exercising with supplemental oxygen
* Long-term oxygen therapy
* Patients with arterial auricular fibrillation and/or heart disease that might hinder physical activity as judged by the physician
Doxycycline Outcomes in Lupus Erythematosus

Cardiovascular disease, specifically from atherosclerosis, is the major cause of mortality in SLE in developed countries. In a recent study the investigators have shown that high sensitivity C reactive protein (hs-CRP) is higher in SLE patients with (versus without) coronary calcium, a measure of subclinical atherosclerosis. In an ongoing two year intervention trial of atorvastatin, the investigators will determine if statins retard coronary calcium and reduce hs-CRP. However, 10% of the patients in the trial were intolerant of statins. The investigators want to now investigate whether there are additional, and potentially safer ways, to reduce hs-CRP in SLE. In this study, the investigators will determine if doxycycline reduces hs-CRP and other vascular inflammatory markers including interleukin 6 (IL-6), soluble vascular cell adhesion molecule (sVCAM-1), soluble inter cell adhesion molecule (s-ICAM-1) and matrix metalloproteinase 9 (MMP-9) in SLE.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a clinical diagnosis of SLE, with a hs-CRP above \> 3mg/L, (high risk level) for the last 3 months, are eligible.
2. Patients must be 18 years of age or older and able to give informed consent.
3. Contraception other than OCPs is necessary if a woman is at risk for pregnancy.

Exclusion Criteria:

1. SLE patients who are allergic to doxycycline or other tetracyclines.
2. Patients who are pregnant or are planning to become pregnant.
3. Patients who are on oral contraceptives (any method of contraception other than OCPs can be used.
4. Tetracycline use within the previous 2 weeks of enrollment.
5. Patients who are currently on statins will be excluded, because statins might reduce hs- CRP.
6. Patients who are on warfarin.
7. Patients whose most recent EKG shows significant cardiac dysrhythmias or heart block.
A Study to Demonstrate the Bioequivalence of Lacosamide Tablets and Dry Syrup in Healthy Male Japanese Subjects

This is a study designed to demonstrate the Bioequivalence between Lacosamide (LCM) Tablet and Dry Syrup in Healthy Male Japanese Subjects


Eligibility Criteria:
Inclusion Criteria:

* Subject is male and between 20 and 55 years of age (inclusive)
* Subject is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a subject has all 4 Japanese grandparents born in Japan)
* Male subject confirms that when having sexual intercourse with a woman of childbearing potential, he will use condoms during the study and 1 week after the last dose of study drug

Exclusion Criteria:

* Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study.
* Subject has clinically relevant out-of-range values for hematology, and serum chemistry, or urinalysis variables at the Screening Visit.
* Subject has any clinically significant abnormal physical examination (Screening Visit or Day -1) and vital signs (Screening Visit).
* Subject has any clinically relevant ECG finding at the Screening Visit.
Celebrex and Metformin for Postoperative Hepatocellular Carcinoma

This prospective trial aims to compare the role of celebrex alone, metformin alone, and celebrex plus metformin in preventing HCC recurrence after hepatic resection.

Hepatic resection is a popular curative treatment for patients with early-stage HCC and well-preserved liver function. Although overall survival after resection has been increasing, the median 5-year disease-free survival rate after resection remains at only about 37% for early-stage HCC. In fact, the 5-year recurrence rate is as high as 74% for intermediate and advanced HCC. Postoperative recurrence may be due to intrahepatic metastasis arising from the primary tumor or it may be de novo metastasis (multicentric) that arises spontaneously in the residual liver. Intrahepatic metastasis is the primary mechanism of early recurrence, which occurs \<2 years after resection; multicentric metastasis is the principal mechanism behind late recurrence, which occurs at least 2 years after resection.

In the past few years, some observational studies with small sample size found metformin and celebrex (selective cyclic oxidase-2 inhibitors) may reduce the rate of HCC after surgery. However, no prospective study compare their efficacy in preventing HCC recurrence. This trial aims to compare the role of celebrex alone, metformin alone, and celebrex plus metformin in preventing HCC recurrence after hepatic resection.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients
* Patients have Child-Pugh A or B liver function
* No previous neoadjuvant treatment
* No evidence of macrovascular invasion, metastasis to the lymph nodes and/or distant metastases on the basis of preoperative imaging results and perioperative findings
* No malignancy other than HCC for 5 years prior to the initial HCC treatment

Exclusion Criteria:

* History of cardiac disease
* Known history of human immunodeficiency virus (HIV) infection
* Known Central Nervous System tumors including metastatic brain disease
* History of organ allograft
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
* Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study Pregnant or breast-feeding patients
Immediate Effect of Cervical Manual Therapy Methods in Patients With Neck Pain

Chronic neck pain is an important health problem in modern society and is frequently encountered today. Approximately 10% of the adult population experiences neck pain at least once in their lives.

Anamnesis of the patient with neck pain; It should include the patient's complaints, illness history, family history, social status, work life and leisure activities.

The age of the patient, the severity of the symptoms, the mechanism of the injury, the activity history, the duration of the symptoms, the location and limits, the spread of the pain, the relationship of the complaints with the change in position, the restrictions during movement, and the sleeping positions should be taken into account. In addition, past diseases, operations and current diseases, medications used should be recorded.

Among chronic pains, neck pain ranks second after low back pain. Physical stresses in daily living activities, maintaining static posture and sleeping habits, carrying bags and weights in the wrong position, muscle imbalance are important factors in neck pain. Although cervical spine involvements have a great effect on neck pain, almost all of them have paravertebral muscle spasm, especially trapezius muscle spasm. Physiotherapy applications are widely used in the treatment of chronic neck pain.

Therapeutic approaches are frequently used to reduce inflammation and accelerate the healing process. Reducing pain in neck diseases, ensuring sufficient length of the muscle, strength balance, improving strength and function, improving postural re-education and cervical movements are the main goals. With the increasing prevalence of neck pain, the search for new treatment methods is increasing.

It includes manual therapy, manipulation, acupuncture, and soft tissue therapy for chronic neck pain. Neck pain results from deep muscle dysfunctions and altered fascia structures. In this case, it may cause the disruption of the continuous musculofacial corset-like system. In addition, changes in the fascia (increased fascial thickness and disruption of fascial alignment) may affect this system more. Myofascial release is one of the soft tissue treatment applications. Although there are studies reporting that myofascial release is a method that can achieve positive effects such as reducing pain intensity and improving muscle function, there are few studies on this subject in the literature and sufficient evidence has not been reached.

Eligibility Criteria:
Inclusion Criteria:

* Neck pain
* Being between 20-60 years old

Exclusion Criteria:

* Cardiopulmonary disease
* malignancy and pregnancy
* Operation, injection, etc. for the neck in the last 3 months. those with a history of treatment
* Spine surgery
* Psychological discomfort
* Neurological and orthopedic deficits
A Study to Demonstrate the Efficacy and Safety of Motilitone®

This is a phase IV , comparative study to evaluate the efficacy and safety of Motiltone® in treatment of the patients with functional dyspepsia. The study is conducted with following methods: multi-centers, double blind, randomization, parallel. The subjects will receive Motilitone® or/and Pantoline®.


Eligibility Criteria:
Inclusion Criteria:

* Roman III criteria
* One or more conditions are applied: epigastralgia, burning feelings in the solar plexus early satiety, uncomfortable fullness
* No organic lesion

Exclusion Criteria:

* has been administered or was administered within a month
* had a surgery that might affect gastrointestinal motility
* Tegaserod
Hepatitis B Reactivation During Treatment With Direct-Acting Antiviral Agents for Chronic Hepatitis C Infection

Background:

Treatment of some diseases can suppress the immune system. This can cause other conditions to reactivate. Recent cases have shown that hepatitis B virus (HBV) reactivates in people who had already recovered from it during treatment for chronic hepatitis C (CHC). Their treatment was direct-acting antiviral (DAA) agents. Researchers want to see how common this reactivation is. They want to learn what the effects are. They will study data that have already been collected.

Objectives:

To study HBV reactivation in people with CHC and resolved HBV infection who are being treated with interferon-free DAA-based therapy.

Eligibility:

Data were collected from adults 18 and older in studies that were done in 2012 and 2016.

Design:

Researchers will screen the records from the previous studies. They will identify participants who had HBV infection before they got DAA-based treatment.

Researchers will take data from those records. This will include data on:

* Age, sex, race, and ethnicity
* Treatment and disease status
* Lab results

Researchers will test stored samples. They will test samples that were taken before, during, and after treatment. They will check if HBV was reactivated. They will also check if other clinical outcomes occurred.

Reactivation of hepatitis B is well known to occur with immunosuppression as in the setting of high dose immunosuppressive therapy, cancer chemotherapy and bone marrow or stem cell transplantation. It is usually subclinical but at times can manifest as an acute hepatitis, hepatic decompensation and death. Often times this leads to interruption of cancer chemotherapy.

Recently, several case reports and case series have revealed evidence of hepatitis B virus (HBV) reactivation in previously recovered persons being treated for chronic hepatitis C (CHC) with direct-acting antiviral (DAA) agents. Given the severity of some cases, the U.S. Food and Drug Administration (FDA) has issued a Black Box warning regarding the risk of HBV reactivation to HCV DAA labeling to screen all hepatitis C patients for HBV before initiation of therapy and to monitor those with previous HBV infection for signs of reactivation while on treatment. However, since the FDA warning, retrospective experiences on clinical trials have failed to reveal evidence of viral reactivation. Further, the frequency of HBV reactivation and its risk factors and monitoring frequency in HCV patients receiving Interferon-free DAA therapy are yet unknown. Hence, we aim to conduct a multicenter retrospective analysis to investigate these issues.

Eligibility Criteria:
* INCLUSION CRITERIA:
* Adult patients (greater than or equal to 18 years) with CHC who underwent treatment with an Interferon-free DAA-based therapy.
* Evidence of resolved HBV infection prior to starting interferon-free DAAbased therapy (HBsAg-negative with positive anti-HBc +/- positive anti-HBs)

EXCLUSION CRITERIA:

- Treatment with Nucleos(t)ide Analogues (NA) active against HBV prior to initiation of interferon-free DAA therapy
the Safety and Efficacy of Meplazumab in Patients With COVID-19

This is a multicenter, double-blind, randomized, placebo-controlled phase 2/3 clinical study. Based on the results of the Phase I clinical study, one repeat dose group and one placebo group are used for the standard treatment of the Novel Coronavirus Pneumonia Protocol (Trial 8) The treatment regimen is a one-time intravenous infusion of either mprozumab or placebo on day 1 (D1) and day 8 (D8) of the treatment period at a dose of 0.2 mg/kg based on body weight. An estimated 150 subjects will be randomly assigned to either Meplazumab or placebo in a 2:1 ratio A short-term efficacy evaluation was performed to determine the efficacy and safety of Meplazumab in each subject within 14 days of initial administration and a long-term follow-up evaluation was performed 28 days after initial administration to determine the safety of Meplazumab.


Eligibility Criteria:
Inclusion Criteria:

* 18 years ≤Subject ≤ 75 years, Male and/or female;
* Clinical confirmation of COVID-19 patients in accordance with novel Coronavirus Diagnosis and Treatment Protocol (Trial Version 8) of the NHC
* Participants must be able to understand and willing to participate in this research, this study and signed informed consent form (if incapacitated subjects, the researchers believe the subjects to the test in its own interests, should be signed by its legal guardian informed consent, or telephone inform consent (recording) and note it in the original medical records and other relevant documents)

Exclusion Criteria:

* Subjects with any unstable conditions, a history of significant hypersensitivity, or known allergy to components of the investigational agent;
* SARS-CoV-2 infection by PCR ≥ 96h;
* Platelet (PLT) \< 50×10\^9/L, or hemoglobin (HGB) \< 60g/L;
* Total bilirubin (TBIL) \> 2×ULN (upper limit of normal value), or alanine transferase (ALT), aspartate transferase (AST), alkaline phosphatase (ALP) \> 5×ULN;
* glomerular filtration rate (GFR) \< 30mL/min·1.73m\^2, or serum creatinine increased by 0.5mg/ dL within 7 days, or oliguria (\<400mL/24hr), or anuria (\<100mL/24hr);
* Pregnant or breast feeding;
* Persons who have family planning or do not agree to use effective non-drug contraceptive measures within 6 months after signing the ICF;
* Subjects participating in another clinical study. There will be a need for washout with 5 half lives depending on the study treatment or 30 days since any previous study, whichever is longer;
* he inestigators concluded that the patients had other reasons for not being eligible for the study.