cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Drug Interaction Study Between Gemigliptin and Glimepiride in Healthy Male Subjects

The objective of the study was to investigate the pharmacokinetic drug interaction between gemigliptin and glimepiride in healthy male subjects after oral administration concomitantly and each alone.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 to 45, healthy male subjects (at screening)
* BMI between 18 - 27 (at screening)
* FPG 70-125mg/dL glucose level (at screening)
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the

Exclusion Criteria:

* Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
* Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
* Subject who had drug hypersensitivity reaction.(gemigliptin, glimepiride, aspirin, antibiotics)
* Subject who already participated in other trials in 90 days
* Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently
The METRIC Study Protocol

The goal of this clinical trial is to test the effects of spinal manipulative therapy in individuals with chronic primary low back pain and determine the neurophysiological mechanisms underlying pain relief. The main questions it aims to answer are: • Is pain relief produced by spinal manipulative therapy in patients with chronic primary low back pain caused by a reduction of C-fiber-related nociceptive processing? • Are these effects greater when spinal manipulative therapy is applied to the whole spine where it is clinically indicated compared with lumbar spine only? • Are these effects greater after 36 treatments over 3 months compared with 12 treatments over 1 month. Participants will receive spinal manipulative therapy (all clinically indicated spine segments or back only) or a control intervention. A group of healthy volunteers will be recruited to assess secondary outcome measures over the same time period, as reference data for comparisons. Researchers will compare the two groups receiving spinal manipulative therapy to the group receiving the control intervention to see if clinical pain relief and the reduction of temporal summation of second pain (produced experimentally) is significantly greater with spinal manipulative therapy.


Eligibility Criteria:
Inclusion Criteria:

* Duration of current low back pain (LBP) episode ≥ 6 months;
* Average LBP intensity during the last 7 days ≥ 3/10;
* (For healthy volunteers only) To be of the same sex and age (± 1 year) as a participant with low back pain.

Exclusion Criteria:

* Diagnosis of back conditions other than chronic primary LBP e.g., failed back surgery syndrome, spondylosis, spondylolisthesis, spinal stenosis, herniated disc, infection, etc.;
* Presence of pain in another body location that is more severe than the pain in the lower back;
* Presence of a neurological deficit i.e., sensation loss, muscle weakness, decreased deep tendon reflexes;
* Presence of contraindications to spinal manipulative therapy e.g., recent fracture, history of spinal surgery, cauda equina syndrome, inflammatory arthritis, taking anticoagulant medication, active cancer, moderate to severe osteoporosis, abdominal aortic aneurysm;
* Underwent surgery in the last 3 months;
* Pregnancy, ≤ 3 months post-partum or planning to get pregnant in the next 12 months;
* History of spinal manipulative therapy in the past 12 months;
* Scoliosis ≥ 20°;
* BMI ≥ 40;
* Insufficient language skills in French to complete the questionnaires;
* Open or pending litigation for LBP or seeking/receiving disability compensation;
* Diagnosis of an illness affecting the sensorimotor functions e.g., diabetes, multiple sclerosis, amyotrophic lateral sclerosis;
* Diagnosis of mental health disorders (with the exception of anxiety and depression);
* Current drug or alcohol dependence;
* Skin of type I on the Fitzpatrick scale;
* (For healthy volunteers only) Regular use of pain medication or usage in the 48 h prior to data collection;
* (For healthy volunteers only) History of chronic pain;
* (For healthy volunteers only) Acute pain on the days of data collection.
Dynamic Contrast Enhancement Computed Tomography Based Technic to Assess Gastro Intestinal Wall Perfusion : Feasibility Study

This feasibility study has therefore several aims:

1. construct a dedicated CT perfusion protocol for GIT wall perfusion;
2. used a two-compartment pharmacokinetic model which is more adapted that a unique compartment model;
3. from the image acquired, evaluate current parameters of perfusion including the permeability ones


Eligibility Criteria:
Inclusion Criteria:

* all patients over fifty years old with clinico-biological suspicion for acute GITischemia admitted at our institution

Exclusion Criteria:

* contra-indication to contrast agent injection as so defined by the European Society of UroRadiology in 2014
* inability to provide informed consent
Prospective Data Collection of IVMRI Cases

The study purpose is to prospectively collect data for a set of predefined variables in clinical cases where coronary plaque lipid characterization by IVMRI was performed during diagnostic or interventional procedures in order to gather incremental information beyond angiography and other diagnostic modalities.


Eligibility Criteria:
Inclusion Criteria:

* An adult patient ≥ 18 years old.
* The patient, or legal guardian, has been informed of the nature of the study, agrees to its provisions, and has sign the approved informed consent.
* The patient and the treating physician agree to attend the follow-ups as defined in the study protocol.
* Indication for diagnostic and/or interventional procedure.
* Lesions in a native vessels where IVMRI interrogation may provide additional information beyond angiography and other diagnostic tools.

Exclusion Criteria:

* Culprit lesions within 48 hours following STEMI.
* Tortuous vessels, calcified or thrombotic lesions.
* Significant stenosis of an unprotected left main coronary artery.
* IVMRI interrogation of an unprotected left main coronary artery.
* Patients with pacemaker or cardioverter defibrillator.
* The patient is suffering from transplant mediated coronary artery disease.
Multiple Dose Dental Pain Study Of Ibuprofen Extended Release

The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide analgesic efficacy superior to placebo over 12-hour dosing intervals.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 16 to 40 years of age
* Subjects who undergo surgical removal of at least two third molars
* One of which must be a partial or full bony mandibular impaction
* Subjects must have at least moderate baseline pain (a score of 2 on the categorical pain severity rating scale) confirmed by a score of at least 50 mm on the 100-mm visual analog scale-pain severity rating scale (VAS-PSR)

Exclusion Criteria:

* Acute localized dental infection at the time of surgery that could confound the post-surgical evaluation
* Presence or history of any significant organ disease
* Use of prescription or OTC first generation antihistamines
* Females who are pregnant, lactating or of childbearing potential and not using a medically approved method to prevent pregnancy
A Study to Evaluate the Tolerability, Safety and Pharmacokinetic Characteristics of DA-3803

This is a single-blind, randomized, comparative, phase I study to evaluate the tolerability, safety and pharmacokinetic characteristics of human chorionic gonadotropin between two recombinant hCG products named DA-3803 injection and ovidrel liquid injection, in healthy subjects. The subjects will injected with these two injections at the the 21day-interval of time and their conditions including vital signs, blood, clinical examination will be carefully observed.


Eligibility Criteria:
Inclusion Criteria:

* No medical history relating to the alimentary system, liver system, heart system, haematological disease
* Ideal body weight +/- 20%

Exclusion Criteria:

* acute disease within 28 days
* medical history that might affect the absorption, distribution, secretion, metabolism of drugs
* metrectomy surgery
* desexualization
* tubal ligation
* menopause
* pregnancy
* not able to use contraception
* drink alcohol more than 14 units/week
* smoker who smokes 10 or more cigarettes
India PanOptix Post Marketing Study

The purpose of this Post Marketing Study is to study the safety and effectiveness of the ACRYSOF IQ PanOptix intraocular lens (IOL) in an Indian population.

The study population will consist of adult Indian males and females, at least 18 years of age or older at the time of screening, with no ocular pathology that could confound study outcomes, who are advised bilateral cataract extraction and who desire an IOL that provides the potential for correction of near, intermediate, and distance vision. Both eyes will be implanted. The second eye surgery will take place 15-30 days after the first eye surgery. Subjects will be followed for approximately 3 months after the second eye surgery. Total individual subject participation will be approximately 4 months. This study will be conducted in India.

Eligibility Criteria:
Inclusion Criteria:

* Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
* Advised cataract extraction in both eyes and agreed for bilateral implantation of ACRYSOF IQ PanOptix lens;
* Preoperative regular keratometric astigmatism of ≤1.0 D in both eyes.

Exclusion Criteria:

* Pregnant or lactating, current or planned, during the course of the study;
* Retinal abnormalities (Macular Degeneration, dystrophy, edema , traction or other pathologies affecting vision);
* Clinically significant corneal abnormalities;
* History of retinal conditions;
* Previous refractive surgery, including LASIK;
* Glaucoma;
* Any condition that may not be appropriate to this study, as per the Investigator's expert medical opinion.

Other protocol-specified inclusion and/or exclusion criteria may apply.
Study to Identify if OVR Health's VR-Kit is Safe to Use and Helps to Improve Focus, Attention and Reduce Worry & Rumination.

This is a randomized-controlled interventional treatment study with three arms of comparable demographics to evaluate the safety and efficacy of OVR Health's VR experience to improve control over the focus of attention and reduce worry and rumination in individuals who have reported problems with these issues.


Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years old
* Must be in good general health
* Self-reported with the following symptoms (as assessed by questions and questionnaires in study material):
* Finding it hard to let go of difficult thoughts.
* Looking out for signs of a potential threat in their environment (or in their body) that unhelpfully maintains their problem.
* Engaging in repetitive, unhelpful patterns of negative thinking (worry \& rumination). • These may be due to a diagnosis of a mental health condition, but this is not required for entry into the study.
* Good understanding of written and spoken English
* Willing and able to give informed consent
* Willing and able to follow the study protocol
* Willing and able to use VR headset at home
* WiFi connection to connect VR headset at home
* Willing and able to return VR headset

Exclusion Criteria:

* Current diagnosis of epilepsy, dementia, or another neurological disease that may prevent the use of VR hardware and software
* Individuals with suicidal or self-harm thoughts
* Significant visual, auditory, or balance impairment
* Insufficient comprehension of English
* Primary diagnosis of alcohol or substance abuse disorder, or personality disorder • Significant learning disability
* Current active suicidal plans or self-harm (in which case participant will be referred to appropriate crisis service)
* Receiving current alternative psychotherapy treatment
* Unwilling to provide consent
* Unwilling to follow the study protocol
Prone Positioning Short-term Effects on Tissue Oxygen Saturation in Critical COVID-19 Patients

The purpose of this study is to monitor short-term changes in tissue oxygen saturation and local blood flow as results of changing from supine to prone position in ARDS COVID-19 patients

After obtaining consent to participate in the study, the subjects included in the study will undergo a baseline 15-minute measurement of tissue oxygen saturation (StO2) measured non-invasively on the forearm by means of near-infrared spectroscopy (NIRS). Once a baseline stable StO2 value is obtained, a provocative test, consisting of a transient vascular occlusion, will be performed. The test will allow the obtention of a local metabolic rate, and a StO2 recovery rate after the ischemic stimulus.

Tissue oxygenation measurements will be performed in supine position, immediately before changing to prone positioning, and repeated after 20 minutes of stabilization, once in prone position.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 patients admitted in the ICU receiving invasive mechanical ventilation and requiring prone positioning for severe hypoxemia management, as decided by the medical team

Exclusion Criteria:

* Severe peripheral vasculopathy
* Raynaud's syndrome
* Skin lesions/trauma in upper limbs interfering the placement of the NIRS probe and/or the occlusion tourniquet
* Deep venous thrombosis in the upper limbs
Tissue Perfusion During Emergency Laparotomy

This study is investigating the effect of intraoperative Noradrenaline on cardiac preload and stroke volume, after initial fluid resuscitation, in order to assess whether there is a masked preload responsiveness and ultimately whether the correction of this potential preload-responsiveness with fluid therapy will translate into increased tissue perfusion in emergency laparotomy.

Early detection and treatment of insufficient tissue perfusion and oxygenation is the main purpose of perioperative haemodynamic monitoring and management. Hypovolemia, septicaemia, and low flow states affecting central and peripheral perfusion are frequent in patients undergoing emergency laparotomy.

This study aims to assess the effects of Noradrenaline (NA) on cardiac preload, and tissue perfusion in patients undergoing emergency laparotomy, to investigate potential macro/microcirculatory uncoupling.

A single-centre, prospective interventional non-blinded single-arm study at the Department of Anaesthesiology and Intensive care Unit, Copenhagen University Hospital Hvidovre, Denmark. We will include patients undergoing emergency laparotomy. The study start is January 2021. After informed consent, patients will be included if they have an intraoperative need for Noradrenaline infusion \>0.1 mcg/kg/min to maintain MAP ≥65 mmHg after resuscitation with a goal-directed fluid therapy algorithm. 20 patients will be included.

Intervention: At a steady state (MAP ≥65 mmHg) during the surgical procedure, we will reduce NA to investigate whether patients will be preload responsive while maintaining MAP \> 50 mmHg and limiting stroke volume reduction to no more than 30%. After a subsequent fluid challenge, we will increase the dose of NA to re-establish a MAP ≥65 mmHg. In addition, peripheral and central perfusion indices, including gut perfusion, will be measured.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (18 years or over) undergoing emergency laparotomy/laparoscopy for following abdominal pathology:

   1. Perforated viscus
   2. Intestinal obstruction
2. Emergency re-operations after elective surgery owing to paralytic/obstructive ileus, anastomotic leakage
3. Provided verbal and written informed consent
4. Must speak and understand the Danish language
5. Intraoperative indication for Norepinephrine infusion

Exclusion Criteria:

1. Appendectomies, cholecystectomies, negative diagnostic laparoscopies/laparotomies, herniotomies without bowel resections, sub-acute internal hernias after gastric bypass surgery, sub-acute surgery for inflammatory bowel diseases.
2. Reoperation owing to fascial separation with no other abdominal pathology identified and sub-acute colorectal cancer-surgery will be excluded from the cohort. Sub-acute surgery is defined as surgery planned within 48 hours.
3. Intestinal Ischemia
4. intraabdominal bleeding
5. Traumas, gynecological, urogenital and other vascular pathology, pregnant patients.
6. Dementia and/or cognitive dysfunction (diagnosed). If the patient is not awake, alert, and oriented, times three (to person, place, and time), this also qualifies as an exclusion criterion.
A Study of TQA3526 in the Treatment of Primary Biliary Cirrhosis (PBC)

TQA3526 is a modified bile acid and FXR agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion. It is hypothesized that regular treatment with TQA3526 will improve liver function in persons with Primary Biliary Cirrhosis (PBC).


Eligibility Criteria:
Inclusion Criteria:

* 1.18 and 70 years old, male or female. 2.Proven as PBC, as demonstrated by the patient presenting with at least 2 of the following 3 diagnostic factors:

  * History of increased ALP levels for at least 3 months prior to Day 0 in previously treated PBC patients，or ALP levels increased during screening in treatment naive PBC patients； ② Positive AMA titer (\>1:40 titer on immunofluorescence or M2 positive by ELISA) or PBC-specific antinuclear antibodies (anti-GP210 and anti-SP100 positive)； ③ Liver biopsy consistent with PBC within 24W prior to randomization； 3.ALP value between 1.67 and 10 × ULN; 4.Taking ursodeoxycholic acid (UDCA) for at least 12 months (stable dose for ≥ 3 months) prior to Day 0, or unable to tolerate UDCA (no UDCA for ≥ 3 months) prior to Day 0.

Exclusion Criteria:

* 1.Has other virus infected ; 2.History or presence of other concomitant liver diseases； 3.Presence of clinical complications of PBC or clinically significant hepatic decompensation； 4.Child-pugh grade B or C in patients with cirrhosis； 5.Creatinine (Cr) ≥1.5 times the upper limit of normal value and serum creatinine clearance rate \<60mL/min； 6.ALT or AST\>5×ULN；TBil\>3×ULN； 7.Patients with a history of severe pruritus within 2 months prior to day 0; 8.History or presence of clinically concerning cardiac arrhythmias, the duration of the study may affect survival; 9.Presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the intestine; 10.Medical conditions that may cause nonhepatic increases in ALP (e.g., Paget's disease) or which may diminish life expectancy to \< 2 years.
A Study to Evaluate Efficacy and Safety of HCP1803 in Patients With Essential Hypertension

A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HCP1803 in patients with essential hypertension


Eligibility Criteria:
Inclusion Criteria:

1. Patients with essential hypertension whose blood pressure measured in visit1 corresponds to the following conditions

   * mean sitSBP \<180 mmHg and mean sitDBP \< 110 mmHg for patients receiving any BP-lowering drug within 1 month prior to Visit 1
   * 140 mmHg ≤ mean sitSBP \< 180 mmHg and 60 mmHg ≤ mean sitDBP \< 110 mmHg for patients not receiving BP-lowering drugs within 1 month prior to Visit 1
2. Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP \< 180 mmHg and 60 mmHg ≤ mean sitDBP \< 110 mmHg at Visit 2

Exclusion Criteria:

1. Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
2. Orthostatic hypotension with symptoms within 3 months prior to visit 1.
3. Secondary hypertensive patient or suspected to be
4. Uncontrolled diabetes mellitus(HbA1c \> 9%) or type I diabetes mellitus
5. Active gout or hyperuricemia (uric acid ≥ 9mg/dL)
6. Severe heart disease or severe neurovascular disease
7. Moderate or malignant retinopathy
8. Clinically significant hematological finding
9. Severe renal diseases (eGFR\<30mL/min/1.73m2)
10. Severe or active hepatopathy (AST or ALT ≥ 3 times of normal range)
11. Hypokalemia or Hyperkalemia(K\<3.5mmol/L or K ≥ 5.5mmol/L)
12. Hyponatremia or Hypernatremia(Na\<135mmol/L or Na ≥ 155mmol/L)
13. Hypercalcemia
14. History of malignancy tumor
15. History of autoimmune disease
16. History of alcohol or drug abuse
17. Positive to pregnancy test, nursing mother, intention on pregnancy
18. Considered by investigator as not appropriate to participate in the clinical study with other reason
The Human Immunodeficiency Virus and Osteopathic Manipulation Evaluation Study

Treatment options that increase immune function, such as Osteopathic Manipulation Treatment (OMT) lymphatic techniques, may provide improved short or long term performance of the immune system. However, the efficacy of OMT to boost immune function among people living with HIV has not yet been examined in a controlled study. Our experiment is designed to examine the short (45 minutes) term impact of OMT on the white blood cells counts of HIV positive men who are either antiretroviral therapy (ART) naïve or have not taken ART for at least 12 months prior to enrollment in the study.


Eligibility Criteria:
Inclusion Criteria:

* are either Antiretroviral Therapy (ART) naïve or not have taken ART for the past 12 months
* are between the ages of 18 to 65
* have a CD4+ T cell count between 200-700cells/mm3
* have viral loads less than 100,000 copies/mL
* do not have any medical condition that limits his ability to participate in this study as defined by his physician (e.g., cancer, blood clotting disorder etc.)
* are willing to provide informed consent
* are not using any drugs recreationally
* are not on prescribed systemic steroids
* are willing to recruit a friend/partner, aware of the their HIV serostatus, to be trained in OMT techniques and apply it to him daily.

Exclusion Criteria:

* history of malignancy excluding both squamous cell carcinoma and basal cell carcinoma of the skin and/or any malignancies fully treated and considered cured by the treating physician for at least 1 year
* aortic aneurism/disease
* vertebral artery disease
* carotid artery stenosis/disease
* abdominal hernias
* portal hypertension
* cirrhosis
* cervical disc disease currently exhibiting radicular symptomatology (i.e. numbness, burning, muscle weakness, etc)
* infectious mononucleosis in the past 12 weeks,
* pneumothorax
* bone disease
* Participants with a medical access port and/or a noncompliant ribcage will be excluded from the study.
* The potential causes for ribcage noncompliance include:

  * congestive obstructive pulmonary disorder (COPD)
  * spinal arthritis
  * costochondritis
  * congestive heart failure (CHF)
  * pulmonary edema
  * recent trauma to the ribcage
  * certain connective tissue disease such as Ankylosing Spondylitis
* There is a risk of abdominal aortic aneurysm (AAA) rupture in participants with AAA and these participants are excluded from the study.