cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Non Erosive Reflux Disease

The purpose of this study is to demonstrate the superiority of efficacy of CJ-12420, once daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4

This is a double blind, randomized, placebo-controlled, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (CJ-12420 50 mg or 100 mg or placebo).

All subjects will be asked to take two tablets at the same time each day throughout the study, and also all subjects will be asked to record daily symptom in a subject diary on a daily basis.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged between 20 and 75 years
2. Subjects who had experienced a minimum three-month history of main symptom(heartburn and regurgitation)
3. Subjects were to have normal esophagus confirmed by endoscopy within 14 days prior to randomization
4. Subjects who is able to understand and follow the instructions and is willing to participate throughout the entire study
5. Subjects who voluntarily signed written informed consent form
6. Subjects who agreed to use medically acceptable contraceptives during the period of study
7. Subjects who had experienced heartburn and regurgitation within 7 days before randomization. Entry into study also required that patients had experienced at least mild upper gastrointestinal symptoms on at least 2 days/week or at least moderate upper gastrointestinal symptoms on at least 1 day/week

Exclusion Criteria:

1. Subjects who cannot undergo EGD
2. Subjects who have esophageal stenosis, ulcer stenosis, gastroesophageal varices, Barrett's esophagus, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by EGD
3. Subjects who have erosive esophagitis, acute upper gastrointestinal bleeding, gastric ulcers or duodenal ulcers, acute erosive gastritis within 2 months before randomization. Subjects with gastric or duodenal erosions are allowed to be included.
4. Subjects who have warning symptoms of malignant gastrointestinal tract such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool
5. Subjects with eosinophilic esophagitis
6. Subjects diagnosed with functional dyspepsia, primary esophageal motility disorder, IBS, IBD, etc. or with suspected IBS in the last 3 months
7. Subjects who have a history of gastric acid suppression surgery or upper gastrointestinal, esophageal surgery
8. Subjects who have bipolar disorder, anxiety disorder, panic disorder, somatoform disorder, personality disorder and psychiatric disorders.
9. Subjects who are taking antipsychotic drugs, antidepressants or antianxiety medications
10. Subjects who should continuously administer NSAIDs during the trial.
11. Pregnant or lactating women
12. Subjects with a history of clinically significant hepatic, renal, cardiovascular, respiratory, endocrine and CNS system disorder
13. Subjects with a history of hypersensitivity to the active ingredient or excipients of the study drug, etc.
14. Subjects who participated in the other clinical trial within 4 weeks prior to randomization
The Effect of Antenatal Corticosteroid on Umbilical Artery Doppler Velocimetry in IUGR

The purpose of this study is to evaluate the effect of antenatal corticosteroid administration on umbilical artery Doppler velocimetry measurements in pregnancies complicated by IUGR.

This study was conducted with pregnant women who were likely to have preterm birth and were treated with antenatal corticosteroids. Betamethasone was used as an antenatal corticosteroid. UA Doppler measurements (PI, S/D ratio, RI) before antenatal corticosteroid administration and 24 and 48 hours after the last dose of corticosteroid administration were evaluated in pregnant groups complicated with IUGR and uncomplicated with IUGR and compared with each other.

Eligibility Criteria:
Inclusion Criteria:

pregnant women who were likely to have preterm delivery and were treated with antenatal corticosteroids.

Exclusion Criteria:

Pregnant women who had complicated pregnancy with fetal anomaly, who had multiple pregnancies, who left their pregnancy follow-up unfinished, and those under 18 years of age were excluded from the study.
Effect of Preoperative Diclofenac Potassium on Postoperative Endodontic Pain

The purpose of this study is to assess the effect of preoperative a single-dose of 50 mg diclofenac potassium on postoperative endodontic pain in mandibular molars with symptomatic irreversible pulpitis.

Patients with moderate-to-severe preoperative pain are selected. Patients receive either a single-dose of 50 mg diclofenac potassium (group A) or a placebo tablet as a control (group B). All patients receive the assigned premedication one hour before single-visit root canal treatment. Postoperative endodontic pain is measured at the following time points: 6 , 12,24,48 h after treatment. The incidence of analgesic intake is also recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients with active pain (moderate-to-severe) in mandibular molars.
* Patients with prolonged response to cold testing and electric pulp tester.
* Patient with the ability to understand and use pain scales.
* Patient with vital coronal pulp tissue on access.
* Patient who accept to enroll to the study.

Exclusion Criteria:

* Patients' allergies or any other contraindication to diclofenac potassium or articaine.
* Pregnant and lactating females.
* Patients having pain medication in the last 6 hours.
* Patient has more than one symptomatic mandibular tooth in the same quadrant.
* Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments.
* Patients with active peptic ulcer and gastrointestinal disorders.
* Patients with history of bleeding problems or anticoagulant use within the last month.
Time Prediction and Cerebellum: Magnetic Transcranial Stimulation (TMS) in Healthy Volunteers

The aim of the study is to check the role of the cerebellum in time prediction in healthy volunteers, by means of magnetic transcranial stimulation targeted on the cerebellum, and recording of behavioural measures indexing time prediction


Eligibility Criteria:
Inclusion Criteria:

* Participant, male or female, between 18 and 60 years old
* Subject affiliated to a social health insurance scheme (beneficiary or entitled person)
* Subject who has dated and signed an informed consent form
* For a woman of childbearing age, negative pregnancy test and effective contraception throughout the study

Exclusion Criteria:

* - Participant with substance use disorders (as defined by DSM-V)
* Participants taking benzodiazepines and related substances (in the period before inclusion, for a duration equivalent to 5 half-lives of the product), cannabis (in the 2 months before inclusion) or hallucinogenic substances (in the period before inclusion, for a duration equivalent to 5 half-lives of the product).
* Participant with neurological pathology or sequelae
* Participant with Attention Deficit Hyperactivity Disorder (ADHD)
* Participant with a borderline personality disorder
* Participant with disabling sensory impairments, including visual acuity (corrected, if applicable) \< 0.8 (due to use of visual material) (Freiburg Vision Test, Bach 1996)
* Participant deprived of liberty or subject to the safeguard of justice
* Participant under guardianship or curatorship
* Participant in a period of exclusion defined by another clinical study or participant in a study that may impact on research results
* Pregnant or breastfeeding woman
* Subject with a contraindication to performing an MRI or TMS: presence of non-removable ferromagnetic body, prosthesis, pacemaker, medication delivered by an implanted pump, vascular clip or stent, heart valve or ventricular lead, certain intracerebral clips, cochlear implants, history of epilepsy, skin pathology at the point of contact with the electrodes.
* Subject with a history of major neurological or psychiatric illness with current psychotropic medication (i.e., antidepressant, thyroid regulator, antipsychotic, benzodiazepine and related drugs, or hypnotic).
The Endocannabinoid System in Human Gestational Tissues in Labor

The purpose of this research study is to determine if the endocannabinoid (a biological system) plays a role in the labor process.

This is a pilot study to determine the feasibility of identification and quantification of various components of the endocannabinoid system in the labored versus non-labored myometrium, placenta and gestational membranes.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women ages \> 18 years old
* Pregnant women 22 weeks, 0 days through 42 weeks, 0 days gestation undergoing cesarean section
* Singleton gestation

Exclusion Criteria:

* Cannabinoid use during pregnancy
* Illicit drug use during pregnancy
* Nonsteroidal anti-inflammatory drug use within 7 days of cesarean section
* Maternal comorbidities including pre-existing diabetes, pre-existing hypertension, hypertensive disorders of pregnancy (preeclampsia, eclampsia), epilepsy currently being treated with antiepileptic medication, intraamniotic infection
* Uterine abnormalities
* Fetal anomalies
* Drug use or dependency
D-cycloserine for Major Depressive Disorder

For many depression patients treatment changes are required, including switching to another antidepressant and addition of a second antidepressant or a non-antidepressant agent ("augmentation"). The need to modify treatment is usually necessary because of partial or no response to first-line monotherapy or the failure to achieve remission although treatment response (improvement) has been obtained. These caveats of presently available antidepressant drugs highlight the need for innovative pharmacological treatment strategies. Recent data suggest that N-methyl-D-aspartate receptor (NMDAR) antagonists and partial agonists at the NMDAR-associated glycine binding site may represent a novel type of antidepressant medications. These types of compounds protect vulnerable neurons against a variety of insults, including stress-induced damage, and may serve to enhance and maintain normal synaptic connectivity. In animal models, these compounds mimic the effects of clinically effective antidepressants. Furthermore, down-regulation of the glycine site of the NMDAR was found to be a common feature of currently used antidepressant medications. D-cycloserine (DCS , Seromycin) is a broad spectrum antibiotic, in use for over thirty years against tuberculosis, that acts as a partial agonist at the NMDAR-associated glycine site. Beneficial antidepressant effects have been reported with 500-1000 mg/day DCS regimens in depressed tuberculosis patients and recent preliminary findings suggest that DCS may also be beneficial in the treatment of major depressive disorder. The antidepressant effects of DCS seem to reflect consequences of its capacity to reduce NMDAR receptor function. In the present project, it is proposed to assess, using a random assignment, parallel-group, double blind, placebo controlled design, the effects of a NMDAR -antagonist DCS dose regimen, 250 --\> 1000 mg/day for 6 wks, as adjuvant pharmacotherapy for treatment-resistant major depressive disorder patients. The study methodology includes the assessment of DCS effects upon symptoms profile, neurocognitive tests performance, amino acids serum levels, and brain electrophysiology parameters associated with the prepulse inhibition-startle response paradigm. It is hypothesized that significant beneficial DCS treatment effects will be registered.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of major depression .
* HAMD scale score of ≥20 despite at least two adequate antidepressant treatment trials during the current episode.

Exclusion Criteria:

* Underwent ECT treatment during the 3 months preceding the study.
* Change in psychotropic medications doses during the 3 weeks preceding the study.
* Concurrent unstable medical or neurological illness.
* Patients are judged to be potentially violent towards themselves or others, or have a history of drug/alcohol abuse.
Patient Benefit From the New Modular Shoulder Prosthesis PROMOS

Overall study design:

This study is a prospective, non-randomized, multicenter postmarket clinical follow-up study with two study arms using the two shoulder prosthesis PROMOS™ STANDARD (group A) and PROMOS REVERSE™ (group B). The study will collect efficacy and safety data over 10 years.

Primary objective of the study:

The primary objective is to quantify patient benefit after primary total shoulder arthroplasty with the modular PROMOS™ shoulder system in a multicenter cohort study (real world approach). Patient benefit will be quantified using objective and validated subjective measures of function, activities of daily living (ADL) and quality of life (QoL).

Secondary objectives:

* Rate of implant related findings like radiological loosening of the glenoid and complications like intraoperative stem fissures
* Prosthesis survival at common time points, e.g. 5 and 10 years

Eligibility Criteria:
Eligibility:

* Ages eligible for study: minimal age of 18 years
* Genders eligible for study: both
* Accepts healthy volunteers: no

Inclusion Criteria:

* Primary or secondary omarthrosis as an indication for primary total shoulder arthroplasty
* Massive rotator cuff rupture
* Willing an able to give written informed consent to participate in the study including follow-ups

Exclusion Criteria:

* Previous ipsilateral shoulder arthroplasty (group A and B)
* Late stage rotator cuff disease (only group A)
* Acute shoulder trauma (group A and B)
* General medical contraindication to surgery (group A and B)
* Legal incompetence (group A and B)
* Tumour / malignoma (group A and B)
* Recent history of substance abuse (group A and B)
* Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder) (group A and B)
* Known hypersensitivity to the materials used (group A and B)
* Bacterial infection at the time point of operation (group A and B)
A Study to Evaluate Safety and Efficacy of PBK_M2101

This clinical trial was prospective, randomized, single-blind, 3-treatment arm, parallel treatment group, and active-controlled. , Multi-center, Phase 3 confirmatory clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients who is informed and give a consent in voluntary
* Patients who is scheduled a esophagogastroduodenoscopy and colonoscopy
* BMI 19≤and\<30

Exclusion Criteria:

* Patients who participate in other interventional study or had participated within 30 days before screening
* Pregnant or breast-feeding women who do not want to stop breast-feeding
* Uncontrolled hypertension
* Uncontrolled diabetes
* Fluid or electrolyte (Na, K, Ca, Mg, chloride, bicarbonate) disturbance
* HIV infection and/or chronic hepatitis B or C
* Patients who has a difficulty to participate because of severe nausea or vomiting
* History of colon surgery and abdominal surgery within 6 month; need an emergency surgery
Effect of Nutrition Supplementation Combined With Resistance Exercise in Elderly With Sarcopenia.

The purpose of this study was determine whether milk or soy milk supplements combined with resistance exercise improved sarcopenia in the elderly. This study was randomized controlled trail that recruited elderly people ≧65 years old with sarcopenia in the nursing home of Taipei Veterans General Hospital Su-Ao and Yuanshan Branch from June 2017 to December, 2017. The participants were divided into three groups, such as control, milk supplement and soy milk supplement. The milk and soy milk groups provided 200 mL milk or soy milk two times per day. Moreover, all participants joined the resistance exercise training program, three times per week (30 min/time). After 12 weeks, the anthropometry, sarcopenia index, blood biochemical index, nutrition status index, inflammation index, insulin resistance index, and dietary intake were measured.

The anthropometry data included body weight and body fat. The sarcopenia index included appendicular skeletal muscle mass index, calf circumferences, hand grip and gait speed. Moreover, blood biochemical index (liver function as ALT, kidney function as creatinine), nutrition status index (prealbumin, 25-hydroxyvitamin D) were also analyzed. The blood hsCRP level was as inflammation index and insulin resistance index included fasting blood sugar, insulin, HbA1c and HOMA-IR. The daily dietary intake were also recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age ≧ 65 years old
* No allergies to milk and soy milk
* Sarcopenia cases (AWGS)
* Active ability

Exclusion Criteria:

* End-of-life patient or estimated death within six months
* Last stage of cancer
* Chronic kidney disease stage 4
High VS Low Flow Nasal O2 for Acute Hypercapnic Respiratory Failure

Chronic lung conditions such as smoking related lung damage lead to breathing fail. This results in accumulation of gases such as carbon-di-oxide in the body especially during periods of illness known as exacerbation.

Current management of carbon-di-oxide accumulation is administration of oxygen, nebulisers, antibiotics etc and if necessary, provide a tight fitting mask around the face to provide breathing support. If this fails, then a patient is placed on a mechanical ventilator. The tight fitting mask therapy is also called non-invasive ventilation and is used widely but patients acceptability of the therapy is limited.

Providing a high flow of air with some oxygen could potentially provide the same benefit of the non-invasive ventilation and may also be better accepted by patients.

Currently the knowledge and evidence from studies suggest a beneficial role for this high flow therapy but this has not been investigated in well designed studies.

In the proposed study we aim to investigate whether use of the high flow therapy reduces the need for non-invasive ventilation in patients who present with a recent onset accumulation of carbon-di-oxide in their body due to long-term lung disease. If this shows benefit, it will lead to a bigger trial with patient benefiting by reduction in the non-invasive ventilation or indeed a need for an invasive breathing machine.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients \> 18 years of age
2. Acute Hypercapnic respiratory failure with pH \< 7.35 and pCO2 \> 6 KPa

Exclusion Criteria:

1. Age \< 18 years
2. Pregnant or Breast-Feeding
3. Patient cannot read and understand English
4. Hypercapnia secondary to a drug toxicity or non-pulmonary aetiology
5. Hypercapnia secondary to exacerbation of asthma
6. Contraindication to NIV
7. Contraindication to HFNC
8. Not for escalation to NIV
9. pH \< 7.15
10. GCS 8 or less
11. Shock defined as systolic \< 90 mmHg or a reduction by 20mmHg from usual systolic BP despite volume resuscitation
12. Respiratory or cardio-respiratory arrest
13. Any other indication that requires immediate invasive/non-invasive mechanical ventilation
Optical Coherence Tomography to Evaluate Ticagrelor and Clopidogrel

A number of 352 patients scheduled for elective percutaneous coronary intervention (PCI) with a native coronary stenosis suitable for DES implantation and OCT imaging are openly randomized 1:1 to either BRILINTA™ (ticagrelor) or Plavix® (clopidogrel bisulfate).

The study is prospectively conducted at 4 high-volume PCI center in China with OCT expertise. Angiographic follow-up and OCT imaging with motorized pull-back at 20-36 mm/s are planned in all patients 12 months after implantation of the study stents. OCT endpoints are: (1) Subclinical intra-stent thrombus, defined as a mass protruding to the lumen with significant attenuation, and respectively (2) endothelial coverage, expressed as % of struts without coverage and % of stent length containing non-covered struts. The study is powered for OCT endpoints, which are likely to reach significance at the level P \< 0.05 even at a follow-up drop-out rate up to 10%.

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures;
* Men and women 18 years and older;.
* Established indication to PCI according to the guidelines of American Heart Association and American College of Cardiology;
* Native coronary lesion suitable for drug-eluting stent placement and OCT imaging.

Exclusion Criteria:

* Pregnancy and breast feeding mother;
* Co-morbidity with an estimated life expectancy of \< 50 % at 12 months;
* Scheduled major surgery in the next 6 months;
* Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
* Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days
* Cardiogenic shock
* Previous subacute or late coronary stent thrombosis
* Known allergy against ticagrelor, or against clopidogrel, or aspirin
* History of major hemorrhage (intracranial, gastrointestinal, etc.)
* Active pathological bleeding
* Acute or chronic hematologic disorder including a Hemoglobin less than 10 g/L or a platelet count less than 10×109/L before procedure
* Any history of Severe renal or hepatic dysfunction (hepatic failure, cirrhosis, portal hypertension and active hepatitis);
* Neutropenia,
* thrombocytopenia;
* Known acute pancreatitis
* Arterial aneurysm, arterial/venous malformation and aorta dissection.
* Culprit lesion within the proximal 10 mm of the right or left coronary artery
* Saphenous vein grafts
* Lesion length \> 30 mm
* Involves a side branch ≥2.0 mm in diameter by visual estimate which requires treatment
* In-stent restenotic lesions
* Thombus-containing lesions
Cytokine REmoval in CRitically Ill PAtients Requiring Surgical Therapy for Infective Endocarditis (RECReATE)

Infectious endocarditis (IE) and other severe infections are well-known to induce significant changes in the immune response including immune functionality in a considerable number of affected patients. In fact, numerous patients with IE develop a persistent functional immunological phenotype that can best be characterized by a profound anti-inflammation and/or functional anergy. This was previously referred to as "injury-associated immunosuppression (IAI)" by Pfortmüller et al., published in Intensive Care Medicine Experimental 2017. IAI can be assessed by measurement of cellular (functional) markers. Persistence of IAI is associated with prolonged ICU length of stay, increased secondary infection rates, and death. Immunomodulation to reverse IAI was shown beneficial in immunostimulatory (randomized controlled) clinical trials. CytoSorb® treatment is currently used as standard of care in some institutions in surgically treated IE patients. The investigators aim to investigate two accepted treatment protocols and aim to explore whether adsorption with a cytokine adsorption filter can increase immune competence in treated individuals.


Eligibility Criteria:
Inclusion Criteria:

* Subjects scheduled for routine cardiac surgery for infectious endocarditis (diagnosed according to the predefined "DUKE" criteria) with antibiotic therapy for ≤ 14 days.
* Presence of informed consent
* Age ≥18 yrs.

Exclusion Criteria:

* Previous treatment (last 6 months) with immunologically-active biologicals or specific immunomodulatory drugs (e.g. Rituximab)
* high-dose chronic (i.e. before onset of infectious endocarditis) steroid medication with prednisone equivalent of \>30 mg/d
* Patients on Extracorporeal membrane oxygenation (ECMO), or any other (pre-operative) cardiac assist device
* Moribund patient (life expectancy \<14 days)