cyrilzakka/clinical-trials huggingface dataset:
Bismuth for PCAB-based H. Pylori Eradication

Tegoprazan is a new potassium-competitive acid blocker (PCAB) that has been clinically available since 2018 in South Korea. P-CAB is highly active drugs targeting H+, K+ -ATPase in the gastric acid secretion of parietal cells. The mechanism of action is different from that of PPIs. Conventional PPIs require 3-5 days to achieve maximal and steady-state gastric acid inhibition, whereas P-CAB increases the intragastric pH to nearly 7 within four hours. In Japan, H. pylori eradication success rates has increased by therapies using P-CAB than those using proton pump inhibitors, owing to the stronger acid suppression capability of P-CAB.

Bismuth has long been used to treat peptic ulcer disease, dyspepsia, parasite infections, and infectious diarrhea. The antibacterial effects of bismuth include inhibition of protein and cell wall synthesis in H. pylori. The main role of bismuth is to increase the eradication rate by 30%-40% in resistant H. pylori strains.

The investigators aim to evaluate the success rate and adverse drug events of bismuth added to PCAB-based triple therapy as a first-line regimen for H. pylori infection.

Eligibility Criteria:
Inclusion Criteria:

* Gastroscopy can be performed
* H. pylori test and pathological analysis can be performed

Exclusion Criteria:

* Age \< 20 or \> 80 years
* Anemia (serum hemoglobin level \< 10 g/dL)
* Severe systemic disease
* Advanced chronic liver disease
* Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
* History of H. pylori eradication
* Drug allergy to antibiotics
* History of gastric surgery
* Recent history of upper gastrointestinal bleeding
Effect of Time Delay and Syringe Surface Area on Blood Gas Samples Analysis

To detect the effect of time delay and syringe surface area on the oxygen tension (PaO2), oxyhaemoglobin saturation (SaO2), acidity (pH), and carbon dioxide tension (PaCO2) in both arterial and venous blood gas outcomes.

Arterial blood gas (ABG) analysis and monitoring is a crucial process for the diagnosis and management of the oxygenation status and acid-base balance of high-risk patients during surgery, as well as for the critical care of critically ill patients in the Intensive Care Unit .

Acid-base imbalance anomalies can have major repercussions in a number of medical scenarios, and in a few rare instances, they may even be a risk factor for death.

ABG test explores the arterial blood's pH, oxyhaemoglobin saturation (SaO2), bicarbonate concentration (HCO3), oxygen tension (PaO2), and carbon dioxide tension (PaCO2).

Traditionally, the concept "blood gas testing" has been used to describe measuring the blood's pH, oxygen saturation of haemoglobin (SaO2), and partial pressures of the physiologically active gases (pO2, pCO2). But now available commercial equipment can measure electrolytes (sodium, potassium, chloride, ionized calcium, and magnesium), glucose, lactate, and creatinine, usually all at the same time, in addition to haemoglobin quantification and co-oximetry

Eligibility Criteria:
Inclusion Criteria:

* Critically ill-patients, and intraoperative patients who aged above 18 years.

Exclusion Criteria:

* Patients with haematological diseases e.g. sickle cell anaemia
* burn patients with risk of carbon monoxide poisoning
* ARDS
* pulmonary oedema
* samples that were clotted
A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate

This study is to evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid Arthritis patients who showed unsuccessful response against methotrexate.


Eligibility Criteria:
Inclusion Criteria:

* Patients with more than 6 months history of rheumatoid arthritis according to ACR criteria
* Patients who have been treated unsuccessfully to more than single DMARDs including methotrexate at the discretion of investigator
* ESR ≥ 30 mm/h or CRP ≥ 1.0 mg/dL (ESR: Erythrocyte Sedimentation Rate, CRP: C-Reactive Protein)
* Patients are required to have at least 3 of 66 joints assessed as swollen
* Patients are required to have at least 6 of 68 joints assessed as painful with pressure

Exclusion Criteria:

* Pregnant or breast-feeding patients. Patients who plan to bear children or breast-feed during the study and within 6 month after completion of study
* Previous experience of tacrolimus (ointment excluded)
* Renal impairment or serum creatinine \> 1.4 mg/dL
* Liver function failure as follows: viral hepatitis, non-viral hepatitis, cirrhosis, SGOT/SGPT \> 2x upper limit normal
* Patients with history of pancreatitis, glucose intolerance or complication or who indicates any of the following criteria:Blood glucose level \>110mg/dl before the meal and \>200mg/dl after the meal HbA1c \> 6.4%
* Cardiac disease(ischemic heart disease, treatment-requiring arrhythmia, heart failure)or complications
* Other investigational drug within last 30 days
* Patients who have been treated with infliximab, adalimumab, or leflunomide within 8 weeks of start of the study
Iguratimod in Systemic Sclerosis

The purpose of this study is to evaluate the safety, tolerability and efficacy of iguratimod in adult subjects with diffuse cutaneous systemic sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of systemic sclerosis (SSc), as classified using the 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc.
* Diffuse Cutaneous Systemic Sclerosis (dcSSc) as defined by 2001 LeRoy and Medsger Disease duration ≤ 3 years (defined as time from the first non-Raynaud phenomenon manifestation).
* Agree to use effective contraception during the study period (women of childbearing age).
* Smokers agreed to quit smoking during the study.
* Ability to provide informed consent.

Exclusion Criteria:

* The following drugs have been used within one month before screening: including TNF-α inhibitors (continuous use for more than 14 days), IL-6 inhibitors, abatacept (continuous use for more than 14 days), JAK inhibitors (continuous use for more than 14 days).
* Used rituximab within 3 months before screening.
* SSc with tumor.
* People with various lung infections, asthma or other lung diseases such as bronchiectasis.
* For patients with severe heart, liver, kidney and other important organ dysfunction, the evaluation criteria are as follows: ALT or AST is greater than 2 times the upper limit of normal, or total bilirubin rises twice; CPK\>400; Renal crisis, or hypertension of various causes (≥160/100mmHg) is not controlled; Creatinine clearance rate \<30ml/min; White blood cell count\<3×109/L; Hemoglobin \<80g/L; Platelet count\<60×109/L; Heart function level III-IV; PaO2\<50mmHg in resting state; FEV1/FVC\<0.7.
* In the period of acute or chronic infection (not including finger ulcer combined infection).
* A history of peptic ulcer or bleeding within 6 months before screening.
* People with allergies or multiple drug allergies.
* People with mental illness or other reasons who cannot cooperate with treatment.
Delaying Alzheimer Disease Symptoms With Anti-Inflammatory Drugs

The purpose of this study is to determine whether the anti-inflammatory drug celecoxib can delay the onset of Alzheimer Disease (AD) in people with Age Associated Memory Impairment (AAMI). This study will also evaluate genetic risk and brain structure as potential predictors of mental decline.

AD is one of the most common mental disorders of late life. Preliminary studies indicate that anti-inflammatory drugs may attenuate or prevent AD symptoms, but efficacy trials are needed.

Participants in this study will be randomly assigned to receive either celecoxib or placebo for 18 months. Participants will undergo positron emission tomography (PET) and magnetic resonance imaging (MRI) scans of the brain. Routine laboratory blood tests, cognitive tests, and an electrocardiogram (ECG) will be performed. Participants will also be screened for Parkinson disease. Follow-up testing will be conducted at specific intervals following the study.

Eligibility Criteria:
Inclusion Criteria:

* NIMH diagnostic criteria for Age Associated Memory Impairment (AAMI)
* Mini-Mental State Examination (MMSE) score between 26 and 30 (unless \< 8 years of educational achievement)
* No significant cerebrovascular disease
* Estrogen replacement therapy and thyroid replacement therapy (if the participant is euthyroid) are permitted if the therapies are stable for \> 1 month
* Memory and verbal fluency cut-off scores that increase the probability of incipient dementia (Buschke-Fuld: 34; verbal fluency: 46 for letters, 7 for categories; Benton Visual Retention: 5)
* Adequate visual and auditory acuity to allow neuropsychological testing
* Normal screening laboratory tests and electrocardiogram (ECG)

Exclusion Criteria:

* Possible or probable Alzheimer Disease (AD) or other dementia
* Neurologic or other physical illness that could produce cognitive deterioration
* History of transient ischemic attacks (TIAs), carotid bruits, or lacunes on an MRI scan
* History of myocardial infarction within the previous year or unstable cardiac disease
* Uncontrolled hypertension (systolic BP \> 170 or diastolic BP \> 100)
* History of significant liver disease, pulmonary disease, diabetes, or cancer
* DSM-IV criteria for major psychiatric disorders within the previous 2 years
* Past or present history of alcoholism or drug dependence
* Untreated depression as determined by a Hamilton Depression Rating Scale (HAM-D) score of 12 or more
* Drugs that may significantly affect psychometric test results
* Centrally active beta-blockers, narcotics, clonidine, anti-Parkinsonian medications, antipsychotics, benzodiazepines, systemic corticosteroids, medications with significant cholinergic or anticholinergic effects, anti-convulsants, warfarin, vitamins other than the standard multivitamin supplement, ginkgo biloba, and any nutraceuticals. Occasional chloral hydrate use will be allowed, but discouraged, for insomnia.
* Investigational drugs within the previous month or longer, depending on drug half-life
* Contraindication for MRI scan (e.g., metal in body, claustrophobia)
Food-Based Intervention and Psychosocial Stimulation to Improve Growth & Development of < 24 Month Indonesian Children

WHO has urged all developing countries to develop programmes to improve complementary-feeding (CF) practices because of their importance for optimal growth, development and health of infants and young children While supplementation programmes and/or highly-fortified "super-foods" have limited success in improving CF-practices in disadvantaged environments, population-specific food-based dietary guidelines (FBDG), based on locally-available foods and requires minimal changes to local food pattern, will enhance the chances of programme success.

Our previous study was able to identify the need for, potential and finally develop FBDG for CF of 6-8mo and 9-11mo infants using combined linear-and-goal programming approach (LP approach). This research is therefore being made to support the next phase of the study i.e. to assess the efficacy of FBDG, for improving CF/dietary-practices and growth in \<24mo children (window of opportunity). As growth and development is inter-related, home-based stimulation will be included in this trial to see the effect on child development. While studies have shown that stimulation at early age benefits children through their late adolescence; evidence from Indonesia is lacking. This study therefore aims to see the effect on growth and development of community trial using food-based dietary guideline and stimulation. It is expected that findings from this study will provide scientific evidence as the basis for program formulation.


Eligibility Criteria:
Inclusion Criteria:

* children aged 9-11 month on enrolment,
* weight-for-age Z-score \<-1.00 but \>-3.00

Exclusion Criteria:

* having mental or physical disabilities
A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens

This study was conducted to evaluate the clinical performance of an investigational silicone-hydrogel lens against Senofilcon A toric lens.

The study results were not used for design validation of the investigational product.

This will be a randomized, bilateral, 2-week cross-over, double-masked, dispensing study comparing the investigational test lens against the Senofilcon A Toric for Astigmatism control lens.

Eligibility Criteria:
Inclusion Criteria:

* A person is eligible for inclusion in the study if they:

  1. Are at least 18 years of age and have full legal capacity to volunteer;
  2. Have read and signed an information consent letter;
  3. Are willing and able to follow instructions and maintain the appointment schedule;
  4. Are an adapted soft contact lens wearer;
  5. Require spectacle lens powers in both eyes;

     1. Sphere: between -1.75 to -6.00 diopters and
     2. Astigmatism: between -1.00 to -2.25 and
     3. Axis: 180 ± 20 degrees
  6. Are willing to wear contact lenses in both eyes;
  7. Have manifest refraction visual acuities (VA) equal to or better than logMAR (log of the minimum angle of resolution) equivalent of 20/25 in each eye;
  8. To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit including toric orientation as acceptable.

Exclusion Criteria:

* A person will be excluded from the study if they:

  1. Are participating in any concurrent clinical or research study;
  2. Have any known active\* ocular disease and/or infection;
  3. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  4. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  5. Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  6. Are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
  7. Are aphakic;
  8. Have undergone refractive error surgery;
Operative Versus Non Operative Treatment of Proximal Humerus (Shoulder Joint) Fractures

To determine if operative treatment of non operative management of these fractures is best. Hypothesis: There is no difference in functional outcome between operative and non-operatively treated 3- and 4-part proximal humerus fractures at one year's time.

Participants of 70 years of age or older who have been medically assessed as 'fit for surgery' are randomly (like flipping a coin) to either operative or non operative management of their injury. Clinical follow-up including x-rays, and physical assessment of injured shoulder, and outcomes questionnaires will be used to determine which if either resulted in the best outcome.

Eligibility Criteria:
Inclusion Criteria:

* Proximal humerus fracture patients
Resistance Training in People Living With HIV/AIDS

The aim of this study will be to verify effects of resistance training in people living with HIV/AIDS.

The aim of this study was verify effects of resistance training in cognitive function, body composition and biochemical parameters of inflammation and oxidative stress in people living with HIV/AIDS. The sample was composed by patients with HIV/AIDS of both sexes. The patients were randomized in two groups, a exercise group (EG), which was receive intervention with eight weeks of resistance training, and a control group (CG), that was not to do exercise. The cognitive function was analyzed with Stroop Test and Trail Test; body composition was evaluated by bioimpedance; blood tests was use to analyze biochemical parameters of inflammation and oxidative stress. For statistical analysis was used ANOVA of two factors for repeated measurements, having the (EG and PG) group and the time (pre and post exercise). Level of significance adopted was P \< 0,05.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnostic for HIV/AIDS.
* Clinical condition and viral count stabilized.
* Have been using (HAART) for 6 months or more.
* Not have participated in physical exercise programs in six months before beginning of study.
* Not have muscle or joint injuries that make it impossible to practice physical activity.
* Not be pregnant.

Exclusion Criteria:

* Not attending more than 15% of the intervention sessions or visits to the laboratory.
* Aggravation of the disease.
* Stick to a physical activity program in addition to that offered by the study.
Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy

The primary objective of this study is to retrospectively compare the perioperative and short-term (discharge through 30 days) outcomes of intracorporeal and extracorporeal anastomosis in minimally invasive right colectomies for benign and malignant disease.

The secondary objective of this study is to retrospectively compare the rates of incisional hernia (up to 6 month post procedure) between intracorporeal and extracorporeal arms.

This is a multi-center, retrospective chart review study of all consecutive cases of right colectomy performed by participating surgeons at their respective institutions that meet all inclusion and exclusion criteria. All cases of right colectomy performed with intracorporeal or extracorporeal anastomoses or via laparoscopic or robotic platforms that meet the study inclusion and exclusion criteria, will be considered for inclusion. The chart review will be performed in a reverse chronological order starting at a minimum of 30 days prior to IRB approval of the study at the site until the number of robotic-assisted and laparoscopic cases to be included per surgeon has been met. Study initiation at the participating site will occur once a research agreement has been executed between Intuitive Surgical and the participating Institution/Investigator and IRB approval has been obtained.

It is anticipated that the retrospective chart review will span the period between January 1, 2010 through 30-days prior to IRB approval of the study in 2016. Baseline patient characteristics, perioperative and post-operative short term clinical and pathological outcomes, and incisional hernia data will be obtained from hospital records for a total of up to approximately 1000 robotic and laparoscopic cases, among the 4 subgroups: robotic-assisted right colectomy with intracorporeal anastomosis (RRCIA), robotic-assisted right colectomy with extracorporeal anastomosis (RRCEA), laparoscopic right colectomy with intracorporeal anastomosis (LRCIA) and laparoscopic right colectomy with extracorporeal anastomosis (RRCEA). Since the data will have been de-identified, and is archival in nature, there will be no active subject recruitment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients with benign or malignant right colon disease
* Patients who have undergone robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to mid-transverse colon

Exclusion Criteria:

* Patients with perforated, obstructing or locally invasive neoplasm (T4b)
* Emergency procedures
* Patients undergoing right colectomy as a secondary procedure
* Patients undergoing radiation therapy for malignant neoplasia before and after procedure
Clinical Trial : TROCC (Quick Oral Treatment of Cluster Epileptic Seizures)

This is a double blind, placebo controlled, add-on clinical trial, of levetiracetam efficacy and safety, in epilepsy cluster seizure.

Efficacy is evaluated in the range of 2 to 24 hours after taking the tablet. If the patient has a seizure during this interval, he is considered as a non-respondent patient.

Seizure clustering has been defined as a series of unusual frequency of seizures with return to baseline between events. The most common definition of cluster seizure is three seizures per 24 hours.

The usual treatment of cluster seizure is benzodiazepin. This is recognized efficient therapy but has many side effects. Thus it is important to develop as an new therapeutic to improve patient care. Levetiracetam is an antiepileptic drug used in addition to other antiepileptic drugs with less side effects than benzodiazepin.

The aim of this study is to evaluate the effectiveness and safety of levetiracetam in epilepsy cluster seizure.

This is a double blind, placebo controlled, add-on clinical trial with two phases :

Phase 1 : Double blind phase during 24 hours (H0 to H24). After consent signature and randomization, the patient takes two tablets of levetiracetam or placebo. If the patient has a seizure between H3 and H24, he is considered as a non-respondent patient. If there is a risk of rapid evolution to an statue epilepticus, the investigator can break the blind and adapt the patient treatment accordingly.

Phase 2 : This is an open phase after H24. this phase consists of breaking the blind with free adaption of the therapy by the investigator, and patients follow-up during 1 month.

The randomization is stratify by center. The size of randomization blocks is random because of the systematic breaking blind after 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65
* Drug resistant epilepsy, partial seizure
* Epilepsy diagnosed for more than 2 years
* Epilepsy treated for more than 1 year with no change of treatment in the month before the enrolment
* Onset of cluster seizure in the 24 hours before enrolment
* For women : effective contraception
* Affiliation to the French social security

Exclusion Criteria:

* Inability to tolerate levetiracetam, likely poor compliance
* Patient taking antiepileptic treatment (benzodiazepine) in addition to current treatment during the last 48h00.
* Patient taking 1g/day of levetiracetam with Creatinin clearance \< 50ml/min
* Patient taking 2g/day of levetiracetam with Creatinin clearance \< 80ml/min
* Patient taking more than 2g/day of levetiracetam
* Hepatic or cardiovascular pathology
* Progressive psychiatric pathology
* Degenerative neurologic disease
* Cluster seizure due to an acute symptomatic reason
* Disorder of consciousness
* Suspicion of status epilepticus or rapid evolution to status epilepticus
* Suspicion of psychogenic nonepileptic seizure
* Pregnant woman or nursing woman
* Suicidal thoughts
* Incapacity to give consent, minor patient
Mobile Messages Affects Adherence of Stent Removal or Exchange in Patients With Benign Pancreaticobiliary Diseases

Plastic and covered metal stents need to be removed or exchanged within appropriate time in case of undesirable complications. However, it is not uncommon that patients does not follow the recommendation for further stent management after ERCP. we hopothesized that short message service (SMS) intervention monthly could improve the adherence in patients with benign pancreaticobiliary after ERCP.


Eligibility Criteria:
Inclusion Criteria:

* be able to communicate via SMS by mobile phones of themselves or relatives living together

Exclusion Criteria:

* primary or secondary sclerosing cholangitis (PSC)
* malignant or suspected malignant stricture of biliary or pancreatic duct
* implantation of pancreatic duct (PD) stent for prevention of post-ERCP pancreatitis
* expected survival time less than 6 months
* plan of surgery within 6 months
* pregnant or lactating women
* patients who could not give informed consent.