cyrilzakka/clinical-trials huggingface dataset:
Bismuth-containing Quadruple Therapy for Helicobacter Pylori First-line Treatment of Different Tetracycline Doses

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a dose and frequency of tetracycline 500mg tid or qid of bismuth quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. If the subject meets the selection criteria but not the exclusion criteria, and signs an informed consent form, the researchers randomized the subjects in groups: subjects received a dose and frequency of tetracycline 500mg tid or qid of bismuth-containing quadruple eradication therapy. The medication of groups are as follows. 6-8 weeks after the eradication treatment, the subjects will review the 13C-urea breath test, and the researcher records the results.

After all subjects were tested, the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group were calculated.

According to the course of treatment, it is randomized into a tid treatment group and a qid treatment group. The two groups of bismuth quadruple regimens are the same, as follows:

Tid group: Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 20mg bid Qid group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 20mg bid

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70.
* Patients with H.pylori infection (Positive for rapid urease test or 13C/14C-urea breath test).
* Patients who have never received H. pylori eradication treatment.

Exclusion Criteria:

* Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate \<50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.
* Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
* Patients with active gastrointestinal bleeding.
* Patients with a history of upper gastrointestinal surgery.
* Patients allergic to treatment drugs.
* Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks
* Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
* Patients who are unwilling or incapable to provide informed consents.
Evaluation of LDL Cholesterol in Patients Switched From 10 to 5 Milligrams of Zetia (Ezetimibe)

The purpose of this study is to compare the effect on LDL cholesterol levels of converting patients who are receiving the cholesterol absorption inhibitor Zetia at a dose of 10 milligrams to 5 milligrams, when prescribed as a split 10 milligram tablet.


Eligibility Criteria:
Inclusion Criteria:

* Subjects receiving ezetimibe 10 mg
* Subjects who have demonstrated compliance with ezetimibe as evidenced by the following Proportions of Days Covered patterns (which represent a PDC of more than 75%):

  * 90 day prescriptions: Filled a ezetimibe prescription within the previous 4 months
  * 60 day prescriptions: Filled a ezetimibe prescription within the previous 2.5 months
  * 30 day prescriptions: Filled a ezetimibe prescription within the previous 1.5 months
* Patients willing and able to provide signed informed consent

Exclusion Criteria:

* Patients not receiving ezetimibe
* Patients receiving ezetimibe 5 milligrams
* Patients with a history of being titrated from ezetimibe 5 to 10 mg. Stroke,TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within the 3 months
* Cancer undergoing active treatment
* Participation in any clinical study within the last 30 days
* Drug addiction or alcohol abuse within the past 6 months
* Patients unwilling or unable to provide informed consent
* Patients with poor compliance
* Women of childbearing potential
Comorbidities Resolution After MGB Surgery and Change in Body Composition

This observational study aims to learn about the correlation between the improving comorbidities associated with obesity after MGB (Mini-Gastric Bypass) surgery and changes in body composition in morbidly obese patients. The main questions it aims to answer are:

To study the correlation between the improving comorbidities associated with obesity after MGB(Mini-Gastric Bypass) surgery and changes in body composition.

Other objectives are:

* Changes in the parameters of the metabolic syndrome after surgery
* Changes in the cardiovascular risk biomarkers after metabolic surgery
* Emergence in complications arising out of surgery requiring any intervention or causing a prolonged hospital stay, or requiring additional outpatient visits.

Type of Study: An observational study in which participants with morbid obesity will undergo mini-gastric bypass surgery as per routine protocol. No separate experimental interventions will be done in the study for the participants.

Evidence supports that bariatric or metabolic surgery is more effective than conventional therapy in controlling obesity and its related comorbidities. Although bariatric surgery has been widely practised for many years worldwide, there is still a need to understand the correlation between improving comorbidities associated with morbid obesity and body composition change post-surgery. Amongst the comorbidities, type II diabetes, sleep apnea, hypertension, and hypothyroidism are the significant ones associated with morbid obesity. A disturbed quality of sleep results in daytime sleepiness, cardiac problems, renal problems, etc., which in turn grossly reduces the work efficiency of an individual and increases morbidity and mortality. From our experience, after a metabolic surgery (mini-gastric bypass -MGB), the investigators find comorbidities, especially sleep apnoea and type II diabetes, getting controlled early before significant weight loss has started. Also, there is an improvement in the parameters of the metabolic syndrome after metabolic surgery. The prospective cohort study aims to correlate the comorbidities resolution after mini-gastric bypass surgery for morbid obesity and change in body composition.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing laparoscopic MGB surgery for morbid obesity and it's associated comorbidities

Exclusion Criteria:

* Patients not giving consent for the study
* All patients who were undergoing a redo-procedure for recurrence were excluded from the study
Comparison of Therapeutic Effects Between Intravitreal Injection of Bevacizumab With Intravitreal Injection of Bevacizumab and Targeted Laser Photocoagulation of Non Perfused Areas of Retina in Patients With Acute Retinal Vein Occlusion

Patients with new onset retinal vein occlusion in less than 3 month whom has visual acuity less than 20/40 and central macular thickness more than 250micrometer and non perfused areas of retina more than 10 DD are included in over study and devided into 2 groups randomizely, Group A under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness, if in month four or more the CMT is more than 250 micrometer and the visual acuity is less than 8/10 the injection is repeated and follow up in this manner is continued until 9 months.

Group B is as the same of group A but patients in this group undergone laser photocoagulation of retinal non perfused areas based on FAG wide field imaging .

After 9 month follow up the outcomes such as Vusal acuity, Central macular thickness, intraocular pressure, neovascular formation are compared,


Eligibility Criteria:
Inclusion Criteria:

* Center-involved macular edema secondary to RVO on clinical exam
* Symptoms less than 3 months
* BCVA= 20/40 or worse
* Mean center point thickness \>250 μm
* Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs

One eye per participant is enrolled in the trial

Exclusion Criteria:

* Macular edema due to a cause other than CRVO
* An ocular condition such that visual acuity would not improve from resolution of the edema (eg, foveal atrophy)
* Substantial cataract estimated to have reduced visual acuity by \>3 lines
* Prior treatment with intravitreal or peribulbar steroid injection
* History of macular photocoagulation or PRP
* Prior pars plana vitrectomy
* Hx of Intraocular surgery (including cataract extraction)
* uveitis, NVG, exudative AMD, diabetic retinopathy, any malignancy, optic neuropathy, amblyopia
* vitreomacular traction or epiretinal membrane \*uncontrolled glaucoma ( \> 30mmHg with anti-glaucoma medications)
The Expression of Aquaporin 3, 8 and 9 in Placenta in Normal and Preeclamptic Pregnancies: Perinatal and Neonatal Outcomes.

The etiologic agent responsible for the development of preeclampsia remains unknown. Aquaporins, members of integral membrane proteins, are responsible of water molecules movements through the plasma membrane channels, energy metabolism and associated with changes in cellular volume during apoptosis.

İn such placental pathology as preeclampsia, characterized with superficial implantation and increased apoptosis leading to a relative hypoxia between mother and fetus, the hypothesis of aquaporins important role in energy homeostasis and apoptosis maybe suggested.

The investigators are carrying out a study of 210 pregnant women , from whom 105 will have pregnancy complicated with preeclampsia and 105 with normal pregnancy.

The investigators aim is to investigate the role of the placenta, umbilical cord and amniotic membrane aquaporin expression in etiopathogenesis of preeclampsia. The investigators will compare aquaporin levels in preeclamptic and normal placentas, umbilical cords and amniotic membranes , and investigate relation between aquaporin levels and perinatal ( maternal blood pressure, proteinuria, maternal-fetal doppler ultrasound, amniotic fluid index, fetal intrauterine growth) and neonatal ( Apgar score, biometry, complications) finding.

Eligibility Criteria:
Inclusion Criteria:

* Preeclamptic pregnants
* Normal non-complicated pregnants

Exclusion Criteria:

-Pregnants with another obstetric complications
Pharmacists Management of Diabetes

The hypothesis is that patients with poorly controlled diabetes would have greater improvement in their blood sugar control when managed by a clinical pharmacist than when managed with usual medical care. Patients with poor control are randomized to pharmacist management or to usual medical care for one year.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* A1c greater than or equal to 9.0

Exclusion Criteria:

* Not expected to live for the duration of the study
* Managed by an endocrinologist
* Unwillingness to participate and attend pharmacist visits
Reducing Mesh Infections in Open Hernia Repairs

Soaking meshes in a vancomycin solution just prior to their use in open hernia repairs will decrease rates of mesh infection


Eligibility Criteria:
Inclusion Criteria:

* open ventral or inguinal hernia repair

Exclusion Criteria:

* laparoscopic hernia repair
* non ventral or inguinal hernia repairs
Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP

Oral PrEP regimens (FTC/TDF have been the mainstay of HIV prevention however patients now have more options for HIV prevention. In addition to oral PrEP regimens, the FDA approved the use of long acting Cabotegravir (CAB-LA) as the first long-acting medication for HIV prevention. This study will evaluate real world clinical outcomes of cisgender female patients who start CAB-LA for PrEP.


Eligibility Criteria:
Inclusion Criteria:

1. Cisgender females, ages 18 years and older
2. Negative HIV test at baseline
3. Negative Pregnancy test at baseline
4. Weigh at least 35 kilograms
5. Already Prescribed CAB-LA (Apretude)

Exclusion Criteria:

1. Transgender females or males
2. Cisgender males
3. Cisgender female who is actively breastfeeding
4. Severe hepatotoxicity
5. Evidence of Hepatitis B Infection
6. History or presence of allergies to cabotegravir or its components
Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus

To demonstrate the efficacy of renal denervation therapy in treating resistant hypertension and its effect on glucose metabolism in patients with type 2 diabetes mellitus


Eligibility Criteria:
Inclusion Criteria:

* Age ranges from 18 to 70 years inclusive
* Essential hypertension
* Office Systolic BP (SBP) ≥ 150 mmHg or Diastolic BP (DBP) ≥ 90mmHg
* 3 or more anti-hypertensive medications of different classes, including a diuretic, or documented intolerance to multiple medications
* Type 2 Diabetes Mellitus on oral hypoglycaemic agent (OHA)
* 2 functional kidneys; eGFR ≥ 45 mL/min/1.73m² (MDRD formula)
* Suitable renal anatomy compatible with the endovascular denervation procedure

Exclusion Criteria:

* Individual has renal artery anatomy that is ineligible for treatment including:
* Patients with secondary hypertension
* Myocardial infarction, unstable angina pectoris, cerebrovascular accident within 6 months
* Patient with type 1 diabetes mellitus
* Patient on insulin due to oral drug failure
* Renovascular abnormalities (including severe renal artery stenosis, previous renal stenting or angioplasty, or known dual renal arteries)
* Pregnancy
* Patient with any implantable device incompatible with radiofrequency energy delivery
* Hemodynamically significant valvular heart disease for which reduction of BP would be considered hazardous
* Any serious medical condition, which in the opinion of the investigator, may limit the life expectancy of patients or adversely
Assessment of Cystic Fibrosis Lung Involvement With UTE Pulse Sequences

Non-invasive assessment of lung involvement is a crucial issue for the follow-up of cystic fibrosis patients. Currently, CT is the method of reference to evaluate and quantify the lung morphological changes in cystic fibrosis adults but it remains a radiation-based technique. MRI with ultrashort echo time (UTE) pulse sequences is a promising non-ionizing alternative for lung imaging. The investigators' objective is to evaluate cystic fibrosis lung involvement using CT and MRI-UTE, and to test the agreement between both techniques.

Cystic fibrosis is a recessive autosomic fatal disease, affecting about 6000 people in France. Thanks to progress in symptomatic care, median survival is increasing. The lung involvement is the most common and responsible for most deaths. The evaluation of respiratory disease severity is based on pulmonary functional tests (PFT) and imaging. Multi-slice computed tomography (CT) is the method of reference to quantify lung involvement in cystic fibrosis. It detects respiratory lung involvement earlier than PFT, and it reveals lesions associated with the onset of respiratory exacerbations, the mortality increase and the reduction of quality of life. However CT provides ionizing radiation, thus limiting the possibility of long-term follow-up. MRI is a non-ionizing 3D imaging technique; nevertheless, lung MRI is technically challenging with the result that it is currently not used in routine practice. Indeed, both low proton density and susceptibility effects lead to very low signal intensity derived from lung parenchyma. Recently, pulse sequences with ultrashort echo time (UTE) have been implemented by the use of half radio-frequency excitations and radial projection reconstruction. These UTE sequences make it theoretically possible to retrieve more signal from the lung parenchyma. The investigators aim at using 3D T1-weighted UTE pulse sequences on a 1.5T magnet (Avanto dot, Siemens) in cystic fibrosis patients in order to assess lung involvement severity. Thirty three cystic fibrosis adults are expected to take part in the study. All will benefit from PFT, CT and MRI. The investigators' strategy is to establish a semi quantitative score of pulmonary severity (Helbich score) using MRI and CT in subjects, testing for correlations between MRI and CT measurements and assessing the reproducibility of lung lesions quantification using MRI. The investigators' objective is to demonstrate that MRI-UTE pulse sequence at 1.5T is accurate and reproducible in evaluating and quantifying pulmonary involvement in cystic fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* cystic fibrosis adults
* written informed consent

Exclusion Criteria:

* Subjects without any social security or health insurance
* Pregnancy
* MRI contraindications: Magnetically activated implanted devices (cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants), metal inside the eye or the brain (aneurysm clip, ocular foreign body), cardiac valvular prosthesis (Starr-Edwards pre-6000), subject with claustrophobia.
Fluorescence Imaging in Sentinel Lymph Node Biopsy for Breast Cancer and Melanoma

The NIR light source of our device is based on light-emitting diodes (LEDs), which can deliver sufficient light to biological tissues and induce fluorescence emission to meet the needs of the planned clinical studies. It should be noted that the light source is still well under the US FDA recommended limit for NIR exposure and ANSI standard. In addition, the light source is not laser-based, which is significantly safer than other optical imaging systems utilizing laser technologies. The fluorescence signals will be received by the detector portion of our device. Gain-settings could be easily adjusted during operation to optimize the contrast between high fluorescence areas (tumors) and low fluorescence areas (normal tissues). Real-time fluorescence video will be displayed in the goggle eyepiece as well as on a secondary monitor to facilitate viewing by other surgeons in the room.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with clinically node-negative breast cancer or melanoma being staged with SLN biopsy.
* Negative nodal basin clinical exam.
* At least 18 years of age.
* Able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Contraindications for surgery.
* Receiving any investigational agents.
* History of allergic reactions attributed to ICG or other agents used in the study, including known iodide or seafood allergy.
* Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of the breast and/or axilla, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant.
* Breastfeeding. Patients who are breastfeeding are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ICG dye.
Effectiveness of Methods to Remove Residual Orthodontic Adhevsie

The aim of this study is to compare the clinical efficacy of different residual orthodontic adhesive removing methods for rebonding debonded metal attachments.

1. To evaluate and compare the bond failure rates of rebonded brackets using two methods to remove the adhesive remnant and comparing them with contralateral teeth.
2. To evaluate and compare the bond failure rates of rebonded brackets between different quadrants and arches.
3. To evaluate and compare the bond failure rates of rebonded molar tubes using two methods to remove the adhesive remnant and comparing them with contralateral teeth.
4. To evaluate and compare the bond failure rates of rebonded molar tubes between different quadrants and arches.

Eligibility Criteria:
Inclusion Criteria:

1. Patients need metal fixed orthodontic appliance treatment;
2. Complete set of permanent dentition with fully erupted teeth on both arches;
3. Intact teeth and mainly their buccal surfaces are free from caries, fillings, or gingival hyperplasia;
4. No occlusal interferences that can affect the ideal position of attachments, especially in the lower arch.

Exclusion Criteria:

1. patients have crown, missing teeth, or craniofacial anomalies.
2. patients have congenital enamel defects specially their buccal surface.
Efficacy and Toxicity of SCART

This study is expected to enroll patients for a period of five years, with a total of 30 participants. It is a prospective observational study involving cancer patients with tumors having a longest diameter greater than or equal to 5 cm. Systemic drug therapy may be administered concurrently. The following inclusion criteria must be met for participation in the study: age greater than or equal to 18 years, Eastern Cooperative Oncology Group (ECOG) score ≤ 2, pathological confirmation of cancer diagnosis, tumor with a maximum diameter greater than or equal to 5 cm, one or more lesions, not suitable for surgery, patient has provided informed consent, patient receives SCART, and reproductive-age women must agree to take adequate contraceptive measures during the study and for six months after discontinuation of medication. The patient will receive a dose of 21 Gy in 3 fractions, with the dose maintained at 5 Gy per fraction for the entire tumor gross target volume (GTV) boundary. For certain patients, an additional two fractions of 5 Gy each were added using Stereotactic Body Radiotherapy (SBRT), resulting in a total dose of 5 Gy × 5 for the GTV boundary.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* ECOG score ≤ 2, pathological confirmation of cancer diagnosis
* Pathologically proved malignant tumor with a maximum diameter greater than or equal to 5 cm
* One or more lesions, not suitable for surgery
* Patient has provided informed consent

Exclusion Criteria:

* Pregnant
* Life expectancy less than six months
* Uncontrolled angina, arrythmia, and congestive heart failure
* History of malignant pleural effusion
Cetuximab in Treating Patients With Ménétrier Disease at High Risk of Developing Stomach Cancer

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This clinical trial is studying how well cetuximab works in treating patients with Ménétrier disease at high risk of developing stomach cancer.

OBJECTIVES:

* Evaluate clinical and biochemical parameter response in patients with Ménétrier disease at high risk of developing gastric cancer treated with cetuximab.

OUTLINE: This is a non-randomized study.

Patients receive cetuximab IV on days 1, 8, 15, and 22. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients complete a quality of life questionnaire at baseline and during week 4.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed Ménétrier disease

  * Symptomatic disease, including gastrointestinal symptoms which interfere with daily life

    * Patient is considering surgery
* Must have failed medical therapy that was given for 6 months
* No Helicobacter pylori infection

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No NYHA class III-IV cardiovascular disease
* No clinically unstable pulmonary disease
* No chronic disease requiring ongoing therapy for stabilization, including any of the following:

  * Uncontrolled diabetes mellitus
  * Malignancy
  * Thyroid disease
  * Hypertension
  * Active infections requiring systemic antibiotics, antivirals, or antifungals
  * Uncontrolled seizure disorder
  * Active neurological disease
* No unstable coagulation disorders (e.g., hemorrhagic diatheses or active bleeding disorders) that require medical management

PRIOR CONCURRENT THERAPY:

* Not specified