cyrilzakka/clinical-trials huggingface dataset:
5 Day Concomitant Versus 10 Day Sequential Therapy for Eradication of H. Pylori Infection

A five day quadruple concomitant therapy is as effective and safe as a 10 day sequential therapy for eradication of H. pylori infection.

The investigators studied 180 consecutive patients with H. pylori infection who were randomized to 5-day concomitant therapy (90 patients) and to 10-day sequential therapy (90 patients). 6 and 10 weeks after the end of therapy, patients were evaluated for their H. pylori status by 13C Urea Breath Test. Side effects and costs of either regimen were evaluated. In patients whose H pylori status at entry was assessed by endoscopy, culture was performed and antimicrobial resistance was determined

Eligibility Criteria:
Inclusion Criteria:

* H. pylori-infected patients who were at least 18 years of age and who had never received H. pylori eradication treatment were included in the study.

Exclusion Criteria:

* previous treatment for H. pylori infection,
* use of inhibitors of acid secretion and/or antibiotics during the 6 weeks before the study,
* gastrointestinal malignancy,
* previous gastro-oesophageal surgery,
* severe concomitant cardiovascular,
* respiratory or endocrine diseases,
* clinically significant renal or hepatic disease,
* hematologic disorders,
* any other clinically significant medical condition that could increase risk,
* history of allergy to any of the drug used in the study,
* pregnancy or lactation,
* alcohol abuse,
* drug addiction,
* severe neurologic or psychiatric disorders, and
* long-term use of corticosteroids or anti-inflammatory drugs.
Relieving Surgical Pain and Nausea with Light Therapy

The goal of this clinical trial is to investigate the effectiveness of colored (green and blue lens) glasses as a non-pharmacological method in relieving post-surgical pain and postoperative nausea in kidney donors. The main hypothesis it aims to test:

H1: Postoperative use of green-lensed glasses by patients who are kidney donors is effective in relieving surgical pain and postoperative nausea.

H2: Postoperative use of blue-lensed glasses by patients who are kidney donors is effective in relieving surgical pain and postoperative nausea.

Researchers will compare the blue-lens glasses and green-lens glasses groups to the transparent (colorless) glasses group and the non-glasses group to see if the colored lenses have an effect on postoperative pain and nausea.

Participants in the intervention groups will be asked

* to wear the glasses (according to their randomly assigned group (blue/green/colorless/), immediately after they admitted to the ward postoperatively, at least 8 hours in a day, until their discharge
* to respond the pain and nausea assessment (every 2 hours during postop day 1 and every 4 hours during postop day 2) until their discharge

Participants in the control group will be asked

- to respond the pain and nausea assessment (every 2 hours during postop day 1 and every 4 hours during postop day 2) until their discharge

Since the hospital's architecture and clinical operation where the data will be collected have features that prevent patients from different groups from meeting, the single blind feature can be preserved. The pain assessment of the patients will be made with the numerical pain scale, and the nausea assessment will be made with the numerical nausea rating scale. In addition, data will be collected with the Patient Information Form prepared by the researchers in line with the literature.

Eligibility Criteria:
Inclusion Criteria:

* Being a donor for kidney transplantation
* Not having an obstacle to wearing glasses
* Being able to communicate verbally

Exclusion Criteria:

* Being color blind • Developing post-operative complications during the study period
Potential Use of Indocyanine Green as a Fluorescent Agent for Definition of Surgical Margins in Cancer

The surgeon may remove a very small amount of additional tissue compared to what would be removed if you were not enrolled in the study. This tissue may prove to contain tumor or it may contain normal tissue. The surgical cavity will be examined by a special laser pen after the tumor is removed, and if areas of fluorescence are seen, that may indicate tumor cells where the ICG dye collected are still remaining and the surgeon would then remove those. After the tumor and the tissue around it are removed and sent to the laboratory, the tissue may be examined using that same laser pen to see where the cancer cells are and compare that to what the laboratory sees when it looks at the tumor and tissue with a microscope. It is hoped that what the dye shows and what is seen with the microscope will be alike.

PRIMARY OBJECTIVES:

I. To validate the use of intraoperative indocyanine green (ICG) for better definition of tumor margins therefore, minimizing the necessity of a second surgical procedure to obtain negative margins.

OUTLINE:

Patients receive indocyanine green solution intravenously (IV) between 2-8 hours before surgery. Fluorescence measurements are taken from all specimens removed during surgery.

After completion of study, patients are followed up at 48 hours.

Eligibility Criteria:
Inclusion Criteria: Patients with a tumor that will be treated surgically.

Exclusion Criteria:

* Patients with a known history of reaction to iodine or iodine-containing compounds.
* Pregnant women. Any patients found to be pregnant will be excluded from the study.
Interoceptive Engagement

The proposed project is the first pilot test to examine interoceptive function as a mechanistic biomarker underlying Mindful Awareness in Body-oriented Therapy (MABT). MABT, an empirically-validated and manualized protocol is explicitly designed to teach interoceptive awareness skills for emotion regulation and is thus an ideal intervention approach in which to address this gap in research. This study uses a two group, randomized design to examine neural and physiological biomarkers in response to MABT. Twenty-four individuals reporting moderate stress will be recruited from the community and randomized to 8-week MABT intervention or the control condition. The study aims are to: 1) evaluate whether interoceptive training improves interoceptive function in the MABT vs control condition, and 2) explore whether changes in interoceptive function correlate with improved health outcomes. Analyses will include within and between-group ANOVA of brain activity with symptom change as a covariate. This is the first study to test whether a clinical intervention aimed specifically at cultivating interoceptive awareness effects change on interoceptive biomarkers. The results will support larger NIH proposals to more comprehensively validate neuro and behavioral biomarkers of interoceptive training to enhance mental health, particularly targeting depression and substance use disorder that have identified interoceptive dysfunction and poor emotion regulation.


Eligibility Criteria:
Inclusion Criteria:

* adult (over 18)
* Perceived Stress Scale scores indicating moderate stress levels
* naive to mindfulness-based approaches (no prior experience)
* agrees to forgo (non-study) manual therapies (e.g., massage) and mind-body therapies (e.g., mindfulness meditation) for 3 months (baseline to post-test)
* fluent in English
* can attend MABT and assessment sessions
* right-handed (for uniformity of neuroimaging results)

Exclusion Criteria:

* lifetime diagnosis of mental health disorder
* unable to complete study participation (includes planned relocation, pending inpatient treatment, planned extensive surgical procedures, etc.)
* cognitive impairment, assessed by the Mini-Mental Status Exam (MMSE) if demonstrated difficulty comprehending the consent
* use of medications in the past 30 days that affect hemodynamic response
* lifetime head injuries or loss of consciousness longer than 5 min
* currently pregnant
* contraindications for MRI, e.g., claustrophobia, metal objects in body, etc.
Mirtazapine Reduces ICD Shocks in ICD Patients With Depression and Anxiety

The purpose of this study is to evaluate if the use of antidepressant medication in depressed patients with implantable cardioverter defibrillator reduces the number of ICD's shocks as it improves depressive affect.

episodes of arrhythmia remain present even after icd implantation, this is specially true in depressed patients. it is hypothesized that improving mood state by means of an antidepressant drug . namely mirtazapine. could be responsible of alleviating the number of appropriate shocks delivered by the cardioverter. this could be due to a direct effect of the drug itself or an indirect effect of improving anxious and depressive affect. the mood and anxiety state are measured with the HADS scale

Eligibility Criteria:
Inclusion Criteria:

* cardioverter implanted patients
* depression
* anxiety

Exclusion Criteria:

* heart failure
* other diseases reducing physical fitness
Lactobacillus Plantarum: Thumb Osteoarthritis Following Orange Peeling

Case Description osteoarthritis + amputation of the distal phalanx of the right thumb caused by Lactobacillus plantarum after an orange peel. The natural habitat of the bacteria being the orange zest and the bacteria is considered harmless.

Case Description osteoarthritis + amputation of the distal phalanx of the right thumb caused by Lactobacillus plantarum after an orange peel. The natural habitat of the bacteria being the orange zest and the bacteria is considered harmless.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of an osteoarthritis,
* Amputation of the distal phalanx of the right thumb

Exclusion Criteria:

* Not exclusion criteria
Automated Assessment of PVI Using a Novel EP Recording System

A prospective, multi-center study with the CathVision Cube® system and the PVI Analyzer software in radiofrequency (RF), cryo-balloon (CB), and Pulse Field Ablation (PFA) procedures.

Subjects with paroxysmal or persistent atrial fibrillation (AF) who are indicated to undergo first pulmonary vein isolation (PVI) procedure and meet all eligibility criteria will be enrolled in the Study. Intracardiac signals will be passively recorded using the investigational CathVision Cube® System in parallel with the conventional (CE marked) EP recording system. The investigational device will not be used for direct clinical care decisions or therapy. The validation of the automated algorithm for PVI will be performed offline

The primary objective is to validate the PVI Analyzer software with a novel EP recording system (CathVision Cube® System) for assisting assessment of isolation status following PVI ablation.

The secondary objective is to determine the feasibility of "real-time" assessment of PVI analysis and rhythm dependent performance using the PVI Analyzer and CathVision Cube® System.

Eligibility Criteria:
Eligible subjects will meet all of the following inclusion criteria:

1. Subjects undergoing first-time pulmonary vein isolation indicated by investigator for the treatment of atrial fibrillation
2. Male or non-pregnant female aged ≥21 years.
3. Able and willing to provide written informed consent prior to any clinical investigation related procedure

Eligible subjects will not meet any of the following exclusion criteria:

1. Pregnant or nursing subjects.
2. Current participation in another investigational drug or device study that interferes with this Study.
3. Subjects who, in the opinion of the investigator, are not candidates for this Study.
4. Patients who have had a prior ablation procedure
5. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
6. Life expectancy less than 12 month
7. Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.
Investigating Motor Cortex Processing for Pain Modulation

The purpose of this study is to investigate the effects of different types of interventions (motor learning, somatosensory learning, observation task, mental imagery and tDCS) on the perception of pain and motor cortex excitability in healthy male subjects. This is an exploratory study of healthy subjects only.

There are 5 experiments:

Exp1: motor learning (3 groups, crossover) - motor leaning with and without visual feedback and a control group.

Exp2: sensory learning (4 groups, parallel) - sensory learning with and without feedback, an simple activation task and a control group.

Exp3: observational task (2 groups, parallel) - an motor observational task and a control group.

Exp4: mental imagery (2 groups, parallel) - a motor mental imagery and a control group.

Exp5: tDCS over the motor cortex (2 groups, crossover) - active and sham tDCS. Note that this study has never been completed.

Eligibility Criteria:
Inclusion Criteria

1. Provide informed consent to participate in the study
2. 18 to 64 years old
3. No presence of rheumatologic disease as self reported
4. No clinically significant or unstable medical or psychiatric disorder as self reported
5. No history of alcohol or substance abuse within the last 6 months as self reported
6. No neuropsychiatric co-morbidity as self reported
7. No Contraindications to single pulse TMS (TMS will be used to measure cortical excitability)

   * history of seizures
   * unexplained loss of consciousness
   * metal in the head
   * frequent or severe headaches or neck pain
   * implanted brain medical devices
8. No Contraindications to tDCS

   * metal in the head
   * implanted brain medical devices
A Contralateral Dispensing Clinical Trial of Study Test Sapphire Lens Against Enfilcon A Silicone Hydrogel Lens

This was be a randomized, contralateral, double-masked, dispensing study comparing the Study test lens against the control lens over one month of lens wear.

The study results were not used for design validation of test lens.

Subjects were randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses were used in a daily wear modality for one month.

The study results were not used for design validation of test lens.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will only be eligible for the study if:

  1. Is at least 18 years of age for the USA and has full legal capacity to volunteer;
  2. Has read and signed an information consent letter;
  3. Is willing and able to follow instructions and maintain the appointment schedule;
  4. Is an adapted soft contact lens wearer;
  5. Requires spectacle lens powers between -0.50 to -6.50 diopters sphere;
  6. Has no more than 0.75 diopters of refractive astigmatism;
  7. Willing to wear contact lens in both eyes;
  8. Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye;
  9. 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 as acceptable.

     Exclusion Criteria:
* Subjects will not be eligible to take part in the study if:

  1. Is participating in any concurrent clinical or research study;
  2. Has any known active\* ocular disease and/or infection;
  3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
  7. Is aphakic;
  8. Has undergone refractive error surgery; \* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Dysfunctional Uterine Bleeding After Tubal Sterilization

In this study, the investigators will compare the frequency and amount of bleeding after tubal sterilization and salpingectomy

Dysfunctional uterine bleeding is common after tubal sterilization.

The investigators will compare the frequency and amount of bleeding after two techniques eithe tubal sterilization by pomeroy's method during cesarean section or complete salpingectomy

Eligibility Criteria:
Inclusion Criteria:

* Age 20-40
* Patient completed her family
* Patient on cesarean delivery

Exclusion Criteria:

* Tubal sterilization by other methods
* Salpingectomy by laparoscopy
* Patient wishing fertility
Efficiency of Using Osseodensification Protocol

the goal of this clinical trial is to learn if the new osseo-densification technique works to provide enough bone width and quality prior to implant placement in the upper jaw the main question it aims to answer is: Is the use of osseo-densification protocol better than the standard alveolar ridge widening techniques; regarding efficiency and comfort in obtaining sufficient alveolar ridge width in horizontally atrophic alveolar ridges?

a new osseo-densification protocol using specially designed Densah burs was compared to conventional hand Osteotome technique to test its efficiency in providing sufficient bone quantity and quality in cases of horizontally deficient maxillary edentulous alveolar ridge sites that require expansion prior to dental implant placement

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old.
* In cases of an initial ridge width ≤ 5mm that contains ≤ 2mm of trabecular bone core.
* Alveolar ridges with narrow crest and wider base.

Exclusion Criteria:

* Uncontrolled diabetic patients
* Heavy Smokers
* Patients suffering from osteoporosis
* Patients receiving chemo or radio therapy
* Patients suffering from bleeding disorders
* Patients suffering from intraosseous lesions at the proposed site of implant
* Patients with insufficient alveolar bone hight less than 10 mm.
* Resorbed ridge with a narrow base.
Non Invasive Electrical Impedance Technology (EIT) for Diagnosing Liver Diseases Severity

The aims of this study are to assess the performance of the non-invasive Electrical Impedance Technology (EIT) in evaluating the liver fibrosis stage in patients with chronic liver diseases, in comparisons with a liver biopsy and/or Shear wave elastography and Liver Ultrasonography.

The second aim is comparing between Liver Ultrasonography and Electrical Impedance Technology (EIT) to quantify the hepatic steatosis grade in patients with Non Alcoholic Fatty Liver Disease (NAFLD) .

The study will include 210 patients with chronic liver diseases. Relevant clinical data such as sex, age, weight, height, alcohol intake, medical history and routine lab results will be collected.

The study will include three groups:

1. Patients with indication for liver biopsy will undergo a routine liver biopsy and also routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT) (70 patients).
2. Patients with chronic liver diseases will undergo routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT) (70 patients).
3. Patients with Non Alcoholic Fatty Liver Disease will undergo routine liver Ultrasonography, Shear wave elastography and quantification of liver steatosis using the Electrical Impedance Technology (EIT) (70 patients).

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic liver diseases

Exclusion Criteria:

* Patients who don't have chronic liver diseases
Effects of Insulin Detemir and NPH Insulin on Renal Handling of Sodium, Fluid Retention, and Weight in Type 2 Diabetic Patients

Hypothesis: Changing type 2 patients treatment from Insulin Insulatard to Insulin Detemir will increase their excretion of sodium in the urine and thereby decrease their extracellular volume and body weight. 24 patients are divided into 2 groups and their insulin treatment is shifted while their body composition, sodium excretion, weight and extracellular volume is monitored.

Type 2 diabetic patients experience weight gain when receiving insulin treatment. There has been reports that the weight gain is less or absent when patients are treated with Insulin Detemir. Patients with diabetes have increased total body sodium and increased extracellular volume. We hypothesize that part of the weight gain seen is due to increase in extracellular volume and that the lesser weight gain seen in patients treated with Detemir is due to an lesser increase in extracellular volume. We believe that the cause of this difference is the different pharmacokinetic properties of insulin Detemir. Insulin Detemir i protein bound and is therefore not excreted in the kidneys. This may cause less sodium reabsorption, than with other insulins, and therefore less increase in extracellular volume.

We test this hypothesis by examining urinary sodium excretion, extracellular volume by GFR measurements, Body composition by DEXA scan, body weight, and 24 hour blood pressure.In patients that are changed from Insulin Insulatard to Insulin Detemir and back.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes according to WHO 1999 criteria for at least 3 month
* Insulin treated for at least 1 month
* BMI 25-40
* Age 18-80
* Hb1Ac \< 10%

Exclusion Criteria:

* Hypertension not well regulated
* Serum creatinine \> 130 micromol/l
* Non-diabetic kidney disease
* Disease that may cause invalid hgbA1c measurement
* Substance abuse
* Recent use of Detemir
* Pregnancy or risk of becoming pregnant
* Any condition that may disturb protocol adherence (language barrier etc) urinary albumin \> 30 mg/24hours ( before screening)
* Use of drugs that may influence blood glucose (except oral antidiabetics)
* Use of drugs that may influence sodium balance,i.e diuretics ( tiazides accepted)
* Clinical significant disease that may influence outcome ( cancer etc)