cyrilzakka/clinical-trials huggingface dataset:
High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori RescueTreatment

Dual therapy containing high dose of proton pump inhibitor (PPI) and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined the the efficacy of high dose of dual therapy or dual therapy plus metronidazole for H. pylori rescue treatment.This study is designed to evaluate the efficacy and safety of the addition of metronidazole to high dose of dual therapy for H. pylori rescue treatment.


Eligibility Criteria:
Inclusion Criteria:

* Participants with non-ulcer functional dyspepsia or peptic ulcer disease
* Ability and willingness to participate in the study and to sign and give informed consent
* Confirmed H. pylori infection and with previous treatment failure

Exclusion Criteria:

* Less than 18 years old or older than 80 years
* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs
* Administration of antibiotics, bismuth,antisecretory drugs in 8 weeks prior to inclusion
Effects of Transport on Patients With Traumatic Brain Injury

Hospitalized patients are often moved from their rooms to other hospital locations, particularly imaging facilities. For patients with traumatic brain injury, such movements may raise the risk of secondary brain injuries. The purpose of this study is to monitor brain injured patients during transport and to measure the resulting changes in intracranial pressure. This will allow for documentation of the frequency of secondary injury and help in understanding their causes.

Secondary insults, such as hypoxia and hypotension, may worsen a brain injury. We hypothesize that secondary brain insults may occur frequently during in-hospital transport in patients with traumatic brain injury (TBI). We additionally hypothesize that automated data collection devices used during transport could more reliably document the frequency of these events and help us to understand the causes. During transport of patients with TBI, intracranial pressure and arterial blood pressure will be continuously recorded to a monitor and saved for later analysis. Additional continuous measurements of pulse oximetry, end-tidal carbon dioxide, and mechanical ventilation settings will be made. The study will identify patients at risk for secondary insults, the etiology of these insults, and assist in development of a road map to prevent future incidents.

Eligibility Criteria:
Inclusion Criteria:

* presence of traumatic brain injury and intracranial pressure monitoring
* requiring mechanical ventilation
* presence of an indwelling arterial catheter for monitoring blood pressure
* Age of at least 18 years

Exclusion Criteria:

* Age less than 18 years
* diagnosis of brain death
* non-English speakers
* prisoners
* mentally ill persons
Effect Narrow-Band UVB Radiations

Narrow-band UVR affects Interleukin 17 which has a major role in the pathogenesis of psoriasis Vulgaris. the aim of this study to evaluate the serum levels of Interleukin 17 in psoriatic patients and compare with the levels in healthy controls \& evaluate the effect of narrow-band ultraviolet B (NB-UVB) on the serum of Interleukin 17 and the treatment of psoriasis Vulgaris.

Nowadays Interleukin 17 has a major role in the pathogenesis of psoriasis Vulgaris.

the aim of this study to evaluate the serum levels of Interleukin 17 in psoriatic patients and compare them with the levels in healthy controls \& evaluate the effect of narrow-band ultraviolet B (NB-UVB) on the serum of Interleukin 17 and the treatment of psoriasis Vulgaris. This prospective randomized clinical trial was carried out in Dermatology Department, South Valley University Hospitals included from September 2020 to August 2021, enrolled 40 psoriatic patients and 40 controls. The study was submitted for approval from the Scientific and Ethical Committees and coded as ( SVU.MED.DVA021, Code 1, N 76). Forty patients were treated with NB-UVB by starting the dose from 0.5 mJ/cm2 for all cases (Skin phototypes III or IV). The dosage is subsequently increased by 20 % per session. Sessions were given three times weekly on non-consecutive days for 12 weeks (three months). Serum Interleukin 17 levels were measured pre-and post-12 weeks narrow-band ultraviolet B by performing an enzyme-linked immune sorbent assay (ELISA). Main outcome and Measures: Improvement of psoriasis Severity Index score after 12 weeks narrow- Band UVR treatment and serum-decreased IL17 by performing an enzyme-linked immune sorbent assay (ELISA).

Eligibility Criteria:
Inclusion Criteria:

* Patients with psoriasis diagnosed clinically

Exclusion Criteria:

* Patient with history of skin cancer. Patient with history of photosensitivity. Patient receiving immune suppressive drugs .
Frequency of Airway Complications During General Anaesthesia After Introducing Five Handling Adaptations

The purpose of this study is to determine if five simple adaptations in airway management of patients undergoing general anaesthesia can reduce minor and major airway complications.

After a first detection of causes of airway complications during general anaesthesia investigators initiated five different interventions in airway management, which were: immediate bag-valve mask ventilation after administering of muscle relaxants, optimized preoxygenation, introducing of a preinterventional checklist, increased usage of video laryngoscopy and immediate change of provider in case of failed intubation.

In a second phase of this observational study investigators want to evaluate if these five interventions can reduce minor and major airway complications during general anaesthesia.

Additionally, investigators want to record how many critical incidents (CIRS) occur during this observational period and how many of them will be reported by the involved stuff.


Eligibility Criteria:
Inclusion Criteria:

* Must receive a general anaesthesia with any form of airway management

Exclusion Criteria:

* Anaesthesia without airway management
* Patients who do not give or who withdraw general consent
Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of two combination chemotherapy regimens in treating patients with Hodgkin's disease and HIV infection.

OBJECTIVES:

* Investigate the effects on survival, life expectancy and quality, toxicity, and immunological status in low risk patients with Hodgkin's Disease and HIV infection treated with the Stanford V regimen and in high risk patients treated with epirubicin, bleomycin, vinblastine, and prednisone.

OUTLINE: Patients are stratified into 2 groups designated as low and high risk on the basis of ECOG performance status (0-2 vs 3-4), presence or absence of AIDS before the diagnosis of Hodgkin's Disease, and immune status (CD4+ cell count greater vs no greater than 100/mm\^3).

* Low risk patients (those with no risk factors) receive the EBVP regimen, as follows:

  * Epirubicin intravenously on day 1
  * Bleomycin intramuscularly or intravenously on day 1
  * Vinblastine intravenously on day 1
  * Prednisone orally on days 1-5
  * Patients also receive daily injections of filgrastim (granulocyte colony-stimulating factor; G-CSF) on days 6-15. This schedule is repeated every 3 weeks for 6 courses.
* High risk patients (those with one or more risk factors) receive the Stanford V regimen, as follows:

  * Doxorubicin and vinblastine intravenously on days 1 and 15
  * Mechlorethamine intravenously on day 1
  * Vincristine and bleomycin intravenously on days 8 and 22
  * Etoposide intravenously on days 15 and 16
  * Prednisone orally daily
  * Patients also receive daily injections of G-CSF on days 3-7, 9-13, 17-21, and 23-26. This schedule is repeated every 28 days for 3 courses.

Patients are followed every 2 months the first year and then every 3 months thereafter.

PROJECTED ACCRUAL: 20-30 patients will initially be accrued in this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven Hodgkin's disease:

  * Clinical or pathologic stage II - IV
  * Stage I with bulky disease (tumor size greater than 10 cm) and B symptoms
* Confirmed HIV infection

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* WHO 0-4

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Cardiovascular:

* No severe cardiac disease

Pulmonary:

* No severe pulmonary disease

Other:

* No severe neurologic or metabolic disease
* No concurrent or prior second malignancy except:

  * Nonmelanomatous skin cancer
  * In situ cancer of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* No prior therapy for Hodgkin's disease
* Concurrent triple-drug antiretroviral therapy (including one protease inhibitor) required
A Randomized, Placebo-Controlled Trial of BMS-275291 Given Daily for 12 Months to Women With Stage 1c-IIIA Breast Cancer Receiving Adjuvant Chemotherapy and/or Hormonal Therapy

This clinical trial will assess whether BMS-275291 can be administered safely in combination with standard adjuvant therapy for early breast cancer and whether plasma concentrations at trough exceed a target minimum.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed pathologic stage 1c-IIIA adenocarcinoma of the breast which has been completely resected.
2. Systemic therapy is planned according to one of the following three regimens:

   * Tamoxifen (20mg) given orally once per day
   * Adriamycin (60 mg/m2 IV on Day 1) plus cyclophosphamide (600mg/m2 IV on Day 1), repeated every 21 days for four courses (to begin within 8 weeks after definitive surgery)
   * Adriamycin (60mg/m2 IV on Day 1) plus cyclophosphamide (600mg/m2 IV on Day 1), repeated every 21 days for four courses, followed by Taxol (175mg/m2 IV on Day 85) repeated every 21 days for four courses (to begin within 8 weeks after definitive surgery).
3. ECOG performance status 0 or 1.
4. Adequate organ function as evidenced by:

   * ANC \> 1500/mm3
   * Platelets \> 100,000/mm3
   * Serum Creatine \< 1.5 ULN
   * Total bilirubin \< 1.5 x ULN
   * AST \< 2 x ULN
5. Patients to receive adriamycin must have LVEF \> 50% or acceptable function per the institutional practice as assessed by MUGA.
6. Signed informed consent.
7. Women age =/\> 18 years
8. Patients must have recovered from reversible adverse events of prior surgery and any radiation therapy.
9. Women of childbearing potential must have a serum or urine pregnancy test within 72 hours prior to the start of study medication.

Exclusion Criteria:

1. Patients in whom breast cancer is present at the margin or surgical resection are not eligible in this study. Patients suspicious for residual disease following resection are not eligible.
2. Prior chemotherapy or immunotherapy for breast cancer.
3. Documented metastatic breast cancer.
4. Other malignancy (except carcinoma in situ of the cervix or surgically treated non-melanoma skin cancer) within 5 years of study entry.
5. Pregnant or breastfeeding females.
6. Women of child bearing potential not employing adequate contraception.
7. History of autoimmune diseases such as systemic lupus, rheumatoid arthritis, scleroderma.
8. Any serious underlying medical conditions which would impair the ability ot the patient to receive the planned treatment or which may interfere with the completion of this trial.
9. Planned chemotherapy, hormonal therapy or biological therapy other than those described above. Patients should not be enrolled in any other clinical trials. Use of other investigational agents is not permitted.
10. Any condition that does not permit compliance with the protocol.
Nutrition, Body Composition, and Sleep

The purpose of the research is to determine if protein and omega-3 fatty acid supplementation improve sleep, improve body composition, and improve markers of metabolic health in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

- Postmenopausal women (12+ months following last reported menstrual cycle)

Exclusion Criteria:

* food allergies
* diet restrictions
* do not habitually eat breakfast
* picky eaters\\regularly consume protein or omega-3 related supplements
* consume omega-3 fatty acid rich fish (tuna, salmon, etc.) greater than two times per month -have any other diet-related conditions that would prevent them from consuming whey protein supplements and/or omega-3 fatty acid supplements
* smoking
* habitual alcohol consumption (\> 4 drinks/week)
* medication impacting appetite or metabolism
* Lipid or blood pressure lowering medication
* Hormone replacement therapy
Hypertrophic Cardiomyopathy Federated Learning Implementation Platform

HCM FLIP study is a two-phase protocol focusing on the detection of Hypertrophic Cardiomyopathy using Electrocardiograms and Echocardiograms through Federated Learning.

HCM FLIP (Hypertrophic Cardiomyopathy Federated Learning Implementation Platform) aim to build and test a model's system impact to detect hypertrophic cardiomyopathy (HCM) by training a machine learning (ML) model with electrocardiograms (ECGs) and echocardiograms (ECHOs). Approximately 10-1000 HCM cases and 30-10,000 age/sex-matched controls per institution, depending on size, will be included in the study. We hypothesize that a federated ML model will discriminate cases of HCM from those without HCM in a real-world setting.

Eligibility Criteria:
HCM-Labeled Case Inclusion Criteria:

* Patients with maximum left ventricular wall thickness exceeding 15 mm (including the right ventricular component of the septum) without any other explanation for ventricular hypertrophy (e.g., severe hypertension, cardiac amyloidosis, severe AS, as determined by local investigators). The measurement could be made in an ECHO or on magnetic resonance imaging (MRI).
* Patients must have \> one (1) ECG and/or \> one (1) ECHO available that meet minimum compatibility requirements. If multiple ECGs and ECHOs are available per patient, then all available data meeting compatibility requirements will be used for model training purposes.

HCM-Labeled Case Exclusion Criteria:

* Any sign of infiltration found in cardiac MRI, if performed.

Control Case (Non-HCM) Inclusion Criteria:

* No diagnosis of HCM
* Age/sex are matched to HCM cases (+/- 5 years, if possible; +/- 10 years if numbers do not permit).
* Patient must have \> one (1) ECG and/or \> one (1) ECHO available that meet minimum compatibility requirements. If multiple ECGs and ECHOs are available per patient, then all available data meeting compatibility requirements will be used for model training purposes.

Control Case (Non-HCM) Exclusion Criteria

* Suggestion of HCM in a clinically obtained ECHO or cardiac MRI report unless subsequently confirmed no diagnosis of HCM. Any new clinical information discovered during the study will be left to the discretion of the local investigator.
CLEAR SYNERGY Neutrophil Substudy

CLEAR SYNERGY is an international multi center 2x2 randomized placebo controlled trial of colchicine and spironolactone in patients with STEMI. Subjects enrolled in the main CLEAR SYNERGY trial will be asked to participate in this sub study (n=670) to undergo:

1. Evaluation of markers of neutrophil activity at randomization (baseline) and 3 months follow-up in the colchicine versus placebo groups, and;
2. Examination of clinical and genetic factors that determine heterogeneity of treatment response and distinguish colchicine responders from non- responders.

Participants undergo a blood draw at baseline and 3 months follow-up as part of the main trial, and participants who also participate in this sub study will have an additional 2 tablespoons of blood drawn.

The sub study objectives are to:

1. Assess the effect of colchicine on neutrophil activation in response to STEMI.
2. Examine clinical and genetic factors that determine heterogeneity of treatment response anddistinguish colchicine responders from non- responders.
3. Explore the derivation of a risk score that includes markers of neutrophil activity and is associated with adjudicated MACE over 3 years after STEMI, and assess the impact of colchicine on the relation between this risk score and MACE.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are randomized to the drug RCT portion of the CLEAR SYNERGY (OASIS 9) trial will be eligible for participation in this Neutrophil biomarker substudy.

Exclusion Criteria:

* Use of anti-inflammatory agents (except aspirin)
* Active infection
Effect of Breathing Exercises Applied to Hemodialysis Patients on Anxiety, Fatigue and Quality of Life

Breathing exercises are one of the non-pharmacological methods frequently used in health care in recent years. The aim of this study is to evaluate the effect of breathing exercises on fatigue, anxiety symptoms and quality of life in hemodialysis patients.

Introduction: Breathing exercises are one of the non-pharmacological methods frequently used in health care in recent years.

Objective: The aim of this study is to evaluate the effect of breathing exercises on fatigue, anxiety symptoms and quality of life in hemodialysis patients.

Method: This study will be conducted using a randomized controlled experimental research design at the pre-test-post-test level. The research sample will consist of 58 hemodialysis patients who meet the inclusion criteria of the sample and who apply to the hemodialysis unit of a training and research hospital. The research data will be collected using the personal information form, Beck anxiety inventory, Piper fatigue scale and SF-12 quality of life scales. The pre-test data of the research will be filled in the first interview with the patients and the post-test data will be applied at the end of the 6th week.

Conclusion: Maintaining physical and psychological comfort and improving the quality of life of patients receiving hemodialysis treatment are among the primary responsibilities of the nurse. In this regard, it is predicted that breathing exercises will be beneficial in controlling physical and psychological symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Being over the age of 18
* Being willing to participate in the study
* Speaking and understanding Turkish
* Having started hemodialysis treatment at least 6 months ago

Exclusion Criteria:

* Being on hemodialysis treatment with a diagnosis of stage 4 renal failure
* Being on hemodialysis treatment due to acute renal failure
* Having a malignancy related to the respiratory system (bronchus or lung)
* Having chest pain

  . -Having previously done box breathing and diaphragmatic breathing exercises/receiving training
* Having cognitive dysfunction
* Not giving consent to participate in the study
Efficacy and Safety of Alogliptin Used Combination With Metformin in Participants With Type 2 Diabetes in Japan

The purpose of this study was evaluate the efficacy and safety of alogliptin, once dairy (QD) combined with metformin taken twice daily (BID) or three times daily (TID) in type 2 diabetic patients with uncontrolled blood glucose.

Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.

The present study was planned to evaluate the efficacy and safety of alogliptin as an add-on to metformin in type 2 diabetic patients who have uncontrolled blood glucose despite treatment with metformin as well as diet and exercise therapies.

Eligibility Criteria:
Inclusion Criteria:

1. Had been taking metformin at a stable dose regimen (500 mg/day twice daily after meal or 750 mg/day three times daily after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
2. Had an glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
3. Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%\* of the value at 4 weeks after the initiation of the observation period (Week -8) (\*rounded off to the first decimal place).
4. Was receiving specific diet and exercise (if any) therapies during the observation period.

Exclusion Criteria:

1. Had taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0).
2. With a history or symptoms of lactic acidosis.
Clinical Efficacies of Different Agents in Molar-Incisor Hypomineralization

This study aims to assess the clinical effectiveness of GC Fuji Triage ® (GC America Inc., Alsip, Illinois) and BeutiSealant (Shofu, Kyoto, Japan) in children aged 8-13 with multiple molars affected by Molar-Incisor Hypomineralization (MIH). The comparison focuses on permanent first molars affected by MIH.

The study targets children within the specified age range with MIH-affected molars, comparing the clinical outcomes of GC Fuji Triage and BeutiSealant. The assessment will provide valuable insights into the efficacy of these agents in managing severe hypomineralization, contributing to our understanding of effective treatment modalities for MIH.

The evaluation criteria include restoration success, prevention of further decay development, prevention of post-eruption breakdown, alleviation of tooth sensitivity, and measurement of life quality. These criteria will be compared with those of Resin Fissure Sealant.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children aged 8-13 with hypomineralization in their first permanent molars.
* Children without systemic diseases or developmental dental anomalies that could affect hypomineralization.
* Those with at least two molars exhibiting molar-incisor hypomineralization (MIH), specifically scoring 1 and 3 according to the MIH-Tll index.
* Children with a positive or 'definitely positive' cooperation according to the Frankl Behavior Rating Scale (Frankl et al., 1962).
* Absence of spontaneous pain, abscess, mobility, or inter-radicular lesions in the tooth to be treated.
* Patients or their parents consenting to participate in the treatment.

Exclusion Criteria:

* Children with systemic diseases or developmental dental anomalies that could affect hypomineralization.
* To have MIH outside the specified scores.
* Children unable to continue treatment in the chair due to cooperation problems.
* Failure to attend control sessions or a desire not to continue with the study.
* Patients and their parents unwilling to participate in the treatment.
* If the patient cannot attend control sessions or disrupts sessions, they will be withdrawn from the study.