cyrilzakka/clinical-trials huggingface dataset:
Anti-H. Pylori Effect of Deep See Water

Deep sea water (DSW) is characterized by high purity, low temperature, high nutrients and minerals and is obtained from the water flows 200 meters under the surface of the sea. The inhibition of H. pylori growth by DSW has been demonstrated in vitro study. However, up to now, there is few randomized control study to evaluate the anti-bacterial effects of ingesting DSW in patients with H. pylori infection.

The aims of this study are:

1. to evaluate the anti-bacterial effects of ingesting DSW in patients with H. pylori infection;
2. to evaluate the patient adherence and adverse effects of ingesting DSW.

Patients having H. pylori-positive chronic gastritis with/without small erosions or peptic ulcer scars will be recruited. Before treatment, H. pylori infection status will be examined by endoscopy with biopsy or 13C-urea breath test (13C-UBT). All patients will receive 13C-UBT before treatment, at the end of 2 week's treatment and 4 weeks after termination of treatment. A computed generated random numbers sequence will be blocked (2:1; block sizes of six) into two groups, say A and B.

group A - ingesting DSW 200 cc four times a day (one hour before meal and bed time); group B - ingesting non-DSW drinking water 200 cc four times a day (one hour before meal and bed time).

To keep the study in double-blind model, the picture of package for DSW and non-DSW drinking water will be the same.

Prokinetics (metoclopramide 5 mg/tab 1 tid) and antacid (strocain tablet (oxethazaine 5 mg and polymigel 244 mg/tab) 1 tid) will be permitted for relieving the dyspeptic symptoms.

All patients will be asked to complete a questionnaire and to record symptoms and water/drug consumption daily during the treatment period. Post-treatment, the patients will be seen at the Outpatients Clinic to investigate patient adherence and adverse of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients having H. pylori-positive chronic gastritis with/without small erosions or peptic ulcer scars who are aged greater than 20 years and are willing to received anti-H. pylori treatment.

Exclusion Criteria:

* pregnant or nursing woman
* serious concomitant illness and malignant tumor of any kind
* serious bleeding from gastrointestinal tract
* previous gastric surgery
* receiving bismuth salts, Proton pump inhibitors, or antibiotics in the previous month.
Comparative Study Between Autologous Adipose Tissue Graft Versus Microfracture for Treatment of Articular Cartilage Defects

Knee arthroscopy using standard portals will be performed in three groups. Complete evaluation of all intra -articular structures will be performed followed by accurate localization of the cartilage defect and measurement of its dimensions. The cartilage lesion grading according to the International Cartilage Repair Society system (ICRS). The patients assigned for the first group will have Liposuction through a minor 1 cm incision on the abdomen to obtain adequate amount of emulsified adipose tissues (50 - 60 cc). Autologous adipose tissue will be mixed with autologous hyaline cartilage obtained from non-weight bearing areas of the knee in prepared mold. The graft will be mixed with fibrin glue and left to solidify a little. After obtaining the fashioned graft from the mold it will be fixed in to the defect site by fibrin glue through mini open approach and stability of the implant fitted in the site will evaluated by gentle cycling of the joint. During the graft preparation, a high tibial osteotomy will be performed. Patients assigned for the second group will have microfracture in association with open wedge high tibial osteotomy. Patients assigned for the third group will have open wedge high tibial osteotomy. Standard titanium T locked plate will be used to fix the open wedge osteotomy in the three groups.


Eligibility Criteria:
Inclusion Criteria:

* Age group 18 to 60 years old.
* Cartilage defect size range 2-5 cm2.
* Outer Bridge classification II \& III.
* Single full thickness symptomatic femoral condyles ulcer.
* Varus deformity of the affected knee 50 - 100.

Exclusion Criteria:

* Advanced knee osteoarthritis.
* Knee range of motion less than 1000.
* Ligamentous injury of the affected knee.
* Recent intra articular injection of any type with in last 6 months.
* Fracture around the knee.
* Inflammatory joints disorders.
* Tumors.
* Immunocompromised patients.
* Body mass index \< 35
* Valgus deformed knee any degree
* Sever varus deformed knee \< 10 0
Awareness of Osteoporosis in Patients With Hepatitis C Infection

Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Patients with hepatitis c virus infection are at increased risk for developing osteoporosis. Identifying whether patients with hepatitis c virus infection have information and awareness about this disease is crucial. This study is aimed to investigate awareness and knowledge of osteoporosis in patients with hepatitis c virus infection.

Osteoporosis is a common disease of bone loss. The reduced bone strength predisposes an increased risk for fractures in older individuals. It can affect people from different ethnicity. Many factors increase the risk of osteoporosis, including age, postmenopausal state, glucocorticoid use, low body weight, calcium, vitamin D, immobility, and chronic inflammation. Patients with hepatitis c virus infection are at high risk of developing osteoporosis due to chronic inflammation and their medications. Patients' knowledge and awareness about osteoporosis are essential for early detection, implementation of lifestyle changes, and treatment compliance. This study aimed to investigate osteoporosis awareness and knowledge about osteoporosis in patients with hepatitis c virus infection.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hepatitis b virus infection
* Must be between the ages of 18 and 90
* Must give consent to participate in the study

Exclusion Criteria:

• Not giving consent
Innovation in Pulmonary Rehabilitation

The purpose of this study was to compare the effect of exercise treatment combined with breathing retraining (a computerized feedback program), with exercise treatment combined with heliox (a helium and oxygen combination), with exercise only in patients with moderate to severe chronic obstructive pulmonary disease. This was an 8-week intervention study.

Dynamic hyperinflation limits exercise tolerance in patients with chronic obstructive pulmonary disease (COPD). Recently, several innovative approaches have been developed to reduce the burden of dynamic hyperinflation. Two such innovations, ventilation-feedback training and Heliox supplementation during exercise show great promise and posit a reduction in dynamic hyperinflation as a key to their effectiveness. In our recently completed trial, when age, FEV1 and RV/TLC were controlled, exercise plus VF (E+VF) was superior to E training alone (E only) or VF training alone in improving exercise tolerance. The mechanism responsible for this difference was, in part, a reduction in exercise-induced dynamic hyperinflation secondary to a change in breathing pattern. In additional preliminary studies, we determined that exercise tolerance can be increased when patients exercise while inhaling Heliox. Similar to VF, the mechanism for exercise improvement with Heliox was a reduction in exercise-induced dynamic hyperinflation. Although both interventions are promising, there are no definitive data to support use of either intervention as a standard of care for pulmonary rehabilitation.

Hypothesis/Research Questions Overview: The two primary hypotheses are that patients with moderate-severe COPD who successfully complete eight weeks of (a) E+VF training will achieve longer exercise duration than patients randomly assigned to E only and (b) E+heliox training will achieve longer exercise duration than patients randomly assigned to E only.

Methods: This study was a randomized controlled clinical trial. After baseline testing is completed, 103 subjects with moderate-severe COPD were randomized into one of three groups: E+VF, E+Heliox and E training only. Follow-up testing was completed at 8 weeks. testing, activity monitoring, and dyspnea measurements. After baseline testing was completed, randomized subjects trained in the Physical Performance Laboratory three times weekly. Exercise prescriptions were standardized and based on data from the exercise stress test.

Eligibility Criteria:
Inclusion Criteria:

* 40 years of age
* FEV1 70%
* FEV1/FVC \<70%
* RV/TLC \> 120%

Exclusion Criteria:

* Respiratory infection/exacerbation within last 4 weeks
* Exercise limiting heart disease
* Primary asthma
* Congestive heart failure New York Heart Association (NYHA) Class III-IV
* Exercise limiting peripheral arterial disease or arthritis
* Inability to walk on a treadmill
Incidence , Risk Factors and Outcomes of Haemodynamic Instability and Cardiac Arrest During Spine Surgery

Risk factors for cardiac arrest during spine surgery have been well defined, including lumbar fusion, age over 65 years, obesity, cardiovascular disease, ethnicity and ASA status. Bradycardia and asystole have been described under general anaesthesia in combined surgical cohorts: Proposed mechanisms include unopposed parasympathetic activation, enhanced vasovagal response to decreased venous return, and psychiatric stressors. The investigators prospectively will review patients candidates for spine surgery to explore potential incidence, contributory factors and outcomes to unexpected transient intraoperative haemodynamic instability, arrhythmia, and cardiac arrest during spine surgery as these data are needed to aid risk stratification and improve decision making for spine care teams.


Eligibility Criteria:
Inclusion Criteria:

1. Aged more than 18
2. Gender: both.
3. ASA grade I-II (American society of anesthiologists).
4. Prepared to spine surgery under general anesthesia

Exclusion Criteria:

1. Ischemic heart patients
2. Hypertensive patients
3. Patients with atrial fibrillation or any previous history of attack of arrhythmias
4. Patients on B.B ( beta-blockers)
5. Chronic use of neuropsychiatric medications
6. Renal Impairment
7. Liver Dysfunction.
8. Any complications during the procedure as massive hemorrhage
9. Surgery for traumatic spinal cord
Post-Approval Study to Investigate the Long Term (8 Year) Survivorship of STAR Ankle Among Continued Access Study Patients

The purpose of this study is to examine the long term survivorship of the Scandinavian Total Ankle Replacement (STAR). Specifically, this study focuses on the revision and/or removal rate of any component of the STAR ankle.


Eligibility Criteria:
The study population consists of all living subjects who participated in the continued access arm of the IDE clinical trial.

Inclusion Criteria:

* Only patients that participated in the continued access study make up the patient cohort for this long-term follow-up study.
* Willing and able to give informed consent.

Exclusion Criteria:

* Subjects who were withdrawn or withdrew consent to participate in the investigation
* Subjects who do not consent to participate in long-term or provide personal contact information to the sponsor(solely for the purposes of tracking subjects to help ensure follow-up compliance)
Asthma Link: A Real World Application of School Supervised Asthma Therapy

The goal of this study is to assess the feasibility of a clinical trial to evaluate the impact and process of deploying school-supervised asthma therapy in a real-world setting for children with poorly controlled asthma (aged 6-17 years).

The proposed 4-site pilot cluster randomized controlled trial will assess the feasibility of conducting a clinical trial of Asthma Link, a real-world school-supervised asthma therapy program. We will compare the impact of Asthma Link deployed in 2 pediatric practice sites versus Enhanced usual care deployed in 2 comparator sites, with 18 parent-child dyads enrolled per site (N=72 dyads).

Primary trial outcomes will be participant recruitment, retention, and intervention fidelity. Secondary trial outcomes will be differences in the frequency of asthma symptoms, emergency department visits, hospital admissions, courses of oral corticosteroids, spirometry values, medication adherence and school absences between intervention and enhanced usual care sites at 3, 6 and 12 month follow up. Additionally we will assess process outcomes (acceptability, adoption, costs, sustainability).

Eligibility Criteria:
STUDY INCLUSION/EXCLUSION CRITERIA:

Child Inclusion Criteria:

* Meet the eligibility criteria for Asthma Link (as described below)
* Enrolled in Asthma Link (if randomized to the Asthma Link Condition)
* Able and willing to provide informed assent

Child Exclusion Criteria:

* Unable or unwilling to provide informed assent
* Diagnosis of a serious co-morbid illness during the past 5 years
* Developmental delay that would prevent study participation.
* Planning on moving from primary residence or moving outside of the school district in the next 1 year
* A sibling to a child participating in this study

Parent Inclusion Criteria:

* Parent/guardian to patient
* 18 years or older
* Able to understand and communicate in English or Spanish
* Able and willing to provide informed consent.

Parent Exclusion Criteria:

* Adults lacking capacity
* Prisoners

Medical Provider, School Nurse, Asthma Champion Inclusion Criteria:

• Able and willing to provide informed consent

Medical Provider, School Nurse, Asthma Champion Exclusion Criteria:

• Unable or unwilling to provide informed consent

Child eligibility for children enrolled in Asthma Link:

* children aged 6-17 years (enrolled in grade 1-12)
* prescribed daily inhaled corticosteroid (ICS) for asthma
* 1 or more courses of oral steroids in the past 2 years OR 1 or more hospitalizations or ED visits for asthma in the past 2 years OR 1 or more sick visits for asthma in the past year OR Asthma Control Test (ACT) score \<19
* parent/child report of poor ICS adherence on adherence checklist- i.e. child or parent says "Yes" when provider asks if they have difficulty remembering to take their medication or if they regularly take medication holidays or breaks
* able and willing to assent
* parental permission
* English or Spanish speaking
Diagnosis of Atrial Fibrillation in Postoperative Thoracic Surgery Using a Smartwatch

Postoperative atrial fibrillation (POAF) occurs in approximately 20% of patients following thoracic surgery. Early diagnosis is essential to prevent complications such as heart failure, stroke, myocardial infarction, and increased mortality. Smartwatches equipped with single-lead ECG capabilities and algorithms to detect asymptomatic atrial fibrillation (AF) offer a potential solution. This study aims to evaluate the effectiveness of smartwatches in detecting POAF compared to standard care.


Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years old).
* Patients undergoing major thoracic surgery with one-lung ventilation within the past 48 hours.
* Scheduled pneumonectomy or lobectomy.
* Admission to a conventional surgical unit postoperatively.
* Ability to perform single-lead ECG using a smartwatch.
* Coverage under a social security system.
* Signed informed consent

Exclusion Criteria:

* History of atrial fibrillation.
* Requirement for telemetry for AV block or tachyarrhythmias (\>140 bpm).
* Dependency on a pacemaker.
* Participation in another interventional clinical trial affecting POAF incidence.
* Mediastinal, pleural, or chest wall surgery.
* Reoperations or surgeries performed more than 48 hours prior.
* Pregnant women.
* Patients under guardians or similar legal protection.
Computerized Exercise Training for Cognitive Remediation in Adults With Multiple Sclerosis Treated With Gilenya

This study is investigating the efficacy of computer-based cognitive exercises as a means of cognitive remediation in patients with Multiple Sclerosis (MS) who are beginning the disease modifying pharmacotherapy Gileyna.

Gilenya represents the most recent advance in MS disease-modification therapy (DMT) and shows promise for neuroprotection, a feature relevant to the progressive neurologic damage associated with the disease. Cognitive impairment accompanies MS in 40-60% of cases and when present, additional symptomatic treatment combined with DMT is required. To date no symptomatic pharmacologic therapy has shown a consistent benefit on MS associated cognitive dysfunction. However, non-pharmacologic approaches show promise. With recent technical and scientific advances, cognitive training is rapidly evolving to become the most effective intervention for the cognitive impairments associated with a wide range of neurological conditions. However, these training programs have not yet been studied in MS.

This study will be a randomized open-label clinical pilot trial to compare a plasticity-based and adaptive cognitive remediation (PACR) program to an active control (ordinary computer games) in 20 adults with multiple sclerosis (MS) starting Gilenya therapy. Primary outcome measures will be used as preliminary indicators of effect, with improvements on program task-related measures and changes in cognitive measures. Secondary outcome measures will determine the feasibility of the use of these programs in patients with MS, as indicated by compliance and patient-reported experience.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-70
* Relapsing Remitting MS Diagnosis \[81\]
* Initiating Gilenya therapy, or current Gilenya therapy (kept constant for the past one month)
* No relapse or steroids in previous month
* Reading score on WRAT-3 of 37 or greater
* Visual, auditory and motor capacity to operate computer software, as judged by treating neurologist or study staff.

Exclusion Criteria:

* Previous trial of Gilenya therapy
* History of mental retardation, pervasive developmental disorder or other neurological condition associated with cognitive impairment
* Primary psychiatric disorder or unstable medical disorder that would influence ability to participate
* History of computer-based training with procedures similar to those proposed
* Learned English language after 12 years of age
* Unable to comply with study procedures
The Effects of Reaching Task Following Selective Trunk Stability Exercise

This study is performed in a controlled randomized, two-period crossover design to test the efficacy of Abdominal drawing-in maneuver (ADIM) exercise compared to conventional physiotherapy in chronic stroke survivors.

All participants provided written informed consent and are assigned to Group A or Group B. The inclusion criteria are Exclusion criteria are

Abdominal drawing-in maneuver exercise is following as:

It's for strengthening the Transversus Abdominis muscle(TrA). The simple device, that observes the pressure changes by the gauge. Subjects receive intervention 2 times a week for 4 weeks. Each session is 40 minutes. From the supine position to the hook-lying position (hip joint at 40 degrees and the knee joint at 80 degrees) and pull the navel deeply to the lumbar region through the Stabilizer™ Pressure Biofeedback that stabilizes transversus abdominis muscle. At this time, subjects are controlled to maintain contraction while keep breathing lightly, to contract slowly, also to not move the pelvis and chest while exercising The device assists in body control movements of the spine and abdominal muscle.

Conventional physiotherapy is following as:

Release pain, limb stretching, mobilization of joint and pelvic movement. Subjects receive 2 times a week for 4 weeks. Each session is 40 minutes. Group A received Abdominal drawing-in maneuver exercise for 4 weeks on period 1. Afterward washout period in a month, follow period 2 of conventional physiotherapy.

On the other side, Group B receives first conventional physiotherapy on period 1. Afterward washout period in a month, follow period 2 of Abdominal drawing-in maneuver exercise.

Eligibility Criteria:
Inclusion Criteria:

* The subject consisted of the physician's confirmation of chronic hemiplegia
* onset ≥ 6 months
* Mini-mental state examination≥25
* Biceps ≤2, Triceps≤2
* Ability to Sit on a chair alone
* FMA UE score ≥ 21points, FMA UE≤ 60 points

Exclusion Criteria:

* Biceps\>2, Triceps\>2
* Flaccid
* Neglect syndrome
* Have neurological disease and orthopedic disease
* Lack of coordination
Efficacy Optimizing Extension Study of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

The purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B patients with inadequate response to NUC therapy


Eligibility Criteria:
Inclusion Criteria:

* Subjects who completed the 104-week Dragon study.
* Subjects who are willing to participate the extension study.

Exclusion Criteria:

* Subjects who could not compliance with the protocol judged by investigators
Hemodynamics and Extravascular Lung Water in Acute Lung Injury

The purpose of this study is to test a treatment that tries to reduce the amount of fluid in the lungs of subjects with acute lung injury to see if this is helpful.

The objective of this study is to conduct a randomized, controlled trial of a goal directed therapy designed to improve outcome in patients with acute lung injury (ALI). The investigators are comparing two algorithmic approaches in managing patients with ALI - one, the control arm, attempts to reduce the amount of fluid in the lung in patients with ALI by diuresis based on central venous pressure and urine output, the other the treatment arm attempting to reduce lung water by directing therapy to measured lung water and using more sensitive indicators of preload status than CVP. The protocol uses measured extravascular lung water (EVLW) to direct diuresis and appropriate fluid restriction in a goal directed fashion in order to lower EVLW towards the normal range.

Eligibility Criteria:
Inclusion Criteria:

Acute onset of:

1. PaO2/FiO2 less than or equal to 300.
2. Bilateral infiltrates consistent with pulmonary edema on the frontal chest radiograph.
3. Requirement for positive pressure ventilation through an endotracheal tube or tracheostomy.
4. No clinical evidence of left atrial hypertension that would explain the pulmonary infiltrates. If measured, pulmonary arterial wedge pressure less than or equal to 18 mmHg.

Exclusion Criteria:

1. Age younger than 18 years old.
2. Greater than 24 hours since all inclusion criteria first met.
3. Neuromuscular disease that impairs ability to ventilate without assistance, such as C5 or higher spinal cord injury, amyotrophic lateral sclerosis, Guillain-Barré syndrome, myasthenia gravis, or kyphoscoliosis (see Appendix I.A).
4. Pregnancy (negative pregnancy test required for women of child-bearing potential).
5. Severe chronic respiratory disease (see Appendix I.C).
6. Severe Chronic Liver Disease (Child-Pugh 11 - 15, see Appendix I.E)
7. Weight \> 160 kg.
8. Burns greater than 70% total body surface area.
9. Malignancy or other irreversible disease or conditions for which 6-month mortality is estimated to be greater than 50 % (see Appendix I.A).
10. Known cardiac or vascular aneurysm.
11. Contraindications to femoral arterial puncture - platelets \< 30, bilateral femoral arterial grafts, INR \> 3.0.
12. Not committed to full support.
13. Participation in other experimental medication trial within 30 days.
14. Allergy to intravenous lasix or any components of its carrier.
15. History of severe CHF - NYHA class ≥ III, previously documented EF \< 30%.
16. Diffuse alveolar hemorrhage.
17. Presence of reactive airway disease (active will be defined based on recent frequency and amounts of MDI's use and steroids to control the disease).