cyrilzakka/clinical-trials huggingface dataset:
Early Application of Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union

The investigators hypothesized that early applied pulsed electromagnetic field treatment on delayed union might lead to increased rate of fracture union and shortened period of treatment.


Eligibility Criteria:
Inclusion Criteria:

* The failure of healing after at least 16 weeks and not more than 9 months following surgical reduction and fixation of the fracture.

Exclusion Criteria:

* Implant loosening or failure, infection, established nonunion, fracture gap greater than 5 mm, presence of implant within the fracture gap, metabolic disorders or received medication affecting fracture healing
Comparison of Lung Ultrasound and Chest Radiography for Pleural and Pulmonary Diagnosis in Pediatric Intensive Care Unit

In pediatric intensive care unit of Strasbourg, two exams are easily used for pleural and pulmonary diagnosis : chest radiography, which is the "historic" and reference exam, and commonly systematically the lung ultrasound.

However, chest radiography produces radiation and is less accessible in our unit, because it depends on the radiology department.

On the opposite, the lung ultrasound doesn't produce radiation, is simple, reliable, easily accessible (the investigators have two ultrasound systems in the unit), and simply and quickly achievable at the patient's bedside, including for less experienced operator.

We will evaluate the diagnostic performances of lung ultrasound and chest radiography for pleural and pulmonary diagnosis in pediatric intensive care unit.


Eligibility Criteria:
Inclusion criteria:

* Age under 18 years
* Patient in pediatric intensive care unit
* Patient registered with a social security scheme
* Agreement of the persons entitled to give parental authority over minor
* Patient which has, during his stay in pediatric intensive care unit, in order to have a pleural or pulmonary diagnosis, a chest radiography and then a lung ultrasound, at less than 2 hours interval.

Exclusion criteria:

- Refusal of the patient or of the persons entitled to give parental authority over minor to participate in the study
IN CONTROL--Hypertension Reduction in Inner City Seattle

To implement and evaluate with a randomized, controlled trial interventions to improve control of hypertension among inner city low- income and minority residents of Seattle.

BACKGROUND:

Low income residents of inner city Seattle especially African Americans, have significantly higher rates of cardiovascular mortality and morbidity than other Seattle residents. Hypertension is a major risk factor for these excess deaths. The prevalence of both hypertension and uncontrolled hypertension is also higher among low income and minority residents, especially young men.

The study was in response to a demonstration and education initiative, "Improving Hypertensive Care for Inner City Minorities", which was reviewed and approved by the Clinical Applications and Prevention Advisory Committee in April 1992 and by the National Heart, Lung, and Blood Advisory Council in May 1992. The Request for Applications was released in October 1992.

DESIGN NARRATIVE:

Two interventions were studied, both of which improved upon existing activities and strengthened the relationship between community and clinic-based hypertension control activities. The first intervention improved the identification and entry into care of new and uncontrolled hypertensives in the community with an emphasis on bringing more young males (especially African American) through: (a) screening and education activities (b) a microcomputer-based client tracking system to follow persons with elevated blood pressure (c) an outreach system to improve follow-up into clinical care.

The second intervention enhanced access to and compliance with hypertension care among patients using the participating clinics (both currently registered patients and new patients referred through community screening activities) through: (a) microcomputer-based patient tracking system at each clinic to identify nonadherent and other high risk patients (b) placing a hypertension patient care coordinator at each clinic who created an individualized care plan for each patient and coordinated a wide range of services, including specific strategies to enhance compliance (c) making available outreach workers to assist in efforts to keep patients in care.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Effect of Transcutaneous Auricular Nerve Stimulation vs Body Rocking Exercises on Spasticity of Upper Limb

The primary aim of this study is to compare the effect of TANS and body rocking exercises on reducing upper limb spasticity in young stroke patients( under 50). Specific objectives include evaluating changes in muscle tone, motor function, pain reduction, and functional independence following each intervention.

This randomized controlled trial, RCT, will involve 42 young stroke patients with upper limb spasticity randomly assigned to three groups, transcutaneous auricular nerve stimulation, body rocking exercise, or control group, usually rehabilitation. Participants will receive 30-minute transcutaneous nerve stimulation session or 20 to 30-minute body rocking exercise in session 3 to 4 times a week over an 8-week period. Key outcome measures include the Modified Ashworth Scale for Spasticity, the Fusel-Meyer Assessment for Motor Function, the Numeric Rating Scale for Pain, and Stroke Impact Scale for Functional Independence.

Eligibility Criteria:
Inclusion Criteria:

* Age 35-50 years
* Diagnosed with stroke (ischemic or hemorrhagic)
* Upper limb spasticity (Modified Ashworth Scale score ≥1)
* Post-stroke duration of ≥3 months
* Able to follow verbal and physical instructions
* No contraindications to electrical stimulation or exercise therapy

Exclusion Criteria:

* Severe cognitive impairment or communication disorders
* History of epilepsy or uncontrolled seizures
* Pacemaker or implanted medical devices
* Severe cardiac, orthopedic, or neurological conditions
* Uncontrolled hypertension or diabetes
* Participation in another spasticity-related trial
Helicobacter Eradication Relief of Dyspeptic Symptoms

A double-blind clinical trial investigating if a sub-group of functional dyspeptic patients without any use of NSAID or gastric erosions could have a better evolution of their dyspeptic symptoms after Helicobacter eradication than the placebo control group

Objective: investigate if a sub-group of functional dyspeptic patients without any use of NSAID or gastric erosions could have a better evolution of their dyspeptic symptoms after Helicobacter eradication than the placebo control group

Design: A randomized double-blind placebo controlled clinical trial

Inclusion Criteria: Patients with more than 18 years, Functional dyspepsia accordingly Rome III criteria, Helicobacter pylori infection by two diagnostic tests

Exclusion Criteria: No concordance with informed consent; Pregnant woman or breast feeding or no trust anticonceptional method; Structural gastrointestinal abnormalities except gastritis, duodenitis or hiatal hernia; Previous treatment for Helicobacter pylori infection; Previous surgery on esophagus, stomach or duodenum; Hypersensitivity to the drugs in study; Proton pump inhibitor use in the previous 15 days; H2-antagonists use in the previous 07 days; Antibiotics use in the previous 30 days; Patients unable to answer the study questionnaires; Alcohol abuse; Drug use; Serious comorbidities; Biliary colic; Irritable bowel syndrome; Gastroesophageal Reflux Disease

Interventions: amoxicillin, clarythromycin, omeprazole for 10 days

Control: Placebo

Outcomes:

Primary: Proportion of patients with 50% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire Secondary: Proportion of patients with 100% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire; Need of rescue medication; Median difference of score between groups; Mean SF-36 scores evolution between groups; Lost of productivity measured by WPAI between groups

Visits: screening, baseline, 4, 8, 12 months

Endoscopic evaluation: screening, 12 months

Helicobacter detection methods: urease, histology (3 pathologists) performed at screening and 12 months

Eligibility Criteria:
Inclusion Criteria:

* Patients with more than 18 years
* Functional dyspepsia accordingly Rome III criteria
* Helicobacter pylori infection by two diagnostic tests

Exclusion Criteria:

* No concordance with informed consent
* Pregnant woman or breast feeding or no trust anticonceptional method
* Structural gastrointestinal abnormalities except gastritis, duodenitis or hiatal hernia
* Previous treatment for Helicobacter pylori infection
* Previous surgery on esophagus, stomach or duodenum
* Hypersensitivity to the drugs in study
* Proton pump inhibitor use in the previous 15 days
* H2-antagonists use in the previous 07 days
* Antibiotics use in the previous 30 days
* Patients unable to answer the study questionnaires
* Alcohol abuse
* Drug use
* Serious comorbidities
* Biliary colic
* Irritable bowel syndrome
* Gastroesophageal Reflux Disease
Cryoballoon Ablation of Pulmonary Veins After Failed RF Ablation in Patients With Paroxysmal AF

The aim of this prospective randomized double-blind study was to compare the efficacy and safety of cryoballoon ablation with the RF approach in the treatment of paroxysmal AF after failed first radiofrequency ablation.


Eligibility Criteria:
Inclusion Criteria:

* Previous failed first radiofrequency ablation procedure (only circumferential PV isolation without linear lesions) in patients referred for second catheter ablation of AF
* \> 3 months after first PVI

Exclusion Criteria:

* Congestive heart failure
* Ejection fraction \<35%
* Left atrial diameter \>60 mm
Gene Expression Profiles in Predicting Survival of Patients With Head and Neck Cancer

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict survival of patients with head and neck cancer.

PURPOSE: This laboratory study is assessing gene expression profiles in predicting survival of patients with head and neck cancer.

OBJECTIVES:

* Identify gene expression profiles associated with survival by DNA microarray assay analysis using RNA from formalin-fixed paraffin-embedded tissue samples from patients with squamous cell carcinoma of the head and neck treated on clinical trial RTOG-9501.

OUTLINE: Formalin-fixed paraffin-embedded tissue samples are analyzed by DNA microarray analysis for gene expression profiling.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of squamous cell carcinoma of the head and neck, including 1 of the following sites:

  * Hypopharynx
  * Larynx
  * Oral cavity
  * Oropharynx
* Stage II-IV disease
* Must have received treatment on clinical trial RTOG-9501
* Formalin-fixed paraffin-embedded tissue samples available

Exclusion Criteria:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
A Study to Assess Persistence, Adherence and Changes in Disease Activity in the Children Population of Juvenile Arthritis Patients Treated With Adalimumab (HUMIRA®)

The objective of this study is to assess persistence, adherence and changes in disease activity in the children population of juvenile arthritis patients treated with adalimumab (HUMIRA®) in the routine clinical settings in the Russian Federation.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of polyarticular Juvenile Idiopathic Arthritis (JIA) according to International League of Associations for Rheumatology (ILAR) criteria .
* Planned treatment with HUMIRA according to the local product label and prescription guidelines. Alternatively, subjects assigned to HUMIRA treatment not more than 1 month prior to inclusion can be enrolled.
* Negative result of tuberculosis (TB) screening procedure and TB specialist permission to start biologic therapy.
* Patient's informed consent form signed by the parent or guardian/and by the child, if applicable.

Exclusion Criteria:

* Has contraindications for the treatment with HUMIRA according to the latest version of the locally approved label.
* Any biologic drugs taken prior to 3 months of enrolment in the study.
* Patients treated with any biosimilar version of HUMIRA
* Previous participation and dropout from this study.
* Patients participating in another clinical and/or observational study priory 3 months before the enrolment to this study.
Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution

The purpose of this study was to compare lens comfort on Day 30 for Air Optix® lenses cared for with OPTI-FREE® PureMoist® (OFPM) Multi Purpose Disinfecting Solution (MPDS) compared to Acuvue® Oasys® lenses cared for with habitual MPDS.

Prior to the 30-day study period, subjects were fitted with study lenses in a masked manner and underwent a run-in period of 4-8 days to adjust to the randomized lenses.

Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent.
* Currently wearing weekly/monthly contact lenses on a daily wear basis, as specified in protocol.
* Willing to wear contact lenses on a daily wear basis for the duration of the study.
* Currently using a multi-purpose solution, as specified in protocol.
* Vision correctable to 20/30 (Snellen) or better in each eye at distance at Visit 1.
* Willing to follow the study procedures and visit schedule.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Currently wearing Air Optix, Acuvue Oasys, or Acuvue Advance brand of lenses.
* Currently using any Opti-Free brand of multi-purpose solution.
* Must wear contact lenses on an extended wear (overnight) basis during the study.
* Known sensitivity or intolerance to POLYQUAD® or ALDOX preserved lens care products.
* Monocular (only one eye with functional vision), fit with only one lens, or monovision modality of wear.
* Use of additional lens care products other than a multi-purpose solution within 7 days prior to Visit 1.
* Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of contact lens rewetting drops, within 7 days prior to Visit 1.
* Any abnormal ocular condition observed during the Visit 1 slit-lamp examination.
* Current or history of ocular infections (i.e., microbial keratitis, conjunctivitis) or severe inflammation (i.e., iritis, infiltrates) within the 6 months prior to Visit 1.
* Ocular surgery within the 12 months prior to Visit 1.
* Any systemic diseases at Visit 1 (including allergies, respiratory infections or colds) that affect the eye and could be exacerbated by use of contact lenses or contact lens solutions.
* Participation in any clinical study within 30 days of Visit 1.
* Other protocol-defined exclusion criteria may apply.
The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 on Children With Rheumatic Diseases

The study aims to explore the therapeutic value and mechanism of Interleukin-2 on children with rheumatic diseases (Systemic Lupus Erythematosus, Primary Sjögren Syndrome, Juvenile Idiopathic Arthritis).

The investigators designed a single center, open-label, prospective study that routinely administered low-dose IL-2 therapy to monitor the improvement of clinical and laboratory parameters to explore its efficacy and to observe changes in immune cell subsets and cytokines.

Methods: Patients were divided into two groups. One received standard therapy, while another one administrate with low-does IL-2 plus standard therapy.

Eligibility Criteria:
Inclusion Criteria:

1. age \<18 years old
2. meet the diagnostic criteria of disease classification
3. HIV negative;Negative for Hepatitis B Virus and Hepatitis C Virus.

Exclusion Criteria:

1. heart failure (cardiac function ≥ grade III NYHA)
2. liver insufficiency (upper limit of normal range of transaminase \> 2 times)
3. renal insufficiency (creatinine clearance ≤30ml/min)
4. acute or severe infections such as bacteremia and sepsis
5. malignant tumor
6. high-dose steroid pulse therapy or intravenous injection of glucocorticoids in the last 1 month;Rituximab, infliximab or other biological agents were used
7. mental disorders or any other chronic illness or substance abuse may interfere with the ability to comply with agreements or provide information
8. Inability to comply with IL-2 treatment regimen.
Evaluation of Morphology Abnormal Cornea Stability With Corneal Biomechanical

To evaluate the corneal biomechanical properties of stable eyes with abnormal morphology, and introduce a biomechanical stable index to evaluate the stability of the eyes with abnormal morphology at the first diagnosis.


Eligibility Criteria:
Inclusion Criteria:

1. Best corrected visual acuity (BCVA) ≥ 20/20;
2. No other eye diseases except myopia and astigmatism;
3. The cornea was transparent, and there was no cloud or pannus;
4. No clinical manifestation of keratoconus（Corneal stromal thinning, Cone-shaped anterior protrusions, Fleischers ring, Vogts striae, Epithelial or subepithelial scarring） Exclusion Criteria:1) corneal disease;

2) ocular trauma; 3) Patients were required to stop wearing soft contact lenses for at least 2 weeks and rigid contact lenses for at least 4 weeks before examination; 4) Pregnant and lactating women;
Coracoid Tunnel Widening After ACJ Tight Rope Fixation

studying coracoid tunnel widening after arthroscopic fixation of acute acromioclavicular joint (ACJ) dislocation using TightRope system and its correlation with loss of reduction and the functional scores.

Abstract Purpose: To detect coracoid tunnel widening after arthroscopic fixation of acute acromioclavicular joint (ACJ) dislocation using TightRope system and its correlation with loss of reduction and the functional scores.

Methods: From July 2016 to Dec 2018, a prospective study was performed at our hospital. Twenty-three patients with acute grade III-V ACJ dislocation were included in the study. Arthroscopic double tight-rope repair of the ACJ was performed. Coracoid tunnel widening was measured by computed tomography (CT) and coraco-clavicular distance was measured on the x-ray immediately post-operative and at 12 months. Constant Shoulder Score, Oxford Shoulder Score, Nottingham Clavicle Score and Visual analogue scale were used as outcome measures at 12 months.

Level of evidence IV Keywords Acute acromioclavicular joint injury . TightRope . Coracoid tunnel dilatation. Loss of reduction.

Eligibility Criteria:
Inclusion Criteria:

* patients with acute (≤ 3 weeks after injury) Rockwood grade III-V ACJ dislocation

Exclusion Criteria:

* Patients with associated coracoid fracture, associated rotator cuff tears or glenohumeral arthritis
Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy

The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.

Is a continued treatment with alendronate for another two years after a preceding therapy with bisphosphonates of at least four years able to reduce the incidence of new osteoporotic fractures in patients at high fracture risk compared to a therapy-free interval?

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women or men \> 60 years
* DXA T-Score at lumbar spine, total hip or femur neck \<-2,0 before the start of the bisphosphonate therapy or at baseline or at least one low trauma vertebral fracture grade 2-3 or multiple low trauma vertebral fractures independent of bone mineral densitiy
* Pretreatment with bisphosphonates for at least four years
* Risk for hip and vertebral fractures min. 30% according to DVO-guideline for osteoporosis 2009
* Signed informed consent

Exclusion Criteria:

* Other pharmacological treatment of osteoporosis during the last 48 months
* Other bone diseases
* Malabsorption syndromes
* Renal insufficiency with a calculated creatinine clearance \< 35 ml/min
* Diseases of the esophagus, delayed esophageal clearance
* UUnability to realise the intake instructions
* Hypocalcemia
Development a Predictive Nomogram for Primary Ovarian Insufficiency

The purpose of this research is to develop a predictive nomogram for primary ovarian insufficiency.

Many researches show primary ovarian insufficiency(POI) etiology is related with gene,immunization,iatrogenic, infection factors and social factors etc. In fact, approximate 70-90% POI have no definite cause, so a lot of patients don't know what will happen when they in occult stage of POI. In this research, researchers will investigate all possible factors in POI patients and normal women and select the valuable risk factor by integrated by statistical method to establish the reasonable predictive model.

This study consists two stages.The fist stage is the model establishment, the second stage is the certificate and evaluate the model.

Eligibility Criteria:
Inclusion Criteria:

* Age18--42
* Definite spontaneous last menstrual period
* Informed consent for participating this research and could answer the questionnaires faithfully.

Exclusion Criteria:

* Congenital gonadal dysgenesis and non organic diseases lead to menstrual disorders.
* Endocrine diseases such Polycystic ovary syndrome, hyperprolactinemia, dysfunctional uterine bleeding, low gonadotropin menstrual disorders and hyperthyreosis
* Reproductive toxicity of drugs used
* Release of chemotherapeutic drugs
* Accept sex hormone medicine in recent 3 months
* Pregnant and lactating women
* With serious heart, liver, kidney and other diseases
* With severe psychiatric disorders
Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM

Phase 3b, single arm, single site simplification study of HIV-1 infected patients with virological suppression under the combination of Lamivudine (150 mg BID) plus Raltegravir (400 mg BID) switching to Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD): Roll-over study of the RALAM clinical trial (NCT02284035)


Eligibility Criteria:
Inclusion Criteria:

* Patients in the switch arm who have completed the 24-week follow-up of RALAM (NCT02284035) study and remain virologically suppressed (viral load \<50 copies/mL) on dual therapy with lamivudine plus Raltegravir
* Patients who have signed informed consent to participate in the study.

Exclusion Criteria:

* Pregnancy, lactation, or planned pregnancy during the study period
* Any disease or history of disease which, in opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment
* Hepatitis B co-infection