cyrilzakka/clinical-trials huggingface dataset:
Akin Osteotomy With or Without Fixation

The study is a prospective randomized study about hallux valgus surgery. The investigator try to assess if the fixation of percutaneous Akin osteotomy with a cannulated screw have an incidence in the first ray mobility since the two technics ( fixation and no-fixation) are described and practiced, and since the stiffness of the first metatarso-phalangeal joint is determinant in the result of this functional surgery.

It's a prospective monocentric randomized work about forefoot surgery. Every patient included undergoes an hallux valgus chevron osteotomy of the first metatarsal associated with a percutaneous Akin osteotomy of the first phalange. The investigators study the impact of the fixation of percutaneous Akin osteotomy ( osteotomy of the first phalange of hallux) with two arms: one with fixation of the percutaneous Akin osteotomy, and one with a non-fixed percutaneous Akin osteotomy This study as been approved by Institutional review board; written informed consent is required for all patients before inclusion.

The clinic follow-up of each patients included in the study will be the same of the normal follow-up for this type of surgery in our practice. This includes clinical exam, radiologic exam, and functional score AOFAS before surgery, at 6 weeks after the surgery, four months after surgery and finally one year after the surgery.

The primary outcome measure which is the first metatarso-phalangeal global mobility will be blindly measure by an observator.

Eligibility Criteria:
Inclusion Criteria:

* patient which need hallux valgus surgery

Exclusion Criteria:

* hallux rigidus
* Trouble of rotation of the the hallux
* Rheumatoid forefoot
* Pregnant women
Use of EMG to Assess Clinical Hypertonia

A handheld surface electromyography device will be tested by clinicians on children with limb hypertonia, and inter-rater reliability will be assessed with and without the device.

Hypothesis:

Qualitative surface EMG measurement during passive movement will increase the inter-rater reliability of clinicians for diagnosis of spasticity and dystonia in children with hypertonia.

Specific Aims:

1. Develop a handheld surface EMG device with auditory output that can be used similarly to a stethoscope to listen non-invasively to the activity of muscles.
2. Provide clinicians at 5 different institutions with a device to test for 2 months in their own clinics.
3. Bring all 5 clinicians to Stanford University for a single-day exercise in which each clinician will examine 10 children with hypertonia. Each clinician will rate the children without using the device, and then again with the device. Intra-class correlations and kappa statistics will be used to assess whether the use of the device leads to improved inter-rater reliability.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-18
* hypertonia in at least one limb due to spasticity

Exclusion Criteria:

* any condition that would increase the risk of participation
Duration of Blockade of Peripheral Nerves With Bupivacaine Depending of the Adjuvants

The main aim of the investigator's study is to propose combination of local anesthetics and adjuvants that provides both adequate anesthesia during surgery and prolonged post-operative analgesia.

Peripheral nerve plexuses blocks are performing as a component of analgesia in patients undergoing orthopedic surgery on the upper or lower extremities. Patients are divided into two groups depending on the adjuvant to the local anesthetic: 1st group - patients whose blockade is performed with a solution of bupivacaine 0.375% together with dexamethasone 0.02%; Group 2 - patients whose blockade is performed with a solution of bupivacaine 0.375% together with dexamethasone 0.02% and epinephrine 0.00018%. The duration of the blockade is estimated by puncturing the skin with a needle. The intensity of pain is assessed at 6, 12, 24 and 36 hours after blockade using Visual analog scale (VAS). The amount of narcotic anesthetic used in the postoperative period is also recorded. In addition, patients underwent electromyography of the innervation area of the blocked nerve before the surgery and 24 and 36 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing upper or lower extremity orthopedic surgery

Exclusion Criteria:

* diabetes mellitus;
* diseases of the peripheral nerv system
Patient Reported Outcome Study on Long Term LoFric Users

A prospective, observational cohort study evaluating Patient Reported Outcome in subjects with a long term experience from intermittent catheterization using the LoFric catheter. Prescription and use of LoFric catheters fall within current practice and is not dictated within this Non-Interventional Study.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent.
2. Female or male aged 18 years or older at time of signing informed consent.
3. Use of LoFric catheters for urethral intermittent catheterization for ≥ 6 years and currently using LoFric.
4. Able to read and write.
5. By investigator judged as able to comprehend and answer study questionnaires.

Exclusion Criteria:

1. Use of other catheter brand(s) than LoFric for \> 8 weeks in total during the past 12 months.
2. Simultaneous participation in any interfering clinical study as judged by the investigator.
3. Involvement in the planning and/or conduct of the NIS (applies to both Wellspect HealthCare staff and staff at the study site).
4. Previous enrolment in the present NIS.
Short- and Long-term Health Effects of Air Pollution in Poland

The effects of air pollution on the frequency of hospital admissions and mortality due to acute coronary syndromes, atrial fibrillation, and renal disfunction are noted also in areas perceived as pollution-free (due to the lack of large industry). The aim of the project is to assess the impact of air pollution in Eastern Poland on regional public health.

The project will be conducted in Eastern Poland - the area characterized by unique natural features, large areas covered by forests, lack of factories, and relatively low industrialization. On the other hand, the region is also characterized by low socioeconomic status, in the cold season the residents' suboptimal heating choices are in result posing a major anthropogenic threat to air quality in the form of low emissions. The vast majority of studies on air pollution were conducted in highly polluted areas, in which patients are exposed to moderate and extreme concentrations of pollutants. Taking into consideration the scarce number of surveys from areas with a low level of pollution the investigators intend to analyze the relationship between air pollution and cardiovascular and renal outcomes in Eastern Poland. The examination of the impact of so-called "Polish smog" on mortality and morbidity in the study area is not without significance. It would be the first major study of the impact of this type of pollution on human health.

In the subsequent part of the study, we will evaluate the effects of Polish smog in the entire country.

In light of extant body of literature, the following will be considered as the public health indicators: acute coronary syndromes, episodes of atrial fibrillation, ischemic strokes, kidney disease hospitalizations or emergency room visits, cardiovascular and renal mortality.

Eligibility Criteria:
Inclusion Criteria:

* Residents from the analyzed area

Exclusion Criteria:

* None
Immunoreactivity to Cetuximab in Cancer Patients

RATIONALE: Studying samples of blood in the laboratory may help doctors predict which patients will develop hypersensitivity to cetuximab.

PURPOSE: This research study is looking at hypersensitivity to cetuximab in patients with head and neck cancer or advanced colorectal cancer previously treated with cetuximab.

OBJECTIVES:

* To examine serum samples from patients with head and neck cancer or advanced colorectal cancer previously treated with cetuximab for the presence of antibodies against cetuximab.

OUTLINE: Serum samples are examined by immunoreactivity screening of IgE, IgG, IgA, and IgM antibodies and complement reaction.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of one of the following:

  * Head and neck cancer
  * Advanced colorectal cancer
* Previously treated with cetuximab
* Serum samples available from patients enrolled in one of the following clinical trials:

  * VU-VICC-GI-0410 (colorectal cancer)
  * VU-VICC-GI-0622 (colorectal cancer)
  * VU-VICC-HN-0356 (head and neck cancer)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Role of CVVH in Patients With Acute Paraquat Poisoning

Paraquat poisoning is characterized by multiple organ failure and pulmonary fibrosis with respiratory failure. Accumulating evidence suggested that continuous venovenous hemofiltration (CVVH) had a beneficial role in the treatment of multiple organ dysfunction. The investigators hypothesized that CVVH might restore multiple organ function and reduce the high mortality rate of paraquat poisoning. To confirm it, an prospective clinical study would be carried out.

Paraquat (1,1 '-dimethyl-4,4'-bipyridylium dichloride) is widely used as a herbicide. Accidental or intentional ingestion of paraquat is common in many developing countries such as China, Sri Lanka and Korea because of easy access. The high mortality rate of paraquat is due to its high toxicity and the lack of effective treatments. Thus, the paraquat poisoning becomes one of major medical problem in the developing countries.

Paraquat poisoning is also one of major causes of death among young patients with acute poisoning in China. It is characterized by multiple organ failure and pulmonary fibrosis with respiratory failure. A growing body of evidence suggested that continuous venovenous hemofiltration (CVVH) had a great beneficial role in the treatment of multiple organ dysfunctions. We hypothesized that CVVH might reduce the high mortality rate of paraquat poisoning via restoring the multiorgan function, such as acute hepatic lesion, acute kidney injury, acute lung injury and acute pancreatic injury. We expect to enroll 100 patients from our hospital within 1 week after oral intake of paraquat. All patients were divided into Group 1 and Group 2. Group 1 were treated with a standardized therapeutic regimen including stomach lavage, emergency haemoperfusion and drugs. Group 2 were accepted with standardized treatment plus CVVH. The aim of this prospective clinical study was to evaluate the safety and efficacy of CVVH for the treatment of patients with paraquat poisoning. The survival rate, clinical manifestations and clinical parameters between these two groups were compared.

Eligibility Criteria:
Inclusion Criteria:

* All patients recruited in this study should meet the requirements as follows:

  1. history of exposure to Paraquat
  2. concentration in urine or plasma from all patients who arrived at our hospital within 1 week of paraquat ingestion was more than 0.1 mg/L.
  3. Patients with a light blue, navy blue or dark blue color in urine dithionite tests within 1 week of PQ ingestion, were classified as having PQ intoxication and were included in this study.
  4. patients with acute organ dysfunction such as acute kidney injury, hepatic injury or pancreatic injury.

     Exclusion Criteria:

Patients who had colorless urine PQ tests, who arrived at any hospital more than 24 h after intoxication, who had not orally ingested PQ or any other drug poisonings, who were younger than 14 years or older than 70 years, or who had been included in any previous control trials were excluded.
Microbiologic Contamination of Home Non Invasive Ventilators

Home non-invasive ventilators are daily used by patients with chronic respiratory failure. There are frequently used with warming and humidifying systems. These systems need to be cared for and frequently washed by the patient.

The aim of this study is to evaluate if the humidifying system of home ventilators are colonized by microbiological germs.

The use of non-invasive ventilators is common for treating respiratory failure. Their care relies on the patients and their carers.

No study has assessed the efficacy of such care with respect to the number of microbiological specimens that remain in the humidifier.

Eligibility Criteria:
Inclusion Criteria:

* Patient established on home non invasive ventilation for more than 6 months
* With a compliance \>4hours/day
* Who brought their ventilator for the assessment
* Diagnosed with COPD or Obesity hypoventilation syndrome (OHS)
* Who consent
* With an age \> 18 years

Exclusion Criteria:

* Age under 18
* Ongoing exacerbation
* Not able to consent
* Pregnant or breastfeeding
Miniplate Versus k Wires in Management of Metacarpal Fracture

To compare between buried k wires and miniplate in management of metacarpal fracture.

Fractures of the carpals, metacarpals and phalanges account for approximately 15-19% of fractures in adults, with 59% of these occurring in the phalanges, 33% in the metacarpals and 8% in the carpal bones \[1\]. The single most common fracture site in the hand is the sub capital region of the fifth metacarpal bone (boxer's fracture) \[2\], which usually results from a direct blow to the metacarpal head \[3\]. Most hand fractures are caused by accidental falls or other sports-related injuries \[4\]. Hand fractures are among the most common fractures of upper extremity \[5, 6\]. Hand fractures can be treated conservatively or surgically, depending on the severity, location and type of fracture. The main objective of both operative and non-operative treatments is to provide fracture stability for early mobilization \[7\]. Surgical fixation is mainly indicated for displaced fractures because casts are often not sufficient to maintain reduction \[8\]. Open reduction with internal fixation (ORIF), using pins or plates, has historically been used to stabilize hand fractures which have rotational deformity or lateral angulation \[9\]. Open reduction may result in scarring, joint stiffness and tendon adhesion \[7\]. Closed reduction with internal fixation (CRIF), using percutaneous K wire or screws, is now used to treat the majority of unstable closed simple hand fractures \[10\]. It is generally considered percutaneous Kirschner wire (K wire) fixation may not provide adequate stabilization to allow for early mobilization \[8\] .

Eligibility Criteria:
Inclusion Criteria:

1. Age: ( 20-60) years,
2. Fresh (fixed within 3 days),
3. Single or multiple fractures of metacarpals.

Exclusion Criteria:

1. Pathological fracture,
2. Major systemic illness, malignancy,
3. Patient on drugs affecting fracture healing like steroid, anticancer drugs,
4. Polytrauma patients,
5. Extensive comminution of the metacarpal or phalanx detected pre- or intra-operatively,
6. Dislocations at either end of the fractured bone
7. Parents/guardians/patients not willing to participate in study.
Comparison of Two Graft Choices in Mediale Patellofemoral Ligament Reconstruction (MPFL)

The purpose of this study is to elucidate surgical techniques for reconstructing MPFL in the treatment of chronic patella instability. The two techniques are conventional technique with the gracillis and screw fixation in the femur which is compared with new technique where the QT tendons and anchor fixation in the femur are used.

It would be investigated which technique provides the best stability with the least postoperative pain from the reconstruction and the lowest frequency of patellar reluxation.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 15 and 40 years of age with chronic tendency to lateral patellar dislocation (defined as 2 or more verified dislocation cases)
* The growth zones must be found closed - verified by MRI scan

Exclusion Criteria:

* Patients with known rheumatoid arthritis.
* Patients with arthroscopically detected osteoarthritis (grade 3 cartilage lesion)
* Inability to follow a normal rehabilitation regime.
* Previous ligament surgery in injured knees.
MICBT for Non-underweight Adults With Eating Disorders

Eating disorders (ED) are severe but treatable conditions, but there are large margin for improvements in terms of efficacy and adherence. There is room to explore new treatment options who are either more capable to retain patients in therapy, more effective. Alternative their efficacy may match the ones of current available treatments but offer new options to ones that did not respond to available therapies. Here the investigators explored if a combination of CBT-focused plus Metacognitive Interpersonal Therapy (MIT) is an empirically supported therapy for personality disorders and could be a new viable treatment option for non-underweight ED. MIT targets some aspects of ED such as poor awareness of mental states and maladaptive interpersonal schemas that are not included in the transdiagnostic model underlying the most investigated empirically supported treatment for ED that is CBT-E. It is reasonable therefore that targeting these aspects of psychopathology can be a path to treatment adherence and effectiveness

The study is a pilot randomized controlled trial that aims to evaluate the feasibility and effectiveness of weekly MIT in addiction to CBT-F in a group of adults diagnosed with ED. Specifically, the investigators will investigate in a sample of non-underweight adults presenting with ED whether once compared to CBT-E, a treatment combining MIT and CBT-F is a) feasible, b) well-tolerated and c) potentially effective on eating disorders symptoms and other outcomes.

The investigators expect that the experimental group CBT-F+MIT would be able to have high treatment adherence and retention on the ground of previous studies of MIT for personality disorders. They will also expect good outcomes in the primary outcome. Given the small sample this is just a pilot study so any conclusions about other outcomes will be considered preliminary. Results will provide new evidence that may lead to consider CBT-F+MIT a treatment option for ED deserving investigations in larger trials.

Eligibility Criteria:
Inclusion Criteria:

* ED diagnosed in the past 6 months
* Seeking treatment for eating disorder
* Able to provide written, informed consent
* BMI \> 18.5

Exclusion Criteria:

* Acute psychotic episode, psychotic symptoms, Bipolar I disorder; antisocial personality disorder
* Suicidal ideation
* Substance abuse
* Previous psychological intervention for other eating disorders
* Currently involved in other ongoing treatment
D-dimer Levels During and After Anticoagulation in Patients With a Previous Venous Thromboembolism: Effects on the Risk of Recurrence

The results of the Prolong study, currently submitted for publication, show that patients with a first unprovoked venous thromboembolic event who have altered D-dimer levels, measured one month after anticoagulation with vitamin K antagonists is stopped, have a high rate of recurrences (about 14%) and a prolongation of anticoagulation is effective in reducing significantly this rate. Those patients with normal D-dimer (about 60% of all patients examined) have a low rate of recurrences (about 5%) and likely a prolongation of anticoagulation in all these patients cannot be recommended.

In line with these results, the Prolong-Two study aims at assessing the predictive role for recurrence of D-dimer levels measured: a) during anticoagulation, b) one month after its withdrawal and c) periodically during follow up.

Patients with a first unprovoked venous thromboembolism (including proximal deep vein thrombosis of a leg and/or pulmonary embolism) which are treated with vitamin K antagonists for not less than 6 months are considered for the study. D-dimer assay is performed during anticoagulation and patients with altered results continue the anticoagulation for 6 more months. Those with normal D-dimer stop the anticoagulant treatment and are again examined one month later. Anticoagulation is resumed for 6 more months in those patients with abnormal D-dimer results but is permanently stopped in those with a normal assay. The latter patients are examined and D-dimer assay performed again every two months to evaluate the natural history of the assay after anticoagulation is stopped and the possible predictive value for recurrence of a change of the assay during follow-up from normal to abnormal results.


Eligibility Criteria:
Inclusion Criteria

* Age \> 18 years
* After a first documented idiopathic proximal deep vein thrombosis and/or pulmonary embolism
* After at least 6 months of oral anticoagulation
* After written informed consent

Exclusion Criteria:

* Age \> 82 y
* Recurrent venous thromboembolism
* If the Venous thromboembolism occurred:
* during pregnancy or puerperium
* after recent (i.e. within three months) fracture or plaster casting of a leg,
* after immobilization with confinement to bed for three consecutive days after surgery with general anesthesia lasting longer than 30 minutes
* Patients with:
* active cancer
* antiphospholipid antibody syndrome
* antithrombin deficiency
* serious liver disease or renal insufficiency (creatininemia \> 2 mg/dL),
* other indications for anticoagulation or contraindications for this treatment
* limited life expectation
* Patients who live too far from the clinical center
Long-term KRd in Relapsed and/or Refractory Multiple Myeloma

Research question: Is KRd therapy effective and safe in the real-world Asian patients?

Primay objective: To evaluate the effectiveness of KRd in RRMM patients

Secondary objectives:

To evaluate the effectiveness of investigational treatment strategy by

* PFS difference according to the high-risk disease subgroups and previous treatment
* OS
* Overall response rate and clinical benefit rate
* Duration of response To evaluate the safety and tolerability of KRd in RRMM patients

Key study variables:

Demographic data, ISS, R-ISS, cytogenetic abnormalities on FISH and G-banding, previous treatment regimens, response to previous treatment regimens, existence of extramedullary plasmacytoma, MM-related symptoms, whether or not M protein has increased twice or more in 2-3 months at the time of KRd commencement, response to KRd therapy, duration of KRd treatment, adverse events during KRd therapy, disease progression and progression date, survival, and censored date or day of death

Eligibility Criteria:
Inclusion criteria

1. Patients ≥ 19 years
2. Relapsed and/or refractory multiple myeloma patients
3. Patients who had received KRd combination chemotherapy from February, 2018 to February, 2020.

Exclusion criteria

1. Patient who had not been treated with KRd combination therapy from the first cycle of treatment
2. Patients who had received KRd combination chemotherapy before February, 2018 and after February, 2020.
Screening for Glaucoma in Namil Area, South Korea

The purpose of this study is to study the prevalence of glaucoma in Korea, the investigators selected Namil area in Geumsan city, located in central Korea. The residents aged over 40 in this area are to be recruited to full ophthalmologic examination to detect and classify the glaucoma.

Screening includes following examinations; Questionaire and Consent form, Visual acuity test, Auto-refraction, IOL Master measurement, Pachymetry, FDT Perimetry, Fundus Photography, Slit lamp examination, Goldmann applanation Tonometry, Gonioscopy, and Binocular optic disc evaluation. For the cases showing any abnormality in FDT perimetry, optic disc morphology, or intraocular pressure, Humphrey automated visual field test is to be performed as an extended examination. Finally, optic nerve head evaluation by OCT or GDx analyzer is to be used as a confirmation test, as well as additional Humphrey visual field test.

Eligibility Criteria:
Inclusion Criteria:

* All residents aged over 40 in Namil area

Exclusion Criteria:

* Individuals registered but not actually living in this area