cyrilzakka/clinical-trials huggingface dataset:
Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury

Treatment of syndesmotic injury with Weber C fracture. A randomized study comparing ZipTight suture endobutton and one tricortical 3,5 mm syndesmotic screw.

Syndesmotic injuries are common and often associated with unstable ankle fractures. The most common treatment is with a syndesmotic screw through the fibula and tibia which is later removed, usually after 10-12 weeks. The ZipTight suture endobutton (Biomet) is used for the same indication. It does not need removal and thus avoids subsequent surgery. This trial will compare these two methods and see if they are equal.

patients 18-70 years presenting to one of the three hospitals with and acute syndesmotic injury are eligible for inclusion. 120 patients are randomized to two treatment groups. One group will be treated with a ZipTight suture endobutton fixation and the other receives a tricortical screw fixation. Neither suture endobutton or screw is routinely removed. Follow up intervals are at 6 weeks, 6, 12 and 24 months with clinical and-points. Standardized CT scans are taken postoperatively and at 12 and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years
* Acute syndesmotic injury with Weber type C fracture

Exclusion Criteria:

* Prior injury og the same ankle
* Severe injury of the same leg affecting rehabilitation
* Symptomatic osteoarthritis of same ankle
* open injury
* Decubital injury affecting surgical site
* Dementia or unable to sign informed consent
* neuropatic conditions affecting same leg
Evaluation of Treatment Factors in the Management of Chronic Iliotibial Band Syndrome in Female Distance Runners

The primary objective of this study is to determine if a more specific exercise routine that incorporates a progressive hip stability program will help to rehabilitate the hip and reduce symptoms of iliotibial band syndrome more than conventional hip exercises. Three different exercises interventions will be compared to determine its effectiveness in reducing pain, improving function and returning subjects to running symptom free. Secondary objective for this study is to establish an intervention program for female runners with this injury. There will be three treatment arms and participants will be randomly assigned to one of three groups: Group A- control (stretching), group B (conventional hip exercises and group C (experimental treatment- specific progressive hip exercises).

The gluteus medius muscle is part of a muscle group called the hip abductor muscles. The gluteus medius originates at the dorsal ilium (uppermost, largest bone of the pelvis) below the iliac crest and inserts at the top outside surfaces of the greater trochanter (top of the thigh bone). It is the major abductor of the thigh (moves the leg away from the midline of the body). The anterior fibres rotate the hip internally and the posterior fibres rotate the hip externally. Based on the anatomy and function of this muscle, the gluteus medius plays a major role in the mechanics of running. Research has shown that runners with iliotibial band syndrome have been shown to have weakness in this muscle. Most conventional exercises that have been research have been exercises that focus on only activation of this muscle in an unloaded position (non-weightbearing). Group B of this study will focus on those exercises that have been researched. Group C will be the experimental group in which we will begin with the conventional exercises and progress the exercises from a floor (unloaded) position to a more dynamic functional position (standing). This will be geared towards running specific exercises. We would like to know if there will be a difference in how fast symptoms reduce and strength gains occur and at what rate.

Eligibility Criteria:
Inclusion Criteria:

1. Female between the ages of 19-45 years;
2. Have been diagnosed or been affected by ITBS (pain on the outside of the knee) for no less than 3 months;
3. A distance runner averaging a minimum of 15 Km per week of road running;

Exclusion Criteria:

1. Have previous history of knee surgery or knee trauma to the affected side;
2. Have been diagnosed with any other knee pathology such as patellofemoral pain syndrome, degenerative joint disease, chondromalacia patella, tendinitis or tendinopathy in the affected knee;
National Database of Bone Metastases

BDMO is an Italian multicentre, observational, prospective study that collects data from all patients with bone metastases referred to each participating centre, using an on-line software 'tailor-made' for data collection.


Eligibility Criteria:
Inclusion Criteria:

* Radiological and/or histological diagnosis of bone metastasis from histologically established solid tumor
* Males or females aged \>= 18 years
* Informed consent

Exclusion Criteria:

* Not applicable
INVISION - An Observational Study to Explore Effectiveness, Tolerability and Safety of Paliperidone ER in Patients With Schizophrenia

The purpose of this study is to explore efficacy, tolerability and safety of paliperidone Extended Release (ER) in 250 schizophrenia patients who started treatment with paliperidone ER in a naturalistic setting.

This is an observational, prospective, multicenter 6-month study to explore efficacy, tolerability and safety of paliperidone Extended Release (ER) in 250 schizophrenia patients who started treatment with paliperidone ER in a naturalistic setting. The primary objective is to explore changes in Clinical Global Impression of Severity (CGI-S) score from baseline up to 26 weeks, in subgroups of schizophrenia patients who started treatment with paliperidone ER. Secondary objectives are: 1) To explore changes in mental health and social functioning based on routine outcome assessments in the Netherlands, the Health of the Nation Outcome Scales (HoNOS) and Global Assessment of Functioning (GAF), in schizophrenia patients who started treatment with paliperidone ER ; 2) To explore changes in patient's satisfaction with treatment, changes in number of ambulant contacts, changes in body weight, changes in concomitant therapy and to explore adverse events in schizophrenia patients who started treatment with paliperidone ER; and to explore possible association between CGI-S, GAF and HoNOS.

The patients will receive paliperidone ER (6 mg, 9 mg or other dosages as directed on the label) once daily for the period of 6 month. Which dosage of paliperidone ER the patients receive will be at the discretion of the investigator and according the Summary of Product Characteristics (SmPC). Because the study is observational, dosage, administration and duration of treatment is at discretion of treating physician.

Eligibility Criteria:
Inclusion Criteria:

* Patient meets the DSM-IV criteria for schizophrenia
* Switched to or started on paliperidone ER, not longer than two weeks ago
* In 24 hours before initiation of paliperidone ER treatment, CGI-S, patient satisfaction with treatment, concomitant therapy, body weight, GAF and HoNOS data are available
* Patient or legal representative has signed the informed consent form within two weeks after starting treatment with paliperidone ER

Exclusion Criteria:

* No use of paliperidone ER, clozapine, any conventional depot neuroleptic or long acting atypical antipsychotic drugs during 3 months before starting paliperidone ER
* No participation in an investigational drug trial in 30 days prior to starting paliperidone ER
* No history of neuroleptic malignant syndrome
* No known hypersensitivity to paliperidone ER or risperidone
* No patients hospitalized for a period longer than 12 weeks
Effect of Abdominal Massage on Bowel Evacuation After Cranial Surgery

Many factors in patients undergoing cranial surgery (CS) may affect the bowel evacuation of patients, resulting in constipation, which could lead to the use of the valsalva maneuver. The aim of this study was to determine the effect of abdominal massage (AM) on bowel evacuation of patients treated in intensive care units (ICU) after CS.

The sample of this prospective parallel two-arm randomized controlled trial included 80 patients who underwent CS. The patients were randomly assigned (1:1) to the AM and control groups. The constipation risk of all the patients following CS was assessed with Constipation Risk Assessment Scale (CRAS). Those patients in the AM group received a total of 30 minutes of massage, 15 minutes every morning and evening, until the first defecation. The bowel sounds of all the patients in the AM and control groups were assessed on a daily basis. The days when bowel sounds were heard and the first defecation took place were recorded in a Bowel Evacuation Form.

Eligibility Criteria:
Inclusion Criteria: Patients who

* volunteered to participate in the study,
* were 18 years old or older and underwent CS,
* stayed in the ICU for ≥ 3 days,

Exclusion Criteria: Patients who

* have percutaneous endoscopic gastrostomy,
* abdominal hernia,
* irritable bowel syndrome
* bowel cancer,
* history of abdominal surgery,
* pregnancy,
Weight Loss as Treatment in Heart Disease

30 obese moderate-to-severe heart failure patients will be randomized to intervention or control in groups of 5-10 subjects.

All will receive dietetic advice according to randomization and according to the European Heart Association.

Intervention subjects will initiate with 8 weeks low energy diet, 800-1000 kcal/d by formula diet and subsequent four weeks reintroduction to regular foods supplying 1200 kcal/d substituting two daily meals with formula meal replacement.

Control subjects are advised to follow the Nordic Nutrition Recommendations.

Patients will be monitored by blood sampling and assessed by change in physical performance.


Eligibility Criteria:
Inclusion Criteria:

* bmi \>30
* heart failure, moderate to severe, new york heart association II og III
* stable disease
* age \>18 years
* out-patients
* perform a six minutes walk test
* given consent

Exclusion Criteria:

* unstable disease
* insulin treated diabetes
* pregnancy or lactating
* unstable weight past 6 months (+- 10 kg)
* planned procedures in the time of intervention
Anatomic and Visual Function Assessments on Asymptomatic HIV-positive Patients

The purpose of this study is to assess retinal nerve fiber layer thickness and macular thickness measured with optical coherence tomography (OCT) on patients infected by HIV virus without ocular manifestations and to correlate these results with perimetric findings assessed by frequency doubling technology perimetry (FDT).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of AIDS
* Best-corrected visual acuity 20/25 or better
* Refractive error of 0±5.0 diopters and astigmatism of 0±3.0 diopters
* Normal intraocular pressure (≤21mmHg)

Exclusion Criteria:

* Cataract or any visible media opacity
* HIV-related infectious retinopathy
* Risk factors for the development of glaucoma
Certification Standards and Diagnostic Accuracy for Surgeon-performed Ultrasonography

Ultrasonography (US) is an operator depended image modality that is difficult to reproduce and interpret by others. Competence of the US operator is crucial for reliable diagnostics but no evidence-based certification of head and neck US skills has been developed. Investigators conducted an experimental study aimed to explore diagnostic accuracy and establish validity evidence for certification standards in surgeon-performed ultrasonography.


Eligibility Criteria:
1. Ultrasonography-experienced surgeons

   Inclusion Criteria:
   * Board certified otolaryngologist
   * Daily use of head and neck Ultrasonography
2. Ultrasonography novices:

Inclusion Criteria:

* Medical doctor during internship

Exclusion Criteria:

* experience with head and neck Ultrasonography
* experience with head and neck surgery
Checklist for AI in Medical Imaging (CLAIM) Consensus Panel

The investigators will revise the Checklist for AI in Medical Imaging (CLAIM) guideline using Delphi consensus methods. An international panel of physicians, researchers, and journal editors with expertise in AI in medical imaging -- including radiology, pathology, dermatology, GI endoscopy, and ophthalmology -- will complete up to 3 web-based surveys. Participants who complete all survey rounds will be credited as contributors on resulting publications.

The survey will be administered in collaboration with:

* Anthony A. Gatti, PhD (Stanford University)
* Michail E. Klontzas, MD, PhD (University of Crete School of Medicine) \*
* Linda Moy, MD (New York University Grossman School of Medicine)
* John Mongan, MD, PhD (University of California San Francisco)
* Seong Ho Park, MD, PhD (University of Ulsan College of Medicine)
* Ali S. Tejani, MD (University of Texas Southwestern Medical School)

(\*) Survey administrator

Eligibility Criteria:
Inclusion Criteria:

* More than 70 invited panelists -- physicians, AI researchers, and journal editors -- have agreed to participate in the surveys. Those who participate in all rounds of the survey will be named as contributors in any resulting publications

Exclusion Criteria:

* Non physicians, AI researchers and journal editors
The SMArTVIEW, CoVeRed

The SMArTVIEW program evaluates the use of remote, automated monitoring in hospital and at home, on patients undergoing cardiac and major vascular surgery, to determine the effect on the 45-day risk of a composite of hospital readmission and emergency department/urgent care centre visits (not requiring hospital admission). Half of participants will receive the SMArTVIEW intervention of increased monitoring, while the other half will receive standard care after surgery.

SMArTVIEW is an eHealth-enabled service delivery program that combines remote automated monitoring, education, and self-management training. SMArTVIEW is a two-stage intervention program. Stage 1 supports seniors after cardiac or major vascular surgery in hospital on the surgical unit (post-ICU). Participants are assigned automated, cableless, vital sign monitoring devices that are worn during their entire stay on the surgical unit (blood pressure cuff, respiration pod, and oxygen saturation probe). Any signs of deterioration are sent via handheld device to the primary care nurse for early intervention.

With a view to seamless transition home, Stage 2 supports these individuals at home during the first 30 days of recovery. Participants are sent home with Bluetooth enabled monitoring equipment including a tablet, blood pressure cuff, thermometer, pulse oximeter and weight scale. From home, the tablet uploads patients' vital signs and measurements automatically and sends them, via secure cloud infrastructure, to the SMArTVIEW Nurse on the surgical ward back at the hospital. The tablet interface also prompts patients to respond to brief, easy to read, daily surveys in order to inform the nurse about their status. The tablet also supports secure daily video visits and daily interaction with the nurse for postoperative assessment and support, surgical wound photographs, as well as patient access to customized educational materials.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 60 years;
2. Patient has undergone major cardiac or vascular surgery and has been admitted post-op to the surgical floor;
3. Anticipated length of stay (LOS) on the surgical floor is ≥ 48 hours;
4. Patient has a negative Confusion Assessment Method (CAM) test result preceding, or within 12 hours of arriving on the surgical floor and is randomized within the first 24 hours after arriving on the ward;
5. Patient is able to provide consent autonomously.

Exclusion Criteria:

1. Patient is unable to communicate with research staff, complete surveys and questionnaires, or a telephone interview;
2. Patient has an intolerance/allergy to adhesive;
3. Patient unable to complete 30 days of at-home follow up due to current or planned relocation to nursing home or rehab facility; and
4. Patients with radial graft sites
Comparison of Osteoporosis Disease Management Strategies (0000-039)

The purpose of this study is to assess the impact of disease management interventions on bone mineral density screening rates and osteoporosis treatment rates in women age 50-64 years at high risk for osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Members of the Harvard Pilgrim Health Plan

Exclusion Criteria:

* Individuals who are not members of the Harvard Pilgrim Health Plan
Safety and Tolerability of LIM-0705 in Healthy Male Subjects

LIM-0705 dosed separately and in combination with tacrolimus will be safe and well tolerated.


Eligibility Criteria:
Inclusion Criteria:

* Male age 18-50
* Patient in good health as deemed by pre-study exam and history
* BMI 20-30 kg/sq. meter
* Absence of tremors
* Must be willing to remain in confinement for 17 days/16 nights
* Systolic BP 90-140 mmHg, diastolic BP 50-90 mmHg, resting HR 45-90 bpm
* Subject must be non-smoker or willing to abstain from smoking day -4 through day 30.
* Subject must abstain from alcohol, grapefruit,and caffeine-containing beverages starting Day -2 through Day 30.
* Subjects must use double-barrier contraception through course of study + 90 days following study

Exclusion Criteria:

* Allergy to red wine or onions
* Strict vegetarians
* Use of any non-study medication
* Use of chemotherapy within 5 years prior to Screening visit
* Use of any dietary aids
* Difficultly swallowing oral medications
* cognitive or psychiatric disorders
Measuring Comfort During Palliative Sedation

Background. In case of untreatable suffering at the end of life, palliative sedation may be chosen to assure comfort by reducing the patient's level of consciousness. An important question here is whether such sedated patients are certainly completely free of pain. Because these patients cannot communicate anymore, caregivers have to rely on observation to assess the patient's comfort. Recently however, more sophisticated techniques from the neurosciences (fMRI, EEG) have shown that sometimes consciousness and pain is undetectable with these traditional behavioral methods.

Therefore there is an urgent need for a more reliable way of assessment by combining existing observational scales, subjective assessments of caregivers and family and neuroimaging techniques.

Aim. The aim of this study is to better understand how unconscious palliative sedated patients experience the last days of their life and to find out if they are really free of pain.

Methods In this study the investigators will observe 40 patients starting with initiation of palliative sedation until death.

Assessment of comfort based on behavioural observations will be related with the results from a NeuroSense monitor, an EEG-based brain monitor used for evaluation of the adequacy of anesthesia and sedation in the operating room and an ECG-based Analgesia Nociception Index (ANI) monitor, which informs about the comfort or discomfort condition of the organism, based on the parasympathetic tone (including calculation of ANI). Additionally, the researchers will investigate whether changes of these measures can be linked to changes in the patients' experience as observed by caregivers and relatives, especially in the last moments of life. An innovative and challenging aspect of this study is its qualitative approach, implying all the different types of data will be used to link "objective" and "subjective" data to achieve a holistic understanding of the study topics.

The following data will be collected:

* assessment of pain/comfort by the patients themselves before loss of consciousness due to deep continuous sedation (if possible) by scoring a Visual Analogue Scale (VAS)
* brain function monitoring (NeuroSense monitor)
* monitoring of parasympathetic tone (ANI monitor)
* assessment by caregivers on 3 VAS scales (different scales or 3 different caregivers?)
* relatives' perception of the quality of the dying process on 3 VAS scales (idem)
* assessment by 2 trained investigators using observational scales
* observation: video and audio registration


Eligibility Criteria:
Inclusion Criteria:

Patients may be included if they are considered by their treating physician as:

1. in their last week of life
2. in conditions that might, when not treated, cause high levels of distress
3. sedated
4. unable to communicate

Exclusion Criteria:

-
Solifenacin Succinate 5mg or 10mg Once Daily in the Treatment of Urgency Symptoms

Prospective, double-blind, double-randomised, 2-arm parallel group study. Optimal dose increase. Primary efficacy assessment of OAB symptoms by patient diaries.


Eligibility Criteria:
Inclusion Criteria:

* Patient is willing and able to complete the micturition diary correctly.
* Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for \>= 3 months
* At least 3 episodes of urgency with or without incontinence in last 3 days
* At least three episodes of urgency with or without incontinence (PPIUS grade 3 or 4) during the 3-day micturition diary period
* Patient must experience frequency of micturition on average \>= 8 times per 24-hour period during the 3-day micturition diary period

Exclusion Criteria:

* Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practising an unreliable method of birth control or will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants and injectable or patch contraceptives
* Clinically significant outflow obstruction (at the discretion of the investigator)
* Significant post void residual volume (PVR\>200ml)
* Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator
* Patient with indwelling catheters or practising intermittent self-catheterisation
* Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
* Hypersensitivity to solifenacin or to any of the excipients, uncontrolled narrow angle glaucoma, myasthenia gravis, urinary or gastric retention, severe renal impairment (GFR ≥30 ml/min), moderate or severe hepatic impairment, chronic intestinal disease, megacolon, requirement for dialysis, concomitant use of a strong CYP3A4 inhibitor, e.g. ketoconazole
* Non drug OAB treatment such as bladder-training, biofeedback and pelvic floor exercises are permissible if established at least 4 weeks prior to study start and intended to be continued throughout the study; electrostimulation therapy is not permissible at any time
* Use of drugs intended to treat urinary incontinence
* Diabetic neuropathy
* Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the trial
* Participation in any clinical trial within 30 days prior to randomisation
* Employees of the Yamanouchi Group, third parties associated with the study, or the study site
* Patient who did not complete the micturition diary according to the instructions