cyrilzakka/clinical-trials huggingface dataset:
Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty

Background: The aim of this study was to compare operative outcomes after lesser toe deformity correction with either proximal interphalangeal (PIP) joint arthrodesis or PIP joint resection arthroplasty.

Methods: A prospective randomized controlled trial was performed on 37 patients (48 toes) who underwent one of these two procedures. The Numeric Rating Scale (NRS) for pain, American Orthopaedic Foot and Ankle Society (AOFAS) score, osseous consolidation, and clinical outcome were evaluated preoperatively and at 6 weeks and 6 months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Patients with one or more claw toes with rigid PIP joint flexion and extension deformity of the MTP joint scheduled for surgical intervention in the investigator's department

Exclusion Criteria:

* known osteoporosis or other bone metabolism disorders
* prior surgery on the toe scheduled for the intervention
* immunodeficiency or immunosuppressive drug intake
* pregnancy
* non-palpable pulses of the posterior tibial artery or the dorsalis pedis artery
* anticoagulation therapy with the exception of acetylsalicylic acid
* a lack of sufficient physical resilience to allow free self-mobilization and walking.
Safety Study of Eteplirsen to Treat Early Stage Duchenne Muscular Dystrophy

This is an open-label study to assess the safety, tolerability, efficacy and pharmacokinetics of eteplirsen in patients with early stage Duchenne muscular dystrophy (DMD) who are amenable to exon 51 skipping.

Safety, including adverse event monitoring and routine laboratory assessments, will be followed on an ongoing basis for all patients.

Clinical efficacy, including functional tests and MRI, will be assessed at regularly scheduled study visits. Patients will undergo one baseline and one follow-up muscle biopsy.

Population and serial PK will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Male 4-6 years of age.
* Diagnosis of DMD, genotypically confirmed.
* Stable dose of oral corticosteroids for at least 12 weeks or has not received corticosteroids for at least 12 weeks.
* Intact right and left biceps muscles or two alternative upper arm muscle groups.
* Parent that is willing to provide consent and comply with study procedures.

Exclusion Criteria:

* Use of any pharmacologic treatment (other than corticosteroids) within 12 weeks that may have an effect on muscle strength or function (e.g., growth hormone, anabolic steroids).
* Previous or current treatment with any other experimental treatments within 12 weeks or participation in any other clinical trial within 6 months.
* Major surgery within 3 months prior to the first dose of study drug, or planned surgery during this study which would interfere with the ability to perform study activities.
* Presence of other clinically significant illness.
Safety and Efficacy of Chronic Hypnotic Use 2

This proposal will assess risks for transition from therapeutic hypnotic use to abuse in people with insomnia. The investigators will study a hypothesized at-risk sub-population, insomniacs with hyperarousal, and compare two hypnotics, a drug with mood effects, eszopiclone, versus one without mood effects, zolpidem.

Persons with DSM-V diagnosed insomnia disorder, aged 18-65 yrs, with no other sleep disorders, unstable medical or psychiatric diseases or drug dependency will be entered to the trial. Following a screening NPSG and MSLT, participants will be randomized to zolpidem XR 12.5 mg (n=60), eszopiclone 3 mg (n=60), or placebo (n=50) nightly for 6 months. After 6 months of nightly use, over a 2-week choice period, they were instructed to discontinue hypnotic use, but if necessary, to self-administer either 1, 2, or 3 capsules of their assigned "blinded" medication (zolpidem XR 6.25 mg, 6.25 mg, placebo; eszopiclone 2 mg, 1 mg, placebo as capsules 1, 2 and 3 respectively; or 3 placebos). Nightly sleep at home will be recorded by actigraphy for one week after the screening NPSG and MSLT and before treatment is initiated and actigraphy again during the two week discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* DSM-5 diagnosis of insomnia

Exclusion Criteria:

* acute or unstable medical disease,
* current or past history of psychiatric disease, alcoholism or drug abuse, and other primary sleep disorders
The Dose Effect of Extracorporeal Shock Wave Therapy in Patients With Carpal Tunnel Syndrome

The shock wave is a new and potential intervention for the reinnervation of peripheral nerve. The purpose of this study was to assess the dose effect of extracorporeal shock wave therapy on carpal tunnel syndrome.

The investigator perform a prospective randomized, single-blinded study to investigate the dose effect of ESWT in patients with carpal tunnel syndrome.

The evaluation was performed pretreatment as well as on the 4th, 8th, 12th, 16th and 24 week after the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 20-80 year-old.
2. Typical symptoms and signs of CTS, such as positive Tinel's sign or Phalen's test, numbness/tingling in at least two of the first, second, or third digits, and in whom the diagnosis was confirmed using an electrophysiological study.

Exclusion Criteria:

1. Cancer
2. Coagulopathy
3. Pregnancy
4. Inflammation status
5. Patients who had conditions mimicking CTS, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for CTS.
Epidemiology and Treatment Strategy of Open Respiratory Phenotype in Critically Ill Patients

Monitoring airway pressure is essential for patients with mechanical ventilation. However, static airway pressure does not reflect alveolar pressure at all. Airway pressure is supposed to completely interrupt the communication between proximal airway opening and the distal alveolar and/or small airway structures. In this condition, some alveoli may still be inflated but do not communicate with proximal airways and auto-PEEP will give a biased estimated of mean alveolar pressure. To be note, distinguishing the airway closure and alveolar collapse can be challenging at times. The quasi-static PV curve is a useful bedside tool to set mechanical ventilation, which may help us to identify the airway closure and alveolar collapse. Meanwhile, the quasi-static PV curve can only reflects a global behaviour of the lung, while EIT may be a useful tool to assess the regional information on airway closure and alveolar collapse.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing controlled mechanical ventilation
* The duration of endotracheal intubation \< 48 hrs

Exclusion Criteria:

* Severe hemodynamic instability
* Severe chronic lung disease requiring long-term home oxygen therapy
* Patients without analgesic sedation
* Decline to participate in the study
* Refusal to sign informed consent
Infection Rates Between Using of Vancomycin Versus Gentamycin in Primary ACLR

The purpose of the study is to compare the efficacy of Vancomycin versus Gentamycin , in reducing infection rates following Anterior Cruciate Ligament Reconstruction .

There has been a marked increase in the number of cases of anterior cruciate ligament reconstruction (ACLR) worldwide. ACLR helps in the restoration of knee instability. But infection following ACLR is a big complication(1) .It may require multiple reoperations in the form of irrigation and debridement, prolonged use of antibiotics, removal of the graft, and sometimes graft revision surgery. It also has increases the risk of early osteoarthritis, and causes graft failure (2,3) .

There are a number of contributing factors that can lead to infection, like the presence of comorbid conditions like diabetes or concomitant open surgical procedures, Use of larger incisions, longer tourniquet time, and use of drain are other contributing factors(4) .Some studies have reported increased chances of infection with hamstring autografts in comparison to patellar tendon autografts and drain application(5,6). The harvested graft is prone to infection from skin flora, and an adequate concentration of antibiotics to inhibit bacterial growth can be achieved with the local application of antibiotics over the graft(7) .The most common pathogen after ACLR is staphylococci, accounting for 90% of cases of septic arthritis (8,9).

Vancomycin is commonly used locally in the surgery in Orthopaedics because of the relative safety for local use in high dosis, and bactericidal action against organisms like Staphylococcus aureus (10) on the other hand there are concerns about its use because of antibiotic resistance, high cost, and graft toxicity(11) . Several studies evaluated the effect of gentamicin solution on ACLR(7). Gentamycin offers an advantage in terms of activity against staphylococci, Gram-negative pathogens, and pseudomonas, along with being cost-effective(7).

The objective of the present study is to compare the infection rate with pre-soaking of harvested grafts in Vancomycin vesus Gentamycin during ACLR.

Eligibility Criteria:
Inclusion Criteria:

* 1) any patient for ACLR

Exclusion Criteria:

* 1) Revision ACL surgery 2) Previous Knee Surgery 3) Associated knee operations other than meniscal surgery (eg.HTO) 4) Open ACL reconstruction 5) Immune suppressed patients (eg. diabetic and patients taking steroids )
Continuous Chest Wall Vibration in COPD Rehabilitation

Dyspnea, the sensation of breathing discomfort or shortness of breath, is one of the main symptoms for patients affected by Chronic Obstructive Pulmonary Disease (COPD), particularly during exercise. Previous study show that chest wall vibration decrease dyspnea in COPD patients and precisely when applied during the inspiration phase, called "in-phase vibration" (IPV) which provide vibration directly on intercostal muscles. These findings have been obtained in laboratory context and the intercostals muscles vibration has been tested only in single phases of breathing, during inspiration with IPV and during exhalation with out-of-phase vibration (OPV). None study has evaluated the effect of a continuous chest wall vibration (CCWV), namely muscles vibration during the whole cycle of breathing, on dyspnea in patients with COPD in a clinical context. Continuous high frequency vibration has been proven to reduce myoelectrical manifestation of fatigue, probably modifying the centrally driven motor unit recruitment hierarchy, in healthy subjects.

Moreover, CCWV is a modality of provide vibration more suitable and cost-effective in a clinical context than single-phases vibration that requires specific instruments for the detection of breathing phases and the coupling with vibration device.

On these bases, the investigators hypothesized that CCWV at high frequency, applied during a cycle ergometer training program, could decrease dyspnea and enhance the exercise tolerance in COPD patients. Therefore, the aim of this study is to evaluate the effects of high frequency CCWV on dyspnea and exercise tolerance in patients with COPD patients compared to usual care and to sham intervention.


Eligibility Criteria:
Inclusion Criteria:

- COPD diagnosis (GOLD stage: 2-3-4)

Exclusion Criteria:

* Restrictive lung disease
* Active pulmonary infection
* Pulmonary embolism (less than 3 months)
* Pneumotorax
* Thoracic/abdominal operation (less than 3 months)
* Myocardial infarction (less than 6 months)
* Congestive heart failure/ heart failure/ right heart failure
* Angina/severe angina
* Incapability of perform the cycle ergometer training (e.g. orthopaedic or urogenital conditions)
* Incapability to understand the intructions required to carry out the tests and assessments planned
Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis

The purpose of the study is to determine whether mesalazine granules compared to placebo is effective in prevention of recurrence of disease.

The purpose of the study is to demonstrate the superiority of mesalazine granules compared to placebo in terms of the primary efficacy variable proportion of recurrence-free patients within 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of left-sided uncomplicated diverticular disease confirmed by ultrasonography or computed tomography
* Presence of at least one diverticulum of the left colon
* Most recent attack of left-sided uncomplicated diverticulitis responding to antibiotics and/or dietary modification within the last 6 months
* C-reactive protein (CRP) \> upper limit of normal (ULN) at the start of the most recent attack

Exclusion Criteria:

* Complicated diverticular disease
* Right-sided diverticulitis
* Previous colonic surgery
* Presence of symptomatic organic disease of the gastrointestinal tract
* Active colorectal cancer or a history of colorectal cancer
* Hemorrhagic diathesis
* Active peptic ulcer disease, local intestinal infection
* Asthma if careful medical monitoring is not ensured
* Abnormal hepatic function or liver cirrhosis
* Abnormal renal function
Consultations in Psychiatry Through Videoconference

Online consulatations through videoconference in the field of psychiatry given to general practitioners will reduce costs of medical treatment and improve service.

CLINICAL STATE, SATISFACTION AND COST EFFECTIVENESS WILL BE CHECKED DURING 1 YEAR OF ONLINE VIDEO CONFERENCE CONSULTATION TO GENERAL PRACTITIONERS. BPRS, HAMILTON ANXIETY AND DEPRESSION AND CGI SCALES WILL BE COMPLETED.COSTS OF MEDICATIONS, NUMBER OF VISITS, LAB AND OTHER EXAMINATIONS, HOSPITALIZATIONS, MISSING WORKING DAYS WILL BE EVALUATED.

Eligibility Criteria:
Inclusion Criteria:

Referral by general practitioner Age: \>18 - Speaking Hebrew or Russion

Exclusion Criteria:

CGI\>4 Dementia Drug or alcohol addiction -
Syndesmotic Injury and Fixation in Supination-External (SE) Ankle Fractures

The aim of our study was to determine whether transfixation of unstable syndesmosis is necessary in supination-external rotation type ankle fractures. Our hypothesis was that syndesmotic ligaments heal at the proper length after malleolar reduction and that syndesmotic transfixation is not needed in supination-external rotation fracture types.

A prospective randomized study comparing syndesmotic transfixation to no fixation in AO/OTA Weber B-type ankle fractures was designed. To show a clinically significant difference (Olerud-Molander ankle score 20%, standard deviation (SD) 24 points, from our previous study) between the groups, the sample size was estimated (α=0.05, β=0.2, 20% drop out) to be 30 patients per group.

All skeletally mature patients (≥16 years old) with a unilateral Lauge-Hansen supination-external rotation type 4 ankle fractures treated within one week after injury at our hospital were considered eligible for the present study. Exclusion criteria were bilateral ankle fractures, pathologic fractures, concomitant tibial shaft fractures, previous significant injury or a fracture of either ankle, significant peripheral neuropathy, soft tissue infection in the region on either injured ankle, or inability to complete the study protocol.

After bony fixation, the 7.5-Nm standardized external rotation (ER) stress test for both ankles was performed under fluoroscopy. A positive stress examination was defined as a difference of more than 2 mm side-to-side in the tibiotalar or tibiofibular clear spaces on mortise radiographs. If the stress test was positive, the patient was randomized to either syndesmotic transfixation with 3.5-mm tricortical screws or no syndesmotic fixation.

Clinical outcome was assessed using the Olerud-Molander scoring system, RAND 36-Item Health Survey, and Visual Analogue Scale (VAS) to measure pain and function after a minimum 1-year of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* All skeletally mature patients (≥16 years old) with a unilateral Lauge-Hansen supination-external rotation type 4 ankle fractures treated within one week after injury at our hospital

Exclusion Criteria:

* Bilateral ankle fractures, pathologic fractures, concomitant tibial shaft fractures, previous significant injury or a fracture of either ankle, significant peripheral neuropathy, soft tissue infection in the region on either injured ankle, or inability to complete the study protocol.
Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer

The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in combination with radiation therapy for patients with intermediate-high risk localized prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak has shown synergy with radiation without added toxicity and lower than expected recurrence rates in previous clinical trials. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak or control arm at a 2:1 ratio. Both arms receive standard external beam radiation therapy. Short-term androgen deprivation therapy may be given but is not required.


Eligibility Criteria:
Inclusion Criteria include:

* Localized prostate cancer meeting the NCCN criteria of Intermediate Risk or patients having only one NCCN high-risk feature

  * NCCN Intermediate Risk is defined as having at least one of the following: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c
  * High Risk with a single high risk feature is defined as having only one of the following: PSA\>20 ng/ml, Gleason score 8-10, or T3a
  * Excluded are those in the following risk groups: Low risk; High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1
* Planning to undergo standard prostate-only external beam radiation therapy
* ECOG Performance Status 0-2

Exclusion Criteria include:

* Liver disease, including known cirrhosis or active hepatitis
* Patients on systemic corticosteroids (\>10mg prednisone per day) or other immunosuppressive drugs
* Known HIV+ patients
* Regional lymph node involvement or distant metastases
* Patients planning to receive whole pelvic irradiation
* Prior treatment for prostate cancer, except TURP or ADT. For ADT, it may only be given for a maximum of 6 months
* Patients who had or plan to have orchiectomy as the form of hormonal ablation
* Known sensitivity or allergic reactions to acyclovir or valacyclovir
Oncology-patient-reported Anxiety, Mood, and QoL During the COVID-19 Pandemic

ONCOVID is a prospective cohort study investigating oncology-patient-reported anxiety, mood, and quality of life during the COVID-19 pandemic. Participants complete a survey consisting of sociodemographic information and self-administered questionnaires (COVID-19 Peritraumatic Distress Index, Depression Anxiety Stress Scale-21, and WHO Quality of Life-BREF). Data collection occurs at baseline and follow-up surveys are performed after 6, 12, and 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Histologically confirmed cancer
* Receive systemic therapy (including chemotherapy, targeted small-molecule therapy, anticancer monoclonal antibody, immunotherapy, endocrine therapy, or investigational agent) (either exclusively or in combination with other anticancer therapy) between February 14, 2020 and March 31, 2020 (Note: Patients whose systemic treatment administration was initially planned for this period but was modified, delayed, stopped, or withheld due to COVID-19 measures are also eligible for inclusion)

Exclusion Criteria:

* Insufficient understanding of the Dutch language
* Severe cognitive impairment
* Acute psychiatric crisis
* Not able to give informed consent
* Confirmed or clinically suspected COVID-19
* Endocrine therapy in (neo)adjuvant setting (Note: Patients whose (neo)adjuvant systemic treatment was initially planned as chemotherapy, targeted small-molecule therapy, anticancer monoclonal antibody, immunotherapy, or investigational agent (either exclusively or in combination in combination with other anticancer therapy) but was modified to endocrine therapy due to COVID-19 measures are also eligible for inclusion)
Study of ACE-041 in Patients With Advanced Solid Tumors or Relapsed/Refractory Multiple Myeloma

For cancer cells to grow, they need to have nutrients supplied to them through blood vessels. The study drug, ACE-041, is designed to work by blocking the growth of those blood vessels and preventing cancer cells from growing. The purpose of this study is to establish safe dose levels of ACE-041 in patients with advanced solid tumors or relapsed/refractory multiple myeloma following multiple dose administration. This study will also evaluate if ACE-041 has an effect on tumors.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metastatic or unresectable advanced solid tumors (solid tumors must be measurable) or relapsed/refractory multiple myeloma for which the disease has progressed despite available standard therapies or for which no standard therapy exists.
* Life expectancy of at least 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) Performance status of 0, 1, or 2 (not declining within 2 weeks prior to study day 1).

Exclusion Criteria:

* Central nervous system (CNS) metastases.
* Chemotherapy or other anti-cancer therapy within 4 weeks prior to study day 1, and/or nitrosoureas within the 6 weeks prior to study day 1.
* Lack of recovery from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, and/or experimental therapy with the exception of alopecia.
* Radiation therapy within 4 weeks prior to study day 1.
* Clinically significant pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal or genitourinary disease unrelated to underlying solid tumor or multiple myeloma
* Significant cardiac risk (e.g. history of myocardial infarction, unstable angina, pulmonary hypertension, clinically significant arrhythmia, congestive heart failure within 1 year prior to study day 1).
* Diagnosis or family history of hereditary hemorrhagic telangiectasia.
* Major surgery within 6 weeks prior to study day 1.
* Parenteral antibiotics, or any life-threatening or active infection requiring parenteral antibiotic therapy within 1 month prior to study day 1.
* Therapeutic anti-coagulation.
* Uncontrolled hypertension.
* Autoimmune or hereditary hemolysis.
* Clinically significant gastrointestinal bleeding or any other clinically significant active bleeding within 3 months prior to study day 1.
* Treatment with another investigational drug or device, or approved therapy for investigational use within 28 days prior to study day 1.
* Pregnancy or lactation for female patients.
A Study of Plasmatic Concentrations of Endothelin-1 (ET1), Atrial Natriuretic Peptide (ANP) and Brain Natriuretic Peptide (BNP) in Acute Ischemic Stroke.

A study of plasmatic concentrations of endothelin-1 (ET1), atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP) in acute ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* male or female
* age \> 18
* with an ischemic stroke

Exclusion Criteria:

* cardiac failure
* renal failure