cyrilzakka/clinical-trials huggingface dataset:
Testing the Effect of Zinc Supplementation to Improve the Treatment Effect of Botulinum Toxin for Oculofacial Spasm

The purpose of this study is to determine whether zinc supplements are effective in enhancing the treatment of oculofacial spasm disorders with botulinum toxin.

Botulinum Toxin (Botox) has been used for many years in the treatment of oculofacial dystonias such as blepharospasm and hemifacial spasm. It has also gained widespread use for cosmetic purposes. The efficacy and duration of its effect is not constant amongst all patients. Some patient respond very well, while others have no clinical benefit or the clinical benefit does not last as long as expected. Zinc is known to be an important co-factor in the molecular effects of Botox. The investigators hypothesize that one of the many factors that may contribute to the variability in the response to Botox may be the level of Zinc available within the neuromuscular junction of those patients. The investigators plan to to test whether or not giving patients supplemental Zinc with their Botox injections would help improve the magnitude and duration of the intended clinical effect.

Eligibility Criteria:
Inclusion Criteria:

* greater than the age 18 years old
* patient with hemifacial spasm
* patient with benign essential blepharospasm.

Exclusion Criteria:

* patients who have received Botox within 3 months time,
* patients prone to malabsorption (i.e. those with Celiac disease, inflammatory bowel disease, liver disease, laxative use)
* patients who cannot tolerate zinc supplementation due to kidney disease, gastrointestinal disease, or any other medical condition.
Efficacy of Omalizumab in Adults (18-60 Years of Age) With Moderate-Severe, Persistent Allergic Asthma, Despite Receiving Inhaled Corticosteroids and Long Acting Beta-agonists

This study aims to investigate the effect of omalizumab on the number of tissue eosinophils and other markers of airway inflammation and remodeling, including thickness of the lamina reticularis, in moderate to severe asthmatics with persistent symptoms and evidence of airway inflammation despite treatment with inhaled corticosteroids and long acting beta-agonists. This study will also investigate the correlation between systemic and pulmonary inflammation, and the correlation between clinical outcomes and changes within the tissue, to assist in the future identification of patients with tissue eosinophilia and their response to treatment, without the need for invasive bronchoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18-75 years of age with moderate to severe persistent allergic asthma receiving a high dose inhaled corticosteroid (≥800µg per day BDP or equivalent) and a regular long acting beta-agonist for at least 3 months prior to screening
* With a body weight between 20 and 150kg and a serum total IgE level of 30 to 700 IU/mL
* With ≥2% eosinophilia in induced sputum at screening
* With post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥60% predicted
* With a positive skin prick test (diameter of wheal ≥ 3 mm) or RAST test to at least one perennial aero-allergen (eg. dust mite, cat/dog dander, cockroaches), documented within the past 2 years or demonstrated at Visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study.

Exclusion Criteria:

* Patients who've had an asthma exacerbation during the 4 weeks prior to randomization
* Current smokers, stopped smoking within the last 12 months or have a smoking history of \>10 pack years
* History of severe allergy to food or drugs
* Previous treatment with omalizumab
* Any patient considered to be unsuitable to bronchoscopy, according to the judgment of the investigator

Other protocol-defined inclusion/exclusion criteria applied.
Evaluation of Clinical and Radiographic Outcomes of Surgically Treated Multiligamentous Knee Injuries

Multiligament knee injuries are typically caused by high-energy mechanisms and are classified according to the number of ligaments involved using Schenk's classification (Knee Dislocation) into KD 1, KD 2, KD 3, and KD 4. These types of injuries can have devastating consequences on the individual's quality of life, affecting their ability to return to sports and perform daily activities.

In the literature, there is still no consensus on the management of these types of traumas, both due to the wide range of situations that can present to the orthopedic surgeon and the difficulty in their diagnostic and therapeutic framing. The main controversies concern the conservative or surgical management of the injuries and the timing of when to undertake surgical treatment, if at all.

The instability resulting from multiligament knee injuries is poorly tolerated by patients, who find their daily activities limited. It is also well known that this instability can dramatically accelerate the development of osteoarthritis, leading to the need for joint replacement surgery even in young individuals, thus increasing the likelihood of revisions and re-operations over time.

Due to the lack of standardized and satisfactory treatment, the economic cost of the outcomes of multiligament knee injuries is particularly high. A recent study by XXX showed that only XXX% of individuals are able to return to work. The rate of participation in sports is even lower, which has a long-term potential impact by increasing the risk of sedentary lifestyle-related diseases such as obesity, diabetes, and cardiovascular diseases.

The choice of surgical treatment aims to eliminate the patient's subjective feeling of instability and to repair, when possible, or reconstruct the injured ligament structures to reduce the risk of secondary osteoarthritis. Available studies in the literature are often case reports presenting short- and medium-term results of non-standardized surgical techniques with great heterogeneity in rehabilitation protocols, so the real long-term effectiveness of these treatments in terms of joint stability and osteoarthritis prevention is not known.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged between 18 and 65 years at the time of surgery
2. Male and female gender
3. Patients undergoing multiligamentous knee reconstruction from January 1, 2000, to December 31, 2019, at the Rizzoli Orthopedic Institute.

Exclusion Criteria:

1. Patients no longer reachable;
2. Patients who do not consent to be included in the study;
3. Pregnant women;
4. Presence of infection or hematologic, rheumatic, or coagulative disorders at the time of evaluation.
Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

This multicentre, adaptive, pragmatic, double-blind, three-arm, placebo-controlled, randomised, non-inferiority clinical trial will compare the incidence of surgical site infection and other healthcare associated infections, health economic and microbiological impact after intraoperative only (Arm A), to 24 hours (Arm B) and, to 48 hours (Arm C) of IV cefazolin and placebo postoperative surgical antimicrobial prophylaxis in patients undergoing cardiac surgery

This trial will evaluate the clinical effectiveness, health-economic outcomes and microbiological impact of intraoperative (only) compared with intraoperative plus postoperative prophylaxis durations in patients undergoing cardiac surgery.

CALIPSO, a multicentre, adaptive, double-blind, three-arm, placebo-controlled, phase IV, noninferiority trial will examine the incidence proportion of SSI following cardiac surgery. Our three-intervention trial will compare:

Arm A Administration of prophylaxis in intraoperative period only Arm B Administration of prophylaxis in intraoperative plus for 24 hours postoperatively Arm C Administration of prophylaxis in intraoperative plus for 48 hours postoperatively

Eligibility Criteria:
Inclusion Criteria:

- Adult patients undergoing cardiac surgery involving a median sternotomy

Exclusion Criteria:

* Age \<18 years
* American Society of Anesthesiology (ASA) 5
* Subjects with GFR \<40mL/min/1.73m2 or those requiring continuous renal replacement therapy, haemodialysis or peritoneal dialysis
* Surgery for suspected or proven endocarditis or deep sternal wound infection
* Documented cefazolin hypersensitivity
* Documented methicillin resistant Staphylococcus aureus (MRSA) colonisation or infection in the 12-months prior to index surgery
* Cardiac transplantation
* Procedures involving insertion ventricular assist device or mechanical circulatory support device
* Procedures not involving a median sternotomy
* Patients previously enrolled and randomised to the CALIPSO trial
Assessment of Self-Collected Sample Compared to Clinician Collected Sample in COVID-19 and Influenza Program

We are trying to see whether a self-collected saliva swab in the home setting is as good as or better than a study clinician-collected anterior nose swab in evaluating whether you are positive for COVID-19 or Influenza A/Influenza B. You may have no symptoms, so you may be positive and capable of spreading the infection to others and you don't know it. Knowing whether you are positive is important because you would have to quarantine and not go out to prevent spreading the infection to others.

In some research studies, saliva has been shown to be as good as or even better than an anterior nares or nasopharyngeal specimen in detecting SARS-CoV-2; we are interested in making sure that is the case. Being able to collect a specimen at home and mail it in would help with patient compliance and would reduce the need for clinicians (nurses or other health care professionals) to use personal protective equipment (PPE), which is in short supply. Also, people would not have to go to a healthcare facility or other testing site to have the COVID-19 or the Influenza A/Influenza B testing done. We are using a sensitive method (RT-PCR) to look for the three viruses.

Once you have had the anterior nose swab collected by the study clinician, your participation would last only as long as it takes to complete the self-collected saliva collection and return the sample to the researchers. The self-collection of the saliva specimen should be collected as soon as possible after the collection of anterior nares and saliva samples by the clinician You will mail in the saliva swab in a prepaid mailer no later than 10 days after sample collection and the result will be available within one day of our lab receiving the swab. Once our lab receives your specimen, the gift card which you received will be activated and your participation will be complete. Biocerna, LLC (Fulton, Maryland), is the commercial laboratory to which the research subjects' samples will be shipped and tested.

We anticipate approximately 500 subjects will be enrolled. You qualify because you live in a location which is reporting an increased number of COVID-19 positive cases. Incidence of Influenza A/Influenza B is also useful to track to find out whether social distancing and/or wearing masks decreases the number of Influenza A/Influenza B cases during the winter months.

Eligibility Criteria:
Inclusion Criteria: Patients will qualify because they live in a location which is reporting an increased number of COVID-19 positive cases. Incidence of Influenza A/Influenza B is also useful to track to find out whether social distancing and/or wearing masks decreases the number of Influenza A/Influenza B cases during the winter months.

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Exclusion Criteria:

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Postamputation Pain: Peripheral Mechanisms

Stump and phantom pain after amputation are common, but the responsible mechanisms are still not clarified. It has been suggested that phantom limb pain can be reduced by regional anaesthesia and in several recent studies, pain was reduced following intrathecal and intraforaminal blocks. In this study, the investigators want to investigate if spontaneous and evoked pain in amputees will be relieved by regional nerve blocks involving the damaged nerves.


Eligibility Criteria:
Inclusion Criteria:

* Amputees with chronic amputation pain (stump or phantom pain) 3 or above on NRS (numerical ratio scale).

Exclusion Criteria:

* Severe somatic or psychiatric diseases
* Other peripheral neuropathy
* Lack of ability to cooperate to the clinical examination
* Allergy to Lidocaine or similar analgetics
Effect of Menstrual Cycle on the Manual Dexterity of Female Dentists

The aim of this observational study was to investigate the effect of the menstrual cycle on the manual dexterity of female dentists.

This study was conducted to answer the following question:

- Is there any effect of the menstrual cycle on the manual dexterity of female dentists?


Eligibility Criteria:
Inclusion Criteria:

* All participants were nulliparous female dentists having a regular menstrual cycle which was confirmed by using a calendar of three consecutive menstrual cycles.
* Their ages ranged from 25 to 35 years old.
* Their BMI was within the normal range (18.5 to 24.9 kg/m²).

Exclusion Criteria:

* Pregnant female dentists.
* Irregular menstrual cycle and any type of hormonal therapy that may affect normal hormonal level fluctuation.
* History of either orthopedic or neurologic diseases causing functional defects of hand strength such as fracture, carpal tunnel syndrome, or De-Quervain's syndrome.
* Upper limb or hand surgery.
* History of systemic diseases like diabetes mellitus.
The Impact of Point-of-Care Ultrasound

Point-of-care ultrasound (POCUS) has been found to be useful for aiding in the prediction of fluid responsiveness. It is unknown if trainees can effectively utilize this tool to improve their assessment of fluid responsiveness.

In this prospective, observational study, pulmonary and critical care fellows are asked to make 2 assessments of fluid responsiveness in adults with shock: (1) based on clinical exam alone (Clinical) and (2) after performing a POCUS (Clinical + US). The accuracy of their pre- and post-ultrasound assessments are compared using a bioreactance monitor and passive leg raise test as the gold standard of fluid responsiveness in this study.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 or older admitted to the MICU with a diagnosis of shock while a fellow was on duty.

Exclusion Criteria:

* None
The Effect of Broccoli Sprout Extract and Probiotics for Eradication of Helicobacter Pylori

In Korea, the first-line therapy to treat Helicobacter pylori (Hp) consists of a proton pump inhibitor (PPI) and two antibiotics for one week. But, eradication has become less successful due to low compliance and high resistance to the antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. In vitro study, we previously reported that a broccoli sprout extract containing sulforaphane may prevent lipid peroxidation in the gastric mucosa and play a cytoprotective role in Hp-induced gastritis. Also, several studies suggested that probiotics could be effective for improving Hp eradication rate or reducing adverse events. But, their effect for eradication of Hp is not yet conclusive. The aims of this prospective study is to investigate the efficacy of a broccoli sprout extract containing sulforaphane and probiotics for eradication of Hp, compared with standard triple therapy.


Eligibility Criteria:
Inclusion Criteria:

* Helicobacter pylori infected patients
* Patients with active or healing gastric/duodenal ulcers

Exclusion Criteria:

* prior Hp eradication therapy
* previous gastric resection
* previous use of proton pump inhibitors, bismuth, H2 receptor antagonist or antibiotics within 4 weeks of the study
* Patients who were pregnant or lactating
Differences of Small Airways Function Between Chronic Obstructive Pulmonary Disease(COPD) and Asthma-copd Overlap(ACO)

The purpose of this study is to research the differences of small airways function between subjects with diagnosis of chronic obstructive pulmonary disease(COPD) and asthma-COPD overlap(ACO).The assessment of quality of life is also carried out through questionnaires.

This is a randomized,open-label study to research the differences of small airways function between simple chronic obstructive pulmonary disease(COPD) and asthma-COPD overlap(ACO).Assessment of small airways is conducted at baseline,including forced expired volume in one second(FEV1),forced vital capacity(FVC),peak expiratory flow(PEF),maximum expiratory flow rate at 75% of vital capacity(MEF75),maximum expiratory flow rate at 50% of vital capacity(MEF50),maximum expiratory flow rate at 25% of vital capacity(MEF25),impulse oscillometry,diffusion function,residual volume(RV) and total lung capacity(TLC).Budesonide(160ug) and formoterol(4.5ug) bid will be given to both groups(chronic obstructive pulmonary disease and asthma-COPD overlap) for 3 months.Quality of life is assessed through questionnaires including modified Medical Research Council dyspnoea scale(mMRC),St George's Respiratory Questionnaire(SGRQ) and chronic obstructive pulmonary disease assessment test(CAT).All of the patients will have a follow-up visit after 3 months' treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18 to 80 years-old.
* A diagnosis of chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Disease(GOLD 2018) guidelines are recruited to the chronic obstructive pulmonary disease group.A diagnosis of asthma-chronic obstructive pulmonary disease overlap according to Global Initiative for Chronic Obstructive Disease(GOLD 2018),Global Initiative for Asthma(GINA 2018) and Spanish COPD Guidelines(GesEPOC 2017) are recruited to the asthma-chronic obstructive pulmonary disease overlap group.
* Willing and able to provide written informed consent.
* Willing and able to attend all study visits and adhere to all study assessments and procedures.

Exclusion Criteria:

* Severe comorbidities including unstable cardiac or pulmonary disease or any other medical conditions including unstable ischemic heart disease,unstable cardiac arrhythmia or heart failure,life threatening arrhythmias,etc.
* Recent history of chronic obstructive pulmonary disease exacerbation requiring hospitalization or need for increased treatments for chronic obstructive pulmonary disease within 6 weeks.
Sonography Outcomes Assessment Program for Lower Extremity Deep Venous Thrombosis

Currently, most emergency physicians have limited access to obtaining formal radiology ultrasound studies, particularly overnight. Many are forced to adopt risky and expensive strategies in managing their patients with suspected deep venous thrombosis (DVT) who present during off-hours: for low risk patients, discharging without anticoagulation and arranging for outpatient studies; for moderate to high risk patients, empirically anticoagulating and admitting to the hospital to await definitive testing. If emergency physicians could reliably perform an accurate ultrasound exam for DVT, such risks could be obviated.

This is a prospective, observational cohort study assessing the accuracy of emergency physician diagnosis of proximal DVT using compact ultrasound equipment and a simplified compression technique. The value of color flow doppler and augmentation will also be assessed. Outcomes (sensitivity, specificity, positive likelihood ratio and negative likelihood ratio) will be assessed at 30 days.

Prior to enrolling patients in the study, emergency physicians will undertake a 2 hour training course on the performance of the simplified compression technique for the diagnosis of lower extremity DVT. Emergency physicians will perform the DVT ultrasound exam on study subjects with suspected DVT. Clinical management of the study subjects will not be altered; all subjects will proceed to receive a formal DVT ultrasound study by the radiology department which will serve as the criterion reference for the study.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria:

  1. Presenting signs and symptoms sufficiently suspicious for lower extremity DVT to warrant a formal radiology study in the opinion of the treating physician AND EITHER 2a. Moderate or high pre-test clinical probability of DVT (Wells Criteria) OR 2b. Low pre-test clinical probability of DVT with a positive D-dimer

Exclusion Criteria:

* Exclusion criteria:

  1. Documented lower extremity DVT within the past 60 days
  2. Anatomic abnormality that, in the judgment of the investigator, would preclude imaging of both femoral and popliteal veins on the affected leg (i.e. above-knee amputation or severe scarring from intravenous drug abuse in the inguinal area)
  3. Patient below the age of 18 years.
Impact of Adding Cognitive Behaviour Therapy to Supervised Pilates-based Core Stability Training in Patients With Multiple Sclerosis

To investigate the effect of adding cognitive behaviour therapy to supervised Pilates-based core stability training on balance, walking, fatigue and function in patients with multiple sclerosis

Multiple sclerosis (MS) is characterized by widespread demyelinating lesions and neurodegeneration in the central nervous system, leading to muscle weakness and compromised sensory-motor integration. Muscle weakness predominantly seen in lower extremities and decreased postural control deteriorate physical performance and gait function. Also , respiratory dysfunction and fatigue has been occurred. Optimal trunk control is provided by the somatosensory, motor, and musculoskeletal integrity, which is mostly damaged in MS. Core stability, is defined as the ability to control the position and movement of the trunk on the pelvis to allow optimum power and movement generation, transfer, and control in other segments. A decrease in core stability affects both trunk control and the quality of limb movements due to the kinetic chain in the body. Pilates-based core stability training (PBCST) is a controlled form of exercise used to improve the stabilization of the trunk muscles. The purpose of PBCST is to train the core muscles more effectively by using the basic principles of Pilates integrated into core stabilization exercises and the activation effect of breathing on deep muscles. Transversus abdominis (TrA) activation is crucial in this training. TrA is activated by a feed-forward mechanism of neuromuscular control before sudden spinal loads or limb movements and provides postural adaptation. Thus, effective TrA activation contributes to both distal mobility and postural control by increasing trunk stability (Freeman el al., 2012). We have recently developed a cognitive behavior therapy to explain MS fatigue that integrates the findings across biological and psychosocial research. This model proposes that primary disease factors trigger the initial symptom of fatigue in MS, and the fatigue is perpetuated or worsened depending . fifty patients with MS will be assigned randomly into two equal group; first one will receive cognitive behavioral therapy and pilates and the other will receive pilates only for eight weeks

Eligibility Criteria:
Inclusion Criteria:

* A score of 3.5 or less on the Expanded Disability Status Scale (EDSS) because individuals with an EDSS score greater than 3.5 need more assistance, being less independent.
* Age over 18 years
* All definite multiple sclerosis patients diagnosed as MS according to revised McDonald criteria 2017
* Both males and females were included

Exclusion Criteria:

-Individuals who had orthopedic, neurologic, and psychological problems that accompanied MS that might affect the treatment results-

* serious cognitive problems; performed regular exercise; were involved in another physiotherapy and rehabilitation program related to MS(Kurtzke, 1993)
* Pregnant were not included.
* Individuals who had an exacerbation during the treatment period