cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)

The main purpose of this study is to measure how well adults with new-onset gMG (which means they've had generalized disease signs and/or symptoms for less than 1 year) respond to treatment with efgartigimod PH20 SC. The study consists of a treatment period of 51 weeks. The study duration for each participant will be approximately 58 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years when signing the ICF
* Has been diagnosed with gMG of MGFA class II, III, or IV
* Is seropositive for AChR-Ab
* Is treatment-naive for gMG or has been administered AChEI for the treatment of gMG
* Had onset of generalized MG signs and/or symptoms within 12 months before screening; candidates who also had onset of ocular MG signs and/or symptoms within 24 months before screening may be enrolled in the study
* Has an MG-ADL score ≥5

Exclusion Criteria:

* gMG diagnosis of MGFA class I or V
* Underwent a thymectomy prior to screening, except thymectomy for treatment of nonmalignant thymoma prior to the gMG diagnosis
* Prior or current use of any of any systemic corticosteroid therapy or nonsteroidal immunosuppressive therapy for the treatment of gMG
Development of a Laboratory Test for the Detection of a Fluorescent-labeled Urease Inhibitor Marker Attached to Helicobacter Pylori

The aim of this study is to compare the usual rapid urease test (RUT) to a new florescent-labeled urease inhibitor marker to diagnose Helicobacter Pylori.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing gastroendoscopy with suspected Helicobacter Pylori

Exclusion Criteria:

* Patients with active bleeding
* Patients treated with anti-coagulation medication
Dextrose Prolotherapy on Articular Cartilage

Dextrose prolotherapy is a controversial injection therapy in sports medicine. Currently, 25% hypertonic glucose solution is commonly used in clinical practice. Although this method has a certain therapeutic effect, there is still some controversy about the molecular mechanism of dextrose prolotherapy. In the past, it was thought that local stimulation would increase inflammatory reactions such as local leukocyte and macrophage infiltration and restart the "self-healing mechanism." However, some studies have pointed out that this treatment can cause cell apoptosis. In my clinical work, I often perform dextrose prolotherapy. I deeply feel the importance of exploring the detailed mechanism of action of this therapy in order to apply this therapy more appropriately to patients. We believe that the concentration of 25% hypertonic glucose solution should show a stepwise decrease in the joint cavity. Our preliminary cell experiment results using 2-fold serial dilutions of 25% glucose solution showed that 25%, 12% and 6% glucose solution will trigger the apoptosis of chondrocytes, vascular endothelial cells and immune cells, and will also inhibit the expression of the pro-inflammatory factor IL-6. Glucose solution below 3% will not have the effect of inducing apoptosis on cells. We believe that the therapeutic effect of 25% hypertonic glucose solution in the joint cavity may have cell-specific effects as the concentration changes dynamically. Therefore, in this study, we will clarify the therapeutic mechanism of dextrose prolotherapy for arthritis through basic research and clinical specimen analysis. The clinical research part will use clinical synovial fluid specimens to verify the therapeutic mechanism of hypertonic glucose dissolution. The joint pain level assessment of different types of patients (OA and RA) before dextrose prolotherapy (preliminary period), 1 month after treatment (midterm period) and 3 months after treatment (late period) will be collected, and joint effusion will be measured. Further analyze the cell apoptosis and concentration changes of inflammatory response factors in the liquid.

We hope that through this study, we will have a clear understanding of the molecular mechanism of dextrose prolotherapy on joint component cells. This result will have reference value for the more appropriate application of dextrose prolotherapy in the treatment of human cartilage-related lesions.


Eligibility Criteria:
Inclusion Criteria:

* Willing to sign a written consent form
* Adult men and women with arthritis

Exclusion Criteria:

* Pregnant or lactating women
* Septic arthritis
* Those who have undergone joint surgery within 30 days
The Effect of Simulated Obstructive Apnoea and Hypopnoea on Heart Rhythm in Patients With Paroxysmal Atrial Fibrillation

In this randomised controlled cross-over study we will investigate whether intrathoracic pressure changes induced by simulated obstructive apnoea and hypopnoea trigger premature supraventricular and ventricular contractions as well as atrial fibrillation in patients with paroxysmal atrial fibrillation.


Eligibility Criteria:
Inclusion criteria:

* Age 18-75 years
* History of ECG-documented paroxysmal atrial fibrillation within the last 12 months and currently in sinus rhythm
* Informed consent

Exclusion criteria:

* Mental or physical disability precluding informed consent or compliance with the protocol
* Amiodarone or Dronedarone medication
* Previous radiofrequency ablation for atrial fibrillation
* Severe structural heart disease
Glycemic Index/ Load and Mental Disorders

A total of 300 adults would be included in the present cross-sectional study. glycemic index (GI) and glycemic load (GL) would be assessed by using a validated self-administered dish-based semi-quantitative food frequency questionnaire. Validated Iranian versions of Hospital Anxiety and Depression Scale and General Health Questionnaire-12 would be used to assess anxiety, depression and psychological distress.

Frequency of 5 food groups will be asked in dish-based semi-quantitative food frequency questionnaire and they would be converted to grams. GI and GL will be estimated by using international table of GI and GL.

Validated Iranian versions of Hospital Anxiety and Depression Scale and General Health Questionnaire (GHQ)-12 were used to assess anxiety, depression and psychological distress.

Possible score range for anxiety and depression is from 0 to 21. Scores of 8 or higher on either section were considered as the presence of anxiety or depression and scores of 7 or less were considered as normal status. In the present study, participants who got scores of 4 or more from GHQ were considered to have psychological distress.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18-75 years of free-living individuals.

Exclusion Criteria:

* Over or underestimating of total energy intake
* Uncompleted questionnaire (more than 30% of questions)
Detection and Analysis of MBC With Heterogeneous ER Expression

To investigate the treatment pattern and efficacy of MBC patients with ER heterogeneity using a novel convenient way of 18F-fluoroestradiol positron emission tomography/computed tomography (18F-FES PET/CT).


Eligibility Criteria:
Inclusion Criteria:

* Patients received 18F-FES PET/CT in Fudan University Shanghai Cancer Center from 2017-2021.
* Patients had both FES positive (FES+) and negative (FES-) lesions in FES exam.
* Patients received further treatment.

Exclusion Criteria:

* Incomplete medical records.
Qualitative Analysis of Interviews Between Pharmacist and Elderly Patients Treated with Antithrombotics for an Ischemic Stroke.

Cerebrovascular accident is the 2nd leading cause of death and the leading cause of disability in the world. There are brakes and levers of medication adherence in the context of secondary prevention treatment in stroke.

Cerebrovascular accident is the 2nd leading cause of death and the leading cause of disability in the world. The probability of stroke recurrence is high: about 25% the first year , and 30 to 40% in the 5 years following the stroke. Recurrent strokes are responsible for significant disability, institutionalization, major neurocognitive disorders, and death.

In order to reduce the risk of stroke recurrence, multiple secondary prevention strategies have demonstrated their effectiveness, such as the prescription of drugs (in particular statins and antithrombotics), the establishment of a balanced diet, the practice of an activity physical, or even tobacco addiction.

However, the effectiveness of these strategies is optimal if and only if patients adhere to them.

In addition, previous studies have focused on the brakes and levers of medication adherence in the context of secondary prevention treatment in stroke.

In elderly patients, other obstacles could have been identified by specific studies, such as cognitive, sensory, functional disorders or even isolation.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 65 and over
* Patients hospitalized for an ischemic stroke or a recurrence of ischemic stroke, already being treated with an antithrombotic treatment (antiplatelet agent or anticoagulant ) prior to the stroke
* Patients living at home and with a plan to return home.
* Patients who did not object to the study and who gave their consent for the recording of the interview

Exclusion Criteria:

* Patients with cognitive disorders or stroke sequelae that do not allow a semi-directive interview to be carried out (at medical discretion).
* Non-French speaking patients
Molecular Breath Print of COPD Patients With Exacerbations Despite Triple Inhalational Therapy

Determination of specific molecular breath patterns by secondary electrospray ionization mass spectrometry (SESIHRMS) during and 8 weeks after a COPD exacerbation. Furthermore, breath patterns will be assessed for correlation and association with clinical outcomes and treatment.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* age \>= 18 years
* staged according to GOLD recommendations
* GOLD stage 2-4, GOLD ABE classification
* hospitalization due to COPD exacerbation
* subjects adherent to triple inhalational therapy (beta-2-sympathomimetics, anticholinergics, steroids)
* suitable for follow-up assessment
* \<48 hours after initiation of antibiotic therapy or systemic steroid therapy

Exclusion Criteria:

* physical or intellectual impairment precluding informed consent or protocol adherence
* known pregnancy
* congenital defects with direct impact on central metabolism e.g. amino acid metabolism defect
* uncontrolled diabetes (e.g. HbA1c \>11% or Glc \>20mmol/l)
* acute or chronic pulmonary disease other than COPD
* renal failure or renal replacement therapy (GFR \< 15 mL/min)
Comparative Study of Minimally Invasive Surgical Approaches for Total Hip Arthroplasty

Total hip arthroplasty is a method of choice for treating advanced osteoarthritis of the hip and one of the most frequent orthopedic procedures. Of all hip surgical approaches described, the tendency for minimally invasive techniques has been dominated over the last few years due to faster patient mobilization, reduced postoperative pain and need for blood transfusion. Two of the most common approaches used for minimally invasive total hip arthroplasty are: AMIS anterior approach and mini-posterior approach, which is a modification of the standard posterior approach. The purpose of this study is the biochemical, imaging and clinical evaluation of the tissue damage caused by the above-mentioned techniques of minimally invasive total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients that sign the Informed consent
* Patients aged 18 years and over who are going to undergo primary total hip arthroplasty

Exclusion Criteria:

I. Active infection II. Previous hip operation in any leg III. Any kind of operation the past 3 months IV. Obesity (BMI, Body Mass Index \>30) V. Autoimmune diseases or myositis of any etiology VI. Active cancer
Study to Assess the Efficacy and Safety of Dysport® in the Treatment of Chronic Plantar Fasciitis

This study will investigate the hypothesis that the analgesic effect of a single injection of Dysport (200 MU) induces a significant reduction of symptoms in chronic cases of plantar fasciitis.


Eligibility Criteria:
Inclusion Criteria:

* Chronic plantar fasciitis (duration of disorder at least 4 months)
* At least 4 points on the visual analogue scale (0-10) for the most severe pain within the last 48 hours
* At least 2 previous unsuccessful conservative therapies
* Age 18 and older

Exclusion Criteria:

* Rheumatoid diseases (M. Bechterew, chronic polyarthritis, psoriasis-arthritis, para /post-infectious arthritis etc.)
* Previous surgery in the affected area of the foot
* Pre-treatment with Botulinum toxin A (only de novo patients)
* Prohibited concomitant treatment: local injections during the study and 2 weeks prior to start of study
Tumor Bed Hypofractionated IMRT After Surgery for Patients With Single,Large Brain Metastases From Solid Tumor

Investigators designed a study of a multimodality approach: surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach for patients with single, large brain metastases from solid primary tumor

Investigators designed a study to recruit patients with single, large brain metastases from solid primary tumor for a multimodality approach: surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach. The potential advantage of this treatment is to improve local control and to reduce toxicity compared with WBRT or SRS after surgical resection.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Karnosky performance status (KPS) ≥70
* All Solid tumor (esclusion SCLC and Germinal tumors)
* Controlled primary tumor
* Controlled other metastatic site
* Single metastatic lesion at diagnosis
* Lesions ≥ 2.1 cm in maximum diameter (4 cm3), \< 3 cm conditioning mass effect or neurological deficits or massive aedema, unknown primary tumor
* Estimated survival ≥ 3 months.
* Written informed consent

Exclusion Criteria:

* Prior WBRT
* KPS ≤ 70
* Other primary cancer
* Pregnant women
A Study to Evaluate the Effect of Analgesics on a Walking Model of Knee Pain (0000-105)(COMPLETED)

This study will evaluate a walking model of osteoarthritis for use in testing of new therapeutic agents. The primary hypothesis is that participants treated with Naproxen or Ultracet will have lower Pain Intensity (PI) than those treated with Placebo during self-paced walks on Day 3 of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Has osteoarthritis of the knee and primary source of pain is knee
* Females must not be pregnant or nursing and must agree to use birth control throughout the study
* Is willing to limit alcohol and caffeine intake
* Is willing to abstain from smoking during study visits
* Must be able to walk on a treadmill at a pace of at least 1 mile/hour

Exclusion Criteria:

* Has a medical/arthritic disease that would interfere with evaluation
* Is unable to take naproxen or Ultracet
* Has congestive heart failure or angina
* Has a history of stroke
* Has a history of uncontrolled high blood pressure
* Has a history of cancer
* Regularly uses a walker or cane
Quit and Fit: Teen Smoking Cessation

The long term goal of the study entitled "Quit \& Fit" was to revise, evaluate, and disseminate the American Lung Association´s (ALA) teen smoking cessation program called Not On Tobacco (N-O-T), with an added physical activity module. The physical activity module was intended to encourage youth to adopt a more physically active lifestyle. Research showed that physical activity may increase the odds of smoking cessation. The general N-O-T program goals are to help adolescents quit smoking; reduce cigarette use (for participants who are unable to completely quit); increase healthy lifestyle behaviors; and improve life skills such as stress management, decision making, communication, and interpersonal skills. The primary aim of the current research project was to reduce smoking among West Virginia teens. A two-prong secondary aim was to (a) increase participants´ physical activity behavior by supplementing the intervention with a physical activity component and (b) assess the mediating/moderating impact of physical activity on cessation outcomes. If participants quit smoking, the likelihood that they will develop smoking-related diseases is diminished. Participating in this project may aid smoking cessation and therefore improve participants´ health. Research was conducted among 19 of the 123 West Virginia public high schools. 236 teens were recruited to participate in the study over 3 years. This study is a clinical behavioral trial using a 3-group design, with subsequent random assignment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be eligible to participate in this study if they:

  1. Volunteer to participate
  2. Are between the ages of 14-18
  3. Obtain written parental consent•
  4. Provide written assent
  5. Report smoking on at least 1 day in the past 30 days
  6. Speak and understand English •NOTE: Teens ages 18 or older will provide consent rather than assent. Parental consent will not be required.

Exclusion Criteria:

* WV high schools will be excluded from participating in the research study if school enrollment does not meet or exceed 300 students in grades 9-12.
Assessment of Airway in Patients With Acromegaly for Predicting Successful Tracheal Intubation

Acromegaly is associated with increased risk of difficult intubation and its management. The overall incidence of difficult intubation in patients suffering from acromegaly is four to five times more than those without acromegaly.The difficult intubation scenario in these patients can be managed by various methods ranging from awake fiberoptic intubation to tracheostomy. Difficult tracheal intubation accounts for 17% of respiratory-related injuries and results in significant morbidity and mortality in general population. In patients with acromegaly, inability to mask ventilate or intubate can lead to 28% of all anesthesia related deaths. Therefore, the need and importance of airway assessment in patients with acromegaly cannot be overemphasized. Various tests of airway assessment have to be used to assess difficult airway and tracheal intubation in acromegalics.

The investigators aim to assess the various tests of airway assessment affecting the outcome of patients with acromegaly undergoing pituitary surgery and identify which was best suited.

All the patients of either gender, diagnosed as a case of acromegaly scheduled for pituitary surgery will be enrolled. This observational study will be conducted over a period of 3 years. A written informed consent will be taken from all the patients. The clinical diagnosis will be made on the basis of growth hormone (GH) levels and magnetic resonance imaging (MRI) findings. All patients will be evaluated preoperatively, a day before surgery by an independent observer. Airway assessment for difficult intubation will be performed using Modified Mallampati classification in sitting and supine position followed by mouth opening, upper lip bite test, measurement of thyromental, thyrohyoid, sternomental and hyomental distance. Next the length of upper incisors, presence of receding mandible and neck movement will be checked. An associated history of OSA will also be taken in to account for assessing the difficult intubation followed by OSA grading in acromegalic patients posted for pituitary surgery. In situation of difficult tracheal intubation the fiberoptic intubation would be the preferred choice, which is a gold standard.

General anesthesia will be induced with fentanyl 2µg/kg, propofol 2 mg/kg and rocuronium 1mg/kg. After 90 seconds of mask ventilation, laryngoscopy will be performed with an appropriate sized Macintosh laryngoscope and thereafter Cormac lehane grading will be noted. External laryngeal manipulation (ELM) if carried out will be noted. A standard anesthesia protocol will be followed. After completion of the surgery, neuromuscular blockade will be reversed with neostigmine 0.05mg/kg and glycopyrrolate 0.01mg/kg intravenously. Once the patient follows the verbal command and respiratory parameters are satisfactory, endotracheal tube will be removed. All patients will be shifted to neurosurgical ICU for observation and supportive management.

Eligibility Criteria:
Inclusion Criteria:

* Acromegalic patients undergoing surgery

Exclusion Criteria:

* None
Internal Compartment Knee Osteoarthritis: ODRA (Orthosis Distraction and Rotation for osteoArthritis) Made-to-measure Hinged Knee Brace Versus Usual Care.

This is a biomedical study on a medical device. 120 patients will participate in this study and will be split into 2 groups:

* 60 patients in the "usual care" group: these patients will receive the usual care proposed by their doctor for 12 months.
* 60 patients in the "ODRA" group: these patients will wear the ODRA brace for 12 months in addition to their usual care. They will be instructed to wear the brace for at least 6 hours per day, 5 days per week and to take it off during rest periods when lying down.

The distribution of patients in the groups will be randomized. For this study, patients will be followed for 12 months, spread over 3 visits: inclusion visit, follow-up visit at 6 months and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Knee osteoarthritis (defined according to American College of Reumatology criteria):

  * radiological stage II, III or IV according to the Kellgren and Lawrence (KL) classification documented by a radiological examination in the previous 12 months.
  * Predominantly affecting the internal compartment (internal KL stage greater than external KL stage) and symptomatic with a Pain Visual Analogue Scale \> 40/100 on the target side (side with the most symptomatic disease)
* Patients who have provided written consent
* Patients able to understand simple instructions, to read, write, and to give informed consent
* Patients with national health insurance cover

Exclusion Criteria:

* Severe venous insufficiency in the lower limbs
* History of deep venous thrombosis in the lower limbs
* Inflammatory flare of knee osteoarthritis (synovial effusion) on the target side
* Person over 18 under guardianship or unable to provide consent
* Pregnant or breast-feeding women
A Study of LY3871801 in Healthy Asian and Non-Asian Participants

The main purpose of this study is to evaluate the safety and tolerability of LY3871801 when administered as multiple doses in Healthy Asian and Non-Asian Participants. The study will also evaluate the amount of LY3871801 that gets into the blood stream and how long it takes the body to get rid of it in these participants. The study will be conducted in two parts (A \& B). The study will last up to approximately 24 days excluding the screening period.


Eligibility Criteria:
Inclusion Criteria:

* Are Japanese, Chinese, or Non-Asian participants who are overtly healthy as determined by medical evaluation
* Have body weight of \>/= 45 kilograms (kg) \& a body mass index (BMI) in the range of 18.5 to 29.5 kilogram per square meter (kg/m²). The Japanese participants must have a body weight of 45 to 85 kg and a BMI of 18.0 to 29.5 kg/m²

Exclusion Criteria:

* Have known allergies to LY3871801, related compounds, or any components of the formulation, or history of significant atopy
* Have a significant history of or current cardiovascular or heart failure (based on New York Heart Association Functional Classification), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Are females who are lactating or have a positive pregnancy test at screening or Day 1
* Positive for drug or alcohol screen at screening or Day -1
* Smoke more than 10 cigarettes per day