cyrilzakka/clinical-trials huggingface dataset:
Study of INS115644 Ophthalmic Solution in Subjects With Ocular Hypertension or Glaucoma

The purpose of this trial is to evaluate the safety and tolerability of INS115644 Ophthalmic Solution in subjects with bilateral ocular hypertension or early primary open angle glaucoma and to investigate the intraocular pressure lowering effects of INS115644 Ophthalmic Solution.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of bilateral ocular hypertension or early primary open angle glaucoma
* Have best corrected visual acuity in both eyes of at least +0.5 or better
* Have normal endothelial cell counts and morphology

Exclusion Criteria:

* Are diagnosed with closed angle glaucoma, exfoliation syndrome or exfoliation glaucoma, and pigment dispersion or secondary glaucoma
* Have a history of any type of intraocular surgery, except for cataract surgery
* Have had cataract surgery within three months
Post Marketing Surveillance (PMS) Study of Ryzodeg™ (Insulin Degludec/Insulin Aspart) in Patients With Diabetes Mellitus in Routine Clinical Practice in India

This study is conducted in Asia. The aim of this study is to evaluate long term safety and efficacy in patients with diabetes mellitus in routine clinical practice in India.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any study-related activities. (Study-related activities are any procedures that are related to recording of data according to the protocol). The historical data including the data before informed consent obtained (e.g., HbA1c (Glycated Haemoglobin ), FPG (Fasting Plasma Glucose), PPPG (Postprandial Plasma Glucose), severe hypoglycaemia before the start of Ryzodeg™ therapy) can be used for baseline data
* Patients with insulin requiring diabetes mellitus and who are scheduled to start treatment with Ryzodeg™ based on the clinical judgment of their treating physician

Exclusion Criteria:

* Known or suspected allergy to Ryzodeg™ any of the active substances or any of the excipients
* Previous participation in this study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Patients who are or have previously been on Ryzodeg™ therapy
* Patients who are participating in other studies or clinical trials
* Patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months
Surgical Apgar Score in Clinical Practice: a Pilot Study

Background Surgeons lack a routine, objective evaluation of patient condition after surgery. We currently rely on subjective assessment of available patient data. The current scoring methods such as Acute Physiology and Chronic Health Evaluation and Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity are complex and cumbersome and have therefore not been adopted into routine practice.

The Surgical Apgar Score (SAS) is a simple score on a scale of 0 to 10 calculated from 3 parameters collected during the operation: lowest heart rate, lowest blood pressure, estimated blood loss (Regenbogen et al., Arch Surg 2009).

Previous validation studies have shown a good correlation between the score and incidence of major complications or death occurring within 30 days. For example, 75% patients with a score of 0-2 had major complications, whereas it was only 5% in those with a score of 9-10. To date, the SAS has never been clinically applied and tested in a trial.

We believe that routine use of the SAS will lead to a reduction in major complications and deaths after surgery. We also believe that it will lead to a reduction in the severity of the complications.

This is based on our theory that the SAS eliminates the guesswork. Using this score will add objectivity and clarity to clinical decisions that are presently based on clinical instinct or 'gut feeling'. The score will more clearly highlight those patients who are at an increased risk of developing complications or dying and will flag them up for increased monitoring, a higher index of clinical suspicion and a lower threshold for early management of problems.

Primary Aim The primary aim of the pilot is to strengthen the design and assess the feasibility of the main study on the SAS. We aim to recruit 100 patients in each group, 200 in total. The primary aim of the main study will be to establish if clinical application of the SAS leads to a reduction in 30-day post-operative morbidity and mortality.

Study Design The design of this pilot is the same as what the main trial will eventually be: a multicentre single-blind randomised controlled trial (RCT). Current data suggests the overall expected major complication or death rate in our target population would be 21%. The sample size of the future RCT is therefore estimated to be 986 each group to detect a 5% reduction in complications (Significance 0.05%, Power 80%).

Outcomes Our primary outcome will be major complications or death within 30 days of operation. Our secondary outcomes (all within 30 days of operation) will be minor complications, primary and secondary critical care admissions and length of stay, duration of therapeutic antibiotics, number of additional operations under general anaesthetic to treat complications, and overall length of stay.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18y+)
* General or vascular surgery
* Elective or emergency surgery
* Routine outpatient follow-up required

Exclusion Criteria:

* Those without capacity to consent to involvement in the trial
A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).

The primary efficacy objective is to assess the effect of BLU-5937 on 24-hour cough frequency in adults with refractory chronic cough (including unexplained chronic cough) at 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Capable of giving signed informed consent
* Refractory chronic cough (including unexplained chronic cough) for at least one year
* Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose

Exclusion Criteria:

* Current smoker/vaper (all forms of smoking and inhaled substances, including , cannabis/tobacco smoke and nicotine vapors) or individuals who have given up smoking within the past 6 months, or those with \>20 pack-year smoking history
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, idiopathic pulmonary fibrosis or uncontrolled asthma
* Respiratory tract infection within 4 weeks before screening
* Laboratory confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection at screening
* History of malignancy in the last 5 years
* History of alcohol or drug abuse within the last 3 years
* Has a positive serologic test for human immunodeficiency virus (HIV), hepatitis B virus surface antigen, or hepatitis C virus.
* Previous participation in a BLU-5937 trial
Effectiveness of the Suboccipital Inhibition Technique in Patients With Mechanical Neck Pain

The project is based on checking the effectiveness of the technique of suboccipital inhibition in patients with mechanical neck pain. Suboccipital inhibition technique involves the placement of the hands of the physiotherapist under the patient's head so that fingers can feel the spinous processes of the cervical vertebrae. Then the fingers slowly leads upward to contact the occipital condyles. At this point the investigator should gently move your fingers down, finding the space between the condyles and the spinous process of the axis. Then, flexing the metacarpophalangeal joints at 90 degrees, slowly raises the skull. In this technique the investigator would be carrying out the relaxation of the suboccipital muscles: lower rectus capitis posterior, superior oblique head straight back and head higher. It is a technique used very often but without knowledge about the time needed for implementation. In several studies that have used the technique it has been maintained for 2.4 or 10 minutes without agreeing how long is necessary. The study will consist of three groups formed by patients with mechanical neck pain that they applied the technique two, four or ten minutes and a control group of patients with mechanical neck pain. The four groups were measured before and after treatment the pain threshold to pressure by algometer and conduct the test repositioning of the head to show any changes after application of the technique.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women of full age .
2. ≥ 15/50 rating in the Neck Disability Index
3. Participants with good adhesion to the study .
4. Participants who have signed informed after appropriate informed consent.

Exclusion Criteria:

1. Cancer , inflammatory , infectious , vascular , neurological and metabolic processes.
2. Patients who are under medical treatment.
3. Patients with psychiatric illnesses.
4. Women : pregnancy.
5. Patients who have not signed the informed consent.
Efficacy and Safety of Heparin-grafted Membrane for CRRT

The investigators hypothesize that the use of heparin-grafted membrane versus conventional membrane in critically-ill patients with bleeding-risk undergoing continuous renal replacement therapy, will effectively prolong the circuit lifespan, without worsening of the systemic APTT or underlying bleeding risk.

Aims and objectives:

We aim to compare the performance and safety of heparin-grafted AN69 membrane (oXiris, Gambro) with the conventional AN69 membrane (M150, Gambro) without systemic anticoagulation during continuous renal replacement therapy (CRRT), in critically ill patients with acute kidney injury (AKI) admitted to the intensive care unit (ICU), who has moderate bleeding risk and in whom systemic anticoagulation is contraindicated.

Eligibility Criteria:
Inclusion Criteria:

Adult patients (age 21 and above) who are admitted to ICUs or CCU and requiring CRRT for acute kidney injury or ESRD Patients who has moderate bleeding risk (see below definitions) Patients with NO systemic or regional circuit anticoagulation Informed consent taken from the patient, or proxy if the former is unable to sign due to medical reasons Anticipated need for prolonged CRRT \> 3 days

(Moderate bleeding risk criteria:)

Moderate bleeding risk is defined by any of the following:

1. Platelet count \< 100 x 109 mm3 (but \> 50)
2. INR \> 1.5 (but \< 2.5)
3. APTT \> 50 seconds (but \< 75)
4. Post-surgery for \< 48 hours
5. Post-invasive procedures (eg. Pericardiocentasis) \< 24 hrs
6. Post major artery puncture or catheter removal from major arteries (carotids, subclavian, or femoral) \< 24 hours
7. Recent internal or gastrointestinal bleeding within 48 hours (should be secured bleeding with no relapse noted)

Exclusion Criteria:

Patients with very high bleeding risk (for which they should also fall outside of the below inclusion criteria - see below) Patients who are known to have heparin-induced thrombocytopenia or allergic to heparin Patients with other medical conditions for which heparin is contraindicated. Patients who require systemic anticoagulation for medical indications (We will accept patients who are on prophylactic doses of anticoagulation for DVT prophylaxis) Patients who are pregnant Patients/legally accepted surrogate who decline to consent
A Deep Learning Approach to Submerged Teeth Classification and Detection

Objectives: The study aimed to compare the success and reliability of an artificial intelligence application in the detection and classification of submerged teeth in orthopantomography (OPG).

Methods: Convolutional neural networks (CNN) algorithms were used to detect and classify submerged molars. The detection module, which is based on the state-of-the-art Faster R-CNN architecture, processed the radiograph to define the boundaries of submerged molars. A separate testing set was used to evaluate the diagnostic performance of the system and compare it to the expert level.

Results: The success rate of classification and identification of the system is high when evaluated according to the reference standard. The system was extremely accurate in performance comparison with observers.

Conclusions: The performance of the proposed computer-aided diagnosis solution is comparable to that of experts. It is useful to diagnose submerged molars with an artificial intelligence application to prevent errors. Also, it will facilitate pediatric dentists' diagnoses.

Pre-processing, Training, and Classification The study was conducted with balanced data sets. The case and control data sets were randomly divided into two parts, the training group (27 case group/27 control group) and the test group (10 case group/10 control group) to prevent the use of the visuals in the training group for retesting. The testing data set was not seen by the system during the training phase.

All 2943-by-1435 pixel images in the data set were resized to 971 by 474 pixels prior to training. All OPG images used include the whole dentitions. The training and test data sets were used to estimate and generate weight factors for the optimal CNN algorithm. An arbitrary sequence was generated using open-source Python programming (Python 3.6.1, Python Software Foundation, Wilmington, DE, USA, https://www.python.org/) language and OpenCV, NumPy, Pandas, and Matplotlib libraries. In this study, Tensorflow for model development was used to classify submerged primary molars. InceptionV3 architecture was used as transfer learning, and the transfer values were saved in the cache. Then, fully connected layer and softmax classifiers were combined to form the final model layers. The training was carried out using 7000 steps with 16G RAM and a PC equipped with NVIDIA GeForce GTX 1050.

Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:

OPG images of poor quality (metal artifact, artifacts due to position errors during shooting, etc.) were excluded.
Physical Condition and Self-efficacy in People With Fall Risk

Middle-aged or older people with fall risk were assessed and invited to a multidisciplinary falls prevention program. This program consisted on an adapted exercise program.

Two sessions per week were performed, during 6 weeks supervised by a physiotherapist.

At the end of this program, measures of physical condition and of self-efficacy were repeated to determine its related-effect.


Eligibility Criteria:
Inclusion Criteria:

* Fall Risk (Morse scale)

Exclusion Criteria:

* Had no capacity to walk independently
Efficacy of Acyclovir in Combination With a Glucocorticosteroid on UV-Induced Herpes Labialis

The primary objective was to compare the efficacy of ME-609 cream vs placebo cream on the time to healing (loss of hard crust) of delayed classical herpes labialis (HSV) lesions experimentally induced after ultra violet radiation (UVR) exposure.

The primary objective was to compare the efficacy of ME-609 cream vs placebo cream on the time to healing (loss of hard crust) of delayed classical herpes labialis (HSV) lesions experimentally induced after ultra violet radiation (UVR) exposure. Secondary objectives were to compare the time to normal skin, incidence of lesion development (number and type of lesions), maximum lesion size, length of lesion stages, frequency/severity/duration of pain, frequency/severity/duration of tenderness, redness and/or oedema in the UVR exposed area, frequency of virus positive lesions, time to cessation of viral shedding and safety of ME-609 cream vs placebo cream.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* A history of reactivation of recurrent herpes labialis with overexposure to sunlight in the last 12 months, or 2 or more cold sore lesions in the last 12 months
* Generally healthy as determined by medical history and verbal interview
* Females who were still able to conceive were to have had a negative pregnancy test on enrolment
* Fritzpatrick skin type category of I to IV

Exclusion Criteria:

* Previous inclusion in this study

  * Participation in clinical investigational drug studies in the 4-week period prior to enrolment
  * Participation in any herpes UVR reactivation study within the previous 3 months
  * Previous herpes vaccination at any time
  * Occurrence of herpes labialis (end of episode) within one month prior to enrolment
  * Inflammatory, congenital or iatrogenic underlying immunodeficiency disorders
  * Use of topical steroids in or near the face or on the forearms, systemic steroids (within 30 days from enrolment) or anti-inflammatory drugs (within 10 days from enrolment)
  * Women who were pregnant, lactating or breast feeding
  * Women of child bearing potential not using adequate contraception as judged by the investigator
  * Recent history of alcohol or drug abuse which in the opinion of the investigator could interfere with compliance
  * Significant skin disease such as atopic dermatitis or eczema, that would interfere with the assessment of lesions
  * Allergy or hypersensitivity to steroids, acyclovir, penciclovir and/or other nucleoside analogues
  * Administration of any drug commonly associated with photosensitivity (tetracycline, Retin A) within one week of UVR exposure
  * Any antiviral therapy within 14 days prior to enrolment
  * History of allergy or sensitivity to sunscreen
  * History of herpes keratitis
Clinical Investigation of the Medtronic EnTrust™ Implantable Cardioverter Defibrillator (ICD), Model D153ATG

People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD). An ICD is implanted surgically just under the skin in the upper chest area and it sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm.

The purpose of this study was to evaluate the safety and efficacy of the EnTrust ICD device. A feature of this device allows it to send small, painless electrical impulses (Anti-tachycardia pacing or ATP) to the heart instead of shocking it out of a rhythm that is too fast. Stopping a dangerous heart rhythm this way does not cause any pain whereas a shock to the heart can feel like a punch in the chest. This device also allows the heart to beat on its own when it can and helping it (by pacing, or sending it electrical signals) when it needs help. This feature is important because previously studies have shown that pacing the heart too often can increase the risk for heart failure or for atrial fibrillation (having too rapid of heart beats in the atrium).

This study is now complete and the device has since been approved by the FDA.


Eligibility Criteria:
Inclusion Criteria:

Subjects with failure but no symptoms (NYHA Class I) or subjects with mild heart failure that only sometimes interferes with daily activities (NYHA Class II)

Subjects who have, or are risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD)

Subjects who have, or are at risk of developing, rapid beats in the upper chambers of the heart (atrial tachyarrhythmias)

Exclusion Criteria:

Subjects with rapid heart beats in their ventricles (lower chambers of the heart) associated only with reversible causes

Subjects with mechanical tricuspid heart valves (A structure in the heart, located between the right atrium and right ventricle, which allows blood to flow down from the atrium into the ventricle.)
The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

The purpose of this study is to determine if FDA approved food safety guidelines are equivalent to a low bacterial diet (the neutropenic diet) with respect to the acquisition of infections during neutropenia in a sample of pediatric cancer patients.

Historically, many interventions have been tried to reduce the incidence of infection by reducing patients' exposures to potential pathogens. The neutropenic diet is one such intervention that was intended to reduce the introduction of bacteria into the host's gastrointestinal tract. This diet excludes foods considered to be high risk for bacterial colonization, especially raw fruits and vegetables. The only studies evaluating this diet have used this intervention in combination with germ free environments, which have been phased out of practice, and the independent effect of this diet remains unknown. In addition, pediatric oncology patients suffer significant gastrointestinal side effects secondary to cancer therapy, which are likely to affect their satisfaction with this dietary regimen. Qualitative data in these children suggests that decreased pleasure from food is a major concern for them and preliminary data on the neutropenic diet showed that although patients were able to stick to it, they found it difficult. The Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) offer more liberalized food safety guidelines for immunocompromised patients. We hypothesize that the neutropenic dietary restrictions offer no advantage over the FDA and CDC endorsed food safety guidelines and that the food safety guidelines will afford patients an improved quality of life through increased choice and control over their diet. The results of this study could potentially modify clinical practice to improve the quality of life of these patients without adverse effects on their rate of infection. Furthermore, the allowance of fresh fruits and vegetables back into the diets of these patients may have a positive impact on their health.

Eligibility Criteria:
Inclusion Criteria:

1. Patients between the ages of 1 and 30 years with:

   * Acute lymphoblastic leukemia/lymphoma
   * Malignant brain tumor
   * Non-CNS solid tumors
   * Acute myeloblastic leukemia
   * Non-Hodgkin's lymphoma Hodgkin's disease
   * Head and Neck tumors
2. Patients MUST also be ready to receive a cycle of chemotherapy that predictably renders neutropenia at least 70% of the time OR has a risk of febrile neutropenia of at least 20%. This can be any cycle number, it does NOT need to be the FIRST cycle of chemotherapy they are to receive.

Exclusion Criteria:

* Patients receiving myeloablative chemotherapy in preparation for allogeneic or autologous bone marrow or stem cell transplant.
* Co-morbidity with immunosuppressive disease such as AIDS.
* Asplenia.
* Patients with documented infection at time of enrollment.
* Patients who are not fed orally (G-tube dependant, TPN-dependant).
* Patients actively receiving radiation to the brain or gastrointestinal tract for sarcoma.
Intravenous Artesunate and Malaria

Intravenous artesunate is egual to quinine in the treatment of severe malaria

Intravenous artesunate is egual to quinine in the treatment of severe malaria in the form of fever clearance time and parasite clearance time

Eligibility Criteria:
Inclusion Criteria:

severe P.falciparum malaria-

Exclusion Criteria:

mixed infection Pregnant women -
Rates and Risk Factors of Contact Between the OTX-TIC Intracameral Ocular Implant and Corneal Endothelium

To determine what proportion of patients have inferior angle recess dimensions that could accommodate the OTX-TIC, and what are risk factors for implant contact with the corneal endothelium.


Eligibility Criteria:
Inclusion Criteria:

* Age over 40 years
* No history of ocular surgery other than cataract surgery

Exclusion Criteria:

- Media opacities that preclude OCT imaging of the anterior segment