cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

Part 1: To identify Maximum Tolerated Dose (MTD) levels of LEO 43204 after once daily treatment for two consecutive days

Part 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle


Eligibility Criteria:
Inclusion Criteria:

* Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the arm
* Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the extremities or trunk

Exclusion Criteria:

* Location of the treatment area

  * within 5 cm of an incompletely healed wound
  * within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
* Prior treatment with ingenol mebutate gel on the treatment area
* Lesions in the treatment areas that have:

  * atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or
  * recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)
Non-invasive Transcranial Focused Low-intensity Ultrasound Stimulation in Patients With Mild Lewy Body Dementia

A randomized controlled clinical study was conducted in the xuanwu hospital Single Center of Capital Medical University to preliminarily explore the efficacy and safety of transcranial focused low-intensity ultrasound stimulation in the treatment of dementia with Lewy bodies in the early stage, to clarify the effective mechanism and form an effective clinical treatment plan.

This project plans to recruit 20 patients with mild Lewy body dementia.They were randomly divided into transcranial focused low-intensity ultrasound active stimulation group and sham stimulation group. Patients receive treatment three days a week, and the daily treatment time is 20-30 minutes.The duration of treatment is 4-12 weeks. Before treatment, cognitive assessment, resting EEG, head MRI and PET examination of glucose metabolism were completed.Complete the overall cognitive assessment, resting EEG and MRI examination within one week after the treatment, and complete the overall cognitive assessment and PET examination of glucose metabolism at the follow-up 6 months after the treatment.Fill in the treatment side effect scale and adverse event form.Keep the original oral drug dosage unchanged during the treatment process.

Eligibility Criteria:
Inclusion Criteria:

* Male or female DLB patients between the ages of 50-85;
* The psychological evaluation was in accordance with MMSE score of 18-24 (including 18 and 24) and CDR score of 0.5.
* Can cooperate to complete clinical research.

Exclusion Criteria:

* There is a definite history of cerebrovascular stroke, and there are definite symptoms or signs of neurological deficit at the time of onset, and there are corresponding responsible lesions left by neuroimaging。
* Those who have a history of alcoholism, or drug addiction, or neurological diseases such as brain trauma, epilepsy, encephalitis, normal intracranial pressure hydrocephalus, etc. that can cause cognitive impairment.
* Suffering from systemic diseases that may lead to cognitive impairment (such as liver and kidney insufficiency, endocrine diseases, vitamin deficiency).
* Have a history of using antipsychotics for more than five years before diagnosis.
* There are contraindications for head MRI examination.
A Pilot Study of HP802-247 in Dystrophic Epidermolysis Bullosa

This is a pilot study designed to see if HP802-247, an investigational treatment with living human skin cells, helps to heal blisters or wounds in subjects with Dystrophic Epidermolysis Bullosa (DEB). The durability of the skin in healed wounds treated with HP802-247 will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Written consent must be obtained from a parent or legally authorized representative. Assent will be obtained according to local requirements.
* Subjects with a clinical diagnosis of DEB with recurring blisters, ≥ 2 years of age at Screening. Subjects may be of either sex and of any race or skin type provided that their skin color, in the opinion of the Investigator, will not interfere with the study assessments.
* A parent or legally authorized representative must be willing and able to ensure subject is present for all required study visits.
* A parent or legally authorized representative must be able to follow instructions.
* Have an open wound for ≤ 72 hours that:

  * is still open and has not scabbed or crusted over
  * has no dermatologic disease and/or condition in the treatment area (other than DEB with recurring blisters), including active or recent infection (within 7 days) that may be exacerbated by treatment, require treatment with antibiotics / antifungals /antivirals, require a surgical intervention, or cause difficulty with examination
  * is ≥ 4 cm² and ≤ 48 cm2 in total area (open portion)
* Females of childbearing potential (defined as post-menarcheal as documented in the medical history) may participate in the study if they meet all of the following conditions:

  * they are not breast feeding;
  * they have a negative urine pregnancy test at Week 1 Period 1;
  * they agree to undertake scheduled urine pregnancy tests at Week 1 for Periods 1, 2, \& 3 and at study exit
  * they do not intend to become pregnant during the study;
  * they are using adequate birth control methods and they agree to continue using those methods for the duration of the study
* A parent or legally authorized representative must be willing and able to ensure subject is present for all required study visits (for minor subjects)
* A parent or legally authorized representative must be able to follow instructions (for minor subjects)

Exclusion Criteria:

* Contraindications or hypersensitivity to the use of the test article, their components (e.g., aprotinin, fibrinogen), or substances used in the manufacture of the test article (e.g., penicillin, streptomycin, amphotericin B, bovine serum albumin).
* Therapy with another investigational agent within thirty (30) days of the Screening Visit, or during the study.
* Have uncontrolled intercurrent or chronic illness that, in the opinion of the Investigator, would limit compliance with study requirements, represents a potential safety risk, or require treatment with an excluded drug/treatment.
* The Investigator or Medical Monitor may declare any subject ineligible for a valid medical reason.
Variability of Heart Rate as a Marker of Complication of Colorectal Surgery

Heart rate variability reflects the autonomic nervous system on the intrinsic activity of sinus node cells. Sympathetic hyperactivity is an adaptation to stress, while parasympathetic hyperactivity is present at rest. Thus, any variability in the heart frequency rate reflects variations in sympathetic and parasympathetic components in the autonomic nervous system. Failure to return to normal or a reduction in the variability of the heart rate in the postoperative period is correlated with complications in colorectal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients operated for a scheduled colorectal resection due to cancer, diverticulitis, or Chronic Inflammatory Bowel Disease,
* American Society of Anesthesiologists score 1-2
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

* Patient taking antidepressants, antipsychotics, antihypertensive beta blocker type, anti-arythmic or oral contraception
* Uncontrolled diabetes or associated with a neuropathy
* Arrhythmias and conduction disturbances, , coronaropathy and heart failure, kidney failure
* Neuropathies
* Pacemaker or defibrillator
* The subject is participating in another interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
Scoring System for Thyroid Gland Pathologies

Although anamnesis and physical examination remain the place in the evaluation of patients today; laboratory values, imaging methods and pathology results have come to the fore in the decision-making of surgery for patients. As a result of all other criteria, a follow-up decision can be changed in a patient with a single fine needle aspiration biopsy result, or despite all the examinations the investigators have, a clear result cannot be achieved, and patient management may be disrupted. A holistic approach to thyroid gland pathologies is planned thanks to the scoring system that will be created in this study.

In routine clinical practice, the criteria the investigators consider during the pre - op period in patients evaluated due to thyroid pathologies include anamnesis, physical examination, laboratory values, especially thyroid function, thyroid-neck ultrasonographies, fine needle aspiration biopsies, according to which decisions about operation or nonoperative follow-up are made with the patient. The investigators aim to create a common scoring system by taking into account the pathology results of patients who have undergone thyroidectomy and comparing these results with the results of pre-op examination and thus to address patient management in a more objective and comprehensive way.

Eligibility Criteria:
Inclusion Criteria:

* patients who undergone surgery for thyroid gland pathologies

Exclusion Criteria:

* patients who did not want to be involved in the study
* patients who missed in the follow-up period
* pregnant patients
Analysis of Hyperthermia as a Complementary Treatment to Evidence-based Clinical Intervention in Subjects With Carpal Tunnel Syndrome:

This project aims to analyze the use of hyperthermia within a treatment protocol for Carpal Tunnel Syndrome (CTS), as well as to determine the difference between two and three sessions per week. Study participants will be divided into four intervention groups: the first will receive two sessions per week for a period of six months, while the second will receive three sessions per week for the same period. The treatment protocol will consist of therapeutic physical exercise focused on the hand flexor muscles and neural stretching, the application of hyperthermia to the carpal tunnel and adjacent areas, and the use of a night splint. The third and fourth intervention groups will receive the same treatment as mentioned above, but without hyperthermia. The third group will receive three sessions per week, while the second group will receive two sessions per week. Two different types of measurement variables will be used: objective variables will be used to measure hand flexor muscle strength and wrist free range of motion. Subjective variables will also be used through validated questionnaires covering physical activity, perceived functional limitations, upper limb functional assessment, neuropathic pain, and a visual analogue scale for pain perception.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis confirmed by performing an electromyography of Carpal Tunnel Syndrome
* Have not yet received physiotherapy treatment.

Exclusion Criteria:

* Have undergone surgery.
* Those who refuse to participate in this study.
* Patients with muscle atrophy due to CTS.
* Medical conditions that are contraindications for hyperthermia therapy.
Hepatic Effects of Gastric Bypass Surgery

Liver disease in the morbidly obese is thought to occur due to the long-term presence of fat deposits in the liver, resulting in inflammation and scarring of the liver over time, which reduces liver function. However, many of these patients are unaware that their liver is damaged. There is currently no consensus regarding what the long-term effects of gastric bypass surgery are on pre-existing liver disease in morbidly obese patients. This study will determine the long-term effects on the liver after this type of surgical procedure.

Before or on the day of surgery liver function will be determined using the DDG-2001 Analyzer. This monitor is able to detect the concentration of a dye called indocyanine green dye (ICG) when present in the blood stream. A dose of 0.5 mg/kg of ICG will be injected into an IV in the arm. Over approximately fifteen minutes the DDG-2001 Analyzer will determine how quickly the liver removes the dye ICG from the blood stream. This value represents how well the liver is functioning. Blood samples are drawn before injection of ICG to measure liver function using standard liver function tests.

This same routine for injecting ICG and obtaining blood for routine liver function tests will happen one more time, after surgery, once the subject has lost a significant amount of the original weight (60% of excess weight). This amount of weight loss typically occurs between 12 to 18 months after gastric bypass surgery. This second ICG measurement will occur during an outpatient follow-up visit to CCF.

A biopsy will be taken from the liver during surgery. A second biopsy taken after the 60% weight loss will be compared to determine the effect of this surgery on the liver.

Eligibility Criteria:
Inclusion Criteria:

1. BMI \> 40.
2. Documented failed non-surgical treatment for morbid obesity.
3. Ability to undergo long-term follow-up after LGBS.

Exclusion Criteria:

1. BMI \< 40.
2. Subject age \< 18 years.
3. Inability to undergo long-term follow-up after LGBS (living distance \> 300 miles).
4. Patients with known ESLD.
5. Patients found to have evidence of ESLD during preoperative evaluation for LGBS including portal hypertension, ascites, and coagulopathy.
6. Patients with known iodine sensitivity or allergy.
Evaluation of the Palmaz Mach-5 Grooved Bare Metal Coronary Stent System Versus the Palmaz Bare Metal Coronary Stent System in Patients With Symptomatic Ischemic Heart Disease: A Safety and Performance Study

This is a six (6) month, randomized, un-blinded, study to assess the safety and performance of the Palmaz Mach-5 Grooved Coronary Stent System vs. the Palmaz Bare Metal Coronary Stent System.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients of any race greater than or equal to 18 years and of legal consent
2. Patients must be willing to comply with the specified follow-up evaluation schedule
3. Patients who sign an informed consent (signed and dated) prior to any study-related evaluation or procedure.
4. Patients who are willing to undergo a follow-up coronary angiogram and Endovascular Imaging via Optical Coherence Tomography
5. Patients willing to be maintained on Aspirin and Clopidogrel bisulfate (Plavix) for ninety (90) days post procedure.
6. Patients with a de novo coronary lesion causing angina and/or a positive function test
7. Patients who are eligible for percutaneous coronary interventions
8. Low risk NSTEMI defined as patients with ACS, unstable angina, positive cardiac biomarkers and hemodynamically stable as assessed by the Investigator.
9. Patients with an acceptable risk for coronary bypass graft surgery (CABG)

Intra-Procedure Angiographic Criteria:

1. Single de novo target lesion \>50% diameter stenosis by angiography
2. Single target vessel 2.75 to 3.25 mm diameter
3. Lesion length of 14 to 20mm which is suitable for Palmaz Mach-5 Grooved Coronary Stent System or the Palmaz Bare Metal Coronary Stent System.

Exclusion Criteria:

1. Known allergy or sensitivity to cobalt chromium (CoCr) alloy or its components.
2. Known sensitivity or allergy to aspirin, radiographic contract agents (that cannot be pre-treated adequately).
3. Patients unable to tolerate anticoagulant therapy or antiplatelet therapy.
4. History of bleeding or known coagulopathy.
5. Patients with thrombocytopenia and or neutropenia.
6. More than one stenosis \>50% in target vessel.
7. Lesion in aortic ostium.
8. Left main or LAD, CX lesions within 2-mm from the origin.
9. Ejection Fraction \<45%.
10. STEMI in evolution.
11. Disabling stroke within previous 30 days.
12. Patients currently enrolled in another Investigational device or drug study.
13. Previous enrollment in this study.
14. Women who are currently pregnant. (A negative pregnancy test for female subjects of child bearing potential is required within 24 hours of procedure.)
15. Known or suspected active systemic infection.
16. Evidence of severe or uncontrolled systemic diseases, including chronic renal insufficiency, or any condition which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)

The purpose of this 2-year extension study is the evaluation of the efficacy and safety

1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response \[CRR\] or partial renal response \[PRR\]) on double-blind treatment at the end of the SIRIUS-LN core study, and
2. of open-label ianalumab 300 mg treatment in patients who, at the end of the SIRIUS-LN core study, were either already receiving ianalumab open-label treatment or did not meet CRR/PRR criteria on double-blind treatment at the end of the SIRIUS-LN core study.

The SIRIUS-LN extension study is a 2-year open-label extension study for participants who have completed the treatment periods (blinded Treatment Period-1 and blinded Treatment Period-2) of the SIRIUS-LN core study on double-blind or open-label study treatment.

Investigators will use their clinical judgment to decide if it is beneficial for participants to continue with the extension study. In this extension study participants who achieve CRR or PRR status at Week 140 will be withdrawn from study treatment and will maintain the SoC medication as required. These 2 additional years in the extension study will allow to measure sustained remission, flares and safety off-study treatment. However, in the event of renal flares during the extension study, these participants who withdraw study treatment will have the option to receive open-label ianalumab.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent prior to participation in the extension study.
2. Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on double-blind or open label study treatment.

Exclusion Criteria:

1. Use of prohibited therapies
2. Pregnant or nursing (lactating) women.
TraceBook: the Clinical Proof of Concept on the Intensive Care.

The effectiveness of current checklists is hampered by lack of acceptance and compliance. Recently, a new type of checklist with dynamic properties has been created to provide more specific checklist items for each individual patient. The proof of concept of this dynamic clinical checklist (DCC; BJA 2017 (DOI: 10.1093/bja/aex129)) was tested in a simulation trial with improved outcomes and high acceptance scores. The purpose of this study is to investigate if the outcomes of this real-life clinical proof of concept study are similar with the outcomes of the simulation trial for the intensive care unit (ICU) ward.

Method A prospective single center (Catharina Hospital Eindhoven) controlled before-and-after study.

The before period will be used as control group in which ward rounds and nurse handovers will be observed by the investigators for two months. Then TraceBook will be introduced and clinicians, ICU doctors and nurses, will be able to use checklists of TraceBook for ward rounds, their shifts and handovers in which they will be observed for two months. The goal is at least 120 observations per period.

Endpoints The primary outcome is the percentage of items that were checked per ward rounds and nurse handovers during the before and the after implementation period. Secondary outcomes will be clinical outcomes of admitted patients, pharmacist specific outcomes, specific checkable item related outcomes, and user experience and acceptance scores.

Hypothesis TraceBook, with the use of digital dynamic checklists, improves compliance to care processes on the intensive care with a high user acceptance score.

Eligibility Criteria:
Inclusion Criteria:

* Physicians working on the ICU
* All admitted patients on the ICU during the study periods.

Exclusion Criteria:

* Physicians objecting participation in the trial
Effects Of Optimized Blinking Training on Visual Function and Tear Film Parameters in Individuals With CVS

"Computer vision syndrome (CVS), refers to a range of eye and vision issues caused by extended use of computers, tablets, e-readers, and smartphones. Computer users experience visual symptoms, such as eyestrain, headaches, eye discomfort, dry eyes, double vision, and blurred vision, especially after long periods of looking at screens, whether up close or at a distance.

Individuals will be randomly assigned to either an experimental group (group A) receiving OBT with routine rehabilitation CVS management 20-20-20 rule, blue light-blocking glasses, and polyvinyl alcohol eye drops or a control group (group B) receiving only routine rehabilitation, including the 20-20-20 rule, blue light-blocking glasses, and polyvinyl alcohol eye drops. OBT consisted of structured blinking exercises performed thrice daily for three months. Objective outcomes, including tear film parameters and visual function using subjective Computer Vision Syndrome Questionnaire (CVS-Q) shall be evaluated. The collected data will be analysed by using SPSS."

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18-40 years who work on computers or digital devices for at least 3 to 6 hours daily.
* Both Male and Female.
* Individuals who could undergo a complete ocular examination.
* Presence of symptoms consistent with digital eye strain.
* Presented with eye complaints such as eye fatigue, burning, irritation, redness, and blurred vision due to long-term computer or digital screen use.
* Symptoms worsened during exposure to digital screen light.

Exclusion Criteria:

* Use of medications that might influence tear production or ocular surface status (e.g., antihistamines, antidepressants).
* Diagnosed neurological or systemic conditions that impact vision or blink patterns (e.g., Parkinson's disease, multiple sclerosis).
* Individual's with a history of ocular surface diseases such as conjunctivitis or keratitis.
* History of any psychiatric diagnosis."