cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality During Skin Prick Test

Skin prick testing (SPT) is a cornerstone diagnostic procedure for identifying allergic sensitizations in pediatric patients. Despite being minimally invasive, it often provokes considerable anxiety, fear, and pain, potentially compromising test accuracy due to poor compliance. Virtual Reality (VR) has emerged as a promising non-pharmacological tool for procedural distress management, yet its application in allergy diagnostics remains underexplored.

To evaluate the effectiveness of VR in reducing procedural anxiety, fear, and pain, and in improving compliance in children undergoing SPT.


Eligibility Criteria:
Inclusion Criteria:

* a confirmed history of allergic symptoms related to either environmental or food allergens
* between 4 and 18 years of age

Exclusion Criteria:

* history of seizure disorders,
* motion sickness,
* severe developmental delay,
* non-Italian-speaking patients
* Participants who had used systemic antihistamines or corticosteroids within the past seven days
A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin

The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. Participants will administer tirzepatide or placebo along with their previous glucose lowering medications. The study will last approximately 47 weeks and may include about 23 visits.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with type 2 diabetes mellitus (T2DM) and have been treated with insulin glargine (U100), once daily with or without metformin ≥3 months prior to screening visit.
* Have HbA1c between ≥7.0% and ≤10.5%.
* Have a stable weight (± 5%) for at least 3 months before screening.
* Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²) at screening.

Exclusion Criteria:

* Have type 1 diabetes mellitus.
* Have had chronic or acute pancreatitis any time prior to study entry.
* Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment.
* Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.
* Have an estimated glomerular filtration rate \<30 mL/minute/1.73 m² \[for participants on metformin, estimated glomerular filtration rate \<45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)\]
* Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.
* Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2.
* Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.
Perineural Dexamethasone in Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery

Effect of Perineural Dexamethasone on the Duration of Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery

This study is proposed to explore the effect of perineurial Dexamethasone on the duration of supraclavicular brachial plexus block for analgesia after pediatric ankle surgery.

After hand and wrist surgery, children need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.

The safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

There is considerable research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a massive lack of research regarding children.

In this study, investigators compare different doses of perineural Dexamethasone. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg and 0.05mg/kg added to local anesthetic.

The investigator's goal is to find a dexamethasone dose that is as low as possible but simultaneously covers the need for good pain relief and fast recovery postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* children scheduled for hand/wrist surgery
* body weight \> 5kg

Exclusion Criteria:

* infection at the site of the regional blockade
* coagulation disorders
* immunodeficiency
* ASA= or \>4
* steroid medication in regular use
Effect of the Cervical Interlaminar Epidural Steroid Injection on Quality of Life, Pain and Disability

To evaluate the effect of cervical interlaminar epidural steroid injections on the neuropathic pain, quality of life and disability patients with cervical radiculopathy. After the clinical and MRG evaluations of patients with neck and arm pain, injection was given to eligible patients.

Patients undergone the procedure were evaluated before and after injection for neuropathic pain, quality of life and disability.

Neck and arm pain related to cervical radiculopathy is the second indication for epidural steroid injections after lumbar radiculopathy in the many a pain clinic. In this procedure corticosteroids and local anesthetics were given to the epidural space with fluoroscopy-guided special techniques. The underlying mechanism of action of these epidurally administered medications is not clear and ıt is believed to be due to anti-inflammatory properties of corticosteroids. In addition local anesthetics is thought to be as effective as corticosteroids in spinal pain of various origin. So far, many studies have shown the efficacy of these injections in acute/chronic pain of cervical radiculopathy. Although mixed pain is seen in most of patients, the relationship between pain pattern and treatment response is unclear. This study aims to evaluate the treatment responses of the patients who were diagnosed with neuropathic pain and the patients who weren't by means of LANSS. It is also intended to serach whether the presence of neuropathic pain will help to predict the treatment response or not. In this regard, the patients were evaluated with LANSS, SF-12 and neck pain and disability scale before the procedure. Categorized as the patients with neuropathic pain and the patients without, their treatment responses were compared.

Eligibility Criteria:
Inclusion Criteria:

* Neck pain and / or unilateral arm pain for at least 3 months
* Inadequate response to conservative treatment methods
* Visual analog scale\>5
* Treatment of neuropathic pain:

Patients who received adequate treatment for a sufficient period of time (Gabapentine ( ≥4 wk ve ≥ 1200 mg) or Pregabaline ( ≥4 wk ve ≥ 300mg )) and did not respond adequately

Exclusion Criteria:

* Cervical epidural injection history applied in the last 3 months
* Presence of systemic and / or local infection
* Bleeding diathesis
* Pregnancy
* Presence of a history of allergy to contrast agent and local anesthetic agent
* Systemic inflammatory disease ( rheumatoid arthritis, SLE..)
* Presence of malignancy
* Presence of polyneuropathy, multiple sclerosis or demyelinating nervous system diseases
* Patients with a history of surgical operations for cervical disc hernia and / or spinal stenosis
* Patients with myelomalacia due to spinal cord compression
Identify Predictors That Distinguish Between Tofacitinib Responders and Non-responders Based on Genotype and Cellular and Molecular Profiles From Pinch Biopsies, Blood and Stool Samples

This is a prospective cohort study enrolling ulcerative colitis patients who initiate tofacitinib therapy. Investigators will collect clinical data, blood and stool samples prior to initiation of tofacitinib and, at minimum, monthly after the start of therapy. They will collect tissue from colonoscopies prior to initiation of therapy and within 6 months on therapy. Clinical characteristics and response to treatment will then be associated with genotype, blood immune profiles, stool microbiota, and cellular and molecular profiles of the biopsies to generate a treatment response model. Using predictors identified in our model, we will then attempt to validate the model and findings with the OCTAVE (Pfizer), SPARC (CCF), and RISK (CCF) data.


Eligibility Criteria:
Inclusion Criteria:

* Total mayo score between 6 and 12
* Endoscopic subscore of 2 or 3

Exclusion Criteria:

* Recent use of antibiotic therapy (\<4 weeks)
* Current extreme diet (parenteral nutrition, specific carbohydrate diet).
* Active infection or malignancy.
* Significant underlying liver or renal disease.
Changes of Depression After First-year of Tofacitinib in RA Patients

12-month, single arm, prospective, non-interventional, multi-center study according to Czech legal definitions (Law 378/2007 Sb.).The primary objective of this study is to describe and evaluate the changes of depression level within 12 months from the start of tofacitinib therapy in patients with RA and at least minimal level of depression. Primary goal is to find out if treatment by tofacitinib reduces the depression by at least 10% during 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years.
* Moderate to severe activity of rheumatoid arthritis (DAS28 ≥3.2).
* Patient for whom the physician decision has been made to initiate a treatment with Tofacitinib.
* Patient with at least minimal level of depression (CUDOS questionnaire ≥11 points).
* Capable of understanding and signing a written informed consent form.
* Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study is a requirement for inclusion into this study.

Exclusion Criteria:

* Patients unwilling/unable to fill in printed patient questionnaires.
GB1275 Monotherapy and in Combination With an Anti-PD1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancreatic Adenocarcinoma

This first-in-human (FIH ) study is an open-label, multicenter study that consists of a Phase 1 Dose Escalation/Expansion phase of GB1275 monotherapy or in combination with Anti-PD-1 Antibody or in combination with Standard of Care in Patients with Metastatic Pancreatic Adenocarcinoma followed by a Phase 2 Basket Expansion phase in Patients with Specified Metastatic Solid Tumors

Note: The Phase 2 portion of the study was not initiated.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
* Women of childbearing potential must use an acceptable method of contraception

Phase 1

Subjects with the the following:

* Regimen A and B:

  * pancreatic adenocarcinoma,
  * esophageal adenocarcinoma, or esophageal squamous cell carcinoma, or
  * gastric/gastroesophageal junction adenocarcinoma, or
  * TNBC, or
  * prostate cancer, or
  * colorectal adenocarcinoma, or subjects with tumor types that have progressed after receiving initial treatment benefit rom the last single agent checkpoint inhibitor that is approved for the indication or in combination with standard of care therapy, for example, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, urothelial carcinoma, renal cell carcinoma, and hepatocellular carcinoma, etc.
* Regimen C: newly diagnosed stage IV pancreatic cancer

Phase 2

* Cohort 1: pancreatic cancer.
* Cohort 2: colorectal cancer
* Cohort 3: gastric/GEJ adenocarcinoma

Exclusion Criteria:

* History of another malignancy within 2 years prior to first study drug(s) administration, unless the malignancy was treated with curative intent and the likelihood of relapse is \<5% in 2 years
* Pregnant or nursing
* Known history of testing positive for human immunodeficiency virus (HIV)
* Gastrointestinal (GI) tract disease causing the inability to take oral medication.
* Positive test for Hepatitis B virus surface antigen (HBsAg) or a and/or positive Hep C antibody result with detectable hepatitis C virus (HCV) ribonucleic acid (RNA) indicating acute or chronic infection.

Other protocol-defined inclusion/exclusion criteria will apply
Musculoskeletal Complaints in an Industry

The hypothesis of this study is that there will be a variety of factors influencing the musculoskeletal complaints among workers of different sectors.

Work-related musculoskeletal disorders (WMSDs) account for more than 30% of occupational diseases in the world. In order to organize the strategic actions that will be developed for the prevention of MSDs, it is essential to analyze in advance the peculiar situations of the different sectors of a workplace. The objectives of this study were to determine the prevalence of musculoskeletal complaints among workers in a medium-sized industry by comparing its sectors and to investigate the influence of occupational and non-occupational factors in the increase of complaints.

The Nordic questionnaire was used to asses musculoskeletal symptoms as well as questionnaires about lifestyle and work-related conditions in 185 workers divided into three sectors of an industry (factory - microelectronics, office and logistics)

Eligibility Criteria:
Inclusion Criteria:

* work in the industry

Exclusion Criteria:

* work less than a month in the industry
Limb-Girdle Video Assessment

The purpose of this study is to develop a new remote-based video assessment outcome measure for Limb-Girdle Muscular Dystrophy (LGMD) trials. The overall objectives for this study are: 1. Identify domains and tasks meaningful to participants with a Limb-Girdle Muscular Dystrophy (LGMD) for development of the LGVA, including considerations for subtype heterogeneity and functional subgroup branching; 2. Determine the feasibility and reliability of the LGVA with test-retest of the LGVA Video Capture Manual; 3. Assess and refine the LGVA Video Capture Manual to ensure standardization and incorporate feedback from participants; 4. Collect source material videos using the LGVA Video Capture Manual to support the development of scorecards for the LGVA.

The purpose of this study is to gain insight from people living with an LGMD and gather source material videos to develop and test Limb-Girdle Video Assessment (LGVA), a new outcome measure designed to assess changes in functional abilities of participants in LGMDs clinical trials. The LGVA is being designed as a remote video capture to assess nuanced changes in compensatory movement patterns over time. This study involves two stages. In the concept elicitation stage, the tasks for the LGVA Video Capture Manual will be finalized based on feedback from participants living with an LGMD 2A, 2B, or 2I in various stages of disease progression. After finalizing the LGVA Video Capture Manual, source material videos will be collected to evaluate the feasibility and appropriateness of the LGVA tasks, standardize capture procedures, and inform the development of scorecards for the LGVA.

Eligibility Criteria:
* Person with confirmed diagnosis of an LGMD 2A, 2B, or 2I
* ≥14 years of age at the timing of consent (if age 14 - 17, consent from the parent/ legal guardian is also needed)
* Able to read, speak, and understand English
* Residing in the USA
* Willing and able to complete an electronic survey, which includes questions about personal characteristics and medical history as well as review of tasks
* Willing and able to discuss their experiences as a person living with an LGMD in a group setting
* Willing and able to complete 2 rounds of video capture following instructions in the LGVA Video Capture Manual in a 30-day period
* Willing and able to complete an exit interview to discuss their experiences capturing and recording videos with the LGVA Video Capture Manual
Evaluation of Therapeutic Efficacy in Use of Chamomilla Gel, Chamomilla Infuse and Urea in Radiodermatitis

This study aims to evaluate therapeutics interventions in radiodermatitis in patients with breast or head and neck cancer. The data collect is going to begin after determining the better dose in a dose-response curve that is being conduct now in the same institution. To evaluate the skin reaction will be applied scale of the Radiation Therapy Oncology Group (RTOG) - Acute Radiation Morbidity Scoring Criteria, Common Terminology Criteria for Adverse Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS).

Hypothesis:

Chamomila gel is more effective than urea (usual care); Chamomila infuse is more effective than urea (usual care); Chamomila gel is more effective than chamomila infuse; Chamomila infuse is more effective than chamomila gel; Chamomila gel is as effective than urea (usual care); Chamomila infuse is as effective than urea (usual care); Chamomila gel is as effective than chamomila infuse; Chamomila infuse is as effective than chamomila gel.

Eligibility Criteria:
Inclusion Criteria:

Being an adult, over the age of 18 years old; Owning diagnosis of breast or head and neck cancer; Being first referred to the radiotherapy protocol; Presenting radiodermatitis grades 1 or 2, second RTOG score, in the place where is receiving radiation therapy; No history of previous hypersensitivity reaction to chamomile or any plant of the Asteraceae or Compositae family or Urea; Demonstrate understanding to continue the intervention in their home environment when necessary.

Exclusion Criteria:

Medical prescription, during the process of data collection, some kind of intervention to prevent radiodermatitis
Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018)

The primary objective of this study is to evaluate the efficacy and the safety of ezetimibe (SCH 58235) co-administered with either atorvastatin or simvastatin in participants with homozygous familial hypercholesterolemia (FH).


Eligibility Criteria:
Inclusion Criteria:

* With a diagnosis of homozygous familial hypercholesterolemia
* All females must have a negative pregnancy test prior to study entry. Women of child bearing potential must agree to practice an effective barrier method of birth control for the duration of the study, until one month after treatment.
* Postmenopausal women who are receiving postmenopausal hormonal therapy or raloxifene must be maintained on a stable estrogen (ERT), estrogen/progestin (HRT) or raloxifene regimen during the study period. ERT, HRT or raloxifene cannot be changed during study period.
* Must follow prescribed or stricter diet, and demonstrate completion of Diet Diaries

Exclusion Criteria:

* A history of mental instability, drug or alcohol abuse; or have been treated or are being treated for severe psychiatric illness which, in the opinion of the Investigator, may interfere with optimal participation in the study.
* With underlying disease likely to limit life span to less than 1 year.
* Have previously been randomized in any studies examining ezetimibe
* Pregnant or lactating women.
* With known hypersensitivity or any contraindication to statin therapy.
A Prospective Researcher-led Clinical Study of Neopep-S-based EasyDew MD Regen Cream

This clinical study is conducted prospectively for 3 months after medical device treatment.

It is a comparative clinical study of the leading control group.

Subjects need tissue transplantation to repair skin defects, so partial layer skin transplantation is performed. After proceeding, the patient is no longer subject to exudation. Subjects (and/or legal representatives) have agreed in writing to participate in the clinical study Perform a post-screening test.

Evaluating the screening test results, meeting the selection criteria, and meeting the exclusion criteria those who do not are registered for clinical research.

In the case of the study group among the subjects of the clinical study, whether partial layer skin transplantation was performed or not, Apply an appropriate amount of EasyDew MD Regen Cream twice a day (morning and evening) and can be absorbed well.

The control group is a non-treatment group, and for 3 months after the procedure. General moisturizers that have been used or will be used are available. The control group's Moisturizer is recommended twice a day (morning and evening) on whether skin grafts are collected or not Apply and allow good absorption. After applying medical devices and moisturizers for clinical research, the progress will be observed for 3 months, Subjects are a screening visit (Visit1), the day of medical device application (Visit2), and after medical device application.

Visit the research institution regularly for one month (Visit3) and three months after application (Visit4) for validity and it will be evaluated for safety.

Eligibility Criteria:
Inclusion Criteria:

* adults over the age of 19
* Subjects with partial layer skin transplantation
* There is no evidence of infection in the skin transplant process, and exudate is no longer present a person who does not arise
* Decide to participate in this clinical study arbitrarily and in the written informed consent a person

Exclusion Criteria:

* showing signs of infection requiring antibiotic administration throughout the body or skin transplantation Case
* In situations where the requirements of a clinical study cannot be complied with
* When the researcher's judgment determines that the participation of the study is inappropriate (e.g. Kelloid personality)
Renal MRA Crossover Study Comparing Multihance to Another Contrast Agent

This is an explorative small pilot study comparing two MRA contrast agents, one of which has been on the market for a few years and the other fairly new to the market. Since the study is explorative and designed to provide preliminary information for consideration for a future larger study, sample size is not based on statistical assumptions.


Eligibility Criteria:
Inclusion Criteria:

* Known or suspected renovascular disease based on one of the following criteria:

  * severe hypertension
  * hypertension refractory to standard therapy
  * abrupt onset of moderate to severe hypertension at age \< 35 years
  * normalized blood pressure by an ACE inhibitor in a patient with moderate or severe hypertension
  * unexplained by stable elevation of serum creatinine \> 2Mg/dL
  * positive findings for stenosis from another imaging modality